Thursday, March 27, 2008
FDA Drug Approval Near Deadline Linked to Safety Problems
Article in the Wall Street Journal -- Late Drug Approval Linked To Safety Issues, by Keith J. Winstein. Here's an excerpt:
Although every unsafe drug is different, most of them have something in common: last-minute approvals by the Food and Drug Administration, according to a new study.
Liver problems led Pfizer Inc. to withdraw its diabetes drug Rezulin from the U.S. market in 2000. Bayer AG pulled cholesterol-lowering Baycol in 2001 because it caused muscle damage in some patients. Vioxx, Merck & Co.'s controversial painkiller, was withdrawn in 2004 because it sometimes caused heart attacks and strokes.
These and other unsafe drugs all received approval shortly before the FDA deadline for deciding on new-drug applications.
Since 1993, the 97 drugs approved near the FDA's deadline had a 14% rate of severe safety problems down the road, compared with 3% for 216 other drugs. That's according to an analysis in Thursday's issue of the New England Journal of Medicine by Daniel Carpenter, a professor of government at Harvard University. The FDA says some of Dr. Carpenter's data are inaccurate, and disputed his conclusions.