Agent Orange: Persisting Problems With Communication of Ranch Hand Study
Data and Results (Testimony, 03/15/2000, GAO/T-NSIAD-00-117).

Pursuant to a congressional request, GAO discussed its recent reports on
the Air Force's Ranch Hand study, which was designed to investigate
whether exposure to herbicides in Vietnam led to or would lead to
adverse health effects, focusing on: (1) what impact the study has had
on veterans' compensation decisions; and (2) how the study disseminated
results and data, communicated its limitations, and implemented measures
to ensure that it was conducted with scientific independence and
appropriate outside scientific oversight.

GAO noted that: (1) the Ranch Hand study has had limited impact on
decisions affecting veterans' compensation; (2) its most significant
impact so far has been on a decision by the Department of Veterans
Affairs to provide compensation to Vietnam veterans' children born with
spina bifida, but it has not contributed either positively or negatively
to decisions to compensate for any other diseases; (3) the study has
also led to increased discussion and further study of the association
between herbicide exposure and diabetes; (4) currently, Vietnam veterans
with diabetes are not eligible for compensation; (5) the relatively
small size of the Ranch Hand population limits the study's ability to
detect increases in risks of rare diseases, including many forms of
cancer; (6) although the Air Force has conducted many aspects of the
study rigorously, GAO found several past and ongoing problems, including
delays in the dissemination of some results, limited public access to
detailed data, inadequate communication of the study's limitations,
failure to implement some measures to ensure rigor and independence, and
insufficient outreach to veterans; and (7) though many of these problems
have been resolved, they have led some critics to question the openness
and credibility of the study.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  T-NSIAD-00-117
     TITLE:  Agent Orange: Persisting Problems With Communication of
	     Ranch Hand Study Data and Results
      DATE:  03/15/2000
   SUBJECT:  Herbicides
	     Medical research
	     Birth defects
	     Government information dissemination
	     Veterans
	     Veterans disability compensation
	     Carcinogens
	     Health statistics
	     Air Force personnel
IDENTIFIER:  Air Force Ranch Hand Study
	     Agent Orange
	     Vietnam War

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   * For Release on Delivery
     Expected at 10:00 a.m.

Wednesday,

March 15, 2000

GAO/T-NSIAD-00-117

Agent Orange

Persisting Problems With Communication of Ranch Hand Study Data and Results

        Statement of Kwai-Cheung Chan, Director,

Special Studies and Evaluations,

National Security and International Affairs Division

Testimony

Before the Subcommittee on National Security, Veterans Affairs, and
International Relations, Committee on Government Reform, House of
Representatives

United States General Accounting Office

GAO

Mr. Chairman and Members of the Subcommittee:

We are pleased to be here today to discuss the findings of our report
examining the Air Force's ongoing Ranch Hand study, an expensive and
in-depth epidemiological study of Vietnam veterans. The study was designed
to investigate whether exposure to herbicides, including Agent Orange, in
Vietnam led or would lead to adverse health effects. The study follows the
health (morbidity) and mortality rates of the so-called Ranch Hands-the
almost 1,300 Air Force personnel who sprayed herbicides from the air in
Vietnam.

Since its inception in 1982, the Ranch Hand study has been controversial.
Initially, official government and nongovernment reviewers of the study's
design expressed concern that the public would not consider the study
credible because the Air Force, which conducted the spraying of herbicides
in Vietnam, would also conduct the study. Because of these concerns about
the appearance of conflict of interest, the design of the study protocol
included several safeguards intended to ensure scientific rigor and
objectivity. Among these measures was the establishment of a monitoring
group, which currently consists of an Advisory Committee (administered by
the Food and Drug Administration) responsible for providing independent
scientific review.

Our testimony today summarizes the results of our investigation of the Ranch
Hand study. We assessed (1) what impact the study has had on veterans'
compensation decisions and (2) how the study disseminated results and data,
communicated its limitations, and implemented measures to ensure that it was
conducted with scientific independence and appropriate outside scientific
oversight.

The extent to which most Vietnam veterans were exposed to herbicides is not
well known, and one reason the Ranch Hands were selected for the study was
that the Air Force believed that they were heavily exposed to herbicides.
The study compares the Ranch Hands with a comparison group of Air Force
personnel who served in Southeast Asia but who were not involved in the
spraying. The comparison group was matched to the Ranch Hands in terms of
age, race, and military occupation. Results of the study, along with those
of other scientific studies of veterans and other populations, are used by
the Department of Veterans Affairs to determine whether veterans are
eligible to receive disability compensation for conditions believed to be
connected to service in Vietnam.

Summary

Although the Air Force has conducted many aspects of the study rigorously,
we found several past and ongoing problems, including delays in the
dissemination of some results, limited public access to detailed data,
inadequate communication of the study's limitations, failure to implement
some measures to ensure rigor and independence, and insufficient outreach to
veterans. Though many of these problems have been resolved, they have led
some critics to question the openness and credibility of the study.

In our December 1999 report, we recommended several actions to improve the
communication of study results and data. Both the Air Force and the Food and
Drug Administration agreed with our recommendations and indicated they were
taking steps to address them.

Background

In 1984, and again in 1991, Congress revised the process used by the
Department of Veterans Affairs to determine whether Vietnam veterans are
eligible to receive compensation for health effects from exposure to
herbicides. Since 1991, the Department has been required to contract with
the National Academy of Sciences to perform reviews of scientific
literature, including published reports from the Ranch Hand study, on the
association between diseases and herbicide exposure. Largely on the basis of
these reviews, the Department determines which diseases show a positive
association between herbicide exposure and the disease. Vietnam veterans
with such diseases are then eligible for disability compensation.

Study Has Had Limited Impact on Compensation Decisions

In part because of its statistical limitations, the study has not
contributed either positively or negatively to the Department's decisions
concerning compensation for any other disease, including nine (in addition
to spina bifida) for which Vietnam veterans are currently eligible to
receive compensation. The study's relatively small sample size provides
limited potential for addressing possible links between herbicide exposure
and many forms of cancer. For instance, in order to detect a statistically
significant increase in the risk of non-Hodgkins lymphoma (for which
veterans can receive compensation), the study would have to find an
incidence of the disease among Ranch Hands more than twice as high as among
members of the comparison group. A finding of a possible association between
herbicide exposure and diabetes was first reported by the Ranch Hand study
in 1991. This finding led to further review of the issue by the National
Academy of Sciences and further scientific investigation by the Air Force
and others. However, the Department of Veterans Affairs has not yet
determined whether Vietnam veterans with the disease are eligible for
compensation, though in 1999 it did request that the Academy issue an
interim report on diabetes, currently due in March or April 2000.

Problems Have Led Critics to Question the Study's Credibility

Publication of Study Results and Update of Birth Defects Report Were Delayed

A detailed report on reproductive outcomes was also delayed. Although it
reported preliminary findings in 1984, the Air Force did not release the
more detailed update until 8 years later, in 1992. The delay was caused by
the Air Force's decision to verify birth defects data extensively and to
perform additional data analyses without releasing any interim findings. The
amount of data verification was highly unusual and virtually unprecedented
for a study of this size. Although these additional efforts ultimately
strengthened the scientific basis of this portion of the study, the length
of the delay and the decision not to release an interim report led to
concerns by some veterans and scientists that the study was being purposely
delayed to suppress information. One scientist told us that preliminary
findings could have been useful for making decisions affecting veterans'
family planning or prenatal care. Others stated that earlier reporting might
have led to an earlier decision to compensate for spina bifida.

Public Access to Study Data Remains Limited

Study Limitations Have Not Been Clearly Communicated to the Public

As far back as 1980, a government working group emphasized that the public
needed to understand clearly the limitations created by the study's sample
size. However, in its first two morbidity reports, the Air Force described
the study's lack of findings as "reassuring" because they detected few
statistically significant increased risks of disease. The use of such
language could have led to the misinterpretation that the study showed
herbicides were safe. The Air Force stopped using this type of language in
1990, and while communication of study limitations to the public has
improved over the years, additional improvements are possible. The Air Force
still reports the study's findings through press releases and executive
summaries that do not make the study's limitations clear.

Implementation of Oversight Measures Had Problems

Problems Remain With Advisory Committee's Outreach to Veterans

Recommendations

We recommended in our report that the Secretary of Defense direct the Air
Force scientists in charge of the Ranch Hand study to establish and
publicize a timetable for the release of all study data and release the data
through a medium (such as CD-ROM or the Internet) that is easily accessible
to the general public. We also recommended that the Air Force include more
information on the study's limitations in its press releases and executive
summaries of study reports. In particular, we recommended that it provide
clear information on the limited applicability of study results to other
Vietnam veterans and on the study's limited ability to detect small to
moderate increases in risks of rare diseases. The Air Force concurred with
our recommendations and indicated that it was taking steps to address them.

In addition, we recommended that the Advisory Committee's Executive
Secretary at the Food and Drug Administration provide direct and timely
notification to veterans' organizations of scheduled Committee meetings and
of opportunities for nominations of Committee members. The Food and Drug
Administration concurred with our recommendation and stated that it has
begun working to ensure that veterans' organizations are notified of the
Committee's activities in a timely manner.

Objectives, Scope, and Methodology

This concludes our formal statement. If you or other members of the
committee have any questions, we will be pleased to answer them.

For future contacts regarding this testimony, please contact Kwai-Cheung
Chan at (202) 512-3652. Individuals making key contributions to this
testimony included Dr. John Oppenheim and Dr. Weihsueh Chiu.

(713060)

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