Was Merck's Vioxx properly reviewed - NE Journal of Medicine

Comments from an editorial on December 11, 2005 om the New York Times

Has Merck & Co.'s Vioxx been properly described in New England Journal of Medicine articles or has yet another medical industry-backed study suppressed the whole truth?

When a prominent medical journal accused Merck-sponsored researchers of excising data from a scientific paper to play down the heart risks of the painkiller Vioxx, it further tarnished the reputation of a company once revered for its corporate ethics. The accusation may well have an impact on the myriad lawsuits filed against Merck because it undermines Merck's contention that it disclosed all it knew about the risks of Vioxx. More broadly, the incident underscores the danger that industry-backed studies may not tell the whole truth about products vital to a company's bottom line.

The paper in question was published in The New England Journal of Medicine five years ago. It found a small increase in heart attacks among patients taking Vioxx as compared to those taking another painkiller, naproxen, but explained the difference away by suggesting that naproxen actually protected people from heart attacks, rather than Vioxx causing them.

What aroused the ire of the journal's editors was an internal company memo revealing that the researchers knowingly suppressed data on three additional heart attacks among Vioxx users that was available months before the paper was published. Had that data been included, Vioxx would have looked five times as risky as naproxen, not four times, and would have looked potentially dangerous even in patients deemed at low risk of heart attacks. The journal also complained that data on other adverse cardiovascular events, like strokes and serious vascular problems, had been deleted from the paper two days before it was submitted.

Merck insists that all this data was submitted to the Food and Drug Administration, so the scientific paper may have had little impact on regulatory matters. But publication in a prestigious journal surely affected the attitudes of doctors and presumably helped Merck in its marketing efforts. Journals have only limited resources to look behind the data submitted to them, so doctors are on notice that they will need to take the findings of industry-backed studies with skeptical caution.

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