Angell addresses ethics of clinical trials in Third World

For those who think physicians always place a higher priority on research, Dr. Marcia Angell, Executive Editor of the New England Journal of Medicine, has another opinion.

"People are not guinea pigs," argued Angell in her speech in Dodds Auditorium last night, explaining that humans cannot be used as the means to an end, even if the end is a worthwhile one.

"Research must hold human welfare above the interest of society and science," she said. "If you breach this principle, you're on a slippery slope where first humans are exploited for worthwhile purposes, then for not so worthwhile purposes."

Angell discussed the ethical issues surrounding the scientifically accepted method of clinical trials used to study the effects of new treatments. She focused on these problems in connection with testing in Third World countries.

Doctors involved in research, she said, "wear two hats: that of a doctor doing his best for his patients and that of a researcher answering a question."

She explained that a tension exists between these two roles. "It is not true that the best scientific study is the best ethical study."

Ethical principles

"The recognition of this tension has given rise to formulations of ethical principles that govern the conduct of researchers," she said, adding that these regulations incorporate two basic principles.

The first principle is that researchers should have "no prior reason to believe the new treatment is better than the present one," Angell said. According to Angell, if scientists continue with experiments after they have verified the superiority of the new treatment, they are deliberately exposing the control group to inferior treatment.

Second, Angell said, researchers should fully explain the trial to the volunteers, and the volunteers must have a chance to accept or decline without incurring "undue penalties."

Research in the Third World, she said, presents many problems. For instance, most researchers do not provide control groups with the best available method of treatment, knowingly letting half of the group contract a disease, according to Angell.

"The standards for research abroad must be equal to those at home," she said. "Researchers are responsible for the subjects they . . . have to care for."

Any deviation from this principle, she said, would be "exploitative and imperialistic."

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Though state officials give their consent to the tests, overseas testing is unacceptable, Angell said.

"Consent never makes an unethical study ethical, even if it was given by the participants," she said, adding that at times the citizens of these countries are not well enough informed to make these decisions.

"And it's a little patronizing to suggest that all Ugandans speak with one voice," she said.