Remember the FDA's hair-trigger on fen-phen?
In July 1997, news broke that the effective and widely used diet drug combination known as "fen-phen" caused heart valve problems. The news was based on 52 mostly unverified case reports -- not a scientific study.
By late summer, more unverified case reports appeared. The FDA claimed that as many as 30 percent of fen-phen users had heart valve problems. Shortly thereafter, the FDA forced the diet drug combination off the market.
Since then, several reports on fen-hen have appeared, shedding little definitive light on the controversy. Among the problems of studying fen-phen and heart valve problems include: uncertainty in diagnosing subtle heart valve defects; an absence of relevant medical information, including echocardiograms, on fen-phen users before they started using fen-phen; and uncertainty about the frequency and causes of heart valve abnormalities.
A new study in the Annals of Internal Medicine (December 1, 1998) examined a group of patients who had undergone echocardiography before taking fen-phen. The study was small (only 46 patients) but the results quite interesting:
- Two patients (4.3 percent, 95 percent confidence interval 0.6 percent to 14.8 percent) had developed valvular heart disease.
- But one of these patients had valvular heart disease before taking fen-phen.
- The only patient who clearly developed valvular heart disease after taking fen-phen had a baseline echocardiogram that was done more than 8 years before taking fen-phen. The study authors wrote "Thus, the temporal relation in this patient is less convincing."
Noting the study was not a randomized, controlled trial, the researchers stated "These outcomes may have been coincidental and not causally related to use of [fen-phen].
While this study does not vindicate fen-phen, it adds to the doubt over the wisdom of the FDA's ready-fire-aim approach in taking fen- phen off the market.
Fen-phen was a widely prescribed diet medication for the simple reason that it worked. The quick-draw FDA has made sure it will not work again.
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