Wednesday, August 11, 2010

University of Minnesota

Defends Conflicts Policy

From Pharmalot:

Last week, the University of Minnesota finally released its long-awaited conflicts of interest policy

But some present and former faculty argue the rules come up short. They say the new policy lacks sanctions; there is no ban on consulting fees; there is no requirement for public disclosure of ties or holdings that may represent a conflict, and industry-funded continuing medical education is permitted, despite proposals to eliminate such financing.

“Read the fine print,” says Bill Gleason, an associate professor [in the medical school], who has blogged about the process (take a look). “This is not the cutting edge policy they talked about.”

And Gary Schwitzer, a former associate professor the in School of Journalism and Mass Commucniaton, and former director of the Health Journalism graduate program, says “there was an opportunity to be a world-class leader. This is not world class.”

The initiative has been controversial from the start. For instance, a professor who initially led the effort was disciplined in 2004 for secretly steering a $501,000 research grant to his own company. Leo Furcht was reprimanded for a “serious violation” of university conflict-of-interest policies in connection with a grant from Baxter Healthcare for stem cell research at the meed school. Interestingly, the med school dean chose him because of his transgression. “That seemed to me to be a compelling reason to appoint him to that role,” she said (see here).

And late last year, two committee members were found to have ties to drug or device makers. One was Scott Crow, a professor in the medical school’s psychiatry department, who reportedly received about $273,000 from various drugmakers between 2002 and 2008. Another was David Polly, a nationally known spine surgeon at the university who was under fire for his consulting relationship with Medtronic (back story).

He [General Counsel, Mark Rotenberg] says the effort took as long as it did because officials belatedly decided the policy should encompass the entire university, not just the med school and related health centers.

He also maintains sanctions will be in place when the policy is finally adopted later this year and punishments will vary according to “workforce classifications,” although he could not offer specific examples of any proposed disciplinary measures.

He then argues that a state law, the Minnesota Government Data Practices Act, prevents state government employers, such as the university, from requiring its state employees to disclose certain private info.
[You wouldn't want to go over to the State Legislature and get that fixed, Mr. Rotenberg?]

And what about CME?

“The general practice, to our knowledge, at most major academic medical centers is to allow other entities to support CME, but they have certain limitations. We know the University of Michigan has just decided to bar that support entirely. But we don’t believe that’s necessary to ensure integrity and transparency of our research and teaching."
[That's a comfort... Trust us? After all that has happened? Why, Mr. Rotenberg, why?]

His remarks concerning CME suggest there will be no changes to this portion of the policy and, of course, the details regarding violations are likely to be closely scrutinized, given the history of undisclosed conflicts - such as the psychiatry chair who promoted Seroquel as better than other drugs in its kind, despite data showing no such evidence existed, and while he consulted for AstraZeneca, the manufacturer.

So expect the criticism to continue when the university re-opens for business at the start of the fall semester and faculty return. As one faculty member noted, the policy was disclosed in the middle of the summer when faculty are mostly absent, which was perhaps an effort to blunt criticism and further negative publicity.


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