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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.
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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.
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Representative terms from entire chapter:
committee reported
