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INTRODUCTION This is the third and final volume in a series that reports the findings of five panels of the National Research Council's Committee on Toxicology regarding possible long-term health effects of exposure of volunteers to a variety of experimental chemicals in 1955-1975. All exposures took place at the U.S. Army Laboratories (formerly Army Chemical Center), Edgewood, Maryland. The work of the panels began in 1980, when the Department of the Army asked the Committee on Toxicology in the Board on Toxicology and Environmental Health Hazards of the National Research Council's Assembly of Life Sciences (now the Commission on Life Sciences) to review the Edgewood experimental studies and advise on the long-term or delayed health effects that the volunteer test subjects might have sustained. There are two important reasons for conducting these studies, one moral, the other scientific. The first involves the U.S. government's responsibility to its soldier test subjects to learn whether its investigations have resulted in delayed or long-term adverse health effects. The second involves curiosity in the wake of experiences with new chemical entities that resulted in unanticipated problems, such as the sulfanilamide disaster of 1938, the thalidomide episode of 1963, and the genital tract effects of diethylstilbestrol (DES); all those contributed to a Food and Drug Administration requirement that new drugs be monitored, especially during the first months of market- ing. One excellent example of the benefits of careful postmarketing surveillance is the P WA (psoralen-ultraviolet light therapy for psoriasis) program conducted by dermatologists. This led to identi- fication of a qualitative and quantitative carcinogenic potential of P WA. In 1982, the Committee reported (Volume 1~9 on possible long- term health effects of two pharmacologic classes of chemicals tested at Edgewood: 15 anticholinesterase chemicals and 24 anticholinergic chemicals that had been administered to some 3,200 subjects. Two panels, each consisting of about 10 scientists in various disciplines, provided the main framework for the report. In 1984, the Committee reported (Volume 2~° on three other pharmacologic classes of chemicals: four cholinesterase Deactivators, administered to approxi- mately 775 subjects; 12 psychochemicals, administered to approximately 288 subjects; 98 irritants, administered to almost 2,000 subjects; and mustard gas, administered to 152 subjects. Three panels of scientists were involved in that work. Summaries of the two earlier reports are presented in Appendix A. —1—
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A questionnaire was sent to the test participants in 1984 to learn about their current health status. A coordinating committee reviewed the findings of the questionnaire and had two charges: · To prepare a final report for the series Possible Lon~-Term Health Effects of Short-Term Exposure to Chemical Agents on the basis of results of the questionnaire. · To evaluate the implications of findings from the questionnaire for any of the conclusions reported In Volumes 1 and 2. This volume focuses on the analysis of results of the question- naire. It also updates the analysis of deaths among the subjects after testing (reported in Volume 1) to include 1,454 tests unavail- able at the time of the earlier work (see Appendix B). The numbers of volunteers did not change, but the numbers of tests performed, and hence the numbers of chemicals and possibly chemical groups to which the men were exposed were increased, because additional information was available. The new material did not change the original findings concerning deaths; no excess of mortality appeared among subjects tested with the five classes of chemicals or with LSD, which was the subject of a separate report., 4 Some 6,720 volunteers participated in the Army tests. For 325 of these, a claim for burial allowance had been received by the Veterans' Administration by 1984, leaving 6,395 presumed to be still living. Of these, 1,399 were lost because current mailing addresses could not be obtained, owing to the absence or inaccuracy of personal information available from Army records. It is not known whether this could be a serious source of bias in the comparison of treatment groups. The 911 men who received the questionnaire and failed to respond were consid- ered to constitute another potential source of bias, inasmuch as their failure to respond could have resulted from an unhappy test experiences Because the Army was interested in learning more about soldiers who did not respond to the questionnaire, a subcontract was arranged with the Research Triangle Institute, Research Triangle Park, North Carolina, to find out why some men failed to respond. The findings are summarized in this report. Development of a single questionnaire suitable to the needs of five panels of about 50 scientists working with five pharmacologic classes of chemicals administered to different numbers of subjects proved to be a formidable task. The concerns and difficulties encountered are discussed in Appendix C. —2—
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