The editor of the prestigious New England Journal of Medicine is calling for stronger restrictions on stock ownership and other financial incentives for researchers, saying growing conflicts of interest are tainting science.
Dr. Marcia Angell joins a wave of critics who say an explosion of research money from drug and medical-equipment makers is injecting commercial concerns into the scientific process in troubling ways.
"When the boundaries between industry and academic medicine become as blurred as they are now, the business goals of industry influence the mission of medical schools in multiple ways," she cautioned.
She laid down the challenge in Thursday's issue of the journal in an editorial headlined "Is Academic Medicine for Sale?" The Boston-based journal is widely regarded as medicine's most distinguished periodical.
Angell, the journal's outgoing editor, acknowledged that rising research funding from biotechnology and drug companies has helped lead to dramatic advances against many diseases in recent years.
At the same time, she said, medical schools have struck a "Faustian bargain" with the industry.
She said industry representatives are lavishing giveaway products, other gifts and trips on doctors. She said speaking and consulting fees, along with other compensation, are subtly swaying researchers toward more favorable findings on products of companies making the payments.
She said researchers may also be focusing on trivial - but marketable - differences between similar drugs.
As a remedy, she said major medical schools should adopt a strong, common code for conflicts of interest, banning some writing and speaking arrangements and stock ownership in companies making the products under study. She said drug companies should not promote products and offer gifts to students and doctors at teaching hospitals. And she suggested that researchers' consulting income could go into a common research pool.
Dr. Jeffrey Drazen, an asthma researcher at Brigham and Women's Hospital, has been named to replace Angell, probably later this year.
Drazen's own ties to the drug industry came under scrutiny Feb. 24 when the journal disclosed that it had published 19 articles on drug treatments without disclosing the authors' industry links. One of the authors was Drazen, who had accepted grants or an advisory role at eight companies.
Angell pointed to a study of depression treatments in Thursday's issue with an unusually long list of potential conflicts. Its lead author, Brown University psychiatrist Dr. Martin Keller, said in an interview that industry money was badly needed for the large study of 681 patients at 12 sites.
He said the personal integrity of scientists helps resist conflicting pressures, and he suggested "a balance between what's reasonable and fair - and what would be so overly strict that it would be restrictive."
His study was funded by drug maker Bristol-Meyers Squibb. Company spokeswoman Tracy Furey said she does not feel that providing research grants necessarily influences the outcome of medical research. Neither she nor Keller would discuss details of personal compensation to researchers.
Michael Werner, a lawyer for the Washington-based Biotechnology Industry Organization, said disclosure of financial ties and government regulation sufficiently protect the public. He said companies have every reason to shun poor research because of the liability and the bad publicity that could result from a recall.
Underscoring the editor's message in the same issue, journal correspondent Dr. Thomas Bodenheimer of the University of California at San Francisco said 70 percent of money for clinical tests of drugs and devices now comes from industry, not government.
David Rothman, director of the Center for Society and Medicine at Columbia University, said researchers used to face heavier pressure to fudge research for reputation rather than for wealth.
"I think it is more benign to be after fame than after fortune. You're less likely to cut corners," he said.
Harvard University, with some of the most stringent restrictions on conflict of interest, is now under pressure from some researchers to ease rules, acknowledged Margaret Dale, an associate dean at its medical school. She said they argue that there is a potential even for a school like Harvard to lose researchers to more laissez-faire schools.
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