ACCME Proposes Another Limitation on CME Production
Good lord almighty. I'm beginning to think that the ACCME should move to Cuba.
The council that bestows accreditation on organizations to provide CME is now proposing that independent physicians or writers who are involved in the production of any kind of promotional material for pharma cannot be involved in the development of content for CME. This would arguably prohibit any non-industry physician involved on a company's advisory board or speakers' bureau from participating in the production and delivery of CME. Likewise, any independent writer who produces promotional material for a company could not be involved in the creation of CME content about the same drug class. Yeesh, what's next, ACCME? Little Mao caps?
The ACCME's new proposal is evidently based on the following:
In May 2008, the Attorney's[sic] General of thirty US states won a judgment against a commercial interest that included the stipulation that a promotional speaker for the commercial interest could not also be a CME speaker, on the same class of drugs discussed in the promotion activity, in a CME activity that received funding from the commercial interest.
As Thomas Sullivan at the Policy and Medicine blog points out, the ACCME's characterization is not exactly accurate. In May 2008, Merck actually agreed to a multistate* settlement (it was not a judgment) regarding its Vioxx ads. With respect to the funding of CME, the settlement indicated that Merck will comply with the ACCME's Standards of Commercial Support (nothing particularly earth-shattering) and that any person acting in a promotional capacity for Merck shall disclose to CME participants this promotional relationship (again, nothing particularly earth-shattering). This settlement also indicated that Merck cannot fund a CME program, if it has foreknowledge that a CME speaker has been a promotional speaker for Merck during the last 12 months (a minor tremor, given that Merck could not recommend CME speakers anyway, according to the ACCME standards).
In addition, the ACCME cites a June report from the AAMC Task Force, which urged academic medical centers to discourage their faculty from participating in industry-sponsored speakers' bureaus. But the Task Force also wrote,
To the extent that academic medical centers choose to allow participation of their faculty and staff in industry-sponsored, FDA-regulated programs, they should develop standards that define appropriate and acceptable involvement.
1. Academic medical centers should require full transparency and disclosure by their personnel to the centers and when participating in such programs; and
2. Academic medical centers should require that payments to academic personnel be only at fair market value.
So the ACCME, given the full details of the Merck settlement and the AAMC opinion, is overgeneralizing and grossly overstepping its purview, IMO, by proposing that non-industry physicians limit their communication to other physicians, depending on the setting. Moreover, the ACCME's proposal would needlessly undermine opportunities for independent medical writers to earn a living.
Or to provide another free-speech comment: Blpppht.
AAMC = Association of American Medical Colleges; ACCME = Accreditation Council for Continuing Medical Education.
* Twenty-nine states and Washington, DC.
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Good editorial, except for the last line. Free speech has nothing to do with this--the government is not involved. ACCME can do whatever it wants; it's a private organization.
I don't know. The issue seems complicated.
Yes, the ACCME, as a private org, could impose its restrictions on its member (ie, accredited) organizations. Although the limitations on who can speak or write promotional vs CME material would be imposed ultimately on nonmembers--ie, independent physicians and writers. But then again, does the constitutional right of free expression apply to independent physicians' and writers' "right" to engage in commercially supported speech?
Also some ACCME-accredited institutions (eg, medical schools, academic centers) receive government funding. Does that further cloud the issue? I don't know. I would defer to constitutional experts, who are likely to have a range of opinions anyway.
In the end, the ACCME proposal just FEELS like a restriction on free speech.
Are you all sure this is not a first amendment issue? It seems clear cut.
If the May, 2008 judgment came through a federal court, that puts the judgment in jeopardy of being overturned by reference to the 1st amendment.
If conflict of interest were upheld as a precedent for gag orders, Washington D.C. would become the quietest place in the world.
I would think an appeal to that part of the judgment would be defensible.
Further, if the free speech avenue is explored, one could launch an attack on the ACCME related to such a position. At various points in their operations, ACCME interfaces with the federal and state governments. Should any state medical board seek to require ACCME accreditation for CME courses, one could sue that the government organization was aligning themselves illegally with an organization which prevents free speech.