September 3rd, 2008
Drug profit incompatible with scientific method?
A serious dispute has broken out at the New England Journal of Medicine, questioning whether the scientific method and profit motive are compatible.
While it’s couched in scientific jargon, the NEJM editorial suggests a link may exist between Zetia or Vytorin and cancer, that Schering-Plough and Merck spun studies disputing the link for their own profit.
Zetia, which is designed to clear cholesterol from the digestive system, is combined with generic simvastatin to produce Vytorin. Heavy consumer marketing has turned them into a $5.2 billion market.
A big part of the problem is that, so far, scientific studies on a link between the drugs and cancer have been inconclusive. We just don’t know if the link is real. The FDA approved these drugs before all the evidence was in.
But doctors have been prescribing the drugs since 2004 and they are a major profit driver for Schering-Plough and Merck.
Thus we have a conflict the regulatory system was designed to avoid. Drugs are being advertised and dispensed which may not work, and which may actually do harm. Or which may work and may not do harm.
We just don’t know. This is already proving catnip to lawyers, but if the system had worked this would not have happened.
A Supreme Court case to be argued this fall, Wyeth vs. Levine, could make the drug makers immune to those suits, based on the idea that the FDA approval preempts the courts.
The result of that could be a political explosion that will make the Sarah Palin arguments look like a minor kerfluffle.
Dana Blankenhorn has been a business journalist since 1978, and has covered technology since 1982. He launched the Interactive Age Daily, the first daily coverage of the Internet to launch with a magazine, in September 1994. See his full profile and disclosure of his industry affiliations.
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