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Archive for March, 2009

The power of a student movement

In recent weeks, there’s been growing news about a student movement at Harvard Medical School to change the university’s COI policy regarding faculty consulting with pharma, and such. The most recent edition is this NY Times article: Harvard Medical School in Ethics Quandary. As my student Catherine Olivier noted, “Maybe the younger generation will get rid of COI’s in universities”.

Here’re some related stories:

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Why good policies are necessary

A great story in the AMA News about the importance of building clear and practical policies to help manage COI; the story — Most IRB rules don’t ban finder’s fees for clinical trials — focuses on institutional review boards (IRBs) in the US. According to a recent study by Leslie E. Wolf published in IRB: Ethics & Health Research, most IRBs simply don’t have the necessary poicy support to deal with issues like patient recruitment fees. But as Professor Wolf notes,

“If there is a written policy, it suggests there may be more consistency within an institution,” said Wolf, associate law professor at the Georgia State University College of Law. “If it’s written down and you’re coming to the IRB for the first time and asking questions about what’s appropriate, they can say, ‘Oh, wait, we have a policy that answers this question.’ “

P.S. See this detailed analysis of the issue over at the Research Ethics Blog: Most Ethics Boards Permit Docs “Finder’s Fees”

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Who judges the judges?

This story, while not about universities or research (the focus of this blog), is an interesting example of how systemic problems in governance can undermine the transparent conduct of judicial or public proceedings, and thus, public trust. In this case, the issue is about an state environmental review panel in Arkansas, rejecting calls to disclose interests of panel members with regards to their evaluation of coal power plants: Ruling denies call for panel to disclose conflicts.

Opponents of the plant claim to have information that one of the commission members has ties to two companies working on the project, but

administrative hearing officer Michael O’Malley of the Arkansas Pollution Control and Ecology Commission found “no authority” that legally compels him or commission members to answer any of the requests made by opponents of the plant.

Here’s a situation where badly written guidelines and legislation create a loophole for a regulator with an apparent COI, to avoid anything resembling public disclosure.

Concerning conflicts of interest, O’Malley acknowledged state ethics code 21-8-1001, which states that “no member of a state board or commission … shall participate in, vote on, influence, or attempt to influence an official decision” in matters in which members have a monetary interest.

He also noted an exception to the code – one that opponents failed to mention.

It states that commissioners can influence and vote on official decisions, so long as the monetary interest “is incidental to his or her position” or comes to “no greater extent” than it would for other members of their profession, occupation or overall group.

In addition, O’Malley stated that he found “no language” within 21-8-1001 or the Arkansas Code of Judicial Conduct that requires commissioners to answer plant opponents’ questions.

Thanks to Chris MacDonald for bringing my attention to this story.

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Managing influence on physicians

Following on recent stories about attempts to set financial thresholds and disclosure requirements in order to reduce pharma’s influence on health professionals, this story — New rules on conflicts proposed — at U. Wisconsin makes some interesting points. Banning physician gfits, dinners, etc. may be a good step, but,

the recommendations do not fully address drug company funding of continuing medical education, or CME. Observers say that continuing medical education has been used by the industry to market expensive brand-name drugs, in part by promoting non-approved uses for the drugs. “The one missing piece is CME,” Kassirer said. “That’s too bad.”

Further, even if there are stringent mechanisms in place about disclosure, they have to be enforced. Quoting Eric Campbell, the article notes that

It is one thing for a university to demand disclosure of payments, he said. It is another to actually check a disclosure against a doctor’s tax return.

Nonetheless, its interesting to look at the full extent to which UW is willing to go. These include prohibiting ghostwriting (where MDs are paid to sign off on scientific articles written by others) and all gift, and requiring reporting of participation at educational events, while and non-accredited events would be discouraged…

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