Officials of the Environmental Protection Agency, with the cooperation of a major chemical manufacturing company, devised experiments in 1975 for feeding known cancer-causing fungicides to convict volunteers at a Tennessee state prison to see how it would affect the human thyroid, Newsday has learned. When that proposal fell through, EPA officials gave preliminary approval for a similar experiment on student volunteers.
Neither experiment was funded, and the volunteers were never sought. The proposed experiment on convicts was rejected as too dangerous by a committee for the protection of human subjects at Vanderbilt University, which would have administered the test. The EPA officials, faced with tight restrictions on human testing in the United States, quietly abandoned the idea of experimenting with students.
Instead, as Newsday disclosed in an article last month, senior EPA officials attempted to avoid U.S. restrictions and, through a $100,000 contract with a Mexican gynecological hospital, to feed Mexican citizens massive doses of the cancer-causing fungicides. This program also was blocked.
Several of the officials who participated in one or both proposals either still occupy government positions or have received promotions that give them even greater control over federal decisions on how much protection the public should be guaranteed against exposure to carcinogens.
Internal EPA memos and confidential documents from a Philadelphia-based chemical firm, Rohm and Haas Co., show that the company and the agency worked together to draw up proposals for a test of the effects of the fungicides on humans. The proposals suggested that subjects for the experiments be drawn from students in nursing schools, medical schools and the paramedical profession.
The attempt to experiment with carcinogens on humans was pursued vigorously by EPA officials in spite of the fact that other government agencies such as the Department of Health, Education and Welfare had imposed rigid restrictions on the testing of dangerous substances on humans in medical experiments.
The fungicide group that EPA wanted to test is known chemically as EBDC, a chemical manufactured in large quantities (more than 250 million pounds annually) for use in killing fungi in vegetables. Rohm and Haas Co. is one of the leading manufacturers in a market that amounts to about $20 million a year in the United States and $192 million worldwide, company officials said.
The widely used fungicide poisons have been under government scrutiny for several years, because they break down both in the environment and in the bodies of test animals into a thyroid-cancer-causing residue.
The EPA administrator at the time, Russell E. Train, said Tuesday that he was not informed of either the proposed prison experiment or the idea of testing on student volunteers.
"My personal reaction is that I am shocked and appalled by it," said Train, who said the proposals should have been sent to EPA's science advisory board, which was established to report to the director on such matters. "My reaction is that the thing should have been shut off at the very start without even dignifying it by referral to an advisory board. But given the fact that at least some of the satff felt that these [proposed human experiments] were possible courses of actions, then it seems they really cried out loud to be examined by an outside group of scientists."
From interviews with officials involved and from internal documents, Newsday has pieced together the following chronology:
In November, 1973, the late Dr. Leonard Axelrod, former director of criteria and evaluation in EPA's pesticide program, contacted Dr. Eli Swisher, manager of agricultural chemical standards for Rohm and Haas. According to Swisher, Axelrod said that the EPA wanted human studies conducted - and would conduct them itself - to help the agency decide how to regulate EBDC residues on crops sold at the supermarkets.
During the following year EPA sought proposals for human testing of EBDCs and received a proposal, dated Sept. 20, 1974, from Dr. Wayland J. Hayes, professor of biochemistry at Vanderbilt University. Hayes wanted to test both anabuse (a drug used to combat alcoholism) on patients at a veterans hospital and an EBDC fungicide manufactured by Rohm and Haas on convict volunteers in Tennessee State Prison.
The Hayes proposal didn't suit EPA officials. They wanted Hayes to feed not only the fungicide but also the pure thyroid-cancer-causing residue ETU to the prisoners.
On Nov. 7, 1974, Dr. Lamar B. Dale Jr., chief of the metabolics branch in Axelrod's division, wrote a memo for Axelrod's signature. The memo, addressed to Edwin Johnson, EPA's deputy assistant administrator for pesticide programs, stressed the need for "two basic toxicological studies" on the fungicides and the pure cancer-causing residue.
In his view, the Vanderbilt proposal adequately covered the request for a fungicide study. He said it would "be a simple matter to add . . . short term studies in humans with ETU to establish a level which has no adverse effect on thyroid function."
Dale, a senior scientist in the EPA division charged with determining human health risks from pesticides, has acknowledged that he had recommended approval of the experiments on Tennessee prison inmates.
Johnson, the recipient of the memo, is in charged of a high-priority EPA program - the safety registration of thousands of pesticides. He is responsible for taking action to suspend or cancel the use of pesticides that pose an unacceptable carcinogenic risk to humans.
It was Johnson who eventually stopped the proposed human tests in Mexico after receiving a strong protest from former EPA attorney Jeffrey Howard. Johnson told Newsday last month that he killed the Mexican proposal because "general ethics on testing don't permit us to test on humans. I just said absolutely no. I'm not inclined to look favorably on testing anything on human beings."
But documents obtained by Newsday show that Johnson did reluctantly approve the proposal to test the fungicides on convicts. In a handwritten note to Axelrod in December, 1974, Johnson said, "I'm not fully convinced of the need for this study as currently formulated. You are apparently convinced it is needed. You may proceed if you feel you must do this."
Interviewed again last week, Johnson said, "He [Axelrod] insisted it was the scientifically informative thing to do and was needed information . . . I guess by that note you would say that I did go along with it grudgingly."
The Tennessee prison project failed for two reasons. Hayes, the biochemistry professor from Vanderbilt, could not be convinced to feed pure ETUs to the prisoners. In addition, the committee on human experimentation at Vanderbilt rejected the idea of feeding any EBDCs to the prisoners, according to Vanderbilt chemistry professor Robert Neal, Hayes' scientific consultant on the project.