Letters: May 13, 2002

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At Your Own Risk

Your report on clinical trials paints a vivid picture of the tragedies that individual research subjects have endured, but it does not adequately depict the millions of patients who have benefited from such trials [MEDICINE, April 22]. Tests of experimental medications provide access to treatments that would otherwise be unavailable or cost prohibitive. Oversight of clinical trials is essential, and an investigation of the review process may be necessary, but your article may have had the sad effect of making patients less inclined to participate. JEFFREY J. WALLINE Columbus, Ohio

Thank you for examining the often overlooked public-health crisis of research on human subjects. I have worked in the field for two years at a major research university. I have been astounded by the lack of concern of principal investigators and their study coordinators for the safety of the subjects in their clinical trials. They will use every device, subtle and overt, to downplay trial risks. I would definitely advise my family and friends not to enroll in a clinical trial. If you are taking part in a trial, you should be aware that your safety is often the last priority. And never forget that you are not a patient being treated; you are a subject in an experiment. NAME WITHHELD BY REQUEST Tampa, Fla.

There are horror stories in any field. You should have included specific drug trials that have resulted in saving lives, and there have been many. VALARIE MCGEE Atlanta

Dow Agrosciences' clinical trial of chlorpyrifos [an active ingredient in pesticides], to which you referred, was conducted in 1998 in a reputable clinical laboratory and in full compliance with all relevant U.S. and international laws, including prior review and approval by medical professionals. The volunteers (average age: 30) were fully informed; they freely agreed to take part in the tests and understood that they could end their participation at any time. Prior to conducting these trials, extensive animal research had shown that the doses to be used would not harm the participants. As expected, the trials did not result in any exposure-related effects. MICHAEL C. SHAW, PH.D. Dow AgroSciences Indianapolis, Ind.

Clinical researchers believe in their treatments, as they should. Yet this belief needs to be scrutinized by unbiased scientists working in the patients' interest. Our trials can never be too safe. But we should not lose sight of the fact that our system has given rise to spectacular advances in cancer therapy, including Gleevec for leukemia; the control of aids; treatments for breast cancer; and others. As a new era of molecular genetic research dawns, we need to make certain that the strides we make in devising new therapies are matched by progress in ensuring patient safety. FRANK G. HALUSKA, M.D., PH.D. Director, Melanoma Program Massachusetts General Hospital Boston