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What the Doctors Aren't Disclosing


A new study shows how authors of medical journal articles flout rules on revealing conflicts of interest

A group of researchers at Duke University scoured 746 studies on heart stents published in medical journals over the course of a year and were shocked to discover two huge omissions. First, 83% of the papers failed to disclose whether any of the authors were paid consultants for companies, even though many journals formally require that information. And of those articles specifically describing clinical trials, 72% didn't say who funded the research. When it comes to policing their disclosure rules, says lead author Kevin Weinfurt of the Duke Clinical Research Institute, "these journals should be doing better."

Virtually every medical organization urges physicians to be up front about their financial ties to industry. It's especially a concern when doctors who publish studies about drugs and medical devices receive funding from the companies that make those products. Over the past few years, a spate of safety warnings and product recalls has left journal editors fearful that company-paid researchers might be filtering their results to highlight the positive. So the publications have toughened up their disclosure policies, hoping that transparency by itself would neutralize conflicts of interest.

The Duke study shows that even when authors do divulge their connections, some statements are less than forthright. In all, 168 authors out of 2,985 made disclosures in the journal articles, which were published in 2006. Through simple Internet searches, the Duke team discovered that some physicians who said they had no conflicts of interest in fact served on advisory boards of companies that make stents. One person co-founded a stent company. (The Duke paper doesn't name doctors.)

The report reveals just how deeply corporate interests have infiltrated medical research. The top funding sources named in disclosure statements were stentmakers Johnson & Johnson (JNJ), Boston Scientific (BSX), and Medtronic (MDT), as well as drugmakers Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). The last two co-market the blood thinner Plavix, which is widely prescribed to stent patients.

Contacted by BusinessWeek (MHP), spokespeople for Bristol-Myers Squibb, Boston Scientific, and Sanofi said in e-mails that they require authors to disclose all financial support from their companies. (J&J and Medtronic did not respond by publication time.)

BUILT-IN LIMITATIONS

Some journal editors gripe that there's only so much they can do. Once they issue disclosure rules, they have no choice but to trust authors to follow them. "I'm not a cop. I'm not the FBI," says Dr. Catherine DeAngelis, editor-in-chief of the Journal of the American Medical Assn. With several thousand authors contributing every year to her publication, DeAngelis says, she can't expect her editors to research every disclosure to determine whether it's accurate. And she's frustrated so many authors are resisting the call to disclose. "It should be a no-brainer," DeAngelis says. "It doesn't mean the worthiness of the paper is marred. But if they're not disclosing because they think it's marred, then maybe it is."

Transparency has some built-in limitations. If all authors consistently disclosed every possible conflict of interest, the world would be awash in information that's hard to interpret. After all, most disclosure statements don't say how much money the authors receive, whether they're paid in cash and/or stock, or what services they provide in return. "The whole system is pretty slipshod," says Dr. Jerome P. Kassirer, former editor-in-chief of The New England Journal of Medicine and author of On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health. "When you know an author has a conflict of interest, you're still in the dark."

Join a debate about whether physicians should accept gifts from drugmakers.

Weintraub is a senior writer for BusinessWeek's science and technology department.

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