Cover Story

      In 1996, the National Institutes of Health linked both Redux and fen-phen, a combination of two drugs widely taken by dieters — fenfluramine (also made by Wyeth-Ayerst) and phentermine — to short-term memory loss. Fenfluramine and phentermine were separately approved by the FDA, never as a combined treatment, as they came to be used.

      Medical reports also connected fen-phen to lung problems and, by summer 1997, at least 24 deaths had been reported involving Redux or fen-phen — but no action came from the FDA.

      In early September 1997, after the death of the wife of the mayor of North Miami Beach was ascribed in part to fen-phen, the Florida Board of Medicine declared the combination constituted a public health threat and banned fen-phen for 90 days by emergency order. It was announced that board members would be studying the drugs’ effects and drafting rules regarding their use — something the FDA should have stepped in to do long ago.

      Shortly thereafter, on September 15, Wyeth-Ayerst withdrew fenfluramine and Redux from the market following reports that 92 out of 291 people taking the drugs — 31.6 percent — had developed abnormalities in the valves of their hearts which allowed blood in and out. It was yet another shocking announcement for the millions of Americans that had taken these drugs, believing them to be “safe.” An estimated 20.6 million prescriptions were written for Redux or fen-phen in 1996 alone.

No Sleep Lost

      Likewise, when Stadol was approved by the FDA in 1992 as a headache remedy, it was not known that the substance would turn out to be addictive and, in some cases, deadly. Recent research by Dr. Morris Fisher, a Chicago neurologist, explored the drug’s dangers, which reportedly include 34 possible deaths and 959 other adverse reactions. Fisher became interested in the drug after his 24-year-old son killed himself in 1995 while trying to withdraw from it.

      The FDA gave a green light to a record 53 new drugs in 1996. “Those are 53 potentially lethal substances which may result in tens of thousands of deaths,” said William Moore, Atlanta attorney and FDA expert. “Trouble is, it will be years until the tally comes in — and by then, for those people affected and their loved ones, it will be too late. But it is hard to imagine anyone in the FDA losing sleep over this.”


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