Drug giant Merck & Co. is paying the families of more than 3,100 Vioxx painkiller users who died of heart attacks and strokes that were blamed on the drug. Merck introduced Vioxx in 1999 but withdrew it from the market in 2004 when a study showed the drug doubled the risk of heart attacks and strokes. By 2007, Merck had set up a fund of $4.85 billion (yes, that’s billion with a ‘B’) to cover claims of death and lesser injuries, after reserving $1.9 billion to fight over 26,600 Vioxx lawsuits in court. Houston attorney Mark Lanier observed at the time:
“We don’t know any drug right now with this number of deaths associated with it. This is a very sad chapter in the tragedy of pharmaceutical companies gone wild.”
And – quelle surprise! - Vioxx turns out to be one of countless prescription drugs that have been fraudulently promoted in industry-funded ghostwritten articles in medical journals.
According to a study published in April 2008 in the Journal of the American Medical Association, Merck hired medical ghostwriters who drafted dozens of ‘research’ studies for Vioxx, then lined up well-known doctors who agreed to fraudulently claim to be the actual authors for submission to journals.
JAMA itself published one of the ghostwritten Vioxx ‘research’ articles. The New England Journal of Medicine sold 929,400 reprints of a single Vioxx-friendly ‘research’ article (mostly sold directly to Merck for their sales reps to distribute to physicians as part of the sales pitch) bringing in more than $697,000 in revenue for that journal.
The New York Times reported at the time:
“The JAMA study provides a rare, detailed look at the industry practice of ghostwriting medical research studies that are then published in academic journals.”
Investigation of Merck’s internal documents unearthed e-mail messages and documents about 96 journal publications, which included review articles and reports of clinical studies. In some cases, Merck’s marketing department was involved in developing plans for manuscripts, the JAMA article said.
And in 16 of 20 published papers that reported on Vioxx clinical trials, a Merck employee was designated as the author of the first draft of the manuscript. But the name of an outside academic was listed as the lead author by the time these studies was published.
Merck, which is set to buy rival drug company Schering-Plough Corp. by the end of 2009, won 11 of 16 Vioxx suits at trial before agreeing to settle all claims. Analysts estimate these claims to be as much as $20 billion overall.
The plaintiffs claimed Merck should have moved more quickly to warn about the dangers of Vioxx after a 2000 study reported that the medicine caused five times more heart attacks than another painkiller, naproxen. Merck took two years to negotiate a change in Vioxx’s side effects labelling with the FDA.
Dr. Jerome Avorn of Harvard Medical School explained:
“The company’s own data makes it clear that if people had not been on that drug, they would not have had heart attacks or strokes.”
He added that it took Merck over five years to finally admit these risks. Dr. Avorn, who wrote a paper warning of the drug’s risks before it was pulled from the market, testified for no fee as an expert witness in Vioxx litigation on behalf of patients and their families.
November 23, 2009: Evidence of cardiovascular risks associated with taking the anti-inflammatory drug Vioxx (rofecoxib), could have been identified nearly four years before its manufacturer voluntarily pulled the drug from the market.
Led by Dr. Joseph Ross, MD, MHS, at Mount Sinai School of Medicine, a team of six investigators analyzed 30 randomized, placebo-controlled trials of Vioxx that were made available through litigation, and published their findings in the November 23rd issue of Archives of Internal Medicine.
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