Wednesday, August 20, 2008
Drug Trials - Buyer (and Physician) Beware
Pharmaceutical companies often perform drug trials to prove the effectiveness of their drug by paying physicians to participate in a clinical trial and use the drug on their patients, using the trial protocols. The Annals of Internal Medicine wisely asks the question this month:
"Why would pharmaceutical companies go to the expense and bother of conducting numerous trials with private physicians and a few of their patients, rather than conduct large trials at medical centers to accomplish the same scientific results with greater efficiency?"
Dr. Harold Sox (editor and brilliant thinker) answers it: "The true purpose is to get physicians in the habit of prescribing a new drug." A secondary purpose is to get physicians to be "opinion leaders" and advocate with their colleagues about the new drug. They get paid to do so and become de facto marketers for the drug, without really being aware of it.
These drug studies are called "seeding trials" and they are exceedingly common. But those days are coming to an end as greater awareness of how drug company sponsored trials, and the physicians who consult on them are made public.
As Sox says:
"Physicians have a fiduciary obligation to ask questions on behalf of their patients, as do institutional review boards and researchers, which have the skill set and personnel to judge whether a trial is asking an already-answered question. They could look for other clues, such as a study with an open-label design, no control group, a very large projected enrollment relative to the importance of the question, a short-term study of a chronic disease, a study of an already approved drug, and so forth. None of these clues is highly specific, but institutional review boards should start asking questions when a study has several of them. "
Private practice physicians have no "institutional review board" and will need to rely on their own ethical and professional barometer. As Dr. Sox says "Just Say No to Seeding Trials". This practice is marketing in the guise of science.
Posted by Toni Brayer, MD at 7:07 AM