Two Boston scientists have charged that medical researchers often use unethical methods when they conduct experiments and the federal government is encouraging the practice.
At issue is the use of placebos, the worthless pills that help researchers judge the true effectiveness of proposed treatments. Placebos are vital to medical experiments because patients who receive them, in the belief they are getting a viable treatment, often feel better anyway.In an article to be published in Thursday's New England Journal of Medicine, Kenneth Rothman of Boston University School of Public Health and Karin Michels of Harvard University School of Public Health said it is unethical to give a placebo to a volunteer when an effective treatment is already available.
In such cases, they said, researchers should compare the best established treatment with the treatment being tested. Too often that is not done, the authors charged. "Patients in trials are often denied `best proven' treatments," they said.
One example cited by Rothman and Michels was a 1992 study published in the Journal of Clinical Psychiatry, in which half of a group of severely depressed patients were given placebos despite the fact that the researchers had acknowledged that "effective antidepressant compounds have been available for over 30 years."
Other examples cited were three research projects, the results of which were published between 1990 and 1993, that compared placebos to the anti-vomiting drug ondansetron, even though several drugs were known to reduce the risk of nausea in people getting chemotherapy.
Rothman and Michels also referred to cases where placebos were improperly used in tests of arthritis treatments. "Participants who receive placebos in these studies are at risk for serious and irreversible degenerative changes that can, to some extent, be prevented," they said.
They further contended that the U.S. Food and Drug Administration (FDA), which approves new drugs, encourages the unethical use of placebos.
"Placebo groups are, in effect, required for disorders of moderate severity and pain, even when an alternative treatment is available," Rothman and Michels said. "In at least one instance, the FDA refused to approve a new drug, a beta-blocker for use in angina pectoris, even though the application showed that the new drug had an effect similar to that of propranolol, an already approved drug. The application was rejected because the drug has not been tested against placebo."