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In 2002, four intrepid researchers filed a Freedom of Information Act. But they weren't looking for information on Guantanamo or revelations from Cheney's lair. All they wanted was the FDA's drug analysis data. Taxpayer funded research. They got it. The studies examined were conducted between 1987 and 1999 andcovered Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor. They found, on average, that placebos were 80 percent as effective as the drugs. Put aside the surprising results: Why didn't the public know about these studies? Why wasn't the medical community informed? The answer, as Marcia Angell argues in an important New York Review of Books article, is that our system of clinical evaluation is so riddled with conflicts of interests that "it is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines."The causal line is simple: This country's pharmaceutical system puts the cost of conducting research onto the drug companies. The fox is given the contract to provide security at the henhouse. Forcing pharmaceutical companies to fund the research also gives them control over much of the research. A review of seventy-four clinical trials of antidepressants found that thirty-seven of thirty-eight positive studies were published. Of the thirty-six negative studies, thirty-three were either not published or published in a form that implied a positive outcome. That is to say, in a form that lied. To a doctor reading the published literature, 94% of the trials conducted were positive. In reality, 51% were positive. And these are not exceptions to a rule of transparency. In the medical research and evaluation industry, dual loyalties are common:
In a survey of two hundred expert panels that issued practice guidelines, one third of the panel members acknowledged that they had some financial interest in the drugs they considered. In 2004, after the National Cholesterol Education Program called for sharply lowering the desired levels of "bad" cholesterol, it was revealed that eight of nine members of the panel writing the recommendations had financial ties to the makers of cholesterol-lowering drugs. Of the 170 contributors to the most recent edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM), ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia. Perhaps most important, many members of the standing committees of experts that advise the FDA on drug approvals also have financial ties to the pharmaceutical industry.Those ties are often direct. Take Dr. Charles B. Nemeroff, of Emory University, who ran a $3.95 million investigation into GlaxoSmithKline drugs. Nemeroff, it turned out, had already received $500,000 from GlaxoSmithKline for dozens of talks promoting their products. When Emory questioned Nemeroff's service on the corporate boards of pharmaceutical companies, Nemeroff wrote them a letter, pointing out, quite reasonably, that they'd benefitted too. "Surely you remember that Smith-Kline Beecham Pharmaceuticals donated an endowed chair to the department and there is some reasonable likelihood that Janssen Pharmaceuticals will do so as well," he said. "In addition, Wyeth-Ayerst Pharmaceuticals has funded a Research Career Development Award program in the department, and I have asked both AstraZeneca Pharmaceuticals and Bristol-Meyers [sic] Squibb to do the same. Part of the rationale for their funding our faculty in such a manner would be my service on these boards." Charles Nemeroff, as you might imagine, remains at Emory University. And why not? "A recent survey found that about two thirds of academic medical centers hold equity interest in companies that sponsor research within the same institution. A study of medical school department chairs found that two thirds received departmental income from drug companies and three fifths received personal income." Nemeroff's behavior is par for the course.Defenders of the system will point out that this doesn't mean the resulting recommendations are wrong. Maybe so. But they are not credible. And you need a credible system. There's a lot of talk about evidence-based medicine, but evidence-based medicine only matters insofar as the evidence is complete and unbiased. Right now, it isn't. As Angell concludes, this isn't a job for disclosure. Admitting conflicts of interest is not the same as eliminating them. But this is a job for policy. If the pharmaceutical companies will not fund research, then someone else must. Dean Baker has some useful thoughts on that score.Image used under a CC license from I Y E R S.