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Vioxx studies proven to be marketing scams

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Unread 09.15.08, 09:50 AM
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Vioxx studies proven to be marketing scams

Just in case you might be thinking that I bash Big Pharma too hard and too often, there's a new twist in the awful Vioxx story. Back in 2004, Vioxx was withdrawn from the market because it was linked to increased incidence of heart attack and stroke. The FDA estimates that in the five years Vioxx was on the market, its use caused between 88,000 and 139,000 heart attacks – of which as many as 40 percent were probably fatal.

And now, four years after Vioxx was pulled from the market, the story just keeps getting worse.

According to Merck internal memos uncovered by lawyers working on the Vioxx lawsuits, one of the "studies" that helped establish Vioxx as a superior painkiller wasn't a real study at all, but was, in fact, a stealth Merck marketing strategy.

A memo from two top Merck executives even nominated the "study" for one of the company's internal marketing awards!

When Vioxx was about to launch in 1999, Merck started something called the ADVANTAGE study. "ADVANTAGE" ostensibly being an acronym for "Assessment of Differences between Vioxx and Naproxen to Ascertain Gastrointestinal tolerability and Effectiveness."

I can think of a shorter acronym they should have used: B.S.

Merck's actual motive for the study had nothing to do with a further clinical vetting of Vioxx. It was nothing more than a marketing tool designed to get doctors and patients familiar with the drug. The internal Merck memo summed up the study's goals this way: "The objectives were to provide product trial among a key physician group to accelerate uptake of Vioxx as the second entrant in a highly competitive new class."

You'll notice, there's not one word in this "objective" about finding out if the drug is actually safe for consumers.

My thoughts on this? FINALLY. For years, many have suspected Big Pharma companies of conducting "seeding" or marketing studies where the "clinical trial" was conducted by pharmaceutical company marketers rather than independent doctors. But there's been no smoking gun… until now.

Dr. Kevin Hill, a staff psychiatrist at McLean Hospital in Massachusetts who is working as a paid consultant for lawyers representing plaintiffs in the Vioxx suits, was indignant at the discovery, and wondered how it could impact future clinical trials. "ADVANTAGE was marketing framed as scientific research," he said. "I don't think people would be willing to [risk side effects] if they knew that the aim of a clinical trail was to boost profits for a pharmaceutical company."

What's even more depressing is the fact that the dummy ADVANTAGE trial worked like a charm for Merck. In the five years Vioxx was on the market, it reaped annual profits as high as $2.5 billion.

So now what? The editors of the Journal of the American Medical Association (JAMA) suggest that the institutional review boards that run clinical studies should simply ask whether a new trial is a seeding study, especially when a new experiment has all the hallmarks of a possible marketing stunt.

But what's the point in asking for the truth from companies who seem to be in the business of lying? Apparently, the JAMA editors lack my kind of cynicism.

Always a big skeptic of Big Pharma,

William Campbell Douglass II, M.D.
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