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The Double Blind Placebo Controlled Trial
The blind allegiance to what I call the “fool's gold standard” lives on. Anyone with even a passing interest in bioethics knows it is unethical to conduct a double blind placebo controlled trial where standard therapy exists, except under limited circumstances. The exceptions are where: 1) there is no risk of harm if the patient forgoes treatment during the placebo phase such as in a trial for a drug that seeks to cure hair loss or impotence; 2) the standard therapy carries such severe side effects that patients might choose to avoid it; or 3) the standard therapy is otherwise of questionable efficacy. See, eg, Emanuel EJ, MD, PhD, Miller, FG, PhD: The Ethics of Placebo-Controlled Clinical Trials — A Middle Ground. N Engl J Med Vol. 345:915-919, (September 20, 2001), at http.//content.nejm.org/ cgi/content/short/ 345/12/915?query= TOC; Hellman S: Of Mice But Not Men: Problems of the Randomized Clinical Trial. N Engl J Med, Vol 324 (May 30, 1991); Levine RJ: The Use of Placebos in Randomized Clinical Trials. IRB — A Review of Human Subject Research, Vol. 7, No.2, (March/April 1985); Bok S: The Ethics of Giving Placebos. Scientific American, Vol. 231, No. 5 (November 1974).
Still, sponsors and researches continue to design and conduct such trials, providing the familiar excuse: “The FDA made us do it.” Indeed, in at least one case I have brought on behalf of an injured subject, I have seen the minutes of a meeting with an FDA official who advised the drug company that only a placebo controlled trial would be acceptable even though the drug company advised the official that standard therapy existed and there might be a risk of harm to the subject during the placebo phase. Even more startling is the response I have received in depositions of physician/principal investigators who believe such trials are the gold standard and are perfectly acceptable in the context of medical research as long as the subject signs the informed consent.
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