True, False, Whatever
Physicians are putting a stop to the publication of misleading drug data
But such coziness has a price, and it's that conflict that has the editors concerned. Companies often want researchers to keep findings secret in order to protect proprietary information. Steven Rosenberg, chief of surgery at the National Cancer Institute, says one company asked him to keep study results confidential for 10 years; when he refused, the collaboration fell through. "Science depends on the open and free flow of information," Rosenberg says. "As more and more research is performed by private companies, the normal ethos of business intrudes on the normal ethos of science."
Some researchers are so cowed by the power of drug companies that they're reluctant even to voice disagreement. Says Steven Cummings, director of the clinical research program at the University of California-San Francisco: "Industry sponsors decide who to work with. Sometimes researchers are excluded from trials and opportunities to help with research if their views conflict with the company." By contrast, those whose views are favorable to a company's product are invited to speak at expense-paid conferences and to sign on to papers that appear in prestigious publications. In short, a good relationship with industry can advance an academic career.
Numbers game. How study data are analyzed and reported is at the heart of many of the conflicts between researchers and company sponsors. Curt Furberg, a professor of public health sciences at Wake Forest University School of Medicine in Winston-Salem, N.C., ran a trial comparing a new calcium channel blocker with a diuretic. The purpose was to see if the drug lowered blood pressure and reduced hardening of the arteries, but Furberg says the findings showed the diuretic worked better than the calcium channel blocker. The company, Sandoz (now Novartis), disagreed with Furberg's analysis of the data, and the drafting of the paper was contentious. "We went through the draft and presented our version of the results to the company," he says. "But the company kept changing it back to an older version that we didn't agree with." After 10 drafts, Furberg and four others gave up and took their names off the paper. "It was five years of work, and we got nothing out of it," he says. "But you have to have principles."
Stephen Lagakos, a professor of biostatistics at Harvard University School of Public Health, along with James Kahn, associate professor of medicine at UCSF, were denied access to complete data from a study of an HIV vaccine after they refused to include the company's analysis of the results in their research paper. They published the study in the Journal of the American Medical Association, using the partial data they had, and the company, Immune Response, responded by suing UCSF for damages of up to $10 million. UCSF countersued to get the rest of the data; the university won, but it took considerable time and money for Lagakos and Kahn to get access to the material.
Researchers and companies share the goal of publication in prestigious journals. It is a powerful medium by which scientists communicate, and it allows companies to promote new uses of their products with the imprimatur of rigorous peer review. Harvard's Angell, who is also the former editor of the New England Journal of Medicine, says she hopes the new policies of the medical journals will help to create more of the arm's-length relationship that academic researchers once had with companies. "All of the conflicts of interest cannot be eliminated," she says. But "the public should not have to wonder whether medical research can be believed."
THE CRACKDOWN
The journals signing on to the new policy:
Annals of Internal Medicine
Journal of the American Medical Association
New England Journal of Medicine
Canadian Medical Association Journal
Journal of the Norwegian Medical Association
Lancet
MEDLINE/Index Medicus
New Zealand Medical Journal
Norwegian Medical Association
Dutch Journal of Medicine
Medical Journal of Australia
Western Journal of Medicine
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