Merck made Vioxx look safer by manipulating data
Additional evidence that Merck fudged Vioxx research and hid risks of the drug has emerged. In a harshly critical editorial in the New England Journal of Medicine, one of the most prestigious medical journals in the world, Gregory Curfman, Stephen Morrissey, and Jeffrey M. Drazen, say that Merck did not deliberately include data that could have changed the conclusions of the so-called VIGOR trial.
Vioxx has been criticized by the medical community for years but the bad news never got reported due to aggressive public relations campaign by Merck. However, since the drug was recalled last year, reports of highly unethical practices have emerged. All the way from misleading the FDA to manipulating the data to intimidation of the critics. This new development is bound to seriously undermine company’s position on the safety of the drug and how it marketed it.
The editors charge that lack of inclusion of the data resulted in an understatement of the difference in risk of myocardial infarction from Vioxx and misleading conclusions about safety of Vioxx and naproxen or Aleve.
Merck did not voluntarily provide this new piece of information. On the other hand, the Journal became aware of this after getting access to a memo through subpoena in the ongoing Vioxx litigation. The editors conclude, “[t]hese inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events.”
Merck refuses to take responsibility for its action
Afraid that its chances of prevailing in Vioxx lawsuits will go down, the company is denying that it did anything wrong. In a statement released by the company, it says that “[t]he company promptly and appropriately disclosed the results of the VIGOR (VIOXX Gastrointestinal Outcomes Research) study.”
It is not clear how this development will affect the outcome in the ongoing federal trial in which the jury is already deliberating, but the stock market definitely did not like the news. Merck shares sank yesterday and are expected to slide even further today. Derek Lowe, an expert who tracks the pharmaceutical industry, believes that Merck’s failure to disclose “would seem to be fodder for a mistrial motion, though, if the verdict doesn’t go the plaintiff’s way.”
Related articles: Top cardiologist Dr. Eric Topol criticizes Merck’s position on safety of Vioxx
Merck admits that Vioxx is dangerous for short-term users too
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