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You can’t lose weight if you’re dead
The costliest drug recall in history began on Sept. 15, 1997, when Wyeth predecessor American Home Products withdrew the two types of pills comprising fen-phen (fenfluramine and phentermine) from the market at the FDA’s request.
The popular anti-obesity combination’s component parts had been available since the 1970s. However, fen-phen as a single treatment had only exploded into the public consciousness in 1992, when pharmacology professor Dr. Michael Weintraub first published the results of a four-year weight-loss study conducted on 121 obese patients. The patients, most of whom were women, lost an average of 15% of their body weight, which had been 200 pounds on average at the start of the trials. Anyone struggling to lose weight can tell you that this much weight loss is indeed a big deal, and interest soon ran so high that some doctors set up fen-phen mills to dispense doses to thousands of patients.
In 1995, Wyeth petitioned the FDA to approve a more effective form of fenfluramine called dexenfluramine. Its trials had lasted only a year and turned up the distressing possibility that this improved drug increased the risk of a potentially fatal heart condition. A fierce debate raged in the FDA’s approval committee: Did the benefit of helping millions lose weight outweigh what was seen as a one-in-a-million risk? The committee agreed that it did, and the drug was approved in 1996. Problems began to crop up almost immediately, as The New York Times‘ Gina Kolata wrote the week after the recall:
[After approval] dexfenfluramine sales soared and it was taken by a total of two million Americans, said Audrey Ashby, a spokeswoman for Wyeth.
Then, in July of this year, doctors at the Mayo Clinic in Rochester, Minn., reported that 24 women taking fenfluramine or dexfenfluramine developed a rare and gravely serious heart valve abnormality. The F.D.A. asked doctors across the country to report any patients with similar valve damage and soon accumulated more than 100 cases.
This month, five medical centers independently told the F.D.A. that they had examined a total of 291 patients, mostly women, taking one of the two drugs and found that a third of them had damaged aortic or mitral valves, although none had symptoms like tiredness or shortness of breath.
Up to 6.5 million people were thought to have taken the drug combination before its recall. Pfizer Inc. (NYSE:PFE) — which acquired Wyeth in 2009 — may now be on the hook for damages in excess of $21 billion, which was the amount Wyeth had set aside to pay off as many as 50,000 plaintiffs in 2005. Pfizer Inc. (NYSE:PFE) was still fighting some of these costly suits in 2012.
The article When a Crisis Became a Catastrophe originally appeared on Fool.com is written by Alex Planes.
Fool contributor Alex Planes holds no financial position in any company mentioned here. Add him on Google+ or follow him on Twitter, @TMFBiggles, for more insight into markets, history, and technology.The Motley Fool recommends and owns shares of AIG, Bank of America, and Google and has options on AIG.
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