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Celebrex
M. Michael Wolfe, a gastroenterologist at Boston University, admits he was duped by the Pharmacia Corporation, the manufacturer of the blockbuster arthritis drug Celebrex. In the summer of 2000, The Journal of the American Medical Association asked Wolfe to write a review of a study showing that Celebrex was associated with lower rates of stomach and intestinal ulcers and other complications than two older arthritis medications, diclofenac and ibuprofen. Wolfe found the study, tracking 8,000 patients over a six-month period, persuasive, and penned a favorable review, which helped to drive up Celebrex sales.
But early the next year, while serving on the Food and Drug Administration’s (FDA) arthritis advisory committee, Wolfe had occasion to review the same drug trial again, and was fabbergasted by what he saw. Pharmacia’s study had run for one year, not six months, as the company had originally led both Wolfe and the Journal to believe. When the complete data was considered, most of Celebrex’s advantages disappeared because the ulcer complications that occurred during the second half of the study were disproportionately found in patients taking Celebrex. Celebrex, an anti-inflammatory drug similar to Vioxx, is once again in the news due to concerns that it may be associated with the same cardiovascular risks that caused Vioxx to get yanked from the market. In recent months, we’ve heard a great deal about conflicts of interest at both the FDA, the agency that approves drugs for public safety, and the National Institutes of Health, where publicly funded scientists moonlight as consultants for the very companies that manufactured the drugs they are testing. Still largely ignored, however, is the role played by the once-autonomous ivory tower and the university scientists who, either knowingly or unknowingly, facilitate the pharmaceutical industry’s manipulation of drug testing by lending it an aura of objectivity. In the past, for example, it was common for university scientists to initiate the research protocol. Now, studies are frequently conceived and designed in the company’s own pharmacological and marketing departments, thus removing this formative stage of the research from academic hands almost entirely. The company then shops the study around to various academic institutions (and a growing number of competing for-profit subcontractors that run clinical trials) in search of investigators to conduct the research. As university medical schools have grown more dependent on industry grants to sustain their operations, their professors have become increasingly willing to accept an industry-initiated protocol without modification, even though the study may be largely designed to secure a company’s market position. Should a professor reject the study or insist on changes, another university scientist will very likely be more solicitous. Research suggests that publicly funded science, most of it performed at universities, was a critical contributor to the discovery of nearly all of the 25 most important breakthrough drugs introduced between 1970 and 1995. If university scientists lose their independence, who will perform this pathbreaking research and objectively evaluate the safety and effectiveness of drugs already on the market? Conficts of interest are more than an academic concern. When it comes to health policy, they pose a serious threat to public health.
Drew Voight
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