Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Does Vytorin increase the risk of cancer death? The question seems like it would be simple to answer, yet finding the answer requires navigating through a murky labyrinth of botched test results, apparent cover-ups, possible payoffs, and a whorl of conflicting interpretations that sometimes resemble self-interest, sometimes truth, depending on whom you ask.

The University of Washington’s Thomas Fleming is one respected statistician and adviser to the FDA who cautions against dismissing Vytorin’s link to cancer as merely an anomaly. Leading researchers involved with the SEAS study, which uncovered a Vytorin-cancer link, maintain that the results were a fluke.

In an editorial published in The New England Journal of Medicine, Fleming says that at this point in time, it’s too early to dismiss the Vytorin-cancer link. He suggests that the drug may have more adverse side effects than actual benefits. “ … There are numerous recent cases in which it has been established or strongly suggested that [side] effects of such [drugs] have adversely altered their risk–benefit profile.”

Scientists quick to dismiss Vytorin’s apparent link to cancer support their case by pointing to two larger ongoing studies that appear to diminish the drug’s risks. According to Fleming, however, “There are clinically important increases in the risk of cancer-related death that are not ruled out by this data.” He also argues that prematurely releasing results from the other tests jeopardizes their conclusions.

Vytorin sales soared to the tune of $5 billion in 2007, but dropped by a third after reports of negative tests began to surface. Considering such profits, altering and masking potentially harmful clinical trial data might seem like a good profit-preserving strategy, but it makes you wonder what it’s like to work in the Public Relations department at Merck and Schering-Plough.

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