Dr. Arthur Hull Hayes, now commissioner of the Food and Drug Administration, was one of a number of doctors who conducted drug tests for the Army on volunteers at Edgewood Arsenal, Md., during the mid-1960s, according to a copyrighted story in the Long Island newspaper Newsday.
Hayes, then a young Army Medical Corps doctor, conducted an experiment starting in 1966 to determine the effect of a mind-disorienting drug called CAR 301,060 on the reactions of soldiers who volunteered for the experiment.
On a research plan signed by Hayes and his Edgewood superiors, Hayes was designated as "principal investigator" and "responsible physician."
Newsday said Hayes had also worked on an experiment involving three other drugs: atropine, scopolamine and ditran.
Hayes, through an aide, confirmed to The Washington Post that he had worked on the CAR 301,060 experiment and an atropine experiment at Edgewood.
But he said he did not work on scopolamine and ditran and added that drug experiments were only a small part of his work, which also included "lectures still used on videotape on protecting yourself from mustard and nerve gas."
Hayes said his experimental work with drugs included "a few dozen well-informed volunteers testing the safety of atropine, a very old drug carried by soldiers as an antidote to nerve gas, and controlled tests on minimal levels of a product that promised to be better than tear gas for crowd control. It didn't pan out, to my knowledge. My volunteers signed written consent forms and none as far as I know, and we followed them, had any problem from the tests."
Hayes' experiments were part of a broad project at Edgewood, carried on from 1958 until 1975 and involving hundreds of drugs and about 7,000 soldier volunteers, to determine how mind-altering drugs would affect soldiers and others under various conditions. The project was ended in 1975 after a congressional investigation raised major questions on whether volunteers had been sufficiently informed about the health dangers they faced by participating. The long-time chief of the project was Dr. Van M. Sim, who headed medical research for the Army.
Hayes denied any improprieties in his experiments, and Newsday said a 1976 Army inspector general report "exonerated the Edgewood researchers of any medical improprieties."
The National Academy of Sciences now is conducting Army-sponsored studies to determine the long-range impact of the experiments on the lives and health of the soldiers who were used as subjects.
A spokesman said NAS had completed studies of two classes of drugs used at Edgewood and had concluded that age-adjusted death rates of soldiers who had received the drugs were not significantly higher than rates for the general population. Similar studies are being conducted on three other classes of drugs and on the health of test volunteers still alive.
Newsday said the recently declassified 1976 report by the Army inspector general had raised the possibility that Edgewood researchers, including Hayes, might have conducted experiments with a class of drugs called glycolates (which included CAR 301,060) for several years after 1966 without the required approval of the secretary of the Army.
Newsday said that Hayes in 1966 had signed a research plan to study the use of CAR 301,060 as a riot control agent; this plan was approved by his superiors at Edgewood. It said that, in 1972, after Hayes had left, a new plan for glycolate experiments was submitted by Edgewood medical personnel, and that the text of the 1972 plan asserted that similar experiments had been approved twice before.
The Army IG report, according to Newsday, also raised general questions not specifically focusing on Hayes, on whether the Edgewood project had adequately carried out the requirement to notify subjects of all possible health dangers.
Newsday quoted Hayes as saying in an interview that while he told subjects in some detail what reactions to expect, "I did not tell them every specific," because "then very often they will tell you that's in fact what happened, or they will look for it themselves."
Hayes, in his statement to The Post, said that in informing volunteers, he felt he followed standards more stringent than required at the time.