[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
GULF WAR VETERANS' ILLNESSES: THE CURRENT RESEARCH AGENDA
=======================================================================
HEARING
before the
SUBCOMMITTEE ON NATIONAL SECURITY,
VETERANS AFFAIRS, AND INTERNATIONAL
RELATIONS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
SECOND SESSION
__________
FEBRUARY 2, 2000
__________
Serial No. 106-147
__________
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
67-151 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
HELEN CHENOWETH-HAGE, Idaho (Independent)
DAVID VITTER, Louisiana
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
David A. Kass, Deputy Counsel and Parliamentarian
Lisa Smith Arafune, 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-HAGE, Idaho
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Lawrence J. Halloran, Staff Director and Counsel
Robert Newman, Professional Staff Member
Jason Chung, Clerk
David Rapallo, Minority Counsel
C O N T E N T S
----------
Page
Hearing held on February 2, 2000................................. 1
Statement of:
Bell, Iris, M.D., Ph.D., associate professor, program in
integrative medicine, University of Arizona College of
Medicine; Claudia Miller, M.D., M.S., assistant professor,
environmental and occupational medicine, University of
Texas Health Science Center; Howard Urnovitz, Ph.D.,
scientific director, Chronic Illness Research Foundation... 107
Chan, Kwai, Director, Special Studies and Evaluations Group,
General Accounting Office, accompanied by Sushil Sharma,
Ph.D., Assistant Director, and Betty Ward-Zukerman,
National Security and International Affairs Division....... 7
Feussner, John, M.D., Chief Research & Development Officer,
Department of Veterans Affairs; John Mazzuchi, Ph.D.,
Deputy Assistant Secretary for Health Affairs, Department
of Defense; Robert Foster, Ph.D., Director, Biosystems,
Department of Defense; Lt. Gen. Dale Vesser, USA (Ret.),
Deputy to the Special Assistant for Gulf War Illnesses,
Department of Defense; and Drue Barrett, Ph.D., Chief,
Veterans' Health Activity Working Group, Centers for
Disease Control & Prevention............................... 34
Letters, statements, et cetera, submitted for the record by:
Barrett, Drue, Ph.D., Chief, Veterans' Health Activity
Working Group, Centers for Disease Control & Prevention,
prepared statement of...................................... 79
Bell, Iris, M.D., Ph.D., associate professor, program in
integrative medicine, University of Arizona College of
Medicine, prepared statement of............................ 111
Chan, Kwai, Director, Special Studies and Evaluations Group,
General Accounting Office, prepared statement of........... 9
Chenoweth-Hage, Hon. Helen, a Representative in Congress from
the State of Idaho, prepared statement of.................. 6
Feussner, John, M.D., Chief Research & Development Officer,
Department of Veterans Affairs, prepared statement of...... 37
Foster, Robert, Ph.D., Director, Biosystems, Department of
Defense, prepared statement of............................. 58
Mazzuchi, John, Ph.D., Deputy Assistant Secretary for Health
Affairs, Department of Defense, prepared statement of...... 50
Miller, Claudia, M.D., M.S., assistant professor,
environmental and occupational medicine, University of
Texas Health Science Center, prepared statement of......... 123
Urnovitz, Howard, Ph.D., scientific director, Chronic Illness
Research Foundation, prepared statement of................. 136
Vesser, Lt. Gen. Dale, USA (Ret.), Deputy to the Special
Assistant for Gulf War Illnesses, Department of Defense,
prepared statement of...................................... 74
GULF WAR VETERANS' ILLNESSES: THE CURRENT RESEARCH AGENDA
----------
WEDNESDAY, FEBRUARY 2, 2000
House of Representatives,
Subcommittee on National Security, Veterans
Affairs, and International Relations,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2154, Rayburn House Office Building, Hon. Christopher
Shays (chairman of the subcommittee) presiding.
Present: Representatives Shays, Blagojevich, Tierney,
Allen, Sanders, and Schakowsky.
Also present: Representative Metcalf.
Staff present: Lawrence Halloran, staff director and
counsel; Robert Newman, professional staff member; Jason Chung,
clerk; David Rapallo, minority counsel; Earley Green, minority
assistant clerk; and Chris Traci, minority staff assistant.
Mr. Shays. I would like to call this hearing to order.
In November 1997, after extensive hearings on Gulf war
veterans' illnesses, this committee found, quote, current
approaches to research, diagnosis and treatment unlikely to
yield answers to veterans' life-or-death questions in the
foreseeable, or even far distant, future. We called for an
aggressive, well-coordinated research effort, independent from
constitutional inertia and bureaucratic self-interest, to
support the goals of accurate diagnosis, effective treatment
and fair compensation for all Gulf war veterans.
Since 1997, the Departments of Defense, Veterans Affairs,
and Health and Human Services, have spent more than $121
million trying to meet basic research goals to better
understand the extent, the causes and the cures of Gulf war
veterans' illnesses. More than 150 studies have been funded.
The Office of the Special Assistant for Gulf War Illnesses
contracted for additional studies and surveys.
To assess the productivity of this substantial research
program, we asked the General Accounting Office, GAO, to
examine the extent to which the agenda is being managed
effectively, efficiently and with an appropriate sense of
urgency. Their findings validate our initial assessment and
confirm our worst fears about the pace and prospects of the
search for answers for sick Gulf war veterans.
The group charged to coordinate the research effort has not
even assessed how well the current portfolio is meeting
established objectives. More than half of DOD's total
expenditures took place outside the multi-agency coordination
framework designed to focus research and avoid costly
duplication. Nine years after the Persian Gulf war, basic
questions remain unanswered. We still don't know how many
veterans are suffering unexplained illnesses. We still don't
know how their illnesses progress, and we still don't know if
they're getting any better.
We are, of course, mindful of the incremental nature of
scientific inquiry. Many Gulf war veterans' illnesses are
difficult to diagnose, can only be treated symptomatically, and
may be impossible to associate with a wartime exposure or
event. But patience is no excuse for a lack of vigilance. We
must be certain all Federal research into Gulf war illnesses is
well designed, vigorously pursued, and keenly focused on the
most promising hypotheses.
Our witnesses today represent the GAO, the Federal
departments and agencies conducting Gulf war studies, and
private researchers who have made some of the most significant
findings in this area, often without Federal funding. We look
forward to their testimony. And I might say, given the number
of witnesses, it will be more testimony than questions.
Mr. Shays. My colleague, Mr. Sanders.
Mr. Sanders. Thank you very much, Mr. Chairman, and thank
you for all of your efforts over the last several years.
I will be brief. I think there's some good news, and I
think there is some bad news out there. The good news is that
when you and I and others began bringing this issue to the
floor because we were responding to the pleas of thousands of
Gulf war veterans all over this country who told us they were
hurting, who told us when they walked into the VA hospital they
were ignored or at best told they had a psychological problem,
I think we can say fairly that, since that point, we have made
some progress. That's the good news.
The bad news, as you've just indicated, that after all the
large amounts of money that the government has spent on Gulf
war research, the truth of the matter is that today we do not
have a treatment for the close to 100,000 veterans who are
hurting. We do not fully understand the cause of the problem.
What is the good news? The good news is that, over the last
number of years, there have in fact been a number of studies
which we hope are bringing us closer to the truth. And I will
just point out a few.
Right now--and I see Dr. Jack Feussner here, and I'm glad
he is here--there is an important study being conducted at the
VA hospitals throughout this country testing a hypothesis.
Microplasma infection may in fact be one of the causes of Gulf
war illness, and a treatment protocol is being developed. That
is a step forward.
Just the other day, we read in the papers that at Tulane
University it appears that Gulf war veterans who are suffering
from a variety of illnesses have antibodies to squalene in
their blood. This may tell us something.
A couple of months ago, we heard from the Veterans'
Administration. Despite, Mr. Chairman, all that we had heard in
the past that pyridostigmine was ever so benevolent, it turns
out that a study came out from them that says that may not be
the case, and they're not going to rule that out as a cause of
Gulf war illness. We have studies that suggest that veterans
who are susceptible for multiple chemical sensitivity may in
fact have higher incidences of Gulf war illness than others.
There are studies coming out of Texas that suggest that people
who are suffering from Gulf war illness now have determinable
brain damage that can be objectified and seen. There are a
number of other studies out there as well.
Now, my conclusion is that some serious scientists in this
country are making some serious progress. I am pleased to see
that the VA is beginning, in terms of the microplasmic study,
to begin to move forward, but clearly they are not doing it
enough and fast enough.
My own hope, Mr. Chairman, is that we will be supportive of
those people in academia who have begun to make some
breakthroughs and give them the support that they need. The
truth of the matter is that, from World War II to today,
whether it is radiation illness, whether it is Agent Orange,
whether it is Gulf war illness, the sad truth is that the U.S.
Government has not treated veterans with the dignity and the
care that they deserve. And I would hope that we support those
men and women who put their lives on the line who are hurting
today by supporting that research out there which is leading us
closer to understanding the cause of this terrible problem and
developing an effective treatment.
Mr. Shays. Thanks.
Before calling on the first panel, I would also like to
welcome Mr. Metcalf, who has been very interested and active in
this issue and welcome any statement you would like to make for
the committee and also appreciate your participation in the
hearing.
Mr. Metcalf. Thank you very much, Mr. Chairman.
Thank you, Congressman Sanders, for signing my letter and
for your testimony today.
I would like to thank the other members of the subcommittee
for allowing me to participate in this hearing and express my
concerns regarding the Federal Government's research efforts
into the causes and treatment also of Gulf war illnesses. I am
deeply grateful that you have remained steadfast in your
efforts to try to find the truth and to require accountability.
This hearing is focused on the fact that the Federal
Government has spent more than $133 million in research to
determine the causes of Gulf war illnesses and to find
treatments. I applaud this committee for asking what American
taxpayers got for their money, $133 million. Sadly, however, I
must state that, in my mind, far too little has been
accomplished to actually help veterans suffering from Gulf war
illnesses.
I would like to draw the subcommittee's attention to a new
piece of research that could make a significant contribution in
addressing the health issues of those suffering from Gulf war
illnesses. The paper is ``Antibodies to Squalene in Gulf War
Syndrome,'' is an article that has just been published in the
February 2000, issue of Experimental and Molecular Pathology.
Today, I am providing copies of this important study for
members of the subcommittee. Joined by several colleagues,
yesterday I wrote to Secretary of Defense William Cohen asking
for an objective analysis of this research.
This peer-reviewed article found anti-squalene antibodies
in a very high percentage of sick Gulf war-era veterans. As a
biomarker for the disease process involved in Gulf war
illnesses, the assay/blood test cited in the study could
provide a vital diagnostic tool. I hope this will quickly lead
to improved medical treatments for many who are suffering.
Many who have heard about this issue are anxious to
understand the ramifications, especially those veterans and
their families whose lives sadly have been directly affected.
We certainly acknowledge the need for further research.
However, that should not preclude a vigorous examination of the
immediate benefits this study may provide medical practitioners
treating those who suffer from Gulf war illnesses.
The House-passed version of the fiscal year 2000 defense
appropriations bill included report language instructing the
Department of Defense to develop and/or validate the assay to
test for the presence of squalene antibodies. This action was
taken in response to DOD unwillingness to cooperate with the
March 1999, General Accounting Office recommendation. It is my
firm belief that the integrity of the assay was the first step
in finding answers.
Now that this study has been peer-reviewed and published,
we need to take the next step and build on established science.
An internal review by the same individuals within the DOD who
were unwilling to cooperate for months does not constitute the
kind of science that those who sacrificed for this Nation
deserve. Given the published article, it seems prudent to use
the assay if it could help sick Gulf war veterans. At this
critical juncture, I fervently hope that Secretary Cohen
agrees. All agencies charged with helping our Gulf war era
veterans should closely review this now peer-reviewed study.
Mr. Chairman, I want to thank you again for your leadership
and look forward to continuing to work with you to find answers
and the best in medical treatment for our Gulf war era
veterans. Thank you.
Mr. Shays. Thank you.
We've been joined by two other Members--Ms. Schakowsky from
Illinois--and welcome any statement you would like to make.
Ms. Schakowsky. Thank you, Mr. Chairman.
I just wanted to say that it was my honor to join
Congressman Metcalf in that letter to Secretary Cohen asking
for an objective analysis of the article, the study, the
Antibodies to Squalene in Gulf War Syndrome, and certainly hope
that we can do everything possible to quickly lead to improved
medical treatments for the many, many who are suffering.
Mr. Shays. Thank you.
Mr. Allen, nice to have you here.
Mr. Allen. Mr. Chairman, I'm happy to be here. I want to
thank you for holding these hearings. If I have other comments,
I'll add them later. Thank you.
Mr. Shays. Thank you.
We have three panels. The first panel we have one speaker
accompanied by someone else as well, and we have on the second
panel five speakers and in the third panel four. The staff will
pay for this later. But we will be very attentive; and it will,
in fact, be helpful. There's really no way to get around it. We
do need to hear from each and every one of you, but we will
have to give deference to the testimony more than to the
questions.
Our first panel is Mr. Kwai Chan, Director of Special
Studies and Evaluations Group, General Accounting Office,
accompanied by Dr. Sushil Sharma, Assistant Director from the
same group. And we are also going to have someone else as well,
Dr. Betty Ward-Zukerman from the GAO National Security and
International Affairs Division.
If you would all three stand and I'll swear you in.
[Witnesses sworn.]
Mr. Shays. The answer is yes on the part of all four.
Would you identify yourself for the record as well?
Mr. Woods. My name is William Woods. I'm with the Office of
the General Counsel of the General Accounting Office.
Mr. Shays. I appreciate your being sworn in in case we need
to rely on you for an answer to a question. Thank you.
I ask unanimous consent that all members of the
subcommittee be permitted to place an opening statement in the
record and that the record remain open for 3 days for that
purpose. Without objection, so ordered.
[The prepared statement of Hon. Helen Chenoweth-Hage
follows:]
[GRAPHIC] [TIFF OMITTED] T7151.001
Mr. Shays. I ask further unanimous consent that all
witnesses be permitted to include their written statement in
the record. Without objection, so ordered.
Mr. Chan, you have the floor.
STATEMENT OF KWAI CHAN, DIRECTOR, SPECIAL STUDIES AND
EVALUATIONS GROUP, GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY
SUSHIL SHARMA, PH.D., ASSISTANT DIRECTOR, AND BETTY WARD-
ZUKERMAN, NATIONAL SECURITY AND INTERNATIONAL AFFAIRS DIVISION
Mr. Chan. Mr. Chairman and members of the subcommittee, it
is my pleasure to be here today----
Mr. Shays. I'm going to remind you to put that mic down a
little bit farther and turn it that way a little bit.
Great, thanks.
Mr. Chan. It's my pleasure to be here today to discuss the
results of our work evaluating the outcome of Federal
investment on Gulf war illnesses research conducted by VA, DOD,
and HHS.
Before I begin, Mr. Chairman, I would like to go back to
our June 1997, report and repeat two of our major findings.
First, we found that neither DOD nor VA knew whether ill Gulf
war veterans had gotten better or worse since they were first
examined. Second, we reported that the ongoing epidemiological
research would not provide any meaningful information regarding
the causes of veterans' illnesses.
Today I regret to report that little has changed. In spite
of considerable additional expenditures, we still do not know
whether our Gulf war veterans are any better or worse off since
they were first examined. Basic questions about the causes and
treatment of their illnesses still remain unanswered, and these
agencies still have not adopted one or more case definitions
that might focus Federal research efforts.
Let me discuss our results. I have four findings to report.
First, DOD, VA, and HHS spent over $121 million on research
investigations in fiscal year 1997 and 1998. DOD efforts
account for over 90 percent of that total. Over half was spent
by DOD's Office of the Special Assistant for Gulf War
Illnesses, which I will refer to as OSAGWI.
Our second finding concerned the results of these
expenditures. In this regard, we have three observations.
No. 1, the Persian Gulf Veterans' Coordinating Board's
Research Working Group has not published any assessment of the
extent to which its specific research objectives have been
satisfied. We recommended and the agency agreed that such an
assessment should be published by the end of this year.
No. 2, most research is still ongoing. By mid 1999, of the
151 projects funded by the Federal Government, 30 percent had
been completed. While OSAGWI has received 19 of the 20 reports
due from its contractors, it has publicly released only 6 of
them. Of these reports, 14 had remained in draft or in review
status for a year or longer.
No. 3, even basic questions regarding the number of
veterans with unexplained symptoms and the causes and
progression of the illnesses remain unanswered. In addition,
the Research Working Group has not endorsed any case
definitions that might focus Federal research efforts. Most of
the federally funded epidemiologic studies have been
descriptive and not designed to test specific hypotheses about
causes of veterans' illnesses.
Our third finding pertains to the activity of OSAGWI. We
found its research activities were not effectively coordinated
with the Research Working Group. The rationale given to us was
based on semantic distinctions. Both VA and DOD tell us
OSAGWI's activities involve investigations rather than research
and therefore are not subject to oversight or monitoring by the
Research Working Group. This weak coordination resulted in some
duplication of effort. For instance, OSAGWI, VA, and HHS
commissioned separate reviews of the literature on the health
effects of depleted uranium. In addition, OSAGWI and VA have
funded RAND and the National Academy of Sciences respectively
to perform literature reviews regarding potential Gulf war
exposures.
Finally, with regard to the management of contracts
supporting OSAGWI, we found that task orders worth over $20
million were awarded improperly, and the office discouraged
competition for another task order by specifying a preferred
vendor. Because OSAGWI is likely to continue to spend a
significant part of its budget on support contracts, it needs
to ensure that its contracts fully comply with applicable laws
and regulations.
Mr. Chairman, this concludes my statement; and I would be
happy to answer any questions you may have.
Mr. Shays. Thank you.
[The prepared statement of Mr. Chan follows:]
[GRAPHIC] [TIFF OMITTED] T7151.002
[GRAPHIC] [TIFF OMITTED] T7151.003
[GRAPHIC] [TIFF OMITTED] T7151.004
[GRAPHIC] [TIFF OMITTED] T7151.005
[GRAPHIC] [TIFF OMITTED] T7151.006
[GRAPHIC] [TIFF OMITTED] T7151.007
[GRAPHIC] [TIFF OMITTED] T7151.008
[GRAPHIC] [TIFF OMITTED] T7151.009
[GRAPHIC] [TIFF OMITTED] T7151.010
[GRAPHIC] [TIFF OMITTED] T7151.011
Mr. Shays. The chair recognizes Mr. Sanders.
Mr. Sanders. Thank you, Mr. Chairman.
Mr. Shays. I'm sorry. I do want to recognize Mr.
Blagojevich.
Mr. Sanders. Mr. Chan, thank you for your testimony.
Let me ask you a question. What concerns me is that a
number of studies have been done, a lot of money has been
spent. In your judgment does--do the people who are funding
these studies now in the VA and the DOD and the relevant
committees, can they come before us today and say, look, the
good news is that we are making some progress here. We are
looking at this. This theory has now been disregarded. We know
this, we know that. Or are we going to continue to see a myriad
of studies all over the place leading us nowhere?
The question is, 9 years later, where are we? Where are we
going to go? I'll ask representatives of the VA and DOD this
question in a little while.
But what have we learned? It doesn't do us any good to have
a million studies if we don't have any conclusions. What have
we learned? It sometimes sounds nice or it is a good press
release. We are spending $5 million for another study. What
have we learned? Where are we going? What are we trying to
prove?
So what I'm asking you is, what hypotheses are out there
based on all of these studies? Where do you recommend that we
continue to go? What theories should we be pursuing?
It seems to me that in recent years, as I said a moment
ago, there have been what appears to those of us who are laymen
some breakthroughs. Are those being pursued?
Now, a couple of years ago, before this committee, we were
told by many of the VA and the DOD people that the problem was
``stress.'' Is that still a hypothesis that is being advanced
or have we gone beyond that?
Bottom line is, after all of this money, where are we
today? Where do you think we should be going?
Mr. Chan. Should I answer question one or two?
Mr. Sanders. Both.
Mr. Chan. We said that there are over 151 of these projects
and that Federal research began back in 1994, so if you look at
it from that perspective, we are generating probably two
projects a month over this period. So we have lots of work in
progress.
And, initially, I think, we started very slowly. I'm
talking about the agencies' acceptance that in fact the
illnesses are out there. By the time they accepted it, I think
they had attached to a specific hypothesis, which was stress,
to the exclusion of any other kinds of hypotheses. When
Khamisiyah came along, then it became another set of hypotheses
about low-level exposure to chemicals and then suddenly have a
whole set of different possible causes or agents. And so now
what you see is really almost like fruit trees with lots of
fruit hanging and we are picking one or the other.
I think you're right that, in a certain way, we reached a
certain stage. Now there are, in fact, some scientific results
that show promise; and we are beginning to find that--in fact,
I think CDC had found that, through its Pennsylvania study--
that there are potentially some broad case definitions to allow
people to at least focus on where the efforts should be.
But generally, I think, a different way to answer your
question, is that the impression from the outside is that the
agencies are very slow in accepting that, in fact, they need to
investigate in this area, that the pursuit of science is the
end goal of this research, not treating the soldiers. So in
1997 when we testified before you, our comment was that in fact
a lot of projects are focused on epidemiolog study and there
are potential problems in gathering that information because of
difficulty in recall and specifying locations and exposure and
the problem of not having a case definition.
Mr. Sanders. Let me just reiterate, Mr. Chan, and I'll end
at that.
If we had before us today a panel of experts dealing with
AIDS, for example, they could tell us over the last 10 years
what has been discarded, what has been accepted, and where they
are going and where they hope to be in the next 5 years. I have
the unfortunate feeling, the unpleasant feeling that that is
not the case with Gulf war illness, that we may well hear the
same testimony, well, we're not quite sure. It may be stress.
It may be not. Blah, blah, blah. And after $120 million there
will not be somebody from the VA or DOD to say, well, we have
discarded this theory. It is not stress, that is for sure,
because of a, b, and c. We're narrowing in on this. We've made
some progress on that. We're going to put more money into that,
but that's no longer relevant.
Is my statement a fair statement?
Mr. Chan. I believe so. I think initially DOD basically
stated that there were no problems out there; and when we found
there were some problems, they said, well, they are not unique.
When we found there are unique things have been found then DOD
says we need more research. That's the paradigm you have.
If I step back from it, my question would be not so much
are these successful research projects but rather ``now what?''
Where do we go from here? At what point do we decide to
emphasize moving on to diagnosis and treatment because the
research really doesn't touch the soldiers in the way you
intended.
Mr. Sanders. I'm concluding by saying we hope the result--
one clinical test that is out there is testing the mycoplasmic
theory. The VA is doing that. We hope if that test turns out to
be positive, we will in fact have a treatment. Other than that,
I'm not quite sure I know what the VA and DOD are doing.
Mr. Chairman, thank you; and, Mr. Chan, thank you.
Mr. Shays. Ms. Schakowsky.
Ms. Schakowsky. Thank you, Mr. Chairman.
Being new to this panel, I learn things every day that
astonish me. That of the nearly 700,000 veterans of the Gulf
war, I understand from our committee memo, 100,000 or more have
been complaining of illnesses. And we hear about $121 million
and all of these committees and 9 years. And so let me ask a
couple of I think pretty obvious questions that come to mind.
In one part of your testimony, you said there is no
government research specifically directed toward understanding
the progress of these illnesses over time. What do you mean by
that?
And in another part of this, the testimony, you mentioned
an HHS project to assess the persistence and stability of
veterans' symptoms over time. What's the difference? On the one
hand you say there isn't one and there's an HHS study.
Mr. Sharma. I think what we said before in 1997, that since
we cannot conclude what may have caused their illnesses because
of the absence of precise and accurate information about how
many agents they were exposed to for how long, et cetera, a
different way of approaching this issue would be to understand
the natural history of the disease by following these
individuals over time and monitor the progression of the
disease.
At the same time, you take a look at what kind of
symptomatic treatment physicians are currently providing
because they are being treated by a number of physicians all
over the country. Some of those treatments may or may not be
effective, and therefore you take a look at what works, what
doesn't work, and then you share this information with the rest
of the physician community.
That type of research was not being done and after a
considerable amount of time, VA has now reluctantly agreed to
do this type of work. The CDC report that we are referring to
is a survey in which they looked at two points in time but this
is the kind of work that should be systematically done.
Ms. Schakowsky. To followup on something that Mr. Sanders
was saying, it seems like there's a lot of data and none of it
fits together and none of it leads anywhere and none of it
seems to make any sense in the end. You talk a good deal on the
report about coordination. What can we do to get better
coordination?
You have, for example, lack of coordination which could
result in duplication as in the literature review contracts
from the VA and DOD. The VA responded in comments to your draft
report that these two projects used different methods, have
different goals and are not duplicative. Do you agree?
Mr. Chan. No. I think that example is symptomatic of the
problem in the approach being taken toward research.
You know, literature review is great if the literature
includes relevant cases, but basically they are not really
there. The problems with pyridostigmine bromide have been known
for a long time. I said, so what? What do we do from here?
I think there's a disconnect here basically between science
and policy. And I really hate to bring it up at this stage like
that, but, generally, the public wants answers to questions
like who is sick, how many are sick, are they being treated,
are they being taken care of, how well are they being treated,
are they getting better, are they worse, is there something
that is helpful, that can be shared with others? Those are the
kind of questions people are asking.
The inside researchers are focused on testing specific
hypotheses. Is it this agent, is it that agent, is it chemical,
is it PB, is it Leishmaniasis, is it oil well fires, and so on.
They focus on very specific agents and toxins that can affect
the body. So the two types of questions are disconnected in a
sense. Then when you find out that one agenct is an unlikely
cause, the other one is also unlikely and so on, it doesn't
satisfy the people who are left suffering.
I'm trying to look for an analogy. It's almost like if
someone tells you we have reduced the sulfur level in the air
by X percent, the question that you want to ask is, can I
breathe? We're not answering that. That's the disconnect I see.
So I agree that, in a way, we're advancing through
hypotheses and find some interesting stuff. But in the end you
find the people who are suffering just want treatment and
attention.
Ms. Schakowsky. Thank you.
Mr. Shays. Mr. Allen.
Mr. Allen. Thank you, Mr. Chairman.
Forgive me for groping on this issue a little bit, because,
obviously, there are those of you who spent a good deal more
time trying to understand this than I have, but I am struck by
a couple of your comments, Mr. Chan, and some other things that
I have been through. I am just going to talk for a moment and
then I would like your reaction to what I say. Because though
I'm obviously in a field that is not my field, there are a
couple of things that strike me about how this research might
be going based on what you said and how it might be redirected.
It strikes me that to the extent--you just said that a lot
of the research focuses on specific toxins as if the analogy
were to find the particular virus that was causing a particular
illness that basically acts the same way on all human beings
and that, it strikes me, is a path of the research that may not
be particularly productive because we may be dealing with
something that is different.
And I'm going to mention now a woman in my district has
just put together this collection called Casualties of
Progress: Personal Histories from the Chemically Sensitive. Her
name is Allison Johnson. And what she's done--she's published
this at her own expense--is a series of stories. Six of them
are stories of Gulf war veterans, but they are stories about
people who are afflicted with multiple chemical sensitivity.
And though I would not pretend to have read this, I only got
this 2 days ago, what I would say is this.
It strikes me that you have very individual reactions of
the multiple chemically sensitive to a wide variety of
different kinds of--and I hesitate even to use the word
toxins--chemicals of different kinds. But what's striking is
the reaction. The symptoms may be different for different
individuals; and, in fact, the causation, the chemicals, the
agents that are causing a human being to react this way are
different for different people. So to the extent we do research
pursuing is it PB, is it the oil, whatever, that research is
not as likely to lead anywhere productive.
What I am struck with from just glancing this moment at
your report is appendix III and the failure and the effort to
reach a working definition and, in particular, Mr. Haley's
definition saying the three primary syndromes are impaired
cognition, confusion-ataxia, this is page 31 of the report, and
arthro-myo-neuropathy. I guess that's how you pronounce it.
Isn't it the case that if we're going to get a grip on this
problem that there needs to be sort of some consensus about how
to go at it, what kind of problem we're dealing with?
To me, that's not so much a problem of research. It's a
problem of conceptualizing what it is we're talking about.
And so what I guess what I'm asking is, is any of the
research directed, first of all, specifically to the multiply
chemically sensitive to this sort of area and, second, is there
in your opinion a focus of the research that is off track or
needs to be changed or whatever?
That's a long, rambling statement, but I trust you can do
something with it.
Mr. Chan. Let me try.
I think the approach that's been taken over the past 9
years is the classic scientific approach one would take. That
is, you look for possible agents and then determine potentially
what's the exposure level, are there responses to it, are there
potential causes and effects. If there is something, then what
the diagnosis should be and then the treatment and measure
outcome. That can be done if it's merely a single exposure,
particularly if we're talking about a virus or other things of
that kind.
I think that worked well in the past as a model that I've
seen, and certainly there are lots of success stories from
that. But I think--I tend to agree with you that this model may
not work here, that a different model may be needed--not so
much because scientists cannot arrive at conclusions but rather
because you're talking about multifactorial effects.
The approach basically they have done is to take out the
possible potential causes individually rather than accepting
multifunctional causation as a possibility. That is, if you
have one agent and find it can cause a 1 percent change and
that's not significant, then you withdraw that and try another
one. But putting them together may identify synergisms that
occur. So I don't think the model used starts out looking at it
that way.
Back in 1997, we felt that reliance on the traditional
model of those responses and exposures which we didn't know
much about for this particular war, then why not begin to
diagnose the problem of the illness and then look for treatment
that may turn out to be successful or even failure, to learn
from that. That's how we ended up with our recommendations.
So I agree that you have to look at it differently.
Mr. Shays. Mr. Blagojevich.
Mr. Blagojevich. Thank you, Mr. Chairman.
First of all, Mr. Chan, let me just reiterate what
Congressman Schakowsky said about 700,000 Gulf war veterans
across the country. Of them, over 100,000 nationwide--in our
State of Illinois, 3,500 of them are sick due to possible toxic
exposure during the Gulf war, yet we have no diagnosis or a
cure. My question to you, sir, is are we getting any closer to
understanding the causes of the Gulf war illness? That's my
first question.
Mr. Sharma. I think there are several testable hypotheses
that have been proposed in the published research that was done
outside the Federal Government funded research.
One way to approach this issue is to test those hypotheses
and see if indeed these individuals could get better.
The second approach is that if you're not going to do a
hypotheses testing research, then you monitor these individuals
over time because these individuals are experiencing symptoms
which we may not be able to explain why, such as headaches or
arthritis, but there are certainly some symptomatic treatments
available. If those symptomatic treatments are effective and
working and different people have different approaches for
treating the same thing, then that kind of information should
be systematically collected, evaluated and then disseminated to
others. This is currently not being done. Specifically, there
are several testable hypotheses. They are not being proactively
and vigorously pursued.
Mr. Blagojevich. You've mentioned that researchers face
persistent problems in ascertaining veterans' specific
exposures. What do you mean when you say that?
Mr. Chan. Well, most of the data that's gathered through
the registries and the studies, through telephone interviews,
are based on recall. They ask questions not only on where you
were. It's very difficult for a soldier to say I think I have
been exposed to, let's say, chemical agents without knowing
it's ever been used. That's the difficulty about it and that's
what I meant by the need to know what you've been exposed to.
And even tracking who got what type of vaccine was
difficult because the records weren't clear as well as how many
PB pills that you would take and could you be affected by
radiation because when we start bombing Iraq the radiation
could leak out and so on.
The soldiers have no idea about what they were exposed to.
All they know is they're feeling bad, and these are the kinds
of symptoms that they have. So it's hard to reconstruct. And I
think the example one would go back to is how difficult it was
for us to track the use of dioxins such as Agent Orange back in
Vietnam.
Mr. Blagojevich. Thank you.
Mr. Shays. Mr. Chan, we want our troops properly diagnosed.
We want them effectively treated, and we want them fairly
compensated. That's the bottom line. Do we know who is sick?
Answering this way doesn't allow the recorder to respond. Do we
know who is sick?
Mr. Chan. We know some people who are sick. We don't know
how many are sick and whether they are coming through the
system or going to private physicians.
Mr. Shays. Do we know how sick they are?
Mr. Chan. No.
Mr. Shays. Do we know if they are getting any better or any
worse?
Mr. Chan. We don't know.
Mr. Shays. Has there been any progress in GAO's 1997
recommendations to the research board?
Mr. Chan. Well, there were a few more studies done, but
generally I would say that concerning the progress to the end
goal or treatment, no, there hasn't been any progress toward
that.
Mr. Shays. To what extent does the Federal research effort
on Gulf war illnesses include the development of a system to
track, diagnose, and treatment outcomes of veterans?
Mr. Sharma. I don't think there has been any systematic
approach to following up these individuals over time. These
agencies have not shared with us any such plan.
Mr. Shays. To what extent have the 21 major research
questions set by the Research Working Group in 1995 been
answered?
Ms. Zukerman. The Research Working Group hasn't published
an assessment of the extent to which those questions have been
answered. They told us last year that some of them had been
answered more completely than others.
Mr. Shays. So there have been--there's been none, correct?
Ms. Zukerman. No assessment, that's right.
Mr. Shays. In what ways was OSAGWI's support contracts
improperly awarded?
Mr. Chan. I can answer in general. I think we looked at the
contract and we found a problem with three of the contracts
that were made. The problem with one was the statement of work
was too broad. The second was that it was outside of the scope
of the contract for what the contractor was doing. And,
finally, OSAGWI made known up front that they have a preferred
vendor so, as a result, they are the only one who actually
compete for it. But the general principle we go by is that
these contracts should be there to enhance competition, and by
these actions we find that it did not enhance competition.
Mr. Shays. The President established a Research Working
Group which was to get the DOD and the VA and HHS to work
together. What are the consequences of OSAGWI's decision to
avoid coordination of its activities with the Research Working
Group?
Mr. Chan. Well, the consequences that you end up having
duplication. We have two examples of that, particularly with
depleted uranium and PB.
Ms. Zukerman. The review of literature.
Mr. Chan. Right, the review of literature and so on. I
think those were the examples. And I think the issue is really
not so much of the costs involved but rather the lost
opportunity to address other more important issues that need to
be addressed.
Mr. Shays. In your four findings--obviously, we spent $121
million in 2 years. You said that the Persian Gulf War
Coordinating Board's research group has not published any
assessment to the extent of to which its specific research
objectives has been satisfied. That's just a devastating
finding. You said research is ongoing, and then you said OSAGWI
has received 19 of the 20 reports due from its contractors. It
has published only six. Of these reports, 14 remained in draft
or review status for a year or longer. That to me is
unbelievable. I'd like to know what the heck is going on as it
relates to that point.
Mr. Chan. Well, when we initiated our study at your request
one of the purposes was to examine the contracts--particularly
the ones with RAND--and at that time OSAGWI had six of the
draft reports to review. And the review, that they're talking
about, occurred when the contractor had delivered the product
to DOD and then it was reviewed internally.
Mr. Shays. But it sounds like, one, you don't like the
results or you're trying to change the results. But the bottom
line is you paid for a study. Show us the study.
Mr. Metcalf, you have the floor.
Mr. Metcalf. Thank you, Mr. Chairman.
Yes, Mr. Chan, I would like to ask you and your colleagues
to comment on this new peer review study, if you will. Since it
has now met the criteria that the Department of Defense had set
forth, that is, peer review publication, and the antibodies to
squalene and Gulf War Syndrome appears to me to meet that
request, how should we best use what we now know to date?
Mr. Chan. Well, at your request, we did a study and
published it back in March of last year; and at that time I
think we did not really evaluate the science of developing an
assay to the squalene. We did find it's plausible that it could
be done but certainly we did not examine the possible cause and
effect in terms of the health of the veterans. But,
nevertheless, I think the title of our report stated that
questions about presence of squalene antibody in veterans, can
be resolved.
I want to emphasize the words ``can be resolved''. At the
time, the Department of Defense, particularly in the Office of
Health Affairs, said we never gave them the squalene, and it's
not our problem, and if indeed it's a case, it's important for
the research to publish their results through a peer-reviewed
journal.
At that time we also said that we disagreed with DOD in
regard to that issue, because we felt that DOD should take the
opportunity to begin addressing the potential and possibly
resolving the question of whether or not the squalene antibody
could be contributing to the illness of Gulf war veterans. And
what we suggested was a very small step. The small step is,
well, if it takes too much effort internally to develop such an
assay and develop it, why don't we just go and ask the
researchers at Tulane and try it out if in fact the researcher
is willing to share their own assay. And DOD did not do that.
And so, as a result, I think finally this article has been
published; and I hope DOD would consider this thing seriously.
Mr. Metcalf. Has there been a serious examination of the
role that vaccinations may have played in Gulf war illnesses
and should there be a serious examination in your view by the
DOD?
Mr. Chan. I think the answer is yes, but I would like to
raise it in light of--unfortunately, I'm trying to recall.
I think it's important to understand--not just to focus on
the Anthrax vaccine per se but also that the soldiers received
over a dozen and a half different vaccines during that period
because they are being deployed into areas where it's unclear
how well they are prepared to meet the environmental
conditions. So not only did they have the normal type of
vaccines but also vaccines against biological agents and even
countermeasures against chemical agents such as PB pills and so
on. So there are a lot of things that the soldiers received.
There's no study as to whether the combination of these things
the soldiers received could have any effect on them in general.
Mr. Metcalf. Thank you.
Mr. Shays. We will go back to other committee members and
see if they have a followup question, but I want to just ask
you how many peer review studies has Federal research spending
produced in the last 2 years?
Ms. Zukerman. We looked at those projects that had been
completed by the end of 1998 to see what portion of the
completed projects had resulted in one or more peer reviewed
reports, and we found that about two-thirds of them had. I
think Dr. Feussner can probably provide current information on
the total number of publications.
Mr. Shays. Thank you.
Mr. Sanders.
Mr. Sanders. Thank you, Mr. Chairman.
Let me get back to a point that I tried to raise before.
During World War II, the U.S. Government wanted to build an
atomic bomb, and they developed--that was the end goal. For
better or worse, they wanted an atomic bomb.
The President then put together a project called the
Manhattan Project. They assembled the best minds in the
country. They went forward in a relatively short time. They got
their goal. My thought had been from the very beginning that,
to solve the problem of Gulf war illness, that is something
that we had to do as well. What I am stunned and distressed
about is the absolute lack of direction.
Now, the military knows something about winning wars. It
doesn't matter if you win a battle over here or if you do
something over there. The goal is to win the war.
Our goal is to understand the cause of Gulf war illness and
to develop an effective treatment. That's clearly what we want
to do. We don't want to scatter over a million different
directions. We need a general, somebody who is ultimately
saying this is good research. We're gaining on it. This is
useless, forget it. Let's keep going. We're putting our money
in here.
Clearly, it seems to me that has not been the case, at
least from the U.S. Government. That's the bad news.
The good news, it seems to me, is that, as I think Dr.
Sharma indicated, outside of Federal funded research, there
appears to have been some breakthroughs. None of us to the best
of my knowledge here are scientists. That's our problem. We
have to rely on you and others to tell us the truth and the
validity of some of the studies that we're seeing.
This is my question. Mr. Metcalf raised this a moment ago.
Just the other day at Tulane a study comes out that says that
it is, in layman's terms, if somebody has squalene antibodies
in them, it is likely that they are suffering from Gulf war
illness. If they do not, it is likely they are not suffering.
From a layman's point of view, this seems to be a breakthrough
done outside, I guess, of federally funded research. Simple
question. After 9 years, has the U.S. Government itself, the
VA, the DOD, been doing research on this issue?
Mr. Chan. Not in terms of the effect of squalene on
individuals, but they have done research using squalene in
other vaccines.
Mr. Sanders. Let me again, as a layman, if it turns out
that he has squalene antibodies, he does not have squalene
antibodies, he has Gulf war illness, he does not. Am I wrong in
suggesting that is a significant breakthrough, that we have
learned something?
Mr. Chan. Potentially, yes.
Mr. Sanders. Potentially, yes. It stuns me that we need
Tulane to come up with this, and where was the VA?
Dr. James Fleckensteen from the Texas Southwestern Medical
Center says, according to the AP, brain scans of soldiers who
believe they suffer from Gulf war illness indicate evidence of
brain damage. Now, again, I don't know whether it's true or
not. That's what Dr. Fleckensteen says.
If I go to the VA or the DOD, what are they going to tell
me about those studies? Have they tested that hypothesis? Has
the VA or the DOD said, yeah, we've done a brain scan. There's
brain damage. He was in the Gulf war. We have learned
something. He may have a treatment.
What has the U.S. Government done with that? Anything?
No, OK. Multiple chemical sensitivity, Tom Allen talked to
that, and I talked to that particular woman on the phone. I
have talked to hundreds of veterans in the State of Vermont who
are suffering from Gulf war illness. Some of them tell me when
they are around perfume, they get sick. If they walk through a
grocery store and detergent smell comes up, they become sick.
What studies have been done to say are these guys crazy or have
they been exposed to chemicals and do more chemicals impact
them?
If I am suffering from multiple chemical sensitivity, the
last thing that I want is to be eating certain foods that make
me ill. What does the U.S. Government have to say about the
truth about that hypothesis? Does the Government say we are
going to pursue that? Are there any studies to help me with
whether these people are crazy or not?
No.
You remember years ago we heard shocking testimony about
the potential of pyridostigmine bromide. I gather a number of
months ago the VA said yeah, we cannot rule that out.
I mean, we cannot rule that out.
What studies have been done to tell us if in fact
pyridostigmine is part of the problem? Have they told us after
$120 million that we cannot rule it out?
Dr. Robert Haley said that a genetic trait can predispose
people to Gulf War Syndrome. People can have the same exposure,
but with a genetic trait, you are more likely to get sick. Is
Haley right or wrong?
In other words, there is some important research taking
place out there. We are not scientists. We can't judge the
validity of that. Some people are making important statements
which if they are correct sounds to me like we are going in the
right direction. Who in the Government is making the judgment
no, this is wrong, we have tested that. That is nonsense, this
is right. Who is the general in charge of telling us what
direction we should go?
There is some good news, Garth Nicolson out in California
had a hypothesis that mycoplasma infection might be a cause.
The VA is testing that hypothesis. The VA is doing the right
thing.
But where else is the VA doing the right thing to validate
or not these and other hypotheses. That is my question?
Mr. Chan. Well, I think what you've said describes the
basic frustration that we hear from the veterans about the
process. They don't feel that the agencies are hearing them,
representing them, responding to them to address those issues
in a vigorous way. They raise all kinds of questions and those
are pretty well known questions that you brought up. It
requires an extraordinary effort to have the agency to initiate
something that is coming from the outside.
So I think there is a natural distrust of the agency as a
result. Therefore, even when vigorous research done by the
Federal Government comes out as saying that there are really no
problems out there with this particular exposure, it is
difficult to make it believable because I don't think if you
look at the structure that is made, the veterans are not
represented in terms of the voices within the VA, DOD and HHS.
So that is what I meant that there is a real disconnect
here in terms of science and policy. I am not questioning the
science and the research done, let me make sure that you
understand that. But at the same time, veterans are saying,
``That is not what is happening to me and who is listening to
me?'' First they say, you know, the diseases you mentioned are
not in ICD-9 code; and, therefore, we don't consider those.
Then we go to the next thing.
Yet then you come out and say even though there is a higher
prevalence of this kind of disease, it is not unique. So then
you begin to say, what do I have to do to prove to you--and I
am speaking from the veterans' point of view--that I am sick?
You see what I am saying? We keep on raising the bar to a
different level.
Mr. Sanders. Let me jump in and conclude my remarks. Mr.
Chairman, what I have concluded and what Mr. Chan has said,
what we are dealing with is a new type of illness. If someone
was wounded in battle with shrapnel or gunshot wounds, I
suspect the VA and the DOD is best to treat those problems. But
we are dealing with something which is new and different. There
is not familiarity or an openness to understanding that new
type of illness which may have been caused by environmental
degradation and toxicity and so forth and so on.
It seems to me, Mr. Chairman, that we have got to conclude
that while there is some important research going on around
this country, the Federal Government is not taking advantage,
it is not trying to grapple with that research and give us a
direction where to go, and I think we have got to conclude that
ultimately we should be taking the responsibility for going
forward out of the Federal Government and giving it to those
people who believe that there is an illness and who know how to
manage the research so we finally will understand the cause of
this problem and develop a treatment. I think you will agree,
Mr. Chairman, 5 years from now we don't want to go through a
similar hearing.
Mr. Shays. Thank you. Ms. Schakowsky.
Ms. Schakowsky. I have to say I was stunned once again when
the chairman asked a series of obvious and very simple
questions, the response to which was we don't know.
When I look at the research objectives identified by the
Research Working Group of the Persian Gulf Coordinating Board,
the 21 questions that were asked, 11 of those questions would
indicate to me that you have to go to the veterans themselves.
The first question, what is the prevalence of symptoms,
illnesses in the Persian Gulf veteran population? Questions
like do Persian Gulf veterans have a greater prevalence of
altered immune functions? There are 11 questions that deal
specifically with the veterans themselves.
Then I look at the reports received and released, the
research which has been done, the many studies which have been
done, and what I, in looking through these, and again I am not
a scientist, what I see is two which would address themselves
specifically to the veterans. One that says birth defects among
children of Gulf war veterans and potential nerve agent
exposure, a report which was completed in draft of 1998 and has
not been released, and a comprehensive clinical evaluation,
reports on findings from a telephone survey of Persian Gulf war
veterans, a draft submitted in 1997 and not released, so when
you talk about a disconnect, it seems like all of the money,
and it is clearly considerable, $121 million, not all on
research, but why is it that the studies which have been done
seem not to connect with the research questions that have been
asked? And why do so few of them actually focus on the
veterans?
Mr. Sharma. I think you have really hit on a very important
issue. Questions have been raised about the credibility of the
Federal research in this arena. When we went out and talked to
the veterans, there was an overwhelming perception that the
Federal Government is only interested in demonstrating that
their illness is not unique or it is psychological. And if much
of the findings of the federally funded research shows there is
no difference. No difference does not imply that they are no
illness. We still need to provide them some treatment, and we
also must pay attention to what may have caused their
illnesses.
Our in depth examination of that research showed that
because there are some significant methodological problems with
that research that would question the conclusions that have
been reached.
One in particular that I will discuss with you is the birth
defect studies. In that study they looked at----
Ms. Schakowsky. I'm sorry, which study?
Mr. Sharma. The birth defects.
Ms. Schakowsky. Thank you.
Mr. Sharma. First of all, they only looked at the military
hospitals in that study, and we know that if you are going to
have a complicated pregnancy, that you are more likely to be
referred out.
Second, they only looked at those who were on active duty
so it wasn't a very comprehensive, well-designed study which
would allow you to conclude definitively on this issue, but the
way that the study was presented, case closed. That brings some
question into the minds of some of the veterans who are
experiencing these illnesses.
Ms. Schakowsky. Why was that study not released? It says
here no.
Ms. Ward-Zukerman. The report that was done for us, we
looked at the rates of release among products due from OSAGWI's
research contracts just to see how productive their
expenditures in that direction had been. We didn't draw any
conclusions about why they were not released.
Ms. Schakowsky. Thank you, Mr. Chairman.
Mr. Shays. Thank you, Ms. Schakowsky. Mr. Blagojevich.
Mr. Blagojevich. First of all, Congressman Sanders, the
last time anyone suggested I had brain damage was the last
election.
Let me followup on what Congressman Sanders and
Congresswoman Schakowsky asked the panel. What exactly is the
Research Working Group charged with coordinating?
Ms. Ward-Zukerman. They are charged with coordinating
research in general. There is nothing in the law to prevent
them from coordinating other things. They are just to organize
the Federal research effort.
Mr. Blagojevich. And that includes only medical research or
other things as well? What would you say that their
jurisdiction is, or where is it established?
Ms. Ward-Zukerman. There is no reason that they could not
coordinate with, for example, the Office of the Special
Assistant and its work on exposures.
Mr. Blagojevich. Let me be more specific. Which agencies
are currently operating projects that are coordinated through
the Research Working Group?
Ms. Ward-Zukerman. The Department of Defense, Health and
Human Services, Veterans Affairs. At one point they had a
representative from the Environmental Protection Agency.
Mr. Blagojevich. Is there anything that you can tell us
about what we might need to go forward to make serious progress
in these research efforts, something positive to suggest here
about the future on this?
Mr. Sharma. As Mr. Chan mentioned earlier, we need to be
proactive. We have several testable hypotheses out there. They
have been published in peer reviewed journals, and we must have
an open mind and aggressively pursue those hypotheses.
When we look at the portfolio of the existing research, we
still see that those researchers from the private sector that
have come out with some testable hypotheses are still not being
funded by the Federal Government. A couple of them initially
did get funded through OSAGWI's efforts, but later on the funds
were withdrawn so they still are not receiving any Federal
support. It is very difficult to explain why or why not. When
they come, you can ask them and they will be able to address
this issue better.
Mr. Chan. Let me answer the question a different way.
I believe what I said earlier about the mismatch between
public policy and the science side, particularly in the
questions that Mr. Allen had asked. When I mention things such
as disconnect, to me it needs to be a totally different way to
look at science and how to approach it.
To me it seems like science has a tendency to look at
research as an end goal rather than treating people as an end
goal, and I am not denigrating science in any sense, but each
time you find some findings such as what was done in the RAND
study, what is the bottom line. The bottom line is we need to
do more research.
So you find from the general public's point of view there
is a great finding, we got something after a long time of
reviews and so on, but let's look some more. Let us be sure. I
think we can never reach that stage where we are so certain
about cause and effect even on a single agent.
So to keep on pursuing it to the nth degree I think it is
fine from the science point of view in terms of research, but
from the health side, I don't think that model is the best way.
I am not taking a position and discussing this in terms of what
one would question in terms of where does one go from here, but
I think the kind of research that Mr. Sanders talked about are
people with expertise out there who say hey, based on the
description of these patients, I have similar kinds of
experience with them. Let me try that out. It is more from that
direction than to say I need to know exactly what they are
exposed to and what the dose is and what kind of response are
they having. Are they common to a single person, is it only
applied to women versus men and all of that stuff. They just
say hey, this looks like something that I am aware of, and they
talk a long time before the agency would accept putting money
in, and it is usually through congressional pressure.
So in that sense I am talking about the process itself. It
needs to be examined from that light because otherwise we can
never solve the problem. Maybe we will never know what caused
these illnesses, but at the very least, we try our very best to
take care of the soldiers, and they are indeed sick; and
meanwhile science can march on on its own.
Mr. Sanders. Mr. Chan, isn't really what you are saying is
that in one sense we are looking at theory, and in the other
sense we have a soldier who is sick and after 9 years of
research, what is the treatment? Is that what you are really
saying?
Mr. Chan. Yes.
Mr. Shays. Mr. Allen.
Mr. Allen. Mr. Chan, thank you. I think what you were
saying just now is the heart of the matter. It comes back to
what I was saying earlier about there needs to be a conceptual
shift here in terms of the objectives. While the conversation
has been going on, I looked back at the research objectives
identified by the Research Working Group, and it is
interesting. You add up the number of questions that are about
specific exposures, and then you add up the number of questions
about specific symptoms in this group as opposed to the control
group, and you have pretty much exhausted the entire list.
If our focus were on the veterans, and you just said that
certainty in determining cause and effect, you said in so many
words, is not achievable perhaps in this area. Or at least if
it is achievable in some measure, it will take us some period
of time to get there. And the focus really should be dealing
with the veterans' problems as they exist and figuring out how
to help them. There needs to be I would say a new focus to the
research.
I have to say while I am here looking through this report,
I was struck by appendix 6, the comments from the Centers for
Disease Control and Prevention because they refer to two
studies, one a health assessment of Gulf war veterans from Iowa
and a CDC-Air Force study, and I want to mention that CDC-Air
Force study. On page 54 they defined a case as having one or
more chronic symptoms from at least two of three categories,
fatigue, mood cognition and musculoskeletal. So they are not
requiring that each case be exactly the same, but are saying
two of these three categories you would have to have a symptom.
And it is categorized as mild to moderate or severe. The
prevalence of mild to moderate and severe cases were 39 percent
and 6 percent respectively among 1,155 Gulf war veterans.
Versus 14 percent compared to 39 percent and 0.7 percent
compared to 6 percent among 29 nondeployed veterans.
The interesting thing about this is that they found no
association between the chronic multi-symptom illness and a
variety of factors involving service in the Gulf war. They also
found these symptoms were prevalent in 15 percent of the
control group. Think about that.
That means that the Gulf War Syndrome is a subset of a
larger problem. And so to the extent we are focused on specific
chemicals in the Gulf war, we are going to miss the point in
part, that if it is something like multiple chemical
sensitivity, it is prevalent in the rest of the population,
too, and we would advance our research about Gulf war if we
looked at the rest of the population that has these symptoms
and if we refocused the research on trying to deal with the
symptoms and with the veterans and not the particular chemical
that may or may not have been present in the Gulf war.
I guess there is not a question buried in there, but is
that a direction that we ought to move in?
Mr. Chan. I think, you know, I would agree with you that we
should look at it in a different way and see if we can really
resolve some of these issues. I agree with you, yes.
Mr. Sanders. Tom, if I can interject, and I agree with
everything that you have said, after years of discussion about
multiple chemical sensitivity, to the best of my knowledge the
U.S. Government does not own one what we call environmental
chamber by which you can begin to treat and better understand
multiple chemical sensitivity. A few million dollars, and we
still don't own that.
Mr. Shays. I would share with you the observation that
Henry Kissinger made of Jimmy Carter's foreign policy and say
that I think it applies to the Research Working Group. He said
when you don't know where you are going, any road will get you
there.
We will go to our next panel. It is comprised of five
people: Dr. John Feussner, Chief Research & Development
Officer, Department of Veterans Affairs; Dr. John Mazzuchi,
Deputy Assistant Secretary for Health Affairs, Department of
Defense; Dr. Robert Foster, Director of BioSystems, Department
of Defense; General Dale Vesser, U.S. Army (Ret.), Deputy to
Special Assistant for Gulf War Illnesses, Department of
Defense; and Dr. Drue Barrett, Chief Veterans Health Activity
Working Group, Centers for Disease Control & Prevention, DHHS.
I invite all our witnesses to stand, and I will swear them in.
[Witnesses sworn.]
Mr. Shays. I note for the record that all five witnesses
have responded in the affirmative.
We will do it in the order that I called you. Let me just
say that any comments that you want to make about observations
about the first panel are welcome. This is your opportunity to
make your points.
Dr. Feussner.
STATEMENTS OF JOHN FEUSSNER, M.D., CHIEF RESEARCH & DEVELOPMENT
OFFICER, DEPARTMENT OF VETERANS AFFAIRS; JOHN MAZZUCHI, PH.D.,
DEPUTY ASSISTANT SECRETARY FOR HEALTH AFFAIRS, DEPARTMENT OF
DEFENSE; ROBERT FOSTER, PH.D., DIRECTOR, BIOSYSTEMS, DEPARTMENT
OF DEFENSE; LT. GEN. DALE VESSER, USA (RET.), DEPUTY TO THE
SPECIAL ASSISTANT FOR GULF WAR ILLNESSES, DEPARTMENT OF
DEFENSE; AND DRUE BARRETT, PH.D., CHIEF, VETERANS' HEALTH
ACTIVITY WORKING GROUP, CENTERS FOR DISEASE CONTROL &
PREVENTION
Dr. Feussner. Thank you, sir. Mr. Chairman and members of
the subcommittee, thank you for the opportunity to discuss
research in Gulf war veterans' illnesses today. I do request
that my formal statement be entered into the record as if read.
Mr. Chairman, at the outset let me say that as a physician
and scientist with over 25 years experience I believe that the
research challenge posed by Gulf war illnesses represents one
of the greatest recently faced by the medical research
community. These veterans' illnesses, their fears about their
current and future health, their frustrations with a paucity of
hard answers and ready treatments motivate all of us to persist
in our efforts to understand the nature of their illnesses, to
explore new treatment strategies, and to be responsive when new
concerns or potential illnesses arise. In my opinion these
veterans earned and in fact deserve every consideration and
every effort that we can muster on their behalf.
Mr. Chairman, by year's end the Federal Government will
have expended approximately $159 million for health research in
the Gulf war. Right now there are over 150 projects in a
research portfolio. To date 47 projects have been completed,
resulting in 98 peer reviewed publications in the scientific
literature. There are currently 116 principal investigators
from DOD, VA, HHS, universities and other nongovernment
organizations engaged in this effort.
Because of the obvious importance of our ensuring
appropriate effective treatment of Gulf war veterans'
illnesses, my office invited proposals for multi-center trials
for candidate treatments of medical syndromes or illnesses
among Gulf war veterans. The VA Cooperative Studies Program is
conducting two treatment trials known as the ABT, for
antibiotic treatment, and EBT, for exercise and behavioral
treatment. Patient characteristics for entry into both of these
trials are similar. All Gulf war veterans who served in the
Gulf between August 1990 and 1991 may participate. Patients are
considered eligible for enrollment into the trial if they have
at least two of three symptoms: Fatiguing illness,
musculoskeletal pain and neurocognitive dysfunction.
The ABT trial, the antibiotic trial, seeks to study 450
Gulf war veterans at 28 sites throughout the United States. The
hypothesis of this study is antibiotic treatment directed
against mycoplasma species would improve functional status of
patients with Gulf war veterans illness who are tested as
mycoplasma positive at baseline. Early demographic information
from the study shows that 15 percent of the participants are
women, nearly 20 percent are minority groups, and about 70
percent are currently employed. Nearly 85 percent currently
enrolled in this study have all three symptoms that I mentioned
earlier.
The EBT trial seeks to study about 1,350 Gulf war veterans
at 20 sites throughout the United States. The primary
hypothesis is that aerobic exercise and cognitive behavioral
therapy will significantly improve physical function in
veterans with Gulf war illnesses and that the combination of
CBT and exercise will be more beneficial than either treatment
alone. So far nearly 500 veterans have joined this study.
Mr. Chairman, I now want to update you on a national survey
of Gulf war veterans authorized by public law. The survey has
been conducted in three phases. My office awarded funds for
Phase III of the National Health Survey in November 1998.
Currently 16 sites are participating in this nationwide study,
which involves special examinations, including neurologic,
rheumatologic, psychologic and pulmonary or lung evaluations.
To date over 1,000 veterans have participated in this study and
1,230 spouses and children of these veterans have been
examined.
Our broad research partnership has yielded important new
information about our veterans and their health problems. Mr.
Chairman, I would like to share some of these with you today.
The Iowa study of Gulf war veterans indicates that nearly
90 percent of veterans rated their health status as good to
excellent while the remainder rated their health status as fair
to poor. Of Gulf war veterans, 14 percent said they experienced
a significant decline in their health status. Based on VA and
DOD mortality studies it appears that there are not more deaths
from disease-related causes among Gulf war veterans, but we
continue with this study.
From a DOD study, infants of Gulf war veterans have not
experienced a greater prevalence of birth defects but studies
here also continue.
The Baltimore VA is following 33 United States soldiers
wounded by DU during the Gulf war. The team recently
demonstrated elevated urine uranium excretion by these soldiers
who have retained DU shrapnel. Importantly, there is no
evidence of a relationship yet between the uranium excretion
and kidney function. While we have no evidence of adverse
outcomes from the uranium exposure, these veterans remain under
close surveillance.
One chemical study in mice indicated, for example, that
swimming stress increased penetration of pyridostigmine bromide
across the blood-brain barrier. We had discussed that study in
our February 1998 hearing. However, other studies in Guinea
pigs exposed to extreme heat stress suggested that PB does not
cross the blood-brain barrier. Yet another research project
recently reported that the effects of low-dose PB on the
neuromuscular junction were fully reversible following
cessation of PB treatment.
The Research Working Group will continue its research on
the toxicology of such chemicals. Veterans of the Gulf war have
voiced concerns about possible association between ALS,
amyotrophic lateral sclerosis, and service in the war. Although
there is no indication of an excess rate of ALS, available data
may underestimate the true rate. The VA is leading an effort to
identify all cases of ALS among Gulf war veterans. This case
finding effort will take about 1 year and will provide
definitive information about the rate of ALS among Gulf war
veterans.
Mr. Chairman, thank you for giving me the opportunity to
appear before your subcommittee. My written testimony covers in
more detail these and other matters of concern to the
subcommittee. I conclude my remarks now and will await your
questions.
[The prepared statement of Dr. Feussner follows:]
[GRAPHIC] [TIFF OMITTED] T7151.012
[GRAPHIC] [TIFF OMITTED] T7151.013
[GRAPHIC] [TIFF OMITTED] T7151.014
[GRAPHIC] [TIFF OMITTED] T7151.015
[GRAPHIC] [TIFF OMITTED] T7151.016
[GRAPHIC] [TIFF OMITTED] T7151.017
[GRAPHIC] [TIFF OMITTED] T7151.018
[GRAPHIC] [TIFF OMITTED] T7151.019
[GRAPHIC] [TIFF OMITTED] T7151.020
[GRAPHIC] [TIFF OMITTED] T7151.021
[GRAPHIC] [TIFF OMITTED] T7151.022
Mr. Shays. Thank you. Mr. Mazzuchi.
Dr. Mazzuchi. Thank you, Mr. Chairman, and members of the
subcommittee, I am pleased to be here today to provide
testimony on our current clinical and research efforts to
understand and treat illnesses among Gulf war veterans. I too
would ask that my formal statement be entered for the record.
This is a summation of it in the interest of time.
The Office of the Assistant Secretary of Defense for Health
Affairs has a primary interface in the Department's biomedical
research program and that derives primarily from our role as
co-chair along with the Director of the Department of Defense
Research and Engineering of the Armed Services Biomedical
Research Evaluation and Management Committee, which facilitates
consideration of DOD biomedical research. The Assistant
Secretary of Defense for Health Affairs also serves as the
primary alternate member and primary DOD liaison official with
the Military and Veterans Health Coordinating Board and is a
voting member of the board's research working group which Dr.
Feussner chairs.
Through many years of research and progress in military
medicine, tremendous strides have been made in medical
protection and care provided to our soldiers, sailors, airmen
and marines. The medical consequences of the Gulf war made it
clear, however, that threats remain--some threats remain poorly
understood and inadequately addressed. Despite few combat
casualties and low rates of disease in nonbattle injuries in
both the buildup to the war and the war itself, many veterans
have since reported health problems, including medically
unexplained symptoms which followed their service in the Gulf
war. These unexplained illnesses have proven to be both
frustrating to diagnose and frustrating to treat. Efforts
within the Department of Defense to care for Gulf war veterans
have reinforced our appreciation of the seriousness of their
health problems, and military physicians fully recognize that
these veterans require compassionate evaluation and care.
The lack of predeployment health and deployment exposure
data is recognized as a chief limitation in the evaluation of
Gulf war veterans illnesses. Numerous improvements are being
made to gain and analyze such data regarding future U.S.
military deployments. These efforts include capturing better
service entry health data, pre and post-deployment health data,
environmental and morbidity data during deployment, improved
communication with troops regarding deployment health risks,
and focused clinical evaluation and epidemiologic research
programs of our deployed populations.
In the 1998 report to Congress, Effectiveness of Medical
Research Initiatives Regarding Gulf War Illnesses, the
Department of Defense identified the need for a coordinated
capability to apply epidemiologic research to determine whether
deployment related exposures are associated with post-
deployment health problems. Subsequent to this report, Congress
authorized the Secretary of Defense to establish a center
devoted to ``longitudinal study to evaluate data on the health
conditions of members of the armed forces upon their return
from deployment.''
On September 30, 1999 Dr. Sue Bailey, the Assistant
Secretary of Defense for Health Affairs, directed the
establishment of DOD Centers for Deployment Health, creating a
research center at the Naval Health Research Center, San Diego,
CA with the mission of longitudinal study to evaluate data on
the health conditions of members of the armed forces upon their
return from deployment. A clinical center was also established
at the Walter Reed Army Medical Center to oversee the
Department's clinical evaluation program for deployed service
personnel.
One of the many lessons learned of the Gulf war is that the
lack of ongoing population based longitudinal health studies
has limited our capability to identify deployment-related
health outcomes. Additionally, the only way to determine health
status change is through a prospective monitoring of health.
Recognizing the challenges of conducting such studies, DOD and
VA asked the National Academy of Sciences Institute of Medicine
to suggest appropriate scientific and practical methodologies
to do this. In response the Institute of Medicine recommended
in its report, Gulf War Veterans Measuring Health, that DOD and
VA institute longitudinal cohort studies of both Gulf war and
other deployed veterans. DOD and VA have initiated planning to
develop a research program of ongoing longitudinal studies with
a specific aim of determining how the health of U.S. military
veterans changes over time. This study, entitled the Millennium
Cohort Study, will focus on U.S. military cohorts of the future
yet be constructed so as to enable comparison to military
cohorts of the recent past. A concurrent program will use
similar data collection methods to study a comparable Gulf war
veteran population. The goal for these two comprehensive
studies is to determine how the health of several veterans'
cohorts changes over time. The specific goal of the Millennium
Cohort Study is to identify and prospectively follow health
outcomes of future U.S. military cohorts beginning in the year
2001. In this study we intend to guide the development of DOD
medical information programs so that future investigators will
not have to rely so much on special investigative studies to
determine the effects on health of military deployments.
We appreciate the interest this committee has shown in the
health of our men and women who have served their Nation in the
armed forces. The military health system wants to achieve its
goal to care for those men and women and their families and to
protect their health. We also recognize that our commitment to
veterans' health cannot end when they leave active service. We
will maintain a strong post-deployment evaluation and care
program in coordination with the VA and move forward to
strengthen our force health protection program.
Again we appreciated the opportunity to testify before the
subcommittee, and look forward to receiving your questions.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Mazzuchi follows:]
[GRAPHIC] [TIFF OMITTED] T7151.023
[GRAPHIC] [TIFF OMITTED] T7151.024
[GRAPHIC] [TIFF OMITTED] T7151.025
[GRAPHIC] [TIFF OMITTED] T7151.026
[GRAPHIC] [TIFF OMITTED] T7151.027
[GRAPHIC] [TIFF OMITTED] T7151.028
Mr. Shays. Thank you, Dr. Mazzuchi. Dr. Foster.
Dr. Foster. Thank you, Mr. Chairman, and members of the
subcommittee. Thank you for the opportunity to briefly discuss
the Department's science and technology program addressing Gulf
war veterans' illnesses and general deployment health concerns.
I too request that my formal testimony be entered for the
record, and I will be abstracting some of the information from
that formal testimony.
In my remarks today, I will focus on a research program
that was initiated with the fiscal year 1999 defense
appropriation in the research development test and evaluation
account. With that appropriation, the Department established
the dedicated program element to support basic research into
Gulf war illnesses and related deployment health concerns.
The Department's research program has three overarching
research objectives in mind. We want to further the
understanding of illnesses relevant to service during conflict,
including the Gulf war deployments, we want to provide enhanced
diagnostic capabilities and effective treatments for these
illnesses, and we want to support the establishment of policies
and preventive measures that minimize the risk for such
illnesses during future military operations. This research
program will be of the highest quality.
In this enterprise we are pleased to have the Army's
Medical Research and Materiel Command at Fort Detrick as the
program management agency. They have an exemplary record of
achievement in managing medical research. The Army's program
manager for this effort, Lieutenant Colonel Karl Friedl, is
seated just behind me. We should all thank him for his untiring
efforts on behalf of our veterans.
Turning to the funding associated with research in this
area, from 1994 to 1998 there were ``special appropriations''
for Gulf war illnesses issues and research, and we have gained
numerous insights from research projects initiated with that
funding.
We have now transitioned to a formal defense research
program. This occurred with the fiscal year 1999 defense
appropriation. The funding is in the basic research account.
This provides more stable funding for systematically tackling
research gaps in our understanding of Gulf war veterans'
illnesses and in force protection issues. The program will be
addressing issues in five research thrust areas, and will
support any continuation of promising leads from the previous
program.
Our program management approach includes periodic
evaluation of progress resulting in an annual tailored
solicitation for research proposals from anyone anywhere who is
willing to propose to do research. This annual investment plan
is carefully developed in coordination with the interagency
Research Working Group. An important characteristic of this new
dedicated program is the ability to plan and implement a long
term strategy of deployment health research in support of the
Department's force health protection initiative. Indeed,
establishment of a dedicated research program is a key enabler
for this initiative. The 1999 program, the first year of our
program, had four solicitations. We received 81 proposals and
we will probably make about 17 awards from those proposals. I
have provided the current statistics and examples of the
research covered in the written testimony.
With fiscal year 2000 funding, new research solicitations
will be developed and issued. We are also initiating an
investment in the longitudinal cohort study that Dr. Mazzuchi
mentioned that addresses the recommendations of the IOM's
assessment entitled, ``Gulf War Veterans Measuring Health.''
I think that the program is proving highly effective in
providing new information on the impact of Gulf war service on
health-related problems and identifying new areas to explore
with research, and in prompting new force protection
initiatives that provide for medical surveillance during future
operations.
Although the investment in Gulf war veterans' illness
research has already provided meaningful results, we must be
cautious in anticipating the true impact of this research. That
impact may not be fully assessed and realized for years after
this early stage of the program and the awards have been made.
In conclusion, I believe that the organizations testifying
before you today that are engaged in research share a genuine
concern for and a recognition of the magnitude and consequences
of the medical and scientific challenges before us. While there
may be no quick solutions to the health problems experienced
with Gulf war veterans, the participants in our interagency
Research Working Group and our research program are genuinely
committed to a responsible and aggressive pursuit of reasonable
hypotheses and to the prevention of similar illnesses following
future deployments.
This concludes my remarks, Mr. Chairman, and I am pleased
to answer your questions.
[The prepared statement of Mr. Foster follows:]
[GRAPHIC] [TIFF OMITTED] T7151.029
[GRAPHIC] [TIFF OMITTED] T7151.030
[GRAPHIC] [TIFF OMITTED] T7151.031
[GRAPHIC] [TIFF OMITTED] T7151.032
[GRAPHIC] [TIFF OMITTED] T7151.033
[GRAPHIC] [TIFF OMITTED] T7151.034
[GRAPHIC] [TIFF OMITTED] T7151.035
[GRAPHIC] [TIFF OMITTED] T7151.036
[GRAPHIC] [TIFF OMITTED] T7151.037
[GRAPHIC] [TIFF OMITTED] T7151.038
[GRAPHIC] [TIFF OMITTED] T7151.039
[GRAPHIC] [TIFF OMITTED] T7151.040
[GRAPHIC] [TIFF OMITTED] T7151.041
[GRAPHIC] [TIFF OMITTED] T7151.042
Mr. Shays. Thank you, Dr. Foster. General Vesser.
General Vesser. Mr. Chairman, I appreciate the opportunity
to appear before your subcommittee to review with you and its
members the support the Office of the Special Assistant for
Gulf War Illnesses, referred to earlier as OSAGWI, provides to
the ongoing research into the potential causes of Gulf war
illnesses.
As you know, the Office of the Special Assistant for Gulf
War Illnesses does not directly undertake medical research and,
with a few exceptions, does not directly sponsor medical
research. Our primary tasking when established was to find out
what happened on the battlefield. Dr. Rostker was specifically
tasked to find out what the problems are and to fix them. When
the office was established the then Deputy Secretary of
Defense, Dr. John White, reconfirmed the Department's policy
that the Assistant Secretary of Defense for Health Affairs was
responsible for the Department's medical programs. In that
regard, the Assistant Secretary of Defense for Health Affairs
and the Deputy Under Secretary of Defense for Science and
Technology represented the Department on the Research Working
Group of the Persian Gulf Veterans Coordinating Board, which
coordinates pertinent medical research for DOD, Veterans
Affairs, and Health and Human Services. We do have an observer
who also sits with that group.
Over the last 3 years, the Office of the Special Assistant
has been instrumental, however, in funding or impacting the
funds of several medical research programs that, for one reason
or another, were not being supported by the traditional medical
research funding process. Generally speaking, these did not
receive sufficiently high evaluation scores in the competitive
medical review process, but had become a great concern with a
significant number of Gulf war veterans. Our work in OSAGWI
begins and ends with the veterans. We recognize, therefore,
that sometimes exceptions need to be made to the competitive
medical review process. Specifically, we believe that in the
case of Gulf war illnesses, it is important to listen to our
veterans and provide any assistance we can by researching
claims to the potential cause and cures for unexplained
illnesses that are affecting many of them.
Frankly, we have a credibility problem with some veterans
who believe that we are not funding promising research because
we either don't care about their health or that we have
something to hide. In such cases, we can demonstrate that
neither is the case. We owe it to our veterans to apply
accepted medical research standards to determine if the theory
being proposed can help either explain why veterans are ill or
help in their treatment.
Let me highlight for you the projects that we have either
directly funded or have been instrumental in making sure that
funds were provided. This is in addition to the general work of
our office.
Specifically, we have funded or impacted the funding of the
work of Dr. Garth Nicolson, tests for mycoplasma fermentans
incognitus strain in human blood, and Dr. Robert Haley, multi-
disciplinary pathophysiologic studies of neurotoxic Gulf war-
related syndromes. We have also funded a review of the medical
records of the Saudi Arabian National Guard by the Uniformed
Services University of the Health Sciences and the Naval Health
Research Center.
As you know, we have commissioned a number of medical
literature review papers prepared by the RAND Corp. These
papers are not medical research in the traditional sense, but
were important to inform and direct the work of our office.
These papers, case narratives, information papers, and our
environmental exposure reports are available on the Internet at
GulfLINK, and have been reviewed by the Presidential Special
Oversight Board headed by former Senator Warren Rudman.
We also helped to coordinate for DOD funds to be provided
to the Department of Veterans Affairs program in Baltimore to
monitor the health of veterans exposed to depleted uranium. I
am pleased to say that the last published results for this
program, ``show no evidence of adverse clinical outcomes
associated with uranium exposures at this time in these
individuals.''
Again, thank you, Mr. Chairman, for giving me the
opportunity to put the work of the Office of the Special
Assistant into the proper context. I stand ready to answer any
questions you or the subcommittee may have, and I ask that my
remarks be made part of the record.
[The prepared statement of General Vesser follows:]
[GRAPHIC] [TIFF OMITTED] T7151.043
[GRAPHIC] [TIFF OMITTED] T7151.044
[GRAPHIC] [TIFF OMITTED] T7151.045
Mr. Shays. Thank you, General Vesser. Dr. Barrett.
Dr. Barrett. Thank you, Mr. Chairman. Thank you for the
opportunity to update the subcommittee on the Centers for
Disease Control and Prevention's research programs pertaining
to Gulf war veterans' illnesses, and to discuss the General
Accounting Office's report.
I am Dr. Drue Barrett of the National Center for
Environmental Health. I serve as CDC's liaison to the
Department of Health and Human Services on Gulf war issues, and
I am a member of the Research Working Group of the Persian Gulf
Veterans Coordinating Board.
Our research efforts on Gulf war veterans' health concerns
date back to 1991, with the larger epidemiologic studies
beginning in 1994. I would like to briefly mention our most
recent Gulf war activities and refer you to my written
testimony for further details. Two completed CDC-funded studies
directly pertain to questions raised by the GAO regarding the
success of the Federal Government in documenting the symptoms
of Gulf war veterans.
The Iowa study conducted in collaboration with the Iowa
Department of Public Health and the University of Iowa was one
of the first population-based epidemiologic studies to document
that Gulf war veterans are reporting more medical and
psychiatric conditions than their nondeployed military peers.
In fact, the study was recently described by the Institute of
Medicine as perhaps ``the strongest study on Gulf veterans'
experience of symptoms related to deployment in the Gulf.''
The Iowa study found that the Gulf war military personnel
were more likely than those who did not serve in the Gulf war
to report symptoms suggestive of cognitive dysfunction,
depression, chronic fatigue, post-traumatic stress disorder and
respiratory illness. The conditions identified in the study
appeared to have had a measurable impact on the functional
activity and daily lives of these Gulf war veterans.
Likewise, the CDC-Air Force study has significantly
contributed to our understanding of the health consequences of
the Gulf war. This study organized symptoms into a case
definition, characterized clinical features, and evaluated risk
factors. The key observation of the study was that Air Force
Gulf war veterans were significantly more likely to meet our
case definition of illness than were nondeployed personnel.
However, there was no association between this chronic
multisymptom illness and risk factors specific to combat in the
Gulf war, such as month or season of deployment, duration of
deployment, duties in the Gulf war, direct participation in
combat, or locality of Gulf war service.
We found that nondeployed veterans also met our case
definition, suggesting that the illness observed in this
population is not unique to Gulf war service. The clinical
evaluation component found that ill Gulf war veterans did not
have clinically significant abnormalities on physical
examination or routine laboratory tests. However, they did
report a significant decrease in functioning and well-being.
The results from both the Iowa study and the Air Force
study were published in the Journal of the American Medical
Association. In addition, both of these studies have resulted
in a number of other articles which have been published or
about to be published. CDC is currently funding a followup to
the Iowa study focusing on evaluating self-reported symptoms of
asthma. We are also funding the Boston University School of
Public Health to conduct a study examining the relationship
between cognitive function and symptom patterns among Gulf war
veterans, and we are funding the University of Medicine and
Dentistry of New Jersey to conduct a study examining case
definition issues.
In addition to these current research projects, in 1999 CDC
sponsored a conference to develop future Gulf war research
recommendations. We brought together scientists, clinicians,
veterans, veteran service organizations, congressional staff
and other interested parties to discuss and make
recommendations regarding the direction of future research of
undiagnosed illnesses among Gulf war veterans and their links
with multiple chemical and environmental exposures.
The conference highlighted the importance of including
veterans in the process of planning and implementing research.
A report is soon to be released that summarizes the outcome of
the conference.
Finally, I would like to briefly address the issue of
coordination of Federal research efforts. There has been HHS
representation on the Research Working Group since its
inception. In addition to CDC, the Office of the Secretary, the
National Institutes of Health, and the Agency for Toxic
Substances and Disease Registry are represented. Through its
membership, HHS has been involved in providing guidance and
coordination for DOD, VA and the HHS research activities
relating to Gulf war veterans.
In conclusion, an intensive research effort to address Gulf
war veterans' health concerns has been mounted by Federal
agencies. The research projects funded to date represent a
broad spectrum of efforts ranging from small pilot studies to
large scale epidemiology studies. In addition, numerous review
panels and expert committees have evaluated the available data
on Gulf war veterans' illnesses.
As noted in the GAO report, despite these extensive
research and review efforts, many questions remain regarding
the health impact of the Gulf war. These remaining questions
reflect the complexity of assessing and predicting the health
impact of military deployments.
Mr. Chairman, this concludes my oral remarks, and I would
be happy to answer any questions the subcommittee may have.
[The prepared statement of Dr. Barrett follows:]
[GRAPHIC] [TIFF OMITTED] T7151.046
[GRAPHIC] [TIFF OMITTED] T7151.047
[GRAPHIC] [TIFF OMITTED] T7151.048
[GRAPHIC] [TIFF OMITTED] T7151.049
[GRAPHIC] [TIFF OMITTED] T7151.050
[GRAPHIC] [TIFF OMITTED] T7151.051
[GRAPHIC] [TIFF OMITTED] T7151.052
[GRAPHIC] [TIFF OMITTED] T7151.053
[GRAPHIC] [TIFF OMITTED] T7151.054
Mr. Shays. I would just make the observation it is almost
like we have two separate hearings. We had the GAO who was
basically commenting on your work and had some extraordinarily
significant statements, and you didn't address any of them. You
just had your statements.
Mr. Sanders.
Mr. Sanders. Thank you, Mr. Chairman.
Let me start off with General. Thank you very much for
being with us. Let me call on your military background,
General, to ask you a question. If the U.S. military were
engaged in a major military operation with unlimited resources
befitting the wealthiest Nation on Earth, and we were fighting
that war for 9 years and at the end of those 9 years the
military objectives were not one step closer to being obtained
in the sense of winning the war, would it be fair to say that
it would be in the country's best interests to remove the
generals who are in charge of that military operation?
General Vesser. Of course it would be appropriate, but one
has to ask what the objectives are.
Mr. Sanders. If the objectives here are quite clear, they
are not complicated, the objectives that we have close to
100,000 men and women who are ill, and the objective is we want
an understanding of their illness and we want an effective
treatment, and it seems to me 9 years later we have zero in
that regard from the U.S. Government, tell me why given that
rather sad track record the chairman and I and Members of
Congress should not say thank you very much for your well-
meaning efforts, you have failed, we need other people to take
up the battle?
General Vesser. I would say to you what have we done. I can
speak only for my office. My office was charged to discover
what happened on the battlefield. I am not a medical person. I
was a line officer, and I am both a Vietnam vet and also served
as a civilian during Desert Storm in the desert.
I would say to you that we have developed models to
estimate who was exposed to the low levels of chemical warfare
agent. We have target notified over 157,000 veterans by letter
of their potential exposure to that and to other hazards that
we have looked at.
Mr. Sanders. General, we don't have unlimited time, and I
don't mean to be rude in interrupting you. I am aware of that.
I am not saying that is insignificant, but using the analogy of
a military conflict, we are not winning this battle. We are
losing it. We have tens and tens of thousands of people who are
ill. Let us see our eyes on the prize. What are we talking
about. We are talking about treating sick veterans. We are zero
step closer today it seems to me. And I think the record on the
part of the VA and the DOD has not been a good one.
Let me speak to Dr. Foster, if I might.
I notice on page 5 and on you comment on some of the
research. Let's deal with that.
It seems to me that in fact there have been some
breakthroughs. What concerns me in terms of the last panel, the
words that we keep hearing is lack of focus, disconnect, a lack
of sense of urgency. In other words, it appears that there have
been some studies which are making some breakthroughs and it
seems to me that we have got to put our resources into those
studies. I am not happy to hear from Dr. Barrett that after 9
years we have concluded that some people are ill or are not
ill. We are starting with the assumption that there are tens of
thousands of people who are ill. That was a 9-year-old
discussion.
What we want to know now is what are you doing to discover
the cause of illness and what treatments have you developed.
Now on page 5 you mention Dr. Garth Nicolson's study, and I
will be talking to Dr. Feussner about this. We have put a
significant amount of money into Nicolson's hypothesis. Is
Nicolson right or wrong. If he is wrong, we have learned
something. If he is right we may have a treatment model. Thank
God we have something, good.
Haley has come before this committee on several occasions.
He has impressed some of us as being a vigorous and intelligent
researcher. He has suggested, among other things, that a
genetic trait can predispose people to Gulf War Syndrome. In
other words, what he has suggested is two people with the same
exposure will react differently. What are we doing? That is an
important step forward.
He and his researchers have suggested that we can now
objectively look at a brain scan and maybe tell us who has Gulf
war illness and who does not. As a layman, that seems to me to
be a breakthrough. It objectifies. It ends the discussion
whether somebody is ill or not ill. If we can see changes in
the brain, we know something. What are we doing to go forward
on that particular study?
Dr. Foster. I believe Dr. Feussner would like to speak to
that rather than me.
Dr. Feussner. Yes, I would like to speak to that,
Congressman.
Before I do, we have had numerous discussions in the past
that I would characterize as straightforward.
Mr. Sanders. Yes.
And I would say that, as you know, I agree with you that we
have tens of thousands of veterans who are sick. We are
treating hundreds of thousands of veterans in VA hospitals. I
believe last year almost 300,000 Gulf war veterans received
care in VA making in excess of 3\1/2\ million outpatient visits
to VA.
I think there's no question that Gulf war veterans are
being treated. I think the difficulty that we have is that
they're not being fixed; that is, they are not being cured. And
you are quite correct that we have no cure for Gulf war
veterans' illness. That is absolutely, unequivocally correct.
It's also absolutely, unequivocally correct that we have no
cure for AIDS.
Mr. Sanders. John, let me interrupt you. We have no cure
for AIDS?
Dr. Feussner. But we have treatments.
Mr. Sanders. Here is an important distinction if you want
to make an analogy between Gulf war illness and AIDS.
Researchers today have made significant progress. If you or I
had AIDS, we'd be better treated today, have a longer life-span
than was the case 10 years ago. Research has resulted in
improved treatment.
What I asked General Vesser and Dr. Foster is, has research
in Gulf war illness resulted in better treatment in terms of
curing people who are sick? I think the answer is no.
Dr. Feussner. I concur.
The issue about the brain--the brain issue, I think, is
quite a pertinent one, and in my lengthier testimony--I
apologize in my effort to beat the red light--I omitted my
comments about our brain imaging studies. But what I would like
to say is, yes, these imaging studies are highly important. The
research portfolio at the moment includes seven studies using
sophisticated brain imaging technologies ranging from the
typical one that you would encounter in a hospital--
traditional, conventional magnetic resonance imaging, which
looks at issues of anatomy; functional magnetic imaging, that
tends to look at issues of function; magnetic resonance
spectroscopy and SPECT scanning, which can actually look at
chemical reactions in the brain without invading the skull.
Mr. Sanders. Let me interrupt you and ask you this
question. Again, I'm a layman.
What seemed to me important about Haley's work is we are
beginning--I don't know what the scientific word is, but
looking at--in an objective way, if you're looking--you can
show me on a piece of paper the brain damage of somebody and
say, this person has Gulf war illness, it seems to me to be a
significant breakthrough.
Are your studies confirming what Haley has shown or are you
not?
Dr. Feussner. The studies haven't been completed yet,
unfortunately. What--but I can tell you what the studies are
focused on. The studies are somewhat different than Dr.
Haley's. Dr. Haley focused on a general chemical in the brain
that's dispersed throughout the brain and is a potentially
general marker for nerve cell damage.
The studies that we have looked at focus on parts of the
brain that are known to be associated with memory processing
called a hippocampus and others, since many of the patients
complain of having memory dysfunction, et cetera.
The other major focus of the research is looking at
chemical neurotransmitters; that is, chemicals in the brain
that allow cells within the brain to communicate among
themselves and with other parts of the brain.
But there is research in the pipeline, yes, sir, that will
confirm, advance, et cetera, the results of Haley's work.
Mr. Sanders. I want to say something that while I have been
very critical, and I think quite rightly, of the DOD and VA, I
think Dr. Feussner is a bright light and probably will get you
fired. But nonetheless I think he is at least one person trying
to get forward.
Here is the point; let's get back to the treatment aspect.
Presumably, if Haley is right, maybe--I don't know this, but if
he is right--there might be a treatment that can be built
around that understanding. I mean, don't we want to develop a
treatment? How close are we developing a treatment based on the
brain research that you're doing?
Dr. Feussner. We're not close to developing treatment based
on brain research that anyone has done to date. But I think
your assertion is fundamentally correct; that is, you don't
want to give a patient with hypertension insulin, because
you'll do much more harm than good. And one of the conundrums
of the research process is, fundamental understanding about
some of the mechanisms might allow you to make better judgments
about treatments that are likely to provide more benefit than
treatments that are likely to do more harm. And that's the
pathway we have taken, as you asserted earlier, with the
mycoplasma idea. Those are the pathways we are taking as a
matter of fact with the EBT trial.
Congressman Allen commented on the fact that the working
case definitions could actually be useful, and I would like to
point out that that is, in fact, correct; and in both our
treatment trials those working-case definitions are being used
to select subgroup of patients for treatment, and what we have
observed is that those patients are quite sick, based on the
measures we're making of their health status.
Mr. Sanders. Let me ask you this. Let me shift gears a
little bit and go to the issue which Mr. Allen, among others,
has raised; that is the issue of multiple chemical sensitivity.
Again, you're talking to a Member of Congress for whom this is
not an abstract issue. I have talked to hundreds of veterans in
the State of Vermont. As you know, I think Vermont probably
ranks the highest in the country in terms of participation in
the mycoplasmic study. We have worked very hard to involve
people in that study and to work with veterans.
A veteran in Springfield, VT, tells me if he is exposed to
his wife's perfume or walks into a grocery store, he becomes
ill. It sounds to me like this is a reasonably conventional
symptom of what we call ``multichemical sensitivity.'' What are
you doing to treat, to acknowledge that problem and to treat
that problem?
I have a nightmarish feeling that there are thousands of
veterans who are walking around today who probably have a lot
of toxicity within their systems or damage in their systems as
a result of exposure to toxicity, who continue to get exposed
to the food they eat, the air they breath, the work that they
do, to toxic elements that perhaps make them iller than they
otherwise should be if they avoid that type of environment and
yet they are not told about that.
What are we doing to understand and treat multiple chemical
sensitivity? There are a number of studies--perhaps we'll hear
from Dr. Miller in a little while--that suggest that what we're
seeing in some of our Gulf war veterans are not dissimilar from
what doctors are seeing from civilians who have been exposed to
excessive amounts of chemicals. Now, this is an issue not just
for Gulf war veterans but for the population at large. What are
we, in fact, doing on that issue?
Dr. Feussner. The research that's ongoing in low-level
chemical exposures and low-level chemical toxicity is small. I
think probably fewer than a dozen projects that look at efforts
to understand how exposures to various chemicals, low doses of
chemicals might affect various body systems. We have no
treatment trials at the moment.
Mr. Sanders. It seems to me, Dr. Feussner, that is a great
lack. That is one of the important hypotheses out there.
Why is the VA not going forward on it?
Dr. Feussner. Well, in part, I think you already know the
answer to this question, but let me try to answer it
nonetheless. I think there are two issues. One of the issues is
that some of the treatment strategies that are proposed require
unique environmental chambers, and the Department has no or
virtually no such facilities at the moment. So it doesn't
permit any research that one would want to do----
Mr. Sanders. Let me interrupt. I don't mean to be rude. I'm
a fan of yours. I'm not being rude here, but let's stop for a
moment.
You've spent, gentlemen, how much, $130 million? Almost
everybody is of the opinion that one of the causes of Gulf war
illness may be the fact that our veterans were exposed to a
very toxic environment. There's no doubt about it. We,
generally speaking, call that type of process multiple chemical
sensitivity. How could it be that when an environmental chamber
costs a few million dollars and you need that environmental
chamber to do the work that needs to be done to fully
understand multiple chemical sensitivity, that after spending
$120 million-plus, we still do not have that chamber.
Doctor.
Dr. Feussner. Well, I don't know the answer to that
question, Congressman. What I would say is that in--with
regards to our Environmental Hazard Research Center in East
Orange, in East Orange, that the low-level exposure research
that's going on there avails itself of the collaboration with
the Robert Wood Johnson Medical School, which does have access
to such chambers, and MCS research is going on there using the
university-based chamber.
Mr. Sanders. Let me interrupt you again.
Dr. Feussner. Now, the other issue, however----
Mr. Sanders. Sorry. Let me interrupt you again. I open it
up to any of the five people up there.
Tell me why if exposure to chemicals is considered to be
one of the important causes, what might be one of the important
causes of Gulf war illness. If an environmental chamber is
absolutely needed to better understand this problem, tell me
why for a few million dollars the U.S. Government does not own
one environmental chamber? Can anybody answer me that question?
Mr. Chairman, I must tell you I put in the last----
Dr. Feussner. Congressman, if I may say, I believe the
Federal Government does own such chambers. I'm not specifically
aware of DOD, but I'm quite aware that the EPA site at the
University of North Carolina in the Research Triangle has, I
believe, such facilities.
Mr. Sanders. I am not aware of that. I may be wrong on
this. I will----
Dr. Feussner. But I think in terms of----
Mr. Sanders. Even if they do, where is the collaboration?
Why are you not availing yourself of that chamber if, in fact,
it does exist? How many years do we have to go through the
routine of talking about multiple chemical sensitivity and
understanding it? Now, I do understand it.
Here's the root of the problem, I think--I know I'm taking
up much too much time--multiple chemical sensitivity or
multiple chemical illness is a controversial definition, right?
There are some people in the medical world who simply do not
agree with it, I understand that, but it seems to me in
fairness to Gulf war veterans who are ill, we have got to
pursue every avenue that is out there.
Dr. Feussner, what you are telling me is, you think there
may be a chamber, but certainly it is not a chamber that I
gather any of the research here has worked with.
I would mention, Mr. Chairman, in the last military
appropriations bill, I put in some language--I guess, calls for
the need for a chamber, but I would hope very much that with
all of the money we are spending, we will build a chamber so we
can better understand multiple chemical sensitivity. I think
it's an outrage that we don't have one.
Dr. Feussner, let me give it back to you. Do you agree?
Dr. Feussner. Well, I think there's no question that having
a facility available certainly would facilitate use of that and
subsequent research. You also are aware that that problem
confounding us, we are receptive to research in this area that
specifically focuses on treatment trials, I think, all of us
that are receptive to that research--NIH, DOD, and VA.
Mr. Sanders. Tell me about the research--all right. He gets
sick--I keep pointing to my colleagues here--if his wife has
perfume. I don't know if you talked to them, but in Vermont we
have veterans. Dr. Vesser, he is nodding his head. That is a
symptom that you picked up, right?
General Vesser. I have talked to over 3,000 veterans in our
town halls that come to tell us what their problem is, and
probably another--my teams have probably talked to another
20,000. And this is one of the symptoms that we hear, sir.
Mr. Sanders. Good. So we're in agreement. What are we doing
to better understand that and treat that so a man can be with
his wife who wears perfume? What have we learned from that all
of these years?
Dr. Vesser, you want to help me with what we've learned?
I've heard it; you've heard it; what have we learned? If a guy
gets sick exposed to detergent or perfume, what have we
learned?
Who wants to tell me what we have learned? What are we
doing to treat that?
Dr. Feussner. I don't know that we've learned very much,
but what I would say on the other hand is that this issue
suffers from some of the same problems that Gulf war veterans'
illnesses have, vis-a-vis sharply defining the patient
population, defining interventions that are testable and that
can be given homogeneously across populations and then having
explicit outcome measures.
Mr. Sanders. John, will you promise me this--and you've
been a man of your word: It sounds to me like we're really
lacking going forward, and I understand that it's
controversial, and I understand that some of the researchers in
this area get criticized and they don't have all the peer
reviews and everybody else--millions of Americans.
Dr. Vesser, you have heard the same thing that I have
heard, right?
General Vesser. That's correct, but it's General Vesser,
sir, not doctor, with all due respect.
Mr. Sanders. I'm sorry. You've heard the same thing and you
have just told me by your silence that we're not doing very
much in responding to those concerns that the veterans have?
General Vesser. Well, my own office is trying to do some
environmental reports. One of them will deal with pesticides,
because we know that all soldiers who served in the Gulf war
were exposed to pesticides, one chemical that we are concerned
about, so we're trying to get some information about potential
dosage.
Mr. Sanders. Dr. Feussner, can you make a promise to this
committee today that you will make multiple chemical
sensitivity a top priority, that you will work with us for an
environmental chamber so that we can begin to treat and
understand that problem better? Can you make that promise or
commitment to us?
Dr. Feussner. Yes, I think that I will--I think, sir, I
have tried to work with you on this effort in the past and,
yes, I will continue to work with you on this effort.
Mr. Sanders. You have worked with us, and I applaud you for
that. But we have not worked effectively--you have worked very
well on the mycoplasmic theory. I applaud you.
We have not worked effectively on MCS.
Dr. Feussner. Which we have not gotten to, yes, yet.
Mr. Sanders. You will make that commitment to us?
Dr. Feussner. Yes, sir, I will certainly continue to work
with you.
Mr. Sanders. Will you support our effort to fund an
environmental chamber?
Dr. Feussner. I believe I've made that commitment to you in
the past, that if there was a way to find the money, I would be
with you.
Mr. Sanders. But this is what is a little bit crazy. We're
talking about spending $130 million. The Congress has not been
cheap. We've allocated a lot of money. There is money out
there; you can make that happen if you want.
Mr. Chairman, you've been very gracious here. I've gone
three times over my limit here. I thank you.
Mr. Shays. I will try to get you all out before we have to
vote, so you don't have to wait for us.
You are all parts of various departments who are part of
the coordinating working group, and not only do I feel like the
GAO's report before yours was ignored by your statements; but I
also don't have a sense of comfort that you are part of one
group.
Who is in charge right now of the working group? Dr.
Feussner.
Dr. Feussner. I am sir.
Mr. Shays. How does the system work? It rotates every 3
months or what?
Dr. Feussner. No, sir. I became chairman of the Research
Working Group in 1996, and I have been chair of the Research
Working Group through the entire subsequent time.
Mr. Shays. I get the feeling that OSAGWI is basically the
10,000-pound gorilla in this group though. Hearing from you,
General Vesser, it's like you're just getting an assessment of
where our soldiers are coming from and that's the extent of it.
Isn't your agency basically doing most of the funding?
General Vesser. We have spent a lot of money on our
investigations and all that work hasn't gone solely on
investigations. The Research Working Group, as we understand
it, is concerned primarily with medical research and research,
scientific research.
Mr. Shays. Is it your testimony that you don't do 90
percent of the research projects?
General Vesser. Ninety percent of the research projects?
Mr. Shays. Of the $121 million, how much are you spending?
General Vesser. OSAGWI isn't spending any of that, sir.
That money is in a separate account.
Mr. Shays. You're in charge of coordinating DOD's effort,
correct?
General Vesser. Dr. Rostker is in charge of coordinating
DOD's efforts, but they do not extend, as I said in my prepared
statement, to the conduct of medical research, the research
that the Research Working Group is responsible for.
Mr. Shays. I just want to pursue that. You work as the
Deputy to the Special Assistant for Gulf War Illnesses; your
office does this?
General Vesser. That's my office, yes, sir.
Mr. Shays. Are you telling me that your office makes no
determination on who gets funded and who doesn't get funded?
General Vesser. That's correct. We're not voting members of
the Research Working Group in terms of funding these $121
million of projects you've heard about. We're concerned with
modeling to find out what soldiers who served in the Gulf might
have been exposed to in terms of low levels of chemicals,
funding the experiments at Dugway, funding the chemical rocket
warheads that had to be made, trying to define the hazards that
people----
Mr. Shays. How much money do you spend on research and
studies?
General Vesser. Research per se? I don't have the figure
right in front of me, but I'll provide an answer for the
record, sir.
Mr. Shays. Give me an idea.
General Vesser. I'd say all together, thus far, on the
subjects we're talking about, we've probably spent something on
the order of $10 to $13 million, including the travel for
people to come in and help us determine where our soldiers
were, on declassification of----
Mr. Shays. Let me say this to you. I'm going to say this to
each and every one of you.
Every accusation that the GAO made about the working group
or your participation in the working group stands as fact
unless you refute it--stands as fact. Now, one of the
statements they said was, first, DOD, VA, and HHS spent over
$121 million in research investigation in fiscal 1997 and 1998.
DOD's efforts account for 90 percent of the total.
Now, you are my representative of DOD. Dr. Foster and Dr.
Vesser, do you guys coordinate? I mean, who is in charge here?
Dr. Foster. The research account that I have oversight for
is the investments coordinated through the Research Working
Group, and we actively solicit as part of the research strategy
the input from the VA and Health and Human Services and from
OSAGWI, and the actual investment is tailored to their advice.
Mr. Shays. Does that constitute 90 percent of the funding?
Dr. Foster. No.
Mr. Shays. You were here. You heard this statement. If this
statement is inaccurate, tell me it's inaccurate.
General Vesser. I believe that statement is inaccurate, Mr.
Chairman, because it includes all the money that we spent on
investigations, on other types of scientific efforts that are
not medical research that comes under the Research Working
Group.
Mr. Shays. I'm sorry, I'm going to have to hold you over.
I'll go vote and I'll come back. I thought I could get us done.
I'm sorry. We'll stand in recess.
Why don't we do this? Why don't you--I'll be back here in
20 minutes.
[Recess.]
Mr. Shays. I'd like to call the hearing to order. When I
was gone, I was just trying to think what my frustration is,
and I don't like to use that word often. One of the things I
realize is that I can be up here in the chair, and I can yell
at witnesses and I have tried not to do that. I have tried not
to do that for the many years I've been chairman. I've tried to
realize that I have a special advantage up here, and I can just
throw stones and I don't have to answer.
But it does strike me as not unreasonable that if you had
the GAO that basically tore apart the working group and each of
you had your own statements that somehow are self-contained,
that there would be some recognition that it deserves to be
responded to. And so I do think it's fair to say that GAO tore
apart the working group, and now I think the working group
needs to respond. And I began to realize that I think for
instance, Dr. Feussner, you're speaking from the perspective of
the VA; and you're speaking, Dr. Mazzuchi, from the DOD's
perspective; and Dr. Foster from DOD's perspective; and General
Vesser's from DOD's perspective; and Dr. Barrett from HHS's
perspective. But you're part of a working team that just got
clobbered this morning, and I want, before we end, to know
where you agree or disagree. And, for instance, in the document
that they provided, they share with us the fact that you had
certain objectives and you haven't responded to any of them
that told us where you are on them.
So I want to know, Dr. Feussner--I'm going to go right down
the list--I want to know where you agree and disagree with GAO.
Dr. Feussner. Sir, I haven't seen the final GAO report, but
I have seen the GAO report that they shared with our group 6
months ago, and VA did respond to the criticisms of the GAO.
One of the criticisms----
Mr. Shays. Let me back up a second, Doctor. You were here
this morning. You did hear what they said today.
Dr. Feussner. That is correct.
Mr. Shays. OK.
Dr. Feussner. My full statement does refer to comments that
the GAO made earlier.
Let me say we did concur with the GAO criticism that we
have not summarized perhaps optimally the status of the
research that has been going on in the Research Working Group
on the one hand. On the other hand, GAO has noticed correctly
that most of the research is ongoing and not complete. And it's
really been only recently that a series of research products
have become available.
One of the reasons for not synthesizing comments about the
original working plan is that the research results are just now
becoming available. We have given updates in the annual report
to Congress, that says what has gone on recently; and we have
concurred with the GAO recommendation that we develop this
synthesis during the course of this fiscal year, and we will do
that.
Now, several of the activities that are going on in the
research arena have had, I think, important results, and
several of those important results I alluded to in my
testimony. Unlike the GAO, I think that the epidemiological
research has been quite important and quite beneficial. It sets
the context for Gulf war veterans' illnesses. It shows
preliminary information about mortality, birth defects. It
shows preliminary information about health status, and that's
very valuable information.
When the GAO criticizes us for saying that the research
work needs--that we need to continue the work, they don't seem
to appreciate that many of these exposures have long latencies,
so that while I can say today that the mortality study has
shown no increase in disease-specific mortality, that's not a
completed statement. That's--that mortality observation needs
to be made for 5, 10, 15 more years.
Similarly, with depleted uranium, we can say that for
patients known to have embedded DU shrapnel, that they are
mobilizing radioactive urine--excuse me, sir, radioactive
uranium. They are excreting it in their urine. At this point in
time, it has caused no ill effects on the kidneys and it has
caused no other ill health effects, but it's too early to say
that the depleted uranium is harmless. We need to keep those
patients under surveillance.
The situation with the oil well fires and the measures of
the hydrocarbon, potential hydrocarbon toxicity is very
helpful. The National Cancer Institute study, a small study of
soldiers from Germany to the Gulf, immediately after the war
back to Germany, showing more toxicity while in Germany than in
theater--a very useful observation.
The pyridostigmine bromide, we were concerned 2 years ago
about penetration of the blood brain barrier. GAO might say
that we are duplicating this research. We are not duplicating
this research; we are replicating the research.
I can't tell Congressman Sanders if the result from Dr.
Haley is a breakthrough. It could be. But if two, three other
investigators make the same observation, if this looks like
it's a reproducible observation, then it could be a
breakthrough. So I feel like, in many areas we've made
substantial progress.
In the infectious disease area, this research plan that we
put together is organized by exposures, yes, but it's also
organized by research strategies; and it provides guidance, but
it also provides flexibility. We, in essence, have diminished
the research commitment to infectious disease research because
it seemed to be going nowhere beyond the issue of
leishmaniasis. Well, we have changed that with the business
being raised about mycoplasma, with a question that chronic
antibiotic therapy might be able to affect that. We revisited
that issue.
So in my sense, we have difficulty because the research
portfolio is complex. It's not just one virus causing one
illness. There's a long latency with many of these exposures
and the spectrum of research goes from animal research, basic
research, to population-based epidemiology to patient-based
treatment trials.
Now, we've talked with GAO about that and we are working
now. I think the criticism about the synthesis is fair with the
caveat that much of the work is just now being finished, so we
actually now have some things to synthesize. We will produce
that this fiscal year, no later than September 30.
The other responses with regards to the coordination, I do
disagree with and we disagreed for the record. All of these
groups are represented on the Research Working Group. We
discuss the research products; we discuss new research
directions.
Mr. Shays. In DOD, we have three people from DOD. Who on
DOD is on that board? So both of you serve?
General Vesser. We have an observer.
Dr. Feussner. Dr. Kilpatrick was on the board as an
observer.
Mr. Shays. How does it work? Is it one from VA, one from
HHS and four or five from DOD? How does it work?
Dr. Feussner. No. There are several from DOD. There are
three from VA. There are representation from EPA and ATSD, the
toxic substances and disease registry. There is NIH, the
Secretary's office, CDC. So there are multiple representatives
on the Research Working Group from each of the departments.
Mr. Shays. Before I'm concluded, I have to have a better
comfort level of the coordination between OSAGWI and the
working group, because I really feel that OSAGWI is basically
kind of outside in a tremendous capacity to dominate and just
do some on their own. But that's my feeling and your response
is helpful. Thank you.
Dr. Barrett, I would like to know where you agree and
disagree with the GAO findings.
Dr. Barrett. I think the criticism that we haven't provided
any information that addresses the objectives is unfair
criticism. I think there is--there's been numerous publications
that have addressed many of the objectives. It may not--like
Dr. Feussner has said, it's not synthesized in such a way that
it's--specifically states objective one and ``this is what we
found,'' but certainly an example is the objective regarding
prevalence of symptoms and understanding the conditions.
Now, there is a criticism that we should be beyond that.
Well, we do have current projects that are trying to move us
beyond that. The New Jersey study is looking at the issue of
stability of symptoms over time, how have the veterans' health
conditions changed over time? The Boston study is trying to
look at the issue of brain functioning and how brain function
relates to this complex of symptoms.
Mr. Sanders. May I interrupt for 1 brief second, Mr.
Chairman.
What I'm hearing from both Dr. Feussner and Dr. Barrett is
interesting, but it is missing one point and that is one word
called ``treatment.'' What you're working for is to help close
to 100,000 people who are ill. It is interesting and it is
important to know prevalence, et cetera, but if there is
somebody over there who tells you that they have short-term
memory loss or blinding headaches, what are we doing?
Now, I know--I would hope that Dr. Feussner would say that
if the clinical trial with doxycycline goes well, you may in
fact have a treatment for some of the symptoms. That is good
news.
Tell me one other example where you're ready to have a
treatment, based on $121 million of research. Do I hear any
other?
Dr. Feussner. The EBT trial.
Mr. Sanders. But that's more disease management in
fairness.
General Vesser. I think, sir, that it's useful to talk
about outreach, which is one of our activities. The nearly 30
town halls we have conducted, we bring together representatives
of the VA, of the military hospital or treatment facility in
the area so that they can answer veterans' questions directly
in terms of referring veterans who have had difficulty getting
treatment. Now, that's not funded, as I said earlier, through
research funding, but rather through O&M funding.
Mr. Sanders. General, we can refer people all we want, but
if there is no treatment, there are rather limits in terms of
what we're referring.
Now, it's not complicated. If Dr. Feussner's clinical trial
is successful, as I understand it, we will have a treatment for
some veterans. That is good influences. What I'm asking you is,
what other treatments are you developing right now? All the
research you're doing is important, it's good, but it's not
going to help make one veteran better tomorrow; and that's what
they want and that's what our job is.
Mr. Shays. We're going on two tracks here, so I'm going to
suspend that. I'm going to suspend the answer to that question
and you'll have time to think about how you further want to
answer it but I just want to be clear as to, in your mind,
where you agree with GAO and where you disagree. And I'm
getting a better sense of it.
Dr. Barrett, had you concluded your response?
Dr. Barrett. I think regarding the question about whether
we have information of how veterans are currently faring, I
think again there is research going on in that area. Again, the
projects are starting to get to the end of their funding
period, so hopefully some results will be coming out soon on
that regard; but again, this research takes time.
Mr. Shays. Now, among DOD, first let me be clear as to your
office, General Vesser. My view is that you are basically--your
office was established to coordinate DOD's effort in dealing
with Gulf war illnesses. If I'm incorrect, which I could be, I
want it explained to me.
Is that accurate or not?
General Vesser. We are the single point of contact for the
Department for Gulf war issues, sir, but in effect, as I said
in my opening statement, the tasking order that came from the
then-Deputy Secretary of Defense John White gave us that
authority in all areas except medical programs, and that was
seen at the time to include programs for medical research which
lies specifically with health affairs and with the, as I
indicated in my opening statement, with Mr. Foster's office or
Dr. Foster's office.
I would go on to note that our person on their board who
coordinates has made available the results of all our
investigations as they became available and kept the Research
Working Group apprised of the areas that we were working in,
but we are not voting members on the Research Working Group, so
consequently we have no direct say in the award of the
contracts for medical research.
Mr. Shays. But DOD has votes in there?
General Vesser. Dr. Foster and Dr. Mazzuchi.
Mr. Shays. But you basically oversee their activities. Is
that not true?
General Vesser. We do not oversee that activity because
that activity is overseen by the Assistant Secretary of Defense
for Health Affairs, according to the tasking division that was
made by the Deputy Secretary of Defense.
Mr. Shays. I have no vested interest one way or the other
on whether what the GAO says is accurate or inaccurate. I'm not
trying to prove they're accurate. I just want to know whether
they are accurate or not. I want to know if this statement is
accurate.
First, DOD, VA, and HHS spent over $121 million in research
and investigation in fiscal year 1997 and 1998. DOD's efforts
account for 90 percent of the total. That's the statement that
Mr. Chan made. Over half was spent by DOD's Office of the
Special Assistant for Gulf War Illnesses, which I will refer to
as OSAGWI, which is your office.
Now, is that accurate?
General Vesser. That statement is accurate, but it
overlooks the fact that there are two different kinds of money.
One is R&D money and second is operations and maintenance
money.
When OSAGWI was established, initially we received $4
million from Health Affairs in O&M money. Subsequently all our
funding has been from Defense-wide O&M. We pointed this out to
the GAO in additional Department of Defense comments when we
commented on their draft report. This is a distinction that
they do not recognize evidently.
Mr. Shays. Now, in that report, on page 15, it says
OSAGWI's activities have not been effectively coordinated with
those of the Research Working Group in order to maximize the
efficient use of resources. We found conflicting information
about the nature of OSAGWI's work and whether it should be
coordinated; specifically, the Research Working Group and
OSAGWI's officials told us that OSAGWI's activities involve
investigation, not research, and therefore are not subject to
coordination. Is that something that basically I should leave
on the table? Is that what you're telling me?
General Vesser. I'm telling you, sir, that we have done
very little medical research other than the people we have
responded to veterans thinking they had things that might
provide some insight into what was making them ill, that our
work has primarily been investigations.
Mr. Shays. How much money have you spent on investigations?
General Vesser. Investigations and scientific work done
associated with that, the creation of meteorological models,
the use of diffusion models, bringing people together for
conferences to find out where our troops were located. Those
are the kinds of things we've been doing, sir.
Mr. Shays. Those are very important things to do, General.
I am just trying to assess if that is part of the $121 million
or not.
General Vesser. That is part of the $121 million that
they're reporting to you, yes.
Mr. Shays. And it is your view that all of that effort does
not have to go before the Research Working Group?
General Vesser. That is correct, because it is a different
science. It is focused on trying to understand and make sense
of what happened on the battlefield.
Mr. Shays. I'm going to release the floor in just a second,
but Mr. Chan's No. 2 point that he wanted to make was, most
research is ongoing in mid-1999. Of the 151 research projects
funded by the Federal Government, 30 percent have been
completed while OSAGWI had received 19 of the 21 reports due
from its contractors. It had publicly released only six of
them. Of these reports, 14 had remained in draft or review
status for a year or longer.
Now I want to know, are those investigative reports or
research reports?
General Vesser. I believe that some of them are
investigative reports and some are research reports. The
Presidential Advisory Committee told us to use risk
communication in communicating with veterans. This is how one
communicates bad news essentially without frightening the
individual who is receiving that news.
All of the work we do goes through a risk communication
specialist to make certain that it has been looked at from that
perspective. In addition, we often receive reports from
contractors which are currently undergoing thorough scientific
review, and we get a draft; and until the thorough scientific
review by other like experts is complete, there's no way that
those reports can be released.
In addition, we----
Mr. Shays. Why not?
General Vesser. Because they may lack credibility, take our
first report on the Khamisiyah plume. We were told by the
Congress we had to have that work peer reviewed by the Senate
investigation unit, because they felt that it was not properly
peer reviewed. We're refining that work now and when the work
is refined, it will have been peer reviewed and those things
take time, sir.
Mr. Shays. General, you just touched a real sensitive
chord. We had a witness years ago who was going to come in on a
Tuesday to point out that the DOD had not been telling the
truth that our troops had been exposed to defensive chemicals
in Khamisiyah. We had this individual with his video and at 12
noon on Friday before our Tuesday hearing, DOD announces at 4
p.m. they will have a press conference in which they announce
that our troops were exposed. And that's why you just touched a
real sensitive chord.
So when you talk about how you want to deal with Khamisiyah
and everything else, you lost me.
General Vesser. I'm sorry I wasn't in the business then,
sir, but I wouldn't have done that. I think that's not the way
to behave.
Mr. Shays. Thank you for saying that.
I will just conclude by asking you this. Of these 14
reports that are in draft or review status for over a year, how
many of them relate to your investigative and how many relate
to the medical research side?
Dr. Foster, can you answer that?
Dr. Foster. If the 14 reports were commissioned by OSAGWI,
then none of them would be medical research.
Mr. Shays. So these are all relating to the investigative
side?
General Vesser. We'd have to get you an answer for the
record by identifying the reports that the GAO has identified
and giving you their exact status, sir.
Mr. Shays. Thank you, General. Dr. Foster, I'm going to
give you an opportunity to then clarify the issue of these
reports. Are all the medical research investigations, all
medical research, that goes through your office?
Dr. Foster. Medical research funded by the Defense research
appropriation go through my office, yes. If there are clinical
studies done in the health care side of the House, that is
managed and monitored by the Assistant Secretary for Health
Affairs.
Mr. Shays. Which is not OSAGWI?
Dr. Foster. Not OSAGWI, no. So the medical community is
together through the ASBREM Committee but they would fund
clinical type investigations with operations and maintenance
money. I fund primary research science from the research
appropriation, and the appropriations that we received specific
to Gulf war illness are summarized on page 4 and those are
the--those, up through 1998, are----
Mr. Shays. Four of----
Dr. Foster. Of my written testimony. Those are research and
development test evaluation funds that we oversee.
Now, all those were special appropriations. They weren't
part of the President's budget request. So they were added to
the research account in those fiscal years.
Mr. Shays. If I were you, Dr. Mazzuchi, or even General
Vesser, I think my response to--if I'm hearing you correctly,
and I want you to correct me if I'm stating it incorrectly, I
would say that GAO is crazy if they are implying that these 14
studies referred to anything dealing with the working effort of
this Research Working Group; that all the medical research we
have disclosed, we are not waiting for draft review status,
that is, something dealing with investigations of OSAGWI which
are not being or should be--I won't say ``should be,'' but are
not coordinated.
Is that--are not part of the research effort. Is that
accurate or not accurate?
Dr. Foster. That is correct, and I would say if you ask the
question coming down the line, that I feel that the GAO has
just basically confused the issue in the title of the report
having to do with research because we have mixed together
research and what is normally termed ``general medical
operations'' into one lump, and it's very difficult for you all
to separate the two in your minds.
Mr. Shays. What stands is all of your comments that their
recommendation that we need a better assessment of where we're
at, and that will be done this year, will be done?
Dr. Feussner. Yes, sir, this fiscal year.
Mr. Shays. Fiscal year by the end of September?
Dr. Feussner. Yes, sir.
Mr. Shays. Thank you.
Dr. Foster. If I could leap in for one other thing, I would
say the other area that I have a disagreement with the GAO is
their assertion that the epidemiology studies are not useful.
They're absolutely essential to the scientific community.
We have to understand what the medical conditions are out
there so we can formulate hypotheses to be tested. And they
were going down an argument line that the investment by the VA
and by the health care part of DOD was not very helpful to us,
and I fundamentally disagree; and that's why the Research
Working Group is so important because you have the medical
practitioners, basic scientists and other folks, including the
studies folks from OSAGWI, working together to try to define
the set of problems so that we can bring to bear research
clinical studies, and health care type of approaches to helping
the veterans, in order to understand the fundamental
phenomynology.
And it's a good team. I've only been together with this
1\1/2\ years, and coming from the outside of into it, I
thought, great, this is really going to help me in overseeing
the medical research account and the investment strategies that
will develop. I can't imagine another venue since these folks
see the patients that I could imagine that would allow me the
insight to help focus the research.
Dr. Mazzuchi. If I might followup on that, one of the
pieces I mentioned in my oral testimony, as well as my written
testimony, was the Millennium Cohort Study. I think that is a
very pivotal piece for the Department.
One of the issues that has occurred over and over--and we
agree with the committee--is, it's very difficult to assess
someone's health status or to understand what happened to a
person in a deployment if you don't have good baseline data and
if you don't follow them. What we do not know and what we are--
this cohort study which we believe will give us the
information--going to do is to follow a cohort of both deployed
and nondeployed military personnel and then to follow people
who come into the military in 2001 and follow their health
status noting their different deployments because one of the
issues that epidemiologic research has shown us is that while
there seems to be no new disease entity, clearly people who
have gone to the Persian Gulf have suffered conditions and
symptoms and diseases at different rates. What we need to know
is, is it deployment itself or a combination of deployments or
multiple deployments that adds to that? We don't have the
answer to that.
The epidemiologic research that is being funded and very
well coordinated with the Research Working Group, I think it
seems will be able to give us those answers.
In addition, I think one of the major lessons learned from
the health community from the Persian Gulf experience is that
we need not only to get baseline data, but we need to follow
groups over time and then we need to find if there are
interventions that work. As Mr. Sanders has said, we need to
apply them.
We are working very hard with the VA to develop a practice
guideline which will help our primary care providers both
diagnose and recognize early symptoms of--I'll lump them into
chronic fatigue syndrome-type symptoms so that treatments can
be effected earlier, which ought to mitigate against chronicity
of chronic disease symptoms. All of these things flow from the
epidemiologic research.
The other thing I want to say is, I agree with Dr. Foster.
I believe that the General Accounting Office confused--because
they used the word ``research'' in a broad sense, confused the
effort I believe, and I've been with the Department for almost
30 years, that the research effort under Dr. Feussner's
guidance has been unbelievably well coordinated and well
thought through.
There are other efforts that are complementary, not
contradictory to these that are being led by the OSAGWI group
to look at veterans' complaints to find out what actually did
happen on the battlefield. You could certainly call that
research, but when we speak of research, we're talking about
R&D dollars, research and development dollars, that are used in
the scientific process for medical research. I think that's
where some of the confusion has come in. That's why you have
two very different stories from our group versus the GAO group,
because we're talking more narrowly.
Mr. Shays. Can I--just for the record, I am getting a
little uneasy. Some of the RAND studies were medical studies;
they weren't investigative studies.
General Vesser. All of our studies were reviews of medical
literature in the sense that although--in some sense they could
be characterized as medical. They were an effort to inform the
veterans. The Presidential Advisory Committee had about one
paragraph on a number of topics.
Mr. Shays. But the problem is that some of these are not
even out. So if the effort is to inform the veterans, they are
not even out.
General Vesser. Five of the eight that we have commissioned
from RAND are out. And the others are slow. The reason some of
these are slow--and I didn't go into that--is that some of the
authors are very elderly and one is fighting cancer. This has
slowed down release of some of the reports.
In addition, some of the authors are doing more than a
single report. So they are switching from one report to
another, but essentially what they are doing is compiling
medical literature so that veterans have an idea what it is
that the medical community says about stress or PB or oil well
fires or depleted uranium; so there are facts that are
available.
Mr. Shays. Let me just say that just introduces a whole new
level of discomfort that I have because you have responded that
some of these are medical. Their purposes are to inform our
soldiers, but it would strike me that they would be coordinated
with this working group. I am just going to share with you I
have some real discomfort.
In other words, in my judgment there is enough truth to the
GAO's concern, and maybe technically I can agree with you that
one is medical research and one is slightly different. They do
come perilously close and do seem to invite that there would be
some coordination.
We could go on longer. I am going to suspend my time with
you to get to the third panel. I will concur with you and
recognize you, Mr. Sanders. You may have as much time as you
want.
General Vesser. May I make one comment.
You asked what we disagreed with in the GAO report.
We in OSAGWI do not feel that the GAO has demonstrated that
our contract awards were in fact improper. We have made every
effort to comply with the law, to use the system that is
established, and contracting officers award contracts, not the
sponsoring office.
On the other hand, the GAO points out we have the
responsibility in their comments on the material we submitted
to them for determining its requirements for support, a process
that in one instance resulted in naming a preferred contractor
and in another led to an overly broad statement of work. I
would say that the guidance on this systemic process says that
the contracting officer will review your requirements package
for scope, accuracy, and completeness. Corrections and/or
clarifications may be required.
So we did everything we could at the time. I would also
note that with respect to the preferred contractor, we had a
little bit of difficulty figuring that out because the
contractor that they cited had four task orders, tasks to be
performed. We believe that they are referring to the
requirement that we get a risk communication service provided.
That contract was posted. We had one inquiry. Others couldn't
provide the expertise. There was only one contractor who could
provide the expertise.
Last, I would say that we are sensitive to the GAO
recommendations that we use a different contract vehicle for
the BDM-TRW task. Consequently, we are currently working with
Defense Supply Services and BDM-TRW on the creation of a
blanket purchase agreement that will combine several GAO
schedules to provide the services that we currently obtained
through the MOBIS vehicle which they are critical of.
By creating this blanket purchase agreement, we are
attempting to comply with the provisions of the audit while
still continuing to fulfill our mandate to seek out potential
sources of the illnesses being experienced by our veterans
without interruption. We have also met with OSD space
management personnel to discuss bringing our current lease
space under a GSA lease to better meet the concerns of the GSA
contract managers.
Mr. Shays. The bottom line is that the contract method is
wrong, but you are going to change it in the future?
General Vesser. We have tried to work within the system. We
have tried to point the GAO when they raised the issue with us
toward those parts of the system. We are not contract
specialists. We don't know the philosophy of differences in
contracting approach, but we are for competition and for
getting the best price on the work that is done.
Mr. Shays. Let me tell you where I think we are at, and
then I am going to recognize Mr. Sanders.
I am going to leave with the confidence that you all are
going to be making a heroic effort to assess where we are at
and do it before the end of the budget year, and we can have
another hearing and know where you are at.
I am going to share with you that I am uneasy with the
outside investigative effort of OSAGWI's efforts and say to you
that as we got more into it, I felt that there could be better
coordination and sharing even though it is outside your
technical definition of medical research; and I would also say
to you that I think after 9 years we have got to get to some
kind of treatment and that has ultimately got to be our goal,
that we want to properly diagnose and effectively treat and
fairly compensate. And so Mr. Sanders' ultimate goal to
treatment, I think, stares us in the face. With that, Mr.
Sanders, you have the floor.
Mr. Sanders. Thank you. I will be brief. You have been very
generous in allocating time.
I think it is very important as General Vesser said that we
adequately inform veterans and keep them abreast what is
happening. I think understanding what happened on the
battlefield is absolutely important. I happen to believe very
strongly in epidemiologic research and the National Cancer
Registry Act, which is one of the important epidemiological
tools being used by cancer researchers. No argument.
But after all is said and done, as the chairman just
indicated, what 100,000 veterans want to know is how are they
going to get better? That is what they want to know.
And in that respect, in all honesty I must say that given
the fact that we have spent $120 million so far, we have done a
rather poor job.
It seems to me, and let me--and Dr. Feussner, jump in if
you think I am wrong. Where we are right now, I hope within a
year we will know whether or not the use of doxycycline can
treat some symptoms. We will know that and if it turns out
positive, we will have a treatment; is that correct?
Dr. Feussner. Approximately a year, yes, sir.
Mr. Sanders. What I think--and I don't think that the U.S.
Congress should be micromanaging, but I think we should be
saying right now within another year we want five different
treatments from you. We want treatments. That is what the
veterans want.
Now, you have breakthroughs that are going on. I don't know
what this squalene means, I don't know what you can learn from
it, but I want you to translate that research into a treatment.
I don't know what Haley's brain scan implications are, but
if it can be translated into a treatment, do it.
Multiple chemical sensitivity, we know that there are
treatments out there. Start testing it. It is beyond
comprehension that after 9 years we have not developed one
treatment through the VA to treat those people who may have
been made ill as a result of exposure to chemicals.
I don't know the possibility. You are studying
pyridostigmine bromide. That is very important, and I know that
relates to a treatment. Why don't we start. I think that I
speak for veterans who say look, we recognize you don't have
the magic bullet. But try to do something. If it fails, I will
support you in saying we tried it. It failed; do something.
So I would hope, and we will be working together, Dr.
Feussner, you will be hearing from me. I want treatments. That
is what I want. I think I speak for the veterans' community in
stating that.
Mr. Shays. We are going to get to our next panel, but I am
very willing to have any of you make a closing statement.
Dr. Feussner. If I may, sir, I would just like to agree
with Congressman Sanders. As I think he knows, we are quite
interested in identifying treatments that are likely to benefit
patients.
The only caveat, the squalene story is not associated with
a treatment option at this point, but we will keep an eye on
it.
The observation of the brain is not associated with a
treatment option yet; but again we will be attentive to that,
just like there are efforts to treat other brain diseases,
Alzheimer's, et cetera. We will be very attentive to that. I
think that the only caveat that the Congressman agrees with,
the treatment trials involve human studies and the human
studies are justly due the dual protections under the common
rule of scientific review and informed consent. That is the
only caveat. I know that Congressman Sanders concurs with that.
Mr. Shays. Thank you all very much. We appreciate your
patience.
We will conclude with our third panel comprised of Dr. Iris
Bell, associate professor, Program in Integrative Medicine,
University of Arizona College of Medicine; Dr. Claudia Miller,
assistant professor, Environmental & Occupational Medicine,
University of Texas Health Science Center; and Dr. Mohamed
Abou-Donia, professor, Department of Pharmacology and Cancer
Biology, Duke University Medical Center; and Howard Urnovitz,
scientific director, Chronic Illness Foundation. If you will
remain standing, I will swear you in.
[Witnesses sworn.]
Mr. Shays. We have three witnesses, Dr. Bell, Dr. Miller
and Dr. Urnovitz. I really appreciate your patience. It is
toward the end of the day rather than the beginning of the day;
but your testimony is very important, and we are grateful that
you are here.
Dr. Bell, we will start with you.
STATEMENT OF IRIS BELL, M.D., PH.D., ASSOCIATE PROFESSOR,
PROGRAM IN INTEGRATIVE MEDICINE, UNIVERSITY OF ARIZONA COLLEGE
OF MEDICINE; CLAUDIA MILLER, M.D., M.S., ASSISTANT PROFESSOR,
ENVIRONMENTAL AND OCCUPATIONAL MEDICINE, UNIVERSITY OF TEXAS
HEALTH SCIENCE CENTER; HOWARD URNOVITZ, PH.D., SCIENTIFIC
DIRECTOR, CHRONIC ILLNESS RESEARCH FOUNDATION
Dr. Bell. Thank you, Mr. Chairman. I am speaking today as
both a VA-funded researcher and as an independent researcher in
the sense that I have funding from the VA; but at this point I
am speaking primarily as an individual researcher who has been
involved in multiple chemical sensitivity research for many,
many years.
As the GAO report noted, the data from several studies in
Gulf veterans with unexplained illness really converges on the
likelihood that a large number of these individuals may have
conditions that fall in the broad spectrum of chronic fatigue
syndrome, fibromyalgia and chemical sensitivity.
However, in addition to that, from the data available,
there appear to be a number of Gulf veterans who are suffering
from something that falls along a continuum that may not reach
a level of case definition criteria from an epidemiologic point
of view. This creates methologic issues in terms of identifying
people who are sick versus not sick but certainly does not
eliminate the high likelihood that a number of people have this
problem to a degree.
The trouble is that when a problem is so clinical in nature
or is polysymptomatic, as in these conditions, generally
conventional medicine has very little to offer for these
difficulties. Most of these in fact are not specifically
associated in a clear linked way with the toxicity with
specific toxins in the environment, which again has made it
difficult in terms of prior research to identify specific
causes.
Unfortunately, assuming even if the medical profession were
to accept the validity of these polysymptomatic conditions,
which they at this point frequently do not, conventional
psychiatry in medicine has very few tools to treat them.
Typically, medicine labels these individuals as having some
form of, ``somatoform disorder,'' which is basically a
nonetiological label for having multiple symptoms in multiple
systems with no known treatment and no other known diagnosis
that can be identified.
This has led, I believe, to the unusual emphasis on stress
research specifically within the Gulf war work, but this has
indicated also that there may be more things to examine. Many
Gulf veterans with these problems, such as chronic fatigue and
chemical sensitivity, do have psychiatric issues as
comorbidities. A definitely large number of them have no
psychiatric problems; and yet in this area, the area of
psychiatry has been emphasized to the exclusion of other
possible mechanisms.
In the civilian population, a large proportion of affected
individuals have given up on what conventional medicine may
have to offer and have chosen to resort to various forms of
what is called complementary and alternative medicine. The
field of environmental medicine within which multiple chemical
sensitivity does fall within the definition of the National
Center for Complementary and Alternative Medicine at NIH is an
area that could be researched but in general has not been at
this point. However, because of the controversy around both the
illnesses and the treatments, there are significant
difficulties in people having addressed these issues up to this
point.
My recommendation is that we take a patient-centered rather
than a disease-centered approach to treatment research. That
involves, as Congressman Sanders indicated, focusing on what
the veterans are telling us they have tried and what they think
helps them. That is a very pragmatic approach, but it appears
to be time to do so; and it is quite possible that at this
point this would be quite an appropriate time to pursue
aggressive research on chemical sensitivity and related
syndromes.
In my own research I have been looking at patient-centered
mechanisms that have not been as specifically focused on
specific toxins as on vulnerable individuals. In our own work
in a very small but random sample at the Tucson VA, we found
that 86 percent of ill Gulf veterans versus 30 percent of
healthy Gulf veterans and 30 percent of healthy area veterans
were reporting that they considered themselves especially
sensitive to certain chemicals.
We have used this screening question in literally thousands
of civilians, and we get a rate in answer to this particular
screening question of about 30 percent in the general
population. And so indeed we see it in veterans who were not in
the Gulf, but we see it in a much higher rate by self-report in
the ill Gulf war veterans.
At this point from the standpoint of looking at this issue,
the Gulf veterans also reported without attributing particular
cause that they had multiple chemical exposures, including oil
well spills, pesticides, diesel fuel, et cetera, that they had
these exposures at higher rates than the people who were
healthy.
They particularly focused in this situation on insect
repellants and pesticides. Conventional toxicology has no easy
explanation for a diversity of eliciting factors, or for this
enhanced low dose reactivity at this point. They are pursuing
certain avenues, but this has not been overly fruitful to date.
The field of pharmacology does offer a phenomenon which has
been studied extensively for other purposes and can accommodate
this diversity and enhanced reactivity. It is called
neurosensitization.
Sensitization is a progressive amplification of response in
the host to repeated intermittent exposures to an initiating
stimulus. It is not seen when the exposure is continuous, which
is a model frequently used in toxicology research. Once the
sensitization is initiated, reexposures to the same or other
cross-sensitizing stimuli can elicit a heightened response.
This amplification process probably reflects changes in
cell functioning rather than structure and does not necessarily
require the immune system, although it can be affected by a
similar process. Our own research in this area in civilians has
shown that, even though these people are psychologically
distressed, they differ in their brain wave status even at
baseline from individuals who are depressed but do not have
chemical sensitivity by self-report and from normal people.
We have found also that when tested over repeated sessions
with extremely low level exposures, persons with chemical
intolerance exhibit sensitization to whatever they are exposed
to in the session, in brain waves, heart rate and their blood
pressure. These effects are not seen in controls of various
types.
We have found also evidence for individual difference
susceptibility factors in civilians that parallel those in
sensitizable animals who have been studied the most in these
areas. These factors of vulnerability include being female,
having certain genetic characteristics. In our human research
this has been converging on information that they may have
family histories of substance abuse even though they themselves
cannot tolerate alcohol. We also see spontaneous preference for
sucrose, both in animals who are more sensitizable and in the
civilians who are reporting this problem, and a baseline
hyperreactivity to novel environments.
This kind of work has been pursued in animals and there are
animal models demonstrating sensitization to chemicals. And
this work is still ongoing, but to my knowledge it has not been
directly pursued in terms of Gulf war. Our sense is that
sensitization and cross-sensitization could help account for
the fact that some veterans have different exposure histories
and stress histories during military service, but they end up
with similar polysymptomatic conditions.
The mechanism could allow us to explain that multiple
interventions could in fact be helpful, coming at this problem
from different directions because by removing any eliciting
stimulus of any class, be it chemical, stress or otherwise, we
might reduce the frequency and severity of the currently
sensitized symptoms, but this would not necessarily prove a
role for any specific etiologic factor.
In our VA funded study, we are testing the possibility that
the chronically ill Gulf veterans are persons who are at least
now more sensitizable than our healthy veterans. We are using
extremely low levels of exposure that are not detectable by
smell.
In our preliminary analyses of our initial data set, we
have found some evidence for sensitization looking at the
heartbeat itself during repeated sessions over a period of
weeks. These individuals have been receiving, in order to do
the sensitization, undetectable levels of jet fuel JP8 versus
clean compressed air. We have much further research to do and
many other analyses to do before we can say with certainty that
this finding will be validated; but we are very encouraged that
it has been there from the start of our work when we began to
look at our interim analyses.
In conclusion, the phenomenon of sensitization is well
documented in basic neuroscience research. It depends on time-
related changes in functioning, not structure of nerve cells in
response to repeated intermittent stimuli and could help
explain the emergence of problems in veterans after they return
from the Gulf and the difficulty in identifying particular
causes because this phenomenon has both an initiation and an
elicitation phase which can be essentially separated.
The stimuli capable of initiating and eliciting sensitized
responses are diverse in nature, and they range from chemicals
to stress which can cross-sensitize with each other. Some
people do sensitize more readily than others. This mechanism
deserves further evaluation as a possible mechanism by which a
number of Gulf war veterans may have become ill.
Thank you.
Mr. Shays. Thank you, Dr. Bell.
[The prepared statement of Dr. Bell follows:]
[GRAPHIC] [TIFF OMITTED] T7151.055
[GRAPHIC] [TIFF OMITTED] T7151.056
[GRAPHIC] [TIFF OMITTED] T7151.057
[GRAPHIC] [TIFF OMITTED] T7151.058
[GRAPHIC] [TIFF OMITTED] T7151.059
[GRAPHIC] [TIFF OMITTED] T7151.060
[GRAPHIC] [TIFF OMITTED] T7151.061
[GRAPHIC] [TIFF OMITTED] T7151.062
[GRAPHIC] [TIFF OMITTED] T7151.063
Mr. Shays. Dr. Miller.
Dr. Miller. Thank you. There is an old parable: for want of
a nail, the horseshoe was lost; for want of a shoe, the horse
was lost; for want of a horse the rider was lost; then the
battle, the war and finally the kingdom all for the want of a
nail.
This is precisely the situation we find ourselves in today.
For want of a paradigm, our veterans are lost in a sea of
inconclusive reports, redundant studies, expanding budgets and
programs and committees and cries of conspiracy all for want of
a paradigm, something to explain the relationship between the
exposures they experienced during the Gulf war and the
multisystem symptoms that now plague them.
We have veterans seeing different specialists who apply
different monikers to their symptoms. The rheumatologist sees
them and diagnoses myalgias based on diffuse muscle pain; the
neurologist hears head pain and nausea and diagnoses migraine
headaches. The pulmonologist finds airway reactivity and
diagnoses asthma. The psychiatrist seeing chronic malaise
diagnoses depression. The gastroenterologist notes GI
complaints and diagnoses irritable bowel syndrome.
Most ill veterans have symptoms involving several organ
systems simultaneously. For them there is no unifying
diagnosis, no known etiology and no identified disease process.
This is not the first time doctors have found themselves
baffled by wartime disease. 130 years ago during the Civil War,
doctors were faced with a similarly mysterious syndrome
characterized by fever. Hundreds of thousands of soldiers died.
The doctors did what good epidemiologists do today, they
classified the cases. Since the hallmark symptom was fever,
they classified the cases by fever type: remittent,
intermittent, relapsing.
In doing so, they unknowingly lumped together dozens of
unrelated illnesses, everything from typhus and typhoid to
malaria and tuberculosis and other diseases. Who would have
dreamed it at the time, the germ theory of disease. This war
going on between invisible invaders and the body's immune
defenses with the only outward sign being literally the heat of
battle.
Today, we face this same situation with Gulf war veterans;
only this time the hallmark symptom is not as simple as fever.
It's the newly acquired intolerances these veterans have been
experiencing since the war. Like the mechanic who before the
war used to bathe in solvents and now becomes ill after one
whiff of gasoline. Or the young woman soldier who recalls how
she used to be able to drink any man in her company under the
table, but since the war she can't take even one drink without
becoming violently ill. The vast majority of sick veterans
report these newly acquired intolerances which date from their
experiences in the Persian Gulf.
During the past 7 years, I have served as the environmental
medical consultant to the Houston VA's regional referral
center. Approximately 90 percent of the veterans interviewed
described new onset intolerances to everyday chemical exposures
which set off their symptoms; 78 percent were intolerant of
fragrances, tobacco smoke, gasoline vapors and other chemical
inhalants; 78 percent also described food intolerances; 66
percent reported alcohol intolerance; 25 percent were
intolerant of caffeine; and nearly 40 percent reported adverse
reactions to medications--all since the Gulf war. These
intolerances, resulting in flare-ups of symptoms, including
fatigue, headaches, GI problems, mood changes, cognitive
impairment and diffuse musculoskeletal pain are like the fevers
experienced by the Civil War soldiers. They are the outward
manifestation of the underlying disease process.
This is not the first time this illness pattern has
appeared on the medical landscape. Researchers have described
these same new onset intolerances and multisystem symptoms in
demographically diverse groups in more than a dozen countries--
sheep dippers in the United Kingdom exposed to organophosphate
pesticides; radiography workers exposed to x-ray developing
chemicals; including glutaraldehyde in New Zealand and other
countries; aerospace workers on the West Coast of our country
exposed to solvents and plasticizers; and environmental
scientists exposed to indoor air contaminants during remodeling
at the EPA's own headquarters building in Washington, DC, to
name a few.
What ties all these groups together is the common
experience of an initiating toxic exposure followed by newly
acquired intolerances and multisystem symptoms. These
observations provide compelling scientific evidence for a
shared underlying disease mechanism, one involving a
fundamental breakdown in natural tolerance. This two-step
mechanism an initiating toxic exposure followed by newly
acquired intolerances that trigger multisystem symptoms has
been referred to by the acronym TILT, or toxicant-induced loss
of tolerance.
This two-step process is the key to understanding Gulf war
illness. It doesn't matter so much which exposure caused the
breakdown intolerance, whether it is pesticides, smoke from oil
well fires, pyridostigmine bromide or indoor air contaminants.
Those things have long since left these veterans' bodies. It is
the aftermath of those exposures, the new onset intolerances to
low-level chemical exposures which appear to be perpetuating
their symptoms. In some cases, it may be difficult to sort out
what individual intolerances or triggers may be operating
because of a phenomenon called ``masking.'' This occurs when
individuals are reacting to so many different exposures that
they become a confusion of symptoms.
But the confusion clears for both the patient and the
physician when the underlying paradigm is understood, and
questions that could not be answered are now answered.
Like why some veterans became ill and others didn't--
because individuals react differently to toxic exposures and
some have no response at all. Or why researchers have been
unable to isolate a single culprit exposure--because the answer
to the question, what caused the Gulf war illness, is more
likely to be all of the above.
It explains why veterans remain sick almost a decade after
the war, long after their initiating exposures. It explains why
symptoms wax and wane unpredictably--as their daily exposures
are waxing and waning. What can be done to diagnose and treat
the chemically intolerant? There is evidence that removing them
from the exposures that are affecting them now by putting them
in an environmental medical unit will cause their symptoms to
subside. The EMU is designed to help patients avoid common low-
level exposures. Previous experience shows that within days of
entering a facility of this kind, patients will arrive at a
clean baseline and their exposure-related symptoms will
disappear. During the next 2 weeks, each patient is exposed to
potential triggers, such as caffeine, gasoline, perfumes,
various foods, medications, and tobacco smoke, one at a time,
to determine what is setting them off.
Epidemiological data and literature reviews can only go so
far in determining the nature of a new disease process. New
paradigms require new approaches and new tools. EMU studies
will enable doctors to witness this disease mechanism firsthand
and understand Gulf war illness for what it is, while providing
a built-in treatment component--one that enables the veterans
to understand their disease and emerge less confused, less
hopeless, and more in control of their lives.
A validated questionnaire about chemical intolerance is
available in the medical literature, and I have enclosed it in
this testimony, which the VA and military doctors could use as
a first step toward introducing physicians and patients to this
paradigm so they can begin to see it for themselves. If we are
going to help these veterans what is needed is not more
epidemiologic studies and literature reviews, but rather to use
a term that Congressman Sanders has used in the past, a
Manhattan Project-style approach consisting of EMU studies and
other patient-oriented diagnostic and treatment studies.
Mr. Shays. Thank you, Dr. Miller.
[The prepared statement of Dr. Miller follows:]
[GRAPHIC] [TIFF OMITTED] T7151.064
[GRAPHIC] [TIFF OMITTED] T7151.065
[GRAPHIC] [TIFF OMITTED] T7151.066
[GRAPHIC] [TIFF OMITTED] T7151.067
[GRAPHIC] [TIFF OMITTED] T7151.068
[GRAPHIC] [TIFF OMITTED] T7151.069
[GRAPHIC] [TIFF OMITTED] T7151.070
[GRAPHIC] [TIFF OMITTED] T7151.071
[GRAPHIC] [TIFF OMITTED] T7151.072
[GRAPHIC] [TIFF OMITTED] T7151.073
Mr. Shays. Dr. Urnovitz.
Dr. Urnovitz. Thank you. I am grateful to the committee for
allowing me the opportunity to review the GAO report and for
inviting me to present my views and recommendations on research
directions for Persian Gulf war-related illnesses, or Gulf War
Syndrome.
My name is Dr. Howard Urnovitz. I received my doctorate
degree in microbiology and immunology from the University of
Michigan in 1979. My entire CV is submitted with my written
testimony. I currently hold the position of scientific director
of the Chronic Illness Research Foundation as well as my
current position as the chief science officer of a publicly
traded biomedical company.
With respect to my views on government research programs
concerning Gulf War Syndrome, I concur with the GAO report that
many of the research objectives identified by the research
working group of the Persian Gulf veterans coordinating board
have not been reached. Some of the government-funded
epidemiological studies, particularly those of the Centers for
Disease Control and Prevention and the University of Texas
Southwestern have been very meaningful.
Most of the government-funded research conducted thus far
has focused on trying to quantify exposures with little or no
data, identifying single exposure agents as the sole causative
factor, or summarizing the research of others. The
identification of the range of toxic exposures would assist
greatly in determining the array of causative factors
associated with Gulf War Syndrome. Today we are already have a
great deal of information on the potential exposures during the
Gulf war. Unfortunately, since a significant amount of the data
was not collected, we will never know with any degree of
certainty what the extent and combination of the exposures were
in the case of each individual patient.
Further, identification of these exposures alone will not
reveal the disease mechanisms involved in the progression of
these illnesses. Identifying the disease mechanism has been the
focus of our research. I recommend that Congress strongly
encourage the Department of Defense, the department of Veterans
Affairs and the department of Health and Human Services to
fully acknowledge nongovernment-funded published peer-reviewed
independent research to further expand the total information
base on Gulf War Syndrome. I am concerned that we in the
independent research community do not have a structure for free
dialog with government agencies and researchers. To exclude
these contributions to science is not productive.
The GAO report recognizes medical science's conventional
approach to chronic illnesses. The paradigm continues to be a
search for a single causative agent. The weakness in this
conceptual approach is that most chronic diseases are multi-
factorial. The single causative agent approach was formulated
long before science recognized that the human body can sustain
damage at the cellular and molecular level from a variety of
physical, chemical, and biological insults and long before we
determine the vast arrays of hazardous materials to which these
veterans were exposed. Assigning any one entity as the
causative agent will impede any progress in designing medical
control or treatment of a chronic disorder.
I thank the subcommittee for recognizing the contributions
my colleagues and I have made to the Gulf War Syndrome medical
literature. It is my hope that our unique approach to
understanding Gulf war illnesses may serve as a platform for
research into other chronic ailments. My colleagues and I
approach Gulf War Syndrome like most other chronic illnesses by
asking the follow question: What is common among people who
suffer from chronic diseases? For brevity, I will summarize our
research findings published in six peer-reviewed papers in 1999
on four different diseases. One of these papers is attached to
my written testimony.
It would appear that the human body has a mechanism for
confronting toxic exposures. We all know that we are given our
physical characteristics from genetic material, or genes, one
set of genes received from each parent. What we learned by
simultaneously studying Gulf War Syndrome, cancer, AIDS and
multiple sclerosis is that genes have the ability to reshuffle
and create new genes. We reasoned that these new genes are used
to adapt to the toxic environment in which we live. It seems
that there are confounding events that turns this reshuffling
mechanism from a normal protective process to a disease state.
One of the next phases in our research plans is to
determine what events trigger these reshuffled genes to convert
from helpful to harmful. Through a research blood test we
recently developed, we have been able to identify material in
the sera of patients suffering from chronic illnesses that
likely play a critical role both as a marker of the illness and
as a mechanism for the reshuffling.
This discovery of the reshuffling process resulted from the
identification and analysis of a type of nucleic acid, RNA,
found in the serum or plasma of Gulf war veterans. It took us
several years to break the code on just one RNA molecule that
we were able to isolate. It has been our goal to collect RNA
from as many veterans with Gulf War Syndrome and control and
clone, decode and catalog the reshuffled genes with respect to
patient symptomology. This approach should allow us to group
ailments according to the pattern of each gene sequence.
The modern marvel of mapping the normal human genome is
close to completion. We plan to initiate our own program,
mapping the detours that the human genome takes with respect to
toxic exposure and chronic disease. The ensuing catalog of
reshuffled genes should assist in establishing diagnostic
protocols and tailoring treatments for each patient. The single
greatest obstacle to achieving this goal with respect to
veterans has been the lack of sufficient private-sector funding
for research into an issue that most people believe is the
responsibility of the government.
I include supporting testimony from my colleague, Professor
Luc Montagnier, whose laboratories with 4 decades' experience
of evaluating the biomedical and medical significance of RNA,
led the research effort into discovering the AIDS-associated
viruses: HIV-1, 2, and group O. We jointly concur that to
understand the origin of diseases associated with RNAs in Gulf
War Syndrome, a major effort must be launched on understanding
a family of genes referred to as retroelements. Retroelements
make up over 6 percent of the genes in the human body and
appear to be central to the origin of disease-associated RNA.
I would like to state for the record that it is my
professional opinion that the clues to solving significant
medical problems in the world today, cancers, AIDS, heart and
liver diseases, autoimmune and neurologic disorders, vaccine
safety, chemical injuries and military-associated ailments lie
in the blood of these veterans who suffer from Gulf War
Syndrome and possibly in the blood of their families. Once we
break and catalog the code of reshuffled RNA, we may finally
have a clear direction on how to treat chronic illnesses in
general. The Gulf war veterans will become heroes again for a
second time.
I ask that the full text of my statement along with the
prepared statement from my colleague, Professor Montagnier, be
submitted for inclusion in the hearing.
[The prepared statement of Mr. Urnovitz follows:]
[GRAPHIC] [TIFF OMITTED] T7151.074
[GRAPHIC] [TIFF OMITTED] T7151.075
[GRAPHIC] [TIFF OMITTED] T7151.076
[GRAPHIC] [TIFF OMITTED] T7151.077
[GRAPHIC] [TIFF OMITTED] T7151.078
[GRAPHIC] [TIFF OMITTED] T7151.079
[GRAPHIC] [TIFF OMITTED] T7151.080
[GRAPHIC] [TIFF OMITTED] T7151.081
[GRAPHIC] [TIFF OMITTED] T7151.082
[GRAPHIC] [TIFF OMITTED] T7151.083
Mr. Shays. Before I ask my questions, I want to thank Mr.
Chan for staying and hearing other witnesses and also Dr.
Feussner and Dr. Mazzuchi and Dr. Foster. It is appreciated
that you listen to the other witnesses.
I am struck by the fact that if you had testified 4 years
ago, it would almost seem like you were speaking a foreign
language, and it doesn't seem so foreign to us today so there
is some kind of progress here.
I think the thing that I recognized, the most astounding
thing that I felt was beginning to understand why our veterans
were faced with this kind of lack of sympathy and lack of
receptivity to their illnesses. We had no doctors in VA except
a few occupational therapy-types that were thinking the way
that you are thinking. They are competent doctors, but they
weren't involved in occupational hazards.
So I guess what I would ask, it seems to me what you are
suggesting is we are making some progress. You are here and
there are others who have testified before you, but that the
paradigm that we are using is still wrong.
Dr. Urnovitz. That's correct.
Mr. Shays. And all three of you have been able to make your
case, some who sit on the board.
Where do you all disagree with each other?
Dr. Miller. Can I say maybe what the context here is?
Mr. Shays. Yes.
Dr. Miller. There are some very specific mechanisms that
can relate to the continuing symptoms that the veterans are
having, and it might be on the basis of genetic changes or
neurosensitization. There are many specific mechanisms
including inflammation that people have proposed to explain
some of these ongoing health problems.
With respect to the intolerances that people have now, we
don't understand the underlying mechanism any more than we did
back when people had the germ theory of disease. They didn't
know how cholera, for example, operated; but they had a
particular concept which could be tested.
I think it is important to keep in mind if there were this
initial event, exposure, and people develop intolerances, we
can intervene without knowing the specific mechanisms. In fact,
when people recognized if you washed your hands or wore gloves
going from one child-bearing to the next, one birth to the
next, you wouldn't transmit child bed fever; but people didn't
know about the germs that caused child bed fever. They had this
crude theory of disease, but it allowed them to operate in a
way that prevented the transmission of disease.
If we have in mind there is a toxic exposure for at least
some people, and they lose tolerance for other common
exposures, what we can do is minimize the exposures that they
are having currently and start to prevent any unnecessary
exposures in future wars, and maybe identify early some of the
susceptible people that I think both Dr. Bell and Dr. Urnovitz
alluded to.
Mr. Shays. One of the things that I concluded over time was
that there was no incentive to get into the field that you are
getting into for a variety of reasons. Economically there
didn't seem to be an incentive. How did each of you get into
this area?
Dr. Urnovitz. I actually tried to tell you 4 years ago, and
I ran out of time then.
I got involved because my mom died 30 years ago of cancer,
and I have been trying to figure out why. There is no single
causative agent.
We were born in Detroit, which I love dearly. However, it
was a toxic exposure. We were exposed to many chemicals getting
rid of Japanese beetles. We were given 26 monkey viruses in
vaccines. We were living in one of the greatest economic growth
centers of the world in manufacturing. There is no single
cause.
I have been trying to figure out how cancer works. I have
been trying to do that for 3 decades and the germ theory I
reject for chronic illnesses. It is great for the acute bugs;
we can cure them. We can cure them with doxycycline, no
problem. We are talking about chronic diseases. These take
decades to develop.
You must reject the germ theory. Just like we had to reject
the single atomic theory and go to quantum mechanics to
understand relativity, you have to start a new paradigm.
You can't start the Manhattan Project until some Einstein
writes some Roosevelt a letter saying we just split the atom.
That letter has never been written; that is why we don't have
the Manhattan project for these chronic diseases. We are trying
to write that letter to you.
You asked originally what is the difference between our
testimonies, nothing. There is nothing mutually exclusive here.
What Dr. Miller said, I agree completely. She describes the
different phases of these diseases. They are multiphasic as
well as multifactorial. Throw out the book. Start over again
and start with the fact that we are living in a toxic
environment. We are trying to keep up with a toxic environment.
We love the modern marvels of science. I love them, faster
computers. But the thing is, we are not going to give them up.
We love our modern marvels, and we are not going to give them
up. Medicine has to keep up. We have to figure out how we can
keep up with the changes in the toxic environment that we live
in, and we are going to constantly add pollutants to our
environment, and we are going to constantly have our genes
rearranged.
The treatments that we come up with for Gulf War Syndrome
will be used throughout all aspects of medicine. I am sending
this message out to the private sector, because that is where
we get money from. We can build products, both diagnostic and
pharmaceuticals, to help us keep up with modern medicine if we
all recognize as a medical and scientific community that our
genes do rearrange in response to toxic exposures.
That is what Gulf War Syndrome taught us. We gave 28-year-
olds the biggest whopping dose of toxic exposures I can think
any human ever got, and that is Gulf War Syndrome.
Mr. Shays. How did you get in this field?
Dr. Miller. First, to amplify on one statement and that is
about the different theories of disease. The importance of
rejecting what we have in the past and what we are seeing,
these characteristics in these individuals, does not fit the
germ theory. It does not fit the immune theory of disease, our
classic theories of disease.
So just as when the germ theory came along, we need to have
a new model that does fit observations by physicians and
others, what is going on with the patients. I want to say that
is absolutely right, you have to reject what you have right
now. The problem is with epidemiology. Classically, it
developed out of looking at infectious diseases and looking at
patterns of illness, and it doesn't work as well in this
situation.
The paradigm here is in-depth talking with patients, 4 to 6
hours with a patient, trying to figure out what they are saying
and they are all reporting these intolerances. There is a
thread of a hallmark symptom and you can make sense if you
spend the time. But veterans are shuttled from specialty clinic
to specialty clinic, and no one has time to put together what
is really going on with them, and it takes time to get these
kinds of histories, and the VA has not had the physicians to do
that.
If I could just say how, I worked before I went to medical
school as what is called an industrial hygienist looking at
people in work places who got ill and noticed that there was a
subset that continued to be sick, whether it was in a sick
building or after pesticide exposure and out of interest in
that went to medical school and trained in allergy and
immunology and found that I had gone into the wrong specialty.
I don't know what specialty this is any more but--and this led
me into research, writing the New Jersey report on multiple
chemical sensitivity and some other--many papers on the
subject, and finally the Gulf war veterans came along years
after we were seeing this in civilians and the pattern looks
the same. It looks identical.
Mr. Shays. With Dr. Kaiser and the VA, basically we were
being told that low exposure did not lead to injury or death
and yet in my own environment as a State legislator, I was
passing laws right and left to prevent there being exposure to
low-level chemicals because we ultimately felt like it would
lead to injury or death. I spent so many years of my life
trying to protect workers from a bad environment.
Dr. Miller. There is a reason. When you talk about low-
level exposures in terms of a toxicologist's view of it and
what would affect people that were healthy to begin with, that
is one thing. When you attack people who had been exposed and
lost normal tolerance, now they can't tolerate--one alcoholic
drink, they can't tolerate. They can't tolerate medications
they took for years. Remember the guys who took decongestants
many times before the Gulf war, and now one tablet makes them
feel strung out for many days. There is a fundamental loss of
tolerance, and now you have thrown into something that is
orders of magniture less tolerant than what you started with.
So when EPA talks about low levels of exposure, they are
talking in the average general population, and these people are
on a different scale.
Dr. Bell. Before I address the question of how I got into
it, I would like to amplify on some of the other comments. I
believe that part of the issue is that science in general has
taken a very productive direction toward reductionism, which
means finding as simple an answer as one can control all of the
variables for. This is an issue where we have been forced by
the nature of the phenomenon to deal with multiple variables in
interaction. There are statistical techniques for doing this
and methodological approaches in science for doing it, but it
is not the prevailing way science has been done and certainly
not medical research. It is not easy to do, and it is very
expensive frequently because when there are multiple variables,
you require even more subjects than you would for other kinds
of studies, and you have less absolute certainty that what you
have found is the answer because frequently it is in fact a
multifactorial answer.
This means that in terms of us all saying these various
points that factors such as nutrition, factors such as genetics
and factors such as environment all interplay and you will hear
people in science adamantly proclaiming that any one factor is
a major issue having controlled for all of these other
variables, and in fact that is valuable information. But the
whole picture in terms of what happened to the individual
requires an understanding that they can interplay and interact,
and that is not something that is typically looked at in a lot
of research.
In terms of my own interest, as Dr. Miller was alluding to,
the kind of things I did as a graduate student in neuroscience,
I was working with a group of patients who have narcolepsy, a
sleep disorder where they fall asleep against their will at
undesirable times; and I listened to what they said. And what
they told me is when they ate certain foods, they fell asleep.
And that led me to meet with doctors who were working in food
and chemical sensitivity, and I became fascinated by its
potential usefulness as an area to study within clinical
neuroscience; and I pursued it from that perspective for many
years.
Mr. Shays. Thank you. Thank you for your patience. You have
the floor.
Mr. Sanders. Thank you, Mr. Chairman. I just want to thank
and congratulate all three of you for the extraordinarily
important work you are doing. Some day I think you will get the
recognition that you deserve. Maybe not tomorrow, but it will
come. What you are doing is extremely important.
It seems to me--I got into this, Mr. Chairman, because a
constituent of mine in Montpelier, VT, was made ill by exposure
to a coffin, and her children were made ill. I didn't believe
her, and we investigated it and so forth and so on, and I think
the coffin industry has perhaps changed how they manufacture
the product.
I have met with hundreds of Gulf war veterans in the State
of Vermont who, as I said before, cannot tolerate being around
perfume. Mechanics, just as you described, Dr. Miller, used to
work as mechanics, they no longer can do their job. They suffer
short-term memory loss, nausea, et cetera.
Let me--and I happen to accept the paradigm that you are
throwing out. We are living in an increasingly toxic
environment, and it is hard not to believe that all of us have
suffered as a result of that and those folks over in the Gulf
suffered even more, and I want to underline the statement that
all of you made that the research taking place on Gulf war
illness will have an enormous impact on the general society as
well.
I remember in my office there was a woman who actually was
a nurse. She was visiting a patient. She went into the bathroom
and the woman had used heavy duty detergents, and she was ill
as a result. I have heard this a dozen different times, and I
cannot believe but that these anecdotes are true.
Mr. Chairman, you will remember the major from Connecticut,
the pilot, who became ill after jogging at a military base
after they had sprayed with some pesticide.
Dr. Urnovitz. Dr. Donnelly came down with Lou Gehrig's
disease.
Mr. Sanders. His feeling is that he was hit right after
they had sprayed. That is a coincidence, perhaps; but I have
heard too many of these stories.
Let me ask some specific questions, if I might. Before I
do, let me tell you a story. The story was that I took one
researcher, one gentleman whose views are not different from
yours because I felt so strongly about this about 5 or 6 years
ago, I took him up to Jesse Brown, who was then head of the VA.
He made his case and Brown was interested. I urged him to
submit a grant for funding, and he said they will never fund
me. I said please do it. He did it. And not only was he
rejected, he got a letter back which he sent to me which
basically said are you crazy. You are a quack and a fraud. You
don't have any peer reviews, and they insulted him. Not a
rejection, but an insult.
It seems to me that one of the problems is that people are
living in different paradigms. You can have a scientist coming
here and people saying you are crazy; we don't accept what you
are doing. In fact, many of the definitions that you are using
are not accepted by large numbers of physicians and scientists
in this country. We are living in two different worlds, and I
think honest people are rejecting you because they think you
are crazy.
I think our challenge is how do we introduce in the
Congress an acceptance or at least a willingness to fund and
take seriously this research. Let me start off with a question
to all three of you--and I know the answer will be different--
but basically what kind of response have you gotten from the
government in terms of requests for funding the research that
you all are doing?
Dr. Urnovitz. Congressman Sanders, I only play in the
sandbox with people that like me. I don't bother going to
places that don't understand the theory. We have gone to the
private sector for funding. I can't tell you the great honor I
have by having Dr. Montagnier submit a written testimony,
knowing the ramifications. This is probably one of the greater
scientists in the world today.
I think that we should recognize an important factor of how
discovery is made in the world. I have thought about this for 3
decades.
Discovery is made in small groups of people, 5, 10 people
just passionate, living, breathing new ideas. I come from the
San Francisco Bay area where the standard issue is a Diet Coke,
cheeseburger and working at your computer for 3 days in a row;
and those are the kinds of people who make discoveries.
I just don't know what the wisdom is in asking agencies
that collect data, regulate data and disseminate information,
to do discovery and that is Health and Human Services and they
do the first part very well. I don't know if it is really
proper for us to do discovery and legislate to make
discoveries. Maybe if we thought about it from the terms of who
is successful and gets up in Sweden and gets these little Nobel
Prizes, it is people in small discovery groups and academia,
private research, occasionally a federally funded agency; but
it is the small groups.
And I ask Congress to think about maybe the resource
management is where we need to think about this. How can you
create an environment for discovery that we then take that
information and the CDC has to verify it and the FDA has to
regulate and the NIH has to vet it.
I think discovery should be made in small groups and we
should find some way to do that and maybe we should take it out
of the executive branch and put it in Congress so we separate
that power and balance it a little bit more. That's the short
answer.
Mr. Sanders. Have you particularly gone to the government
for funding?
Dr. Urnovitz. I have not because it just doesn't make sense
to me to think outside the box and then ask the box to fund it.
So I've gone to the private sector it's just an observation of
a few years.
Mr. Sanders. Basically you've given up, and you don't
think----
Dr. Urnovitz. I never started. I go where the money goes.
The money is in biotechnology. The money is in venture
capitals. And venture capitalists have a long view that they'll
wait 10 years for a product. I've successfully taken three
products to the FDA. A urine test for AIDS which is exciting.
It's an epidemiologic tool. It's unfortunate the People's
Republic of China will adopt it first as their mainstream AIDS
test because--well, that's another hearing. Let's just talk
about the fact that the--we were proud we have our co-author
Jim Fuite, whom the committee knows very well has handed out
our papers to everybody. We know that they're there. We're just
waiting every day with bated breath to hear how we can work
with the VA and DOD to introduce these tests.
You know, what's going to happen--may I predict on the
record under oath what's going to happen with your mycoplasma
study? I don't need data to tell me how things are going to
happen. You're going to find out it's worse than you thought
because some veterans are going to do very well on this
doxycycline program but it may be the fact is we know that the
doxycycline also inhibits RNA formation.
What's going to happen is a year from now you're going to
sit here going well why are only 25 percent of the people
responding? Are they the only ones who have mycoplasma. I hope
I put a little seed in your brain under oath that there are
other ways that doxycycline works.
So I ask that you look at the bigger picture here and that
we take control of it. The problem is I have no way of getting
that dialog except every 4 years sitting here and telling you
my thoughts on things of how to tell the Federal Government
about other research programs that are out there, a vast array
of literature we're not quoting at all. So there are two
different worlds. There is the greatest physicians in the world
and they are probably in this country and they're doing
medicine and health care better than anywhere else in the
world, but I never expected them to read the literature and do
the discovery work. That's what I do. How do I get my work into
their hands. There's only one way I know to do that and that's
put it in the peer review journals.
Mr. Sanders. Thank you.
Dr. Miller. The kind of research we talked about with using
an environmental medical unit doesn't have the same commercial
potential. So going to a private donor for this is virtually
impossible. So we've turned to various Federal agencies. I've
testified to Congress not 4 years ago but probably 7 or 8 years
ago going forward. I think I testified to different groups
including the Presidential committee, IOM, CDC, all kinds of
groups 10 times in the last 8 years.
And it's been on the same thing, just looking what are the
observations in these veterans, look at the common thread, the
new onset of intolerances is an important clue just as fever is
an important clue to infectious diseases, let's pursue the
clue. But it doesn't go any further than that. In fact,
Congress not only has heard about this but they actually
authorized funding for an environmental medical unit in 1993.
And then it went through a series of a progression. And in
the long run the funds were diverted elsewhere. And I know
Congressman Sanders has done some things even more recently,
and he can describe those better than I in terms of trying to
get agencies perhaps to work together to find funding for this
kind of treatment. And it's actually dual-research, treatment,
and diagnosis--three things in one, in trying to sort out what
is getting on with the Gulf war veterans.
There was a time when some of the Federal agencies like
NIEHS had an interest in supporting research but there was no
facility and they couldn't fund a facility. And so there was
this effort, initial effort to get the funding just for the
facility. But as you know, there isn't an environmental medical
unit yet. We've submitted, I think, three or four times through
VA and DOD, and the kinds of reviews that you get back are
confused.
People don't understand it. They are operating out of old
paradigms, and they will say this is still controversial.
That's the purpose of the study. Yes, it's controversial. We
have to study to settle the controversy because it's one that
is costing not only veterans but civilians huge sums of money.
And they'll say it's too costly. And of course when I found out
how much money has been spent on research in reviewing
literature, I'm very sad to hear that this is not worthy of
funding.
I think it's going to take this kind of Manhattan-style
project to make this area happen, and I'm also worried about
playing in the sandbox with people that don't like me, that
it's very difficult having worked closely with a number of
Federal agencies on this issue trying to get them to use
questionnaires and so on. It has not happened yet after this
long a period of time. And I don't see the willingness yet to
have it transpire, and I don't see a home for this right now. I
wish I did.
Dr. Bell. I have tried for many years to be funded through
Federal agencies. I started with NIH and so on. When the Office
of Alternative Medicine was originally set up, I was very
enthusiastic and thought that this would be a particular
opportunity; and when I spoke with them at that time early in
their existence, they basically said this isn't controversial
enough. And they discouraged me from applying because I wasn't
studying some of the even more controversial areas within the
area of a complementary and alternative medicine. I don't know
where they would stand at this point. I have not made any
further attempts to apply through that agency.
Generally the reviews that come back are ``I don't like
this area. I don't like multiple chemical sensitivity.''
Frequently I do not get thoughtful scientific critiques of the
actual work. That's what happens when I get rejected.
I have to say that after several attempts of being funded
by VA, we were--we did attempt to be funded for an
environmental hazard center that had a focus on chemical
sensitivity; and we were not funded. It was the time when the
VA was very much emphasizing or at least the overall research
effort was emphasizing epidemiology, and that was not our
strength. Our strength was in the chemical sensitivity
question.
I applied twice for the funding that I currently have
through a merit review at the VA and got very favorable reviews
both times and eventually did get the funding. I have applied
to the DOD because I feel that my EEG work while not specific
and not as elegant as some of the work with functional MRI and
so on, would allow us to find some biomarker that's very
inexpensive and non-invasive to identify people who might be at
risk for chemical sensitivity. This might be a way of
identifying personnel before they are put in harm's way. That
was favorably reviewed but not funded.
And one of the issues often is any of this is my reading of
the way the reviews go at this point in time. This is an
interesting area. They're beginning to take us a little more
seriously scientifically, but it's not a priority topic to them
because there are so many other areas that they feel are
stronger scientifically. And so as the way the field is going,
they don't feel that they want to invest the limited resources
that are available in that particular direction.
Mr. Sanders. My last question, Mr. Chairman. As you heard
from previous panels, I've been concerned that we have not
developed treatment protocols, and that's what the veterans
want. If you had the money and the resources, what treatments--
could you develop treatments that actually might improve life
for veterans who are ill right now? Dr. Miller, why don't you
start on that.
Dr. Miller. The approach would be straightforward. It would
be using a controlled environment to take patients, have them
go into this controlled hospital environment, spend the first
week getting to baseline, a clean baseline. This is not--I want
to draw a bright line here between an environmental medical
unit and exposure chamber. This is not a chamber like they have
in North Carolina or at Robert Wood Johnson. Those are strictly
for maybe a few hours exposing people to a substance.
I'm talking about an inpatient hospital facility sort of a
treatment progression. Patients will stay in there for about 3
weeks, the first week getting to clean baseline, the next
couple of weeks testing them to single foods and common low
level chemical exposures.
Mr. Shays. Would you define clean baseline?
Dr. Miller. Clean baseline means you've gotten them away
from all the usual low level fragrances, disinfectants, other
things that might be present in the air.
Mr. Shays. It takes a week to go through their system?
Dr. Miller. That's right. It takes about a week. This is by
reports by many, many physicians now that they'll get to a
clean baseline after about a week. So that any exposure related
symptoms from volatile organic chemicals for example would
decrease at that point to the point where you get them so
they're feeling better, and this is what patients report and
then you can challenge.
Mr. Shays. Your second week is?
Dr. Miller. The second and third weeks would be
reintroducing foods and then very judicious low-level
exposures.
Mr. Sanders. What we would have learned about that is to
say to that patient you better stay away from A, B, and C.
Dr. Miller. That's right. They would have identified their
specific triggers and the information we have now is the people
that avoid exposures that set off their symptoms gradually
regain tolerance, and then they can----
Mr. Sanders. Do you have the concern that there may be tens
of thousands of veterans who every day are sticking their heads
into things that are simply making their illness recur?
Dr. Miller. This is what the veterans tell me. Many of them
have gone off--tried to get away from these things, but it's
been difficult. I had a call only the week before I came to
testify from a mother whose son was at the San Antonio VA and
he's extremely ill, multiple, multiple diagnoses; and she was
begging to get into the environmental medical unit. I had to
tell her there is no environmental medical unit right now.
There just isn't one. So veterans and their families have heard
about this idea. They recognize these intolerances in
themselves; and yet they have no recourse, nowhere to go.
Mr. Sanders. You're telling us that you have a treatment
that you think certainly deserves to be reviewed and you think
could be successful?
Dr. Miller. That's correct. It would give you insight not
only to the underlying mechanisms but it would provide
treatment and diagnosis.
Mr. Sanders. To the best of our knowledge that is not being
done by the government right now?
Dr. Miller. There is no place in the government or any
research center doing this work.
Mr. Sanders. Dr. Urnovitz and Dr. Bell.
Dr. Urnovitz. This is what I'm doing from the funding
source we're raising right now. It's a parallel track. What
we're going to do--you've alluded to it. The AIDS deaths have
dropped. We're all very excited about it. It's been a very,
very hard road to go and we're excited about it but let's look
at how that worked. It worked because of the fact that we had
drugs that could knock out the virus in tissue culture, what's
called AZT. Didn't work. The AIDS deaths weren't dropping.
What was the single event that got the AIDS deaths to drop?
They had a marker to shoot for. Remember I said outside the
box, this is out of the box thinking that some very clever
physicians did about 10 years ago by having a marker called the
viral load test which by the way measures RNA in the blood
except this RNA is the virus HIV-1.
All of a sudden they realized that AZT alone in mono
therapy isn't bringing the virus load down. That's when they
said maybe if we combine a bunch of therapies together, throw
in some protease inhibitors, guess what happened. The viral
load went undetectable. Guess what one of the by-products of
that was. The AIDS deaths dropped.
In other words, you've got to find a viable marker. The
squalene antibody is solid work. Professor Bob Garry, I know
him personally. He's a world class scientist. We talked
privately about this. This is an antibody that may also be an
autoimmune antibody. It's a marker. It's not going to be the
cause of Gulf War Syndrome. It is a marker and should be put
into the panel of things that we test for to see if it includes
or not includes certain patterns.
You need a biomarker first. Before you go out and you start
treating Gulf war vets, you're going to need a biomarker. I
can't tell you at this point whether this RNA in the blood is
the biomarker. We're going to proceed in that way.
I will tell you we have submitted a paper in multiple
myeloma, a cancer, based on what we found in Gulf War Syndrome.
Out of 30, 20 who have active disease have the marker, and 1
out of 30 who are in remission do not have the marker. This
doctor then started to prescribe a drug called Biaxin, a
different type of antibiotic and those people that responded
lost the marker in their blood. Those who did not----
Mr. Sanders. What you're saying when you have a marker you
know what you're shooting for.
Dr. Urnovitz. When you have a marker, you know what to
shoot for. Right now we're flying a plane with no windows on
it. We have no idea where we're going and all roads get us
there to reiterate what Congressman Shays said. You have a
marker you know now how to tailor the treatment, and it's not
going to be the same. My recommendation is--well, let me tell
you what I'm doing and then if you wish to work with us, we'd
be happy to do so.
We're going to use combination therapies to knock the RNA
expression out. We're going to use things that are antibiotics
which, by the way, evolved or co-evolved with RNA. We're going
to use those. We're going to use things that induce things
called interferons in the cell. We're going to add interferons,
and we're going to physically remove the RNA from the body.
We're looking at combination therapies right now to remove this
marker.
I personally know that things like doxycycline in some
cases was a miracle. Some people are alive and working and
paying taxes today because of that. Lots of people are not. So
what does that mean? It means that this individual responded to
the therapy. That's all it means.
Why? That's where we need to get at the root of this. It
will require what we learned in the AIDS epidemic which by the
way is exciting but it's not done. No one is cured. The reason
why is we've got to get rid of the other RNA in the blood of
people with AIDS. That's what we found and will be publishing
this summer. We need to take an approach that gets rid of all
of these markers to get people back on the health track so they
can start living their lives all over again. We need to find
those markers.
Mr. Sanders. Are you optimistic that some day we will?
Dr. Urnovitz. It will happen.
Mr. Sanders. Dr. Miller.
Dr. Bell. I would agree with what the other two speakers
have said in general. However, one can also take the point of
view as one would in complementary and alternative medicine
that indeed the patient's vulnerability is what has to be
focused on.
One can take a very innovative approach, such as Dr.
Urnovitz has done, but we can also be concerned that when we
intervene in any particular mechanism, that we may imbalance
other mechanisms. There are long-standing systems of
alternative medicine that are available starting with the work
that's been done more recently in environmental medicine.
Again, the controversial work that's available, it provides
a foundation for giving the patient a way to begin rebuilding
their health. In reality, in clinical practice when you work
with people over many years, you find they need more than
avoidance. They have to start with avoidance. The patients will
identify that as the central thing that helps them.
However, as I said in terms of the multiple
vulnerabilities, frequently they go after other things in
alternative medicine to the extent they can tolerate them. And
that's one of the advantages of the avoidance technique, that
gradually over time there's a certain amount of ability to
regain the ability to tolerate things because these are
individuals where even if they're found, for example, to have a
nutritional deficiency, they can't tolerate the vitamins no
matter how cleanly prepared they are and how few contaminants
and other problems or source problems they might have.
But eventually it's a sequential treatment process and so
what one starts with is the foundation and then one builds from
there. When they get the nutrition, when they get some of these
other kinds of interventions, then they begin to again handle
more and more things. At that point I've also--in the early
stages of treatment, I've also referred patients successfully
for treatment such as acupuncture which can be used without the
use of any chemicals and so on and which is frequently capable
of being titrated to the sensitivity of the patient.
These kinds of approaches are in themselves controversial.
I haven't heard of them necessarily being studied in Gulf war,
but I wouldn't be surprised if we had many roads to the same
answers and there would be ways of strengthening the
individual.
Dr. Miller. I just want to point to Allison Johnson's book
that was handed out earlier that she surveyed and other people
have surveyed many chemically intolerant patients and as Dr.
Bell mentioned, sort of the fundamental, the basis of their
improvement starts with avoiding things that set off symptoms--
chemicals, foods, medications, and so on and hopefully they get
to a point where they can regain some tolerance and try other
things.
I also want to say in terms of biomarkers, biomarkers are
very important. We don't have them yet. We don't know how many
years right now they are away. I hope it's next month, frankly,
that we have biomarkers. But when we don't have biomarkers, we
still have the ability to put people in a controlled
environmental, get them to a clean baseline, challenge them in
a blind way to see if symptoms recur.
It's just like again with the germ theory, at first we
could do prevention and had not identified the first germ, the
first microorganism. Cholera was being treated in London by
shutting off certain water sources that were contaminated, 30
years before Koch discovered the bacterium that causes cholera.
Mr. Sanders. I would just conclude, Mr. Chairman. I have to
run upstairs. Once again, I feel refreshed having listened to
this testimony. And I think we should be embarrassed, frankly,
that after the expenditure of over $120 million, that we are
not doing more to support this entire line of research which I
think is breathtaking and just enormously important for not
only Gulf war veterans but for the American people in general.
And I just would hope that we're going to work together to
support folks like this and just thank you again very much for
your testimony.
Mr. Shays. Thank you. I concur with his remarks. I think
it's been a fascinating three panels and with the three of you.
And thank you very much. I have a feeling though, it won't be
another 4 years before we meet again. Thank you. This hearing
is adjourned.
[Whereupon, at 2:40 p.m., the subcommittee was adjourned.]