STATEMENT OF ROBERT J. EPLEY
DIRECTOR, COMPENSATION AND PENSION SERVICE
VETERANS BENEFITS ADMINISTRATION
DEPARTMENT OF VETERANS AFFAIRS
BEFORE THE HOUSE COMMITTEE ON GOVERNMENT REFORM
SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS,
AND INTERNATIONAL RELATIONS

March 16, 2000

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. You have asked that our testimony include information on the impact of the study on determinations of diseases for which Vietnam veterans are eligible to receive compensation benefits. The Department of Veterans Affairs (VA) agrees with the recent assessment by the General Accounting Office, that its impact on these determinations has been limited. My testimony will summarize VA’s past use of Ranch Hand and other herbicide study data, and our intentions for using such data in the future.

Delays in Publication of Ranch Hand Findings

In 1984, Congress passed the Veterans’ Dioxin and Radiation Exposure Compensation Standards Act, Pub. L. No. 98-542. Pursuant to that Act, VA adopted regulations on how VA would evaluate scientific studies to determine which diseases are related to veterans’ Agent Orange exposure. VA conducted this ongoing evaluation process throughout the 1980’s.

As noted by the General Accounting Office (GAO) in its December 1999 report entitled "Agent Orange: Action Needed to Improve Communications of Air Force Ranch Hand Study Data and Results" (GAO/NSIAD-00-31), no Ranch Hand study results were published until 1989, more than seven years after the study began. While this obviously delayed VA’s opportunity to consider this data in reaching our Agent Orange compensation decisions, VA did obtain and analyze a significant amount of other research on the health effects of herbicide exposure during this time.

The Agent Orange Act of 1991

Section 3 of the Agent Orange Act of 1991, Pub. L. No. 102-4, directed the Secretary to seek to enter into an agreement with the National Academy of Sciences (NAS) to review and summarize the scientific evidence concerning the association between exposure to herbicides used in support of military operations in the Republic of Vietnam during the Vietnam era and each disease suspected to be associated with such exposure. Congress mandated that NAS determine, to the extent possible: (1) Whether there is a statistical association between the suspect diseases and herbicide exposure, taking into account the strength of the scientific evidence and the appropriateness of the methods used to detect the association; (2) the increased risk of disease among individuals exposed to herbicides during service in the Republic of Vietnam during the Vietnam era; and (3) whether there is a plausible biological mechanism or other evidence of a causal relationship between herbicide exposure and the suspect disease.

Section 3 of Pub. L. No. 102-4 requires that NAS submit reports on its activities every two years (as measured from the date of the first report) for a ten-year period.

Section 2 of Pub. L. No. 102-4 provides that whenever the Secretary determines, based on sound medical and scientific evidence, that a "positive" association, (i.e., as defined in the Act, the credible evidence for the association is equal to or outweighs the credible evidence against the association), exists between exposure of humans to an herbicide agent used during the Vietnam War and a certain disease, the Secretary will publish regulations establishing presumptive service connection for that disease. Although Pub. L. No. 102-4 does not define "credible," it does instruct the Secretary to "take into consideration whether the results [of any study] are statistically significant, are capable of replication, and withstand peer review.'' Section 2 of Pub. L.

No. 102-4 also requires that the Secretary's determinations be based on consideration of the NAS reports and all other sound medical and scientific information and analyses available to the Secretary. If the Secretary determines that a presumption of service connection is not warranted, he must publish a notice of that determination, including an explanation of the scientific basis for that determination.

VA’s Reliance on National Academy of Sciences Reports

NAS issued its initial report, entitled "Veterans and Agent Orange: Health Effects of Herbicides Used in Vietnam," (VAO) on July 27, 1993. The Secretary subsequently determined that a "positive" association exists between exposure to herbicides used in the Republic of Vietnam and the subsequent development of Hodgkin's disease, porphyria cutanea tarda, multiple myeloma, and certain respiratory cancers (of the lung, bronchus, larynx, or trachea). The Secretary also determined that there was no "positive" association between herbicide exposure and any other condition, other than chloracne, non-Hodgkin's lymphoma, and soft-tissue sarcomas, for which presumptions already existed. VA promulgated regulations implementing its determination.

NAS issued its second report, entitled "Veterans and Agent Orange: Update 1996'' (Update 1996), on March 14, 1996. The Secretary subsequently determined that a "positive" association exists between exposure to herbicides used in the Republic of Vietnam and the subsequent development of prostate cancer and acute and subacute peripheral neuropathy in exposed persons. The Secretary further determined that there was no "positive" association between herbicide exposure and any other condition, other than those for which presumptions already existed. VA promulgated regulations implementing its determination.

Also based on Update 1996, the Secretary determined that a "positive" association exists between exposure to herbicides used in the Republic of Vietnam and the subsequent development of the birth defect spina bifida in the offspring of exposed persons. Based on this finding, the Secretary and the President sought legislation providing VA benefits for these children. In October 1996, Congress passed Pub. L. No. 104-204, which provides health care, a monthly monetary allowance, and vocational rehabilitation benefits to these children.

Veterans and Agent Orange: Update 1998

NAS issued its third and most recent report, entitled "Veterans and Agent Orange:Update 1998'' (Update 1998), on February 11, 1999. The focus of this updated review was on new scientific studies published since the release of Update 1996 and updates of scientific studies previously reviewed. In Update 1998, NAS assigned hepatobiliary cancers, nasal/nasopharyngeal cancer, bone cancer, breast cancer, female reproductive cancers, urinary bladder cancer, renal cancer, testicular cancer, leukemia, abnormal sperm parameters and infertility, motor/coordination dysfunction, chronic peripheral nervous system disorders, metabolic and digestive disorders (including diabetes mellitus), immune system disorders, circulatory disorders, respiratory disorders (other than certain respiratory cancers), and skin cancer to a category labeled inadequate/insufficient evidence to determine whether an association exists. This is defined as meaning that the available studies are of insufficient quality, consistency, or statistical power to permit a conclusion regarding the presence or absence of an association with herbicide exposure.

Also in Update 1998, NAS assigned gastrointestinal tumors and brain tumors to a category labeled limited/suggestive evidence of no association. This is defined as meaning several adequate studies do not show a "positive" association with herbicide exposure.

As he did after the release of the prior NAS reports, the Secretary again formed a VA task force to review the report and pertinent studies and to make recommendations to assist him in determining whether a "positive" association exists between herbicide exposure and any condition. The task force completed that review and submitted its recommendations to the Secretary.

In the Secretary’s judgment, the comprehensive review and evaluation of the available literature which NAS conducted in conjunction with its report has permitted VA to identify all conditions for which the current body of knowledge supports a finding of an association with herbicide exposure. Accordingly, the Secretary determined that there is no "positive" association between exposure to herbicides and any other condition for which he has not previously determined that a presumption of service connection is warranted. (However, as noted below, the Secretary requested that NAS conduct an additional review of diabetes mellitus.)

On November 2, 1999, as required by law, VA published a notice in the Federal Register that the Secretary of Veterans Affairs, under the authority granted by the Agent Orange Act of 1991, had determined that a presumption of service connection based on exposure to herbicides used in the Republic of Vietnam during the Vietnam era was not warranted for the following conditions: Hepatobiliary cancers, nasal/nasopharyngeal cancer, bone cancer, breast cancer, female reproductive cancers, urinary bladder cancer, renal cancer, testicular cancer, leukemia, abnormal sperm parameters and infertility, motor/coordination dysfunction, chronic peripheral nervous system disorders, metabolic and digestive disorders (other than diabetes mellitus), immune system disorders, circulatory disorders, respiratory disorders (other than certain respiratory cancers), skin cancer, cognitive and neuropsychiatric effects, gastrointestinal tumors, brain tumors, and any other condition for which the Secretary had not specifically determined a presumption of service connection is warranted.

This notice also conveyed the Secretary's determination that a new study concerning the possible association between exposure to herbicides and diabetes mellitus that was published since NAS completed Update 1998, is potentially significant. The Secretary has requested NAS to review that new study and, after reviewing NAS’ response, will determine whether a "positive" association exists between herbicide exposure and diabetes mellitus.

NAS’s Analysis of the Ranch Hand Study

As noted by the General Accounting Office (GAO) in its December 1999 report entitled "Agent Orange: Action Needed to Improve Communications of Air Force Ranch Hand Study Data and Results" (GAO/NSIAD-00-31), the three NAS reports on Vietnam veterans and Agent Orange, including their conclusions on specific diseases, were based on numerous studies besides Ranch Hand. This fact alone has limited the impact of Ranch Hand on the NAS’ conclusions.

Moreover, to the extent NAS has relied on the Ranch Hand study, NAS has carefully analyzed both the strengths and weaknesses in the study and publication of study results. The NAS has included this critical analysis in all three of its reports. For example, NAS included such analysis in Veterans and Agent Orange: Health Effects of Herbicides Used in Vietnam (1993), at pages 231-232, 279-280, 722-724 and 757-763 (this last section was an appendix entitled, "Methodological Observations on the Ranch Hand Study"). NAS also included such analysis of the Ranch Hand study in Veterans and Agent Orange: Update 1996 at pages 293-296. NAS also included such analysis in Veterans and Agent Orange: Update 1998 at pages 447-449, 453, 457-458, and 498-500.

VA’s Recognition of Ranch Hand’s Strengths and Weaknesses

As stated in the GAO report, "reports and articles by the Ranch Hand study comprise only a small fraction of the information the National Academy of Sciences reviews and the Department of Veterans Affairs then considers when weighing scientific evidence." The Department agrees with this GAO assessment.

In the same report, GAO 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 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 these determinations very limited.

VA recognizes that simply comparing the number of studies which found an association between herbicides and a certain disease, to the number of studies which did not find an association, is not a valid method for concluding whether there is a "positive" association between herbicides and that disease. Differences in statistical significance, confidence levels, control for confounding factors, bias, and other pertinent characteristics, make some studies less credible than others. For example, some studies did not explicitly address the issue of smoking, a potential confounding factor which may have skewed their results. Therefore, the Secretary has given the more credible studies more weight in evaluating the overall weight of the evidence concerning specific diseases.

VA’s Future Use of Ranch Hand and Other Herbicide Study Data

NAS has informed VA that it expects its report on Agent Orange and diabetes to be issued this spring. After reviewing the report, the Secretary will determine whether to add diabetes to the list of diseases for which VA allows a presumption of service-connection. Similarly, when NAS issues its next comprehensive biennial report, which is expected in 2001, the Secretary will review it to determine which, if any, health effects should be considered for presumption of service-connection. As required by law, the Secretary will continue to consider not only the NAS report, but also all other sound medical and scientific information and analyses available. Also as required by law, the Secretary will continue to take into consideration whether the results of any study are statistically significant, are capable of replication, and withstand peer review.

Conclusion

In summary, we believe that NAS has done a very credible job of pointing out the strengths and weaknesses of the Ranch Hand study, as well as the other research NAS has reviewed. The Department has paid close attention to these strengths and weaknesses in making its determinations on which diseases warrant presumptive service connection. We believe that this process has proven to be effective in forming a solid basis for compensation for Vietnam veterans.

While we still have work left to do, we feel that over the past decade, the Department has made significant progress in the compensation of Vietnam veterans for diseases related to Agent Orange exposure. Mr. Chairman, as I have said before, we owe veterans and their families the best service we can provide in the most sensitive, caring way possible to ensure that they receive benefits in a manner befitting their service to our Nation.

This concludes my prepared statement. My colleagues and I will be pleased to answer any questions Subcommittee members might have.