| Many Medical Schools Allow Drug Companies Substantial Control of Clinical Trials, Study Finds |
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By LILA GUTERMAN Academic medical centers tolerate widely differing levels of drug-company control of the clinical trials they conduct, according to a study published on Thursday in The New England Journal of Medicine. In the study researchers report that no consensus exists on many issues in industry-financed clinical research, such as whether the pharmaceutical-company sponsor can draft manuscripts to be published in cooperation with the academic researchers. The study suggests that such diversity in industry-academe contracts could allow drug companies to grant funds only to researchers at the medical schools that are most willing to cede control over data and publishing -- in other words, to shop around to find the academics with the least-stringent policies. Industry-financed research makes up about 70 percent of all clinical trials, according to the research team. To conduct the study, researchers led by Michelle M. Mello, an associate professor of health policy and law at the Harvard School of Public Health, sent questionnaires to research administrators at the 122 accredited medical schools in the United States; 107 responded. Ms. Mello's team found broad agreement on a few issues. Almost all of the schools polled said they would allow a sponsor to review manuscripts before publication, for example, and almost none of them said they would allow a drug company to decide that the results should not be published. But little agreement existed on other issues. Half of the respondents said they would allow an industry sponsor to write up the results for publication, with the academic researchers only suggesting revisions, while almost as many would prohibit that, and a few were not sure. (The study did not identify responding medical schools by name.) More than half of the respondents said they would permit, or were not sure if they would allow, a drug company to include its own statistical analyses in manuscripts. The "yeses," "noes," and "not sures" split almost evenly on whether they would allow a sponsor to store the data, releasing portions to the investigators. Most of the institutions -- 82 percent -- had experienced conflicts with an industry sponsor of a clinical trial within the past five years, often over payment, and 69 percent of the administrators said that competition for sponsors had put pressure on them to compromise their standards. Ms. Mello told The Chronicle that one of her paper's peer reviewers had called the results "nothing short of scandalous." Indeed, Gregory D. Curfman, executive editor of The New England Journal of Medicine, said the results were very disappointing given that, three years ago, the journal published a similar study, conducted by researchers at Duke University (The Chronicle, "There hasn't been a lot of progress," Dr. Curfman said. "Industry in many ways does control the research agenda. ... The academic medical community really does need to take tangible steps to take back the research agenda." He said it was particularly discouraging that half of the institutions would allow sponsors to write manuscripts. "When a research manuscript is basically drafted by someone in a marketing department," he said, "that's not, in my opinion, scholarship anymore." Dr. Curfman argued that an important step would be for medical schools to join forces and promote greater academic control of agreements with drug companies. "The investigators and the administrators and the journals all need to be on the same page," he said. The article, "Academic Medical Centers' Standards for Clinical-Trial Agreements With Industry," is available to the journal's subscribers on its Web site. |
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