Maker of Vioxx Is Accused of Deception
Wednesday, April 16, 2008
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.
The two JAMA papers -- which were based on access to company documents made public through the lawsuits -- say they provide a look at widespread practices in the pharmaceutical industry. This view was endorsed in an editorial signed by Catherine D. DeAngelis, the journal's editor, who wrote: "But make no mistake -- the manipulation of study results, authors, editors, and reviewers is not the sole purview of one company."
Although the two studies question the integrity of dozens of physicians and scientists, the JAMA authors did not seek responses from them. Several of those people yesterday called the conclusions incorrect, incomplete or unfair.
A spokesman for Merck's legal team dismissed the JAMA authors as "people in the pay of trial lawyers."
In the study questioning Merck's reporting of deaths, Bruce M. Psaty, a physician and epidemiologist at the University of Washington, examined documents from two clinical trials testing the theory that Vioxx could slow the progress of dementia in elderly people.
In July 2001, Merck filed a report with the FDA saying that out of the roughly 1,000 people in each "arm" of the study, 29 who were taking Vioxx had died, compared with 17 taking a placebo. An internal company document three months earlier, however, contained a more ominous and lopsided report -- 34 deaths in the Vioxx group compared with 12 deaths in the placebo group.
The difference in the numbers apparently resulted from two ways of counting the deaths.