Healthy Skepticism Library item: 13526
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Publication type: news
Sternberg S.
Reports: Data on Vioxx was misused
USA Today.com 2008 Apr 15
http://www.usatoday.com/news/health/2008-04-15-vioxx-drug-conflicts_N.htm?csp=34
Full text:
Corporate and government documents from Vioxx lawsuits indicate that the drug’s maker, Merck & Co., apparently downplayed evidence showing the painkiller tripled the risk of death in Alzheimer’s-prone patients, researchers report today.
A separate analysis of court documents revealed that many Vioxx studies were prepared or written by Merck employees or paid consultants, not the doctors named as the studies’ lead authors, researchers say.
Doctors involved in the analyses, published in The Journal of the American Medical Association, some of whom served as plaintiffs’ witnesses, say the trove of information that Merck was compelled to produce offers a rare window into the world of billion-dollar drugs and the lengths to which a company will go to advance and protect its interests.
“The drug industry appears to treat scientific data as if they were a marketing tool,” says the University of Washington’s Bruce Psaty, a co-author of one of the JAMA articles. “That’s not appropriate.”
The Vioxx disclosures are “just the tip of the iceberg,” JAMA editor Catherine DeAngelis says. “I’ve been sitting in this office for eight years, watching physicians and clinical researchers be used by pharmaceutical companies in ways that can end up with patients being hurt. Physicians have allowed it to happen, and it’s time to stop.”
FIND MORE STORIES IN: Drug Administration | Food | Medical Association | University of Washington | Merck | R-Iowa | Vioxx | Reed | Senate Committee | Finance | Susan Cruzan | Hubbard | Bruce Psaty | Catherine DeAngelis
The Vioxx evidence comes from two company-sponsored trials designed to test whether Vioxx could slow the progression to Alzheimer’s. Instead, the studies found that patients on Vioxx were three times more likely to die of any cause than patients taking placebo.
Merck officials denied that the company misrepresented data, and Merck lawyer James Fitzpatrick of Hughes, Hubbard & Reed called the allegations a “trial brief masquerading as scientific debate.”
“Merck thoroughly disclosed these data both to the FDA and the scientific literature. And, in fact, Merck looked carefully at the mortality data from all of its studies and concluded across the body of data they didn’t see any difference in mortality related to Vioxx.”
When the Food and Drug Administration asked Merck in 2001 whether “excess” deaths in the first of the trials should prompt the company to halt the second trial to protect patients, the firm dismissed the finding as “small numeric differences” that could be caused by “chance,” according to the journal. But the second trial produced the same result. There were 34 deaths among 1,069 Vioxx patients and 12 deaths among 1,078 placebo patients in both studies.
Merck took Vioxx off the market in 2004 after researchers linked the drug to an increased risk of heart attacks and strokes.
“You could ask a hundred scientists whether a threefold, statistically significant increase in total mortality in two separate studies signals a safety (concern). I think you?d be hard pressed to find any to say that it doesn’t,” Psaty says.
Fitzpatrick also said the academic doctors named as authors of the studies were indeed involved in writing up the research.
Steven Ferris of New York University, the second author of one of the company-funded Alzheimer’s studies (lead author Leon Thal died last year), said he played a key role by judging the accuracy of Alzheimer’s diagnoses. Ferris added that he played no role in analyzing the data itself. “I never had in my hands – I didn’t request it and I wasn’t given it – the reams of statistical analyses that get digested into a draft manuscript.”
Sen. Charles Grassley, R-Iowa, as chairman of the Senate Committee on Finance, held a hearing on Vioxx three years ago. He demanded in a letter Tuesday that Merck and Scientific Therapeutics, a firm that wrote several Vioxx articles, respond to his questions about the trials.
“These reports reveal just how far a drug maker might go to market its product and try to bury information that might hurt sales even when that information directly affected the health and safety of the people taking their medicine,” Grassley said.
The FDA’s Susan Cruzan said the agency “will evaluate the issues” raised by the JAMA papers.
