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.
Vioxx, whose generic name is rofecoxib, went on the market in 1999. It became a "blockbuster," with $2.3 billion in sales in 2003, but Merck voluntarily withdrew it in September 2004 after several studies showed that it increased the risk of heart attacks and strokes.
Since then, Merck has been named in 26,500 lawsuits by people who say the drug harmed them. Last fall, the company created a $4.85 billion fund to settle the claims while not admitting that Vioxx caused heart attacks, strokes or deaths.
Yeah, more proof that self-monitoring the industry really, really works!
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