A report that 72% of journal articles on heart stents in 2006 failed to note who funded the research draws sharp criticism of disclosure practices
A group of researchers at Duke University scoured more than 700 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 the authors were paid consultants for the companies that made the products they wrote about.
Perhaps more surprising, 72% of articles describing clinical trials and other research-related matters didn't identify who funded the research. The Duke paper, published May 7 in the online journal PLoS One, raises fresh questions about the ever-growing financial ties between doctors and companies, and the adequacy with which those relationships are communicated to the public.
Doctors who study drugs and medical devices often get financial support from the companies that make those products. It's a symbiotic and important partnership, especially as federal funding for medical research dries up (BusinessWeek, 5/8/08). But in the past few years, the medical community has become increasingly concerned that some physicians who author studies about products could be biased by the money they get from industry. That may prompt them to downplay dangerous side effects, critics say, or simply not publish studies that come to negative conclusions about experimental products.
Tougher Policies After Vioxx
In the wake of the controversy surrounding Vioxx—the Merck (MRK) arthritis pill that was pulled from the market in 2004 after it was linked to heart attacks and strokes—publications such as the New England Journal of Medicine and The Journal of the American Medical Assn. (JAMA) toughened policies requiring authors to disclose financial ties to industry. The idea was that such transparency would allow doctors, patients, regulators, and insurance companies to see the studies in light of their backers, and decide for themselves how serious the potential for bias might be.
But the Duke study suggests the quest for transparency has failed. Aside from the revelation that most authors are ignoring journals' disclosure rules, the study suggests the disclosures themselves may be suspect.
The researchers zeroed in on the 170 or so authors, out of a total of 2,985, who fulfilled their duty to disclose in the journal articles, which were published in 2006. By doing informal Internet searches, they discovered that some of the physicians who said they had no conflicts of interest in fact served on the advisory boards of companies that make stents. One person co-founded a stent company. (The Duke paper doesn't name individual doctors.) Of the 75 authors who disclosed relationships with companies, only two did so consistently; the rest named their corporate sponsors in some journals but not others.
Lead author Kevin Weinfurt of the Duke Clinical Research Institute says journal editors are as much to blame as authors are for the lack of transparency. "These journals should be doing better" at policing their disclosure rules, he says. "We hope this is a wake-up call."
The Companies Respond
Disclosure guidelines are set by the journals, and they're completely voluntary. Some federal legislators have proposed mandating a national database that would list all doctors' financial ties to companies, but so far those efforts have stalled.
The study also reveals just how deeply corporate interests have infiltrated medical research. The top funding sources named in the disclosures that the Duke researchers found were stentmakers Johnson & Johnson (JNJ), Boston Scientific (BSX), and Medtronic (MDT), as well as drugmakers Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). Those last two companies co-market the blood thinner Plavix, which is widely prescribed to stent patients.
Weinfurt says that going in, he predicted the papers would at least disclose who funded the overall research, because most journals started requiring that information long before they started asking individual authors to reveal their personal connections to industry. "We were surprised that 72% [of papers] did not identify the source of their support," he says. "We'd like to know who funded those studies."
BusinessWeek contacted all five companies. A spokesperson for Bristol-Myers Squibb said in an e-mail that the company has an official policy stating, "Any BMS funding or involvement in a publication must be disclosed in the publication." A spokesperson for Boston Scientific sent this statement: "Boston Scientific requires disclosure of our involvement as a sponsor in any publication or presentation relating to a clinical study or its results. The manner in which an author reports that involvement to an academic journal to comply with the journal's author financial disclosure requirements remains the responsibility of each author." The other companies had not responded as of publication time.
What About the Disclosure System?
Some journal editors gripe that there is 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 JAMA and a longtime advocate of disclosure. With several thousand authors contributing every year to her publication, DeAngelis says, she can't expect her editors to Google (GOOG) every disclosure to try 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."
Underlying the disclosure debate is a larger question: What good does transparency do anyway? If everyone was disclosing consistently, the world would be awash in information that could be hard to decipher. Most disclosures are simply lists of companies: They don't say how much money the authors receive from those companies, 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 Kassirer, former editor 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're reading an article and you know an author has a conflict of interest, you're still in the dark."
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