[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
AGENT ORANGE: STATUS OF THE AIR FORCE RANCH HAND STUDY
=======================================================================
HEARING
before the
SUBCOMMITTEE ON NATIONAL SECURITY,
VETERANS AFFAIRS, AND INTERNATIONAL
RELATIONS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
SECOND SESSION
__________
MARCH 15, 2000
__________
Serial No. 106-163
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
__________
U.S. GOVERNMENT PRINTING OFFICE
67-153 WASHINGTON : 2000
______
COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio
Carolina ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
LEE TERRY, Nebraska THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
HELEN CHENOWETH-HAGE, Idaho (Independent)
DAVID VITTER, Louisiana
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
David A. Kass, Deputy Counsel and Parliamentarian
Lisa Smith Arafune, Chief Clerk
Phil Schiliro, Minority Staff Director
------
Subcommittee on National Security, Veterans Affairs, and International
Relations
CHRISTOPHER SHAYS, Connecticut, Chairman
MARK E. SOUDER, Indiana ROD R. BLAGOJEVICH, Illinois
ILEANA ROS-LEHTINEN, Florida TOM LANTOS, California
JOHN M. McHUGH, New York ROBERT E. WISE, Jr., West Virginia
JOHN L. MICA, Florida JOHN F. TIERNEY, Massachusetts
DAVID M. McINTOSH, Indiana THOMAS H. ALLEN, Maine
MARSHALL ``MARK'' SANFORD, South EDOLPHUS TOWNS, New York
Carolina BERNARD SANDERS, Vermont
LEE TERRY, Nebraska (Independent)
JUDY BIGGERT, Illinois JANICE D. SCHAKOWSKY, Illinois
HELEN CHENOWETH-HAGE, Idaho
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Lawrence J. Halloran, Staff Director and Counsel
Robert Newman, Professional Staff Member
Jason Chung, Clerk
David Rapallo, Minority Counsel
C O N T E N T S
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Page
Hearing held on March 15, 2000................................... 1
Statement of:
Albanese, Dr. Richard, Senior Medical Research Officer, U.S.
Air Force, former Ranch Hand Principal Investigator; Dr.
Linda Schwartz, associate research scientist, Yale
University School of Nursing, consultant, Veterans Health
Care; and Dr. Ronald Trewyn, dean of graduate school and
vice provost of research, Kansas State University, former
member Ranch Hand Advisory Committee....................... 92
Chan, Kwai-Cheung, Director, Special Studies and Evaluations,
National Security and International Affairs Division,
General Accounting Office, accompanied by Dr. John
Oppenheim, Assistant Director, National Security
International Affairs Division, General Accounting Office;
and Dr. Weihsueh Chiu, Project Manager, Agent Orange Study,
National Security and International Affairs Division,
General Accounting Office.................................. 7
Michalek, Dr. Joel, Senior Principal Investigator, Air Force
Health Study on Exposure to Herbicides, Department of
Defense; Robert J. Epley, Director, Compensation and
Pension Service, Veterans Benefits Administration,
Department of Veterans Affairs, accompanied by Dr. Susan
Mather, Chief Public Health and Environmental Hazards
Officer, Department of Veterans Affairs; Ronald Coene,
Executive Secretary, Ranch Hand Advisory Committee, Food
and Drug Administration; and Dr. David Butler, Senior
Program Officer, Veterans and Agent Orange Reports,
Institute of Medicine, National Academy of Sciences........ 39
Letters, statements, et cetera, submitted for the record by:
Albanese, Dr. Richard, Senior Medical Research Officer, U.S.
Air Force, former Ranch Hand Principal Investigator,
prepared statement of...................................... 95
Butler, Dr. David, Senior Program Officer, Veterans and Agent
Orange Reports, Institute of Medicine, National Academy of
Sciences, prepared statement of............................ 70
Chan, Kwai-Cheung, Director, Special Studies and Evaluations,
National Security and International Affairs Division,
General Accounting Office, prepared statement of........... 10
Coene, Ronald, Executive Secretary, Ranch Hand Advisory
Committee, Food and Drug Administration, prepared statement
of......................................................... 60
Epley, Robert J., Director, Compensation and Pension Service,
Veterans Benefits Administration, Department of Veterans
Affairs, prepared statement of............................. 47
Evans, Hon. Lane, a Representative in Congress from the State
of Illinois:
Letters dated January 21 and March 9, 2000............... 30
Prepared statement of.................................... 26
Michalek, Dr. Joel, Senior Principal Investigator, Air Force
Health Study on Exposure to Herbicides, Department of
Defense, prepared statement of............................. 42
Schwartz, Dr. Linda, associate research scientist, Yale
University School of Nursing, consultant, Veterans Health
Care, prepared statement of................................ 100
Shays, Hon. Christopher, a Representative in Congress from
the State of Connecticut, prepared statement of............ 3
Trewyn, Dr. Ronald, dean of graduate school and vice provost
of research, Kansas State University, former member Ranch
Hand Advisory Committee, prepared statement of............. 112
AGENT ORANGE: STATUS OF THE AIR FORCE RANCH HAND STUDY
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WEDNESDAY, MARCH 15, 2000
House of Representatives,
Subcommittee on National Security, Veterans
Affairs, and International Relations,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:05 a.m., in
room 2247, Rayburn House Office Building, Hon. Christopher
Shays (chairman of the subcommittee) presiding.
Present: Representatives Shays, Lee, and Sanders.
Also present: Representative Evans.
Staff present: Lawrence J. Halloran, staff director and
counsel; Robert Newman, professional staff member; Jason M.
Chung, clerk; David Rapallo, minority counsel; Ellen Rayner,
minority chief clerk; and Earley Green, minority assistant
clerk.
Mr. Shays. Good morning, I would like to call this hearing
to order.
This week saw the first visit to Vietnam by a U.S.
Secretary of Defense since the war ended. While there,
Secretary Cohen cited our ``absolute, sacred obligation'' to
persist in the search for those still missing in action, those
long remembered but too long unaccounted for.
The same obligation to those who fought brings us here this
morning. The search for long latent illnesses associated with
exposure to herbicides in Vietnam demands the same persistence,
the same integrity, the same willingness to confront hard
truths.
Eighteen years ago, the Air Force began a 25-year, $140
million research program to assess the relative health of 1,300
ranch hands, air and ground crew members who handled and
sprayed Agent Orange and other defoliants in Vietnam. The Ranch
Hand Study was designed to generate significant scientific data
and analysis to be used by the Department of Veterans Affairs
[VA], and others in making health care and compensation
decisions regarding Vietnam veterans.
But according to a recent study by the General Accounting
Office [GAO], requested by our colleague, Representative Lane
Evans from Illinois, ranking member on the House Veterans'
Affairs Committee, Ranch Hand has been slow to publish
findings, unwilling to share data, inconsistent in conveying
design limitations, and resistant to congressionally mandated
participation by independent parties.
Controversial from the outset, the Ranch Hand study has
been consistently criticized for both scientific and
administrative shortcomings. Many believe Ranch Hand has so far
failed to fulfill its promise as the pivotal longitudinal study
of herbicide toxicity. Some conclude it never will. Others
believe this research was designed to fail, or manipulated to
avoid controversial findings.
Vigilance and independence are needed to resist
institutional biases and sustain the pace and rigor of long
term research. Today, we ask if the Ranch Hand study meets that
test.
It has been said history teaches us the mistakes we are
about to make. The history of the Ranch Hand study has much to
teach about the mistakes that should not be repeated as the
research proceeds, and similar studies are designed for gulf
war veterans, anthrax vaccine recipients, and the veterans of
future toxic conflicts.
Our witnesses this morning bring a great deal of
experience, expertise, and passion to this important
discussion. We look forward to their testimony. And we welcome
everyone who is here today.
[The prepared statement of Hon. Christopher Shays follows:]
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Mr. Shays. At this time, I would like to recognize Mr.
Sanders, who has really been at the cutting edge of this issue
and gulf war illnesses, as well as anthrax. Mr. Sanders.
Mr. Sanders. Thank you very much, Mr. Chairman.
Let me begin by applauding the chairman for holding this
hearing and for saying that he and I and others have been
working for a number of years on gulf war illness and on other
veteran issues. And for people who think that we are going to
disappear and go away and give up the fight, they are wrong. We
are going to stay with it, no matter how long it takes to get
justice for American veterans.
Agent Orange, as I think everybody knows, is one of the
most toxic chemical compounds that has ever been invented.
According to Jacqueline Veret of the FDA, it is ``100,000 times
more potent than thalidomide as a cause of birth defects in
some species.''
There are many veterans, there are many Members of
Congress, there are many Americans who believe the Department
of Defense and the Veterans Administration have been less than
candid about the health effects that Agent Orange has had on
them and on veterans' children. While the Government has
acknowledged that some illnesses the Vietnam veterans developed
are associated with Agent Orange exposure, and that these vets
can receive disability benefits, many veterans believe that the
health problems associated with Agent Orange are far more
serious and widespread than the Government has acknowledged up
to this point.
Also, many veterans believe that the VA and the DOD have
been less than effective in developing an outreach program
which informs veterans about what benefits they might be
entitled to from VA relating to Agent Orange exposure and how
they might access those benefits.
In other words, there are two issues. One is the scientific
study to determine what health problems are associated with
Agent Orange exposure. But the next issue, equally important,
is that once you have developed those conclusions, we have the
moral obligation to reach out to the veterans and tell them
that if they are suffering from this or that disease, they are
entitled to benefits.
And I believe that the record that the VA has established
in that regard, of reaching out to veterans, of making them
aware of what they are entitled to, has been very, very poor.
Some of you may have noticed recently there was an article
in the papers throughout this country where the Government of
Vietnam has indicated that approximately 1 million people in
Vietnam have been hit with health effects as a result of
exposure to Agent Orange. And that should wake us up, in terms
of the damage that was done to American soldiers who were over
there.
The Ranch Hand study, about which the subcommittee will
hear today, was supposed to answer many of the questions and
concerns that veterans and those of us who support veterans
have about the health effects of Agent Orange. This
epidemiological study, which was begun by the Air Force in
1982, has been criticized by many years by scientists, Members
of Congress, and the veterans community.
So far the study has cost some $100 million, an
astronomical sum of money. And while the study looked at the
health effects of Agent Orange on Air Force personnel who
sprayed the herbicide, it will not answer the questions about
the health effects of Agent Orange on soldiers on the ground in
Vietnam who were exposed to Agent Orange differently, including
through the ingestion of it in food, swimming in it in the
water, or drinking.
So we are not quite convinced that even that those people,
who were most exposed to Agent Orange have been fully studied.
It is beyond my comprehension that with all the resources of
the U.S. Government, we have not been able to track down those
people who are most exposed and take an objective look at the
health problems that they have suffered.
I would point out that in 1984 a lawsuit was settled, and
that it was a very controversial settlement, between Vietnam
veterans and the wartime manufacturers of Agent Orange, Dow
Chemical, Monsanto, Uniroyal, Diamond Shamrock, et al. What was
interesting about that settlement, as many of you know, is that
over 200,000 veterans received compensation from the chemical
companies for harm resulting from Agent Orange exposure.
Meanwhile, and this is an important point, to date according to
the VA's own figures only about 7,500 veterans have received
service-connected disability compensation from the U.S.
Government.
While we acknowledge that the standards were different, I
think it should give us some pause for thought as to how
200,000 veterans could get some compensation from the chemical
companies, and after all of these years only 7,500 veterans
have gotten disability benefits from the Government.
Mr. Chairman, let me conclude by once again thanking you. I
look forward to hearing the testimony of our witnesses.
Mr. Shays. I thank the gentleman very much.
At this time, I would ask if Lee Terry from Nebraska would
have any comments he would like to make?
Mr. Terry. No, thank you.
Mr. Shays. Let me take care of some housekeeping first, and
ask unanimous consent that all members of the subcommittee be
permitted to place an opening statement in the record and the
record remain open for 3 days for that purpose. Without
objection, so ordered.
I ask further unanimous consent that all witnesses be
permitted to include their written statements in the record.
Without objection, so ordered.
I would ask unanimous consent to insert a statement from
James G. Zumwalt, son of the late Admiral Elmo Zumwalt, who
long advocated Agent Orange research. He has eight points to
make, and we will insert that in the record. We might share
some of it later today. Without objection, so ordered.
I will recognize our first panel. It is wonderful to have
you gentlemen here. We have Kwai Chan, Director, Special
Studies and Evaluations Group, General Accounting Office;
accompanied by Mr. John Oppenheim, Assistant Director, National
Security International Affairs Division, General Accounting
Office; and Dr. Weisueh Chiu, Project Manager, Agent Orange
Study, National Security International Affairs Division from
the same office.
Gentleman, I would ask you to rise to swear you in, as we
always do.
[Witnesses sworn.]
Mr. Shays. I would like the record to note that all three
of our witnesses have responded in the affirmative.
It is my understanding, Mr. Chan, that you will have the
testimony and that you will be assisted by your able colleagues
in responding to questions. Thank you.
STATEMENTS OF KWAI-CHEUNG CHAN, DIRECTOR, SPECIAL STUDIES AND
EVALUATIONS, NATIONAL SECURITY AND INTERNATIONAL AFFAIRS
DIVISION, GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY DR. JOHN
OPPENHEIM, ASSISTANT DIRECTOR, NATIONAL SECURITY INTERNATIONAL
AFFAIRS DIVISION, GENERAL ACCOUNTING OFFICE; AND DR. WEIHSUEH
CHIU, PROJECT MANAGER, AGENT ORANGE STUDY, NATIONAL SECURITY
AND INTERNATIONAL AFFAIRS DIVISION, GENERAL ACCOUNTING OFFICE
Mr. Chan. Thank you. Mr. Chairman, members of the
subcommittee, it is my pleasure to be here today to discuss the
findings of our report examining the Air Force's ongoing Ranch
Hand study. This study is one of the most expensive and in
depth studies of the long-term health of a small group of
Vietnam veterans. Many have described the Ranch Hand study as
the definitive health study of Vietnam veterans exposed to
herbicides such as Agent Orange.
Before I discuss our findings, let me first provide some
background and context surrounding this study. During the
Vietnam war, the United States sprayed millions of gallons of
herbicide, including Agent Orange, over Vietnam. In the late
1970's, concerns began to emerge over the long-term health
problems of the veterans. Although they could have been exposed
to many potential hazards, including herbicides, pesticides and
infectious diseases, attention focused on herbicides. Several
herbicides, including Agent Orange, contain the chemical
dioxin. This chemical is known to cause a variety of adverse
health effects in animals, but its effects in humans remain
controversial.
The Ranch Hand study follows the health and mortality of
the so-called Ranch Hands, the almost 1,300 Air Force personnel
who sprayed herbicide from the air in Vietnam. The 25-year
study began in 1982 and is scheduled to end in fiscal year
2006. It costs over $100 million in then-year dollars to date,
and it's projected to cost a total of $140 million by its
conclusion.
Since its inception, the Ranch Hand study has been very
controversial. Initially, many reviewers expressed concern that
the public would not consider this study credible. This was
because the Air Force, which conducted the spraying of
herbicides in Vietnam, was also given the responsibility to
conduct the study. These concerns about the appearance of
conflict of interest led to the inclusion of several safeguards
intended to ensure scientific rigor and objectivity. Among
these measures was the establishment of an advisory committee
of outside experts who were responsible for providing
independent scientific review.
The Ranch Hand study is one of the few ongoing studies of
the health effects of herbicides in human populations. This is
of particular importance with regards to the process for
determining whether Vietnam veterans can receive disability
compensation for health conditions associated with herbicide
exposure. Because, when making compensation decisions, the
Department of Veterans Affairs places primary importance on
evidence of adverse health from human studies, not on evidence
from animal or laboratory studies.
Let me now discuss our key findings. First, though there
were high expectations that the Ranch Hand study would help
resolve health questions surrounding herbicide exposure, we
found that the study has had limited impact on veterans
compensation decisions. The most significant impact of the
Ranch Hand study so far has been on a decision in 1996 to
provide compensation to Vietnam veterans' children born with
the birth defect spina bifida. The study has not contributed
either positively or negatively to decisions to compensate for
any other diseases.
Currently, the Department of Veterans Affairs has
recognized a total of 10 diseases, including spina bifida, for
which Vietnam veterans can receive compensation.
The study has also led to increased discussion and further
study of the association between herbicide exposure and
diabetes. This was first reported by the Ranch Hand study in
1991, but currently Vietnam veterans with diabetes are not
eligible for compensation.
Let me turn to the implementation of the study. Although
the Air Force has conducted many aspects of the study
vigorously, we found several past and ongoing problems. Though
many of these problems have been resolved, they have led
critics to raise questions about the openness and credibility
of the study. The problems we found are as follows.
First, delays have occurred in the dissemination of some
important study results. For example, although the Ranch Hand
study has reported its results periodically in official Air
Force reports starting in 1983, publications of the study's
health findings in peer-reviewed scientific journals did not
begin until 1990.
Also, a key update to the study findings on reproductive
outcomes and birth defects was delayed for 8 years and not
released until 1992. This was because the Air Force conducted
additional data verification and analysis without releasing any
interim information. We found that the degree of verification
was highly unusual and virtually unprecedented for a study of
its size.
Second, public access to data remains limited. Currently,
the public can only access the 1987 physical examination data
which was released in 1995. Data from 1982, 1985, 1992, and
1997 have not been released.
We recommended in our report that the Air Force establish
and publicize a timetable for the release of all study data and
release the data through a medium that is easily accessible to
the general public. The Air Force concurred with our
recommendation. They have since posed a timetable for the
release of study data on their website. In addition, they are
investigating ways to release the data in a more accessible
format.
Third, communication of key study limitations by the Air
Force has been inadequate. The study has difficulty detecting
increased risk of rare diseases, including many forms of
cancer. This is because of the relatively small size of the
Ranch Hand population.
Furthermore, the study's findings cannot be generalized to
all Vietnam veterans. This is because the Ranch Hands and
ground troops were exposed to different levels of herbicide in
Vietnam in different ways. For instance, while Ranch Hand
appear to have been exposed to herbicide primarily through skin
contact, ground troops report exposure through contaminated
food and water, as well as contaminated clothing worn for
extended periods of time. Little is known about the potential
impact of these differences.
Despite these limitations, early study press releases and
executive summaries contained language that may have been
misinterpreted to mean that the study showed herbicide were
safe. More recent press releases and executive summaries still
do not clearly communicate the study limitations to the public.
We recommended in our report that the Air Force include
more information on the study's limitations in its press
releases and executive summary. The Air Force concurred with
our recommendation.
Fourth, in the early years of the study, two measures
intended to ensure that it was conducted independently and
without appearance of bias were not carried out as planned. One
of these measures, specified in the study's protocol, was that
the Air Force scientists in charge of conducting the study have
primary responsibility over the scientific aspects of the
study. However, in 1984 and 1985 the Air Force management and
the White House tried to direct certain aspects of the Air
Force scientists' research.
In addition, the protocol specified that the study's
advisory committee include scientists nominated by veterans
organizations. However, the committee did not include veterans'
representatives until 1989.
Finally, the advisory committee's outreach to veterans is
still an issue. Better notification of committee meetings and
vacancies would help ensure that veterans groups perceive the
committee as fulfilling its role as an independent and unbiased
oversight body. The Food and Drug Administration concurred with
our recommendation and stated that it has begun to work to
ensure that veterans organizations are notified of the
committee's activities in a timely manner.
Mr. Chairman, this concludes my statement. Thank you.
[The prepared statement of Mr. Chan follows:]
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Mr. Shays. Mr. Chan, thank you.
At this time, I would ask Lee Terry if he has any
questions.
Mr. Terry. Thank you, Mr. Chairman.
I want you to expand on the third point of the credibility
issues, which was the limitations of the study. And the reason
I want to focus on that is because obviously this is an
oversight committee. We need to make informed opinions as to
the credibility of the study. And obviously, if the limitations
are such that the credibility is questioned, then I think we
have to ask the question should we continue.
So let us go back to the study and the limitations. You
raised a couple of points, but I would appreciate it if you
would go over those limitations to the Ranch Hand study and
discuss them in a little bit more detail and then I am going to
ask some of the followup questions.
Mr. Chan. We raised two points in terms of the--one is that
of the sample size and the second is the representativeness of
the Ranch Hands themselves. Let me talk about the sample size
first.
Basically, the Ranch Hands consist of about 1,300 people,
and that's all you have. You are limited by this small
population.
Mr. Terry. And who are those folks?
Mr. Chan. They are Air Force pilots and ground crews where
they handle and sprayed the herbicides in Vietnam. The majority
of the spraying was done by this group of people. So in the
early stage, it was believed that this is a likely group of
people who might be exposed to the herbicide in the greatest
quantity-wise, in terms of exposure. The opportunity for
exposure is much greater. That is the belief they have.
But the sample size itself, basically what they did is they
picked the entire population of the Ranch Hands. And then,
because it was a study looking for Agent Orange, the effect of
Agent Orange, they picked the control group in various sizes as
a ratio of one to five to as many, so that they can replace
those people. So currently we have about 1,200 Ranch Hands
versus about 1,800 of the control size for comparison.
These people were also in Vietnam doing--in the war, but
they were not supposedly exposed to Agent Orange. So the
control group is not really sort of like the Vietnam-era
veterans who did not go to Vietnam who were never exposed to
anything.
Let me clarify that point right away. That's how the
comparison is being done.
Mr. Terry. Is there difficulty, from a scientific point of
view, of that being a credible control group for a scientific
study?
Mr. Chan. Let me give you my own opinion then, since we did
not address that in our report. In a way, you would love to
have three groups. One is those supposedly exposed to the Agent
Orange, those who were there and supposedly have not been
exposed, and those who never went. Because that one actually
would not have any exposure to pesticide, to drinking the
water, to taking showers, to eating food and all those things
that possibly could affect them, as well.
But the intent of the study is really to look for the
affect of Agent Orange, not on anything else. This is not a
general health study, per se. So therefore, the third group was
not included in that study. That's the first point.
Now when you have a comparison of 1,300 as the treatment
group, it's statistically extraordinary to detect any kind of
rare disease where let's say it happens 1 out of 100,000
subjects, once in 100,000 and so on. Because statistically, out
of these 1,300, it's very difficult to find these rare
diseases, as we stated.
So as a result of that, since you cannot expand the size of
this group like an accordion, it's difficult to have rare
disease showing up for comparison purposes because of the
sample size. I mean, we can go through a statistical way to
analyze this, but clearly the larger the sample size, the more
likely you would find people with those rare diseases. So
that's one problem with it.
The second problem is really that of representativeness. I
think in our statement we did say that this is solely
represented by the Air Force personnel. They are not the people
who were on the ground, such as the Marines, exposed to the
spray at the time when they're out in the open as the spraying
is being done, or maybe exposed to the dioxin in a different
manner than this. There are different medium by which they may
have been exposed.
So those are two major problems that we note.
Mr. Terry. Can you help me work through the latter part,
because I am having difficulty understanding. The
representatives in this group are just Air Force. You said
others that may have been exposed, Marines, are not part of the
representative group?
Mr. Chan. That's true.
Mr. Terry. But talking about the credibility of the study,
whether it is scientifically based, explain to me how that may
create some issues of its credibility? Do you understand what I
am saying? Just because some of the Marines were excluded, to
me it is not clicking why I should be concerned.
Mr. Chan. It is really the medium of exposure. One clearly
is the following, I think, to think of logically. The spraying
is done through an aircraft so therefore, the handling of the
dioxin of itself, the herbicide. The other way is the soldier
may have been exposed while the spraying is going on by our own
people. And water could be contaminated where they may be
drinking from it or taking showers and so on and intake of
food, and so on.
So what I'm saying as well as the possibility of the
soldiers, particularly some of them told us they were out there
in the jungles for a long period of time where their clothing
may be contaminated and they couldn't wash, unlike the pilots.
They can finish spraying, go back to their place, and then take
a shower and have clean clothing and so on. So there are
different ways that you might be exposed to the herbicide.
That's what we're saying.
Mr. Terry. So in this representative group, has the Air
Force at least identified the types of exposure that the sample
size, the group would have, whether it has been on clothes,
from the ground, water, drinking? Have they gone through the
steps that you just laid out?
Mr. Chiu. They have investigated, through surveys,
different ways in which the ground crew and the pilots were
exposed. And they were able to correlate that with measurements
of dioxin in those people's blood. They found that most of the
exposure from the Ranch Hands was through handling, bare skin
contact, being sprayed in the face when a valve was opened.
I guess my feeling is that the problem with credibility is
more in the communication of those limitations not necessarily
the fact that they exist. Because all studies will have
limitations. Just making sure that you have a balanced
communication of what the study can tell you and what it can't
tell you. If for instance, we did find some adverse health
effect, then you need to make clear whether the finding is more
or less representative of other veterans. Especially of
negative results. If they don't find anything, then there are
limitations as to what that says. That doesn't necessarily mean
that something isn't happening in other veterans.
Mr. Terry. And that is a great point, and that is
ultimately the goal of this study. So my question to you is
based on the sample size and the representatives in this group.
Can we scientifically make conclusions that we can communicate
the details that you just stated, Doctor? Or do we question
whether we can credibly communicate specifics to various
veterans groups or types of representatives that are involved?
Mr. Chiu. I think it is possible to effectively communicate
the study's findings and its limitations.
Mr. Terry. Well, can we rely on those? Reliably? We can
communicate anything. It doesn't have to be reliable, as I'm
learning in my first 13 months in Congress.
Mr. Oppenheim. Mr. Terry, part of the problem, too, is in
the early reports that came out of the study. There are some
statements in there that, as Mr. Chan mentioned, had the
potential to be misinterpreted. Terms such as reassuring were
used in one report when no adverse health effects were found.
And I think that gets to the communication issue. The
limitations weren't communicated to the public in particular. I
think the scientific community recognized the limitations.
Mr. Terry. And that goes to another issue of how people are
going to perceive the study and whether they believe it. That
is the next phase, I think, for us. But right now, we have to
determine if we find it to be a credible study.
Thank you, Mr. Chairman.
Mr. Shays. I thank the gentleman.
Mr. Sanders, you have the floor for 10 minutes.
Mr. Sanders. Thank you, Mr. Chairman.
Let me begin by asking the panelists, I think most lay
people, most citizens, would say spending $100 million to study
1,300 people, and then coming up with the conclusion that the
study has not contributed either positively or negatively to
the decisions to compensate for any other diseases, that is a
hell of a lot of money to be spent. How did they manage to
spend so much money with so little results, Mr. Chan?
Mr. Chan. First of all, it's a 25 year longitudinal study.
So if each year you spend an average of a few million dollars,
it adds up. And also, the actual physical examination of
individuals was extraordinarily detailed and very complete, and
it costs money to do that.
Mr. Sanders. I appreciate that, but $100 million. Do you
think that that is--that sounds to me like it is quite
inflated. It seems to me you could do a heart transplant for
each of these people for probably less money.
Mr. Chan. $100 million averages what, about $5 million a
year?
Mr. Shays. $5.6 million each year.
Mr. Chan. And these are in then-year dollars, let me say
that, too. It's a very detailed scientific endeavor and we are
quite impressed with what they've done. But you're right, also,
it's very expensive but they expected up front that it would
cost this amount of money.
Mr. Sanders. Let me just switch gears and pick up on a
point that Mr. Terry was making, and tell me what I am missing
here. Common sense would suggest that those people who were
most exposed to Agent Orange might suffer the most serious
consequences. That is what common sense would suggest.
We know that there were groups of soldiers who were really
in the midst of this thing, who were in the areas that were
sprayed for week after week, wearing the same clothes, drinking
water. I talked to guys in Vermont, they were drinking the
water from the rivers. They were eating food in the area. They
were really living in this stuff.
How did the Department of Defense manage not to take a hard
look at those people? Would not common sense have suggested let
us look at those people who were most exposed and see the
health impact that that exposure might have had on them. What
is wrong with that approach?
Mr. Chan. I believe they did consider the other possible
candidates for this study and they ultimately dismissed them. I
might add that as far back as 1979 GAO issued a report that
basically said that the United States ground troops in South
Vietnam were an area sprayed with herbicide Orange where we
found that Marines to units in sprayed areas can be identified.
Mr. Sanders. Can be?
Mr. Chan. Yes, but the Army personnel in the sprayed areas
cannot be identified because Army records are incomplete. But
10 of 13 major Army units reviewed, report having Agent Orange
in their area of operation. So we do have some ideas of those
exposed from our previous studies that we have done, back in
1979. But they did consider and they found that this is the
most credible group to study.
Mr. Sanders. What do you think? Why would we not look at
those folks who were most exposed and just, I would be curious
to see. I mean, we hear anecdotally what people tell us, my
child was born with birth defects, this one died of cancer.
That is anecdotal. Why was it so difficult, if we are prepared
to spend so much money, why was it so hard to get better
information on the epidemiology of those people most exposed,
in your judgment?
Mr. Oppenheim. Mr. Sanders, when they started planning the
study back in the late 1970's, I think there was the belief
that this Ranch Hand population was a heavily exposed
population. Second, I think there was some logistical concerns.
One issue was that the Ranch Hand group was a very defined
population and it was a very reachable population. So it was an
easy study to--not an easy study, but it was a study which
could be developed without too much difficulty and you could
reach that population.
Mr. Sanders. I appreciate that and that is not
unreasonable. But tell me your views if somebody would argue
that the life experiences and the type of exposure of somebody
on the ground, who was wearing the same clothing week after
week, was swimming in this stuff, is a different type of
exposure. I am not opposed to looking at a group of Air Force
people, but it seems to me to be somewhat incorrect to ignore
those who were most exposed.
What am I missing in that analysis?
Mr. Oppenheim. I think that the other piece of it was that
when the Ranch Hand study was started, there was an
understanding that there would be other studies conducted at
the same time.
Mr. Sanders. Has that happened?
Mr. Oppenheim. Which may have covered the ground troops.
Mr. Sanders. Has that happened?
Mr. Oppenheim. There's been some to a limited extent.
There's a Chemical Corps study that the VA is conducting, but
it's much smaller and a much less in-depth study, I would say,
than the Ranch Hand study.
Mr. Sanders. Is there any study being done right now
involving the health of those people who were most exposed to
Agent Orange, to your knowledge?
Mr. Oppenheim. I think this Chemical Corps population was
another population believed to be heavily exposed, so that's
one study.
Mr. Sanders. What are the results? Do we have any published
results on that?
Mr. Oppenheim. Help me out a little bit here, Weihsueh.
Mr. Chiu. Not to my knowledge.
Mr. Sanders. So what kind of study is it, that we do not
have any results. The war did not end yesterday, we are a few
years down the line.
Mr. Chiu. The Chemical Corps study, Mr. Sanders, was
initiated after the National Academy of Sciences recommended
that such a study be done in 1993. In the 1980's, there were
several other studies done, one of which was the Vietnam
Experience study, which studied--basically compared people who
went to Vietnam to people who didn't go to Vietnam. There was
an attempt to conduct a study relating to exposure to Agent
Orange, but the CDC decided, after conducting a pilot study,
that they couldn't develop a methodology for exposure
assessment. There was some hearings in the late 1980's on that
study.
Mr. Sanders. Mr. Chairman, I would just say, and I am going
to get to another question in a moment, that after so many
years it really seems to me that the kind of information that
we would like is sorely lacking. We have spent a hell of a lot
of money, a lot of years have gone by, and I think that we do
not have the kind of information that we need.
Let me ask our panelists one other question. Mr. Chan, your
report indicates that the VA asked the National Academy of
Sciences to evaluate the scientific literature on the
association between exposure to herbicides and adult onset
diabetes. Based on your review, what do you think the likely
result of that review be? Will diabetes be one of the diseases
listed as having been caused by Agent Orange?
Mr. Chan. Let me say that the Air Force Ranch Hand study
issued a report in 1991, I believe, and observed this finding
in terms of high risk of diabetes for the Ranch Hands. And we
were quite impressed that, in fact, it's a rather strong study,
if anything, I thought.
But as we stated in our statement, it's still being
considered by VA as of today. I really don't know how it's
going to come out, to be honest with you. But they plan to
issue a report next month, in the year 2000. So I think----
Mr. Sanders. So in other words, what you are saying is the
Ranch Hand study suggested that diabetes might be caused by
exposure to Agent Orange but the VA has not done anything with
that information?
Mr. Chan. They've been asked to further review, obtain more
information, and so on. The decision has not been made as of
today, as to whether the veterans should be compensated for
diabetes.
Mr. Sanders. Just say a word or two on a point that you
made, and that is that veterans were concerned that for many
years the scientific community and their representatives were
not able to get the information. Why did that occur? And what
would be the effect of opening up that information to the
general population?
Mr. Chan. As we stated, the only available data that has
been given to the public is the 1987 data, and there were total
of five sets of data, I think. The Air Force is planning to
release the information hopefully by this year, but it's taking
a long time. Even the 1987 data was not released until 1995, so
it's taking them quite a while.
Mr. Sanders. Maybe they need more money. Maybe $100 million
was not enough.
My last question is recently, on March 3rd, the Vietnamese
Government released a report that an estimated 1 million
victims of Agent Orange exist in Vietnam. Obviously, that is an
unscientific statement, I am sure. But that is a heck of a lot
of people in a fairly small country. What might that do to our
whole discussion about Agent Orange and the problems that some
of our own soldiers have had?
Mr. Chan. Well, I think from a science point of view, more
information is needed to understand this relationship between
herbicide and health. I do not know, as you said, it's a very
large number of people exposed and with health problems. So
whether in fact one can verify that or not. I still see it as a
very promising area.
Mr. Sanders. Then my last question leads us to this point.
It would seem that if, in fact, so many Vietnamese are
suffering health effects from exposure to Agent Orange, then
that is something the United States Government would want to
learn about, if for no other reason than to see how it affects
American soldiers. Has the U.S. Government done enough to
understand the impact of Agent Orange on the Vietnamese people?
Mr. Chan. I think some private efforts have been devoted to
that.
Mr. Sanders. There was a study done by some Canadians, and
the Vietnam Veterans of America have been interested. What
about the U.S. Government. Is that not an area that we should
be studying, in your judgment?
Mr. Chan. Yes, I believe so.
Mr. Sanders. Thank you, Mr. Chairman.
Mr. Shays. I thank the gentleman. In my opening statement,
I made reference to Lane Evans, who had requested this study,
the ranking member on the House Veterans' Affairs Committee,
and someone I deeply respect, and a very good friend.
I would like to invite you to make a statement that you
would like to make for the record, and this time would be very
appropriate.
Mr. Evans. Thank you, Mr. Chairman. I appreciate your
leadership on this issue and I am glad we are holding a joint
hearing. I think this is a more economical use of our time, our
witnesses' times, so I appreciate that. This may be a rare
occurrence in Congress, but I am following my tenant. I am
Bernie's landlord, so I hope to do as well as you did, Bernie.
I have had a longstanding interest in the effects of
herbicide exposure on veterans and their dependents. I
introduced legislation that served as the catalyst for
providing compensation to America's veterans from the Vietnam
era for conditions arising from herbicide exposure.
I also have worked to ensure that the DOD and the VA make
use of existing medical evidence to make the right decisions
about what conditions should be service-connected and
compensated. We must remain vigilant and your scheduling this
important subcommittee hearing, Mr. Chairman, assures me that
you are willing to join on this watch.
25 years after the official end of the Vietnam war,
veterans are still questioning the effect of their exposure to
herbicides, including Agent Orange, which contains the
contaminant dioxin on their health. The Ranch Hand study was to
lay a scientific groundwork that the Government would use to
identify conditions to which veterans might be compensated. It
has been the target of much of the criticism in the veterans
community and they have been very vocal about it.
Because of the new and ongoing allegations, in the fall of
1998, I requested GAO to examine the Ranch Hand study. As Mr.
Chan will attest, GAO found that there are continuing problems
with effective communications with our veterans. In addition,
many of the valid concerns veterans initially had about the
Ranch Hand study still remain.
This January, Senator Tom Daschle and I sent letters to
Secretary Shalala of the Department of Health and Human
Services, and to Defense Secretary Cohen. I requested that they
provide detailed plans to address the problems reported in the
GAO report.
Secretary Cohen has indicated that Brooks Air Force Base
would make the newest data from the Ranch Hand study available
to the Government Printing Office on CD-ROM for a nominal fee,
as GAO has recommended. I am happy to provide a copy of this
letter, along with Secretary Cohen's response, to your hearing,
Mr. Chairman.
I will certainly continue to monitor this issue to assure
that interested parties can make use of the complete
information. I understand a response from Secretary Shalala is
forthcoming.
While I believe that the Ranch Hand study should continue,
the long-standing concerns about its integrity must also be
quickly and fully addressed. The bottom line is that veterans
want and deserve to be informed about the process and the
results of an important study.
Chairman Shays, Ranking Member Blagojevich, I appreciate
the opportunity to be with you this morning. Again, thank you
for asking me to attend.
[The prepared statement of Hon. Lane Evans follows:]
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Mr. Evans. I would like to ask that those letters be part
of the record.
Mr. Shays. Without objection, so ordered.
[The information referred to follows:]
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Mr. Shays. Again, thank you for requesting the study and
thank you for all the work you have done over all the years.
I would like to use some of my time to just put on the
record and ask Mr. Chan, Mr. Oppenheim and Dr. Chiu, if you
have any response to this. This is a statement from James G.
Zumwalt, the son of Admiral Zumwalt. I will just read his eight
points but not the details.
He said I believe Agent Orange research should not be
undertaken by the U.S. Government, especially when research on
humans is involved.
He said I believe the Air Force Ranch Hand study contains
several major methodological flaws.
He then says data such as the reproduction and development
data collected by the Ranch Hand researchers must be turned
over to trained university-based researchers for evaluation.
He then says published studies, when negative, should
always point out their weaknesses, such as small sample size
where rare events would not be expected to be found because of
the limited numbers, i.e., a group of only 600 exposed men or
their children.
He says to be balanced, a scientific study should include a
wide range of expertise.
Point six, the issues raised by the recent GAO report
conclude communications is not good between the Ranch Hand
researchers on the one hand, and the veterans community, the
general public, and other dioxin research on the other. It must
be addressed.
We now know dioxins cause increases in the number of
various cancers and cancer related deaths, heart disease
related deaths, diabetes, even at general population levels,
health problems in children whose mothers experience high
dioxin levels, et cetera.
And finally he said, as my father did before his death, I
too support dioxin research in other countries where Agent
Orange was sprayed and populations have been exposed, including
Vietnam, Cambodia, and Laos.
I would like you to respond to any of those points that he
made.
Mr. Chan. Generally, I think I have very little
disagreement with what he said. Basically, the only issue he
raised is the first one, which is research should not be done
by the Government. I can certainly understand this perspective,
given the past history of the so-called lack of trust.
I am not quite sure what he's talking about in terms of the
methodological flaw. Maybe it's because of the
generalizability, sample size issues, and so on. But I don't--
we didn't address that part.
But certainly, the others I would agree with him. And if
indeed, the last point that's made about supporting dioxin
research, particularly in humans, I think that's a very
important area because, quite frankly, industry has basically
used less and less dioxins for industrial use. So as a result,
you really don't have a lot of data out there, people who have
been exposed to dioxins, per se, except our Vietnam veterans,
as well as the Vietnamese people.
Mr. Shays. Thank you. Dr. Chiu, or Mr. Oppenheim, would you
like to make any comments on anything?
I wrote next to your point one, Mr. Chan, unbelievable.
Particularly this statement, also a key update to this study's
findings on reproductive outcomes and birth defects was delayed
for 8 years and not released until 1992.
I am going to read it again. Also, a key update to the
study's findings on reproductive outcomes and birth defects was
delayed for 8 years and not released until 1992. I mean, if you
had said 8 months, I would have said that is pretty bad.
Would you comment on why you think that happened?
Mr. Chan. For various reasons, I think. If you look at it
on a case-by-case, that seems to be a rather egregious problem,
in terms of issuing it. At the time, I think, there were a lot
of reasons why they felt they shouldn't release the information
from the Air Force perspective. One is because it was not part
of the protocol, they were not required to release the
information. They were asked to look into it more carefully,
verify in fact that the birth defects, in fact, were true
because the data collection instrument they used was basically
collected through a questionnaire.
At the same time, given the sensitivity of this information
and the high level of interest there's really a need to
communicate to the veterans in a timely manner.
So we sort of look at it and wish the interim report was
released.
Let me say it in a very different way.
If one designed a research study to gather information in
this manner, then it seems to me that once one receives the
results and determine that where the study requires further
examination, suggests that the study itself wasn't designed
well up front. Because either you have a good study or you
don't have a good study. But by having a study out there,
releasing some of the information, I think was important.
And indeed, as we said, the checking and verification of
the reported birth defects was extraordinary at that time. And
in our report, we list a couple of examples where, similar
studies did not go through that kind of checking. We were
surprised by it, but it's also a very solid way to approach it
if you're interested in research methods.
Mr. Shays. What did we gain? Tell me one thing we gained by
waiting 8 years?
Mr. Chan. You gain by having a much more solid scientific
study. What you lose is basically, in a different way, the
people, the veterans, if they knew about it, they can in fact
use the information in preventive ways, to make sure that their
health is OK and if they plan to have children to take steps to
provide the right kind of care before the child is born. So
there is the positive and negative.
I think in here this is pursing the study as an end rather
than pursuing the study as the means toward an end, if I may
say it that way.
Mr. Shays. Say that last sentence again.
Mr. Chan. I said this appears to be a study that becomes an
end in itself. That is, we want to make sure we're right. We
want to make sure we check everything. First we check the
people who have live births and then you want to make sure that
those kids are OK up to the year 18 years old, and so on. All
those are really the right thing to do.
But in a different way, as I said, it's an end in itself
rather than the means toward and end. The means toward the end
is to allow the veterans to know that----
Mr. Shays. It strikes me as somewhat arrogant to think that
you could not release this information and put qualifiers on
it, and then let other people, who happen to be intelligent,
and happen to have knowledge, to look at this information. It
strikes me as extraordinarily arrogant that somehow adults
could not deal with this information and recognize there was
some limits to it.
Mr. Chiu. If I might comment, the advisory committee at
that time was one that pressed for the Air Force not to release
their draft update until they had done the additional
verification. So it wasn't solely an Air Force----
Mr. Shays. You know, additional research, another year,
another 2 years. Another 8 years?
One thing we are going to do is we are going to be paying
close attention on what data is being released and so on. I
mean, that is your biggest objection. I think there are others
there, and I realize you were not asked to do everything we
might have wanted you to do, but this has been helpful.
Does any other Member have a question, before we get to the
next panel? Do any of the three of you? And Mr. Oppenheim, you
do not lose your job by responding. I can guarantee you, Mr.
Chan is a very good man.
I sometimes believe that the people who accompany the
person who gives the testimony sometimes have more enlightened
comments to make. No offense, Mr. Chan. Any other comments?
Mr. Oppenheim. I would just add the one comment that I
think Kwai has sort of touched on. And that seems to be this
conflict that exists between the needs to do really credible
in-depth research versus what the needs of the public and the
veterans community are. I think there are a number of steps
along the whole sequence of this research study in which there
could have been greater effort on the part of the Air Force to
really communicate what was going on and to create a really
more open kind of research environment that would engage
outside input into the research itself, either through putting
data out that's accessible to the public, providing greater
opportunities for the veterans to participate in the advisory
committee, and so forth.
So I don't know how you really deal with that conflict, but
it's just something that's existed in this study, and I'm sure
it exists in other studies like this, as well.
Mr. Shays. I think we should expunge from the record my
comment more enlightened, just additional great comments, in
addition to what Mr. Chan has said.
Mr. Chan. I would like to raise an issue which I always
felt all along, in doing this study and the work that we've
done in gulf war illnesses, is that to me there's a fundamental
problem between the gathering of the scientific evidence and
research in general, versus policymakers in terms of their
intent.
On one hand in science we really want to understand if
there's a relationship, an association, or correlation. If we
find there's a correlation, we then want to make sure that
there is a statistically significant relationship. Once we have
that, we want to make sure there's a linear dose response. That
means the more stuff you have the worse you get, in terms of
your physical well-being. And ultimately, we want to establish
cause-and-effect.
Now what we do here, is keep on raising the bar to achieve
that end goal and it's a very, very important part of science
to pursue in research.
Over time the science wants to establish sort of a beyond a
reasonable doubt we are doing the right thing.
On the other hand, I think, Congress, through various
legislation including Public Law 102-4, basically suggests that
we wanted to give the benefit of the doubt to the veterans.
That is, if they are sick, but we can't clearly establish cause
and----
Mr. Shays. We just do not want to wait until they die
before we help them.
Mr. Chan. I understand.
But my point is that the science doesn't quite support that
approach. Giving them the benefit of the doubt means that the
risk for the people exposed is higher for than the normal
population. So the risk means that the percentage of people who
are exposed sick, versus those who were not exposed but sick of
the same illness, is greater than one.
Science doesn't work that way. It emphasizes in a
statistical significance of I want to make sure that 19 out of
20 times I'm correct in this decision. So as a result then what
happens is that scientific information that----
Mr. Shays. I would feel more comfortable though, Mr. Chan,
if this scientific research was being done by a party that was
not a major player, and I would have a greater comfort level.
And I believe that, as a policymaker, I have the right to
determine that even there's not a shadow of a doubt, there's
every indication that, I'm happy to move forward and commit
dollars to helping people. I just think you give the benefit of
the doubt.
I hear your point.
Mr. Chan. Then what happens is that when the Academy looks
at scientific information what they're seeing are so-called
the----
Mr. Shays. They found flaws in the----
Mr. Chan [continuing]. Beyond a shadow of a doubt. Because
if you have a piece of paper that actually shows that the risk
is only a little higher, you can't publish that article. It's
not even in the data base for consideration. Do you see the
problem?
Mr. Shays. You do not think that information can be shared
without certain caveats that there may have been a flaw here or
there? That they cannot let other researchers look at it and
come to certain conclusions?
Mr. Chan. I agree with that.
Mr. Shays. I need to move on here. Did you want to make a
comment, Dr. Chiu?
Mr. Chiu. I just have one short comment and this has to go
back to the very beginning, the inception of this study. It has
to do with scientific credibility versus public and veterans
credibility, credibility to the public and veterans.
In 1980, no one questioned the Air Force's scientific
ability to carry out the science of the study. All the
questions were about whether they could maintain public
credibility. What we found, in sum, in our report is that many
small actions, each of them justifiable in itself. But when you
add them all up, it erodes the credibility of the study.
And so I guess, as a lesson for future studies, especially
if the decision is for the Government to conduct them, is to
have constant attention over the lens of public credibility
that is going to be focused on every decision in the conduct of
that study.
Mr. Shays. Thank you. I would like the record to show we
are spending $140 million. That is an average of $5.6 million a
year. We are not seeing much to show for this at this point.
I would like to call the next panel. Thank you.
Dr. Joel Michalek, who is Senior Principal Investigator,
Ranch Hand Study, Department of Defense; Robert J. Epley,
Director, Compensation and Pension Service, Veterans Benefits
Administration, Department of Veterans Affairs, accompanied by
Susan Mather, Chief Public Health and Environmental Hazards
Officer, Department of Veterans Affairs; Ronald Coene,
Executive Secretary, Ranch Hand Advisory Committee, Food and
Drug Administration; and Dr. David Butler, Study Director,
Veterans and Agent Orange Reports, Institute of Medicine.
If you would stand, I would like to swear you all in.
[Witnesses sworn.]
Mr. Shays. I would note for the record that our five
witnesses have responded in the affirmative. We have four
testimonies and we will start as I called you and go down the
row. Dr. Michalek.
STATEMENTS OF DR. JOEL MICHALEK, SENIOR PRINCIPAL INVESTIGATOR,
AIR FORCE HEALTH STUDY ON EXPOSURE TO HERBICIDES, DEPARTMENT OF
DEFENSE; ROBERT J. EPLEY, DIRECTOR, COMPENSATION AND PENSION
SERVICE, VETERANS BENEFITS ADMINISTRATION, DEPARTMENT OF
VETERANS AFFAIRS, ACCOMPANIED BY DR. SUSAN MATHER, CHIEF PUBLIC
HEALTH AND ENVIRONMENTAL HAZARDS OFFICER, DEPARTMENT OF
VETERANS AFFAIRS; RONALD COENE, EXECUTIVE SECRETARY, RANCH HAND
ADVISORY COMMITTEE, FOOD AND DRUG ADMINISTRATION; AND DR. DAVID
BUTLER, SENIOR PROGRAM OFFICER, VETERANS AND AGENT ORANGE
REPORTS, INSTITUTE OF MEDICINE, NATIONAL ACADEMY OF SCIENCES
Dr. Michalek. Members of the committee, panel members and
guests, thank you very much for inviting us here today. I'm
Joel Michalek, principal investigator of the Ranch Hand study.
I'm always pleased to have an opportunity to tell people about
the study.
I want to emphasize that our first concern is the veterans.
I've been a part of the study since 1978. We have spent
countless hours with over 2,000 veterans during the physical
exam cycles in San Diego and Houston. We have developed close
relationships with many veterans who risked their lives for
their country in an unpopular war. So believe me, we will leave
no stone unturned to find any connection between exposure to
Agent Orange and adverse health effects.
For that reason, we welcome the GAO study and we welcome
any recommendations you may have to help us toward that goal.
As our reviewers have described it, due to its size, scope,
data quality, and the use of a biomarker, the Ranch Hand study
is one of the best epidemiological studies ever conducted.
Every effort has been made to adhere to the protocol, collect
complete and accurate data, and obtain unbiased interpretations
of the results.
By design, the study has benefited from an independently
administered advisory committee of experts in medicine,
toxicology and statistics, biannual review by the National
Academy of Sciences, and submission of all results to peer-
reviewed scientific journals.
Peer-reviewed articles in the areas of birth defects and
immunological function have resulted from collaboration with
national experts from the Centers for Disease Control and
Prevention and Northwestern University and Evanston Hospital in
Illinois.
Research in diabetes, peripheral neuropathy, cardiovascular
disease and fertility is being co-authored with faculty from
the University of California at Davis, the University of
Arkansas, the University of Michigan, Yeshiva University of New
York, the University of Southern California and the University
of Texas.
My point is that interpretations are made by individuals
outside of the study recognized as experts in their fields. The
peer-review process itself provides an additional level of
quality assurance and rigor. The publication process is long
but the effort is focused and the end result is the best
achievable.
In November 1998 an article appeared in the San Diego Union
Tribune that was critical of the study alleging management
interference and coverup. I wrote a rebuttal and presented it
to the professional staff of the Senate and House Veterans'
Affairs Committee that same month. At the end of the
presentation a House staff member asked me if we would be
willing to undergo a GAO audit. I said yes. Personally, I'm
always happy to invite review and critique because I know that
is the best way to display the quality and thoroughness of our
work.
Subsequently, through most of last year we gave GAO
investigators unlimited access to all documents, including
medical records, electronic data, correspondence, reports and
articles. We hosted them twice at our facility. We produced a
randomized and blinded sampling plan for their review of
medical records in their check of our files against our
electronic data bases.
The end result was what we regard as a comprehensive and
positive report. The GAO report recommended that we improve our
communication of the limitations of the study and establish a
time table for the release of data to the public. We concur
with their conclusions and have made their recommendations our
No. 1 priority.
We now highlight study limitations in our reports, report
summaries, and press releases, and have established a timeline
for the release of all data to the public by the end of this
calendar year.
We are planning to provide data in easily accessible
formats on compact disks. In an effort to increase
communication and available information with veterans and the
public we have already placed executive summaries of morbidity
reports, abstracts of our published articles, all annual
reports to Congress and target dates for the release of our
data on our webpage.
This ends my prepared statement. We would be happy to
answer any questions you may have.
[The prepared statement of Dr. Michalek follows:]
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Mr. Shays. Thank you. Mr. Epley.
Mr. Epley. Mr. Chairman and members of the subcommittee,
thank you for the opportunity to testify today on the Air Force
Ranch Hand study and its impact on veterans benefits.
The VA agrees with the recent assessment by the General
Accounting Office that the Ranch Hand study has had limited
impact on benefits determinations. Our written statement
summarizes VA's past use of Ranch Hand study data and the
general framework within which we make determinations for
service-connected compensation benefits, so I won't repeat that
information verbally right now.
Public Law 102-4 directed the Secretary of Veterans Affairs
to seek to enter into an agreement with the National Academy of
Sciences to review and summarize the scientific evidence
concerning the association between the exposure to herbicides
used in support of military operations in Vietnam and specific
diseases. The NAS has submitted three reports as a result of
Public Law 102-4. Those three reports have resulted in a
determination that several diseases are associated with
exposure to herbicides in Vietnam.
The Ranch Hand study has been considered in each of the NAS
reviews but numerous other studies have also been considered
and have minimized the impact of Ranch Hand findings.
The recent GAO report concluded that the Ranch Hand study
has had almost no impact on VA determinations on which diseases
warrant presumptive service connection because of the small
size of the Ranch Hand population and the relative rarity of
the many cancers. The Department agrees that these and other
limitations in the Ranch Hand study noted by NAS over the years
have made its impact on our determinations very limited.
We believe the review process outlined in Public Law 102-4
has provided an effective basis for identifying diseases
associated with herbicide exposure. Clearly, the work in this
area is not done.
We understand that this committee is concerned about
information dissemination to Vietnam veterans and we're working
to improve our outreach efforts.
We look forward to working with NAS and with this committee
to assure that we provide the best possible service, the most
informed decisions, and all appropriate benefits to the
veterans of our Nation.
This concludes my statement. Dr. Mather and I will be
pleased to answer any questions.
[The prepared statement of Mr. Epley follows:]
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Mr. Shays. Thank you, your statement was concise and right
to the issue, and I thank you for that. I also wanted to thank
Dr. Michalek. Your statement was helpful, as well, and it will
enable us to have a good dialog.
I just want to clarify one thing and then we will get right
to you, Mr. Coene. Did you say you started this study in 1968,
Dr. Michalek? When did you start?
Dr. Michalek. Actually, talk about the protocol and its
design stage began, I think, in 1976, was when I was originally
hired at Brooks Air Force Base.
Mr. Shays. So you started in 1976?
Dr. Michalek. Yes, sir.
Mr. Shays. So this is something that you have worked long
and hard on, and I thank you for that work. I know you have
been very devoted.
Whatever else happens in this hearing, I want that to be
part of the record. Mr. Coene.
Mr. Coene. Mr. Chairman, members of the committee, my name
is Ron Coene and I'm the Deputy Director for Washington
Operations of the National Center for Toxicological Research. I
serve as the executive secretary to the advisory committee
known as the Ranch Hand Advisory Committee. I'm pleased to be
here to discuss my role as executive secretary to that
committee.
The committee, as chartered, advises the Secretary and the
Assistant Secretary for Health concerning its oversight of the
Ranch Hand study being conducted by the Air Force, as well as
providing oversight to the Department of Veterans Affairs Army
Chemical Corps Vietnam Veterans Health Study. The committee is
made up of nine members, including the chair, and members are
appointed for overlapping 4 year terms.
My written testimony, which has been submitted for the
record, describes in more detail my role as executive
secretary. Let me get to the substance of the GAO report and
concerns of this oversight.
The General Accounting Office report on Agent Orange
examined the Ranch Hand study and recommended that improvements
be made in communication between the advisory committee and
veterans organizations. In managing the committee, we utilize
the Federal Register the legal requirement to notify the
public, including veterans organizations, of its activities,
namely meeting times, dates, places and preliminary agendas.
In maintaining and assuring the proper mix of committee
appointees among veterans organizations, we utilize the
Secretary's Office of Veterans Affairs to obtain nominations of
qualified veterans to fill vacancies on the committee. But we
acknowledge that these informal practices could possibly lead
to the perception that the committee was not fulfilling its
role as an independent, unbiased oversight body.
I would like to discuss the steps the Department has taken
to ensure that, both in perception and practice, veterans
organizations are being involved in the conduct of the advisory
committee's activities. While the GAO investigation was
underway this past summer, these issues became known to us. We
took steps to use the Department's Office of Veterans Affairs
and Military Liaison to identify and intensify outreach and
contact the veterans organizations concerning the committee's
planned meeting in October of this past year.
In January of this year, that office began sending letters
requesting nominations for vacancies that currently exist on
the committee. To date 13 veterans service organizations have
been contacted. Six organizations have expressed a desire to
participate in the nomination process. The Department has
received two nominations each from the American Veterans
Committee, the Ranch Hand Vietnam Association, one nomination
from the American Legion, and three draft nominations from the
Vietnam Veterans of America. The Veterans of Foreign Wars also
has indicated an intention to submit nominations.
Additionally, the Disabled Americans Veterans have
expressed the desire to participate by reviewing the list of
nominees and providing their endorsement. The Vietnam Era
Veterans Association did not make a nomination but indicated
they planned to send observers to the advisory committee
meetings. Finally, the American Ex-Prisoners of War also
responded to our outreach but did not make a nomination.
The Department is continuing to followup with the remaining
organizations, seeking their input to this process.
I foresee closing out the nomination process by veterans
representatives by early next month and, in consultation with
the chairperson of the committee, we will select two
individuals from each of the three veterans organization
vacancies that exist from the nominations that we have received
from the VSOs and forward them to the Secretary for a final
selection. The new members should be on board in 90 days from
the time the Secretary selects the panel members.
We also are beginning to recruit for other vacancy
positions that exist on the panel. We expect the next meeting
of the full advisory committee will be in late summer to
discuss the scope of work of the contract for the physical
examinations of the Ranch Hand study which will occur in 2002.
Similarly to what we have done for the nomination process,
we will also ensure the veterans organizations are provided, by
letter, logistical and agenda information of advisory committee
meetings. These letters should go out around the time we place
the meeting notice in the Federal Register.
This ends my testimony, Mr. Chairman, and I look forward to
answering any of your questions.
[The prepared statement of Mr. Coene follows:]
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Mr. Shays. Dr. Butler.
Mr. Butler. Good morning, Mr. Chairman, Mr. Sanders. My
name is David Butler. I am Senior Program Office in the
Institute of Medicine, a private non-profit organization that
provides health policy advice under a congressional charter
granted to the National Academy of Sciences. The Institute of
Medicine has three ongoing studies related to the evaluation of
the health impacts of herbicide and dioxin exposure on Vietnam
veterans.
I serve as study director for all three studies, which
include the third biannual update of the ``Review of the Health
Effects in Vietnam Veterans of Exposure to Herbicides;'' the
``Review of Evidence Regarding a Link Between Exposure to Agent
Orange and Diabetes; and Phase Three of the Historic Exposure
Reconstruction Model for Herbicides in Vietnam.''
In response to the request of the subcommittee, I will
review the status of these studies, what's been learned to
date, and future study plans.
As Mr. Epley stated, the Agent Orange Act of 1991 directed
the Secretary of Veterans Affairs to request the National
Academy of Sciences to do an independent comprehensive review
and critical evaluation of the scientific studies and medical
evidence concerning the health effects of herbicide exposure.
This act prompted the first of the three research efforts I
will briefly review.
A committee convened by the Institute of Medicine conducted
an initial investigation and in 1994 published the report
``Veterans and Agent Orange.'' The Agent Orange Act also called
for subsequent reviews every 2 years for a period of 10 years
from the date of the first report.
The committees responsible for these studies evaluate
epidemiologic and toxicologic data on exposures to the types of
herbicides used in Vietnam and the contaminant dioxin. The
epidemiologic studies comprised three primary categories:
occupational studies, such as those conducted by NIOSH;
environmental studies, like those conducted in the aftermath of
an industrial accident in Seveso, Italy; and veterans studies,
including the Ranch Hand studies. Information from all of these
sources is considered in drawing conclusions.
Based on their evaluation of the scientific literature for
Update 1998, the committee found sufficient evidence of a
statistical association between exposure to herbicides and
dioxin and four conditions: chloracne, soft tissue sarcoma,
non-Hodgkin's lymphoma and Hodgkin's disease. The committee
found limited or suggestive evidence of an association with
respiratory cancers, prostate cancer, and multiple myeloma.
They also found limited or suggestive evidence that exposure
may be associated with porphyria cutanea tarda, the acute
transient form of peripheral neuropathy, and the congenital
birth defect known as spina bifida in the children of fathers
who were exposed to herbicides.
For most of the other cancers, diseases and conditions
reviewed by the committee, the scientific data were not
sufficient to determine whether an association exists.
The third biannual update is presently underway and is
scheduled to be completed by the end of this year. The future
plans for this research effort are to complete the mandate
specified by the act.
A second Agent Orange research effort being conducted by
the National Academies was prompted by the 1999 request from
the Department of Veterans Affairs to call together a committee
to conduct an interim review of the scientific evidence
regarding one of the conditions addressed in the ``Veterans and
Agent Orange'' series of reports, Type II diabetes.
The committee convened for this review examined studies
published since the deliberations of the Update 1998 committee
in light of the whole of the literature on the subject. Their
draft report is presently under review. It is expected to be
released in May of this year.
The third research effort underway addresses one of the
greatest problems encountered by the Agent Orange committees in
their work, a severe lack of information about the exposure of
Vietnam veterans to herbicides. In response to this information
gap, the Department of Veterans Affairs requested that the
National Academies help facilitate the development and
evaluation of models of herbicide exposure for use in studies
of Vietnam veterans.
For this effort, a committee developed a request for
proposals for research and invited interested individuals and
organizations to submit responses. Committee members thoroughly
evaluated the technical and scientific merit of these responses
and unanimously concluded that a proposal submitted by
Professor Jeanne Stellman of the Columbia University School of
Public Health and colleagues merited funding.
In the present phase of the project, the research proposed
by the Columbia University group is being conducted with the
continuing oversight of the committee. Most recently, in
December 1999, the researchers reported on the progress in
developing a data base of military units that served in
Vietnam, improving the data base of herbicide spraying
missions, developing models of troop movement and otherwise
establishing the information foundation for their modeling
work. Present plans call for this research to be completed by
the end of 2001.
These three research efforts comprise the work on the Agent
Orange issues presently being supported at the National
Academies. Thank you.
[The prepared statement of Mr. Butler follows:]
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Mr. Shays. Thank you very much. Again, I want to say that I
know that every one of you is a dedicated public employee and
wants only the best for our veterans. I just want to establish
that for the record. And I know that you all have lots of
responsibilities and you are doing your best to fulfill them
well.
When I ask some of these questions, they are going to
basically relate to my sense that you are players in a bigger
picture. And you may play out your part, but in the end, do we
get what we need from what happens?
I also acknowledge that this study basically was fairly
limited and that there is a general consensus that the GAO
findings are accurate and there will be efforts to comply with
their recommendations. Frankly, their recommendations are
fairly limited and center primarily on communications.
But let me first ask you, Mr. Coene, I am unclear. This
study has gone on from 1982 and it will be concluded in the
year 2006. It is a 25 year study.
Mr. Coene. Correct.
Mr. Shays. You became the director of the advisory group
when?
Mr. Coene. In 1989.
Mr. Shays. In 1989, and you work for the Food and Drug
Administration?
Mr. Coene. Correct.
Mr. Shays. This is, in a sense, one of your assignments?
Mr. Coene. It is.
Mr. Shays. This is not your primary assignment?
Mr. Coene. No, sir. I'm the deputy director of NCTR,
National Center for Toxicological Research. It was an
assignment that the Secretary asked us to take on.
Mr. Shays. I get the sense that the facts support, and you
kind of concede, that this advisory group has not been all that
active and that it has had vacancies?
Mr. Coene. We have vacancies at the moment, but we have
always had a quorum at any of our meeting?
Mr. Shays. What is a quorum?
Mr. Coene. A quorum would be five, sir.
Mr. Shays. And how large is the committee?
Mr. Coene. Nine.
Mr. Shays. How often have you met?
Mr. Coene. We have met 12 times over the period since 1989,
since I have taken the responsibility.
Mr. Shays. Just say that again and then tell me what you
think about that?
Mr. Coene. We have had 12 meetings over the last 10 years,
approximately one a year. And we responded to the need to
review information that the Air Force was producing and also
oversighting the scope of work for the next round.
Mr. Shays. The sense I get is that you view yourself more
as a responder rather than a catalyst.
Mr. Coene. That would be a correct characterization. We
responded to the need to oversight information and, at least
during the period that I have been executive secretary to the
committee.
Mr. Shays. I do not want to dwell on this, sir, too much
but I will tell you that I find that sad because it would
strike me that veterans deserve a catalyst in an advisory
group. I think your view of your responsibility is very
different than mine or most veterans. And I think it points out
to some of the reason we are in this mess.
Dr. Michalek, you have been working, the reason I
interrupted the flow is I just thought I was not hearing right
and I wanted to ponder. You have been working on this project
since when?
Dr. Michalek. Actually, I was hired at the School of
Aerospace Medicine in 1976. I was, prior to that, an assistant
professor at Syracuse University in upstate New York.
Talk about the Agent Orange issue and the possibility of
writing a protocol began in 1977, shortly after I was hired. I
co-authored the protocol. I was involved with the planning
stages and during the protocol review. The protocol was
reviewed by the Armed Forces Epidemiologic Board, for example,
the National Academy of Sciences, the Air Force Scientific
Advisory Board during the period 1978 roughly to 1980.
During that period, all of the issues that we have talked
about today were talked about in great detail. For example,
should the Air Force do the study at all? What about this
limited sample size and the limited power? What about this
possibility of using other control groups? What about the
exposure metric? All of those things were discussed in great
detail. And there's an audit trail showing all of these
discussions in minutes of the meetings.
Many of the resolutions of those discussions were described
in the protocol. All of the concerns that we mentioned today
actually are discussed in the protocol. So we have visited
these issues many times.
Mr. Shays. Which is to say we were forewarned?
Dr. Michalek. We ourselves were faced with a daunting
scientific issue, as to how to study--how to apply an
epidemiologic template in an unprecedented setting, where we
did not know the disease outcome and we did not know clearly
who was exposed among the Ranch Hand unit. We knew that the
best scientific method was to isolate that group which we could
identify and which we could be reasonably assumed to be heavily
exposed, namely the Ranch Hand unit.
The prerequisites were already satisfied. We had military
records to show us who was in the Ranch Hand unit. We could
identify them. And we believed, from standard epidemiologic and
industrial hygiene concepts, that this group would be
candidates for the most exposed cohort in the entire Vietnam--
or one of the most exposed in the entire Vietnam population.
Not that there are not others. In fact, we've talked about
those today already. For example, the Army Chemical Corps
veterans.
So yes indeed, all of the principles that we've talked
about today were mentioned and clearly argued out back in the
late 1970's.
Mr. Shays. So would it be your conclusion that this was a
mistake for us to begin this study?
Dr. Michalek. It was not a mistake to begin the study. In
fact, it has been an unprecedented and noble effort on the part
of the Government to launch a study of this magnitude in a
situation where there was widespread fear about the possible
consequences of exposures.
We launched a study without knowing what we were going to
find. We committed funds, we committed resources, and we
committed people to a long-term epidemiologic effort, not
knowing what the outcome was going to be. That was a very noble
effort on the part of our Government and I'm proud of it.
Mr. Shays. But what do you think the outcome is?
Dr. Michalek. The outcome is that we have an unprecedented
wide data base and collection of data of unprecedented scope
and quality to address the issue. If you're asking me about
findings, that's a different question.
Mr. Shays. So right now the outcome so far is that we have
a data base and the data base is not being shared very
willingly with the rest of the scientific community.
Dr. Michalek. I'd like to address that, for a minute.
You're talking about data release.
Certainly, the concept of data release has evolved over the
last 25 years. In fact, 1977-1978 the issue of data release was
never mentioned by any of our review bodies during the time
that we were writing the protocol. Data release was not
mentioned in the protocol specifically.
In fact, the idea of data release has evolved in the entire
scientific community since the middle 1970's, to the current
time where I actually attended a National Academy workshop in
December on the gulf war. The prevailing attitude there is that
in all federally funded studies from this point forward, data
will be released to the public immediately. That's an
unprecedented decision. And that illustrates the evolution of
attitude and philosophy that has taken place since the middle
1970's.
So to take you back to the middle 1970's, in 1978, 1979,
certainly the intent of the study and of the principal
investigators and of the advisory committee was to conduct a
credible and scientifically defensible effort in this
direction, although data release itself was not specifically
mentioned.
Among the principal investigators, of which I am one, and
by the way I was appointed principal investigator in 1985, our
attitude has been No. 1, we will release to the public that
data which we are sure is correct. And No. 2, we will not
change any data. When we receive data from the clinics, such as
in Houston or in San Diego, the data bases remain untouched. If
we find mistakes, data in the computer which doesn't match with
data on the records, we make fixes or corrections in our
computer code. So that our attitude there was that this was as
much a legal investigation as it is a medical investigation.
So with those two constraints that we had self-imposed
ourselves back in the early 1980's, we have already made data
release very difficult. It can't be done quickly.
On top of that, we have privacy concerns with the veterans
themselves. The immediate release of data, if not carefully
done, would certainly violate privacy because names and Social
Security numbers and other private information are in many of
these datasets.
And when you speak about data you need to realize that
there are many different kinds of data that are in our
possession at Brooks Air Force base, not just computer data
files. We have approximately 4 million documents collected on
the medical records from the men themselves, their children,
and their wives. And we have approximately 50,000 specimens of
biological materials such as serum, adipose tissue, urine, and
semen in our institutional freezers. We have an archive of
information on these individuals that's very extensive. Data
release has to be done very carefully.
Another constraint on data release that you may not be
aware of is that when this study began our emphasis was on
carefully auditing data release such that it could be made
official. That meant we would release data through the National
Technical Information Service in Virginia. At that time, in
1978, 1979 and early 1980's, the prevailing computer technology
was far different from what it is today. Computers were--
datasets were in very crude what are called flat file format,
where they had to be individually documented. That was the
requirement for the National Technical Information Service,
that they receive what are called flat files.
The other constraint is that once an agency such as us
releases data to the National Technical Information Service, it
can never be retrieved. Meaning that whatever we give out, we
can never get back. That puts a constraint on what we release,
because we want to release data that contains no mistake. In
other words, data that can be item-by-item verified as being
the same as what is in the medical record.
So the data release concept is as difficult and perplexing
for us as it is for you.
Mr. Shays. I want to be clear for the record. The record is
I want to be clear that I am understanding, Mr. Epley, what you
said. Basically, your testimony is to date the Ranch Hand study
has not been a factor one way or the other in decisions made on
compensation to veterans, in terms of their general health
care? That is the essence of what I got.
Mr. Epley. That's correct.
Mr. Shays. So really where we are right now, in my judgment
is----
Mr. Epley. With one exception, Congressman, if I may. In
the issue of spina bifida, that was material.
Mr. Shays. OK. Dr. Michalek, what I still wrestle is you
are basically saying that we were told things would turn out
the way they have. I am not quite sure I am comfortable with
that. In other words, everything we are talking about now was
talked about when we began this study. All the concerns about
data release and so on.
I get the sense that, in a way, that this is turning out to
be a study that will be great for scientists and great for
someone who follows maybe years from now, so I do not belittle
that part in that sense, our solders to come. But in terms of
the Vietnam veterans, by the time we are going to get some
solid information from the data that is still not being
disseminated and still being developed, that they are almost--I
do not want to say guinea pigs in a bad sense, but they have
provided all of this information but they may not benefit from
it. That is the sense I am getting.
Dr. Michalek. I think the conflict has been described
already by Dr. Chan from the GAO. There's definitely a conflict
here between expectations and reality, as far as science is
concerned.
When we say, for example, that our first published article
occurred in 1990, you need to know that work on that paper
began in 1986, only 1 year after the second physical.
Mr. Sanders. Excuse me for interrupting, you are really not
answering the Congressman's question. I think basically what he
was saying is we are spending $120 million. There are a whole
lot of interesting scientific questions out there. Although
neither of us were in Congress when this process began, we
presumed that what Congress wanted to know and wanted to learn
was how Agent Orange affected the men and women who served in
Vietnam. That is what they wanted to learn.
And what Mr. Epley has just told us, what Mr. Chan has told
us, is basically we have learned very, very little from
Operation Ranch Hand in terms of how that affects our soldiers
who were over there and how we can provide compensation to
them.
So it may be the world's greatest scientific and
epidemiological study, but in terms of what the U.S. Congress
wanted, I would agree with the chairman that apparently we have
not gotten a whole lot for that.
Mr. Shays. I am going to give you a chance to respond. I
guess the bottom line is my sense is that that was what, an
unrealistic hope? An unrealistic expectation?
Dr. Michalek. All I am saying is that the timelines in
science are much longer than the timelines in public health
policy. It takes up to 7 years to get an article published in a
peer-reviewed journal, for example. It took us----
Mr. Sanders. Let me jump in and say something. You know, we
are talking about people who believe that they are dying, that
their kids are being affected. And it takes 7 years to get a
peer-reviewed article accepted? Well, do something about it.
In other words, this gets back to the point. We are not
dealing with some academic exercise. You are dealing with the
lives of Americans who suffered in that war. And to say well,
it takes 7 years for us to get it peer-reviewed is
unacceptable.
Can you respond to that?
Dr. Michalek. Yes, I can. Of course, we have two different
kinds of products from the study. We have un-peer-reviewed
Government reports that we put out subsequent to every physical
examination, each numbering in the thousands of pages. We've
produced approximately 20,000 pages of reports, all of them
available through the Government Printing Office. They're all
official Government reports summarizing every single physical
examination.
So that all of the data you've just mentioned has been
described already in those reports. Separately, we intend and
are publishing the data from those reports in a distilled form
in research articles published in scientific journals. So that
the immediate timelines you're talking about are met by the
Government reports, not by the journal articles themselves
which come out many years later.
Mr. Shays. Go ahead, Mr. Sanders.
Mr. Sanders. Thank you, Mr. Chairman.
The advantage, in some respects, for scientists testifying
before a congressional hearing is that Congressman do not
necessarily know a whole lot about science. But you know what
we do know about? Do you know what we are the world's greatest
experts about? It is outreach.
Because if we were not good in outreach, we would not be
here. Whether it is Mr. Shays, myself, Mr. Bush and Mr. Gore,
they have to reach out to the people or else they do not get
elected. Right? That is what politics is all about.
So we know a whole lot about outreach. We spend a whole lot
of money on outreach, et cetera.
Now I would like to ask Mr. Epley to describe, and I want
to thank him and Dr. Mather for joining me last week in my
office to go over some of these issues. After all is said and
done, we have about 7,585 men and women who are receiving
benefits for health effects due to Agent Orange. Is that a
correct number? That is the number you gave me, and I am
presuming it is.
Mr. Epley. That number is accurate in reflecting the
Vietnam vets who are receiving service-connected compensation
due to the presumptive conditions.
Mr. Sanders. I have nine diseases listed, I guess spina
bifida is not here, so maybe there are some more.
We had approximately 3 million men and women over there; is
that correct? And probably nobody in the world knows how many
of them were exposed to Agent Orange and so forth?
Mr. Epley. That is the best number I've heard, sir.
Mr. Sanders. Off the top of my head, would you agree with
me or disagree with me, Mr. Epley, it would seem to me that
7,585 folks receiving compensation is a pretty small number.
Would you agree or not agree?
Mr. Epley. Relative to the number of veterans that served
in Vietnam, it is a low number. If I may, I would add to that,
though, the number of people who are receiving compensation who
asserted disability from Agent Orange is higher. Let me explain
that, if I may.
We have about 99,000 vets, a few more than 99,000 veterans
from Vietnam who have claimed service-connected benefits and
asserted that their disability related to Agent Orange.
Mr. Sanders. 99,000.
Mr. Epley. Right. The 7,500 comes out of that population.
But also out of that population, about 65,000 of those veterans
are service-connected for one or more disabilities. They're not
the disabilities on the presumptive list. But that number
certainly is a more representative figure.
Mr. Sanders. So 99,000 came forward requesting benefits?
Mr. Epley. Yes, sir.
Mr. Sanders. 66,000 are receiving benefits?
Mr. Epley. About, yes.
Mr. Sanders. And 7,500 are getting----
Mr. Epley. I need to add to that. Some of those veterans
may be service-connected and at the zero percent. We did a data
run to determine how many of the 99,000 have one or more
service-connected conditions. That's the 65,000-plus. Some of
those could be zero, so they may not all be receiving money,
but certainly the vast majority of the 66,000 are receiving
compensation.
Mr. Sanders. Explain to us why, if 99,000 came forward,
understanding that people are receiving benefits for other
things, only 7,500 approximately are receiving benefits from
exposure to Agent Orange?
Mr. Epley. That 7,500 represents the number of Vietnam
veterans who have one of the presumption conditions, the 9 or
10 on your list. It is a low number, but we did a quick check
based on the Agent Orange studies and our informal discussion
on expectations. And the 1993 study, the Agent Orange study did
do some estimations of what populations they would expect to
see by the year 2000 to have contracted the conditions.
The numbers are not that different from what we have in our
7,500 list. By example, the 1993 study said the expected cancer
cases among male Vietnam vets in the year 2000 for non-Hodgkins
lymphoma would be 494. We're paying 1,464. For prostate cancer,
their expectation in 1993 was 855 and we're paying 1,441.
Mr. Sanders. But if I can interrupt you, that's an
interesting statement. But in fact, these prostate cancer and
the other illnesses are on this list because we have concluded
that exposure to Agent Orange causes these problems. And so the
real question to be ask is, given the fact that X numbers of
people were exposed, is the numbers that you have here a
reasonable response to those numbers? Do you understand what I
am saying?
Mr. Epley. Yes, sir.
Mr. Sanders. So we are not talking about the general
population, we're talking about those who, in fact, have been
exposed to Agent Orange, which is a cause of these illnesses.
Off the top of my head, I would say that is not a
particularly high number.
Mr. Epley. I understand.
Mr. Sanders. Mr. Epley, let me ask you this, we held a town
meeting in Vermont a couple of weeks ago and the question I
asked the veterans who were there is they really have not heard
a whole lot about this issue. They do not know what they are
entitled to. And you can disagree with me if you want, please.
I would say if we did a poll of Vietnam vets and we said to
them do you know what particular illnesses the Government has
determined were caused by exposure to Agent Orange, of which
you are entitled to benefits, would you think a large number of
the vets would know that?
Mr. Epley. I think that a large number would not be able to
recite the conditions.
Mr. Sanders. I know that. I do not mean as an exam. But I
mean to say if I was a Vietnam vet, which I am not, and if I
had prostate cancer, do you think I would automatically say
geez, I read something and I know that that is something that
might be caused by Agent Orange? Do you think the average vet
would know that?
Mr. Epley. I think there is a general understanding that
it's an issue to be pursued and I think that's indicated by the
number of vets who have filed claims. It's indicated by the
number of vets who, at least initially, applied to the Agent
Orange lawsuit that you referred to earlier.
I think there's a sense that hey, I can go somewhere and
pursue this. Maybe not much more than that.
Mr. Sanders. Would you be willing to guess, and we do not
have the information, that there are perhaps thousands of
veterans who served in Vietnam who were exposed to Agent Orange
who have prostate cancer and have no idea that they are
entitled to benefits from the United States Government? Would I
be right or wrong, do you think?
Mr. Epley. I think there are some.
Mr. Sanders. Some?
Mr. Epley. Yes.
Mr. Sanders. Do you want to broaden that; 1, 2, 5,000, how
many? I know you do not know.
Mr. Epley. I don't know.
Mr. Sanders. Let me ask you this question, and we discussed
this last week. You gave me, and I appreciate you giving me
this, some pretty good publications. How many of these do you
publish, and who reads them?
These are publications, for the record, Agent Orange:
Information For Veterans Who Served in Vietnam, general
information. And also, there is an ongoing publication called
Agent Orange Review. How many of these do you publish? Does the
average veteran get this? Or is this really for the scientific
community or the veterans organizations?
Ms. Mather. The Agent Orange Review, which is the
newsletter that comes out several times a year, goes to all of
the veterans who have signed up for the Agent Orange registry
exam. And as of February 24th, that was 298,234 veterans. So
that many goes out.
Also, copies go to the veterans service organizations who
are our strongest ally in outreaching to veterans. The Vietnam
Veterans of America do a wonderful job of outreaching, as does
the American Legion and the VFW and the DAV.
Mr. Sanders. So approximately 300,000 of these go out.
Ms. Mather. Those go out to individuals.
Mr. Sanders. Right, that is a lot, and that is good. The
problem is we had about 3 million men and women over there.
What effort are you making to reach out to the others, A. And
B, I am a great fan of the service organizations, and I think
they do a very good job, and obviously they must be involved.
The Vietnam Veterans of America, VFW, American Legion, DAV must
be involved in this effort.
But the fact of the matter is that we have 27 million
veterans in the United States and less than 3 million of them
belong to the service organizations. And some of them belong to
more than one organization. That leaves about 25 million
veterans who are not in contact with the service organizations.
What effort is being made to reach out to those people? For
example, and you and I discussed it, how many town meetings
have you had on this issue? How many PSAs have gone out? How
many press conferences have you had around the country? How
would the average veteran, who is not associated with the VSO,
know what he or she might be entitled to?
Mr. Epley. We do do regular town meetings through the
regional office system that we have. This year we have
scheduled 59 stand-downs, which is a process that we do at
various locations around the country to provide general
benefits dissemination. It's not geared specifically to Agent
Orange, but general benefits dissemination, general medical----
Mr. Sanders. How do you advertise those meetings? How many
people come to those meetings? How do you advertise them?
Mr. Epley. They're advertised locally, basically through
the medical system.
Mr. Sanders. How many folks might attend those meetings?
Mr. Epley. At the ones that I've attended, it has ranged
from 150 to 300.
Mr. Sanders. And you are explaining the benefits that
veterans are entitled to?
Mr. Epley. Yes, in a very informal way, but it's set up to
allow the vets to come in and look for what they need.
Mr. Sanders. I am going to invite you to Vermont to do
that.
Mr. Epley. I think I knew that was coming.
Mr. Sanders. But in addition, I have to tell you something.
I have been working on an issue of prescription drugs and
veterans. As you know, of course, that if a doctor examines a
veteran, that veteran is entitled to prescription drugs at, I
think, $2 a prescription which is an enormous saving for many
veterans.
Do you know what? In the State of Vermont many, many
veterans did not know that that benefit existed. I am sure that
that is true all over America. I sent out a newsletter. We
probably had 300 veterans respond to it.
If veterans do not know that they are entitled, going
through the VA, to get inexpensive drugs, I have my doubts
about how many of them are going to know about the benefits
that they are entitled to through Agent Orange. Would you agree
with me?
Mr. Epley. It's hard to know. If you don't know, you just
don't know. You don't know where to go.
Mr. Sanders. I heard Mr. Coene talk about the service
organizations, but I am concerned about your being overly
dependent on the service organizations. In other words, how are
you going to get to the vast majority of the veterans who are
not members of service organizations? What is your plan?
Mr. Epley. We do have a toll-free number available to
veterans, on which we receive about 10 million phone calls a
year for general benefits information.
Mr. Sanders. When people call what do they get? A human
being? Do they get a tape recorder? What do they get?
Mr. Epley. They get a human being. They get an opportunity
to go to the team that manages their case, if they have an
active case. They do, in some instances, get an interactive
voice response if they're looking for general information. They
can do that automatically.
Mr. Sanders. You got 10 million calls.
Mr. Epley. About 10 million a year is what we respond to.
Mr. Sanders. For information about veterans benefits?
Mr. Epley. We do the stand-downs, as I mentioned. As Dr.
Mather mentioned, we do the newsletters. We also notify
veterans on the registry when there are results from the NAS
reviews. We let them know that there's potential change in the
benefits, and those are to the 300,000.
Mr. Sanders. Would you agree with me that if we have about
10 percent of the folks who were over there on the registry,
yes? That is not a particularly high number is it?
Mr. Epley. No.
Mr. Sanders. What are we doing to increase the number of
people? I mean, it sounds to me like you are trying. Dr. Mather
indicated that you are trying to do a good job in communicating
with the folks who are on the registry. The concern is the 90
percent of the vets that are not on the registry.
Mr. Epley. One of our main focuses or foci recently, in
terms of outreach, has been to separating servicemen. I know
that that does not apply directly to this population. But we
have initiated a project under transition assistance where we
are trying to reach out and give full orientation of benefits
to departing servicemen before they leave the service, so they
get an understanding of the full range of benefits.
Last year we conducted about 80,000 personal interviews in
that effort and we're expanding to the point now where we have
VA personnel either permanently or itinerantly at about 60 of
the major separationsites.
Mr. Sanders. I think that that is, by the way, a very good
idea.
I was told by at least one veteran so I do not know if it
is the God's truth or not, that this information is not often
seen at VA hospitals. Are these publications available? Are
they on the racks?
Ms. Mather. They are sent out. They have been very popular.
I think the fact that they may not always be available is just
our inability to keep up with the demand. That just did come
out this year, however.
Mr. Sanders. But what I mean is do you make, in terms of
trying to get the word out, do you send this to every VA
hospital in the country?
Ms. Mather. We do send these, yes.
Mr. Sanders. And you will insist that they put in a place
where veterans can pick it up?
Ms. Mather. Yes.
Mr. Sanders. Let me just ask Dr. Michalek a question. How
do you respond to the recent information that came out from the
Vietnamese Government that they estimate that there are 1
million victims of Agent Orange in Vietnam, suggesting that it
is a very serious health problem over there. They suggest they
have a million victims, and I know that that is totally
unscientific and an estimate. And we have 7,500 men and women
who are collecting Federal benefits from exposure to Agent
Orange.
What do we learn from the serious problems that may be
existing in Vietnam? Does that mean anything to you?
Dr. Michalek. Yes, it's meaningful to me because, of
course, if you're going to look for people who were exposed,
that would be the place to go. And to see evidence of concern
over there and a counting of individuals with adverse effects
should motivate more research. In my opinion, I'm not saying
agency policy here.
Mr. Sanders. But you said that might be the place to go?
Dr. Michalek. Yes.
Mr. Sanders. Have we gone?
Dr. Michalek. I understand that certain individuals have
visited. We've seen video of Dr. Arnold Schecter, for example,
visiting Vietnam. We know the Canadians are there, taking very
systematic sampling.
Mr. Sanders. But what about the U.S. Government?
Dr. Michalek. I have not seen any official--personally, I
haven't seen any official evidence of United States involvement
in Vietnam.
Mr. Sanders. Again, I am not a scientist but it would seem
to me that if I wanted to learn about the impact that exposure
to Agent Orange might have on human health, I might want to go
to that place where people were most exposed.
Now whether the Vietnamese Government is right or not that
there are 1 million victims, I do not know. We have heard, and
I am sure you have heard anecdotally and probably seen
photographs, of children who were born with birth defects and
other problems.
I do not quite understand how people who are studying the
impact on Agent Orange on human health have not quite made it
over to the country where the exposure seems to be most great.
Anyone want to comment?
Dr. Michalek. Personally, I agree with you completely.
Mr. Sanders. Thank you.
Mr. Shays. Dr. Butler, I would like to draw you in here a
bit, and I think that Congressman Sanders has made an obvious
statement. This is not our expertise, but the value of this is
that if you can explain it to us, then the rest of the world
can understand it.
Mr. Chan kind of introduced this in talking about the
certainty of scientific research versus our needs and policy.
In your testimony, you talked about how you are basically in
charge of three epidemiological studies in three areas: the
occupational studies, environmental studies, and veterans
studies.
Excuse me, you are doing three studies: the review of the
health effects of Vietnam veterans exposure to herbicides;
review of evidence regarding link between exposure to Agent
Orange and diabetes; and phase III of the historic exposure
reconstruction model for herbicides in Vietnam?
Mr. Butler. That's correct.
Mr. Shays. You are looking at the occupational studies,
environmental studies, and veterans studies?
Mr. Butler. Yes, sir.
Mr. Shays. You then make the point, you say the committees
have found a common approach established by the first committee
to summarize their evaluation of the evidence. They have
classified disease into four categories. The first category,
sufficient evidence of a statistical association between the
disease and exposure to herbicides or dioxins. The second,
limited or suggested evidence. The third, inadequate and
insufficient evidence to determine whether an association
exists. And the fourth category, limited suggested evidence of
no association.
Mr. Butler. That's correct.
Mr. Shays. When we have to look at what you do to determine
compensation, what level should we be at?
Mr. Butler. That's a policy rather than a scientific
decision. What the committees were tasked with doing was doing
a comprehensive review of the scientific information and
presenting a consensus opinion, if you will, looking at----
Mr. Shays. That it would be one of the four categories you
described?
Mr. Butler. That's right. In trying to summarize a vast
amount of scientific literature on this subject, scientific
groups in the past have used general categories like this to
try to give a general feel for where the consensus of the
science is.
This particular set of categorizations was one that was
first used by the International Agency for Research on Cancer
and was subsequently borrowed by this committee.
Mr. Shays. Well, you did not really answer the question,
but I will come back to it because this is helpful. I guess
what I am trying to come to grips with is, in your work, have
you relied on data from Ranch Hands? Are you basically waiting
for information?
Tell me how you would like to utilize the information from
this 25 year study.
Mr. Butler. Ranch Hands is one of the studies that is
carefully examined by National Academy of Sciences committees
when they reach their conclusions. It isn't the only piece of
information, though.
For example, there is also information available from the
Australian Commonwealth Department of Veterans Affairs on their
Vietnam veterans population.
Mr. Shays. I understand you are not going to just wait for
this, but we are spending on an average $5.6 million a year. We
are hoping that this study has more than just outcomes on more
than just data. I am just trying to ask you, it has not been
very helpful to date to the Department of Veterans Affairs.
I guess we could do the inverse and say well, it could be
helpful in one sense, we could take the inverse and say well,
we are not feeling we have to compensate anyone yet, or many
people. So it has not put many people on our list. And some
could interpret it to say that so far there is nothing that has
caused us a proactive effort to do that.
Now from my standpoint I may not be pleased with that, but
that would be one potential result. But I guess what I am
asking you is has this been very helpful to you?
Mr. Butler. The Ranch Hand study is a helpful study as part
of our examination of the whole of the literature. There's no
one study that's going to be determinative.
Mr. Shays. I accept that, but my sense is, and correct me
if I am wrong, but my sense is there has not been much
information disseminated.
Mr. Butler. We have reviewed a number of reports over the
years in the three Veterans and Agent Orange studies. I'm
afraid I don't have an exact number, but we carefully examine
any information that is published by the Ranch Hand
researchers.
Mr. Shays. I feel like I am playing chess with you here.
The reality is we have got a fairly concise comment from VA
that, to date, it has not resulted in their finding many people
to compensate as a basis of this report. I am asking you if you
have gotten much information here? And did you expect that you
would get more sooner?
Let me just say, I do not want you to carefully consider
your words here. Just as you do not rely on this for the total
basis for all your studies, your answer is not going to be the
total on my conclusions. I just need to get an answer.
Mr. Butler. It is a helpful study. I can tell you that Dr.
Michalek has always been forthcoming in providing information
requested by the National Academy of Sciences committees, and
has been mindful of the observations committee members have
made, the suggestions for future work, and for ways to improve
the study.
Mr. Shays. Let me ask you this question. Did you have an
expectation that you would get more information and you would
get that information sooner?
Mr. Butler. The Academy does not form any expectations of
any study of this sort.
Mr. Shays. That is not what I asked. They have information
that has not been released, they have studies that have not yet
been released. Did you expect you would get information and
studies sooner? It is a simple question.
Mr. Butler. We expect that we will get the information from
the studies, yes, as quickly as it's available. We want as much
information as possible to consider in making our decisions.
Mr. Shays. I am going to ask it again and we will have a
long time here, because it is really a simple question and it
is a waste of time for you to be here if you are not going to
answer basic simple questions. It is a yes or no.
Am I am not saying I am going to like your answer. Did you
expect that you would get information sooner? And did you
expect to get more information than you have received to date?
Mr. Butler. Did we expect to get information sooner?
Mr. Shays. And did you expect to get more information than
you have received to date?
Mr. Butler. No, I don't believe we expected to get
information sooner and no, we don't have any expectation about
getting specific information in the future, except that we are
hoping to get as much as possible as soon as possible.
Mr. Shays. So your expectations were pretty low, frankly.
They certainly were lower than our expectation.
Mr. Butler. In our job, in reviewing all the information,
we can only deal with what's out there. We don't have the
ability to initiate specific studies or to drive the pace at
which others provide information for the committee's
consideration.
Mr. Shays. I understand that. That is not really what I
said. I know you cannot force the information sooner, but you
might have had an expectation you would get it sooner. And your
answer is no. You had really no expectation that you would get
it any sooner than you have. And that is helpful information,
and I thank you for finally answering the question.
I am going to ask you the first question again. You shared
the fact that you classify diseases into four categories. I am
asking you to give me your opinion, and that is the way I
accept it, as your opinion.
At what level do you think Government should consider
compensation? Should we have a no shadow of a doubt? The reason
why I am asking the question is I have come to the conclusion,
based on our work that we have done on gulf war illnesses,
based on our review of Agent Orange, that I have to be honest
with our veterans. By the time we will know the scientific
data, you are dead. You will either have died early or you will
have died in your old age in pain, but you will not get help
from the Federal Government.
That is the honest answer that I have to give people, if in
fact we have to wait until we have 99 percent certainty. What
Mr. Chan said in the beginning, I think, is very helpful to me
and it explains, Dr. Michalek, your approach. You are a
statistician and an expert in your field and you are doing your
job as best you see. And you have already said that a lot of
these questions we have raised were discussed early on.
But it is an eye-opener to me because my view is that I do
not want to wait until you have 99--maybe I would like to be 70
percent certain and then I am willing to go to my taxpayers and
say you are going to pay more to help veterans who were sent to
war. And maybe I am saying it because when my colleagues were
in Vietnam I was in the Peace Corps. Maybe a whole host of
factors are coming into play.
You are a scientist, I am a politician. I am asking you to
step aside from your position as a scientist now and say is
there some solution short of being 99 percent certain where we
can say it trips over and, you know, the odds are, and why do
we not compensate? Is there any solution to this mess I find
myself in, of having to wait until we are 99 percent certain?
Mr. Butler. The Academy gives its opinions on the
scientific information.
Mr. Shays. I understand that.
Mr. Butler. The policy decisions are very clearly outside
of the mandate for the committees, and the committees have
never offered an opinion on the policy decisions which are made
on the basis of that.
Mr. Shays. And so you choose not to offer an opinion?
Mr. Butler. I don't feel it's my role as a study director
to offer a policy opinion.
Mr. Shays. Now you have an opportunity to make a
contribution separate. That is not unusual. We get witnesses
here and we say my God, you have worked on this for years. You
are restrained by your science and you are going to follow
that, you have an opportunity.
And you refuse to give an opinion?
Mr. Butler. I appreciate the opportunity, Mr. Shays. In my
role as the person who facilitates this study, it's my belief
that I do that job best if I act as a neutral, unbiased conduit
of information to the expert committees that are formed by the
National Academy of Sciences who come to the decisions that are
made in these reports.
Mr. Shays. And therefore, you have decided not to answer
that question?
Mr. Butler. That's correct.
Mr. Shays. So who do we turn to? Let us go to the VA. What
I am trying to do is I am not going to wait until we are 99
percent certain. You are going to do your science and you will
be in your nice rooms and you will do it and the veterans will
be guinea pigs because they will be there and they will provide
all your wonderful data. And we have this outcome, all this
data, and they literally grow older. Some of their children are
raised and they are not well.
And maybe they should have been compensated by us, but we
are not 99 percent certain. Is there any scientific level that
we could turn to, short of 99 percent, that would give us some
way to come to a conclusion here?
Ms. Mather. I believe that the Congress gave the Secretary
of Veterans Affairs that charge in the legislation, in which he
took the reports that the National Academy of Science and
Institute of Medicine gave him, and then made a policy decision
as to what diseases should be service-connected.
In reality, we've accepted all the diseases for which the
National Academy of Sciences found there was sufficient
evidence of an association, and limited or suggestive evidence
of an association.
Mr. Shays. That is the top category, is it not?
Ms. Mather. The top two categories.
Mr. Shays. So you have to meet sufficient evidence of a
statistical association or limited or suggested evidence? I do
not think that is true.
Ms. Mather. That is, in fact, what the Secretary has
decided over time, over the 3 years.
Mr. Shays. Now do you release reports, Dr. Michalek, that
would come to a conclusion? Do you grade according to these
four categories?
Dr. Michalek. No, sir, and I'm not aware of any other study
that does. That's an activity carried out by the National
Academy of Sciences for reviewing all studies.
Mr. Shays. So when you release your studies, what do you
have to be certain of?
Dr. Michalek. We're not really certain of anything when we
release a study, except for the fact that we've done the best
job we can. We render an opinion at the end of any article or
report suggesting an interpretation of the data, as to whether
we think this indicates a relation between exposure and disease
or whether it does not. Those interpretations are read by the
National Academy of Sciences and all of our reviewers.
So yes, we do offer an opinion about whether or not there
is a relation between herbicides and exposure in every article
and every report.
Mr. Shays. And how do you grade those opinions? What are
the levels? How do you grade them? Do you say yes, no, or
maybe?
Dr. Michalek. Well, the language that's used in these
reports is not conversational. For example, a statement in an
article or report that the data suggests an adverse relation
between herbicides and health is, in the scientific literature,
a very strong statement. And that's about as strong as it gets
in any scientific article or report.
Mr. Shays. Suggested evidence?
Dr. Michalek. Yes, suggested. And that's the material that
the NAS uses to render an opinion that's ultimately used by the
VA.
Mr. Shays. And is suggested evidence one level below, in
your opinion, sufficient evidence?
Dr. Michalek. I think it's--yes, second level up.
Mr. Shays. Do you have any questions you want to ask?
Mr. Sanders. Mr. Chairman, one thing occurs to me, based on
this discussion, especially with Mr. Epley, that we as a
committee--and it is your decision of course--but at some point
we, as a committee, might want to take a look, a general look,
at how well the VA does in terms of its outreach for veterans
benefits in general, beyond Agent Orange.
Mr. Epley, veterans have told me that it is sometimes a
very difficult process, in terms of filing a claim for a
service-connected compensation regarding Agent Orange, in terms
of not receiving a fair hearing. Is that true, in your
judgment?
Mr. Epley. No, I don't think so. The filing of the
application is a fairly simple procedure. The adjudication of
the claims for the presumptive conditions should be very
simple. That is the intent of it. If the veteran served in
Vietnam and if the veteran has contracted one of the diseases
on the presumptive list, they should be service-connected. Then
we're only dealing with the level of evaluation.
Mr. Sanders. But I am told by some knowledgeable people
that, in fact, that is the case in some of the offices. But in
fact, in other offices there is a great deal of foot dragging,
denying claims, and making spurious requests. Do you think you
have an across-the-board process where all of your offices are
responding well?
Mr. Epley. I think we have a process that is clear and
understood. I would suggest that there is not a level of
consistency that we need in the administration of it day-to-
day.
Mr. Sanders. Doctor, you indicated a moment ago what I
think is common sense, that you think that the U.S. Government
should probably go to Vietnam to start studying the situation.
When will we expect that study to be done?
Dr. Michalek. First of all, I've offered to go myself and
that's still under discussion in our group. As to when it
should begin, that will require a mandate on the part of the
Government to provide the resources and the apparatus to get
something started. I would say as soon as possible, because the
longer we wait, the more difficult it would be.
Mr. Sanders. Require a mandate. Small groups without a
whole lot of money, like the Vietnam Veterans of America could
send over a group of people.
Dr. Michalek. It's not enough.
Mr. Sanders. I agree with you. So what kind of mandate?
That is your job, is it not? You are studying this issue.
Dr. Michalek. The mandate would be similar to the mandate
that established this study, to set up an advisory panel, to
write a protocol, to define the concepts.
Mr. Sanders. Let me tell you something, based on what I
have heard about this study, that would be precisely the last
thing that I would suggest that we do. It would be another 20
years before anyone got there.
Dr. Michalek. It does not have to be a 20 year study.
Mr. Sanders. Mr. Epley, maybe you and I could speak later.
Mr. Epley. May I add one comment? You mentioned outreach
and we are undertaking a study of the outreach efforts in VA,
VBA specifically, to determine whether or not we're meeting the
statutory intents for outreach and if there are gaps what we
need to do to pursue them. As soon as they're available, we'll
be glad to talk with anyone who's interested.
Mr. Sanders. I would be very curious to see that. Thank
you, Mr. Chairman.
Mr. Shays. Thank you very much. I appreciate all of the
witnesses. Your testimony was helpful, very helpful, and very
educational. So that was appreciated.
At this time, I would like to call the next panel. Thank
you.
Our first witness is Dr. Richard Albanese, Senior Medical
Research Officer, U.S. Air Force; Dr. Linda Schwartz, associate
research scientist, Yale University School of Nursing,
consultant, Veterans Health Care; and Dr. Ronald Trewyn, dean
of graduate school and vice provost of research, Kansas State
University, former member, Ranch Hand Advisory Committee.
I would invite the panel to stand and I will swear you in.
[Witnesses sworn.]
Mr. Shays. I appreciate all of you being here for the other
panels. It helps us because you have heard from them and you
can make comments.
For the record, all three of our witnesses have responded
in the affirmative and we will start with you, Dr. Albanese.
STATEMENTS OF DR. RICHARD ALBANESE, SENIOR MEDICAL RESEARCH
OFFICER, U.S. AIR FORCE, FORMER RANCH HAND PRINCIPAL
INVESTIGATOR; DR. LINDA SCHWARTZ, ASSOCIATE RESEARCH SCIENTIST,
YALE UNIVERSITY SCHOOL OF NURSING, CONSULTANT, VETERANS HEALTH
CARE; AND DR. RONALD TREWYN, DEAN OF GRADUATE SCHOOL AND VICE
PROVOST OF RESEARCH, KANSAS STATE UNIVERSITY, FORMER MEMBER
RANCH HAND ADVISORY COMMITTEE
Dr. Albanese. Thank you. I am an Air Force medical research
officer whose travel here has been funded by the Air Force.
However, my testimony does not necessarily reflect Air Force
policy.
I was a principal investigator in the U.States . Force
health study, the Ranch Hand study, from 1978 through 1984. I
am one of four authors of record primarily responsible for
writing the protocol, with Colonel George Lathrop, Colonel
William Wolfe, Colonel Patricia Moynahan and myself. We're the
four authors of record of the study protocol.
During my time with the Ranch Hand program, I observed two
protocol violations. These were the lack of veteran
representation in the science review process and command
influence.
Mr. Shays. What was the second?
Dr. Albanese. Command influence.
In my opinion, the lack of Vietnam veteran representation
denied veterans and their families a fair assessment of health
effects associated with Vietnam service. Important on-the-
ground operational dimensions, and critical study limitations
were missed.
The command influence directly altered report content. In
my opinion, this also denied veterans a fair assessment of
their health status.
Protocol violations, in my opinion, are quite serious. We
advertised to the veterans who came and allowed themselves to
be examined that they would have their interests protected by
representatives in the science review process. We violated
their right of informed consent when we failed to do that. And
command influence is effectively scientific misconduct.
These issues were addressed in the 1980's. The legislation
passed after the 1988 hearings apparently did not fully correct
the problems in the Air Force health study. Public Law 100-687
requires the study monitoring group to conform to the study
protocol with one-third veterans representation.
The December 1999 GAO report to the Honorable Lane Evans
relates that veterans participation has been incomplete or
erratic, despite the public law. As you read in the report,
there were individuals who were representing veterans who
didn't know they were representing veterans. Similarly, the
December 1999 GAO report indicates that study limitations have
not been fully and clearly communicated to the public.
In my opinion, the effects of limited veterans
representation and poor communication are apparent in the
scientific reports issued by the Ranch Hand study. Of very
great concern to me are birth defects and cancer in this group
involved with spraying herbicides. Also, I perceive seriously
inadequate data flow to veterans concerning heart disease,
vascular disease, neurological ailments, endocrine disturbances
and hematological difficulties.
Timely full clear reporting can assist medical personnel to
better care for veterans. And it is my definite medical opinion
that the men in this study need care today. And what they need
today relates also to what other veterans need today.
The hierarchical structure of the military organization,
which is excellent to conduct war, can compromise scientific
and medical research. I am concerned that the recent failures
to report the Ranch Hand study properly are institutionally
influenced. I recommend that the Air Force adapt integrity
programs such as the Office of Scientific Integrity in the NIH
and the FDA program to improve the way they clear research and
other papers for publication.
I personally have experienced management changing a
concluding sentence in an article even after that article was
cleared by the Air Force and accepted in the open literature.
This is not an every day matter, but there are no protections,
that I'm aware of. About 10 percent of my medical articles have
been thus changed. How can I view Dr. Michalek and his people
as free, intellectually free, when I know that I am not and my
other senior colleagues are not?
Clearance processes may be OK when you're building
missiles, but it makes no sense in medical research. It makes
no sense in medical research.
For nearly 20 years, the Ranch Hand study has been unable
to properly include veterans in the scientific review process.
And for nearly 20 years this study has only reported part of
the truth. Real veterans' representation can occur and
reporting can improve in this effort if GAO recommendations are
energetically and scrupulously followed.
I concur with the GAO recommendation on data release to the
general public, but I advocate full, full, full data release to
individuals who are qualified to protect subject
confidentiality, individuals at medical schools and university
who would sign a document agreement to protect confidentiality.
And there's no issue about letting data go that has error.
You publish the data that you've used to write your report and
you earmark it as such, and every scientist knows the
limitations of such data. I am concerned that full data
publication will not occur.
I strongly advocate funded replication and analysis of
Ranch Hand work by independent and qualified individuals. I
would like to think the data itself will attract professors,
but if it doesn't I think funded studies to replicate are
necessary.
If integrity programs are not strengthened and if veterans
are not included, and if data are not really shared, then at
the risk of loss of time and data--and remember, my medical
judgment is these men are ill--I recommend study transition to
another agency.
Thank you.
[The prepared statement of Dr. Albanese follows:]
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Mr. Shays. Thank you very much. Dr. Schwartz.
I am assuming that you work at the West Haven Hospital as a
consultant? But you are at that facility or not?
Ms. Schwartz. No, I am not attached to the VA. I am a
consultant to the Secretary of Veterans Affairs in several
areas, mostly women veterans. And I am myself, of course, a
veteran. And my work, my research has been----
Mr. Shays. But the important thing is you come from
Connecticut.
Ms. Schwartz. But I do not come from your district, I'm
sorry.
Mr. Shays. That is all right. I am magnanimous, it is a
great State. Welcome. I was trying to be positive.
Ms. Schwartz. First of all, you are positive. By having
this hearing you are positive. You and Mr. Sanders have done an
excellent job and you have done a service for the veterans of
our Nation.
Let me explain that yes, I am retired from the U.S. Air
Force Nurse Corps. I have had the opportunity to several times
speak to the National Academy of Science groups when they were
considering their reports. I have completed a study on women
veterans, the health needs of women veterans who were stationed
in Vietnam. And I have just returned from Vietnam and can
address some of the issues that you have raised about research
in that country.
I would first of all like to say that one of the issues
that has been raised earlier this morning, the cost of this
study, is somewhat ironic given the fact that it costs
approximately $140 million. And when you talk about the class
action suit which was done to help the veterans, the cost of
that suit was $180 million. That's how much chemical companies
gave veterans to assist them with the needs that they had.
I would also add that the Vietnam Experience study, which
has been noted earlier today, was 8 years in the making and $43
million. And at the end of all that time and all that money,
they decided they could not do the study. So that's what we're
dealing with here.
I would just like to refer to some of the more important
issues that I brought out in my written testimony.
There is no doubt that the dioxin TCCD, which was very
evident in Agent Orange is a carcinogen. In a recent discovery
of a case in New Brunswick, Canada, evidence made public during
the litigations between the Sprayers of Dioxin Association and
Dow Chemical Co. and Uniroyal clearly shows that in 1965 the
manufacturers of TCCD knew that it was dangerous, it was a
potent carcinogen, but decided to make a pact to keep that
information secret not only from our Government but from any
people that purchased the chemicals.
In the GAO report, the one thing that I would like to
stress is the fact that we have paid a great deal for this
study and we have used very little of the data. And although
the GAO report refers to the fact that we could be looking at
what Air Force has already done, from a scientific point of
view I say that this is a very rich field of information that
has not completely been analyzed.
And so, with that in mind, and to build on my own work of
looking at women veterans, the Yale School of Nursing, where I
am an associate in the research department, has become a
repository for information on the Ranch Hand study acquired
from several sources. I would just like to say that while Dr.
Michalek said that these reports are available, you indeed can
get those reports that he has talked about. But it will cost
you about $1,500 to get them. So that's the cost of getting
those reports. And they are not readily available, nor are they
easily understood by the average veteran.
However, we did go ahead and try to--we did acquire the
1987 dataset which was the variables from the physical
examination which was made available in the public domain. The
cost was $454. At the time we made the order, it was for the
cartridge format. When we got the cartridge format at Yale, we
took it to all of our computer laboratories and we even went to
some of the commercial sources in the area, and some of the
businesses in the area to try to access that data.
So yes, you can buy it. You can't read it. When we made
that order, I would like you to know that when we made the
order we said well, we'll have to make a copy, we don't keep
this in stock. How would you like it? We said we would like it
on CD-ROM. But that was denied. And so we got these rather
antiquated formats for the information. And now, we are going
to try a second try at an additional fund to that.
I also would like to say that when I read the GAO report
and it talked about the reporting in 1992 of the study of birth
defects, I checked the U.S. Air Force Health Study Internet and
found that--I said how did I miss that, 1992? Well, it was
published in Helsinki, Finland. And if I wanted a copy of that
article, I would have had to write to the Health Institute of
Finland. Not knowing that, I was not aware until the summer of
1998, when the Air Force actually did put forth that report,
that there was a report on the birth defects that were studied
in 1984.
One of the greatest limitations that has escaped the public
and many veterans are the fact that findings from the Ranch
Hand study are not applicable to all Vietnam veterans. The
stated purpose of this study was to determine of Ranch Hand
personnel were adversely affected by their proximity and
handling of Agent Orange. And I have heard Dr. Michalek on
several occasions at the advisory committee meetings reiterate
that.
In other words, the question was are Ranch Handers sicker
than other Air Force personnel who served in Vietnam? If you
look at the study from that aspect, then some of this falls
into place. However, many of us did not know this, and I did
not know this until I heard Dr. Michalek say that for sure.
However, the stature of the U.S. Air Force and the fact
that very few other studies could afford to perform serum
dioxin levels--and just so you know, if you want to have a
serum dioxin level done by our CDC it costs $1,000 per person.
So you can see right away that there are many studies that
could not afford, and many would not be funded if they asked
for funding for this. So Air Force had the gold standard in
many respects, because they had the capacity to access serum
dioxin levels.
Another point of potential bias is the fact that all the
subjects and the controls in this study were in Vietnam at one
time. And although the control group did not actually handle
and spray Agent Orange, there is reason to believe that they
did have a disproportionately larger exposure to the dioxin
than other military personnel.
As I said, I have just returned from Vietnam where we
received a briefing from the Hatfield Consultants of Vancouver,
British Columbia. The Hatfield Consultants have been working in
Vietnam since 1969, specializing in environmental assessments
of the human and ecological consequences of large dioxin
contaminations.
I want to tell you that they really shocked us. They
reported that, and I am going to tell you that my statement
must be amended at this juncture where I referred to this.
Because in my statement I say some of the most barren spots the
dioxin level was 1,000 points per trillion. That was not true.
It was on the site of a former United States base, military
base in Vietnam that the 1,000 points per trillion soil dioxin
25 years later was obtained. And so you must realize that that
is not a barren spot. That is where our troops were working on
a daily basis.
In addition, I wish to also amend my statement after
talking with Mr. Hatfield last night. What they found in the
food that people eat, even to this day, in a place called the
Aloui Valley, which many Marines will remember, is their
finding that in the food it's 65 points per trillion in the
ducks and the fish that they are getting from there. And it's
30 points per trillion these many years in the blood and breast
milk of people who live in the Aloui Valley.
Another point of potential bias that is not widely known is
the fact that in this study limited confidentiality extended to
the active duty personnel that participated in the study.
Unlike most research, confidentiality of answers and
information obtained during the study is a sacred covenant
between the researcher and the subject. However, in this
particular instance, the Ranch Hand protocol stated that active
duty personnel would not be given complete confidentiality.
Instead, they were told that the DOD would be notified if any
of the information they provided was a risk to public safety or
national defense.
In essence, this limited confidentiality proviso could have
threatened the promotion potential, the flying status, and
retention in the Air Force of the active duty personnel who
participated in the study and should challenge the validity of
the responses given by these individuals.
Last year, in addressing the issue of the study's conduct
to prevent improper influences, last year I attended two
meetings of the Ranch Hand Advisory Committee which reviewed
the findings prior to the publication of the findings of the
last round of examinations. The notice of the first meeting was
indeed published in the Federal Register, under the FDA,
probably the last place a veteran would look for a meeting
about the Ranch Hand study.
Thoughtful suggestions for improvements in presentation of
the data, concerns about the interpretations of the findings,
and suggestions about the protocol were made by members of the
advisory committee. However, I have to say that one of the
things that came up over and over again was Air Force
researchers repeatedly countered that it would be difficult and
costly to carry some of these suggestions out.
Mr. Shays. If you could bring it to a close.
Ms. Schwartz. I will. Let me just say this.
The Agent Orange Act of 1991 authorizes presumed service
connection disability for diseases from certain herbicides. One
of the things it says, and maybe you don't have to fix this, is
that an association of a disease in human and exposure to
herbicide is considered to be positive of the credible evidence
of an association is equal to or outweighs the credible
evidence against the association. With these parameters in mind
you can see that the fact that the Ranch Hand data has not
completely been made available, and not all of their
associations, only the statistically significant associations.
This means that there may be data there that could help us
understand more about what the exposure is about.
I just would like to say, in closing, that war, like any
other human catastrophe, must be acknowledged as an important
occupational epidemiological event. And you, Mr. Shays, has
certainly pioneered the way for gulf war veterans and Vietnam
veterans. And I would just like to say that by continuing to
have Government entities with a vested interest in the outcome
of science to be allowed to continue to do research is not the
way to go because there are too many questions about the
credibility.
And the idea has been put forth as a freestanding institute
of military medicine and I think it is something that as we
progress we must take a very good look at and consider for the
future.
I thank you for your time.
[The prepared statement of Dr. Schwartz follows:]
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Mr. Shays. Thank you very much. We have a vote. I am going
to go vote and we are going to come right back and, Dr. Trewyn,
you will get to have your say.
You were kind to your comments to me at the end. I just
want to say that Mr. Sanders has actually done more than I have
in this area, and it has been wonderful to work with him.
I will convene you all and I will be right back after I
vote.
[Recess.]
Mr. Shays. I will call the hearing back to order.
Mr. Trewyn, you have the floor. Doctor, excuse me. You
spent many years getting that doctor, did you not?
Mr. Trewyn. I did, more than I would like to talk about,
sir.
I want to thank you for the opportunity to provide a few
brief comments here today. I will try to be brief. I know this
has been a long day.
Most of my comments are in my written testimony. It gets
into a lot of science but I was sort of inspired by
Representative Sanders to maybe try a couple of common sense
sorts of arguments here.
Mr. Shays. Common sense is not allowed.
Mr. Trewyn. OK, I will rethink that and go back to the
other thoughts.
Mr. Shays. No, common sense is allowed, we will take it.
Mr. Trewyn. What I'd like to talk about are briefly
scientific problems, administrative problems which have been
alluded to before. To just let you know how I got involved in
this, I did spend 4 years on the Ranch Hand Advisory Committee
from 1995 through 1999.
Mr. Shays. As a doctor not a veteran? No, you said you were
on the advisory committee. Were you appointed as a veteran or
as a doctor?
Mr. Trewyn. Well, I've never been quite sure. It was, in
fact, Admiral Zumwalt who got me appointed.
Mr. Shays. I am not looking for a long answer, I am looking
for the short answer.
Mr. Trewyn. And I don't know the true answer.
Mr. Shays. That tells me something.
Mr. Trewyn. I was asked that by the GAO and I didn't know
the answer and I don't know if they ever found it when they
went through the paperwork.
But I did spend 20 years of my life doing cancer research
and most of that with a focus on chemical carcinogenesis, so I
do have some scientific background in the area.
What I want to just briefly mention, and this is outlined
in my written material, are three scientific hypotheses that
one can look at here. The first one that started this whole
thing is that Vietnam veterans are suffering from excessive
health problems and those health problems are service-
connected, connected to their service in Vietnam. That is what
launched all of this, and that really remains the most
important question or the questions that underpin that remain
the most important ones to answer.
But somebody figured out that, you know, we sprayed a lot
of herbicides in Vietnam. Those have some nasty things in them,
so maybe the herbicides sprayed in Vietnam caused adverse
health outcomes in veterans who served there. And that, in
fact, is more the question that the Ranch Hand study is
designed to test, is that it was a causal relationship of
herbicides.
But because Agent Orange, the major herbicide sprayed in
Vietnam, contains dioxin--and we've heard a lot about that
today, TCDD, it moved to a third hypothesis and that is that
dioxin, a minor contaminant found in some of the herbicides
sprayed in Vietnam, caused adverse health outcomes in the
veterans exposed to herbicides.
If I could just give a quick example that will maybe
illustrate I think where our problem is with this whole thing
right now, and it's a forest and trees argument. If you were
standing in the middle of a redwood forest and some of the
trees are sick. We've gotten to the point where it's no longer
an issue that you can't see the forest for the trees. People
aren't even seeing the trees anymore in this study.
We've focused down on, in my hypothetical, a small beetle
burrowing into the bark of some of those sick trees. We'll call
it a dioxinite beetle, just for something novel. And you invest
25 years, $140 million and come up with the assessment at the
end, you know, that little beetle caused some problems for
those trees.
But when you step back and look around, you realize there
are no more trees. There's no more forest. We have lost sight
of what the original issue here was, which was health effects,
and sir, some of your predecessors in Congress have to bear
some of the blame here, because I truly believe the Air Force
is doing what they were mandated to do, what they were charged
to do, to study a possible, at the point in time, a probable
cause.
Now because they may not be finding as many adverse health
outcomes as we would like to see doesn't mean if we were
examining the right population, the veterans who were there on
the ground in general, this might not show up.
I could go into a lot of discussions about synergy,
something you've probably encountered in your discussions of
the Persian Gulf situation, mixtures of chemicals, biological
agents. I spent a lot of time in my career studying those
things. Where a couple of small effects can become a huge
effect when you put things together.
There are lots of suspects in Vietnam beyond dioxin, that
may have caused adverse health outcomes.
To just mention briefly a couple of administrative items,
from my role as a member of the oversight committee. In my
view, the advisory committee lacks authority, it lacks
appropriate reporting lines. For example, the committee never
files a report with the Secretary of Health and Human Services
which is then provided to Congress. There's nothing like that.
We talked to the Air Force and for the most part, or did when I
was involved and it still goes on. And for the most part, they
listened to our comments and recommendations on that committee.
But also, I believe the advisory committee lacks sufficient
resources to function properly. The first meeting I attended
after being appointed in 1995, the committee voted, as a body,
very busy people, a number of MDs and other experts on this
committee, voted as a body that we needed to meet every 6
months to really monitor this effectively, both the Ranch Hand
study and the later congressionally mandated Army Chemical
Corps study.
When we next got together 3 years later, we were informed
that well, you know, there really is no budget. The FDA does
not have a budget to do this job. It's just been passed down,
an unfunded mandate. They're supposed to call this group
together as need be and well, we didn't have the money and
there weren't pressing issues.
And I don't blame Ron Coene or the other people in the FDA.
It's a fact of life. They don't have--he has a job, a regular
job, and this has been passed down without the resources to get
the group together to adequately monitor the study.
I do believe that there are studies going on that could be
fixed and made better. The Army Chemical Corps study has some
great potential to yield positive results, hopefully in a
relatively short period of time. I'd be a lot more comfortable
with that if the VA wasn't involved in it. I'm a combat wounded
veteran with a service-connected disability. I stay as far away
from the VA as possible. I'm not on the registry for exposure.
The Vietnam Experience study, that group, if the study was
structured properly, the records are there, could still be
looked at.
And this is more than a veterans affairs issue. It is, in
fact, a national security issue. Because if the country
continues to treat their veterans poorly and, in some cases,
abominably as has been the case with the veterans suffering
from adverse health outcomes from Vietnam, from the Persian
Gulf, we're not going to meet the recruitment and retention
needs in this new era of needing highly educated, highly
technically proficient people. They aren't going to stay in
because why should they, when they know what's going to happen
going out the other end?
So I really do believe this is an opportunity for
Governmental reform and some oversight on this, and trying to
tie it to, at least as I read the mission of this group, of
looking at how to address these needs. And hopefully, something
can be done about this. Thank you for this opportunity.
[The prepared statement of Dr. Trewyn follows:]
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Mr. Shays. Thank you. I think you were more than generous
to the advisory committee because frankly, there are people who
would serve at their own expense. They would come at their own
expense. And the fact that you do not know whether you were a
veteran appointee or appointed in terms of your medical
expertise tells me something. I suspect you were not a veterans
appointee.
And it raises questions in my own mind, and I should have
asked Dr. Coene, when he said he had a quorum of five, can I
make an assumption that the five who were usually there were
not veterans because we had not been filling the spots with
veterans? Which also says somethings to me about the veterans
organizations, that they were not pushing this organization.
But I chose not to dwell on that, because I think it is
pretty evident.
Mr. Trewyn. I was told that it was the American Legion who
recommended my name, but I do not believe the GAO ever found
any record of it, and I never had anything official that
indicated that.
Mr. Shays. Then you may have been an appointee of the
veterans. The bottom line is not to meet for 3 years just
boggles the mind. It certainly was different than what we
anticipated.
Dr. Albanese, would you elaborate on your concerns about
the 1992 IOM reports on birth defects and cancers?
Dr. Albanese. Yes, sir. When you compare the Ranch Hand
sprayers with their control group, there's a more than 50
percent excess in the group that has sprayed. Now that birth
defects excess, using current analytical techniques, does not
regress linearly on dioxin. But that group difference exists.
I am one of four authors of that protocol. The purpose of
this study was to determine whether Agent Orange is associated
with problems. There's also a portion in the protocol which
says we're concerned about the Vietnam experience.
We have sitting on the table a greater than 50 percent
increase in the birth defects. And because it doesn't have a
linear regression with dioxin, which is not the only dangerous
contaminant in Agent Orange, we've ruled it out. And in the IOM
report we have a statement which says let there be an
independent analysis of this data because they severely
criticized this.
Mr. Shays. Does this relate to, Dr. Trewyn, your comment on
your first page on the bottom, with multiple agents and the
potential for synergistic activities among them, there may be
no way to sort out the relative importance of different levels
of exposure to individual components in veterans with different
genetic backgrounds and susceptibilities. And synergy is a
well-known phenomenon in chemical carcinogenesis and other
disease progressions?
Mr. Trewyn. That is correct. And in Agent Orange, 2,4-D
being essentially 50 percent of the mixture, which has been
shown to cause problems. Weed-B-Gone is how it's currently
marketed. But that has problems. You put dioxin, which came in
in the other component, 2,4,5-T, you put those together and I
don't know that anyone has ever scientifically studied the
potential for synergy that these two things together could
cause a much greater effect than either alone.
And those are just a couple of possibilities.
Mr. Shays. Ms. Schwartz, do you have any comment?
Ms. Schwartz. I think the thing is that Ranch Hand was
designed to look at Ranch Handers. What happened was because
they honed in on the ability to be able to measure dioxin, that
became the coin of the realm when indeed it should not be the
coin of the realm. And statistical significance should not be
the way in which you decide what things are compensable
disabilities.
So that's why I'm saying if you could look into the Ranch
Hand data, you could probably see if there were any other
things that had a greater than 50 percent chance----
Mr. Shays. Do you have access to that data?
Ms. Schwartz. There is no access to the data at this time.
As I said, we have the tapes. We just don't have--we cannot
read the data.
Mr. Shays. If we spent an average of $5.6 million a year,
and I should probably ask this to others, but it would strike
me that the relative cost of transferring that onto manageable
equipment would allow so many people to look at this data and
we might come up with some other conclusions.
Ms. Schwartz. That was the intention of the Yale School of
Nursing, to transfer it to CD-ROM and then to say if anybody
wants this data, you have to pay for the CDs but we'll make the
copies for you.
Mr. Shays. So one thing that this committee could do that
would make a contribution would be what would the cost be to
convert this data to a consumable?
Ms. Schwartz. Right.
Mr. Shays. You know, Doctor, if you do not mind coming up
now, you could just respond to that. There me things and you
are more than welcome to come down.
One, I appreciate you staying here. It is appreciated.
Ms. Schwartz. I think, just to answer and I probably
shouldn't steal Dr. Michalek's thunder, but the idea of making
that data available and something that can be used has been on
the Internet for quite some time. The delay, we don't see that.
Mr. Shays. Doctor.
Dr. Michalek. I understand your frustration. We are
preparing a series of CD-ROMs to be released to the public this
year. Each CD-ROM will contain the full report and all
supporting data bases and they will be in there as both flat
files and as sass files. We promise to have all this out by the
end of calendar year 2000.
Mr. Shays. Thank you. Will that be a help, Dr. Schwartz?
Ms. Schwartz. I will be eagerly awaiting this, especially
if it's in a sass file.
Dr. Michalek. Absolutely. For example, we've already
released the birth defect data. Everything that has been
published is now released. The dataset itself is out there at
NTIS. I would invite anyone who wants to have access to the
data and it's inconveniently formatted, just send me a message
and I'll send you a sass dataset.
Ms. Schwartz. I don't think that the birth defect data is
there. If you sent it there, it's not there and it is not
available to the public.
Mr. Shays. This dialog is helpful because we can, by the
fact that we have a public dialog about this, we can do our job
as a committee and just make sure it happens the way it should.
Ms. Schwartz. I would just like to say, as a way of
informing everyone, that the VA did complete a study of the
birth defects associated with women veterans. Agent Orange was
not in the--was not considered in that because of the
presumption that if you served in Vietnam you would be eligible
for this, and that the Secretary of Veterans Affairs found that
the high rates of birth defects in women and the children of
women who served in Vietnam was so high that he did make an
announcement that they would be making efforts to compensate
these women and their children.
And as much of a women's advocate as I am, I see that we
really need to proceed as soon as we possibly can----
Mr. Shays. Do you think that is happening?
Ms. Schwartz. Yes, it is happening.
Dr. Albanese. Congressman Shays, I think it's very
important for me to say, based on what Dr. Schwartz just said,
I studied that report on the birth defects to female veterans.
The pattern in the Ranch Handers is nearly identical to the
pattern in that study. But because they didn't meet the
standard of a linear increase with dioxin, the fact of that
difference hasn't been further pursued. That's the tragedy of
it.
Mr. Shays. Let me just say, Doctor, you might be tempted to
jump in. I will just ask questions of the three panelists, but
I do want to give you the opportunity to come back to the panel
here and respond to anything that you have heard. We like
everything out on the record, and again I thank you for being
here. Let me just focus on the three of you a second and then
we will conclude.
Dr. Albanese, I would like you to give me examples of the
Ranch Hand study of how the hierarchical structure of the
military organization can compromise the work. Tell me how it
becomes compromised, in your judgment?
Dr. Albanese. I'm not going to give you a hypothesis. I'm
going to report on what happened.
Perhaps the most overt effect was a letter from Commander
Mosher who wrote in the name of the Surgeon General Chesney.
And in the mortality report we were directed to use five
controls for every exposed Ranch Hand instead of the 8 to 10
that we had available. We were to put that as a secondary
analysis.
Mr. Shays. You would do that based on what? On someone's
directive?
Dr. Albanese. Surgeon General Chesney perceived that to be
in the peer-review's interest. We had no way of verifying that.
And I want to remind you that this was an improperly
constituted peer-review at that time. There were no scientists
representing veterans.
So we received this letter saying highlight the one to five
analysis, not the stronger, more powerful statistical one to
eight analysis. And report percentages, mortality percentages
rather than numbers.
Now I was the lead statistician at the time. My desire was
to go with the strongest statistical analysis, one to eight,
and feature that. I felt that there were some indications of a
mortality blip. And furthermore, when men and women are young,
in their 40's and early 50's, percentages are small. But
numbers are people, numbers are real. And the thing to do is
actually publish both. General Chesney intervened directly and
changed our report.
Now we have a very small sample size. Very small. A 1 in
1,000 disease is not a rare disease, as the GAO claimed. That's
like leukemia and I wouldn't view leukemia as a rare disease.
If we have 1 in 1,000 extra leukemias, we have 25,000 of them
in the Vietnam veterans. Ranch Hand can't detect 1 in 1,000. It
can't detect 2 in 1,000 excesses. These are the limitations
that haven't been described.
So how can you amplify the size of the study? You can
understand how dioxin affects the metabolism. You can augment
your analysis with models of the toxicology. Now that's what I
was doing as a statistician. And there's a letter in the
record, which the GAO has, which absolutely terminates that
line of research, written by Commander Mosher.
Mr. Shays. Let me ask you, though, it sounds to me that you
were making a determination that you were going to go beyond
the size of the study. Was that your prerogative?
Dr. Albanese. No, no, I was going to augment.
Mr. Shays. Now in your judgment, that is your professional
license to be able to do that?
Dr. Albanese. No, that was part of the protocol, sir, to
use toxicological data. I wrote that protocol and that protocol
says--with Moynahan, Lathrop and Wolfe. And that protocol says
we were going to look at the relationship of Agent Orange to
disease. Not dioxin, Agent Orange to disease.
And we were going to look at the Vietnam experience. There
are two other aspects of the protocol that haven't been
fulfilled. There's an entire time in-country analysis that has
not been featured in any publication that I've been able to
time. And there's been a second analysis. I was just fulfilling
the protocol.
Mr. Shays. I hear you. Thank you.
Dr. Schwartz, would you expand on your testimony that
results of the Ranch Hand study are used to determine health
effects on all Vietnam veterans, especially women?
Ms. Schwartz. The statement is that it does not, it should
not be applicable to all veterans because, first of all, there
aren't any women and that's not the Ranch Handers fault nor the
Air Force's fault. Women just weren't in that.
Mr. Shays. Thank goodness. Thank goodness that they were
not part of Ranch Hand.
Ms. Schwartz. But I think some of the recent findings about
the levels of dioxin in the soil of our bases really casts
another challenge to us about what happened to the folks that
were on those bases, and there were women.
There has not been, to this date, a health study of the
women who served in Vietnam. My own dissertation, it was the
beginning. And the reproductive outcomes has been done by the
VA. But what I am saying is this, that I have heard Dr.
Michalek say, and I understand perfectly, that this study was
about Air Force Ranch Handers and that's the way we should look
at it.
And perhaps it has been too convenient to lean on the
results of this study, to cast the wide net and say that this
involves all of the veterans who served in Vietnam.
Mr. Shays. Just based on that comment, do you think that
the study should continue? One, should the study continue? And
second, should it continue in the Air Force's hands? Should it
be given independently?
Ms. Schwartz. This is a hard question but I feel that if we
put it in the correct perspective, that the work that Dr.
Michalek and all the others have done, that this is probably
the longest longitudinal picture we have of men who were in the
military and the after effects. If we want at that and looked
at that as a way in which we could use the data which has
already been collected, then I say yes, the study should be
continued.
But for us to continue to hang our hat on the fact that
this is the absolute gold standard of what is happening to the
health of veterans who served in Vietnam, no.
Mr. Shays. Do you think it being held up as the gold
standard?
Ms. Schwartz. Yes, it is. I think that when the National
Academy of Science reviews, even though they do mention in
their reports some of the things about Ranch Hand's protocol
and study design, that if it's not statistically significant,
Ranch Hand does not publish it. Therefore, we are not getting
all of the information.
If Ranch Hand is publishing, crafting their reports to fit
into professional journals, then we are not seeing the things
that probably are greater than a 50 percent chance. So we are
denying veterans, or maybe we are denying veterans some
compensation and disability for the facts that we have not
really looked at all.
And also, I think the thing is that the subjects who have
participated in the Ranch Hand study deserve, deserve to know
if there is anything else. Dr. Albanese raised an excellent
point, that the study is of herbicides. There were 15
herbicides used in Vietnam. Agent Orange was one of them.
Mr. Shays. Thank you. Dr. Trewyn, if you were to take the
study out of the hands of the Air Force, the DOD, who would you
give it to?
Mr. Trewyn. I'm not sure that I would take this study out
of the hands of the Air Force, to be honest. During the 4 years
I was on the advisory committee, I found the personnel involved
to be very responsive to any questions, any materials that we
asked for. In their reports they use a number of different
statistical models, some of which provide useful information,
more useful information for making some of the determinations
that this group is interested in here, the health things that
may not sustain the scientific scrutiny that a publication in a
peer-review journal would.
But those things are in the report. And I think the
material is there.
Dioxin, and some of the associations that they're finding
with that, truthfully it's--well, it's not found in chemical
processes like it used to be. There is an environmental burden
of dioxin that we all have to deal with. I used to live in
Columbus, OH and if you were anywhere near the trash-burning
power plant there, your dioxin levels were going to be very
high because they were putting a lot of it out the stack. And
that was not that many years ago.
So there are sources of dioxin. I think as a study of
effects of dioxin, granted this is a herbicide study and the
data is there for that. There's going to be valuable
information that's going to come out of this. But negative
findings in this study mean nothing for any other Vietnam
veteran because of all of these other possible routes of
exposure, other things involved in everything.
And so this really should not be held up for a cure-all
thing, solve-all answer for Vietnam veterans. This isn't the
study to do that. And I believe at the time they started it,
the belief was that it was going to be. It hasn't turned out
that way and I don't think it's necessarily through the fault
of the people involved.
New studies I would put elsewhere.
Mr. Shays. Your analogy of the forest and the trees, and
the description that a lot of the trees are dying, it implies
that even if we cannot identify the cause to Agent Orange, we
know that there are sick veterans who need help.
Do the other two of you agree with that analogy? Are the
trees dying?
Ms. Schwartz. I would just like to say that the fact that
we have not been able to come to conclusions about the rare
diseases and the cancers that are suffered by the veterans,
about the birth defects that they are seeing in their children
and their grandchildren is a great sorrow. It's a great sorrow.
But the fact is that the lag time between the exposure to
Agent Orange and the appearance of symptoms is upon us now. And
I have buried too many friends in the last few years, women
especially, who had never even thought that they had been
exposed to Agent Orange. But I will tell you this, that the
only comfort they got about hearing that their diseases might
be related to Agent Orange is the fact that they could consider
that they were dying for their country.
Mr. Shays. That is a pretty powerful statement. My general
feeling is if I were to ask the VA, they would tell me, and I
would be happy to have them disagree, but they would tell me
that it has not been established that more people are dying who
served in Vietnam.
Mr. Trewyn. I would agree with that, that it has not been
established. And that's one of the flaws in the system. That's
the study, long-term studies of outcomes, morbidity and
mortality, are the sorts of things, tracking a group of
individuals who were involved in the conflict. And so I'm using
this in terms of Vietnam, Persian Gulf, Kosovo, wherever.
Tracking the long-term outcomes to a normal population, a group
that was not subject to the same levels of exposure----
Mr. Shays. You have made your case, I think clearly, that
to compare our soldiers who fought in Vietnam who may not have
had direct contact with Agent Orange to those who had direct
contact would be flawed, because they would have indirect
contact.
But it would seem to me, and I do want to complete here,
but from my simple-minded approach to this, I would want to
determine are more people dying who served in Vietnam, are more
people suffering illness and birth defects. I would want to
know that kind of information, and whether or not we knew the
exact cause--I mean, obviously we want to know the cause for
cures and so on. But at least we could reach out and lend a
helping hand to them.
And I would make an assumption that some would have gotten
this illness for other reasons or died for other reasons. But
so what? We gave them additional help. They did serve in
Vietnam. That is kind of the way my simple mind works.
If you all can help steer me in that direction, I would
love some help.
Dr. Albanese. May I respond to your first question? I think
it's beyond a reasonable doubt that there is a birth defects
excess in the Ranch Hand group. I think the preponderance of
the evidence is that there has been an excess of cancer. I
think it's beyond a reasonable doubt that there are some
neurological effects. And I think there's a preponderance of
the evidence that there are endocrinological effects in the
Ranch Hand group.
Having said that, the issue of how these extrapolate or if
they extrapolate to the veterans as a whole is an open and
interesting question.
Ms. Schwartz. I would just like to address that. In my
particular study we had three groups. We had women who served
in Vietnam. We had women who were in the military but never
served in Vietnam. And we had a cohort of civilian women who
were matched for age and occupation, being nurses. I find that
that design has a lot of strengths to it, because you are then
able to see, because there are other exposures to dioxin now in
our atmosphere.
My data came from the National Vietnam Veterans
Readjustment Study, which was commissioned by the Congress to
look at the readjustment problems of Vietnam veterans. I know
that there has been several proposals that we go revisit this
same group that we studied in 1985, because you have the three
groups and you can see where they are now.
Mr. Shays. Dr. Michalek, would you like to make any
comments?
Dr. Michalek. Just a couple of things. They are fairly
technical and I feel inadequate to respond to some of the
statements that----
Mr. Shays. Let me just say this to you, I am not suggesting
that you have the burden of responding to every testimony here.
So if something is said here and you have not responded, I will
not assume your silence means you agree.
Dr. Michalek. Thank you. I just feel sorry and sorrowful
myself, after listening to Linda talk, and I hate to talk
technicalities after hearing her statements.
Mr. Shays. I understand.
Dr. Michalek. In the area of mortality, we mentioned the
one to five and the one to eight design. You should know that
those analyses were carried out many different ways and in
duplicate in many of our reports. For example, in 1987, we used
a reduced mortality cohort and then we used all mortality study
subjects, up to 19,000. And we showed the results side-by-side.
In fact, every step of the way in this study, whenever
we've changed our models or changed our ideas about statistics,
we do everything twice or three or four times. And so
everything is there, it just takes time to find it.
In the area of data release, yes, we have released the
birth defect data and I'm sorry about its format. That has to
do with NTIS and the way they handle data and we'll certainly
fix that with CD-ROMs. With anybody who would approach me for
that, I'd certainly hand it out right away.
On the birth defect issue, as we've said, we have the most
comprehensive data available. It's been analyzed independently
by the Centers for Disease Control, and that led to the
published article in 1995. That conclusions in that article
were drawn by the Birth Defects and Developmental Disabilities
Branch at CDC. They received the data from us, they interpreted
it, and they wrote the conclusions to that paper.
So what you're seeing here today is a disagreement between
medical doctors on how to interpret data. That would be Dr.
Albanese against the physicians at CDC. The data is now
available and I would encourage anyone who has any ideas on
reanalyzing that to go ahead. And if you need extra help, call
me and I'll send you what you need.
Mr. Shays. Thank you. Thank you very much.
Good things can happen from the effort of the GAO and there
will be some blessings in this and there will be some silver
lining. And I think when you have devoted as much of your life,
Doctor, as you have, it is tough to have this kind of dialog. I
am sure we could have witnesses that would say things are not
exactly this way, so I understand we can also do it that way.
But I think we are all people of good will and I am
absolutely convinced that you care as much as anyone else about
the welfare of our veterans.
So I thank all of you. You all have made a contribution
here.
Let me just allow anyone to make a completing comment if
they want.
Dr. Albanese. One concluding comment would be, I believe,
since you are the Government Reform Committee, that a reform is
needed in the Air Force with respect to medical research.
Medical researchers need the opportunity to compete in the open
literature without having a policy review on their papers.
Mr. Shays. I think that is fair. Dr. Schwartz?
Ms. Schwartz. I would just reiterate that as the technology
of the battlefield becomes more complex and that the idea that
VA may have to look at compensation, that the military may have
to validate or not validate what's going on with their soldiers
that they send to war, that thought should be given to a
freestanding institute of military medicine.
Mr. Shays. Very good, thank you. Dr. Trewyn.
Mr. Trewyn. I would just say that I do think that in the
future, using the existing sort of NIH peer-review process, a
lot of these studies could be done long-term in a mechanism
involving the medical schools and experts around the country to
do this. And I do think that the Congress can have an impact on
some of these existing studies.
Because Congress did not mandate, in the Chemical Corps
study and the National Academy did not mandate in that study
that there be a non-chemically exposed group included, a normal
control baseline, there is no normal control baseline. There
are Chemical Corps workers in Vietnam compared to Chemical
Corps workers in other parts of the world. So you don't have,
you have probably already set the baseline too high.
And there are other studies out there. The old Vietnam
Experience study, whether there are things that could be--if
that could be pulled back in and analyzed and the group studied
at this point to see if there are now significant difference,
could be an important thing to do.
Mr. Shays. Thank you. I appreciate the VA still having
representatives here. Dr. Mather, do you have any, or anyone
else? Or are we all set?
Ms. Mather. Only that I would hate for people to go away
from the hearing feeling that VA doesn't do anything for
Vietnam veterans who don't have service connection. In fact,
Vietnam veterans who think their illnesses are due to exposures
or service in Vietnam can get treatment in VA hospitals, and
they have a priority for that.
Mr. Shays. Dr. Michalek?
Dr. Michalek. Just one more thing. I think one thing that
we've all heard today, and we've said many times, is the
committee itself, the advisory committee, I wish you could find
funding to strengthen the committee, to make it proactive
instead of reactive, and to encourage more frequent meetings.
Mr. Shays. I honestly think if they had been more
proactive, they would have been a help to you rather than a
hindrance, because they would have been coming from the
perspective that would be important. I think that that will be
one of the findings of this committee, and we will try to come
out soon with that, and you have made some suggestions on how
we proceed.
So we have learned a lot and you have all been very
helpful. I thank you so much. I have to run off to a budget
hearing, so I will just say thank you.
This hearing is closed.
[Whereupon, at 1:37 p.m., the subcommittee was adjourned.]