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Don't Ask, Don't Tell: Financial Disclosure Lacking in Literature on Stents

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Duke Health News 919-660-1306

DURHAM, NC – Most published research about coronary stents
does not reveal information about authors' financial
relationships that might bias their interpretation of
scientific data, according to researchers at Duke University
Medical Center.

Coronary stents are the basis of a multi-billion dollar
industry, yet the scientific community remains divided over if,
when and how they should be used.

Dr. Kevin Weinfurt, a member of the Duke Clinical Research
Institute, tracked every article written about stents in
biomedical literature in 2006. He found 746 articles written by
2985 authors in 135 journals. Eighty-three percent of those
articles did not contain any disclosure statements at all.

Weinfurt says he was astonished by the extent of the
problem.

"We actually did our own, informal Internet search on
authors who expressly stated they had no interests to disclose
and found that some of them held membership on stent
manufacturers' advisory boards, or were consultants for stent
makers and companies that made drugs related to stent use. One
person had even founded a company that made stents, and yet had
not disclosed that information," says Weinfurt.

The study appears in the online journal PLoS ONE.

Weinfurt says the study results are troubling because
disclosure and transparency in research reports may be more
important than ever. While two respected professional
organizations representing medical editors' interests – the
International Committee of Medical Journal Editors and the
World Association of Medical Editors – encourage disclosure of
authors' financial interests, Weinfurt notes that some journals
don't ask for the information and some authors don't volunteer
it.

When potential conflicts aren't reported, policy makers and
the public lose their trust in medical research, says Weinfurt.
This may be especially critical for those seeking trustworthy
information about potentially life-saving devices, like
coronary stents.

Stents are flexible metal tubes inserted into coronary
arteries that help maintain healthy blood flow, often used in
the wake of a heart attack. There are basically two types of
stents: bare metal stents and drug-eluting stents, and the
medical and scientific communities have been debating for years
over which may be superior.

Weinfurt says that researchers' statements about the
efficacy and propriety of stents are closely evaluated because
they directly affect not just stent makers, but also products
that support stents and companies that produce alternatives to
stents.

But he adds that they found little consistency in how author
disclosures are made. "We feel this is symptomatic of a
systemic problem that leaves patients and health care
professionals with big gaps in knowledge and the inability to
properly interpret important information," says Weinfurt.

Researchers found that a total of 168 authors had a
disclosure statement in at least one article. Five companies
were cited as the most frequent source of support: Johnson
& Johnson, Boston Scientific, Medtronic, Sanofi-Aventis and
Bristol-Myers Squibb, with support most often given in the form
of research support (25 percent), speaker fees (17 percent) and
consulting (15 percent).

The study did contain one upbeat note, however. The
researchers found that there was generally greater author
disclosure in the more highly respected journals and in those
that endorsed the International Committee of Medical Journal
Editors' guidelines for manuscripts submitted to medical
journals.

Dr. Robert Califf, director of the Duke Translational
Medicine Institute, vice chancellor for clinical research at
Duke and senior author of the study, says the findings point to
the need for an Internet-based national repository of
information – something analogous to the Web's
clinicaltrials.gov for trials registration.

"We can't really tell if the problem resides with the
authors or the journals, but it's likely a systems problem. A
common repository of industry interactions could be a
standardized source of conflict of interest information for all
purposes," he says.

Weinfurt and Califf had support for the study from the
National Center for Research Resources, part of the National
Institutes of Health. Weinfurt and co-author Kevin Schulman had
support from the National Heart, Lung, and Blood Institute.

Additional co-authors of the study from Duke include Damon
Seils, Li Lin and Janice Tzeng.

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