Is It Ethical to Give Patients Placebos in Clinical Trials?
McCann, Brian, Drug Topics
The use of placebo controls is unethical in many studies where they are used." Kenneth Rothman, M.D., a professor of public health at Boston University, was speaking at the annual meeting of the American Society of Clinical Pharmacology & Therapeutics, held recently in San Diego. He claimed that a great number of the studies that use placebos violate the existing ethical codes found in the Declaration of Helsinki, which was laid down in 1964 by the World Medical Association, a federation of national medical associations based in France.
One principle is clear from the Declaration of Helsinki, he said. When there is a conflict between the goals of science and the individual patient, the patient's best interest takes precedence. This means that in the case of clinical trials, the patient must get the best available treatment, including diagnosis and therapy. "If a placebo is not the best therapy for the patient, then this statement is not lived up to."
Many trials found easily in the literature confirm that a placebo is used when a therapeutic agent is already available. Antidepressant trials are a good example, Rothman noted. Many effective agents are on the market, but placebos are still given to gravely depressed patients. And with antihypertensives also, people are given placebos rather than any of the many effective treatments already available.
Susan Ellenberg, director of the Food & Drug Administration's division of biostatistics and epidemiology and also a speaker at the meeting, agreed with Rothman that the patient's welfare takes precedence, but she concurred with little else. She argued that the use of placebo controls is not as clear-cut as Rothman would have it seem. "There are many gray areas."
For example, she said she doubts it is unethical for a placebo to be used in trials of stool-softeners, hair-growth medications, or analgesics for mild conditions.
The use of placebos, instead of being banned outright, she contended, must be decided on a case-by-case basis. …