Article excerpt

Why did the esteemed Journal of the American Medical Association publish a paper showing that blockbuster anti-arthritis drug Celebrex is superior to a $7 bottle of ibuprofen, while the FDA maintains it isn't? Because the scientists who wrote the paper--their expenses paid by Celebrex manufacturer Pharmacia--selectively omitted half their study data to make the boss's drug look good.

The Celebrex case isn't an aberration, according to Public Citizen's Dr. Sidney Wolfe. "People are injured and killed as a result of incomplete data being published and studies being designed in the wrong ways," he says. Corporate researchers attempt to prove marketing claims, not insure public health, critics say, so results are buffed or buried even if it means impeding doctors' understanding of illness and health.

The problems, however, go beyond eager-to-please scientists and eager-to-earn corporations. Medical journals are themselves reliant on drug-industry largesse. As a result, they are ill equipped to exclude unsavory, publicity-seeking corporate research from their public platform.

In September, in an unprecedented joint editorial, editors of thirteen leading medical journals, including JAMA as well as The New England Journal of Medicine, The Lancet and The Annals of Internal Medicine, announced a plan to fight back. Along with previously required disclosures about funding, conflicts of interest and scientific contributions, they declared they would also require authors to confirm that their sponsors gave them independent access to data and control over their publication. (Even the standard disclosures required by hundreds of journals have had limited success. Tufts University's Sheldon Krimsky analyzed the 1997 editions of more than 200 journals, finding that more than half hadn't published a single disclosure, a percentage that is startling given widespread industry support and participation in biomedical research.)

"The pharmaceutical industry has academic clinical investigators in a corner," explains Richard Horton, editor of The Lancet. Medical research on human subjects is poorly funded by the federal National Institutes of Health, Horton and others contend, because the agency favors the control and precision of laboratory science in which experimental subjects don't have complicated needs and rights. The result, not surprisingly, is that academic researchers often turn to the drug industry for cash. Corporations now fund 70 percent of all clinical research conducted in this country. Most of this research is "careful, good work," says former editor of The Annals of Internal Medicine Frank Davidoff. Even so, company sponsors see the academic work they fund as "marketing primarily, not scientific research," he says.

The problems start when expensive, time-consuming clinical trials paid for by the corporations produce negative results that contradict marketing claims. "The academics want to be able to take that information and tease it apart, to look at the good parts and the bad parts too. But the pharmaceutical companies' marketing departments are going to say they don't want to report on the bad stuff," says Dennis DeRosia, chair-elect of the Association of Clinical Research Professionals. In extreme situations, the struggle for control over data resorts to mudslinging and lawsuits. The Immune Response Corporation, for example, slapped a $10 million lawsuit on scientists it had hired to study its therapeutic vaccine Remune who wanted to publish results showing that Remune was ineffective. "I spent over $30 million," the company's president complained to the Baltimore Sun. "I would think I have certain rights." The case was eventually settled out of court, and the study was published in the November 1, 2000, JAMA.

In such cases, journals' new rules may help scientists negotiate better contracts with their industry sponsors. But there is no antidote to the problem of subtle, pro-industry bias toward positive results when scientists are more than willing to sign on. …