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Medical Advice Conflicts
Medical experts must eliminate money conflicts
By Jerome P. Kassirer In a society rife with conflicts of interest, disclosure of such conflicts is usually a good tonic. But in medicine, where decisions on treatment can have lasting effects, mere disclosure isn't enough. Patients need advice they can act on without having to calibrate how likely it is to be biased. Physicians and scientists with financial ties to the pharmaceutical industry should not just have to disclose conflicts - they shouldn't be permitted to issue guidelines at all. But they are permitted, and they do so routinely. The most prominent recent example of this is how the federal government came up with and then defended new recommendations on cholesterol levels for individuals with a high risk of heart disease. It's an enlightening - and depressing - story. On July 13, the National Cholesterol Education Program (NCEP), part of the National Institutes of Health, unveiled tougher guidelines for cholesterol levels - guidelines so stringent that millions of Americans at risk of heart disease would have to take costly statin drugs to meet the new lower limits. What the NCEP didn't unveil was that the recommendations had been written by a panel of doctors, most with financial ties to the pharmaceutical companies that stood to gain enormously from increased use of cholesterol-lowering statins. Critics immediately complained about the hidden financial ties and demanded disclosure. Within days, the highly respected sponsors of the cholesterol guidelines - the NIH, the American Heart Association (AHA) and the American College of Cardiology (ACC) - posted the disclosures on the NCEP's Web site. The extent of the connections was stunning: Of the nine panel members, six had each received research grants, speaking honoraria or consulting fees from at least three and in some cases all five of the manufacturers of statins. If all the members with conflicts had recused themselves, only two would have been left. That didn't look too good, so another note appeared on the site, explaining that the panel's draft proposals had been "subjected to multiple layers of scientific review." "Altogether approximately 90 reviewers scrutinized the draft," the note said. The message to the public: No need to worry about pro-industry bias. The heart association, whose journal Circulation had published the guidelines, sent an e-mail to its board of directors, its national strategic team, its communications advisory team and more than 30 prominent physicians who have worked closely with the organization. It reminded them of the association's conflict of interest policy, namely that "if in any situation, a panelist has a current relationship that could unduly influence guidelines or statements, that individual recuses himself from that aspect of the work of the writing panel. "This process ensures that the guidelines are not inappropriately influenced in any way." (Apparently, none of the panelists felt their drug-company connections required recusal.) But patients deciding whether to take these drugs, and physicians deciding whether to prescribe them, still don't know whether the NCEP panel members consciously or subconsciously colored their analysis in favor of statin manufacturers Merck, Novartis, AstraZeneca, Pfizer and Bristol-Myers Squibb. Cholesterol guidelines have broad impact. They help doctors decide how aggressively to prescribe drugs. When the guidelines promote greater use of statins, they also raise the cost of care. And in some cases, statins cause liver and muscle injury; in rare cases, they have led to kidney failure. So why did three major organizations choose such a conflicted panel to write the guidelines? Quite likely the panelists were experts in the field. Most had helped to write the preceding round of cholesterol guidelines three years earlier. Is it imaginable that using conflicted experts is the best way of getting unadulterated assessments of clinical data? I don't think so. The best collective decisions arise from diverse and independent views. When companies with identical interests are underwriting virtually all the researchers, decision-makers can become susceptible to "groupthink." Does the review of the guidelines by 90 other leading experts guard against potential bias? Not really. Many of the reviewers had conflicts of interest, too. The heart association conceded that in its e-mail, saying: "The best scientists are asked to speak and provide advice, not only by the NIH and the AHA, but by industry. Because of this, many of the top scientists on any issue will likely have received some funding over time from pharmaceutical companies." Even if the 90 other scientists had no conflicts, how diligently did they examine the data or challenge the expert panelists? Was there dissent among those reviewers? If so, did anyone listen? We don't know. There certainly is no unanimity of opinion regarding the lower cholesterol targets. A University of British Columbia group (with no connection to drug manufacturers) has drawn different conclusions from the same studies. How could the NCEP have done a better job of coming up with new guidelines? First, by using physicians without financial ties to statin makers. Second, by including experts in methods of clinical research. If there aren't enough non-conflicted physicians for the panel, at least some independent voices should be mixed in. Better still, we should dissuade leading physicians from doing nonscientific work for pharmaceutical makers. Doctors who want to be respected as independent authorities should not become paid speakers for drug companies or consult on marketing issues. We should save the prized task of preparing clinical practice guidelines for experts without such conflicts. Having a financial conflict is voluntary; physicians can either take it or leave it. We must convince them to leave it. If medical organizations continue to use heavily conflicted experts to make clinical policy, they will erode public confidence. The public needs medical institutions it can trust for help with decisions it can barely understand. Jerome P. Kassirer is editor in chief emeritus of the New England Journal of Medicine and a professor at the Tufts University School of Medicine. |
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Medical Advice Conflicts
"FOB" wrote in message ...
Medical experts must eliminate money conflicts By Jerome P. Kassirer On July 13, the National Cholesterol Education Program (NCEP), part of the National Institutes of Health, unveiled tougher guidelines for cholesterol levels - guidelines so stringent that millions of Americans at risk of heart disease would have to take costly statin drugs to meet the new lower limits. What the NCEP didn't unveil was that the recommendations had been written by a panel of doctors, most with financial ties to the pharmaceutical companies that stood to gain enormously from increased use of cholesterol-lowering statins. Take a look at the donor list for the American Diabetew Association sometimes. So many pharmaceutical companies there it's no wonder they recommend that you eat a high-carb diet and take more pills to control your blood glucose. |
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"FOB" wrote in message ...
Medical experts must eliminate money conflicts By Jerome P. Kassirer On July 13, the National Cholesterol Education Program (NCEP), part of the National Institutes of Health, unveiled tougher guidelines for cholesterol levels - guidelines so stringent that millions of Americans at risk of heart disease would have to take costly statin drugs to meet the new lower limits. What the NCEP didn't unveil was that the recommendations had been written by a panel of doctors, most with financial ties to the pharmaceutical companies that stood to gain enormously from increased use of cholesterol-lowering statins. Take a look at the donor list for the American Diabetew Association sometimes. So many pharmaceutical companies there it's no wonder they recommend that you eat a high-carb diet and take more pills to control your blood glucose. |
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