Agent Orange:

Actions Needed to Improve Communications of Air Force Ranch Hand Study Data and Results

NSIAD-00-31: Published: Dec 17, 1999. Publicly Released: Jan 18, 2000.

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Pursuant to a congressional request, GAO examined the conduct and findings of the Air Force's Ranch Hand study on the long-term health effects of exposure to herbicides, such as Agent Orange, in Vietnam, and assessed the study's impact on determinations of veterans' compensation, focusing on: (1) whether the study's findings and data have been properly and promptly reported and disseminated; (2) the statistical limitations of the study and whether they have been adequately reported and communicated; (3) the measures established to monitor the study's conduct and to prevent improper influence, particularly those involving the Ranch Hand Study's Advisory Committee; and (4) the impact of the study on determinations of diseases for which Vietnam veterans are eligible to receive compensation benefits.

GAO noted that: (1) the Air Force has conducted all scheduled phases of the Ranch Hand study and has periodically reported the results in official reports; (2) however, there have been some delays in the publication of morbidity and mortality findings in scientific journals and in the update of a key report on reproductive outcomes; (3) no journal articles on mortality or morbidity outcomes were published until 1990, even though the first mortality and morbidity reports were published in 1983 and 1984, and the Advisory Committee repeatedly recommended that such articles be published; (4) the Air Force reported preliminary reproductive outcomes in 1984 but did not publish a more detailed update until 1992 because it decided to verify the data extensively and perform additional data analysis without releasing any interim findings; (5) public access to study data is limited by the small amount of data available and because its storage format is difficult to use; (6) the public can access only data the Air Force analyzed in 1987; (7) the Air Force intends to make all other data available by the end of 2000; (8) the Ranch Hand study has a number of inherent limitations, but the Air Force has not clearly or effectively communicated these limitations to the public; (9) two limitations are the difficulty in detecting increases in risks of rare diseases and the fact that the study's findings cannot be generalized to all Vietnam veterans; (10) to ensure independent review and prevent any appearance of Air Force management bias, the study protocol mandated that: (a) an independent group of scientists be established to monitor the study's conduct; and (b) Air Force scientists, subject to review by the monitoring group, have primary responsibility over the scientific aspects of the study; (11) until 1989, the Advisory Committee did not include any veterans' representatives, as required by the study protocol; (12) according to documents GAO reviewed from 1984-1985, Air Force management and the White House at the time, tried to direct some of the Air Force scientists research; (13) although these early problems were resolved through executive and congressional actions with the extent of the Committee's outreach to veterans; and (14) partly on the basis of the study's results, Congress passed legislation providing compensation for veterans' children born with spina bifida.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: DOD has published a timetable for releasing data and begun to make data available to users through the internet and computer disks.

    Recommendation: To facilitate public access to study data and more effective communication of study limitations, the Secretary of Defense should direct the Air Force scientists in charge of the Ranch Hand study, in consultation with the Advisory Committee, to establish and publicize a timetable for the release of all study data and provisions to release the data in a format that is easily accessible to the general public.

    Agency Affected: Department of Defense

  2. Status: Closed - Implemented

    Comments: DOD has begun to include additional statements in its reports concerning study limitations.

    Recommendation: To facilitate public access to study data and more effective communication of study limitations, the Secretary of Defense should direct the Air Force scientists in charge of the Ranch Hand study, in consultation with the Advisory Committee, to include more information on the study's limitations in press releases and executive summaries, which should address the limited applicability of the study results (especially negative results) to other Vietnam veterans and the limited ability of the study to detect small to moderate increases in risks of rare diseases.

    Agency Affected: Department of Defense

  3. Status: Closed - Implemented

    Comments: The FDA has recently begun to notify veterans' organizations of scheduled Ranch Hand Advisory meetings.

    Recommendation: To facilitate dissemination of information on the Advisory Committee's activities to veterans, the Secretary of Health and Human Services should direct the Committee's Executive Secretary at the Food and Drug Administration to provide direct and timely notification to veterans' organizations of scheduled Advisory Committee meetings and of opportunities for veterans to nominate Committee members.

    Agency Affected: Department of Health and Human Services

 

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