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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
Page 1 GAO/T-NSIAD-00-117

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,1 an expensive and

in-depth epidemiological study2 of Vietnam veterans. The study was

designed to investigate whether exposure to herbicides, including Agent

Orange,3 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

1 Agent Orange: Actions Needed to Improve Communications of Air Force Ranch Hand Study Data and

Results (GAO/NSIAD-00-31, Dec. 17, 1999).

2 A scientific study of the incidences, distribution, or control of diseases in human populations.

3 Several herbicides, including Agent Orange, contain the chemical 2, 3, 7, 8-tetrachlorodibenzo-pdioxin. This chemical, often referred to as dioxin, is known to cause a variety of adverse health effects

in animals.
Page 2 GAO/T-NSIAD-00-117

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.

To date, the Ranch Hand study has had limited impact on decisions

affecting veterans’ compensation. 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,

4 but it

has not contributed either positively or negatively to decisions to

compensate for any other diseases. The study has also led to increased

discussion and further study of the association between herbicide

exposure and diabetes, an association that was first reported by the Ranch

Hand study in 1991. Currently, Vietnam veterans with diabetes are not

eligible for compensation. 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.

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.

The Ranch Hand study is one of the few ongoing studies of the health

effects of herbicides on human populations. This is of particular

importance because when it makes compensation decisions, the

Department of Veterans Affairs places primary importance on evidence of

an association between herbicide exposure and adverse health in humans,

not on evidence of adverse health from animal or laboratory studies. The

Ranch Hand study is also important because relatively high exposure to a

4 Spina bifida is a birth defect in which the vertebral column (backbone) fails to close, possibly

allowing herniation of the spinal cord.

Summary

Background
Page 3 GAO/T-NSIAD-00-117

substance may be necessary in order for a scientific study to detect

adverse health effects. The 25-year Ranch Hand study, which began in

1982 and is scheduled to end in fiscal year 2006, has cost over $100 million

so far and is projected to cost a total of over $140 million. To date, the Air

Force has conducted all scheduled phases of the Ranch Hand study,

including up to five full physical examinations of each participating

member of the Ranch Hand and comparison groups. It has periodically

reported study results in official Air Force reports.

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.5 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.

The most significant impact of the Ranch Hand study to date has been on

the Department of Veterans Affairs’ decision to provide compensation to

Vietnam veterans’ children with the birth defect spina bifida. On the basis

of Ranch Hand birth defects findings, released in a report in 1992 and

published in a scientific journal in 1995, the National Academy of Sciences

decided in 1996 to upgrade its evaluation of evidence for association

between herbicide exposure and spina bifida in Vietnam veterans’

children. Subsequently, the Department of Veterans Affairs requested, and

Congress approved, legislation allowing the Department to provide

compensation to Vietnam veterans’ children with the disease.

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.6 The study’s relatively small sample size provides limited

5 P.L. 98-542 (1984) and P.L. 102-4 (1991).

6 The 10 diseases for which veterans are currently eligible for compensation benefits are: chloracne,

Hodgkin’s disease, multiple myeloma, non-Hodgkin’s lymphoma, prophyria cutanea tarda, respiratory

cancers (lung, bronchus, larynx, and trachea), soft-tissue sarcoma, acute and subacute peripheral

neuropathy, prostate cancer, and spina bifida in offspring.

Study Has Had

Limited Impact on

Compensation

Decisions
Page 4 GAO/T-NSIAD-00-117

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.7 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.

The Air Force has conducted many parts of the Ranch Hand study in a

rigorous manner. But we found that a number of problems experienced

early on damaged the study’s credibility. Many of these initial problems

have been corrected, although some persist. Past problems included

delays in and limits on dissemination of study results, limited public

access to detailed study data, inadequate communication of study

limitations, failure to implement measures to ensure that the study was

conducted rigorously and independently, and insufficient outreach to

veterans’ organizations. Communication of the study’s data and limitations

and outreach to veterans remain problem areas.

Delays occurred in the publication of morbidity and mortality findings in

scientific journals during the study’s early years. No journal articles on

these findings were published until 1990, even though the first mortality

and morbidity reports were issued in 1983 and 1984, respectively, and even

though the Advisory Committee had repeatedly recommended that such

articles be published in peer-reviewed journals as soon as possible. The

importance of publishing journal articles is illustrated by the fact that even

though the Air Force’s report on reproductive outcomes was released

1992, compensation for veterans’ children with spina bifida was instituted

only in 1996, after a journal article was published in 1995. The pace of

journal article publication has increased in recent years.

7 For instance, the Academy stated in its 1994 report that additional information on characteristics of

dioxin metabolism, particularly with regard to total body fat, was necessary to interpret the observed

association.

Problems Have Led

Critics to Question

the Study’s Credibility

Publication of Study

Results and Update of

Birth Defects Report Were

Delayed
Page 5 GAO/T-NSIAD-00-117

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.

Although the number of published reports has increased in recent years,

some scientists and veterans’ groups want full and ready access to all the

study’s data so they can verify the findings and perform additional

analyses. However, only a relatively small amount of data is currently

available, and its storage format (magnetic tape) is difficult to use.

Currently, the public can access only data the Air Force analyzed in 1987

and released in 1995. Air Force officials have told us that they intend to

make all other data available by the end of 2000. This should help increase

the credibility of the study’s results.

Like all epidemiological studies, the Ranch Hand study has a number of

inherent limitations. However, the Air Force has not clearly or effectively

communicated these limitations to the public. The study has two major

limitations: it has difficulty in detecting low to moderate increases in risks

of rare diseases because of the relatively small size of the Ranch Hand

population, and its findings cannot be generalized to all Vietnam veterans

because Ranch Hands and ground troops were exposed to different levels

of herbicides in different ways. Blood measurements of dioxin (a chemical

in some herbicides that is known to cause adverse health effects in

animals) suggest that the Ranch Hands’ exposure levels were significantly

higher than those of many ground troops. But ground troops may have

been exposed in ways (such as through contaminated food and water) that

Ranch Hands were not, and little is known about the potential effects of

such differences.

Public Access to Study

Data Remains Limited

Study Limitations Have

Not Been Clearly

Communicated to the

Public
Page 6 GAO/T-NSIAD-00-117

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.

During the study’s first several years, two measures intended to ensure

that the study was conducted independently and without any appearance

of bias were not carried out as planned. The study’s protocol (published in

1982) mandated that (1) Air Force scientists, subject to review by an

independent scientific monitoring group (the Advisory Committee), have

primary responsibility over the scientific aspects of the study and (2) the

monitoring group (currently consisting of nine scientists) include

scientists nominated by veterans’ organizations. These requirements were

not fully implemented until 1989. According to documents we reviewed

dating from 1984 and 1985, Air Force management and the White House at

the time tried to direct certain aspects of the scientists’ research. These

attempts deviated from the protocol’s requirement that Air Force

scientists retain primary responsibility over the study’s scientific conduct.

In addition, the White House’s actions bypassed review by the Advisory

Committee. Furthermore, the Advisory Committee did not include any

veterans’ representatives, as required, until 1989.

Although many early problems were resolved through executive and

congressional actions, the Committee’s outreach to veterans is still an

issue. For example, although the Committee’s public meetings are

announced in the Federal Register, the Committee has not routinely

informed veterans’ organizations directly of these meetings. In addition,

the Committee’s informal process for soliciting nominations has resulted

in some interested veterans’ organizations not being notified of

opportunities to nominate Committee members. 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.

Implementation of

Oversight Measures Had

Problems

Problems Remain With

Advisory Committee’s

Outreach to Veterans
Page 7 GAO/T-NSIAD-00-117

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.

To examine the conduct and findings of the Ranch Hand study, we

obtained and reviewed the study protocol, various study memoranda and

correspondence, published study reports and peer-reviewed journal

articles, executive summaries and Air Force press releases, and other

available documents related to the study. In addition, we interviewed

Ranch Hand study investigators, Advisory Committee members, Air Force

program officials, Department of Veterans Affairs officials, veterans’

representatives, and scientists involved in research on the health effects

associated with exposure to herbicides and dioxin. We also visited Brooks

Air Force Base, San Antonio, Texas, to interview members of the Ranch

Hand study team and to review data collection and reporting procedures.

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)

Recommendations

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and Methodology
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