Dr. Catherine D. DeAngelis feels queasy when she thinks about the paper her medical journal refused to publish last year. It was just after her publication, the Journal of the American Medical Assn. (JAMA) adopted a policy requiring that any study funded by a pharmaceutical or medical-device maker undergo a second review by a statistician with no financial ties to that company. One study's authors promptly pulled a manuscript from JAMA and submitted it to another journal, which published it without independent review, JAMA reports. "I'm watching that product," says Editor-in-Chief DeAngelis, who declines to name either the company or the rival journal. "If it turns out to be the next Vioxx, I'm going public."
With concerns about conflicts of interest on the rise, many medical journals are cracking down. Some are demanding more detailed disclosures from authors about how they're compensated by companies, and many are more skeptically scrutinizing papers that academic and company scientists produce together.
A series of embarrassments prompted these actions. Last year editors of the New England Journal of Medicine (NEJM) alleged that information about the heart attack risk caused by the painkiller Vioxx was inappropriately excluded from a study the journal published in 2000. In written statements, Vioxx' maker, Merck & Co., has denied any impropriety. JAMA, meanwhile, has uncovered several examples of authors failing to disclose financial conflicts concerning other drugs. In the June 7 issue, the journal printed four paragraphs of corrected disclosures related to a single study. "As I began to see more slippages and blatant lapses, I had to make it clear we won't accept this," DeAngelis says.
When does an author's relationship with industry raise questions about objectivity? Dr. Jeffrey M. Drazen, editor-in-chief of NEJM, says he's especially wary of authors who have stock options in companies that make the products they're studying. Even though the options may be worthless today, Drazen says, "we've disqualified papers on the basis of appearance. If anything they write can enrich them in the future, we ‘X' them."
Proving just how difficult it has become to untangle business and medicine, however, NEJM loosened its conflict-of-interest policy in 2002. Previously it had refused to publish editorials or reviews by authors with any financial interest in companies they wrote about. Now it disqualifies only authors with "significant" ties. Drazen says it became impossible to enforce the old policy, since most physicians have received something from a company, be it as trivial as a mouse pad or pen. The change incensed former NEJM Editor-in-Chief Dr. Jerome P. Kassirer, author of the 2005 book On the Take, an inside look at the deepening financial ties between physicians and drug companies. "Too difficult to find people without financial conflicts?" Kassirer says. "You just have to look harder."
Other medical journals appear to be moving toward zero tolerance on conflicts. In August the editor of Neuropsycho-pharmacology, Dr. Charles B. Nemeroff, stepped down after the journal published a paper he co-wrote about a device without revealing that he had financial ties to the manufacturer. Nemeroff and his co-authors submitted disclosure forms with the manuscript, but a clerical error caused the information to be left off the published paper, Nemeroff says in an e-mail to BusinessWeek. "A correction regarding that information has been published," Nemeroff writes. "However, the controversy has become distracting to the mission of the journal."
By Arlene Weintraub