Thursday, April 14, 2005

The complaint department is open at the FDA.

According to a USA Today article published earlier this month, reports on drug side effects and drug-related health problems hit an all-time high last year - more than 422,000 - up almost 14 percent over the total complaints reported in 2003. Why the jump in adverse event reports? That depends on who you talk too. An FDA official named Paul Seligman told USA Today that more drugs on the market and a surge in drug use probably account for the rise. (Drug sales in 2004 exceeded sales in 2003 by a little over eight percent.) Sidney Wolfe, M.D., director of the Health Research Group for the advocacy organization Public Citizen agreed with Mr. Seligman's assessment, but added that greater awareness of the problems associated with prescription drugs may play an important role as well. Dr. Wolfe told USA Today that the public has become much more knowledgeable about "drug-induced disease." What a concept! Drug-induced disease. This could be the dawn of an exciting new field of medicine: Doctors who only treat diseases caused by prescription drugs. Mr. Seligman noted that there was no "unusual acceleration" of reports in the last quarter of 2004. So even though the controversy over prescription painkillers like Vioxx and Celebrex hit the fan late in the year, this apparently didn't "spur a rush of new concerns." No rush of new concerns? I don't agree. From what I heard, people who used those painkillers were extremely concerned, not to mention bewildered and probably a little angry. Mr. Seligman seems to be confusing "concerns" with actual "reports of side effects." If the FDA invited consumers to voice their concerns they'd need to staff a 24-hour hotline.


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