The government's guinea pigs

January 11, 1994|By David J. Rothman

THE outrage provoked by the recent disclosures of government radiation research on prisoners, patients and retarded people in the 1940s and '50s should not be deflected by the fact that such abuses were commonplace.

As we have long known, during World War II the government supported research that infected psychotic patients with malaria in order to find a cure and tested experimental vaccines against dysentery on mentally retarded inmates.

After the war, investigators financed by the Army fed hepatitis viruses to retarded infants at New York's Willowbrook State School, just as their counterparts, financed by the Atomic Energy Commission, fed radioactive substances to retarded residents at the Massachusetts Fernald School to study the physiology of digestion.

All the while, the Department of Defense underwrote research that applied whole-body radiation to uninformed terminal cancer patients at the University of Cincinnati General Hospital, and the Central Intelligence Agency supported experiments on unsuspecting patients by a Canadian psychiatrist to learn more about brainwashing.

The critical question now is whether such exploitation could still occur.

Surprisingly, given the dismal record, the answer is an almost unqualified no. In fact, the United States leads all other countries in diligently regulating human experimentation.

How did this come to be? In the late 1960s and early '70s, a few courageous physicians (like Harvard's Henry Beecher) and liberal senators (most notably Walter Mondale and Ted Kennedy) exposed and publicized the most notorious incidents, including the Tuskegee experiments, in which the U.S. Public Health Service deliberately withheld treatment for syphilis from more than 400 black men.

Then the National Institutes of Health, the major sponsor of medical research, intervened. Part of its motivation was self-interest: if remedies were not forthcoming, Congress might cut research appropriations.

Part of it was also an appreciation that a fundamental conflict of interest divided the investigator, seeking new knowledge, from the subject of the experiment, who is typically seeking a cure.

To protect subjects, the Institutional Review Boards were created. Although not well known outside universities and medical centers, since the late 1960s they have provided a sturdy defense against mistreatment.

Every institution receiving federal grants must establish such a body to assess all proposed human experiments, certifying that the risks to the subject do not outweigh the benefits (the radiation research, for example, could not have passed this test), and that investigators have received the subject's informed consent (which, with strict exceptions, precludes research on the mentally disabled).

Critics worried that because Institutional Review Board members are appointed by the institutions and because scientists, always in the majority, can intimidate lay members, the process would become a rubber stamp.

But this has not occurred. For science is not conducted in a vacuum and scientists are responsive to society's values. The earlier research, after all, was not conducted covertly.

Scientists, believing they were acting in the public interest, published their methods and findings in leading journals.

Thus, a social ethic that insists that scientists do not have the right to select the martyrs for mankind will be respected.

Even those who might be tempted will not embarrass themselves before colleagues or jeopardize their funding.

These achievements notwithstanding, the latest disclosures make it vital that independent parties have complete access to past government records, including the names of the researchers involved, so that the full story is known. Such exposes remind us that a utilitarian calculus cannot allow the benefits of research to outweigh the well-being of people at society's margin.

Second, to better ensure that government agencies, or drug companies for that matter, do not corrupt local boards, decisions made by those boards must be much more carefully scrutinized than they are now by a national body.

With rare exceptions, local boards currently have the final say, and there is no formal procedure to reassess the ethically tough cases, as when, for example, a board appears to underestimate the risk of a medical procedure so as to maximize research opportunities.

Third, research conducted by military or intelligence agencies, whether in this country or abroad, must receive special scrutiny, not just from their own boards, but from an independent body.

Although there have been no reports of flagrant research abuses since the mid-1970s, without such oversight we cannot be finally certain of the integrity of government research.

In the end, protecting human subjects requires not only vigorous oversight but an unwavering commitment by the public and the research community that people, whether retarded, terminally ill or incarcerated, must always be treated as ends and never as means.

David J. Rothman, professor of social medicine at Columbia University, is author of "Strangers at the Bedside," a history of medical ethics.

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