Tuesday, April 22, 2008

Who's right? The FDA or the AMA?

The AMA, in a commentary in its Journal of the American Medical Association, http://jama.ama-assn.org/cgi/content/short/299/16/1949, announced that it is against the FDA's recent preliminary ruling that allows pharmaceutical companies to distribute peer-reviewed literature to doctors regarding off-label use of medications http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0053-gdl.pdf. It’s odd that the AMA does not trust practicing physicians to evaluate peer-reviewed literature from respected medical journals in the process of discerning whether a pharmaceutical is effective in managing a disease state. After 4 years of college, doctors go to medical school for 4 years and then do 3-7 years of additional training as interns, residents and fellows to become competent physicians with good judgment. Does the AMA think that an article distributed by a pharmaceutical rep will sway a physician to prescribe a drug incorrectly, or for a condition that it was not intended for? Doctors have sufficient common sense, knowledge and experience to realize that one article from a journal does not make gospel, and we all know that for every article making a point there is another article that disputes the point. We also know that pharma reps are obviously biased to some degree, and we realize that before we use a medication off-label we need additional ample evidence in the form of other articles, lectures and communications with colleagues. Physicians don’t need blinders. The more communications we are exposed to, the more likely we will make the right treatment decisions for our patients. The FDA is right on this one.
Robert Cykiert, M.D.