[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
GULF WAR EXPOSURES
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH
of the
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
JULY 26, 2007
__________
Serial No. 110-38
__________
Printed for the use of the Committee on Veterans' Affairs
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COMMITTEE ON VETERANS' AFFAIRS
BOB FILNER, California, Chairman
CORRINE BROWN, Florida STEVE BUYER, Indiana, Ranking
VIC SNYDER, Arkansas CLIFF STEARNS, Florida
MICHAEL H. MICHAUD, Maine JERRY MORAN, Kansas
STEPHANIE HERSETH SANDLIN, South RICHARD H. BAKER, Louisiana
Dakota HENRY E. BROWN, Jr., South
HARRY E. MITCHELL, Arizona Carolina
JOHN J. HALL, New York JEFF MILLER, Florida
PHIL HARE, Illinois JOHN BOOZMAN, Arkansas
MICHAEL F. DOYLE, Pennsylvania GINNY BROWN-WAITE, Florida
SHELLEY BERKLEY, Nevada MICHAEL R. TURNER, Ohio
JOHN T. SALAZAR, Colorado BRIAN P. BILBRAY, California
CIRO D. RODRIGUEZ, Texas DOUG LAMBORN, Colorado
JOE DONNELLY, Indiana GUS M. BILIRAKIS, Florida
JERRY McNERNEY, California VERN BUCHANAN, Florida
ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota
Malcom A. Shorter, Staff Director
______
SUBCOMMITTEE ON HEALTH
MICHAEL H. MICHAUD, Maine, Chairman
CORRINE BROWN, Florida JEFF MILLER, Florida, Ranking
VIC SNYDER, Arkansas CLIFF STEARNS, Florida
PHIL HARE, Illinois JERRY MORAN, Kansas
MICHAEL F. DOYLE, Pennsylvania RICHARD H. BAKER, Louisiana
SHELLEY BERKLEY, Nevada HENRY E. BROWN, Jr., South
JOHN T. SALAZAR, Colorado Carolina
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
hearing records of the Committee on Veterans' Affairs are also
published in electronic form. The printed hearing record remains the
official version. Because electronic submissions are used to prepare
both printed and electronic versions of the hearing record, the process
of converting between various electronic formats may introduce
unintentional errors or omissions. Such occurrences are inherent in the
current publication process and should diminish as the process is
further refined.
C O N T E N T S
__________
July 26, 2007
Page
Gulf War Exposures............................................... 1
OPENING STATEMENTS
Hon. Phil Hare................................................... 1
Prepared statement of Congressman Hare....................... 42
Hon. Jerry Moran................................................. 2
Hon. Henry E. Brown, Jr.......................................... 2
Prepared statement of Congressman Brown...................... 42
WITNESSES
U.S. Department of Veterans Affairs:
James Binns, Chairman, Research Advisory Committee on Gulf
War Veterans' Illnesses.................................... 20
Prepared statement of Mr. Binns.......................... 57
Lea Steele, Ph.D., Scientific Director, Research Advisory
Committee on Gulf War Veterans' Illnesses, and Associate
Professor, Kansas State University......................... 21
Prepared statement of Dr. Steele......................... 59
Lawrence Deyton, MSPH, M.D., Chief Public Health and
Environmental Hazards Officer, Veterans Health
Administration............................................. 32
Prepared statement of Dr. Deyton......................... 61
______
Mikolajcik, Brigadier General Thomas R., USAF (Ret.), Mt.
Pleasant, SC................................................... 4
Prepared statement of Brigadier General Mikolajcik........... 43
Nass, Meryl, M.D., Internist and Hospitalist, Mount Desert Island
Hospital, Bar Harbor, ME....................................... 17
Prepared statement of Dr. Nass............................... 51
National Vietnam and Gulf War Veterans Coalition, Denise Nichols,
MSN, Vice Chairman............................................. 9
Prepared statement of Ms. Nichols............................ 47
Veterans of Modern Warfare, Anthony Hardie, Legislative Chair and
National Treasurer............................................. 7
Prepared statement of Mr. Hardie............................. 46
SUBMISSIONS FOR THE RECORD
American Legion, Shannon L. Middleton, Deputy Director, Veterans
Affairs and Rehabilitation Commission, statement............... 72
Brown, Hon. Corrine, a Representative in Congress from the State
of Florida, statement.......................................... 76
Fahey, Dan, San Francisco, CA, statement......................... 76
Miller, Hon. Jeff, a Representative in Congress from the State of
Florida, statement............................................. 83
Stearns, Hon. Cliff, a Representative in Congress from the State
of Florida, statement.......................................... 84
MATERIAL SUBMITTED FOR THE RECORD
Post-Hearing Questions and Responses for the Record:
Hon. Michael H. Michaud, Chairman, Subcommittee on Health,
Committee on Veterans' Affairs, to Brigadier General Thomas
R. Mikolajcik, USAF (Ret.), Mt. Pleasant, SC, letter dated
August 2, 2007............................................. 85
Hon. Michael H. Michaud, Chairman, Subcommittee on Health,
Committee on Veterans' Affairs, to Anthony Hardie,
Legislative Chair and National Treasurer, Veterans of
Modern Warfare, letter dated August 2, 2007 [NO RESPONSE
WAS RECEIVED FROM MR. HARDIE.]............................. 86
Hon. Michael H. Michaud, Chairman, Subcommittee on Health,
Committee on Veterans' Affairs, to Denise Nichols, MSN,
Vice Chairman, National Vietnam and Gulf War Veterans
Coalition, letter dated August 2, 2007..................... 87
Hon. Michael H. Michaud, Chairman, Subcommittee on Health,
Committee on Veterans' Affairs, to Meryl Nass, M.D.,
Internist and Hospitalist, Mount Desert Island Hospital,
Bar Harbor, ME, letter dated August 2, 2007................ 113
Hon. Michael H. Michaud, Chairman, Subcommittee on Health,
Committee on Veterans' Affairs, to James Binns, Chairman,
Research Advisory Committee on Gulf War Veterans'
Illnesses, U.S. Department of Veterans Affairs, letter
dated August 2, 2007....................................... 134
Hon. Michael H. Michaud, Chairman, Subcommittee on Health,
Committee on Veterans' Affairs, to Lea Steele, Ph.D.,
Scientific Director, Research Advisory Committee on Gulf
War Veterans' Illnesses, U.S. Department of Veterans
Affairs, and Associate Professor, Kansas State University,
letter dated August 2, 2007 [NO RESPONSE WAS RECEIVED FROM
MR. DR. STEELE.]........................................... 136
Hon. Michael H. Michaud, Chairman, Subcommittee on Health,
Committee on Veterans' Affairs, to Lawrence Deyton, MSPH,
M.D., Chief Public Health and Environmental Hazards
Officer, Veterans Health Administration, U.S. Department of
Veterans Affairs, letter dated August 2, 2007.............. 137
GULF WAR EXPOSURES
----------
THURSDAY, JULY 26, 2007
U.S. House of Representatives,
Committee on Veterans' Affairs,
Subcommittee on Health,
Washington, DC.
The Subcommittee met, pursuant to notice, at 10:00 a.m., in
Room 334, Cannon House Office Building, Hon. Phil Hare
presiding.
Present: Representatives Hare, Moran, and Brown.
OPENING STATEMENT OF HON. PHIL HARE
Mr. Hare. Good morning. The Subcommittee on Health will
come to order. I would like to thank everyone for coming today.
Regrettably, Mr. Michaud, the Subcommittee Chairman, had an
emergency and isn't able to be here today. I'm Congressman Phil
Hare from Illinois. This is, I think, my first opportunity to
Chair a Subcommittee hearing, so I hope you will bear with me.
During this hearing today, the Subcommittee will examine
Gulf War exposures of veterans. The incidences of Amyotrophic
Lateral Sclerosis (ALS) among Gulf War veterans and most
importantly where is the U.S. Department of Veterans Affairs
(VA) in conducting continuing research on Gulf War I exposures
and what they are finding out about the current exposures in
Operation Enduring Freedom (OEF) and Operation Iraqi Freedom
(OIF) veterans. Many of the veterans who served in the Gulf War
were exposed to a variety of potentially toxic substances
during their deployments.
According to the Research Advisory Committee on the Gulf
War veterans, more than 16 years after the end of Operation
Desert Storm, a substantial proportion of veterans continue to
experience chronic and often debilitating conditions
characterized by persistent headaches, cognitive problems,
somatic pain, fatigue, gastrointestinal difficulty, respiratory
conditions, and skin abnormalities.
The Department of Defense (DoD) and the Department of
Veterans Affairs together has spent $260 million on Gulf War
illness research. While there have been numerous studies and
much research conducted on Gulf War illnesses there are still
many unanswered questions. Another aspect of Gulf War I Service
is ALS. ALS is a progressive and nearly always fatal disease
that affects a person's nervous system. According to the
Institute of Medicine (IOM), Amyotrophic Lateral Sclerosis in
veterans review of the scientific literature, there is limited
and suggestive evidence of an association between military
service and developing ALS.
Additionally, in a study sponsored by the Department of
Veterans Affairs in 2003, researchers identified the incidences
of ALS in veterans deployed to the Gulf as twice as high as the
incidences of diseases among those who did not go to the Gulf.
I look forward to hearing from our panelists on these very
important issues. I would now like to yield to my friend, Mr.
Brown of South Carolina, for any opening statements that he may
have. Mr. Brown?
[The prepared statement of Congressman Hare appears on p.
42.]
Mr. Brown of South Carolina. Mr. Chairman, if I might, I
would like to yield to Mr. Moran for an opening statement. Then
I have an introduction I would like to give.
Mr. Hare. Without objection.
OPENING STATEMENT OF HON. JERRY MORAN
Mr. Moran. Mr. Chairman, thank you very much. I only want
to commend this opportunity for us to once again examine the
consequences of various exposures and conditions that our
military men and women have encountered in service to their
country, particularly as it relates to the war in the Gulf.
Over the last 10 years this Subcommittee, this--actually
the full Committee has held ten hearings on the topic of Gulf
War Syndrome. In the past, I chaired the Subcommittee on Health
and this was a significant topic of our agenda and continue to
believe that it is important for us to make certain that we
learn everything possible from our previous exposure to
conditions in the Gulf and to make sure that back in 2002 when
we were entering into Afghanistan, we were trying to make
certain that our military had learned lessons from that
previous Gulf War experience.
Again, I think the consequences of our deployments are
significant and real and need to be fully addressed by our
Committee, but particularly by VA. So these are important
hearings on useful topics, and I am glad to see the seriousness
with which we are approaching the Gulf War Syndrome today.
Thank you, Mr. Chairman. Thank you, Mr. Brown. I yield back
to you.
OPENING STATEMENT OF HON. HENRY E. BROWN, JR.
Mr. Brown of South Carolina. Thank you very much. And it is
absolutely a great honor today to be able to be a part of this
hearing. And I thank the Ranking Member, Mr. Miller, and the
Chairman, Mr. Michaud for conducting this hearing. And I am
glad to have you, Mr. Hare, as leading this charge this
morning.
Within my State of South Carolina and the Nation as a whole
who have served the country during the Gulf War as a Member of
this distinguished Subcommittee, it is my duty, it is our duty
to provide our Nation's veterans with access to the best
healthcare possible. It is our duty perhaps even a moral
responsibility for us here today on this Subcommittee to help
those brave veterans who have helped defend our great Nation.
Today I have the distinct and dignified honor of
introducing someone who answered the call of duty by helping
his country when it needed him the most. And today he comes
before us and asks for our help. His name is Brigadier General
Thomas Mikolajcik.
For many years my personal friend and great American hero,
General Mikolajcik, or General Mik as he is known by his
closest friends, has been a leader in the Charleston Community.
First as commander of the C-17 Wing Base at the Charleston Air
Force base and then as an active contributor to the Charleston
Chamber of Commerce Military Relations Activities following his
retirement in 1996.
But General Mik's dedication to the Charleston Community
would be noteworthy in any case, it is even more impressive
when one realized that his focus on the needs of this community
comes at a time when he is suffering from a debilitating and
deadly disease.
In 2005, General Mik announced that he had been diagnosed
with ALS. While many individuals would have immediately
withdrawn under the pressure and impact of ALS, the General
used it as an opportunity, and with much resolve and endurance
doubled his efforts and dedication. In addition to continuing
his commitment to the Charleston Community, the General has
devoted a great deal of attention to raising awareness within
the community of ALS and improving the quality of life for ALS
patients and their families. Thanks to his efforts, a new ALS
Association Chapter was formed in South Carolina and the only
ALS clinic in the State was founded at Charleston Medical
University of South Carolina.
General Mik is truly an inspiration to many throughout the
Charleston Community, continually thinking of others despite
the great challenges he has faced. Numerous studies have shown
that individuals who have served in the military have a higher
propensity toward being diagnosed with ALS. While the
Department of Veterans Affairs has identified ALS as a Gulf War
I related disease, cases abound that show the spread of this
disease among veterans is much broader.
Indeed, a recent study showed the veterans of all conflicts
have a 60 percent higher chance of being diagnosed with ALS
than the general population. It has been nearly 70 years since
Lou Gehrig made his famous speech and retired from baseball
after contracting this horrific disease. And it has been nearly
17 years since the end of Gulf--first Gulf War, and yet little
has been done about this disease and even less is known about
it's causes.
The work of General Mik has also brought to my attention
the growing number of veterans contracting ALS outside of
service during Gulf War I. My office is aware of a number of
cases in my district from veterans who have developed ALS where
the VA has denied their claims because their service was not
within the presumptive timeframe of August the 2, 1990, through
July 31, 1991.
We don't have a good handle on how many non-Gulf War I
veterans have contracted ALS, what military-related risk
factors exist and what we can do to decrease the chances of ALS
among our veterans and military servicemen and women. This
issue is of special concern as we continue to have troops
deployed in OEF and OIF.
The story of General Mik serves as a testament to the need
for leadership at the Federal level toward developing the
comprehensive ALS research program and declared VA/DoD policy
ensuring that all veterans with service-connected ALS receive
the attention they deserve regardless of whether or not they
served during Gulf War I. We need an agency to step up to the
plate and lead Federal research into the cause of ALS and how
we can better improve it's treatment.
Most importantly, we need to begin these efforts now before
more veterans, including General Mik, succumb to ALS. And I
thank you, Mr. Chairman. And I also would like to identify his
wife, Carmen, who is with him and also his son, John, and Jamie
Haywood, who is founder of the ALS Therapy Development
Institution. And I thank you all very much for coming.
[The prepared statement of Congressman Brown appears on p.
42.]
Mr. Hare. Thank you, Mr. Brown and welcome General. Our
remaining panelists are Anthony Hardie who is a Gulf War
veteran. Anthony, let me first of all thank you for coming and
thank you for your service to this country. And Denise Nichols
who is Vice Chairman of the National Vietnam and Gulf War
Veterans Coalition.
So, General, we will start with you and we welcome your
testimony. Good morning.
STATEMENTS OF BRIGADIER GENERAL THOMAS R. MIKOLAJCIK, USAF
(RET.), MT. PLEASANT, SC (VETERAN); ANTHONY HARDIE, LEGISLATIVE
CHAIR AND NATIONAL TREASURER, VETERANS OF MODERN WARFARE; AND
DENISE NICHOLS, MSN, VICE CHAIRMAN, NATIONAL VIETNAM AND GULF
WAR VETERANS COALITION
STATEMENT OF BRIGADIER GENERAL THOMAS R. MIKOLAJCIK, USAF
(RET.)
Brigadier General Mikolajcik. Thank you, Congressman Hare,
Congressman Brown, Congressman Moran. I really appreciate this
opportunity to testify.
My name is Tom Mikolajcik. I am neither an M.D. nor a Ph.D.
I am a PALS. A patient with ALS. I was diagnosed in October
2003. I was given a death sentence and told to get a second
opinion while given a prescription for Rilutek which has very
limited value. Only by the grace of God am I here to speak with
you today and I have vowed to keep speaking until I no longer
can.
Military veterans like me face a higher risk of this
relentless killer. Fifty percent die in one to 3 years. Another
20 percent die in 5 years. Less than ten percent live to 10
years.
It was learned in 2001 that Gulf War veterans have two
times the incident rate of the general population. We
discovered in 2005 that veterans going back to War World II
have a one point six times higher incident rate then the
general population for developing ALS. In other words, any of
you in this room that are veterans have a 60 percent higher
chance of contacting ALS than non-veterans.
Four short years ago, the VA opened a voluntary ALS
registry. It registered thus far 1,993 veterans suffering from
ALS. I am sad to say and it is unacceptable to me that only 969
are still alive today. That is less than 50 percent. I am one
of the blessed ones that are still alive.
And ladies and gentlemen that also means somewhere between
one and 15 and one out of 30 ALS patients are military
veterans. The government must step up to the plate on this
issue.
We are currently exposing hundreds of thousands more
servicemembers to the elevated risk of this disease. There will
be young men, women and families celebrating a return from Iraq
and Afghanistan alive, who have no idea that they may soon be
facing a certain death from ALS.
We will have to answer those families when they ask what
the government has been doing to prepare for this onslaught.
For this reason, the government is compelled to assume a
leadership role in this issue. If these soldiers were dying in
the field rather than quietly at home as a consequence of their
service, we would leave no stone unturned. We would use the
best of existing resources and programs to make sure they had
whatever they needed to survive to ensure no man or women is
left behind.
Some say that a lot of ALS research has taken place. My
response echoes the famous words of President Lyndon Johnson:
``Research is good, results are better.'' It has been nearly 70
years since Lou Gehrig made his farewell speech and we have
basically nothing. One questionable drug in 70 years? What his
doctors knew then, what my doctors know today, and what
therapies we have are not much different.
How many thousands of private farewell speeches must take
place before we realize we are not doing everything we can?
Will I have to give mine before an appropriate, large-scale,
comprehensive plan to tackle ALS is carried out? ALS is more
complicated than a Rubik's cube which is many sided with
multiple connections, and various colors like this one. One
must consider causes, therapies, biomarkers, genomics, existing
drugs, patient needs, palliative care, as well as all avenues
of research.
Who is in charge of ALS research today? I have found no one
in charge!
[Large rubik's cube placed on witness table.]
What is the strategy for solving this ALS Rubik's cube? I
found no strategic plan! Who oversees and is accountable for
existing medical research activities for ALS? No one! So, yes,
there may be many ongoing efforts into ALS but potential
success is thwarted by little cooperation, coordination, and
sharing of information. From my viewpoint and understanding,
there is no one entity in charge or accountable.
These blocks or boxes represent the ongoing ALS research.
[Various sized wooden blocks spilled on witness table.]
All are separate, none are connected and there is no
communication among them. We have underfunded research across
the country, each working in their own little box. This
approach has been unsuccessful thus far. We need to open the
doors of labs and encourage collaboration. There should be no
more deaths due to protection of ALS related intellectual
property and potential profit. Some of us are in a hurry.
Therefore, it is the government's absolute responsibility
to direct research into a full understanding of ALS. In other
words, my hope would be that we not just think outside the box,
but totally redraw it; enlarge it to fit the enormity of this
horrific disease. Many people come to hearings with problems
and needs. I come before you with a solution also. I fully
understand bureaucracy's aversion to change particularly within
an industry as large as medicine and with the number of
government agencies already dabbling and yes, I mean dabbling
in ALS research.
Let's look back to 1961 when our Nation made a commitment
to put a man on the moon within a decade. One government agency
was put in charge and it was supported by other agencies as
well as private industry and individuals. My proposal is very
similar. It worked then, it should also work now.
This is what I propose: Establish a congressionally
directed ALS Task Force with specific milestones and a time
line. Within 30 days establish a task force made up of
government agencies, ALS researchers, private ALS institutes,
patients, and a facilitating team not related to ALS or the
medical industry. Within 60 days the task force should
recommend which government agency will be in charge and the
supporting roles of the other agencies. In other words, an
executive agency for the government. Within 90 days develop a
strategic plan which outlines all avenues of research to be
included. It must be comprehensive, forward looking, and all
inclusive. The strategic plan should also outline agency and
researchers accountability. An adequate and fair funding stream
must accompany this strategic plan.
The decade of the nineties was the decade of the brain.
However, we invested too little time and too few researchers on
research to understand diseases of the brain, especially such a
devastating disease as ALS. Over 30 years ago our country
launched a war on cancer. Because of that effort we now have
many treatments of this dreaded disease, even some cures. It is
time to launch a war on ALS and other neurodegenerative
diseases so that we can have effective treatments and cures.
We designated and designed the Apollo Program to put a man
on the moon. For ALS we could call it the HOPE Program, Helping
Other People Endure. From this day forward this new direction
can be a model program that has one government agency
designated by Congress which has control and oversight of a
lofty objective--solving this ALS Rubik's Cube. There are many
private models of leadership to draw upon. Innovations have
sprung up driven by those connected to the disease including
several which I am involved with. The ALS Therapy Development
Institute; the ALS Association of America; the Multiple
Dystrophy Association; and the Medical University of South
Carolina's ALS Clinic.
These efforts will succeed with public leadership that
amplifies their private support into an integrated whole. In
the future this model could be duplicated as a test bed for
research on other diseases. Because of the similarities among
neurodegenerative and neuro-inflammatory diseases, advances in
ALS research will likely be relevant to Parkinson's,
Alzheimer's, Huntington's and others.
We must prepare to offer our soldiers, sailors, airmen, and
marines an opportunity to fight this disease. We cannot simply
fight this battle defensively hoping to limit exposure to
environmental risk. We must fight it offensively as well with
an appropriate medical arsenal. Let's do what it takes to
finish off this enemy once and for all. Congress can make the
commitment, take the initiative, legislate a new way forward
and hold agencies accountable. We have the intelligence, the
resources, and the competencies. It is time to apply leadership
to the ALS Rubik's Cube to move the campaign in a new and
uncharted direction.
Let us have the answer ready for our veterans and the
general population suffering from this disease. Let us show
them they were worth a real investment and a real plan. Let us
redraw and enlarge the box to allow for their futures.
Finally, and probably the easiest task I will ask today, is
to immediately establish and fund a national ALS Registry to
ensure comprehensive patient information, tissue, genes, DNA,
etcetera are available for investigation. Such a registry will
facilitate, even stimulate additional research and research
collaboration.
This will provide, ``HOPE'' for future treatment and
increased understanding of this disease. But what about
veterans like me who may not benefit from these future
discoveries and treatments? We owe our veterans treatment now,
however limited. Over 5 years ago, the Secretary of Veterans
Affairs extended service-connected benefits to Gulf War
veterans like me based on the research study results that they
had. Since then,new research has shown an increased incidence
of ALS among all veterans, 60 percent higher than the general
population.
The Secretary for Veterans' Affairs should act now with the
same decisiveness and the same concern for veterans by
extending veterans benefits to all veterans suffering from this
terrible disease. I have attached a copy of the letter I gave
to and discussed with Secretary Nicholson on 23 March of this
year in Charleston.
Thank you for your attention, for allowing me to speak past
my time and for giving me this opportunity to represent
veterans. God Bless our veterans! And God Bless the United
States of America!
[The prepared statement of Brigadier General Mikolajcik
appears on p. 43.]
Mr. Hare. Thank you, General, that was an incredible and
compelling testimony. I thank you for taking the time out to
come this morning. You are an incredibly courageous person and
we will work very hard.
Our next panelist is Mr. Hardie and Mr. Hardie, welcome.
And we look forward to your testimony.
STATEMENT OF ANTHONY HARDIE
Mr. Hardie. Thank you, Mr. Chairman. Mr. Chairman and
distinguished Members, thank you for holding today's hearing on
Gulf War exposures and highlighting and enduring national
significance of these issues. It is truly an honor and a
privilege to be here today. And I hope to help voice some of
the concerns of the many who are not here to share in that this
privilege.
On January 17, 1991 much of America watched Operation
Desert Storm unfold on their evening news decisively ending the
many long months of the mass troops watchful waiting under
Operation Desert Shield. Six weeks and the war was over, but
for many of the nearly 697,000 troops who served our
overarching Gulf War experience had only just begun.
For those who may not be familiar, Gulf War troops were
exposed to a host of toxic exposures often in combination
including multiple low-level exposures to chemical warfare
agents including from bombed munitions factories and detonated
munitions bunkers. Experimental drugs mandated without informed
consent like Pyridostigmine Bromide pills intended to help
survive nerve agent exposure; inhalation of incredibly high
levels of micro-fine particulate matter from the Kuwaiti oil
well fire plumes; experimental vaccines like Anthrax,
botulinum, and others; inhaled and ingested depleted uranium
particulate matter; smoke from the daily burning of trash and
feces; multiple pesticides; petroleum products and byproducts.
For some of us who developed lasting health effects from
this veritable toxic soup of hazardous exposures, it came while
still in the Gulf. For others it did not come until some time
after returning home.
Hearing this list of exposures, most people would find it
of no surprise that so many thousands of Gulf War veterans
became ill, or that so many remain ill and injured today. And
it should be no surprise that so many have developed
diagnosable serious conditions like ALS, Multiple Sclerosis
(MS), and others. What is stunning is that 16 years later,
there are still few tangible results that might improve the
health of those who became ill and remain ill. And we still
have little information of any value to provide the Gulf War
veterans or the healthcare providers that might help to improve
Gulf War veterans health.
Years were squandered disputing whether Gulf War veterans
were really ill, studying stress, reporting that what was wrong
with Gulf War veterans was the same as after every war. An
incredible amount of effort was put into disproving the claims
of countless veterans testifying before Congress of a chemical
and other exposures. Some of that negative effort appears to
continue even today. It is stunning that after nearly two
decades we still have little information to provide the Gulf
War veterans who remain ill from their service. It is true that
VA does still have an open door for Gulf War veterans to be
seen at VA medical facilities, however, being seen is not the
same as being treated.
In terms of informing veterans, the VA's Office of Public
Health and Environmental Hazards website also contains little
information that might be of use to ill Gulf War veterans and
to health providers. Much of the information provided is
outdated. In July of 2006, the VA's Gulf War review included an
article entitled, ``Straight From the Source: VA's
Environmental Agents Service is Serious About Communicating
With Veterans.'' That issue, more than a year ago, was the last
published.
For Gulf War veterans like me whose ``Kuwaiti Cough'' has
never left after having coughed up thick black sputum while
still in the Gulf and for several weeks after returning home,
the report related to oil well fire smoke and petroleum from
this website which seemed to be of particular interest. Perhaps
it's lack of usable content, indicative of the lack of
attention being paid to these issues, is at least in part
related to the fact that it stated principal author was not a
leading scientist, but instead a community college
communications or journalism student summer intern.
I have heard from countless other Gulf War veterans that
they like many before them have stopped going to the VA or have
simply given up and have done their best to adapt to the
substantial lifestyle changes required by their disabilities,
which may or may not be compensated for these disabling
conditions incurred in service. Gulf War veterans have had
unique and special challenges and in May, a VA report show that
only one in four undiagnosed illness claims for Gulf War
veterans has been approved.
On a more positive note, I was encouraged during last
week's meeting of the Research Advisory Committee, on which I
serve, from Dr. Robert Haley and his team describing their
research goals of identifying diagnostic criteria for ill Gulf
War veterans. Success in achieving these goals should finally
help to pave the way for affective treatments. And I remain
encouraged by current efforts in the U.S. Senate to provide
funding for Gulf War health research within DoD's
congressionally directed Medical Research Program focused on
treatments that may aid ill Gulf War veterans.
The five-point statement of goals that came from Gulf War
veterans more than a decade ago still holds true today. Gulf
War veterans deserve then and deserve now an insurance, an
exhaustive investigation has been fulfilled to identify all
possible Gulf War exposures.
Second, that appropriate scientific research is promptly
completed to connect known or potential Gulf War exposures with
health outcomes. Third, that medical treatment is bases on that
scientific research. Fourth, that compensation is provided to
those veterans left disabled by their military service if the
health conditions cannot be reversed. And finally, that every
effort is made to ensure that never again what happened to the
Gulf War veterans be allowed to happen again. For the thousands
of living ill Gulf War veterans, it is time to make good on our
Nation's enduring promise of caring for those who have borne
the battle and their widows and their orphans.
Thank you Mr. Chairman and Members of the Subcommittee.
[The prepared statement of Mr. Hardie appears on p. 46.]
Mr. Hare. Thank you, Mr. Hardie. Ms. Nichols.
STATEMENT OF DENISE NICHOLS, MSN
Ms. Nichols. Good morning, Congressman of the VA House
Health Subcommittee and to all staffers and attendees. It is
indeed an honor to testify at this hearing for all Operation
Desert Storm veterans group which reflects only one part of the
earlier portion of the Iraq war.
It has been since November 1993 that we have been having
hearings on the care and needs of Gulf War veterans. I am a
retired air force flight nurse that served on the border of
Saudi Arabia and Iraq to care for those wounded in that war. I
have continued that duty as a sworn obligation. I am just one
of the 697,000 that were deployed in 1990 and 1991. My
profession, life, and family have been directly affected, as
has been so many others.
The symptoms and life changes I have experienced are not
unique. The war changed our health status and our abilities to
perform our duties in our chosen life roles through no fault of
our own. There are hundreds of thousands of human-case examples
both that were deployed and those that received vaccines and
exposures from secondary sources. In 1994, a total gathering of
ill veterans and DoD officials and VA officials and university
professionals at Bethesda attending the conference held on the
Health Consequences of the Persian Gulf War that we Gulf War
veterans were different. We were a force of highly trained,
educated, and physically fit men and women who served our
country in wartime. And even though we were now damaged due to
that time in a foreign country, we would not give up and we
would find answers and help.
Since then, we have battled for compensation, the exposing
of the full truth and nothing but the truth. We have battled
for the best care and treatment. Sadly, our war has been facing
our own government at times, but as Major Abare an earlier ALS
veteran that testified said, ``So long ago we did swear to
defend against all enemies both foreign and domestic.'' Sadly
this battle seems to be on the domestic end of having a lack of
faith and sworn duty for by our government.
The Gulf War veterans community has deteriorated health,
rising levels. We have lost too many of our own, but we still
stand pushing, prodding, encouraging to get to the truth and to
life saving that has been denied for too long. We were met with
denials, delays, and resistance, but yet if you had listened
and acted many of our lives could have been saved and restored.
We ask for the best diagnostic procedures and treatment, we
were denied that by lack of truth, at times from our own DoD
and government officials.
Some, but not all the truth has been exposed. We felt that
more would have been exposed to back up our acknowledgment of
the multiple exposures that taken alone or in combination would
have a definite affect on our health. We have pushed for the
medical examination and diagnostic treatment that would expose
the truth held within each of our own bodies. We pushed for the
care and treatment we earned by putting our lives on the line
to serve our government. Sadly, we have been delayed by forces
within our own government. We would win a major fire fight in
that battle to face a counter attack or a blocking move. We
still wonder, what is this? Is it financial? Is it a policy? Is
it protecting some secret? But that answer and the battle our
government waged to find the single cause of exposure while we
lay wounded still continues.
Those of us with undying spirit and faith would push the
wounded each time to raise up and fight for yourselves, your
fellow soldier, veteran, your family, and the future soldiers
and veterans to reach the goal. Within my longer supplied
testimony is a recap of just a few of the insights or snapshots
along the road we have traveled in regards to the VA. I have
supplied yet another point paper, action plan, or if you want
to call it an OP order outlined to fix the broken parts, to
move forward the goal of appropriate medical diagnoses and
care.
The system was not broken by us, but the result of a
multitude of errors complicated by a government or it's
employees that denied us the access to the best medical care
for whatever reason. It has cost us lives of your fellow
Americans, your soldiers, your veterans, your family members.
In one 3-month period of grievous data reporting from the VA,
we lost 1,000 of us to whatever causes. The full count is
definitely more. This is morally and ethically wrong. In our
path we have met many civilian experts that have volunteered to
help us out of that morally and ethically wrong situation.
Sadly, many of their careers have been negatively affected
through their joining the battle. We have officers and
individuals that have tried to help from the shadows, well it
is time for the all out assault to fix this and have results.
The veterans have led this battle and we are not done. We
hope that each of our elected reps will listen to us, join us
to fix these problems, remove the road blocks, and move for
true action. Let us move forward together to the best diagnosis
care, treatment, and compensation before we lose more lives.
The veterans have identified something that is critically
important and that could affect every citizen in this country
through the response to critical hazardous substances, weapons
of mass destruction, and environmental exposures. Examples are
the World Trade Center, the Anthrax exposures, radiation damage
and potential terrorist issues in our own country. The advances
made through us could help save lives in the future throughout
the U.S. and other countries.
We need the funding and the commitment from all. Will you
do your part to correct the errors mismanagement, mis-guidance,
obstructions of the past? Will you commitment the funds and the
fast tracking of corrective legislation? Will you be the active
leaders to investigate, deliberate, and be part of the
solution? But please, if you are, you must move quickly and
decisively in order to save lives. Help us to streamline the
process to get the pin pointed research that is needed. Help us
get the right diagnostic care and effective treatment. Do not
study, investigate, or deny each of us to the grave. We need
the blim research to actual diagnosis and care in a cost and
time sensitive manner. We can gain from the clinical data that
can be obtained for a cost effective means within each VA
hospital and merge it with research efforts to find better
diagnostic markers that can be quickly implemented in the
clinical area. We need to have our VA care organized so that
research for treatment by way of treatment trials can be moved
into the clinical area in an expedited manner at true cost
effectiveness.
We need universities to cut their cost of research business
so that we can use funds provided in the most effective way to
implementation. Universities should share their commitments to
the troops and veterans and not make a profit off the endeavor.
We can do this in weapon development with tiger teams
approaches and filled instruments of war in record time. Can we
do the same to save our troops and veterans? Will you have
faith in us that veterans and those civilians as doctors,
researchers, and members of the Veterans Affairs Research
Advisory Committee that have committed to help. Will you put
the full weight of this government and it's resources to this
task? Our remaining lives and qualities of our lives depend
upon you.
Thank you very much for the honor to appear before you
today. I would be delighted to answer any questions you may
have.
[The prepared statement of Ms. Nichols appears on p. 47.]
Mr. Hare. Thank you Ms. Nichols. Thank you very much for
your service to this Nation and for all the work that you are
doing now.
I just want to say one thing before I ask a couple
questions of the panel. General, one of my closest friends was
a retired Catholic priest and I can remember to this day he
would say, ``Phil, we hear about faith, hope, and love, the
greatest being love.'' But he said, ``If you take hope away
from people for them getting up every day and to try to do what
they can do best.'' He said, ``While we talk so much about
love, always remember that hope is, from my perspective,
equally important.''
And I just want you to know that it is my sincere desire
that the HOPE Program that you mentioned, I think it is a
wonderful thing. And I think we need to look at it and I think
we need to work on it, and I think we need to do it now. I
don't think--every hour that goes by is time wasted. And so, I
just wanted you to know that your testimony was very compelling
and I am just incredibly honored to be Chairing this hearing
this morning with such wonderful panelist.
I do want to know, maybe and the whole panel could talk to
me, the General talked about a congressionally directed ALS
task force and the timelines, and establishing it in a 30 and
60, 90-day time line that you suggested, General. Could you all
tell me what, in your opinion, would you suggest would be the
top three goals of that task force.
Brigadier General Mikolajcik. I'm sorry. The----
Mr. Hare. The task force that you were proposing.
Brigadier General Mikolajcik. The top three goals of the
task force would be, number one, determine what agency in
government would take the leadership role. Number two, develop
a strategic plan to be followed. Number three, provide adequate
funding to support that strategic plan.
Mr. Hare. Mr. Hardie. Ms. Nichols?
Mr. Hardie. I would certainly concur with those comments. I
think that is an excellent action plan.
Mr. Hare. Okay.
Ms. Nichols. Very definitely a definite goal timeline to
meet.
Mr. Hare. Okay. Mr. Hardie, in your testimony you stated
that being seen is not the same as being treated. And I would
like, if you could maybe go into it a little bit more regarding
that statement. And then you also said that many Gulf War
veterans have given up going to the VA. Do you know if they are
going elsewhere or they are just not going anywhere at all?
Mr. Hardie. Thank you, Mr. Chairman. In terms of not being
seen is not the same as being treated. VA continues to have an
open door and it is always possible to get appointments with
general medicine practitioners. In terms of being seen by
specialists, if it appears that there is some sort of a
condition as well, I think that Gulf War veterans are able to
be referred to specialty care as well. But again given the lack
of an understanding of the underlying mechanisms causing Gulf
War veterans illnesses, my sense is that many treatment
providers really don't know what to do with Gulf War veterans.
I had, for myself, I have had significant immune
dysfunction growing over the last several years. I had an
absolutely brilliant immunologist tell me, ``I am simply not
smart enough to know what to do with you. Here are some
suggestions for where to go.'' And so, I continually--my
experience has been being seen by, by the way that was not a VA
practitioner. I did seek outside care after having been
shuffled around for quite some time.
In terms of Gulf War veterans going whether they are going
elsewhere or simply stopping getting care, my sense is that
those are some veterans are--some Gulf War veterans are
continuing to seek care at the VA, but again and elsewhere but
after a time it seems that many of the people that I am in
contact--many of the Gulf War veterans that I am in contact
with have simply given up on, until there is some new
breakthrough, there is no point in going back and being told,
``We don't know what to do with you. We see your symptoms. We
can certainly give you limited prescriptions to treat some of
the symptoms that you are experiencing. But in terms of what is
causing these kinds of things, we don't know.'' And until there
is, we simply don't know.
I would hope that gives a sense of the answer to those
questions.
Mr. Hare. Yeah. Just real quickly, because I am running out
of time. Mr. Hardie, outreach can be a great tool and sharing
it with the veterans from past wars so they are kept informed
of any changes or developments that may occur. It has been 16
years since the Gulf War I ended. Just a couple quick
questions.
Do you think the outreach efforts of the VA have diminished
in these 16 years? If so, how? My second follow-up would be
what changes do we need to do to affect that outreach?
That would be for Ms. Nichols, if I could.
Ms. Nichols. Okay. On the point paper I have provided this
morning for you, I went step by step, there is 23 steps there.
But the outreach needs to be very extensive. I think we need to
bring in outside experts in the anti-aging area that is a board
certified field medicine that can help from the top down.
I think a lot of the things that are covered at the VA
Research Advisory Committee meeting, the updates on research,
there is excellent material there. I have encouraged to be
videotaped, get out there on the web, get out there the
physicians in the VA hospital and to the patients, the
veterans. I have encouraged that from day one and it hasn't
been done. That is a simple thing that could be put in place to
you know further the outreach and education of all involved,
not only the patients but the physicians that are to care for
us at the VA.
But I think we need some other experts put on contract to
come in and do some education also on other things that are
available in the civilian world that could help. A lot of it
connects with chronic fatigue and there is a lot of breaking
research in that area.
Mr. Hare. Thank you, Ms. Nichols. Mr. Brown?
Mr. Brown of South Carolina. Thank you, Mr. Chairman and I
really thank the other Members of the panel for coming too. I
know I made my introduction to General Mik, but I am glad to
have you all here.
And General Mik, my first question is to you is, how were
you diagnosed with ALS and how long did it take for you to be
granted your VA benefits?
Brigadier General Mikolajcik. Thank you for asking that
question. And there is no one test that tells you, you have
ALS. I was having an annual physical and there were
fasciculations that the doctor saw on my shoulders. That is
uncontrollable muscle movement. He asked me how long have I had
those fasciculations? I said, ``What is a fasciculation?'' He
said, ``Look in the mirror.'' I looked in the mirror, I said,
``I have never seen them.'' Then I was sent to a neurologist,
who did an EMG; did a CAT scan; did other things. And then they
said, ``You probably have ALS or some other disease.''
So through a process of elimination, it wasn't Lyme
disease, it wasn't Kennedy's disease, it wasn't benign
fasciculations, even though they immediately put me on the one
drug, Rilutek, which was used for ALS. It is a guessing game
until more parts of your body start to lose functionality or
your speech. It took me 2 years before I was granted
disability, partial disability by the VA. And it took another 6
months before I was granted full disability.
There is no one scientific test to identify ALS. That is
why the research is so important to find those biomarkers that
may identify ALS patients whether it be through DNA or
whatever, so that you could start treatment sooner. It is not
like other diseases, cancer or whatever that there is a test
that tells you, you have it. ALS is not that way. Lou Gehrig
gave up his order of batting because he couldn't hold those two
bats in his hands to practice swinging. After 2,130 consecutive
games. He was the iron man of baseball. Most ALS patients are
very healthy. I was taking an 80 milligram a day of aspirin
when I was told I had ALS. Most ALS patients are very athletic.
Why? We got to do the research to find out.
Why do Italian soccer players have a higher incident rate
than non-soccer players? We don't know. Why do pilots have a
2.6 times incident rate of ALS compared to non-pilots? We don't
know. And the reason, Mr. Chairman, I talked about leadership
is I spent 27 years in the Air Force. There was always a
leader. There was always direction. There was always
cooperation on whatever you were doing. There is no leadership
in ALS. Just like these blocks on the table. These are blocks
from when I was a child over 50 years ago. Anybody that had ALS
then or that has it now is not much different than those
blocks. It is a sad state.
So that is why when you ask me what are the three things,
number one, has to be leadership. Number two, you have to have
a strategic plan on how you are going to go do things. And by
having a plan and by having a leadership, you can also save
money in research because you do away with a lot of the
duplication that is going on. I don't know how many
organizations have tested Mynocycline for ALS. We have tested
on mice; we have tested on patients; we keep on giving grants
out to test Mynocycline. Something is wrong in that equation.
Mr. Brown of South Carolina. I notice in your remarks you
said that one of the easiest tasks would be to establish and
fund a national ALS Registry to ensure comprehensive patient
information. You mean we don't have one already?
Brigadier General Mikolajcik. No, there is no national
registry. There has been a number of organizations, the ALS
Association that have been trying for a number of years. It was
voted upon on the House side in one of the conference
subcommittee's and it was passed. There is over 50 percent of
the Congressmen in this Congress that have signed as sponsors
for the bill. I understand that today the full Congressional
Committee is voting on the bill. The Senate, I don't remember
where the progress stands on that. But the ALS registry for
veterans is so small, part of it is you got to know there is a
registry to sign up for the darn thing. If you are not computer
literate, if somebody didn't tell you, your name is not on that
registry.
So the national registry would put many more people into
the database. To find out, have you used pesticides? Have done
certain things? Have you had certain medications? And it
doesn't cost a lot for that national registry to be formed. So
I would encourage this Subcommittee and the Members to support
the registry that is being voted upon in this Congress.
Mr. Brown of South Carolina. I know my time is expiring,
Mr. Chairman. If I might just make one statement. I know that
there is, I hope there is some collaboration between the DoD,
National Institutes of Health (NIH), and other ALS research
funding. I know that in the Defense Bill that the Appropriation
Bill coming before us, we requested $4.8 million for an ALS
Therapy Development Institute. And this support would support
cutting edge first fast track drug discovery and traditional
research. We were able to get one and a half million dollars,
General. And so we hope this will help. And but that is a shame
if we got to make their marks look like, you know, DoD should
take this responsibility on their own. But we are pleased to
announce that.
Brigadier General Mikolajcik. That sure is. And that is a
small amount of money for the task ahead. I visited the ALS
Therapy Development Institute a little over a year ago in
January. I was visiting my mother in Connecticut. I heard about
them. I asked if I could come visit. I wanted to see the mice
that were taking the same drugs I was taking. See what they
looked liked. What was going on? What is the technology there?
And I was overwhelmed by their discipline and their sole focus
on ALS. I am a believer in where they are and where they are
going as they move forward in that direction.
And there are other laboratories that are doing work. What
we don't have is the drug companies are not putting much money
into ALS research. Why? What is the return on investment?
Bottom line. What is the return on investment? BioGen a very
large drug company in the State of Massachusetts about a year
or so ago disbanded their whole ALS research center. That is
why the government has a responsibility, because private
industry won't step up unless you give them some money to do
that.
Mr. Brown of South Carolina. Well, look, I thank you for
your testimony. And I will yield back my time, Mr. Chairman.
Brigadier General Mikolajcik. I would like to make one more
comment in relation to that.
Mr. Hare. Absolutely.
Brigadier General Mikolajcik. We all know a lot of patients
that have Multiple Sclerosis. The incident rate of Multiple
Sclerosis and ALS is not that much different. ALS is somewhere
between 5,600 to 6,000 a year. For MS the incident rate is
somewhere around 8,000, 8,500 a year. Why are there so many MS
patients? It is because MS patients live 20, 30 years. We
don't. Our statistics, you know, the doctor told me, ``You have
1 to 3 years to live. Get another opinion. Take Rilutek. Come
back and see me in 6 months.''
So the numbers are small because there are not many of us
and a lot of us can't speak. Thank you, Mr. Chairman.
Mr. Hare. Thank you, General. Mr. Moran?
Mr. Moran. I thank you, Mr. Chairman. I want to thank you,
General, for speaking. I only have a few questions, but I
suppose perhaps more important than questions is that all of
your testimony is a reminder of the importance of us providing
greater leadership, more emphasis, and support for the efforts
that you are outlining. And so, I appreciate the opportunity to
be here this morning just to remind me that there is a cause
that needs champions in Congress and across the country.
So, if, despite the information that you are conveying to
me, perhaps more important you are conveying to me the need to
go to work. I appreciate all of you providing me with that
challenge, that opportunity, and that--a reminder of my
responsibilities.
Is ALS, is it unique in it's correlation between military
service and incidence as compared to any other condition or
disease? Is this a very unique circumstance? A very rare
correlation?
Brigadier General Mikolajcik. It is a fact. Why? I don't
know. Is it unique for military service?
Mr. Moran. Is it, compared to any other disease or
condition, is----
Brigadier General Mikolajcik. I know of no other disease--
--
Mr. Moran [continuing]. Incidence of ALS and its
relationship to military service is it very unique?
Brigadier General Mikolajcik. Yes. I know of no cancer that
is associated just with military service or other things.
You know I looked through the Defense Bill and there is
about a billion dollars in earmarks for different research
within in the DoD Bill. The only disease that I saw that had a
direct connection to military service was ALS. The rest of them
were not. Prostrate cancer, breast cancer or other types of
things. It is unique.
Oh, and the Gulf War Syndrome. I am sorry. And the Gulf War
Syndrome, ALS is the only named disease within that
terminology.
Mr. Moran. The Gulf War Syndrome is a broader description
of a variety of conditions, ALS is a subset of that broader
description?
Brigadier General Mikolajcik. Yes. But how do you look at
veterans from Somalia, veterans from Haiti, veterans from
Bosnia, veterans from Korea, World War II and Vietnam. Why do
they have a 60 percent higher incident rate?
Mr. Moran. Is that incident rate, that correlation, is it
the similar percentage regardless of location of service?
Whether you were in Somalia or you were in Iraq or Afghanistan,
same statistical relationship?
Brigadier General Mikolajcik. We don't know the answer.
Mr. Moran. Okay. Again, it goes back perhaps to the
registry, the facts?
Brigadier General Mikolajcik. Right.
Mr. Moran. Okay.
Brigadier General Mikolajcik. To gather that data to run
the test, to do the DNAs, to spend more on specific research
for ALS. I am disappointed in some of the government's research
just on exposure and toxins. Because when you look across the
broad spectrum it is not just exposures or toxins that probably
trigger the disease in it. We may all have it and something
triggers it. What it is, we don't know. But to narrowly focus
on exposures and toxins to me is delaying the time in which we
will find a therapy or a cure.
That is why a multi disciplinary approach with leadership
is what we need.
Mr. Moran. General, thank you for your testimony. Mr.
Hardie and Ms. Nichols, thank you very much for your advocacy.
Mr. Hare. Let me again thank the panel for coming this
morning and thank you for your service to this Nation. I just
want to let you know that from my perspective I will do
everything I can, General, to help on this. I think it is way
overdue.
And, finally, Ms. Nichols you asked a series of questions
in your testimony and yes to all of the ones you asked. So
thank you very much for coming this morning.
Brigadier General Mikolajcik. Mr. Chairman, I would like to
make one more comment----
Mr. Hare. Sure.
Brigadier General Mikolajcik [continuing]. If I may,
please? I would like to thank Congressman Brown from the first
congressional district of South Carolina, for all that he does
for the veterans not only of South Carolina, but also of our
country. I personally want to thank him for supporting me over
these years as we have gone through this struggle to set up an
ALS Chapter in our State, to make a loan closet, to have an ALS
clinic. And I am deeply indebted to you, Congressman Brown,
thank you very much.
Mr. Hare. Thank you, General. And thank the panel.
This panel is excused. And thank you again, General, for
taking the time to be with us.
We welcome our second panel. I would like to introduce at
this time, Dr. Meryl Nass from Mount Desert Island Hospital who
has treated Gulf War veterans; James Binns the Chairman of the
Research Advisory Committee on Gulf War Veterans' Illnesses;
and Dr. Lea Steele, Scientific Director for the Research
Advisory Committee on Gulf War Veterans' Illnesses. I got all
that right. Not too bad for a rookie here.
So I thank the second panel and, Dr. Nass, we will begin
with you.
STATEMENTS OF MERYL NASS, M.D., INTERNIST AND HOSPITALIST,
MOUNT DESERT ISLAND HOSPITAL, BAR HARBOR, ME; JAMES BINNS,
CHAIRMAN, RESEARCH ADVISORY COMMITTEE ON GULF WAR VETERANS'
ILLNESSES, U.S. DEPARTMENT OF VETERANS AFFAIRS; AND LEA STEELE,
PH.D., SCIENTIFIC DIRECTOR, RESEARCH ADVISORY COMMITTEE ON GULF
WAR VETERANS' ILLNESSES, U.S. DEPARTMENT OF VETERANS AFFAIRS,
AND ASSOCIATE PROFESSOR, KANSAS STATE UNIVERSITY
STATEMENT OF MERYL NASS, M.D.
Dr. Nass. Thank you very much for holding this hearing. I
practice internal medicine in Maine. I have a background in
Anthrax and biological warfare and conduct a specialty clinic
for patients with multi-symptom syndromes, including Gulf War
Syndrome, Anthrax vaccine-induced illnesses, fibromyalgia, and
chronic fatigue syndrome.
The stories of those with Gulf War or Anthrax vaccine-
induced illnesses are usually heartrending. Most became
disabled in their twenties to forties with a combination of
physical impairments, cognitive problems, and psychiatric
disorders. They carry 10 to 15 diagnoses each on average. Five
patients gave me permission to share their medical records with
this Committee if you wish to see them.
My care for more and more of these individuals has
compelled me to continue to research and write about their
plight, to try to prevent further ``friendly fire'' injuries
and to address the barriers to good care for the injured. I
want to tell you four things today.
First, Anthrax vaccine can cause a wide range of disorders,
but most commonly causes a syndrome clinically
indistinguishable from Gulf War Syndrome. Many studies have
shown that it was a contributor, but certainly not the only
contributor, to Gulf War illnesses. Data from the military's
Defense Medical Surveillance System have shown that vaccinated
servicemembers have significantly elevated rates of heart
attacks, several cancers, asthma, diabetes, Crohn's disease,
psychoses, depression, and blood clots, compared to pre-
vaccination rates.
A U.S. government Accountability Office (GAO) report last
month cited the Centers for Disease Control and Prevention
(CDC) and Military Vaccine Healthcare Center officials saying
that one to 2 percent of Anthrax vaccine recipients may
experience potentially disabling side effects or death. The
Assistant Secretary of Defense for Health Affairs concurred
with this report. I would like to refer you to my written
testimony for the details and sources; I am going to talk
broadly in this verbal testimony.
Second item, DoD and Department of Veterans Affairs funded
a huge portfolio of research that was carefully designed to
create a smoke screen around both Gulf War illnesses and
Anthrax vaccine injuries, presumably to deflect culpability
from government decisions and actions that led to the massive
collateral damage caused to Gulf War veterans and Anthrax
vaccine recipients. The result is confusion in the minds of
patients, medical practitioners, and policy makers. Last week,
a patient of mine and his wife cried in gratitude in my office
when I told him he had Gulf War syndrome and not a psychiatric
illness, even though I said it could not be cured. His VA
doctor, he said, didn't believe in Gulf War illnesses. That
should not be happening today, and it is largely a consequence
of the failed body of Gulf War research.
The VA and DoD-funded research has been successful at
delaying the provision of pensions and appropriate care for
affected veterans, and taking away their self respect.
Third item. This situation does not need to continue. Both
the research, treatment and disability assessment for veterans
can be improved and made fair.
Fourth. Troops would not so easily be placed in harm's way
if the Department of Defense bore the long term costs of their
injuries. DoD continues to expose soldiers to a range of
potentially debilitating exposures, such as aerosolized
depleted uranium, illegal levels of toxins on military bases,
and known dangerous vaccines for which no threat has been
demonstrated and for which safer approaches exist.
Ill soldiers are medically discharged and the cost of their
future care shifted to the VA. If Congress made sure that some
of these costs were borne by the Pentagon, it is certain the
long-term health of soldiers would be taken more seriously.
What should be done? In terms of research, a total of seven
Federal advisory groups and the Committee on government Reform
have made detailed recommendations for the types of long term
studies that should be done on Anthrax vaccine. Their
recommendations should be carried out. These groups include
three Institute of Medicine Committees, the Advisory Committee
on Immunization Practices of CDC, VA's Research Advisory
Committee, the Armed Forces Epidemiology Board, and the GAO.
The CDC has been conducting a trial of Anthrax vaccine in
1,500 civilians since 2002. Over 100 adverse event reports have
been filed with FDA on trial subjects, but no preliminary data
have been released to the public and the investigators have
decided to focus on short-term adverse events.
Congress could investigate this study and insist that
adequate long-term safety data are collected. Studies like this
have the ability to tell us once and for all the precise side
affect profile of this vaccine and the rates of adverse
reactions.
What should not be done? History should cease repeating
itself. In 1997, Phil Shenon of the New York Times reported on
Congressman Shays' investigation of Gulf War illness research.
He said, ``The Pentagon and Department of Veterans Affairs have
so mishandled the investigation of the veterans' health
problems that Congress should create or designate an agency
independent of them to coordinate research into the cause of
the ailments.''
Now it is 10 years and $260 million later and absolutely
nothing has changed.
Failed research does not happen by itself. In the case of
Gulf War and Anthrax vaccine studies, a number of issues can be
identified that led to unusable results: the wrong questions
were asked; data was withheld; dubious methods were chosen;
sample sizes were inadequate to answer the questions asked;
control groups contained exposed subjects; and exposed groups
contained unexposed subjects.
Those government officials who deliberately wasted hundreds
of millions of dollars on a wild goose chase should be subject
to charges of research misconduct. Congress can pass a law to
establish criteria and penalties for such conduct, similar to
existing NIH regulations.
The officials responsible for this research charade could
be barred from future government grants and contracts and
future government employment. A new Federal agency should be
created with a responsibility for only drug and vaccine safety.
Currently, agencies responsible for promoting drugs and
vaccines are also responsible for safety, and this inherent
conflict of interest has resulted in repeated failures to
regulate appropriately. A bill like this was introduced in the
last Congress, I believe by Representatives Carolyn Maloney and
Dave Weldon.
Finally, government officials who supported and expanded
Anthrax vaccinations while in office are now on the payroll of
the vaccine manufacturer or companies with government contracts
related to Anthrax vaccine. This includes two former U.S.
Department of Health and Human Services (HHS0 secretaries.
Congress should pass a law to prevent such egregious conflicts
of interest in future.
In conclusion, we know Anthrax vaccine and other toxic
exposures are dangerous to susceptible individuals. Clear steps
can be taken to reduce future injuries, treat the injuries that
exist and achieve accountability for the deliberate failures
that have occurred. Thank you very much.
[The prepared statement of Dr. Nass appears on p. 51.]
Mr. Hare. Thank you. Mr. Binns?
STATEMENT OF JAMES BINNS
Mr. Binns. Mr. Chairman, Members of the Subcommittee, it
has been my privilege to Chair the Research Advisory Committee
on Gulf War veterans illnesses. This public body of
distinguished scientists and veterans is mandated by Congress
and appointed by the Secretary of Veterans Affairs. Dr. Steele
to my left is a member and Scientific Director of the
Committee. She will provide highlights of the Committee's
cientific findings, I will address the status of Federal
research programs.
Gulf War illnesses remain a major, unmet veterans health
problem. According to the Department of Veterans Affairs most
recent study, 25 percent of Gulf War veterans suffer from
chronic multi-symptom illness above the rate in other veterans
of the same era. This confirms five earlier studies showing
similar rates. Thus, 16 years after the war, one in four of
those who served 175,000 veterans remain seriously ill. There
are currently no effective treatments.
Gulf War veterans also suffer from ALS, as you have heard,
at double the rate of other veterans of the same era. That is
double the rate of people in the military which we have already
heard is in excess of the normal background level in society.
The Federal Government has spent over $300 million in Gulf
War illness research. Much of that money, however, was spent on
the false theory that these illnesses were caused by
psychological stress. Part of an overall effort to portray
these illnesses as nothing unusual, the kind of thing that
happens after every war rather than the result of toxic
exposures.
Very little money was invested in treatment research. I am
pleased to report that a major change for the better has
recently taken place in the direction of VA research. Following
our Committee's 2004, report then Secretary Principi determined
that VA would no longer fund research based on stress.
Secretary Nicholson appointed new leadership at the Office of
Research and Development and placed most of VA's research
program at the University of Texas Southwestern Medical Center,
a leading site for Gulf War illnesses research.
I am pleased to see VA Gulf War illness research in the
hands of scientists committed to solving the problem and funded
at the $15 million level recommended by the Research Advisory
Committee. I regret that I must also inform you, however, that
other VA officials continue to minimize these illnesses. For
example, a fact sheet provided in recent weeks to three U.S.
Senators asserted, ``Gulf War veterans suffer from a wide-range
of common illnesses which might be expected in any group of
veterans their age.''
That is utter hogwash. This fact sheet is the work of the
VA Office of Public Health and Environmental Hazards, which is
testifying before you today. It is also the office charged with
implementing the law requiring VA to contract with the
Institute of Medicine for reports on the health affects of
toxic exposures for use and benefits determinations. For 7
years, these reports have been structured to restrict the
scientific information considered in their conclusions in
express violation of the statute, misleading the Secretary,
Congress, doctors, and medical researchers.
Dr. Lawrence Deyton who directs this office and will speak
to you later this morning assumed his position relatively
recently and did not initiate these practices. I urge this
Subcommittee and Dr. Deyton to order these misleading and
unlawful activities terminated. While VA Gulf War illness
research is adequately funded at last, two-thirds of Gulf War
illnesses research has historically been sponsored by the
Department of Defense. Over $30 million annually. Since the
start of the current war, however, this research program has
been eliminated. As a result, the total Federal program is at
one-third strength.
Last year Congress initiated an innovative new pilot
program at DoD focused on studies of treatments already
approved for other illnesses. It is open to all researchers on
a competitive basis. It's initial solicitation last fall
attracted 80 proposals compared to only two treatments studied
in the entire previous history of Gulf War illness research.
Yet, DoD has again excluded this promising program from it's
proposed fiscal year 2008 budget. It's future depends entirely
on Congress.
Mr. Chairman and Members of the Subcommittee, in recent
months this country has renewed it's obligation to care for the
health of veterans that return home from war. Hundreds of
millions of dollars have been appropriated to address the
problems of currently returning veterans and rightfully so. But
it is now time, in fact long past time, to address the health
problems of 175,000 ill veterans of the last war.
Will we follow the example of the current war and address
them now while there is still hope they can live out their
lives in better health? Or will we follow the example of
Vietnam and agent orange and admit the problem only as they are
dying? The answer begins with you and your colleagues.
[The prepared statement of Mr. Binns appears on p. 57.]
Mr. Hare. Thank you, Mr. Binns. Dr. Steele?
STATEMENT OF LEA STEELE, PH.D.
Dr. Steele. Good morning. I am Dr. Lea Steele. I am an
epidemiologist and a professor at Kansas State University. And
I have been involved in research on Gulf War veterans for
almost exactly 10 years when 10 years ago my home State of
Kansas stepped up to the plate and sponsored a research and
service program for Gulf War veterans in Kansas. And we much
appreciated the interest and support of Congressman Moran for
that program over the years.
But now at this time, I am privileged to serve as the
scientific director for the Research Advisory Committee on Gulf
War veterans illnesses. As Mr. Binns said, this is an
auspicious group of scientists and veterans who are dedicated
to addressing these problems. We have now reviewed thousands of
scientific studies, government reports, special investigations,
special Committee reports, all related to what happened during
the Gulf War and the health consequences for Gulf War veterans.
My purpose today is to just give you the highlights of some
of what we have learned in the course of our scientific work.
But I wanted to let you know that later this year we will be
issuing a major comprehensive report that contains our
scientific findings and recommendations based on this extensive
information. And I think you will find that report to be of
great interest.
Let me just first start by distinguishing a couple of the
items that have been raised already today. First, most of my
comments will focus on what we are calling Gulf War illness.
This is what was previously called Gulf War Syndrome. This is
the undiagnosed multi-symptom illness that has been described
by veterans and several of our speakers this morning. I want to
distinguish that from the diagnosed conditions that also affect
Gulf War veterans. These include ALS, a very serious condition.
And as Mr. Binns has said, we know that it affects Gulf War
veterans at twice the rate of other military veterans. So as
new information becomes available saying that all military
personnel from whatever era or whether they deployed or not, if
all military personnel have higher rate of ALS then the general
population, the fact that Gulf War veterans have twice as high
a rate as other veterans remains a particular concern in
relation to Gulf War service.
There are other diagnosed conditions that have been raised
as possibly affecting Gulf War veterans. One recent one is
brain cancer. I think many of you are familiar with one
incident that happened just after the cease fire in the Gulf
War in which the Pentagon has estimated that 100,000 Gulf War
veterans were potentially exposed to nerve agents, sarin and
cyclosarin. We have only known since 2005 that those veterans
have died from brain cancer at twice the rate of veterans who
were not in that area.
So that is another diagnosed condition. But again I want to
distinguish these important issues and very serious issues from
Gulf War illness. And that is because, although these are
serious medical conditions, they have affected relatively few
veterans of the Gulf War in contrast to the alarming numbers of
Gulf War veterans who have been affected by Gulf War illness.
And I think you all have a pretty good idea of what Gulf
War illness looks like. Multiple symptoms in multiple body
systems that occur all at the same time and can be quite
debilitating; severe headaches, memory problems, concentration
problems, dizziness, fatigue, pain throughout the body,
gastrointestinal problems. We know many veterans have had
diarrhea for 16 years. This is very serious and can be quite
debilitating for affected veterans.
So it is not what we see in the general population and it
is not what we see in any veterans group of similar age.
Luckily, as I said, a lot of research has been done on this
condition. We now have some answers and know some things about
Gulf War illness. We have a pretty good idea of how many
veterans are sick. We have a pretty good idea of who is most
affected and we also have strong evidence regarding what may
have caused this condition. And again, I will just share with
you some of the highlights.
First, as we have heard earlier today, Gulf War illness is
a big problem. That is 25 to 30 percent have been shown in
study after study to be affected by this multi symptom
condition. As Mr. Binns said that translates to between 175,000
Gulf War veterans and 200,000 Gulf War veterans.
Second, I want to be very clear about this. The evidence
clearly indicates that Gulf War illness was not caused by
psychological stress. We now have many, many studies that have
looked at psychiatric illness and psychological stress in the
Gulf War. No comprehensive well-conducted studies have found
any connection between combat stress and Gulf War illness.
In addition, rates of psychiatric conditions like post
traumatic stress disorder are much lower in Gulf War veterans
than in veterans of any other war that we have looked at. And
this stands to reason. As Mr. Hardie said the war was over in a
matter of days, the ground fighting, and the whole war was over
in 6 weeks. Most Gulf War veterans did not engage in combat and
were not even in areas of theater in which combat took place.
So Gulf War illness is not a stress condition.
The next major point is that if stress didn't cause Gulf
War illness, what did? Well we know there are a lot of
potential candidates and we have heard about some of them this
morning. Burning Kuwaiti oil wells, numerous military vaccines,
depleted uranium munitions, low-dose exposure to chemical
weapons. What I can tell you is that the most consistent
evidence and the strongest evidence points to a group of
chemicals that we know can have toxic affects on the brain.
This group of chemicals includes a little white pill that
personnel were given to protect them from the affects of nerve
gas. They took this pill around the clock in the event of
exposure to nerve gas. The second neurotoxin we are concerned
about relates to the massive and wide spread use of many
different kinds of pesticides during the war. And the third
neurotoxin that we are concerned about are the low-level
exposures to nerve agents.
What you may not know is that this group of chemicals
actually have similar affects on the brain and many of them
affect one specific brain chemical, acetylcholine. This is also
compatible with what we know about the biology of Gulf War
illness. That is we now have multiple studies showing brain
damage and reduced brain function in sick Gulf War veterans.
These have been covered in the media recently showing that
veterans with reduced brain function also have reduced volume
in specific areas of their brains.
So, again, we are very concerned about this, but it is
useful to note that this large body of evidence all sort of
converges on the central point of neurotoxins. Now my last very
important point has been raised before by veterans who are ill
and by Mr. Binns. And that is there are no effective treatments
for Gulf War illness. We now have four studies that have
followed up the health of Gulf War veterans over time and they
all tell us the same thing. And that is very few Gulf War
veterans with Gulf War illness have recovered over time and
very few have even substantially improved over time. So as a
result we have many, many veterans with Gulf War illness that
have been sick for as long as 16 years.
Our Committee has long considered treatment research to
have the highest priority of all research related to Gulf War
veterans.
So in short, I will just summarize by saying that Gulf War
illness is real. It is serious. And it is still widespread
among veterans of the 1991 Gulf War. It is not the result of
psychological stress and it is certainly not the same thing
that happens after every war.
We have seen some progress in understanding the big picture
questions about Gulf War illness and our Committee believes
that remaining important questions can be answered and must be
answered. And this is of course because the government has an
obligation to take care of veterans who are chronically ill now
as a result of their military service, but it also because we
want to be sure that by more completely understanding Gulf War
illness we can prevent anything like this from happening in
future deployments. Thank you.
[The prepared statement of Dr. Steele appears on p. 59.]
Mr. Hare. Thank you all very much for coming and testifying
this morning. I have a question of the panel and then maybe a
couple for you, Dr. Nass.
The General proposed in his testimony that a
Congressionally directed ALS Task Force be established. And I
just wanted to know from the panels' perspective your thoughts
on creating another task force or entity to look into ALS, and
if you believe the direction the VA is taking with ALS is the
correct way?
Mr. Binns. Let me comment on the aspects of the question
that I can address. First of all, I am not a scientist. My
background is in business in developing medical equipment.
Specifically, if you have had an ultrasound scan that is the
kind of equipment that the companies that I was involved in
starting and building developed.
The General is absolutely on target when he points to the
blocks and says that this is the kind of disjointed effort that
is produced by government and university research in general.
It is not just true in ALS, it has been true with what I have
seen in Gulf War illness.
So a comprehensive and coordinated program such as he
suggests is an excellent idea. And it is one that only people I
would say who have been outside of this what I would call
government academic complex with due apologies to my colleagues
here can understand. Unless you have been in the military or
you have been in the private sector, somehow it is not just
answering interesting questions that we are about here. It is
trying to achieve a goal. And the programs as they are
conducted, and this is not through any malice necessarily at
all, but just because of the nature of them don't accomplish
that.
I am not familiar with the details of the Federal--the VA
Gulf--ALS program, so I can't comment on that.
Mr. Hare. Thank you.
Dr. Nass. I would just agree with everything Mr. Binns has
said.
Dr. Steele. I as well.
Mr. Hare. Thank you.
One more question for the panel. We have had 16 years that
have passed and the veterans of the Gulf War are still fighting
to be recognized and not forgotten.
What would your recommendations be on how to effectively
improve Gulf War illness research, outreach, education, and
treatment?
Dr. Steele. Well, you have our 2004 report and we gave very
specific recommendations about the research arm of what you are
asking about.
Mr. Hare. Thank you.
Dr. Steele. Our next report will also give detailed
recommendations. But part of the issue was, as the General and
Mr. Binns raised, just having a comprehensive and well-planned
program to actually solve the problem instead of study little
pieces of it around the periphery. That is a major issue.
The other issue has to do with funding, of course. We have
seen so many dollars spent on Gulf War illness research over
the years. But as you have heard, a lot of it has gone down the
wrong alley.
And now that we are finally beginning to understand Gulf
War illness, it is really the time to put some more dollars
behind it, but put it in the right hands and put it into a
program that has managed to achieve results.
Mr. Binns. Let me take a----
Mr. Hare. Sure.
Mr. Binns [continuing]. Chapter from the--another chapter
from the General's message and offer you an answer and not just
a problem.
We now have, I think, a very good start on a comprehensive
Federal program. As I mentioned, VA has $15 million which is
what the Research Advisory Committee has recommendation
committed to this effort. And they have placed most of it in
the hands of researchers at the University of Texas
Southwestern who believe in the problem.
We now need to make sure that they do their job and develop
a comprehensive program. Their program is oriented toward
treatments. But in the long haul, that is the conventional
medical approach, scientific approach of understanding the
basic science, targeting what the underlying mechanisms are,
and ultimately identifying or developing treatments to address
that mechanism.
At the same time, thanks to Congress, not to the Department
of Defense, in 2006, a pilot program was started at DoD which
is looking at what you might consider the quick, less likely,
but quicker approach to developing treatments which is to see
if you have a treatment already on the books, on the shelf that
could work for this application.
And I am not suggesting you try treatments willy nilly, but
there are logical ways of approaching treatments to detect
which ones are promising and studying them.
As I mentioned, with this Congressionally managed proposal
put out, they received 80 proposals from researchers around the
country and some of them from other countries suggesting
treatments and diagnostic tests that could be tried.
So this program unlike many of the programs in the past has
a strategy that is promising and works. All that is needed now
is to fund it to balance the program that VA is funding at the
University of Texas.
The problem is this is actually the bigger piece. DoD has
funded two-thirds of research in the past and they are not
funding anything as of this minute.
So if you want to have a comprehensive program, you have
the makings of it. You just need to fund the $30 million in the
DoD budget to balance the $15 million in the VA budget and you
will have a very coordinated program.
Mr. Hare. Thank you, Mr. Binns. My time is out, but I would
like to, on my second round, Doctor, ask just a couple brief
questions. So, Mr. Brown?
Mr. Brown of South Carolina. Thank you very much for your
testimony. And if I might address this to Dr. Steele or anybody
can include in, but apparently one time, you worked with the
University of Kansas?
Dr. Steele. Kansas State University.
Mr. Brown of South Carolina. Kansas State. Okay.
Dr. Steele. I still do.
Mr. Brown of South Carolina. Okay. And, Dr. Binns, you
mentioned about Texas, a research program there. And I guess
that was one of the things that the General alluded to, that
apparently there is diverse testing around the country and who
has the umbrella to kind of digest all the results of these
tests.
And I was alarmed to find that in all the research, there
is not a data bank that monitors, you know, all the folks that
are involved with ALS. And I know that you all are addressing
other diseases besides ALS. But what can we do to kind of bring
some kind of oversight to the process so we can have, you know,
one path that everybody is traveling?
Dr. Steele. Are you asking me or Mr. Binns? Actually----
Mr. Brown of South Carolina. It was directed to you
primarily.
Dr. Steele. Thank you.
One of the charges to our Committee is to provide this
oversight of all the research related specifically to the
health of Gulf War veterans. The question about ALS, I believe
there is no such oversight Committee.
So we are in the position to monitor all of the research
related to the health of Gulf War veterans including ALS and
Gulf War illness.
Mr. Brown of South Carolina. I did not mean to interrupt,
but you are focusing--ALS is one of the Gulf War components,
right?
Dr. Steele. Yes. That is one of the diseases affecting Gulf
War veterans, correct.
Mr. Binns. Let me distinguish, though, between what we are
charged to do and able to do and with what, I think, you are
asking about, sir.
We are advisors. Dr. Steele has a staff of two other people
to look at a very large body of research and we can prepare
reports suggesting areas to look at. We conduct public hearings
and so forth.
What is necessary to achieve the goal you are speaking
about, whether it be for Gulf War illness research or for ALS
research, is a larger body of scientists who are focused on
doing that role full time and nothing else, who are not
conducting necessarily their own studies, but who are
assimilating and directing the studies of others. Nobody does
that in medicine today except for a very handful of people in
private organizations. And NIH may do this. I can say with
respect to Gulf War illness, nobody does it.
Mr. Brown of South Carolina. Yes. That would be my leading
question is, are you all applying for NIH grants to try to
further your research? Is that one of the money sources or you
just go to the VA and the DoD?
Dr. Steele. We serve on the Advisory Committee and we do
not do research ourselves in that capacity. I can tell you that
other researchers cannot apply to NIH for research funding for
Gulf War illness research. ALS researchers can apply to NIH in
some circumstances.
Gulf War illness research is handled exclusively by the
Department of Veterans Affairs and the Department of Defense.
And as you just heard, Department of Defense has not funded any
this year and the Department of Veterans Affairs only funds
researchers that are working at the Department of Veterans
Affairs.
So as a result, there are no widely available funds to do
research on Gulf War-related health problems.
Mr. Brown of South Carolina. I think you were here when I
made mention that we were able to get a million and a half
dollars earmarked for ALS, you know, Therapy Development
Institute and we asked for really four and a half million.
So we did that through an earmark, not from the DoD
recommendations. So I guess we could continue to try to support
the program through additional earmarks if enough Members, you
know, were involved in that process.
But we are looking for some kind of direction that we can
move forward. I know that ALS has been around predominantly for
70 years and the Gulf War has been around 17 years. And I know
there is a lot of fragmented research out there.
We are just looking for some way that we can get focused,
you know, just in one war. That is what we keep talking about
one war force, right? That is what we talk about in the
military now, one force.
So this is kind of what we are looking for here. If you all
could kind of give us some direction, we would appreciate it.
Dr. Steele. It is a very important issue. Unfortunately,
the two realms of ALS research and Gulf War illness research
are separate, but we do have specific recommendations for
providing funding for Gulf War illness research programs.
Mr. Hare. Mr. Moran.
Mr. Moran. Chairman Hare, thank you very much.
First of all, I would comment to Mr. Brown that there is a
difference between Kansas University and Kansas State
University.
Dr. Steele. There certainly is.
Mr. Moran. I will not take sides as to who is the leading
institution in Kansas, but they are different.
Mr. Brown of South Carolina. Kansas City.
Mr. Moran. Very good.
Let me say that we heard lots of compelling testimony, but
the testimony of Mr. Binns, you indicated in your written as
well as oral testimony, ``this government manipulation of
science and violation of law to devalue the health problems of
ill veterans is something I would not have believed possible in
the United States of America until I took this job.''
That is a very strong statement. It is very disturbing to
me. I have little doubt but that it is true, and I am confused
as to why that would be the case. Why is not everyone's
motivation here to find the right answers, cause and effect,
and to pursue a cure or treatment of the conditions that our
veterans find themselves in.
What is the systematic circumstances we find ourselves in
in which you believe that people systematically are trying to
avoid accurate information?
Mr. Binns. You have asked the $64,000 question,
Congressman. I do not know the answer. I can speculate, but I
think you could get better answers under oath perhaps from the
people who followed those policies over the last 15 years.
Obviously you can speculate that it has to do with either--
there is a whole long list, but I have no facts to back up what
they might be.
Mr. Moran. I always assume in life that people's
motivations are honorable and I would certainly think that is
the case when it comes to the care and treatment for men and
women who have served this country.
I can guess what people's motivation is, spending of money,
the priorities, budget, but just on balance, I cannot fathom
why we would ever take the position that we are trying to find
a lack of cause and effect. I mean, we ought to have scientific
research based upon science, on a neutral initial position.
I suppose I would argue that if there is a bias to be had,
it would be in favor, if there is uncertainty, that we as
policy makers, not those as scientists, ought to be making
decisions based upon the bias toward our veterans. Science
ought to be providing us with the evidence, the accurate
evidence so that we can make intelligent decisions.
Mr. Binns. If I may just comment further, I think the
attitude on this goes in waves and I think that in the post
Vietnam era, there was clearly an attitude on the part of many
who were managing Federal policy in this area that was also
oriented toward denying and delaying and minimizing this
problem. It took over 20 years for Agent Orange to be
acknowledged as a problem. Now we know it was a very serious
problem.
I think that part of what happened in the Gulf War is that
the same philosophy, perhaps some of the same individuals were
involved in the government at that time. Just in the last 6
months, there has been a renewal of the commitment of the
country brought about, I think initially, by newspaper
reporting, but certainly by the attitude of Congress, which I
am sure will be reflected in the Federal bureaucracy as that
message gets delivered to them.
But I know that for the last--well, even this Committee has
held hearings in the past, it has been, I think, more than 5
years because I have been Chairman of this Committee for more
than 5 years and I was delighted to get called here.
So the interest in veterans' health begins at Congress. We
have seen everything that has happened that I described that is
good has been because Congress is interested.
Mr. Moran. The last hearing that either the full Committee
or this Subcommittee had in regard to Gulf War illnesses was in
2002.
Dr. Nass, you seem to want to respond to my comments.
Dr. Nass. Thank you. Yes.
I actually made a memorandum written by Mr. Ross Perot
available to Chairman Michaud. I cannot tell you where the
initial impetus comes to misdirect research and minimize
benefits for veterans.
But what I can tell you is that a small group of people
were promoted and were switched around between VA, DoD, CDC,
but that this same group has managed to push the theory that
stress was the cause of Gulf War illness and to minimize it.
And Perot named names and talked about a meeting that was held
in which these people were given the order that the cause of
Gulf War Syndrome that you are to promote is going to be
stress.
Mr. Moran. Dr. Steele indicated that the scientific
evidence of that conclusion is clear and it is not stress
related. I believe that is what you are telling us.
Does the attitude that it is stress related still prevail
within DoD or the VA?
Dr. Nass. There is a lot of confusion. As I said, a VA
doctor told the patient who met the CDC criteria for Gulf War
Syndrome that she did not believe it existed.
There continue to be articles published in the literature,
repeatedly, by people who have been funded by VA and DoD which
minimize, obfuscate. These articles claim we are seeing the
same diseases we saw after every war. Yet the fact that 25
percent of Gulf War veterans remain chronically ill is
unprecedented. Such articles are just designed to confuse the
issue.
Mr. Moran. I guess Mr. Binns has testified as to that
attitude still prevails. It is just a normal occurrence?
Mr. Chairman, I know my time is expired.
Let me ask if there is any different attitude between the
VA and the DoD? Is this a monolific circumstance or there is a
different approach depending upon whether you are at DoD or VA?
Mr. Binns. There is a different approach within VA. The VA
Office of Research and Development has changed its attitude,
but the Office of Environmental Hazards has not.
Dr. Steele. And it is also not the same top down. Some
people within DoD understand the science and some have really
not looked into it and perhaps still minimize these problems.
Mr. Moran. Dr. Steele, thank you for joining us today. As a
fellow Kansan, I appreciate your efforts in our home State.
Dr. Steele. Thank you.
Mr. Moran. Thank you, Mr. Chairman.
Mr. Hare. Thank you, Mr. Moran.
Dr. Nass, I just have a couple quick questions for you that
I wanted to ask before. You acknowledge the symptoms of Gulf
War are not unique and that they relate closely with other
diseases, conditions, and syndromes.
Just a two-part question here. Could you describe the
health effects, if there is a typical case--I do not mean to
say that every case is the same--but a typical case of Gulf War
illness and how do you treat a patient that is suffering from
Gulf War illness?
Dr. Nass. Yes. The typical case meets the CDC definition
which is they have a widespread pain syndrome, pain
amplification. They hurt in odd places. You cannot find tissue
damage and if they do have tissue damage, you know, if they
have an injury, they hurt ten times more than a normal person
would.
They have cognitive problems which have been documented in
repeated neuropsychological studies. They have problems with
memory, focus, attention, concentration. They frequently have
psychiatric problems.
The patients I see tend to have labile affects. They cry
easily. They are easily upset. They are not able to control
themselves in public the way most of us can.
In addition, very frequently, they have chronic diarrhea.
They frequently have chronic respiratory problems. And then
there are a range of--they are fatigued. Almost all of them are
fatigued. They are stiff.
Some of them have frank musculoskeletal disease so that the
Vaccine Healthcare Center came up with a case definition of an
Anthrax vaccine-associated muscle disorder, in which muscle
enzymes were elevated and the muscle did not function well and
people hurt.
The Vaccine Healthcare Center doctors worked with CDC, but
somehow they never published a case definition. And when I
asked one of the doctors at CDC who is responsible for some of
this type of research, he tried to tell me that CDC was
completely uninvolved with it. So they wanted to bury this.
They did not want anyone to know that these exposures actually
may cause some new illnesses.
In addition, as Lea said, I agree with everything Lea said
about this, you may see a variety of autoimmune and
neurological illnesses that are occurring at what appear to be
higher rates. So I have been in touch with three people who had
shrinking of their cerebellum, for instance, part of the brain.
But we do not have good data to look at the rates, and be
able to define what the rates are of these various individual
conditions within the Gulf War population, or within military
populations. And I think there are reasons for that, and that
they are related to the overall obfuscation of Gulf War
illness.
Congress directed the military to maintain databases of
exposures, of troop movements, of illnesses and created a
defense medical surveillance system back in the late 19nineties
in which all the services' data would be linked.
However, at least three different people have looked at the
accuracy of these records and found that the error rate varies
from ten to thirty percent and sometimes is greater.
Mr. Hare. Doctor, I do not want to interrupt you, but could
you tell me how do you treat----
Dr. Nass. Sure.
Mr. Hare [continuing]. A patient that is suffering from----
Dr. Nass. All I know how to do, and most other people who
are doing this also, go symptom by symptom--so that if they
have chemical exposures that they are sensitive to, you teach
them about that condition and have them avoid the noxious
exposures which can make them acutely worse for a period of
time.
If they have diarrhea, there may be causes that are
treatable. Some people have abnormal gut flora that you can
treat with antibiotics or anti-yeast medications. There are
other medicines that will frequently control the diarrhea. They
all have sleep disorders. You find medication that helps them
sleep.
And it is a combination of piecemeal interventions--trying
to work on every one of these symptoms and trying to teach the
patients how to choose a lifestyle that will allow them to live
better, teaching their relatives about it, educating them that
it is a real syndrome and people should not think they are
crazy. And you can improve their function maybe 30 or 40
percent, but they certainly do not get cured.
Mr. Hare. Thank you, Doctor.
I want to thank the panel for taking the time to be with us
this morning and I appreciate your testimony. Thank you very
much.
Dr. Nass. Thank you.
Mr. Hare. We are going to bring up the third panel. While
we do, I am going to recess the hearing for about 5 minutes and
then I will be right back. Thank you.
[Recess.]
Mr. Hare. The Committee will now reconvene.
Our third panel is Dr. Lawrence Deyton, the Chief Public
Health and Environmental Hazards Officer, Office of Public
Health and Environmental Hazards, U.S. Department of Veterans
Affairs.
He is accompanied by Dr. Mark Brown, who is the Director of
Environmental Agents Service, Office of Public Health and
Environmental Hazards, U.S. Department of Veterans Affairs.
And Dr. Timothy O'Leary, who is the Director of Biomedical
Laboratory Research and Development Service and the Director,
Clinical Science Research and Development, Office of Research
and Development, U.S. Department of Veterans Affairs.
And Dr. Eugene Oddone?
Dr. Oddone. Correct.
Mr. Hare. Dr. Eugene Oddone, who is the Director for the
Center for Health Services Research in Primary Care. He is a
Principal Investigator of the National Registry of Veterans
with ALS, U.S. Department of Veterans Affairs.
Let me thank you all for coming this morning. I look
forward to your testimony.
And, Dr. Deyton, we will start with you. Thank you.
STATEMENT OF LAWRENCE DEYTON, MSPH, M.D., CHIEF PUBLIC HEALTH
AND ENVIRONMENTAL HAZARDS OFFICER, VETERANS HEALTH
ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS;
ACCOMPANIED BY MARK A. BROWN, PH.D., DIRECTOR, ENVIRONMENTAL
AGENTS SERVICE, OFFICE OF PUBLIC HEALTH AND ENVIRONMENTAL
AGENTS SERVICE, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT
OF VETERANS AFFAIRS; TIMOTHY O'LEARY, DIRECTOR, BIOMEDICAL
LABORATORY RESEARCH AND DEVELOPMENT SERVICE, AND DIRECTOR,
CLINICAL SCIENCE RESEARCH AND DEVELOPMENT, OFFICE OF RESEARCH
AND DEVELOPMENT, VETERANS HEALTH ADMINISTRATION, U.S.
DEPARTMENT OF VETERANS AFFAIRS; AND EUGENE ODDONE, M.D., MHSC,
DIRECTOR, CENTER FOR HEALTH SERVICES RESEARCH IN PRIMARY CARE,
PRINCIPAL INVESTIGATOR, NATIONAL REGISTRY OF VETERANS WITH ALS,
VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS
AFFAIRS
Dr. Deyton. That is quite all right. Thank you very much,
Congressman Hare, Congressman Brown. And I know Congressman
Moran had to leave. Thank you for the opportunity to be here
this morning to talk about these very important issues.
First, I think we all have to and want to express our honor
and are moved by the experiences and examples of the veterans
we heard from on our first panel this morning.
I must, and really want to, respond specifically to General
Mikolajcik's moving testimony. I am an active clinician in the
VA healthcare system. I help care for persons living with ALS
and I have some appreciation of the struggle such a
catastrophic condition brings to a person and to their family.
We all need to pay attention, very careful attention to the
challenges the General has laid down before us today. That the
General has so selflessly dedicated his energies to educating
all of us about ALS inspires me and I know inspired Secretary
Nicholson when they met recently.
General Mikolajcik's service makes me all the more proud to
serve him and all of our veterans, and I thank you, General,
for being here today.
My written testimony, Congressman, addresses three major
topics. First is VA's efforts to improve clinical care and our
understanding of the illnesses affecting veterans who served in
the 1991 Gulf War.
Second, how these efforts have helped us respond to the
healthcare needs of our troops fighting in this same region
today.
And, third, VA's response to concerns about potential
increased risk of ALS among military servicemembers.
As you are well aware, Mr. Chairman, every conflict in
which our troops take part has the potential of both short-term
and long-term health effects for those involved. The possible
short-term health effects are the obvious risks of the battle.
The risk of longer term health effects are manifold and
sometimes emerge years or even decades later. Those risks may
be related to many factors including exposures to toxic
substances, some of which are known, others not, but may have
their health effects emerge years or decades later.
VA has learned from past conflicts that the sooner we can
collect health information on our troops and our veterans, the
sooner we can initiate epidemiologic surveillance and well-
designed studies on these populations of servicemembers to
understand the longer term health effects of combat and
establish a solid foundation of knowledge upon which we can
build a coherent health program for our veterans.
I hasten to add the mission of combat is to accomplish the
tasks assigned and protect our troops. Thus, the battlefield is
a poor source of epidemiologic information. So we, the
healthcare team caring for our veterans years later, are
frequently left with less than perfect knowledge with which to
understand those exposures to which these brave men and women
have endured during their service.
That less than perfect knowledge may hinder our
understanding of the cause of some of the health problems, but
it does not keep us from providing world-class healthcare to
our veterans then and now.
In order to better understand the health effects of the
1991 Gulf War, in 1992, VA established a Gulf War Veterans
Health Examination Registry which offers comprehensive physical
examinations and collects data from those veterans who
participate.
As of June of this year, over 100,000 Gulf War veterans
have enrolled in the Gulf War Registry and it continues to make
new enrollments every day. In fact, over 7,000 veterans from
the current conflict have enrolled.
Mr. Chairman, while registries help us reach out to the
veterans and help us better characterize their health status,
registries cannot replace well-conducted epidemiologic or
biomedical studies of the health effects reported by those
veterans. Thus, VA has initiated multiple epidemiologic and
biomedical research studies to allow us to continue to provide
knowledge on Gulf War related illnesses both to veterans and
their families as well as to educate our clinicians.
Mr. Chairman, as the first Gulf War conflict ended, we all
learned and worried about veterans returning from that theater
with hard to diagnose, multi-system complaints. To better
understand the causes and identify treatments, VA has funded
the epidemiologic and biomedical research I just mentioned and
also has established war-related illness and injury study
centers to provide specialized healthcare for those veterans
with difficult to diagnose or undiagnosed but disabling
illnesses.
These centers have assisted many veterans and have
contributed significantly to the medical literature on both the
diagnosis and treatment of these real but vexing clinical
situations.
One of the most important responsibilities we have in VA is
to assure our veterans and their families are aware of the VA
programs and information about how we can assist them with
their healthcare needs. Thus, for our veterans who served in
the first Gulf War, VA publishes and mails to over 400,000
veterans the Gulf War Review Newsletter and has also
distributed over a million copies of a brochure summarizing VA
benefits.
General Mikolajcik, with his moving testimony and his
dedication to improve veterans' healthcare needs leads me to
conclude my statement with some comments about VA's action in
relation to ALS.
Mr. Chairman, VA became aware of reports of possible
increased incidence of ALS among veterans in 2001. In that
year, VA implemented a policy for referring Gulf War veterans'
ALS disability claims to VA's central office for review and
special consideration.
Since that time, VA's continued concern about possible
increased incidence of ALS among veterans led us to create a VA
ALS registry which has enrolled nearly 2,000 veterans.
In addition, VA has initiated multiple research projects to
improve the diagnosis and treatment of ALS. And in 2005, VA
asked the Institutes of Medicine to conduct an independent
review of the scientific basis of all the relevant studies on
ALS to help us determine the validity of the evidence
connecting ALS and military service.
The results of that report concluded that although there
are very few relevant studies which have been completed and
there are significant limitations in the studies which have
been conducted, the Institute of Medicine concluded there is
limited and suggestive evidence of an association between
military service and later development of ALS.
In response to that IOM report, Secretary Nicholson
convened a task force to review the IOM's assessment. That task
force has completed its review and Secretary Nicholson wants
the Committee to know that all veterans who have or suspect
they may have ALS, VA treats veterans with ALS. ALS is a
catastrophic disease and veterans with significant impairment
are eligible for priority category four which will assure they
have access to VA healthcare.
It is the Secretary's view that the question of whether ALS
should have presumptive service connection still requires more
research. While preliminary studies as cited by the IOM show
there may be some association, the research is not extensive
enough to be conclusive.
The Secretary would like more research to see if a strong
correlation exists and he has directed us today to help conduct
that research.
Again, I want to thank you for calling this hearing. There
are many topics that we have discussed today. And I want to
particularly thank General Mik for his continued service to our
Nation and to our veterans.
That ends my oral statement. I am happy to take any
questions, sir. Thank you again very much.
[The prepared statement of Dr. Deyton appears on p. 61.]
Mr. Hare. Thank you, Dr. Deyton. Mr. O'Leary?
Mr. Hare. Just Dr. Deyton. I am sorry.
Mr. O'Leary. I did not come with a prepared statement, sir.
Mr. Hare. Pardon me?
Mr. O'Leary. I did not come with a prepared statement.
Mr. Hare. That is fine. This is my first hearing that I am
chairing, so you will have to bear with me for my errors.
Okay. Thank you.
I just have a couple questions here. The Gulf War
Newsletter which is a publication that the VA initiated to help
veterans of the Gulf War and their families be more aware of VA
healthcare and other benefits, it is reported that that
newsletter has not been mailed out for over a year.
And I was wondering what have you done to ensure that the
outreach to Gulf War veterans is being done on a regular basis,
that that outreach is.
Dr. Deyton. The Gulf War Registry is continuing. It is a
very important publication for us and it is continuing to be
released. Dr. Brown helps run that--he can provide a specific
response.
Dr. Brown. Yes. The last publication was July of 2006. We
expect to come out with the next edition of that at the end of
the summer. It is in preparation now.
Mr. Hare. Thank you.
Because they suffer from a multitude of illnesses, the
treatment of Gulf War veterans is by most accounts pretty
complex. I think we could all agree.
When you heard Anthony Hardie in his testimony today state
that the VA's Office of Public Health and Environmental
Hazards' Web site contains little information that might be of
any use to Gulf War veterans and/or their health providers,
could you tell the Committee what type of training or
continuing medical education requirements are in place
currently at the VA to ensure healthcare professionals have the
most current and up-to-date information of the Gulf War
illness?
Dr. Deyton. Yes, sir. As I said, I am a practicing
clinician in the VA system and I think the theme that we have
heard from all the panelists today is that there is much more
knowledge needed in all of these areas, more research needs to
be done to better understand.
So as a practicing physician, I want to know everything I
possibly can so I can treat my patient who comes into my clinic
complaining of some of those multiple system complaints that
Dr. Nass so specifically told us about on the last panel.
And so we have developed multiple education tools for VA
clinicians, for veterans and their families as well, to help
understand that long list of multi-system illnesses and
diseases that could compromise a veteran's health.
There is a Veterans Health Initiative Program that our
office runs that has consolidated what knowledge we know and
are continually updating that knowledge as more research is
revealed about both the symptoms, the diagnoses that might be
applied to those symptoms, and the possible treatments for that
long list of symptoms.
And I think Dr. Nass really hit the nail on the head. You
really have to go through a very long list of clinical
possibilities, take them one at a time, and examine each one
fully and do the right diagnostics and try and treat them one
at a time.
Mr. Hare. Let me ask again, Dr. Brown, are there other
clinical education components that we provide to VA providers
and the public?
Dr. Brown. Yes. It is a good question. I think we see
outreach to veterans and their families and we see education of
our healthcare providers as a top priority about veteran health
issues in general and about issues surrounding Gulf War
veterans, those who served in the 1991 Gulf War, and
unexplained illness as a specific health issue.
And it is a long list. I would invite you to take a look at
our Web site at www.va.gov/environagents and there is also a
Web site specifically for Gulf War. And you can see some of
these products.
We have, for example, this issue of unexplained pain and
unexplained fatigue that you heard from some of the previous
panels is a problem with veterans of the 1991 Gulf War. And so
we pulled together what is called a clinical practice guideline
which is essentially a tool kit for our healthcare providers to
give them information about how to respond to these illnesses
that we developed that is up on that Web site.
Another example you heard somebody mention earlier concerns
brain cancer among some troops that were around where some
chemical weapon munitions were blown up at the end of the war,
when the 1991 cease fire was declared. There is some data now
showing that some of those exposed may have greater risk for
brain cancer. As Dr. Steele mentioned, it is a rare disease
fortunately. But for those who it affects, it is obviously
extremely serious.
We have information letters talking about the background
and the medical issues surrounding that that a healthcare
provider could read and that also a veteran and his or her
family could also read.
I think if you look at our Web site, it may be that not
everything is absolutely up to date as it possibly could be and
that is something that we are continuing to work on, but I
think we try to cover a wide range of health issues that are of
interest to veterans and their families.
You received written testimony submitted for the record
from Mr. Fahey, depleted uranium which is another concern of
veterans and their families. We have background information on
that. We also have information on vaccines and so forth.
I suppose the problem that we face is that there are so
many risk factors that people have looked at that it is a
challenge to keep up with it, but I think it has been helpful.
Mr. Hare. I know I am out of time, but just one question
and then a comment.
Dr. Deyton, the General spoke this morning about an ALS
task force. I think it is a wonderful idea and having the lead
agency and, the other two items, the money and the other things
that are necessary.
I wanted to know what your thoughts might be on that and do
you believe that VA is taking--what direction you think the
VA--if you think they are taking the right direction on ALS
along the way.
Dr. Deyton. I think General Mik's suggestion is very sound.
And to have cross-agency, public and private communication and
coordination to make sure all the bases are being covered and
being done in a consolidated, organized way is brilliant.
And so both officially from a VA point of view, I cannot
commit for the department, but I can tell you we would be at
that table and wanting to be a major player in assisting with
that task.
Mr. Hare. Thank you, Doctor. Mr. Brown?
Mr. Brown of South Carolina. Thank you very much and we
certainly appreciate your testimony. And it has been a real
interesting dialog as we had the three panels.
But my question would be that the Gulf War veterans are
considered a disability if they contract ALS. Why would not all
veterans be qualified with a disability compensation if they
have ALS?
Dr. Deyton. Certainly any veteran who has the diagnosis of
ALS or other disabling condition like that can come to VA for
healthcare. When I spoke with the Secretary's office this
morning and my own feeling as a practicing clinician, we want
to make sure those veterans know they can come and should be
coming to VA for their care.
With the disabling conditions, they would likely be
categorized in priority category four which is a higher
priority so that they would be sure to get the medical care
that they need.
The issue raised about all veterans and their increased
risk of ALS is very complicated. I personally agree with the
findings in the Institute of Medicine's report that there is an
association that has been demonstrated by scientific research.
The Institute of Medicine also went on to say they could
not attribute any known factor to that increased risk. And we
heard on the first panel, particularly, several cogent
arguments for what those factors might be.
General Mik's point is exactly right. We need the research
to be done to help nail down what the etiology is and, very
importantly, a parallel path development of effective
treatments and effective diagnoses.
The whole point is to establish a diagnosis before there is
serious irreparable damage to the nervous system. So how do we
find men or women who might be developing this and intervene
immediately to preserve their neurologic function before there
is any major deficit?
I think the ALS registry that VA has started and Dr. Oddone
has been running is a very important tool. The research that VA
has been conducting in ALS both in diagnostics as well as in
treatments for ALS and other like diseases is very important.
And, again, back to General Mik's point of view. Having a
consolidated cross-government, public-private communication
about these issues, I think, would be very important. And,
again, VA would welcome the opportunity to participate in that.
Mr. Brown of South Carolina. You heard the testimony when
General Mik said that it was 2 years before, I guess, before he
was able to get some consideration after basically he was
diagnosed.
The other members of the military that come down with ALS,
how long before they are eligible to be treated as a class
four, do you know?
Dr. Deyton. That is a good question, sir. I think that that
depends upon the diagnostics and the degree of impairment that
that particular individual would have. So at the point of a
diagnosis of ALS, relatively significant impairment would
likely have occurred and they would be eligible at that point
based on that impairment.
Let me ask Dr. Oddone. Maybe you have some other factors or
perspective on that.
Dr. Oddone. Yeah. I think it is like General Mik said. One
of the difficulties with ALS is that there is not a single
diagnostic test that confirms the disease. And so it is time
often a second opinion, the experience he had where he had a
first physician that said this looks like it could be this, but
I would like you to get a second opinion.
And so all of those sort of delay in time, unlike you would
get with a heart attack or something like that where it is
pretty clear. There is a marker in the blood that tells you
what it is. There is an EKG that tells you what it is. It is
not that clear always in ALS and so the process takes time.
I cannot answer how that might affect policy.
Mr. Brown of South Carolina. I am just concerned. I know
that one of the things he also requested was some kind of a
common data bank and that we do not have one available.
Dr. Oddone. Sir, you know, I think one of the reasons that
the VA funded the registry was to do that, was to try to
collect as complete as possible a group of veterans who have
developed the disease. That started in 2003, pretty soon on the
tail of when we found out that there was an increased incidence
of the disease in veterans who were deployed to Persian Gulf
War.
And so one of the purposes of that was, A, to do several
things. One, do more in-depth studies about cause and etiology
of the disease and several of those are ongoing now.
Second was to provide a collection for those veterans so
that when we would find out about treatments, that we would
know how to let them know about those.
Mr. Brown of South Carolina. And I guess my question is, if
we have got the data bank and we are actually using it, we
ought to be able to have some method to be able to determine
early detection. Even if you do not have a treatment, we ought
to be able to at least not have to have someone wait for 2
years before we recognize, you know, in effect, he has been
inflicted with that disease.
Mr. O'Leary. If I may address that, sir. I think that VA
research actually has a pretty coordinated and comprehensive
approach to this problem of ALS, looking at causes, earlier
diagnosis, methods to retard the progression of the disease,
research on the use of adult stem cells to perhaps reverse some
of the effects of the disease, and, then finally, for those
people that are suffering very badly, to palliate the effects
of the disease and help them to cope more effectively.
I think there is some very promising research that has been
done on the development of early biomarkers which in
combination may provide a clue that would allow us to reach a
diagnosis much, much earlier in the disease.
Having said that, it is relatively early research. It needs
some confirmation. It needs some time to prove that it is true
because not every exciting research finding turns out to be
confirmed in later studies.
But if this does prove to be true, it would be quite useful
because that earlier diagnosis gives us the possibility then to
intervene in the disease before so much destruction has
occurred. And I think that is a really, really critical goal
for us to achieve.
Mr. Brown of South Carolina. To the benefit side, what
would it take to trigger allowing members of the Armed Services
that contract ALS to become eligible for disability payments
early on rather than wait until it is too late?
Dr. Deyton. That is a complex question, sir. Let me try and
I want to answer it in a couple different----
Mr. Brown of South Carolina. It is not a large number,
right?
Dr. Deyton. I am sorry.
Mr. Brown of South Carolina. It is not a large number, is
it, outside of the Gulf War?
Dr. Deyton. I do not know what the number would be. Dr.
Oddone might----
Dr. Oddone. I do not have a census. I know how many
patients are in the registry. It is nearly 2,000 patients in
the registry. At the beginning of the registry, we made some
estimates about how many veterans we would have based on the
total U.S. veteran population and we anticipated that it would
be between 1,500 and 2,500 veterans at any given time.
Mr. Brown of South Carolina. So we are not talking about a
tremendous amount of money, right?
Dr. Deyton. I do not know how much money it would be, but
it is really not the money. It is the right thing to do for the
veteran.
Mr. Brown of South Carolina. That is my question and I am
just trying to justify a good answer from you all.
Dr. Deyton. I am sorry. Ask the question again.
Mr. Brown of South Carolina. Okay. My question is, what do
we have to do to be able to qualify those veterans that are not
involved with the Gulf War that come down with ALS? I mean, how
can we qualify them for immediate benefits?
Dr. Deyton. The Secretary has the authority to grant
presumptive service connection to any category that he or she
wants. Congress could also enact a requirement for us to do
that.
Mr. Brown of South Carolina. Well, I do not know if we have
got a bill that could track with that. Could you all persuade
the Secretary maybe to do the right thing?
Dr. Deyton. And the good news is that the Institute of
Medicine report that we requested that they do to look at the
evidence is in the Secretary's hands. He has read it and his
statement today is very clear that he wants to invest in the
research necessary to understand that connection better and
better. And so we will be doing that.
Mr. Brown of South Carolina. And maybe he could do that as
his parting action. That would be great.
Thank you all very much.
And I apologize, Mr. Chairman, for overextending my time,
but this has absolutely been a great dialog.
And thank you all for participating.
Mr. Hare. Thank you, Mr. Brown.
Mr. Brown, I would not apologize at all. I think your
questions were wonderful and thank you for hanging in with this
rookie this morning.
Let me just close by thanking everybody that came this
morning and into this afternoon.
I just want to say a couple things. If you would please
convey to the Secretary the appreciation that I have in terms
of the level four for ALS patients.
I have said on this Committee many times, and I know I am a
freshman Member, but my opinion is I believe that we have a
fundamental responsibility to do everything that we possibly
could do for our veterans regardless of when they served, where
they served, what branch they served in.
I cringe sometimes when I hear how are we going to afford
it because to me, the question should be not how are we going
to afford it. The statement ought to be we cannot afford to not
do this.
I believe for people like General Mik and for other people
and for the other witnesses that testified, the Gulf War vet
that is still here with us, I think we have a moral obligation
to do everything that we possibly can.
I hope that as we move down the road, and I talked to my
friend here and colleague, Mr. Brown, about what we can do to
try to help the General and other patients with ALS and coming
up with the necessary funding. I always hope that we will err
on the side of the veteran first and foremost and then worry
about how we are going to figure it out on the other side
because it is the right thing to do and, it sends an incredibly
poor message, I think, if we make the veterans have to go
through hoops that they simply cannot go through, cannot make
it through, or we do not give them the information that they
need to be able to get the kind of help that they are so
desperately in need of.
So, you know, from this, I guess, very freshman Member of
this Committee, I would hope that you would convey to the
Secretary my sincere desire that--you know, I think Mr. Brown
brings up a good point. Before he leaves, this would be a
wonderful way, I think, of his leaving and to the new
Secretary, whoever he or she may be, that we really lead by the
presumption on our vets, that they are our best and our
brightest and that we do have this moral obligation.
And, you know, we will figure out the money. I know we have
PAYGO, but these are people who have given everything they
have. And when you see somebody like General Mik--I am sorry.
Brigadier General Mikolajcik. I wondered, Mr. Chairman, if
I could I make another statement.
Mr. Hare. I was a Sergeant. You are the General, so go
right ahead, sir.
Brigadier General Mikolajcik. The VA talked about, we help
all veterans that have ALS. Well, in my support group in
Charleston, there is a veteran by the name of Tech Sergeant
George Jarrell. He spent 24 years in the Air Force, served in
Vietnam. He was on duty during the Gulf War, but not in the
Gulf War. Because he is categorized as category eight, he did
not even get as much help from the VA as the blocks on the
table I had, nothing.
There is a huge difference between service-connected
disability and just being a veteran. And we can continue to do
more studies. This town is great for them. But it is time to
make a decision. Secretary Principi had courage when he took
the data that he had and moved forward and said we are going to
grant service-connected disability. And I think as the Chairman
has just said, we owe that to the rest of our veterans. Forget
the studies. Make a decision and help them.
George has had to mortgage his house to put a ramp into it.
Congressman Brown and his office had gone to the VA in
Charleston to get him an appointment and he still does not have
it.
I am sorry to be so emotional, but my emotion is honest.
Thank you, sir.
Mr. Hare. Thank you, General. Again, thank you for being
here and your courage is incredible and your voice in terms of
standing up for veterans is wonderful. And this Nation owes you
a tremendous debt of gratitude not just for the service that
you had but for what you are doing now. And I want to thank you
on behalf of the Committee and I appreciate your wife coming
with you.
And, you know, I hope I have done a fairly decent job of
chairing this meeting this morning. And when Congressman
Michaud gets back, if you would tell him that I did not mess it
up too bad, I would be honored.
But I thank you all very much for coming. And with that,
the hearing is adjourned. Thank you very much.
[Whereupon, at 12:29 p.m., the Subcommittee was adjourned.]
A P P E N D I X
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Prepared Statement of Hon. Phil Hare
The Subcommittee on Health will come to order. I would like to
thank everyone for coming today.
Regrettably, Mr. Michaud, the Subcommittee Chairman had an
emergency and is unable to be here today.
During this hearing today, the Subcommittee will examine Gulf War
exposures of veterans, the incidence of ALS among Gulf War veterans and
most importantly, where is the VA in conducting continuing research on
Gulf War One exposures and what are they finding out about the current
exposures in OEF/OIF veterans.
Many of the veterans who served in the Gulf War were exposed to a
variety of potentially toxic substances during their deployments.
According the Research Advisory Committee on Gulf War Veterans'
Illnesses more than 16 years after the end of Operation Desert Storm, a
substantial proportion of veterans continue to experience chronic and
often debilitating conditions characterized by persistent headaches,
cognitive problems, somatic pain, fatigue, gastrointestinal
difficulties, respiratory conditions, and skin abnormalities.
The Department of Defense and VA together have spent $260 million
on Gulf War illness research. While there have been numerous studies
and much research conducted on Gulf War Illness, there are still many
unanswered questions.
Another aspect of Gulf War One service is ALS. ALS is a progressive
and nearly always fatal disease that affects a person's nervous system.
According to the Institute of Medicine's Amyotrophic Lateral Sclerosis
in Veterans, Review of the Scientific Literature, there is limited and
suggestive evidence of an association between military service and
developing ALS.
Additionally, in a study sponsored by the Department of Veterans
Affairs in 2003, researchers identified that the incidence of ALS in
veterans deployed to the Gulf was twice as high as the incidence of the
disease among those who did not go to the Gulf.
I look forward to hearing from our panelists on these very
important issues.
Prepared Statement of Hon. Henry E. Brown, Jr.
Good morning. Chairman Michaud and Ranking Member Miller I want to
thank you for holding this hearing to discuss important issues that
have impacted many veterans, within my state of South Carolina and the
Nation as a whole, who have served their country during the Gulf War.
As a Member of this distinguished Subcommittee, it is my duty--it is
our duty to provide our Nations veterans with access to the best heath
care possible. It is our duty, perhaps even a moral responsibility for
us here today, on this Committee to help those brave veterans who have
helped defend our great Nation.
Today, I have the distinguished and dignified honor of introducing
someone who answered the call of duty by helping his country when it
needed him the most; and today he comes before us and asks for our
help. His name is Brigadier General Thomas Mikolajcik. For many years,
my personal friend and great American hero, Gen. Mikolajcik, or Gen.
Mik as he is known by those closest to him, has been a leader in the
Charleston community. First, as the commander of the C-17 wing based at
the Charleston Air Force Base, and then as an active contributor to the
Charleston Chamber of Commerce's military relations activities
following his retirement in 1996.
While General Mik's dedication to the Charleston community would be
noteworthy in any case, it is even more impressive when one realizes
that his focus on the needs of his community come at a time when he is
suffering from a debilitating and deadly disease. In 2005, General Mik
announced that he had been diagnosed with Amyotrophic Lateral Sclerosis
(ALS). While many individuals would have immediately withdrawn under
the pressure and impact of ALS, the General used it as an opportunity,
and with much resolve and endurance doubled his efforts and dedication.
In addition to continuing his commitment to the Charleston community,
the General has devoted a great deal of attention to raising awareness
within the community of ALS and improving the quality of life for ALS
patients and their families. Thanks to his efforts, a new ALS
Association chapter was formed in South Carolina, and the only ALS
clinic in the state was founded at Charleston's Medical University of
South Carolina. General Mik is truly an inspiration to many throughout
the Charleston community, continually thinking of others despite the
grave challenges he faces.
Numerous studies have shown that individuals who have served in the
military have a high propensity toward being diagnosed with ALS. While
the Department of Veterans Affairs has identified ALS as a Gulf War I-
related disease, cases abound that show the spread of this disease
among veterans is much broader. Indeed, a recent study showed that
veterans of all conflicts have a 60 percent higher chance of being
diagnosed with ALS than the general population. It has been nearly 70
years since Lou Gehrig made his famous speech and retired from baseball
after contracting this horrific disease, and it has been nearly 17
years since the end of the first Gulf War; and yet little has been done
about this disease and even less is known about its causes. The work of
General Mik has also brought to my attention the growing number of
veterans contracting ALS outside of service during Gulf War I. My
office is aware of a number of cases in my district from veterans who
have developed ALS where the VA has denied their claims because their
service was not within the presumptive timeframe of August 2, 1990
through July 31, 1991. We don't have a good handle on how many non-Gulf
War I veterans have contracted ALS, what military-related risk factors
exist, or what we can do to decrease the chances of ALS among our
veterans and military service men and women. This issue is of special
concern as we continue to have troops deployed in OEF/OIF.
The story of General Mik serves as a testament to the need for
leadership at the Federal level toward developing a comprehensive ALS
research program and a clear VA/DoD policy ensuring that all veterans
with service-connected-ALS receive the attention they deserve,
regardless of whether or not they served during Gulf War I. We need an
agency to step up to the plate and lead Federal research into the
causes of ALS and how we can better improve its treatment. Most
importantly, we need to begin these efforts NOW, before more veterans,
including General Mik, succumb to ALS.
Prepared Statement of Brigadier General Thomas R. Mikolajcik,
USAF (Ret.), Mt. Pleasant, SC
Chairman Michaud, Congressman Brown and Committee Members, thank
you for this opportunity to testify.
My name is Tom Mikolajcik. I am neither an MD nor a PhD. I am a P-
A-L-S. A patient with ALS.
I was diagnosed in October 2003. I was given a death sentence . . .
and told to get a second opinion, while given a prescription for
Rilutek which has limited value. Only by the Grace of God am I here to
speak with you today. . . . And I have vowed to keep speaking until I
no longer can.
Military veterans, like me, face a higher risk of this relentless
killer. Fifty percent die in 1 to 3 years, another 20% die within 5
years and only 10% may live to 10 years. It was learned in 2001 that
Gulf War veterans have two times the incident rate of the general
population. We discovered in 2005 that all veterans dating back to
World War II have 1.6 times the incident rate of the general population
for developing ALS.
Four short years ago, the VA opened its voluntary ALS Registry. It
registered 1,993 veterans suffering from ALS. I am sad to say, and it
is unacceptable to me, that only 969 (less than 50%) are still alive
today. And, ladies and gentlemen, that also means that somewhere
between 1 out of 15 and 1 out of 30 ALS patients are military veterans.
The government must step up to the plate on this issue!
We are currently exposing 100's of thousands more service members
to the elevated risk of this disease. There will be young men, women,
and families celebrating a return from Iraq and Afghanistan alive, who
have no idea that they may soon be facing a certain death from ALS. We
will have to answer those families when they ask what the government
has been doing to prepare for this onslaught. For this reason, the
government is compelled to assume leadership of this issue.
If these soldiers were dying in the field . . . rather than quietly
at home as a consequence of their service, we would leave no stone
unturned. We would use the best existing resources and programs to make
sure they had whatever they needed to survive . . . to ensure that no
man or woman is left behind.
Some say that a lot of ALS research has taken place. My response
echoes the famous words of President Lyndon Johnson: ``Research is
good, results are better!'' It's been nearly 70 years since Lou Gehrig
made his farewell speech--and we have basically nothing--one
questionable drug in 70 years!? How many thousands of private farewell
speeches must take place before we realize we're not doing everything
we can? Will I have to give mine before an appropriate, large-scale,
comprehensive plan to tackle ALS is carried out?
ALS is more complicated than a Rubik's cube which is many sided,
with multiple connections and various colors--like this one. One must
consider causes, therapies, biomarkers, genomics, existing drugs,
patient needs, palliative care as well as all avenues of research. Who
is in charge of ALS research today? I have found no one in charge! What
is the strategy for solving this ALS Rubik's cube? I've found no
strategic plan! Who oversees and is accountable for existing medical
research activities for ALS? No one!
So, yes, there may be many ongoing efforts into ALS, but potential
success is thwarted by little cooperation, coordination, and sharing of
information. From my viewpoint and understanding, there is no one
entity in charge or accountable.
These blocks or boxes represent ongoing ALS research. All are
separate, none are connected and there is no communication among them.
We have under-funded researchers across the country; each working in
their own little ``box''. This approach has been unsuccessful thus far.
We need to open the doors of labs and encourage collaboration.
There should be no more deaths due to protection of ALS related
intellectual property or potential profit. . . . Some of us are in a
hurry. Therefore, it is the government's absolute responsibility to
direct research into a full understanding of ALS.
In other words, my hope would be that we just not think outside the
box, but totally redraw it; enlarging it to fit the enormity of this
horrific disease. Many people come to hearings with problems and needs.
I come before you with a solution also. I fully understand
bureaucracy's aversion to change particularly within an industry as
large as medicine and with the number of government agencies already
dabbling, yes, dabbling, in ALS research.
Let's look back to 1961, when our Nation made a commitment to put a
man on the moon within the decade. One government agency was put in
charge and it was supported by other agencies, as well as private
industry and individuals. My proposal is very similar. It worked then,
it should also work now.
THIS IS WHAT I PROPOSE:
Establish a Congressionally directed ALS Task Force with specific
milestones and a time line. Within 30 days, establish an ALS Task Force
made up of government agencies, ALS researchers, private ALS
Institutes, patients and a facilitating team not related to ALS or the
medical industry. Within 60 days, the Task Force should recommend which
government agency will be in charge and the supporting roles of other
agencies. Within 90 days, develop a strategic plan which outlines all
avenues of research to be included. It must be comprehensive, forward
looking and all inclusive. The strategic plan should also outline
agency and researchers' accountability. An adequate and fair funding
stream must accompany this strategic plan.
The decade of the nineties was the decade of the brain. However, we
invested too little time and too few resources on research to
understand diseases of the brain, especially such a devastating disease
as ALS. Over 30 years ago our country launched a war on cancer. Because
of that effort, we now have many treatments for this dreaded disease,
even some cures. Isn't it time for us to launch a war on ALS and other
neurodegenerative disease so that we can have effective treatments and
even cures?
We designed and designated the Apollo Program to put a man on the
moon. For ALS, we could call it The Hope Program--Helping Other People
Endure.
From this day forward, this new direction can be a model program
that has one government agency, designated by Congress, which has
control and oversight of a lofty objective--solving the ALS Rubik's
cube. There are many private models of leadership to draw upon.
Innovations have sprung up driven by those connected to the disease
including several with which I am involved (ALS-Therapy Development
Institute, ALSA, MDA and MUSC ALS Clinic). These efforts will succeed
with public leadership that amplifies their private support into an
integrated whole. In the future, this model could be duplicated as a
test bed for research on other diseases. Because of the similarities
among neuro-degenerative and neuro-inflammatory diseases, advances in
ALS research will likely be relevant to Parkinson's, Alzheimer's',
Huntington's and others.
We must prepare to offer our soldiers, sailors, airmen and marines
an opportunity to fight this disease. We can not simply fight this
battle defensively, hoping to limit exposure to environmental risk. We
must fight it offensively as well, with an appropriate medical arsenal.
Let's do what it takes to finish this enemy off once and for all.
Congress can make the commitment, take the initiative, legislate a
new way forward and hold agencies accountable. We have the
intelligence, the resources, and the competencies. It's time to apply
leadership to the ALS Rubik's cube to move this campaign in a new and
uncharted direction!
Let's have the answer ready for our Veterans and the general
population suffering from ALS. Let's show them they were worth a real
investment and a real plan. Let us redraw and enlarge the ``box'' to
allow for their futures.
Finally, and probably the easiest task, is to immediately establish
and fund a national ALS Registry to ensure comprehensive patient
information, tissue, genes, DNA, etc., are available for investigation.
Such a registry will facilitate, even stimulate, additional research
and research collaboration. This will provide ``HOPE'' for future
treatment and increased understanding of this disease.
But what about veterans like me who may not benefit from these
future discoveries and treatments? We owe our veterans treatment now,
however limited.
Over 5 years ago, the Secretary for Veterans Affairs extended
service connected benefits to Gulf War veterans like me based on the
research study results. Since then new research has shown an increased
incidence of ALS among all veterans. The Secretary for Veterans Affairs
should act now with the same decisiveness and the same concern for
veterans by extending veterans' benefits to all veterans suffering from
this terrible disease.
I've attached a copy of a letter I gave to and discussed with Sec.
Nicholson on March 23rd of this year.
Thank you for your attention and for giving me this opportunity to
speak.
God Bless Our Veterans! And God Bless America!
**Included with my testimony is the letter which I presented and
discussed with Secretary Nicholson on 23 March 2007.
______
Mt. Pleasant, SC.
March 23, 2007
Secretary R. James Nicholson
Department of Veterans Affairs
Washington, DC
Dear Secretary Nicholson,
In 2001, the Veterans' Administration and Department of Defense
rightly recognized the relationship between Gulf War service and
Amyotrophic Lateral Sclerosis (ALS), commonly referred to as Lou
Gerhig's Disease. At that time the VA duly decided that Gulf War
veterans with ALS automatically received a service connected
disability. It also expedited ALS cases because this relentless
disease, which is a death sentence, progresses so rapidly. This
decision was widely applauded because of the compassion it showed to
those who have served our country so bravely.
Since that time, an important study conducted at The Harvard School
of Public Health has concluded that not just Gulf veterans, but all
veterans are a higher risk of developing ALS. The 2005 Weisskopf study
found that veterans who have served at any time in the last century are
at a 60% greater risk than the general population. In a recent review
of all relevant scientific literature, the National Academies'
Institute of Medicine concluded that ``the implication is that military
service in general-not confined to exposures specific to the Gulf War-
is related to the development of ALS.''
These findings would suggest that the VA is therefore only granting
benefits to a specific portion of those exposed to whatever trigger is
responsible for our veterans' increased risk. How can we differentiate
between all veterans with a 1.6 higher incident rate and Gulf War
veterans with a 2.0 higher incident rate than the general population?
Because of the appropriate precedent set in 2001 and the additional
studies subsequent to that, the VA should now grant service connected
disability to all veterans! I would be more than happy to discuss this
further with you or your staff. You may contact me at 843-971-5000.
Very respectfully,
Thomas R. Mikolajcik
Brig. Gen. USAF (Ret.)
Prepared Statement of Anthony Hardie, Legislative Chair and
National Treasurer, Veterans of Modern Warfare
Mr. Chairman and Distinguished Members of the House Subcommittee on
Health, thank you for holding today's hearing on Gulf War Exposures and
highlighting the enduring national significance of these issues. It is
truly an honor and a privilege to be here today, and I hope to help
voice some of the concerns of the many who are not here to share in
this privilege.
On January 17, 1991, much of America watched Operation Desert Storm
unfold on their evening news, decisively ending the many long months of
the massed troops' watchful waiting under Operation Desert Shield. Six
weeks of aerial bombing--interspersed with cross-border incursions and
the Battle of Khafji and followed by a 3-day ground war--and the
Persian Gulf War 1991 was over.
But for many of the nearly 697,000 troops who served, our
overarching Gulf War experience had only just begun.
For Members of the Committee who may not be familiar, Gulf War
troops were exposed to a host of toxic exposures experienced, often in
combination, including: multiple low-level exposures to chemical
warfare agents, including from bombed munitions factories and detonated
munitions bunkers; experimental drugs mandated without informed consent
like Pyridostigmine Bromide (PB) pills intended to help survive nerve
agent exposure; inhalation of the incredibly high levels of micro-fine
particulate matter from the Kuwaiti oil well fire plumes; experimental
vaccines like anthrax, botulinum, and others; inhaled and ingested
depleted uranium (DU) particulate matter; smoke from the daily burning
of trash and feces; multiple pesticides; and petroleum products and
byproducts.
For some of us who developed lasting health effects from this
veritable toxic soup of hazardous exposures, it came while still in the
Gulf. For others, it did not come until sometime after returning home.
Hearing this list of exposures, most people would find it of no
surprise that so many thousands of Gulf War veterans became ill, or
that so many remain ill and injured today. And it should be no surprise
that so many have developed diagnosable, serious conditions like ALS,
MS, and others.
What is stunning is that 16 years later, there are still few
tangible results that might improve the health of those who became ill
and remain ill. And we still have little information of any value to
provide to Gulf War veterans or their health care providers that might
help to improve Gulf War veterans' health.
Years were squandered disputing whether Gulf War veterans were
really ill, studying stress, reporting that what was wrong with Gulf
War veterans was the same as after every war. An incredible amount of
effort was put into disproving the claims of countless veterans
testifying before Congress about chemical and other exposures. Some of
that negative effort appears to continue even today.
It is stunning that after nearly two decades, we still have little
information to provide to Gulf War veterans who remain ill from their
service.
It is true that VA does still have an open door for Gulf War
veterans to be seen at VA medical facilities.
However, being seen is not the same thing as being treated.
The VA's Office of Public Health and Environmental Hazards website
contains little information that might be of any use to ill Gulf War
veterans or their health providers. Much of the information provided is
dated between 1996 and 2001, years before the more recent research
discoveries related to ill Gulf War veterans that affirm what Gulf War
veterans have been saying all along--that their Gulf War exposures are
what made them ill.
In July 2006, the VA's ``Gulf War Review'' included an article
entitled, ``Straight from the Source: VA's Environmental Agents Service
is Serious About Communicating With Veterans.'' That issue, a year ago,
was the last issue published.
For Gulf War veterans like me whose ``Kuwaiti Cough'' has never
left after having coughed up thick black sputum while still in the Gulf
and for several weeks after returning home, the report related to oil
fire smoke and petroleum notes on the Office of Public Health and
Environmental Hazards website would seem to be of particular interest.
Perhaps its lack of usable content, indicative of the lack of attention
being paid to these issues, is at least in part related to the fact
that its stated principal author was not a leading scientist, but
instead a community college communications/journalism student Summer
Intern.
I have heard from countless other Gulf War veterans that they, like
manyVietnam veterans before them, have stopped going to the VA, or have
simply given up, and have done their best to adapt to the substantial
lifestyle changes required by their disabilities, which may or may not
be compensated for these disabling conditions incurred in service.
In addition to the commonly recognized long wait times and
difficulties in the claims process, Gulf War veterans have had unique
and special challenges due to the currently medically undiagnosable
nature of many of their health conditions. In May, a VA report showed
that only one in four undiagnosed illness claims for Gulf War veterans
has been approved. And, at a Wisconsin Department of Veterans Affairs
conference in January on Gulf War veterans' illnesses, we heard service
officers telling their success stories of alternative methods in
achieving service-connection for ill Gulf War veterans that bypassed
the near impossibilities of undiagnosed illness claims. Clearly there
remains much to be done to improve the disability claims process for
ill Gulf War veterans.
On a more positive note, I was encouraged during last week's
meeting of the Research Advisory Committee on Gulf War Veterans'
Illnesses on which I serve to hear Dr. Robert Haley and his team
describe their research goals of identifying diagnostic criteria for
ill Gulf War veterans. Success in achieving these goals should finally
help to pave the way for effective treatments.
And I remain encouraged by current efforts in the U.S. Senate to
provide funding for Gulf War health research within the Department of
Defense Congressionally Directed Medical Research Program budget
focused on treatments that may aid ill Gulf War veterans.
The five-point statement of goals that came from Gulf War veterans
more than a decade ago still holds true today: Gulf War veterans
deserved then and deserve now an assurance that an exhaustive
investigation has been fulfilled to identify all possible Gulf War
exposures; that appropriate scientific research is promptly completed
to connect known or potential Gulf War exposures with health outcomes;
that medical treatment is based on that scientific research; that
compensation is provided to those veterans left disabled by their
military service if the health conditions cannot be reversed; and that
every effort is made to ensure that never again can what happened to
Gulf War veterans be allowed to happen.
For the thousands of living, ill Gulf War veterans, it is time to
make good on our Nation's enduring promise of caring for those who have
borne the battle, and their widows, and their orphans.
Prepared Statement of Denise Nichols, MSN, Vice Chairman,
National Vietnam and Gulf War Veterans Coalition
Good morning Congressman Michaud and Representatives of the VA
House Health Subcommittee and the audience in attendance this morning.
I am honored to be here today representing the National Vietnam and
Gulf War Veterans Coalition other Gulf War Veteran's groups that came
forward to our elected representative since shortly after we returned
from Operation Desert Storm in 1991.
I am Denise Nichols a Gulf War veteran and retired registered nurse
with an MSN who served along the border of Saudi Arabia and Iraq in
1990-91 with the USAFR out of the 32nd Aeromedical Evacuation Group,
Kelly Air Force Base, TX. When deployed all the Air Force Aeromedical
Evacuation resources came under the 1611 AES(P). Our facilities were
deployed throughout the theater with units at KKMC, KFMC, and all along
the border of Saudi Arabia, Kuwait, and Iraq.
My particular Mobile Aeromedical Staging Facility (less than 50
people) was located at Log Base Charlie between Rafha and Hafa Al
Batin. Our unit was theoretical in the exposure zone from Khamisiyah
bunker complex demolition since we were assigned to the 44th Medical
Group with the Army 7th Corp. Although it appears that the Air Force
units were never included in lists provided by the DoD despite all my
efforts with DoD during the time of the Office of Special Investigation
of Gulf War illness and all the other committees and boards during the
1990's. The Army COSCOM unit was down the tapeline Road toward Hafa al
Batin and a bit further was the Army Engineer Brigade site that was
over the 37th Engineers that actual did the demolition. In the
direction toward Rafha were the Army Hospitals (3) we received patient
flow from the closest one being an Alabama Army Guard Medical Hospital
I believe it was the 115th or the 110th.
I can tell you now that the symptoms of Gulf War illness began to
appear when we hit Riyadh and then as we moved forward thru KKMC to our
forward location. We just were not fully aware of what the symptoms
were representing at the time. We had rashes, visual sensitive to
light, joint aches, urinary urgency, and diarrhea occurring. When you
are in a desert environment and you are at war your job and duty comes
first. We also had weird accidents I called them the clumsy/stupidity
type accidents--falling from stairs of buses is but one example and
then the weird ones of troops breaking training and handling explosive
ordnance they found. We also had respiratory problems surfacing but
again a lot of these symptoms were downplayed. And of course all the
tens of thousands of alarms which were going off and we were being told
that they were false. We had had our first round of anthrax shots in
Riyadh and being a nurse I insisted that it be documented on my
international immunization record (Type A vaccine but no lot number
recorded and date). Probably not too many got documented because they
had us signing a roster, which I have been told was lost in transit. We
also were order to take the PB tablets. We also had to deal with the
sand flies--leichmanasis. We also had pesticide spraying occurring at
all the locations of troop deployment within Saudi. We also had shots
on mobilization. Despite having been in charge of our mobilization shot
scheduling for our whole 32nd Aeromedical Evacuation Group and I
believe that our unit personnel were at the highest level for
compliance for required world wide duty we still had additional shots
thrown at us in the deployment line to include IGG, polio vaccine, and
hepatitis and others. I had attempted personally to assure that my shot
record was current so I was surprised when more shots were thrown at
us. I had already as a medical person gone to Lowry AFB in Denver to
get my hepatitis shots that I knew would be required for medical
personnel and that is based on building up immunity levels. I had also
pushed to have pre-deployment dental review done in Denver. I was in
Deployable Ready status and didn't want anything to slow us down when
we were called to report because we would be busy as officers being
sure that all our unit personnel and equipment was ready to go.
The symptom that I believe we all missed was the mental
irritability/mental cognitive/neurological functioning changes that
began to surface when we hit Riyadh. This showed up in weird behavior
that I now can attribute to behavior much like Brain Concussion cases
where you have a change in mental cognitive and behavior functioning.
This was not PTSD!
Since our return from the Gulf War in 1991, the Gulf War veterans
were directed to the DoD/VA Clinical Evaluation Program, these programs
have all but died because of VA neglected. Testing that was done in
these programs to include EEG's, EMG's, and neurocognitive functions
and many other tests were never compiled and released to the veterans
or to the researchers that would follow. Many research studies listed
in the Presidential Advisory Report have never been published.
In the majority of the VA Hospitals there is no information posted
directing the Veterans of Operation Desert Storm Veteran Gulf War 90-91
how to access this program i.e. the Registries and what list of tests
to anticipate. The Environmental Agents names and locations within each
VA are not posted and therefore veterans seeking help have no
information. The Gulf War veteran support groups at the VA hospitals
were quickly dismantled. Some of our veteran advocates have asked
individual VA's to place posters and information and provide the
information desk with information that occurs immediately after we
bring it to their attention but slowly every time the information
vanishes.
The registry was suppose to be an ongoing program and updated but
that has not occurred. Physicians and health care providers at the VA
have not kept up on the advancements made and are not well informed. So
a sick Gulf War veteran appears at their doorstep there is no
information and the physicians and staff don't even have knowledge of
the latest research findings. The Veterans themselves like Anthony
Hardy, myself and many others of us try to bring materials to them and
update them. Thank goodness I did this with a VA Emergency room doctor
because it was shortly thereafter one of our young female veterans
presented to that ER after being told by staff she called by phone she
was just having indigestion. Well she was having an MI (myocardial
infarction/heart attack). He took her seriously and did an EKG and she
remembers him being astonished. She was quickly given a coronary
catherization and taken to surgery. She lived others I know that went
for help died because of lack of examining our Gulf War veterans. The
data on heart conditions has not been shared. The data gained from
autopsies and cause of death is not shared. This is simply not
acceptable to have clinical staff that are not knowledgeable and to
have valuable data and statistics not available.
The expertise on treating a multitude of toxic exposures is not
within the VA. Very few Gulf War veterans that came to the VA even got
a true physical neurological assessment the kind you do at the bedside
not with all the brain scans etc. Therefore they were never truly
assessed, then ordered follow up neurological testing. As a nurse with
a master's degree I was taught the basic physical assessment that
medical students are taught and I was astounded at the lack of physical
neurological assessment. I was also astonished to have Drs like Victor
Gordon that had done SPEC SCANS on many Gulf War veterans that showed
abnormalities to be discounted. I had many words over the years with
people like Dr Fran Murray that were denying the findings by SPEC and
PET Scans and saying they were not valid. I was also upset that basic
blood work to examine our hormones, adrenal, thyroid and pituitary
functioning were not tested. I was upset when I asked early on for
heavy metal testing and it was denied. I wondered if they were really
wanting to find answers and give us competent care and diagnosis.
They do not even ask physicians in the civilian world involved in
environmental health or anti aging which is a board certified field to
be involved in training their physicians. In fact it has been
documented that these doctors have approached the VA headquarters and
different VA's to offer their expertise and to help train the
physicians that are seeing Gulf War veterans and they were turned down!
There are advances in the treatment of these conditions and also in the
area of Chronic fatigue and Oxidative Stress that could immediately
benefit Gulf War veterans who are suffering from ill defined or
undiagnosed illnesses. We have had many veterans go to civilian doctors
for help and this is unacceptable when they fought the war they were
told to fight and have to find money to go to civilian doctors. It is
also unacceptable for ill patients who look to doctors for relief to
have to be bring in stacks of research that shows the direction the
physicians should be examining and then to be ignored. It is
unbelievable that patients, our fellow veterans--this country's
veterans--who are ill suffering with neurological cognitive damage and
other bodily system damage are having to share the expertise and teach
doctors what they should know and practice and how they should be
looking, examining, and testing the veterans.
The VA Newsletters to veterans has not been distributed for years.
The VA central office has not responded to our request to update
manuals, keep the newsletters up, or develop a means of keeping their
staff informed of research findings throughout the years since 1990-91.
The VA is also dismantling the Environmental Agents at each VA hospital
or are not replacing them as they leave.
When veterans bring them research findings that could help the
veterans even providing reprints and Drs and researchers names and
phone numbers I doubt they even read the material much less try to make
improvements in clinical care of the Gulf War veterans at their
facilities.
A case in point at a brainstorming session at the CDC conference in
1999-2000 with a physician, I pushed the idea of checking the veterans
for hypercoagulation (meaning thick blood that decreases the ability
for the blood to flow to all major organs). This condition is similar
to what I saw as a critical care nurse in at Wilford Hall USAF Hospital
that resulted in Disseminated Intravascular Coagulation. The symptoms
that we were experiencing that led me to this idea was the bleeding
gums, the nose bleeds, the uncontrollable menstrual cycles, and the
bleeding in stools. Sadly our females were not worked up but given
hysterectomies early in life as a result. This is also a condition that
had previously been studied in Chronic Fatigue patients and can be
treated. An independent study was done and all Gulf War veterans in the
study were tested by HEMEX Labs in Phoenix, AZ and all were found to be
abnormal. The exploratory study and results were published in November
2000 in the Journal of Coagulation and Fibrinolysis, a peer reviewed
journal. I had my own blood in that sample and the veterans that I
contacted throughout the country to send in samples had theirs. This
was a small sample study but represented a cross section of branches of
services, location in theater, duty titles, etc. I took the published
study in and briefed my primary physician, a hematology specialist, and
gave her all the authors names and contact information. I asked her
treat me for the condition she refused having previously told me her
hands were tied in regards to Gulf War veterans with Gulf War illness.
I asked her to start testing the other veterans of the Gulf War at the
VA Denver Hospital. Not getting anywhere I was rightfully upset and at
that time she offered me a consult to psychiatry. Here we had found a
clue to help in our treatment, an independent civilian lab had gone in
debt testing our blood and yet the VA was going to ignore the clues. I
really was upset a week later when I found out the Director of the Lab
at the VA hospital Denver was the EDITOR for the journal that published
the study. That was in 2000 now in 2006 the VA funds a study into
hypercoagulation. Now I ask you why not just start testing in the
clinical area and treat! Why not read the current work on Chronic
fatigue that is looking at HPA axis abnormalities and start testing
every Gulf War veteran at that facility re blood work on adrenal,
pituitary, thyroid, and hormones. Test and treat! The values on
abnormal lab work that would be found in Gulf War veterans could then
be shared with the researchers. Why is research being treated separate
and distinct from clinical testing and care? These two areas should be
interlinked so clinicians feed in the data that researchers need and
researchers when they find a treatment by small clinical trials can
readily and quickly share their findings with clinicians and large
scale treatment trials would be integrated more quickly in the clinical
area. I offer my observations that this would be cheaper and more
effective to enhancing the clinical diagnosis and care of Gulf War
veterans. Much of the research could be done at a savings by
integrating the sampling and testing by using clinical abilities and
facilities (and cost) that are present and available at VA hospitals.
We would get answers much more rapidly. This is but one example of our
continuous saga of Gulf War veterans illness being ignored, mishandled,
and not addressed in an effective manner!
The veterans that have developed symptoms of ALS or MS often have
to be told to go outside the VA to get tested to find out if they have
that diagnosis. The first veteran I knew with Gulf War illness that
developed into ALS was Colonel Don Kline a wing commander of the Air
Force who served in the Gulf. I met him in 95 while organizing the
Unity Conference for Gulf War Veterans in Dallas, I convinced he and
his wife to attend the meeting. He was already in a wheelchair with
respiratory assistance. He died shortly after that. He had prior to
developing the symptoms, luckily had left the military and was hired by
Delta and Delta took care of his medical needs. The next one I met was
Major Mike Donnelly AF F16 pilot--Top Gun Bred! . . . and soon after I
met Captain Randy Hebert USMC(who had gone through the breech into
Iraq), I took each of them to Representative Shays government Reform
Committee to testify. Mike Donnelly's family took on the cause and
advocated for answers for the Gulf War veterans with ALS, they sent
their son all over the world for medical consults and in there pursuits
I believe the number of Gulf War veterans we found with ALS was 60 and
that is when the VA started quietly caring for that group but without a
law to cover them as being presumptions or service connected. I have
found in my travels and in my communications with veterans in person,
over the phone and Internet others who had suffered and died without
proper assistance from the VA. Major Mike Donnelly died 2 years ago and
I am not sure of Major Hebert's status. This same situation is
repeating itself with Gulf War veterans with MS. I believe we now have
an estimated 500 cases of Gulf War veterans with MS.
We have asked repeatedly that the VA provide data on all known
diagnosed illnesses that are being experienced by Gulf War veterans to
include all diagnoses including on the top of the list all neurological
autoimmune type diagnoses, cancers of all types, kidney diseases,
thyroid diseases, liver diseases, respiratory diseases, the whole
picture of all organ diseases. We need a semiannual account of the
numbers that are showing up in the diagnosed illness category. This is
possible through each VA hospital and thru central VA Health Affairs.
We are asking that this data be mandated to be collected and updated at
least semiannually and available for all on the VA website. Only in
this way can practitioners, patients and researchers be aware of the
health problems that are developing and then act proactively to screen
other Gulf War veterans that they see. In this way the Gulf War
veterans have a chance at early diagnosis and life saving care and
treatment. Again we have gotten no ACTION on this item. Independently I
was given data on the cancers that had been diagnosed in Gulf War
Veterans from 1991-1995, that was data directly from within the VA
system. I have copies of the actual data collection sheets. I have
presented this data to the VA RAC GWI and to many members of the House
and Senate. We also have an earlier listing that was obtained by
Congressman Upton. As a nurse I was astonished at the numbers and types
of cancers. I even consulted by phone to an Oncologist specialist in
Texas that consults with the military hospitals and shared the data
with him and he was also very concerned and frankly astonished. Early
on I had reports of veterans with multiple cancers in single
individuals having been diagnosed and one of these individuals even
went to the Mt Sinai Hospital in New York for treatment on her own,
sadly I feel she has died without any help from the VA because contact
after she went for help ended. These are just a few of the snapshot
pictures of the situation that still persists in the VA as far as
clinical diagnosis, care, and treatment.
We need to have a law that offers the Service Connection to ALS,
MS, Brain Cancer, and any other disease that is found to be above the
expect rate of occurrence in the general population. These need to be
added to our presumptive list by law not by arbitrary action of the VA
that can change and does not get publicly covered. Consideration must
be given to giving the veteran the true benefit of the doubt when you
are exposed to radiation, chemicals (pesticides and nerve agents, jet
fuel and other service related exposures), biologicals (including
vaccines), endemic diseases in the area of operations. By having the
data base public to all we do the right thing by shining truth on the
subject. WE served our country proudly and the debates must end. This
country dishonors its servicemen and women to do no less and it sure
doesn't show ``Support the troops'' to speak the words and not carry
through in a timely manner. And doing battle with the VA which writes
the contracts to IOM that is truly not independent is a deception to
the troops, the families, and to this country's sworn duty to care for
its troops and veterans. The rat's maze of circles of different
government entities of denial must be stopped and the broken system put
aside!
The Gulf War veterans are also reporting problems with vision and
dental problems but unless they are 100% they are not seen and
assessment and data on that part of the picture is ignored. They are
left to fend on their own and the total picture of our rapidly
declining multi system failure is not seen. Too many young Gulf War
veterans have ended up with full dental extractions and dentures with
no exploring for the cause or connecting problems. This ties in with
oxidative stress theory.
Jim Binns and the VA RAC GWI have written a letter months ago to
the Secretary of the VA recommending other advisory Committees in the
area of clinical care and benefits to be formed for Gulf War Veterans
from Operation Desert Storm . . . NO ACTION still after 16 years. Will
you consider making that into a law as our RAC GWI was brought about.
In regards to Research we need answers--diagnostic biomarkers and
treatments now! But do not research us into the GRAVE. Integrate the
Research and the clinical testing now so that more veterans can get
answers and possibly some treatment to help them stop the health
decline. WE have all advocated for a targeted response in research to
Diagnostics, biomarkers, and treatment. WE have asked for defense
appropriations and defense authorization to be at the level it was
prior to 911 for the Operation Gulf War Veterans from 1990-91 and it is
like we are now the forgotten ones. The MS society has asked for 15
million. The Gulf War illness Advocates have asked for 30 million this
money will finally be directed and focused in the Right direction
thanks to the VA RAC GWI. Our money from 1991-2006 was misspent on
stress/PTSD/ psychologist coordinated research. That time has passed.
WE got 5 million for Fy06 funding and those reviews were just completed
by the CDMRP Committees of which I was proud to serve as a Scientific
merit reviewer. In FY07 we got 0 dollars. It was past due to involve
the suffering veterans into the review process as oversight directly so
we support the CDMRP program.
So much to inform you of in a short time and I have only hit the
highlights and a few examples. I thank the Committee for having this
hearing it is long overdue and we hope that it stimulates not only more
hearings and a response to our funding needs but also to real action
that fixes the broken system we enter in 1990-91.
Thank you and I would be overjoyed to address any questions you may
have.
Prepared Statement of Meryl Nass, M.D., Internist and Hospitalist,
Mount Desert Island Hospital, Bar Harbor, ME
Thank you for inviting me to testify before this Health
Subcommittee. My name is Meryl Nass, and I practice internal medicine
in Bar Harbor, Maine. I have conducted a specialty clinic to treat
patients with fibromyalgia, chronic fatigue syndrome and Gulf War
illnesses for 8 years. I also have a longstanding interest in the
scientific evaluation and prevention of bioterrorism, particularly
anthrax. Since 1998, I have spoken and written about the many soldiers
and veterans who became ill after receiving anthrax vaccinations,
usually with illnesses indistinguishable from Gulf War Syndrome. I hope
to clarify outstanding questions about the vaccine in this talk.
Is There a Gulf War Syndrome?
How can I possibly ask that question, 16 years after the Gulf War
ended? I brought it up because many people still deny the reality of
this frequently serious illness. Last week, a new patient of mine, who
presented with a severe, classic case of Gulf War Syndrome (per the
CDC's case definition,\1\) and was unable to work, informed me that his
VA doctor did not believe in Gulf War Syndrome. He had never been given
a diagnosis, and both he and his wife wondered if his problems were
`all in his head.'
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\1\ Fukuda K et al. created the first definition of Gulf War
Syndrome in this paper: Chronic Multisymptom Illness Affecting Air
Force Veterans of the Gulf War. JAMA 1998; 280: 981-988.
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Six months ago, the Washington Post ran a front page article on
Gulf War Syndrome titled, ``Funding Continues for Illness Scientists
Dismiss'' written by David Brown, a physician journalist. Brown
misrepresented the findings of the Institute of Medicine, claiming it
``reached the same conclusion that half a dozen other expert groups
had: Gulf War syndrome does not exist.'' \2\ Brown set up a straw man
he then knocked down: that there is no cluster of symptoms unique to
Gulf War veterans. He is correct: the symptoms of Gulf War Syndrome are
not unique. Instead, they overlap closely with those of chronic fatigue
syndrome, fibromyalgia, multiple chemical sensitivity, and irritable
bowel syndrome.
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\2\ Brown D. Funding Continues for Illness Scientists Dismiss.
Washington Post. December 3, 2006. A1.http://www.washingtonpost.com/wp-
dyn/content/article/2006/12/02/AR2006120201291
_pf.html
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But why should anyone expect Gulf War Syndrome to be a novel
illness? The body has only limited ways of responding to environmental
insults. Different noxious exposures can cause identical lung or kidney
diseases, or cancers. Although Gulf War Syndrome may not be absolutely
unique in its clinical features, the development of this syndrome in
25% of U.S. veterans of one war is unprecedented.
According to the 2004 Report of the DVA's Research Advisory
Committee on Gulf War Veterans' Illnesses, there are an estimated
200,000 Gulf War 1 veterans with chronic, `Gulf War' illnesses related
to their deployment.\3\ According to the Washington Post's David Brown,
199,000 Gulf War veterans receive compensation for such illnesses.
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\3\ VA RAC 2004 Report: www1.va.gov/rac-gwvi/docs/
ReportandRecommendations_2004.pdf ``A substantial proportion of
veterans of the 1990-1991 Gulf War continue to experience chronic and
often debilitating conditions characterized by persistent headaches,
cognitive problems, somatic pain, fatigue, gastrointestinal
difficulties, respiratory conditions and skin abnormalities . . .
Research studies conducted since the war have consistently indicated
that psychiatric illness, combat experience, or other deployment-
related stressors do not explain Gulf War veterans' illnesses in the
large majority of ill veterans. . . .'' Progress in understanding Gulf
War veterans' illnesses has been hindered by lack of coordination and
availability of data maintained by DoD and the Department of Veterans'
Affairs.''
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Why Is This Illness so Often Dismissed?
DoD and DVA together have spent $260 million on Gulf War illness
research.\4\ But the research findings are often contradictory; a large
number of studies focused on psychological factors instead of physical
illness; and there have been very few breakthroughs. According to John
Feussner, M.D. (in the aforementioned Washington Post article) who was
DVA's chief research officer from 1996 to 2002, ``After hundreds of
millions of dollars and a decade or better of research, we really
haven't made any significant findings.''
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\4\ 2005 Annual Report to Congress on Gulf War Veterans' Illnesses.
Page 39 http://www.research.va.gov/resources/pubs/GulfWarRpt05.cfm
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However, the research methods used in these studies have been
repeatedly criticized by GAO. For example, models investigating sarin
exposure and subsequent illness were inadequate to identify areas of
sarin exposure.\5\ Insufficient coordination and analysis of the huge
Gulf War research portfolio has persisted.\6\ Media reports have
focused more on the lack of a unique syndrome and the negative studies
than on the clinically relevant, validated research results.
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\5\ GAO-04-821T. June 1, 2004: ``The modeling assumptions . . .
were inaccurate because they were uncertain, incomplete and
nonvalidated.'' ``DoD and VA's conclusions about no association between
exposure to CW agents and rates of hospitalization and mortality . . .
cannot be adequately supported because of study weaknesses.''
\6\ GAO-04-767. June 1, 2004: ``Interagency coordination of Gulf
War illnesses research has waned. In addition, VA has not reassessed
the extent to which the collective findings of completed Gulf War
illnesses research projects have addressed key research questions. . .
. This lack of comprehensive analysis leaves VA at greater risk of
failing to answer unresolved questions about causes, course of
development, and treatments for Gulf War illnesses.''
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Gulf War Syndrome does not have an ICD-10 code. It is not described
in medical textbooks yet, and it is not taught in medical schools. The
massive, confusing body of published research is extremely difficult
for the non-specialist, let alone a journalist, to understand. Veterans
have so many symptoms they often appear to have psychiatric, rather
than physical, illness to uninformed medical practitioners. Therapies
recommended by the DVA emphasize the use of psychiatric medications as
primary treatment modalities.\7\ All these factors have conspired to
create a smoke screen that both the ill veteran, the competent medical
practitioner and policymakers have trouble penetrating.
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\7\ http://www.oqp.med.va.gov/cpg/cpgn/mus/mus_cpg/frameset.htm
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A closely related smokescreen has been created around the safety of
anthrax vaccine and its role in Gulf War illnesses.
Despite the finding by a Senate Committee in 1994 that anthrax
vaccine was being considered as a possible cause of Gulf War
illnesses,\8\ and the statement by the Persian Gulf Veterans
Coordinating Board that ``all potential causes [of Gulf War illnesses]
that have been identified are being investigated,'' \9\ when I first
reviewed the portfolio of Federal research on GWS in 1999, I was
surprised to find that of 166 studies listed, none looked specifically
at anthrax vaccine.\10\ Since 1999, a dozen Congressional hearings and
seven expert Committees have investigated anthrax vaccine safety and
made research recommendations. Yet, since then the DVA and DoD have
failed to correct the omission of anthrax vaccine-specific Gulf War
illness research.
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\8\ Senate Committee on Veterans' Affairs. Is military research
hazardous to veterans' health? Lessons spanning half a century.
December 8, 1994. S. Prt. 103-97. http://www.gulfweb.org/bigdoc/
rockrep.cfm
\9\ Persian Gulf Veterans Coordinating Board. Unexplained illnesses
among Desert Storm veterans. A search for causes, treatment,
cooperation. Arch Intern Med Feb 13, 1995; 155:262-8.
\10\ Research Working Group of the Persian Gulf Veterans
Coordinating Board. The Annual Report to Congress: federally Sponsored
Research on Gulf War Veterans' Illnesses for 1998, Appendices.
Department of Veterans Affairs. June 1999. pp 7-13.
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I reviewed the (latest available) 2005 Annual Report to Congress on
Gulf War Veterans' Illnesses, which lists a total of 300 separate
studies at a cost of $260.6 million dollars.\11\
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\11\ http://www.research.va.gov/resources/pubs/GulfWarRpt05.cfm.
Not one title mentions anthrax vaccine.
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Contrary to the DVA and DoD research funding priorities, anthrax
vaccine has not been dismissed as a possible cause of Gulf War
illnesses by the experts. Since 2000, three expert panels have reviewed
Gulf War illnesses and commented on the possible role of anthrax
vaccine. Here are some of their findings and recommendations:
1. Institute of Medicine Committee on Health Effects Associated with
Exposures During the Gulf War: \12\
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\12\ Institute of Medicine Committee on Health Effects Associated
with Exposures During the Gulf War. Gulf War and Health. Volume 1:
Depleted Uranium, Pyridostigmine Bromide, Sarin, Vaccines. National
Academy Press, Washington, DC. 2000.
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Studies of the anthrax vaccine have not used active
surveillance to systematically evaluate long-term health outcomes.
The committee recommends a long-term, longitudinal study
of participants in the Anthrax Vaccine Immunization Program.
The committee recommends a careful study of current
symptoms, functional status, and disease status in cohorts of Gulf War
veterans and Gulf War era veterans for whom vaccination records exist.
These cohorts should include nonimmunized, deployed and nondeployed
Gulf War veterans; and immunized, deployed and nondeployed Gulf War
veterans.
Future research should consider issues related to
potential long-term adverse effects of the combinations of these and
other vaccines routinely given to armed forces personnel.
2. 2004 Independent Public Inquiry on Gulf War Veterans' Illnesses (UK)
report:\13\
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\13\ http://www.lloyd-gwii.com/report.asp
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It is of the highest importance to discover the cause or
causes of the illnesses from which the veterans are suffering, because
only if the causes can be discovered is there any prospect of finding
effective treatment.
A third strong candidate must be the multiple
vaccinations, especially the combination of anthrax and pertussis. This
would be the best explanation for those few [ill veterans] who received
the vaccines but were never deployed to the Gulf.
On balance, the inquiry concluded that the immunological
impact of the multiple vaccinations administered was unusual, possibly
unprecedented. The consequences for health of this vaccination
programme remain uncertain.
3. VA Research Advisory Commmittee on Gulf War Veterans' Illnesses:
\14\
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\14\ VA Research Advisory Committee on Gulf War Veterans'
Illnesses. Scientific Progress in Understanding Gulf War Veterans'
Illnesses: Report and Recommendations. September 2004. www1.va.gov/rac-
gwvi/docs/Report and Recommendations_2004.pdf
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That VA work with Federal agencies (CDC, NIH, DoD)
involved in conducting vaccine trials that include administration of
AVA [anthrax vaccine adsorbed] to ensure that these trials include
follow-up assessments of study subjects a minimum of 5 years after
inoculation. Such studies should utilize methods and instruments
capable of capturing chronic symptoms and cognitive difficulties
similar to those experienced by Gulf War veterans.
That VA conduct a retrospective cohort study that
compares chronic symptoms and diagnosed conditions experienced by
veterans who received AVA as part of the military's mandatory anthrax
vaccination program to those of a comparable group of veterans who did
not receive this vaccine.
The research to determine the extent of anthrax vaccine's contribution
to Gulf War illnesses has simply not been done.
Could the smokescreen be deliberate? The Office of the Secretary of
Defense contracted with the RAND Corp. to produce eight volumes on
various Gulf War illness exposures. Since 2000, only one has remained
unavailable: the study of vaccines and Gulf War illnesses. Dr. Beatrice
Golomb completed this report in 1999, but it was not published. At DoD
direction she revised the report in 2004-5, and for a time the RAND
website promised publication in 2005, but it still remains
unpublished.\15\ Neither DoD nor RAND has explained why.
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\15\ http://www.rand.org/multi/gulfwar/publications.html
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Even the journal Science commented on the perceived lack of
objective science in Gulf War illness research:
``Questions about the Pentagon's ability to objectively study Gulf
War illness have dogged the department for years and spawned numerous
conspiracy theories. Removing those doubts has proven difficult. Just 6
weeks ago, an independent panel reported that the Pentagon had worked
``diligently . . . to leave no stone unturned.'' But that conclusion
was spoiled by nasty disputes among panel members and staff, some of
whom charge that its review was flawed and anything but independent.''
\16\
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\16\ Enserink M. Medicine: Restoring Faith in the Pentagon. Science
2001;291(5505):816.
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What do we know about anthrax vaccine and adverse health effects?
There are two diametrically opposed bodies of work on this subject.
Studies performed by the Defense Department since 1998 have uniformly
found the anthrax vaccine to be safe, as did one Institute of Medicine
(IOM) Committee funded by the Defense Department. However, that
Committee chose to ignore all anthrax vaccine-related studies of Gulf
War illnesses,\17\ and also failed to use the traditional weight-of-
evidence approach.\18\ The DoD studies are filled with methodological
errors, as outlined by FDA in the vaccine label.\19\ Yet it was these
studies that formed the primary basis for the 2002 IOM report used by
DoD to validate the vaccine's safety.
---------------------------------------------------------------------------
\17\ from Chapter 4: ``The Committee did not include various
studies that sought to identify risk factors for the health problems
reported by some Gulf War veterans.'' Committee to Assess the Safety
and Efficacy of the Anthrax Vaccine. Medical Follow-Up Agency,
Institute of Medicine. Anthrax Vaccine: Is it Safe? Does it Work?
National Academy Press 2002; Washington, DC.
\18\ Ibid. Committee to Assess the Safety and Efficacy of the
Anthrax Vaccine. Medical Follow Agency, Institute of Medicine. Anthrax
Vaccine: Is it Safe? Does it Work? National Academy Press 2002;
Washington, DC. From Chapter 1: ``Several previous IOM Committees
evaluating possible causal associations between vaccines or other
exposures and specific health outcomes have chosen to describe their
findings with a weight-of-evidence approach (IOM, 1991, 1994, 2000b). .
. . The current committee chose not to use that approach because it was
not asked to evaluate exposure to AVA as a cause of specific health
outcomes. Rather, the Committee was asked to provide an overall
evaluation of the anthrax vaccine's safety.''
\19\ http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0040-bkg0001.pdf
FDA criticized these studies' methodologies in the vaccine label,
stating: ``In addition to the VAERS data, adverse events following
anthrax vaccination have been assessed in survey studies conducted by
the Department of Defense in the context of their anthrax vaccination
program. These survey studies are subject to several methodological
limitations, e.g., sample size, the limited ability to detect adverse
events, observational bias, loss to follow-up, exemption of vaccine
recipients with previous adverse events and the absence of unvaccinated
control groups.''
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Because the U.S. Army developed the anthrax vaccine, owns the
patent, owns the production equipment, owns most of the vaccine
stockpile, has indemnified the vaccine manufacturer against all claims
regarding lack of safety or efficacy, and chose to vaccinate its troops
with an insufficiently tested and improperly licensed vaccine \20\ on a
mandatory basis, it is potentially at risk for large financial losses
if the vaccine is found to be dangerous, its production negligent, or
if the vaccine stockpile cannot be used. (One case of a disabled
civilian Merchant Mariner, vaccinated with anthrax and smallpox
vaccines, was settled for 2 million dollars.) \21\
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\20\ The vaccine license was pulled by Federal Judge Emmett
Sullivan of the 1st District Court in December 2003 and
October 2004 for failures in the licensing process. FDA subsequently
issued a Final Rule and a comment period, reestablishing the license,
but new litigation was filed in December 2006 challenging the license
on the basis of inadequate safety and efficacy data.
\21\ Francis v. Maersk Line Limited and United States of America.
Case No. C03-2898C. U.S. Dist Ct. for the Western District of
Washington, ruling by Judge John C. Coughenour, Dec 9, 2005 to deny
Def. motion to deny admissibility of Plaintiff expert witness
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The non-DoD studies suggest the anthrax vaccine was a contributor
to Gulf War illnesses, and a cause of multiple chronic medical
problems. These studies include one by Unwin et al., which found
British anthrax vaccinations to have increased the risk of chronic Gulf
War illnesses by 50% in Gulf War veterans, and by 230% in a small
cohort of vaccinated Bosnia veterans.\22\ The Canadian Department of
National Defense hired a contractor to investigate Gulf War exposures
and subsequent illnesses. Anthrax vaccine recipients had a 92% greater
chance of developing chronic fatigue than unvaccinated veterans.\23\ A
DoD-HHS Anthrax Vaccine Expert Committee found that combinations of
symptoms suggestive of Gulf War illnesses reported to the FDA-CDC's
Vaccine Adverse Event Reporting System (VAERS) occurred 2-3 times as
often as would have been expected by chance alone.\24\ Females have had
higher rates of Gulf War illnesses than male veterans; females also
have two times the rate of immediate systemic adverse reactions to
anthrax vaccine as males, and file reports to VAERS at 3 times the rate
of males. Schumm \25\ and Wolfe \26\ both determined that anthrax
vaccine was a risk factor for Gulf War illness in separate cohorts of
veterans.
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\22\ Unwin C, Blatchley N, Coker W, Ferry S, Hotopf M, Hull L, et
al. Health of UK servicemen who served in Persian Gulf War. Lancet.
1999 Jan 16; 353(9148):169-78.
\23\ Goss-Gilroy. Study of Canadian Gulf War Veterans: NR-98.050.
Study contracted by the Canadian Department of National Defense,
released June 29, 1998 and published on its website, accessed between
1999 and 2001 but no longer at the previous URL: http://www.dnd.ca/
menu/press/Reports/Health/health_study_eng_1.htm.
\24\ Sever JL, Brenner AI, Gale AD et al. Safety of anthrax
vaccine: an expanded review and evaluation of adverse events reported
to the Vaccine Adverse Event Reporting System (VAERS).
Pharmacoepidemiology and Drug Safety 2004; 13: 825-840.
\25\ Schumm WR, Jurich AP, Bollman SR et al. The long term safety
of anthrax vaccine, pyridostigmine bromide tablets, and other risk
factors among Reserve Component Veterans of the First Persian Gulf War.
Medical Veritas 2005;2:348-362.
\26\ Wolfe J, Proctor SP, Erickson DJ, Hu H. Risk factors for
multisymptom illness in U.S. Army veterans of the Gulf War. J Occup
Environ Med. 2002 Mar; 44(3):271-81.
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As of June 26, 2007, the Vaccine Adverse Event Reporting System had
received a total of 5359 adverse event reports for anthrax vaccine.
These included 670 reports that FDA had designated serious, and 44
reports of deaths.\27\
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\27\ Copies of the serious VAERS reports and all VAERS reports were
obtained by FOIA and uploaded to my website: http://
www.anthraxvaccine.org/serious_VAERS_reports.pdf and http://
anthraxvaccine.org/all_VAERS_reports.pdf
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Raw data from the military's Defense Medical Surveillance System in
2001 \28\ revealed statistically significant increased rates of
hospitalizations after vaccination, compared to pre-vaccination, for
heart attacks, psychosis, depression, breast cancer, thyroid cancer,
gallbladder and bile duct cancers, uterine cancer, diabetes, blood
clots, asthma, multiple sclerosis and abnormal PAP smears in 300,000
soldiers. Yet no focused studies of these relationships have been
conducted or made public since.
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\28\ Presented to the Committee to Assess the Safety and Efficacy
of the Anthrax Vaccine. Medical Follow-up Agency, Institute of
Medicine. Washington, DC. 2001. Can be accessed in the IOM reading
room. 4 tables are published in Appendix G of the IOM report (cited in
footnote 17) provide some of this data. I have uploaded some of the raw
data tables for public access at the following locations: http://
merylnass.googlepages.com/AMSAtitlepage.pdf http://merylnass.google
pages.com/AMSASurveillanceofadverseeffectsofAV.pdf http://
merylnass.google pages.com/IOMMentalDisorders.pdf
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An unpublished Navy study of active duty women inadvertently
vaccinated during the first trimester, revealed a 39% greater rate of
birth defects in vaccinated mothers, compared to mothers who received
anthrax vaccine at any other time.\29\ An Army study found no increased
rate of birth defects in vaccinated mothers, but did not examine first
trimester vaccinations, and was admittedly not adequately powered to
examine the issue.\30\
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\29\ http://www.anthrax.osd.mil/resource/qna/qaAll.asp?cID=312
\30\ Wiesen AR, Littell CT. Relationship between pre-pregnancy
anthrax vaccination and pregnancy and birth outcomes among U.S. Army
women. JAMA 2002; 287
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Easily verifiable, but non-public, DoD and CDC data suggest that
anthrax vaccine is associated with birth defects and long-term adverse
effects. Just last month the GAO, citing CDC and Vaccine Healthcare
Center officials as sources, reporting that 1-2% of anthrax-vaccinated
individuals ``may experience severe adverse events, which could result
in disability or death.'' \31\ Since the CDC has been conducting a
trial of anthrax vaccine in 1564 subjects since 2002, and the Vaccine
Healthcare Centers have performed full evaluations on over 2,400
putative vaccine injuries, most following anthrax vaccinations,
officials of these agencies should be knowledgeable about the effects
of the vaccine. However, no published studies exist to confirm that 1-
2% of vaccine recipients have serious or life-threatening adverse
events, and the true number may be more or less than this. The number
of deaths that were definitely caused by the vaccine is also unknown.
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\31\ GAO-07-787R. Military Health: DoD's Vaccine Healthcare Centers
Network. June 29, 2007. http://www.gao.gov/cgi-bin/getrpt?GAO-07-787R
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The evidence is convincing that anthrax vaccine is a contributor,
but not the only contributor, to Gulf War illnesses.
How many individuals may be affected?
It is uncertain how many deployed Gulf War and non-deployed Gulf
``era'' veterans received this vaccine. The Pentagon estimated that
150,000 deployed 1991 Gulf War veterans received anthrax vaccine. The
VA Research Advisory Committee on Gulf War Veterans' Illnesses staff,
using the 40% anthrax vaccination rate in self-reports, estimated that
285,000 veterans received anthrax vaccine in the Gulf War period.\32\
Reports exist of experimental anthrax vaccines that were used in
addition to the licensed vaccine.\33\ There are very few available
records of who received any anthrax vaccines in theater during
Operations Desert Shield and Desert Storm. (Yet the Pentagon did a
study in over 400 Fort Bragg soldiers 2 years after the war, in which
booster doses of anthrax and botulinum toxoid vaccine were
administered. The Pentagon was somehow able to identify the number of
anthrax and botulinum toxoid vaccines administered during the subjects'
Gulf War deployment, and the dates, for all soldiers in the study.\34\)
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\32\ LaClair B. Overview of exposures and health conditions
reported by countries who served in the 1990-1991 Gulf War allied
coalition. Presentation to the Department of Veterans' Affairs Research
Advisory Committee on Gulf War Veterans' Illnesses. December 12-13,
2005. Washington, DC.
\33\ Takafuji ET and Russell PK. Military immunizations. Past,
present and future prospects. Infect Dis Clin North Am 1990; 4(1):143-
58.
\34\ Pittman PR, Hack D, Mangiafico J et al. Antibody response to a
delayed booster dose of anthrax vaccine and botulinum toxoid. Vaccine
2002; 20(16):2107-15.
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Subsequent to the Gulf War, FDA estimated that 475,000 soldiers
received anthrax vaccine between 1991 and 1998, yet very few veterans
have anthrax vaccine listed in their medical records from this
period.\35\ Since 1998, 1.6 million soldiers have received anthrax
vaccinations, averaging 4 doses each. An unknown number of military
contractors and merchant mariners have also received anthrax
vaccinations.
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\35\ Clifford J (FDA). Statement to the Institute of Medicine
Committee on anthrax vaccine safety and efficacy. October 3, 2000.
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Thus over two million American soldiers have been vaccinated since
the 1991 Gulf War, half of whom have been vaccinated since the start of
Operation Iraqi Freedom. Consequently, DVA may continue to see large
numbers of veterans who have become ill as a result.
How can DVA improve its research and its care of ill Gulf War veterans?
1. DVA has the ability to conduct the long-term anthrax vaccine
safety studies, and should do so, as advised by every expert Committee
that has investigated the vaccine.\36\ Matched vaccinated and
unvaccinated cohorts could be studied longitudinally to finally resolve
questions about the types and rates of illness associated with the
vaccine.
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\36\ Compilation of expert Committee recommendations: http://
www.anthraxvaccine.org/every.htm
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2. DVA should support the Research Advisory Committee on Gulf War
Veterans' Illnesses recommendations regarding areas of research that
are likely to bear fruit. Clinical research intended to improve the
treatment of veterans should receive the highest priority.
3. DVA should improve its ability to provide care to veterans with
Gulf War illnesses and vaccine-associated illnesses. DVA designated
physicians at each facility to care for Gulf War veterans, but the
level of support and training provided to these physicians has not been
adequate. Although DVA has convened consensus panels and created
clinical algorithms for its practitioners, the fact remains that to
effectively evaluate and treat these patients is extremely difficult.
The patients often have idiosyncratic responses to medications,
particularly if they are chemically sensitive. They may react adversely
to odors in the clinic. They usually have cognitive and often emotional
problems, and often forget their doctor's advice. They require a very
patient and understanding clinician, and need detailed written
instructions to take home. These patients require care from multiple
medical specialists and therapists, and their primary provider needs to
supervise this process. They have more symptoms, and require much
longer visits, than other patients.
Ideally, DVA will follow the model that DoD and CDC, under
Congressional directives, pioneered. DoD and CDC jointly created a
Vaccine Healthcare Centers Network of four clinics, which perform very
detailed and complete evaluations of patients. This provides a solid
basis for treating complex patients by establishing firm diagnoses, and
furthermore allows for a strong bond to develop between the patient and
the provider. This bond is particularly important for the patients,
whose condition is likely to be poorly understood by other providers,
and who may have lost trust in the military and DVA systems.
DoD also created a Deployment Health Center at Walter Reed,
where a similar detailed diagnostic process can take place, and
patients undergo inpatient training about their condition and how best
to manage it. This type of center might also be beneficial for Gulf War
illness and vaccine-injured patients.
4. Treatment trials for those with Gulf War illnesses are sorely
needed. For example, many Gulf War veterans have chronic diarrhea.
Empiric trials that included antibiotics, anti-yeast drugs, dietary
manipulation, digestive enzymes and probiotics such as Lactobacillus
rhamnosus could be done in conjunction with studies of motility, stool
flora, and autonomic nervous system dysfunction. Veterans should be
screened for hypogonadism, and offered replacement hormone if positive.
Those with sleep disorders should undergo formal sleep studies and be
given C-PAP trials as indicated. A specialty Gulf War clinic could make
such evaluations routine.
5. Accurate, linked medical records between DoD and DVA are a
prerequisite for optimal care of veterans. According to GAO, ``In 1997,
the President, responding to deficiencies in DoD's and VA's data
capabilities for handling service members' health information, called
for the two agencies to start developing a comprehensive, lifelong
medical record for each service member.'' \37\ Yet the databases are
still not linked. Congressional attention to this issue might generate
more progress than has been made in the 10 years since this policy was
put in place.
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\37\ GAO-02-478T. VA and Defense Health Care. Military Medical
Surveillance Policies in Place, but Implementation Challenges Remain.
February 27, 2002.
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6. DoD and DVA receive entirely separate funding. Thus, the
Defense Department does not have to pay for the long-term care required
by soldiers who become ill as a result of DoD's medical
countermeasures. Ill soldiers are medically discharged, and costs are
shifted to the DVA.
If DoD was required to contribute to the long-term care of
some ill soldiers, it might place a higher priority on the safety of
the countermeasures and other exposures to which its troops are
subjected. Congress should consider instituting a mechanism that would
extract a financial penalty from the Pentagon when its decisions lead
to high rates of (preventable) chronic medical illnesses in its
soldiers.
7. A huge amount of effort and money was expended to research Gulf
War illnesses for very little return. After arranging for 300 studies,
it is striking that DVA and DoD have not published quality reviews of
this body of work, which would make an understanding of the subject so
much easier for the public. The officials in charge of this failed
research project have, for the most part, remained in control for the
past 10 years. Congress must assure accountability by insuring that
future funding of Gulf War illness research is conducted objectively,
and is independent of the institutional biases so far demonstrated by
DoD and DVA.
Prepared Statement of James Binns, Chairman,
Research Advisory Committee on Gulf War Veterans' Illnesses,
U.S. Department of Veterans Affairs
Mr. Chairman, Members of the Committee, for the past 5 years, it
has been my privilege to chair the Research Advisory Committee on Gulf
War Veterans Illnesses. This public advisory body of distinguished
scientists and veterans is mandated by Congress and appointed by the
Secretary of Veterans Affairs. Its membership includes leading experts
in the field, a former president of the American Academy for the
Advancement of Science, and the head of the CDC Neurotoxicology
Research Laboratory. Dr. Steele (to my right) is a member and an
epidemiologist who has devoted the past 10 years of her career to the
full time study of Gulf War illnesses, most recently as scientific
director of the Committee. The Committee's statutory mission is to
review research studies and plans related to the illnesses suffered by
veterans of the 1991 Gulf War.
Dr. Steele will provide highlights of the Committee's scientific
findings. I will address the status of Federal research activities.
Gulf War illnesses remain a major unmet veterans' health problem.
According to the Department of Veterans Affairs most recent study, 25%
of Gulf War veterans suffer from chronic multisymptom illness over and
above the rate in other veterans of the same era. This confirms five
earlier studies showing similar rates.
Thus, 16 years after the war, one in four of those who served--
175,000 veterans--remain seriously ill. And there are currently no
effective treatments.
Gulf War veterans also suffer from amyotrophic lateral sclerosis,
ALS, at double the rate of other veterans of the same era.
The veterans whom you have heard today are not exceptional cases.
They are representative casualties of the 1991 Gulf War.
The Federal Government has spent over $300 million on Gulf War
illnesses research, roughly one-third by VA and two-thirds by DoD. Some
of that research was productive, as you will hear from Dr. Steele. Much
of that money, however, was misspent on the false theory that these
illnesses were caused by psychological stress. As late as 2003, 57% of
new VA Gulf War illnesses research was directed at psychological
stress.
This emphasis on stress was part of an overall effort to portray
these illnesses as nothing unusual, the kind of thing that happens
after every war, rather than the result of toxic exposures particular
to the Gulf War. Very little money was invested in treatment research.
I am pleased to report that a dramatic change for the better has
taken place in the direction of VA research. Following our Committee's
2004 report, then VA Secretary Principi announced that VA would no
longer fund studies based on stress. Secretary Nicholson appointed new
leadership at the VA Office of Research and Development, and has placed
most of VA's Gulf War illnesses research program at the University of
Texas, Southwestern Medical Center, the leading site for Gulf War
illnesses research. Congress added $15 million to the VA research
budget for this program, which is just getting underway. I am extremely
pleased to see VA Gulf War illnesses research in the hands of
scientists committed to solving the problem and fully funded at the
level recommended by the Research Advisory Committee.
At the same time that these positive developments have taken place,
however, other key VA officials continue to minimize these illnesses at
every opportunity. For example, a ``fact sheet'' provided in recent
weeks to three U.S. Senators baldly asserted that ``Gulf War veterans
suffer from a wide range of common illnesses, which might be expected
in any group of veterans their age.'' That is utter hogwash.
This fact sheet is the work of the VA Office of Public Health and
Environmental Hazards, which is testifying before you today. It is also
the VA office charged with implementing Congress's mandate that VA
contract with the National Academy of Sciences' Institute of Medicine
to prepare reports on the association between toxic exposures in the
Gulf War and health effects for use in benefits determinations. For 7
years, these reports have been structured to restrict the scientific
information considered in their conclusions, in express violation of
the statute.
This government manipulation of science and violation of law to
devalue the health problems of ill veterans is something I would not
have believed possible in the United States of America until I took
this job. Until this practice is stopped, the products of Gulf War
illnesses research will be distorted, misleading the Secretary,
Congress, veterans' doctors, and the scientific community.
Dr. Lawrence Deyton, who now directs this office and who will speak
to you later this morning, assumed his position relatively recently and
did not initiate these practices. I urge Dr. Deyton to order these
misleading activities terminated and previous IOM reports re-done in
conformity with the statute.
The largest sponsor of Federal Gulf War illnesses research is the
Department of Defense. Historically, DoD has funded approximately two-
thirds of Gulf War illnesses research, in excess of $30 million
annually. Since the start of the current war, however, this program has
been eliminated.
In FY06, Congress initiated a new pilot program for Gulf War
illnesses research at DoD. This innovative program gives first priority
to pilot studies of existing treatments already approved for other
illnesses, and so offers the possibility of identifying treatments that
could be put to immediate use. It complements the VA/University of
Texas research program that is focused on understanding the basic
science. It is open to all researchers, inside or outside of
government, through peer-reviewed competition, and is administered by
the Congressionally Directed Medical Research Program.
Its initial solicitation last fall received eighty proposals--
compared to only two treatments studied in the entire previous history
of Gulf War illnesses research. Only a small fraction of these
proposals can be funded within the $5 million FY06 pilot program, but
the response demonstrates the interest of the scientific community in
finding treatments to improve the health of Gulf War veterans, as well
as current and future military personnel and civilians at risk of
chemical attack.
Yet DoD has again excluded this promising program from its proposed
FY08 budget. Its future depends on the success of bipartisan efforts in
the House and Senate to add it to the DoD budget at the $30 million
level consistent with the recommendations of the Research Advisory
Committee and historic funding commitments.
Mr. Chairman and Members of the Committee, in recent months this
country has renewed its obligation to care for the health of veterans
following their return home from war. Hundreds of millions of dollars
have been appropriated to address the health problems of currently
returning veterans, and rightfully so. But it is now time--in fact,
long past time--to address the serious health problems of 175,000
veterans of the last war who remain ill as a result of their service.
Will we follow the example of the current war and address them now,
while there is still hope they can live out their lives in better
health? Or will we follow the example of Vietnam and Agent Orange, and
admit the problem only as they are dying? The answer begins with you
and your colleagues.
Prepared Statement of Lea Steele, Ph.D., Scientific Director, Research
Advisory Committee on Gulf War Veterans' Illnesses, U.S. Department of
Veterans Affairs, and Associate Professor, Kansas State University
Good morning and thank you for inviting me here today. I'm Dr. Lea
Steele, an epidemiologist and associate professor at Kansas State
University. I first became involved in Gulf War research 10 years ago
when I directed a state-sponsored research and service program for Gulf
War veterans in Kansas. Our work there provided important insights
about Gulf War illness. I am now ``on loan'' from my university to the
Federal Government to serve as Scientific Director of the Federal
Research Advisory Committee on Gulf War Veterans' Illnesses. Our
Committee has reviewed and analyzed a vast amount of scientific
research and government investigative reports that provide extensive
information on the Gulf War and the health of Gulf War veterans. We
will be issuing our scientific findings and recommendations in a major
report to be released later in the year. My purpose today is to share
with you some highlights of what the Committee has learned in the
course of our scientific work.
First, I want to distinguish between the condition known as Gulf
War illness and other health issues related to the 1991 Gulf War. Gulf
War illness is a complex of symptoms found at high rates in Gulf War
veterans-an illness not explained by standard diagnoses and medical
tests. This symptom complex affects Gulf War veterans from different
units across the U.S. and also from some allied countries. It affects
more Gulf War veterans, by far, than any other identified health
condition.
There are also other health issues related to Gulf War service. A
problem of great concern is ALS, as you've heard. According to a large
VA study, ALS affects twice as many Gulf War veterans as other veterans
of that period. This neurodegenerative disease usually strikes people
over age 55, but one study has reported that Gulf War veterans may
develop ALS at much younger ages. A more recent study has suggested
that those who have served in the military, in general, are at
increased risk for ALS. If true, this could raise even greater
concerns, since Gulf War veterans have ALS at twice the rate of other
military veterans.
Brain cancer has also been recently identified as a Gulf War health
issue. You may be familiar with a well-known incident near Khamisiyah,
Iraq, in March 1991. The Pentagon has estimated that about 100,000 U.S.
military personnel were potentially exposed to low-level nerve agents
in connection with demolitions at a large weapons depot that contained
sarin and cyclosarin. A 2005 study found that veterans who were
downwind from those demolitions have died from brain cancer at twice
the rate of veterans in other areas of theater.
There might also be problems related to other diagnosed diseases,
but studies are lacking. The Research Advisory Committee has
recommended research to assess conditions such as multiple sclerosis,
Parkinson's diseases, and cancer in Gulf War veterans. While all of
these issues are important, far fewer Gulf War veterans have ALS or
brain cancer than the very large number affected by Gulf War illness.
So I will focus my scientific comments today on what we know about Gulf
War illness.
First, let me briefly describe what Gulf War illness looks like, in
case you don't have a complete picture from veterans who have testified
or whom you know personally. Veterans with Gulf War illness have
multiple, persistent symptoms that affect different body systems. These
include neurological-type problems--severe headaches, memory and
concentration problems, dizziness, and mood changes. Persistent and
widespread pain is also a prominent feature of Gulf War illness, as
well as a profound fatigue. Other troubling symptoms include
gastrointestinal problems--we know many veterans have had persistent
diarrhea for 15 years. Respiratory symptoms--coughing and wheezing--are
also common, as well as unusual skin lesions and rashes. Veterans with
Gulf War illness experience multiple different types of symptoms
together, which is why we call it a symptom complex or multisymptom
illness. We now know quite a lot about Gulf War illness-how many
veterans are sick, who is most affected, and what may have caused this
condition. Here are some of the highlights.
Gulf War illness is a big problem.
25-30 percent of veterans who served in the Gulf War are
affected by this complex of symptoms as a consequence of their Gulf War
service. This has been shown by multiple studies, including VA's most
recent large follow-up study. That means that Gulf War illness affects
between 175,000 and 200,000 of the 700,000 Americans who served in the
Gulf War.
Gulf War illness was not caused by psychological stress.
Comprehensive studies have found no connection between Gulf War
illness and combat experiences in the war. In fact, rates of
psychiatric conditions like PTSD are considerably lower in Gulf War
veterans than veterans of other wars. This stands to reason since, in
contrast to current deployments, severe stress and trauma were
relatively uncommon in the 1991 Gulf War. A decisive victory was
achieved after a 4 day ground war; most troops did not see combat and
were never even in areas where battles occurred.
Research studies consistently identify links between Gulf
War illness and neurotoxic chemicals.
Many different Gulf War exposures have been suggested as causes
or contributors to Gulf War illness. These include the smoke from over
600 burning Kuwaiti oil wells, receipt of numerous military vaccines,
depleted uranium munitions, and low-dose exposure to chemical weapons.
The most consistent and extensive amount of available evidence
implicates a group of chemicals to which veterans were exposed that can
have toxic effects on the brain. These chemicals include pills (NAPP
pills or pyridostigmine) given to protect troops from the effects of
nerve agents, excessive use of pesticides, and low levels of nerve gas
in theater. Many of these chemicals have a similar type of action; they
adversely affect the neurotransmitter acetylcholine. Studies also show
that these chemical toxins can act synergistically, that is, combined
exposures are worse than any single exposure by itself.
A link between Gulf War illness and exposure to neurotoxic
chemicals is also compatible with what we know about biological
processes affecting ill veterans. Diverse studies have identified
abnormalities in the brain and the autonomic nervous systems of sick
Gulf War veterans. Diverse types of brain scans and neurocognitive
tests have identified problems that affect different brain processes
and areas. For example, in recent months, news stories have widely
reported on studies showing that Gulf War veterans have reduced volume
in specific brain regions.
Effective treatments for Gulf War illness are urgently
needed.
Studies show that few veterans with Gulf War illness have
recovered or even substantially improved over time. As a result, many
Gulf War veterans have been sick for as long as 16 years. Effective
treatments for Gulf War illness have not been identified--very few have
even been studied. The Research Advisory Committee continues to
identify research that can lead to treatments that improve the health
of ill Gulf War veterans as the highest priority area of Gulf War
research.
In short, Gulf War illness is real, it is serious, and it is still
widespread among veterans of the 1991 Gulf War. It is not the result of
psychological stress and is not the same thing that happens after every
war. Progress has been made in understanding ``big picture'' questions
about Gulf War illness and health issues affecting Gulf War veterans.
The Research Advisory Committee believes that remaining important
questions can also be answered and must be addressed. The Federal
Government has a continuing obligation to attend to the health problems
affecting veterans of the 1990-1991 Gulf War. Further, a more complete
understanding of Gulf War illness is required to ensure that similar
problems do not affect future American troops deployed to war.
Prepared Statement of Lawrence Deyton, MSPH, M.D., Chief Public Health
and Environmental Hazards Officer, Veterans Health Administration, U.S.
Department of Veterans Affairs
Mr. Chairman and Members of the Subcommittee, thank you for
providing the Department of Veterans Affairs (VA) this opportunity to
discuss VA's response to the health care and other needs of veterans
who have served in combat in Southwest Asia. With me today is
Mark Brown, PhD, Director, Environmental Agents Service,
Office of Public Health and Environmental Hazards
Timothy O'Leary, Director, Biomedical Laboratory Research
and Development Service, Director, Clinical Science Research and
Development Service, Office of Research and Development and
Eugene Oddone, MD, MHSc, Director, Center for Health
Services Research in Primary Care and Principal Investigator, National
Registry of Veterans with ALS
My testimony today will address three major topics: (1) VA's
efforts toward improving clinical care and our understanding for the
illnesses affecting veterans who served in the 1991 Gulf War, (2) how
these efforts have helped us in responding to the health care and other
needs of our troops fighting in this same region today; and (3) VA's
response to concerns about potential increased risk of Amyotrophic
Lateral Sclerosis (ALS, or ``Lou Gehrig's Disease) among military
service members.
BACKGROUND
The United States deployed nearly 700,000 military personnel to the
Kuwaiti Theater of Operations (KTO) during Operations Desert Shield and
Desert Storm (August 2, 1990, through July 31, 1991). Within months of
their return, some Gulf War veterans reported various symptoms and
illnesses that they believed were related to their service. Veterans,
their families, and VA subsequently became concerned about the possible
adverse health effects from various environmental exposures during
Operations Desert Shield and Desert Storm.
Of particular concern have been the symptoms and illnesses that, to
date, have eluded specific diagnosis. More than 130,000 Gulf War
veterans have participated in the two health registries that VA and the
Department of Defense (DoD) maintain. In addition, more than 335,000
have been seen at least once as patients by VA. Although the majority
of veterans seeking VA health care had readily diagnosable health
conditions, we remain very concerned about the veterans whose symptoms
could not be diagnosed.
I would like to provide a brief description of some of the programs
and initiatives VA developed in response to health concerns of veterans
of the 1991 Gulf War. I will also focus on how these new programs have
benefited the veterans who are now returning from the current conflicts
in Southwest Asia, specifically veterans from Operation Enduring
Freedom (OEF) and Operation Iraqi Freedom (OIF) and their families.
VA INITIATIVES FOR SOUTHWEST ASIA COMBAT VETERANS
The VA Gulf War Veteran Health Registry. Even before the 1991 Gulf
War cease-fire VA had concerns that returning veterans might have
certain unique health problems including respiratory effects from
exposure to the intense oil fire smoke.
In response, VA quickly established a clinical registry to screen
for this possibility. The new voluntary health registry examination
also helped encourage new combat veterans to take advantage of VA
health care programs. VA has long maintained health registries on other
at-risk populations, including veterans exposed to radiation, and
Vietnam veterans exposed to Agent Orange.
Formally established by law in 1992, VA's Gulf War Veterans' Health
Examination Registry is still available to all Gulf War veterans,
including veterans of the current conflict in Iraq. It offers a
comprehensive physical examination, and collects data from
participating veterans about their symptoms, diagnoses, and self
reported Gulf War hazardous exposures. As of June 2007, this program
evaluated over 100,000 Gulf War veterans, or about 1 in 7 veterans.
The program has also seen nearly 7,000 veterans who served in the
current conflict in Iraq, who as Gulf War veterans themselves, are
eligible for this program.
After 15 years, the principal finding from VA's systematic clinical
registry examination of about 14 percent 1991 Gulf War veterans is that
they are suffering from a wide variety of common, recognized illnesses.
However, no new or unique syndrome has been identified. Registry data
has significant limitations. VA recognizes that in the long run,
establishing high quality epidemiological research studies is the best
approach for evaluating the health impacts of service in the 1991 Gulf
War (or in any deployment). VA has adopted that approach.
New Compensation for Undiagnosed Illnesses. Many new Gulf War
veterans encountered problems when they tried to prove that their
difficult-to-diagnose or undiagnosed illnesses were connected to their
military service. This affected their access to disability
compensation. In response, VA asked Congress for authority, granted
under Public Law 103-446, to provide compensation benefits to Gulf War
veterans who are chronically disabled by undiagnosed illnesses when
certain conditions are met. This statute as amended authorizes VA to
pay compensation for disabilities that cannot be diagnosed as a
specific disease or injury, or for certain illnesses with unknown cause
including chronic fatigue syndrome, fibromyalgia and irritable bowel
syndrome.
Symptoms potentially covered include 1) fatigue; 2) skin signs or
symptoms, including hair loss; 3) headache; 4) muscle pain; 5) joint
pain; 6) neurologic signs or symptoms; 7) neuropsychological signs and
symptoms, including memory loss; 8) signs or symptoms involving the
respiratory system; 9) sleep disturbances; 10) gastrointestinal signs
or symptoms; 11) cardiovascular signs and symptoms; 12) abnormal weight
loss; and 13) menstrual disorders. This is a unique benefit for Gulf
War veterans, and more than 3,300 have received service connection for
their undiagnosed or difficult to diagnose illnesses under this
authority. Veterans from the current conflict in Iraq are also eligible
for this special benefit.
Epidemiological Research on Gulf War Veterans. Despite the value of
VA's Gulf War Health Registry program, additional epidemiological
research is required to properly characterize any possible long-term
health effects of Gulf War 1 service to the average Gulf War veteran.
This is because the registry participants are self-selected, and
therefore do not represent the average veteran. Registry findings
demonstrate that Gulf War veterans are not showing up with any unique
health problems; however, these findings do not tell us if veterans are
suffering from any diagnoses at rates different from expected. That
requires population-based epidemiological and related research studies,
which VA has carried out.
VA Gulf War Veteran Mortality Study. VA researchers have been
continuously monitoring the cause-specific mortality of all Gulf War
veterans in comparison to their non-deployed peers. In post-war
monitoring, Gulf War veteran mortality from most causes is not
significantly different in comparison to non-deployed peer as controls.
Moreover, the mortality for both groups is less than half that of
matched civilian controls. This is almost certainly because people who
choose to go into the military are healthier to begin with.
Initially, Gulf War veterans have shown an increased risk of death
from accidents, especially motor vehicle accidents. VA's data shows
that this is a temporary effect, and by 6 years post-war this
difference has disappeared. This overall pattern is very consistent
with earlier mortality data from Vietnam veterans.
New Clinical Guidelines for Combat Veteran Health Care. Early on,
VA recognized the need to assure training of our health care providers
to allow them to best respond to the specific health care needs of Gulf
War veterans with difficult-to-diagnose illnesses. With that in mind,
and in collaboration with the Department of Defense (DoD), VA developed
two Clinical Practice Guidelines on combat veteran health issues. This
included a general guideline on post combat deployment health, and a
second dealing with diagnosis of unexplained pain and fatigue. These
clinical guidelines give VA health care providers access to the best
medical evidence for diagnoses and treatment. Developed in response to
veterans of the 1991 Gulf War, today VA highly recommends these for the
evaluation and care of all returning combat veterans, including
veterans from OEF and OIF. (also available online at www.va.gov/
EnvironAgents)
New VA ``War-Related Illness & Injury Study Centers:'' Specialized
Health Care for Combat Veterans. In 2001, as part of VA's overall
health response for veterans returning from the 1991 Gulf War, VA
established two War Related Illness and Injury Study Centers (WRIISCs),
at the Washington, DC, and East Orange, NJ VA Medical Centers (VAMCs).
Today, these two centers are providing specialized health care for
combat veterans from all deployments who experience difficult to
diagnose or undiagnosed but disabling illnesses. VA now anticipates
concerns about unexplained illness after virtually all deployments
including OEF and OIF, and we are building on our understanding of such
illnesses.
Currently, VA is expanding on this program to better meet the
health care needs of new combat veterans suffering from mild to
moderate traumatic brain injury. To that end, VA is establishing a
third WRIISC at the Palo Alto VA Health Care System. This will take
advantage of their unique assets including a Polytrauma Unit,
interdisciplinary program on blast injuries which integrates the
medical, psychological, rehabilitation, prosthetic needs of injured
service members, their programs in traumatic brain injury, spinal cord
injury, blind rehabilitation post traumatic stress disorder, and
research into new and emerging areas of combat injuries and illnesses.
This is a critical development because combat injuries we see today
among OEF and OIF veterans are much more likely, compared to previous
wars, to involve some degree of traumatic brain injury. This has been
the result of the types of weapons commonly used to attack our troops,
including improvised explosive devices, blasts from landmines,
artillery and mortar attacks, and the resulting shrapnel produced from
such devices. Many of the long-term chronic health effects from
traumatic brain injury appear similar to the difficult-to-diagnose and
treat illnesses currently being treated by the WRIISC programs today.
Expanded Education on Combat Health Care for VA Providers. In
response to health problems faced by veterans of the 1991 Gulf War, VA
developed the Veterans Health Initiative (VHI) Independent Study Guides
for health care providers titled, ``A Guide to Gulf War Veterans
Health.'' Although originally focusing on health care for combat
veterans from the 1991 Gulf War, this study guide remains highly
relevant for treating OEF and OIF combat veterans, since many of the
hazardous deployment-related exposures are the same for both conflicts.
VA also developed several additional VHI Independent Study Guides
and other materials relevant to veterans returning from Iraq and
Afghanistan. These include the Under Secretary for Health Information
Letter ``Preparing for the Return of Women Veterans from Combat
Theater,'' (IL 10-2003-011), which provides guidance on the special
care needs for women OEF and OIF combat veterans.
Another VHI independent study guide in this series, ``Endemic
Infectious Diseases of Southwest Asia,'' provides guidance to health
care providers about the infectious disease risks in Southwest Asia,
particularly in Afghanistan and Iraq. The emphasis is on diseases not
typically seen in North America.
Similarly, ``Health Effects from Chemical, Biological and
Radiological Weapons'' was developed to improve recognition of health
issues related to chemical, biological, and radiological weapons and
agents.
The guideline, ``Military Sexual Trauma,'' was developed to improve
recognition and treatment of health problems related to military sexual
trauma, including sexual assault and harassment.
Similarly, ``Post-Traumatic Stress Disorder: Implications for
Primary Care'' is an introduction to PTSD diagnosis, treatment,
referrals, support and education, as well as awareness and
understanding of veterans who suffer from this illness.
``Traumatic Amputation and Prosthetics'' includes information about
patients who experience traumatic amputation during military service,
their rehabilitation, primary and long-term care, and prosthetic
clinical and administrative issues.
Finally, ``Traumatic Brain Injury'' presents an overview of TBI
issues that primary care practitioners may encounter when providing
care to veterans and active duty military personnel. All are available
in print, CD ROM and on the web at www.va.gov/VHI.
VA National Training on Health Care for New Combat Veterans. Based
on our experience treating veterans from the 1991 Gulf War, VA
recognized the need to quickly familiarize all VA health care providers
on the unique health concerns of new combat veterans returning from
Iraq and Afghanistan. VA has sponsored multiple regional education
conferences and a 3-day National Conference on ``Providing Health Care
for a New Generation of Combat Veterans Returning from OEF and OIF,''
in April 2007.
The conference objective was to sharpen the response of VA
providers to new and transitioning combat veterans coming to us today,
and to the new physical and behavioral health care challenges that
these returning veterans bring with them. The meeting included plenary
sessions featuring VA and DoD leadership, and breakout presentations
from national and international experts describing their clinical and
research experiences with new combat veterans.
Approximately 1,400 people attended this event, from throughout all
of VHA. The target audience was VA primary care providers from around
the country, including social workers, psychologists and mental health
professionals, physicians, physician assistants, nurses, and others who
provide direct care to new combat veterans returning from Iraq and
Afghanistan.
National subject matter experts from VA, DoD, and academia,
presented their recent experiences responding to the health care needs
of new combat veterans. The goal was to give VA healthcare
professionals the tools they will need to respond to the unique and
sometimes complex healthcare needs of returning combat veterans, and to
develop the necessary competencies to provide optimal care. The
deliberately multidisciplinary approach also helped providers to focus
on more integrated health care delivery, foster networking. and share
best practices, all of which should enable us collectively to improve
outcomes for returning wounded service members.
Breakout session topics covered Polytrauma; Pain Management;
Behavioral Health; Diversity Issues; Prosthetics; and Special Topics
for New Combat Veterans.
Outreach to Combat Veterans and Their Families. VA has many
programs designed to help returning combat veterans and their families.
To help veterans of the 1991 Gulf War and their families be more aware
of VA's health care and other benefits that are available for them, and
of new research results on Gulf War veterans' health, VA initiated the
``Gulf War Review'' newsletter, which is regularly mailed out to over
400,000 veterans from that conflict.
VA has developed many new outreach and information products for new
combat veterans and their families. The Secretary sends a letter to
every newly separated OEF and OIF veteran, based on records for these
veterans provided to VA by DoD. The letter thanks the veteran for their
service, welcomes them home, and provides basic information about
health care and other benefits provided by VA.
Similarly, in collaboration with DoD, VA published a new short
brochure called ``A Summary of VA Benefits for National Guard and
Reservists Personnel.'' To date, over one million copies have been
distributed. The new brochure summarizes health care and other benefits
available to this special population of combat veterans upon their
return to civilian life (also available online at www.va.gov/
EnvironAgents). ``Health Care and Assistance for U.S. Veterans of
Operation Iraqi Freedom'' is a new brochure on basic health issues for
that deployment (also available online at www.va.gov/EnvironAgents).
Finally, VA started the ``OEF and OIF Review,'' which is mailed to
all separated OEF and OIF veterans (over 700,000 individuals as of July
2007) and their families, on VA health care and assistance programs for
these newest veterans (also available online at www.va.gov/
EnvironAgents).
Combat-Theater Veterans' Enhanced Access to VA Health Care. VA
provides combat veterans enhanced enrollment placement and cost-free
health care services and nursing home care for conditions possibly
related to their service in a theater of combat operations after
November 11, 1998 for a 2-year period beginning on the date of their
separation from active military service. These veterans are placed into
enrollment Priority Group 6 if not otherwise qualified for a higher
enrollment Priority Group assignment and have full access to VA's
Medical Benefit Package.
Veterans, including activated Reservists and members of the
National Guard, are eligible if they served on active duty in a theater
of combat operations during a period of war after the Gulf War or; were
in combat against a hostile force during a period of ``hostilities''
after November 11, 1998 and, have been discharged under other than
dishonorable conditions.
Veterans who enroll with VA under this authority retain enrollment
eligibility even after their 2-year post discharge period ends under
current enrollment policies. At the end of this 2-year period VA will
reassess the combat veteran's information (including all applicable
eligibility factors existing at this time) and make, as appropriate, a
new Priority Group assignment.
Special Depleted Uranium (DU) Surveillance Program. Special armor
piercing munitions and tank armor made from depleted uranium (DU) was
used with great effect by U.S. forces during the 1991 Gulf War, as well
as more recently during the initial phases of OEF and OIF. However,
some veterans returning from these conflicts have had concerns that DU
may have affected their health. In response, in 1993, VA established
the DU Follow-up Program at the Baltimore VA Medical Center to monitor
the health of veterans who had retained DU fragments in wounds--
typically from ``friendly fire'' incidents in 1991 Gulf War. The
program provides ongoing and thorough detailed physical examinations
for affected veterans, including a broad array of testing of the blood,
immune, reproductive, and central nervous systems, and of kidney and
liver function.
In 1998, in response to increasing concerns among Gulf War
veterans, this program was expanded to offer DU screening for any
veteran concerned about possible DU exposure, and not just those with
possible retained DU fragments or with other types of high exposure
risks. The program is also open for veterans who served in OEF and OIF.
Researchers with VA's DU Follow-up Program have not identified any
clinically significant uranium-related health effects among veterans
from exposure from inhalation or from retained DU fragments. There are
however some concerns about certain physical changes that have been
noted in imbedded DU fragments, and indications for surgical removal of
fragments are currently under review by this group.
VA and DoD will continue to monitor health effects in this
population, which includes both 1991 Gulf War veterans and veterans
from the current conflict in Iraq.
New VA Toxic Embedded Fragments Surveillance Center. In response to
health concerns for new OEF and OIF combat veterans suffering from
retained embedded fragments composed of a wide range of metals and
other materials as a result of blast injuries from improvised explosive
devices, VA is establishing the Toxic Embedded Fragments Surveillance
Center (TEFSC) at the Baltimore VA Medical Center. New studies indicate
that some metals, such as certain tungsten alloy fragments, are highly
carcinogenic in rats and may pose a health hazard in veterans. Some
metals are also known or presumed to be human reproductive hazards,
including lead, cadmium, nickel, and copper.
The Baltimore VA DU Surveillance Program has shown us that retained
DU fragments and other materials are not necessarily inert in the body,
and may change over time to produce potential toxic health effects.
Such effects may be minimized and managed through careful ongoing
medical surveillance.
New Combat Veteran Health Surveillance. The long-term
epidemiological studies supported by VA assessing the health effects of
the 1991 Gulf War on veterans who were deployed to Southwest Asia took
a considerable amount of time. Today, we appreciate the importance of
rapidly monitoring the health status of new combat veterans and have
initiated surveillance and studies to more rapidly identify any health
effects that may occur from this current conflict. This has been made
possible via VA's electronic inpatient and outpatient medical records,
which summarizes every single visit by a combat veteran including all
medical diagnoses. For example, according to VA's July 2007 update
``Analysis of VA Health Care Utilization among Southwest Asian War
Veterans,'' since fiscal year (FY) 2002 over 700,000 OEF and OIF
veterans have left active duty and become eligible for VA health care.
About 35 percent of these new veterans (over 250,000) have received VA
health care at least once since 2002.
This simple surveillance shows that new OEF and OIF veterans are
coming to VA with a wide range of medical and psychological conditions.
No special conditions stand out, and therefore these new combat
veterans are being assessed individually to identify all their
outstanding health problems. VA will continue to monitor the health
status of recent OEF and OIF veterans using updated deployment lists
provided by DoD to ensure that VA tailors its health care and
disability programs to meet the needs of this newest generation of war
veterans. Also using this new combat veteran roster, VA has developed a
new clinical reminder in the electronic health record to assist VA
primary care clinicians in providing timely and appropriate care to new
combat veterans.
INDEPENDENT REVIEWS ON GULF WAR VETERANS' HEALTH
VA has sought advice on the health of combat veterans serving in
Southwest Asia from a wide range of external advisory groups. For
example, VA has long relied upon the independent scientific advice of
the National Academy of Sciences (NAS) Institute of Medicine (IOM) to
help evaluate potential associations between environmental hazards
encountered during various military deployments and specific health
effects. This external review process has resulted, for example, in VA
recognizing about a dozen diseases as presumed to be connected to
exposure to Agent Orange and other herbicides used during the Vietnam
War, and to the dioxin impurity some contained.
The National Academy of Sciences was established in 1863 with the
signature of President Abraham Lincoln, to ``investigate, examine,
experiment, and report upon any subject of science or art'' for
agencies in the Federal Government. In 1970, the NAS created the IOM to
provide independent, objective, authoritative, credible and timely
scientific analyses on medical and health issues.
The U.S. Congress, through U.S. Government agencies, regularly
seeks the IOM's unique scientific advice on a broad range of health-
policy issues. Their studies are conducted by independent Committees of
volunteer scientists composed of leading nationally and internationally
recognized experts, selected by the IOM based on their expertise, good
judgment and freedom from conflict of interests. The IOM requires that
a Committee's formal findings and recommendations are evidence-based
whenever possible and noted as only expert opinion when that is not
possible. Each IOM report undergoes extensive formal internal and peer
review by external experts who are anonymous to the Committee, and
whose names are revealed only once the study is published.
Congressionally Mandated NAS/IOM Veterans' Health Reviews. The NAS/
IOM's highly developed formal review process has proven invaluable to
VA for establishing fair, scientifically based disability policies for
veterans. Their reputation for objectivity, scientific integrity, and
independence means that their reports stand as authoritative even when
their findings fail to please all stakeholders. Since 1991, IOM has
completed nineteen independent reviews of Gulf War health issues (see
attachment). For evaluation of Gulf War-related health effects,
Congress directed (in Public Laws 105-277 and 105-368) the NAS to
``identify the biological, chemical, or other toxic agents,
environmental or wartime hazards, or preventive medicines or vaccines
to which members of the Armed Forces who served in the Southwest Asia
theater of operations during the Persian Gulf War may have been exposed
by reason of such service.'' Public Law 105-277 further required the
NAS, for each substance or hazard considered, to determine, to the
extent feasible, (1) whether a statistical association exists between
exposure to the substance or hazard and the occurrence of illnesses,
(2) the increased risk of the illness among exposed human or animal
populations, and (3) whether a plausible biological mechanism or other
evidence of a causal relationship between the exposure and illness
exists.
VA RESPONSE TO PREVIOUS NAS COMMITTEE ``GULF WAR & HEALTH'' REPORTS
The 2000 Report. The initial 2000 NAS Committee report in this
series, ``Gulf War & Health Volume 1,'' reviewed health effects from
exposure to the four potential hazardous exposures related to the 1991
Gulf War. These included sarin, depleted uranium, vaccinations, and
pyridostigmine bromide (``PB,'' a nerve agent protecting drug used by
DoD). The report contained 13 findings, of which four indicated a
positive association between some health outcome and the reviewed
general risk factors. Many were obvious, such as an association between
a large exposure to the military nerve agent sarin and severe health
effects including death. Others were related to common side effects of
drugs and vaccines seen among civilians or military personnel using
these agents to protect their health.
Following review by a VA Task Force, VA determined that
establishing new presumptions of service connection for any diseases
based on the report findings was not necessary. This was primarily
because the types and degree of exposures associated with long-term
health effects described in the NAS Committee report had either not
occurred during the 1991 Gulf War (for example, severe, life-
threatening and immediate nerve agent poisoning), or that the related
health effects were transitory and short-lived (for example, a normal
sore arm following a vaccination). Those findings were published in the
Federal Register, as required by the relevant statutes that established
this process.
The 2002 NAS Report. The second 2002 NAS Committee report, ``Gulf
War & Health Volume 2,'' reviewed health effects from exposure to
pesticides and solvents used during the 1991 Gulf War. An important
issue was that virtually all the pesticides and solvents used during
that conflict were in common approved use throughout the civilian and
military at that time. The report contained 77 findings, of which 21
indicated a positive association between a pesticide or a solvent and
some general health outcome. These were primarily for various cancers
and serious hematological disorders (e.g., leukemias, non-Hodgkin's
lymphoma, multiple myeloma and aplastic anemia), subtle general
neurological effects detected via neurobehavioral tests, and other
health effects (e.g., reactive airway dysfunction syndrome, and
allergic contact dermatitis).
Following review by a VA Task Force, VA determined that it was not
necessary to establish new presumptions of service connection for any
diseases based on the report findings. This was in part because the NAS
Committee findings were generally limited to long-term, chronic
occupational exposures that do not directly correlate to potential
hazards of service or exposure scenarios for the 1991 Gulf War.
Furthermore, individuals who were chronically exposed to relatively
high levels of these environmental hazards as part of their military
occupation, whether or not during service in that war, may qualify
under existing VA service connection policies for benefits for diseases
resulting from such exposures. It should be pointed out that VA's
decision to not establish any new presumptions does not alter existing
claim procedures, nor does it prevent any veteran from establishing
service connection for any disease that could be related to their
service in the 1991 Gulf War. Rather, it merely means that each case
must be decided on its facts and merits, as is currently the case for
veterans from any era.
The 2004 NAS Sarin Update Report. In 2004, at the request of the
Secretary of Veterans Affairs, a new NAS Committee completed a special
update on long-term health effects from exposure to the nerve agent
sarin. The initial 2000 NAS Committee report described above had
concluded that available scientific evidence could not show an
association between trace sarin exposure and subsequent long-term
adverse health effects. In response, the Secretary of Veterans Affairs
determined that there was not an adequate basis to support establishing
presumptive service connection for any long-term health problems
resulting from low-level sarin exposure.
After the completion of the 2000 NAS Committee report, several new
studies on sarin effects in laboratory animals were published that were
not available to the NAS Committee when they conducted their initial
review, and which some saw as requiring a new look by the NAS
committee. The new NAS Committee reviewed 19 epidemiological studies of
sarin health effects published since the earlier 2000 report, including
studies of U.S. and U.K. veterans of the 1991 Gulf War potentially
exposed at Khamisiyah, Iraq in 1991, of civilians exposed during the
Japan sarin terrorist attacks in 1994 and 1995, and all the studies
used in the earlier 2000 NAS Committee report. They also reviewed over
100 animal studies.
The August 2004 NAS Sarin Update came to the same conclusions as
the earlier 2000 report. In other words, and consistent with their
earlier findings, the NAS Committee was not able to find a scientific
basis to associate any disease with exposure to low levels of sarin,
based upon their exhaustive review of the relevant scientific
literature.
The 2004 NAS Report. The third full NAS Committee report, ``Gulf
War & Health Volume 3: Fuels, Combustion Products, and Propellants,''
contained nine positive findings on long-term health effects related to
exposure to the reviewed agents. These included associations between
exposure to combustion products (e.g., smog) and lung cancer, cancers
of nasal cavity and nasopharynx, cancers of the oral cavity and
oropharynx, laryngeal cancer, bladder cancer, low birth weight/
intrauterine growth retardation and exposure during pregnancy, preterm
birth and exposure during pregnancy, and incident asthma. They also
reported an association between exposure to hydrazine rocket fuels and
lung cancer. As with previous reports, an important point is that most
of the agents considered were in common use throughout the civilian and
military at the time of the 1991 Gulf War.
The NAS Committee considered over 33,000 potentially relevant
references, and focused on about 800 epidemiological studies on
persistent health outcomes associated with exposure to oil-fire
products, diesel-heater fumes, hydrogen sulfide (a specific combustion
product), hydrazines and red fuming nitric acid (as rocket
propellants), and gasoline and jet fuel. The Committee pointed out that
fuels and related combustion products are common pollutants with an
abundant scientific health literature available for their review.
Combustion products included ambient air pollution ``smog,'' combustion
products from motor vehicles, and fumes from stoves and heaters using a
wide variety of fuels. Fuels included gasoline, kerosene, diesel and
military fuels including JP-4, JP-5 and JP-8. Finally, to ensure a
focus on information that would be the most relevant to veterans of the
1991 Gulf War, the Committee emphasized studies of long-term rather
than short-term health effects. A VA Task Force reviewing the new NAS
Committee report determined that new presumptive service connections
were not warranted because none of the specific hazardous agents
reviewed, or the exposure levels experienced by most Gulf War service
members, were significantly different compared to U.S. civilians or to
troops not deployed to the Gulf War.
The 2006 NAS Report ``Volume 4: Health Effects of Serving in the
Gulf War:'' The September 2006 fourth full NAS report reviewed peer-
reviewed scientific literature on the health status of veterans of the
1991 Gulf War. The report was intended to inform VA about illnesses and
clinical issues including possible relevant treatments, which might
have been overlooked among this population, regardless of the specific
underlying cause. It documented increased rates of certain illnesses
among Gulf War veterans, based on a review of 850 epidemiological and
other studies of this group, which they selected from among over 4,000
potentially relevant reports. They concluded that ``VA and DoD have
expended enormous effort and resources in attempts to address the
numerous health issues related to the Gulf War veterans. The
information obtained from those efforts, however, has not been
sufficient to determine conclusively the origins, extent, and potential
long-term implications of health problems potentially associated with
veterans' participation in the Gulf War.''
The NAS Committee identified numerous serious limitations in
existing epidemiological studies of Gulf War veterans, in large part
due to the lack of veteran exposure data. However, they did ``not
recommend that more such studies be undertaken for the Gulf War
veterans.'' Rather, the Committee recommended ``continued surveillance
to determine whether there is actually a higher risk in Gulf War
veterans'' for illnesses that current research has identified as
possibly appearing at higher rates among Gulf War veterans,
specifically, brain and testicular cancer, ALS, birth defects, and
post-deployment psychiatric conditions.
The NAS Committee also concluded, ``Every study reviewed by this
Committee found that veterans of the Gulf War report higher rates of
nearly all symptoms examined than their nondeployed counterparts.'' Not
surprisingly, they reported that symptom-defined ``unexplained
illnesses,'' consistent with Chronic Fatigue Syndrome, Fibromyalgia,
Irritable Bowel Syndrome and Multiple Chemical Sensitivity, were the
most common health problem reported in studies of Gulf War veterans.
However, they concluded that ``the results of that research indicate
that although deployed veterans report more symptoms and more severe
symptoms than their nondeployed counterparts, there is not a unique
symptom complex (or syndrome) in deployed Gulf War veterans.''
They also found that ``Gulf War veterans consistently have been
found to suffer from a variety of psychiatric conditions,'' including
PTSD, anxiety, depression and substance abuse. Similarly, they found
that available studies have ``not demonstrated differences in cognitive
and motor measures'' in deployed versus non-deployed veterans, and show
no apparent increase in risk of peripheral neuropathy, cardiovascular
disease or diabetes. Finally, they reported difficulties in
interpreting data on birth defects, and found little data supporting
objective respiratory illnesses among Gulf War veterans. A VA Task
Force reviewing the new NAS Committee report determined that new
presumptive service connections were not warranted because existing VA
policies and procedures for disability compensation effectively cover
veterans with these health problems. These include, for example, VA
policies recognizing service connection for PTSD, and for service
connection for difficult to diagnose or undiagnosed illnesses.
The 2006 Report ``Infectious Diseases.'' The October 2006 fifth NAS
report in this series, ``Gulf War and Health Vol. 5: Infectious
Diseases,'' reviewed published, peer-reviewed scientific and medical
literature on long-term health effects from infectious diseases
associated with Southwest Asia, including those diseases relevant to
the 1991 Gulf War and to Operations Iraqi Freedom and Enduring Freedom
(OIF/OEF). They identified over 20,000 potentially relevant scientific
reports, and focused on 1,200 that had the necessary scientific
quality.
They focused on nine infectious diseases that were 1) prevalent in
Southwest Asia, 2) diagnosed among U.S. or other troops serving there,
and 3) known to cause long-term health problems. They also focused upon
those infectious diseases that appeared to be of special concern to
veterans who served in Southwest Asia. These were Brucella (causing
brucellosis); Campylobacter; Salmonella and Shigella (causing diarrheal
disease); Coxiella burnetii (causing Q fever); Leishmania (causing
leishmaniasis); Mycobacterium tuberculosis (causing tuberculosis);
Plasmodia (spp) (causing malaria) and West Nile Virus (causing West
Nile fever). They selected these from among about 100 naturally
occurring pathogens that potentially could have infected U.S. troops in
the 1991 Gulf War, or in OIF/OEF. The NAS Committee identified 34
different long-term health effects in their report that might appear
weeks to years after initial infection, associated with these nine
infectious diseases. Most if not all identified long-term health
effects are well-known to be associated with the initial acute
infection. A VA Task Force is currently reviewing the new NAS Committee
report to determine if new presumptive service connections are
warranted.
OTHER REVIEWS ON GULF WAR VETERANS' HEALTH
The IOM's reputation for scientific rigor, independence from the
political process, and freedom from bias has made it an influential
source of information on the nature of Gulf War veterans' health. In
addition, since the end of the 1991 Gulf War, at least 13 other
committees have been established, both in the United States and the
United Kingdom, to help evaluate Gulf War veteran health issues. Other
Committees (and date of publications) include:
Armed Forces Epidemiological Board (AFEB). U.S.
Department of Defense, 1996, 1999, 2000, 2000.
Goss Gilroy Inc. Canadian Epidemiological Study of Gulf
War Veterans. 1998.
The Rt Hon The Lord Lloyd of Berwick. Independent Public
Inquiry on Gulf War Illnesses. 2004.
U. S. Department of Veterans Affairs, Research Advisory
Committee on Gulf War Veterans Illnesses, James Binns, Chair.
Scientific Progress in Understanding Gulf War Veterans' Illnesses:
Report and Recommendations, 2004.
U.S. Department of Defense Special Oversight Board for
Department of Defense Investigations of Gulf War Chemical and
Biological Incidents. Final Report, 2000.
U.S. Department of Defense. Report of the Defense Science
Board Task Force on Persian Gulf War Health Effects, 1994.
U.S. Department of Health & Human Services, National
Institutes of Health Technology Assessment Workshop Panel. The Persian
Gulf Experience and Health. 1994 U.S. government Accountability Office
(GAO). Gulf War Illnesses: DoD's Conclusions About U.S. Troops'
Exposure Cannot Be Adequately Supported. 2004
U.S. Presidential Advisory Committee on Gulf War
Veterans' Illnesses: Interim Report. 1996
U.S. Presidential Advisory Committee on Gulf War
Veterans' Illnesses: Final Report. 1996.
U.S. Presidential Advisory Committee on Gulf War
Veterans' Illnesses: Special Report, 1997.
United Kingdom Parliamentary Office of Science and
Technology. Gulf War illnesses: Dealing with the Uncertainties. 1997.
U.S. Senate, Committee on Veterans' Affairs, Report of
the Special Investigation Unit on Gulf War illnesses. 1998.
Collaboration with the VA Gulf War Veterans Research Advisory
Committee. One of the most recent advisory groups on Gulf War veteran
health issues has been the VA Research Advisory Committee (RAC) on Gulf
War Veterans Illnesses, chaired by Mr. James Binns. VA has been pleased
with recent efforts with the RAC to lay the groundwork for improved
research on Gulf War veterans' health. VA and the RAC have agreed to
several important steps to improve the quality of VA's Gulf War
research portfolio. The RAC has recommended scientific experts to serve
as research review panel members of a new scientific merit review
board. In addition, VA consults with the RAC regarding the relevancy of
proposals that have been identified as being fundable. VA and the RAC
will also work together to identify researchers who can partner with VA
investigators.
VA RESEARCH ON GULF WAR VETERANS' HEALTH
VA's Office of Research and Development (ORD) early on recognized
that while there were few visible casualties associated with the 1991
Gulf War, many individuals returned from this conflict with unexplained
medical symptoms and illnesses. To date, VA, DoD and the Department of
Health and Human Services (HHS) have funded a total of 330 projects
pertaining to the health consequences of military service in the Gulf
War, as described in Annual Reports to Congress on federally Sponsored
Research on Gulf War Veterans' Illnesses. Although the causes and
successful treatment of GWVI remain illusive VA's ORD has committed to
continued funding of relevant research in this area.
In addition, the Institute of Medicine recently announced (in a
report described in more detail later) that Gulf War and other combat
veterans may be at increased risk for amyotrophic lateral sclerosis
(ALS, also known as Lou Gehrig's disease) as a result of their service.
Accordingly, VA's ORD is supporting a research portfolio composed of
studies dedicated to understanding chronic multi-symptom illnesses,
long-term health effects of potentially hazardous substances to which
Gulf War veterans may have been exposed to during deployment and
conditions and/or symptoms that may be occurring with higher prevalence
in Gulf War veterans, such as ALS, multiple sclerosis and brain cancer.
While VA, DoD and HHS funds its Gulf War research independently,
each closely coordinates its efforts with the others to avoid
duplication of effort and to foster the highest standards of
competition and scientific merit review for all research on illnesses
in Gulf War veterans. The Research Subcommittee of the Deployment
Health Work Group, which is a component of the VA/DoD Health Executive
Council, currently conducts this coordination. HHS participates in both
the Deployment Health Work Group and its Research Subcommittee.
ALS RISK AMONG VETERANS
ALS is a rare, progressive and nearly always fatal disease of the
nervous system. About 5 to 10 percent of cases appear to be inherited
but the cause of the remaining 90 to 95 percent of cases is not known.
Although certain environmental exposures have been considered as
potential causes of ALS, none have been clearly tied to this disease.
In December 2001, based on pre-publication announcements from two
studies suggesting that Gulf War veterans were at greater risk for ALS,
VA announced that it would explore options for compensating veterans
who served in the Gulf War and who subsequently develop amyotrophic
lateral sclerosis (ALS). VA in 2001 implemented a policy of referring
all Gulf War ALS claims to VA's Central Office for special review.
More recent scientific publications suggest that all veterans may
be at greater risk of developing ALS. A 2005 study published in the
journal Neurology (Weisskopf et al.) evaluated ALS risk among veterans
from World War 2, and the Korean and Vietnam Wars, and reported as a
group these veterans were at significantly greater risk for ALS
compared to civilians. The two studies that supported VA's ALS policy
for Gulf War veterans were published in 2003, and also suggested that
veterans from the 1991 Gulf War were at similarly greater risk for ALS
(Horner et al., Haley).
In response to the suggestion that all veterans might be at an
increased risk of ALS, in May 2005, VA contracted with the NAS/IOM to
evaluate the scientific basis of all relevant studies. In their
November 10, 2006, report the IOM Committee concluded that although
there are significant limitations to these studies, there is ``limited
and suggestive evidence of an association between military service and
later development of ALS.''
What the IOM Found. Following a thorough review of relevant
scientific literature, the IOM Committee in their November 2006, report
identified one ``high-quality cohort study that adequately controlled
for confounding factors and reported a relationship between serving in
the military and later developments of ALS'' (the Weisskopf study).
They also found ``three related studies [that] supported the
association'' but which were of variable quality (which included the
Gulf War veteran studies).
They concluded, ``On the basis of its evaluation of the literature,
the Committee concludes that there is limited and suggestive evidence
of an association between military service and later development of
ALS.'' This is the IOM's weakest positive category of association for a
health effect. However, the Committee concluded, ``[a]lthough the study
has some limitations... overall it was a well-designed and well
conducted study. It adequately controlled for confounding factors (age,
cigarette use, alcohol consumption, education, self-reported exposure
to pesticides and herbicides, and several main lifetime occupations).''
A VA Task Force consisting of the Under Secretaries for Health and
for Benefits, the OGC, and the DAS for Policy and Planning was
established to review the new IOM report.
VA Research on ALS. Although presently, there is no effective
treatment for ALS, ORD currently supports a broad research portfolio
dedicated to understanding the cause(s) and treatment for this
devastating disease. Recent advances in neurological research may allow
for the development of strategies to promote the restoration of nerve
function. The development of novel strategies and technologies for the
development and delivery of therapeutics for ALS patients remains an
important goal in ALS research. ORD-funded projects are directed toward
improving our understanding of the continuum of the development,
progression, treatment and prevention of ALS.''
Several VA investigators are conducting research on ALS as it
relates to military service during the first Gulf War. This work
includes identification of biological markers to identify cases of ALS,
examination of the effects of pesticides and insecticides used during
the Gulf War on the progression of ALS and examination of the
prevalence of ALS in Gulf War veterans. One project is examining the
overall and cause-specific mortality risk of ALS, multiple sclerosis
(MS) or brain cancer in a group of more than 620,000 Gulf War veterans
and assessing the demographic, military and in-theater exposure
characteristics associated with the risk of deaths from these diseases.
VA researchers are also studying new ways to selectively increase
the ability of therapeutic agents to enter the brain and spinal cord
without compromising the blood brain barrier. While this barrier
protects the central nervous system from harmful agents, it also limits
the ability of many therapeutic agents to enter the brain.
VA investigators have ongoing research projects studying the use of
stem cell transplants as a means to restore lost function following the
loss of neurons associated with ALS, Alzheimer's disease, Parkinson's
disease, spinal cord injury and stroke. Stem cells derived from
neurons, as well as from hematopoietic (blood) cells, are being
studied. It is hoped that these stem cells will mature into adult
neurons and replace damaged neurons. In addition, VA investigators are
examining gene therapy to deliver growth factors and other small
molecules needed for regeneration and/or protection of the brain and
spinal cord.
VA investigators are also examining the use of a neuromotor
prosthesis to enhance communication and increase independence for
veterans suffering from ALS. A neuromotor prosthesis is a brain-
computer interface that uses an electrode that picks up brain signals
and sends them to a computer for decoding. The brain signals are
translated into commands to power electronic or robotic devices, or to
communicate via word processing, e-mail or the Internet. VA researchers
have already demonstrated the potential usefulness of this technology
in an ALS patient and are developing multi-site studies designed to
improve this technology and improve the lives of individuals suffering
from this disease and their families.
ORD also supports a national registry of veterans with ALS to
identify, as completely as possible, all veterans with ALS and to
collect data for studies examining the causes of ALS. The registry is
designed to track the health status, collect DNA samples and clinical
information and provide a mechanism for VA to inform veterans with ALS
about research studies for which they may be eligible to participate.
The registry will provide VA with a valuable mechanism for involving
veterans in clinical trials and other studies that may yield improved
outcomes for ALS. In addition, data gathered as part of the registry
has the potential to benefit not only veterans, but also the larger
community of individuals with ALS.
Other exciting ALS projects supported by ORD include a 15-site
clinical trial to determine the tolerability and efficacy of sodium
phenylbutyrate (NaPB) as a new therapy for ALS, and a study examining a
compound that has been shown to delay the onset of ALS symptoms in
animal models of the disease. Finally, ORD supports a cooperative
effort to collect and store high-quality biological specimens donated
by veterans diagnosed with ALS for use in biomedical research.
Anthrax Vaccine Research. ORD supports a study utilizing state of
the art technology to investigate and characterize the response of
human cells to anthrax vaccination and other agents. This study
represents a novel approach to identifying underlying mechanisms
operating in specific cell populations which are influenced in response
to exposure to anthrax vaccination. It is hoped that this study will
disclose biological processes that may improve our understanding of the
illnesses affecting Gulf War veterans.
LESSONS LEARNED
VA developed a wide range of health care and research programs to
benefit veterans of the 1991 Gulf War. Lessons learned from this
process have provided significant benefits to new combat veterans
returning today from Southwest Asia. Both groups of combat veterans--
those who served in the 1991 Gulf War and those who are serving in OEF
and OIF, remain a high priority for VA. This issue of a possible
increased risk for being diagnosed with ALS for all service members
remains a large concern for VA. In response, VA has initiated new
research on this possibility, and is considering how to respond to
findings of the recent IOM report on this issue.
Attachment: 19 Studies on Gulf War Veterans' Health Issues by the
National Academy of Sciences Institute of Medicine (IOM)
(available on line at www.nap.edu).
------------------------------------------------------------------------
------------------------------------------------------------------------
Congressionally Mandated ``Gulf War & Health'' Studies (by Public Laws
105-277 and 105-368)
------------------------------------------------------------------------
``Gulf War and Health: Volume 1. Depleted ``Gulf War and Health: Volume
Uranium, Pyridostigmine Bromide, Sarin, 3. Fuels, Combustion
and Vaccines.'' 2000 Products, and Propellants.''
2005
------------------------------------------------------------------------
``Gulf War and Health: Volume 2. ``Gulf War and HealthVol. 4:
Insecticides and Solvents.'' 2003 Health Effects of Serving in
the Gulf War.'' 2006
------------------------------------------------------------------------
``Gulf War and Health: Updated Literature ``Gulf War and Health Vol. 5:
Review of Sarin.'' 2004 Infectious Diseases.'' 2006
------------------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
Other Gulf War Veteran's Health Studies--Clinical and Policy
Evaluations--continued
------------------------------------------------------------------------
``Gulf War Veterans: Treating Symptoms ``An Assessment of the Safety
and Syndromes.'' 2001 of the Anthrax Vaccine: A
Letter Report.'' 2000
------------------------------------------------------------------------
``Protecting Those Who Serve: Strategies ``Strategies to Protect the
to Protect the Health of Deployed U.S. Health of Deployed U.S.
Forces.'' 2000 Forces: Detecting,
Characterizing, and
Documenting Exposures.'' 2000
------------------------------------------------------------------------
``Measuring the Health of Persian Gulf ``Gulf War Veterans:
Veterans: Workshop Summary.'' 1998 Measuring Health.'' 1999
------------------------------------------------------------------------
``Strategies to Protect the Health of ``National Center for
Deployed U.S. Forces: Medical Military Deployment Health
Surveillance, Record Keeping, and Risk Research.'' 1999
Reduction.'' 1999
------------------------------------------------------------------------
``Adequacy of the VA Persian Gulf ``Adequacy of the
Registry and Uniform Case Assessment Comprehensive Clinical
Protocol.'' 1998 Evaluation Program: A Focused
Assessment.'' 1997
------------------------------------------------------------------------
``Adequacy of the Comprehensive Clinical ``Health Consequences of
Evaluation Program: Nerve Agents.'' 1997 Service During the Persian
Gulf War: Recommendations for
Research and Information
Systems.'' 1996
------------------------------------------------------------------------
``Health Consequences of Service During
the Persian Gulf War: Initial Findings
and Recommendations for Immediate
Action.'' 1995
------------------------------------------------------------------------
Statement of Shannon L. Middleton, Deputy Director,
Veterans Affairs and Rehabilitation Commission, American Legion
Mr. Chairman and Members of the Subcommittee:
The American Legion appreciates the opportunity to offer our views
on this very important issue. American military forces are currently
engaged in combat operations in Iraq and Afghanistan and it is easy to
forget that there are still thousands of veterans from the 1991 Gulf
War still suffering from unexplained multi-symptom illnesses related to
their service in Southwest Asia. We applaud this Subcommittee for not
forgetting these veterans and holding this hearing.
History of Undiagnosed Illness Compensation
Shortly after the end of the 1991 Gulf War, thousands of Gulf War
veterans began complaining of unexplained multi-symptom illnesses
(headaches, fatigue, muscle pain, joint pain, gastrointestinal
problems, neurological signs and symptoms, etc.). In most cases,
doctors were not able to provide definitive diagnoses. As a result,
compensation claims filed with the Department of Veterans Affairs (VA)
were being denied outright since VA was prohibited by law from
``service-connecting'' conditions that could not be diagnosed. As
result of strong lobbying efforts by the veteran service organization
community and others to correct this problem, Public Law 103-446 (38
USC Sec. 1117) was enacted in 1994, authorizing VA to pay compensation
to disabled Gulf War veterans suffering from undiagnosed illnesses. The
undiagnosed illness must have become manifest either while the veteran
was in the Southwest Asia theater of operations or prior to January 1,
2012, if symptoms first developed after the veteran left Southwest
Asia. Although PL 103-446 was clearly intended to compensate ill Gulf
War veterans suffering from undiagnosed or medically unexplained
conditions, vague wording in the final version of the law allowed VA to
publish restrictive implementing regulations, resulting in a very high
denial rate under the new law. Conditions such as fibromyalgia,
irritable bowel syndrome, and chronic fatigue syndrome, although
medically unexplained, were considered to be ``diagnosed'' conditions
and were being denied under the new undiagnosed illness law.
The VSO community again turned to Congress for help. The result was
Public Law 107-103, signed into law on December 27, 2001. Effective
March 1, 2002, provisions of this law clarified and further expanded
the definition of undiagnosed illness under the law to include
medically unexplained chronic multi-symptom illness, such as chronic
fatigue syndrome, fibromyalgia, and irritable bowel syndrome, that is
defined by a cluster of signs or symptoms. Signs or symptoms that may
be a manifestation of an undiagnosed or chronic multi-symptom illness
include the following: fatigue, unexplained rashes or other
dermatological signs or symptoms, muscle pain, joint pain, neurological
signs or symptoms, signs or symptoms involving the upper or lower
respiratory system, sleep disturbances, gastrointestinal signs or
symptoms, cardiovascular signs or symptoms, abnormal weight loss, or
menstrual disorders. A disability is considered chronic if it has
existed for at least 6 months.
Despite the enactment of PL 107-103, clarifying and expanding the
definition of undiagnosed illness, the denial rate for these claims
remains very high (approximately 75 percent). The restrictive nature of
VA's final rule, published in the Federal Register on June 10, 2003,
implementing the Gulf War provisions of PL 107-103 has reinforced this
pattern. As of May 2007, less than four thousand such claims, out of
almost 15,000 that have been processed, have been granted service
connection.
The American Legion urges the House Veterans' Affairs Committee to
conduct oversight of the Gulf War-related provisions of PL 107-103.
Compensation for Amyotrophic Lateral Sclerosis (ALS)
Preliminary findings of a joint Department of Veterans Affairs (VA)
and Department of Defense (DoD) study, released in December 2001, of
nearly 2.5 million veterans indicated that deployed Gulf War veterans
(August 2, 1990 to July 31, 1991) are twice as likely as their non-
deployed counterparts to develop ALS. The Secretary of Veterans Affairs
immediately announced that he would explore VA's options for
compensating Gulf War veterans who have been diagnosed with ALS. VA
subsequently directed all VA regional offices to submit all Gulf War
ALS cases to VA Central Office for expeditious adjudication. VA
service-connected all Gulf War veterans (with service in Southwest Asia
during the period of August 2, 1990 to July 31, 1991) identified with
ALS at that time (approximately 40) on a direct basis, using the
preliminary research findings as evidence to link ALS to the veterans
Gulf War service.
Despite the Secretary's announcement and subsequent action, VA did
not have plans to draft a regulation establishing an ALS presumption
under current law guaranteeing compensation for Gulf War veterans who
develop ALS in the future. The joint VA and DoD study was published in
the scientific journal ``Neurology'' in September 2003, resulting in
the Secretary publicly announcing that this ``final study'' supports
his 2001 decision to compensate Gulf War veterans stricken with ALS.
Despite this public announcement and the Secretary's initial decision
to expeditiously service-connect, on a direct basis, Gulf War veterans
diagnosed with ALS, VA informed The American Legion that it would be
``premature'' to create a regulatory presumption of service connection
for Gulf War veterans with ALS. Bottom-line, although VA expeditiously
service-connected a small number of veterans diagnosed with ALS, it has
not established ALS as an official Gulf War presumptive disability and
it has no plans to do so at this time based on its responses to
specific American Legion inquiries. Without an actual presumption in
place, there is nothing to ensure that Gulf War veterans diagnosed with
ALS in the future will receive the same treatment as those discussed
above. Due to the media coverage of VA's actions to expeditiously
service-connect Gulf War veterans with ALS in December 2001, many
people are under the erroneous belief that ALS is a Gulf War
presumptive disability.
Additional studies have shown that military veterans in general
have a greater likelihood than non-veterans of developing ALS. A study
published in 2005 in the journal ``Neurology'' titled ``Prospective
study of military service and mortality from ALS,'' [M.G. Weisskopf et
al., 2005; 64:32-37] evaluated ALS risk for veterans from World War 2,
and the Korean and Vietnam Wars. This study concluded that these
veterans were at significantly higher risk for ALS compared to
civilians. In November 2006, the Institute of Medicine (IOM) released a
report concluding ``there is limited and suggestive evidence of an
association between military service and later development of ALS.'' We
understand that VA has finished its evaluation of the November 2006 IOM
report in order to determine if any changes in VA health care or
disability compensation policies are warranted but has determined that
more research is needed and a presumption is not warranted at this
time. Although IOM also noted that additional research is needed
regarding a link between military service and ALS, we submit that IOM's
finding of ``limited and suggestive'' evidence between ALS and military
service is sufficient, under current law, for VA to move forward and
establish official ALS service connection presumptions. Even though
veterans can, in theory, establish service connection without a
specific military presumption, it is extremely difficult in most cases
for the veteran to meet the burden of proof required by VA for
establishing direct service connection and many veterans will be
precluded from establishing entitlement to service connection for ALS
without an actual presumption.
Gulf War Presumptive Disabilities
Research is inextricably intertwined with an ill Gulf War veteran's
ability to receive VA compensation for specific conditions he/she
believes are related to his/her Gulf War service. 38 USC Sec. 1118 (PL
105-277), allows the Secretary of Veterans Affairs to establish
presumptions of service connection for specific diagnosed conditions/
diseases when scientific research supports a positive association with
a known Gulf War exposure (vaccines, nerve agents, depleted uranium
(DU), oil well smoke, etc.). The Secretary relies primarily on the IOM
literature reviews and subsequent reports (Gulf War and Health) to
determine whether a positive association exists to justify the
establishment of a presumption. IOM?s reports to date (Volume 1:
Depleted Uranium, Pyridostigmine Bromide, Sarin, Vaccines; Volume 2:
Insecticides and Solvents; Volume 3: Fuels, Combustion Products, and
Propellants; Volume 4: Health Effects of Serving in the Gulf War;Volume
5: Infectious Disease), and an August 2004 updated literature review of
sarin have not provided the scientific evidence necessary for VA to
establish presumptive disabilities for any of the exposures looked at
by IOM so far. As a result, not one presumptive disability has been
established to date under this law.
Congress directed IOM's reports to be based on findings from the
full range of human and animal studies that provide information on the
effects of Gulf War-related exposures, as well as both diagnosed and
undiagnosed illnesses affecting Gulf War veterans. IOM's ``Gulf War and
Health'' series of reports, as commissioned by VA, have not adhered to
requirements set forth by Congress in mandating the reports. As a
result, they have not comprehensively addressed key questions regarding
Gulf War-related health conditions in relation to Gulf War exposures.
IOM's reports to date have not considered findings from epidemiologic
studies of Gulf War veterans (i.e. association of Gulf War veterans'
illnesses with exposures), nor have they considered animal studies in
drawing its conclusions. A perfect example of this is the August 2004
updated literature review of sarin. The Secretary of VA commissioned
this review because studies published subsequent to IOM's September
2000 report (Volume 1), that addressed sarin, showed that exposure to
sarin even at levels too low to cause immediate/acute effects can still
have long-term adverse health effects (brain damage). Even though these
studies were the reason the Secretary wanted IOM to look at sarin
again, IOM did not even consider this research when drawing its
conclusions because they were animal-based studies.
Research
In the Research Advisory Committee on Gulf War Veterans' Illness
(RACGWI) initial report released in November 2004, it was found that,
for a large majority of ill Gulf War veterans, their illnesses could
not be explained by stress or psychiatric illness and concluded that
current scientific evidence supports a probable link between neurotoxin
exposure and subsequent development of Gulf War veterans' illnesses.
Earlier government panels concluded that deployment-related stress, not
the numerous environmental and other exposures troops were exposed to
during the war, was likely responsible for the numerous unexplained
symptoms reported by thousands of Gulf War veterans.
Gulf War research is moving away from the previous stress theories
and is actually starting to narrow down possible causes. However,
research regarding viable treatment options is still lacking. The
American Legion applauds Congress for having the foresight to provide
funding to the Southwestern Medical Center's Gulf War Illness research
program. The Center, headed by Dr. Robert Haley at the University of
Texas Southwestern, was awarded $15 million, renewable for 5 years, to
further the scientific knowledge on Gulf War Veterans Illnesses
research. This research will not only impact veterans of the 1991 Gulf
War, but may prove beneficial for those currently serving in the
Southwest Asia Theater and the Middle East during the Global War on
Terror. The purpose of the research is to fill in the gaps of knowledge
where there is little, yet suggestive, information. Dr. Haley's
research will further this knowledge about Gulf War veterans' illnesses
and hopefully help improve the lives of ill Gulf War veterans, and
their families who suffer beside them. We owe ill Gulf War veterans our
exhaustive efforts in finding treatments for their ailments. The
American Legion believes that VA should continue to fund research
projects consistent with the recommendations of the Research Advisory
Committee on Gulf War Veterans' Illness (RACGWI). It is important that
VA continues to focus its research on finding medical treatments that
will alleviate veterans' suffering as well as on figuring out the
causes of that suffering. The American Legion also recommends that the
Subcommittee thoroughly review the RACGWI's second report, which will
be released this fall.
Health Care
Public Law 103-210, which authorized the Secretary of Veterans
Affairs to provide priority health care to the veterans of the Persian
Gulf War who have been exposed to toxic substances and environmental
hazards, allowed Gulf War Veterans to enroll into Priority Group 6. The
last sunset date for this authority was December 31, 2002. Since this
date, information provided to veterans and VA hospitals has been
conflicting. Some hospitals continue to honor Priority Group 6
enrollment for ill Gulf War veterans seeking care for their ailments.
Other hospitals, well aware of the sunset date, deny Priority Group 6
enrollment for these veterans and notify them that they qualify for
Priority Group 8. To the veterans' dismay, they are completely denied
enrollment because the VA has restricted enrollment for Priority Group
8 since January of 2003. Even more confounding is the fact that
eligibility information disseminated via Internet and printed materials
does not consistently reflect this change in enrollment eligibility for
Priority Group 6. The American Legion has been assured by VA that this
issue will be rectified.
The American Legion believes priority health care should be again
extended to Gulf War veterans seeking treatment for ailments related to
environmental exposures in theater. Although these veterans can file
claims for these ailments and possibly gain access to the health care
system once a disability percentage rate is granted, those whose claims
are denied cannot enroll. According to the May 2007 version of VA's
Gulf War Veterans Information System (GWVIS), there were 14,874 claims
processed for undiagnosed illnesses. Of those undiagnosed illness
claims processed, 11,136 claims were denied. Because the nature of
these illnesses are difficult to understand and information about
individual exposures may not be available, many ill veterans are not
able to present strong claims. They are then forced to seek care from
private physicians who may not have enough information about Gulf War
veterans' illnesses to provide appropriate care.
Since VA doctors would be more knowledgeable about the exposures
Gulf War veterans experienced in theater, it is important that VA keeps
Gulf War Continuing Medical Education (CME) updated to reflect current
science. It is equally important that, once updated, VA makes Gulf War
CMEs a requirement, not an option, to better serve this population of
ill veterans. Although reputable research Committees have shown that
Gulf War veterans are sicker than those who did not deploy to the
Southwest Asia theater, The American Legion is still contacted by
veterans complaining that some VA doctors do not know how to treat
their Gulf War illnesses. In fact, some ill Gulf War veterans are still
being told that their illnesses are all in their heads.
Outreach
It is The American Legion's understanding that VA has stopped
mailing out printed copies of the Gulf War Review and is now only
posting it online. We are concerned, not only because not all Gulf War
veterans have Internet access, but the VA's Gulf War veterans page is
difficult to locate from VA's main web page. Only those who know where
it is located, or that it even exists, will have access to the
information. The American Legion has had several calls from those who
inquired about the printed newsletter, as well as those who were
interested but had no Internet access. We urge VA to resume mailing out
printed versions of the Gulf War Review in addition to posting it on
the web.
Again, thank you Mr. Chairman for giving The American Legion this
opportunity to present its views on such an important issue. We look
forward to working with the Subcommittee to address this and other
issues affecting veterans.
Statement of Hon. Corrine Brown,
a Representative in Congress from the State of Florida
Thank you, Mr. Chairman for calling this hearing today.
Gulf War Illnesses have bedeviled the doctors of the Department of
Defense and the Veterans Administration.
About 670,000 troops from the United States served in this
conflict. They served from just after the invasion of Kuwait on August
2, 1990 until June 13, 1991.
While the troops have long been returned home from this conflict,
their suffering continues, 16 years later. For years, the VA and DoD
rejected the complaints of the veterans that they were sick and were
told they were imagining things.
Well, they were not imagining things and the experience of war
affects everyone differently. We are learning that from the current
wars in Iraq and Afghanistan.
What have we learned from the Persian Gulf War?
Are we taking these lessons and protecting the soldiers in Iraq and
Afghanistan?
I know the Department of Defense is collecting data from soldiers.
Is it the right data?
Is the VA and DoD cooperating in the discussion of symptoms and
illnesses soldiers are coming home with? Are they sharing the data.
Do we have numbers of veterans complaining of unknown illnesses? We
have a pretty good idea of those suffering from TBI or PTSD. What about
what we don't know?
I look forward to hearing the testimony today.
Statement of Dan Fahey, San Francisco, CA (Ph.D., Candidate, University
of California-Berkley)
Dear Chairman Filner and Honorable Members of the House Veterans
Affairs Committee:
I respectfully submit to you this written testimony on the occasion
of your hearing on Gulf War veterans' illnesses to call your attention
to serious problems with the Department of Veterans Affairs (DVA) study
of Gulf War veterans exposed to depleted uranium (DU). Since 1993, I
have interviewed hundreds of veterans about battlefield exposures to
dust and debris from armor-piercing DU ammunition and presented my
research findings to numerous Federal investigations of Gulf War
veterans' illnesses. I am including with this testimony a copy of my
most recent presentation at the 28 June 2007 meeting of the Institute
of Medicine (IOM) Committee that is reviewing scientific and medical
literature on the health effects of DU exposure. My IOM presentation
provides more detailed information in support of this statement.
The Department of Veterans Affairs study of DU is neither
structured nor functioning to provide basic information about the
possible health effects of DU exposure among Gulf War veterans. There
are two major flaws with the study that undermine its integrity and
value. First, the DVA study is undersized. From its inception in 1993,
the study included only a tiny fraction of the number of veterans with
known or suspected exposures to DU. Consequently, we have no
information about the possible health effects among the thousands of
Gulf War veterans exposed to DU in friendly fire incidents; during the
recovery, transport, and inspection of contaminated equipment; and as a
result of the July 1991 munitions fire at Doha, Kuwait.
Second, the DVA study has become politicized. In recent years,
officials from both the Department of Defense (DoD) and DVA have
repeatedly presented false and incomplete information about the
existence of cancers and tumors among the few dozen veterans being
studied. The deceitful statements and omissions by DoD and DVA
officials undermine the integrity of the study and call to question its
purpose.
The DVA study of veterans exposed to DU is located at the Baltimore
VA Medical Center and directed by Dr. Melissa McDiarmid. When DVA
created the study in 1993, only 33 Gulf War veterans were enrolled.
These individuals had been heavily exposed to DU as a result of being
inside vehicles hit by DU rounds in friendly fire incidents; some had
been wounded by DU fragments while others inhaled DU dust. A 1993 DVA
report on the creation of the study noted: ``The small size of the
population--[makes it] highly unlikely that definitive conclusions
concerning cancer induction will be obtained from the study.'' By 2000,
however, DoD belatedly admitted that ``thousands'' of Gulf War veterans
may have been exposed to DU during and after the Gulf War, including
approximately 900 veterans who are believed to have had heavy exposures
to DU during friendly fire incidents, vehicle recovery operations, and
the Doha, Kuwait munitions fire. Despite this admission, since 2001 the
DVA study has examined only 46 individual Gulf War veterans. Since
numerous laboratory studies have demonstrated that DU may cause
cancers, tumors, neurological problems, and other effects, it is
imperative to expand and improve the DVA study in order to clarify the
association between exposure to DU and cancer induction or other
illnesses among Gulf War veterans.
In addition to studying only a few dozen veterans, the DVA study
director has not honestly and completely presented study findings
either publicly or in the medical literature. This fact first emerged
in 2001, when DoD and DVA officials responded to European concerns that
the use of DU munitions by U.S. jets during the Kosovo conflict had
affected the health of NATO troops and civilians. At the height of the
European controversy in January 2001, DVA study director Dr. Melissa
McDiarmid wrote in the British Medical Journal that no veterans in her
study had developed ``leukemia, bone cancer or lung cancer,'' yet she
inexplicably failed to mention that in 1999 one veteran in the study
had Hodgkin's lymphoma and a second veteran had a bone tumor. Moreover,
a 2006 journal article co-authored by Dr. McDiarmid supposedly
summarized all study findings for the period 1993 to 2005, yet this
article notably failed to mention the findings of the Hodgkin's
lymphoma and bone tumor among the few dozen study participants. During
her 28 June 2007 presentation to the IOM committee assessing the
possible link between exposure to DU and health effects among veterans,
Dr. McDiarmid again neglected to mention the findings of the Hodgkin's
lymphoma and bone tumor.
These deceitful statements and omissions suggest that the DVA study
is less a scientific study than a political tool used to downplay
public concerns about DU and to mislead investigations of the
connection between DU and health effects--such as the current IOM
investigation--that could lead to an extension of service-connected
benefits to Gulf War veterans for cancers or other illnesses.
I respectfully make the following recommendations to the House
Veterans Affairs Committee:
Initiate a U.S. Government Accountability Office
investigation to clarify the purpose and findings of the DVA study, and
to recommend how the study could be restructured to better serve the
interests of both veterans and scientific inquiries into the health
effects of exposure to depleted uranium; and
Summon DVA study director Dr. Melissa McDiarmid to appear
before the Committee to testify under oath about the number and type of
cancers and tumors among study participants, and to explain why she has
not honestly and thoroughly reported findings of cancers and tumors in
the medical literature or to the IOM.
What is clearly needed at this point--16 years after Operation
Desert Storm--is a study of all veterans with known or suspected DU
exposures to determine rates of cancers, tumors, neurological problems,
and other health effects potentially related to DU exposure;
furthermore, there is an urgent need for a new study director who will
accurately report study findings. I thank Chairman Filner for his
sustained interest and action to investigate Gulf War veterans'
illnesses and stand ready to assist the House Veterans Affairs
Committee in its future work on this subject.
______
ADDENDUM TO
``DEPLETED URANIUM AND VETERANS HEALTH:
A FLAWED TESTING PROCESS AND AN UNDERSIZED, POLITICIZED STUDY LIMIT
EVALUATION OF EXPOSURES AND EFFECTS''
Dan Fahey
Institute of Medicine
Washington, DC
28 June 2007
The following tables and narrative contain additional information
about recommended limits on intake, exposure estimates, tumor
formation, and Hodgkin's lymphoma. This information supplements my
Power Point presentation to the Institute of Medicine, and is excerpted
from:
Fahey, D. In press. ``Depleted Uranium and Its Use in Munitions,''
and ``Environmental and Health Consequences of Depleted Uranium
Munitions,'' in Avril McDonald (ed.) The International Legal Regulation
of the Use of Depleted Uranium Weapons: A Cautionary Approach. Den
Haag: Asser Press.
Table 1. Recommended limits on intake
----------------------------------------------------------------------------------------------------------------
United States Others
----------------------------------------------------------------------------------------------------------------
Members of the Public 0.05 mg/15 minutes \1\ 0.035 mg/day \3\
0.5 mg/day \2\ 4.5 mg/year \4\
----------------------------------------------------------------------------------------------------------------
Occupational Workers 0.18 mg/15 minutes \5\ 0.18 mg/15 minutes \9\
2 mg/day \6\ 2mg/day \10\
10mg/week \7\ 130mg/year \11\
480mg/year \8\
----------------------------------------------------------------------------------------------------------------
Table compiled by Dan Fahey
The recommended limits on intake provide a basis from which to
assess the significance of theoretical exposure estimates in a range of
battlefield scenarios (Table 2). The Royal Society has generated a
series of estimates intended to be generic for soldiers and civilians
in conflicts where DU munitions are used.\12\ In 1999, the U.S. Army
Center for Health Promotion and Preventive Medicine developed a set of
exposure estimates that were subsequently criticized as ``incomplete
and misleading'' by the Presidential Special Oversight Board on Gulf
War Veterans' Illnesses.\13\ Consequently, the Army undertook a series
of live-fire tests of DU rounds, known as the Capstone Project, and
released revised estimates in 2004 (figures listed below are the
Capstone estimates).\14\ In 2005, Sandia national Laboratories (U.S.)
published a study that included exposure estimates. The Royal Society,
U.S. Army, and Sandia estimates are similar in some cases; in others
they vary by orders of magnitude.
Table 2. Estimated intakes in exposure scenarios, durations of exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Royal Society Royal Society U.S. Army ``Most U.S. Army ``Upper Sandia ``Nominal Sandia ``Maximum
``Central'' ``Worst-Case'' Likely'' Estimate Bound'' Estimate Exposure'' \19\ Exposure'' \20\
Estimate \15\ Estimate \16\ \17\ (Time) \18\ (Time) (No duration (No duration
(Time) (Time) specified) specified)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Soldiers in an armored vehicle 250 mg (1 minute) 5000 mg (1 hour) 10-280 mg (1 91-970 mg (1 hour) 250 mg inhalation 4000 mg inhalation
penetrated by a DU round minute) 43-710 mg 110-1000 mg (2 330 mg fragments 1800 mg fragments
(5 minutes) hours) 15 mg ingestion 500 mg ingestion
--------------------------------------------------------------------------------------------------------------------------------------------------------
Soldiers who enter vehicles to 250 mg (1 minute) 5000 mg (1 hour) 27-200 mg (10 No estimate 250 mg inhalation 4000 mg inhalation
rescue occupants immediately minutes) 15 mg ingestion 500 mg ingestion
after a DU impact
--------------------------------------------------------------------------------------------------------------------------------------------------------
People who work in and around DU- 1 mg inhalation 200 mg inhalation 0.45 mg inhalation 14.5 mg inhalation 40 mg inhalation 600 mg inhalation
impacted equipment 0.5 mg ingestion 50 mg ingestion 10.6 mg Ingestion 10.6 mg ingestion 30 mg ingestion 300 mg ingestion
(1 hour) (10 hours) (1 hour) (1 hour)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Child at play No estimate No estimate No estimate No estimate 54 mg inhalation 226 mg inhalation
3000 mg ingestion 9000 mg ingestion
--------------------------------------------------------------------------------------------------------------------------------------------------------
People downwind of DU-impacts 0.07 inhalation 4.9 mg inhalation 0.00006 mg 0.04 mg inhalation 0.003 mg 0.1 mg inhalation
(passage of plume) (passage of plume) inhalation (passage of plume) inhalation
(passage of plume)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inhalation of resuspended DU 0.8 mg \21\ (27 80 mg \22\ (27 No estimate No estimate 0.001 mg 0.003 mg
from soil days) days) inhalation inhalation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table compiled by Dan Fahey
5.1 Cancer
Laboratory studies have clearly demonstrated that DU is
carcinogenic, but the link between DU and cancer in humans remains
uncertain. Some of the uncertainties are related to the long latency
period for development of cancers related to DU and the fact that few
exposed humans have been studied. While the use of DU munitions appears
unlikely to cause widespread cancers, sufficient evidence exists to
support concerns that exposure to DU may lead to an elevated risk of
cancer in heavily exposed populations.
5.1.1 Laboratory studies
*****
[TUMOR FORMATION]
Research conducted by the U.S. Armed Forces Radiobiology Research
Institute (AFRRI) found that DU transformed human cells to a pre-
cancerous phase; these cells then produced tumors when they were
injected into mice.\23\ The transformed cells also induced genetic
instability and reduced production of a key tumor-suppressor
protein.\24\
Other AFRRI studies found that DU causes DNA damage that might
initiate and promote the formation of tumors.\25\ The damage to DNA
appears to be caused by both alpha radiation and chemical effects,\26\
with delayed chromosomal damage observed in cells not directly
irradiated by DU (the so-called ``bystander effect'').\27\
``Considering that conventional understanding of potential DU health
effects assumes that chemical effects are of greatest concern, results
demonstrating that both radiation and chemical effects are involved in
DU-induced cellular damage could have a significant impact on DU risk
assessments.'' \28\
*****
5.1.3.1 Hodgkin's Lymphoma
The one cancer that has repeatedly shown up in surveys of veterans
is Hodgkin's lymphoma (also known as Hodgkin's disease). Hodgkin's
lymphoma develops in the lymph nodes, and it is a rare form of cancer
(2.58 cases per 100,000 people in more developed countries; 0.94 cases
per 100,000 in less developed countries \29\) with no known risk
factor.\30\ According to the Institute of Medicine:
``The lymphatic system is an important potential target for uranium
radiation because inhaled insoluble uranium oxides can remain up to
several years in the hilar lymph nodes of the lung. Studying the effect
of uranium exposure on lymphatic cancer is more difficult than studying
lung cancer because lymphatic cancer is much less common.'' \31\
In general, Hodgkin's lymphoma occurs more often among men and in
people aged 15-34 and over 55.
In the United States, one out of 50 veterans examined in 1999 by
the Department of Veterans Affairs'' DU Program had Hodgkin's
lymphoma.\32\ It is worth noting that although this cancer was first
reported in 1999 and discussed during an October 1999 meeting between
the doctor in charge of the study and several Pentagon officials, in
January 2001 a Pentagon official publicly denied the existence of this
or any cancer among U.S. veterans in the DU study.\33\
In August 2002, the UK Ministry of Defence released a study showing
that deaths due to lymphatic cancers were nearly twice as high among
Gulf War veterans compared to a control group.\34\ There is no publicly
available information about the number of cases of Hodgkin's lymphoma
versus the more-common Non-Hodgkin's lymphoma, but of the 3,172 Gulf
veterans seen at the UK Gulf Veterans'' Medical Assessment Programme as
of 31 January 2003, 11 cases of lymphoma (including Hodgkin's and Non-
Hodgkin's) had been reported.\35\ The Ministry of Defence denies a link
between these cancers and DU, but has initiated an additional study to
clarify this finding.
Among Italian soldiers who served in Bosnia and/or Kosovo, ``there
is a disproportionately high number, which is statistically
significant, of cases of Hodgkin's Lymphoma.'' \36\ Although the
Italian Defense Ministry could not identify the causes of this
increase, it stated: ``The results of sample studies carried out on
Italian soldiers on duty in Bosnia and Kosovo have not shown evidence
of depleted uranium contamination.'' \37\ Overall, the Defense Ministry
found a smaller-than-expected number of cancer cases among these
soldiers.\38\
Endnotes
\1\ This limit is for inhalation of insoluble uranium based on a
short-term exposure limit of 0.15 mg/m\3\ based on a breathing rate of
9.6 m\3\ per 8-hour working day. U.S. National Institute for
Occupational Safety and Health (NIOSH), ``Pocket Guide to Chemical
Hazards,'' 1994; see also United Nations Environment Programme,
``Depleted Uranium in Bosnia and Herzegovina.'' (Geneva: UNEP, 25 March
2003) p. 261.
\2\ This limit is for inhalation of insoluble uranium based on
chronic exposure limit of 0.05 mg/m\3\ based on a breathing rate of 9.6
m\3\ per 8-hour working day. NIOSH supra n. 107; see also United
Nations Environment Programme, ``Depleted Uranium in Bosnia and
Herzegovina.'' (Geneva: UNEP, 25 March 2003) p. 261. Another reference
states that the limit for inhalation of DU for members of the public
equates to breathing a mass of 0.2 mg/day; R.L. Fliszar, ``Radiological
Contamination from Impacted Abrams Heavy Armor,'' Technical Report BRL-
TR-3068 (Aberdeen Proving Ground, MD, Ballistic Research Laboratory
December 1989) p. 18.
\3\ The International Commission on Radiological Protection and the
World Health Organization prescribe slightly different limits on intake
by inhalation for members of the public, based partly on differences in
limits based on chemical toxicity and radiation dose. To resolve this
discrepancy, a recommendation has been made ``that a unified . . .
daily intake of 35 [micrograms] would be acceptable in most cases. This
value would satisfy the constraints imposed by radiation dose and
chemical toxicity. However, for protracted exposure to highly insoluble
uranium compounds, a further threefold reduction may be considered
appropriate.'' N. Stradling et al, ``Anomalies between radiological and
chemical limits for uranium after inhalation by workers and the
public,'' 105 Radiation Protection Dosimetry (2003) 178.
\4\ This refers to an inhalation of type S (insoluble) natural
uranium and is based on a 1 micron activity mean aerodynamic diameter
(AMAD). As noted above (see supra n. 8), the majority of DU particles
created by an impact are insoluble. The limit for intake by inhalation
of type M (moderately soluble) natural uranium is 13 mg/year; for type
F (soluble) it is 75 mg/year. N. Stradling et al, ``Anomalies between
radiological and chemical limits for uranium after inhalation by
workers and the public,'' 105 Radiation Protection Dosimetry (2003) p.
176. Another reference states ``The Annual Limit of Intake for uranium-
238, for a member of the public, as specified by the International
Committee for Radiological Protection, equates to breathing in a mass
of approximately 8 mg of Depleted Uranium.'' The Lord Gilbert, UK
Ministry of Defense, letter to The Countess of Mar, 2 March 1998 (in
author's files).
\5\ For brief exposures, the American Conference of governmental
Industrial Hygienists (ACGIH) set a short-term exposure limit (STEL) of
0.6 mg/m\3\ over a 15-minute period. At a breathing rate of 9.6 m\3\
per 8-hour working day, this equates to a recommended short-term limit
on inhalation intake of 0.18 mg. U.S. Agency for Toxic Substances and
Disease Registry (ATSDR), ``Toxicological Profile for Uranium''
(Washington, DC: U.S. Public Health Service, September 1999) p. 9
(hereinafter, ATSDR Report). ``The STEL (i.e. less than a 15 minute
exposure followed by periods of minimal or no exposure) would apply to
the shorter term exposures occurring in the Gulf War (e.g., entering
damaged equipment).'' The Office of the Special Assistant to the Deputy
Secretary of Defense for Gulf War Illnesses, Depleted Uranium in the
Gulf (II) (Washington, DC, 2000) p. 19.
\6\ Based on an 8-hour workday, 40-hour workweek maximum air
concentration limit of 0.2 mg/m\3\, with an average breathing rate of
9.6 m\3\ per 8-hour working day. U.S. Agency for Toxic Substances and
Disease Registry (ATSDR), ``Toxicological Profile for Uranium.''
(Washington, DC: U.S. Public Health Service, September 1999) pp. 322,
329. The 2 mg figure applies for both soluble (type F) and insoluble
(type S) compounds; N. Stradling et al, ``Anomalies between
radiological and chemical limits for uranium after inhalation by
workers and the public,'' 105 Radiation Protection Dosimetry (2003) p.
177; Dr. Naomi Harley, statement to the Presidential Special Oversight
Board for Department of Defense Investigations of Gulf War Chemical and
Biological Incidents (Washington, D.C., 19 July 1999); The Office of
the Special Assistant to the Deputy Secretary of Defense for Gulf War
Illnesses, Depleted Uranium in the Gulf (II) (Washington, DC, 2000) p.
18.
\7\ U.S. Code of Federal Regulations, 10 CFR 20, ``Standards for
Protection Against Radiation,'' Subpart C, 20.1201, ``Occupational Dose
Limits for Adults, 1 January 2001.
\8\ The annual limit on inhalation intake is based on the volume of
air that a worker is assumed to breathe in a year (2,400 m\3\), and the
occupational exposure limit of 0.2 mg/m\3\. U.S. Agency for Toxic
Substances and Disease Registry (ATSDR), ``Toxicological Profile for
Uranium.'' (Washington, DC: U.S. Public Health Service, September 1999)
pp. 321, 329; U.S. Code of Federal Regulations (CFR), 29 CFR 1926.55,
Appendix A, ``Threshold Limit Values of Airborne Contaminants for
Construction,'' Uranium, 1 July 2000.
\9\ For brief inhalation exposures, the UK Health and Safety
Executive (HSE) set a short-term exposure limit (STEL) of 0.6 mg/m\3\
over a 15-minute period. At a breathing rate of 9.6 m\3\, this equates
to a recommended short-term limit on intake of 0.18 mg, based on
chemical toxicity. UK Health and Safety Executive (HSE), Occupational
Health Exposure Limits 2000, EH40/2000 (Sudbury, Suffolk, HSE Books
2000).
\10\ This is the occupational exposure limit for soluble natural
uranium compounds (0.2 mg/m\3\), at a breathing rate of 9.6 m\3\ per 8-
hour working day, based on chemical toxicity. Ibid.
\11\ This refers to an inhalation of type S (insoluble) natural
uranium based on a 5 micron activity mean aerodynamic diameter. As
noted above (see supra n. 8), the majority of DU particles created by
an impact are insoluble. The limit for intake by inhalation of type M
(moderately soluble) natural uranium is 430 mg/year; for type F
(soluble) it is 1290 mg/year. N. Stradling et al, ``Anomalies between
radiological and chemical limits for uranium after inhalation by
workers and the public,'' 105 Radiation Protection Dosimetry (2003) p.
176.
\12\ The Royal Society, ``The health hazards of depleted uranium
munitions, Part I.'' (London: Royal Society, 2001) p. 5.
\13\ Presidential Special Oversight Board for Department of Defense
Investigations of Gulf War Chemical and Biological Incidents, ``Special
Oversight Board Analysis (Ver. 2) of OSAGWI''s DU Report,''
(Washington, DC, 19 February 1999) (in author's files).
\14\ M.A. Parkhurst et al, ``Depleted Uranium Aerosol Doses and
Risks: Summary of U.S. Assessments,'' PNWD-3476 Prepared for the U.S.
Army by Battelle (Richland, WA: Battelle, October 2004) http://
www.deploymentlink.osd.mil/du_library/du_capstone/index.pdf.
\15\ The Royal Society''s central estimate ``is intended to be
representative of the average individual within the group (or
population) of people exposed in that situation.'' The Royal Society,
``The health hazards of depleted uranium munitions, Part I.'' (London:
Royal Society, 2001) pp. 6, 41-43. See also Annexe C of the Royal
Society Report online at http://www.royalsoc.ac.uk/policy/du_c.pdf.
\16\ ``We calculated a ``worst case'' estimate using values at the
upper end of the likely range, but not extreme theoretical
possibilities. The aim is that it is unlikely that the value for any
individual would exceed the worst case. . . . If even the worst-case
assessment for a scenario leads to small exposures, then there is
little need to investigate more closely. If, however, the worst-case
assessment for a scenario leads to significant exposures, it does not
necessarily mean that such high exposures have occurred, or are likely
to occur in a future battlefield, but that they might have occurred, or
might occur in future conflicts, and further information and assessment
are needed.'' The Royal Society, ``The health hazards of depleted
uranium munitions, Part I.'' (London: Royal Society, 2001) pp. 6, 41-
43.
\17\ M.A. Parkhurst et al, ``Depleted Uranium Aerosol Doses and
Risks: Summary of U.S. Assessments,'' PNWD-3476 Prepared for the U.S.
Army by Battelle (Richland, WA: Battelle, October 2004) Chapters 3, 4.
\18\ M.A. Parkhurst et al, ``Depleted Uranium Aerosol Doses and
Risks: Summary of U.S. Assessments,'' PNWD-3476 Prepared for the U.S.
Army by Battelle (Richland, WA: Battelle, October 2004) Chapters 3, 4.
\19\ A.C. Marshall, ``An Analysis of Uranium Dispersal and Health
Effects Using a Gulf War Case Study,'' Sandia Report SAND2005-4331,
(Albuquerque, NM: Sandia national Laboratories, July 2005) p. 59-60.
\20\ Ibid, pp 59-60.
\21\ It is assumed that ``soldiers spend 4 weeks in an area,
starting from the time it is contaminated with 1 g m\2\DU; all the DU
is respirable; and the soldiers'' activities cause enhanced
resuspension of the DU owing to normal heavy vehicle movements, but the
soldiers are not undertaking digging, ploughing or clearance
operations.'' ``The central estimate is based on UK-like conditions. .
. .'' The Royal Society, ``The health hazards of depleted uranium
munitions, Part I.'' (London: Royal Society, 2001) p. 43, Annexe C.
\22\ It is assumed that ``soldiers spend 4 weeks in an area,
starting from the time it is contaminated with 1 g m\2\DU; all the DU
is respirable; and the soldiers'' activities cause enhanced
resuspension of the DU owing to normal heavy vehicle movements, but the
soldiers are not undertaking digging, ploughing or clearance
operations.'' ``[T]he worst case [estimate] is based on arid, dusty
conditions.'' The Royal Society, ``The health hazards of depleted
uranium munitions, Part I.''(London: Royal Society, 2001) p. 43, Annexe
C.
\23\ Alexandra Miller et al, ``Transformation of Human Osteoblast
Cells to the Tumorigenic Phenotype by Depleted Uranium-Uranyl
Chloride,'' Environmental Health Perspectives (1998) 106: 469.
\24\ Ibid., p. 470.
\25\ A.C. Miller et al, ``Depleted uranium-catalyzed oxidative DNA
damage: absence of significant alpha particle decay.'' 91 Journal of
Inorganic Biochemistry (2002) p. 251; A.C. Miller et al, ``Genomic
instability in human osteoblast cells after exposure to depleted
uranium: delayed lethality and micronuclei formation.'' 64 Journal of
Environmental Radioactivity (2003) p. 248.
\26\ A.C. Miller et al, ``Depleted uranium-catalyzed oxidative DNA
damage: absence of significant alpha particle decay.'' 91 Journal of
Inorganic Biochemistry (2002) pp. 246, 251
\27\ A.C. Miller et al, ``Genomic instability in human osteoblast
cells after exposure to depleted uranium: delayed lethality and
micronuclei formation.'' 64 Journal of Environmental Radioactivity
(2003) p. 257.
\28\ A.C. Miller et al, ``Depleted uranium-catalyzed oxidative DNA
damage: absence of significant alpha particle decay.'' 91 Journal of
Inorganic Biochemistry (2002) p. 251.
\29\ In 1999 the incidence of Hodgkin's lymphoma among U.S.
residents was 2.8 per 100,000 people (3.0 for men, 2.5 for women). For
men and women aged 25-29, the incidence was 5.4 per 100,000; for ages
30-34 the incidence was 4.1 per 100,000. L.A.G. Ries, M.P. Eisner, C.L.
Kosary, B.F. Hankey, B.A. Miller, L. Clegg, B.K. Edwards, eds., SEER
Cancer Statistics Review, 1973-1999, National Cancer Institute,
Bethesda, MD, http://seer.cancer.gov/csr/1973-1999/, 2002. Incidence
rates in other countries with forces that served in the Gulf War or
Balkans are similar: Italy--3.62; The Netherlands--2.32; United
Kingdom--2.26; Saudi Arabia--2.69; Kuwait--4.33; Iraq--2.10. J. Ferlay,
F. Bray, P. Pisani and D.M. Parkin, GLOBOCAN 2000: Cancer Incidence,
Mortality and Prevalence Worldwide, Version 1.0, IARC CancerBase No. 5,
Lyon, IARCPress, 2001, Limited version available from: URL: http://www-
dep.iarc.fr/globocan/globocan.htm, last updated on 03/02/2001.
\30\ U.S. National Cancer Institute, ``Information about detection,
symptoms, diagnosis, and treatment of Hodgkin's disease,'' NIH
Publication No. 99-1555, 16 September 2002.
\31\ U.S. Institute of Medicine, Gulf War and Health, Volume 1,
``Depleted Uranium, Pyridostigmine Bromide, Sarin, Vaccines.''
(Washington, D.C., National Academy Press 2000) p. 142.
\32\ M. McDiarmid, et al, ``Surveillance of Depleted Uranium
Exposed Gulf War Veterans: Health Effects Observed in an Enlarged
``Friendly Fire'' Cohort,'' 43 J Occup Environ Med (2001) p. 998.
\33\ See discussion of U.S. DU Program at end of Chapter 2.
\34\ UK Ministry of Defence, ``UK Gulf Veterans'' Mortality
Figures,'' August 2002. http://www.mod.uk/issues/gulfwar/info/
gen_reports/mortfigs_jun02.htm.
\35\ Statement of Lewis Moonie, UK Defence Minister, in response to
Dr. Gibson, House of Commons Hansard Written Answers for 11 February
2003, http://www.parliament.the_
stationery_office.co.uk/pa/cm200203/cmhansrd/cm030211/text/
30211w04.htm.
\36\ Original in Italian: ``Esiste un eccesso, statisticamente
significativo, di casi di Linfoma di Hodgkin.'' Istituita dal Ministro
Della Difesa, ``Relazione Finale Della Commissione Istituita dal
Ministro Della Difesa Sull''Incidenza di Neoplasie Maligne Tra I
Militari Impiegati in Bosnia e Kosovo,'' 11 June 2002, p. 21.
\37\ Original in Italian: ``I risultati dell''indagine a campione
svolta sui militari italiani impiegati in Bosnia e Kosovo non hanno
evidenziato la presenza di contaminazione da uranio impoverito.''
Istituita dal Ministro Della Difesa, ``Relazione Finale Della
Commissione Istituita dal Ministro Della Difesa Sull''Incidenza di
Neoplasie Maligne Tra I Militari Impiegati in Bosnia e Kosovo.'' Ibid,
p. 21.
\38\ Original in Italian: ``Per le neoplasie maligne (ematologiche
e non), considerate globalmente, emerge un numero di casiinferiore a
quello atteso.'' Ibid., p. 21. See also C. Nuccatelli et al, ``Depleted
uranium: possible health effects and experimental issues,'' 79
Microchemical Journal (2004) 332.
[The presentation by Mr. Fahey entitled, ``Depleted Uranium and
Veterans' Health: A Flawed Testing Process and an Undersized,
Politicized Study Limit Evaluation of Exposure and Effects,'' dated
June 28, 2007, is being retained in the Committee files.]
Statement of Hon. Jeff Miller, Ranking Republican Member, Subcommittee
on Health, and a Representative in Congress from the State of Florida
Thank you Mr. Chairman. I believe it is very important for us to be
holding this hearing on Gulf War exposures.
We cannot forget the sacrifices of veterans who fought in the first
Gulf War and must be vigilant in our responsibility to provide for the
health care needs of all service men and women who have put their lives
on the line to protect our freedom.
It has been over a decade since the first Gulf War. Unfortunately,
to date, neither a cause nor a single underlying disease process has
been identified for a wide variety of medical problems that thousands
of Gulf War veterans have suffered from.
Yet, the scope of Federal research on Gulf War illnesses is broad,
ranging from small pilot studies to large-scale epidemiology studies
involving large populations and major center-based research programs.
Between VA, DoD, and HHS, the Federal Government has sponsored over 300
distinct projects related to health problems affecting Gulf War
veterans and spent nearly $300 million on research relating to Gulf War
veterans illnesses from FY 1992 through FY 2005, and, the research
continues today.
However, because there was a lack of systematic baseline medical
data and reliable exposure data, researchers have faced many
difficulties and as a result many of the health concerns of Gulf War
veterans may never be fully understood or resolved.
Of particular concern is the rate of ALS in the Gulf War veteran
population. The relationship between military service and ALS should be
aggressively investigated and the provision of health benefits for
those suffering with this debilitating disease should be provided
without question.
At today's hearing, we will review what is currently being done to
address the health consequences of the Gulf War. We will also examine
if lessons learned have led to subsequent improvements in deployment
health monitoring and evaluations, recordkeeping research and health
risk communication.
I appreciate the participation of all of our witness and look
forward to the testimony. We will hear from several veterans of the
Gulf War. Their unique perspective is extremely valuable to helping us
avoid past mistakes and respond to the health needs of military
personnel currently serving in the Global War on Terror.
Thank you Mr. Chairman, I yield back the balance of my time.
Statement of Hon. Cliff Stearns, a Representative in Congress from the
State of Florida
Mr. Chairman,
Thank you for holding this hearing. I hope to hear from our panel
what kinds of exposures our servicemen and women are encountering in
Iraq and Afghanistan in this conflict, the possible connection these
exposures may have to debilitating diseases, such as ALS, and the steps
the VA has taken to meet this critical health problem.
In the mid-1990s, Gulf War Syndrome became the center of media
attention, and the focus of fear by Gulf War veterans and their
families. Clusters of undiagnosed, mysterious illnesses, as well as
persistent, debilitating, and unexplainable symptoms began to surface.
However, under the Clinton administration, the appointed ``Presidential
Advisory Committee on Gulf War Veterans' Illnesses,'' reported on
December 31, 1996 that scientific evidence had not produced ``a casual
link between symptoms and illnesses reported by Gulf War veterans to
exposure [to] pesticides, chemical warfare agents, biological warfare
agents, vaccines, . . . infectious diseases, depleted uranium, oil-well
fires and smoke, and petroleum products.'' This Advisory Committee also
recommended that VA closely examine the relationship between wartime
stress and ``the broad range of physiological and psychological
illnesses currently being reported by Gulf War veterans.''
We now know that some of their illnesses were, as the report
indicated, were often the result of psychological stress. Combat
stress, a constant risk of warfare, is known to affect the brain,
immune system, cardiovascular system, and hormonal responses. Therefore
the stress could certainly have been a contributing factor to some of
the symptoms and illnesses reported, although not all. Now it is
believed by most medical experts that there was no unique Gulf War
Syndrome, but rather a number of illnesses arising from numerous
causes. The list of possible causes includes, but not limited to, the
exposure to: Chemical and biological warfare; Depleted uranium dust;
Infectious diseases; Medical measures used to protect against the
threat of chemical and biological warfare; Multiple vaccines; Nerve
agents too low to cause acute symptoms that can cause chronic adverse
effects on nerve and immune systems; Pesticides; Toxic hazards, oil
fires, smoke, petroleum products; and Sarin gas.
In the years since the war, a number of Gulf War veterans were
developing ALS (or Lou Gehrig's disease). Cancers and impairments of
the neurological, circulatory, respiratory, and reproductive systems
have been studied for their links to exposures during Desert Shield and
Desert Storm. Still, a substantial proportion of veterans' illnesses
remain undiagnosed to this day.
I was here in Congress when we attempted to help these veterans who
were suffering under these ailments. In the Veterans Programs
Enhancement Act 1998, Congress required the National Academy of
Sciences to review the available scientific evidence and determine
whether there is an association between illnesses experienced by Gulf
War veterans. Additionally, this law required VA to submit an annual
report on the results, status, and priorities of research activities
related to the health consequences of military service in the Gulf War
to the Committees on Veterans' Affairs. The law also established VA
authority for priority health care to treat illnesses resulting from
combat during any period of war after the Gulf War or during any other
future period of hostilities.
I look forward to hearing from our panels of witnesses about the
progress that the VA has made in providing for these veterans, and also
what challenges, if any, veterans are encountering when seeking medical
care for their illnesses.
Thank you.
POST-HEARING QUESTIONS AND RESPONSES FOR THE RECORD
Committee on Veterans' Affairs
Subcommittee on Health
August 2, 2007
Brigadier General Thomas R. Mikolajcik, USAF (Retired)
1751 Omni Blvd.
Mt. Pleasant, SC 29466
Dear Tom:
In reference to our Subcommittee on Health hearing on ``Gulf War
Exposures'' held on July 26, 2007, I would appreciate it if you could
answer the enclosed hearing questions by the close of business on
October 2, 2007.
In an effort to reduce printing costs, the Committee on Veterans'
Affairs, in cooperation with the Joint Committee on Printing, is
implementing some formatting changes for materials for all full and
Subcommittee hearings. Therefore, we would appreciate it if you would
provide your answers consecutively and single-spaced. In addition,
please restate the question in its entirety before the answer.
Please provide your response to Cathy Wiblemo at the Committee. If
you have any questions, please call 202-225-9154.
Sincerely,
MICHAEL H. MICHAUD
Chairman
______
GULF WAR EXPOSURE--OUTREACH
Response from Brig. Gen. Thomas R. Mikolajcik, USAF (Ret.)
2. Outreach--Effective outreach can be a great tool in ensuring
that veterans from past wars are kept informed of any changes or
developments that may occur in the years after the conflict. Sixteen
years have passed since Gulf War One ended.
Have the outreach efforts of VA diminished in the last 16
years and if so, how?
Answer: I am not familiar with the VA Outreach efforts and do not
feel qualified to answer this question. My experience with the VA for
my condition of ALS was very trying at the beginning. It took me over 2
years to be granted a service connected disability of 90% and another 5
months to be categorized with 100% disability. The time between
appointments seemed excessive and the amount of paperwork was daunting.
Once in the VA system, routine appointments are easy to obtain, however
specialty appointments can take several months. It is very apparent
that the caseload of veterans far exceeds the ability to care for them.
Since 2003, category 8 veterans have not been seen because of budget
limitations and staffing.
With regard to the care and equipment available, there is no one
source which can lead you through that maze. The same applies to
benefits and compensation. The individual veteran needs to research,
ask questions and continually follow through for everything he needs.
The unfortunate thing is that many veterans don't have the energy,
skill or ability to research and follow through. Since my
correspondence from the VA granting me 100% disability with
accompanying documents, I have received no other outreach information
updating me on any new programs or benefits. I've had a motorized
wheelchair for 1.5 years and I just learned through a disabled veterans
newsletter that I am authorized a small clothing allowance. When I was
issued the wheelchair, why didn't the VA give me the appropriate form
to fill out for the clothing allowance?
The VA has a robust website however, one must have a computer and
understand how to navigate the website system.
What would you do to change that? Is this a statement
applicable to VA overall, suggesting that even with the Vet Center
program VA does not have the capacity to treat veterans?
Answer: When veterans enter the VA system, they should receive a
comprehensive briefing on their entitlements along with the pamphlet
they now receive. Periodic mailings and group counseling sessions
should be used to update veterans on changes. Funding by Congress must
be increased in order for all veterans to receive proper and well
deserved care. Our government helps people all over the world, yet many
veterans at home are ill cared for and do not understand the benefits
they are entitled to.
Committee on Veterans' Affairs
Subcommittee on Health
August 2, 2007
Anthony Hardie
National Treasurer
Veterans of Modern Warfare
1722 N. Sherman Ave.
Madison, WI 53704
Dear Anthony:
In reference to our Subcommittee on Health hearing on ``Gulf War
Exposures'' held on July 26, 2007, I would appreciate it if you could
answer the enclosed hearing questions by the close of business on
October 2, 2007.
In an effort to reduce printing costs, the Committee on Veterans'
Affairs, in cooperation with the Joint Committee on Printing, is
implementing some formatting changes for materials for all full and
Subcommittee hearings. Therefore, we would appreciate it if you would
provide your answers consecutively and single-spaced. In addition,
please restate the question in its entirety before the answer.
Please provide your response to Cathy Wiblemo at the Committee. If
you have any questions, please call 202-225-9154.
Sincerely,
MICHAEL H. MICHAUD
Chairman
______
Questions for the Record
Hon. Michael H. Michaud, Chairman
Subcommittee on Health
House Committee on Veterans' Affairs
July 26,2007, 10:00 a.m.
Room 334, Cannon House Office Building
Follow-Up Questions for Anthony Hardie
1. ALS_Mr. Mikolajcik proposed in his testimony that a
congressionally directed ALS Task Force should be established to help
provide direction in ALS research and to develop a strategic plan to
tackle this illness. The 30- 60- 90-day timeline he suggested in his
testimony lays out some structural parameters.
What are your thoughts on this plan and do you think that
it would be effective, given the apparent stagnation in Gulf War
research and treatment of the Gulf War illnesses?
What do you suggest should be the top three goals of such
a task force?
2. Outreach--Effective outreach can be a great tool in ensuring
that veterans from past wars are kept informed of any changes or
developments that may occur in the years after the conflict. Sixteen
years has passed since Gulf War One ended.
Have the outreach efforts of VA diminished in the last 16
years and if so how?
What would you do to change that? Is this a statement
applicable to VA overall, suggesting that even with the Vet Center
program VA does not have the capacity to treat veterans?
3. Treatment--Mr. Hardie, you state in your testimony that ``being
seen is not the same as being treated''.
Could you go into more detail regarding that statement?
Ms. Nichols and Mr. Hardie--have you found that the
medical doctors that treat Gulf War veterans are ill informed?
Mr. Hardie, you mention that many Gulf War veterans have
given up going to VA. Do you know if they are going elsewhere or not
going anywhere?
[RESPONSES WERE NOT RECEIVED FROM MR. HARDIE.]
Committee on Veterans' Affairs
Subcommittee on Health
August 2, 2007
Denise Nichols, M.S.N.
Vice Chairman
National Vietnam and Gulf War Veterans Coalition
500 Fifth Street NW
Washington DC 20001
Dear Denise:
In reference to our Subcommittee on Health hearing on ``Gulf War
Exposures'' held on July 26, 2007, I would appreciate it if you could
answer the enclosed hearing questions by the close of business on
October 2, 2007.
In an effort to reduce printing costs, the Committee on Veterans'
Affairs, in cooperation with the Joint Committee on Printing, is
implementing some formatting changes for materials for all full and
Subcommittee hearings. Therefore, we would appreciate it if you would
provide your answers consecutively and single-spaced. In addition,
please restate the question in its entirety before the answer.
Due to the delay in receiving mail, please provide your response to
Cathy Wiblemo at [email protected]. If you have any
questions, please call 202-225-9154.
Please provide your response to Cathy Wiblemo at the Committee. If
you have any questions, please call 202-225-9154.
Sincerely,
MICHAEL H. MICHAUD
Chairman
______
National Vietnam and Gulf War Veterans Coalition
Washington, DC
October 2, 2007
Hon. Michael H. Michaud
Chairman
Subcommittee on Health
Committee on Veterans' Affairs
United States House of Representatives
335 Cannon House Office Building
Washington, DC 20515
Dear Congressman Michaud:
I am honored to respond to your written questions following the
July 26 hearing on ``Gulf War Exposures.''
1. ALS_What are your thoughts on General Mikolajcik's thoughts on
this plan and do you think it would be effective, given the apparent
stagnation in Gulf War research and treatment of the Gulf War
illnesses?
The General hit it right on the mark! He clearly and briefly nailed
the identification of the problem as a lack of leadership. I would like
to say that this is also the problem overall with Gulf War illness.
Leadership is suppose to identify problems, strategize the solution,
the solution is then broken down into tasks with clearly defined
timetables and project target goals, and then the plan is executed.
Each project has an assigned individual that is held to accountability
and responsibility. Leadership also is then held accountable and
responsible for the success and failure of each component and projects
individuals' actions or nonaction. Leader should be named as well as
each subsequent project leader. Then Congress has to do their part of
overseer and true Oversight and they have shared accountability and
responsibility to the taxpayer to show results that get transferred to
the clinical application of research and results on the large scale.
There is a lack of focus and direction in all medical research. The
end result should be measuring the patient veterans' improvement in the
clinical area. There are huge disconnects in the VA/DoD health system
in this regard. We can effectively employ tiger teams to solve a
battlefield problem and get research and equipment fielded in a
somewhat timely and effective manner but we do not have this robust
system in place for diagnosed or undiagnosed illnesses and chronic life
threatening medical problems.
This is what is truly lacking in DoD/VA and the government
(Congress and the Administration) actions' to the problem of exposures
that occurred in 90-91 with Operation Desert Storm and the resultant
health effects. The logs and reports that would have given us the whole
truth on exposures were destroyed (ordered by General Blanck and
confirmed by GAO and the author Cy Hurst) and not one person has been
held responsible for that destruction of government records that were
critical to the health effects after the war. These logs and
information would have given us the information to lead us quickly to
what resulting health problems we would have seen in a timelier manner.
The actions to address Gulf War illness and resulting illnesses
both diagnosed and undiagnosed show that our system of health care for
veterans is broken and has been for a long time (example Agent Orange).
The government responded by funding research studies overwhelming
on stress for 13 years while the veterans composed of all prior ranks
were screaming and trying to get the truth out on exposures and how our
health was rapidly deteriorating. There were not even annual hearings
with the VA Committees with veterans (individuals) to identify to you
what was reality! Veterans' health problems have led to broken
marriages, inability to maintain their careers, and to the point of
veterans aging family members (Moms and Dads) having to try to help
these adult soldiers-veterans.
ALS thankfully was recognized as occurring in higher numbers in
Gulf War veterans than should have occurred in a normal population. The
VA is recognizing that but congress has yet placed this into a bill to
make it legal! MAKE THE BILL/LAW happen within 30 days that ALS will be
an Immediate Presumption with fast track priority and VA ratings
accomplished within 30 days.
WE have asked for that several times. We now are finding Multiple
Sclerosis in Gulf War veterans at a greater than expected level and no
unified leadership or effort is being seen yet again. WE have Cancers
and other diagnosed illnesses but no one has put the pressure on VA's
Health area to share data to get the whole picture.
The General spoke clearly identified the problem and spoke to a
solution on one area--ALS. Mike Donnelly (Major--F16 pilot died 2\1/2\
years ago) and Randy Hebert (Major, Marine) were brought forward by me
to Congressman Shay's Committee years ago to testify. Other Gulf War
veterans with ALS from earlier are Randy Hebert, Jeff Tack, and Tom
Oliver. And we still can't give them much more than get them
compensated. Well that is not enough! In addition, I am hearing that
the benefits that they are entitled to in regards to nursing care and
assistance, home improvements for their care, specialty equipped vans,
and educational benefits for their spouse and children is not fully
communicated to each and every one of them and means to get that
assistance in a timely manner is not coordinated. All of this
information should be readily supplied to them in writing and also
easily assessed on the VA Web site. I contacted the Donnelly's because
that family turned into true advocates. His dad a former marine and
state legislator of Connecticut did everything he could for his son and
all the others. Tom Donnelly and I talked over the general's testimony
and the followup questions his comment to me is very revealing. I asked
him if I could share it with you. His comment was that he doubted that
the government would ever do anything useful. He felt that there would
never be true effective action and that other entities outside the
government would have to solve the problem. He also compared the Gulf
War veterans of 90-91 to the past veterans of Agent Orange and the
problem with getting any help now with so many of our current OIF/OEF
casualties needing care. Mike and his wingman are now dead as are
others. His comrades have formed 2 separate nonprofits in AZ that hold
annual golf tournaments and awards dinners. Their purpose to look after
the children left behind and to fund scholarships for those children.
The Donnelly's still reach out to the other ALS veterans and assist
them as much as possible. This family and the General need to be
recognized by the CONGRESS for their unending efforts in supporting and
leading the Gulf War Veterans with ALS.
The General was right with his strategic goals and timetable. Yes I
support it wholeheartedly.
I would also recommend highly that the VA ALS registry be more
public and include data on how many Gulf War veterans both deployed and
non-deployed and risk factors with each. We need to know if anthrax or
other vaccines may be causing this increase. We also need to have data
re on where in theater each veteran with ALS was located and what was
their duty and unit and what other exposures may be contributing to the
development of this deadly disease. This data without exposing names
should be public on a Web site so that researchers and the public can
join in the battle to tackle the illness with ideas and information.
The Gulf War veterans with ALS should be the lead cohort for any ALS
study because they were previously healthy and we do have more health
data in the military than normal individuals in the population. Also
our duty as a nation should be to place the troops and veterans health
as the priority. We also have the depository at DoD that has blood and
other specimens on this group of veterans that should be allowed to be
used by non DoD/VA researchers to find answers NOW. I include a recent
article on the depository at DoD that highlights this problem for your
review. I also include one other article on cancer data not being
reported from VA that is altering National Cancer data.
YES THIS PLAN SHOULD BE DONE AND WITH IT I THINK THE PROGRAM ON
GULF WAR ILLNESS WOULD BE INVIGORATED BECAUSE IT WOULD SERVE AS A ROLE
MODEL. I WOULD START RIGHT NOW IN THE SAME DIRECTION WITH AN MS GULF
WAR VETERANS PROGRAM. THESE TWO PROGRAMS SHOULD BE OCCURRING
CONCURRENTLY BECAUSE THEY ARE BOTH RELATED TO NEURO MUSCULAR AND
POSSIBLE AUTOIMMUNE OR VIRAL SEQUELE TO NEUROTOXIC SUBSTANCES.
What do you suggest should be the top three goals of such a task force?
1. Separate ALS Gulf War Veterans from other veterans and
civilians to use as a specialty Cohort.
2. Designate THREE VA HOSPITALS as specialty centers--ALS
EXCELLENCE CENTERS. BE SURE that One is East Coast--One Central--One
WEST Coast. Leadership overall should be named and each center should
have named individual.
3. SET UP COORDINATION WITH CIVILIAN ALS CENTERS OF EXCELLENCE.
SET UP UNIVERSITIES/CIVILIAN MEDICAL CENTERS IN EACH GEOGRAPHICAL
LOCATION EAST--CENTRAL--WEST to be RESEARCH CENTERS OF EXCELLENCE WITH
NAMED INDIVIDUALS.
4. Designated by name lead individuals in each government agency
that will be involved.
5. Set up VETERANS and their support system for ALS at each
regional VA-VISN as Task Force. SET up from each of those a national
VETERANS ALS TASK FORCE.
The ALS situation is time critical and should go top down and down
up along with lateral off spouts. The initial setting up is crucial and
necessary support and communication should be considered as essential.
The VA should be in direct communication with each of these veterans
and families on a continuing and scheduled basis to follow up on their
needs proactively. My complements to General Mikolajcik for his clear
leadership and my prayers and concerns go out to each veteran and their
family that has encountered ALS that this effort will rapidly succeed
for them and alleviate their burdens.
My thanks to you personally Representative Michaud and to the House
VA Health Subcommittee for highlighting the issue and having this
hearing.
I encourage you to have other hearings on Gulf War illness, one on
benefits delivery and one on Clinical Care. I offer my time and ideas
and suggestions on these efforts.
2. Outreach_Have the outreach efforts of VA diminished in the last
16 years and if so how?
The answer is YES. The congress including VA Committees on both
sides Senate and House and the Current Government Reform and Oversight
Committee of the House has been absent. The need is for continual
programmed Committee hearings to keep a focus on this issue and to
provide oversight to corrective action and true implementing of the
laws by the word of the law and the sense of the Congress.
There needs to be accountability and responsibility in action and
not just words.
What would you do to change that?
The VA has failed to update clinical guidelines, to provide
training to all VA hospital individuals, and the VA has failed to be
sure that progress reports on funded all Gulf War illness research
projects. There is a need for interim research findings at 6 month time
periods and a final report of each research project finding and
recommendations from each project. WE need this in an organized format
that is communicated thoroughly. WE need all research project reports
not just the published peer reviewed journal result because some of
these projects that are funded are never published in peer reviewed
journals. This extends to DoD research projects also. WE need the full
300 plus study white paper. Validate to the veterans and the taxpayers
what they paid for over the last 16 years.
The VA has let lapse the newsletter for Gulf War illness and we no
longer are getting them mailed to the veterans. These newsletters need
to be on the VA website from each issue to the current in an easy to
find format. The DoD has also fell down on the job since re-titling the
area DEPLOYMENT Medical. The veterans nor the medical professionals
receive updates on research projects and their findings and
implications.
The VA hospitals have no signs up about the VA Gulf War Registry
and information sources and the kiosks in each VA have no information
on Gulf War illness.
The VA has lost focus for one of the largest veteran's populations
that of those exposed to Hazardous toxic exposures. A significant
effort must be made to rectify this situation. I made numerous
suggestions during my House and Senate testimonies. I would suggest it
is time for the Congress to step in and legislate that these actions
occur and hold them responsible.
Mandate training, annual meetings, training and hiring physicians
with toxicological, anti-aging, environmental medicine training, set up
task forces at each VA hospital to include veterans, administration,
and medical personnel to address concerns from Gulf War exposures and
other eras (Agent Orange, atomic veterans, and project shad). Then
institute regional and headquarters task forces set up to rectify the
problems that have been created by the ineffective leadership at the VA
in regards to Gulf War illness. Provide materials on hazardous
exposures ie newsletters, training programs, update VA Web site to
include this information, and provide video conferencing so that the VA
RAC GWI meetings can be shared system wide for medical professionals,
researchers, and veteran patients.
Registry exams must be available, and the specialty clinics we had
set up early in 1994 need to be reestablished, and the WRIISC centers
in DC and Orange, New Jersey need to be expanded to at least 3 more
locations (South, Central, and West Coast). These WRIISC centers have a
good reputation so far but referrals to them are not readily available
and health care professionals have not understood their availability
and funding was not set up for veteran patient travel.
There has also been concern that Gulf War veterans are being
minimized and not fully screened on an ongoing basis because of lack of
funds and the ability to meet the need of younger veteran population
from OIF and OEF, Gulf War Veterans, and all the other veterans due to
staffing shortages.
There is also a potential problem with veterans not being able to
access eye exams and dental exams unless they are rated at 100%. These
vital body systems are affected by hazardous exposures and those huge
factors to health are being totally neglected and no data even
available.
Two new advisory Committees need to be implemented for Gulf War
illness one on clinical care and one on benefits. The VA GWI identified
the need to the Secretary of the VA months ago and no action occurred
so therefore Congress must step up and legislate these to be formed in
somewhat the same as the VA RAC GWI.
I would suggest more veterans to be at the table and only one VSO
at a time to serve and at least one family member to also be included.
Then specialists on benefits will be needed for the benefit advisory
committee.
Then health care professionals in and out of the VA system for the
clinical care advisory Committee. This committee must interact with the
research advisory Committee in order to be able to take the research
findings and implement them throughout the VA system. This clinical
care Gulf War illnesses advisory Committee should include experts in
the area of anti-aging, environmental medicine, and toxicology. The key
here is to have interaction with each hospitals' task force locally and
with regional task forces. So issues can be shared and worked at
different levels. The chair and co chair must have management business
skills and communication people skills to set long and short term goals
and move toward resolution of problems. There must be commitment from
the VA Administration and from both the congress and the President to
move the VA forward into the new century where consumer client veteran
patients feel there is a commitment and is evident through actions.
I would suggest to initial start with Gulf War illness and Gulf War
veterans as these prove successful then Agent Orange, Atomic Veterans,
and project shad advisory Committees need to be started.
The VA health division needs to set up databases that collect
diagnosis information for Gulf War veterans--cancers, all diseases.
This data needs to be reported semiannually to the veterans, to
congress, to civilian medical organizations and needs to be available
on a Web site. Registries for MS, cancers, other diseases, birth
defects should be manned at each VA hospital, each regional VA center,
and then to the health division. A death registry that contains name,
age, cause of death, unit assigned in the Gulf War would be invaluable
in honoring our veterans but also provide researchers data on deaths of
Gulf War veterans. These registries must be public and transparent on
the VA Web site. One of the articles I am enclosing talks about cancer
data from the VA not being shared. This quarantine of information must
immediately be stopped.
Bills currently introduced by Representative Pelosi and Senator
Clinton, H.R. 3643 and S.B. 2082 must be reviewed, supported with some
changes, and made into law before the end of this congressional
session. Veteran data needs to be collected from the civilian side of
house also because not all veterans can or do utilize the VA. Death
records in many states do not record Veteran service or war in which
they served unless they have a VA file number. Birth records need to
record parents and grandparent service and war time service to be
complete in regards to hazardous exposures. Our data on birth defects
can not be judged to be total and complete until all states have birth
defect registries that also include a means of documenting health
issues that arise after birth an example is autism, learning disorders,
or health defects found later after birth. There must be some thought
to how to add current information to existing records.
The whole process of VA contracting with the IOM for exposure
relationships to establish presumption of connection must be totally
revamped. Due to the IOM process the adversarial position of the
veterans begins. I suggest a simplified approach of comparison of
veteran population with age and the general population data that is
already available and updated regularly to be utilized. If veterans are
showing increases with known diseases that are above a random
occurrence then that disease needs to be presumed service connected
within 60 days. I encourage the government reform Committee and VA
Committee hold joint hearings and investigation into this area of
concern.
There must be a revamping of the VA benefit claim process now. It
is a black mark on this nation to treat its veterans as it has over the
last 50 years. To have sick veterans with cancers and other diagnosed
illnesses that are probably connected to their service exposures die
without any assistance from their government is wrong. To leave their
spouses to start the process all over and to continue the battle is
wrong. This adversarial process impacts the belief of the active duty
and reserves when they agree to serve. It impacts prior service
families from encouraging their offspring to serve their country thru
military service.
Only through going through each of these steps and showing
transparency and a full commitment will the faith of the veterans,
their families, and the public be restored.
Through these efforts and more that faith to trust the government
will be healed and recruiting for active duty and reserves will benefit
because the promises will have been restored.
Only through all of these efforts will our Nation be ready to deal
with environmental exposures from WMD and WTC health concerns. The
military medicine in the past led the way as examples in the
implementation of the best care techniques for gun shot wounds and
rapid air evacuation that has impacted civilian medical practice that
has saved lives. WE can do this again with changes now in policy
changes in relation to Gulf War illnesses.
Is this a statement applicable to VA overall, suggesting that even with
the Vet Center program VA does not have the capacity to treat
veterans?
I think the Vet Center program is a needed program and needs to be
continued. I will suggest that you contact others with more expertise
in that area to have suggestions for improvement. I do feel that there
is newer breaking research in the area of PTSD treatment that the Vet
Centers specialize in that needs to be brought to the Vet Centers and
implemented across the country rapidly to meet the needs of the
returning OIF/OEF veterans. I believe that civilian counseling should
also be set up for active duty, Reservists, Guard members, and veterans
so that this overwhelming need can be met in a timely urgent means. I
also feel that advisory group on PTSD should be initiated and ongoing
until the problem is resolved. I also feel the need for local,
regional, and central task forces that involve the veteran client,
family members, and experts would help facilitate the revamping,
communication, and upgrading in this area as in the clinical area would
be beneficial.
I do not think it is time to dismantle the VA, veterans do have
unique needs and have the most unusual social, emotional, and physical
networks that were formed in service to their country. They have unique
management, organization, and leadership abilities that need to be
tapped and utilized to correct the problems. The ability to blend in
civilian experts and facilities exists and we have seen them reaching
out so help facilitate and make it happen.
As you can see there are needs for the Committees to have more
hearings and joint senate and house hearings would be most effective to
get the facts and let the veterans be heard and be a part of the
process that will benefit them and future veterans. The need for
committees to ask for insightful written and oral testimony with
suggestions for what can be done on the legislation, administration,
clinical care, and benefits can not be overstated. The need for good
questions both at the hearing and as follow up is extremely important.
The need to have FULL Committee Hearings outside VA in possibly six
locations throughout the country (divide the country line from North to
south and then intersecting with east-west lines then pick center
geographically for 6 locations) would be beneficial to the veterans and
to you the Committee Members.
The Committees also should consider assisting financial for
veterans in regards to airfare and hotels for these hearings. Veterans
do not have an excess of funding to participate and be witnesses.
3. Treatment
Being seen is not the same as being treated and have you found that
medical doctors that treat Gulf War Veterans are ill informed?
Are Gulf War veterans giving up on going to the VA, going
elsewhere, or not going anywhere?
YES DOCTORS ARE ILL INFORMED. They are also restrained by policy
whether written or unwritten that began when we returned from the Gulf
War in 90-91. The doctors are not allowed to have an inquiring mind to
find answers. The example I gave on the research I provide the doctor
at the VA on Hypercoagulation in Gulf War Veterans and treatment
suggestions is my most graphic example.
When I found out that the doctor had not followed up on contacting
the doctors and authors of the paper and refused to retest or provide
treatment to me or other Gulf War veterans and instead offered me a
psychology consult, was the insult that pushed me not to return and to
seek answers and treatment elsewhere. When the doctor, told me her
hands were tied even prior to that visit, I knew that what other
veterans and the doctors that tried to do the right thing within the VA
and then were told to not see Gulf War Veterans or were cut from the
staff at VA hospitals were saying was true. When I found out the editor
of the journal that published the independent research on Gulf War
veterans with hypercoagulation worked at the VA Hospital Denver Lab it
just was over the top. It showed me that they were not listening to
find clues and help in testing and treating Gulf War veterans. Other
items I witnessed and experienced are many and I will try to make this
as short as possible. First of all exams where not to a high standard.
I was a nurse with a Masters Degree and varied clinical and teaching
experience in the military active duty, reserve duty, and civilian
positions which included teaching nursing. When I had been taught
Clinical assessment we used the same physical assessment textbooks as
medical students and this was in the mid 70's. The neurological
physical exams that should have been very thorough and looking for
changes when it was known we were exposed to neurotoxins and a mixture
of exposures was very limited. Dr Bill Baumzweiger is an expert to be
consulted in regards to his exams and what he found. The comments I had
at the VA were gee you are complaining of a skin rash you need to see a
dermatologist and then when I asked to see one they said no you will
have to go to a civilian this was during the initial CCEP at the VA. I
had to push for any follow up for the ringing in my ears that continues
to this day. I was never referred to neurology, infectious disease
specialist, endocrinology, or immunologist.
I also participated in the DoD CCEP at Fitzsimmons USAH, Denver.
The person doing EEGs noted to me he was seeing abnormalities with each
of the Gulf War veterans I never got my report on my own test results.
WE veterans have not seen the compilation of all those exams that were
done. I did have the hearing tested by an audiologist that had been
hired back at Fitzsimmons, he did the air percussion testing to the
ears and he was puzzled and had me return to be retested at that time
we got into a discussion I asked him if it was hearing lost from noise
since I had been a flight nurse on C-130's and had been exposed to
constant generator noise during the war. He said no, I said what is it
then and he said he saw signs indicating ototoxicity. I at that time
showed him the full Senator Reigle report at which point he got very
interested and wanted to keep the copy I had shown him which I
willingly gave to him. I had taken no chemotherapy, antibiotics, or
aspirin or any other item that would cause this damage except exposures
in the Gulf War.
At the dermatology clinic I was seen by a female fully qualified
dermatologist that was very interested in my rash. She documented it
but said she had to have me released by the chief of service. He came
in and blamed it on age and psoriasis. After he left, she shut the door
and wanted to talk. She was a West Point Graduate and her husband had
served in the Gulf with us and was experiencing the symptoms we all
had. She asked me for any and all information I could share with her.
Within 2 weeks I returned with copies of everything from hearings on
the hill, to information on CFS and MCS and presented it to her. Well
later I found out from a Veteran (first SGT Army) from KS that was
there getting tested that this same DR had been seen flying into the
office of the Dr that was in charge of the CCEP at Fitzsimmons right in
front of him waiting to see the same Dr. He recounted to me how upset
she was in her verbal encountered with this chief DR. This was the same
chief doctor I had heard about from soldiers at Fort Carson that were
being seen in the Medical Hold unit. Extensive vision testing was done
at Fitzsimmons that I never received copies of to include in my record.
Again the veterans that participated in these extensive testing have
never seen the compilation of all the exam results on all of us. EMG's
were also done and again the doctor was curious and asked for any
information I could share. Again no copies of the results and again no
compilation of these results on all of us Gulf War veterans has ever
been seen. When you left the DoD CCEP after cognitive testing and all
the other testing you felt they knew more than they were telling. I
witnessed and spoke to veterans that were being told it was all in
their minds or that it was because of their age, this was despite the
fact that these were young soldiers in their 20's. I witnessed
disparities in the testing that was done on some veterans and not
others. I confronted the chief doctor that he was not being honest as a
doctor should be after that I was subject to his harassment that was
witnessed by the other veterans that were there being seen and staying
at Fitzsimmons since they came from a number of active duty bases. I
supplied notebooks of hearing documents and materials related to
questionnaire for Ross Perot investigation for these soldiers to have
in their dayroom. I supplied the copying and the notebooks at my own
cost and the troops were very interested in reading them. The only
problem is they kept vanishing and the specialist that was there to
schedule the exams finally confided in me that the chief doctor kept
taking them away.
The last item of interest is I would see these same military
doctors appear at the VA in civilian clothes in white lab coats seeing
the Gulf War veterans there.
The veterans that were also Vietnam veterans as well as Gulf War
veterans were very jaded and told me the system would never change.
General Horner who I saw at the tenth anniversary of the war hosted by
the Kuwaiti Ambassador told me in front of another Gulf War veteran
they just didn't realize how bad the system was broken. In Pueblo,
Colorado we had an Army Reserve doctor who had served with us that
would see Gulf War veterans in his civilian practice and was trying his
best to help other veterans accurately documented their cases to the
VA. He too eventually ended up to ill and had to retire from practice.
The last time I saw him was in Phoenix AZ at the Environmental Medicine
meeting where he had suck in since he didn't have funds for
registration and was trying to gather information. At that point I
introduced him to Lea Steele and Jim Binns of the VA RAC GWI. I also
introduced them to Dr. William Rhea and had Dr. Rhea verbally telling
them how he had approached the Secretary of the VA in 1990-91 to offer
assistance and to train VA physicians on the care of the
environmentally exposed. He was turned down. This is interesting since
he had served as chief of Thoracic surgery at the VA Dallas before he
started into environmental medicine.
Through independent testing with Hemex Labs, AZ and Immunoscience
Labs, Calif and other labs I have found answers on my own condition.
This testing needs to be done for all Gulf War veterans and would
definitely help us get answers and treatment in the right direction
started. I also had arterial and venous blood oxygen testing done and
the results of that simple test was also enlightening but how many
other Gulf War veterans have had that testing that showed the body was
oxygenated but the transfer of oxygen to the body was being interfered
with resulting in high venous oxygenation. These are the clues in blood
testing that the VA should have been exploring all along.
But despite getting some answers I am still not receiving any
consistent clinical care and most definitely not from the VA. The VA
has caused a lot of the PTSD since our return from the Gulf War. It is
simply exhausting when you are ill to have to keep pushing and
explaining to doctors and hoping they are listening so most Gulf War
veterans sit back quietly surviving and looking for supplements from
Vitamin Cottage that might help.
This is a disaster, as a nurse and Gulf War veteran with years of
practice and training I have focused on identifying the problems,
giving voice, collecting data, going to hearings, commissions, IOM, and
VA RAC GWI, coming to the hill and briefing staffers since 1994,
working closely with Congressman Shay's Committee staff through the
years of hearings he conducted, working to get cosponsors on each of
our Gulf War veterans legislation efforts, talking and discussing with
researchers what they are finding and what their thoughts are and
sharing with them any information that would help them, and providing
information to Gulf War veterans and asking the veterans for continuing
updates from them. I have tracked research findings, searching for
connections and future ideas for researchers. I have compiled obits for
our own death registry.
I am upset that pro active screening for cancers and other
diagnosed illnesses is not happening for Gulf War veterans.
I decided to deal with the government at the highest level to push
for change as long as I can. After all we had been called whiners, were
not believed, hit the policy from up high not to reveal all the
exposures the Gulf War veterans know about, and from doctors that told
us their hands were tied. Many veterans are not being seen at all and
have lost faith.
The question is will the policy and changes be made now or ever?
Additional Thoughts on Research:
Research needs to feed into changes in clinical care for Gulf War
veterans now and continuously. Researchers need to finally be briefed
on all the exposures that occurred. DO not spend money into research
alone or we will all die without having received any benefit of this
taxpayer spent money. Do put the funds into the DoD CDMRP program where
consumer advocates serve on the review panels.
Do find a way to provide chromosome testing ie SKY testing
(attachment provided) that will clearly show the highest level of proof
of damage to the Gulf War veterans. WE veterans all deserve at least
that testing so veterans that still wish to have children can have
tests results that may affect their ability to have healthy children.
We deserve that test to prove once and for all the damage done.
I am including the two articles I mentioned in my answers above and
my written invited testimony to the Senate VA Committee along with my
point paper that lists problems and solutions that I had done for the
VA House Committee hearing for you to review.
I stand ready to assist you, Members of the Committees, and other
Members of the Congress with help in whatever you may need be it more
information, suggestions, suggestions of experts and veterans to bring
forward, assistance in organizing, etc.
I apologize for the length of the answers to your questions but I
strive to answer completely with definitive action ideas.
Respectfully submitted,
Denise Nichols, MAJ, USAFR (ret), RN (ret), MSN
Gulf War Veteran Flight Nurse
Vice Chair
Eight attachments follow.
______
Attachment 1
VA Cancer Data Blockade May Imperil Surveillance
By Michael Smith
Senior Staff Writer, MedPage Today
LOS ANGELES--Stonewalling by the Veterans Administration is putting
U.S. cancer surveillance and research in jeopardy, according to many of
the researchers involved in those fields.
After decades of sharing data freely and allowing researchers to
get in touch with its patients, the agency has been blocking such
activity for the past several years, according to Dennis Deapen,
Dr.PH., of the Los Angeles Cancer Surveillance Program and the
University of Southern California.
The result, Dr. Deapen said, is that California state data on
cancer incidence rates are being skewed. And that, he said, is likely
to have serious effects on national data.
The California Cancer Surveillance Program has seen a sharp drop in
the agency's reporting of new cases to Californian cancer registries
beginning in late 2004--from 3,000 cases in 2003 to almost none by the
end of 2005, according to an article in the September issue of Lancet
Oncology.
But the problem is not restricted to California, according to Holly
Howe, Ph.D., of the North American Association of Central Cancer
Registries (NAACCR) in Springfield, Ill.
``California has been very energetic in evaluating the impact of
the loss of VA cases on completeness and the ability to produce
accurate incidence data,'' Dr. Howe said.
``But it's not just California--it's nearly every state,'' she
said.
However, California and Florida--where VA reporting of cancer cases
has also been blocked--have large populations of veterans and large VA
medical facilities, she said.
Missing data from those two states has the potential to warp
national estimates, she said.
Lancet Oncology quoted Raye Ann Dorn, the VA's national coordinator
of cancer programs, as saying that only California and Florida were
withholding data, mainly because of privacy concerns.
Dorn was not immediately available for comment on the eve of the
Labor Day weekend.
Lancet Oncology said other VA officials pointed out that of the 130
medical centers that collect cancer data, only 29 withheld cases from
state cancer registries in 2006.
But the journal also said that, according to CDC data, VA centers
in seven states are not reporting cancer cases and in six others, at
least one VA facility is not reporting.
All told, ``40 000 to 70 000 cases are potentially missed
nationally each year,'' the journal quoted a CDC spokesman.
Dr. Howe said her organization and others have been trying to
persuade the VA to resume wholehearted data-sharing, but with little
success. ``We've been trying to solve this for over 5 years,'' she
said.
Asked if she knows what's behind the policy, Dr. Howe said flatly:
``No.''
Representatives of a ``whole cadre of associations''--including
NAACCR, the CDC, the American Cancer Society, and the National Cancer
Institute--met in early August to discuss the issue, Dr. Deapen said.
He said the VA position has two main effects.
The skewing of national and state cancer incidence rates, he said,
is ``correctable.''
``The VA still has the data,'' he said. ``They could hand it out
and then we could correct incidence rate data.''
What is ``incorrectable,'' he said, is the effect the data blockade
could have on research.
Dr. Deapen said, for example, that researchers investigating the
causes of a particular type of cancer might be misled if they were not
aware of a cluster of cases being treated in VA hospitals.
``Once that study is done, (the researcher) doesn't get to go back
and do it over,'' Dr. Deapen said. Research during this period ``will
forever require an asterisk'' to remind other researchers that it might
not be correct.
But even when states get VA data, some cases may slip through the
cracks under a related VA policy that forbids interstate data-sharing,
he said.
For instance, he said, it's common for veterans in some eastern
states to seek treatment in neighboring states.
The host state doesn't count them, because they live next door. And
the VA refuses to notify the home state or let the host state do so, so
that some cases are simply never counted, Dr. Deapen said.
Several of the cancer registries that are being locked out of VA
data take part in the Surveillance Epidemiology and End Results (SEER)
program, according to Brenda Edwards, Ph.D., of the National Cancer
Institute, which operates the database, a valued resource for
epidemiological research.
``This will significantly impact reporting in SEER,'' Dr. Edwards
told Lancet Oncology.
The collection of disease incidence data is a state responsibility,
Dr. Deapen said, but the VA--as a Federal agency--is under no
obligation to comply with state laws.
Nonetheless, for years the VA voluntarily shared its data and
allowed access to patients, he said.
``We had it right and we were doing a good job,'' Dr. Deapen said.
``Now we need to get back on track.''
Primary source: Lancet Oncology
Source reference: Bryant Furlow. ``Accuracy of U.S. cancer
surveillance under threat.'' Lancet Oncology 2007;8:762-63.
______
Attachment 2
A MILITARY MALPRACTICE
Serum Samples From Service Members Go Unanalyzed. Battlefield Doctors
Are Unable To Access Records. Who's Tracking The Troops?
By REMINGTON NEVIN August 26, 2007
The Department of Defense is failing to properly monitor the long-
term health of soldiers, airmen, sailors and Marines more than 15 years
after the outbreak of mysterious Persian Gulf War illnesses.
Following the first Gulf War, the Defense Department began
collecting millions of serum specimens from service members returning
from deployments, and placing them in large freezers for future study.
If thawed, this serum--which was bled from service members teaspoons at
a time--would total thousands of gallons.
But to help the service members, someone would have to study these
specimens, and that is rarely done. Although it houses the largest
inventory of serum specimens in the world, the Defense Department
repository employs only one full-time scientist and has never been
awarded a permanent budget to test specimens for toxic exposures or
other health threats.
The repository also is running out of space--bursting at the seams
with more than 42 million specimens. More than 5 million of the
repository's oldest specimens--collected before the Gulf War--are now
stacked floor to ceiling in teetering cardboard boxes, inaccessible to
researchers, while the Defense Department's health leaders slowly
discuss how and where to build a new repository facility and who would
run it.
The inventory continues to grow at more than 2 million specimens
annually. Millions more specimens from the Gulf War era will need to be
boxed up later this year.
And while leading civilian repositories now store frozen serum
specimens in ultra-cold minus-80-degree Centigrade storage to minimize
degradation, the Defense Department continues to store its newest serum
specimens in outdated walk-in freezers at a comparatively balmy minus-
30 degrees Centigrade, potentially harming the delicate protein and
chemical biomarkers that might contain evidence of toxic and infectious
exposures.
Urine specimens are another useful tool in monitoring health, as
any doctor will attest. Yet the Defense Department discards the 2
million-plus urine specimens it collects every year during routine drug
testing.
Monitoring health also requires access to modern medical records
systems. Military hospitals in Iraq and Afghanistan are forced to use
relatively archaic systems that don't communicate in real time with the
rest of the electronic medical record. These systems don't even talk
among themselves.
Doctors treating patients transported between facilities on the
battlefield often can't access electronic records written by surgeons
minutes earlier. Frustration has been so intense that doctors treating
patients evacuated through Germany have developed a separate Web-based
system to work around the problem. Confusion over which system the
doctors in the field are supposed to be using continues, compromising
the quality of the health data.
One solution, off-the-shelf Web-based technology--such as VPNs
(virtual private networks), used commonly by corporations to allow
remote access to computer networks--has yet to reach the battlefield.
Service members stationed in Afghanistan on remote snowy mountainsides
routinely access their personal e-mail on the Web, but medics are not
empowered by the Defense Department to use the Web to view and interact
with vital medical records stored on systems in the United States.
Instead, medics in the field are instructed to record medical
information using outdated handheld computers that often break down or
run out of power. More often than not, medics simply don't use them,
leaving no trace of medical care and giving the impression of a falsely
low rate of disease and illness among deployed troops.
Despite these problems, the Defense Department reassures Congress
and the American public that service members have their health
comprehensively monitored, including a lengthy reassessment a few
months after they return from deployment.
These assessments are little more than poorly worded, multi-page
forms of little use to clinicians and epidemiologists in screening for
diseases. The reassessments have demonstrated little efficacy in
increasing access to military mental or physical health care. They
often distract doctors, nurses and other health workers from providing
therapeutic patient care.
And now the requirement to complete this lengthy reassessment form
is being waived for soldiers sent back into the war zone after serving
more than a year there. Tragically, these overworked service members--
the ones who need the most careful physical and psychological
assessments--are often deploying again after completing a token two-
page form containing only a single mental health question. Often, no
one confirms both the accuracy of the information and the suitability
of the service member for repeated deployment.
Because of this, large numbers of service members on psychoactive
medications are still being deployed, including many on anti-psychotic
medications and anticonvulsants. As many as one in seven deployed
service members has a recent history of psychoactive medication use.
But just which of these deploying service members have potentially
serious psychiatric disorders is unclear, because the data systems that
monitor pharmacy prescriptions are not linked to the Defense
Department's deployment database.
Nor are these linked to the larger medical surveillance database
that tracks medical diagnoses. The Defense Department would be hard-
pressed to quickly identify the service members deployed this year with
a history of treatment for bipolar disorder or psychosis--in direct
violation of its new policy.
What isn't monitored can't be measured or reported. Nor can it
improve care to service members, or forecast what will be needed to
care for the next generation of veterans.
The health data in the Defense Department's databases and the serum
repository have shed light on possible causes of multiple sclerosis,
schizophrenia and various cancers, and contributed to our understanding
of the epidemiology of mental and physical diseases. But so much more
could be done.
Sadly, many key military health organizations are led by careerists
with little experience in this type of work. There is little incentive,
and significant risk, for Defense Department health leaders to point
out problems, to explore controversial findings or to contradict
military leadership when the health of service members is at stake.
Monitoring the health of service members is a responsibility too
important to be left to a military leadership distracted by the
exigencies of war. Responsibility for monitoring health should be
consolidated under a new Armed Forces Health Surveillance Center, under
the direction of an independent civilian expert in public health.
Service members cannot wait another 15 years.
Capt. Remington Nevin is a Johns Hopkins-trained Army public health
physician currently serving in Afghanistan. His opinions do not reflect
those of the Department of Defense.
______
Attachment 3
Testimony of Montra Denise Nichols, Major, USAFR (ret)
Vice Chairman National Vietnam and Gulf War Veterans Coalition
to the U.S. Senate Veterans Affairs Committee September 25, 2007
Hearing on Gulf War Veterans Illness Research
Thank you Senators for having this important hearing today related
to Gulf War Illness and Research for the Gulf War Veterans of Operation
Desert Storm 1990. It has been since 2000 since your last hearing on
this issue. During the intervening 7 years, some small progress has
finally been made in getting research moving in the right direction. It
has been too long in coming and a major effort is needed starting now
to make up for lost time. No progress has been made in improving the
health of ill veterans. The majority of us are still waiting for
definitive diagnosis and any effective treatment for our exposures.
There is an overwhelming desperation that has developed year by year.
We veterans feel betrayed and abandoned. We are angry at the lack of
truth, accountability, and responsibility from our government. This is
a National Security Issue because the way veterans are treated when
they return directly has and will reflect on armed services
recruitment. Funding for a war and the aftermath of exposures in war
should be considered as a total. Needs of veterans of exposures in war
are not to be considered as an afterthought!
I am not a constitutional lawyer but a citizen, former nurse, and
affected Gulf War veteran and this is how a majority of Gulf War
veterans view what has happened: We have seen this pattern through the
years both from the Democratic and Republican Party and this has to
stop now. Section 8 of the Constitution states clearly one of the
duties of congress is to ``raise and support Armies and militia.''
There are a lot of appropriations and authorizations that occur that
are not called for in section 8 and Veterans that have been exposed to
hazardous toxins should not have to beg and fight their own government
for years and decades after exposures in war! Our needs should be
addressed as the priority not as an afterthought or not to be balanced
and compete with items not covered in section 8 of the Constititution!
As of the May GWVIS report from the VA we have 212,867 claims have
been granted out of 696,842 that served in combat in Operation Desert
Storm. This figure is getting close to \1/3\ of the force. We have more
than 175,000 with Gulf War illness than the VA study picked up. We also
have 13,517 veterans that have died according to the GWVIS data. WE the
veterans are concerned if this count is accurate because it does not
match the statistics in their own report (GWVIS) of the number that
have served and the number of estimated living veterans. These are not
just numbers these are human beings that served and put their life on
the line. Today I am handing in to you the obituaries we have
collected, this three ring notebook containing 800 pages of 1,473 have
been researched over the last 6 months and we have thousands more that
we are currently working on using a rigorous process of verifying and
posting using copyright guidelines. We do not have all of them but what
is interesting is to review the age of death and one can see clearly
something is definitely wrong and we needed help from the time of
exposure.
One of the Gulf War Veterans that died this month is Colonel Dr.
Gil Ramon. Colonel Gil Ramon had five degrees, served in law
enforcement in Wichita, KS as the youngest person at the time to attain
the rank of Sergeant in the Sedwick County Sheriff's Department, served
as the Assistant Vice President for Academic Administration at the
University of Northern Colorado from 1975-1977, served as the Regional
Director of the Denver, Colorado office which covered a six-state
region served as an undersecretary in the Department of Education,
served as Deputy Assistant Secretary of Operations, in Washington,
D.C., named Executive Director of ``The White House Initiative on
Educational Excellence for Hispanic Americans,'' served as Deputy
Commander of the 311th Evacuation Hospital, Army Medical Service Corps,
Operation Desert Storm, where he served as Chief of Operations, U.S.
Army Central Command, the Persian Gulf. Colonel Roman provided
administration and operations guidance in the administration of a
combat filled hospital (400 bed augmented). He was a remarkable person,
when he testified before Representative Shays' Committee he did not let
a massive nose hemorrhage that occurred while he was testifying stop
him, only Representative Shays could do that by ordering a break in the
hearing so that he could get it under control, clean up, and then
continue his testimony. But most of all he and I were a team trying to
help our fellow veterans of the Gulf War in Colorado by doing whatever
we could including writing white papers for our Colorado delegation and
candidates for office. He was my friend and I dedicate my testimony
today to him and all of these hundreds of thousands of dead and living
but injured veterans. I include his obituary as an attachment to
represent one of tens of thousands of our lives that are no longer with
us. His private cardiologist later wrote: ``What is clear is that he
[Colonel Roman] served in the Middle East and that he was a
cardiomyopathy. I would submit that this may well be part of the Gulf
War Syndrome.''
Our Special Forces commander in Desert Storm died in July, General
Wayne Downing, his death is connected because of immune system
deterioration from exposures that is happening to all of us. I ask you
how long do we wait. How many must pay with their lives and their
quality of life before full attention and funding to fight these deadly
exposures. This is the biggest black mark on our country ever! It is
the largest post war casualty and morbidity ever in the history of this
country! It has been worse because of policy and delay and denial
techniques employed by all in the government that started with the
atomic veterans and has continued through over 50 years. This is the
same government that we veterans swore to defend! Everyone from the
President to the Congress to the DoD and the VA from the past years has
not shown the leadership and commitment that we deserved.
If you are going to fund the continuing war then you must fully
fund the needs of the veterans, we refuse to be an after thought or
disposable GI's. We also believe you should consider this war that
started with us in Operation Desert Storm and has continued through
Operation Iraqi Freedom and Enduring Freedom as one. You must address
all legislative needs of Operation Desert Storm as you address the
current troops and veterans. Our voices are united in that point. We
also fully believe that Veterans of Agent Orange, Atomic Veterans,
Anthrax vaccine veterans and Project Shad fall within the same domain
of Environmental Exposures. What we find thru our push to breaking
science in medical research for diagnosis and treatment will reach
backward as well as forwards.
It has been 16 years almost 17 years since our health was affected
in Operation Desert Storm. One of the initiatives that we as veterans
and advocates have started is the Web site www.honorthenames.com. It is
a shame and disgraceful that the VA can not provide the basic death
data that we have asked for to include Name, Rank, Unit assigned, Age,
and cause of death to be on a public registry online. At least if this
data was available patients, doctors, nurses, and researchers could be
more informed and possibly be more aggressive in follow up for our
living veterans whether it be more focused efforts to screen for
cancers, cardiac, or renal problems. I recommend this become a
legislative effort to make this into a bill and then into law. Included
in this bill would be a mandate that death certificates list if the
deceased was a veteran and what war or time period they served.
Currently many states' health departments would only know if the
deceased was a veteran if a VA file number is indicated we need this
uniform across all 50 states. If we can publish the names of those
killed in Iraq then we should have the same for veterans that served at
the beginning in Operation Desert Storm. If the VA can not do this,
then write a bill/law that the Social Security Administration will do
it. It is not appropriate to wait for periodic death mortality studies
when this information can be of clinical significance. If we have a
higher rate of automobile accidents then this should be investigate and
information given to veterans and their family members. The memory
problems, cognitive problems and vision problems impact on auto and
truckdrivers and also pilots.
On the same subject of data sharing we need data on all diagnostic
codes be it ALS, MS, Seizures, all types of cancers, cardiac, renal,
liver disorders from the veterans health care data for the Gulf War
veterans at a minimal of annually again to be on the VA website open to
all to review for the purpose of providing data that could show trends
that need to be monitored for all Gulf War veterans in the clinical
setting whether by the VA or civilian health care providers. Having
been a practicing nurse, patient educator, critical care provider, and
educator I know this data would be useful not only to health care
providers but to the patients. This data would be as useful as the
patient family history and past medical history in evaluating a
patient's health risks that all health care providers use in educating
and screening patients for other medical conditions that are likely to
emerge. The veterans have already started unofficial registries by
online email groups for MS, ALS, Parkinson's, Cancers, Cardiac
problems, and for Anthrax vaccine reactions, so we ask the VA to do
these things (public registries on all of these and more) when they
don't we as veterans will lead. We need the diagnostic codes occurring
by age group, units assigned (if possible), and what it compares to in
civilian population data by age group. This would also trigger
researchers in those areas to pursue potential connections whether it
is exposures or potential treatment or diagnostic tests that need to be
evaluated. Please consider this an identified legislative issue to be
enacted by a congressional bill/law.
I include data that we obtained from within the retired/deceased VA
physicians on Cancers that were occurring in the early years after
Operation Desert Storm that shows 4 cancers that were occurring at an
elevated rate from the normal population expected occurrences. In
addition to this listing Congressman Upton had gotten a listing from
the VA in the mid nineties on cancers occurring in the Gulf War
veterans. This is critically important data that needs to be shared to
all. Knowing that these cancers have occurred alerts the patients (our
veterans) and doctors (both VA and Civilian) to do earlier screening
and testing to catch cancers in the earliest stage which is needed for
fast treatment to save lives!
By following through on these two efforts we might possibly
identify the diagnoses that need to be included in Presumption of
Service Connected for Operation Desert Storm Veterans. In addition the
veterans of the Gulf War would appreciate a bill that identifies ALS,
Brain Cancers, and possibly MS as Presumption of Service Connection be
introduced and passed. We don't want simple VA regulations but we want
laws that back those up. Therefore all VSO's, doctors, patients and
their family members will know these conditions are recognized!
If needed GAO (scientists/officials) could be utilized again to
collect the data and report on the above concerns on deaths (ages,
cause of death) and on diagnostic codes to the Congress. The Gulf War
Veterans believe that GAO reports on the whole are more balanced and
complete than what we are seeing through the IOM studies. The IOM
studies have proven to be almost useless and to very little benefit to
the Gulf War veterans. This procedure/policy of using IOM as an arm of
the VA to deny help and assistance to veterans needs to be the focus of
a full Senate Investigation.
I propose a change be made for veterans, basically data that is
data on diagnosed illnesses by Diagnostic code could be compared by
data on the same diagnostic codes in the general population by age
groups. When we experience above the normal population there should be
no delays or intermediate steps to connect and compensate the veterans
for those diagnostic codes and conditions. The intervening compounding
factor is simply a war exposure that triggered the disease. Finally the
veterans would receive the benefit of the doubt with no delay that
further impacts the lives of the veteran, the quality of their lives,
and the impact for the families of the veterans.
Congress needs to review the process that is occurring at the IOM
in relation to Gulf War illness and exposures. This has been testified
to before in front of Representative Shays Committee in Nov 2005 and no
effective action has occurred. This is not what the Gulf War veterans
expect of congress, to leave issues that have been identified to not be
investigated and corrective action taken for over 2 years. This is
simply unacceptable!
Since the last Senate Hearing during 2000 on Gulf War illness some
hope of progress has been made. But hope is not enough! The VA RAC GWI
was finally implemented years after the law requiring it was past. This
is not acceptable and directly relates to policy of delay and denial
that we have seen from all parties since 1991.
The 2004 Report of the VA RAC GWI finally slowed down the
misdirecting of research money to Stress Psychological Studies of Gulf
War Veterans. That took 12 years to accomplish, there are still efforts
to downplay Gulf War illness as psychosomatic or stress and pushing
Gulf War veterans to psychological visits away from medical internal
medicine, immunology, and other clinics. This is how policy and
research impacts actual care and treatment of Gulf War veterans. I
believe this is due to the physicians at each VA hospital not receiving
adequate knowledge of what was being done in congressional hearings or
information withheld by the DoD on exposures. Training and updates of
all the work that has been done is the responsibility of the VA Central
Headquarters i.e. Environmental Agents i.e. Mark Brown has failed in
his job. There is still a policy in place at the VA headquarters or
higher that is interfering with providing what the Gulf War Veterans of
Operation Desert Storm and those with reactions stemming from anthrax
vaccine actually need in regards to diagnosis and treatment. Training
of physicians and health care providers and sharing of all data is a
central leg of our stool to reach better diagnosis and treatment of
desert storm veterans in the VA health care system or in the civilian
health care system. This has been and continues to be the most
neglected area that affects Operation Desert Storm Veterans and
potential civilian casualties that may still occur in the current War.
Some one or several need to be fired! Policy from the Top down needs to
be changed now not in 50 years when we are dead or when an attack
occurs on civilians within the U.S. (which has happened already re WTC
health effects). Truth, Responsibility, Accountability, and the best
Training and Resources are what the Active Duty, Guard, and Veterans
stand for and give their lives for in service to our country. It is a
travesty that our Presidents, Congress, and all departments do not give
that to us.
We ask that you mandate and call for a change of White House
Policy, VA policy, and DoD policy now. It is will pass time that
roadblock of denial and delay be completely removed publicly. The
policy change will benefit our Nation and not only our veterans.
The VA research money is now being sent to the Dallas Collaborative
center and this is because for years we watched the VA continue to fund
research that was not focused in the right direction even after 2004.
Studies that were on multiple year programs needed to be stopped but
that was not done. WHY? The answer is because there was not a thread of
oversight from the Congress or hearings! Money was misspent that we
needed desperately to make the breaking research that would impact
clinical care for us Gulf War veterans.
We are happy that the UTSW medical will now be a VA Collaborative
Center. This effort is where the research for the long term effort to a
potential cure will be placed. This is the long term approach but it
needs input and oversight. Besides their plans to nail down the best
neurological imaging/diagnostic testing more needs to be done. They
must submit there plans for spending the money and other areas they
will be investigating. This must be documented in a very public manner
on a website with a forum for researchers and veteran patients to input
their concerns and suggestions.
The other stool leg needs to be addressed re the DoD funding on
Gulf War illness that disappeared in 2001 except for 5 million in FY06.
The DoD Congressional Directed Medical Research Program has proven to
us to be a place that can coordinate the needs of the Gulf War Illness
Research. This program is the really stabilizing leg.
Through using this program Researchers that are in and out of the
country that can not be funded through the VA funds due to requirement
of VA employment time can become involved and help us solve the
problem. An example of the problem that was faced is when Dr Paul
Greengard a Nobel Peace Prize nominee in neurology was turned down for
funding by the VA Research. He had stopped his busy schedule to respond
to the need of Gulf War illness research. If the DoD CDMRP program had
been in place then it would have been able to meet the need. The DoD
CDMRP would be high gain, high risk for breaking science that relates
more directly to diagnosis tailored to potential exposures that need
DoD collaboration i.e. DU, anthrax vaccine, nerve agent exposure, and
other hazardous exposures singularly and in combination. The treatment
modalities that could be developed using the same type initiative that
we use to fund weapon development from theory to rapid field use could
be employed to make the rapid short term progress we need. That is why
30 million annually is needed in that area. Both to fund hypothesis
developed/driven research and invited research efforts for diagnostic
breaking science and treatment options. Initially I was skeptical of
this program but after participating as part of the Scientific Merit
Review Committee for studies that were submitted and I am now convinced
that this is a workable system since it includes consumers of the
illness as part of the CDMRP panels. Through this effort we can truly
bring in the best minds of this country and other countries to find
answers now. As I stated earlier we have large numbers ill and DYING
and for 16 years this effort was misdirected and did not serve the
needs of a large group of ill combat theater veterans exposed to a
hazardous environment, questionable medical practices, and a major
misstep in policy when we returned ill and simply asked for the medical
care we earned by serving our country. Yes there is a desperation that
has been there since the start that has built over time as the quality
of our lives have been affected to the point that many of our careers
have been terminated, our ability to live normal day to day life has
been significantly deteriorating, and too many have died.
I would like to place in the official record videotapes of the
Montel Williams show ``Dying to Serve'' and the Discovery channel's
recent program on Gulf War illness where they tested 5 veterans using a
Chromosome Sky Testing that was developed and used at 3-4 medical
universities (1998-2000) to show that the veterans are definitely
damaged in much more severe ways than has been seen in any condition
before (articles submitted as atchm). Dr Urnovitz's work in the mid
1990's showed RNA problems with the Gulf War veterans. This is the
cutting edge diagnostic markers that are currently available and are
not being utilized. In fact, the University that tested the 5
individuals has already experienced efforts to not make these tests
available. Similar to what has occurred during the best test on DU in
urine and squalene antibodies testing in individuals that received the
Anthrax vaccine during Operation Desert Storm. The policy needs to be
changed now. The standard that we have to reach i.e. the goal posts
keeps changing because of these policies. It is time these diagnostic
tools are used fully to help the Gulf War veterans seeking answers and
treatment for 17 years! Interfering with scientist and doctors is an
example of implementing bad policy decisions. This practice is
detrimental to our very lives and to future potential civilian
casualties and is against our constitutional rights and individual
rights and must be stopped.
Every month we see breaking science news that could be used in Gulf
War Veterans ill with Gulf War illness. I am enclosing attachments that
review several of these new approaches to be considered by the DoD for
invited research proposals for Gulf War illness. With every research
proposal, the DoD should stress that universities should consider their
cost factors that range from 40-60% and lower this factor if at all
possible to encourage that more research can be done to benefit our
Gulf War veterans with their assistance. The DoD officials should
understand that we demand a tiger team approach including expert
consultants on every research proposal in order to streamline the
research in regards to time to completion and plans for clinical
implementation. If we can do this for weapons development and troop
protection, we should have same approach for Gulf War illness. The DoD
and the VA Collaborative Research centers must involve clinicians i.e.
Doctors, Nurse, Pharmacists, Lab experts, etc in the total process in
order to have their inputs and also to speed the transition of research
findings to clinical usage in the most timely manner. All proposals
should consider ways in which more interactions and sample collection
can occur from all VA hospitals. Methods making it possible for more
veterans across the nation to be directly involved should be
considered.
Other areas that are being neglected in research on impact of Gulf
War illness are in the areas of vision changes, dental changes, viral
evaluations, Cardiac implications, renal implications, and Liver
implications. Some of these areas could blend clinical input from
actual testing in the VA hospitals and then correlating the findings
and submitting the final findings as Clinical based research.
The VA needs to ready the clinical areas to put new diagnostic
tests and treatments in place. The VA needs to implement the request by
the VA RAC GWI for a Clinical Advisory Committee for Gulf War illness.
If the VA does not do this within 30 days after a new Secretary of the
VA is in place then Congress must come forth with a bill and fast track
it to a law. The integration of research findings into clinical
practice at the VA has to be preplanned. The VA should be mandated by
Congress to produce this plan to the Veterans Affairs Committee of the
House and Senate within 60 days. Congress must respond by holding a
hearing as soon as this plan is ready.
This should start with a new training and research sharing program.
An excellent way to do this would be to set up teleconferencing the VA
RAC GWI presentations on Research Reviews and Researcher presentations
that occur at the VA RAC GWI. The VA headquarters should implement
video taping of these quarterly meetings for distribution to each VA
hospital and mandate the health care professional viewing as
professional development and training. The plan should also address the
need to set up a Gulf War Illness task force at each VA hospital to
include physicians, directors, health care professionals, and Gulf War
veterans. VA should update all their training documents on Gulf War
Illness. VA Researchers and physicians should be offered the
opportunity to attend the VA RAC GWI meetings in person. Publications
of the VA RAC GWI need to be covered in the VA Newsletters on Research
and Clinical Areas. Their should be a plan to bring the Gulf War
Veterans that registered through the registries to be brought back in
for screenings for cancers, new diagnostic tests, and sharing of
current research findings and research projects materials should be
included in these sessions. These updates need to be available to Gulf
War veterans being seen at the VA at each appointment. By having
physicians and nurses involved in providing this information all
concerned parties will be fully involved and aware of what is occurring
on the research for diagnostic modalities, biomarkers, and treatment
trials. The VA needs to reestablish its Gulf War Illness Specialty
Centers keeping in mind they need to be geographically located in each
VISN. The two War Related Centers being on the East Coast close to each
other needs to be reevaluated because referrals are not happening and
these centers must be strategically located across the U.S. to better
serve the Gulf War Veterans with Gulf War illness.
The VA should also consider training at least one physician from
each VISN in accordance with the Anti-aging board certified program and
the American Environmental Training program. Both of these programs
have had physicians on the civilian side of the house treating Gulf War
veterans. I would be more than willing to get the VA in contact with
former military doctors that are involved in these two specialty areas
that have offered their expertise to assist since the early 90's.
The research proposals for treatment should also evaluate IV
vitamin, COQ10, glutathione combinations that some Gulf War veterans
have found as relief in dealing with their illnesses. In addition
chelating treatment that has been used with nuclear plant workers need
to be evaluated for use with Gulf War veterans that are testing
positive for DU. Also Dr Montoya's use of Valganciclovir in Chronic
fatigue patients with viral infections needs to be a treatment trial
for Gulf War veterans. Many of our Gulf War veterans have never
received complete blood work up studies that are available from Dr
Vjordani's lab in California or Dr Berg's Hemex lab in AZ. These two
labs have found treatable conditions in our Gulf War veterans that have
gone to the outside civilian world to get answers. It is strange to me
that Dr Vjordani's lab was recognized by the VA as outstanding but they
have not utilized it in any form to get blood work done on repository
samples and samples from current Gulf War Veterans seeking answers and
care at the VA hospitals nationally. Dr Berg's lab did the initial
sample study and paper on hypercoagulation (a treatable condition) and
yet the VA has not utilized that lab or the knowledge on a treatable
condition in Gulf War Veterans. This is particularly upsetting to me as
a Gulf War veteran nurse because answers are out there and VA refuses
to accept the answers. I am enclosing a number of medical news items
that have appeared in the last 6 months that need follow up and
possible invitations to be part of the researcher invited program of
the CDMRP program. A great deal of research in the field of MS is
available and treatment trials are there that should also include Gulf
War veterans but this has not happened.
In addition there are 2 articles that I am including that need to
be reviewed by Congress. One out of Los Angeles concerns stonewalling
by the VA regarding cancer surveillance that is affecting the state of
California collection of cancer data that could effect on the national
data on Cancer. The other article concerns the millions of serum sample
of Gulf War veterans at the DoD Repository and how they are running out
of space and are seldom used by researchers to find answers for Gulf
War veterans. Both of these items need follow up by Congress now.
I also have a large file on current research abstracts concerning
Depleted Uranium that I am making available to the Congress. I include
as an attachment my written testimony from a previous house hearing to
cover my own personal experience as a Gulf War veteran.
Now I have covered a three legged stool in my testimony but to make
that stool really solid to stand on we need the fourth leg and that is
our elected leaders of this country the Congress and the executive
branch of government. I have already stated the problem we have
experienced due to policies of our government and lackluster effective
action. Now for my final comments/suggestions to you.
I have asked the Committee staff to consider other experts to bring
forward to testify. I believe the most important would be to have the
preventive medical team sent into theater to finally testify to the
Senate VA Committee of what happened in theater and since on Gulf War
exposures. In fact I would offer a suggestion to have joint hearings of
the Senate and House Veterans' Affairs Committees to cover Gulf War
Exposures and Directions in Research and Clinical Implementations
needed for Gulf War Illness. It is past time for this to occur! You
have had General Powell and General Stormin Schwarzkopf appear years
ago but the team that had the designated duty to set up medical care in
theater has never been brought forward! Before we lose them to death
like we lost General Boomer, General Downing, Colonel Roman and others
please consider this as a priority now. Their information could help
all of us! They were the ones after the Gulf War that briefed the
pentagon why not have them brief the Senate?
I have also mentioned to the committee other medical experts that
need to testify before you so that the information on medical
treatments that are available can finally have the attention through
this Committee to be evaluated fully. We respectfully ask that the
Senate VA Committee have more hearings to cover this issue fully. There
have been too many gaps and time periods that the Gulf War Illness
issue lost your attention and focus that is so needed. As I said we
were sent off to the maze of IOM studies just like previous wars i.e.
Agent Orange and effective action led from the Congress has been lost!
We are in a period of amazing medical research that could benefit
Gulf War veterans to a better quality of life but leadership is needed
from the Hill and the Executive Branch.
We can make a difference for others to follow and possibly the
civilians' ill from the WTC exposures give us that opportunity and the
resources needed please.
I have asked the House Veterans Affairs Committee and now I will
ask you the following questions:
Will you have faith in us the veterans and those civilians as
doctors and researchers and members of the VARACGWI that have committed
to help to listen and hear us? Will you commit to putting the full
weight of this government and its resources to this task finally? Will
you listen and implement our requests? Will you follow thru with
oversight on implementation? We veterans that have been in this
struggle since after the Gulf War, 17 years ago, have led by ideas,
suggestions, actions, and continual pleads to you our elected
representatives and Senators. Please do not abandon us. Please provide
us prompt and effective medical care and compensation.
______
Attachment 4
Chromosome testing, Sky Testing
NIH NEWS ADVISORY
NATIONAL INSTITUTES OF HEALTH, National Human Genome Research Institute
New Way Of Detecting Human Chromosome Defects Promises Better Diagnosis
Of Cancer And Other Diseases
EMBARGOED FOR RELEASE
NHGRI Media Contacts:
Monday, Mar. 31, 1997
Jeff Witherly, (301)
402-8564
5:00 PM Eastern Time
Galen Perry, (301)
402-3035
Bethesda, Md--Utilizing multi-colored displays, scientists at the
National Human Genome Research Institute (NHGRI) have developed a new
technology for detecting defects in human chromosomes that promises to
improve significantly the diagnosis of certain types of cancer and
possibly other diseases as well.
In the April issue of the journal Nature Genetics, the researchers
report that their novel approach, called spectral karyotyping or SKY,
is far more accurate in diagnosing leukemia-associated chromosome
defects than is the standard, Giemsa--or G-banding method, today's most
widely used medical test for detecting chromosome aberrations.
``This new advance is a gratifying example of how the Human Genome
Project, an ambitious effort to map and sequence all of the human DNA
by the year 2005, is spinning off technologies with almost immediate
benefit to clinical medicine,'' says NHGRI director, Dr. Francis
Collins.
Currently, physicians use G-banding to look for abnormalities in
any of a patient's 46 chromosomes--coiled strands of DNA carried in
nearly every cell that contain all the genetic information necessary
for the body's proper functioning. By staining chromosomes using a
substance dye called Giemsa stain, laboratory specialists can produce a
karyotype, or arrangement of chromosomes, that shows a distinctive
banding pattern for each chromosome.
In patients with certain cancers, such as leukemia, and birth
defects, such as Down syndrome, that banding pattern can reveal various
types of chromosomal aberrations. Parts of chromosomes can be
translocated, or swapped between one chromosome and another. Other
chromosomes can be deleted or duplicated either in whole or in part.
Unfortunately, the limited staining in a G-banding karyotype does
not always reveal those aberrations. Subtle translocations in
chromosomes, for example, are sometimes undetected in G-banding
karyotypes, even by the keen eye of a trained specialist because the
banding pattern of the ``swapped'' chromosome ends is identical.
SKY, on the other hand, produces brightly colored chromosomes that
can clearly reveal chromosome aberrations that G-banding misses. In a
study of 15 patients with different forms of leukemia, teams led by Dr.
Thomas Ried at NHGRI and by Dr. Janet Rowley at the University of
Chicago found chromosome aberrations in the leukemia cells that went
undetected using G-banding in every case.
``Recently, cytogeneticists have used a technique called
fluorescence in situ hybridization, or FISH, which enables the
scientist to locate the precise position on the chromosome of one or
several different DNA probes using different dyes to label each probe.
SKY has the enormous advantage in that it can simultaneously uniquely
identify all of the chromosomes in a single cell.'' says Dr. Rowley.
According to Rowley, the question then becomes, are any pieces of
chromosomes in the wrong place, i.e., has there been a translocation we
did not detect? Moreover, in cancer cells, there are many so called
``marker'' chromosomes whose size or shape is so unusual that we cannot
identify them. SKY can help unravel the composition of these marker
chromosomes even when they contain pieces of three or more chromosomes
joined together.
SKY is a hybrid technology based on a standard genetics research
tool called FISH, short for fluorescence in situ hybridization,
combined with another technology called spectral analysis--a technique
commonly used in astronomy to separate out the rainbow-like components
of light from distant stars. SKY employs molecules called probes that
attach themselves to parts of chromosomes and glow when exposed to
light. The tagged portion of each chromosome appears in a specific
color, creating a multi-color pattern which vividly distinguishes one
chromosome from another.
Ried and his colleagues are already testing to see whether SKY can
be used to detect chromosome aberrations in other diseases, such as
certain birth defects. If the new technology proves successful, the
researchers say, it might soon start augmenting or perhaps even
replacing the current G-banding method, which is now performed some
500,000 times a year in hospitals and research centers across the
United States and Canada to diagnose a wide range of diseases.
Although SKY is still a more expensive technique to carry out
compared to G-banding, Ried believes that SKY's benefits outweigh its
extra costs. First, because SKY provides more accurate diagnoses,
doctors can better treat patients with appropriate therapies earlier
and potentially avoid unnecessary and costly therapies later on. And
second, because of the well-defined patterns, SKY could be assessed by
computers, which would greatly speed up the diagnoses of certain
diseases.
``SKY has the potential to become an important tool in molecular
genetics for identifying subtle and complex chromosome aberrations
without requiring any preconceived notions of the abnormalities
involved,'' says Ried.
The NHGRI oversees the role of the National Institutes of Health
(NIH) in the Human Genome Project, an international research effort to
develop tools for gene discovery. The NHGRI is one of 24 institutes,
centers, and divisions that make up the NIH, which is part of the U.S.
Department of Health and Human Services and the Federal Government's
primary agency for the support of biomedical research.
NCBI National Cancer Institute SKY/M-FISH Database SKY or M-FISH and
CGH Techniquies
Spectral Karyotyping (SKY) and Multiplex Fluorescence In Situ
Hybridization (M-FISH)
SKY and M-FISH are molecular cytogenetic techniques that permit the
simultaneous visualization of all human (or mouse) chromosomes in
different colors, considerbly facilitating karyotype analysis.
Chromosome-specific probe pools (chromosome painting probes) are
generated from flow-sorted chromosomes, and then amplified and
fluorescently labeled by degenerate oligonucleotide-primed polymerase
chain reaction. Both SKY and M-FISH use a combinatorial labeling scheme
with spectrally distinguishable fluorochromes, but employ different
methods for detecting and discriminating the different combinations of
fluorescence after in situ hybridization.
In SKY, image acquistion is based on a combination of
epifluorescence microscopy, charge-coupled device (CCD) imaging, and
Fourier spectroscopy. This makes possible the measurement of the entire
emission spectrum with a single exposure at all image points. In M-
FISH, separate images are captured for each of the five fluorochromes
using narrow bandpass microscope filters; these images are then
combined by dedicated software. In both techniques, unique pseudo-
colors are assigned to the chromosomes based on their specific
fluorochrome signatures.
The applications of SKY and M-FISH for screening genomes for
chromosomal aberrations in human disease and animal models of human
cancer are manifold. By making possible the unambiguous identification
of even complex and hidden chromosomal abnormalities, SKY/M-FISH is
particularly useful in:
Mapping of chromosomal breakpoints
Detection of subtle translocations
Identification of marker chromosomes, homogeneously
staining regions, and double minute chromosomes
Characterization of complex rearrangements.
The notoriously difficult analysis of murine chromosomes has now
become greatly simplified, extending the application of SKY/M-FISH to
the visualization of chromosomal aberrations in mouse models of human
cancer.
Visit the Ried Laboratory WebSite for SKY protocols
Selected SKY/M-FISH References
Schrock E, du Manoir S, Veldman T, Schoell B, Wienberg J,
Ferguson-Smith MA, Ning Y, Ledbetter DH, Bar-Am I, Soenksen D, Garini
Y, Ried T. Multicolor spectral karyotyping of human chromosomes.
Science 273:494-497, 1996
Speicher MR, Gwyn Ballard S, Ward DC. Karyotying human
chromosomes by combinatorial multi-fluor FISH Nat Genet 12:368-375,
1996
Liyanage M, Coleman A, du Manoir S, Veldman T, McCormack
S, Dickson RB, Barlow C, Wynshaw-Boris A, Janz S, Wienberg J, Ferguson-
Smith MA, Schrock E, Ried T. Multicolour spectral karyotyping of mouse
chromosomes. Nature Genet 14:312-315, 1996
Ried T, Liyanage M, du Manoir S, Heselmeyer K, Auer G,
Macville M, Schrock E. Tumor cytogenetics revisited: comparative
genomic hybridization and spectral karyotyping. J Mol Med 75:801-814,
1997
Weaver ZA, McCormack SJ, Liyanage M, du Manoir S, Coleman
A, Schrock E, Dickson RB, Ried T.A recurring pattern of chromosomal
aberrations in mammary gland tumors of MMTV-cmyc transgenic mice. Genes
Chromosomes Cancer 25:251-260, 1999
Azofeifa J, Fauth C, Kraus J, Maierhofer C, Langer S,
Bolzer A, Reichman J, Schuffenhauer S, Speicher MR An optimized probe
set for the detection of small interchromosomal aberrations by 24-color
FISH. Am J Hum Genet 66:1684-1688, 2000
Knutsen T, Ried T. SKY: A comprehensive diagnostic and
research tool.A review of the first 300 published cases. J Asso Genet
Technol 26:3-15, 2000
Padilla-Nash HM, Heselmeyer-Haddad K, Wangsa D, Zhang H,
Ghadimi BM, Macville M, Augustus M, Schrock E, Hilgenfeld E, Ried T.
Jumping translocations are common in solid tumor cell lines and result
in recurrent fusions of whole chromosome arms.Genes Chromosomes Cancer
30:349-363, 2001
Phillips JL, Ghadimi BM, Wangsa D, Padilla-Nash H,
Worrell R, Hewitt S, Walther M, Linehan WM, Klausner RD, Ried T.
Molecular cytogenetic characterization of early and late renal cell
carcinomas in Von hippel-Lindau (VHL) disease.G enes Chromosomes Cancer
31:1-9, 2001
Comparative Genomic Hybridization (CGH)
Comparative genomic hybridization (CGH) is a fluorescent molecular
cytogenetic technique that identifies DNA gains, losses, and
amplifications, mapping these variations to normal metaphase
chromosomes. It is a powerful tool for screening chromosomal copy
number changes in tumor genomes and has the advantage of analyzing
entire genomes within a single experiment. It is particularly
applicable to the study of tumors which do not yield sufficient
metaphases for cytogenetic analysis and can be applied to fresh or
frozen tissues, cell lines, and archival formalin-fixed paraffin-
embedded samples.
CGH is based on quantitative two-color fluorescence in situ
hybridization. Equal amounts of differentially labeled tumor genomic
DNA and normal reference DNA are mixed together and hybridized under
conditions of Cot-1 DNA suppression to normal metaphase spreads. The
labeled probes are detected with two different fluorochromes, e.g.,
FITC for tumor DNA and TRITC for the normal DNA. The difference in
fluorescence intensities along the chromosomes in the reference
metaphase spread are a reflection of the copy number changes of
corresponding sequences in the tumor DNA.
CGH has the advantage of requiring only genomic tumor DNA, making
it highly useful for cancer cytogenetics, circumventing the need for
high quality tumor metaphase spreads. The ability to study archival
material allows retrospective analysis which can correlate chromosomal
aberrations with the clinical course. Since its introduction in 1992,
CGH has been applied to a broad variety of tumor types which have
previously defied comprehensive cytogenetic analysis by traditional
methods. CGH has, for example:
Revealed consistent genetic imbalances and multiple
amplification sites in carcinomas of the brain, colon, prostate,
cervix, and breast. For instance, it identified chromosome 7 gain and
chromosome 10 loss as landmark aberrations in glioblastomas, and
specific gains of chromosomes 1, 8, 17, and 20 and loss of 13q and 17p
in breast cancer.
Found chromosomal aberrations in human leukemia,
lymphoma, and solid tumors has identified non-random tumor and tumor-
stage specific genetic changes. This information can guide positional
cloning efforts.
Become an important initial screening test for
chromosomal gains and losses in solid tumor progression, and the
results derived from these experiments can be applied to the
development of more specific diagnostics.
Visit the Ried Laboratory WebSite for CGH protocols
Selected CGH References
Kallioniemi A, Kallioniemi OP, Sudar D, Rutovitz D, Gray
JW, Waldman F, Pinkel D Comparative genomic hybridization for molecular
cytogenetic analysis of solid tumors. Science 258:818-821, 1992
Heselmeyer K, Schrock E, du Manoir S, Blegen H, Shah K,
Steinbeck R, Auer G, Ried TGain of chromosome 3q defines the transition
from severe dysplasia to invasive carcinoma of the uterine cervix. Proc
Natl Acad Sci USA 93:479-484, 1996
Ried T, Liyanage M, du Manoir S, Heselmeyer K, Auer G,
Macville M, Schrock E Tumor cytogenetics revisited: comparative genomic
hybridization and spectral karyotyping.J Mol Med 75:801-814, 1997
Forozan F, Karhu R, Kononen J, Kallioniemi A, Kallioniemi
OP. Genome screening by comparative genomic hybridization. Trends Genet
1997 Oct;13(10):405-9, 1997
ClinicalTrials.gov
A service to the U.S. National Institutes of Health
Linking patients to medical research
Developed by the National Library of Medicine
Evaluation of Patients With Unresolved Chromosome Abnormalities
This study has been completed.
Sponsored by: National Human Genome Research Institute (NHGRI)
Information provided by: National Institutes of Health Clinical Center
(CC)
ClinicalTrials.gov Identifier: NCT00001639
Purpose
The purpose of this research is to study a new way to test for
chromosome abnormalities. Chromosomes are strands of DNA (the genetic
material in the cell nucleus) that are made up of genes-the units of
heredity. Chromosome abnormalities are usually investigated by staining
the chromosomes with a dye (Giemsa stain) and examining them under a
microscope. This method can detect many duplications and deletions of
pieces of chromosomes and is very accurate in diagnosing certain
abnormalities. It is not useful, however, for identifying very small
abnormalities. This study will evaluate the accuracy of a test method
using 24 different dyes for finding small chromosome abnormalities.
Children and adults with various chromosome abnormalities may be
eligible for this study, including, for example, people with
developmental delay or mental retardation, abnormal growth features or
growth retardation, and certain behavioral disorders. Participants will
be evaluated in the clinic over a 1- to 3-day period, depending on
their symptoms. All participants will be examined by a genetics
specialist and will have a physical examination and possibly X-rays,
computerized tomography (CT) scans, magnetic resonance imaging (MRI),
ultrasound studies and medical photography. Blood will be drawn for
chromosome testing-about 3 tablespoons from adults and 1 to 3 teaspoons
from children.
When the test results are available, participants will return to
the clinic for follow-up evaluation and review of the test findings.
The genetic and medical evaluations, along with their implications,
will be discussed.
Condition
Abnormalities
Failure to Thrive
Mental Retardation
Microcephaly
MedlinePlus related topics: Birth Defects; Developmental
Disabilities;
Facial Injuries and Disorders; Growth Disorders; Head and Brain
Malformations
Genetics Home Reference related topics: Developmental Disabilities
Study Type: Observational
Study Design: Natural History
Official Title: Evaluation of Patients With Unresolved Chromosome
Aberrations
Further study details as provided by National Institutes of Health
Clinical Center (CC): Total Enrollment: 263
Study start: December 1996; Study completion: October 2000
There is a range of genomic aberrations from aneuploidy down to
single base pair deletions or inserts. Present technology uses
microscopic cytogenetics for detection of large rearrangements (greater
than 2 Mb) and molecular techniques for small rearrangements (less than
2 Mb). There is a gap in practical diagnostic technology in that
microscopic cytogenetics has poor sensitivity for aberrations less than
5 Mb and the molecular techniques are cumbersome for clinical use in
the megabase range. In many cases it is possible to determine that an
aberration is present by microscopic cytogenetics but cannot be
characterized. We propose to use Spectral Karyotyping (SKY) and
supplementary FISH and molecular techniques to characterize these
aberrations. Subjects will be seen in OP9 for a clinical genetics
evaluation and phlebotomy for SKY. Confirmation of SKY results will be
performed by standard FISH, genomic content mapping, and other standard
techniques.
Eligibility
Genders Eligible for Study: Both Criteria
Physical anomalies or developmental anomalies.
Karyotype showing derivative chromosome abnormality that is not
fully characterized.
No abnormal parental karyotype.
No prenatal specimens.
Probands of all ages, genders, and ethnic origin are eligible.
The proband must have a non-mosaic abnormal G-banded chromosome
analysis of good quality that shows one or more derivative chromosomes
whose foreign component cannot be determined by standard G-banding
techniques.
The parents should also have G-banded chromosome analysis prior to
eligibility for consent 2. If this has not been done by the referring
physician, it may be done as part of the protocol.
The proband with the abnormal karyotype should have one or more of
the following features: dysmorphic features; developmental delay or
mental retardation; growth retardation, microephaly, short stature or
failure to thrive; behavioral disorder
Biological parents must be willing to supply a blood specimen. If
they have any of the features listed above, they must attend the clinic
if the proband is to be eligible.
The proband must be evaluated by the NCHGR clinical genetics
service by the PI, a co-investigator, or his associates.
Mothers will be queried about potential non-paternity. If non-
paternity is possible, the family will need to undergo clinical
paternity evaluation before they are enrolled in the study.
Location Information
United States, Maryland
National Human Genome Research Institute (NHGRI), Bethesda,
Maryland, 20892, United States
More Information
Study ID Numbers: 970045; 97-HG-0045
Last Updated: July 10, 2006
Record first received: November 3, 1999
ClinicalTrials.gov Identifier: NCT00001639
Health Authority: Unspecified
ClinicalTrials.gov processed this record on October 03, 2007
University of Pittsburgh Cancer Institute
A National Cancer Institute (NCI)-designated Comprehensive Cancer
Center
UNIVERSITY OF PITTSBURGH RESEARCHERS USE ``FISH'' AND ``SKY'' TO STUDY
CHROMOSOMES
PITTSBURGH, Nov 17, 1997--Using two state-of-the-art technologies,
scientists at the University of Pittsburgh's Department of Human
Genetics are lighting up human chromosomes in a colorful display to
easily locate errors that give rise to disease. These technologies are
FISH (Fluorescence In Situ Hybridization) and SKY (Spectral
Karyotyping).
Each person has 23 pairs of chromosomes, large coils of genetic
material. Pitt researchers are probing human chromosomes with FISH and
SKY to reveal the tapestry of genes that instruct the body to develop
and function properly and to yield information that could help
biomedical researchers develop sensitive tests to detect disease and
possibly aid in choosing the best treatments for specific disorders.
``With our new FISH and SKY instruments, we can visualize specific
genes or chromosomal regions to identify the defects at a fundamental
level in a variety of disorders, such as what chromosomal changes are
associated with the development and progression of a variety of
cancers,'' said Susanne Gollin, PhD, associate professor of human
genetics at the University of Pittsburgh, where she is the director of
the Cytogenetics Laboratory.
``Already, these technologies are allowing us to detect chromosomal
alterations in otherwise normal looking cells lining the mouth of
patients with oral cancer. These alterations identify cells that may
grow into new cancers. Using such information, we may be able to screen
individuals at risk for oral cancer, as well as develop and apply much
better prevention and treatment strategies,'' noted Dr. Gollin, who
also directs the University of Pittsburgh Cancer Institute's
Cytogenetics Facility. Pitt's cytogenetics capabilities are unique in
the region. SKY is not available elsewhere in the tri-state region,
including Pennsylvania, Ohio, and West Virginia, according to its
manufacturer, Applied Spectral Imaging of Carlsbad, CA. Aside from
detecting the most subtle chromosomal flaws underlying disease, FISH
and SKY can be used to learn whether a chromosome has received a new
gene delivered as part of a gene therapy; track the integration of
foreign, disease-causing viruses into chromosomes; and assess how anti-
cancer drugs alter chromosomes before they kill tumor cells. Not only
are these technologies more informative when studying abnormal cells
than standard ways of examining chromosomes (called karyotyping), they
are also quicker because they combine powerful visualization
capabilities with rapid, computerized analysis, according to Dr.
Gollin.
With FISH technology, researchers expose a cell's chromosomes to
fluorescent probes made of normal human DNA segments. These probes bind
(hybridize) tightly to a specific region of a cell's genetic material.
Investigators use FISH to count the number of chromosomes and/or copies
of a particular gene in a cell and to identify unusual regions that are
amplified, or present in extra copies. Too few or too many chromosomes
or gene copies indicate a serious genetic defect in that cell. Using a
different form of FISH, called comparative genomic hybridization,
investigators can identify chromosomal regions that are gained or lost
in abnormal cells, including tumor cells. For instance, researchers can
expose human cells to a probe made of normal DNA (labeled red) and a
probe made of tumor DNA (labeled green). This technique enables
scientists to learn whether chromosomes have lost a section of DNA
containing a normal gene that suppresses cancer growth (hence the
absence of any green) or gained too many copies of a DNA section
containing a normal gene that drives a cancer's growth (extra green).
SKY technology, yet another form of FISH, is used to study more
complex changes in genetic material because some of the probes it
employs are labeled with not one but several colors. These multicolored
probes bind to the chromosomes. This new portrait's panoply of colors,
many of which are similar, cannot be differentiated by the human eye,
but SKY's spectral imaging hardware and computer software can
discriminate even the finest variations in the wavelengths of color
(spectra) emitted by each dye or combinations of dyes marking a
chromosome. After the SKY instrumentation processes this information,
the result is a vivid display. Using SKY, researchers can plainly see
the chromosome rearrangements in a cell. Normal chromosomes are each
one color. Abnormal chromosomes may be composed of two or more
different colors, signifying their origination by mixing and matching
of two or more different chromosomes. Recently, Pitt became the first
test site in the United States for software-driven remote access to
classical and molecular cytogenetic results. CytoNet software and the
CytoVision System are produced by Applied Imaging, headquartered in
Santa Clara, Cal., with its North American sales office located in
Pittsburgh.
``The CytoNet provides novel communications capability,'' said Dr.
Gollin. ``The CytoNet is envisioned to serve two currently unmet needs:
viewing of clinical cytogenetics results by cytogeneticist consultants
or laboratory directors who are offsite to obtain professional input or
second opinions; and viewing of research results and discussion between
an investigator and the director of a specialized cytogenetics core
laboratory, such as the UPCI Cytogenetics Facility. Not all
institutions have cytogeneticists or cytogenetics laboratories for
research applications. This software facilitates use of these shared
resources by investigators at other institutions.'' The Cytogenetics
Facility is funded by the UPCI's cancer center support grant from the
National Cancer Institute. Funding for the SKY and CytoVision
instrumentation was provided by the National Center for Research
Resources, National Institutes of Health. For additional information
about the UPMC Health System or the University of Pittsburgh Cancer
Institute, please access the web links.
UPMC News Bureau
______
Attachment 5: Point paper Highlight of Actions needed
POINT PAPER SUMMARY OF TESTIMONY
ACTION PAPER FOR ADDRESSING ISSUE OF GULF WAR ILLNESSES
1. The last benefits law(2000) for Gulf War illness had within
the original bill not only Chronic Fatigue Syndrome and Fibromylagia
but also Neurological Autoimmune Diseases/Disorders. Unfortunately the
Neurological Autoimmune diseases/disorders was removed and now in 2007
we are asking that wording to be added. We are asking for a bill to be
moved quickly that adds Brain Cancers, ALS, and MS to the presumption
of service connection for Gulf War Veterans. The Brain Cancers and ALS
should have no problem since the VA has agreed by regulation. We need a
bill that is fast tracked to be completed this session of congress. We
want this done by Law not by VA discretionary action.
2. In regards to legislation in the authorization and
appropriations area, the congress and senate should follow the Lead of
the VA Research Advisory Committee on Gulf War Illness and Gulf War
Veteran's Organizations. Just yesterday the House Appropriations
Committee did not do that and has in effect caused potential
detrimental action in the needs of the Gulf War veterans community.
3. VA attitude starts at the top and goes down. The hearing today
will show the detrimental effect that attitude has caused for 16 years.
That attitude has to be turned on its head. People within the VA system
have directly affected tens of thousands no hundreds of thousands Gulf
War Veterans in regards to the VA Benefits, VA Health Care, and VA
Research. It is time now that certain people be removed from their
positions for their deliberate misguidance, mismanagement, and ill
regard to Gulf War veterans needs.
4. All VA Directives/Policies/Guidance/Contracts must be faced
with a Stop Order and Investigated. They have led to a Direct Breech of
Duty to the Gulf War Veterans.
5. New Directives/Policies/Guidance/contracts must be submitted
and reviewed by the VA RAC GWI and other congressional Committees
before they are officially released.
6. Dental and Eye Exams must be Mandated for ODS Veterans now.
Data that must be gathered and shared with the VA RAC GWI and House and
Senate VA Committees and government Reform Committee. Treatment for
Dental and Eye conditions should be allowed through the VA for these
veterans regardless of VA rating.
7. VA Outreach and all forms of Communication to ODS Veterans
must be started in a robust manner expeditiously. This should include
the newest research information and exhibit a new VA attitude a true we
are here to serve the veteran.
8. VA physicians and medical personnel must be notified to
perform expansive lab work measurements to cover:
A. Immune System Function
B. Viral Panels
C. Hypercoagulation Lab work
D. Thyroid system functions
E. Adrenal Gland Function
F. Pituitary Gland Function
G. Hormonal function
H. Renal Function
I. Cardiac Function
J. Liver Function
K. Screening Cancer workup labs
9. Data gathered from lab work needs to be collected and analyzed
and sent to the Research Advisory Committee and reports on same should
be issued on the VA Website so that physicians, researchers, and
patients alike have the information.
10. Treatment of any abnormalities should be started as soon as
results are obtained.
11. Data on all causes of deaths should be assembled and posted as
Data Report from the VA on its website.
12. Data on all Diagnosed illnesses for ODS Veterans must be
collected and also published on the VA Website.
13. Two additional advisory Committees similar to the VA RAC GWI
in the areas of Clinical Care and Benefits should be legislated and
should be implemented ASAP.
14. New Clinics should be initiated at each VA Hospital
specifically for Operation Desert Storm Veterans. The staff should be
dedicated and then thoroughly brought up to current state of knowledge
on relevant physiological based research that has occurred. Then the
educational process for Medical staff and medical personnel should be
expanded rapidly.
The educational process should involve routine scheduled
teleconferences and videotape reviews. The Videotaping of Jim Binns,
Lea Steele, Beatrice Golumb, Dr Roberta Hailey, and Dr Roberta White
should be produced and distributed ASAP. New tapes with other leading
researchers and clinicians should follow.
15. The registry program and environmental agent program should be
renewed and expanded. The individuals that went thru these registries
should be brought back in for updating of medical progress, expanded
lab work, and any other diagnostics.
16. A proactive aggressive Cancers and Neuro Auto Immune Diseases/
Disorders Screening Program for Operation Desert Storm Veterans should
be legislated and implemented ASAP.
17. A directive should be sent out to all VA hospitals that
symptoms suggestive of ALS or MS need to have through and complete
diagnostic workups done regardless of VA Rating.
18. Anti Aging Board Certified Physicians and Environmental
physicians should be proactively recruited for contracts with the VA
headquarters and VA hospitals to provide consultation and physician
education programs immediately.
19. DOD AND ACTIVE MILITARY SERVICE MEDICAL PROFESSIONALS NEED
UPDATE TRAINING ON ASSESSMENT OF ENVIRONMENTAL EXPOSURES AND REVIEW OF
CURRENT RESEARCH.
20. New DoD and Service Components guidance and regulations on all
environmental exposures need to be initiated. Documentation of
potential exposures and tracking for active duty needs to be reviewed.
Any and all potential health affects need to be documented.
21. DoD must review and update exposure lists to include AF, Navy,
and Marine units and notify the individuals affected.
22. Assurance needs to be in place by oversight that DoD Military
services are recording all vaccines appropriately with lot numbers.
23. Individuals listed in Exposed areas must be notified by DoD
and VA by letter of the increase risk of Brain Cancers/ALS.
______
Attachment 6
Ms. Julie Wilson, United States Department of Veterans Affairs,
Illiana VA Medical Center, Danville, Illinois. and to The United States
Department of Veterans Affairs, The Inspector General, Washington, D.C.
The latest nonsense comes from the American Legion. I have
confirmed that the American Legion sent this out with Mr. Bill Johnson
(317-630-1239) from the American Legion National Headquarters in
Indianapolis, Indiana. Please let all Indiana VA staff and all VA
National staff and VA facilities staff members nationwide know what was
done and that the Legion has absolutely no authority to suspend or tell
veterans that our benefits have lapsed and then to demand payment of
$20 in check or credit card for reinstatement of benefits.
I REQUEST FORMAL IMMEDIATE WRITTEN CONFIRMATION FROM THE DIRECTOR
OF THE ILLIANA VA MEDICAL CENTER AND FROM THE UNITED STATES OF AMERICA
DEPARTMENT OF VETERANS AFFAIRS SECRETARY appointed by the President of
the United States that my benefits have not lapsed as stated by Mr.
Robert Spanogole, National Adjutant, The American Legion, in the SIGNED
letter THAT I received from the HIM AND THE American Legion on October
2, 2007. ALTHOUGH MR, JOHNSON OF THE AMERICAN LEGION TOLD ME THIS WAS A
ERROR NEEDLESS TO EXPLAIN I DO NOT TRUST ANYONE.
The specific--relevant information follows:
I received a letter on October 2, 2007 from Robert Spanogle,
National Adjutant, American Legion, National Headquarters, P.O. Box
7017, Indianapolis, Indiana that quote: ``This letter is to inform you
that benefits you are entitled to as a Veteran of the United States
Armed Forces have lapsed.
Through a special reinstatement program, you are being given this
opportunity to reinstate these important benefits, for which you remain
eligible in accordance with the enclosed publication 57 ``Veterans
Guide to additional Benefits.
To reinstate your benefits you need only return the enclosed
Reinstatement Form according to the instructions printed on the form.
Please note the reinstatement period designated for your last name at
the top of the page of this notice. The absolute deadline is 3 pm on
the last date shown above.
(from top of the form), Deadline: November 5, 2007, 3:00 pm ET
Reinstatement period for veterans with last names beginning R-S
September 24-November 5, 2007 3:00 PM ET'' end quote
The implication is that I must renew my membership in American
Legion Post 71; Urbana, Illinois by November 5, 2007 at 3pm ET by
sending them a check for $20 made payable to ``The American Legion'' to
reinstate my VETERANS benefits.
I have TWICE called the American Legion National commander Marty
Conaster, Champaign, Illinois 217-359-4211 and asked him to call me
immediately,. NO RESPONSE! I called the Urbana Post 71 at 367-3121. The
Urbana American Legion Post 71 officer I spoke to did not know this was
sent out on their behalf. He agreed this was wrong! He called me back
today with an apology.
THIS IS ABSOLUTE NONSENSE AND PURE INTIMIDATION TO OBTAIN $20 FROM
ME.
I must ask if any Federal laws were broken if so what must be done?
I BELIEVE that Mr. Spanogles's treatment of me as a retired and 60%
disabled veteran who fights for medical care for all of our veterans
and myself is simply unacceptable and deserves a Department of Veterans
Affairs censure for scaring not only me and my wife but thousands of
others who probably received this same letter. We did not sleep well
last night and today has been a roller coaster.
MR. SPANOGOLE'S TREATMENT OF OBVIOUSLY THOUSANDS OF VETERANS WHO
ARE SEEKING HELP AND WHO RECEIVED THIS SAME LETTER IS A TRAVESTY.
I suspect that I am only one of many who received this letter.
I believe that I and all others who received this letter deserve a
nationwide public apology for this action.
At the bottom of the letter:
quote: ``Important; There is no mandate to extend the deadline
shown or to offer additional periods of reinstatement. do not delay in
returning your reinstatement form.'' end quote
I have absolutely confirmed that the American Legion sent the
letter. It is directly from the American Legion National headquarters.
The suspect that this organization is just trying to scare me--us
into sending them $20 for membership. The membership demand in my case
is renewal of my membership in American Legion Post 71 in Urbana. I
belong did belong to this Post but have not renewed my membership
because they simply refuse to help us when we needed and asked for
help.
The envelope has return address of: ``The American Legion National
Headquarters, Department of Veteran Notification, National Adjutant, P.
O. Box 7017 Indianapolis, In. 46207-7017''
The envelope has the huge letters ``Deadline Notice for Veterans of
the United States Armed Forces to Reinstate Benefits''
the enclosed return envelope has the address: Benefit
Reinstatement, c/o the American Legion National Headquarters, P.O. Box
7017, Indianapolis, In 46207-7017
The letter says I can reinstate my benefits by visiting
www.members.legion.org
It gave me a temporary membership number of 2022422818. The direct
telephone number of the American Legion National Headquarters in
Indianapolis, in. is 317-630-1200.
Thank you,
Major Doug Rokke, Ph.D.
U.S. Army, retired
______
Attachment 7
This is a brief of my experiences. My name is Brent Casey, a Gulf
War veteran, served as a medic with the 82nd Airborne in 90-91. Sept
05' I received a letter from the DoD which was a unit list released by
the Pentagon. These units were exposed in and around the Kamisiyah
demolition pit in Spring 91' and my unit (3rd/73rd Armor) was on this
list.
Scared to death and already suffering terribly from what I now know
is fibromyalgia, and never having been to a VA hospital in my life, my
family convinced me to go see a VA doctor for a check-up. My first
visit resulted in medication for hypertension, and 19 19 flagged on a
PTSD checklist, and obviously a diagnosis. After 6-8 months of PTSD
counseling (keep in mind I had never heard of PTSD), groups and one-on-
one, I discovered a Gulf War exam offered at the hospital and I signed
myself up for the exam.
By Sept. 06' I was diagnosed with fibromyalgia, depression, chronic
rhinitis, paresthesias, erectile dysfunction, fatigue, hypertension and
after 2 sleep studies, sleep apnea. In Oct. 06' in my own research, I
discovered a PTSD Residential Rehabilitation Program in Lexington, KY
(42-day), I completed the program in Dec. 06'. While in Lexington,
again through my own research, I discovered the WRIISC in New Jersey
and started working on a referral from a primary care physician.
I was accepted into WRIISC for a 2-day very intense work-up and
history including, exposure assessment, social work evaluation,
psychological assessment, neuropsychological assessment, and complete
physical, all with special attention to deployment related concerns of
mine. Overall recommendations that I just received from WRIISC include
but are not limited to: Mr. Casey meets the criteria for the
unexplained condition of Chronic Fatigue Syndrome, and Mr. Casey meets
the criteria for Irritable Bowel Syndrome. I was also tested for DU
(24-hr. urine) only after my own research and request, it was tested in
Baltimore in Nov. 06' and supposedly the results are normal and I will
not have any adverse consequences.
Anyhow, it is now exactly 2 years later--and to say the least I am
still blown away--but I do have a few answers to some of my questions.
I have an agent who is helping me with my claim, but I'm still not sure
if I am coming or going. I had 5-6 Dr. appt. last month and have about
that many so far to keep up with in Oct. (Mental health, Rheumatology,
PTSD Groups, Primary care and labs an EENT referral, and Physical
medicine specialist referral, and an ophthalmology referral, so my
healthcare is a full-time job. I have had a MRI, CT-scan, EMG, Sperm/
fertility test, C-PAP machine nightly, CXR, and numerous blood tests of
coarse. I hope this is appropriate information for your compilation and
I would love to help any way that I can. Feel free to call me to
discuss anything that will help you.
Sincerely,
Brent Casey
______
Attachment 8
I am increasingly frustrated. . . . I am asking veterans of Desert
Storm to write and tell us of your discoveries that could help others
re diagnosis findings . . . what was found, who tested, how others can
get the same. . . .
Treatment . . . what have you found? Who got you there? Where can
other vets get it?
And most of all
How is your quality of life . . . what have you managed to do re
education, work, family HORRIBLE! Everyone is SICK!
How are your spouses and children? What has been found on their
medical condition that could help other veterans? My only child (M-
31,has degenerative joint disease and its eating away at him, he has
high b/p, and his teeth are just wearing away, they aren't rotting???
Just crumbling?? My wife same thing with her teeth, and she hurts all
the time and again, they just try and pass it off as diabetic, and its
FREAKING NOT!
How has your testing and treatment been at the VA? NO, I have been
blown off by them for yrs. said it was all in my head! (yah it is I
have seizures).
Have you found civilian help? Where and who should veterans contact
. . . which doctors? HAH your joking right! NO ONE WANTS TO HELP US, we
are just waiting to die.
How many are having significant dental problems? YES! root canals,
and got tired of that rout and just having them pulled out now.
How many have had hearing tests that show ototoxicity? NO TEST, but
my hearing isn't great anymore and my ears hurt a lot. and they just
say old age *54 yr old.
How many are experiencing increasing vision problems? Yes and had
surgeon to correct it, and now find I have cataract forming anyway.
Are you having thyroid, hormone problems, cardiac, renal
conditions? Are they being tested for? By who? Are you being treated
for these? Again, never tested for anything and just tired of being
blown off and told its all our own fault for, thinking we feel ill.
Like I said, we are just waiting to die, figure its got to be
better than the hell we are living in now.
Tom Daggett 10 yrs U.S. Army 54 and also FED UP
Committee on Veterans' Affairs
Subcommittee on Health
August 2, 2007
Meryl Nass, M.D.
Mount Desert Island Hospital
Box 8
Bar Harbor, ME 04609
Dear Meryl:
In reference to our Subcommittee on Health hearing on ``Gulf War
Exposures'' held on July 26, 2007, I would appreciate it if you could
answer the enclosed hearing questions by the close of business on
October 2, 2007.
In an effort to reduce printing costs, the Committee on Veterans'
Affairs, in cooperation with the Joint Committee on Printing, is
implementing some formatting changes for materials for all full and
Subcommittee hearings. Therefore, we would appreciate it if you would
provide your answers consecutively and single-spaced. In addition,
please restate the question in its entirety before the answer.
Please provide your response to Cathy Wiblemo at the Committee. If
you have any questions, please call 202-225-9154.
Sincerely,
MICHAEL H. MICHAUD
Chairman
______
1. Gulf War Illnesses_Everyone on this panel agrees that Gulf War
Illnesses are real and that more should be done by way of research,
outreach and treatment.
In your professional estimation, what is the biggest
challenge facing VA today with regard to Gulf War Illnesses?
For at least 10 years, the personnel in place to implement Gulf War
Illness programs have prevented good research, good diagnostics and
good treatments for Gulf War veterans. A group of individuals at VA
have had control over research, outreach and treatment, and these
officials have ensured that the focus of both research and treatment
has been primarily psychological. The medical evaluation strategies
adopted by the VA have specified that investigations of veterans'
symptoms be limited, and the recommended treatment strategies have
primarily used psychiatric drugs. However, I must assume that these
individuals have carried out VA policy, since there is no evidence they
were instructed to do otherwise. Unless and until VA policy aligns with
the goal of doing our best for GW veterans, things cannot change.
A true story: in 1999, a Committee on government Reform staffer
told me that the reason Gulf War veterans were being diagnosed and
treated for psychiatric illnesses was because disability pensions could
be limited to 2 years more easily than if they were acknowledged to
have physical illness. I cannot confirm if this is true, but it may be
relevant to the question of why VA made the choices it did regarding GW
research and patient care. Recent revelations about the use of
``personality disorder'' diagnoses \1\ by the Army to discharge
veterans without a medical board or pension suggest that these choices
have been deliberate.
---------------------------------------------------------------------------
\1\ http://www.thenation.com/doc/20071015/kors Joshua Kors.
Specialist Town Takes His Case to Washington. The Nation. September 27,
2007.
What would your recommendations be to VA to ensure that
what has happened to the Gulf War veterans does not happen to the
---------------------------------------------------------------------------
newest generation of veterans returning from OEF/OIF?
At the Senate Veterans Affairs Committee hearing where I testified
on Sept. 25, 2007, DoD's representative, Michael Kilpatrick, M.D.,
stated in answer to a question that ``15-20% of those who've fought in
Iraq recently are returning with ``'ill-defined' medical symptoms,
Kilpatrick said.'' (McClatchey-Tribune, Sept 26) Later Kilpatrick told
a reporter he did not mean to imply they all had GWS.
It should be a concern to all of us that DoD has already identified
a developing medical problem in a significant number of returning
soldiers.
In order to provide optimal care to OIF and OEF veterans, VA needs
to know the types and severity of medical conditions these veterans
face, and their frequency. An accurate needs assessment cannot be made
without reliable information from DoD to VA. Media reports suggest VA
relies on information from military medical boards, but note that many
veterans whose status should prompt a medical board are not going
through the board process. How has this affected VA planning?
Therefore, since information supplied by DoD on the health of
troops has not always been accurate and complete, VA should be
performing its own surveillance of new veterans, in order to best
predict the medical needs of returning soldiers.
New entrants to the VA system should complete a detailed
questionnaire and evaluation by practitioners who are knowledgeable
about the physical and psychological needs of veterans returning from
combat. Creating a database from these assessments could help to
prepare further investigations and treatments for returning troops, and
identify those who have developed chronic medical conditions for
specialized care.
Congressional oversight should address VA's programs for dealing
with the 15-20% of troops with ill-defined conditions identified by Dr.
Kilpatrick, as these veterans are most at risk of slipping through the
cracks in the way that happened to veterans with Gulf War Illnesses.
2. DoD/VA_Getting accurate, up-to-date information on pre-
deployment and post-deployment health records, where service members
were located and other pertinent information from DoD, has, in the
past, been characterized as difficult.
Do you believe that this exchange of information between
VA and DoD has improved with current deployments to Afghanistan and
Iraq?
Regarding whether things have improved, I can only refer to the GAO
report of September 26, 2007: \2,3\ DoD and VA: Preliminary
Observations on Efforts to Improve Health Care and Disability
Evaluations for Returning Servicemembers. See pages 19-22.
---------------------------------------------------------------------------
\2\ http://www.gao.gov/new.items/d071256t.pdf DOD and VA:
Preliminary Observations on Efforts to Improve Health Care and
Disability Evaluations for Returning Servicemembers. GAO-07-1256T,
September 26, 2007. Pages 19-22 cover the data sharing issue.
\3\ Hope Yen. GAO Again Slams VA and DoD for Failing to Care for
Wounded Iraq War Veterans. AP/Army Times September 27, 2007. ``The
report said the Pentagon and VA still remain far away from having a
comprehensive system for sharing medical records as injured veterans
move from facility to facility.''
---------------------------------------------------------------------------
http://www.gao.gov/new.items/d071256t.pdf
Clearly, information exchange is not where it should be.
My experience has been that DOD jealously guards information on the
health of troops. Spokespersons have not always reported accurately to
media on this issue, and military medical studies are frequently at
odds with independent research on the health of troops. The
Congressionally mandated Defense Medical Surveillance System database
is being maintained, but the data are not shared with independent
researchers, despite Federal advisory Committee recommendations. The
data are only 80-90% accurate, according to GAO, CDC and the Navy
Environmental Health Center in San Diego. Presumably, more effort could
be made to improve the accuracy of the database. Congress could require
that data be shared.
Unpublished studies of the database are not shared either.
Accompanying this response, I have included two lists, obtained via
Freedom of Information Act requests, of titles of informal studies
performed by the Army Medical Surveillance Activity, which used this
database for the studies. I have so far been unable to obtain any of
the actual studies from the Army (using FOIA). Many of these studies,
especially those on GWS and on anthrax vaccine, should be of interest
to the Congress and the VA.
[One list appears at the end of these responses and the other list
is being retained in the Committee files.]
In your professional opinion, would you say the lack of
information exchange or delayed exchange was a primary factor in
hindering research efforts regarding Gulf War Illnesses?
Yes. Procedures for investigating and dealing with toxic exposures
could have been initiated, appropriate infections sought, etc., had VA
been aware of the types of exposures that had been experienced by
individual veterans when they first arrived in the VA system. The lack
of good information from DOD made it very difficult to study most of
the Gulf War exposures, since without accurate information it was
uncertain who was exposed to what, and the magnitude of the exposures.
The problem is only partly one of information exchange; it is uncertain
whether DOD monitored and recorded noxious exposures to which its
soldiers were exposed. This includes exposures to sarin, to unvented
tent heaters, to vaccines, pyridostigmine bromide (PB) and depleted
uranium. Thus the later research had to rely on so-called ``self-
reports'' of exposures--but the research was also criticized for using
these unvalidated reports.
However, the main factor that hindered good Gulf War illness
research after the immediate post-war period was the lack of will to do
so, shared by VA and DOD.
3. ALS_Mr. Mikolajcik proposed in his testimony that a
congressionally directed ALS Task Force should be established to help
provide direction in ALS research and to develop a strategic plan to
tackle this illness. The 30- 60- 90-day timeline he suggested in his
testimony lays out some structural parameters.
What are your thoughts on creating another task force or
entity to look into ALS?
A task force is a good way to review the problem and recommend
directions to pursue. However, the value of a task force is totally
dependent on its chairman, members and staff. It also needs to be given
unfettered access to data, and the power to have its recommendations
carried out in a meaningful way.
For example, exposure to electromagnetic fields has been linked to
ALS in a number of studies.\4\ In order to pursue this link most
productively, information on the electromagnetic fields generated by
DOD weapons, communications systems and other equipment would need to
be known, and the exposures in different groups of soldiers identified.
It is unlikely that DOD would cooperate in providing these data.
---------------------------------------------------------------------------
\4\ Christoffer Johansen and Jorgen H. Olsen. Mortality from
Amyotrophic Lateral Sclerosis, Other Chronic Disorders, and Electric
Shocks among Utility Workers. American Journal of Epidemiology Vol.
148, No. 4: 362-368. ``The excess mortality from amyotrophic lateral
sclerosis seems to be associated with above-average levels of exposure
to electromagnetic fields and may be due to repeated episodes with
electric shocks.'' http://aje.oxfordjournals.org/cgi/content/abstract/
148/4/362
---------------------------------------------------------------------------
In order to avoid reinventing the wheel, it should be noted that in
2001, a UK (government) expert panel made some research recommendations
about ALS and electromagnetic fields: \5\
---------------------------------------------------------------------------
\5\ ELF Electromagnetic fields and neurodegenerative disease.
Report of an advisory group on non-ionising radiation. National
Radiological Protection Board, 2001. 12(4).http://www.hpa.org.uk/
radiation/publications/documents_of_nrpb/pdfs/doc_12_4.pdf
---------------------------------------------------------------------------
``Case-control studies are, however, appropriate for investigating
the aetiology of amyoptrophic lateral sclerosis and, in view of the
rarity of the disease, are generally preferred to cohort studies. A
large-scale case-control study might, therefore, be profitably
undertaken in which special enquiries were made about:
1. employment in electrical occupations, with special reference to
the occurrence of severe electric shocks.
2. medical treatment with electroconvulsive therapy that could be
confirmed from hospital records.
3. exposure to transcranial magnetic stimulation (Walsh and Cowey,
1998), a technique for magnetic induction of neuronal activity in small
brain volumes, which is used both experimentally and clinically.
More work is needed to explore the effects of electromagnetic
fields on neurons and glial cells. In particular, the effects of both
brief explicit shock and prolonged exposure to electromagnetic fields
on intracellular Ca2+, superoxide dismutase (SOD) activity and enzyme
function in neurons deserve particular attention.''
Do you believe that the direction VA is taking with ALS
is the right way?
I cannot comment. ALS has been one disease that has been associated
with 1991 Gulf War service. We do not know how many more diseases may
also be associated, as the (relatively simple) epidemiological research
to study this has not been done by VA and DOD.
4. Where Do We Go From Here_Sixteen years have passed and veterans
of the Gulf War are still fighting to be recognized and not forgotten.
What would your recommendations be on how to effectively
move forward with Gulf War Illnesses research, outreach, education and
treatment?
As I was preparing my responses to these questions, the Senate
Veterans Affairs Committee asked me to provide testimony on Gulf War
Illnesses. My response is included in that document, which I am
attaching.
[The Senate Committee on Veteran's Affairs testimony appears at the
end of this document.]
Accountability for program success is crucial to the effort, and
Congress should demand regular reports on the Gulf War Illness program.
5. Gulf War Syndrome_Dr. Nass, you acknowledged that symptoms of
Gulf War Syndrome are not unique and that they overlap closely with
other diseases, conditions and syndromes.
Can you please describe the health effects of a typical
case of Gulf War Syndrome?
How do you treat a patient suffering from Gulf War
Syndrome?
[The response to these questions are contained in the Senate
Committee on Veteran's Affairs testimony, which appears at the end of
this document.]
6. Research_Dr. Nass, you said that the research to determine the
extent of which the anthrax vaccine may have contributed to Gulf War
Illnesses has simply not been done.
Based on my practices and studies, do I believe there is
a connection (between anthrax vaccine and Gulf War Illnesses)?
There is no doubt about their connection, which has been identified
in at least 6 different studies. What I was trying (clumsily) to say in
my testimony was that the magnitude of the anthrax vaccine contribution
to Gulf War Illnesses was not known. In other words, we do not know
what percentage of cases might be due to anthrax vaccine alone, though
we do know the vaccine alone has caused an illness identical to GWS in
non-deployed soldiers. (Even the FDA-approved label for anthrax vaccine
lists GWS, as defined by CDC, as a reported adverse reaction.) In my
opinion, anthrax vaccine added to the burden of toxic exposures faced
by soldiers in the Gulf and increased the number of soldiers who
developed chronic illnesses. Many soldiers who never received anthrax
vaccine became ill, but receiving the vaccine almost certainly
increased one's risk of developing GWS.
Meryl Nass, M.D.
September 30, 2007
LISTS OF TITLES OF INFORMAL STUDIES PERFORMED BY THE ARMY MEDICAL
SURVEILLANCE ACTIVITY
21JAN05 BURDEN OF HIV, HEP C, COLORECTAL CA DISEASE IN ALL
BENEFICIARIES/MTF ONLY (TRICARE MGT ACTIVITY)
6DEC99 BOSNIA AND SWA ANTHRAX VACCINATIONS (OSD) 20DEC99 ANTHRAX
IMMUNIZATIONS FOLLOW-UP (OTSG)
4JAN00 SERUM FROM SWA VETS (AFMOA)
5JAN00 ANTHRAX VACCINE AND THYROID DISEASE (AFMOA)
5JAN00 ANTHRAX VACCINE AND GUILLAIN BARRE SYNDROME (AFMOA)
15FEB00 POTENTIAL ANTHRAX OUTCOMES (OTSG)
1MAR00 ANTHRAX VACCINATIONS BY LOCATION (CDC)
3MAR00 ACUTE LEUKEMIA AND ANTHRAX VACCINE OTSG TIMING NOTICED LEUK
PROB AFTER AVA INITD
16MAR2000 POSSIBLE ANTHRAX IMMUNIZATION-RELATED NEOPLASMS
24MAY00 CRUDE RATES OF AMBULATORY VISITS BY ANTHRAX STATUS (AFMOA)
31MAY00 POSSIBLE RISK FACTORS FOR REPORTING ADVERSE REACTIONS TO
ANTHRAX VACCINE (OTSG)
1JUN00 PREGNANCY OUTCOMES FOLLOWING ANTHRAX VACCINATION (OTSG)
13JUN00 SUMMARY OF OTHER VACCINES RECEIVED THE SAME DAY AS ANTHRAX
(ANTHRAX VACCINE PROGRAM)
14JUN00 SAME DAY IMMUNIZATIONS (AMSA)
21JUN00 PREGNANCY OUTCOMES RELATIVE TO ANTHRAX VACCINATION (AMSA)
6SEP00 ANTHRAX RISK FACTORS PART 2 (OTSG)
16OCT00 BREAST CANCER AND ANTHRAX VACCINATIONS (OTSG)
6NOV00 ANALYSIS OF SIDR-EIDS DATABASE (AMSA)
6NOV00 INCIDENCE ANALYSIS OF ANTHRAX VACCINE AND POTENTIAL ADVERSE
EVENTS (OTSG)
1DEC00 ANTHRAX QUARTERLY REPORT
12MAR01 ANTHRAX REPORT FOLLOW-UP QUESTIONS (OTSG)
19MAR01 VARICELLA RATES, 1995-1999 (OTASG)
27MAR01 NUMBER OF VACCINATIONS BY YEAR AND SERVICE (OTSG)
8MAY01 APRIL ANTHRAX REPORT (AMSA)
5JUL01 JULY ANTHRAX/BIRTHDAY ANALYSIS (AMSA)
11JUL01 ANTHRAX QUARTERLY REPORT CODE (AMSA)
30JUL01 JULY ANTHRAX REPORT(AMSA)
5SEP01 ANTHRAX ANTIBODIES SERUM STUDY (AMSA)
21SEP01 ANTHRAX REPORT FOR INSTITUTE OF MEDICINE (SPECIAL ISSUE)
(OTSG)
26OCT01 POOL OF CASES FOR ANTHRAX SERUM STUDY (AMSA)
7JAN02 ANTHRAX VACCINATIONS IN DOD BY MONTH (USUHS)
5FEV02 ANTHRAX VACCINATION DATASET (otsg)
14FEB02 VARICELLA COUNTS AND RATES IN AD SOLDIERS--RECRUITS AND
NONRECRUITS (CHPPM)
22FEB02 FOLLOW-UP TO ANTHRAX SERUM STUDY (WRAIR)
26FEB02 ANTHRAX IMMUNIZATION DATA REVISITED (OTSG)
7MAY02 AD ARMY WOMEN WITH ANTHRAX VACCINE (AMSA)
8MAY02 OHO--DEPLOYMENT HEALTH OUTCOMES ANALYSIS (AMSA)
8MAY02 QA IMMUNIZATION DATA (AMSA)
16JUL02 BALANCED SCORECARD C1C ANTHRAX IMMUNIZATIONS COMPLIANCE
(USACHPPM, ATTN: MCHB-TS-EDE)
19JUL02 DESCRIPTIVE STUDY OF CELLULITIS AMONG U.S. ARMED FORCES,
1998-2001 (MSMR)
29JUL02 DEPLOY FORMS WITH EXPOSURE DATA (USUHS)
5AUG02 PENTAGON DATASET (WRAMC)
8AUG02 ANTHRAX IMMUNIZATION SERUM STUDY (WRAIR)
30AUG02 SLEEP DISORDERS (AMSA)
23SEP02 RE-RUN VA ANNUAL REQUEST FOR DATA ON BOSNIA/KOSOVA VETERANS
(VA)
15APR03 30 DAY SERUM FOR SMALLPOX VACCINEES (EXEC SECRETARY,
AFEB)16APR03 SUMMARY OF ANTHRAX TOPICS FOR FDA/CDC LIST (CDC)
16APR03 LIVE BIRTHS AND STILLBORNS IN AD WOMEN (FORSCOM)
24APR03 SMALLPOX VACCINATION SURVEILLANCE FOR ADVERSE EVENTS (AVIP
AGENCY)
1MAY03 GAO DEPLOYMENT INFO (N=277) (GAO)
6MAY03 AGE DISTRIBUTION OF SMALLPOX VACCINEES WITH SERUM SAMPLES
BEFORE AND 7-21 POST (EXEC SEC, AFEB)
6MAY03 VITAMIN D (ASSOCIATED WITH MS STUDY) (HARVARD SCHOOL OF
PUBLIC HEALTH)
27MAY03 FOLLOW-UP OF SUMMARY OF ANTHRAX TOPICS FOR FDA/CDC LIST
(CDC)
9JUN03 SMALLPOX VACCINATION SURVEILLANCE FOR ADVERSE EVENTS (MSMR)
10JUN03 UPDATE OF HEART DIAGNOSES FOR SMALLPOX (OTSG)
18JUN03 PENTAGON SURVEY OF DE-IDENTIFIED DATA (USACHPPM)
1JUL03 AVAILABLE SERUM AMONG ANTHRAX VACINEES (VACCINE HEALTHCARE
CENTER)
15AUG03 VACCINATION FOR ANTHRAX/SMALLPOX AND 3RD PERSCOM (OTSG,
POPM)
21AUG03 CONCOMITANT VACCINATIONS RECEIVED WITH SMALLPOX VACCINATION
(AVIP AGENCY)
21AUG03 CONGESTIVE HEART FAILURE AMONG SMALLPOX VACCINEES--BEFORE
AND AFTER (AMSA)
11MAY04 PEMPHIGUS AUTOANTIBODIES AND ANTHRAX/SMALLPOX VACCINATION
(WRAMC)
23JUN04 PEMPHIGUS/ANTHRAX VACCINE SERUM STUDY--GROUP 3 (WRAMC)
23JUN04 PEMPHIGUS/ANTHRAX VACCINE SERUM STUDY--GROUP 1 (WRAMC)
20SEP04 ANTHRAX SERCONVERSION IN AD, BY SERIES SCHEDULE COMPLIANCE
(WRAIR DIV OF PM)
19DEC05 PEMPHIGUS/ANTHRAX VACCINE SERUM STUDY--GROUP 2 (SMALLPOX)
(WRAMC)
29DEC05 AIR FORCE--YELLOW FEVER VACCINE (YFV) ADVERSE EVENTS
(UPDATED ICD-9 CODES) (USUHS)
29DEC05 ARMY, NAVY, MARINE YELLOW FEVER VACCINE ADVERSE EVENTS
(UDPATED ICD-9 CODES) (USUHS)
4JAN06 MARINE CORPS OIF Q FEVER SEROCONVERSTION STUDY (FDPMU-WEST)
11JAN06 COUNTS OF INFECTIOUS DISEASES FOLLOWING DEPLOYMENT (CHPPM
PAO)
17JAN06 MUMPS CASES PRE-AND POST-DX SERUM (MILVAX)
8MAR06 AIR FORCE DD2796 COMPARISON TO HOGE JAMA PAPER (WRAIR)
Gulf War Illnesses
Testimony to the Senate Veterans Affairs Committee
September 25, 2007
Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
207 288-5081 ext. 220
http://anthraxvaccine.blogspot.com
http://www.anthraxvaccine.org
Thank you very much for your invitation to discuss Gulf War
Illnesses and ideas for improved research and treatment of affected
veterans. I practice general internal medicine, have a background in
bioterrorism, anthrax and vaccine injuries, and have conducted a clinic
for Gulf War (GW) veterans and others with multi-symptom syndromes
(fibromyalgia, chronic fatigue syndrome, multiple chemical sensitivity)
since 1999.
Because so much confusion and controversy has surrounded this
illness, I thought it would be helpful to discuss persisting issues
using a question and answer format, while reviewing recent literature
on Gulf War Illnesses. I hope to clarify what is already known, as well
as what needs to be known in order to provide the best treatment to
affected veterans. I will then discuss my treatment approaches. I use
the terms Gulf War Illnesses (GWI) and Gulf War Syndrome (GWS)
interchangeably.
1. What is Gulf War Syndrome?
As early as 1993, Senator Donald Riegle's staff produced a report
that said, ``Over 4,000 veterans of the Gulf War suffering from a
myriad of illnesses collectively labeled ``Gulf War Syndrome'' are
reporting symptoms of muscle and joint pain, memory loss, intestinal
and heart problems, fatigue, running noses, urinary urgency, diarrhea,
twitching, rashes and sores.'' \1\ In 1998 CDC developed a case
definition of the illness, which omits some common symptoms, but
confirms the illness Riegle's staff identified, and provides clinicians
with a reasonable basis for diagnosing veterans and starting treatment.
So there is a long, well-documented history of the reality of this
illness.
---------------------------------------------------------------------------
\1\ Staff report to Senator Donald Riegle. Gulf War Syndrome: The
case for multiple origin mixed chemical/biotoxin warfare related
disorders. September 9, 1993.
---------------------------------------------------------------------------
Yet many physicians are unaware of the CDC case definition, and
have been bamboozled by the media into thinking Gulf War Illnesses
either do not exist, are psychosomatic or a result of stress.
Surprisingly, this includes physicians at VA facilities who care for
affected patients. This widespread ignorance is compounded by the VA
treatment guidelines (posted on the VA website for clinicians), which
emphasize the use of psychotropic medications and cognitive behavioral
therapy, although the science to support this is exceedingly weak.\2\
---------------------------------------------------------------------------
\2\ Donta ST, Clauw DJ, Engel CC Jr et al. Cognitive behavioral
therapy and aerobic exercise for Gulf War veterans' illnesses: a
randomized controlled trial. JAMA. 2003 Mar 19;289(11):1396-404.
---------------------------------------------------------------------------
An estimated 200,000 1991 Gulf War veterans (25-30% of all deployed
veterans) and some vaccinated, nondeployed Gulf ``era'' veterans suffer
from illnesses related to their service,\3\ and have been awarded
partial or full disability benefits by the VA. Although the signs,
symptoms and severity of illness vary considerably between affected
veterans, the combination of symptoms known as ``Gulf War Syndrome''
probably affects most of the 200,000 veterans who are ill.
---------------------------------------------------------------------------
\3\ Steele L. Prevalence and patterns of Gulf War illness in Kansas
veterans: association of symptoms with characteristics of person,
place, and time of military service. Am J Epidemiol. 2000 Nov
15;152(10):992-1002.
---------------------------------------------------------------------------
Their symptoms are not confined to the CDC's defining triad of
musculoskeletal pain, fatigue and cognitive and/or emotional
disturbance.\4\ Their medical conditions have been variously described
in different studies. For example, one UK study found that Gulf War
veterans were 20 times as likely as other veterans to complain of mood
swings, 20 times as likely to complain of memory loss and/or lack of
concentration, and 5 times as likely to complain of sexual
dysfunction.\5\ It is my opinion that the increased mental disorders
reported in GW veterans \6\ reflect central nervous system (brain)
dysfunction, manifested in a variety of ways.
---------------------------------------------------------------------------
\4\ Fukuda, K. et al. Chronic Multi-symptom Illness Affecting Air
Force Veterans of the Gulf War. JAMA 1998; 280: 981-988. ``. . . a case
was defined as having 1 or more chronic symptoms (more than 6 months)
from 2 of the following categories: fatigue; mood and cognition; and
musculoskeletal.''
\5\ Simmons R, Maconochie N, Doyle P. Self-reported ill health in
male UK Gulf War veterans: a retrospective cohort study. BMC Public
Health. 2004 Jul 13;4:27.
\6\ Toomey r, Kang HK, Karlinsky J et al. Mental health of U.S.
Gulf War veterans 10 years after the war. Br J Psychiatry 2007; 190:
385-93.
---------------------------------------------------------------------------
Furthermore, some affected veterans have developed anxiety and/or
depression as a result of their loss of function, as well as
frustration resulting from the lack of validation of their illnesses by
DOD, VA and civilian health providers, and failure to receive
beneficial treatment. Many veterans have endured the suspicion of
military superiors and colleagues, friends and family that they are
malingering, a result of the mediocre level of much popular and
professional discourse about this illness.
2. Can we make medical sense of the multiple symptoms that occur in
Gulf War veterans?
According to Gronseth, ``Although an objective marker to GWS would
be useful for studies, the absence of such a marker does not make the
syndrome any less legitimate. . . . The real debate surrounding
medically unexplained conditions is not whether or not they exist, but
defining their cause.'' \7\
---------------------------------------------------------------------------
\7\ Gronseth GS. Gulf War syndrome: a toxic exposure? A systematic
review. Neurol Clin. 2005 May;23(2):523-40.
---------------------------------------------------------------------------
Many patients with GWS meet criteria for other medically
unexplained conditions, also known as multi-symptom syndromes, such as
chronic fatigue syndrome,\8\ fibromyalgia, and multiple chemical
sensitivity.\9\ These conditions are poorly understood, but have a very
similar pattern of symptoms and findings as GWS. Some underlying
mechanisms have been shown to be the same as well.\10\
---------------------------------------------------------------------------
\8\ Thomas HV, Stimpson NJ, Weightman AL et al. Systematic review
of multi-symptom conditions in Gulf War veterans. Psychol Med 2006; 36:
735-47.
\9\ Ibid.
\10\ Baraniuk JN, Casado B, Maibach HA. Chronic Fatigue Syndrome--
related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec
1;5:22.
---------------------------------------------------------------------------
An important VA study in which 1000 deployed 1991 Gulf War and 1000
nondeployed Gulf era veterans were carefully examined 10 years after
the Gulf War, found that deployed veterans were 2.3 times as likely to
have fibromyalgia, and 40.6 times as likely to have chronic fatigue
syndrome as nondeployed era veterans,\11\ confirming a relationship
between these conditions and GWS.
---------------------------------------------------------------------------
\11\ Eisen SA, Kang HK, Murphy FM et al. Gulf War veterans' health:
medical evaluation of a U.S. cohort. Ann Intern Med 2005; 142: 122.
---------------------------------------------------------------------------
3. Does the CDC case definition identify all deployment-related
illnesses in Gulf War veterans?
No. We know ALS (amyotrophic lateral sclerosis or Lou Gehrig's
disease) occurs twice as often in GW vets as in the civilian
population, but it also occurs 50% more often in soldiers in
general.\12\ The military exposures leading to these increased ALS
rates are unknown.
---------------------------------------------------------------------------
\12\ Weisskopf MG, O'Reilly EJ, McCullough ML et al. Prospective
study of military service and mortality from ALS. Neurology
2005;64(1):32-7.
---------------------------------------------------------------------------
Possible reasons ALS has been studied more carefully in GW veterans
than other illnesses, are that a) veterans develop the illness at a
younger age than the civilian population,\13\ b) Congressional
testimony by affected, now deceased Gulf War veteran Michael Donnelly
in 1997 gave the illness visibility,\14\ and c) ALS only affects a
small number of people.
---------------------------------------------------------------------------
\13\ Haley RW. Excess incidence of ALS in young Gulf War veterans.
Neurology. 2003 Sep 23;61(6):750-6.
\14\ http://members.aol.com/vetcenter1/donnelly.htm
---------------------------------------------------------------------------
Chronic diarrhea is another illness commonly seen in GW veterans,
but it is not included in the CDC's case definition. GW veterans have
developed a variety of other medical illnesses. What we still don't
know is whether there are, for instance, more heart attacks in deployed
GW veterans than there would have been, had they not deployed. The
research is contradictory on whether various illnesses occur more often
in Gulf War veterans, although several studies list a large number of
symptoms that are seen more commonly in GW veterans.
4. Why don't we know whether deployed veterans have more illnesses
(like heart attacks) than they would have otherwise?
The results of research depend on the methods used to investigate
the research question. Epidemiological research is limited to
evaluating a statistical relationship between an exposure and an
illness. But statistically significant relationships occur for many
reasons other than cause and effect. Thus, statistics alone cannot
prove cause and effect. Only when all other factors that can bias the
result have been taken into account, will the results be reliable. Here
is one example of why some Gulf War research results may be
contradictory:
As Steele \15\ showed, many nondeployed Gulf ``era'' veterans were
given vaccinations in preparation for deployment, and these vaccinated
``era'' veterans reported multi-symptom illness at 3 times the rate of
unvaccinated, nondeployed ``era'' veterans.
---------------------------------------------------------------------------
\15\ Steele L. Prevalence and patterns of Gulf War illness in
Kansas veterans: association of symptoms with characteristics of
person, place, and time of military service. Am J Epidemiol. 2000 Nov
15;152(10):992-1002.
---------------------------------------------------------------------------
According to the military's Defense Medical Surveillance System
(DMSS) raw data, soldiers vaccinated with anthrax vaccine have heart
attacks at a greater rate than prior to vaccination.\16\ Thus, if
deployed veterans are compared to a nondeployed group, of whom many
received deployment vaccines, determining whether deployed veterans
have more heart attacks than expected is confounded (made unreliable)
by the nondeployed group's vaccinations.
---------------------------------------------------------------------------
\16\ Data DOD shared with the Institute of Medicine in 2001: http:/
/merylnass.googlepages.com/AMSAtitlepage.pdf http://
merylnass.googlepages.com/AMSAHeartattackdata.pdf
---------------------------------------------------------------------------
Military and VA health databases have not been made available to
independent researchers to study.
5. Has the health of Gulf War veterans improved over time?
Veterans who developed this syndrome have, for the most part,
remained ill.\17\ Ten years later, one study found that 29% of deployed
veterans had chronic, multi-symptom illness.\18\
---------------------------------------------------------------------------
\17\ Ozakincy G, Hallman WK and Kipen HM. Persistence of symptoms
in veterans of the First Gulf War: 5-year followup. Environ Health
Perspectives 2006; 114: 1553-7.
\18\ Blanchard MS, Eisen SA, Alpern R et al. Chronic multisymptom
illness complex in Gulf War 1 veterans 10 years later. Am J Epidemiol
2006; 164: 708-9
---------------------------------------------------------------------------
6. Do GW veterans die at a higher rate?
Three studies have demonstrated that GW veterans had an
approximately 50% greater risk of accidental deaths, particularly from
motor vehicle accidents. Although this has been attributed to elevated
risk-taking behavior in deployed GW soldiers by some, others (including
myself) suspect it is at least partly related to the cognitive problems
faced by GW veterans, particularly their difficulties with attention
and concentration.
One study found that testicular cancer rates were increased in
Persian Gulf War veterans.\19\ This is usually a curable cancer that
occurs in young males, so would not be expected to increase overall
mortality rates significantly.
---------------------------------------------------------------------------
\19\ Levine PH, Young HA, Simmens SJ et al. Is testicular cancer
related to Gulf War deployment? Evidence from a pilot population-based
study of Gulf War veterans and cancer registries. Mil Med 2005: 170:
149-53.
---------------------------------------------------------------------------
Other statistical studies have shown no more deaths and no more
birth defects in offspring of GW soldiers than in comparable groups.
However, was the control group truly comparable? Deployed troops are
known to be much healthier than a group of age and sex-matched
civilians, and this is commonly termed the ``Healthy Warrior'' effect.
But they may also be healthier than the Gulf ``era'' troops who were
not deployed, although ``era'' troops usually form the comparison
group.
Steele showed that in Kansas veterans, the rate of multi-symptom
illness varied by deployment location.\20\ Since different units had
very varied exposures during their deployments, high rates of birth
defects and/or deaths in certain units are possible. Yet the types of
large epidemiological studies that have been performed have usually
obscured possible localized effects of service in the Gulf.
---------------------------------------------------------------------------
\20\ Steele L. Op. cit.
---------------------------------------------------------------------------
7. Self reports
The validity of studies of GW veterans' health and exposures has
been criticized on the basis that the exposure and illness data are
reported by veterans, and not obtained from more reliable sources, such
as military or VA databases. Some measures of current health could be
obtained from those databases, but the data would be incomplete.
Exposure data have not been a part of the available record for most
veterans. Exposure data that have been supplied by DOD have been
unreliable (in terms of the Khamisiyah plume modeling, according to GAO
\21\) or the data contradicted the self-reports (as in immunization
data supplied by DOD to VA, following presentation of a VA study that
linked anthrax vaccinations to subsequent ill health \22\), or the data
are missing or classified. The number, names and locations of all sites
at which chemical warfare agents were exploded remain unknown to the
public.
---------------------------------------------------------------------------
\21\ GAO-04-821T. June 1, 2004: ``The modeling assumptions . . .
were inaccurate because they were uncertain, incomplete and
nonvalidated.'' ``DOD and VA's conclusions about no association between
exposure to CW agents and rates of hospitalization and mortality . . .
cannot be adequately supported because of study weaknesses.''
\22\ Mahan CM, Kang HK, Dalager NA Anthrax vaccination and self-
reported symptoms, functional status, and medical conditions in the
National Health Survey of Gulf War Era Veterans and Their Families. Ann
Epidemiol. 2004 Feb;14(2):81-8.
---------------------------------------------------------------------------
Are self-reports valid? Two recent studies indicate that GW
veterans give reliable answers to questions.\23\ A study that compared
GW veterans with Gulf era veterans' performance on neuropsychological
examinations found that only 1% of GW veterans provided ``noncredible''
exams versus 4% of era veterans.\24\ Therefore, self-reports by GW
veterans can safely be judged credible.
---------------------------------------------------------------------------
\23\ Kelsall HL, Sim MR, Forbes AB et al. Symptoms and medical
conditions in Australian veterans of the 1991 Gulf War: relation to
immunisations and other Gulf War exposures. Occup Environ Med. 2005
Mar;62(3):142-3. ``More than 10 years after the 1991 Gulf War,
Australian veterans self-report all symptoms and some medical
conditions more commonly than the comparison group. Further analysis of
the severity of symptoms and likelihood of the diagnosis of medical
conditions suggested that these findings are not due to over-reporting
or to participation bias.''
\24\ Barrash J, Denburg NL, Moser DJ et al. Credibility of
neuropsychological performances of Persian Gulf War veterans and
military control subjects participating in clinical epidemiological
research. Mil Med 2007; 172: 697-707.
---------------------------------------------------------------------------
8. Why has the reality of Gulf War Syndrome been so contentious?
Perhaps remarks by Alabama Congressman Glen Browder in a 1993 House
Armed Services Oversight and Investigations Subcommittee meeting shed
some light on this:
``I have asked a lot of questions about why the Pentagon
continues to stonewall these Gulf War veterans, or why are they
so resistant to full and open examination of this problem. I
don't have any conclusive answers but I can speculate.
First, it may be pride. To acknowledge these mystery
casualties may blemish our Persian Gulf victory. Or, such an
acknowledgement may be a terrifying admission that the United
States did not and perhaps cannot protect our military men and
women against chemical and biological warfare.
But I personally suspect that dealing openly and fully with
these mystery ailments, and therefore the dirty little secret,
will require the Pentagon to make budgetary and programmatic
adjustments that it does not want to make.'' \25\
---------------------------------------------------------------------------
\25\ Use of chemical weapons in Desert Storm. Hearing before the
Oversight and Investigations Subcommittee of the Committee on Armed
Services, House of Representatives. 103d Congress, 1\st\ session.
November 18, 1993.
Military doctrine calls for continuing use of anthrax and smallpox
vaccines, multiple simultaneous vaccinations, pyridostigmine bromide
tablets for prophylaxis of nerve gas exposure and depleted uranium
munitions and armor. Thus military studies that concluded these
exposures were safe should come as no surprise. Yet evidence of their
adverse effects on health is abundant.
The American Type Culture Collection (ATCC) supplied various
microbial cultures to Iraq, in shipments approved by the Department of
Commerce, during a period in which the United States assisted Iraq in
its war with Iran. This may have influenced why infections due to
Brucella melitensis, one of the bacteria provided to Iraq, were not
investigated. Vollum \26\ strain anthrax (which had been weaponized by
the U.S. military before the Biological Weapons Convention came into
force in 1975) was provided to Iraq by ATCC. Knowing a U.S. corporation
provided Iraq virulent anthrax (not a strain used to make vaccines) may
have influenced the defense department's decision to vaccinate troops
against anthrax. Similarly, the ATCC provided Clostridium botulinum to
Iraq; some soldiers were later vaccinated for potential exposure to
botulinum toxins.
---------------------------------------------------------------------------
\26\ Identified by Geoffrey Holland, who investigated the
provenance of the ATCC anthrax strains supplied to Iraq.
www.abc.net.au/worldtoday/content/2005/s1434633.htm
---------------------------------------------------------------------------
Admitting that soldiers became ill as a consequence of what the
U.S. gave Iraq may be politically unacceptable, undermining the
likelihood that credible scientific studies of these exposures, funded
by the government, would be performed.
According to the House Committee on government Reform and Oversight
in 1997,
``VA medical policy may have been biased against findings of
chemical exposure by relying on DOD assertions and unproven theories of
toxic causation. VA continues today to maintain that chronic symptoms
in Gulf War veterans cannot be attributed to toxic exposures unless
acute symptoms first appear at the time of exposure.'' \27\
---------------------------------------------------------------------------
\27\ House Committee on government Reform and Oversight. Gulf War
Veterans' Illnesses: VA, DOD continue to resist strong evidence linking
toxic causes to chronic health effects. November 7, 1997. House Report
105-388. 105\th\ Congress, 1\st\ Session.
---------------------------------------------------------------------------
Yet the requirement for acute symptoms to occur in order to be
harmed by chemical weapons (organophosphates) is scientifically
insupportable.
Investigating certain GW exposures has been a career killer. While
some researchers were amply rewarded for finding stress/psychological
causes for Gulf War Illnesses, other researchers were punished for
exploring politically unacceptable causes:
Jim Moss, PhD on pyridostigmine potentiation research:
``Middle and upper level management at USDA promised me I would be
blackballed if I did not stop the research, or if I ever disclosed my
research to anybody (this was before I appeared before the Senate VA
committee). My biggest regret from my 1994 Senate VA Committee
testimony has been that I did not tell the Committee about the
threats.''\28,29\
---------------------------------------------------------------------------
\28\ Personal communication, September 17, 2007
\29\ Chaney LA, Rockhold RW, Mozingo JR, Hume AS, Moss
JI.Potentiation of pyridostigmine bromide toxicity in mice by selected
adrenergic agents and caffeine. Vet Hum Toxicol. 1997 Aug;39(4):214-9.
---------------------------------------------------------------------------
Charles Gutierrez, MS found microorganisms resembling
Brucella melitensis in stools of dozens of Gulf War veterans in
Tennessee, but had his studies halted: ``In the years following the
Persian Gulf War, extensive clinical studies on samples from Persian
Gulf War veterans were performed at the James Quillen VA in Mountain
Home, Tennessee. This work was not adequately pursued by the VA, and
was instead ordered stopped. The findings in these patients need to be
addressed, as they may fill in gaps in the existing body of GW illness
research.''\30\
---------------------------------------------------------------------------
\30\ Personal communication, September 17, 2007
---------------------------------------------------------------------------
Garth Nicolson, PhD on mycoplasma studies: ``I was told
by the President of my institution (the Univ. of Texas M.D. Anderson
Cancer Center) to stop my GWI research or face disciplinary action. I
refused to stop my research, and my professional career, academic
position (and any possible future academic position) were destroyed by
character assignation and outright lies about my research activities.
This occurred even though our work was published in peer-reviewed
academic journals. This was described in our book Project Day Lily
(www.projectdaylily.com).'' \31,32,33\
---------------------------------------------------------------------------
\31\ Personal communication, September 17, 2007
\32\ Nicolson GL, Nasralla MY, Haier J, Pomfret J. High frequency
of systemic mycoplasmal infections in Gulf War veterans and civilians
with Amyotrophic Lateral Sclerosis (ALS). J Clin Neurosci. 2002
Sep;9(5):525-9.
\33\ Nicolson GL and Nicolson NL. Diagnosis and treatment of
mycoplasmal infections in persian Gulf War llness illness-cfids
patients. Journal of Occupational Medicine, Immunology and Toxicology
5: 69-78, 1996.
---------------------------------------------------------------------------
9. How is it that Federal public health ``watchdog'' agencies and
oversight mechanisms failed to prevent the public health
disaster of GWS?
Federal agencies that could have weighed in on the safety of drugs
and vaccines given to soldiers in the Gulf have become politicized, and
their decisionmaking processes are opaque. The regulation of toxic
substances is fragmented, overseen by a variety of agencies. Recent FDA
decisions, and the agency's structure, suggest safety has a low
priority.
FDA permitted use of unlicensed drugs and vaccines, and
use of licensed products for unproven purposes, during the Gulf War and
later
FDA repeatedly approved anthrax vaccine use for
bioterrorism preparedness in the absence of required human data
demonstrating effectiveness, and despite ample evidence of safety
concerns
Astonishingly, FDA drug and vaccine safety experts have
no regulatory authority \34\
---------------------------------------------------------------------------
\34\ Smith SW. Sidelining safety-the FDA's inadequate response to
the IOM. NEJM September 6, 2007. 960-3.
---------------------------------------------------------------------------
FDA ``safety experts work largely in isolation, with
limited resources and outdated technology.'' \35\
---------------------------------------------------------------------------
\35\ Ibid.
---------------------------------------------------------------------------
``The FDA has bungled its effort to build a new system
for detecting the side effects of medicines after they go on the
market, delaying its implementation by at least 4 years, according to a
report commissioned by the agency itself . . . the FDA has wasted an
estimated $25 million on its efforts.'' \36\
---------------------------------------------------------------------------
\36\ Mathews AW. Report blasts FDA's system to track drugs.
Consultant says mission is hobbled by missteps; agency disputes claims.
Wall Street Journal. March 3, 2007. A1.
---------------------------------------------------------------------------
CDC continues to misinform recipients of anthrax vaccine
with an official Vaccine Information Statement affirming vaccine safety
that is in conflict with the vaccine's FDA-approved package insert,\37\
and what CDC officials told GAO about adverse events following
vaccination. The GAO, citing CDC and Vaccine Healthcare Center
officials as sources, reported that 1-2% of anthrax-vaccinated
individuals ``may experience severe adverse events, which could result
in disability or death,'' in June 2007.\38\
---------------------------------------------------------------------------
\37\ http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0040-bkg0001.pdf
\38\ GAO-07-787R. Military Health: DOD's Vaccine Healthcare Centers
Network. June 29, 2007. Web address: http://www.gao.gov/cgi-bin/
getrpt?GAO-07-787R
---------------------------------------------------------------------------
CDC conducted a trial of anthrax vaccine in 1564 people
beginning in 2002 and provided an interim report on the study to FDA.
Yet CDC has released no information to the public about the trial
findings, despite filing over 100 adverse event reports on trial
subjects to the Vaccine Adverse Event Reporting System.
These federal agencies know that injured military
servicemembers are prevented by the Feres Doctrine \39\ from seeking a
remedy for their injuries through the legal system.
---------------------------------------------------------------------------
\39\ http://usmilitary.about.com/library/milinfo/blferes.htm
---------------------------------------------------------------------------
There are no viable legal remedies to hold military or
government personnel accountable for deliberate cover-ups resulting in
denial of healthcare and disability benefits mandated by Federal law.
10. What Gulf War exposures did soldiers face, and what do we know
about the injuries they may cause?
a. Depleted uranium (DU)
DU is comprised of uranium that has had 40% of its radioactive
isotope, uranium-235, extracted. However, the DU used by the United
States military also contains ``recycled'' nuclear reactor waste,
including small amounts of highly radioactive plutonium-239, neptunium-
237, technicium-99, americium etc.\40,41\
---------------------------------------------------------------------------
\40\ http://www.nato.int/du/docu/d010118b.htm
\41\ Alvarez R. The legacy of depleted uranium in the United
States. Institute for Policy Studies monograph. June 2003.
---------------------------------------------------------------------------
Both munitions and armor may be made from DU. When a DU munition
strikes an object, or when DU armor is struck, it ignites and up to 50%
of its mass can aerosolize into minute particles that may be inhaled
and will contaminate the area for the foreseeable future. Inhaled DU
may have prolonged retention in the lungs, accumulates in specific
brain regions (in rat experiments) \42\ and settles in bone. Inhaled DU
led to behavioral effects in animals.\43\ It is excreted by the
kidneys. Its toxicity is both chemical and radiological.
---------------------------------------------------------------------------
\42\ Fitsanakis VA, Erickson KM, Garcia SJ et al. Brain
accumulation of depleted uranium in rats following 3- or 6-month
treatment with implanted depleted uranium pellets. Biol Trace Elem Res
2006; 111: 185-97.
\43\ Monleau M, Bussy C, Lestaevel P et al. Bioaccumulation and
behavioural effects of depleted uranium in rats exposed to repeated
inhalations. Neurosci Lett. 2005 Dec 16;390(1):31-6.
---------------------------------------------------------------------------
The only veterans who have been studied longitudinally for DU
exposure comprise a small group with embedded DU shrapnel. They have
shown limited findings of genotoxicity and are otherwise well,\44\ but
have a ``relatively low uranium burden compared to historical uranium-
exposed controls.'' \45\ However, other veterans with inhalation
exposures are probably at greater risk of DU toxicity. One study found
that reported exposure to DU doubled the risk of dying from
disease.\46\ (Reported pesticide exposure in this study doubled the
likelihood of accidental death.)
---------------------------------------------------------------------------
\44\ McDiarmid MA, Engelhardt SM, Oliver M et al. Health
surveillance of Gulf War 1 veterans exposed to depleted uranium:
updating the cohort. Health Phys 2007; 93: 60-73.
\45\ McDiarmid MA, Engelhardt SM, Oliver M et al. Biological
monitoring and surveillance results of Gulf War 1 veterans exposed to
depleted uranium. Int Arch Occup Envir Health 2006; 79:11-21.
\46\ MacFarlane GJ, Hotopf M, Maconochie N et al. Long-term
mortality amongst Gulf War veterans: is there a relationship with
experiences during deployment and subsequent morbidity? Int J Epidemiol
2005; 34: 1403-8.
---------------------------------------------------------------------------
Consider that the recycled nuclear materials added to DU may not be
evenly dispersed. If so, there are likely some veterans with greater
exposure to highly radioactive materials, who are at increased risk of
cancers, immune and reproductive effects. Recent evidence also points
to uranium as an endocrine disruptor.\47\
---------------------------------------------------------------------------
\47\ Raymond-Whish S, Mayer LP, O'Neal T et al. Drinking water with
uranium below U.S. EPA water standard causes estrogen receptor-
dependent responses in female mice. Envir Health Perspectives 2007;
online September 14, 2007.
---------------------------------------------------------------------------
If we review the health of workers in uranium processing plants, we
can obtain clues about what to expect in DU-exposed veterans. Uranium
workers have had elevated rates of cancers, especially kidney and
respiratory tract cancers. They also had elevated levels of chronic
kidney disease.
The Energy Employee Occupational Illness Compensation Program Act
of 2000 (P.L. 106-398) established a ``special cohort'' of workers
employed at three Department of Energy uranium gaseous diffusion plants
and Alaska's nuclear test site: because of the absence of exposure
records, and the presence of ultra hazardous workplace exposures, the
burden of proof has been shifted to the government for ill workers at
these facilities.\48\ The combination of an ultra hazardous workplace
and absent exposure records \49\ mirrors the plight of Gulf War
veterans, and suggests to us that burden of proof requirements could be
changed for veterans who suffer from illnesses characteristic of their
toxic exposures.
---------------------------------------------------------------------------
\48\ Alvarez R. Op. cit.
\49\ Committee on government Reform and Oversight. Gulf War
Veterans' Illnesses: VA, DOD continue to resist strong evidence linking
toxic causes to chronic health effects. Second Report. November 7,
1997. 105\th\ Congress, 1st session. Page 61.
---------------------------------------------------------------------------
``Personal medical records of veterans, including sick call
records, are inadequate or missing. Documents which could help verify
possible exposures and military unit locations remain in DOD files.
Most of the military NBC logs, which are records of toxic warfare agent
detections, are missing or destroyed. . . .''
b. Sarin
Sarin is an organophosphate ``nerve'' agent or anticholinesterase,
which leads to excessive accumulation of the neurotransmitter
acetylcholine at nerve synapses. It is in the same family as pesticides
such as parathion and malathion. A recent study found a significant
association between levels of estimated sarin/cyclosarin exposure and
reduced white matter in the brain.\50\ The same researchers also found
that ``Sarin and cyclosarin exposure was associated with less
proficient neurobehavioral functioning on tasks involving fine
psychomotor dexterity and visuospatial abilities 4-5 years after
exposure.'' \51\
---------------------------------------------------------------------------
\50\ Heaton KJ, Palumbo CL, Proctor SP et al. Quantitative magnetic
resonance brain imaging in U.S. veterans of the 1991 Gulf War
potentially exposed to sarin and cyclosarin. Neurotoxicology 2007
28:761-9.
\51\ Proctor SP, Heaton KJ, Heeren T et al. Effects of sarin and
cyclosarin exposure during the 1991 Gulf Waar on neurobehavioral
functioning in U.S. Army veterans. Neurotoxicology 2006; 27: 931-9.
---------------------------------------------------------------------------
According to the Congressional Office of Technology Assessment
(OTA) in 1990:
``Of particular concern are the delayed neurotoxic effects of
some of the organophosphorous (organophosphate) insecticides.
Some of these compounds cause degeneration of nerve processes
in the limbs, leading to changes in sensation, muscular
weakness and lack of coordination. Because of this property,
the EPA requires that organophoshorous insecticides undergo
special testing for delayed neurotoxicity.'' \52\
---------------------------------------------------------------------------
\52\ Congressional Office of Technology Assessment. Neurotoxicity:
Identifying and controlling poisons of the nervous system. April 1990.
OTA-BA-436. Page 50.
Thus despite claims by DOD that lack of acute sarin toxicity
precluded later disease, it was common knowledge at the time of the
1991 Gulf War that delayed adverse effects do occur from exposure to
this class of compounds.
Furthermore, a VA study of mortality in 100,000 veterans said to be
exposed to sarin at Khamisiyah found a statistically significant
doubling of deaths from brain cancer in the exposed group, compared to
unexposed Gulf War veterans, as well as a limited dose-response
relationship.\53\
---------------------------------------------------------------------------
\53\ Bullman TA, Mahan CM, Kang HK et al. Mortality in U.S. Army
Gulf War veterans exposed to 1991 Khamisiyah chemical munitions
destruction. Am J Public Health 2005; 95:1382-8.
---------------------------------------------------------------------------
According to a popular toxicology textbook, anticholinesterases may
cause ``drowsiness, lethargy, fatigue, mental confusion, inability to
concentrate, headache, pressure in head, generalized weakness.'' \54\
---------------------------------------------------------------------------
\54\ Klaassen CD. Cassarett and Doull's Toxicology. 5\th\ edition,
1996. McGraw Hill, N.Y. p.657.
---------------------------------------------------------------------------
c. Other pesticides
Carbamate pesticides were used in the Gulf and also cause
acetylcholine accumulation. They would augment the adverse effects of
sarin and organophosphate insecticides. Organochlorine and pyrethrin
insecticides have different mechanisms of action, but are also toxic to
the peripheral and central nervous system, so their adverse effects
might compound those of the anticholinesterases. Some pesticides have
adverse immunotoxic effects as well.\55\ A recent review by NIH's
National Institute of Environmental Health Sciences researchers
discussed the state of knowledge of pesticide toxicity, and suggested
that general malaise associated with mild cognitive dysfunction may be
a sensitive marker for pesticide neurotoxicity.\56\
---------------------------------------------------------------------------
\55\ Congressional Office of Technology Assessment. Identifying and
controlling immunotoxic substances. Neurotoxicity: Identifying and
controlling poisons of the nervous system. April 1990. OTA-BA-436.
government Printing Office. 1991.
\56\ Kamel F and Hoppin JA. Association of pesticide exposure with
neurologic function and disease. Environ Health Perspect. 2004
Jun;112(9):950-8.
---------------------------------------------------------------------------
d. Organic Solvents
These include jet and vehicle fuels, some cleaning agents and other
industrial chemicals. According to the Office of Technology Assessment:
``Acute exposure to organic solvents can affect an individual's
manual dexterity, response speed, coordination and balance. Chronic
exposure of workers may lead to reduced function of the peripheral
nerves and such adverse neurobehavioral effects as fatigue,
irritability, loss of memory, sustained changes in personality or mood,
and decreased ability to learn and concentrate.'' \57\
---------------------------------------------------------------------------
\57\ Congressional Office of Technology Assessment. 1990. Op. cit.
page 30
---------------------------------------------------------------------------
Therefore, sarin nerve gas, organophosphate and other pesticides,
and solvents have the potential to induce the neurological and
neurobehavioral effects seen in Gulf War veterans. This was known prior
to the first Gulf War.
e. Endemic diseases and/or biological weapons exposures
It remains unknown whether troops faced any biological attacks.
Exposure to novel microorganisms has never been ruled out. The role of
infections endemic to the middle east in Gulf War Illnesses is also
unknown. The following three microorganisms probably infected some Gulf
War veterans, but other microorganisms may also contribute to GWI.
Leishmaniasis, due to a parasite spread by the sandfly,
is endemic in Iraq, but the visceral form of the disease is difficult
to diagnose. Until better diagnostics are available, it is certain that
cases will be missed. It can take months or even years to develop
symptoms, and leishmaniasis may develop into a chronic, debilitating
illness.
Brucella melitensis is both endemic to Iraq and a
potential biological warfare agent. It can cause a slowly developing,
fatiguing illness with a variety of possible signs and symptoms,
especially joint pain and fever. It is difficult to diagnose because
standard tests usually miss it, so unless it is considered in the
differential diagnosis and special tests ordered, it will be
overlooked.
Mycoplasmas have been linked to chronic multisymptom
illnesses.\58\ They are widely distributed, and the known spectrum of
clinical illness they cause continues to expand.\59\ A significant
percentage of GW veterans have antibodies to mycoplasma.
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\58\ Nasralla M, Haier J, Nicolson GL. Multiple mycoplasmal
infections detected in blood of patients with chronic fatigue syndrome
and/or fibromyalgia syndrome. Eur J Clin Microbiol Infect Dis. 1999;
18(12):859-65.
\59\ Baseman JB, Tully JG. Mycoplasmas: sophisticated, reemerging,
and burdened by their notoriety. Emerg Infect Dis. 1997 Jan-Mar;
3(1):21-32.
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f. Contaminated water
Possible contaminants include endemic or deliberately added
microorganisms and petroleum products. Soldiers reported that some
storage tanks supplying drinking water were also used for vehicle
fuels, and the water contained fuel residues.
g. Smoke from oil well fires
Little reliable data on the contents and concentrations of
materials comprising the oil well fire smoke is available.\60\ Toxic
inhalants could have been burned deliberately by retreating Iraqi
troops.
---------------------------------------------------------------------------
\60\ Committee on government Reform and Oversight. Gulf War
Veterans' Illnesses: VA, DOD continue to resist strong evidence linking
toxic causes to chronic health effects. Second Report. November 7,
1997. 105\th\ Congress, Ist session. Page 67.
---------------------------------------------------------------------------
h. Pyridostigmine bromide (unlicensed use) a.k.a. PB, NAPPS
Also increases acetylcholine at nerve synapses; will augment the
adverse effects of sarin, organophosphate and carbamate insecticides.
Multiple studies have linked PB use to later illness in GW troops.\61\
---------------------------------------------------------------------------
\61\ Schumm, W. R., Reppert, E. J., Jurich AP et al. Pyridostigmine
bromide and the long-term subjective health status of a sample of over
700 male Reserve Component Gulf War era veterans. Psychological Reports
2002; 90: 707-721.
---------------------------------------------------------------------------
i. Other unlicensed drugs approved for use in the Gulf theater \62\
---------------------------------------------------------------------------
\62\ Rettig R. Military use of drugs not yet approved by the FDA
for CW/BW defense. RAND Monograph on Lessons from the Gulf War. 1999.
---------------------------------------------------------------------------
Centoxin (J5 monoclonal antibody), purchased by the
military, prior to licensure of the drug, to treat sepsis in Gulf War
veterans. Found later to increase mortality rates in treated
patients.\63,64\ Never licensed.
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\63\ Shulman R. Current drug treatment of sepsis. Hospital
Pharmacist 2002; 9: 97-101.
\64\ Quezado ZM, Natanson C, Alling DW et al. A controlled trial of
HA-1A in a canine model of gram-negative septic shock. JAMA 1993; 269:
2221-7.
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Ribavirin, purchased by the military for use in
unspecified viral illnesses. Yet when used later as an experimental
treatment for SARS, Ribavirin produced anemia, bradycardia and
hypomagnesemia, increasing mortality.\65\ Other researchers later
noted, ``Ribavirin should not be used empirically for the treatment of
viral syndromes of unknown etiology.''\66\ Ribavirin also causes
immunotoxicity.\67\ Its adverse reactions include fatigue and
depression, which may persist after the drug is stopped.
---------------------------------------------------------------------------
\65\ Chiou HE, Liu CL, Buttrey MJ et al. Adverse effects of
ribavirin and outcome in severe acute respiratory syndrome in two
medical centers. Chest 2005; 128:263-72.
\66\ Muller MP, Dresser L, Raboud J et al. Adverse events
associated with high-dose ribavirin: evidence from the Toronto outbreak
of severe acute respiratory syndrome. Pharmacotherapy 2007; 27: 494-
503.
\67\ Office of Technology Assessment. Identifying and controlling
immunotoxic substances. April 1991. OTA-BP-BA-75.
---------------------------------------------------------------------------
j. Electromagnetic fields
Electromagnetic weapons, including high power microwaves,\68\ were
used to disrupt and destroy Iraqi electronic systems. Generation of
electromagnetic fields may have been used for other effects, and for
communication. Whether electromagnetic fields contributed to illness is
unknown, as are the types and magnitudes of the exposures. However, the
European Union's European Environment Agency has just called for
immediate action to reduce exposure to microwaves, following an
international scientific review, which concluded that safety limits set
for the radiation are ``thousands of times too lenient.'' \69\
---------------------------------------------------------------------------
\68\ http://www.globalsecurity.org/military/systems/munitions/
hpm.htm
\69\ Lean G. EU calls for urgent action on wi-fi radiation. New
Zealand Herald. September 16, 2007. http://www.nzherald.co.nz/section/
2/story.cfm?c_id=2&objectid=10463870
---------------------------------------------------------------------------
k. Vaccines
Botulinum toxoid vaccine, manufactured by Michigan
Department of Public Health, meant to immunize against botulinum
toxins. The toxins block neurotransmission, as does the toxoid. Never
licensed. Very little known about safety or efficacy.
Anthrax vaccine, licensed with inadequate data.
Concentration increased 100 times due to manufacturing changes at the
time of the Gulf War. Identified as a risk factor for Gulf War
illnesses by multiple studies.\70,71,72,73,74\ The vaccine's package
insert lists the CDC definition of Gulf War Syndrome as a reported
adverse event following anthrax vaccine. Many of the over 5,000 reports
to the Vaccine Adverse Event Reporting System of FDA-CDC for anthrax
vaccine indicate chronic illnesses whose symptoms resemble GWS. I have
treated many soldiers who became ill following anthrax vaccine given
since the 1991 Gulf War, and the majority experience cognitive
impairment, generalized pain and fatigue, among other symptoms, meeting
the CDC's case definition for GWS. See my testimony to the House
Veterans Affairs Health Subcommittee for additional information.\75\
---------------------------------------------------------------------------
\70\ Unwin C, Blatchley N, Coker W, Ferry S, Hotopf M, Hull L, et
al. Health of UK servicemen who served in Persian Gulf War. Lancet.
1999 Jan 16; 353(9148):169-78.
\71\ Goss-Gilroy. Study of Canadian Gulf War Veterans: NR-98.050.
Study contracted by the Canadian Department of National Defense,
released June 29, 1998 and published on its website, accessed between
1999 and 2001 but no longer at the previous URL: http://www.dnd.ca/
menu/press/Reports/Health/health_study_eng_1.htm.
\72\ Schumm WR, Reppert EJ, Jurich AP et al. Self-reported changes
in subjective health and anthrax vaccination as reported by over 900
Persian Gulf War era veterans. Psychol Rep. 2002 Apr;90(2):639-53.
\73\ Boyd KC, Hallman WK, Wartenberg D, Fiedler N, Brewer NT, Kipen
HM. Reported exposures, stressors, and life events among Gulf War
Registry veterans. J Occup Environ Med. 2003 Dec;45(12):1247-56.
\74\ Wolfe J, Proctor SP, Erickson DJ, Hu H. Risk factors for
multisymptom illness in U.S. Army veterans of the Gulf War. J Occup
Environ Med. 2002 Mar;44(3):271-81.
\75\ http://merylnass.googlepages.com/writtentestimony7-26-07.doc
---------------------------------------------------------------------------
Multiple vaccines given together within a short time
period. Are multiple simultaneous vaccinations dangerous? Although the
question has been discussed by the Institute of Medicine, the Armed
Forces Epidemiology Board and the British Ministry of Defense, they
provide no conclusive answer. Studies of multiple vaccinations
associated with Gulf War Illnesses have shown a positive, dose-response
relationship, suggesting they did contribute to GWI.\76,77\ Soldiers
engaged in Operation Iraqi Freedom have also reported Gulf War Illness-
like disease following multiple vaccinations, with both acute and
chronic effects.\78\ British military policy now separates anthrax and
smallpox vaccinations from other vaccinations by at least 5 days.\79\
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\76\ Kelsall HL, Sim MR, Forbes AB et al. Symptoms and medical
conditions in Australian veterans of the 1991 Gulf War: relation to
immunisations and other Gulf War exposures. Occup Environ Med. 2004
Dec;61(12):1006-13.
\77\ Cherry N, Creed F, Silman A ET AL. Health and exposures of
United Kingdom Gulf War veterans. Part II: The relation of health to
exposure. Occup Environ Med. 2001 May;58(5):299-306.
\78\ http://www.bmj.com/cgi/content/full/326/7401/1234-a
Dyer O. Ministry of Defence accused of contravening inoculation
guidelines. BMJ 2003;326:1234.
\79\ Ibid
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11. What can we conclude about the exposures?
a. Several of the exposures can individually produce the symptoms
GW veterans are experiencing. Injuries from these substances can affect
cognition, emotion, motor and sensory function. These include sarin,
pesticides, solvents, anthrax vaccine and some chronic infections, at a
minimum.
b. Combined exposures to certain toxic substances (and
simultaneous exercise) greatly magnify the potential for adverse
reactions:
Somani et al. Exercise plus Pyridostigmine Bromide
amplified oxidative injury in skeletal muscle of mice.\80\
---------------------------------------------------------------------------
\80\ Jagannathan R, Husain K and Somani SM. Interaction of
pyridostigmine and physical stress on antioxidant defense system in
skeletal muscle of mice. J App; Toxicol 2001; 21: 341-8.
---------------------------------------------------------------------------
Abou-Donia et al. ``These results suggest that exposure
to real-life doses of malathion, DEET and permethrin, alone or in
combination, produce no overt signs of toxicity but induce significant
neurobehavioral deficits and neuronal degeneration in brain.'' \81\
---------------------------------------------------------------------------
\81\ Del-Rahman A, Dechkovskaia AM, Goldstein LB et al.
Neurological deficits induced by malathion, DEET and permethrin, alone
or in combination in adult rats. J Toxicology and Environmental Health
2004; 67: 331-356.
---------------------------------------------------------------------------
McCain et al. ``A significant increase in lethality
occurred when PB, permethrin and DEET were given concurrently, when
compared to expected additive values.'' \82\
---------------------------------------------------------------------------
\82\ McCain WC, Mark RL, Johnson JS et al. Acute oral toxicity
study of pyridostigmine bromide, permethrin, and DEET in the laboratory
rat. J Toxicology and Environmental Health 1997; 50: 113-124.
---------------------------------------------------------------------------
Haley RW et al. ``Some Gulf War veterans may have
delayed, chronic neurotoxic syndromes from wartime exposure to
combinations of chemicals that inhibit butyrylcholinesterase and
neuropathy target esterase.'' \83\
---------------------------------------------------------------------------
\83\ Self-reported exposure to neurotoxic chemical combinations in
the Gulf War. A cross-sectional epidemiologic study.
---------------------------------------------------------------------------
Haley RW, Kurt TL. JAMA. 1997 Jan 15;277(3):231-7.
c. Multiple simultaneous vaccinations increased the risk of GWS.
d. For some other exposures, there is very little available
information on toxicity.
e. Depleted uranium likely contributed to chronic illnesses (and
deaths in soldiers tasked to clean up DU.) \84\
---------------------------------------------------------------------------
\84\ Doug Rokke, PhD. Personal communication September 18, 2007.
---------------------------------------------------------------------------
f. Illnesses resulting from infections, electromagnetic fields,
smoke, drugs and possibly other exposures have not been ruled out in GW
veterans.
12. What is known about underlying pathology in GWS?
a. Autonomic nervous system function has been shown to be altered
in Gulf War veterans in multiple studies, as has hypothalamic pituitary
adrenal function.\85\
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\85\ Clauw D, Groner G, Whalen K. Hypothalamic pituitary adrenal
function in veterans with unexplained illness, compared to fibromyalgia
subjects and controls. Presented at the Conference on Illnesses among
Gulf War veterans: A decade of scientific research. January 24-26,
2001. Alexandria, VA.
---------------------------------------------------------------------------
b. Altered immune function reflects another aspect of this
disorder for many veterans.\86\
---------------------------------------------------------------------------
\86\ Zhang Q, Zhou XD, Denny T et al. Changes in immune parameters
seen in Gulf War veterans but not in civilians with chronic fatigue
syndrome. Clin Diagn Lab Immunol. 1999 Jan;6(1):6-13.
---------------------------------------------------------------------------
c. One's genes affect the speed of processing of toxic substances
and later manifestation of toxic effects.\87\
---------------------------------------------------------------------------
\87\ Haley RW, Billecke S, La Du BN. Association of low PON1 type Q
(type A) arylesterase activity with neurologic symptom complexes in
Gulf War veterans. Toxicol Appl Pharmacol. 1999 Jun 15;157(3):227-33.
---------------------------------------------------------------------------
d. Gulf War soldiers encountered an unprecedented mix of noxious
substances, which are known to cause neurological, immunologic and
other adverse effects. Gulf War Illness research even suggests a dose-
response relationship between some exposures and symptoms.\88\
---------------------------------------------------------------------------
\88\ Kelsall HL, Sim MR, Forbes AB et al. Symptoms and medical
conditions in Australian veterans of the 1991 Gulf War: relation to
immunisations and other Gulf War exposures. Occup Environ Med. 2005
Mar;62(3):142-3. ``Increased symptom reporting was associated with
several exposures, including having more than 10 immunisations,
pyridostigmine bromide tablets, anti-biological warfare tablets,
pesticides, insect repellents, reportedly being in a chemical weapons
area, and stressful military service experiences in a strong dose-
response relation.''
---------------------------------------------------------------------------
* A very reasonable hypothesis is that those who became ill reached
a tipping point, where their body's ability to safely process the toxic
materials they took in was exceeded. Chronic illness may have resulted
from tissue damage (such as permanent loss of neurons) and/or
persisting metabolic abnormalities, which have yet to be defined, but
are suspected to include impaired oxidative phosphorylation \89,90\
and/or other fundamental changes in body chemistry that can affect
multiple organ systems.
---------------------------------------------------------------------------
\89\ Rose MR, Sharief MK, Priddin J et al. Evaluation of
neuromuscular symptoms in UK Gulf War veterans: a controlled study.
Neurology. 2004 Nov 9;63(9):1681-7.
\90\ Wong R, Lopaschuk G, Zhu G et al. Skeletal muscle metabolism
in the chronic fatigue syndrome. In vivo assessment by 31P nuclear
magnetic resonance spectroscopy. Chest. 1992 Dec;102(6):1716-22.
---------------------------------------------------------------------------
13. Why have we no effective treatment strategies 16 years after the
end of the war?
VA Treatment Trials \91,92\
---------------------------------------------------------------------------
\91\ Donta ST, Clauw DJ, Engel CC Jr et al. Cognitive behavioral
therapy and aerobic exercise for Gulf War veterans' illnesses: a
randomized controlled trial. JAMA. 2003 Mar 19;289(11):1396-404.
\92\ Donta ST, Engel CC Jr, Collins JF et al. Benefits and harms of
doxycycline treatment for Gulf War veterans' illnesses: a randomized,
double-blind, placebo-controlled trial. Ann Intern Med. 2004 Jul
20;141(2):85-94.
---------------------------------------------------------------------------
The original two VA treatment trials were exorbitantly
expensive, particularly given the number of subjects and cost of the
interventions. Failure to conduct additional treatment studies was
rationalized by these trials' high cost.
The mycoplasma/doxycycline trial was a ``failed study''
in that positive results seen at 3 and 6 months did not carryover to 9-
and 12-month followup, possibly due to a high dropout rate.\93\ Yet it
was not repeated with a larger number of veterans to reach a definitive
conclusion regarding the benefit of antibiotic treatment.
---------------------------------------------------------------------------
\93\ Personal communication with Sam Donta, MD, the Principal
Investigator.
---------------------------------------------------------------------------
The cognitive behavioral therapy/exercise trial showed
extremely modest gains and a high dropout rate; these treatments are
known to be of little value in patients with chronic fatigue syndrome,
and exercise can make them worse; yet cognitive behavioral therapy and
exercise are primary treatments recommended for GW veterans, who have a
high rate of chronic fatigue syndrome.
* We do not need to continue to examine whether the noxious
exposures already studied can cause GWI. They can, and they did. And we
should have expected it. Some people were genetically more susceptible;
some people received more or larger exposures. The result is that many
veterans became chronically ill.
The manner in which DOD and VA pursued GW research was flawed for a
variety of reasons.
A significant amount of research focused on stress or
psychiatric causes of illness.
Certain exposures were studiously avoided as objects of
study.
Methodologies chosen were sometimes inadequate to answer
the questions posed.
Exposure data provided by DOD to researchers was not
necessarily accurate.
Funded studies were not selected on the basis of whether
they would lead to a treatment, or to a policy change to protect future
soldiers. Instead, some might suspect the research was designed to
avoid uncovering negative information regarding use of DU,
pyridostigmine bromide and anthrax vaccine.
This review of some GWI research shows that completed research
projects have:
confirmed the symptoms of the illnesses
identified specific neurological deficits in affected
veterans and some of their anatomic/physiologic correlates,
provided partial information on rates of different GW-
associated illnesses, and
furthered our knowledge of the adverse effects caused by
some noxious GW exposures, alone and in combination.
14. Where should the research go from here? How can we meld our
research goals with the need to develop effective treatment
strategies?
Infections (where a treatment payoff could be very large)
Perform conclusive research to determine if GW veterans
have untreated chronic infections. Utilize all modalities including
microscopy, specialized cultures, serology, PCR, etc. Develop new
diagnostics when needed, such as for visceral leishmaniasis.
Also seek novel infections (biological agents), using
above techniques, genetic techniques, monoclonal antibodies, etc.
Perform empiric antibiotic trials in veterans who test
positive, including a repeat trial of antibiotics for veterans with
positive mycoplasma forensic PCR (the test used to screen veterans for
the earlier trial).
Value for money
A large number of small, inexpensive pilot studies should
be funded instead of a few large, mainly epidemiologic studies; later
give larger grants to those projects that show the most promise in
terms of treatment strategies.
Make the grant application process inclusive. Encourage
clinicians who have been caring for GW veterans to participate. Reduce
the complexity, time and cost needed to complete grant applications.
Don't restrict VA research grants to VA employees, as has been the
case: open the process to the best scientists and proposals.
Note the low cost, excellent methodology, analysis and
results of Lea Steele's Kansas veterans study,\94\ compared to numerous
Federally funded studies that cost at least ten times more and yielded
much less information. Use her strategies as a model for other studies:
passion for the subject, careful use of funds, thoughtful design and
analysis.
---------------------------------------------------------------------------
\94\ Steele L. Prevalence and patterns of Gulf War illness in
Kansas veterans: association of symptoms with characteristics of
person, place, and time of military service. Am J Epidemiol. 2000 Nov
15;152(10):992-1002.
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The selection process for grants must be transparent,
which has not previously been the case.
Promising areas-basic research
The underlying causes of all the multi-symptom syndromes remain
unknown. It is very probable that the molecular and cellular origin of
these syndromes will be the same, although they are likely triggered by
a variety of noxious exposures combined with genetic susceptibility.
Because together these syndromes affect an estimated 6 million
Americans, research identifying their underlying causes will pay
enormous dividends, and should point the way to more effective
treatment and prevention strategies.
Gene expression studies have the potential to identify
fundamental physiological processes that have been altered.\95,96,97\
Genetic and proteomic studies of both predisposing gene patterns and
protein differences between affected and unaffected veterans have
already shown promise in pilot studies,\98,99\ and should be continued.
---------------------------------------------------------------------------
\95\ Cameron B, Galbraith S, Zhang Y, Davenport T, Vollmer-Conna U,
Wakefield D, Hickie I, Dunsmuir W, Whistler T, Vernon S, Reeves WC,
Lloyd AR; Dubbo Infection Outcomes Study. Gene expression correlates of
postinfective fatigue syndrome after infectious mononucleosis. J Infect
Dis. 2007 Jul 1;196(1):56-66.
\96\ Fang H, Xie Q, Boneva R, Fostel J, Perkins R, Tong W. Gene
expression profile exploration of a large dataset on chronic fatigue
syndrome. Pharmacogenomics 2006 Apr;7(3):429-40.
\97\ Whistler T, Jones JF, Unger ER et al. Exercise responsive
genes measured in peripheral blood of women with chronic fatigue
syndrome and matched control subjects. BMC Physiol. 2005 Mar 24;5(1):5.
\98\ Baraniuk JN, Casado B, Maibach H et al. A chronic fatigue
syndrome-related proteome in human cerebrospinal fluid. BMC Neurol
2005; December 1: 5:22.
\99\ Vladutiu GD and Natelson BH. Association of medically
unexplained fatigue with ACE insertion/deletion polymorphisms in Gulf
War veterans. Muscle Nerve 2004; 30: 38-43.
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Abnormal ion channel function may provide a conceptual
and physiologic bridge between fatigue, neuropathies and motor neuron
disorders like ALS, providing clues to why different disorders develop
after similar exposures.\100,101\ It may also help explain episodic
alterations in mental status, arrhythmias and epileptic seizures in
veterans. Maintaining ion gradients across membranes requires a lot of
cellular energy. This can potentially be improved with supplements that
improve intracellular adenosine triphosphate (ATP) production and oral
electrolytes.
---------------------------------------------------------------------------
\100\ Kuwabara S, Misawa S. Axonal ionic pathophysiology in human
peripheral neuropathy and motor neuron disease. Curr Neurovasc Res.
2004 Oct;1(4):373-9.
\101\ Chaudhuri A, Watson WS, Pearn J, Behan PO. The symptoms of
chronic fatigue syndrome are related to abnormal ion channel function.
Med Hypotheses. 2000 Jan;54(1):59-63.
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Specific studies that could reap valuable rewards
Detailed study of individual families, in which family
members have developed illnesses similar to the ill veteran. An
exhaustive search for microorganisms should be undertaken. Search for
DU that may have been present on items that returned home with the
veteran. Seek other toxics in the home as appropriate to illnesses.
Investigate gene expression in these families.
Study illnesses and mortality in selected units that have
reported high death rates; try to recapture their locations, job
descriptions and exposures when deployed.
Collect several hundred very ill GW veterans and perform
exhaustive investigations on them, followed by treatment trials.
Investigate those hypotheses for which researchers were
threatened or forced to end their studies. Investigate the
electromagnetic field strengths and frequencies of all weapons,
communications devices and other equipment that may have been used in
the war, and try to determine which areas or units were exposed and
estimate the magnitude of exposure.
The choice of control groups in research is critical to a
meaningful outcome: compare GW veterans with controls who did not
receive deployment vaccines and had demonstrated equivalent health
status. Review all research projects with independent experts prior to
funding, to minimize confounding and bias.
Eight expert Committees have made recommendations on the
research studies needed for anthrax vaccine since 1999.\102\ Their
recommendations are excellent, and should be followed.
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\102\ http://merylnass.googlepages.com/Selectedfindings.doc
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Eight hundred Israeli soldiers received U.S. anthrax
vaccine or a similar Israeli anthrax vaccine several years ago, and
dozens have reported chronic illnesses they believe are related to
their vaccinations.\103\ Information from this trial should be
obtained, along with follow-up examinations to document what illnesses,
if any, have developed and rates of illnesses.
---------------------------------------------------------------------------
\103\ http://www.haaretz.com/hasen/spages/863699.html
---------------------------------------------------------------------------
A clinical trial of various strategies to remove toxic
substances would be extremely useful. Do antioxidants, vitamins,
saunas, or other strategies safely remove toxins after an exposure and
lead to better health?
Obtain relevant information from existing government databases
The Army Medical Surveillance Activity has performed many
analyses of its raw data (the Defense Medical Surveillance System) on
the health status of soldiers and GW veterans. These studies were not
published, nor are they easily available. A researcher \104\ who filed
Freedom of Information Act requests to learn what was studied, shared
66 pages with approximately 40 study titles listed per page with me. I
have filed a Freedom of Information Act Request for the contents of 60
of these studies that pertain to the health of Gulf War veterans; my
request is pending. Any serious study of Gulf War veteran health needs
to make use of this material and the available military and VA
databases. The Institute of Medicine noted that, ``Analysis of DMSS
data should be the primary approach for investigation of possible AVA
(anthrax vaccine adsorbed)-related health effects of medical
significance.'' \105\ This should be true of other potential health
impacts, in addition to anthrax vaccine.
---------------------------------------------------------------------------
\104\ Michael Ravnitzky
\105\ IOM Committee to Review the CDC Anthrax Vaccine Safety and
Efficacy Program. An Assessment of the CDC Anthrax Vaccine Safety and
Efficacy Research Program. 2003.
---------------------------------------------------------------------------
VA and military databases, used correctly, can tell us
which other illnesses can be linked to the Gulf deployment, and the
strength of the association, so that appropriate presumptions can be
made about the illnesses' cause; disability decisions can then be made
based on presumption.
Independent researchers who gain access to this data to
study GWI, and determine what other illnesses may be linked with the
1991 Gulf War deployment, should not be subject to the military chain
of command nor be VA employees.
We can learn more about the health risks of toxic GW
exposures by gaining access to data held by Federal agencies. This
includes obtaining information about anthrax vaccine adverse effects
from FDA. What in-house studies or reviews have been done of anthrax
vaccine? How has FDA evaluated the 5600 adverse event reports,
particularly the 670 it judged serious? What assessment was done of the
44 reported deaths associated with anthrax vaccine? How is the vaccine
tested for safety? (I filed several FOIAs with FDA for this information
since 2001. So far, 99% of what I requested was redacted, and much has
never been provided in any form. Yet the material should not have been
withheld according to FDA guidelines (21 CFR20.61 and 21CFR601.51.)
EPA and NIEHS have information about pesticide, heavy
metal and solvent health risks. DOE has information on the makeup and
production of depleted uranium. These sources of information should be
explored for their potential to shed more light on the specifics of the
illnesses causes by these materials.
Anthrax vaccine trials: NIH has data on human trials of
failed anthrax vaccines and CDC has data on its own clinical trial of
1564 subjects who received anthrax vaccine since 2002. What adverse
events occurred in these carefully studied groups? What is the current
health of the subjects? Late follow-up could be done on these subjects
to evaluate for longer term adverse events.
Multiple vaccines: Currently deploying soldiers are
receiving multiple simultaneous vaccinations and should be studied.
The military vaccine healthcare centers have data on over
2,000 soldiers who have become ill after anthrax vaccines. As well as
documenting the illnesses in great detail, the centers have tried a
variety of treatment regimens. Information on the illnesses and the
effectiveness of the treatments is extremely relevant to GW veterans.
15. My medical approach to treatment
GWS is one of medicine's poor stepchildren for many reasons.
Patients with memory and concentration problems require a lot more time
and understanding from both physicians and clinic staff, compared to
other patients. They miss appointments, lose prescriptions, forget the
instructions you gave them. They have an average of eight different
problems to address at each visit. They often have emotional issues.
They are at high risk of family breakdown and economic collapse.
Standard medications don't alleviate their symptoms. Providers may not
understand their illnesses nor the context in which they seek care.
They may be suspected as having secondary gain (desiring a disability
pension) as the driver for medical visits. Yet sometimes almost the
only thing the physician can do for the GWI patient is to aid the
disability process by keeping detailed notes.
This syndrome is not described in textbooks. Journal articles may
list the symptoms, but fail to guide clinicians with information on
effective treatments. If the clinician reads the GWI literature, she
may come away confused as to whether there really is a medical illness,
and whether she should transfer the patient to the psychiatric clinic.
There are no standard medical treatments for the chronic effects of
exposure to pesticides, solvents, toxic materials in inhaled smoke,
etc. A few doctors have experimented with various detoxification
strategies,\106,107\ and some alternative doctors use these treatments
frequently, but they are not proven to be effective and are not
eligible for third party reimbursement.
---------------------------------------------------------------------------
\106\ Krop J. Chemical sensitivity after intoxication at work with
solvents: response to sauna therapy. J Altern Complement Med. 1998
Spring;4(1):77-86.
\107\ Kilburn KH, Warsaw RH, Shields MG. Neurobehavioral
dysfunction in firemen exposed to polycholorinated biphenyls (PCBs):
possible improvement after detoxification. Arch Environ Health. 1989
Nov-Dec;44(6):345-50.
---------------------------------------------------------------------------
Medicine is a business. Third party payers use similar visit codes
to reimburse physicians. Treating four patients in an hour pays much
better than treating one. The maximal visit code pays for a 40 minute
visit. Additional time spent with the patient will not be reimbursed.
Extra time spent by office staff is not reimbursed. I am fortunate that
as a salaried physician, my employer, Mount Desert Island Hospital,
allows me to conduct a specialty clinic as a community service, even
though I could bring in considerably more fees treating patients with
standard illnesses during brief visits. Patients often travel long
distances to see these doctors, who are few and far between. Thus they
need long visits. Few GW veterans can afford to pay out of pocket for
medical care, which is how most doctors who treat multi-symptom
syndromes expect payment, because of the limitations placed on
reimbursement by insurers.
Frankly, until the financial disincentive is changed, I doubt that
treatment of GW veterans will improve greatly.
What do I actually do with patients? First, patients complete
detailed questionnaires prior to their visit to help me determine which
aspects of the illnesses are present in their case. Because I am
familiar with the features of the multisymptom syndromes, I know what
to look for, ask about, and can direct treatment to these aspects of
the illness. For example:
Are they sensitive to odors (especially diesel exhaust),
fluorescent lights or foods?
What happens when exposed to these things?
Do they have intermittent episodes of confusion?
Do they balance their own checkbook?
How is their driving?
How is their GI tract function?
How do they sleep? Has their partner noticed pauses in
breathing?
Do they have chronic pain? Where? What exacerbates or
relieves it?
What kind of activity can they perform? For how long?
What makes them stop?
Do they have rashes?
How is their breathing?
How is their libido and sexual function?
Is there mold, or are there other substances at home or
elsewhere that increase symptoms?
If they have developed multiple chemical sensitivity (which seems
to be present in about 40% of GWS patients), I help them identify the
odors that provoke symptoms so they can avoid them. I prescribe
elimination diets to identify foods that trigger symptoms. I order
tests to rule out other causes of symptoms, such as muscle diseases,
standard autoimmune conditions, thyroid disease, anemia, etc. I may
order sleep studies. Some patients may get a muscle biopsy or other
specialized tests. Stools are cultured and endoscopy performed when
indicated.
I then address treatment for each symptom individually, since we
cannot currently address underlying causes. However, I additionally try
to optimize patients' overall metabolic function with diet, vitamins
and supplements designed to increase cellular energy and provide
substrates for important intracellular molecules such as NADH,
glutathione, ATP. Antioxidants may also be helpful. Most veterans
cannot afford this treatment, however. Vitamins and supplements are not
covered by insurance, although they are usually much cheaper than
prescription medications.
Hopefully, clinical trials will demonstrate whether these
approaches improve health, and if so, perhaps the VA will make vitamins
and supplements available to GW veterans.
I treat the sleep disorder, diarrhea, pain, low hormone levels, or
whatever other symptoms are present. I try one treatment after another,
since there are many adverse reactions to medications, and it is often
difficult to predict which medicines are likely to be effective.
Usually, you can improve sleep considerably, but energy only a little.
You can improve pain. The diarrhea can resolve, though it may return
later. Sometimes sex hormones improve sexual function, but often they
do not. Thyroid hormone may provide a modest energy boost. Autonomic
dysfunction may be treated with increased salt and water intake, drugs
and/or hormones to raise blood pressure, and electrolytes. If you are
very lucky, cognition may improve.
The doctor-patient relationship, and lifestyle coaching, may be
equally as important as medications. Patients need to know you are
their partner, not a representative of a system they fear is pitted
against them. I warn them that marital difficulties should be expected.
I prefer their partners to attend visits, and am happy to answer
partners' questions. Treating psychological problems may be helpful,
but veterans are sensitive that such treatment is a denial they have
physical illness. I explain that they have real medical illness, and
may give them an article or book on GWS that describes the resulting
psychological and physical symptoms, to help them understand their
disorder. I may refer to other therapists. I suggest that people with
limited mental and physical energy reserve their most challenging tasks
for when they feel most rested. I may advise them not to drive alone.
With this treatment, I estimate a veterans' overall function can
improve 30-40% and sometimes more. But it is a piecemeal, palliative,
symptom-based approach that does not provide a cure. It also requires
highly intensive care. A list of many of the treatments I employ was
provided to the VA Research Advisory Committee and listed on my website
at: http://www.anthraxvaccine.org/gulfwartreatment.htm.
I greatly appreciate this opportunity to share my knowledge and
opinions with the Committee.
I would also like to express my appreciation to Walter Schumm, PhD,
Garth Nicolson, PhD, and affected Gulf War veterans Doug Rokke, PhD,
Joyce Riley, RN and Kirt Love for sharing materials on GWS that were
used in this presentation. My deepest thanks also to Lt. Col. John
Richardson, retired Air Force GW veteran (still healthy), who has
worked tirelessly to improve the condition of his fellow GW veterans
and anthrax vaccine-injured soldiers.
Committee on Veterans' Affairs
Subcommittee on Health
August 2, 2007
James Binns
Chairman
Research Advisory Committee on Gulf War Veterans' Illnesses
U.S. Department of Veterans Affairs
2398 East Camelback Road, Suite 280
Phoenix, AZ 85016
Dear Jim:
In reference to our Subcommittee on Health hearing on ``Gulf War
Exposures'' held on July 26, 2007, I would appreciate it if you could
answer the enclosed hearing questions by the close of business on
October 2, 2007.
In an effort to reduce printing costs, the Committee on Veterans'
Affairs, in cooperation with the Joint Committee on Printing, is
implementing some formatting changes for materials for all full and
Subcommittee hearings. Therefore, we would appreciate it if you would
provide your answers consecutively and single-spaced. In addition,
please restate the question in its entirety before the answer.
Please provide your response to Cathy Wiblemo at the Committee. If
you have any questions, please call 202-225-9154.
Sincerely,
MICHAEL H. MICHAUD
Chairman
______
Research Advisory Committee on Gulf War Veterans' Illnesses
U.S. Department of Veterans Affairs
Phoenix, AZ
October 2, 2007
Hon. Michael H. Michaud
Chairman
Subcommittee on Health
Committee on Veterans' Affairs
United States House of Representatives
335 Cannon House Office Building
Washington, DC 20515
Dear Congressman Michaud:
I am pleased to respond to your written questions following the
July 26 hearing on ``Gulf War Exposures.''
1. Gulf War Illnesses_Everyone on this panel agrees that Gulf War
Illnesses are real and that more should be done by way of research,
outreach and treatment.
In your professional estimation, what is the biggest
challenge facing VA today with regard to Gulf War Illnesses?
In recent years, I have observed VA's Office of Research and
Development change course to embrace the reality of these illnesses and
redirect VA research to address the problem, thanks to the active
leadership of Secretary Principi and Secretary Nicholson. Indeed VA
research is responsible for much of the progress that has been made in
understanding that these are widespread, serious health problems,
neurological in nature, rather than the result of battlefield stress.
Even since the July 26 hearing, Dr. Kupersmith, the head of research
and development, has continued this advance by announcing new studies
to investigate the prevalence of MS and brain cancer in Gulf War
veterans.
Other parts of VA, however, notably the Office of Environmental
Hazards, continue to push the old message that minimizes these
illnesses and associates them with psychological causes, whether in
``fact sheets'' provided to Congress or outdated clinical training
guidelines given to VA doctors. This activity misleads the scientific
community that might be engaged in helping these veterans and denies VA
the credit it should be receiving for addressing the problem head-on.
In my estimation, the biggest challenge facing VA today with regard to
Gulf War Illnesses is to project throughout the department the
perspective of VA leadership and the Office of Research and
Development.
Dr. Deyton, who was appointed the new head of the Office of Public
Health and Environmental Hazards relatively recently, has a reputation
as a straightforward and dedicated senior official. am hopeful that he
will address this challenge.
What would your recommendations be to VA to ensure that
what has happened to Gulf War Veterans does not happen to the newest
generation of veterans returning from OEF/OIF?
Our Committee submitted a list of recommendations to Deputy
Secretary McKay before the start of the war in Iraq, a copy of which is
attached, and which formed the basis of a letter from VA leadership to
the Department of Defense.
2. DoD/VA_Getting accurate, up-to-date information on pre-
deployment and post-deployment health records, where service members
were located and other pertinent information from DoD, has, in the
past, been characterized as difficult.
Do you believe that this exchange of information between
VA and DoD has improved with the current deployments to Afghanistan and
Iraq?
As the current war is outside the charter of the Research Advisory
Committee, I regret that I have no personal knowledge to offer.
In your professional opinion, would you say that the lack
of information exchange or delayed exchange was a primary factor in
hindering research efforts regarding Gulf War Illnesses?
It has been a factor that has hindered research.
3. ALS_Mr. Mikolajcik proposed in his testimony that a
congressionally directed ALS Task Force should be established to help
provide direction in ALS research and to develop a strategic plan to
tackle this illness. The 30- 60- 90-day timeline he suggested in his
testimony lays out some structural parameters.
What are your thoughts on creating another task force or
entity to look into ALS?
Do you believe that the direction VA is taking with ALS
is the right way?
Other than the research studies specifically directed at Gulf War
veterans with ALS, our Committee is not charged with reviewing ALS
research and has not reviewed the VA ALS portfolio. Thus I regret that
I am unable to comment knowledgeably on this question. Coming from
private industry, my general impression of government and academic
research programs is that many would benefit from a more comprehensive,
integrated approach. In my opinion, a task force would need to consider
the full scope of ALS research, not only VA, to be effective, and I
would want to know if some entity (such as at NIH?) already has that
responsibility and if they were executing it effectively.
4. Where Do We Go From Here_Sixteen years have passed and veterans
of the Gulf War are still fighting to be recognized and not forgotten.
What would your recommendations be on how to effectively
move forward with Gulf War illnesses research, outreach, education and
treatment?
The Research Advisory Committee is currently preparing a
comprehensive report that will address these topics in detail. I look
forward to providing it to you as soon as it is available, early in the
new year. Certain of these topics that have already been addressed by
the Committee are available now at the Committee website: http://
www1.va.gov/racgwvi/docs/Letter_Recommendations_Feb012007.pdf
Respectfully submitted,
James Binns
Chairman
______
Research Advisory Committee on Gulf War Veterans' Illnesses
U.S. Department of Veterans Affairs
Phoenix, AZ
December 16, 2002
Hon. Leo S. Mackay, Jr., PhD
Deputy Secretary of Veterans Affairs
Department of Veterans Affairs
Washington, DC
RE: ``Lessons Learned''
Dear Mr. Deputy Secretary,
At the recent meeting of the Research Advisory Committee on Gulf
War Veterans Illnesses, you asked if the Committee had recommendations
regarding the prospective conflict with Iraq based on lessons learned
from the Gulf War Illnesses experience.
Because the request came at the end of our meeting, these
observations did not in all cases go through the formal process for
recommendations of a public advisory committee and they are not
comprehensive. However, we appreciate your interest, and offer these
observations for consideration as time is of the essence.
1. DoD should retain health and locational records for future
conflicts. Even if security considerations require classification of
personnel records, they should be retained for health reasons.
2. Predeployment physicals should be standardized.
3. Military exit physical examinations should be conducted in
accordance with procedures that meet VA standards.
4. There should be a single comprehensive DoD/VA patient record.
5. Good immunization records should be maintained.
6. [The following recommendation was formally deliberated and
adopted by the Committee.]
``Substantial questions remain about the possible contribution
of vaccines, including the anthrax vaccine, to chronic ill health
experienced by veterans of the 1991 Gulf War. Evaluation of the
contribution of vaccines in the 1991 conflict would have been aided by
proper and extant vaccination records including specifics of vaccine
lots received and dosage schedules. Should such health problems recur
after future deployments or after civilian vaccination programs, VA's
ability to evaluate and treat affected veterans would require access to
comprehensive vaccination records. To fill this gap of knowledge we
recommend that stringent efforts be made to generate and keep such
records and to perform active surveillance of both short term and long
term adverse health effects of all biodefense vaccines, including the
anthrax vaccine. We therefore recommend to the Secretary of Veterans
Affairs that he initiate discussions with the Secretary of Defense to
ensure that this is achieved.''
7. Several members of the Committee pointed out that most of these
recommendations were enacted into law in the Force Health Protection
statute, PL 105-85. They report, however, that a recent GAO study and
Congressional hearings indicate that compliance with this law is weak
at the operational unit level. Thus, a core recommendation would be to
encourage you and Secretary Principi to work with your counterparts at
the Department of Defense to ensure that these laws are implemented.
Respectfully submitted,
James H. Binns
Chair
cc: Hon. Anthony J. Principi,
Secretary of Veterans Affairs
Committee on Veterans' Affairs
Subcommittee on Health
August 2, 2007
Lea Steele, Ph.D.
Scientific Director
Research Advisory Committee on Gulf War Veterans' Illnesses
Eastern Kansas VA Healthcare System (T-GW)
2200 S.W. Gage Blvd.
Topeka, KS 66622
Dear Lea:
In reference to our Subcommittee on Health hearing on ``Gulf War
Exposures'' held on July 26, 2007, I would appreciate it if you could
answer the enclosed hearing questions by the close of business on
October 2, 2007.
In an effort to reduce printing costs, the Committee on Veterans'
Affairs, in cooperation with the Joint Committee on Printing, is
implementing some formatting changes for materials for all full and
Subcommittee hearings. Therefore, we would appreciate it if you would
provide your answers consecutively and single-spaced. In addition,
please restate the question in its entirety before the answer.
Please provide your response to Cathy Wiblemo at the Committee. If
you have any questions, please call 202-225-9154.
Sincerely,
MICHAEL H. MICHAUD
Chairman
______
Questions for the Record
Hon. Michael H. Michaud, Chairman
Subcommittee on Health
House Committee on Veterans' Affairs
July 26, 2007, 10:00 a.m.
Room 334, Cannon House Office Building
Follow-Up Questions for Lea Steele, Ph.D.
1. Gulf War Illnesses_Everyone on this panel agrees that Gulf War
Illnesses are real and that more should be done by way of research,
outreach and treatment.
In your professional estimations, what is the biggest
challenge facing VA today with regard to Gulf War Illnesses?
What would your recommendations be to VA to ensure that
what has happened to the Gulf War Veterans does not happen to the
newest generation of veterans returning from OEF/OIF?
2. DoD/VA_Getting accurate, up-to-date information on pre-
deployment and post-deployment health records, where service members
were located and other pertinent information from DoD, has, in the
past, been characterized as difficult.
Do you believe that this exchange of information between
VA and DoD has improved with the current deployments to Afghanistan and
Iraq?
In your professional opinions, would you say the lack of
information exchange or delayed exchange was a primary factor in
hindering research efforts regarding Gulf War Illnesses?
3. ALS_Mr. Mikolajcik proposed in his testimony that a
congressionally directed ALS Task Force should be established to help
provide direction in ALS research and to develop a strategic plan to
tackle this illness. The 30- 60- 90-day timeline he suggested in his
testimony lays out some structural parameters.
What are your thoughts on creating another task force or
entity to look into ALS?
Do you believe that the direction VA is taking with ALS
is the right way?
4. Where Do We Go From Here_Sixteen years have passed and veterans
of the Gulf War are still fighting to be recognized and not forgotten.
What would your recommendations be on how to effectively
move forward with Gulf War Illnesses research, outreach, education and
treatment?
[RESPONSES WERE NOT RECEIVED FROM DR. STEELE.]
Committee on Veterans' Affairs
Subcommittee on Health
August 2, 2007
Lawrence Deyton, MSPH, M.D.
Chief Public Health and Environmental Hazards Officer
Office of Public Health and Environmental Hazards
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington DC 20420
Dear Lawrence:
In reference to our Subcommittee on Health hearing on ``Gulf War
Exposures'' held on July 26, 2007, I would appreciate it if you could
answer the enclosed hearing questions by the close of business on
October 2, 2007.
In an effort to reduce printing costs, the Committee on Veterans'
Affairs, in cooperation with the Joint Committee on Printing, is
implementing some formatting changes for materials for all full and
Subcommittee hearings. Therefore, we would appreciate it if you would
provide your answers consecutively and single-spaced. In addition,
please restate the question in its entirety before the answer.
Please provide your response to Cathy Wiblemo at the Committee. If
you have any questions, please call 202-225-9154.
Sincerely,
MICHAEL H. MICHAUD
Chairman
______
Questions for the Record
Hon. Michael H. Michaud, Chairman
Subcommittee on Health
House Committee on Veterans' Affairs
July 26, 2007
Gulf War Exposures
Question 1: Outreach_The Gulf War Review newsletter, which is the
publication VA initiated to help veterans of the Gulf War and their
families be more aware of VA's health care and other benefits has
reportedly not been mailed out in over a year.
What has the VA done to ensure that outreach to Gulf War
veterans is being done on a regular basis?
Response: The Department of Veterans Affairs (VA) places a very
high priority on ensuring broad and wide-ranging outreach to all
veterans, including veterans of the Gulf War.
To achieve this, VA has a great deal of material made available to
Gulf War veterans and their families, including information
newsletters, brochures, wallet cards, posters, and other materials,
both in print, online and as ``pod casts,'' to ensure that veterans and
their families are kept up to date on the VA health care and other
benefits that may affect them.
Some VA outreach materials specifically targeting veterans of the
1991 Gulf War\1\ and their families available online at www.va.gov/
GulfWar and www.va.gov/EnvironAgents (see summary of this outreach
information, Attachment 1).
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\1\ (Note: In the responses the 1990-1991 Gulf War is sometimes
referred to as Gulf War 1.)
---------------------------------------------------------------------------
Since 1992, VA has published 38 editions of the ``Gulf War Review''
newsletter. The next edition will appear in the Fall of 2007. That
edition will highlight a number of new authoritative reports from the
independent National Academy of Sciences Institute of Medicine (IOM)
which will be completed by then, and should be of significant interest
to Gulf War veterans and their families.
Question 2: Treatment_Because they suffer from a multitude of
illnesses, the treatment of Gulf War veterans is by most counts, pretty
complex. Additionally, Anthony Hardie, in his testimony states that the
VA's Office of Public Health and Environmental Hazards website contains
little information that might be of any use to ill Gulf War veterans or
their health providers.
Could you tell us what type of training or continuing
medical education requirements are currently in place to ensure that VA
health care professionals have the most current research findings and
up-to-date information on the Gulf War Illnesses?
Response: VA has a wide range of training and educational materials
on Gulf War veteran health issues, aimed at VA health care providers as
well as for veterans and their families.
Attached is a brief description of some VHA initiatives from the
Office of Public Health' and Environmental Hazards (OPHEH), developed
for training and education purposes for VA health care providers seeing
Gulf War 1 veteran patients (Attachment 2).
Many of these programs have now also been expanded to prepare for
veterans from Operations Enduring Freedom/Operation Iraqi Freedom (OEF/
OIF) and for their families. All of these programs represent ``lessons
learned'' from VA's experiences responding to the health care and other
benefits needs of veterans returning from the 1991 Gulf War, and from
the Vietnam War before that.
The most authoritative sources of health information for veterans
of the 1991 Gulf War is the series of congressionally mandated ``Gulf
War and Health'' reports conducted by the IOM. These reports have
reviewed a wide range of Gulf War risk factors, including health
effects from exposure to oil well fire smoke. Summaries of these
reports are available online at www.va.gov/EnvironAgents for the
benefit of both veterans and VA health care providers.
In addition, VA's Office of Research and Development (ORD)
disseminates an annual report, written jointly with the Departments of
Defense (DoD) and Health and Human Services (HHS), which summarizes
Federally supported research on Gulf War veterans' health available
online at http://www.research.va.gov/resources/pubs/
pubs_individual.cfm?Category=Gulf War Reports.
Question 3: Epidemiological Research_On page 3 of your testimony
you say ``additional epidemiological research is required to properly
characterize any possible long-term health effects of Gulf War One
service to the average Gulf War veterans.
Has VA initiated the needed research and if not, why not?
Response: An enormous amount of epidemiological research has been
carried out focusing on the health of veterans of the 1991 Gulf War.
Some of this research has been supported or conducted by VA
researchers, but most of it has been conducted by a wide range of
academic and government researchers around the world.
The quoted reference in VA's testimony was making the point that
VA's Gulf War Health Registry program was not intended for definitive
evaluation of specific health effects for the average Gulf War veteran.
To do that thoroughly requires epidemiological research to fully
characterize any possible long-term health effects of Gulf War 1
service. Gulf War Health Registry participants are self-selected, and
therefore do not represent the average veteran. Registry findings do
show that no unique health problems are emerging among those Gulf War
veterans who have participated in the special registry program.
However, these findings do not tell us if Gulf War veterans are
suffering from any diagnoses at rates different from that expected
among this group, based on their age and demographic characteristics.
To gain an overview about how this enormous effort has improved our
understanding of Gulf War veteran health issues, in 2004, VA requested
an in depth review by the National Academies of Sciences IOM, of all
epidemiological studies of Gulf War veterans. This was the fourth in a
series of statutorily required (in Public Laws 105-277 and 105-368)
studies by the IOM on the scientific and medical literature on the
long-term health effects from exposure to a wide range of environmental
hazards potentially related to service in the 1991 Gulf War. The 2004
IOM Committee was charged with reviewing all epidemiological studies of
health outcomes among Gulf War veterans to determine their health
status in comparison with other populations.
The resulting 2006 IOM Committee report documented increased rates
of certain illnesses among Gulf War veterans, based on a review of 850
epidemiological and other studies of this group, which they selected
from among over 4,DoD potentially relevant reports. The IOM Committee
concluded:
``VA and DoD have expended enormous effort and resources in
attempts to address the numerous health issues related to the Gulf War
veterans. The information obtained from those efforts, however, has not
been sufficient to determine conclusively the origins, extent, and
potential long-term implications of health problems potentially
associated with veterans' participation in the Gulf War.''
The IOM Committee identified numerous serious limitations in
existing epidemiological studies of Gulf War veterans, in large part
due to the lack of data on veterans' exposure to putative toxic agents.
However, they did ``not recommend that more such studies be undertaken
for the Gulf War veterans.'' Rather, the Committee recommended
``continued surveillance to determine whether there is actually a
higher risk in Gulf War veterans'' for illnesses that current research
has identified as possibly appearing at higher rates among Gulf War
veterans, specifically, brain and testicular cancer, amyotrophic
lateral sclerosis (ALS), birth defects, and post deployment psychiatric
conditions.
The IOM Committee concluded that ``every study reviewed by this
Committee found that veterans of the Gulf War report higher rates of
nearly all symptoms examined than their non-deployed counterparts.''
Of note, they reported that symptom-defined ``unexplained
illnesses,'' consistent with chronic fatigue syndrome, fibromyalgia,
irritable bowel syndrome and multiple chemical sensitivity, were the
most common health problem reported in studies of Gulf War veterans.
However, they concluded that ``the results of research indicate that
although deployed veterans report more symptoms and more severe
symptoms than their non-deployed counterparts, there is not a unique
symptom complex (or syndrome) in deployed Gulf War veterans.'' They
also found that ``Gulf War veterans consistently have.been found to
suffer from a variety of psychiatric conditions,'' including post
traumatic stress disorder (PTSD), anxiety, depression and substance
abuse.
They also reported that studies have ``not demonstrated differences
in cognitive and motor measures'' in deployed versus non-deployed
veterans, and show no apparent increase in risk of peripheral
neuropathy, cardiovascular disease or diabetes.
Finally, they reported difficulties in interpreting data on birth
defects, and found little data to support an objective finding of
increased respiratory illnesses among Gulf War veterans.
VA's Office of Research and Development also prepares an annual
report on Federally sponsored research on Gulf War veterans' illnesses
(their latest report is dated May 2007). Research topics have included
large population-based epidemiological studies 1991 Gulf War veterans,
including on symptoms and general health status, brain and nervous
system function, diagnoses of infectious diseases, health effects of
depleted uranium (DU), chemical weapons, and pyridostigmine bromide,
and multiple exposure effects.
It is important to note that the U.S. government has provided
significant support for research on the health of Gulf War veterans.
From fiscal year (FY) 1992 through FY 2006, VA, DoD and HHS funded 330
distinct projects related to health problems affecting Gulf War
veterans. These projects are broad in scope, from small pilot studies
to large-scale epidemiology studies involving large populations and
major center-based research programs. Federal funding for research on
Gulf War veterans totaled $274.0 million over FY 1997 to FY 2006, and
as of September 2006, 223 projects (68 percent) were completed, while
107 (34 percent) were new or ongoing.
VA's own research activities focusing on veterans of the 1991 Gulf
War include:
1. A comprehensive mortality study, which continues even today;
2. An interagency study on veteran hospitalization rates;
3. VA's National Health Survey of Gulf War veterans and their
families; and,
4. Surveillance on long-term health effects from exposure to DU
among Gulf War veterans.
One example of VA research is a study of mortality and causes of
mortality among all Gulf War veterans. For this effort, VA researchers
have been continuously monitoring the cause-specific mortality of all
Gulf War veterans in comparison to their non-deployed peers. In post-
war monitoring, Gulf War veteran mortality from most causes is not
significantly different in comparison to non-deployed peer as controls.
Moreover, the mortality for both groups is less than half that of
matched civilian controls. This is almost certainly because people who
choose to go into the military are healthier to begin with.
Initially, Gulf War veterans have shown an increased risk of death
from accidents, especially motor vehicle accidents. VA's data shows
that this is a temporary effect, and by 6 years post-war this
difference has disappeared. This overall pattern is very consistent
with earlier mortality data from Vietnam veterans.
The Washington DC VA War-Related Illness and Injury Study Center
(WRIISC) has also initiated significant research on the possible long-
term health effects of the 1991 Gulf War service. These include:
1. Post War Mortality from Neurologic Diseases in Gulf War Veterans
The concept behind this study is that Gulf War veterans may be at
increased risk for neurological disorders, amyotrophic lateral
sclerosis (ALS), multiple sclerosis (MS), Parkinson's disease, or brain
cancer, as a result of their Gulf War service. These risks are related
to potentially hazardous environmental exposures during the war, such
as oil well fire smoke, chemical and biological warfare (CBW) agents,
prophylactic agents against CBW, multiple vaccinations, depleted
uranium, pesticides, and endemic infectious diseases. Therefore, the
Washington, DC-based WRIISC is investigating post-war mortality from
neurological disease in Gulf War veterans. This study compares risks of
mortality due to ALS, MS, Parkinson's, or brain cancer between 620,DoD
Gulf War veterans and 750,DoD non-Gulf War veterans. The study is
scheduled to be completed by the end of 2007.
2. Estimates of Cancer Prevalence in Gulf Veterans Using State
Registries
For this study, WRIISC researchers are evaluating the hypothesis
that 1990-1991 Gulf War veterans are at an increased risk of developing
specific cancers compared to nonGulf War veterans. The objectives of
the study are (a) to assess and compare the prevalence, distribution,
and characteristics of cancer among 621,902 Gulf War veterans to
746,248 non-Gulf War veterans; and (b) to assess demographic, military,
and in-theater exposure characteristics associated with the cancer.
They are identifying Gulf War and non-Gulf War veterans with a
diagnosis of cancer from 1991 to 2005 through record linkage of the
veterans' database with files supplied by state cancer registries. This
study will produce information with adequate statistical power to
address the question on whether or not there is an excess cancer risk
associated with the 1990-1991 Gulf War. The study is scheduled to be
completed by the end of 2008.
3. Autonomic Functions of Gulf War Veterans with Unexplained Illnesses
This population-based, clinical pilot study is designed to measure
and compare functions of the autonomic nervous system in Gulf War 1
veterans who have a cluster of neurological symptoms to Gulf War 1
veterans without these symptoms. Researchers will explore two
questions: first, is autonomic nervous system function impaired in Gulf
War veterans with a cluster of neurological symptoms (e.g., dizziness,
blurred vision, tremor, and excessive fatigue) compared to those
without; second, are these symptoms associated with abnormal testing
for specific functions of the autonomic nervous system. The study is
scheduled to be completed in 2 years.
4. Motor Neuron Function of Gulf War Veterans with Excessive Fatigue
This pilot study is designed to explore whether the number of motor
neurons is significantly reduced in ill Gulf War 1 veterans compared to
controls; and if mitochondrial (energy producing cells) function is
impaired in ill Gulf War One veterans compared to controls. III
veterans will have at least one of the following self-reported
neuromuscular symptoms: muscle weakness, muscle pain or cramp,
excessive fatigue, recurring fatigue lasting more than 24 hours after
exertion, or having chronic fatigue syndrome. The study is scheduled to
be completed in 2 years.
Question 4: WRIISCs_In 2001, VA established the War Related Illness
and Injury Study Centers (WRIISCs), at the Washington, D.C, and East
Orange, NJ VA Medical Centers. The centers were established initially
for returning 1991 Gulf War veterans however the centers see combat
veterans from all deployments. It is good to see that VA is expanding
on this program and establishing a third WRIISC at the Palo Alto VA
Health Care System.
Response: In 2001, as part of VA's overall health response for
veterans returning from the 1991 Gulf War, VA established the two
WRIISCs at Washington, DC, and East Orange, NJ. Today, they are
providing specialized health care for combat veterans from all
deployments who experience difficult to diagnose.or undiagnosed but
disabling illnesses.
Currently, VA is expanding this program to better meet the health
care needs of new combat veterans suffering from mild to moderate
traumatic brain injury. To that end, VA is establishing a third WRIISC
at the Palo Alto VA Health Care System, in Palo Alto, CA.
Question 4(a): How many Gulf War One veterans are seen at the two
centers?
Response: The two existing WRIISCs, established in 2001, have
evaluated 344 Gulf War veteran patients from across the nation.
Question 4(b): Have there been any significant findings or
recommendations that have emanated from the study centers since opening
in 2001?
Response: The two WRIISCs were charged with developing new
approaches for responding to all veterans with disabling but difficult
or impossible to diagnose illnesses. They were required to focus on 1)
specialized clinical care; 2) research on improved diagnoses and
treatments; 3) relevant education for health care providers; and 4)
risk communication and outreach for veterans and their families with
deployment-related health concerns.
The two WRIISCs have achieved a great deal in each of these four
core areas, and we have attached their latest annual reports to provide
more complete information about their accomplishments. (Attachment 3)
Question 4(c): Do you know how many OEF/OIF veterans have been seen
at the centers?
Response: The WRIISC program has evaluated 577 OEF/OIF veterans,
beginning in 2005.
Question 4(d): What types of unexplained disabling illnesses or
difficult to diagnose illnesses are OEF/OIF veterans experiencing?
Response: OEF/OIF veterans present to the two WRIISCs with
musculoskeletal injuries and related pain, dental conditions, PTSD,
mood disorders, and traumatic brain injury (TBI). WRIISCs report that
they generally consider mild TBI as difficult to diagnose among
returning OEF/OIF veterans, especially when, as is commonly the case,
their symptoms are complicated with overlapping PTSD and other mental
health conditions. Clearly, mild TBI was not a significant concern as a
consequence of the 1991 Gulf War, but certainly is one for the current
conflict in Southwest Asia. We are expecting these clinical findings to
appear in future publications from the two WRIISCs.
Many of the long-term chronic health effects from TBI appear
similar to the difficult-to-diagnose and treat illnesses currently
being treated by the WRIISC programs today. To improve our ability to
respond to the health care needs of combat veterans suffering from mild
to moderate TBI, VA is establishing a third WRIISC at the Palo Alto VA
Health Care System. The new WRIISC will take advantage of the unique
assets available there, including a poly trauma unit, interdisciplinary
program on blast injuries which integrates the medical, psychological,
rehabilitation, prosthetic needs of injured service members, their
programs in TBI, spinal cord injury, blind rehabilitation, PTSD, and
research into new and emerging areas of combat injuries and illnesses.
Finally, WRIISC have reported that sleep disturbances are rather
common finding among new OEF/OIF veterans. This is a difficult symptom
because it is sometimes hard to pinpoint their underlying cause.
Commonly, OEF/OIF veterans' circadian rhythm appears to be disrupted as
a result of irregular sleeping patterns in theater, but often this
issue is compounded by PTSD.
Question 4(e): Are the OEF/OIF veterans experiencing different
maladies than those presented by the Gulf War One veterans?
Response: The WRIISCs report that based on recent clinical
experience with these new veterans that in general, health issues among
OEF/OIF veterans have many similarities as well as certain differences
compared to veterans of the 1991 Gulf War. They report that there
appear to be more exposure-related illness concerns among Gulf War 1
veterans, for example, related to oil well fires, chemical weapons
potential, and vaccinations. OEF/OIF veterans also have some concerns
about these deployment-related concerns, including relative to
vaccinations, depleted uranium, and air quality issues. Symptoms and
illnesses vary depending on the conflict in which the veteran served.
However, symptoms related to depression, PTSD, pain, memory
difficulties, respiratory, and skin conditions are common among new
combat veterans.
Significant post-deployment health concerns of Gulf War 1 veterans
are medically unexplained symptoms, including headaches, fatigue,
gastrointestinal disturbances, chronic pain, memory difficulties, and
mood disorders. Gulf War 1 veterans also see Gulf War environmental
exposures as the etiology for their health symptoms. The deployment
health concerns of OEF/OIF veterans include musculoskeletal injuries
and related pain, dental conditions, PTSO, mood disorders and TBI.
Question 5: ALS Research_You mention in your testimony that there
is ongoing research being done by VA regarding ALS.
Do you know when the results of some of this research will be
complete or are these studies that will take years to come to fruition?
Response: Most of the research studies on ALS funded by ORD are
long-term research projects that will take some years to come to
fruition. Projects aimed at identifying genetic markers for ALS are
closer to providing useful tools for clinicians to diagnose ALS and
potentially to follow disease progression, however, there is no
definitive timeframe for completion of these studies. The ORD-sponsored
VA National ALS Registry is currently being used by investigators
funded by a broad spectrum of agencies, including VA and DoD.
Question 6: ALS Registry_There is a national registry of veterans
with ALS to identify, as completely as possible, all veterans with ALS
and to collect data for studies examining the causes of ALS.
Question 6(a): How many veterans are currently on the registry?
Response: Since 2003, VA has enrolled a total 2027 veterans.
Currently, 965 of these veterans are alive and engaged in biannual
follow-up.
Question 6(b): Do you have any veterans from the current conflict
on the registry?
Response: There are 10 veterans from OEF and 3 from OIF enrolled.
Question 6(c): How do you reach out to veterans to make them aware
that the registry exists?
Response: VA makes veterans aware that the registry exists through
a variety of mechanisms including:
The ALS Registry website (http://
www.durham.hsrd.research.va.gov/alsreqistrv.asp)
Letters and brochures sent to all neurologists (VA and
non-VA)
Announcements on ALS and veteran-specific websites
Brochures sent to national and state ALS Associations
Periodic data-pulls from VA Inpatient/Outpatient databases followed
by a contact letter to veterans and a call 1 week later to determine
eligibility
Question 6(d): Have you tried to specifically target veterans from
the first Gulf War given that they are twice as likely to contract ALS?
Response: All veterans in the VA funded study, ``An Investigation
into the Occurrence of ALS Among Gulf War Veterans'' were contacted and
enrolled in the ALS Registry. In addition, VA contacted the Persian
Gulf War Veterans Association and requested that it notify veterans
about the registry.
______
Attachment 1
Partial list of Outreach Materials for Gulf War veterans and their
families available online at www.va.gov/GulfWar. www.va.gov/
EnvironAgents and other sources.
At the www.va.gov/GulfWar Web site, Gulf War veterans and their
families have access to:
VA's Gulf War Veterans Information Helpline (1-800-PGW-
VETS)
The most recent VA Gulf War Newsletter (July 2006)
VA's Gulf War (OIF) Registry Program Handbook (June 2007)
The Annual Report to Congress on Gulf War Veterans'
Illnesses from VA/DoD Research Working Group
Veterans Health Initiative (VHI) Independent Study Guide
for Providers on Gulf War Health Issues
VA's Depleted Uranium Handbook for Gulf War Veterans
(February 2004)
VA's Evaluation Protocol for Gulf War OIF Veterans with
Potential Exposure to Depleted Uranium (DU) Handbook
VA's Southwest Asia Poster (May 2004) (distributed to all
VA medical centers, regional offices and vet centers)
Brochures and Information Bulletins:
Health Care and Assistance for U.S. Veterans of OIF
Q&A Brochure--Gulf War Illnesses, August 2003 (English
and Spanish)
Information Bulletin on Gulf War veteran health issues
10-41 and--42, March 2004 (in Spanish)
Gulf War Fact Sheet April 2 DoD
Depleted Uranium Frequently Asked Questions (FAQs)
VA Gulf War Registry Examination Handbook 2005
Research Reports and Summaries:
Combined Analysis of VA/DoD Gulf War Clinical Evaluation
Programs (Study of Clinical Findings from Systematic Medical
Examinations of 100,339 U.S. Gulf War Veterans)--September 2002
Gulf War Research: A Report to Veterans October 2003
(English and Spanish)
Journal Article Summaries on Gulf War veteran health
issues
Gulf LINK Medical Information (Gulf LINK is DoD's site on
Gulf War veteran health issues containing Gulf-War research-related
information. It is a collaborative effort of DoD, VA, and HHS.
Gulf War Risk Factor Report Reprints (from VA's ``Gulf War Review''
Newsletter):
Introduction
Deplete Uranium
Pesticides
Pyridostigmine Bromide
Infectious Diseases
Chemical & Biological Warfare Agents
Vaccinations including Anthrax & Botulinum
Oil Well Fire Smoke and Petroleum
At the www.va.gov/EnvironAgents Web site, Gulf War veterans and
their families have access to a wide range of information on health and
other information that may affect them, including:
Brochures:
Depleted Uranium & Health Pocket Guide For Clinicians
(May 2007)
Special Health Registry Examination Programs (including
the Gulf War Health Examination Registry Program) (June 2006)
Your Story: Tell Your Military History (November 2005)
Fact Sheets:
OIF Veterans: Information For Veterans Who Served In Iraq
In 2003-04 and Beyond and Their Families (IB 10-166) December 2004
OEF Veterans: Information For Veterans Who Served In
Afghanistan and Their Families (IB 10-71) December 2004
Ionizing Radiation Brief: Fact Sheets For Those Concerned
About Possible Long-Term Health Consequences of Ionizing Radiation
Exposure (December 2004)
Newsletters:
OEF/OIF Review: Information for Veterans Who Served In
Afghanistan and Iraq and Their Families (July 2007)
OEF/OIF Review: Information for Veterans Who Served In
Afghanistan and Iraq and Their Families (April 2007)
Pod Casts (downloadable audio files for veterans):
Polytrauma Centers (April 2007)
Blast Injuries (April 2007)
Transition Assistance Advisors (April 2007)
New Brochure Explains Registry Programs (April 2007)
Newsletter Editor Rosenblum Retires (April 2007)
Readjustment After Deployment (April 2007)
How To Apply For Disability Compensation From VA (April
2007)
En Espanol: Como aplicar para la compensacion de
incapacidad en el VA (Abril 2007)
Special Compensation (April 2007)
Quick Guide To Traumatic Brain Injury (April 2007)
WRIISC: National Referral Program (April 2007)
WRIISC: Transition and Orientation Class (April 2007)
Under Secretary for Health Information Letters (IL):
Under Secretary for Health's IL 10-2006-010: Potential
Health Effects Among Veterans Involved In Military Chemical Warfare
Agent Experiments Conducted From 1955 to 1975 (August 14, 2006)
Chemical Warfare Agent Experiments among U.S. Service
Members (Updated August 2006)
VBA Letter and DoD Fact Sheet and FAQs For Veterans
Involved in Military Experiments at Edgewood/Aberdeen with Chemical
Warfare Agents from 1955 to 1975 (June 30, 2006)
Under Secretary for Health's Information Letter (IL 10-
2006-004): Screening and Clinical Management of Traumatic Brain Injury
(January 25, 2006)
Under Secretary For Health's Information Letter (IL 10-
2005-020): New Study Reporting Increased Risk Of Brain Cancer Deaths
Among 1991 Gulf War Veterans Possibly Exposed To Sarin Chemical Warfare
Agent At Khamisiyah, Iraq (September 15, 2005)
DoD Letter, Fact Sheet and FAQs for Gulf War Veterans Who
Served Near Khamisiyah, Iraq (September 27, 2005)
Under Secretary for Health's Information Letter (IL 10-
2005-004): Health Effects among Veterans Exposed To Mustard Gas And
Lewisite Chemical Warfare Agents (March 14,2005)
Under Secretary for Health's Information Letter (IL 10-
2004-013): Guidance For The Diagnosis And Treatment Of Leishmania
Infection (October 6,2004)
Under Secretary for Health's Information Letter (IL 10-
2004-007): Possible Long-Term Health Effects from The Malarial
Prophylaxis Mefloquine (Lariam) June 23, 2004
Undersecretary for Health's Information Letter (IL 10-
2003-014): Long-Term Effects of Heat-Related Illnesses (November 20,
2003)
Veterans Health Administration Directives:
VHA Directive (2005-020)--Determining Combat Veteran
Eligibility (June 2, 2005)
Veterans Health Administration Handbook--VA Health Care, Benefits and
Eligibility Information for Veterans:
VHA Handbook 1303.2, Gulf War (Including Operation Iraqi
Freedom) Registry Program (March 2005)
``VA Health Care and Benefits Information for Veterans''
is a new wallet card that nicely summarizes all VA health and other
benefits for veterans, along with contact information, in a single,
wallet-sized card for easy reference (available online at www.va.gov/
EnvironAgents)
In collaboration with DoD, VA published and distributed
one million copies of a new short brochure called ``A Summary of VA
Benefits for National Guard and Reservists Personnel.'' The new
brochure does a tremendous job of summarizing health' care and other
benefits available to this special population of combat veterans upon
their return to civilian life (available online at www.va.gov/
EnvironAgents)
VA Health Care Benefits Eligibility (Link to VA Health
Eligibility Home Page)
Special VA Health Care Eligibility for Veterans Who
Served In Combat Theaters Fact Sheet, IB10-162 (December 2003)
Improvements in Health Care Eligibility
Based on VA's experience providing health care to
veterans of the 1991 Gulf War, VA supported legislation that provides
enhanced enrollment (Priority Group 6) placement for veterans who
served in a theater of combat operations after November 11, 1998. This
authority provides a 2 year post-discharge period of cost-free care or
services for conditions potentially related to this service.
Provides full access to VA's Medical Benefits Package for
recently separated combat veterans.
Summarized in the brochure and poster distributed to all
VA facilities called ``Special VA Healthcare Eligibility for Combat
Veterans,'' (available online at www.va.gov/EnvironAgents).
Poster:
Two Years Free VA Medical Care-New Combat Veterans (Sept 2006)
Special Reports on Gulf War Veteran Health Issues from the National
Academy of Sciences Institute of Medicine (The full reports are
available online at: www.nas.edu)
Health Risk Factors by the National Academy of Sciences
Institute of Medicine
Gulf War & Health Volume 1 (2DoD): Depleted Uranium,
Pyridostigmine Bromide
Sarin, Vaccines
Gulf War & Health Volume 2 (2002): Insecticides and
Solvents