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Saturday, November 21, 2009

NIH to Study Conflict of Interest

The government agency tasked with funding crucial life science research needs to focus more attention on ethical quandaries and nefarious business practices that often obscure the path from discovery to public benefit, says a strongly worded letter to Francis Collins, the director of the National Institutes of Health (NIH), signed by more than 100 biomedical researchers, journal editors, and health care administrators in the US.

"...we ask that you acknowledge the research gap on the effect of conflicts of interest and commercial influence on medical decision making," the letter reads, "and set in motion a process that leads to recognition of the importance of funding studies on research ethics, the beliefs and behaviors of researchers and clinicians, and the effects of industry-academic relationships on the generation and dissemination of medical knowledge."

"It would be great to raise [the NIH's] awareness, and maybe have them actually do an RFA [request for applications] on this," said Adriane Fugh-Berman, director of PharmedOut, a group seeking to educate physicians on how the pharmaceutical industry influences prescribing practices, which spearheaded the writing and dissemination of the letter. PharmedOut, based at Georgetown University's School of Medicine, launched three years ago with the help of a chunk of the $430 million settlement drug maker Pfizer paid in 2004 after pleading guilty to encouraging the off-label prescription of its anti-seizure drug Neurontin.

Fugh-Berman, who is also an associate professor in Georgetown's department of physiology and biophysics, admitted that part of the impetus for the letter was the PharmedOut project's empty coffers. "We've been out of money for a year," she told The Scientist. "It's been very difficult to get money for [ethics research] projects."

An NIH spokesperson said this morning that the agency has not yet "officially received" the letter, though a copy of it can be accessed at PharmedOut's website. Collins is expected to review the letter sometime today or tomorrow, the spokesperson told The Scientist.

"I think there's just so much evidence out there that this is a problem area, there probably should be increased funding there," Kay Dickersin, director of the Center for Clinical Trials at the Johns Hopkins Bloomberg School of Public Health and a signatory on the letter, told The Scientist.

"In any budget -- whether you're the head of NIH or anywhere else -- there's always discretionary money for things that come up," she said. "NIH has had funding from the Office of Research Integrity, via small grants, for a number of years" to look into such ethical issues, she added, but the amount of money allocated to study them has been "fairly small."

The letter is signed by several other prominent figures in the biomedical community, including Jerry Avorn, the Harvard MD who invented "academic detailing," the widely-employed practice of educating doctors in cost-effective prescribing practices, Virginia Barbour, chief editor of PLoS Medicine, and Howard Brody, director of the Institute for the Medical Humanities at University of Texas Medical Branch.

Fugh-Berman added that the strong support for the letter, which ended up being passed around and posted on listservs by researchers, was a surprise. "The response to it was amazing when we sent it out to scientists," she said. "It was really sort of unexpected." The letter's signers also include a handful of researchers and administrators outside of the US -- from the UK, Canada, India, Australia, and South Africa. "It jumped the pond," Fugh-Berman said.

From here.

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