November 6, 1996

No, Don’t Relax Ban

The New York Times, Nov 6, 1996 

To the Editor:

As the author of two books on the subject, I think the Nov. 5 front-page article ”Ban on Medical Experiments Without Consent Is Relaxed” overlooks or minimizes important issues about doctors obtaining the right to experiment on unconscious patients without their consent.

The discussion assumes that the Food and Drug Administration has the right to overturn protections against medical experimentation carefully established in precedents such as the Nuremberg Code and the Declaration of Helsinki. United States courts have tied these protections to the Bill of Rights. Others of us consider freedom from involuntary medical experimentation to be a self-evident, inalienable human right.

Doctors are currently limited to providing standard treatment to unconscious emergency patients. Under the new rules, in the absence of family, doctors will be able to set their own agendas. In medical research, there is tremendous pressure to obtain sufficient numbers of subjects to perform statistically valid analyses. Unconscious patients will be easy targets for filling quotas.

In clinical trials, some patients will have to be given no treatment. Would some have preferred a marginally effective treatment to a placebo? Would others have preferred a marginally effective treatment with known hazards to an experimental one with unknown hazards? Most patients in life-threatening situations would probably not opt to become guinea pigs.

The new F.D.A. rules pose a special threat to the homeless poor who are the most likely to be brought unconscious to emergency rooms without benefit of family members to protect them.

PETER R. BREGGIN, M.D. Bethesda, Md., Nov. 5, 1996

National Director, Center for the Study of Psychiatry and Psychology