[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
THE PERSIAN GULF VETERANS ACT OF 1998
=======================================================================
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
FIRST SESSION
__________
APRIL 22, 1999
__________
Serial No. 106-129
__________
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
______
U.S. GOVERNMENT PRINTING OFFICE
65-548 CC WASHINGTON : 2000
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
JOHN T. DOOLITTLE, California (Independent)
HELEN CHENOWETH, Idaho
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
David A. Kass, Deputy Counsel and Parliamentarian
Carla J. Martin, Chief 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, Idaho
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Lawrence J. Halloran, Staff Director and Counsel
Samantha Sherman, Professional Staff Member
Jonathan Wharton, Clerk
Michael Yeager, Minority Professional Staff Member
C O N T E N T S
----------
Page
Hearing held on April 21, 1999................................... 1
Statement of:
Byrd, Robert C., a U.S. Senator from the State of West
Virginia................................................... 7
Mather, Dr. Susan, Chief Public Health and Environmental
Hazards Officer, Department of Veterans Affairs; Dr.
Frances Murphy, Chief Consultant, Occupational and
Environmental Health; John Thompson, Deputy General
Counsel; Robert Epley, Director, Compensation and Benefits;
Susan Stoiber, Executive Officer, Institute of Medicine;
Dr. Carolyn Fulco; and Dr. David Tollerud.................. 15
Letters, statements, et cetera, submitted for the record by:
Byrd, Robert C., a U.S. Senator from the State of West
Virginia, prepared statement of............................ 10
Mather, Dr. Susan, Chief Public Health and Environmental
Hazards Officer, Department of Veterans Affairs, prepared
statement of............................................... 20
Shays, Hon. Christopher, a Representative in Congress from
the State of Connecticut, prepared statement of............ 3
Stoiber, Susan, Executive Officer, Institute of Medicine,
prepared statement of...................................... 29
Tollerud, Dr. David, prepared statement of................... 40
THE PERSIAN GULF VETERANS ACT OF 1998
----------
THURSDAY, APRIL 22, 1999
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 2 p.m., in
room 2247, Rayburn House Office Building, Christopher Shays
(chairman of the subcommittee) presiding.
Present: Representatives Wise, Sanders, and Schakowsky.
Staff present: Lawrence J. Halloran, staff director and
counsel; Newman, Wharton, Raphael, and Gosa.
Mr. Shays. I would like to call this hearing to order and
to welcome Senator Byrd. Senator Byrd, I am just going to read
a very short statement. Then we are going to get right to you.
Last month, witnesses from national veterans service
organizations urged this subcommittee to keep close watch on
the Department of Veterans Affairs [VA] as the Secretary and
his staff implement new statutory mandates to meet the needs of
sick Gulf war veterans. Today we heed their advice.
Legislation enacted in 1998 contains clear directives and
fixed deadlines to create a presumption in favor of those
seeking to connect toxic war exposures to chronic health
effects. But veterans' advocates warned that bureaucratic
resistance and scientific uncertainty threatened more delays in
their 9-year struggle for recognition their illnesses are real,
their wounds war-related. They were right.
Under the Persian Gulf War Veterans Act of 1998, April 21,
1999, yesterday, was the deadline for submission of an interim
report from the National Academy of Science [NAS] to VA on the
toxins to be studied for links to illnesses. But because VA
waited 3 months for the Department of Justice to interpret
overlapping but by no means contradictory provisions of two
statutes, that deadline has already been missed.
The good news: VA contracted with NAS in late 1997 for a
study of exposure-related illnesses that may meet most, but not
all, the requirements of the laws. This hearing is to determine
more precisely, and more publicly, how the VA and NAS plan to
go forward to meet the spirit, if not always the letter, of the
statutes.
The process we oversee today is the culmination of a 3-year
effort by this subcommittee. We held 13 hearings and adopted a
report containing 18 specific recommendations, the first two of
which were that: Congress should enact a Gulf war toxic
exposure act establishing the presumption, as a matter of law,
that veterans were exposed to hazardous materials known to have
been present in the Gulf war theater; and the VA should
contract with an independent scientific body composed of non-
government scientific experts for the purposes of identifying
those diseases and illnesses associated in peer-reviewed
literature with singular, sustained or combined exposures to
the hazardous materials to which Gulf war veterans are presumed
to have been exposed.
We are very honored to be joined this morning by the author
of the Persian Gulf War Veterans Act, Senator Robert Byrd of
West Virginia. While this subcommittee's hearings and
recommendations may have helped keep the cause alive, it was
his vision and determination, and that of his staff that, in
the end, enacted them and put the law on the side of the sick
Gulf war veteran.
Mr. Byrd, we welcome you. We welcome all our witnesses. I
ask if Mr. Wise has any comment that he would like to make and
obviously welcome him to this hearing.
[The prepared statement of Hon. Christopher Shays follows:]
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Mr. Wise. Thank you Mr. Chairman. Mr. Chairman, thank you
for conducting this hearing. You have been one of the leaders
as well in this fight for the Persian Gulf war veterans. I just
wanted to say, Mr. Chairman that it is a privilege to be able
to participate in the same hearing with Senator Byrd.
Senator Byrd knows well that our State of West Virginia has
historically the highest number of veterans per capita. It has
for many, many years. West Virginians, as well as those across
the country always answer the call. When word first began to
develop, and symptoms and problems began to develop, Senator
Byrd cut through a lot of the talk about what could be done and
got something done.
We are delighted now to have the Senator here, and also to
find out what it is that needs to be done to make the promise
of the Congress into reality. Thank you very much.
Mr. Shays. Senator Byrd, I am just going to get two
bookkeeping things out of the way. I would first ask unanimous
consent that all members of this subcommittee be permitted to
place an opening statement into the record and that the record
will remain open for 3 days for that purpose. Without
objection; so ordered.
I ask further unanimous consent that all witnesses be
permitted to include their written statement in the record.
Without objection; so ordered. Senator, I know that Senators
are legendary for having quite a lot to say. With no reluctance
at all, we do not have a clock for you. You are welcome to
speak as long as you would like.
STATEMENT OF ROBERT C. BYRD, A U.S. SENATOR FROM THE STATE OF
WEST VIRGINIA
Senator Byrd. Mr. Chairman, I appreciate that
consideration. I thank you for inviting my comments on the
implementation of the Persian Gulf War Veterans Act of 1998. I
am extremely grateful for the opportunity to appear before this
committee today. I am especially happy to see my colleague,
Robert Wise, here as well.
I think of Bob Wise sometimes as a steam engine in
britches. He is so blessed with energy and drive. He is a very
hard worker for his District. I am sure he works well with his
colleagues here. I consider it a privilege to have the
opportunity to be introduced by him.
Chairman Shays, I have especially enjoyed the way that you
and I have been able to work across a sometimes deep divide
that can separate our Houses and our parties in order to do
what is right and long over-due for the veterans of the Persian
Gulf war. Concern for our Nation's veterans should be non-
partisan in the sense of political parties, but wholly and
completely partisan in our hearts.
Today as we watch daily reports of bombing runs over
Yugoslavia, it is easy to recall the eerie precision of the
video war that was Operation Desert Storm. Many Americans'
initial impression of Desert Storm was of a technically
precise, almost bloodless operation in which bombs dove to
their targets with such deadly accuracy that Iraq's much feared
military might seemed to evaporate before our eyes.
As allied pilots assailed Iraq's chemical and biological
warfare industry, military planners crowed that Iraqi military
commanders could not bring themselves to use the weapons that
we had feared most, the chemical and biological warfare agents
that we suspected Iraq of possessing.
Chemical alarms blared incessantly. To protect troops,
vaccines unproved for military use were employed and other
preventative medical measures were widely taken. To combat
disease, pesticides and repellents were sprayed, adding to the
foul smog created by burning oil wells set alight by retreating
Iraqi forces.
Soldiers quite literally operated in a fog of war for weeks
on end. In retrospect, it is hardly surprising that so many
veterans of the Gulf war have been in ill health as the result
of their service. The official response has been slow; slow to
recognize the prevalence of illness; slow to react; slow to
organize; slow to respond.
Until the admission in June 1997 that United States forces
had in March 1991 blown up large amounts of Iraqi chemical
warfare agents at more than one site, no serious effort has
been made to investigate the role that exposure to chemical or
biological warfare agents may have played in injuring soldiers'
health.
The Persian Gulf Veterans Act of 1998 attempts to make up
for lost time by requiring the National Academy of Sciences
[NAS] to review exposure to many potential hazardous agents
during the war and determine what illnesses may be linked to
those exposures.
The NAS is also required to recommend further studies where
needed in order to resolve questions. With the NAS study in
hand, the Persian Gulf War Veterans Act gives the Secretary of
Veterans Affairs the ability to administratively make a
determination that the illness is service connected for the
purposes of providing health care and benefits to the affected
veterans.
The most critical element of the Persian Gulf War Veterans
Act is that no intervening act of Congress is required to make
a determination of service connection happen. I know that I am
preaching to the choir here when I observe that requiring an
act of Congress to make something happen in a timely manner is
perhaps more difficult than requiring an act of God to happen.
I am far more confident, far more confident, that any
Secretary of Veterans Affairs will exercise undue restraint
than I am, that he or she will be excessively generous in
making such a determination of service connection.
I can only urge this and all future Secretaries of Veterans
Affairs to act in a just and reasonable manner, ensuring that,
to paraphrase President Theodore Roosevelt, veterans get a
square deal. I am getting a bit ahead of myself, however.
Before those determinations can be made, the reviews have to be
conducted.
The first deadline in the act requires the Secretary to
seek to enter into an agreement with the NAS not later than 2
months after the date of enactment of this act. That would have
been December 21st, Chairman Shays, 1998. However, the VA
delayed, seeking a legal opinion from the Justice Department
that was received on March 12, 1999.
It basically told the VA to proceed. The second deadline in
the act called for an interim report from the NAS specifying
the agents, the hazards, the medicines, and vaccines to be
considered. That report should have been delivered on April
21st, which was yesterday, 6 months after the date of
enactment.
The next and first full report should be delivered on April
21st of next year, with the Secretary's determination of
service connection made by June 21, 2000. Even if lost time is
made up, no veteran will receive any benefit from this act
before November 21, 2000--10 years, 3 months, and 20 days after
Iraq invaded Kuwait.
I know that the intent of this hearing is to press the
Department of Veterans Affairs to move out swiftly to implement
this act. I applaud you for your diligence in conducting this
kind of oversight. On the other side of the Capitol, I have
joined the subcommittee on VA, HUD, and Independent Agencies of
the Senate Committee on Appropriations in order to better
oversee the implementation of this and other programs designed
to help our Nation's veterans.
Together, then, we can maintain the same vigilant defense
of our Nation's veterans that they have provided to us for so
long and so well. So, I thank you again for this opportunity to
testify, Mr. Chairman. Thank you and all of the members of the
committee.
[The prepared statement of Hon. Robert C. Byrd follows:]
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Mr. Shays. Senator Byrd, thank you for your willingness to
come today and for your very strong statement. Also, thank you
for not just putting this legislation in and then doing the
next good deed, but making sure that the intent of the
legislation is fulfilled. Thank you as well for serving on that
subcommittee to be a little bit more of an oversight directly
with the VA, which will be extraordinarily helpful.
Senator Byrd. Thank you.
Mr. Shays. We are joined by Bernard Sanders who has been
frankly as strong as any member on this subcommittee in
focusing on this issue. I welcome him as well. I do not have
any questions to ask you, Senator. I do not know if either of
my colleagues would like to make a comment or ask a question.
Mr. Sanders. I just want to echo your thoughts, Senator
Byrd. We knew at the end of this last session when this
legislation was somewhat up in the air, you played a very
important and pivotal role in making sure that it got through.
We appreciate that very much. I agree with you.
After all of these years, these Gulf war veterans deserve a
fair shake and you helped make it happen. We are very
appreciative for your efforts.
Senator Byrd. Thank you, sir. Let me thank on the record my
very able assistant, Lisa Tuite, who is here seated just behind
me. She followed that legislation through its journey, even
into the conference. I cannot over-estimate or over-state the
contribution that she made in the enactment of that
legislation. I thank you, Mr. Sanders.
Mr. Shays. Thank you. Bob, any closing comment?
Mr. Wise. Simply just thank you very much, Senator, for
coming and making us aware, and prompting all of us to make
sure that this legislation is implemented as enacted.
Senator Byrd. Thank you. Mr. Chairman, I served in the
House 47 years ago. You did not have this beautiful building
then. I first served in the House when Speaker Martin, a
Republican from Massachusetts I believe.
Mr. Shays. So, is it a little nostalgic or are you just
happy not to be here?
Senator Byrd. I started in the Longworth Building, I
believe it was and then the Cannon Building. This building was
I guess, not even in the plans, but it is a beautiful building.
I congratulate you on having such a beautiful edifice in which
to serve.
Mr. Shays. Senator, thank you again for being here. It has
really been a pleasure. You have honored our committee and
thank you.
Senator Byrd. Thank you. Thank you very much.
Mr. Shays. We are going to have our second panel.
We welcome Dr. Susan Mather, Chief Public Health and
Environmental Hazards Officer, Department of Veterans Affairs.
I only hesitated a bit because I went to Mather Junior High
School. It is spelled the same way.
She is accompanied by Dr. Frances Murphy, Mr. John
Thompson, and Mr. Robert Epley. Our second testimony will be
from Susan Stoiber, Executive Officer, Institute of Medicine.
She is accompanied by Dr. Carolyn Fulco. Also, our third
testimony is from David Tollerud, professor.
We welcome all testimony, as well as those witnesses who
are accompanying those who are giving testimony.
[Pause]
Mr. Shays. While we are setting up the cards and so on, I
would just preface your testimony by saying that this is not a
hearing on whether there are Gulf war illnesses or not. It is
really a hearing on getting a sense of where the VA and you all
are in terms of following the legislation that is passed.
I do not anticipate that this has to be a particularly long
hearing. We just want to be monitoring what is happening. We
want to know what your thoughts are about how you implement the
legislation.
Now, some of the people who are accompanying, are they just
sitting behind? What I will do is, I would like everyone whose
name I called--are we missing some people here? Now, I read
seven people off and I see five. Are two sitting behind?
Dr. Mather. Dr. Tollerud is on his way from Philadelphia.
Mr. Shays. OK. We will have to swear him in separately
then. If I could invite you all to stand. Let me just say that
we did not swear in Senator Byrd because he was giving a
statement and we were not going to ask him questions, but we
swear in all of our witnesses. Thank you very much.
Do you solemnly swear or affirm that the testimony you will
give before this subcommittee will be the truth, the whole
truth, and nothing but the truth?
[Chorus of ayes.]
Mr. Shays. Thank you very much.
For what it is worth, I would just like to tell you that my
state of mind is one, that this is a new year. I am just
interested in getting this legislation moving forward. So, I am
not as focused as to why it has taken us to this point to get
here, but just really what do we do from here to move forward.
You are welcome to talk about anything you want.
We are going to have the 5-minute clock, but we are going
to roll it over. Hopefully within 10 we can cover what each of
you want. I do not want any of you to leave today if you did
not say something that you felt needed to be said.
So, I will tell you that you will be able to end if you did
not have it in your testimony and we did not ask the question;
have you make sure to make it a part of the record. All set.
Mr. Sanders. Do you want to do opening statements?
Mr. Shays. We did opening statements before, but if you
have an opening statement you would like to give, I would
welcome it.
Mr. Sanders. Yes. Let me make a brief opening.
Mr. Shays. That is fine.
Mr. Sanders. Thank you for holding this important hearing.
We have worked hard on this issue. I think we are making some
progress. Today's hearing is very important to make sure that
we continue to go forward. As all of you know, last year at the
end of the last sessions, Chairman Shays and myself, along with
211 others in a bipartisan way introduced the Persian Gulf War
Veterans Health Act of 1998.
The bill would have established in law a presumption of
service connection for illnesses associated with exposure to
toxins present in the war. The VA's Secretary, under the
proposed legislation, would be required to accept the findings
of an independent scientific body as to the illness' link with
actual and presumed toxic exposures.
By establishing a rebuttal presumption of exposure, and the
presumption of service connection to exposure affects, the bill
places the burden of proof on the VA where it belongs and not
on the sick veteran. That is precisely what we wanted to do and
that is important. Senator Byrd introduced a similar bill in
the Senate.
As we all know, this bill was then concluded in the Omnibus
Appropriations bill and was enacted into law in October 1998.
The presumption of exposure law is critical for our Gulf war
veterans as it requires that they be provided medical care for
Gulf war illness, as well as disability benefits for any
illness that they may have received as a result of toxic
exposure in the Gulf.
The law mentions 31 specific ``biological, chemical, or
other toxic agents, environmental, or wartime hazards, or
preventative medicines, or vaccines to which members of the
Armed Forces who served in the theater of operations during the
Persian Gulf war may have been exposed.''
We are here today to determine if the VA and the National
Academy of Sciences have been doing their work. According to
the law passed last October, the NAS should be delivering an
interim report on the review and evaluation of the 31 toxic
agents, environmental, or wartime hazards, or preventative
medicines, or vaccines associated with Gulf war service that
were enumerated in the legislation. Of course, the NAS cannot
accomplish its duties without the cooperation of the VA.
So, we are here to see if that cooperation is taking place
and if not why not and where do we go from here. The interim
NAS report is the first step in the process of diagnosing the
treating of Gulf war veterans. As I have said, this has been a
long time coming.
Some of us are very mindful of what happened to Vietnam
veterans with regard to Agent Orange. We are very determined,
very determined not to see that happen again. Mr. Chairman, I
look forward to hearing our first report from the VA on the
implementation of this very important new piece of legislation
that you were so active in getting passed. Thank you.
Mr. Shays. Thank you Mr. Sanders. Thank you very much. This
is a team effort; hopefully a bigger team here. Dr. Mather, we
welcome you. Thank you.
STATEMENTS OF DR. SUSAN MATHER, CHIEF PUBLIC HEALTH AND
ENVIRONMENTAL HAZARDS OFFICER, DEPARTMENT OF VETERANS AFFAIRS;
DR. FRANCES MURPHY, CHIEF CONSULTANT, OCCUPATIONAL AND
ENVIRONMENTAL HEALTH; JOHN THOMPSON, DEPUTY GENERAL COUNSEL;
ROBERT EPLEY, DIRECTOR, COMPENSATION AND BENEFITS; SUSAN
STOIBER, EXECUTIVE OFFICER, INSTITUTE OF MEDICINE; DR. CAROLYN
FULCO; AND DR. DAVID TOLLERUD
Dr. Mather. Thank you. Mr. Chairman and members of this
subcommittee, it is a pleasure to appear before you to describe
and discuss implementation of the Persian Gulf War Veterans Act
of 1998, which was enacted on October 21, 1998 as a part of the
Omnibus consolidated appropriations legislation.
Accompanying me today are Mr. John Thompson, Deputy General
Counsel; Dr. Frances Murphy, Chief Consultant, Occupational and
Environmental Health; and Mr. Bob Epley, Director of the
Compensation and Pension Service. Although the letter inviting
us today refers to VA's implementation of the Persian Gulf War
Veterans Act of 1998, VA is also charged with simultaneously
implementing the provisions of Section 101 of the Veterans
Program Enhancement Act of 1998, which established an
overlapping frame work for addressing issues related to the
health status of Persian Gulf veterans.
Thus, our implementation of the former statute must take
into account our responsibilities under the later. The Program
Enhancement Act was passed by the House of Representatives on
October 10, 1998 and subsequently passed without amendment by
the Senate and cleared for the President on October 21, 1998.
Passage by the Senate occurred only hours after its final
action on an Omnibus appropriation measure, which included the
Gulf War Veterans Act provisions based on the adoption of an
amendment offered by Senator Byrd. The Omnibus appropriation
measure was signed into law that day. The Program Enhancement
Act was signed into law on Veterans Day, November 11, 1998.
Thus, VA was presented with the unusual situation of
interpreting and implementing two similar purpose acts that
were passed within hours of each other. Although similar in
purpose, there are several instances in which these measures
take seemingly inconsistent approaches to the study of health
risks associated with service in the Gulf war and the provision
of compensation to veterans who may have incurred disability as
a result of Gulf war service.
In addition, the Gulf War Veterans Act contains a provision
to nullify Section 101 of the Veterans Program Enhancement Act
of 1998 or ``any similar provision of law enacted during the
second session of the 105th Congress requiring an agreement
with the National Academy of Sciences regarding an evaluation
of health consequences of service in Southwest Asia during the
Persian Gulf War.''
In view of the inconsistencies in the two statutes and the
purported nullification provision in the Gulf War Veterans Act,
on December 8, 1998, VA's General Counsel asked the Department
of Justice's Office of Legal Counsel for an opinion regarding
VA's implementation of the two statutes.
The Justice Department responded to the General Counsel's
letter on March 12, 1999. In brief, the Justice Department
opines at Section 1604 of the Gulf War Veterans Act is
constitutionally invalid and ineffective in so far as it
purports to nullify certain described legislation, including
Section 101 of the Program Enhancement Act that might be
enacted in the future.
The respective provisions of the two laws, although
redundant and burdensome in some respects, if both laws are
given effect, are not inherently conflicting or mutually
exclusive. Therefore, the provisions of both laws must be
treated as valid and effective.
With respect to the areas of conflict between the two
statutes, the Justice Department found the most significant
variation between the two bills to be the action required to be
taken by the Secretary after receiving a report from the NAS.
Following receipt of the opinion, VA's General Counsel
conducted an intensive review of the provisions of each statute
in order to ensure proper implementation of both statutes by
all concerned parties. As a result of this review, the General
Counsel has advised VA's program officials as to the measures
needed to fulfill VA's duties under the two laws.
I understand that you are particularly interested in the
contract with the NAS, including its status, terms, conditions,
and time lines. I will briefly summarize this information and
will be happy to provide a copy of the full contract to you.
Because of the real concerns and fears of Gulf war veterans
and their families about the health consequences of military
service in the Gulf war, the Under Secretary for Health sent a
letter to NAS on October 31, 1997 requesting that NAS
comprehensively review, evaluate, and summarize the available
scientific and medical information regarding the association
between exposures during the Gulf war and adverse health
effects experienced by some Gulf war veterans.
The National Academy of Sciences' proposal was accepted and
the contract was signed on June 24, 1998, which was 4 months
prior to the enactment of Public Law 105-277. An NAS committee
will provide a comprehensive review, evaluation, and summary of
available scientific and medical information regarding the
association between exposures during the Gulf war and adverse
health effects experienced by Gulf war veterans.
This review will include an assessment of biologic
plausibility that exposures or synergistic effects of combined
exposures are associated with illnesses experienced by Gulf war
veterans. The NAS will make recommendations for additional
scientific studies to resolve areas of continued scientific
uncertainty related to health consequences.
The total estimated cost of this review is $1,250,000 over
a 27-month period from June 1, 1998 through August 31, 2000.
The initial year funding was established at $500,000. The
project is being conducted in three phases. In the initial
phase, the NAS is identifying health outcomes of interested and
selected exposures to be examined.
Exposures may include, but are not limited to depleted
uranium, pesticides, insecticides, chemical and biological
warfare agents, vaccines, pyridostigmine bromide, health
stress, solvents, paints, fuels, smoke from oil well fires, and
sand.
A review of the literature regarding some prototypic
exposures and associated health effects is being conducted to
develop methods to be used for analysis and synthesis of
different types of research findings.
For example, animal toxicology data, occupational exposure
data, and epidemiology data. Latency periods between exposures
and manifestation of illnesses will also be assessed.
The analysis will take into account the strength of
scientific evidence and the appropriateness of the methods used
to identify association; whether the evidence indicates the
levels of exposure were comparable to the exposures of Gulf war
veterans, and whether there exist a plausible biological
mechanism or other evidence for an association.
A report of the activities and finds of the committee will
be produced. During phase II the remaining exposures will be
subject to similar review and analysis. Finally, VA will seek
to enter into a contract with NAS for a series of updated
reviews to be conducted every 2 or 3 years. The committee plans
to meet 6 or 7 times during the 27 months.
Meetings were held in January and February 1999. The third
is scheduled for April 27th and 28th. A report will be prepared
and issued which describes the framework by which association
is to be determined, criteria by which specific exposures and
adverse health outcomes are to be considered for study, a list
of exposures and outcomes to be considered in the first two
phases, and language to be used to categorize the associations
under study.
The report will include a literature review of the
association between specific health effects and three to six
exposures experienced during Gulf war deployment, and
directions for future scientific research to resolve continued
scientific uncertainty for the exposures assessed within the
report. The exposures covered in this first report will be
chosen to reflect a variety of data sources and methodology
problems.
For example, a review of associations which depend most
heavily on biologic plausibility in animal toxicology data will
differ from associations dependent upon occupational exposure
and populations other than Gulf war veterans, and from
associations dependent on exposure data and epidemiology data
from Gulf war veterans.
Because this effort predated the enactment of Public Law
105-277, it does not conform precisely to the legislative
language. The study has been designed by the NAS to be of high
scientific merit and to be completed in the shortest timeframe
deemed feasible. Therefore, we feel that it fully meets the
intent of Public Law 105-277 and the similar Public Law 105-
368. More importantly, this study will provide a thorough
review of the scientific literature by an expert committee.
Their conclusions are of utmost importance because they will
form the basis for compensation decisions.
We are certain that the current contract sets out the
minimum time required to provide a high quality, comprehensive
literature review. This genuine effort responds to the concerns
of Gulf war veterans and their families and the intent of
Public Law 105-277. The Persian Gulf Veterans Act of 1998 also
asked VA to enter into an agreement with the NAS to review and
identify empirically valid models of treatment for various
chronic illnesses that employ success treatment modalities for
populations with similar symptoms.
Under this review the NAS would make recommendations for
additional scientific studies and treatment trials. In 1998 VA
contracted with the NAS to provide advice on the optimal
methods to assess the health status of Gulf war veterans and
the effectiveness of treatments being delivered by the
Department. The NAS will complete this project in June 1999.
After the final report is completed, the committee will
continue and expand its study to address the mandate of Public
Law 105-277 concerning treatment models.
I understand that some observers have expressed concerns
about delays in research and the negative impact on medical
care and other benefits and services that Gulf war veterans
have earned through their military service. Please be assured
that research efforts and other important efforts on behalf of
Gulf war veterans are continuing uninterrupted. Large numbers
of Gulf war veterans are receiving medical attention from VA.
Over 230,000 Gulf war veterans have received health care
services at VA facilities. More than 74,000 Gulf war veterans
have completed the VA Gulf War Registry Examination Program.
Gulf war veterans with difficult to diagnose illnesses are
still being transferred to our four national Gulf war referral
centers for intensive in-patient examinations and special
consultation. Gulf war veterans with chronic undiagnosed
illness, as well as those with diagnosed service connected
illnesses are receiving disability compensation.
VA has granted claims for service connection for more than
128,000 Gulf war theater veterans have. We are totally
committed to providing the benefits and services to which these
veterans are entitled. Mr. Chairman, we were recently advised
of the committee's interest in the status of the number of Gulf
war veterans disability claims for which additional review was
determined to be warranted.
On July 16, 1996 our Compensation and Pension Service
mandated a review of all previously disallowed Gulf war
disability claims. The purpose of the review was to assure that
all necessary development had been completed, and to assure
that all evidence had been properly considered in reaching the
decision.
At that time, 10,736 claims were developed for
readjudication. The results of that readjudication are as
follows: service connected was granted in 2,802 claims.
Compensation for undiagnosed illness was granted in 1,348
claims. That figure includes 1,044 previously denied
undiagnosed conditions, and 304 newly considered undiagnosed
conditions. Diagnosed conditions were granted service
connection in 1,454 claims. That figure includes 597 previously
denied undiagnosed conditions and 857 newly considered
diagnosed conditions. In 5,264 claims there were no changes on
review, but service connection had already been granted for
another condition. In the remaining claims, service connection
could not be granted for any condition and denial of service
connection was confirmed. There are four cases for which action
has yet to be completed under this review. That concludes my
statement. My colleagues and I would be happy to answer any
questions that you have.
[The prepared statement of Dr. Mather follows:]
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Mr. Shays. Thank you very much, Dr. Mather.
We did not swear in two witnesses. Dr. Tollerud, we need to
swear you in and we also need to swear in Dr. Carolyn Fulco. If
you do not mind standing up and I will administer the oath.
Thank you.
Do you solemnly swear or affirm that the testimony you will
give before this subcommittee will be the truth, the whole
truth, and nothing but the truth?
[Chorus of ayes.]
Mr. Shays. Thank you very much. Thank you Dr. Mather. Now,
we will go to Dr. Susanne Stoiber.
Ms. Stoiber. Good afternoon Mr. Chairman. I am Susanne
Stoiber. I am executive officer of the National Academy of
Sciences Institute of Medicine. My colleagues and I are here
today to provide testimony and answer questions about the
current IOM study related to the health effects associated with
exposures experienced during the Persian Gulf war, and the IOM
contract with the Department of Veterans Affairs, sponsors of
that study. I am accompanied today by Dr. David Tollerud who is
professor at the School of Public Health at the Medical College
of Pennsylvania, Hahnemann University in Philadelphia. Dr.
Tollerud has served on three Institute of Medicine committees
to review the health effects of Vietnam veterans' exposure to
herbicides. He chaired two of those committees. Has indicated,
also present are two senior IOM colleagues, Carolyn Fulco,
Director of the Gulf war study and Dr. Kathleen Stratton who
oversees our general work in this area. My testimony summarizes
the National Academy of Sciences Institute of Medicine
procedures for conducting studies and the history and status of
our current project on the health effects of Persian Gulf war
exposures. I will not repeat that testimony.
The credibility and value of our reports rest on the
processes that we follow to ensure that the work of our
committees is independent and is scientifically rigorous. To
that end, we enlist the Nation's leading scientists to conduct
the studies. These scientists serve without compensation and do
the work for us in addition to their regular jobs. We protect
against bias and conflict of interest and have very rigorous
procedures for ensuring that end.
We require a comprehensive and rigorous review of the
evidence. Following the completion of the committee's work, we
have an equally difficult, rigorous peer review of the
committee's work by a second group of leading scientists who
mirror the expertise on the original committee.
This is a time consuming process, and especially so when
the subject is complex and the evidence to be examined
extensive. The resulting reports however provide accurate and
conclusive answers. That is our commitment. We believe that
nowhere is this more important than in the work we conduct on
behalf of the Nation's veterans.
The IOM is especially pleased to have the opportunity to
work on studies that shed light on the nature of illnesses
experienced by our country's veterans. I will now turn to Dr.
Tollerud who will provide more extensive information on the way
our study committees have conducted their work on Agent Orange.
Our work on Agent Orange provided the model, the blue print
for how we propose to conduct the work on Persian Gulf
exposures. Therefore, I think knowing slightly more detail
about how they proceeded and the difficulties they encountered
will help in our discussion on how quickly work can be
completed on Persian Gulf.
[The prepared statement of Ms. Stoiber follows:]
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Mr. Shays. Can I interrupt you? I feel a little guilty
taking off my coat without inviting any of you to do this. It
is kind of hot in here. Please feel welcome to do so.
Dr. Tollerud. Good morning, Mr. Chairman, and members of
the committee. My name is David Tollerud. I am a professor in
the school of public health at MCP Hahnemann University in
Philadelphia. I also have the unique distinction of having
served as co-chair of the original IOM Committee to review the
health effects in Vietnam veterans of exposures to herbicides,
and as chair of the two followup committees.
In total, I have served on these committees for some 8
years. I appreciate the opportunity to provide testimony to you
today based on my experience from the veterans and Agent Orange
studies. I was requested to provide testimony because the
Vietnam veterans studies are very similar to the Persian Gulf
veterans study that is the subject of this hearing.
The Gulf war committee will use the Veterans and Agent
Orange reports as their model. However, I must point out an
important difference between these efforts. The Veterans and
Agent Orange studies examined only one category of exposures:
the major herbicides used in Vietnam and the herbicide
contaminant dioxin.
Within this category of exposures, the committee focused
primarily on a single compound dioxin; more specifically 2378,
tetrachlorodibenzo-p-dioxin, because of the vast number of
scientific studies suggesting adverse health outcomes that
might be associated with exposure to it.
Each of the Veterans and Agent Orange studies took
approximately 18 months to 2 years to complete. The Gulf war
study will include at least 12 categories of exposures each
comprised of multiple chemicals. I am told there are
approximate 34 specific chemicals or chemical compounds listed
in Section 1603 of Public Law 105-277; a list similar to that
specified in the Department of Veteran Affairs contract with
the Institute of Medicine.
Given the far larger number of categories of exposure
proposed for the Gulf war study, it is my opinion that the
timeframe developed by the IOM and the Department of Veterans
Affairs, and delineated to you today by Ms. Stoiber, is
reasonable.
I do not believe that the time table stipulated in the
Persian Gulf Veterans Act of 1998, which requires a final
report addressing all 12 categories in 18 months would allow an
Institute of Medicine committee to complete its tasks with he
scientific rigor and attention to the interest of veterans that
this work demands.
In support of these opinions, I would like to relate to you
the elements that went into making the Veterans and Agent
Orange series of reports and that are proposed for the Persian
Gulf veterans study. Almost all National Academy of Sciences
reports are written by committees of scientists. Committee
members are individuals who serve on a volunteer basis and
receive no compensation for their work.
Assembling a committee for an effort like the Veterans and
Agent Orange studies and this Gulf war study is a time
consuming task because IOM holds the members of its veterans
health committees to its highest standards for participation.
Committee members must not have any research grants from the
Department of Veterans Affairs because in conducting its work
the committee must operate independently of DVA.
They must also have no research or consulting involvement
with businesses that might have an economic stake in matters
under the committee's consideration. Staff must find scientists
who are willing to devote considerable time and energy to a
project that is not directly related to their own research
because committee members must not have had prior direct
involvement with the issues before them, nor have taken a
public position on them.
Committee members are thus required to learn and comprehend
a new topic; a process that necessarily takes time. The
Veterans and Agent Orange Committee realized from the beginning
that it could not conduct a credible scientific review without
a full understanding of the experiences and perspective of the
veterans.
Therefore, to supplement its standard scientific process,
the committee opened several of its meetings to the public to
allow veterans and other interest individuals to voice their
concerns and opinions, to provide personal information about
their exposures and associated health effects, and to educate
the committee on recent research results and studies still
underway.
While it takes time for the committee to gather this type
of information, it provides a meaningful backdrop for the
numerous scientific articles that the committee reviewed and
evaluated. I am pleased to hear that the IOM proposes to
conduct the Gulf war study in a similar manner. I believe it is
important that they be given the time to do so.
The Veterans and Agent Orange Committee gathered
information from multiple sources, always with the goal of
seeking the most accurate information and advice from the
widest possible range of knowledgeable sources.
Consistent with the procedures of the IOM, the committee
met in a series of closed sessions and working group meetings
in which members could freely examine, characterize, and weigh
the strengths and limitations of the vast array of scientific
evidence.
In addition to these formal meetings, the committee
actively and continually sought information from a broad array
of individuals and organizations with interest or expertise in
assessing the effects of exposures to herbicides, just as the
Gulf war committee has planned. These interactions include
frequent meetings with representatives of veteran service
organizations, congressional committees, Federal agencies, and
scientific organizations. One of the many ways the Vietnam
Veterans Committee heard from the public was through several
hundred telephone calls, letters, and e-mails, each of which
received a response from IOM staff, just as the Gulf war
committee and staff are doing.
This important part of the process takes a great deal of
time. During the course of the first Agent Orange study, which
I would again remind you focused on one exposure, the committee
or staff read approximately 6,400 abstracts of scientific and
medical articles which were all entered into a computerized
bibliographic data base.
I am told that the Gulf war committee and its staff have
already reviewed and cataloged over 10,000 abstracts and their
work is just beginning. As time consuming as the beginning
efforts are in such studies, the real work is in evaluating the
articles, determining the strength of the findings, and
discussing the outcomes among the committee members.
The value of the iterative and deliberate processes that
are the hallmark of such studies is that the result is a
comprehensive, unbiased, scientific review of all of the
available evidence regarding the potential health effects of an
exposure. More importantly, the document that is produced is a
consensus of the collective knowledge of that committee. Each
committee member is able to defend the findings, conclusions,
and recommendations in the final report because each has been
through a lengthy committee process that has built a bond of
trust among all participants.
In my opinion, it is simply not possible to substantially
shorten the period of time necessary for this confidence to
develop. All of the evidence from multiple sources must
ultimately be assembled into coherent chapters. The draft
chapters are discussed, written, and rewritten multiple times
before they accurately reflect the committee's findings and
conclusions.
The chapters must be organized into a document that
characterizes the committee's thinking and conclusions, and
represent a consensus of the committee's collective
recommendations. This process is also iterative and
deliberative and represents an additional investment of time.
Finally, the IOM requires an extensive and lengthy peer
review process for the document in order to assure its
scientific integrity and the appropriateness of its
conclusions. The review process requires identifying and
nominating a panel of external reviewers who are also
volunteers. There is also an internal academy review committee.
These external and internal reviewers provide feedback
which strengthen and enhances the scientific integrity and
effectiveness of the committee's product. This independent
review is regarded as an essential safeguard in maintaining a
high standard for all academy reports and lends credibility to
each approved manuscript.
This process which takes several months to complete is a
hallmark that distinguishes the academy from many other
organizations offering the Federal Government scientific and
technical advice. It is one of the primary reasons that academy
reports are often the final word on issues of importance to the
Government and others.
The review process, like each step in conducting an academy
study, is thoughtful, deliberative, and requires time. I hope I
have been able to provide you with insight into why academy
studies of veterans health issues take time and need to take
time, and to lend support to the time line in the current
Department of Veteran Affairs' contract with the IOM to study
the health effects associated with exposures experienced during
the Persian Gulf war.
Thank you for your attention. I will be happy to answer any
questions.
[The prepared statement of Dr. Tollerud follows:]
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Mr. Shays. Thank you very much, Doctor. I would just like
to first acknowledge the presence of Janice Schakowsky who is
from Illinois. It is nice to have you here. She is a new Member
and a very effective Member of Congress. I am trying to get a
sense of where we are headed here.
One of the things that I take as given, and I would ask the
three witnesses to respond in the order of their testimony; my
general understanding is that the VA accepts the fact that they
have two mandates of Congress that while having some
differences clearly are not incompatible and that the VA
intends to abide by the law and the language. I guess, Dr.
Mather, that is your question.
Dr. Mather. Yes, sir. That is the case.
Mr. Shays. I do not care, given the other things I am
interested in to figure out whether the lawsuit made sense or,
excuse me, the request made sense to the Justice Department or
not. It may have or it may not have. I am less concerned with
that. I am more concerned with getting a sense of the effort to
live by the spirit of the law. I wanted to know what that
means.
You clearly had a contract the year before to begin this
process. Is there any inability on the part of the VA to
renegotiate the contract to try to have it conform as closely
as possible to the law?
Dr. Mather. No, sir. We feel though that the contract that
we have now is a good approach and is the best approach. We
certainly agree that the law is firm in the interim report.
After the meeting on the 27th of this month, we expect that
there will be a report from the committee that will talk about
where they are so far.
It will be a brief report. We get quarterly reports on
contracts anyway. I think this would be a reasonable point at
which to expect a report. We have already talked informally
with the National Academy about the points of the law which do
not appear to be covered in our current contracts and how we
can expand those contracts.
I think what we have now is basically a very sound approach
to a very, very complex problem. I think the current contract
will stand, should stand, and will need to be amended to take
care of the other items within the laws.
Mr. Shays. If something cannot be done, even if the law
requires it, it will not get done, or if it can get done but it
is absurd to try to do it, then there are some issues that have
to be dealt with.
What flexibility does a Department have in deciding, and I
am not even talking the merits of this particular issue, to
basically live by the spirit and not the letter? How does that
work? Maybe Mr. Thompson you could tell me.
Mr. Thompson. That is a fascinating question. What we are
trying to do is to execute the law as faithfully as we can.
Now, if it appears that there is an area that is just not
feasible to do or cannot be done within the time constraints
that Congress has ordained, we would attempt to come as close
as we can. We would notify the committees of interest of what
difficulties we were having.
Mr. Shays. Congress could try to mandate that an elephant
can fly, but it is not going to fly even though I sometimes
think the 747 is kind of like that and it does fly. Dr.
Tollerud, you make it very clear from your testimony that there
is a process that you feel has to be followed and it is going
to take a certain amount of time.
I am going to make an assumption that there is some time
you wanted to take to fit into your schedule and the schedule
of everyone else that is involved in this research. There is
the schedule that Congress wants and they conflict. But I make
an assumption that to the best of your ability, if you can
speed up a process the law requires it, you will do it as long
as it does not create bad scientific results. Is that a fair
assumption?
Dr. Tollerud. I guess I would like to have the IOM answer
from their perspective.
Mr. Shays. Yes. I think that would be more appropriate.
Dr. Tollerud. I will be happy to give you my personal view
based on 8 years of experience.
Mr. Shays. Ms. Stoiber, I am sorry. I should have asked you
to do that question.
Ms. Stoiber. That is fine. Our commitment and our interest
in the IOM is in doing this work as rapidly as we can possibly
do it and still produce scientifically valid and complete
answers. So, we actually have spent a substantial amount of
time with our Persian Gulf Committee.
Dr. Tollerud is not on that committee. He was on the Agent
Orange Committees; talking about whether or not we could devise
a way to do the work faster, given the large number of
exposures to be considered.
After very extensive discussions with the volunteers who
will be doing the analysis on the Persian Gulf Committee, we
concluded that we really could not figure out a way to speed up
the process and still feel confident that we would be able to
deliver accurate and valid results.
We have given it a great deal of thought. It is not just a
matter of the volunteers trying to fit it in with the rest of
their obligations. There is simply an enormous amount of
literature to be absorbed in this and a need to make sure that
we are treating it consistently across the different exposures.
So, our belief is there is not a way to speed up this
particular analysis.
Mr. Shays. Let me do this. Mr. Sanders has to be at another
hearing. So, why do I not give him the floor. I am going to be
here.
Mr. Sanders. Thank you very much. I will do my best to come
back. I think I will be able to do that. Just two questions,
Mr. Chairman. I think Dr. Mather might be the right one to
answer, if not, whoever can answer it. The Persian Gulf War
Veterans Act of 1998 provides the Secretary of Veterans Affairs
with the authority to administratively determine and issue
regulations, determining a presumption of service connection
between the disease, illness condition, and an exposure to a
hazardous material or combination of materials, et cetera,
during service in the Gulf based on the recommendations of the
NAS study.
That is what the Persian Gulf War Veterans Act does. The
Veterans Program Enhancement Act of 1998 requires the Secretary
merely, here is the difference, to review the NAS
recommendations and subsequently forward his recommendations
regarding determination of service connection to Congress.
I know what you are trying to do is implement to the best
degree that you can both laws. You have a conflict over here to
some degree. So, my question is what assurances can you give us
that NAS findings will be reflected completely and accurately
in the regulations called for in the Persian Gulf War Veterans
Act to actually provide assistance to deserving Gulf war
veterans?
In other words, the bottom line of this and the reason that
Chris, others, and I worked so hard on this was not some
academic reason or scientific reason. Essentially we want to
make sure that those people who are hurting were sick as the
result of exposure actually get benefits. Could you, Dr.
Mather, or Mr. Thompson, or whoever else answer that?
Dr. Mather. I can certainly answer from my understanding.
My understanding is that the scientific associations will be
reflected in the Secretary's action on presumptions of service
connection when they are received. He will both report to
Congress and he will use that information to establish
presumption.
This is certainly the way it has happened with the Agent
Orange reports. As the scientific evidence of an association
was sufficient, either the presumption was established or in
the case of birth defects, VA sought legislation to provide
that.
Mr. Sanders. So, if the presumption is established, if we
find the cause and effect----
Dr. Mather. It does not have to be a cause and effect, only
that there is a significant association.
Mr. Sanders. Yes, OK, right. That will then result in
regulations being drawn up. Somebody has the illness and that
person will then get the benefits to which they are entitled.
Dr. Mather. That is my understanding.
Mr. Sanders. OK. The second question; maybe for Dr.
Tollerud. You mentioned using Agent Orange as perhaps a basis
of how we are proceeding here. You referred to Agent Orange
quite often. Would you comment on the fact that if you talk to
the Vietnam Veterans of America, for example, they will
suggest, as many other Vietnam era veterans, that they are not
happy with the status of the Agent Orange work with Operation
Ranch Hand.
The fact that unless I am mistaken, and I do not think I
am, that the vast majority of requests for benefits that go
forward are denied. So, I get a little bit nervous. I am happy
with Dr. Mather's answer, but I get a little bit nervous if you
say, hey, we did Agent Orange pretty well and now we are going
to continue along that path. Some of us have real concerns with
that. Comment on that.
Dr. Tollerud. My comments about the Agent Orange Committee
had to do with process. I do not think that this is the forum
to further debate the findings of the committee. Each of these
committees were made up of, I do not know, 15 to 18 independent
scientists. A part of the reason why it takes time to get there
is that if you take 18 scientists and you put them in a room,
you will get at least 21 opinions about any given question.
It takes time to resolve that. Our commitment was to have a
consensus report that every single committee member could stand
behind. Sometimes that meant going back to the literature,
bringing in others, et cetera. My comparison of Agent Orange to
the Persian Gulf was not dealing with the findings but was
dealing with the process.
When we started that committee, there really was no
template. I mean this was the first, at least in our view, it
was the first time that a committee like this had taken on
quite this kind of an effort, and particularly looking at such
a large number of individuals who were exposed at such a long
time in the past.
So, we took models from other organizations in terms of how
they weighed the evidence. We looked into the process and we
had veterans and other interested parties come and give
testimony. All of that testimony was considered. So, that is
what I was referring to.
Mr. Sanders. That is fair enough. I will just state that in
fact, one of the things that motivated me, and I will not speak
for Chris, is my knowledge that in Vermont and throughout this
country, there are a whole lot of veterans who today are very
upset about how the Government responded to Agent Orange and
their health problems.
In fact, the reason that I played my role in pushing this
thing forward is I did not want to see that happen again. I
wanted the assumption to be that if scientists believe there is
an association between an illness and an exposure to a chemical
or environmental hazard, we are going to give the benefit of
the doubt to the veteran this time and give them the benefits
and the health care they need, rather than fighting them as we
had for so many years with Agent Orange.
Mr. Shays. Ms. Schakowsky, did you have any questions?
Ms. Schakowsky. Yes. Thank you Mr. Chairman.
I am new to this issue. So, you will forgive me if I ask a
silly question. You talked about the time line, Dr. Tollerud
and as you did, Ms. Stoiber, about how long the committee takes
to deliberate. Of course, we want good scientific data.
Why do we just have one committee? Why cannot we have more
committees to look at more substances so that we can move a bit
faster? I mean if one committee is good, why is not two
committees better or three committees better?
Ms. Stoiber. It is a very reasonable question and it is one
we asked ourselves because as we looked at the requirements of
the legislation and understood what the Congress wanted and
obviously what the veterans wanted, we brought together our
core committee for the Persian Gulf study and examined the
question of whether or not we could divide the work and
consider more exposures more rapidly.
I will let Carolyn Fulco comment on this in more detail.
The conclusion was we need first of all to make sure that the
methodology we are using for these exposures is one that will
meet the committee's standards in terms of assessing the
scientific literature.
That phase I of this study in which we will be looking at
five exposures is the process by which we will know that our
approach to this is going to yield the results that we think it
should. Phase II of our study will in fact, in a shorter period
of time, enable us to complete analysis of the remaining
exposures.
Our committee members felt that until phase I is completed,
we simply cannot be certain that it could be divided into
multiple groups and essentially run in parallel. There is an
enormous need to make sure that we keep consistency in the
analysis of the different exposures and also a need to make
certain that we have carefully looked at all of the available
literature.
If we hurry it, we may end up missing some critical
evidence that would establish a conclusion that may be missed
otherwise.
Ms. Schakowsky. Let me just ask you a question then based
on what you have said. After Phase I it would seem to me
possible, unless a methodology is established, that one could
have more committees; could one not?
Ms. Stoiber. We do not believe that multiple committees are
the right approach. We believe that you have to maintain
consistency across all of these. The remaining exposures can be
analyzed as we have proposed more quickly because we have the
methodology in place and we are confident of it.
Dividing the work among independent committees who will
then have to confer with each other and review each other's
work to make certain that everything is being treated
consistently would not shorten the process. It might in fact
lengthen it as we go into the overall review. If I could ask,
Carolyn, do you have anything to add to that?
Mr. Tollerud. Can I add a comment?
Ms. Stoiber. Sure.
Mr. Tollerud. I think from the standpoint of a committee
member, and we have not had any discussions related to that
particular question or issue. I have not been involved with any
of the IOM's internal deliberations. So, this is just off the
cuff from me. First of all, there are no silly questions. There
are only silly answers.
From a committee's standpoint, I guess I would second the
notion that adding manpower essentially and dividing into small
groups is not likely to shorten the process and in fact may
well lengthen the process.
What I observed in three consecutive IOM Committees where
each subsequent committee was made up about 50 percent old
members and 50 percent new members in order to have a new
infusion was this.
The first third or so of the second committee's process or
the subsequent committee's process was heavily involved with
understanding what the first committee had done so that they
could either disagree and do something differently and then
explain it or carry on that process with some consistency.
We as scientists reviewing other scientists' work are
extraordinarily skeptical people. You start with the premise
that you probably screwed up and let us see if we can make it
better. It takes a long time to work through that and make a
decision about whether or not in fact the process did work or
did not work.
Each committee came to the conclusion that the process in
fact did work. By the end of their deliberations all were
confident that the process has worked very well. My concern is
that if you have several committees or two committees going on
in parallel, they are going to be divergent.
You will end up at the end with either a conflict in the
reports or some inconsistency in the reports which I think is
the last message that anybody wants to send to the veterans,
that after all of that amount of time and effort, they still
did not get it right.
I appreciate the committee members' comments that there
continue to be veterans who are dissatisfied with the sum total
of what has been done with Agent Orange. I fully understand
those. As a physician I understand those concerns. Nonetheless,
It has been my sense in talking with veterans' organizations
and my scientific colleagues that virtually nobody agrees with
everything in the report. That is fine. At a minimum, I think
virtually everyone agrees that the process was sound. That the
work has integrity. That it has stood the test of time.
The last committee in fact found very little to tinker with
in terms of the levels of evidence. Each of the conclusions of
the prior committee were found to be strengthened by the dozen
or 2 dozen major new studies that have come out in the last 2
years.
So, that gives us a lot of confidence that we in fact did
it right and that the documents are there and they will stand
the test of time. They will not have to be second- guessed in
the future. I think that is important.
I understand the difference between 18 months and 3 years,
whatever the time difference is, for somebody who is suffering,
for somebody who has a condition, for somebody who is waiting
for compensation, or for somebody's spouse who is waiting for
compensation, or children. It seems like an eternity.
I think it is just critical that we do it right. If you
rush the process and do it wrong, or do it substandard, or do
it in a way that can be challenged, then that difference in
time span will, I think, I mean any level of conflict about the
results, any challenge to the results in my view will absorb
much more time than the marginal amount of time commitment to
do it right the first time. This was just a personal opinion.
Ms. Schakowsky. Can I ask one more?
Mr. Shays. One of the advantages of having less members is
that we do not have a clock.
Ms. Schakowsky. OK. Again, I feel disadvantaged by not
being a scientist. My understanding is the committee is
reviewing these sets of exposures. If there is a certain
methodology that has been established to do it that clearly if
we are talking about 13 groups or 30 different chemicals or
whatever it is, if you have to repeat the same thing over, and
over, and over again, that dividing it up again, explain to me
why once you have established what the scientific method is,
the methodology, why you have to have it all done by the same
group.
Mr. Tollerud. Well, the reason is because the methodology
is not unfortunately a numerical approach where a board or a
group of people can rank different papers or whatever and at
the end of the day count it up and it comes down. I mean the
exposures are complex. The levels of exposures are complex.
The studies to evaluate them are complex. They are rarely,
if ever, sort of direct measurements. There are a lot of
assumptions that go into that. In the end, the reason the IOM I
believe chose to bring together independent scientists who did
not have prior experience is because in the end these are
judgment calls.
There are very few, with Agent Orange for example, there
were a few conditions, which seemed apparent from the
beginning, and they were in the sufficient evidence category.
Frankly, we did not spend a great deal of time looking at
those. If the evidence was clear, if the evidence seemed to be
overwhelming, the evidence was reviewed and it was cataloged,
but that went very quickly.
Unfortunately, for most of the conditions of concern to
veterans, I would say the vast majority of conditions that are
of concern to veterans do not fall into those sort of clean
evidence categories for a variety of reasons, not the least of
which has met most of the concerns that I have heard relate to
conditions that are relatively common in the general public.
The current theme for Agent Orange, for example, one of the
biggest concerns that is sort of on the scientific horizon is
whether or not diabetes might be associated with Agent Orange
exposure. There is an enormous amount of scientific evidence to
go into it.
This is something that is so prevalent in society that it
becomes a very complex question and a lot of judgment to
understand whether in fact this is diabetes in and of itself or
diabetes that might have been related to a specific exposure.
The answer to the question is that it is a difficult
process with a lot of judgment. We say methodology and it
sounds clear cut. The methodology in this that ultimately
decides where conditions are placed in the categories of
evidence which ultimately influences VA's reaction, in terms of
the legislation, if you read those categories of evidence, and
we can provide them if you want, but if you read those
categories of evidence, they are judgmental.
The sufficient evidence means that one or more studies are
evaluated as being high quality without bias and a whole bunch
of other things that can cripple the value of a study. All of
those are judgment calls. For the conditions that are of most
concern there are studies on one side and studies on another
side. It takes a lot of weighing of that evidence to come
forward.
Ultimately what a single committee does is they will make
up their mind in the first part of the study, phase A if you
will or whatever the beginning is. They will make up their
mind. Everybody will sort of lock into it. The committee will
lock into sort of an understanding of where they are going to
make the cuts. What is going to be the standard that this
committee is going to evaluate in terms of strength of
evidence?
It will be a judgment. There is always a gray zone there.
The committee will say that this is going to be our standard
that we are going to stand by. Once you do that, then you can
begin clicking through the various exposures much more quickly
than starting up other committees that have to go through that
whole process, lock into a certain way they are going to make
their divisions between the categories, and pray that, that
committee's divisions are the same as the first.
I think what we all would not like to see is to have
veterans who were exposed to depleted uranium treated
differently than veterans who were exposed to biologicals, for
example, because one committee thought differently from another
committee. Again, I think that the time consuming part of this
process and the gelling of a committee are a real phenomenon.
It is not artificial. It takes time for those independent
thinkers to come to a consensus. Once you have done that, once
you have got that committee gelled, then you can move fairly
quickly through the other exposures. I think that at that point
adding manpower simply dilutes the process.
Mr. Shays. Thank you very much. They were excellent
questions. That was very helpful to the committee and I
appreciate the responses. I know that this committee is going
to attempt to monitor this process, but I am really unclear
right at the moment how we are going to do that.
Jim Toote had given us his reading of the act and the time
line. I believe that the VA has given us their kind of sense of
what the time line is. I think that maybe I need to understand
something pretty basic. The VA has asked you to do this study.
So, this issue is, I mean through Congress, but this issue,
you have a contract with the VA. So, the whole issue of time
lines is an issue that I need to address more with you than
with the VA?
Ms. Stoiber. Our contract has certain time lines specified
in it. In terms of what we are able to do and deliverables at a
certain date, then we need to discuss it. Obviously, any
matters that are at issue with the VA we cannot speak to.
Mr. Shays. Well, let me just cut through some of this as I
see it. If this is an issue that the contract allows you a
certain process, then that is one thing. If it is an issue that
is that science simply does not enable you to do it
differently, then that is another.
As I listened to your questions the gentle lady from
Illinois, I am struck by the fact that says--well, my
understanding is, for instance, the bill requires a list of 34
toxins. It is my sense that we are going to begin with five,
give or take.
Ms. Stoiber. That is correct.
Mr. Shays. You have attempted logically to identify the
five that the veterans were most concerned with and what
scientists as well thought might be the most serious. Is that
correct?
Ms. Stoiber. The scientists felt there were any number of
ways you could begin the analysis and that the proposed
exposures favored by the veterans groups are as good
scientifically as any other approach. There was no difference
in terms of thinking about priorities.
Mr. Shays. Well tell me why, other than resources, you
could not do a study of the five, a study of another five, a
study of another five, and a study of another five all at the
same time, other than resources?
Ms. Stoiber. Right. Let me first answer the question that
was implicit in your preface to the question, and that is was
the contract the constraint for us? When the VA approached us
initially about doing this study, they did not have a specific
timetable specified in their approach to us. They asked us
basically to give them a proposal for how we could approach
this work.
Therefore, the timeline that is provided in our contract is
really a timeline that we recommended to the VA for assessing
the 34 exposures. So, the constraints are not artificial from
the VA to us. They really are reflective of what we thought it
would take to do the job in terms of our committee process.
There are some obviously ancillary issues of interim reports
and so forth that I think can be dealt with. So, that is not
what I am addressing.
Mr. Shays. Let me just tell you. I take a bit of a bias
here and I am going to be really candid. I would always want to
be candid, but I am going to say what I think about that. I can
ask someone to build my house. I am going to tell him what I
want built. He is going to tell me how it fits in with his
schedule of other houses he is building.
I need you to be a little more precise about the timetable
because the law is clear. It would be really misleading for us
to leave today thinking that the only restraint would be good
science. If in fact we put more resources into this, then could
it be done sooner? Were you, for instance, given a specific
contract with a certain amount of money allocated?
Ms. Stoiber. I was not a part of that negotiation. I think
my colleagues could answer that, that was not a part of the
discussion.
Mr. Shays. I need you to come up. Let me say to you that I
would think that you had been given some kind of budget. So, it
is not a criticism. I just want to know the score.
Ms. Stratton. Actually, Mr. Chairman, we proposed a budget
to them. So, VA did not tell us how much they have in their pot
to pay for this study. Rather we decide what it will take to do
the project in the best interest of the science and develop a
budget based on our experience from doing many studies
similarly. Then we submit a proposal with a budget to the VA,
which they accepted in full with no modifications. So, in fact
it really was what we proposed to them.
Mr. Shays. This is basically allowing, in a sense, the
consultants to write their own contract. You are going to write
it, in my judgment, to fit your needs as well as the needs of
the person providing the request.
Dr. Murphy. I do not know that you got a sense of the kind
of process we go through in developing contracts with the
National Academy of Science. They are an independent
organization. We sent a letter to the NAS on October 31, 1997
requesting that they consider doing this committee work for us
with a specific set of criteria that we would like to see the
committee include in their study.
Also, I think that it would be fair to say that the IOM and
the VA had lengthy informal discussions about how to proceed.
They developed a process, developed a budget, gave the proposal
back to us then Kathleen Stratton and I discussed in detail
whether there was any way, knowing the urgency and the concerns
of the Gulf war veterans and their families, whether this
process could be shortened.
From the very beginning, VA recognized that Gulf war
veterans do not want answers 2 years from now or 5 years from
now. They wanted answers back in 1992 when they first returned
from the Gulf.
Mr. Shays. I think that is accurate.
Dr. Murphy. So, we recognized that from the very beginning
and discussed at length about how the process might be
shortened. We came to the conclusion jointly that NAS had
developed the best proposal that would produce valid scientific
answers.
Mr. Shays. Let me just say to you that I was with you until
that last point. It is just hard for me to imagine that it is
only one way and one way only. I cannot believe that. I cannot
believe that with additional resources that it could not be
done more quickly, unless you are telling me that you have to
allocate your resources somewhere else.
Ms. Murphy. The resources that are scarce for us are not
those that we could buy with additional money in the contract.
The core of our work is our ability to identify and engage the
volunteer time of a diverse range of scientists who not only
have to be the leading experts in the given areas on a
committee, but also are precluded as we indicated in the
beginning from holding contracts with the sponsoring agency, of
having any kind of consulting or other financial or personal
relationships with businesses that could benefit or suffer from
the findings of the committee.
So, you start with a relatively small pool of experts who
would be suitable to serve on the committee. You diminish that
pool further by the exclusion of those who might bring bias or
conflict of interest to it. Then you have to find people who
can fit this in their otherwise busy schedules.
The quality and the authority of our work depend entirely
upon our ability to get people to volunteer their time for
this. It is a very significant amount of time that they have to
devote to it. In just the first exposures that we will look at
in the study that we have commenced, the committee members will
be expected to review probably 12,000 to 15,000 articles that
yield information of different quality and different
perspectives on these exposures.
That means a great deal of not only of the literature, but
then coming together to deliberate and argue about the value of
different studies. So, it is an enormous time commitment for
them to make.
So, our constraints are not those of the IOM. I would
gladly go higher several additional staff people and wrap up a
process if that could enable us to give accurate and conclusive
results. Our limitations really are those of finding the
scientists who can meet our standards and participate.
Second, what Dr. Tollerud said of assuring that you do not
create a process in which multiple activities end up giving you
a lesser quality product and one in which different groups of
veterans, depending on the exposure and the committee, might
have different levels of consideration. So, if we could do it
faster, we certainly would and would not hesitate to ask for
the resources to do it.
I want to assure you that we spent a great deal of time
internally trying to figure out if there was a way to create
parallel committees and not diminish the authority of the work
that we provide.
Dr. Tollerud. Could I.
Mr. Shays. Sure.
Dr. Tollerud. I need to follow that up. I am glad you
jumped in front of me. I do consulting for industry. I do
consulting for the city of Philadelphia in dealing with some of
their environmental concerns. I know how consultants work.
There is no question in my mind that VA could find a consultant
to get this done in half the time that is even asked for in the
law and to come up with a document that gave all of the looks
of integrity.
You could not pay me enough to be on this committee, if it
were a matter of resources. I have been at this for 8 years
because it is the Institute of Medicine. There are very, very
few other organizations that I would put this level of effort
into. I belong to a dozen or so professional organizations. I
do not give any of them any comparison level of time that got
me to the first committee.
Mr. Shays. How does that relate to my question?
Dr. Tollerud. Because the whole key to why this takes time
is that the scientific process of those of us who participate
is the limiting factor. It is not staff. It is not anything you
can buy with more money. The fact of the matter is I have been
a part of the selection process of choosing or at least
recommending colleagues of mine to be on the second committee
and the third committee for Agent Orange. There are not very
many of us out there.
Mr. Shays. None of this is intended to be disrespectful or
to anything other than to just try to understand this, but why
do you have to be the only person?
Mr. Tollerud. I do not, but the pool of people who fulfill
the particular criteria that the IOM have taken with respect to
veterans studies, which is a different set of criteria than for
some of the IOM studies I believe. It is one that eliminates
the vast majority of potential candidates for participation.
Mr. Shays. I respect your organization, Ms. Stoiber, more
than you can imagine. So, I kind of give deference to it,
especially since I do not have the expertise and since I would
be a generalist in this issue. I have this analogy. I can
understand that if I plant a seed, then I cannot mandate by law
that this grows into a beautiful plant in 1 month when it is
going to take 3 months. I can wonder why we do not plant more
seeds.
If I have a sense that we are going to do five and then we
are going to wait until that plant grows, then we are going to
study it, and then we are going to plant another seed and wait
until that plant grows and then we are going to study it, you
know, way off in the distance we are going to be able to
collect all of this information, and that is what I am
wondering. Why can't we plant more seeds?
Let me say this to you. Whether you recommend it or not, I
am talking about the cannot. I am talking about that first. I
want to understand if it is resources, if it is that there are
only a few good men and women to do this study, and I do not
mean that sarcastically.
I sounded that way, but I do not. I truly do not; whether
there truly are only a few good people to do it. I want to
understand that. Then I am going to have a better sense of the
timeline.
Ms. Stoiber. It truly is not a question of resources that
are money dependent. It is a question of whether or not we can
first of all conduct the study in a way that meets your
expectations and our expectations for the accuracy and the
conclusiveness of the answers that we give you.
I assure you that the IOM would be very willing to speed up
this process if we believed there were a way to do it without
compromising the final report. Based on the strong need of the
veterans community to have answers to this, and the interest of
the Congress and speeding up those answers, we can certainly
revisit the question with our committee at the conclusion of
phase I in which we have worked through the first exposures. We
will then have a level of experience in whether or not there is
any feasible way to expand the committee, operate with sub-
panels, or in any other way get the process moving faster.
I assure you that until the conclusion of phase I, it is
not possible to even have that conversation, but that we would
have not the slightest hesitation in coming back to you and
coming back to the VA and saying that we could cut this by
months or longer if we were able to accelerate phase II. At
this stage, I do not want to hold out the possibility that we
could do that because we have consulted extensively and do not
think that is possible.
Mr. Shays. Phase I will be done when?
Ms. Stoiber. Phase I is August of the year 2000.
Mr. Shays. We required it to be done when?
Ms. Stoiber. April 2000, but you required that the entire
set of exposures be done by April 2000. We are delivering a
sub-set of exposures by August 2000.
Mr. Shays. Have up to five, give or take?
Ms. Stoiber. Seven, I am sorry. I misspoke.
Mr. Shays. Let me just say this to you. I am not convinced
about this one part. I am not convinced of that, and I could be
just totally off base, but I will tell you. My mind says that
you can do more than or maybe I do not understand this. Does
the same group of people have to do each one of these phases in
order for there to have this common knowledge or can different
people do each one of the toxins? You could have a group of
toxins here and toxins here?
Ms. Stoiber. Let me let my more scientifically qualified
colleagues answer that.
Ms. Stratton. I think it is a little bit of both. The
answer is a little bit of both. Basically, the committees tend
to break into working groups who have primary responsibility
for specific compounds or health outcomes. That is most likely
the way that this Persian Gulf Committee will choose to
operate. We believe that they will.
They will firm that up next week when they have their
committee meeting. That does not mean that they do not need to
spend a great deal of time together explaining to each other
what the primaries for that particular compound have read, have
studied, and the questions. They need to be able to test each
other back and forth and make sure that everyone is in the
agreement and the full breadth of the scientific questions have
been evaluated.
So, they are in small groups. There is a great deal of time
spent as a whole sharing the information back and forth. This
is the consistency and consensus requirement that Dr. Tollerud
referred to that, by experience with veterans and Agent Orange,
we understand to be critical to the quality of the work that we
have done.
Mr. Shays. Let me allow other Members to ask some
questions. I will just say, Ms. Schakowsky, your question
really generates an answer that I am not, well I guess I will
ask you to come back to the subcommittee and just let us know
what truly is a financial restraint and what is a resource
restraint. In other words, there are only so many people that
you can turn to.
If in the end a good faith effort to live by the statute,
which will not be abided by, by the letter it seems fairly
clear by the statements here, but the spirit could be respected
even more. I would love to know if this committee of 18 can be
expanded a bit; if you can be looking at more toxins at the
same time by allowing others to be involved in this process and
still be able to tie it together in a package.
I am going to just conclude at the end, when my colleagues
are done, to go through the timeline with you just a little
bit. Maybe you could start to look at it now and tell me which
ones tend to be the biggest hurdles. That would be very helpful
to me. Mr. Sanders.
Mr. Sanders. Thank you and my apologies to everybody. I had
to run out to another hearing. Let me concur with the
chairman's concerns. I hope I am not repeating and if I am,
please stop me. I do not want to go over the stuff that you may
have gone over.
Very briefly, I became involved in this whole issue, not
only because of concerns with veterans and so forth, but of a
prior experience. That is people in my District were becoming
ill because of exposure to certain types of carbons and so
forth and so on. I became then more involved. I got kind of
sucked into the whole issue of multiple chemical sensitivity.
I do not want to speak for the chairman, but I think one of
the frustrations we have in this whole process is we saw
veterans who came before us who were very terribly ill and the
VA was saying we do not know what the cause of the problem is,
and they do a study, and the study does not show. It proves
that of everything out there, nothing causes the problem.
In my own State of Vermont, I had a meeting. We are a small
State. We did not send a whole lot of folks over to the Gulf. A
couple of months ago I had a meeting in Burlington, VT. We had
120 people who were at the meeting who are ill from Gulf war
illness. Every time we ask the VA what is the cause of the DOD,
there is no cause. We do not know. Where there is a problem, we
do not know. We do not know.
Sometimes I am wondering if they are looking in the right
direction to start with. The bottom line is I, personally,
believe in a phenomenon called multiple chemical sensitivity. I
believe we live in a toxic society. I believe the Gulf war
theater was an enormously toxic environment combined with
pyridostigmine bromide, combined with the possibility that some
of these guys absorbed depleted uranium, combined with the fact
that nerve gas was out there when we blew up a depot.
We are looking at a real toxic environment. Now, my concern
is that there are very honest, decent, intelligent, hard
working scientists who just do not believe this. They do not
believe this. I know the AMA is split on this. I have in my
District guys who when they walk down a supermarket aisle, if
they are exposed to detergents, they get sick.
Their wives cannot wear perfume. They have short-term
memory loss. These are hard working guys who have never
experienced this phenomenon until they went over to the Gulf.
So, my concern is and maybe Dr. Tollerud if you could begin
this discussion, do we have people, and are we going to have
people looking at this who are sympathetic to the concept who
believe in the concept of multiple chemical sensitivity, or do
we have folks that say hey, that is really quackery and fraud
as some believe and there is nothing there?
Dr. Tollerud. I cannot give you a direct answer because
actually I know nothing about the make up of the Gulf war
committee. I can speak from the makeup of the Agent Orange
Committees. I would guess since the process is the same that
the choice of scientists would be similar.
I do not recall in the committee process ever actually
having a discussion about multiple chemical sensitivity. I
think if we had, it would have been set aside right away
because we relied on what the scientific literature said.
For somebody to say I am not going to look at that
scientific article because I do not believe in MCS would be the
same as saying I am not going to look at that article because I
do not believe in leukemia, because I do not believe in brain
cancer, or because I do not believe in diabetes. The fact of
the matter is that the peer review literature, which is what we
relied on, and I mean there is the point.
Mr. Sanders. Who reviews peer review literature? In other
words, if you do not believe in it, and I have seen this many
times, I have talked to several hundred physicians who inform
me that they are treating people who are made ill by carpets. I
am telling you a fact.
I can go to other physicians who say that is all nonsense.
That does not exist. There is no illness made by toxic carpets.
Who is right and who is wrong? If you have as your peer review
those people who do not believe it, then you are going to have
all, and I have seen this. There is a wall between these guys.
Is that true or is that not true?
Dr. Tollerud. That is true. There are similar disagreements
in the scientific community as there is in the therapeutic
community. What I would say with respect to the peer review
literature, which is why we in a scientific sense we always go
back to the peer review literature. That process is one that is
supposed to not allow for opinion to be an overriding
consideration.
In fact, there is a whole appeal process for scientific
journals. If a scientist believes that their article was
crossed out of the journal or prevented from coming into the
journal because of an opinion rather than scientific fact, then
there is an appeal process.
Recently, there has actually been much more use of a
different process where when you submit an article to a
scientific journal, to a high quality journal, you submit the
names of several reviewers who you would suggest as the writer
of the article would have the scientific integrity and opinions
and knowledge to be able to judge that article.
By and large, at least one of those people ends up being
reviewers. The second list that I submit is a list of people
that I believe are conflicted and have a conflict of interest.
I do not have to specify what that conflict is. As in any other
thing, there are scientific people who believe in cold fusion
and who do not believe in cold fusion.
If you are going to submit an article to a scientific
journal, you can list people who you believe have already made
a stance who are closed-minded. Ultimately, it is the editors
of the journal and the editorial boards of the journal who make
that final decision about how exclusionary you can be. That is
the process we use. We needed to rely on that because
otherwise, frankly, we would be faced and we were faced in
testimony, for example, where we would have testimony from
veterans who were clearly affected by disease and who were
explaining the exposures and stuff to us.
Then we would get testimony from somebody else who might
have been a veteran, who might have been a contractor, who
might have been a politician who would have given equally
strong testimony in the other. We did not feel that it was
possible for us to judge the absolute validity of either of
them.
We believe that people were telling us what they thought.
Ultimately, what we could do as scientists, if we wanted to
have something that the VA and Congress could use on which to
base their policy judgment, we simply had to stick by the
science.
Mr. Sanders. All that I would say, and I will conclude in a
moment, is this. There is some good news out there. The good
news out there is that there are a number of scientists and
physicians who I think are making some breakthroughs in Gulf
war illness in terms of understanding the problem and in
treating the problem.
There is right now through the Veterans Administration two
clinical trials for $20 million testing a thesis by Nicholson
who was here from California. There is another trial based on
some of the work done at Walter Reed Hospital for disease
management. That is good news.
The bad news is that, and I would love to be corrected, as
of today, I do not think the Veterans Administration or the
DOD, I think their official position is, yes, there is a
problem. If you were to say to them what is the cause of the
problem? We do not know. We have done this study; nothing. We
have done that study; nothing. Please correct me if I am wrong.
Dr. Mather, am I right or wrong? What is the cause of Gulf war
illness?
Dr. Mather. Gulf war illness, I do not think we know.
Mr. Sanders. That is the answer we have been getting for 8
years, after spending many millions of dollars in studies. Now,
does that mean to say that they have bad scientists, or
scientists who do not want to help the veterans? That is not
what we are saying. I think there is a mindset.
I think what Chris and I, do you remember that; that whole
week over, and over, and over again? There are people who are
approaching these problems in a different way. The VA and the
DOD have been pretty conservative. There are some folks who are
making breakthroughs out there.
So, if all that happens after all of this stuff comes back
that say, well, you know, we know there are 100,000 or 50,000
people who are hurting, they are in my State. I talk to them
every day. They are hurting.
Mr. Shays. Not everyday.
Mr. Sanders. Not everyday. I talk to them often. They are
hurting. We are failing them if all we say is, yes, we know you
have a problem, but after 8 years and tens of millions of
dollars we do not know the cause. We are not doing a good job.
I would hope that you, in whatever capacity you approach this
problem, are more open-minded. Go out to people who you may
think are eccentric.
Every time I hear peer review I get a little nauseous
because it always says to me it is the same old folks saying
this is a crazy idea. It does not work. We do not know what is
going on but this is a crazy idea. Are you following what I am
saying? Does it make any sense to anybody?
Dr. Tollerud. I think that the process that is so difficult
in finding participants for the committees and why in fact as
the problems get more complex and more serious it becomes more
and more difficult to find qualified scientists who have not
already taken a stand. That is one of the resource issues we
are talking about for the reason that popping up several other
committees is just not feasible.
What you do not want is to have those people who have
already made their decisions on the committee. I mean it is
like a jury process where they have already made up their mind
before they are on the committee.
The whole intent of gathering the scientists the way the
IOM is doing it is to have people whom in fact have not made up
their mind. In fact, they have not even spent a great deal of
time thinking about it. Sometimes a fresh look will, you know.
Students do that all of the time. Students ask the
damnedest questions because they are not smart enough to keep
their mouth shut and to not look in a different way. The
committee members are very much like that. They will say, you
know, well why? Why? Why? Why? Why?
Mr. Sanders. The VA has just told us, and please correct me
if I am wrong, that after 8 years and tens of millions of
dollars, they do not know the cause of Gulf war illness. I do
not mean to be critical. I have been critical in the past. I do
not mean to be critical today. It is not a personal thing.
I do not think they are going to get it, not because they
do not want to but for whatever reason. I am asking you to get
it. That means do not continue doing what has failed in the
past. Do not come back 5 years from now say, gee, everybody is
ill. We do not know the cause. Tell us what the cause is.
Go to people you think are a little bit strange who may not
be peer reviewed by the folks who do not know the answer. That
is what I really beg of you because I do talk. We had a
conference. Chris was not there, but some folks were. In
Atlanta, veterans are very frustrated. They are angry. They are
bitter. They do not think they are getting a fair shake. They
are right. They are not getting a fair shake. So, let us break
the model. Let us talk to some different people. Thank you Mr.
Chairman.
Mr. Shays. We are going to conclude very soon. That is not
to say, Ms. Schakowsky, feel free to ask any question.
Ms. Schakowsky. I just have a short comment. I really want
to thank my colleagues, Congressmen Shays and Sanders, for the
years of work that you have done on this. I find with my very
short exposure to this that maybe I understand now why I am not
a scientist. I am not a patient person. What it sounds like you
are saying is that this is going to take a long time.
I think that a part of what is missing in this whole
process, and I do not feel it so correct me if I am wrong, is a
sense of urgency about this. Mr. Sanders has been talking about
the last 8 years. What I do not hear back from this panel is
that an acknowledgment that, you know what, the fact that these
committee members are busy people is not a real good answer for
veterans who are really suffering and looking for an answer.
That may be part of the reality. I think then maybe we have
to figure out how to coordinate schedules better, or whatever
it is going to take, or find more people who are experts. I
would hope that with all of the work that has been done and the
legislation that has been passed, and the crying in the
Districts of the people who are suffering that this will move
quickly.
Mr. Sanders. May I, Mr. Chairman?
Mr. Shays. Sure.
Mr. Sander. Just let me ask one question. Dr. Murphy, Dr.
Mather, after 8 or 9 years of this issue do you in fact believe
that there is such a thing called Gulf war illness? Dr. Murphy,
do you believe it in your heart?
Dr. Murphy. I believe that there are veterans who are ill
and they have multiple different kinds of illnesses. We have
talked about that before. I do not think that everybody was
exposed to the same thing. I do not believe that everyone has
the same symptoms or the same illness. We treat veterans for
the illness that they have.
We have 120 research projects going on. There are
additional requests for proposals out to study this problem. I
think the IOM Committee that has been setup will help us look
at the scientific literature and determine from the available
evidence whether there are associations between the exposures
and any adverse health outcomes.
That will help us in making compensation decisions. We also
have another committee that the IOM will be starting up soon
that will look at the issue of effective and valid treatment
models. That is a separate process. So, we have done the best
we can to try to address this issue as quickly as possible.
What you need to recognize is that sometimes science does
not always give us answers as quickly as we would like.
Sometimes there needs to be a public policy decision about how
to handle these things.
Mr. Shays. Let me just say, that is really a good lead in
though in one sense because that is really why the legislation
took place. Eventually, the VA has gone to the IOM to do what
we would have liked them to have done years ago, but that is
water over the dam as far as I am concerned; somewhat over the
dam.
Mr. Epley, I just want to say I think your presence here
today would have been to address issues dealing with the
presumption issue. I do not want to open a whole door that we
go in for a long time.
I made this assumption and I need to know, we have a
presumption that a veteran who is ill, who served in the Gulf,
that their illness will be related to their service and to the
Gulf, and that they then become eligible for certain
compensation and benefits depending on their illness and so on.
Is that a false assumption that I am making?
Mr. Epley. No, sir. If I understand you correctly it is
not. If under this law, through this study, or under another
law where a presumption is legislated that says exposure to a
toxin creates an association or a presumption that, that
veteran who subsequently comes down with a disease, if that
presumption is legislated or if the scientific community comes
through this study and says there is a significant association,
we can create the regulatory frame work. We can pay
compensation benefits under that.
Mr. Shays. OK. I just want to be a little clearer. It is
not waiting for the results of this study though. We make a
presumption now; correct?
Mr. Epley. Not under the legislative framework we have now.
We have the undiagnosed illnesses and we do pay veterans under
that legislation from a couple of years back. If a veteran
presents himself to us today and says he was in the Persian
Gulf, in the theater of operations, and he is ill, then based
on medical examination we determine that symptomatology does
exist. They cannot diagnose the illness. We will pay
compensation for that undiagnosed illness. We are.
Mr. Shays. We are making the assumption, the presumption
that their illness was service related. I am missing a fine
point here though that you seem to want to make.
Mr. Epley. I am not trying to.
Mr. Shays. No, no, no. Mr. Thompson, do you want to enter
in here? My sense was that the whole issue of presumption would
be that a person who was clearly ill would be presumed to have
had his illness, who served in the Gulf, would be presumed to
have it be service connected.
Mr. Thompson. No, sir. Current law requires that VA be able
to tie a disability to a period of service. Congress, at the
administration's urging a few years ago, legislated a
presumption only for undiagnosed illnesses.
Mr. Shays. Right.
Mr. Thompson. That is, those illnesses which defy medical
science's ability to diagnose. Because of the uncertainty, the
policy was to give the benefit of the doubt with respect to
claimants.
Mr. Shays. The issue though relates to NAS making certain
findings on presumption. I need to have a sense as to--I did
not think it had to be the final package before that assumption
or that presumption kicks in. So, maybe I need to be clear as
to what you all think.
Mr. Thompson. The law requires that as the reports come
back from the Institute of Medicine, the Secretary reviews
those reports and within a specified period, 60 days, make
determinations based upon the IOM report, as well as any other
available evidence, as to whether the level of proof rises to
the levels specified in the law to trigger the administrative
creation of a presumption by regulation.
Mr. Epley. Excuse me, sir, may I add to that?
Mr. Shays. Right.
Mr. Epley. We have done that under the Agent Orange
legislation. It is a tight timeframe, but it is something
administratively we can do.
Mr. Shays. How tight is this timeframe?
Mr. Epley. It is 60 days to make the report and then 60
days to write a regulation.
Mr. Shays. A report after you have a finding?
Mr. Epley. Yes, sir.
Mr. Sanders. Chris, can I jump in and ask a question on
this issue?
Mr. Shays. Yes.
Mr. Sanders. Help me out here. I am a police officer in
Burlington, VT. I have blinding headaches that affect my
ability to do work. I served in the Gulf. I believe it is
associated with service in the Gulf. I walk into the hospital
and I say I really cannot work right now. I am in trouble.
What help and what benefits do I get? Is there any other
category other than Post Traumatic Stress that I can receive
benefits on? What happens if I do not think it is stress? I do
not want that on my record. Can I get a benefit? How many of
those benefits are being given? Who wants to answer that?
Mr. Epley. Let me attempt to. If you present that way and
are examined by a physician, if they diagnose you for a
condition, first of all, and that diagnosis either is within a
year of your separation from service or if it can be
demonstrated.
Mr. Sanders. Can it be demonstrated? I will give you an
example. I served many years ago.
Mr. Epley. Right. If it can be demonstrated that there is
continuity; those symptoms have been in existence since service
we could provide service connected disability.
Mr. Sanders. How often do you? I mean, I gave you an
example. A guy has blinding headaches. It has gotten worse. He
served over in the Gulf. I mean are you going to say, hey
fellow, we cannot tell you that this was cause by service in
the Gulf? We do not know what the cause of it is?
Mr. Epley. In that instance, if there we are not able to
diagnose, the physician examined and said yes, we understand
your symptoms. You have one or more symptoms. We cannot
diagnose that condition. We acknowledge that you have the
symptomology and it is disabling to you. That is a situation
that we would consider for service connection under the
undiagnosed illness rule.
Mr. Sanders. How many people are receiving benefits who
served in the Gulf?
Mr. Epley. People who served in the Gulf, in the conflict
itself, within the theater of operations and when the conflict
was going on, our records show a little over 86,000 veterans
are receiving benefits. That represents 15 percent of the
veterans who served in the Gulf war conflict.
Mr. Sanders. Are these health-related benefits?
Mr. Epley. Yes, sir; service-connected disability or
disabilities that they received coincident with service.
Mr. Sanders. It is 85,000?
Mr. Epley. A little over that, yes, sir.
Dr. Murphy. Any Gulf war veteran can receive health care
from VA if the condition might be related to Gulf war service.
There does not have to be a proven relationship with their
service in the Gulf. If they are a Gulf war veteran, meaning
they served between August 1990 and present day, they can get
healthcare benefits.
Mr. Sanders. What you are saying is that 85,000 does not
necessarily include people that we would consider have Gulf war
illness.
Dr. Murphy. No.
Mr. Epley. That is correct.
Mr. Sanders. All right.
Mr. Epley. May I elaborate on that, sir?
Mr. Shays. Yes, and then I want to claim back my time.
Mr. Epley. Going back to undiagnosed illness, under that
rule the number of people that we are paying service connected
benefits for is 2,800 and a few over that. So, that is a very
much smaller population.
Mr. Sanders. Is it fair to assume that under that rule we
would consider those people to be suffering from Gulf war
illness; that 2,800?
Ms. Stoiber. They have a lot of different things.
Mr. Shays. Dr. Tollerud, what are the toxins? I made a
gigantic assumption that I am having to come to grips with
here. What are the toxins that you intend to be in your first
report?
Mr. Tollerud. I am not on the Gulf war committee.
Mr. Shays. I am sorry.
Mr. Tollerud. I think the IOM could answer that.
Mr. Shays. Right.
Ms. Stoiber. Those to be covered in the initial phase are
nerve agents, including serine and cycleserine; vaccines
anthrax and botulism. I always stumble on this one,
pyridostigmine bromide and depleted uranium; uranium and
depleted uranium.
Mr. Shays. When do we anticipate a finding will be made on
those?
Ms. Stoiber. That is August of the year 2000. As I
understand it then the VA would act on those findings within 60
days of that period. So, for these seven there would not be an
extension beyond that 60 days after the August report delivery.
Mr. Shays. Basically, by the presumption we are giving the
benefit of the doubt to the veteran; that the VA would have to
prove that the illness was not service related. Now, you are
shaking your head, Dr. Murphy. I want to be clear. It is all
right to shake your head. I just want you to straighten me out
here.
Dr. Murphy. After the presumption.
Mr. Shays. You shook your head and I made a comment. Speak
in the mic and tell me the facts.
Dr. Murphy. The IOM Committee will produce its reports.
Based on the scientific evidence that they find, VA will
establish a process to weigh the evidence in that report and
makes recommendations to the Secretary about what presumption
should be created for particular disease entities. People who
are then diagnosed with those diseases are presumed to have
disabilities related to Gulf war service and can be
compensated.
Mr. Shays. Let me just conclude then by asking is there any
determination, for instance, the law requires that there be an
interim report? I would prefer when we are given documents to
have somebody's name that is attached to them. Are these from
the VA or IOM? How would I know this is from the IOM?
Ms. Stoiber. We sent it to your staff with a cover letter.
Mr. Shays. So, it was a part of a cover letter.
Ms. Stoiber. Right.
Mr. Shays. I apologize; my fault. An interim report was
required. That was not done on April 21 for obvious reasons.
When will an interim report be provided?
Ms. Stoiber. We can provide interim report very quickly and
will be happy to do so. It was not called for in our contract.
So, we did not, but we will be happy to do it.
Mr. Shays. This is what I am going to end up then with my
request. I would like very much for the VA to negotiate a new
contract attempting to respect the legislation that passed. If
you feel that the legislation requires something that is not to
the benefit of the veterans, not feasible, or whatever, just
tell me that in a paragraph or two. We will have a dialog about
whether we need to amend the law or we need to somehow close
our eyes to the law, but I would like that stated.
I cannot imagine why an interim report would not be
helpful. I cannot imagine why it cannot be honored. I would
think that we would go out of our way to honor the law as it is
passed.
Dr. Murphy. I think that the IOM, sir, has already
testified that we have an informal agreement without having to
go back and amend or renegotiate this contract.
Mr. Shays. I am just responding to this. I am responding to
what you have provided us. I do not see an interim report here.
Ms. Stoiber. What your staff asked us to do is to compare
what our contract with the VA required versus what the law
requires. So, there is no implication that we would not try to
deal with things that are not in the contract, but just that is
the comparison of fact.
Certainly, we are happy to provide a progress report, an
interim report on where we are. In the other areas, the VA
shortly expects to award the study on treatment models. So,
even though that is not a part of our original contract, we
expect to begin that shortly. We did not mean to imply there
that these were not doable, but just not in the original
contract.
Mr. Shays. Finally, just to conclude again, the first
report is due when?
Ms. Stoiber. On August 2000. The interim report will
obviously come quickly. The first stage report is August 2000.
That will include the seven exposures that I indicated.
Mr. Shays. What I am coming to grips with is the fact that
I made a gigantic assumption. That presumption took place now
either affirmed or not affirmed by the report, which is a
gigantic flaw in my knowledge of the bill. So, I have to take
the blame for that one. It is a shocker for me. I cannot
understand why the VA fought this given that I do not even see
the cost because we do not make a presumption for so damn long.
Dr. Murphy. I would disagree with the assumption that VA
ever tried not to implement this legislation or ``fought''
this. We established the process back in 1997.
Mr. Shays. Then that was done by Congress then. When we
were voting on this last year, Dr. Murphy. When we were voting
on this last year, we had tremendous opposition from the VA on
this bill. That is a fact. Now, I am going to have to find whom
that one person is, but we cannot hide from the fact that we
had to fight tooth and nail to get that bill in.
We were told it was going to cost a horrendous amount of
money. So, I will establish what my opinion was and yours on
the record. So, we have, once again, a gigantic disagreement. I
do not recall your asking that we pass this legislation. I
recall that the VA was not supportive. Mr. Thompson, you can
respond. Dr. Mather, you can respond.
Mr. Thompson. I would be glad to respond. The Department of
Veterans Affairs never opposed such legislation. In fact, 4
months before this legislation was enacted, we had an agreement
with the IOM to get started on the very thing that would create
the sort of evidence that would allow us----
Mr. Shays. Is this your testimony that we had presumption;
that you had anything to deal with presumption? Are you saying
to us that you began the study with a presumption in it?
Mr. Thompson. Has IOM began a study?
Mr. Shays. Right.
Mr. Thompson. Hoping to get information.
Mr. Shays. Right.
Mr. Thompson. With which to create presumptions if the
evidence dictated that presumptions were needed in order to
give veterans a fair shake.
Dr. Murphy. I think I understand how we are not
communicating. Are you asking if VA wanted legislation to
establish presumption of exposure? Is that your question?
Mr. Shays. Yes. That is one of the questions.
Dr. Murphy. No. VA did not ask for that particular
provision.
Mr. Shays. It opposed it. Maybe I am splitting hair here
but my sense is that you were taking a stand against
presumption.
Dr. Murphy. I think perhaps our difficulty in communicating
is due to our different understanding of ``presumption.'' I
mean I think when somebody says there is a presumption of an
association, I would interpret that to mean that anyone who is
sick today who served in the Gulf war we would presume that,
that illness is due to their service in the Gulf war.
I do not think we have any scientific evidence that says
that everyone who is sick today is ill due to Gulf war service,
and we are not saying that there are not people who are sick.
There are people who are sick. There are some people who are
sick that we do not understand why.
Mr. Shays. The whole point of presumption was that even if
50 percent of those who are ill got it from the Gulf war, we
were willing to cover the other 50 percent who were not, who
were sick, who did not get it because we could not wait for
science to catch up to the sickness.
I am slightly embarrassed and I put it on the record that
my sense of presumption is different than evidently the law is
written. I am embarrassed about that. That was my assumption.
It was very clear to me that we took a lot of heat by my
colleagues when this passed because the testimony from the
sources that they were doing on the VA was that this was going
to cost a phenomenal amount of money.
I do not see the cost because we are going to be waiting
for each of these interim reports to happen before we are
willing to make the presumption. By then, I wonder why we even
call it presumption?
So, that is my embarrassment. Fortunately, I am doing it on
a Thursday afternoon. I do not feel that the VA was at all
supportive of this legislation. Let me say something. I did not
intend that we would end this way.
Mr. Thompson. Let me just say that the pattern for both the
Senate bill and the House bill was the recommendation of the
Presidential Advisory Committee on Gulf War Illnesses. Based
upon their recommendation, the Department first drafted the
prototype legislation that was then picked up by advocates in
both the House and Senate and introduced.
That is the reason we got bills that do not look very
different from what the administration first floated and which
were enacted almost simultaneously the same day. So, I can say
with certainty there was not legislation that would have just
proposed that any illness suffered by a Persian Gulf veteran
would be presumed to be service connected. The Department
certainly therefore was not on record as opposing anything like
that.
Mr. Shays. Any other comments? I will be happy to hear from
any of you before we conclude.
Ms. Stoiber. I would just like to say on behalf of the IOIM
that although this has been a calm discussion, it should not
reflect any lack of commitment and real energy on our part to
respond to what we do understand to be urgent needs and
problems on behalf of veterans.
Our committee members and our staff have been working as
rapidly as they could on this, including having a large amount
of time for our committees actually devoted to hearing directly
from the veterans and their representatives for exactly the
reasons Mr. Sanders suggested. That is, you need to hear
directly and not filtered through research what people are
experiencing and their perspectives on it.
Please know that our commitment is to do this as quickly as
we can possibly do it and maintain the integrity of the work.
We will go back and reexamine whether or not there is any
speeding up that can occur. We will discuss it with our
committee when they meet next week or the week after next. If
there is, then we will certainly do it.
Mr. Shays. Thank you. Anyone else?
[No response.]
Mr. Shays. OK. I will let the record note that the VA feels
that they were very supportive of this legislation and that was
not my understanding, but I respect the fact the VA feels that
way.
Thank you. This hearing is adjourned.
[Whereupon, at 4:15 p.m., the committee was adjourned.]
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