True, False, Whatever
Physicians are putting a stop to the publication of misleading drug data
Catherine DeAngelis is not happy. The editor of the Journal of the American Medical Association knows that she is responsible for publishing deliberately misleading research that could have untoward consequences for thousands of patients. A year ago, she ran the results of a six-month study of the popular arthritis drug Celebrex; that probe showed the drug caused fewer gastrointestinal problems than comparable medications. But when the Food and Drug Administration reviewed the same trial five months later, she learned the study had actually lasted a year, and that the full collection of data in fact pointed to a quite different result. Indeed, Celebrex was not easier on the stomach than the other drugs. "The company had 12 months of data and didn't tell me," she says. "They know how upset I am."
The editors from the other major medical journals share DeAngelis's anger and frustration. In a joint editorial published this week, the heads of 12 international journals, including the New England Journal of Medicine, the Lancet, and the Canadian Medical Association Journal, warn that pharmaceutical companies have gained too much control over both medical research and the publication of experimental results. Clinical investigators are often excluded from study design and data interpretation, the editors contend, and in some cases unfavorable results are intentionally buried to avoid public dissemination. In an effort to win back some control over the scientific process, the editors are declaring a radical change in policy: "We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication."
The move is meant to give scientists more "clout" when negotiating contracts with drug companies, DeAngelis says. Harold Sox, editor of the Annals of Internal Medicine, agrees. "In the worst cases, the drug firms design the trial, explain to physicians how to carry it out, analyze the study, do not let the researchers see all of the data, and then control the publication," he says. "Physicians are not happy with this arrangement."
Well, perhaps not completely happy, but they are not shunning the drug companies either. In fact, the relationship between researchers and industry is far from adversarial, and it's often mutually beneficial, with the academic centers receiving much-needed funding and companies gaining access to prestigious university scientists. Only in rare instances, some observers argue, do researchers and their corporate sponsors strongly disagree about what to do with study results.
Cash cow. Still, few dispute the fact that academic medical centers have in the past few years become increasingly dependent on pharmaceutical company grants. Managed care and cuts in Medicare reimbursements have left many university hospitals cash strapped, says Marcia Angell, senior lecturer at Harvard Medical School. Pharmaceutical companies financed 70 percent of the clinical drug trials performed in the United States last year, investing a total of nearly $60 billion. And there are powerful incentives for medical researchers to go after that action. Not only do most rely on such "soft money" to keep their labs running, but the grants often are generous enough to support other research completely unrelated to the drug in question. Moreover, says Sox, "typically universities will get a negotiated amount of money over and above the cost of carrying out the trial." This "indirect cost recovery" pays for expenses such as electricity, library resources, and other essential features that make it possible to run a research university.
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