DR. WEEKS’ COMMENT:
More examples of “reader beware” – too often, we find that “peer-reviewed scientific journals” sell out and serve mostly as advertising arms for Big Pharma? If you doubt that sad assertion, sleuth a bit and learn what percentage of income for the New England Journal Of Medicine, for example, comes from grateful Big Pharma through advertizing efforts.
Investigators: Drugmakers withhold negative data
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 Wednesday.
The evidence comes from two company sponsored trials that were 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 a placebo.
And the report in The Journal of the American Medical Association is just the latest instance in which investigators allege that drug firms have withheld unfavorable data on profitable drugs. “It’s not just Merck,” says the study’s lead investigator Bruce Psaty, of the University of Washington in Seattle. “This is just one example.”
The most recent controversies have allegations that drug firms failed to report possible safety concerns involving GlaxoSmithKline’s diabetes drug Avandia and that a partnership of Merck and Schering Plough withheld data for two years showing that its blockbuster cholesterol-lowering drug Vytorin failed to perform any better than a standard statin.
Merck officials denied that the company misrepresented data from Alzheimer’s studies, and Merck lawyer Jim Fitzpatrick of Hughes, Hubbard and Reed dismissed the allegations as a “courtroom 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 the evidence of “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 documents quoted by the journal. The second trial produced the same result.
“You could ask a hundred scientists whether a threefold, statistically significant increase in total mortality — in two separate studies — signals a safety problem. I think you’d be hard pressed to find any to say that it’s not,” Psaty says.
The results of the first study were published in 2004, the year Merck pulled Vioxx off the market because it had been linked to an increased risk of heart attack and stroke. The second study was published in 2005.
The documents also indicated that many Vioxx studies were prepared or written by Merck employees or paid consultants, not the academic investigators named as the studies’ lead authors.
The second author named on one of the Alzheimer’s studies — the lead author, Leon Thal, was killed last year in a plane crash — told USA TODAY that he was unaware his study showed an increased risk of death among Alzheimer’s patients. “I can’t say that because I never had in my hands — I didn’t request it and I wasn’t given it — the reams of statistical analyses that gets digested into a draft manuscript,” says Steven Ferris, of New York University.
Ferris says he played a more limited role, serving on a committee that judged the accuracy of Alzheimer’s diagnoses.
Catherine DeAngelis, editor of JAMA, which published the two new studies and a sharply worded editorial, says that, given his limited contribution to the study Ferris, would not qualify in her journal as an author.
“This is just the tip of the iceberg,” she adds. “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.”
FDA spokeswoman Susan Cruzan said agency officials have so far declined to comment on the specifics of the reports until they’ve had more time to review them. “FDA will evaluate the issues raised by the JAMA papers on Vioxx,” she says.
Merck has spent more than $1.4 billion defending itself against Vioxx lawsuits since the drug was taken off the market.