Merck manipulated Vioxx data, research

There was a scathing indictment of Merck in yesterday’s Journal of the American Medical Association. Sadly, it’s not a great shock to hear that the pharmaceutical company held back important information about deaths related to Vioxx or that it practiced widespread scientific fraud. David Brown’s story, “Maker of Vioxx is accused of deception,” in the Washington Post has the details. It’s also not surprising to hear the JAMA editors say that this the norm and not the exception when it comes to the pharma industry.

Vioxx was a huge success when it hit the market in 1999 and hit $2.3 billion in sales in 2003. But it was pulled from the market a year later because of studies that showed it was linked to increased heart attacks and strokes. Public Citizen had been warning since 2001 that Vioxx and other drugs of its ilk, such as Celebrex, were not safe.

While Merck is trying to brush off the JAMA reports, some of it sounds pretty damning. From Brown’s article:

Two teams of researchers with access to thousands of documents gathered for lawsuits over the painkiller Vioxx allege that Merck waged a campaign of deception to promote its drug, moving slowly to warn of possible hazards while at the same time dressing up in-house studies as the work of independent academic researchers.

The reports in today’s Journal of the American Medical Association in effect accuse one of the world’s biggest pharmaceutical makers of various forms of scientific fraud.

One study alleges that Merck gave the Food and Drug Administration an incomplete accounting of deaths in a clinical trial of Vioxx in people with mild dementia. Federal regulators eventually received the data, which added to growing evidence that Vioxx increased the risk of heart attacks and strokes.

Simultaneously, Merck was using what the JAMA authors call “guest authorship and ghostwriting” to make it appear that research done by its employees or contractors was the work of scientists at medical schools and universities. That presumably gave the findings more credibility when they were published, in medical journals, boosting Vioxx’s profile in the crowded painkiller market.

Ed Silverman raises more questions on Pharmalot. And here’s a link to one of the JAMA articles.