Rezulin as an Example
As an example of a drug that should never have made it to market in the first place, Kassirer offers Rezulin, the diabetes drug marketed by Warner-Lambert. In 1999 Rezulin was withdrawn from the market after extended hearings and negotiations with the FDA. Relying on the Pulitzer Prize-winning reports of David Willman of the Los Angeles Times, Kassirer treats this episode as an example of dangerous FDA dilly-dallying.
I have helped defend Pfizer in the various lawsuits that grew out of the Rezulin recall, and there is another side to the story. Rezulin offered a new mechanism for managing insulin, and it was, without question, highly effective for many of its 1.5 million users.
But it also was associated with a rise in liver damage. Despite warnings about these side effects, 63 people, all of them already ill, died from liver complications due in whole or in part to Rezulin.
Still, it's doubtful that Warner-Lambert (later Pfizer) should have been pressured to take Rezulin off the market. The benefits to the patients who took the drug count as much as the costs. You can't buy this drug back from these patients, Dr. Steven V. Edelman, a professor of medicine at the University of California, San Diego, told the FDA in March 1999.
The number of people helped by Rezulin dwarfs the number hurt. But after the drug was withdrawn, 9,000 lawsuits were filed, many of them as class actions, seeking recovery for millions of individual users and their insurers.
How did 63 deaths generate so many filings? The suits often demanded a refund of the full price of Rezulin that had been successfully used, without any side effects, on the grounds that the patient wouldnt have used the drug if he or she had fully appreciated its risks. Go figure.
At the time Rezulin was withdrawn, there were two drugs in the same family (Actos and Avandia) on the market. But they arguably did not help some patients as much as Rezulin had, even if they had fewer serious side effects.
Those who could tolerate Rezulin were better off with it on the market. Those who could not were well advised to shift to a different drug: me-too drugs benefit health and safety because of these differences in patients risk profiles.
Currently, it may be acceptable to pull Vioxx off the market because patients who suffer arthritis and chronic pain can switch to Celebrex or Bextra. Without me-too drugs, we put all our eggs in one basket, which is always a dangerous strategy.