Reports: Data on Vioxx was misused ... USA TODAY April 15, 2008

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What is terrible is that, if a product is FDA approved, we have no recourse against the manufacturers.Thank Mr. Bush!Gone are the days when, if you took medication for something, you knew you would soon be well.Rogene

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Reports: Data on Vioxx was misused

By Steve Sternberg, USA TODAY April 15, 2008

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 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." 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 Fitzpatrick of

, Hubbard & 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. 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. 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 Cruzan

said the agency "will evaluate the issues" raised by the JAMA

papers. Copyright 2008 The Associated Press. All

rights reserved. This material may not be published, broadcast, rewritten or

redistributed.

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