Wonder Drugs That Can Kill, Discover Magazine
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How often do today’s medical “breakthroughs” become tomorrow’s discredited science? John P. A. Ioannidis, an epidemiologist at Tufts University School of Medicine in Boston and the University of Ioannina School of Medicine in Greece, studied the question. He examined the most-cited clinical studies published in the top three medical journals between 1990 and 2000 to see how well researchers’ initial claims held up against subsequent research. His findings, published in JAMA, show that the key claims of nearly one-third (14 out of 49) of the original research studies he examined were either false or exaggerated. Small study size, design flaws, publication bias (failure to publish negative results or duplication of positive results), drug-industry influence, and the play of chance were among the problems Ioannidis found that caused false or exaggerated claims.
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Furberg’s efforts to debunk overly enthusiastic interpretations of medical studies have led to occasional clashes with his colleagues. In 2004 the U.S. Food and Drug Administration (FDA) was preparing to hold hearings on the safety of painkillers known as COX-2 inhibitors, including Vioxx, which David Graham, an official in the FDA’s Office of Drug Safety, said may have caused an estimated 39,000 to 60,000 heart-attack deaths in just five years. At the time, Furberg was a member of the FDA Advisory Committee on Drug Safety and Risk Management. But after he told The New York Times that the COX-2 inhibitor Bextra also caused heart attacks, the agency made a surprising move: It removed Furberg from the advisory panel. Sandra Kweder, acting director of the Office of New Drugs, Center for Drug Evaluation and Research at the FDA, told a reporter that Furberg’s comments showed he could not be objective. Furberg now asks, “If bias was a concern, why did they allow 10 advisory members with ties to the manufacturers to be seated?” He was reinstated to the panel two days later and vindicated when the FDA announced that it had asked Pfizer to voluntarily withdraw Bextra from the market.
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Phil Brewer, the doctor whose stroke patient died after being treated with tPA, says media portrayals of new medicines are often “irrationally exuberant.” He points to a May 2007 article in The New York Times that he says typifies the problem. The article, about stroke victims, said that the clot-buster “tPA was shown in 1996 to save lives.” Yet in 2001, the American Heart Association (AHA) had withdrawn the claim that the drug “saves lives” from its promotion of tPA for stroke after the group was challenged to provide scientific evidence to support that claim. The AHA was also the subject of scrutiny when it was revealed that in the decade prior to its recommendation that doctors use tPA for stroke victims, the heart association had received $11 million from Genentech, tPA’s manufacturer.
The same Times article quoted a number of doctors saying that too few stroke patients were receiving tPA, yet failed to mention that many of these same doctors had received funding from Genentech. Nor did the article give a hint of the ferocious battle among doctors about the safety and efficacy of tPA: While a number of professional associations endorsed the drug, many others, such as the American Academy of Emergency Medicine, said it should not be considered the standard of care for acute stroke.
Asked about this reporting, Barbara Strauch, health editor of The Times, responded, “While some researchers had said in interviews that they believed the drug saved lives, our article incorrectly stated that the study had made that conclusion.” Strauch said the paper would publish a correction—which it did this past April, nearly a year later. (This was done in response to DISCOVER’s inquiries.) She added, “It is also true that some researchers quoted in the article, like many stroke researchers and many who study other diseases, are funded by and receive honoraria from the pharmaceutical industry.
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