Specifically, the delegates voted to approve a report of the AMA ethics committee that calls for a near elimination of industry support for CME. The report is entitled "Financial Relationships with Industry in Continuing Medical Education," and can be read in its entirely here.
It is a 12 page report, and CME geeks like me will want to pore over every word, but the essence is found on page 8 under "Recommendations." The third paragraph makes the intent of the AMA explicit:
"CME that is independent of funding or in-kind support from sources that have financial interests in physicians‘ recommendations promotes confidence in the independence and integrity of professional education, as does CME in which organizers, teachers, and others involved in educating physicians do not have financial relationships with industry that could influence their participation. When possible, CME should be provided without such support or the participation of individuals who have financial interests in the educational subject matter." (emphasis added)
What this means is that the AMA now expects that most CME courses will meet two criteria:
1. No commercial support for the activity.
2. Faculty teaching the CME should have no financial relationships (such as being on speakers' bureaus) with drug or device companies.
The report does allow for some exceptions to these criteria: "At times it may be impossible to avoid a financial interest or extraordinarily difficult or even impossible to mitigate its potential impact on an educational activity." They cite examples such as courses involving the use of very expensive material, such as cadavers or sophisticated equipment. Also, they allow that in some remote parts of the country it may be acceptable to take industry money to fly out experts to teach doctors. However, in that same "exception section," they reiterate that: "For the most part, accepting support from a company or permitting participation by an individual when there is an irreducible financial interest would not be ethically acceptable."
1. No commercial support for the activity.
2. Faculty teaching the CME should have no financial relationships (such as being on speakers' bureaus) with drug or device companies.
The report does allow for some exceptions to these criteria: "At times it may be impossible to avoid a financial interest or extraordinarily difficult or even impossible to mitigate its potential impact on an educational activity." They cite examples such as courses involving the use of very expensive material, such as cadavers or sophisticated equipment. Also, they allow that in some remote parts of the country it may be acceptable to take industry money to fly out experts to teach doctors. However, in that same "exception section," they reiterate that: "For the most part, accepting support from a company or permitting participation by an individual when there is an irreducible financial interest would not be ethically acceptable."
What happens next? Since the AMA literally defines "AMA PRA Category 1 Credit" for the ACCME, any company that deviates from the recommendations of this report will be non-compliant with ACCME's criteria for CME. ACCME itself will have to revise its Standards for Commercial Support to clarify that in most cases, commercial support is no longer allowed.
None of this will happen overnight, of course. But you can bet that medical societies and medical education companies that are dependent on commercial support are, even as you read this, holding emergency conference calls with their attorneys to figure out what they need to do next.
None of this will happen overnight, of course. But you can bet that medical societies and medical education companies that are dependent on commercial support are, even as you read this, holding emergency conference calls with their attorneys to figure out what they need to do next.
We have finally entered the era of post-deception medical education. Congratulations to the AMA.
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9 comments:
How do you think your interpretation that "Faculty teaching the CME should have no financial relationships (such as being on speakers' bureaus) with drug or device companies" would be interpreted? As an example, the majority of academic subspecialty medical oncologists direct and enroll patients in clinical trials of new drugs. As one would expect, these trials are sponsored by the pharmaceutical companies which have a chance to profit.
Should physicians who lead and enroll patients in clinical trials, be barred from being CME faculty?
Don't worry, the report states that in cases where a teacher has "unique" knowledge, a financial relationship is acceptable. These situations are rare in most of medicine, but perhaps more common in oncology? I'm not sure.
Your link to the report is broken. Here it is, on p. 92: http://www.ama-assn.org/assets/meeting/2011a/tab-ref-ccb-addendum.pdf
Thanks Kevin--I fixed it in the post.
Re: "When possible"..."Faculty teaching the CME should have no financial relationships (such as being on speakers' bureaus) with drug or device companies."
"When possible"!? Hah! Lawyers love "When possible" and "should" rather than "shall" because it's elastic enough to drive a corrupto-truck through.
The commercial CME guys are no doubt already noodling work-arounds around those specific terms.
I've said this many times before. The CME problem could be solved tomorrow by just having independent reviewers vet CME content and send gamed content back for rewrite. Let any source fund CME and let commercial funders pay the reviewers who would be selected independently. But nah, that's too simple.
Better to have the AMA gods on Olympus generate a 12 doc that is 10 pages of turgid dross. Paranthetically, this is an example of how America is strangling in its own administrivia.
P.S. How long were those guys working on this...?
"We have finally entered the era of post-deception medical education. Congratulations to the AMA. "
I agree. Of course they'll play the loophole game, but it's a powerful statement of intent that sends a solid message. Bravo
"I have the following conflict of interest: since I make (a little bit of) money by publishing an industry-free CME newsletter, I stand to benefit financially if drug companies were not allowed to fund my competitors."
Dr. Carlat is honest about his conflict of interest. These AMA buffoons are not.
Since no evidence of any harm to patients has ever been shown, this is yet another burdensome, pointless, oppressive regulation of the doctor.
Because the AMA is are a quasi-governmental organization, similar in power to a licensing board, this declaration merits a law suit for intentional interference with contract by anyone providing sponsored CME. The AMA sets ethical standards, and can sanction a doctor after a formal hearing, just like a license board. They have a duty to not harm the doctor. They should pay for any loss of fees, plus disgorge any unjust enrichment that results when advertising budgets of drug companies shift payments to advertising in their journals, and when the attendance at any AMA CME activity increases revenue.
During this litigation, I would demand a Daubert hearing, forcing them to present scientifically reliable information that 1) any patient harm has ever taken place,; 2) any doctor has continued to prescribe a treatment that did not work after attending sponsored CME; 3) that patients did not actually benefit from increased knowledge of their doctor after attending sponsored CME.
Dr. Behar (June 24, 2011 9:02 AM),
Absence of evidence is not evidence of absence.
I'm wondering if the same scrutiny would be applied to U.S faculty serving on Speaker's Bureaus overseas where there are no restrictions on pharma involvement in "EDUCATIONAL" activities/conferences? Invited speaking engagements could very easily become very "lucrative" as they likely are at present as well.
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