[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
GULF WAR VETERANS: LINKING EXPOSURES TO ILLNESSES
=======================================================================
HEARING
before the
SUBCOMMITTEE ON NATIONAL SECURITY,
VETERANS AFFAIRS, AND INTERNATIONAL
RELATIONS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 27, 2000
__________
Serial No. 106-270
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
__________
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74-864 WASHINGTON : 2001
_______________________________________________________________________
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COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio
Carolina ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
LEE TERRY, Nebraska THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
HELEN CHENOWETH-HAGE, Idaho (Independent)
DAVID VITTER, Louisiana
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
James C. Wilson, Chief Counsel
Robert A. Briggs, Clerk
Phil Schiliro, Minority Staff Director
------
Subcommittee on National Security, Veterans Affairs, and International
Relations
CHRISTOPHER SHAYS, Connecticut, Chairman
MARK E. SOUDER, Indiana ROD R. BLAGOJEVICH, Illinois
ILEANA ROS-LEHTINEN, Florida TOM LANTOS, California
JOHN M. McHUGH, New York ROBERT E. WISE, Jr., West Virginia
JOHN L. MICA, Florida JOHN F. TIERNEY, Massachusetts
DAVID M. McINTOSH, Indiana THOMAS H. ALLEN, Maine
MARSHALL ``MARK'' SANFORD, South EDOLPHUS TOWNS, New York
Carolina BERNARD SANDERS, Vermont
LEE TERRY, Nebraska (Independent)
JUDY BIGGERT, Illinois JANICE D. SCHAKOWSKY, Illinois
HELEN CHENOWETH-HAGE, Idaho
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Lawrence J. Halloran, Staff Director and Counsel
Robert Newman, Professional Staff Member
Jason Chung, Clerk
David Rapallo, Minority Counsel
C O N T E N T S
----------
Page
Hearing held on September 27, 2000............................... 1
Statement of:
Feussner, Dr. John, Chief Research and Development Officer,
Department of Veterans Affairs, accompanied by Mark Brown,
Ph.D., Director, Environmental Agents Service, Department
of Veterans Affairs........................................ 49
Sox, Harold, M.D., professor and chair, Department of
Medicine, Dartmouth-Hitchcock Medical Center, accompanied
by Samuel Potolicchio, M.D., professor, Department of
Neurology, the George Washington University Medical Center. 27
Letters, statements, etc., submitted for the record by:
Feussner, Dr. John, Chief Research and Development Officer,
Department of Veterans Affairs:
Followup questions and answers........................... 75
Prepared statement of.................................... 52
Metcalf, Hon. Jack, a Representative in Congress from the
State of Washington, prepared statement of................. 4
Sanders, Hon. Bernard, a Representative in Congress from the
State of Vermont, prepared statement of.................... 24
Sox, Harold, M.D., professor and chair, Department of
Medicine, Dartmouth-Hitchcock Medical Center, prepared
statement of............................................... 31
GULF WAR VETERANS: LINKING EXPOSURES TO ILLNESSES
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WEDNESDAY, SEPTEMBER 27, 2000
House of Representatives,
Subcommittee on National Security, Veterans
Affairs, and International Relations,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2247, Rayburn House Office Building, Hon. Christopher
Shays (chairman of the subcommittee) presiding.
Present: Representatives Shays, Sanders, and Schakowsky.
Also present: Representative Metcalf.
Staff present: Lawrence J. Halloran, staff director and
counsel; J. Vincent Chase, chief investigator; R. Nicholas
Palarino, senior policy advisor; Robert Newman and Kristine
McElroy, professional staff members; Alex Moore, fellow; Jason
M. Chung, clerk; David Rapallo, minority counsel; and Earley
Green, minority assistant clerk.
Mr. Shays. I'd like to call this hearing to order, this
hearing of the Subcommittee on National Security, Veterans
Affairs, and International Relations of the Government Reform
Committee, which is conducting a hearing entitled, ``Gulf War
Veterans Linking Exposures to Illnesses.''
Doubts remain, and may always remain, about the role of
battlefield toxins and medicines in causing Gulf war veterans'
illnesses. Today, we continue our oversight of the statutory
process established to resolve those doubts in favor of sick
veterans seeking proper diagnosis, effective treatment and fair
compensation for their war-related injuries.
Embodying a recommendation made by this subcommittee, the
Gulf War Veterans Act of 1998 directs the Department of
Veterans Affairs [VA], not to wait for scientific certainty,
but to look for any plausible association between presumed
exposures and subsequent ill health. If credible evidence for
the association is equal to or outweighs the credible evidence
against, the VA Secretary is authorized to presume the illness
is service related for purposes of health care eligibility and
compensation determinations.
The National Academy of Sciences' Institute of Medicine
[IOM], recently completed a study of peer-reviewed research on
four of the agents of concern to Gulf war veterans: Sarin,
pyridostigmine bromide [PB], depleted uranium [DU], and
vaccines against anthrax and botulinum toxin. The IOM report
now under review by the VA suggests the difficulty and the
urgency of linking presumed toxic exposures with chronic health
effects.
Not surprisingly, medical literature to date contains
little evidence to support any association between low doses of
the agents in question and long term illnesses.
Those findings say far more about the stunted scope of
scientific inquiry over the past decade than about the likely
weight of scientific evidence. The significance of the report
lies in the fact the IOM found virtually no evidence that would
rebut a presumption of a causal association between these
agents and many of the maladies suffered by Gulf war veterans.
As the IOM panel noted, the task of establishing plausible
dose-response relationships was made more difficult by the lack
of hard data on wartime exposures and by the lack of adequate
military medical records.
Based primarily on studies following the Tokyo subway
attack, the committee did conclude sarin exposures inducing
immediate, if moderate, symptoms could also cause longer term
health effects similar to those observed in many Gulf war
veterans. But veterans' illnesses could not be more firmly
associated with sarin because battlefield medical surveillance
did not distinguish between the acute symptoms of mild sarin
toxicity and the myriad of other environmental and stress-
related health effects suffered by U.S. service personnel.
The IOM committee was also hampered by lack of access to
classified information held by the Department of Defense [DOD],
on toxic agents in the war theater. In the course of our
oversight, many have called for full access to DOD records on
chemical and biological detections. Given the statutory mandate
that VA search broadly for information on toxic exposures, the
VA should join us in pressing for declassification of all
records relevant to the health of Gulf war veterans.
Doubts remain. But our obligation to act now on behalf of
those willing to make a certain and timeless sacrifice can be
subject to no doubt, no delay. They earned the benefit of any
doubt about the extent of our debt to them. They should not be
asked to wait for certainty that might come too late, if at
all.
Mr. Metcalf is joining us from the great State of
Washington, and I'd welcome any comment you'd like to make.
Mr. Metcalf. Thank you very much. I do have a statement.
Mr. Chairman, I want to thank you for the opportunity to once
again be a small part of your courageous effort to answer
questions regarding Gulf war illnesses and the vaccines used by
our military personnel. Your determination to move forward and
find answers has provided vital leadership for Congress on this
critically important issue.
Indeed, we have an obligation to pursue the truth, wherever
it may lead us. To do less would be to act dishonorably toward
the dedicated men and women who stand between us and a still
dangerous world.
For that reason, I have issued a report I would like to
present to you and to the IOM committee culminating a 3-year
investigation into the conduct of the Department of Defense
with regard to the possibility that squalene, a substance in
vaccine adjuvant formulations not approved by the FDA, was used
in inoculations given to Gulf war era service personnel.
According to the GAO, General Accounting Office, scientists
have expressed safety concerns regarding the use of novel
adjuvant formulations in vaccines, including squalene.
The report reveals that the FDA has found trace amounts of
squalene in the anthrax vaccine. The amounts recorded are
enough to boost immune response, according to immunology
professor, Dr. Dorothy Lewis of Baylor University. Therefore,
my report concludes that, Mr. Chairman, you are absolutely
correct in demanding an immediate halt to the current Anthrax
Vaccination Immunization Program.
My report further states that an aggressive investigation
must be undertaken to determine the source of the squalene and
the potential health consequences to those who have been
vaccinated, both during and after the Gulf war.
The report also documents at length DOD, Department of
Defense, stonewalling attempts to resolve the squalene issue,
which GAO investigators characterized as a pattern of
deception. I think that's very significant. The GAO stated that
the Department of Defense denied, denied conducting extensive
squalene testing before the Gulf war, then admitted it after
being confronted with the public record.
The DOD denied conducting extensive squalene testing before
the Gulf war and then admitted to it after being confronted
with the public record. I think that's significant. The GAO
revealed that Department of Defense officials deliberating
deployment of the anthrax vaccine expressed a ``willingness to
jump out and use everything,'' that's a quote, in discussing
the experimental vaccines containing adjuvants not approved by
the FDA.
GAO also found Peter Collis, Department of Defense
official, who headed vaccine efforts, refused to cooperate with
them. The report states that the Department of Defense has
refused to act in good faith upon the GAO recommendations to
replicate the findings of a test developed by renowned
virologist, Dr. Robert Garry of Tulane University, although
Department of Defense admitted that they could easily do so.
The work of the Tulane researchers has been peer reviewed in a
scientific publication of high standing.
Finally, my report states that Congress should take
immediate action to review the findings of the GAO and the
Armed Services Epidemiological Board and provide independent
oversight for the immediate implementation of their
recommendations. The board called upon the DOD to engage in
close cooperation with the Tulane researchers.
Congress must get to the bottom of the labyrinth that has
become known as Gulf war illnesses. Mr. Chairman, you have been
in the forefront of this effort. As I am about to leave the
Congress, I just want to once again commend you for your
courage in this leadership role. Please stay the course.
Veterans, active service members and their families deployed
around the world are counting on you.
Thank you very much.
[The prepared statement of Hon. Jack Metcalf follows:]
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Mr. Shays. Thank you, Mr. Metcalf, and I was just going to
comment that you will be very missed. We have appreciated your
interest not only in this issue but in so many others, and I
was sorry when you announced you weren't running again and I
just know whoever gets to return next year, they will certainly
miss you, and I will just say whatever this committee has done
on this issue, and they have done, has been shared equally with
Mr. Sanders on this issue. He has been truly at the forefront,
and I welcome him here and I welcome any statement he'd like to
make.
Mr. Sanders. Thank you very much. And as Jack Metcalf just
said, you have played an outstanding role in keeping this issue
alive on behalf of tens and tens of thousands of men and women
who are suffering from Gulf war illness, and it has been a
pleasure to work with you and I applaud you for your
leadership.
Over the past 5 years you have worked diligently to hold
members of the military establishment accountable for their
actions and, most importantly, their inaction. You and I and
others have worked closely to try to get the Congress and the
administration to fund serious research into potential causes
and cures for the diseases known as Gulf war illness and to
push for compensation for those veterans who have contracted
these diseases. I am sad to say that despite our efforts we
have up to this date only had limited success. The findings of
the IOM study that we are examining today only serves to remind
us how far we have yet to go on this issue.
Some good news is that Chairman Shays and I worked very
hard this year to secure 1.6 million in the defense
appropriations bill for research into whether Gulf war
illnesses is the result of low level multiple toxin exposures
which manifests itself as a condition known as multiple
chemical sensitivity. We will be playing an active role in
making sure that this money goes for serious research into this
area.
I notice that Dr. John Feussner is here and he'll be
speaking later, and I look forward to his discussion, the
clinical study done with doxycycline and what the status is of
that report, which is also an area we've worked on.
Let me begin by stating how I approach the issue of Gulf
war illness, and that is when this country asks men and women
to serve in the Armed Forces and those men and women are
injured, whether in body or in mind or in spirit, the Federal
Government has an absolute, unquestionable obligation to make
those people whole to the maximum medical and scientific extent
possible. In addition, the Federal Government has an obligation
to compensate those veterans fairly, not to argue with them
every single day, but to give them the benefit of the doubt,
and when it is clear that veterans have been injured during
their service, we should not deny them compensation just
because we cannot say which particular exposure or combination
of exposures caused that injury. In my view, on all counts the
Federal Government has failed and failed miserably with respect
to Gulf war illness.
You know, one of the unanswered questions of our time, and
I certainly don't have the answer, Mr. Chairman, is that this
turning one's back on veterans has gone on in this country for
so very long. It started at the very least in World War II when
for years we ignored the impact of radiation illness. It went
to Vietnam, where veterans organizations had to struggle for
years and years to get the VA to acknowledge the horrendous
impact that Agent Orange had, and we're still struggling with
that fight today, and look what we have to do with Gulf war
illness. I don't understand it. I really do not understand why
when we ask men and women to put their lives on the line, when
they come home we fight them. We become the enemy that they--
similar to the enemy they fought in battle.
Over 100,000 veterans have reported suffering from some
combination of symptoms associated with the syndrome we call
Gulf war illness. Certainly it is important that we exhaust
every possible research avenue to find the cause and the cure
but we should not hold up compensation of Persian Gulf war
veterans who have very real illnesses, because we have failed
either through incompetence, insufficient resources or lack of
dedication, or just lack of scientific knowledge, to identify
the specific toxic compound or compounds that are responsible.
This is particularly true because the Pentagon's negligence in
keeping adequate records of exposures in the Gulf theater may
prevent us from ever finding a definitive answer.
As for the IOM study that we are reviewing today, I say
with all due respect to the IOM that this study only confirms
what most of us already knew. There is a dearth of research in
peer-reviewed scientific literature on the long-term health
effects of exposure to various toxins that our soldiers
encountered in the Gulf war theater.
Let me just add something to that. When I used to hear the
word ``peer-reviewed'' I thought that was the right thing. But
since I have been involved in this issue, you know when I hear
``peer-reviewed'' what it often connotes to me is the people
who do not know much about an issue who cannot come up with an
answer in an issue will always tell us what other people are
doing, cutting edge research, that it's not peer reviewed and
the peer-reviewed research that we hear tells us we don't know
anything, that's the good research, we don't know anything when
people are doing breakthroughs, who are doing cutting edge
stuff, is not peer reviewed, and that's a problem I have seen
for many years in this issue, in this area.
As the IOM reported, the peer-reviewed literature contains
inadequate or insufficient information to determine whether
there is an association between Gulf war illness and exposure
to depleted uranium, between Gulf war illness and
pyridostigmine bromide, between Gulf war illness and low level
exposure to sarin gas, between Gulf war illness and anthrax
vaccine or other vaccines or combinations of vaccines. These
findings do not come as a shock to me or anyone else who has
followed this issue.
The reason we do not have this research is that the Federal
Government and, in particular, the Pentagon has failed to keep
faith with the men and women who served in the Gulf. They have
dragged their feet and, were it not for the efforts of people
like Chairman Shays and the Gulf war veterans themselves, the
military long ago would have forgotten about this issue. There
would not have been--there would not be a Gulf war problem
today.
I do want to commend the IOM on their research
recommendations. These track the approach Chairman Shays and I
have been advocating. Instead of looking for one single toxin
as the cause of Gulf war illness, we need to investigate the
impact of the multiple, often low level exposures that Gulf war
veterans experienced. As the IOM report states, this, ``may
provide a more realistic approach toward understanding
veterans' health issues and may provide insights for preventing
illnesses in future deployments.''
Finally, Mr. Chairman, I want to express my concern that
there is still not the will within the military to get to the
bottom of this very real health emergency. In my view, it is
time for the military to make available to properly cleared
independent researchers--you know, if you go back to somebody
who year after year tells you, gee, I don't understand the
problem, gee, I don't have a cure for the problem, what do you
do? You go to a doctor that says, well, I'm not 100 percent
sure that I have it, but this is a breakthrough, we're working
on this. And the good news is you and I know, because you have
brought every serious researcher in the United States to this
committee, there are some good people out there doing some
breakthrough research. Let's put more emphasis on some of those
people.
So I want to just applaud you, Mr. Chairman, and commend
the veterans organizations for their persistence, and you and I
will continue to work on this issue, I'm sure.
Jack, thank you very much for your work over the years.
[The prepared statement of Hon. Bernard Sanders follows:]
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Mr. Shays. Thank you, Mr. Sanders. Just before going on
with our panel, I ask unanimous consent that all members in the
subcommittee be permitted to place an opening statement in the
record and the record remain open for that purpose. Without
objection so ordered.
I ask further unanimous consent that all witnesses be
permitted to include their written statements in the record
and, without objection, so ordered.
And I also without objection ask that the gentleman's
statement, Mr. Metcalf's statement, and report be included in
the hearing record, and I will move to include it in the full
committee hearing on anthrax next Thursday.
You have been patient. Thank you very much. We will call on
Mr. Harold Sox--Dr. Harold Sox, excuse me--professor and chair,
Department of Medicine, Dartmouth-HitchCock Medical Center,
accompanied by Samuel Potolicchio, who is professor, Department
of Neurology, the George Washington University Medical Center.
As you know, gentlemen, we swear you in and then we will take
your testimony. If you would please stand.
[Witnesses sworn.]
Please be seated. I thank our other two staff for standing
up in case you're required to make a statement. Thank you for
anticipating that. It's very thoughtful.
Dr. Sox.
STATEMENT OF HAROLD SOX, M.D., PROFESSOR AND CHAIR, DEPARTMENT
OF MEDICINE, DARTMOUTH-HITCHCOCK MEDICAL CENTER, ACCOMPANIED BY
SAMUEL POTOLICCHIO, M.D., PROFESSOR, DEPARTMENT OF NEUROLOGY,
THE GEORGE WASHINGTON UNIVERSITY MEDICAL CENTER
Dr. Sox. Good morning, Mr. Chairman and members of the
committee. My name is Harold Sox. I chair the Institute of
Medicine Committee on Health Effects Associated with Exposures
During the Gulf War, which released its report about 3\1/2\
weeks ago. I appreciate the opportunity to provide testimony to
you today based on the findings of our report. And I am
accompanied by Dr. Samuel Potolicchio, also a member of the IOM
committee.
The genesis of our report was a request from the Department
of Veterans Affairs asking the Institute of Medicine to study
the available scientific evidence on potentially harmful agents
to which Gulf war veterans may have been exposed. Congress
subsequently mandated a similar study specifying 33 specific
agents. Before going further, I want to clarify the scope of
the committee's work lest there be any misunderstanding.
The committee, IOM committee, was charged with assessing
the scientific literature about potential health effects of
chemical and biological agents present in the Gulf war theater.
The Department of Veterans Affairs will use the findings of the
report as it sees fit as a scientific basis for developing a
compensation program for Gulf war veterans. Our committee was
not asked to examine whether a unique Gulf war syndrome exists
or to evaluate the literature on Gulf war syndrome or
illnesses. The committee was not asked to make judgments about
individual veterans' level of exposure to the putative agents,
as there is a presumption of exposure for everyone who served
in the Persian Gulf theater.
For the first study of the series, the Institute of
Medicine chose to study the agents of most concern to the
veterans who advised us: Sarin, pyridostigmine bromide [PB],
depleted uranium, and the vaccines to prevent anthrax and
botulism.
Because there had been very few published studies of Gulf
war veterans, most of the studies that we examined were about
exposures in occupational, clinical and healthy volunteer
settings. The committee members carefully assessed each study's
quality, limitations and applicability, but it relied upon the
peer review system that precedes publication in scientific
journals as well.
Let me begin with the nerve agent sarin. Relatively high
doses of sarin can cause overstimulation of nerves and muscles
within seconds or hours, creating symptoms such as severe
cramping, difficulty breathing, twitching and heavy sweating.
All of these short-term effects are well-documented and our
committee ranked the evidence as sufficient to establish
causality, the highest level of evidence. The long-term effects
of sarin are a very different story. The evidence is far more
limited in quantity and is weaker.
Studies describing three different populations exposed to
sarin, two involving victims of terrorist attacks in Japan and
one involving industrial accidents in the United States,
establish possible links to neurological and psychological
symptoms that persisted for 6 months or longer after exposure.
In one of these studies some symptoms were still present up to
3 years after exposure. In all three studied populations,
however, the patients all had an immediate, intense, widespread
acute reaction, typical of high levels of exposure to sarin.
Among the symptoms that persisted over the long term in these
individuals were fatigue, headache, blurred vision and symptoms
of post-traumatic stress disorder. It's important to remember
that people who had long-term symptoms had all experienced
intense symptoms immediately.
Because we are dealing with only three studies and because
we could not rule out explanations, other explanations for the
effects, the committee categorized these findings as limited or
suggestive of an association well shy of the evidence needed to
establish a strong link, but clearly warranting further
investigation. We recommend long-term research to track the
health of victims of the sarin attacks in Japan, since
controlled studies of them offer the best opportunity to see if
sarin has long-term health effects.
Few, if any, veterans reported symptoms of acute exposure
to sarin in the Persian Gulf theater. Therefore we concerned
ourselves with possible effects of sarin in doses too low to
cause the acute reaction.
Based on available evidence, we could not form a conclusion
about an association between the long-term health effects and
exposure to doses of sarin that are low enough so that
immediate signs and symptoms did not occur. Yet research with
nonhuman primates gives us a hint that low doses of sarin over
a period of several days may create delayed neurological
reactions. More research is needed to substantiate this single
finding.
The second agent that we considered was the drug
pyridostigmine bromide [PB]. There have been many studies of
the short-term effects of PB. The committee judged this
evidence to be sufficiently strong to demonstrate an
association between exposure and the immediate onset of mild
transient symptoms, a link seen consistently in many studies.
Long-term side effects of PB are another story. There simply
was not enough evidence to draw any conclusion about PB's long-
term effects. In other words, we don't know if they occur and
we can't be certain that they don't occur.
The author of one series of studies has suggested that PB,
either alone or in combination with other chemicals, may be
related to some chronic changes in nerve function reported by
Gulf war veterans. However, weaknesses in the design of these
studies, which include uncertainty about whether exposures
occurred and a small number of affected subjects, made it
impossible for us to decide if exposure to PB is associated
with long-term nerve damage. We recommend further investigation
of this issue using an improved study design.
The third agent was depleted uranium. Health effects of
natural uranium have been widely investigated, mostly in
occupational settings, principally workers in uranium
processing mills. While these studies have shown that uranium
either has no effect or only a small effect, our committee
found weaknesses in many of these studies. We could not draw
conclusions about exposure to uranium and death from a number
of diseases, including lymphatic or bone cancer, nonmalignant
respiratory disease and diseases of the liver and
gastrointestinal tract.
We were able to arrive at more certain conclusions
regarding two diseases, kidney disease and lung cancer. We
concluded that there is limited evidence of no association
between kidney disease and exposure to uranium. We based this
conclusion on adequate consistent studies that showed good
kidney function despite continuous exposure to uranium as it
dissolved from uranium fragments embedded in body tissues.
Similarly, at low levels of exposure to uranium, we found
limited evidence of no association between--with death from
lung cancer. At higher levels of exposure, though, the evidence
did not permit any conclusion about a relationship between
uranium and lung cancer. We recommend followup research on
veterans with embedded fragments of depleted uranium and other
long-term studies.
Finally, our committee considered the vaccines given to
prevent anthrax and botulism. Based on our review of the
scientific literature, we concluded that the evidence is
sufficient to demonstrate an association between these vaccines
and subsequent short-term local and systemic effects similar to
those associated with any vaccination. But when we sought
evidence for more lasting effects, we didn't find any
published, peer-reviewed studies that systematically followed
subjects over the long term. This situation is not unusual as
vaccines are seldom monitored for adverse effects over long
periods of time.
Since troops usually receive several vaccines, often within
a short span of time, some have questioned whether several
vaccines in combination may have created a cumulative effect
that would not occur with any single injection. Although we did
find some research on cumulative effects of combinations of
vaccines, the shortcomings in these studies made it impossible
for us to form a strong conclusion. We did decide that this
evidence was inadequate to determine whether an association
with long-term effects exist.
I have provided a brief overview of our report's findings.
The IOM is beginning the second phase of the study, in which it
will examine the literature on health effects of pesticides and
solvents. This study is scheduled to be completed in 2002, as
the committee must review a vast body of literature on these
compounds. Plans for future IOM studies include completion of
the studies of the remaining agents listed in the legislation.
In addition, the IOM will update its studies and reports as new
studies become available in the published literature.
Thank you. Dr. Potolicchio and I will be happy to respond
to your questions.
[The prepared statement of Dr. Sox follows:]
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Mr. Shays. You needed a cheat sheet like I had,
Potolicchio, correct?
Dr. Potolicchio. It's an Italian name. Just follow all the
vowels.
Dr. Sox. Sorry, Sam.
Mr. Shays. Just trying to get back at all those tough
medical names that you guys have. What we're going to do is
we're going to start out with Mr. Sanders, I'm going to ask
some questions, and then we've been joined--Ms. Schakowsky is
here. I will recognize her third and then we'll go to Mr.
Metcalf, who's not an official member of this committee, though
he has all the rights to ask the same questions we will, but
just then at the end. Mr. Sanders. And we're going to go 10
minutes. We'll do 5 and 5, roll over 5.
Mr. Sanders. Thank you very much, Mr. Chairman. Let me
start off by asking you the question. You say in your
statement, Dr. Sox, that for the first study of the series the
Institute of Medicine chose to study the agents of most concern
to the veterans, sarin, pyridostigmine bromide, depleted
uranium and the vaccines to prevent anthrax and botulism. Now
isn't one of the problems that we have is that we're sitting in
a lovely room here in Washington, DC, but the reality of life,
when you're at war, is that it may not be just one--there may
not be just one agent that impacts on you. For example, 23,
you're sitting there, you're scared to death, sitting in the
heat, that the next day there may be a nerve gas attack on you.
Psychologically what does that do to you? Meanwhile, at some
point during the theater you may have been exposed to sarin,
you may have been given a pyridostigmine vaccine, you may have
had anthrax, you may have been exposed to burning oil wells,
you may have a genetic disposition, you may have come from a
place in your whole life you didn't absorb a lot of chemicals,
so you're more susceptible to multiple chemical sensitivity. So
my life history going into that battle is very different say
than Mr. Shays. And so you add all of those things together,
isn't there a problem that we're not looking at the totality
and the synergistic impact rather than sarin here, depleted
uranium here? Isn't there more to it than just one possible
agent, and isn't that lacking in the way we're approaching this
problem?
Dr. Sox. Well, our--the answer to your question is yes. We
need to be aware of the potential for interactions between
different agents as well as potentially a person's past history
of exposure and, in an ideal study, to try to look at the links
between agents and combinations of agents. We would have a
clear understanding of an individual's personal exposure
history, both before and after service in a theater of war and
then reliable information about subsequent health experiences,
and then we would try to link those together and see if we can
detect effects that would not be seen looking at a single
agent. Most of the research on the health effects of the agents
that we studied were on single agents. In fact, we found only
one study in our search which suggested a possible link between
two agents, one in which mice that were injected with PB were
subjected to the stress of having to swim.
Mr. Sanders. All that I am saying, and I have got a number
of other questions, in the real world it is not just sarin,
she's in the military, she's suffering trauma being there, and
so forth and so on, that's the reality. It's not just we're
sitting in a laboratory and we give somebody some sarin.
No. 2, I want to make sure I understand exactly what your
report says. Am I correct that you have not ruled out, not
ruled out depleted uranium, pyridostigmine bromide, sarin gas,
anthrax vaccine or multiple vaccines or some combination of
these as the cause of Gulf war illness, you have not ruled them
out?
Dr. Sox. Our study was to look at the linkage between these
four exposures and health effects, both diseases that are in
textbooks as well as diseases that are not in textbooks because
they're not well understood, such as Gulf war illnesses, and
while we didn't find any compelling evidence that these
exposures do cause health effects, neither was the evidence
strong enough to conclusively rule out that they were not
present. The closest we came was kidney disease and lung cancer
with depleted uranium.
Mr. Sanders. OK. I know that your mandate was only to
review the peer-reviewed scientific literature on links between
certain toxins and the symptoms that many Gulf war veterans are
experiencing. Clearly, though, you had to undertake some
background research into the types of symptoms these veterans
are experiencing and the extent of those symptoms in order to
do this analysis, is that correct?
Dr. Sox. Yes, sir.
Mr. Sanders. OK. Based on that background review, is it
your medical opinion that in general Gulf war veterans are
suffering from a physical illness or illnesses as opposed to
what might be termed a psychological condition?
Dr. Sox. Again, our committee charge was not to establish
existence of a Gulf war syndrome. We read the published
literature on this subject in order to provide background for
our study of these compounds and their possible health effects,
both on unexplained Gulf war illnesses as well as other
illnesses. So if you want my personal opinion as a physician, I
would say that ever since the Civil War, veterans of combat
have experienced unexplained symptoms, and there's a great deal
of overlap as you look at the symptoms that they experience in
war after war coming right down to the present. So there's no
question in my mind but what veterans do suffer unexplained
illnesses, but this is a personal opinion. It was not a
judgment of our committee. We didn't look at that question.
Mr. Sanders. In your medical opinion, based on the
background research you did, in your own experience does the
fact that over 100,000 Gulf war veterans out of a total of less
than 700,000 soldiers who served in the Gulf war have some
combination of these symptoms suggest to you that these
conditions we refer to as Gulf war illness have a connection to
service in the Gulf war? In other words, if you have 100,000 or
more folks out of 700,000 who have come down with a variety of
illnesses now, it could be absolutely coincidental?
Dr. Sox. Well, again you're asking me to express a personal
opinion, which is somewhat more informed than the average
physician, but I am not expressing an opinion based on the
findings of our committee, and based on my personal reading of
those articles, I think that there's a relationship between
service in the Gulf war and these unexplained illnesses, but
that was not a subject of the study.
Mr. Sanders. Based on your own personal experience.
Dr. Sox. My own personal reading of those articles.
Mr. Sanders. I appreciate that. In your view, is it
possible that we will never establish the precise cause of Gulf
war illness other than to conclude that it has some connection
to service in the Gulf war.
Dr. Sox. I don't know how to answer that, sir. We have a
number of exposures still to study and I would not want to form
a judgment about what those studies might find. I don't have an
opinion on that.
Mr. Sanders. My last question is: Would you please explain
what steps you took, if any, to obtain data from the DOD? Were
they cooperative; were they not cooperative? You apparently did
not get to review the classified materials. Did you request to
and do you have staff who have security clearances?
Dr. Sox. Well, we did not actively seek DOD documents. Our
charge was to study the published peer-reviewed literature, and
there's a history of several hundred years that states that
reliance upon scientific reports that have undergone peer
review forms a credible basis for forming scientific judgments.
And DOD documents, they are not scientific reports and so--but
to answer your question briefly, we did not seek them. We were
not interested in the level of exposure of individual veterans
because that's something that because of presumption of
exposure exists.
So it wasn't part of our charge to study DOD documents, and
we did not request them.
Mr. Sanders. Mr. Chairman, thank you very much.
Mr. Shays. Let me, if you don't mind, not on anybody's
time, but just ask Mr. Potolicchio if he would want to respond
to any of those questions that you asked. Is that all right?
Mr. Sanders. Sure.
Mr. Shays. And then you can followup.
Dr. Potolicchio. I think Dr. Sox has answered the questions
appropriately.
Dr. Sox. If you think I am not doing a good job, you will
interrupt.
Mr. Shays. Let me say because you're both partners here,
you had one statement, but I don't mind if a question is
directed to one of you to have the other jump in either with a
qualifier or with whatever. I'd like either one of you to
respond to--first, I'd like to just make a point. I wrestle
with the fact that in terms of criminal law you're presumed
innocent until guilt is proven and not, at least in the United
States, presumed guilty until proven innocent. But I have the
feeling that veterans are basically sentenced guilty because
they're ill and they're guilty with no help in sight, and I
have this general view that's come about through so many
hearings that because there isn't a proven study or something
that documents, therefore they're not going to have the
presumption of an illness caused by their experience in the
Gulf and therefore they are not going to get the help, not
because there isn't that connection but because we can't
illustrate that in fact there is that connection. And I
understand where you come from as doctors and I think you
understand where we come from as people who actually sent them
off to war. And so I'm troubled by the fact that we still have
a system that is not going to help our veterans and that maybe
20 years from now they will prove there was this connection but
by then it will be too late.
So I don't have the same kind of patience that I think some
people have. My understanding is that you have looked at sarin,
you've looked at pyridostigmine bromide, you've looked at
depleted uranium, and you're looking at vaccines that were
intended to prevent, deal with anthrax and botulism, and it's
my understanding that the committee--let me say this to you
before I ask the specific question. It's also my sense that the
bill we passed makes the presumption of exposure to 33 agents;
in other words, that at least we're not going to debate about
it and then allow--that is the keyword, ``allow''--the VA to
establish a presumption that the exposures are related to
illness and they're going to look at what you all have done and
they are going to come to some conclusion. It allows but does
not require.
Now when you tried to establish the categories of
association from previous IOM studies, you would first agree
that in some cases you were hampered by the fact there weren't
enough studies, is that correct?
Dr. Sox. Enough studies.
Mr. Shays. I'll start with you, Dr. Sox.
Dr. Sox. Well, there were not enough studies of a quality
that allowed you to make a scientific conclusion, yes, sir.
Mr. Shays. But not necessarily related to war experience?
Dr. Sox. Well, there were very few studies related to war
experience. Most of them are in other settings, yes, sir.
Mr. Shays. And none of these studies would enable you to
deal with the isolated--all things being equal, you look at a
particular agent and then you've come up with some conclusions,
is that correct? In other words, everything else is frozen?
Dr. Sox. Most of them are isolated studies in which you
looked at one exposure in isolation of others.
Mr. Shays. And so you would certainly acknowledge, as I
think Mr. Sanders has pointed out, that all things aren't
equal, all things aren't held constant, there's exposure
potentially to something but there's also exposure to others?
Dr. Sox. Yes, sir.
Mr. Shays. Would you make any comment, Dr. Potolicchio?
Dr. Potolicchio. Maybe just one brief comment and that is,
for instance, if you take two of the agents that we're
considering here, pyridostigmine and sarin, actually one of
them is given in order to protect the individual from exposure
to the other. So they are given, they're sort of given
simultaneously, but one hopefully is going to be protective and
there's scientific evidence to prove that's the case.
Mr. Shays. Did you look at any studies that tried to
determine what would happen if someone took more than the
required allotment of PB? For instance, I have this tendency if
I am putting fertilizer on my lawn, at least I did, that if one
bag was good, two bags was better and three bags would be
really terrific and I ended up with a lawn that was totally
dead, and I know for a fact from our witnesses that we had some
who took the pill far in excess of what was recommended, far in
excess. They went through that same logic. Did you look at any
study that would have helped you determine that?
Dr. Potolicchio. There were, we know from--and there's
clinical evidence that if you take a whole bunch of
pyridostigmine, let's say hundreds of pills, that you're going
to really get sick, vomit and know that you have taken it, and
I think that clinical response at least, tells you that we
better not take anymore.
Mr. Shays. You know that from just observation, but did you
look at any studies? In your peer review that dealt with taking
too many pills, not your intuitive sense. But did you, was that
part of your reviews and what reviews did you do? I'd like to
know specifically.
Dr. Potolicchio. Well, there are case reports of people
being overexposed to certain agents, particularly
pyridostigmine, and they will have clinical signs. But were
studies taken in a double blind fashion that, you know, we were
going to see how much can a person take of the drug, just to
see what the side effects are going to be? No.
Mr. Shays. No. The view--we have had extensive testimony
from MDs that have said that once you've taken so many you open
yourself up to exposures that you wouldn't have been opened up
to before, and the question I'm asking you is have you looked
at anything in that regard?
Dr. Potolicchio. The only studies that look at large doses
of pyridostigmine are those confined to myasthenics; in other
words, myasthenics have taken relatively large doses of
pyridostigmine over a long period of time and there really
haven't been any long-term health consequences of that. But as
far as acute exposure to very large doses, will pyridostigmine
kill you basically? We know well that sarin in little drops
will kill you, but pyridostigmine will not kill you.
Mr. Shays. That's not what I'm asking. See, if you had been
on this side you would have been, you would have been exposed
to what we were, and that was that we had--we'd start our
hearings from sick veterans who would explain to us that they
were given really no instructions on what to do with these
pills and that they didn't take them for days and then they
took a lot of them, and then we had researchers come in and say
that the impact on your brain and what it does in terms of it
opens up the potential for other illnesses, so--do you want to
just jump in?
Mr. Sanders. Mr. Chairman, perhaps you have a better memory
than I do, but I recall that we had the pharmacologist from
Maryland, Dr. Teet, I believe his name was, who if I remember
correctly said that that there is evidence if you are--it's one
thing to take PB before exposure to sarin, which is the goal of
presumably what that benefit was, but that if you take PB after
the exposure to sarin it has an extremely negative impact.
That's my memory, and I was wondering if they had looked at
that.
Dr. Potolicchio. There is, there is evidence that that's
true because, you know, sarin, remember sarin is an agent that
irreversibly blocks your cholinesterase. So in other words,
once you're exposed to it and that cholinesterase is basically
crippled, therefore if you take another anticholinesterase on
top of it after having that acute exposure, obviously you're
going to amplify that. That's true. I don't disagree with that.
Mr. Shays. The question I'm asking is was that part of your
peer review?
Dr. Potolicchio. The study that you're referring to is done
only in animals. There is no evidence in humans that that kind
of after exposure is going to lead to further compromise.
Mr. Shays. I still want an answer, though. It wasn't part
of your peer review because there were no studies?
Dr. Potolicchio. In animals.
Mr. Shays. But there were no studies in humans?
Dr. Potolicchio. There are no studies in humans.
Mr. Shays. So it's not part of your peer review?
Dr. Potolicchio. Correct.
Mr. Shays. So what am I supposed to conclude in that? And
what I conclude, I think, is that it kind of relates to your
observation about peer review, there's no peer review there,
but I'll tell you what happened when your report came out. The
press said there's no linkage, you've discounted and--but it's
like not having all the facts, and this is what--you know, I
know you're doing your best but the bottom line is what are we
supposed to conclude.
Dr. Sox. Well, no evidence isn't the same as evidence of no
effect.
Mr. Shays. Say that again.
Dr. Sox. No evidence is not the same as evidence of no
effect. So clearly the press, if they concluded there was no
effect, made a mistake.
Mr. Shays. I understand, but that's the reality.
Dr. Sox. Yeah.
Mr. Shays. Would you walk me through, and then I will go to
my colleague, on the concept of sufficient evidence of a causal
relationship, sufficient evidence of an association, limited
suggested evidence of an association, inadequate, insufficient
evidence to determine whether an association does or does not
exist, and then limited suggested evidence of no association,
so there are five categories. If you would walk me through
those.
Dr. Sox. It will just take me a minute to find them.
Mr. Shays. Yeah, take your time.
Dr. Sox. First of all, the causal relationship. The
evidence fulfills the criteria for sufficient evidence of an
association; that is to say, all of the other levels of
evidence, and satisfies several of the criteria that have been
used to assess causality.
Mr. Shays. So that would be the most certain, you would
have very little doubt there's evidence of a relationship?
Dr. Sox. Yeah, it is very hard to----
Mr. Shays. The causal relationship.
Dr. Sox. Yes, sir.
Mr. Shays. The cause and effect. The second one is
sufficient evidence of an association.
Dr. Sox. And that states that there's been a positive
association between an exposure and a health outcome in studies
where other factors that might confuse the interpretation of
that relationship can be ruled out with reasonable confidence,
so that you think you can focus just on the exposure and not on
other factors that might lead to the same result.
Mr. Shays. The next one is limited suggestive evidence of
an association.
Dr. Sox. Here there's, there is evidence of an association
between an agent and health outcomes, but the strength of the
conclusion that you can draw is limited because you can't be
sure that other factors that might explain the results aren't
present. So you might have four or five things that could
account for the result, one of which is the exposure. You can't
be sure that the other ones aren't there and accounting for at
least part of the effect.
Mr. Shays. We have two more. Inadequate, insufficient
evidence to determine whether an association does or does not
exist, and I would assume that's neutral, you can't go either
direction?
Dr. Sox. It doesn't change your thinking one way or the
other. It's like there isn't any information.
Mr. Shays. But the first three lead you toward----
Dr. Sox. Uh-huh.
Mr. Shays. The last one is limited suggested evidence of no
association. So we have those five. If you would just quickly
tell me, sarin fit which category again?
Dr. Sox. Well, the acute effects of sarin were a causal
relationship.
Mr. Shays. So that's the strongest you could have.
Dr. Sox. Yes, sir. And then there were long-term effects in
people who experienced the acute effects and that came in the
limited suggestive category.
Mr. Shays. OK. That was just one higher than neutral?
Dr. Sox. Inadequate, yes, sir, and then----
Mr. Shays. PB.
Dr. Sox. Just to finish on sarin, evidence for long-term
effects in people who did not experience any short-term effects
of sarin, there was just no information except the one study in
primates, which obviously requires a lot of followup.
Mr. Shays. OK. And PB.
Dr. Sox. In PB, the evidence was sufficient of an
association between PB and acute effects lasting pretty much
during the day that you took it.
Mr. Shays. No long-term harm?
Dr. Sox. But in terms of long-term effects the evidence was
inadequate to determine whether there was or was not an
association.
Mr. Shays. But you didn't look at whether PB then opened
the door for other illnesses with other agents? I mean, that's
on the record, correct?
Dr. Sox. There wasn't, there weren't any studies that
showed us that PB opens the door to other exposures causing,
leading to illness, yes, sir.
Mr. Shays. Thank you, and depleted uranium.
Dr. Sox. Depleted uranium, with two exceptions, the
evidence was inadequate to determine whether an association
does or does not exist. The two exceptions were lung cancer and
kidney disease and in those cases there was limited or
suggestive evidence of no association.
Mr. Shays. OK. And then finally, vaccines to prevent
anthrax and botulism?
Dr. Sox. There was sufficient evidence of an association
between immunization or vaccination and acute effects lasting a
day or two, the sort of thing that many of us in this room have
experienced. But the evidence was insufficient, similarly, just
wasn't there. The studies weren't there----
Mr. Shays. You couldn't determine one way or the other?
Dr. Sox [continuing]. To determine any long-term effects.
Mr. Shays. So that's a neutral issue?
Dr. Sox. Yes, sir.
Mr. Shays. Thank you very much, and, Ms. Schakowsky, I do
appreciate your patience. Thank you.
Ms. Schakowsky. Thank you very much, Mr. Chairman. I
haven't been here as long as the chairman or Mr. Sanders, but I
have to tell you that in the hearings we have had regarding
issues where we put our people in the Armed Services in harm's
way and the kind of information we had, it has been very, very
frustrating. It seems in some ways that the policy of our
government is no news is good news or no findings are good
findings or no studies are good studies. And I'm looking
through your testimony, Dr. Sox, and I see words like ``limited
studies.'' Because of the limited studies in Gulf war veterans,
when it comes to long-term health effects of these substances,
the bottom line is we simply don't know enough on PB. There
simply was not enough evidence to draw any conclusion about PB.
In other words, we don't know long-term effects, if they occur,
and we can't be certain if they don't occur. Weaknesses in the
design of these studies made it impossible for us to decide.
When it came to anthrax and botulism, we've had lots of
hearings on anthrax. When it came to evaluating more lasting
effects, we didn't find any published peer review study. I'm
saying pretty much what everybody has said already. This is not
unusual. As few vaccines have been monitored for adverse
effects over long periods of time. When it comes to
combinations, you say the shortcomings in these studies made it
impossible for us to form a strong conclusion, and I am
wondering if we're going to go on for another 10 years, and I
realize this isn't your fault.
I'm just trying to ask you what we can do about this. We
come and say, well, someone studied your study and what they
found was there wasn't enough information. We keep doing
studies of studies that have been done that say there hasn't
been enough study. So I'm wondering when we get down to doing
some real study and what your recommendations would be so that
next time we have a study we can come back with some real
reports.
Dr. Sox. Well, the wheels of research grind slowly.
Ms. Schakowsky. Are they in process?
Dr. Sox. Pardon me.
Ms. Schakowsky. Are they in process?
Dr. Sox. Basically physicians have known about postwar
syndromes, as I said, since the Civil War and, from my
understanding, serious research into the cause of those
syndromes really has only begun after the Persian Gulf war. So
we're, in my opinion, at the beginning of serious, careful
study of an important group of illnesses that have existed for
100, nearly 140 years and it's going to take a while to
accumulate good evidence.
LBJ declared war on cancer in 1968 and we have made a lot
of progress in understanding the biology of cancer, but
actually we're only now beginning to see some results or
promise of some results from that research 30, 35 years later.
I'm optimistic that we're starting on a process that's going to
lead us to answers, but I don't expect the answers to come
quickly.
Ms. Schakowsky. Well, inconclusive results of real clinical
studies that happen, that's one thing, and research that's
being done, but I'm just wondering what the protocols are, for
example, if we had--we made a decision about how many anthrax
vaccines, how many dosages we should give and etc., and then
when we come back and say well, based on what, what is your
knowledge of this, how do we know about its effectiveness and
its side effects, short and, well, mostly long term, so at what
point should we be doing these studies and I would say that,
that with agent orange, I mean, we have known about these
symptoms that result from exposures during wartime, but are we
engaged directly in the kind of research right now, and if
that's the case, I haven't really heard about it.
I mean, we heard when it came to anthrax all kinds of these
voluntary reporting systems and no real answer as to how are we
going to determine the effects.
Dr. Sox. Well I am not an expert on the current state of
research on Persian Gulf-related illnesses. Dr. Feussner, who
will be speaking to you shortly, I am sure can tell you what
studies are being done.
Ms. Schakowsky. Thank you.
Mr. Shays. Thank you. Mr. Metcalf does not have any
questions.
Mr. Sanders.
Mr. Sanders. Thank you very much Mr. Chairman. As I
indicated earlier because of the diligence of the chairman and
his staff, we have had the opportunity on this committee to
hear from, seems to me, some extraordinary researchers all over
this country who have been doing breakthrough work, and there
are a number of them, and I don't recall all of them, but I
just was kind of curious, two names come to my mind, and I
wonder if you can give me your views having reviewed their
works.
Dr. Robert Hayley is with the University of Texas, and as I
recall, not having his work in front of me, he is not ambiguous
about his belief that exposures in the Gulf have resulted in
brain damage, which are causing severe physical problems for
Gulf war veterans, no ifs, ands, buts and maybes, that is his
belief. What's your view on that?
Dr. Sox. Well, the committee carefully examined Dr.
Hayley's work and had the opportunity to talk with Dr. Hayley
about his work at one of our open sessions, and the committee
ultimately concluded that there were difficulties with the
design of Dr. Hayley's work that made it impossible to draw any
conclusions at this point.
I think our bottom line would be that in a small population
of veterans, Dr. Hayley has done some studies that generate
interesting ideas and hypotheses about the biological basis for
some of the symptoms that people are experiencing, but until
those studies are replicated by other investigators and larger
more representative populations, the evidence that Dr. Hayley
has produced is too weak for us to draw any conclusions upon
which to base in our report.
Mr. Sanders. Too weak in the sense that the number of
veterans, the sampling was too small.
Dr. Sox. Well, the sampling was too small. He studied
basically a group of symptomatic veterans, and he, using some
statistical techniques, put them in the subgroups which seemed
to have different combinations of symptoms, and then he looked
at different measures of brain function comparing one group of
sick veterans to another group of sick veterans. It's a pretty
basic principle of epidemiologic research to include an
unexposed control, somebody who never went into the Persian
Gulf theater, and with the exception of a couple of more recent
studies, he has not had unexposed controls, but even putting
that aside, the history of science is that you don't rely on
one study. You, somebody does a study, and then several people
try to replicate it. Sometimes they succeed and then it becomes
part of the body of scientific understanding, and sometimes
they don't and it falls by the wayside and right now, I think
Dr. Hayley's work is in the category of remains to be repeated
by other investigators.
Mr. Sanders. Are other people, to your knowledge, trying to
replicate that?
Dr. Sox. I will have to ask Dr. Feussner to respond to
that, I don't know.
Mr. Sanders. What about Dr. Urnovitz.
Dr. Sox. Doctor who?
Mr. Sanders. Urnovitz.
Dr. Sox. I don't know about his work. Sam, do you remember
anything.
Dr. Potolicchio. By name, I don't.
Mr. Sanders. Don't know his name, no?
Dr. Sox. None of us.
Mr. Sanders. Dr. Claudia Miller, peer review.
Dr. Potolicchio. Claudia Miller I think--we know we've had
exposure to Claudia Miller.
Dr. Sox. If I remember.
Mr. Sanders. She's involved in multiple chemical
sensitivity.
Dr. Sox. She gave us a presentation. We did not review the
literature on multiple clinical sensitivities and really don't
have a basis upon which to judge her work.
Mr. Sanders. See Mr. Chairman, may I repeat a point I made
earlier, what seems to happen, and I think Ms. Schakowsky was
making this point, we review people who say I don't know the
cause of Gulf war illness, I don't have a cure to Gulf war
illness, that's peer review. The people like Hayley or Urnovitz
or Miller who say, you know, I think we're on to something, I
think there's something real here, those are rejected because
apparently not enough people have peer-reviewed that, we push
them aside. It would seem to me, and correct me if I'm wrong,
given the fact that after--and I don't mean to be critical of
you. I know you're just one part. We've had 100 people up here
who keep telling us the same thing.
So we get a little bit frustrated, but when people come up
here and they say I think we're on to something, it would seem
to me that the logical reaction for Hayley's work or Urnovitz's
work or Miller's work would be for people to jump up and down
and say, thank God, we may have a breakthrough, why are we--are
you recommending for example that resources now be devoted to
replicate Hayley's work so that 5 years from now, we don't have
people coming before us saying Hayley's work was interesting,
but nobody's replicated it, so why don't we replicate it? Tell
us that Hayley is wrong or he is right, or Urnovitz is wrong or
is right.
Dr. Sox. You know the history of scientific enterprise is
somebody comes up with a finding and then somebody funds
studies to try to replicate that study. So the answer to your
question is yes, if somebody comes in here and makes a claim of
an important result, the answer should be to fund other
investigators to replicate the result.
Mr. Sanders. I agree with you but based on that I mean all
that you told me about Hayley, Urnovitz, you've never heard of
Hayley. You said there is nobody, you know, he's out there, we
don't have enough evidence to suggest that he is right or
wrong, but you should be coming in here and saying this guy is
saying something that's significant, it's different to other
people, he's claiming some results, either he's crazy or he's
not, let's find out; true?
Dr. Sox. Well, yes and in our research recommendations, we
called for work to replicate Dr. Hayley's findings.
Mr. Sanders. One of the things that we can use--we have
gone through this for 10 years, so what we would like people to
say is look, there are some breakthroughs here, we cannot tell
you at this moment whether these people are right or wrong,
maybe they're wrong, let's find out and say that they're wrong,
or if they are right, let's devote a whole lot of money to
moving forward so we can use their research to develop a cure
for Gulf war illness. I didn't hear you say that.
Dr. Sox. Did you hear me say it?
Mr. Sanders. No, I didn't hear you say it.
Dr. Sox. Well----
Mr. Sanders. For example, tell me now, based on all of your
research, if you were the President of the United States, or
better yet, if you were going to recommend to the President of
the United States, Mr. President, we have got a problem and I,
based on all of my research, advocate to you that you spend X
dollars in the following areas because we have some promising
breakthroughs, but we just don't know about it. What would you
recommend to the President?
Dr. Sox. Well, I would recommend to the President a program
of research to try to replicate some of the interesting results
of investigators like Dr. Hayley, but I probably also call upon
the President to establish a committee, to establish research
priorities so we don't just focus on the areas where some
scientists are working, but also going out and looking at areas
where nobody has looked yet, perhaps for lack of funding, so in
other words, we need a comprehensive approach to the study of
postwar illnesses, and part of that approach is to followup on
promising results of investigators like Dr. Hayley.
Mr. Sanders. But that's where we were 10 years ago. You've
studied all of the literature. So I am asking you, all right,
give me, at this point, if you can, who are the people out
there that you see are doing breakthrough work that, in fact,
need help right now for additional funding so that we can
determine whether they're right or whether they are wrong. Is
Hayley one of them?
Dr. Sox. I don't know anything about Dr. Hayley's funding,
but clearly, Dr. Hayley is studying veterans and coming up with
some interesting results, but I'm not sure it's Dr.--that Dr.
Hayley needs more money. It may be that other people need more
money to followup on his studies and to take it to the next
step.
Mr. Sanders. That's fine I am not here defending Dr.
Hayley. All I am saying is you've done a lot of research;
you're a scientist we are not. You have studied the literature.
Can you just tell us who are the people out there you are
thinking that you think are doing breakthrough work that we
should try to give more support to?
Dr. Sox. Well, the only name that comes to mind is Dr.
Hayley. I do believe that the Baltimore group has been studying
the veterans with depleted uranium fragments needs continued
support but if--but I really don't think that I should be the
person to tell you who ought to be funded. I think that's
something for more deliberation.
Mr. Sanders. In all due respect, I disagree with that. We
need guidance. We are not scientists, you are, and what we need
help on is for somebody to come before us and say look these
guys have been doing this stuff for 10 years. It's going
nowhere in a hurry, this is possible, this is potential we do
need that kind of help Mr. Chairman.
Mr. Shays. The other place we need help is when you're
looking at what studies are available and you realize there
just aren't any peer review studies in certain areas. I'd like
to--in general, I'd like to read one paragraph, then we're
going to get on to the next panel, unless Ms. Schakowsky has
any questions. But this is the paragraph on page 3. It's a
fairly long one, but I am going to read it all to you. It
starts out--it's kind of in the middle of the page.
All these short term effects are well documented, and we
rank the evidence as sufficient to establish causation, the
highest level of evidence. In part, this means--and we're
talking about nerve agent sarin--in part, this means many
studies have strongly repeatedly and consistently linked these
acute health effects and exposures to sarin, and that the
greater the exposure, the greater the effect, but the long-term
effects of sarin are a very different story. The evidence is
far more limited and much weaker.
Studies describing three different populations, two
involving victims of terrorist attacks in Japan and one
involving industrial accidents in the United States, link
neurological and psychological symptoms that persisted for 6
months or longer. In one of these studies, some symptoms
persisted for up to 3 years, the longest that any of the
subjects were followed.
In all three studied populations, however, the doses of
sarin were high enough to trigger an immediate, intense
widespread and acute reaction. Among the conditions that
persisted over the long term were fatigue, headaches, blurred
vision and symptoms of post traumatic stress disorder. I might
just say parenthetically, that's a very common symptom for our
veterans who have come before our committee. In other words,
people who had long-term symptoms were the ones who had
experienced intense symptoms immediately.
Now, I want--the keyword here is ``intense.'' How did you
define ``intense?'' Was it walking intense or drop dead
intense? I mean, fall down intense? What defines ``intense?''
Dr. Potolicchio. The level of exposure was based only on
clinical findings, and maybe one laboratory test when it was
available. You know, there is no real exposure data on sarin in
any of the Japanese populations. We don't know how much any
individual got at any time. If you look at the reports and the
way they were written up, there was a man that was 100 feet
from the release of the gas in Matsumoto, Japan, and he opened
the window of his room and that man eventually died in
convulsions and respiratory arrest, and he was just a few
hundred feet away, but he probably had a maximum exposure but
nobody knows exactly how much.
Mr. Shays. I am just trying to understand.
Dr. Potolicchio. The thing is that when you get to the
clinical findings, you say, well, there has to be an intense--
in other words, someone's had an exposure, he, at least, had
some symptoms of exposure that we recognize and that would be
the acute cholinergic syndrome.
Mr. Shays. I understand that.
Dr. Potolicchio. Or the enzyme that you measure in the
blood is depressed to such a degree----
Mr. Shays. Let me not get to that. Let me just get to your
concept of ``intense,'' and I want to relate ``intense'' into
war. I mean, I can remember when I was being chased by some
older kids who wanted to beat me up, I've never run so fast. I
didn't even know that I was exhausted. I was so damn afraid. I
ran across a highway without looking either direction, and as
far as I was concerned, I was pretty healthy, but later I
realized I was just, I was just totally--I was sore, I was
always these things and I was sore when I was running, but I
didn't know that. I didn't have people shooting at me. So I
guess what I'm trying to determine is are you making an
assumption that there was not an intense exposure in the Gulf
because people didn't fall down or something?
Dr. Potolicchio. We're not making an assumption about
anything that happened in the Gulf war theater. We're saying if
you have an exposure to sarin, you will have acute symptoms.
Now whether or not you can identify those----
Mr. Shays. Describe those acute symptoms, please.
Dr. Potolicchio. Well, your acute symptoms would be----
Mr. Shays. Would be fatigue, headaches, blurred vision,
what?
Dr. Potolicchio. No.
Mr. Shays. What would they be?
Dr. Potolicchio. Your acute symptoms would be difficulty
breathing, watery eyes, probably GI upset, in other words,
gastrointestinal upset, your muscles might start to twitch, and
you can actually go into a convulsion if the exposure is
intense enough.
Mr. Shays. But not necessarily. All those symptoms I would
wager our veterans have experienced in the Gulf, not all of
them but a good number, blurred vision.
Dr. Potolicchio. You wager they have been exposed to that?
Mr. Shays. We had testimony of people describing those very
symptoms, not after but during. OK. So the symptoms you have
described, just for the record I will state, was statements to
us by veterans that they experienced in the theater, clearly. I
think we're all set unless you have any, Ms. Schakowsky, any
questions. Thank you all very much.
Our next witnesses are John Feussner, Dr. John Feussner
sorry, chief research and development officer Department of
Veterans Affairs accompanied by mark brown Ph.D. director
environmental agents study, department of Veterans Affairs. Do
you all have anybody else that would help you in any testimony?
If so I would ask them to stand up. Thank you and if you're
asked to then respond, we would check out the names. I ask you
to raise your right hands please.
[Witnesses sworn.]
Mr. Shays. Note for the record that our witnesses have
responded in the affirmative and Dr. Feussner, you will be
making the statement, and Dr. Brown you would also be
responding to questions. Thank you very much. Appreciate your
patience.
STATEMENTS OF DR. JOHN FEUSSNER, CHIEF RESEARCH AND DEVELOPMENT
OFFICER, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED BY MARK
BROWN, Ph.D., DIRECTOR, ENVIRONMENTAL AGENTS SERVICE,
DEPARTMENT OF VETERANS AFFAIRS
Dr. Feussner. Mr. Chairman and members of the subcommittee,
thank you for this opportunity to discuss the status of the
current Federal research program on Gulf war veterans
illnesses. Accompanying me today is Dr. Mark Brown, who is the
director of the VA's Environmental Agents Service.
In your invitation letter, you indicated that the purpose
of the hearing was to review the findings and recommendations
of the recent Institute of Medicine report. You also requested
a discussion of the plans for additional research by the IOM
and a status report on other research on Gulf war veterans
illnesses.
To date, the Federal Government is projecting cumulative
expenditures of $151 million of Gulf war research from fiscal
year 1994 through fiscal year 2000. There are over 192 projects
at various stages of completion in the research portfolio on
these veterans illnesses.
For the sake of brevity, Mr. Chairman, I will only
summarize the research recommendation of the Institute of
Medicine report and the response of the research working group.
With regards to sarin specifically, the IOM has recommended
long-term followup of populations exposed to sarin in the
Matsumoto and Tokyo terrorist attacks. The research working
group concurs with the IOM recommendation.
The IOM recommends studies in experimental animals to
investigate the long-term effects of acute, short-term
exposures to sarin at doses that do not cause overt cholinergic
effects. Since 1996, the DOD has funded nine toxicology studies
focusing on the effects of sarin, alone or in combination.
In addition to the IOM recommendations on animal studies on
sarin, the research working group is coordinating three
epidemiological studies that are focusing on the health of
veterans potentially exposed to low level sarin due to the
Khamisiyah demolitions, one at the Navy Health Research Center,
a second at the Oregon Health Sciences University, and a third
by the Medical Followup Agency of the Institute of Medicine.
In addition to the IOM recommendation on animal studies on
sarin, the research working group also is coordinating a
contract to the medical followup agency to perform an
epidemiologic study of the long-term effects of short-term
exposure to nerve agents in human volunteers in experiments
conducted at the Aberdeen Proving Ground in the 1950's to
1970's.
With regard to pyridostigmine bromide, the IOM recommends
research on chemical interactions between PB and other agents,
such as stressful stimuli and certain insecticides. Since 1994,
VA and DOD have funded 30 projects related to PB alone or in
combination with other chemicals or stressful stimuli. One
important and consistent result of recent studies is that
stressful stimuli such as swimming, heat or restraint stress do
not cause an increase in the permeability of the blood brain
barrier or cause pyridostigmine bromide to cross the blood
brain barrier into the brain.
The IOM recommends research on differences in genetic
susceptibility that may contribute to increased risk of
disease. VA and DOD have funded eight projects on genetic
factors that may alter the susceptibility to the effects of PB
or sarin.
Concerning vaccines, the IOM has recommended long-term
systematic research to examine potential adverse effects of
anthrax and botulinum toxoid vaccination in multiple species
and strains of animals. The research working group concurs that
long-term research is needed to examine potential adverse
effects. Such research is underway in DOD laboratories. Also,
the CDC, the Centers for Disease Control and Prevention, plans
to fund nonhuman primate studies of the health effects and
efficacy of the anthrax vaccine later this year.
The IOM has recommended identification of cohorts of Gulf
war veterans and Gulf war era veterans for whom vaccination
records exist. The CDC published a study of Air Force Gulf war
veterans in 1998 which included measuring antibodies to anthrax
and botulinum to determine which individuals had received the
vaccines. The CDC found no relationship between the
vaccinations and development of multisymptom illnesses.
Similarly, researchers in the United Kingdom have also
published a study this year on a cohort of nearly 1,000 Gulf
war veterans for whom vaccination records exist. There was no
association between having received the anthrax vaccine and the
development of multisystem illness.
The IOM has also recommended long-term longitudinal studies
of the participants in the anthrax vaccine immunization
program. In 1999, DOD funded a long-term longitudinal study of
participants in the anthrax vaccine immunization program study
located at the Naval Health Research Center.
Finally with regard to depleted uranium, the IOM
recommended continued followup of the Baltimore cohort of Gulf
war veterans with DU exposure. The research working group
concurs with the recommendation. While the Baltimore clinicians
have seen no definitive evidence of adverse clinical outcomes
associated with uranium exposure to date, the veterans who were
involved in the friendly fire incidents will remain under
continuing medical surveillance.
The IOM has recommended continued followup of the cohorts
of uranium processing workers. The research working group
concurs with this recommendation.
The IOM has recommended additional studies of the effects
of depleted uranium in animals. DOD has funded five toxicology
projects that are investigating the health effects of DU in
experimental animals. For example, there was no detectable
kidney toxicity in rats embedded with DU pellets, even at very
high concentrations of urinary uranium.
Mr. Chairman, we know that combat casualties do not always
result in obvious wounds and that some veterans from all
conflicts return with debilitating health problems. VA
recognizes its responsibility for developing effective
treatments and prevention strategies for such illnesses.
Studies clearly show that some Gulf war veterans report
chronic and ill-defined symptoms including fatigue,
neurocognitive problems and musculoskeletal symptoms at rates
that are significantly greater than nondeployed veterans.
Mr. Chairman, thank you again for permitting me this
opportunity to summarize our work. You have my assurance that
we will continue this effort to resolve, or at least ameliorate
health problems in our patients to the greatest extent
possible.
Mr. Chairman, I will conclude my testimony here and ask
that you enter the entire written testimony into the record. I
actually think you did that.
[The prepared statement of Dr. Feussner follows:]
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Mr. Shays. Already covered, but it doesn't hurt to ask. Let
me just, before recognizing Mr. Sanders, say they wish a lot of
these studies had begun 10 years ago. I think that many of them
are very important and valuable. I think that it's good they're
happening. I wish they could have happened sooner, but I guess
we call that progress, and Mr. Sanders.
Mr. Sanders. Thank you very much, Mr. Chairman. As you
know, I have been very critical of the DOD and the VA for many
years in this area, but I do want to single out Jack Feussner
as somebody who I think for many, many years has been trying to
do the right thing, Jack and I appreciate the work you have
done.
Let me just ask you, you remember, Dr. Feussner, a couple
of years ago at a hearing, I had indicated to you that I was
distressed that there was some apparently breakthrough work
being done around the country, and I asked you if the VA had
begun the process of trying to replicate some of that work,
tell us whether it was right or wrong, and I think out of that
discussion with Chairman Shays' help and so forth, you began a
clinical trial based on I think the work of Dr. Nicholson in
California dealing with doxycycline, and I know that clinical
trial is going on in a hospital in White River Junction in
Vermont, hospitals all over this country, and the thesis was
that large doses of doxycycline over a long period than had
previously been given seemed to indicate that there would be
some alleviation of symptoms.
That was Nicholson's hypothesis. You were testing it. Do
you have anything to report to us today about the progress of
that study?
Dr. Feussner. Yes, sir, I have progress to report. You're
quite correct, the study continues. You're also quite correct
to assert that the treatment was doxycycline and the duration
of the doxycycline was quite long, 1 year. Because this is a--
while tetracycline is not an experimental or novel therapy, the
use of tetracycline----
Mr. Sanders. Doxycycline is what we're talking about.
Dr. Feussner. Yes, sir.
Mr. Sanders. Tetracycline is the same?
Dr. Feussner. Doxycycline is a specific brand of
tetracycline. I will try to keep it straight. At any rate, this
trial, as you recall, was planned as a collaborative effort
between VA and DOD, went through a very rigorous scientific
review process that actually included a formal request for an
FDA IND, an investigational new drug not because the drug is
investigational, but because the condition for which the drug
is being used is not approved by the FDA.
We initiated the trial formally in May 1999. The goal was
to study--enroll up to 450 Gulf war veterans at 28 sites
throughout the United States. We have achieved that goal. As a
matter of fact, as we intended to close enrollment in the
trial, we had a number of veterans who wished to participate,
despite the fact that we had met our patient sample size quota.
Nonetheless, we included an additional 41 veterans into the
trial. The total sample size now is 491. The patient
recruitment period is done and the patients are currently in
the process of going through that 1-year treatment.
Mr. Sanders. Does that include, that 491, is that some of
those--half of those people are getting placebos?
Dr. Feussner. Correct, yes, approximately 50/50.
So the patients are all enrolled in the trial and are all
now being treated with the active agent doxycycline, or
placebo, are in the process of being followed on that treatment
over the course of 1 year. I expect the study to be complete,
the followup to be complete next summer, approximately June or
so, and that we will have the final result some time after
that, some time probably within the next 90 days of completion
of the trial. So the trial has been a success.
Mr. Sanders. In the sense of organizing it?
Dr. Feussner. In the sense of organizing, recruiting
patients, but I can't tell you what the results are yet.
Mr. Sanders. So in June you will be beginning the process--
you'll be completing the study and beginning the process of
analyzing the results?
Dr. Feussner. That is correct. You may recall, Congressman,
we also started another major trial, that one much more
difficult. We call it exercise and behavioral therapy,
organizationally more complex for treatment groups. Similarly,
we have closed the patient recruitment for the EBT trial. There
are four treatment groups, usual care, exercise only, cognitive
behavioral therapy only or both interventions. We did not quite
meet our goal for patient inclusion. We'd hope to have
approximately 1,300 patients enrolled. We have succeeded,
however, in enrolling 1,100 patients in the trial and the
trial, whatever the result, will be statistically robust. So
while we had hoped to have a few more patients, we are very
gratified that 1,100 Gulf war veterans have volunteered to help
us with the trial. That trial, as you recall, is a little later
in the process than the ABT. I don't expect the final end point
of that trial until the fall of 2001, and probably around
September or so with the same issue that at that point, we will
begin the analysis and should have the results--pretty good
result within a 90-day period.
Mr. Sanders. And I presume--is my time up, Mr. Chairman?
Mr. Shays. No, no.
Mr. Sanders. I presume that if one or both of those studies
indicate that approach alleviates symptoms--that approach will
become recommended form of treatment throughout the VA system.
Dr. Feussner. Yes, I would say the answer to that question
would be yes, that the trials, as you know, the trials are
large, they're very expensive and they are constructed to be
definitive. So that if the result is positive, then the
treatment is known to work, and if the result is negative, then
the treatment is known not to work.
Mr. Sanders. Dr. Feussner, I am, as you know, not a
scientist, and the way my mind works, as I mentioned to you
before, and I appreciate you moving with that type of approach,
is that if somebody is doing interesting work, we test the
hypothesis, and frankly, this work was based on what Nicholson
had indicated out in California, is that correct? More or less
through other people?
Dr. Feussner. As you recall, sir, Dr. Nicholson's work was
quite controversial.
Mr. Sanders. I sure do.
Dr. Feussner. There were two observations. While his
results were controversial, one of our own physicians Dr.
Gordon had anecdotal experience----
Mr. Sanders. That's right.
Dr. Feussner [continuing]. On his own in a significant
number, not two or three, but perhaps several dozens of
patients where he had observed clinically that he had tried the
therapy and believed that the therapy worked.
Mr. Sanders. Dr. Gordon from Manchester, New Hampshire?
Dr. Feussner. Yes, sir.
Mr. Sanders. That's right. And it seems to me that a good
administrator, such as yourself, listens to those people, who
may only have anecdotal evidence of some success. OK. So I am
applauding you for this, but let me ask you this, getting back
to the question I asked Dr. Sox a moment ago, if there appears
to be some breakthroughs, what you're saying is if Dr. Gordon
came to you and said listen, I'm applying this treatment, it
appears to be working, let's go further with it and you said
yeah, let's go further with it, Nicholson did his work, and I
think you did exactly the right thing, what about the work that
people like Hayley or Urnovitz or Miller are doing out there?
There is also anecdotal evidence that there may be some
breakthroughs. Are you prepared to say come on in, let's work
together, let's see, in fact, to answer the question that Dr.
Sox raised with Hayley's work that the sampling was too small,
there hasn't been enough replication, are you going to help
us--tell us whether or not Hayley is on to something or whether
he's not?
Dr. Feussner. Well, before we get to Dr. Hayley's work
specifically, Congressman Sanders, you will recall that some
years ago, I believe in 1998, that VA announced an open-ended
what we call RFP, request for proposals, DOD calls BAA, broad
area announcement, indicating our receptivity to treatment
trials of any novel therapy agent. That RFP is still active,
but I will concede that we perhaps should reannounce it just to
make sure that those that need to know are reminded that that
is still active.
Mr. Sanders. What I am asking, Dr. Feussner, you know what
I'm asking, are we welcoming in the door people who have
controversial ideas who are not quote unquote, peer reviewed by
folks who have not given us any information in 10 years? Are
you having the courage to go out and say, look, people may--I
may be attacked for going to somebody who is controversial, but
I'd rather be attacked for going to somebody who is
controversial and may contribute something to our knowledge
rather than go back to the same old folks who 20 years from now
tell us we don't know the cause. Are you prepared to do that,
to take the heat?
Mr. Shays. You recognize that's a loaded question, don't
you?
Mr. Sanders. You understand where I am coming from?
Dr. Feussner. Sir, I certainly do understand where you're
coming from, and what I would say is I think our actions do
speak to that issue, and that is, that we have followed up with
larger scale research, looking at reasonable testable
hypotheses, specifically with regard to Dr. Hayley. Dr. Hayley
published preliminary work in the Journal of the American
Medical Association exploring possible definition for a number
of Gulf war syndromes. You will recall that very early on after
that work is published, I had the opportunity to testify before
the committee. I think that Dr. Sox's point is well taken. Dr.
Hayley studied a small number of study subjects. His response
rate in the initial study, even in a highly selected patient
population, was only 40 percent. There were no controls.
But the observation bore attention, OK. I mean, he put
something on the table. Now, the follow-on to that is it's--as
you know, because we've talked about this a lot, scientific
process. It's not important for the initial investigator to
replicate his or her own work but for other scientists to do
that.
We have supported four follow-on studies looking at those
syndromes, three in the United States and one in the United
Kingdom. The United Kingdom was published in the Journal Lancet
by Dr. Wesley. We have the Naval Health Research Center in San
Diego. We have the CDC study of Fukuda and colleagues, and we
have the Iowa study just recently published this year in the
American Journal of Medicine. None of those studies is able to
replicate Dr. Hayley's initial observations in terms of finding
the kinds of unique syndromes that Dr. Hayley found in his
preliminary hypothesis-generating research.
What we are left with in that effort is, one, we have
followed on the effort to replicate the work. We have not been
able to replicate the work at this point in time. But actually,
there is yet another study that we are supporting in
collaboration with researchers at GW using the same analytical
strategy, etc.
Mr. Sanders. What you're saying is you've taken Hayley's
work seriously, you're putting money and resources into trying
to replicate it, at this point that has not happened.
Dr. Feussner. In that particular one we have not been able
to replicate the work.
With regard to the work on the structural brain disease, we
have talked about that at the hearing in February, and we have
a number of studies ongoing that are looking also at structural
brain disease. The most--and so, an effort is underway to try
to explain, replicate, extend that observation. The most recent
observation, actually I haven't had an opportunity to go over
in detail myself. It is quite recent, within the last week or
so, looking at neurotransmitters, chemicals in the brain that
tell other parts of the brain what to do, and since the brain
tells the rest of the body everything to do, very important,
called--dopamine is the chemical.
We haven't taken a hard look at that yet, but what I will
tell you, the worry here has to do with Parkinson's disease,
and independent of this issue with Hayley, VA is currently
reviewing, as a result of another RFP VA is currently
reviewing, and hopefully later this calendar year will fund up
to six major centers, research centers devoted to the study of
Parkinson's disease and movement disorders. We call them
PADRECC's, Parkinson's Disease, Research Education and Clinical
Centers, modelled after the VA-funded geriatric centers. So
that we will have the capacity, I believe, within--at least
within VA, certainly within the broader scientific community,
to follow on those observations.
So I think what I'm doing, Congressman, is giving you a
long answer to a short question.
Mr. Sanders. It's a good answer. Let me ask you this and
I'll give the mic back to the chairman. I remember, sometimes
there are instances where things occur and you never forget
them, but I remember meeting with many Vermont veterans who are
suffering from Gulf war illness, and one of the symptoms, many
of them relayed to me is when they were exposed to perfume or
detergent smells or other chemical presence, gasoline fuels,
they would become sick, which suggested to me that we're
looking perhaps at what might be called multiple chemical
sensitivity, and as you know, I am sympathetic to the work that
Dr. Claudia Miller and others are doing. Can you tell us a
little bit about some of the research the VA may or may not be
doing in following up on the issue of multiple chemical
sensitivity in Gulf war illness?
Dr. Feussner. I think what I would have to say, Congressman
Sanders, is that the last time you asked that question, I don't
have much of a different answer to give you this time. We have
about half a dozen or so research projects looking at the issue
of multiple chemical sensitivity. They're currently active. In
a response to a meeting that we had with you in your chambers
some time ago, we invested a considerable amount of energy
trying to forge a collaboration between Dr. Miller and VA
investigators, both in San Antonio and, as I recall, in Tucson
with Dr. Iris Bell, who's testified before you in the past.
We have also indicated, as you know, the interest in
explicitly looking at prospective treatment trials and also, as
you know, some of the difficulty in pursuing those ideas
aggressively relate to the infrastructure that is required in
order to do the research. It's not as----
Mr. Sanders. Let me just jump in and bring this to the
point. To the best of my knowledge the U.S. Government, despite
the widespread feeling of many physicians, certainly not all,
that multiple chemical sensitivity is a serious disease not
only facing Gulf war veterans but the American population.
Correct me if I'm wrong, Dr. Feussner, but I don't know that
the Veterans Administration or DOD owns what is called an
environmental chamber where we can do scientific studies
regarding treatment of multiple chemical sensitivity. Is that a
fair statement? I know we're trying to get funding for it, but
it's beyond my comprehension that the U.S. Government doesn't
own one of those units quite yet.
Dr. Feussner. I think I answered that question the last
time and said yes, the U.S. Government does own these
facilities. I am searching my hard drive to find those data,
sir. What I can tell you is the VA does not. I can't recollect
about DOD. I do recollect that EPA has such laboratories in the
research triangle in North Carolina, and I do believe that DOD
has several of these facilities, but I cannot remember the last
time I looked this up. I'll have to----
Mr. Sanders. Short term memory loss, multiple chemical
sensitivity, there it is. Thank you very much, Mr. Chairman.
Mr. Shays. I'm just going to have a slight advertisement
for a committee meeting that we're having next week on Gulf war
illnesses. The Royal British legion formed a Gulf veterans
group some years ago to provide a focus for Gulf veterans
issues. It is made up of Gulf veterans, parliamentarians,
representatives of VSOs and service welfare organizations and
medical and scientific advisers. A delegation from the Gulf war
veterans group visited the United States in July 1995 and
similar group intend to visit Washington, DC, from October 2nd
to 6th. We will be meeting with a group on Wednesday, October
4th from 10 a.m. in room 2154 with Lord Morris, the
distinguished parliamentarian, with a background in trades and
union members; Colonel Terry English, director of welfare at
the Royal British legion; Kathy Walker, director of welfare,
the Soldiers, Sailors and the Airmen Families Association; Dr.
Norman Jones, medical adviser, Royal British Legion; Mr. John
Nichol, author, Gulf war veteran and ex-POW; Professor Malcolm
Hooper, scientific adviser, Gulf Veterans Association.
Let me first ask you, Dr. Brown, is there anything that you
would want to respond to Mr. Sanders, any comment or
observation?
Dr. Brown. No. When it comes to research issues, Jack is
your man.
Mr. Shays. OK. Well, I'll ask either one of you, how many
of the 83 research projects--there are 192 research projects in
Gulf war veterans illnesses at various stages of completion, 83
have been completed, and I want to know of the 83 projects
completed, how many have been published and peer reviewed?
Dr. Feussner. I'll have to get that information for you,
Congressman Shays.
Mr. Shays. Could someone else give us that?
Dr. Feussner. We don't have that off the top of our heads.
Mr. Shays. How many completed projects involve sarin and
have been published and peer reviewed?
Dr. Feussner. I will have to get those data for you as
well.
Mr. Shays. How many involving PB?
Dr. Feussner. How many are already finished and published?
Mr. Shays. Published and peer reviewed.
Dr. Feussner. I think it's approximately six to eight.
Mr. Shays. OK. How many as relates to DU, depleted uranium?
Dr. Feussner. I would say, again, probably six or seven.
Mr. Shays. And how many involving vaccines?
Dr. Feussner. I don't know the answer to that question.
I'll have to get you those data.
Mr. Shays. I know you will do that. I do want to ask the
questions though. What yet unpublished studies are underway
which would address the long-term effects of exposure to these
toxic agents?
Dr. Feussner. Well, there are quite a large number of
projects that are still ongoing. For example, in PB, the total
number of funded projects is about 30. With regard to chemical
weapons, there are about 22. The DU focus at the moment in
humans is pretty much limited to followup of the friendly fire
soldiers in Baltimore, and there are a small number of probably
four or five animal studies in DU.
Mr. Shays. OK.
Dr. Feussner. Did I answer all the parts?
Mr. Shays. Well, it's a pretty extensive question. You said
there are many. Do you think, in fact, there are many?
Dr. Feussner. Yes.
Mr. Shays. OK. And by ``many,'' you would give a number of
what approximately?
Dr. Feussner. For which issue?
Mr. Shays. I just asked what yet unpublished studies are
underway which address the long-term effects of exposure to
these toxic agents which involve those four agents.
Dr. Feussner. Yes, I could do the math real quick.
Mr. Shays. Some you don't know. You said many. Are we
talking 20, are we talking 80? I mean, what are we talking
about?
Dr. Feussner. In terms of total number of projects I think
we're talking about in the ballpark of perhaps 100.
Mr. Shays. And you will get back to us and document those?
Dr. Feussner. You not only want the number of projects, you
want the number of projects, those finished and the
publication?
Mr. Shays. Right.
Dr. Feussner. Yes, sir, I'll have to get you that data.
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Mr. Shays. I understand. According to a January 2000
General Accounting Office report on Gulf war illnesses, the
Department of Veterans Affairs stated that the research working
group, which I'll refer to as RWG, would, ``establish a date in
fiscal year 1999 or fiscal year 2000 for publishing its
assessment of progress toward addressing the 21 research
objectives that's identified in 1995.'' When will the research
group assessment's of progress toward addressing the 21
research objectives be published?
Dr. Feussner. We've actually made a substantial progress in
this area, Congressman. We discussed this at our last hearing,
and the majority, 11 of the 15 papers that we had commissioned
at that time are in draft form. We have worked with a very
prestigious medical journal, and the editor of that journal to
not only produce these papers for the Congress, but to produce
these papers for the larger community. We have a commitment
from----
Mr. Shays. Isn't that the key? The larger community is
complaining to us that they're not getting access to this
research.
Dr. Feussner. Yes, I think that is the issue.
Mr. Shays. To date, we don't really have any published.
Dr. Feussner. The papers have received preliminary review
by the editor of the journal already, but the next step for the
manuscripts will be to go out to independent experts to get an
additional episode of review. I would hope that the manuscripts
would be published electronically after the 1st of the year,
perhaps the second quarter of fiscal year 2001. We have
discussed with the editor the possibility of publishing the
manuscripts electronically while we await for the manuscripts
to appear in print. It is my hope that we can have the
manuscripts in electronic format between January and March and
in print as a special supplement, probably between March and
May.
Mr. Shays. So basically you're in fiscal year----
Dr. Feussner. I am in fiscal year 2001.
Mr. Shays. Right. You're really at the end of that fiscal
year--well, it starts in September.
Dr. Feussner. Yes.
Mr. Shays. Not in the end. You're kind of in the middle.
What is the research working group's role with the Military and
Veterans Health Coordinating Board?
Dr. Feussner. Well, the research working group, the
Military and Veterans Health Coordinating Board has three
subcomponents underneath the executive, the executive leader.
The research is one of those three subgroups. Within the
research group, there will really be two primary foci. The
first will be the Gulf war research activities, since 60
percent of these projects are incomplete. As a matter of fact,
I think just in fiscal year 1999 and 2000, we have launched 42
additional studies.
The second component of the research activity within the
military and veterans coordinating board will deal more
specifically with the generic issue of post deployment health
and three major, at least three major interests within that
area will include an effort to improve the situation with
regards to systematically obtaining baseline data so that after
subsequent deployments, we will systematically have baseline
data; systematically collect data through time on the soldiers
which would also require an integration and a merging of the VA
and DOD data bases; and then increasingly apply research
activities or research results became available that could
document exposures.
Mr. Shays. To what extent will the absorption of the RWG
into the new Military and Veterans' Health Coordinating Board
diminish the RWG's focus on Gulf war illnesses, veterans
illness research?
Dr. Feussner. Well, it is my intent that it not diminish
the focus on Gulf war veterans' illness, and given the
incomplete status of the formal research and the emerging
research that is going to be initiated with regards to post
deployment health issues, I would imagine over the next period
of time, say the next 3 or 4 years, that the dominant research
effort within that larger group will continue to be Gulf war
research projects.
Mr. Shays. I'm going to try to finish because Mr. Sanders
and I need to vote, but to what extent is the new board fully
operational?
Dr. Feussner. The new board has already engaged in a series
of meetings several weeks ago. All leaders of the boards and a
larger community of involved participants had a 2-day retreat
at Andrews Air Force Base. We are completing the formal
strategic planning process for the coordinating board and have
identified the three leaders of the three major subgroups.
Mr. Shays. So you haven't started being operational yet but
you're at that point?
Dr. Feussner. I think that's fair.
Mr. Shays. According to a General Accounting Office, GAO,
January 2000 report on Gulf war illnesses, questions remain
regarding, ``how many veterans have unexplained symptoms and
whether those who have received care in VA facilities are
getting better or worse.'' What progress has been made toward
developing a system of tracking clinical efforts and treatment
outcomes among sick Gulf war veterans?
Dr. Brown. I'll take a stab at that. We have a number of
ways in which we track the health of Gulf war veterans. The
Institute of Medicine recently released a report that I'm sure
you're aware of which made the point that if we really want to
study the long-term health consequences of service in the Gulf
war, that is, your question whether veterans are getting better
or worse are staying the same, that you need to set up
appropriate longitudinal studies to follow those populations.
We have a couple of studies already underway that are
looking at subgroups of veterans. Dr. Feussner mentioned the
Iowa study. I also want to make this committee aware, we just
published a report just last April on a study that was looking
at the health of all Gulf war veterans, called National
Veterans Health Survey, looked at the health of all Gulf war
veterans across the board. I can provide the committee with a
copy of the report. It found similarly to other studies that
when you look at a national survey of all Gulf war veterans,
that you find greater rates of symptoms, greater rates of
illnesses in terms of self-reported symptoms, and a number of
other findings. It is unique in that it's the only study that
looks across the board at all veterans, and it's our
intention--it's my office's intention to follow that study up
in a longitudinal sense.
Mr. Shays. Basically though what I am hearing you say, we
really don't have a system yet to track.
Dr. Brown. I think we do have some initial data.
Mr. Shays. You have data but you don't have a system, you
are not tracking all these.
Dr. Brown. The system that would do that for us would be a
longitudinal study.
Mr. Shays. ``Would be'' is not----
Dr. Brown. We don't have that in place yet.
Mr. Shays. This is all. And finally, what is the Department
of Veterans Affairs doing about obtaining access to classified
information? This really galls me that we don't have
information. I mean we had the DOD who said our troops weren't
exposed to offensive chemical exposure, and yet they were
exposed to defensive chemical exposure. So I want to know what
the VA's doing. Are we just lying back or are we trying to get
this information?
Dr. Feussner. In the research mode, we have not made
efforts to get classified information. Two comments. The first
is that my understanding is that the IOM will gain access at
least to unpublished information about anthrax research in a
new study that is being undertaken by them, and that with
regard to CW, chemical weapons, issues that both the
Presidential Advisory Commission and the Senate Veterans
Affairs Investigating Committee had access to that classified
information.
Mr. Shays. The challenge we do have is the IOM did not have
access to certain information.
Dr. Feussner. That is correct.
Mr. Shays. And I think it galls both me and Congressman
Sanders that that's not made available, and it would strike me
that anybody who's worked with our veterans would demand the
same, so I just plead with you to be a little more aggressive.
We will. We'd like you to be as well. I think what we'll do, I
usually invite comments, if you have a 30 second comment either
one of you, I'd welcome that, but we need to get voting. Any
comment?
Dr. Feussner. No, sir.
Mr. Shays. Thank you both for being here.
[Whereupon, at 12:05 p.m., the subcommittee was adjourned.]
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