[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]




                               before the


                                 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


67-153                     WASHINGTON : 2000



                     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
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
    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)

                      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 

                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
    Carolina                         BERNARD SANDERS, Vermont 
LEE TERRY, Nebraska                      (Independent)
JUDY BIGGERT, Illinois               JANICE D. SCHAKOWSKY, Illinois

                               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

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



                       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 
    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 
    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 
    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:]

    [GRAPHIC] [TIFF OMITTED] T7153.001
    [GRAPHIC] [TIFF OMITTED] T7153.002
    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 
    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. 
    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.


    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 
    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 
    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 
    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 
    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 
    Basically, the Ranch Hands consist of about 1,300 people, 
and that's all you have. You are limited by this small 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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:]

    [GRAPHIC] [TIFF OMITTED] T7153.014
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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 
    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 
    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 
    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 
    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 
    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 
    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 
    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.


    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 
    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 
    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 
    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 
    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 
    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 
    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 
    Mr. Coene. In 1989.
    Mr. Shays. In 1989, and you work for the Food and Drug 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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-
    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 
    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.


    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 
    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 
    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 
    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 
    Ms. Schwartz. But I do not come from your district, I'm 
    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 
    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 
    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 
    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 
    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 
    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, 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    Mr. Shays. You would do that based on what? On someone's 
    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 
    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 
    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 
    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 
    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 
    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.]