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EXAMINING VA IMPLEMENTATION OF THE

PERSIAN GULF WAR VETERANS ACT OF 1998

HEARING

BEFORE THE

SUBCOMMITTEE ON NATIONAL SECURITY,

EMERGING THREATS, AND INTERNATIONAL

RELATIONS

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

NOVEMBER 15, 2005

Serial No. 109–114

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

CHRISTOPHER SHAYS, Connecticut

DAN BURTON, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

CANDICE S. MILLER, Michigan

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

JON C. PORTER, Nevada

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

CHARLES W. DENT, Pennsylvania

VIRGINIA FOXX, North Carolina

JEAN SCHMIDT, Ohio

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

BRIAN HIGGINS, New York

ELEANOR HOLMES NORTON, District of

Columbia

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

SUBCOMMITTEE ON NATIONAL SECURITY, EMERGING THREATS, AND INTERNATIONAL

RELATIONS

CHRISTOPHER SHAYS, Connecticut, Chairman

KENNY MARCHANT, Texas

DAN BURTON, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEVEN C. LATOURETTE, Ohio

TODD RUSSELL PLATTS, Pennsylvania

JOHN J. DUNCAN, JR., Tennessee

MICHAEL R. TURNER, Ohio

JON C. PORTER, Nevada

CHARLES W. DENT, Pennsylvania

DENNIS J. KUCINICH, Ohio

TOM LANTOS, California

BERNARD SANDERS, Vermont

CAROLYN B. MALONEY, New York

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

STEPHEN F. LYNCH, Massachusetts

BRIAN HIGGINS, New York

EX OFFICIO

TOM DAVIS, Virginia HENRY A. WAXMAN, California

LAWRENCE J. HALLORAN, Staff Director and Counsel

KRISTINE FIORENTINO, Professional Staff Member

ROBERT A. BRIGGS, Clerk

ANDREW SU, Minority Professional Staff Member

(III)

C O N T E N T S

Page

Hearing held on November 15, 2005 ...................................................................... 1

Statement of:

Mather, Susan, M.D., MPH, Chief Public Health and Environmental

Hazards Officer, U.S. Department of Veterans Affairs, accompanied

by Dr. Mark Brown, Director, Environmental Agents Service, and Richard J. Hipolit, Assistant General Counsel, U.S. Department of Veterans

Affairs; Dr. Lynn Goldman, Professor of Occupational and Environmental Health, Department of Environmental Health Sciences, Johns

Hopkins Bloomberg School of Public Health, Institute of Medicine; and

Sam Potolicchio, M.D., Professor of Neurology, Department of Neurology, the George Washington University Medical Center, Institute of

Medicine, accompanied by Susanne Stoiber, Executive Director, Institute of Medicine ............................................................................................ 235

Goldman, Dr. Lynn ................................................................................... 255

Mather, Susan ........................................................................................... 235

Potolicchio, Sam ........................................................................................ 275

Woods, Mike, Gulf war veteran; Stephen L. Robinson, executive director,

National Gulf War Resource Center, Inc.; Jim Binns, chairman, Research Advisory Committee on Gulf War Veterans Illnesses; Dr. Rogene

Henderson, senior scientist, Lovelace Respiratory Research Institute;

and Dr. James P. O’Callaghan, member, Research Advisory Committee

on Gulf War Veterans Illnesses ................................................................... 141

Binns, Jim .................................................................................................. 164

Henderson, Dr. Rogene .................................................................................... 210

O’Callaghan, Dr. James P. ....................................................................... 215

Robinson, Stephen L. ................................................................................ 149

Woods, Mike ............................................................................................... 141

Letters, statements, etc., submitted for the record by:

Binns, Jim, chairman, Research Advisory Committee on Gulf War Veterans Illnesses, prepared statement of ........................................................... 167

Goldman, Dr. Lynn, Professor of Occupational and Environmental

Health, Department of Environmental Health Sciences, Johns Hopkins

Bloomberg School of Public Health, Institute of Medicine, prepared

statement of ................................................................................................... 258

Henderson, Dr. Rogene, senior scientist, Lovelace Respiratory Research

Institute, prepared statement of .................................................................. 212

Kucinich, Hon. Dennis J., a Representative in Congress from the State

of Ohio, prepared statement of .................................................................... 6

Mather, Susan, M.D., MPH, Chief Public Health and Environmental

Hazards Officer, U.S. Department of Veterans Affairs, prepared statement of ........................................................................................................... 240

O’Callaghan, Dr. James P., member, Research Advisory Committee on

Gulf War Veterans Illnesses, prepared statement of ................................. 217

Potolicchio, Sam, M.D., Professor of Neurology, Department of Neurology,

the George Washington University Medical Center, Institute of Medicine, prepared statement of .......................................................................... 278

Robinson, Stephen L., executive director, National Gulf War Resource

Center, Inc., prepared statement of ............................................................ 152

Shays, Hon. Christopher, a Representative in Congress from the State

of Connecticut:

Prepared statement of ............................................................................... 3

Prepared statement of various individuals ............................................. 12

Woods, Mike, Gulf war veteran, prepared statement of ............................... 144

(1)

EXAMINING VA IMPLEMENTATION OF THE

PERSIAN GULF WAR VETERANS ACT OF 1998

TUESDAY, NOVEMBER 15, 2005

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON NATIONAL SECURITY, EMERGING

THREATS, AND INTERNATIONAL RELATIONS, COMMITTEE ON GOVERNMENT REFORM, Washington, DC.

The subcommittee met, pursuant to notice, at 1:03 p.m., in room

2154, Rayburn House Office Building, Hon. Christopher Shays

(chairman of the subcommittee) presiding.

Present: Representatives Shays, Dent, and Kucinich.

Staff present: Lawrence Halloran, staff director and counsel; J.

Vincent Chase, chief investigator; Kristine Fiorentino, professional

staff member; Robert A. Briggs, clerk; Andrew Su, minority professional staff member; and Jean Gosa, minority assistant clerk.

Mr. SHAYS. A quorum being present, the Subcommittee on National Security, Emerging Threats, and International Relations

hearing entitled, ‘‘Examining VA Implementation of the Persian

Gulf War Veterans Act of 1998’’ is called to order.

Work by this subcommittee provided critical impetus for passage

of the Persian Gulf War Veterans Act of 1998. That law directs the

Department of Veterans Affairs [VA], to seek independent assessments of possible associations between toxic exposures and the unusual syndromes afflicting many ill veterans.

If a scientifically valid association is found, the VA may, by regulation, establish a presumption of service connection in favor of

those applying for health and disability benefits. That process was

intended to allow the VA to give sick veterans the benefit of the

doubt until hard evidence of causality between the wartime exposures and chronic illnesses emerges from ongoing research. In the

meantime, the law directs the VA to look to studies on animals to

fill gaps in clinical and epidemiological data.

Last year, a VA-sponsored review by the Institute of Medicine

[IOM], on the effects of low-dose Sarin exposure raised questions

whether the statutory mandate to use animal data is being followed. Former VA Secretary Anthony Principi specifically requested a reappraisal of earlier conclusions on Sarin exposure,

based on the emergence of significant new studies showing the

chronic brain function changes in animals after low-dose exposures.

But the IOM committee reported animal studies play only a small

role in their assessment.

Not surprisingly, the expert committee, as before, found no connection between sub-clinical Sarin exposures and human illnesses.

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That conclusion epitomizes what many veterans see as a deeply entrenched reluctance in the VA and allied medical institutions to extrapolate from animal data on fundamental questions of disease

causation.

As the VA sees it, toxicology studies on rats and other animal

data may be useful to probe the biologic plausibility of medical

hypotheses; but only data from studies involving humans can be relied upon to determine a legitimate association between exposure

and human disease.

That sustained unwillingness to rely on animal studies thwarts

a fundamental purpose of the statute: to ease the traditional burden of proof borne by veterans claiming service-connected injury

and disability. Whether motivated by a lack of scientific vision, or

a fear of fiscal implications, the refusal to give greater sway to animal data in Persian Gulf War Veterans Act determinations undercuts the basic intent of the law to expand the scope of evidence

upon which the VA may connect today’s mysterious illnesses to

wartime service a decade and a half ago.

Those that the VA charge with implementation of the statute

have to know the gold standard of human data on Sarin exposure

they demand may never be available. Gulf war veterans don’t know

the dose to which they were exposed, and their fate should not

hinge on the unthinkable prospect we will have more veterans who

are terrorism victims to study.

In terms of research protocols, it is unethical to intentionally expose human test subjects to lethal agents. So only data from animal studies will allow the VA to construct the links between exposure and ailments that sick veterans cannot. But, as we will hear

from close observers of the process today, it appears VA has repeatedly attempted to minimize the role and impact of animal data in

Gulf war studies.

Ironically, another major scientific organization is moving in exactly the opposite direction. The Food and Drug Administration’s

Animal Efficacy Rule allows for approval of certain new drugs and

biological products based solely on data from animal studies. So the

experimental drugs and vaccines soldiers might be ordered to take

against bioterrorism agents can be approved through unprecedented reliance on animal data; but determinations regarding the

toxic causes of their subsequent illnesses still cannot.

Our witnesses, all our witnesses, bring extraordinary commitment to the cause of helping veterans. And we appreciate their

time and expertise, as the subcommittee continues to pursue these

difficult issues.

The Chair at this time would recognize the distinguished gentleman, the ranking member, Mr. Kucinich.

[The prepared statement of Hon. Christopher Shays follows:]

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Mr. KUCINICH. Mr. Chairman, I want to thank you for holding

this hearing. And I also want to thank you for your leadership on

this issue.

It has been 14 years since the end of the Persian Gulf war, and

Congress is still holding hearings on the serious and persistent

health problems suffered by one-third of the veterans who served

in that conflict. Many of these problems have existed throughout

the 14-year period; while others are just starting to appear.

In fact, studies have shown that ALS, or Lou Gehrig’s Disease,

is twice as prevalent in veterans of that war, when compared to

their non-deployed peers. While we now know that stress is not the

cause, there is still much we do not know.

I am happy to say that Mr. Shays, Mr. Sanders, and I were successful this year in our efforts to provide for funding for research

into these Gulf war veterans’ illnesses. The intent of our effort was

not only to discover enough to prevent the offending exposures in

the future, but also to make sure that those already exposed get

the medical treatment they deserve.

The more we know about the links between these illnesses and

their exposures, the more likely the VA will give our soldiers an

adequate disability rating for their exposure. But the VA continues

to ignore a critical body of information that is going to be wasted

as a result of their unwillingness to probe further.

And I know it is harder to pinpoint causes and effects in human

studies, because you cannot intentionally expose people to toxins;

except of course in combat. And human epidemiological studies,

that are a snapshot in time, are sometimes a problem, because you

don’t know if the exposure came before the disease.

This is one of the reasons why we need to review data from all

of the studies that have been done, to assess the toxicity of everyday products we buy and of the pharmaceuticals we take.

I think that this hearing, therefore, is important, Mr. Chairman.

I think you would agree that we owe our Nation’s veterans a debt

of gratitude for their service. We can do better, and we have to do

better. Thank you, Mr. Chairman.

[The prepared statement of Hon. Dennis J. Kucinich follows:]

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Mr. SHAYS. I thank the gentleman. Let me use this opportunity

ask unanimous consent that all Members of the subcommittee be

permitted to place an opening statement in the record and that the

record will remain open for 3 days for that purpose. And without

objection, so ordered.

I ask further unanimous consent that all witnesses be permitted

to include their written statement in the record. And without objection, so ordered.

Let me announce our witnesses. We have two panels. Our first

panel is Mr. Mike Woods, Gulf war veteran; Mr. Steve Robinson,

executive director, National Gulf War Resource Center; Mr. Jim

Binns, chairman, Research Advisory Committee on Gulf War Veterans Illnesses; Dr. Rogene Henderson, senior scientist, Lovelace

Respiratory Research Institute; Dr. James P. O’Callaghan, member

of the Research Advisory Committee on Gulf War Veterans Illnesses. I would welcome them all to come, and I will swear them

in.

[Witnesses sworn.]

Mr. SHAYS. Note for the record, all our witnesses have responded

in the affirmative. Please be seated. Thank you.

Before inviting Mr. Woods to speak first, I ask unanimous consent to place in the record 33 statements and letters submitted regarding the Persian Gulf War Veterans Act of 1998. And without

objection, so ordered. The list includes the 33 names, and we will

submit it.

[The information referred to follows:]

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Mr. SHAYS. Thank you all very much. We have two panels, and

I am going to ask you to stay as close to the 5-minutes as possible.

I will let you run over a few minutes, but we would like to be as

close to the 5 as possible. But don’t read fast.

All right, Mr Woods.

STATEMENTS OF MIKE WOODS, GULF WAR VETERAN; STEPHEN L. ROBINSON, EXECUTIVE DIRECTOR, NATIONAL GULF

WAR RESOURCE CENTER, INC.; JIM BINNS, CHAIRMAN, RESEARCH ADVISORY COMMITTEE ON GULF WAR VETERANS

ILLNESSES; DR. ROGENE HENDERSON, SENIOR SCIENTIST,

LOVELACE RESPIRATORY RESEARCH INSTITUTE; AND DR.

JAMES P. O’CALLAGHAN, MEMBER, RESEARCH ADVISORY

COMMITTEE ON GULF WAR VETERANS ILLNESSES

STATEMENT OF MIKE WOODS

Mr. WOODS. Thank you, Mr. Chairman and members of the subcommittee, for the opportunity to testify here this morning.

Before I begin, I would like to dedicate my testimony to two warriors who are not here with us today. First, Navy Captain Michael

Speicher, who has been missing since January 1991, the start of

the Gulf war, who is officially considered captured; second, Army

Sergeant Matt Maupin, who went missing in April 2004, during the

Iraq war.

No matter how difficult our struggles as veterans may be, they

in no way compare to what these two men must be enduring for

our country. I will remember them, and I hope Congress and the

American public will, too.

In preparing my testimony for you today, I was forced to look

back at many things that have happened with my health care since

I returned home from the Gulf war in 1991. I considered writing

a long drawn-out testimony of my very difficult experience with the

VA. But with the limited amount of time we have here today, I will

summarize my experiences.

In looking back, many Gulf war veterans, including myself, first

made contact with the VA through the VA Gulf War Registry exam

process. You know how things went back then: VA denial of medical problems; long waits to see doctors, just to tell us to return in

15 or 20 years when science has time to catch up with our problems; or to simply be told there is nothing wrong.

Since this time, veterans have organized. We have worked hard

over many years with Congress to try to force the VA to recognize

and treat our illness. We have met with reporters, held meetings,

organized conferences. And we have even held long road marches

across the country. We have worked close with veterans’ groups to

press for the enactment of the Persian Gulf War Veterans Act of

1998, sponsored by you and many members of this subcommittee.

Now let me talk about VA failures after the enactment of the

Persian Gulf Veterans Act. Years ago, I left the VA health care system, after being prescribed a powerful medication by the VA,

‘‘Obecalp’’—a medication to be used with extreme caution. However, it does not work very well. Spelled backward, it is simply

‘‘Placebo.’’ To answer your questions before you even start, I have

never participated in a study; much less one at the VA.

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After leaving the VA and seeking private medical care, I found

a good doctor and neurologist who managed to control my declining

health. Thankfully, my wonderful wife, Jessica, has stuck with me

over the years and has always ensured that I have received good

medical care, even if we had trouble paying for it.

Recently, we sold our home in Florida, and moved back to our

home State of Kentucky; at which time, I returned to the VA for

my health care. My wife and I felt, after everything that has been

done over the years, that surely the VA health care system has improved for Gulf war veterans. But to my surprise, returning to the

VA was like going back in time.

I was once again told there is nothing wrong with Gulf war veterans. Even worse, the doctor I saw on my last visit even stated

that she cannot believe veterans receive compensation for Gulf war

illnesses, because there is nothing really wrong with them that is

related to their service. She even refused to fill prescriptions that

have kept my illness from continuing to decline.

I cannot believe, after all the work that has been done on this

issue, that this is still the normal response from VA doctors. But

when looking at their current training manual, it should not surprise any of us.

In working with Undersecretary Jonathan Perlin, I know that

he, for one, truly cares about ill Gulf war veterans. However, there

seems to be a breakdown between his comments and what VA doctors do at VA hospitals and clinics. This is a breakdown that must

be repaired. When looking at VA claims and how the process

works, there is still much work to be done.

After years of denials, I was finally able to convince the VA to

approve my undiagnosed illness claim. This came about as a result

of a roundtable discussion with Congressman Putnam of Florida,

when I discussed with the VA Regional Director why veterans with

clear evidence showing undiagnosed neurological disorders were

being denied benefits by his VA rating officers. I went on to explain

that the laws and regulations clearly show that they should be approved.

He challenged me on this point, claiming that they properly review all cases by their merit; at which time, I produced a copy of

a report done by my private doctor, who is a neurologist and psychologist, who clearly showed that I suffer from many neurological

problems, to include motor nerve and sensory nerve neuropathy in

all of my extremities, with the worst being in my right leg which

now requires the use of a prosthetic brace to allow me to continue

to walk.

I also showed him reports from spinal taps done by the VA which

show abnormal spinal fluid, that was reviewed by the Armed

Forces Institute of Pathology, which they were unable to diagnose.

This report does go on to say that the findings should be compared

with clinical findings, to rule out such things as MS, ALS, and Parkinson’s Disease, just to name a few. The Regional Director said he

would have to get back to me on this. Several weeks later, I did

not hear from him, but my claim was approved.

While sitting before you today, I would like to urge you to consider the following recommendations: First, to extend the time a

veteran has to file for presumption beyond the current 10-year

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mark. As a result of VA doctors continuing to deny illnesses are associated with veterans’ service, many veterans will continue to put

off applying for benefits until it is their last option. In doing so, it

will take them beyond the current 10-year mark, causing them to

no longer be eligible for benefits they have earned and deserve.

Second, grant service connection as a result of service for ALS,

MS, and Parkinson’s Disease, and other similar neurological disorders. Today’s doctors are trained to diagnose illnesses. It is my

fear that some veterans with very similar problems and the same

test results as mine may have very well been diagnosed with a

neurological disorder that looks and acts like something it is not;

causing their claim to not be covered under current law.

Require all VA doctors to be required to undergo training that

reflects current science, not fiction from the past.

Continue a comprehensive VA Registry exam. As veterans are returning from Iraq today, some are now reporting ill-defined symptoms, as well. My brother, Cole, is set to deploy to Iraq on December the 1st. I hope that he does not have to appear before you 15

years from now, to seek what he earns and deserves.

In closing, if those on the panel to follow us are not ready to

admit that Gulf war veterans are ill because of our exposures, then

allowing them to continue to decide research, treatment, and compensation will continue us down the same road we have been on

for nearly 15 years. The first step to fixing any problem is to recognize the problem is real.

Mr. Chairman, thank you for being one of our top advocates in

Congress. You are a friend of veterans. You have listened, when

others have turned their backs.

[The prepared statement of Mr. Woods follows:]

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Mr. SHAYS. Thank you, Mr. Woods. Part of that is that I sent you

there. And when you send someone there, you would like to think

that the Government is going to respond in kind.

Mr. Robinson.

STATEMENT OF STEPHEN L. ROBINSON

Mr. ROBINSON. Thank you, Mr. Chairman. In the 1991 Gulf war,

relatively few soldiers were injured from bullets and bombs; however, a significantly larger number of Gulf war veterans, who did

not feel the sting of a bullet, have been suffering with, living with,

and in some cases dying with illnesses that are absolutely connected to their wartime service.

This fact is confirmed in VA studies conducted by the VA and the

Director of the VA Environmental Epidemiological Service. It is important to note that today, as we sit here, the Department of Defense and the VA are repeating some of the same errors from the

1991 Gulf war, by failing to collect and share data.

Today, in this war, the VA does not know who has gone to war,

how many of those released from the service are eligible for VA

benefits, and what are the disease trends reported by the Department of Defense.

In order to tell the subcommittee where we are today, we have

to look a little bit at the past. In the 1995 report conducted by the

Institute of Medicine entitled, ‘‘Health Consequences of Service

During the Persian Gulf War,’’ the IOM concluded that research on

Gulf war illness was fragmented and uncoordinated. The report

suggested that serious efforts must be made in the near term to appropriately focus the medical, social, and research response of the

Government and individuals and researchers.

The IOM hit the nail squarely on the head in their first report.

However, for the next 14 years, the VA spent a great deal of effort

focusing their studies, but focusing them on stress, the thing that

wasn’t the problem in Gulf war veterans’ illnesses.

It is well known that a great deal of Federal money has been

spent on a large number of Gulf war related studies since the mid

1990’s—nearly $316 million, as of the VA’s last report in 2003. This

$316 million investment has produced no evidence that stress was

the causal factor in Gulf war veterans’ illness. Rather, it reinforced

that the VA and DOD were looking in the wrong direction.

Overall, Gulf war illness research money invested to date has not

yet answered many key questions that scientists must address to

make meaningful progress. No. 1, what are the specific physical

processes underlying Gulf war illnesses; and No. 2, what treatments can improve veterans’ health?

Because of the lack of progress in addressing these diagnosed

and undiagnosed conditions, President Bush, when elected, ultimately fulfilled a campaign promise to establish the Research Advisory Committee, and veterans were extremely happy when it was

stood up.

The Research Advisory Committee, by law, is the agency and the

organization which advises Secretary Principi, and now Secretary

Nicholson, on all Gulf war related issues, and is supposed to be

privileged to all upcoming studies, future studies, and anything related to Gulf war veterans.

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The Research Committee issued its first interim report and,

based on that recommendation, Secretary Principi promised $20

million for Gulf war illness research. Historically, about 75 percent

of Gulf war veteran research came from DOD. However, since

2002, DOD has shifted its focus to the current war. This is why the

$20 million promise by Secretary Principi was important.

Midway into that year, we learned that only one new study

would be funded in fiscal year 2004, for fewer than $400,000. This

amount fell far short of the $20 million for new research to provide

answers to the long overdue questions.

Overall, Federal Gulf war research funding has fallen dramatically, from $50 million in 2001, to $20 million in 2003. Final figures are not yet available for 2004 and 2005, but it appears that

a downward trend has accelerated, at a time when medical

progress in understanding and treating Gulf war veterans is greater than ever before.

At this time, the VA is the only agency that funds new research

on Gulf war illnesses. In late 2004, the VA Research Advisory Committee submitted the full report to the Secretary. In that report the

committee reviewed government reports and literature which concluded that Gulf war illness constituted a serious health problem

and, for the large majority of veterans, was not explained by stress

or psychiatric illness.

Secretary Principi released the report, and offered to commit $15

million of new research. This funding would include an innovative

new program for identifying treatments for Gulf war veterans.

Well, what has the VA done with that commitment? In September, we received information from the VA’s 2005 research funding

initiative that the VA Office of Research reported they would spend

$9 million for Gulf war research in 2005, and a similar amount in

2006. But a closer look reveals that over $7 million of the $9 million was for projects already in place, and up to $1.7 million funded

new projects in fiscal year 2005—far short of the $15 million.

But worse, of the $1.7 million for projects identified as Gulf war

research, $400,000 was for research specific to Gulf war veterans’

illnesses, and the balance went to study ALS, a disease which has

only affected about 100 Gulf war veterans.

The VA has now identified that ALS is a serious problem, but

it really affects elderly people. It has affected twice the rate for

Gulf war veterans, but not in great numbers. Furthermore, of the

new studies listed as Gulf war research, many have nothing at all

to do with Gulf war illness.

For example, $1.3 million was spent on a study restoring function after loss of limb. Including this and other unrelated projects

in the total representative Gulf war research, this conveys a false

impression that the VA is spending more and doing more to address Gulf war illness than is actually the case.

Another disappointment was that there was no funding in 2005

for the much-needed, much-anticipated new study center for treatments.

There has been a consistent pattern, where the Secretary makes

a commitment, and the veterans respond, but the VA does not deliver. The truth is, very little of the 2005 research funding was for

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new projects as promised by the Secretary, and very few of the new

projects relate specifically to Gulf war illness.

Ill Gulf war veterans are left pretty much where they started in

1995, with no improvements in understanding and nothing new on

the research horizon. Entrenched bureaucrats under Secretary

Nicholson have not upheld the research promises made by Secretary Principi. Secretary Nicholson must take charge of this issue,

and direct his Office of Research and Development to spend the

money promised.

Veterans know that human studies of ALS, brain cancer, and

neurological impairments are linked with their deployments in the

Gulf war, and we are seeing higher rates of Multiple Sclerosis and

Parkinson’s Disease that need immediate investigation and research.

The record shows that DOD and VA failed Gulf war veterans. We

cannot allow this Nation or the VA to abandon the 1991 Gulf war

veteran; nor should we pit their health care and research needs

against returning veterans from this war. With the war escalating

now in the Middle East, the United States has deployed more than

1.1 million soldiers, sailors, airmen, and Marines. And with great

sorrow, I report to you that DOD and VA are not prepared for their

return.

Congress must order DOD and VA to collect data on these new

war veterans and to fund the studies that they have promised for

the 1991 Gulf war veterans. If we fail to act now, I believe another

generation of veterans will be sitting before you in this subcommittee in a few years, demanding to know why veterans groups, Congress, and the administration failed them.

Mr. Chairman, I know that we are short on time, so I will just

ask that the rest of my information be submitted for the record.

And thank you for allowing me to come testify here today.

[NOTE.—The GAO report entitled, ‘‘Department of Veterans Affairs, Federal Gulf War Illness Research Stategy Needs Reassessment, GAO–04–767,’’ may be found in subcommittee files.]

[The prepared statement of Mr. Robinson follows:]

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Mr. SHAYS. Thank you. I want to thank both Mr. Woods and you,

Mr. Robinson, for very thoughtful presentations. Thank you.

Mr. Binns, thank you for your service as chairman of the Research Advisory Committee on Gulf War Veterans Illnesses. It is

a privilege to have you here. And I want to make sure your statement is fully on the record. Thank you.

STATEMENT OF JIM BINNS

Mr. BINNS. Thank you, Mr. Chairman, members of the subcommittee. For nearly 4 years, I have had the privilege of chairing

the Research Advisory Committee on Gulf War Veterans Illnesses.

In the same 1998 law that established the Research Advisory

Committee, Congress directed the Department of Veterans Affairs

to contract with the National Academy of Sciences. The Academy’s

Institute of Medicine [IOM], was to review the scientific literature

regarding the substances to which troops were exposed in the Gulf,

to determine if these substances are associated with an increased

risk of illness.

These reports were to be used by the Secretary of Veterans Affairs in determining whether an illness should be presumed service-connected, and thus trigger veterans’ benefits.

I regret to inform you that for 7 years, VA and IOM staff have

subverted the will of Congress and misled the Secretary of Veterans Affairs regarding scientific research governing veterans’ benefits.

The law provided that the National Academy of Sciences shall

determine whether a statistical association exists between exposure

to the agent and the illness; the increased risk of the illness among

human or animal populations exposed to the agent; and whether a

plausible biological mechanism or other evidence of a causal relationship exists.

Notice, please, that the statute speaks to the increased risk of

the illness among human or animal populations. It is not just about

human health effects and the implications of animal research on

humans. It is equally concerned with animal health effects, per se.

Congress recognized that research on the health effects of hazardous substances necessarily is conducted primarily in animals.

The statute went on to provide that the Secretary of Veterans Affairs should consider animal studies in determining whether a presumption of service connection is warranted. He was to consider

the exposure in humans or animals to an agent, and the occurrence

of a diagnosed or undiagnosed illness in humans or animals.

When the first IOM report was conducted under the law, however, animal studies were omitted from the standard for determining an association. The report states: ‘‘For its evaluation and categorization of the degree of association between each exposure and

a human health effect, however, the committee only used evidence

from human studies.’’ The authors of the report went on to say—

and you will no doubt hear today—‘‘But we did consider animal

studies. We considered them for biological plausibility.’’

But under their methodology, biological plausibility does not even

come into play unless there has been a previous finding of an association based exclusively on human studies.

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The salient fact is that they did not consider animal health effects in determining whether an association exists between an exposure and an illness, as required by law, and the only question

that matters in the determination of benefits.

To express conclusions as to whether an association exists, the

authors set up five categories of association. Each substance was

ranked according to these categories. The authors offered the following explanation of where the categories came from: ‘‘The categories closely resemble those used by several IOM committees

that evaluated herbicides used in Vietnam and other substances

because they have gained wide acceptance for more than a decade

by Congress, government agencies, researchers, and veteran

groups.’’

It is revealing to compare a category of association used in the

Vietnam studies with the same category used in the first Gulf war

report, and all subsequent reports.

Vietnam: ‘‘Evidence is sufficient to conclude that there is a positive association. That is, a positive association has been observed

between herbicides and the outcome in studies in which chance,

bias, and confounding could be ruled out.’’

Gulf war: ‘‘Evidence is sufficient to conclude that there is a positive association. That is, a positive association has been observed

between an exposure to a specific agent and a health outcome in

human studies in which chance, bias, and confounding could be

ruled out.’’ The Gulf war category does indeed closely resemble the

Vietnam category. It tracks it almost precisely, with the exception

of a single word. The word ‘‘human’’ has been inserted in the Gulf

war category.

Like the earlier smokescreen regarding biological plausibility,

this change was no accident. It was a deliberate act to subvert the

intent of Congress. And it has been successful to this moment. It

has been the straightjacket into which every IOM committee has

been put when asked to review Gulf war research.

The law also said that the IOM was to consider combinations of

exposures; and they haven’t. The law said they were supposed to

consider undiagnosed illnesses; and they haven’t.

The most egregious example of this distortion involved recent

animal studies on the nerve gas Sarin, which showed that, contrary

to previous scientific belief, low-level exposures could produce longterm effects on the nervous and immune systems.

Then, VA Secretary Principi wrote the Institute of Medicine, ‘‘Recently a number of new studies have been published on the effects

of Sarin on laboratory animals.’’ He asked the IOM to report back

on whether the research affected earlier IOM conclusions regarding

‘‘the long-term health consequences of exposure to low levels of

Sarin.’’

Last year, the IOM delivered its report. The report did not consider animal studies in the all-important categories of association,

even though new animal studies were the only reason for doing the

report. Not surprisingly, it found no evidence of association.

This year, VA initiated three new IOM reports, which are underway at this moment. They were not reviewed by the Research Advisory Committee, as required by the 1998 statute. One purports to

be a broad review of Gulf war illnesses literature: ‘‘An IOM comVerDate 11-MAY-2000 13:28 Apr 17, 2006 Jkt 000000 PO 00000 Frm 00169 Fmt 6633 Sfmt 6633 D:\DOCS\25667.TXT HGOVREF1 PsN: HGOVREF1
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mittee will review, evaluate, and summarize the peer-reviewed scientific and medical literature to determine what this information

taken together can tell us about the health status of Gulf War veterans.’’ Again, however, the study design excludes animal studies.

These distorted IOM reports are being used widely by the Department of Veterans Affairs. On September 15th, VA Undersecretary of Health, Dr. Jonathan Perlin, sent an information letter to

VA doctors who treat Gulf war veterans. He assured the doctors

that, ‘‘A 2000 congressionally mandated review and a 2004 update

conducted by the IOM concluded, based upon their review of a

large body of scientific literature, that the evidence did not support

any long-term health effects following sub-clinical Sarin exposure.’’

In summary, this fraud has gone on since 1998, and continues

to go on. It has defied the will of Congress. It has distorted the

workings of the Institute of Medicine. It has denied the Secretary

of Veterans Affairs accurate information on which to determine veterans’ benefits. It has misled veterans and their doctors. Most tragically, it has misdirected researchers down blind alleys and away

from paths that might have led to treatments for these debilitating

illnesses.

Mr. Chairman, the Gulf war was the major military conflict of

the United States in the last quarter of the 20th century; 697,000

Americans served. According to the Department of Veterans Affairs’ own most recent study, 25 percent of them are ill with chronic multi-symptom illnesses. That means that more Gulf veterans

are ill than all the American troops in Iraq today.

But no one ever hears about it. No one knows about it. No one

does anything about it.

Why? Because of this. Because of the people who did this, and

who are perpetuating it today; who undermine the Secretary’s research commitments.

I ask myself: What kind of country are we living in, where we

send men and women to war, and government officials treat them

like this when they return?

Mr. Chairman, I urge Congress to use every power at its command to investigate this matter and ensure that the persons responsible are removed from positions of authority and punished.

Until they are, there will be no meaningful progress on Gulf war

illnesses research to improve the lives of ill veterans.

[The prepared statement of Mr. Binns follows:]

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Mr. SHAYS. Nineteen years, and that is one of the more powerful

statements I have ever had any witness deliver.

[Applause.]

Mr. SHAYS. Excuse me. This is a hearing and, I am sorry, applause is not allowed.

Dr. Henderson.

STATEMENT OF ROGENE HENDERSON

Dr. HENDERSON. Thank you, Mr. Chairman, for this opportunity

to testify before the subcommittee. I am Dr. Rogene Henderson, a

senior scientist emeritus at the Lovelace Respiratory Research Institute, an independent, not-for-profit research organization in Albuquerque, NM. I am a National Associate of the National Academies of Science.

I am testifying today concerning the value of animal research in

improving our ability to assess associations between exposure and

health outcome in humans. In particular, for this hearing I am addressing the value of animal research in determining associations

between exposures to noxious agents and health effects in Gulf war

veterans.

Because we are concerned about health problems in humans, one

might question the need for animal research. Why not treat the

conditions in humans symptomatically, as best we can? The answer

is that in some situations, as with veterans returning from war,

the symptoms may be diverse and difficult to diagnose.

Animal research allows us to determine the mechanism by which

the health problems occur. And this is done through conduct of controlled experiments that cannot be done in humans.

If one knows the factors contributing to the development of the

condition, one can then start to work on therapy or intervention

techniques; and hopefully, prevent the same problems from occurring in the future.

It is fair to ask whether animal responses correctly predict what

would happen in humans. Animals have numerous anatomical, cellular, physiological, and biochemical similarities with humans. And

we know a great deal about how to make allowances for known differences. Virtually every medical breakthrough in the past century

has come about as the result of research with animals. These include vaccines for Polio, the use of Insulin to treat Diabetes, kidney

dialysis, and cardiac bypass surgery, just to name a few.

Animal studies are now being used to assess possible associations between symptoms of Gulf war veterans and exposures to

noxious agents. For example, the effects of exposure to low levels

of nerve gas agents that do not cause obvious neurological symptoms have been studied. We all know what high levels of a nerve

gas will do. That kills us. But only recently have studies been completed to determine what low levels will do.

In our laboratory, we found that low level, sub-clinical exposures

of rats to the nerve gas Sarin suppresses the immune system and,

in the presence of high temperatures, results in alterations in areas

of the brain that are involved in cognitive function. Moreover, these

sub-clinical doses of Sarin also affect the neuroendocrine function,

and dramatically decrease serum cortisol levels. We are currently

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testing various therapeutic interventions for the treatment of these

effects.

Work by Dr. Abou-Donia, at Duke University, has shown that

the combined treatment of rats with Sarin and the chemical used

as a counter measure to Sarin, Pyridostigmine, causes death of

neural cells. The rats recover, but suffer persistent memory and

cognitive deficits. These symptoms are similar to those that were

reported by some veterans returning from the Gulf war, and also

in some survivors of the Japanese subway terrorist attacks.

This line of animal research, which would be impossible to conduct in humans, is essential to provide information about potential

health effects and approaches to treatment in veterans exposed

under similar conditions.

Animal studies are also being used to evaluate the risks to veterans from embedded depleted uranium. These studies include investigations to determine if the fragments can cause general toxicity,

or induce cancer, or can partially dissolve and move to the brain

or kidney and cause damage.

This type of information has been used to guide the medical

management of wounded Gulf war veterans. In any study on

human health, information gained from human experience is the

most useful. But when particularly puzzling health problems occur,

animal studies are an excellent tool to help determine potential

causes, effective therapeutic measures, and potential preventative

measures.

In the case of the Gulf war veterans, human information has

been considered. The human data have not been adequate to fully

explain the symptoms in the veterans, and animal research has

been conducted that provides clues to clarify the situation.

We are making good progress in determining the potential exposures that may be associated with the symptoms of the veterans.

In determining these possible associations, we must consider the

weight of evidence from all available sources of information, including human epidemiology studies, short-term clinical studies, and

animal studies. It would be irresponsible to do otherwise. Thank

you.

[The prepared statement of Dr. Henderson follows:]

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Mr. SHAYS. Thank you very much, Dr. Henderson.

Dr. O’Callaghan. Let me ask you, you work for the CDC, correct?

Dr. O’CALLAGHAN. I do. I work for the Centers for Disease Control and Prevention, National Institute for Occupational Safety and

Health.

Mr. SHAYS. And does your statement have to go through a process of approval before you submit it?

Dr. O’CALLAGHAN. Yes, it does.

Mr. SHAYS. Thank you. Dr. O’Callaghan.

STATEMENT OF JAMES P. O’CALLAGHAN

Dr. O’CALLAGHAN. Mr. Chairman and members of the subcommittee, my name is James O’Callaghan. I head the Molecular

Neurotoxicology Laboratory at the National Institute for Occupational Safety and Health, and I was recently appointed to serve on

the Department of Veterans Affairs Research Advisory Committee

on Gulf War Veterans’ Illnesses. I am pleased to be here in my capacity as a member of the Advisory Committee to discuss the use

of data from animal studies to diagnose and treat human brain disorders.

Over the past 25 years, I have focused my research on detecting

and characterizing the adverse effects of chemicals and drugs on

the nervous system—research that includes the use of experimental animals to model human brain damage.

In biomedical research, investigations using animal models are

useful for understanding disease processes and for the development

of relevant therapies for brain disorders that afflict humans. The

use of animal models is useful in the neurosciences because, short

of obtaining post-mortem brain samples at autopsy, there is no

other way to discover and understand the basis of brain disorders.

Moreover, while one might expect that brain disorders and brain

damage may easily be detected in living humans using psychiatric

and neurological examinations or even state-of-the-art imaging,

such is generally not the case.

Think for a moment of the two devastating diseases of the

human nervous system: Alzheimer’s Disease and Parkinson’s Disease. We can diagnose these distinct brain disorders in the living

human, but these are progressive neurological diseases that result

from underlying brain damage that starts decades earlier.

It is estimated that it takes the loss of 70 to 80 percent of the

neurons affected in Parkinson’s Disease before the onset of clinical

symptoms can be detected. This means that one is suffering from

the disease long before symptoms are evident. Thus, as

neuroscientists, we are faced with the problem of having evidence

of end-stage disease, without knowing the cause or even milestones

of disease progression.

This is where animal models are so useful. For example, genetically engineered mice and mice treated with selective neurotoxins

now make it possible to replicate features of diseases such as Parkinson’s and Alzheimer’s in a controlled laboratory setting.

These advances raise hope for a better understanding of the molecular basis of these debilitating diseases, and for the eventual introduction of therapies before symptoms become manifest and before the disease process has advanced.

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Such research and interventions are especially useful to NIOSH’s

work to enhance worker safety and health, since excess

neurodegenerative disease, including Parkinson’s and Alzheimer’s,

has been associated with a variety of occupations and workplace

exposures.

Although animal studies can be quite useful, they do have limitations. The major weakness of such studies is that biological differences between humans and animals may result in different responses to neurotoxins or medical interventions. So it is important

to bear in mind that animal data are not always predictive of

human responses.

When available, scientifically sound epidemiological data—data

that are based on the study of the distribution and determinants

of disease in human populations—are superior to animal data.

However, in cases where information about human exposure is

lacking, research in a controlled experimental setting, generally

using animals, can provide useful scientific information.

Animal models not only hold promise for leading to cures for neurological diseases; they form the cornerstone for safety assessments, and have proven to have predictive validity for setting margins of safety for potential adverse effects of drugs, including adverse effects on the nervous system.

Animal data have been used to help establish the margins of

safety to protect humans from drug-induced toxicity, to set pesticide exposure limits, and to determine if specific agents or mixtures have the potential for adverse long-term outcomes.

As the relationship between chronic, low-level exposures and adverse neurological outcomes has become better understood, the Department of Veterans Affairs and the U.S. Army have established

animal research programs to further our understanding of the relationship between chemical exposures and neurodegenerative diseases.

The long-term goals of these programs are to relate short- and

long-term exposures to specific chemical agents and mixtures to the

development of brain disorders, and to develop specific

neuroprotective agents and strategies to protect against the development of nervous system disorders.

In summary, animal studies have been, and will continue to be,

of great importance in establishing a predictive relationship between specific exposures in humans and subsequent adverse effects

on the nervous system.

Again, thank you for the opportunity to testify before you today.

I will be happy to answer any questions.

[The prepared statement of Dr. O’Callaghan follows:]

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Mr. SHAYS. Thank you very much, Dr. O’Callaghan. Let me start

out with you, Dr. O’Callaghan, and ask you—and I want you to listen to how I am asking the question—separating Mr. Binns’ points

about people being held accountable for what has happened in the

VA in its ignoring, in my judgment, the law, is there anything that

you disagree with Mr. Binns on in his statement?

In other words, setting aside—I would not ask you, as someone

working for the Government, to suggest that people be fired and so

on. I want to know, though, do you disagree with his analysis that

the law has not been followed?

Dr. O’CALLAGHAN. Mr. Chairman, I doubt if I could adequately

respond to any question relating to legal responsibilities. But I

would agree wholeheartedly with Mr. Binns’ suggestion that animal models of long-term neurological effects, as part of the law that

was in place, have not particularly been adequately followed at this

point in time.

But that is based on the fact that in studies that rely solely on

human data and not on experimental animal data, those would not

be complete studies to reveal the broad class of effects that you

would see relationship to long-term, low-level exposures to agents,

such as Dr. Henderson has already talked to us about today.

Mr. SHAYS. Dr. Henderson, I am going to ask you the same question.

Dr. HENDERSON. Well, I would like to say, as I said in my testimony, we are beginning to make great progress on this problem.

And it would be foolish, irresponsible, I think, not to take into account the progress that is being made using animal models on the

effects, particularly of some of the nerve agents such as Sarin; because we are just beginning to find out things.

Mr. SHAYS. Yes, and who funds your projects?

Dr. HENDERSON. Who funds my projects? The first study we did

was from the Gulf war, DOD and the Gulf War Syndrome. And

now DOD has funded our latest studies, and we are applying for

NIH funding now.

Mr. SHAYS. Have you asked for any funding through the VA?

Dr. HENDERSON. No, we have talked. I didn’t think they had the

money to fund it, so we haven’t pursued that.

Mr. SHAYS. Mr. Woods, I am going to ask you the same question.

Mr. WOODS. I would just answer it simply, that I agree 100 percent with Jim Binns that they are failing to obey the law.

Mr. SHAYS. Mr. Robinson.

Mr. ROBINSON. We spoke about this this morning, whether or not

it rose to the level of actually having a special prosecutor look at

whether or not the intent of the law was broken.

I am not a lawyer; neither is Mr. Woods. But we believe the law

has been violated. Clearly, the intent of the law has been violated.

And it has been steered down a road which has harmed individuals

and created delay. So, yes, sir, we believe that it is a very serious,

very serious charge.

Mr. SHAYS. OK. Dr. Henderson and Dr. O’Callaghan, addressing

the point of, ‘‘Evidence is sufficient to conclude that there is a positive association; that is, a positive association has been observed

between herbicides and the outcome in studies in which chances,

bias, and confounding could be ruled out;’’ and then the Gulf war,

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‘‘Evidence is sufficient to conclude that there is a positive association; that is, a positive association has been observed between an

exposure to a specific agent and a health outcome in human studies in which chance, bias, and confounding could be ruled out’’—tell

me the significance of those two different perspectives, Vietnam

and the Gulf war. I will start with you, Dr. O’Callaghan.

Dr. O’CALLAGHAN. They should be the same, and addressing

these problems with animal models and epidemiological data

should be applied across both.

Mr. SHAYS. And it isn’t, based on that definition?

Dr. O’CALLAGHAN. Not necessarily, no.

Mr. SHAYS. And explain why.

Dr. O’CALLAGHAN. Because one takes out ‘‘animals,’’ and one does

not.

Mr. SHAYS. Which takes out ‘‘animals?’’

Dr. O’CALLAGHAN. The Gulf war.

Mr. SHAYS. Thank you. Dr. Henderson.

Dr. HENDERSON. Well, I think it is essential to make use of animal research in both instances; though the way it is written, you

wouldn’t take them into account in the Gulf war.

Mr. SHAYS. So let me just say it again. The way it is written, you

wouldn’t take it in what? Finish your sentence again, please.

Dr. HENDERSON. The way it is written, you would assume they

weren’t taking into account animal studies.

Mr. SHAYS. In the Gulf war?

Dr. HENDERSON. In the Gulf war, no. And I said that I don’t see

any point in tying one hand behind your back. Why not use the information? And it is of such great value. You need it in this case,

because it is not clear from the human data.

Mr. SHAYS. Now, in my statement I made reference, and I think

there was reference by some of your statements, to the fact that

the FDA, in approving drugs, looks at animal studies. And in the

case here, it doesn’t. Does that sound to you—in other words, to affirm and to allow the drug to be used, they will look at animal

studies. Is that correct, Dr. O’Callaghan?

Dr. O’CALLAGHAN. Yes.

Mr. SHAYS. Is that correct, Dr. Henderson?

Dr. HENDERSON. Yes.

Mr. SHAYS. In the case of Gulf war illnesses, it appears they do

not. Explain to me, give me your best argument, both of you, as

to, in spite of the fact that the law requires it—but if I take Mr.

Binns’ comments in every aspect except to suggest that someone be

removed from office and prosecuted, if I take that out, give me the

best argument why the bureaucracy would be so reluctant to look

at animal studies. The best argument.

In other words, I am asking you to say what is their best argument. What is the best logical argument?

Dr. O’CALLAGHAN. Well, to play devil’s advocate, the only thing

you could say is that you had such solid data in hand from human

exposures that would be predictive, and you would understand the

basis for the disorder; which of course, we don’t have that data.

Mr. SHAYS. And why don’t we have that data?

Dr. O’CALLAGHAN. Because the exposures are too difficult to determine. And the multiple agents and the constellation of effects

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are so difficult to assess only under human epidemiological conditions that we need animal models, to study that for a long-term

basis.

Mr. SHAYS. Dr. Henderson, would you add anything to that?

Dr. HENDERSON. Well, I think you are asking me to read someone else’s mind, I mean, to say what is in their——

Mr. SHAYS. No, I don’t care if you read someone else’s mind. I

want you to tell me what the best argument could be for not using

animal data. You don’t have to be in anybody’s mind. Give me the

best reason.

I think, after you give me your answer, you will understand why

I have asked the question. So give me the best reason. You are advising the VA not to use animal studies. Tell me your best scientific

reason for not using them.

Dr. HENDERSON. Boy, that is troublesome. You are talking to

someone who has spent their life in animal research and seen the

value of it. So you are asking me to go against my——

Mr. SHAYS. But you must have heard the arguments.

Dr. HENDERSON. Well, it is money, I guess.

Mr. SHAYS. What is it?

Dr. HENDERSON. It may be that they are concerned about money.

Mr. SHAYS. I am not asking you for motives. You have requested

that I not ask for motives. Give me the best argument for not doing

it. It may not be a good argument, but give me the best argument.

Dr. HENDERSON. Animals are not humans, and we only care

about humans.

Mr. SHAYS. OK. Mr. Binns, a little reluctant to—I want you to

remove your anger—that I share—that the VA has not lived by the

law, and give me the best argument on why you would not use animal studies.

Mr. BINNS. I don’t think there is a good argument. But the argument that has been made, both in the reports and I saw it today

in the paper, is the one that Dr. Henderson mentions: that humans

are not animals, and therefore we have to limit our use of animal

data.

And we don’t know what the dosage levels were in the Gulf, and

therefore we can only consider a conclusion as to humans if we

knew the dosage level. But of course, they will never know the dosage levels, and they know that.

Mr. SHAYS. This subcommittee has held 14 hearings in the

course of our work on this issue. And it is clear there are a lot of

things we don’t know. I mean, it is clear there are a lot of things

we do know.

Most soldiers acted like I acted the first time I decided to put fertilizer on my lawn. I thought if I did it according to the directions,

I would set my Scott spreader at three-and-a-half. That was what

they said would produce results. I used my distorted logic and said,

‘‘Well, if this is so good, double is better.’’ So I set it at six. I ended

up with a burnt lawn.

We had witness after witness in the course of 14 hearings that,

when the alarms went off, they took PB, Pyridostigmine Bromide—

and it took me more than 10 years to be able to say that word—

and they just took them all, all at once. You made reference, I

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think, Dr. O’Callaghan—or did you, Dr. Henderson—to the mixing

of PB and Sarin.

Dr. HENDERSON. Yes.

Mr. SHAYS. And what was the finding that you made?

Dr. HENDERSON. This is work of Dr. Abou-Donia, and he found

that the combined exposures were more deleterious than either one

alone. So both of those compounds act at the same reactive site.

Mr. SHAYS. Describe to me again the outcome.

Dr. HENDERSON. They have a death of neural cells, and there is

a memory deficit that is persistent after the—and this is in rats.

A memory and cognitive function deficit occurs in the rats.

Mr. SHAYS. Dr. O’Callaghan, could you add anything to that?

Dr. O’CALLAGHAN. At least when you look at short- or long-term

toxic effects of compounds, often what you see in humans as well

as animals is that you can get aggregate, or synergistic, toxicity

when multiple agents are put together. So you need to study those

types of events and those types of exposures in a very controlled

setting, to get a reliable outcome that would be predictive of human

data.

So what Dr. Henderson has said is that this is a double exposure

that gave effects that the single ones alone may not have. So this

is another reason to use the animal models, to study these effects.

Mr. SHAYS. And didn’t you, Dr. Henderson, say that your immune system is impacted?

Dr. HENDERSON. Oh, very definitely. And this was a surprise to

us. That is why it is so interesting. We didn’t know what low levels

would do. But it has a drastic suppression of the immune system.

Mr. SHAYS. Did you say ‘‘drastic?’’

Dr. HENDERSON. Yes.

Mr. SHAYS. So low levels in animals had a drastic what?

Dr. HENDERSON. Effect on the immune system. And of course,

this means, if this happens in humans, veterans would be more

susceptible to infectious agents, etc.

Mr. SHAYS. Right.

Dr. HENDERSON. So we are still working on the mechanism by

which this happens. And we are hoping to get some ideas for intervention or treatment.

Mr. SHAYS. Mr. Binns, in your dealing with the VA—and DOD

as well—but in your dealing with the VA, does the VA or DOD

deny that veterans are sick, but just can’t determine their cause—

excuse me. Do they accept the veterans are sick, but feel they can’t

determine the cause of the sickness? Or do they even deny the veterans are sick?

Mr. BINNS. They accept that the veterans are sick, but there is

a disconnect between what they say as to the magnitude of the

problem. On the one hand, they will stress studies showing that

there are small numbers of veterans who are ill with various diagnosed illnesses—standard, off-the-shelf illnesses that people are

used to.

On the other hand, at our last committee meeting we heard testimony from Dr. Han Kang of the VA, on his most recent study of

Gulf war veterans which found that in excess of 25 percent of Gulf

war veterans are ill with chronic, multi-symptom illnesses that

don’t fit into these neat categories.

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So their own research does confirm that large numbers—a quarter or more—are ill. But they act as if it’s only the diagnosed illnesses, which may be a much lower percentage.

Mr. SHAYS. Now, you talked, Dr. Henderson, about motives. And

I wrestle with that issue tremendously, because there is no question—we documented it 100 different ways—that veterans are sick.

I do agree the VA believes the veterans are sick. I do believe the

DOD believes veterans are sick, but is even less interested than

the VA in wanting to deal with this issue.

So, you know, then I get to motives. And while you can’t speculate about motives, I can, and I do. And we are going to ultimately

sort it out. One could be a fiscal issue. They have looked at ALS,

and they said, ‘‘Yes, we are going to make a presumption there.’’

My sense is it is because it is only 100, and it is such a devastating

disease; so it made the list.

But as you start to look at some of these others, then the number

expands significantly. So I think fiscal is a possibility.

I also think that in these studies there is concern about the use

of uranium in the shells and in the protection on the equipment,

and the view that this may be a factor. If your animal studies point

that out, it has significant impact on how we think about the weapons systems and the protections that we provide our soldiers. So

that is another area.

The other one is that the VA, in the course of our hearings, has

very few people who work for it who deal with hazardous material

in the workplace. And so I find myself being more tolerant because

all the folks—there are very few people that have an expertise in

this area: chemicals, the impact of chemicals on the body, and so

on, in the workplace.

We found that of the thousands of people who work for the VA,

they could only name us two people of the doctors, they could only

name us two who had any expertise. So when veterans came in,

they didn’t have people who would intuitively say, ‘‘You know, we

have seen this in the workplace.’’

So Mr. Binns, I am going to have my staff person ask questions

in a second, but did you want to make a response?

Mr. BINNS. Yes. It is true that Secretary Principi authorized benefits for veterans with ALS. But in fact, that has not been serviceconnected as an across-the-board finding. The VA at the moment

has no presumed service-connected illnesses for Gulf war illness.

Mr. SHAYS. Say that again?

Mr. BINNS. The VA has no illness which is currently service-connected automatically under a presumption.

Mr. SHAYS. So explain to me how they cover ALS.

Mr. BINNS. They covered ALS for the subjects who came through.

And I do not know what has happened to people who have contracted ALS since. But it was done on a case-by-case basis.

Mr. SHAYS. Yes, Mr. Robinson.

Mr. ROBINSON. The Secretary has the authority—it is kind of like

a magic wand—to pick out a particular group and say for those

people, ‘‘We will take care of them. We will pay them benefits. It’s

a very debilitating disease.’’ But it was not codified into law as a

presumptive service connection; much like the finding for brain

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cancer will most likely not be codified into law as a presumptive

service connection.

And if I might add, you have been talking about motive. The

clearest motive to me that there is a problem is this document

right here, which educates VA clinicians. It is so full of inaccurate,

old, no longer recognized scientific information.

Mr. SHAYS. And what is that document?

Mr. ROBINSON. This is called the ‘‘Veterans Health Initiative: A

Guide to Gulf War Veterans’ Health.’’

Mr. SHAYS. Is there a date on it?

Mr. ROBINSON. It was originally written in 2002, I believe, which

is what is written on it. And the findings are, ‘‘Most Gulf War veterans have health problems similar to those experienced by veterans of other eras;’’ which is patently false, including the VA’s own

admission from their study which indicates that is not true.

Another section says, ‘‘Panels have been unable to identify a

unique Gulf War Syndrome or find any specific war-time exposure

to be a significant cause of illness amongst veterans.’’ This is the

information that the clinicians are reading, and the reason why,

when Mike Woods walks into the VA in Kentucky, his doctor tells

him, ‘‘I don’t know why you’re here. Gulf war veterans aren’t sick,

and you don’t deserve compensation.’’

This is intent. Nowhere else in the military, in the DOD, or in

Congress, can you put out a document like this, and not keep it

current, and not be telegraphing your intent.

The VA has not kept up, or even consulted with or promoted, the

information that the Research Advisory Committee was stood up to

look at. It is not in this document. It is very rarely talked about.

I think it screams intent. And it is something we would like to get

changed.

Mr. SHAYS. Mr. Binns.

Mr. BINNS. One further comment about ALS. One of the three

new studies that the VA initiated this spring with the IOM relates

to ALS. There are only three studies in the literature pertaining

to ALS and military service, so it is quite extraordinary to ask for

an IOM committee to be stood up for the purpose of examining

three studies.

Mr. SHAYS. I missed that point, I’m sorry. Hit me again with

that.

Mr. BINNS. Usually, the IOM is brought into play when there is

a very large body of scientific literature to review; such as in the

case of exposures to pesticides or something like that. So it is a red

flag to see that the VA has asked IOM to review the literature on

ALS and Gulf war or other military service. And it is not something that would usually be done. It is not something which Congress mandated be done.

And the evidence is suggestive that the motives are not good;

that the finding is going to be that this is something which we

don’t know enough about yet, and therefore we shouldn’t have

‘‘service-connected.’’

Mr. SHAYS. I am going to ask Counsel to ask some questions, and

then I am going to come back for a few more.

Mr. HALLORAN. Thank you. Mr. Woods, in your testimony, you

said you underwent a VA Registry exam after your service. Were

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you asked at that time, or at any time since then, about potential

exposures, toxic exposures?

Mr. WOODS. No.

Mr. HALLORAN. Did you volunteer the information?

Mr. WOODS. They didn’t ask.

Mr. HALLORAN. They didn’t ask.

Mr. WOODS. I don’t think they wanted to hear.

Mr. HALLORAN. In our testimony, you also said, though, that you

did manage finally to get a claim through, based on your illnesses.

Would you describe briefly that process and its outcome? What is

the basis of the claim, and how did you prove it?

Mr. WOODS. In my testimony, I cited that I had been seeing a

neurologist, who is also a psychologist, and he did a multitude of

neurological tests. And I submitted those, as well as the VA’s neurological tests that found the exact same findings as my private

neurologist. And they were unable to diagnose the reason, the

basis, for the signs and symptoms that they found in a neurological

nature. And the claim was approved as an undiagnosed illness

claim.

Mr. HALLORAN. Mr. Robinson, is that your experience, more

broadly, with Gulf war veterans in the disability system?

Mr. ROBINSON. I would just like to add one thing, because I am

very connected with Mike’s case. It is that it should not take a congressional representative’s interaction to get a VA claim approved.

And the reason that his VA claim rose from where it was to importance in the VA is because Congressman Putnam said, ‘‘Well, here

is his evidence. Let’s prove it.’’ And it shouldn’t take that.

My experience is that VA doctors don’t know what the current

science says today. They probably don’t know, if we walked into—

you pick it—VA anywhere in the United States and said, ‘‘Tell me

about the findings of the Presidentially directed, VA-appointed Research Advisory Committee,’’ they would not know what you were

talking about. That is the first problem.

The second problem is adjudicators do not follow the law. And

the undiagnosed illness law has been particularly harmful, because

they have identified, basically, three diagnoses within the

undiagnosed law that you can—if you get CFS, MCS, or irritable

bowel syndrome, then you have undiagnosed illnesses. But you

have to get the diagnosis of CFS to get undiagnosed illnesses. It

is particularly harmful to veterans. It is confusing. The adjudicators don’t know how to do it.

It is my experience that the first thing is, if you don’t look, you

don’t find; if you don’t educate the doctors, then they won’t know

how to diagnose; and if the adjudicators aren’t trained properly and

familiar with what the law says they are supposed to do, then the

veterans’ claims won’t be approved.

Mr. HALLORAN. Mr. Binns, back to the three pending IOM studies, your testimony says that, as you read the law, those studies

should have been passed by the Research Advisory Committee before being submitted to the IOM. Did you raise that issue with VA,

and what was their answer?

Mr. BINNS. Yes, when we learned of the studies, I did bring it

to the attention of Secretary Nicholson. Secretary Nicholson had

been in office about 2 months at that time. I was shown a memo

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from Undersecretary Perlin objecting to my objection. No action

has been taken to review the appropriateness of the actions that

have been started by VA.

Mr. SHAYS. Do you have a copy of that memo?

Mr. BINNS. No.

Mr. SHAYS. I would like to direct the subcommittee to get a copy

of that.

Mr. HALLORAN. With that as background, describe, if you would,

more broadly the committee’s relationship with VA over the course

of your service there. I mean, when was the first time you noticed

this particular problem, and what was their response to that?

Mr. BINNS. This has been raised over 6 months ago. We actually,

last year when the updated study on Sarin was presented, observed

that it seemed bizarre that when the study was initiated solely because of new animal studies, animal studies were not taken into

account in the basic conclusions.

But it was just after these new IOM studies were begun this

spring that we read the law carefully and learned that, indeed, by

law, animal studies were to be weighed with the same evidence as

human studies.

Our broader relationship with VA’s research office has been one

of—I’d say initially, we were kept at arm’s-length as much as possible. We were——

Mr. SHAYS. Excuse me, arm’s-length between whom?

Mr. BINNS. Between the Research Advisory Committee and the

Office of Research and Development. In the fall of 2002, for example, a new deployment health initiative was published by VA. We

were never consulted prior to this initiative being put out, even

though it clearly is a proposed plan within the plain meaning of the

statute.

Then, with the appointment of Dr. Wray, who was briefly the

chief research and development officer, we were more involved, in

the sense that she actually came to our meetings; she paid attention to our work. And she was only in office for about 1 year.

Then, in 2004, as Steve just mentioned, we discovered halfway

through the year that the VA, rather than planning up to $20 million in research, had planned for $400,000 in research. We brought

that to the attention of Secretary Principi. He froze the VA research budget at that moment. And at that point in time, we began

to get much higher levels of communication.

And if you remember the last time I appeared before you, in

June 2004, we appeared to be on a true turnaround at VA, where

a plan had been agreed upon, Dr. Perlin was involved in preparing

it——

Mr. SHAYS. Let me just be clear. That was still under Secretary

Principi?

Mr. BINNS. Yes, it was. And so, unfortunately, shortly thereafter,

a new Acting Chief Research and Development Officer, Dr. Finn,

took office, and we began to see that plan fall apart. And in

November——

Mr. SHAYS. Again, who was the individual when you saw the

plan fall apart?

Mr. BINNS. Dr. Steven Finn. He was the acting chief research

and development officer for about 1 year.

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In November, Secretary Principi announced the plan, as Steve mentioned, to do up to $15 million of new research in fiscal year

2005. As of—well, we were just recently given a report showing

what the VA claimed to have funded in research in 2005. And as

Steve said, while the total is $9 million, if you take out projects

funded in previous years and ongoing projects, the total is only a

few hundred thousand dollars at best.

Mr. SHAYS. Let me be clear. You are saying that the studies that

were done in 2005 were just a continuation of projects begun earlier?

Mr. BINNS. Yes. In some cases, they were new studies, but they

were studies which had actually been done under the 2004 initiative. And oddly enough, while VA takes credit for these as being

evidence of new studies that are started, half of those studies related to stress. And they were the studies that caused Secretary

Principi last November to say, ‘‘We are not going to fund stress on

fiscal year 2005 studies.’’ So to see them using those studies to take

credit for what they did in fiscal year 2005 is extraordinary.

I should add that there is a new chief research officer, Dr.

Coopersmith. And he has launched some—he has actually got a

copy of the treatment development program that is ready to go. But

we have seen them get to first base many times before.

This cycle varies depending upon, frankly, how many times Ross

Perot calls the Secretary of Veterans Affairs. And if he hasn’t

called for a while, they seem to forget us, and they seem to forget

Gulf war illness research. When he calls, then suddenly they become interested again.

So had this new effort by Dr. Coopersmith begun 3 years ago, I

would be much more convinced that it represented a change in attitude. At this point in time, I have seen it too many times. Until

there are actual results to report that make a difference, I don’t believe these guys any more.

Mr. SHAYS. Have you been reappointed to this position?

Mr. BINNS. My term is up in January.

Mr. SHAYS. Are you term-limited? Could you be reappointed legally?

Mr. BINNS. Legally, I could be reappointed.

Mr. HALLORAN. Thank you. Drs. Henderson and O’Callaghan, attached to Mr. Binns’ testimony—I don’t know if you have seen it—

but there is a list of the animal studies conducted in this realm

from 1976 to, I think it is about 2004, including some of your work

Dr. Henderson. And much of this is the body of work that Secretary Principi asked the IOM to review, to see what impact it

might have on their earlier findings regarding Sarin exposure.

Help us understand what besides biologic plausibility, what other

elements of missing epidemiological data can these animal studies

help inform?

Dr. HENDERSON. Well, it defines the exposure level that was required to cause these effects.

Mr. HALLORAN. And can that be extrapolated to humans? I

mean, mice are little things.

Dr. HENDERSON. You could do some modeling and try to extrapolate to humans. The missing information, of course, is what the humans were exposed to. So it indicates that you should look at the

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potential exposures to low levels of Sarin as a potential cause for

some of these effects, and that is a plausibility. But it opens the

way for a lot of new research on how you could do therapy, how

you could do interdiction techniques, etc.

Mr. HALLORAN. But in terms of what you understand about the

IOM project—have you ever sat on an IOM committee?

Dr. HENDERSON. Yes, I have. Two.

Mr. HALLORAN. Oh, OK. So in terms of the process they are undergoing, in terms of these categories of association——

Dr. HENDERSON. Yes.

Mr. HALLORAN [continuing]. Is it, to use your word, irresponsible

or bad science to use animal data to inform your conclusions about

a factor other than biological plausibility?

Dr. HENDERSON. Well, I think, of course——

Mr. HALLORAN. That is where they seem to park it, and so I am

just asking.

Dr. HENDERSON. Yes, I see what you are asking. It does contribute to the plausibility question. But it would also help with the

dose/response information, which is a step further down the road.

How much of this is required?

It also helps with the, you know, persistence and answering

questions. Is this something that persists, or is it something that

goes away very quickly?

But I think the dose/response information is probably the fundamental new information you get from those studies.

Dr. O’CALLAGHAN. Just generally, I would say we are living in

an era of unprecedented advances in the neurosciences. And these

advances are predicated in large measure on basic mechanistic

work done in laboratory animals. And in a toxicological context, as

Dr. Henderson already said, setting dose, setting dosing regimens

for long-term exposures, and then looking for the most sensitive indicators of underlying effects that are adverse—for example, on the

nervous system—are examples of what you can do in animal models, and why you would include those data.

Animal models are not always predictive, however, of the human

condition. But you are interested in the broadest net being cast to

get the answer to the problem.

Dr. HENDERSON. There is one more thing that I was thinking. In

our studies, we found this lowering of serum cortisol levels is quite

interesting as a potential biomarker of exposure that might be used

in the field. In other words, if people came in, you could—you

know, seeing this, you might associate it with exposure to nerve

gases. We are still working on that, whether that is possible.

Mr. HALLORAN. If that is the case, lower cortisol levels, is that

like a blood test, or is that a 36-hour PCR process?

Dr. HENDERSON. Well, I am not sure I understood your question.

Mr. HALLORAN. If lower cortisol levels were to be a biomarker for

exposure——

Dr. HENDERSON. Yes.

Mr. HALLORAN [continuing]. Is the lower cortisol level easily detected? Or is it something you won’t know for 36 or 48 hours or

more, once we take blood or whatever we have to do?

Dr. HENDERSON. I think those are details that we would have to

work out.

231

Mr. HALLORAN. You don’t know.

Dr. HENDERSON. We don’t know the answer to that.

Mr. SHAYS. Dr. O’Callaghan, I understand that the statement

you delivered ultimately has to be approved, correct, by CDC?

Dr. O’CALLAGHAN. That is correct.

Mr. SHAYS. So what was taken out would be your view; not

CDC’s. I am interested to know, was there any part of your statement that was taken out that you felt fairly strongly about?

Dr. O’CALLAGHAN. As you know, as a government employee, this

has to go up the chain of command—actually, quite high.

Mr. SHAYS. Right.

Dr. O’CALLAGHAN. And it has to even go over to the office of——

Mr. SHAYS. And let me just say something. You have a protection

right now. You are under oath.

Dr. O’CALLAGHAN. Yes.

Mr. SHAYS. Let me just say it again. Every one of you is under

oath. You have to respond accurately to the questions I ask. And

I am not asking an unfair question. I am asking, just simply, was

there an issue where your statement as approved by CDC varied

from what you wanted in any noticeable or significant way? And

if so, what area was that?

Dr. O’CALLAGHAN. That is a tough question. I would say maybe

the emphasis that was placed more broadly on the potential data

you can gain from human studies being——

Mr. SHAYS. So let me put it in my words. You were a little more

enthusiastic than CDC would like about animal studies being helpful.

Dr. O’CALLAGHAN. Yes, and that is often the case with lab scientists putting forth their opinions.

Mr. SHAYS. Fair enough. Fair enough.

Dr. O’CALLAGHAN. OK.

Mr. SHAYS. You know, I am not describing any bad faith on the

part of CDC.

Dr. O’CALLAGHAN. All right.

Mr. SHAYS. They want to be a little more cautious.

Dr. O’CALLAGHAN. Right.

Mr. SHAYS. Just wanted to know.

Dr. O’CALLAGHAN. Yes.

Mr. SHAYS. I want to go over one old territory just once more,

to make sure that I am not incorrect on my knowledge and understanding.

I used to chair a subcommittee of this full committee that

oversaw all the Department of Health—the FDA, CDC, and so on.

My recollection has been—and we have had hearings since then, as

well—that as a general rule, when bringing out a new drug, we

would have experiments on animals. And at some point, when we

think that we are ready to go to the marketplace, we take those

drugs and have studies with human beings. Is that correct, Dr.

O’Callaghan?

Dr. O’CALLAGHAN. Yes, it is.

Mr. SHAYS. Yes. But that presents a problem. For instance, if we

wanted to have a prophylactic, a vaccine against some terrible biological agent, we could do it on animals, but then we may not—

since there are no case studies of human beings contracting a parVerDate 11-MAY-2000 13:28 Apr 17, 2006 Jkt 000000 PO 00000 Frm 00235 Fmt 6633 Sfmt 6633 D:\DOCS\25667.TXT HGOVREF1 PsN: HGOVREF1
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ticular disease, we are not going to inflict them with Polio—well,

Polio, we had—but a particular biological agent. That would be unethical and wrong; correct?

Dr. O’CALLAGHAN. Correct.

Mr. SHAYS. Right. So we are faced with this difficult choice of

going to the marketplace just with animal studies, in the cases of

having certain vaccines. Is that correct?

Dr. O’CALLAGHAN. That is correct.

Mr. SHAYS. Right. And we have made a determination in a variety of issues to go to the marketplace without having human studies. I mean, this is the end result. Is that correct?

Dr. O’CALLAGHAN. That is correct.

Mr. SHAYS. OK. Now, in that case, we had no human studies to

validate. Is it your understanding—and I will ask you, Mr. Binns

and Dr. Henderson—is it your understanding that, as it relates to

Gulf war illness, if we aren’t able to use human studies, that this

process of determining, in a sense, the veterans the benefit of the

doubt, that there is no way we can give them the benefit of the

doubt without animal studies? Is that a correct way for me to view

this, in your opinion, Dr. O’Callaghan?

Dr. O’CALLAGHAN. For that purpose, most definitely, because

there would be no other way to get adequate information that

would be predictive of what would happen in man.

Mr. SHAYS. Dr. Henderson.

Dr. HENDERSON. I think, definitely, that is the only way.

Mr. SHAYS. A little louder, love.

Dr. HENDERSON. I think that is definitely true. That is the only

way you can give the veterans the benefit of the doubt. And to protect them. I mean, we have found out things in animals about the

interaction between the Pyridostigmine and the Sarin that wasn’t

known. You wouldn’t find that in humans.

Mr. SHAYS. So just based on what the two of you have responded,

this almost becomes a farce. If we are going to put veterans

through this process without animal studies, they are never going

to get the benefit of the doubt, unless there is just an arbitrary decision on the part of the Secretary to just say ‘‘OK.’’ Mr. Binns, am

I off track here, or on track?

Mr. BINNS. No, sir, let me answer by just giving you a very short

example. If you would turn to Tab 11 of my statement——

Mr. SHAYS. Titled ‘‘Environmental Exposure Report?’’

Mr. BINNS. Yes. This is the cover page of about a 2-inch-thick

study done by the Department of Defense on environmental exposures in the Gulf—I say ‘‘on exposures;’’ this was done on one exposure, the exposure to pesticides.

And if you turn to the second page, you will see the conclusions:

‘‘It is likely that at least 41,000 service members may have been

over-exposed to pesticides.’’ And turn the page further: ‘‘Over-exposures to pesticides, particularly organophosphates and carbamates,

may have contributed to the unexplained illnesses reported by

some Gulf War veterans.’’

This is very clear language from a scientific study that was commissioned by our Government, and done exhaustively on all of the

exposures of pesticides in the Gulf. This is not being considered by

the IOM currently in its reports. To me, this is a much more valid

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type of report on which to base evidence than the ones that have

been produced using the complex language of the IOM reports.

Mr. SHAYS. Now, you may know, or may not know, so tell me if

you know, and tell me if you are speculating, or tell me you don’t

know. Is it your statement before this subcommittee that the IOM

chooses not to look at animal studies, or is prevented from looking

at animal studies because of the way the VA has directed them?

Mr. BINNS. I do not know who set up the original categories of

evidence. But whoever did, that has created the framework in

which the IOM committees have operated.

Mr. SHAYS. OK. And the category of evidence is referred to by

this statement in part?

Mr. BINNS. Yes. It is these standards which only could take into

account human studies and human health effects.

Mr. SHAYS. OK. Let me ask each of you, to conclude. Is there any

question we should have asked that we didn’t? I want you to ask

yourself the question; then I want you to answer the question. Is

there any statement that you would like to make before we conclude?

You have two choices here. You can do both. But if there is a

question we should have asked you that we didn’t, I want you to

ask yourself the question. I will start with you, Mr. Woods.

Mr. WOODS. No sir.

Mr. SHAYS. Thank you. Mr. Robinson.

Mr. ROBINSON. The question I would ask is: Why are we not

moving forward when the science is pushing us in a direction? And

why is the VA, the people who are supposed to take care of veterans and bind up the wounds of war—what excuse do they have for

not knowing what the current science is? And what excuse do they

have for not listening to the committee that was stood up, directed

by the President, appointed by the VA, to help them in understanding these illnesses?

And the answer to my own question is: I don’t know. But it is

incredibly shameful. It is absolutely shameful that somebody in the

VA can give Mike Woods placebo for real pain, and not tell him

what it is, and he would go home and take it. It is shameful that—

and I don’t know how many other Gulf war veterans have been

given this. We just found out about it. But it is shameful.

Mr. SHAYS. Yes, let me be clear. That was given to you by——

Mr. ROBINSON. The VA medical center in Orlando.

Mr. SHAYS. No, I am not asking you, Mr. Robinson. Mr. Woods,

I’m sorry. Mr. Woods, it was given to you by whom?

Mr. WOODS. The VA medical center in Orlando, FL.

Mr. SHAYS. OK. And how do you know it is a placebo?

Mr. WOODS. It says ‘‘Obecalp,’’ which spelled backward is ‘‘Placebo.’’

Mr. SHAYS. Now, let me just be very clear. Just so you know, you

have a lot of credibility with me, but you are coming before a subcommittee under oath, and saying that was given to you by the

VA?

Mr. WOODS. Correct.

Mr. SHAYS. OK. I just want to make sure you know. And when

I ask the question this way, it puts more emphasis on you making

234

sure you are correct when you are further asked about this. And

you will be further asked about this. OK. Thank you.

Mr. ROBINSON. Thank you.

Mr. SHAYS. I am going to end with you, Mr. Binns. So, Dr. Henderson, any question we should have asked that we didn’t, that you

would like to ask yourself? Any statement you would like to make,

before we go to the next panel?

Dr. HENDERSON. I would just say for the future the question running around in my mind is: How do we integrate epidemiology and

animal studies to get the most effective way to determine associations between exposures and effects, specific diseases?

Mr. SHAYS. And so your answer would be?

Dr. HENDERSON. My answer would be: We need to establish that

new framework. And maybe the IOM could work on that, or the

academies at least, in getting a better paradigm for integrating

animal studies into epidemiology.

Mr. SHAYS. Thank you. Dr. O’Callaghan.

Dr. O’CALLAGHAN. Nothing to add, thank you.

Mr. SHAYS. Thank you. Mr. Binns.

Mr. BINNS. I would ask a question that you asked me, Mr. Chairman, a year and a half ago, at the hearing held in June that year,

which was: Should this research responsibility be taken away from

VA? It is apparent to me that there is a conflict of interest in VA

conducting research which also has important benefits implications.

I think that same conflict extends to other branches of the Government. Therefore, I would recommend that Congress designate

that this research be conducted outside of the Federal Government

in the future, and managed by an independent organization outside

of the Government.

Mr. SHAYS. You all have been very helpful witnesses. You have

all contributed to our work. And frankly, a lot of what has been

discussed today is alarming. Thank you all very much.

[Witnesses excused.]

Mr. SHAYS. Our next panel is Dr. Susan Mather, Chief Officer,

Public Health and Environmental Hazards, Veterans Health Administration; accompanied by Dr. Mark Brown, Director of Environmental Agents Service, Department of Veterans Affairs; and

Mr. Richard J. Hipolit, Assistant General Counsel, Department of

Veterans Affairs.

Our second testimony is from Dr. Lynn Goldman, Professor of

Occupational and Environmental Health, Department of Environmental Health Services, Johns Hopkins Bloomberg School of Public

Health, Institute of Medicine; and Dr. Sam Potolicchio, Professor of

Neurology, Department of Neurology, the George Washington University Medical Center, Institute of Medicine; accompanied by Ms.

Susanne Stoiber, Executive Director, Institute of Medicine.

Ms. Stoiber, did I pronounce your name correctly?

Ms. STOIBER. Very close. ‘‘Stoiber’’ is exactly right.

Mr. SHAYS. Stoiber.

Ms. STOIBER. Uh-huh. It is an Austrian variant——

Mr. SHAYS. OK, well, you weren’t taped, so we will try it again

later.

But if I could ask you all to stand, and raise your right hands.

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[Witnesses sworn.]

Mr. SHAYS. All witnesses respond in the affirmative. And let me

just say before we start, I have respect for all of you on this panel.

I have had many disagreements with some of you on this panel,

but I have respect for all of you. And while Mr. Binns stated his

concerns, which I share completely, I don’t share all of his recommendations, and would want that to be part of the record.

But I am deeply concerned by what I heard from the first panel,

as I think you can imagine I would be. And having been involved

in the act in 1998, I do believe that there is no question about Congress’ intent and the reason for Congress’ intent. I don’t think it

is being lived up to, but I am willing to hear why I may be wrong.

And I want you to testify in any way that you think we need to

get this statement out properly for the record.

We are going to start with you, Dr. Mather. And it is important

that you put on the record anything that you want. We are 5 minutes, but if you go another 5 minutes, it is important that you do

whatever you need to do.

STATEMENTS OF SUSAN MATHER, M.D., MPH, CHIEF PUBLIC

HEALTH AND ENVIRONMENTAL HAZARDS OFFICER, U.S. DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED BY DR.

MARK BROWN, DIRECTOR, ENVIRONMENTAL AGENTS SERVICE, AND RICHARD J. HIPOLIT, ASSISTANT GENERAL COUNSEL, U.S. DEPARTMENT OF VETERANS AFFAIRS; DR. LYNN

GOLDMAN, PROFESSOR OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH, DEPARTMENT OF ENVIRONMENTAL

HEALTH SCIENCES, JOHNS HOPKINS BLOOMBERG SCHOOL

OF PUBLIC HEALTH, INSTITUTE OF MEDICINE; AND SAM

POTOLICCHIO, M.D., PROFESSOR OF NEUROLOGY, DEPARTMENT OF NEUROLOGY, THE GEORGE WASHINGTON UNIVERSITY MEDICAL CENTER, INSTITUTE OF MEDICINE, ACCOMPANIED BY SUSANNE STOIBER, EXECUTIVE DIRECTOR, INSTITUTE OF MEDICINE

STATEMENT OF SUSAN MATHER

Dr. MATHER. Thank you for that. Mr. Chairman and members of

the subcommittee, I appreciate the opportunity to appear before

you today to discuss the implementation of the Persian Gulf War

Veterans Act of 1998. I will also briefly discuss the Veterans Programs Enhancement Act of 1998, and provide a status of the studies and reports on Gulf war health conducted by the National Academy of Sciences’ Institute of Medicine.

Mr. Chairman, you expressed interest in the extent and weight

given to data from animal studies in determinations of presumptive

causality of disease. I want to assure you that both VA and NAS

carefully consider all relevant peer-reviewed animal studies, and

we believe that we are fully compliant with the relevant statutes.

In addition to VA’s implementation of the Gulf War Veterans

Act, VA also is charged with simultaneously implementing the Programs Enhancement Act, which establishes an overlapping framework for addressing issues relating to the health status of Gulf war

veterans.

There are several instances where these statutes take seemingly

different approaches to the study of health risks associated with

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service in the Gulf war and to provisions of compensation as a result of that service. In view of the differences between the two statutes, on December 8, 1998, VA’s General Counsel asked the Department of Justice for an opinion regarding VA’s implementation

of them.

On March 12th, 1999, Justice responded in part that the respective provisions of the two laws, ‘‘. . . although redundant and burdensome in some respects if both laws are given effect, are not inherently conflicting or mutually exclusive, and therefore the provisions of both laws must be treated as valid and effective.’’ This is

what we have tried to do.

Congress required VA to contract with NAS to conduct reviews

of the scientific and medical literature on long-term health effects

from exposure to environmental hazards associated with the 1991

Gulf war. These statutes list approximately 33 specific risk factors,

or categories of risk factors, for consideration by NAS in its review

process.

I understand that you are particularly interested in the contracts

with NAS, including their status, terms, conditions, and timeliness.

NAS has already reviewed many of the Gulf war environmental

hazards in a series of four reports conducted under contract to the

VA. The initial NAS report, issued in 2000, on Gulf war health

issues reviewed health effects of depleted uranium, Sarin,

Pyridostigmine Bromide, and vaccines.

We understand that the NAS committee selected those specific

risk factors to start with at the suggestion of the Gulf war veterans

following initial public meetings they arranged. To evaluate the

NAS reports, VA established a taskforce whose members included

the Undersecretaries for Health and for Benefits, the Office of General Counsel, and the Assistant Secretary for Policy, Planning and

Preparedness.

Based on the taskforce’s review, VA published a notice in the

Federal Register, and informed Congress that the information provided by NAS did not warrant developing any new presumptive

service connections.

The second NAS report, issued in 2002, reviewed health effects

of insecticides and solvents used in the 1991 Gulf war. The Department is currently finalizing its notice announcing the Secretary’s

determination regarding that report.

The third NAS report, issued in 2004, reviewed health effects

from fuels, combustion products such as smog, and propellants

such as rocket fuels. VA’s taskforce reviewed the report and provided recommendations to the Secretary.

The NAS reports released to date have addressed a wide array

of potential exposures presenting different concerns. For example,

the reports issued in 2002 and 2004 considered a number of environmental hazards that are generally well studied and not uncommon workplace or urban exposures; such as gasoline, smog, common pesticides, and cleaning solvents. They are known to cause

specific illnesses, particularly among civilian workers who may

have had very large exposures lasting over many years.

A few environmental hazards associated with the first Gulf war

are more unusual; for example, the chemical warfare agent Sarin

and depleted uranium, both of which were addressed in the 2000

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report. Fortunately, IOM had a large amount of medical and scientific literature to review on health effects from exposure to these

agents, including animal studies. Thus, in its initial 2000 review,

and in the followup review in 2004, NAS did not identify any illnesses or disabilities for individuals exposed to trace levels of Sarin

that may have occurred during the 1991 Gulf war.

VA’s task in reviewing these reports is to decide whether additional presumptions of service-connected are warranted by current

scientific evidence for particular diseases. This process would not

in any way limit the right of any veteran under existing claim procedures to establish service connection on a direct basis, and with

VA’s assistance, for any disease that could be related to their service in the Gulf.

IOM is currently conducting three relevant studies: one, the infectious diseases associated with Gulf war and Southwest Asia;

health effects from deployment-related stress, including veterans

involved in the current conflict in Iraq, who are technically also

Gulf war veterans, both to be completed in fiscal year 2006; and

new clinical approaches to treating Gulf war veterans suggested by

a complete review of all scientific publications on Gulf war veterans

health, which is due in December 2005.

Psychological stress is being evaluated in part because it is seen

as a major concern in the current Iraqi conflict, which is taking

place in the same geographic area as the Gulf war.

IOM’s studies will assess the health threats for troops serving in

Iraq today, who share many hazardous exposures with prior Gulf

war veterans. Psychological stress was chosen because it may be a

major co-factor with other environmental health threats. For example, it is hypothesized that greater concentrations of an anti-chemical-warfare agent, PB, enter the brain during times of stress.

Because of concerns raised by a series of scientific publications

that suggest that veterans from all eras may be at greater risk for

ALS, in August VA asked IOM to look at evidence for increased

risk of Lou Gehrig’s Disease among all U.S. veterans, not just Gulf

war veterans. This review will take an estimated 9 months to complete.

I would like to address a contractual relationship between VA

and NAS, and the role of NAS in VA’s decisionmaking process that

translates Gulf war and health reports into health care disability

compensation policies.

VA establishes the basic contracts with IOM to conduct its periodic reviews of the medical and scientific literature on Gulf war

risk factors, according to the statutory requirements. It is important to reemphasize that after IOM completes one of its reviews,

it is not involved in the Department’s decisionmaking process.

Part of the value of IOM to both VA and veterans is its reputation for independence and scientific rigor. In support of this, VA

does not provide precise guidance to IOM on how to conduct their

studies, beyond the basic required contract which explicitly states

the goal of the study. For information on how IOM incorporates the

data from animal studies it reviews, VA defers to IOM; since it can

best answer these questions.

From the onset, VA asks IOM to evaluate all available medical

and scientific literature, which includes studies of both humans

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and animals. The ultimate point of this process is to evaluate potential health effects relevant to veterans.

VA and IOM emphasize findings from human clinical and epidemiologic studies as being the most relevant to the veterans’

health effects. Part of this distinction occurs because laboratory

animals often do not respond to hazardous exposures in the same

manner as humans; and therefore, it can be dangerous to predict

clinical effects in humans based solely upon toxicologic observations

in laboratory animals.

For example, in one IOM report, they describe a nearly 40fold

range in toxicity of Sarin among various laboratory animals. It is

difficult to say which, if any, of these results would be the most reliable predictor of human toxicity.

Animal studies are essential to planning relevant research studies. But the most useful data for predicting health effects in humans is based upon human studies.

In the absence of human studies, animal studies may become the

logical starting point for considering potential human health effects. However, when there are numerous human studies available,

they will probably be the most reliable predictors for future health

effects among humans.

Finally, in cases where an effect is observed in an animal study

but not observed in a well-conducted epidemiologic study, then the

conclusion would have to be that the animal study is probably not

clinically relevant to humans.

However, it would be erroneous to conclude that either IOM or

VA somehow excludes data from animal studies from the consideration of possible health effects among humans. For example, in his

2003 letter to the IOM, former Secretary Principi requested an updated study on Sarin health effects focused upon new animal studies, and directed IOM to consider the new animal studies.

It is clear that the IOM committee reviewed numerous animal

studies in reaching their conclusions. On pages 26 to 46 of the report, the IOM committee cites results from 101 animal studies and

reviews. The committee also reviewed many directly applicable

human studies, including studies of Gulf war veterans possibly exposed to Sarin as a result of the demolitions in Khamisiyah.

The human studies IOM analyzed were highly relevant to evaluating possible effects among Gulf war veterans. The non-Gulf war

veterans studies reviewed were based upon U.S. military volunteers who had been exposed several decades ago to non-lethal doses

of Sarin and other chemical warfare agents, on industrial workers

with documented acute exposure to Sarin, and upon victims of the

Sarin terrorist attacks in Japan in 1994 and 1995.

The committee also specifically reviewed the new published data

from laboratory animals that had precipitated interest in an updated study of Sarin health effects mentioned by former Secretary

Principi in his letter.

The committee concluded that the animal studies were an important step in determining whether a biologically plausible mechanism could underlie any long-term health effects of low exposure to

chemical nerve agents, but more work needs to be conducted to elucidate potential mechanisms and clarify how the cellular effects are

related to any clinical effects that might be seen.

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VA has wide statutory authority to make such a determination

based on sound medical and scientific evidence that is not limited

to the IOM committee findings in determining presumption of illness. VA has responsibility for determining what weight to place

upon various studies in reaching any health care or disability compensation policy conclusions, which are then published in the Federal Register at the same time Congress is informed.

Based upon this approach, VA complies with the statutory mandates to assess the extent and weight of data from human and animal studies in developing presumptive service connection policies.

Thank you again for the opportunity to be here. My colleagues

and I will be glad to answer any questions you may have.

[The prepared statement of Dr. Mather follows:]

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Mr. SHAYS. Thank you very much.

Dr. Goldman.

STATEMENT OF DR. LYNN GOLDMAN

Dr. GOLDMAN. Good afternoon, Mr. Chairman, and thank you for

holding this hearing today. We really appreciate your interest in

the health of the veterans.

I am Lynn Goldman. I am a professor of environmental health

sciences at the Johns Hopkins School of Public Health. And as you

know, I served as Chair of two of the Institute of Medicine Gulf

War committees; one is the committee that is currently working on

the report, ‘‘Gulf War and Health: Review of the Medical Literature,’’ and another committee that produced the report, ‘‘Gulf

War and Health: Fuels, Combustion Products, and Propellants.’’ In

addition, I was a member of the committee that produced ‘‘Gulf

War and Health: Insecticides and Solvents.’’ And therefore, I think

that I am qualified to talk to you about this particular process.

I want to step back for a moment, and reflect on the four separate issues that I have heard discussed today. Because, Mr. Chairman, I think it is very important to understand that these are separate processes completely.

One is the implementation of the statutes that were enacted by

this body with regards to how the veterans would utilize advice

from the Institute of Medicine in determining compensation for

Gulf war related illnesses.

But I have also heard questions with regards to how the research

agenda is created, how veterans’ physicians are educated, what

they know about exposures in the Gulf; and also, even how do we

protect soldiers in the future against harmful exposures. Those last

three questions, I am not going to address in my testimony; not because I don’t think they are important. I think they are exceedingly

important questions that have been raised. I am going to merely

talk about how the Institute of Medicine has provided advice under

the statutes.

And I can assure you right from the get-go that at no time in

any of the committees in which I have participated have I observed

any interference by either the Department of Veterans Affairs or

the Department of Defense. I think that is very important.

These have been independent scientific committees. The scientists involved wouldn’t stand for that kind of interference for a

moment. They wouldn’t serve as volunteers, if they were serving

under those conditions. And so, I just want to put that issue aside.

I think that the issue, though, that is of great importance is how

we have evaluated the evidence; and particularly, how we have utilized animal studies in so doing.

As has been pointed out, the committees have used criteria in

order to assign levels of evidence, categories of association for various exposures during the Gulf and subsequent illnesses, chronic

illnesses that occur years after those Gulf war deployments. And

we have been very concerned to make sure in doing that we can

definitely form a linkage between those exposures and actual

human disease.

In so doing, each committee has gone back to the categories of

association, and labored over how it wanted to tailor those catVerDate 11-MAY-2000 13:28 Apr 17, 2006 Jkt 000000 PO 00000 Frm 00259 Fmt 6633 Sfmt 6633 D:\DOCS\25667.TXT HGOVREF1 PsN: HGOVREF1
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egories to its work. And in the committees that I have chaired and

that I have been a member of, we have come back and back and

back, both to the words and the statute, the charge from the VA

and the categories of association; and worked those over, so that

we felt that we were evaluating the evidence in a way that would

be scientifically defensible, given the questions that we were being

asked. I think it is also important to state that it is not at all true

that animal studies have been ignored in this process.

Mr. SHAYS. I don’t usually interrupt someone, but ‘‘given the

questions we were asked’’ by whom?

Dr. GOLDMAN. Given the questions that we were asked by the

legislation and by the VA in our statement of charge.

Mr. SHAYS. By the VA.

Dr. GOLDMAN. Which had to do with, again, exposures to substances during deployment and subsequent clinical illness years

later. Those were the questions that we were looking at. And I

think that those are, as I said before, very different questions than

questions such as: How do you protect veterans in the future? How

do you educate the physicians in the VA? What should be the research agenda for the VA? We were never asked those questions.

I think that it is important to state that we have relied not only

on, of course, epidemiology and clinical evidence, but also animal

evidence. And I want to explain a little bit about how we did that.

In the first place, certainly, we never have felt—none of the committees have felt—that animal data could be used as a sole basis

for answering that kind of question about an exposure to people

and then later illness. We have never felt that we could rely on

animal evidence alone.

Why is that? First, animal data can tell us about a category of

health outcomes, without telling us exactly which disease will be

created. And so we know from human studies that the chemical

vinyl chloride causes a cancer called angiosarcoma of the liver. But

when we give that substance to animals, we can see other cancers

as well, such as cancer of the zymbal gland of the rat. Now, humans don’t have a zymbal gland; so we are not going to get that

cancer. And it is only through the human epidemiology studies that

we can say it is a specific liver cancer that would be caused.

On the other hand—and this has been said earlier in testimony—

those animal studies may be the best studies that we have for determining the potency, the dose response, how much dose gives you

how much cancer. These animal studies are of vital importance for

potency. But they can’t tell you exactly which disease is going to

be diagnosed in the person; and I think that is an important point,

especially for cancers, birth defects, and certain other outcomes.

Second, many animal studies are not carried out in a way that

is relevant to the experience. We are looking at exposures occurring

at a certain point in time in people’s lives; illnesses much later.

Many animal studies involve chronic dosing, day after day after

day, sometimes beginning in what would be the equivalent of childhood of the animals, and exposures that do not cease. Whereas in

the Gulf experience, what we are concerned about is exposures that

occur; cease; and then there is subsequent illness.

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That is also a challenge with looking at many of the epidemiology

studies, and something that we confronted as scientists over and

over again in trying to do this charge.

The third point is that often times we actually relied on preexisting reviews of the animal toxicology. A lot of effort is gone into for

some very well studied chemicals such as Benzene, which we

looked at in the first committee I served on. Benzene has been reviewed again and again. And in those cases, we often relied on the

work that authoritative bodies have already done to generally review the toxicology where it was not controversial, and then we

picked out—our experts who were toxicologists picked out specific

studies that they thought we needed to examine individually in

order to do our reviews.

So again, no interference was ever observed by me by any government agency, or any other outside group, to this work. And second, while we did rely primarily on human studies, animal studies

have also played a role.

And in closing, I do want to say that I think it is very important

that you are undertaking this careful reassessment of this process.

I do believe that this is a process that is very important to the

health and well being of our veterans. And I also think that it is

a process that does deserve to have careful oversight by Congress

and by your subcommittee, and that oversight is most welcome.

Thank you very much.

[The prepared statement of Dr. Goldman follows:]

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Mr. SHAYS. Thank you, Doctor.

Dr. Potolicchio.

STATEMENT OF SAM POTOLICCHIO

Dr. POTOLICCHIO. Good morning, Mr. Chairman, again, and

members of the subcommittee. I am Dr. Samuel Potolicchio. I am

a clinical neurologist with the George Washington University Hospital.

In addition, I have been a volunteer member of committees that

produced or are currently preparing the following four Institute of

Medicine reports: ‘‘Gulf War and Health: Review of the Medical Literature Relative to Gulf War Veterans Health,’’ ‘‘Gulf War and

Health: Fuels, Combustion Products, and Propellants,’’ ‘‘Gulf War

and Health: Insecticides and Solvents,’’ ‘‘Gulf War and Health: Depleted Uranium, Pyridostygmine Bromide, Sarin, Vaccines,’’ and

the ‘‘Gulf War and Health: Updated Literature of Sarin.’’ It was a

long road.

Because of my experience on those committees, and in particular

my work on the Sarin report, the IOM requested that I testify on

the work of the Sarin committee. I am the longest-living member,

I think. I appreciate this opportunity to speak with you about the

Sarin report.

The Sarin report was conducted following a request from the Department of Veterans Affairs to update an earlier report on the potential human health effects of Sarin. That request followed the

publication of a series of toxicology studies on rats looking at the

effects of relatively low concentrations of Sarin.

Sarin, as everyone knows, is a highly toxic nerve agent produced

for chemical warfare. Sarin can be fatal within minutes to hours.

It is a member of a class of chemicals known as ‘‘organophosphorus

compounds.’’

In humans and other animals exposure to high doses of Sarin

produces a well-characterized syndrome, the acute cholinergic syndrome, featuring a wide variety of signs and symptoms, including:

increased salivation; lacrimation, or increased tears; perspiration,

even bloody tears; blurring of vision; nausea; vomiting; diarrhea

and fecal incontinence; excessive secretions in the bronchi and respiratory system; tightness in the chest; cough; tachycardia, or

quickened heart rate; increased blood pressure; drowsiness and

lethargy; mental confusion; headache; coma; and convulsions. It is

important to remember that the acute cholinergic syndrome is a

very serious effect that requires medical attention and can lead to

death.

I would like to note that, as with the committees discussed by

Dr. Goldman, at no time during the preparation of ‘‘Gulf War and

Health: Updated Literature Review of Sarin’’ did anyone outside of

the committee process influence the work, deliberations, or outcomes of the studies.

In drawing its conclusions, the Sarin update committee evaluated relevant studies that were identified in searches of data bases

that identified approximately 250 articles that were potentially relevant to the committee’s charge. Those articles included studies in

humans and in animals. On the basis of those studies, the committee reached its conclusions.

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The committee, as with previous Gulf war and health committees, made conclusions regarding the existence of the acute cholinergic syndrome following Sarin exposure, the existence of persistent effects in individuals exposed to Sarin who had the acute

cholinergic syndrome, and the existence of persistent effects in individuals exposed to Sarin who did not have any signs of having

had the acute cholinergic syndrome.

The first conclusion is that there is definitely sufficient evidence

of a causal relationship between exposure to Sarin and a dose-dependent effect, seen at high doses, of acute cholinergic syndrome

that is evident in seconds to hours after Sarin exposure and resolves in days to months.

That conclusion is based on data from humans exposed to Sarin,

and is supported by data in animals and on organophosphorus pesticides which are related chemically to Sarin.

The second conclusion is that there is limited, suggestive evidence of an association between exposure to Sarin at doses sufficient to cause the acute cholinergic signs and symptoms, and a variety of subsequent long-term neurological effects. As with the previous conclusion, that conclusion is based on data from humans exposed to Sarin, and is supported by data in animals and data on

organophosphorus pesticides.

And finally, the committee concluded that there is inadequate,

insufficient evidence of an association between exposure to Sarin at

low doses insufficient to cause acute cholinergic signs and symptoms, and subsequent long-term adverse health effects; specifically,

neurologic and cardiovascular effects. That conclusion was based on

a lack of data in humans or animals.

I will focus on this last conclusion; as the first two conclusions

are relatively well established, and not controversial.

As with other Gulf war and health committees, the Sarin update

committee first reviewed the human studies. There were data from

studies of United States and U.K. servicemen who several decades

ago—between the years of 1958 through 1984—volunteered to be

exposed to chemical weapons, including Sarin. It also included industrial workers with documented acute, high-dose exposures to

Sarin; victims of the Sarin terrorist attacks on Japanese subway

systems; and studies of Gulf war veterans.

All of those studies, with the exception of the studies of Gulf war

veterans, focused on the effects in individuals who had shown the

signs and symptoms of the acute cholinergic syndrome, and therefore do not provide information on the effects of Sarin at concentrations below those that cause the acute cholinergic syndrome.

The studies conducted in Gulf war veterans—including United

States, U.K., Danish, and Canadian veterans—were not very useful

in making specific conclusions regarding the health effects of Sarin,

because many do not have objective assessments of exposure to

Sarin—for instance, many rely on self-reports of exposures in surveys taken years after the war, or are in individuals not deployed

to the Gulf until after any of the potential exposures to Sarin are

thought to have occurred—or have other problems with the exposure assessment. In addition, no health outcomes were consistently

seen in those studies.

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Given the limitations of the epidemiology studies, the committee

then reviewed the available toxicology data, focusing on those studies conducted with doses below those that cause the signs and

symptoms of acute cholinergic syndrome, to draw conclusions related to lower exposure to Sarin and health effects.

Although few studies have evaluated the effects of such doses, a

recent series of studies by Dr. Rogene Henderson, which are the

studies that prompted the IOM Sarin update, have evaluated the

effects of low-dose Sarin exposure in rats.

Those studies did show some alterations in some subtypes of a

specific family of receptors in certain areas of the rats’ brains. But

no consistent and persistent effects were seen in the levels of the

neurotransmitters and on behavioral parameters in the rats.

The data on receptors indicate further research areas, but are

not correlated with any particular health outcome in rats; let alone

humans. Those data on receptor density, therefore, are not sufficient to indicate an association with a human health effect; especially given the fact that behavioral effects were not seen in rats

treated with Sarin at the same concentration. Animal studies by

other researchers looking at low-dose effects also showed inconsistent, if any, effects.

In summary, the committee concluded that there is sufficient evidence of a causal relationship between exposure to high amounts

of Sarin and the acute cholinergic syndrome, and there is limited,

suggestive evidence of an association between exposure to Sarin at

those high levels that cause the acute cholinergic syndrome and a

variety of subsequent long-term neurologic effects.

However, given the few epidemiology studies, the limitation of

those studies that look at the effects of exposure to low concentrations of Sarin, and the limited number of relevant toxicology studies and their inconsistent results, the committee concluded that

there was inadequate, insufficient evidence to determine if there is

an association between exposure to Sarin at levels that do not

cause the acute cholinergic syndrome and any human health effects.

Those conclusions were based on available scientific data, and

they were made by the committee without any external pressures

or interference.

With that, I would once again like to thank you for inviting me

to testify before this subcommittee. I appreciate the work of this

subcommittee on National Security, Emerging Threats, and International Relations, and am happy for your interest in this important area of veterans’ health. I look forward to answering any questions you might have.

[The prepared statement of Dr. Potolicchio follows:]

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Mr. SHAYS. Thank you, Doctor. I am going to have the Counsel

start with the questions, and I will be, probably, interrupting him.

Mr. HALLORAN. Thank you. Dr. Mather, I see you brought your

lawyer. And your testimony contains a discussion of two relevant

statutes. Why? Do you think they conflict?

Dr. MATHER. Well, I am not a lawyer, and I have brought a lawyer with me for just that reason. But certainly, as a person involved with implementing both the laws, there were areas that

seemed inconsistent to me.

Mr. HALLORAN. Does one of those areas include or encompass the

way VA would approach the use of animal data?

Dr. MATHER. No.

Mr. HALLORAN. It does not?

Dr. MATHER. But at the time when we were setting up the implementation plan for this, we had enough questions that we referred

them to General Counsel. And I will let Mr. Hipolit take over from

there, since he is a lawyer and I am not.

Mr. HIPOLIT. At the time those two statutes were passed, there

appeared to us to be several inconsistencies in the statutes that

took a somewhat different approach to the same issue. So we were

somewhat confused as to, you know, how we would implement the

two statutes.

We went to the Justice Department, to the Office of Legal Counsel, for advice as to how we would—you know, if one statute would

supersede the other, or if we were to try to implement both, or

whatever. We received an opinion from the Office of Legal Counsel

indicating that both statutes—the statutes were not mutually exclusive, essentially; that we could reconcile the two, implement

both statutes. And they gave us some advice as to how to reconcile

some of the apparent inconsistencies.

Mr. HALLORAN. So it is not the Department’s testimony, then,

that the statutes, read side by side—if one uses different words to

describe the role of animal data, or animal studies, in this mechanism, that you simply are allowed to choose the lesser approach to

animal studies?

Mr. HIPOLIT. No, animal studies wasn’t part of the——

Mr. HALLORAN. It wasn’t?

Mr. HIPOLIT. That wasn’t one of the things we identified as an

inconsistency and asked Justice about.

Mr. HALLORAN. So it is possible that the Department’s approach

to animal data is violating both statutes?

Mr. HIPOLIT. No, I wouldn’t say that. The animal data just

wasn’t an issue as far as reconciling the two statutes.

Mr. HALLORAN. Was the Programs Enhancement Act the act

under which you proceeded with these three latest IOM studies?

Dr. MATHER. Well, both of the laws involve infectious diseases.

In one, it used Sand Fly Fever, Leach Meniasis——

Mr. HALLORAN. Well, no, my question was——

Dr. MATHER. The other one was Malaria. So one of the studies

that the IOM is going to do is infectious diseases. Both of the laws

had a list of infectious diseases. One included Malaria; the other

one didn’t. And as a broader approach, the IOM, who is as independent as they have given the impression here today, thought

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that the broader infectious diseases was a better approach than

limiting it to Sand Fly Fever and Leach Meniasis.

Mr. HALLORAN. But the question was, Mr. Binns testified that

the Research Advisory Committee wasn’t advised about the construct of these studies, as they may have been for past studies. And

so I made the assumption you were proceeding under a statute that

didn’t necessarily refer to or involve the Research Advisory Committee. Is that not the case?

Dr. MATHER. Well, it would be unusual for us, as we work with

the IOM in both fulfilling legislative mandates and sometimes

things that we feel we need that don’t have a legislative mandate

but could use their advice on, it is unusual for us—I can’t think

of an instance where we have taken that to a VA advisory committee; no matter what the subject was. So that is just not the way

we do business.

Mr. HALLORAN. Right. So let’s say that, because one of those

studies was about ALS, in which your testimony says, ‘‘This study

arose out of concerns raised by a series of recent scientific publications that suggested veterans from all eras may be at a greater risk

for this disease.’’ Can you describe those publications? How many?

Are they peer-reviewed?

Dr. MATHER. They were all peer-reviewed. There is a fair amount

of literature on ALS. The recent studies, though, were specifically

on ALS in veterans. And the studies appear to indicate that all veterans, no matter what era, have a higher risk of ALS than do people who did not serve in the military.

This may be consistent with other non-veterans studies that

show athletes have a higher rate of ALS—Lou Gehrig was an athlete—and show that pilots and people in the air industry,

stewardesses—or they don’t call them ‘‘stewardesses’’—attendants,

flight attendants, have a higher rate of ALS.

Mr. HALLORAN. So would such a finding, if the study comes back

and says, ‘‘Yes, indeed, we find that there is no specific incidence

or spike in ALS among Gulf war veterans, but among all veterans,’’

that would preclude under the law, then, VA from making a presumptive conclusion or association between Gulf war service and

ALS?

Dr. MATHER. I can’t speak for the Secretary, but the Secretary

could make a presumption for all veterans, that ALS was a risk of

military service. He could.

Mr. HALLORAN. Right. Thank you.

Dr. MATHER. That would include Gulf war veterans.

Mr. HALLORAN. Were you and/or Dr. Brown involved or aware of

the change in the associational standard that Mr. Binns described?

Dr. MATHER. No. Today was the first day that I had actually

seen a reference to me, the two, the IOM studies, talking about

Agent Orange or talking about Gulf war illnesses are the same.

And in my experience, the five categories are based on occupational

health ways of looking at association, and go back to one that was

not congressionally mandated, but that I was involved with, with

mustard gas and the experiments that took place during World

War II, and the subsequent health effects.

Perhaps Dr. Brown.

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Dr. BROWN. Yes, I would just add that I had never noticed that

difference before. And I was thinking about it, as I saw it up there.

I think my reaction to that is that, I mean, clearly, one has the

word ‘‘human,’’ and the other doesn’t. But I would caution about

over-interpreting what that means.

I think that, in a practical sense, the way that the Institute of

Medicine reviews Agent Orange studies for us, the studies that we

use for Agent Orange to establish—essentially, the same process to

establish presumptive service connection for Agent Orange health

effects—is exactly the same as the process that they use to evaluate the corresponding literature on Gulf war health effects.

And by that, I mean they—as Dr. Goldman and Dr. Potolicchio

pointed out, they do rely primarily on epidemiological studies; but

they also consider a wide range of animal studies. In essence, from

a practical standpoint, they are identical.

You have heard there are over 100 animal studies, for example,

that were part of the recent Sarin update, just to use that as an

example of a Gulf war study. If you look at the most recent veterans and Agent Orange study, they reviewed hundreds and hundreds of animal studies along the same lines, looking at biological

plausibility, using it to reinforce the epidemiological data.

And I would just add that in the history of the Agent Orange

studies, the Agent Orange studies which VA uses to establish presumptive service connections for Agent Orange herbicide health effects, VA has never established a presumptive service connection

based solely on animal studies. That has just never occurred. So

from a practical standpoint, I think that distinction—well, it has no

practical distinction.

Mr. HALLORAN. OK. Well, I don’t take that as good news. Words

have meaning, and the statute was passed here—well, let me go

back.

So that has never been done before. Because in the normal

course of events, without any Gulf War Health Act, the VA would,

when it received definitive scientific evidence of a link between a

cause and effect in terms of human disease and you found that

cause in a veteran, you would associate it and connect it with his

service and be on your way; is that correct? Individually, or as a

group, that’s how it works.

Dr. BROWN. Well, I am not sure about that. I can’t think of too

many presumptives that we have established. You could——

Mr. HALLORAN. No, not presumptives.

Dr. BROWN. You could do that——

Mr. HALLORAN. No, not presumptives. Just cause and effect. Just

service connection.

Dr. BROWN. Well, let me give you an example. The publication

that Dr. Mather pointed out, showing greater rates of ALS amongst

not just one group of veterans, but amongst all veterans from

World War II onward, that causes a great deal of alarm. It seemed

like a pretty good study, a well-done study, large groups of veterans all the way up to Vietnam, Korean War, and so forth.

We decided that it was such a controversial issue and such a difficult issue that we turned to the Institute of Medicine to help us

try and evaluate that overall scientific literature on ALS, on the relationship between ALS and military service. I think actually, as

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I understand it from discussions from the Institute of Medicine

when we were considering how to do that study, there are actually

dozens of studies, a few dozens of studies, that pertain to veterans

and ALS.

We think that is an important issue. Obviously, you know, we

want to find out about that. And if it is a real effect, we could consider the possibility of presumptive——

Mr. HALLORAN. Let’s go back to that word, though, because my

point is this: that the statute was passed for a reason. Those words

were written there for a reason: to make the VA do something different than it would otherwise do, in the treatment of Gulf war veterans who present themselves as ill. And so I guess my one question is, what different did you do?

I mean, it is not persuasive testimony to say that the Institute

of Medicine, which has always approached the relationship between epi data and animal data in this way—that you didn’t interfere with them. I mean, somebody who is already doing what you

want them to do doesn’t need to be interfered with.

Dr. BROWN. OK, I take your point. That is a good question.

Mr. HALLORAN. So I don’t find that persuasive evidence of anything.

Dr. BROWN. That is a good question. I guess I would answer that

by——

Mr. HALLORAN. What different did you do because of this statute?

Dr. BROWN. Actually, I would say we did nothing different. What

we did was, we asked the Institute of Medicine to consider the entire body of scientific literature. And by ‘‘all literature,’’ we meant

all literature. We meant animal studies, we meant human studies,

or any other relevant literature. When we say ‘‘all the relevant literature,’’ that is what we meant. And I think that is what the Institute of Medicine gave us.

Dr. MATHER. And I think that you perhaps could ask the Institute of Medicine why the word ‘‘human,’’ because we certainly

didn’t ask for it. As far as I am concerned, you could take it out,

without a loss; or add it to the Agent Orange ones, without any

great loss. So, you know, to me, it is a point without a difference.

But the experts are here, so why don’t we ask them?

Mr. HALLORAN. Sure. Please.

Dr. GOLDMAN. Well, let me tell you what I think that we did that

was very different and, I think, relates back to the statute. And

what was put up on the board was ‘‘The criteria for evidence is sufficient to conclude there is a positive association.’’ But there was

another level of evidence that is below that, that is ‘‘Evidence is

limited and suggestive;’’ which is a level of evidence that was created by the statute because of the presumption that was built into

the statute of leaning toward the veterans, in terms of finding an

association.

And when you look at—and I attached it to the written testimony, which I hope will be appended to the record—when you look

at the table of all the conclusions that have been developed by

these committees, in fact, many of the conclusions have been in

this ‘‘limited and suggestive’’ area.

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I can’t tell you how hard it was for groups of scientists to do this.

This is not what scientists normally do. This is a shade of gray;

where we usually try to stay away from it. We usually try to say

it is either—you know, it is either probable or possible, or not. And

if you look at every single expert process, other than this one, this

layer doesn’t exist, this particular stratum. It is here because of the

law.

And I think that it is something to really look at, in terms of the

oversight, in terms of what is going to be done. We weren’t sure.

We never tried to stray into that as a committee. We never wanted

to talk about what the implications would be of our findings. We

knew that we were there to talk about the science, and not the policy implications. But clearly, you know, this is a major policy issue,

in terms of what is done with these conclusions about ‘‘limited and

suggestive.’’

Mr. HALLORAN. Dr. Goldman, Dr. Potolicchio, do you find a discussion of the animal efficacy rule in terms of a parallel to this, in

terms of a different approach to animal data in these decisions or

discussions, do you find that parallel inapt?

Dr. GOLDMAN. No, I don’t, actually. Again, I would agree with

some of what was said earlier; that if one needed dosing studies,

as one might need for a pharmaceutical, a vaccine, or perhaps to

understand acutely what a nerve agent does to you, I wouldn’t

want to see those done on people. And you would want to be able

to infer from animals what is going on with people.

However, in that context, you are doing something different. You

are doing something different. You are finding a parallel to something that is a known response in people.

And the problem really is with not so much the sensitivity. I

think animal studies can be very sensitive about finding that there

is an effect. And they can be very useful in telling us the dose response. But it is specificity: Is the specific effect that you see in an

animal the same effect as the effect you might see in a person?

That is very difficult. And so, you know, we don’t have patients

who come in to Dr. Potolicchio with a chief complaint of having

trouble running a maze. And, you know, that is what the challenge

is in connecting the data.

Dr. POTOLICCHIO. Do you want my comment as a clinician.

Mr. HALLORAN. Sure.

Dr. POTOLICCHIO. Well, if you take the animal data, for instance,

let’s say there were studies that were done in monkeys with Sarin,

and humans. And the interesting thing about it is that it changed

a test, one test, which was an EEG; which is something I know a

lot about. The changes that were induced by Sarin in the monkey

and the human were about the same, but there was no real health

outcome from that. It was a test result.

And so we took that information and we said, ‘‘Well, OK, this is

suggestive.’’ I mean, not sufficient, but suggestive of something

going on. In the same way that in an animal you may measure

some receptor that changes a subtype because you expose it to

some Sarin for a certain period of time. But what does that mean

in regards to the human? Probably, nothing at all; until you do the

same kind of exposure and see whether it changes the same thing.

But it is a hard thing to do.

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But there is no clinical outcome. There was no behavioral outcome, either, in the rat. There was none at all. And so therefore,

you have some change that occurs in the brain that has no meaning, really. I mean, it is science, and you need to go forward with

that.

But if it were like, say, the dopamine receptor in the brain that

has a lot more to do with Parkinson’s Disease, and then we found

that Parkinson’s Disease had a higher level among veterans, that

is where you get into plausibility and cause. And we don’t have

that.

Mr. HALLORAN. So in terms of what you are saying, what kind

of animal—I am assuming and hoping there won’t be human epi

data about Sarin exposure any time soon that we can look to——

Dr. POTOLICCHIO. There is, but——

Mr. HALLORAN. There is, I know, but I just don’t want any more.

Dr. POTOLICCHIO. Fair enough.

Mr. HALLORAN. What kind of animal data would you look for to

push plausibility into likely association; a study result that would

show what? Fill in the gap that you see in terms of animal data.

Dr. POTOLICCHIO. Well, if you look at that receptor type, I mean,

you would expect some changes in cognition, maybe an increased

incidence of Alzheimer’s Disease or something like that. I mean, it

would have to have some clinical implication.

Mr. HALLORAN. OK. Dr. Mather, on page 7 of your testimony,

you say, ‘‘VA’s task in reviewing these reports is merely to decide

whether additional presumptions of service connection are warranted by current scientific evidence.’’ We heard before there aren’t

any now, though. Is that word ‘‘additional’’ correct?

Dr. MATHER. Well, I mean, the studies are still underway. There

were 33 categories of exposures that need to be looked at. We are

in the process of looking at them. There may well be additional

presumptions during that——

Mr. HALLORAN. But additional to what? Are there presumptions

now?

Dr. MATHER. Well, I was just thinking of the entire general. We

have some presumptions: the presumptions for Agent Orange, the

presumptions for Mustard Gas, the presumptions for MS and Leprosy, are the ones immediately come to mind.

Mr. HALLORAN. Thank you.

Mr. SHAYS. I have a few questions that I want to ask. I listened

to what the Counsel was asking in the beginning about the two

statutes. And I found myself thinking, you know, ‘‘There we go

again.’’ It is very difficult for someone without a scientific background or a health background to sort out a lot of these questions.

So I don’t need you all to make it more difficult.

And for you to come in and talk about two statutes as if it is relevant to the hearing—because I was left with the impression, well,

the statute requires that you need to use animal data. And then

you come in and say, but there is another statute that you thought

was in conflict. And then the counsel basically says it is not in conflict. And I am thinking, ‘‘Well, you are talking about animal data;’’

and that somehow, in one statute you had to use animal data, and

in another one you didn’t. And then we find out when we ask you

the question that the conflicts don’t even relate to animal data.

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So I am wondering, why the hell do you even bring it up? Why

is it even an issue at this hearing? So someone tell me why.

Mr. HIPOLIT. I believe that was included in the statement by way

of background. I think that portion of the statement reviewed VA’s

statutory obligations, in general, in this area.

Mr. SHAYS. So the bottom line is it is totally irrelevant, though,

to the issue at hand, as it relates to animal data. Correct?

Mr. HIPOLIT. As far as if we are talking about whether we should

use animal data to create presumptions, it is not really helpful, I

think.

Mr. SHAYS. It is totally irrelevant, and not helpful. That is the

bottom line.

You know, you all may be right in the end about this. I mean,

Dr. Goldman maybe what you say is something I have to pay more

attention to. But I have to clear my mind of this whole thing about

the statutes, because they are not in conflict. They aren’t in conflict

as it relates to animal data. They both make reference to animal

data.

And so, now, Dr. Goldman, I believe that we said animal data

has to be considered. That is what I believe. And I believe your

statement is saying, ‘‘We considered it, but—but—but—but—but—

but—but—’’ So I am led to believe that you really didn’t consider

it, because you think animal data isn’t relevant. So, ‘‘Screw Congress, forget the law, we have decided in our scientific way it is not

relevant.’’ That is kind of the way—I am giving you the short, more

concise version of what is in my head right now. So given what I

just say, please respond.

Dr. GOLDMAN. That certainly is not what I intended to communicate in my testimony.

Mr. SHAYS. You have to turn on your mic. Start over again,

please.

Dr. GOLDMAN. It is certainly not what I intended to communicate

in my testimony. We certainly did take the language in the statute

seriously. As scientists, we feebly tried to read it ourselves. We

didn’t feel that it was—that the statutes were contradictory.

We did review the animal data. We reported on it. We referenced

them. And we in no way wanted to do anything except honor the

intent of Congress and do the best job that we could as scientists.

We had on our committees toxicologists who specialize in both

generating and analyzing that kind of data; are not involved with

epidemiology, clinical medicine or science at all. And we were very

respectful of their views; involved them in looking at every single

chemical. So it is not what I meant to convey at all, and I hope

that you can hear that.

Mr. SHAYS. Let me ask you, I understand that if we are going

to introduce a new drug into the marketplace, we don’t want to

have any mistakes. It has to be as perfect as we can make it. Is

it your view that in order to make a presumption of a service-connected disability illness, that we need to rise to that same test?

Dr. GOLDMAN. I think it is up to Congress to decide what the test

should be. I think that, actually, the language in the statutes is

very different than the language that one uses as a standard for

introduction of a new drug.

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When FDA reviews a new drug, it is doing kind of a risk/benefit

determination. There are risks of drugs, but there are benefits; and

FDA tries to decide on the side of the patients that the benefits

outweigh the risks.

I don’t think that is how the legislation was written. It is not

how we read the charge that came from that legislation. We felt

that the presumption should be slanted toward the veterans, in

terms of making sure that the veterans’ health is adequately protected; which is why there is a category of ‘‘limited and suggestive’’

health effects, and why we took that part of it very seriously. So

I think it is different.

I think it is also different, by the way, for introduction of the

chemical exposures in this society. If one were to think about to

what chemicals would it be acceptable for soldiers in combat to be

exposed in the future, that would be a very different kind of review

that might well rely almost completely on animal toxicology. Because there, you are not trying to look at a specific diagnosis, a

clinical diagnosis. You are looking at risk. And I think for risk assessment you can solely rely on animal data. You don’t need

human epidemiology studies for risk assessment.

And I have done a lot of risk assessment, myself, during the time

I served at EPA, and I am very comfortable with the use of animal

data to determine risk. So I just think these are——

Mr. SHAYS. Then tell me why I should feel confidence that you

used animal data?

Dr. GOLDMAN. Well, I think, first and foremost, that the reports

stand on their own, in terms of citing the data, discussing the data,

including the data in the discussions of the substances and the relationships to disease. And so, you know, we could step through

them. And there are literally hundreds, if not thousands, of studies

reviewed in those reports.

You can also look at the composition, the members of the committee. We could point to those who are toxicologists, who were

there to provide that expertise.

Mr. SHAYS. OK.

Dr. GOLDMAN. No one member of any committee like this is an

expert in all of the science that this kind of a group looks at. But

we did have experts in the science of toxicology who were there to

provide that.

Mr. SHAYS. Well, you know, I have become inherently suspicious,

without the background to back up my suspicion. And if you had

been in my place for 14 years, you would be more suspicious than

I am. And I become suspicious when I see a red herring like two

pieces of legislation coming before me—totally irrelevant.

And I become suspicious because we all know that 25 percent,

give or take, of our veterans are sick. And they aren’t getting any

help. They are getting no help. They are getting no help.

And so, I am struck by the fact, and I am going to have to say

to you, your testimony is going to be—I mean no real disrespect,

Dr. Mather, but we have had too many disagreements for me to

feel comfortable with this side of the equation.

Your testimony is going to stand as saying to us, in total confidence, that the first panel was totally wrong. Their statement was

that animal studies were not considered; were not evaluated; they

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were ignored. And you are saying, ‘‘Not so.’’ That is what your testimony is saying to us.

And if you want to carry that burden, I hope it is with total confidence; because I don’t know you, but I am going to have to go

with that. And that is the way.

And if you have any bit of concern that maybe you didn’t look

at animal studies the way Congress intended, this is your chance

to tell us. If you think you could have done a better job, this is your

chance to tell us. Otherwise, it is going to be your statement. It is

on your shoulders. And everything rests on what you say. That is

why I am going to conclude this. That is where I am coming from.

So if you want to be a little more precise, fine. If you want to

have your testimony stand the way it is, that is the way it is going

to stand.

Dr. GOLDMAN. Let me tell you how I think this connects together,

and it might be helpful. I mean, first and foremost, can I sit here

and say that I believe that I am an expert on what the intent of

Congress was in these bills and that I know what all those intentions were? No, I can’t say that. I cannot say that.

Mr. SHAYS. OK, but let’s stop there——

Dr. GOLDMAN. I am not an attorney and——

Mr. SHAYS. No, let’s stop there, though.

Dr. GOLDMAN. I cannot say that.

Mr. SHAYS. No, OK. That is not really what I am asking.

Dr. GOLDMAN. OK. I just want to make that clear.

Mr. SHAYS. Because what I am saying to you is, it was the intent—no one disagrees with it—that animal studies would have a

huge weight. Because we know there is no other way to look at it.

We don’t believe that it is possible to provide any help to veterans

if we don’t look at animal studies, because there aren’t any other

real important studies of any consequence over a long period of

time to rely on—given that we don’t know the intensity of the exposures to our veterans.

So we don’t think you are going to experiment with human

beings on exposures. So if you can’t experiment on human beings,

and you can on animals, animals are our only way, in my judgment, of coming to some conclusion.

Dr. GOLDMAN. I think that our committees may have been, from

that dilemma, salvaged from that by the fact that the substances

to which we were directed for our studies—without an exception

that I can think of—have had extensive amounts of human epidemiological evidence to review; I mean, so much so that our committees were nearly overwhelmed by the amount of work that was required in order to go through even the human studies. We weren’t

looking at——

Mr. SHAYS. Let me ask you something. Let’s just take depleted

uranium. Tell me the studies that you looked at of depleted uranium.

Dr. GOLDMAN. I did not serve on that committee, so I am going

to have to defer that one to somebody else. I am not familiar with

that report.

Mr. SHAYS. So you can only speak to it as it relates to certain

issues related to what?

Dr. GOLDMAN. The three reports that I have been involved with.

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Mr. SHAYS. Refresh me again?

Dr. GOLDMAN. Yes. Let me make sure I am referring to them

properly. The fuels, combustion products, and propellants report;

and the insecticide and solvents report. And then, I am currently

chairing the review of the medical literature report.

Mr. SHAYS. So insecticides, we have a lot of studies from the

workplace.

Dr. GOLDMAN. Yes. And that was true for solvents, as well. There

were many studies.

Mr. SHAYS. And how about Sarin?

Dr. GOLDMAN. Sarin?

Mr. SHAYS. How many studies?

Dr. POTOLICCHIO. How many studies were actually reviewed?

Mr. SHAYS. Yes.

Dr. POTOLICCHIO. I don’t know the exact number. But I can tell

you that in the first committee, there was a large body of toxicology

studies with Sarin that were looked at, in depth. And as a matter

of fact, there was a fairly long——

Mr. SHAYS. Mixing——

Dr. POTOLICCHIO. We are talking about the first——

Mr. SHAYS. Mixing Pyridostigmine Bromide in with it?

Dr. POTOLICCHIO. Exactly, and Sarin.

Mr. SHAYS. Well, how? How would you do it with humans? Did

we experiment with humans?

Dr. POTOLICCHIO. Well, the only experiments that you had in humans came from the Edgewood studies.

Mr. SHAYS. No, I am talking just humans, though. I am not talking animals.

Dr. POTOLICCHIO. Edgewood was the only studies that you actually had measured exposure.

Mr. SHAYS. That is the only study?

Dr. POTOLICCHIO. In humans.

Mr. SHAYS. OK. And with depleted uranium, can you speak to

that?

Dr. POTOLICCHIO. Depleted uranium, there were quite a lot of

studies that were evaluated there; but it was mainly in the miners,

and so forth.

Mr. SHAYS. With depleted uranium?

Dr. POTOLICCHIO. The uranium miners were looked at, particularly.

Mr. SHAYS. OK. All right.

Dr. POTOLICCHIO. They had to look at uranium in general before

they made comments about depleted uranium.

Mr. SHAYS. Yes, but that is a different substance. Depleted uranium is different. Uranium is the same. Depleted uranium is a

hardened metal, correct, that was almost vaporized when they were

hitting tanks. And when our soldiers went into these tanks, they

breathed these hardened metal substances that were in extraordinarily fine pieces, correct?

Dr. POTOLICCHIO. That is correct.

Mr. SHAYS. And we have a study of that kind of circumstance?

Dr. POTOLICCHIO. Well, they looked at the soldiers who, you

know, had depleted uranium fragments in their body. And those

studies are still ongoing, as I understand.

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Mr. SHAYS. No, I understand that. What I am trying to talk

about is, there is no study that we can—we can’t go to a mine and

talk about depleted uranium. It is radiological, it is radioactive in

that sense; but it is not the same substance, correct?

Dr. POTOLICCHIO. It is not the pure substance. But they did look

at uranium miners, because they broadened it to encompass the

whole thing.

Mr. SHAYS. And they looked at the mixture of Sarin with PB?

Where would they have found that?

Dr. POTOLICCHIO. No, there is no study that looks at the mixture.

Mr. SHAYS. See, that is my point. How do you duplicate that,

where you mix the two? We absolutely know for a fact—that when

the alarms went off, the soldiers and others who were in the field

panicked. They took out their PB and took—if they were supposed

to take one, they took four. And they thought, ‘‘My God, if four protects me, I’ll take eight.’’ You know, there is no study to duplicate

that.

Dr. POTOLICCHIO. No, there is no study.

Mr. SHAYS. Yes. So if there is no study, I wonder how we are

able to help those veterans, if we are not able to do animal studies.

And so, you had witnesses before you. Speak to Dr. Henderson’s research, if you could.

Dr. POTOLICCHIO. Well, her research has to do with the, you

know, subtype of receptor in the brain that changes after exposure

to low-dose Sarin.

Mr. SHAYS. Combined with——

Dr. POTOLICCHIO. Combined with——

Mr. SHAYS. PB.

Dr. POTOLICCHIO. With PB.

Mr. SHAYS. Right.

Dr. POTOLICCHIO. No, well, I am not so sure she did that. AbouDonia did that; not Henderson.

Mr. SHAYS. OK. I think she mentioned that. See, I just don’t

know how we find that kind of experience, that data, in terms of

our looking at humans. I think we only find it with animals.

So in those studies, I am inferring from you, Dr. Goldman, that

when she talks about those studies, in spite of the fact that she

saw distortions, it wasn’t the kind of distortions that would lead a

committee to say there was a problem?

Dr. POTOLICCHIO. But you have to look——

Mr. SHAYS. I am asking you, Dr. Goldman.

Dr. POTOLICCHIO. Oh, I’m sorry.

Dr. GOLDMAN. Well, in this, I would just have to be expressing

my personal opinion, because I was not on the Sarin committee.

Mr. SHAYS. Right. I understand that.

Dr. GOLDMAN. But my personal opinion about those studies is

that they are exceedingly valuable, in terms of providing, if you

may, kind of a biological marker that with these low doses there

is something going on in the brain. And they are also highly innovative, because she is using low doses; and most animal studies

don’t do that.

And I think that kind of research is heading in a direction where

in future we are going to see animal studies that are going to be

much more useful to us. You know, I said in my oral testimony

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that a lot of the animal studies are done at such high doses that

it is hard to interpret them. But when I read her study—which,

again, I was very impressed by—I don’t think I would have been

able to draw from it a disease outcome, a health outcome, in people

from it.

Even though it would make me extraordinarily concerned about

the possibility of chronic effects from low-level exposures, I couldn’t

tell you what a patient with those effects might look like, on the

basis of changes in receptors in certain parts of the brain and these

other subtle findings.

And if I had been on the committee, I think where I would have

come down with that is, you know, one, wanting to see a lot more

research on Sarin and, two, wanting to see a lot of effort made to

make sure that in the future, where we have soldiers who might

be exposed to Sarin, that we are out there monitoring it. I would

love to see sniffers of some kind, or badges, or real-time monitors

out there.

Mr. SHAYS. You know, you are being the perfect scientist, and I

respect it.

Dr. GOLDMAN. Not perfect. Not at all perfect.

Mr. SHAYS. Well, no, but you are in a way. You would say——

Dr. GOLDMAN. No.

Mr. SHAYS. No, hear me out a second. You want to see a lot more

studies.

Dr. GOLDMAN. No, not a lot——

Mr. SHAYS. No, no, that is what you did say.

Dr. GOLDMAN. But I don’t think a lot——

Mr. SHAYS. No, no, hold on. I am going to say it, and then you

can respond.

Dr. GOLDMAN. Yes.

Mr. SHAYS. I have given you an opportunity to respond.

Dr. GOLDMAN. OK.

Mr. SHAYS. I am going to say to you that I have heard that for

15 years.

Dr. GOLDMAN. Yes.

Mr. SHAYS. Fourteen years. And so the veterans are right: By the

time we are going to be able to help them, they will all be dead.

They will all be too old. That is the bottom line. Because you are

being that scientist that we want you to be in one respect.

We wanted, though, to bring it down a notch. We wanted to give

a lot more weight to animal studies. You know, the worst thing

that could be is, you might be wrong; and so you help some veterans who are sick. What a terrible thing to have done. In the end,

that is what we would have asked you all to do.

But I feel like the level is just set a little too high. That is kind

of what I am struck with.

Dr. GOLDMAN. Well, let me try a response. And, you know, here

are some possible ways that this could be approached. And one is

to say, OK, the fact that there are these changes, these brain

changes, in animals, but we don’t know what the disease is—but

we could maybe presume that it might be neurological. And this is

a question, I think, that is back to Congress. Then would you say

every neurological disease might then be somehow linked?

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I mean, as a scientist, I can’t tell you what the diseases are. But

that is something that would be a potential, and maybe not an irrational, response.

Another possible response is to say, ‘‘Could you somehow infer

which veterans were more likely exposed to Sarin gas?’’ and presumptively say, well, on that basis—we don’t know what it might

have done to them, but on that basis, say that they deserve to have

some kind of compensation? Again, that is a different question than

saying, can I tell you what disease is caused.

Mr. SHAYS. No——

Dr. GOLDMAN. And you might be right that we have been approaching this with a scientific rigor, because we have thought that

the question was a specific clinical condition connecting it to a specific exposure. That is really hard to do with those kinds of data.

But there are other kinds of inferences that could be made. There

are other ways to approach it.

Mr. SHAYS. What triggers me is when I hear that your immune

system in animals is impacted. I mean, that is the kind of veterans

we kept seeing. Weird things happen to them, weird things: rashes

that were just unexplainable. But you could see it. They were really in bad shape. And then we have doctors, who I respected, say,

‘‘You know, when you take certain chemicals, you impact your immune system in your brain, and tragic things can happen as a result.’’

Now, I want to be real clear here. I am going to invite Mr. Binns

to just respond, but not in any way about who holds responsibility.

I am just going to ask him to respond to the fact—Mr. Binns, if

you are hearing me—to the fact that we had one whole panel that

said one thing, and we have another panel who said another.

I would like you to come up, please. If you would, just pull a

chair on the side of the table.

Your view is a view I share, so you are not alone; even though

you may feel alone with this panel—that the animal studies carried

very little weight. I am not interested in who holds responsibility,

or any part of that dialog. So you may react to this panel.

And then I am going to close by having you all just ask if there

is any question we should have asked, any comments you want to

make.

Yes, sir.

Mr. BINNS. I think it is actually quite simple to reconcile the

comments that have been made. No one has suggested that the

IOM committees have not read a lot of animal studies, written a

lot about animal studies, and presumably in their deliberations discussed animal studies. But the conclusions—which are the only

thing that matters, under the law, for the determination of benefits—have all been expressed within the framework of the categories of evidence.

Dr. Goldman suggested that the categories of evidence were reconsidered by each IOM panel. But—correct me if I am wrong—

have any panels changed the categories of evidence to include animal studies?

Mr. SHAYS. Unless there is a ‘‘Yes,’’ I am going to assume the answer is ‘‘No.’’

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Dr. GOLDMAN. The answer to the first part is ‘‘Yes.’’ And I just

don’t know about the answer to the second part of your question.

I don’t know.

Mr. SHAYS. So the answer is that the criteria has changed; you

just don’t know where the criteria has changed. And the committee

will look at it, so it is a valid point to bring up.

Mr. BINNS. OK.

Mr. SHAYS. I mean, Dr. Goldman, am I expressing your view?

Right.

Mr. BINNS. The copy of the categories of evidence I have from the

first Gulf war report—and I do not have them from all of the reports. But for example, the ‘‘limited, suggestive evidence of association’’ which was referred to, it again is limited to exposure to a specific agent and a health outcome in humans.

So it is not enough to say, ‘‘We have contemplated animal studies,’’ if at the end of the day the boxes that you have choices of

checking are boxes which are defined in terms that exclude animal

studies.

Mr. SHAYS. Thank you. Is there any other point, before I get on?

Mr. BINNS. I would add one more point, and that is the reference

to the effects in animals; that you couldn’t know what these effects

would be. I think Dr. Henderson testified to the fact that there

were cognitive effects. So it is not entirely true to say that there

are no judgments that can be made based on this evidence.

And in fact, I think the doctor used the word ‘‘suggestive’’ in discussing what he felt were the conclusions that could be drawn from

Dr. Henderson’s studies, and I would add, studies by the Chemical

Defense Institute of the Army and others who have also found lowlevel effects of Sarin.

‘‘Suggestive’’ is the term that Dr. Goldman pointed out does meet

what category three is supposed to be: ‘‘Limited suggestive evidence

of an association.’’ So by their own terms, I would find that standard has been satisfied.

Mr. SHAYS. Well, this is a work in process. But I don’t think we

can afford to have this issue just keep going on and going on and

going on.

I am going to invite all of you to just make any comment you

make, or choose not to; or ask any question you choose to ask, and

answer. Dr. Mather.

Dr. MATHER. Well, I really only want to apologize to you for confusing you with the stuff about the legislation, the two pieces of

legislation. I certainly didn’t mean to confuse anybody. But I am

here representing, as you well know, the Department of Veterans

Affairs, and people who know more than I do, perhaps, felt that

was an important piece of background. But I apologize. I could

have fought to keep it out.

I also want to apologize and take responsibility for the fact that

the Gulf War Veterans’ Health Initiative has not been revised. It

is on the list to be revised, and we recognize that it is out of date.

And we certainly are working on a revision. But it simply hasn’t

been finished.

Mr. SHAYS. Thank you for saying that. Dr. Brown.

Dr. BROWN. Thank you, Congressman. I want to thank you for

inviting us here. I do appreciate the fact that you are persisting to

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push this issue. It is an obvious and an ongoing issue. It is very

frustrating.

And I guess, on a personal note, I would just add that, for me,

to hear somebody like Mike Woods, who I have known for some

time—to hear him talk about the problems he has had getting

treatment and recognition of his illnesses from VA, really, it just

breaks my heart. I am sorry. I am just so sorry to hear that.

Mr. SHAYS. Well, I would like you to followup——

Dr. BROWN. I think that I might—on a personal note, I think

that I am going to—I mean, he is one veteran, but every veteran

is an important veteran. I am going to talk to him.

Mr. SHAYS. Well, thank you for saying it. But he testified that

he was given a placebo.

Dr. BROWN. I can’t explain that. I don’t think that VA doctors

would do that, but I will look into that.

Mr. SHAYS. Thank you. Dr. Brown, I am going to ask you to look

into it, and ask you to report back to me.

Dr. BROWN. Thank you, Congressman. I will. He also talked

about having problems with getting a registry exam, and not being

asked questions about his exposure; which is something that also

concerns me, since it is also a program that my office is involved

with. So, yes, I will make that commitment, sir. Thank you.

Mr. SHAYS. And we appreciate your counsel being here. I realize,

given the issue, you were here to respond to that issue. And I

thank you for your honesty in response to my questions. So, thank

you.

Mr. HIPOLIT. Thank you, Mr. Chairman.

Mr. SHAYS. Dr. Goldman.

Dr. GOLDMAN. Yes. I want to thank you for holding this hearing;

and for your concern about the health and welfare of the veterans;

and to say certainly I am available if there are further questions

or discussions you want to have. I am sure that is true for the

other scientists who served on these committees. And just to give

you my assurance that, from what I can tell, that they are all committed to trying to do this job in the way that Congress has intended it to be done.

And if we are not doing that, then we need to hear that. We need

that feedback; and we need to be corrected, so that we are providing the kind of scientific information that you need in order to do

your job. So thank you very much.

Mr. SHAYS. Thank you, Dr. Goldman. Dr. Potolicchio.

Dr. POTOLICCHIO. Well, I would like to thank you for inviting me,

also. And I am sure you are on top of this.

Mr. SHAYS. Well, we aren’t. That is the sad thing. We are trying

to be.

We didn’t ask you to make any comments, so, you know, probably, you will have the greatest wisdom of the whole group right

now.

Ms. STOIBER. Absolutely not. But I do want to say that the Institute takes very seriously the privilege that we have been offered

of doing this important work on behalf of veterans. The scientists

who serve on our committees all serve pro bono, and they give

thousands of hours of work for every committee. And so they do it

as a matter of national interest and personal commitment to get

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the best possible and most accurate scientific outcome in every

analysis.

And so we listen to what you are saying, and we certainly will

make every effort to assure that issues that you have raised are

considered in any work that unfolds from this day forward.

Mr. SHAYS. Thank you. You know, we give the benefit of the

doubt, when bringing out a drug, to making sure we don’t bring it

out unless we are very certain that it is safe. It seems to me, we

should be giving the benefit of the doubt to the veteran, in terms

of the analysis that we make.

Ms. STOIBER. If you could sit in on our committee meetings—

which you can’t, because they are all conducted in private, except

for public sessions—you would hear the committee members really

searching very hard on every shred of evidence to try to figure out

if there are alternate interpretations; and if so, how to do so in a

way that is in the interests of the veterans community. So we will

do that conscientiously; but we already take it as a very important

component of what we do.

Mr. SHAYS. Thank you. Mr. Binns, we appreciate your staying

through and listening to the whole—let me first say, I appreciate

the government folks coming second. It gives me a feeling that you

have more credibility, having heard what was said in the first

panel. So I thank all of you for that.

And I thank those on the first panel for staying and listening to

what the second panel had to say.

Do you have some nice closing comments you would like to

make?

Mr. BINNS. I wish I did. I think the people who met me 31⁄2 years

ago know that I am a person who likes to assume the best and

work with people; and we have tried that for 31⁄2 years.

I also sat in on the first session of Dr. Goldman’s new committee.

As Dr. Stoiber was saying, you can’t sit in on the detailed discussions. The speakers selected by the staff to participate in that session—which is the only session at which outside speakers were permitted—were not a balanced presentation of Gulf war illnesses

work.

And it makes it very difficult for me to believe that the people

who have organized these programs—and I distinctly want to distinguish that from the scientists who have participated in them.

And I respect that they do this out of their dedication to the country and out of their scientific dedication, and I do not wish to in

any way impugn any of their service.

But they have been presented with a stacked program here, from

the categories of evidence to, most recently, what was told them by

the people selected to speak to them.

Mr. SHAYS. Well, let me ask you, it is staffed by whom? It is

staffed by not the Department of Veterans Affairs; is it?

Ms. STOIBER. No. Our committees are staffed by professional

staff of the IOM; many of them, sitting here with me today.

Mr. SHAYS. Right.

Ms. STOIBER. And they work under the direction of the committee. I think we organize information, but every single IOM committee has a great deal of independence to, in fact, approach the study

and the agenda in any way they deem most appropriate.

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Mr. SHAYS. Let me just say, I wanted everybody to be honest

with their feelings; so I appreciate Mr. Binns. I wanted him to say

something positive, but he said what he needed to say.

I would hope, though, that in the course of a presentation, that

you are pretty comfortable that you are having a presentation that

expresses what, for instance, this committee would have heard

time and again. So I will make that point to you, and have confidence that you have confidence in the people who are doing this

work.

Let me say, I thank all of you for coming. And I thank you for

your honest answers to my questions. You have tried to help us

sort this out, and it is very appreciated.

And I will just end with you, Mr. Binns, for your service in what

I know has become very frustrating for you. And since I have experienced this, as well, and since I know how you feel, I particularly

thank you for your service.

With that, this committee is adjourned.

[Whereupon, at 4:10 p.m., the subcommittee was adjourned.]

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