NCPA - National Center for Policy Analysis

Lack Of Evidence In Fen-Phen Withdrawal

August 10, 1999

The Food and Drug Administration acted hastily and without sufficient scientific evidence when it called for a halt in fen- phen use and persuaded American Home Products to pull fenfluramine and another diet drug, Redux, from the market "voluntarily," critics charge.

In fact, the American Heart Association says it's too soon to tell whether fen-phen caused significant heart damage to anyone and whether effects wore off when use stopped.

  • Suspicions about fen-phen arose in 1997, when the New England Journal of Medicine published a Mayo Clinic report that 24 users had heart-valve damage -- although only a few of the cases had actually been verified.
  • The FDA took action after collecting 92 reports of disease among 291 patients tested.
  • Although the drug had been used for years by millions of people, no controlled comparison of heart-value damage among fen-phen users and nonusers was made.
  • One recent study reported no significant increase in heart-valve problems in those who used fen-phen for less than six months, and another study reported no increase in problems among those who took the drug for less than three months.

Nevertheless, the FDA's hasty action caught the attention of plaintiffs' lawyers. Last week, a Texas jury awarded $24 million to a former user of the diet drug -- even though the plaintiff's own cardiologist testified that her heart problems predated her use of fen-phen.

Source: Steven J. Milloy (Cato Institute), "Tort Lawyers Getting Fat Off Fen-Phen? Blame the FDA," Wall Street Journal, August 10, 1999.


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