Marketing: August 2008 Archives

Among the compromises reached by the Massachusetts legislature last week in its health-code bill is the stipulation that drug companies will report any physician gifts exceeding $50 to the state's Department of Public Health. The bill now awaits the signature of Governor Deval Patrick, but 5 trade groups* are attempting to persuade the governor not to sign by way of a full-page ad in The Boston Globe.

In addition, PhRMA senior vice president Ken Johnson wrote yesterday in a press release that the public disclosure of gifts "could chill ongoing clinical research in the commonwealth." Johnson proposes, "Physicians and other healthcare providers who do not want such personal information disclosed may decide to no longer work with the pharmaceutical research companies sponsoring the clinical studies." He adds, "Public disclosure of a pharmaceutical company's arrangements with the principal investigators of its clinical trials also would reveal sensitive, proprietary business information to a company's competitors. This could erode the independent decision-making of companies trying to bring science from research facilities to patient care settings."

However, it seems unlikely that Massachusetts physicians would forego pharma research grants for clinical study given 1) the nature of this particular "gift" and 2) the fact that grant information is already publicly available through the NIH database at clinicaltrials.gov (although the size of the grant, to my knowledge, is not provided).

As far as public disclosure revealing "sensitive, proprietary business information," PhRMA's Julie Corcoran tells Pharmalot that, according to the bill, companies "shall disclose...the value, nature, purpose, and particular recipient of any fee, payment, subsidy or other economic benefit"—which, she argues, is subject to overly broad interpretation. But again, in the case of clinical grants, the nature, purpose, and recipient of the funds are already available through the NIH registry.

* Biotechnology Industry Organization, Massachusetts Biotechnology Council, Associated Industries of Massachusetts, Massachusetts High Technology Council, Cambridge Chamber of Commerce, and PhRMA.

8/11 update: The Boston Globe reports that Governor Patrick signed the bill yesterday.

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.