NIH Panel, Ethics Code & Blood Curdling Restraints

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collinsnihspeechAmid controversy over conflicts of interest and academic researchers, the Advisory Committee to the National Institutes of Health director late last week held a lengthy discussion of the issue. NIH director Frances Collins, in fact, confirmed the agency may change a rule allowing academics to receive NIH grants after switching university jobs, even though sanctions were imposed on a previous university employer because of undisclosed financial conflicts.

What followed, however, was equally interesting. Keith Yamamoto, executive vice dean of the University of California, San Francisco School of Medicine, pointed out that the American Heart Association is being prevented from allowing pharmaceutical industry employees make any presentations duing the scientific sessions of its upcoming annual meeting (for the curious, go to this link and fast forward to about 1 hour minute and 48 minutes seconds to hear this discussion).

Why? Last year, the Accreditation Council for Continuing Medical Education, which promulgates a code governing interaction with drugmakers, clarified a 2004 rule (see questions 8, 9 and 10 here) that prohibits such activity. “The policy is blood curdling,” Yamamoto said. “This is conflict-of-interest considerations run amok.”

Collins, who remarked on the “gasps heard around the room” after Yamamoto spoke, was quick to agree. “This is a breathtaking sweep to squash something that’s really important to us, which is science that is going on in the private sector…This is a seriously distressing step….taking what was an important principle and pushing it in a drection that makes no sense for the progress of science.”

Another panel member, AHA president Clyde Yancy, says the organization is appealing. “We were told we could not integrate the science (from industry employees) into any sessions. We could not invite speakers to be on our programs unless they were in a separate venue. And we could not portray the work unless it was in a separate geographic location from other CME. We’re aggressively appealing and working against it.”

The ACCME rules do not prevent pharma employees from making presentations not in a CME setting. In any event, an ACCME spokeswoman was unable to say whether a formal appeal was made by the AHA or whether exceptions may be granted. We will update you with additional info. However, as The Milwaukee Journal-Sentinel reports in a thoughtful story about this issue, in the 2008-09 fiscal year, the AHA received about $17 million from drug and device makers, including $1.7 million directly for CME. We are awaiting word on the share this represents of the AHA budget. UPDATE: The $17 million represents about 3 percent of total revenue.

UPDATE: As of 6:15 pm EST, the AHA sent this response: “The American Heart Association feels that it is crucial to stimulate scientific exchange and intellectual discussion while also being compliant with the relevant guidelines that allow us to be accredited to provide continuing education. In order to comply with a change in the guidelines from the ACCME, we currently are examining our policies concerning CME credits at our scientific conferences. Our priority is to present the best peer-reviewed science. We are continuing to gather input from leading scientists as well as other national healthcare nonprofit organizations in order to work collectively to address what we believe are unintended consequences of the ACCME position.”

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  1. Give Yamamoto the hyperbole of the year award. What a wanker.

  2. The ACCME rules do not prevent pharma employees from making presentations not in a CME setting

    so what’s more important - the information or the CME credits?

  3. Collins needs to get his stuff together,

  4. Hear more about Dr. Clyde Yancy’s views on conflicts of interest, here:

    http://tinyurl.com/2bj65n6

    Dr. Yancy spent most of his career, including an internship and residency, at UT Southwestern Medical Center in Dallas.

    According to a study published in the Annals of Internal Medicine this week, UT Southwestern ranked low in social mission. The study also found that medical schools that received the most funding from NIH tended to have the lowest social mission scores. Source: Jacobson, S. UT Southwestern ranked low in ’social mission’ study of medical schools some say is flawed. The Dallas Morning News, June 16, 2010. Read more, here:

    http://tinyurl.com/2g64byc

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