Thursday, September 22, 2005

More Vioxx "Agony"

Testimony in the latest Vioxx related court case revealed more dramatic and troubling aspects of Merck's leadership's decisions. According to Reuters (via CNN) , Former Merck research chief Edward Scolnick wrote an email about his concerns that Vioxx had important cardiac risks, "my worry quotient is high. I am actually in minor agony." Yet he fought efforts by the US Food and Drug Administration (FDA) to put a warning about cardiac risks on Vioxx's official label, calling FDA personnel "grade D high school students," and advising "I have never seen being nice to the FDA, except on rare occaisions, pay off." Furthermore, according to the Newark Star-Ledger, he wrote an email to Merck CEO Raymond Gilmartin that it was "impossible to prove" the contention that the apparent increase in cardiac adverse events seen in the VIGOR trial was due to the supposed cardioprotective effect of the comparison drug, naprosyn. This is just more evidence that top Merck leaders suspected that Vioxx had officially undisclosed cardiac risks, yet resisted warning patients and physicians about them.
Finally, the Star-Ledger also reported that David Anstice, a Merck marketing executive in the late 1990s, that Merck marketing executives set up the ADVANTAGE study as a "seeding" study, that is, one meant to primarily to "promote the drug," rather than to be a serious scientific study. Anstice also seemed to admit that Merck marketers had attempted to "neutralize" or "discredit" physicians who were "problems," apparently because they were not supporters of Vioxx. He objected that "neutralize" somehow meant "persuade doctors to prescribe more Vioxx," but admitted "neutralize is not the best term to use." This is more evidence that Merck put marketing ahead of science and patient welfare.
We have posted frequently about the sorry tale of Vioxx (see this post, and its links.) Stories like this raise concerns that pharmaceutical companies, and many other health care organizations, have put their own financial interests ahead of patients' welfare. These concerns are amplified by the financial ties these companies have developed to government agencies (like the FDA and the NIH), and with physicians' organizations (like the AAFP, whose exhibition hall has been characterized as a "truly massive marketing event.")
How are we going to re-organize health care to put the focus back on the patients, not the dollars? Until we do, is it any mystery why costs continue to go up, access continues to go down, and the physicians and nurses in the trenches continue to get more dissatisfied?

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