Tuesday, April 29, 2008

The AAMC Report on Medical Schools' Industry Relationships: A Glass Half Empty

The Association of American Medical Colleges (AAMC) just unveiled a report on relationships among academic medical institutions and the pharmaceutical, biotechnology, and device industry. The report was notable in its toughness in certain areas, laxity in others, and for what it did not mention, and what kinds of conflicts of interest it actually encouraged.

Where it was tough:
  • It advocated banning "acceptance of any gifts from industry by physicians and other faculty, staff, students, and trainees...."
  • It considered "industry supplied food and meals" as "personal gifts" which should be therefore banned (but see below).
  • It advocated prohibiting "physicians, trainees, and students from directly accepting travel funds from industry." (But see below.)
  • It advocated prohibiting "physicians, trainees, and students from allowing their professional presentations of any kind, oral or written, to be ghostwritten by any part, industry or otherwise."

Where it was lax

  • It did not ban interactions among physicians, faculty, staff, students and trainees and pharmaceutical or device representatives (sales people), only restricting such interactions to "nonpatient care areas and nonpublic areas," "by appointment or invitation of the physicians." Furthermore, it suggested that "involvement of students and trainees in such individual meetings should occur only for educational purposes."
  • It allowed "industry representatives who wish to provide educational information on their products" to do so "by invitation in faculty-supervised structured group settings"
  • It allowed "access by device manufacturers' representatives" if they are "appropriately credentialed."
  • It allowed participation in industry funded continuing medical education (CME) programs as long as they are accredited by the Accreditation Council for Continuing Medical Education (ACCME)
  • It allowed industry-sponsored food and meals as long as they are part of ACCME accredited CME.
  • It advocated that "participation by ... faculty in industry-sponsored speakers' bureaus" should be "strongly discouraged," but not prohibited.
  • It allowed industry to reimburse travel "for legitimate reimbursement or contractual services."

What it encouraged:

  • It acknowledged "the value of permitting academic medical center faculty to interact appropriately with industry." It deemed appropriate "faculty participation on industry boards of directors and scientific advisory boards," and faculty "services provided through professional service agreements and consulting contracts," as long as they are "in full compliance with the policies of the medical center and applicable law," and compensated according to "fair market value." It did not require, or even suggest disclosure of such financial relationships.

What it did not mention:

  • Institutional conflicts of interest, in general.
  • Industry manipulation or suppression of clinical research, and how contracts between academic medical institutions and industry allow such manipulation.
  • Some specific kinds of financial relationships between faculty and industry, including faculty holding executive positions with or founding health care corporations, and faculty receiving royalty payments.

In my humble opinion, at best this report, which I suspect will be highly influential, is a glass half empty.

There is reason to ban gifts and food to trainees, and physicians. Such gifts imply the need for reciprocity, and hence may be influential beyond their monetary value. See our posts (here, here, and here) on how gifts are used for marketing purposes by pharmaceutical representatives.

Yet given the evidence (see posts above) that the goal of pharmaceutical (and biotechnology and device) representatives is to market product, not provide education, the report's allowance of "educational" activities by such representatives is at best disingenuous.

Furthermore, given the evidence that industry sponsored CME is likely to be biased in favor of the sponsoring companies' products and services (see posts here, and here, and numerous posts on the Carlat Psychiatry Blog and the Hooked: Ethics, Medicine and Pharma blog ), and the logic behind this assertion, the report's allowance of such "educational" activities is also at best disingenuous.

I believe that the report's failure to address the issue of manipulation and suppression of industry funded research is astonishing given how obvious such problems have become. (Try searching these topics on this blog, to begin with.)

Finally, the report's encouragement of certain often lucrative financial relationships (such as consulting, service on advisory committees, and service on boards of directors of health care corporations), while it ignored other lucrative relationships (service as a corporate executive, founding of health care corporations, and receipts of royalties) suggests cynicism and hypocrisy.

First, even though small gifts may have influence beyond their monetary value, very large payments are likely to be more influential. Even without empirical research, common sense suggests that a faculty member who receives tens of thousands of dollars for consulting or serving on an advisory committee or speakers' bureau is likely to look favorably on his or her corporate part-time employer, and its products or services. Furthermore, serving as an executive of a corporation, and particularly serving on the board of directors of a corporation should demand loyalty to the corporation, and such loyalty can be enforced in court. Surely such loyalty is likely to be much more powerful than warm feelings generated by the receipt of a free pizza.

If there is a reason to ban gifts of pens, coffee mugs, or pizza slices due to the concern that such gifts may influence trainees and physicians' behavior, there is more of a reason to ban service on speakers' bureaus and advisory committees, consulting contracts, and particularly service as company executives, and on boards of directors.

Otherwise, we may well see the spectacle of a the director of a health care corporation punishing a medical student for accepting a pen with that corporation's logo on it.

And a postscript - It appears that this report may be so ambivalent about conflicts of interest because several of its authors were affected by such conflicts. On the PharmaLot blog, Ed Silverman reported that three authors are on the boards of directors of large health care corporations, and three other authors had significant financial relationships with health care corporations. None of these relationships were disclosed in the report. The report did disclose that four other authors were not academics or medical college administrators, but CEOs of pharmaceutical or biotechnology corporations. Why the AAMC saw fit to ask such people, who are obviously likely to be more loyal to their corporations than to academic medicine, is a mystery yet to be solved.

Note, see somewhat more optimistic opinions about this report on the Carlat Psychiatry Blog and the Hooked: Ethics, Medicine and Pharma blog. Also, a New York Times editorial accused of the AAMC of "flinching" from banning service on speakers' bureaus, and industry supported CME, but did not mention the report's support of consulting, service on advisory committees and boards of directors, service as a corporate executive, etc. But I agree with its general conclusion, "Patients need to be assured that their doctors are prescribing what’s best for them, not what’s best for companies. "

ADDENDUM (30 April, 2008) - See also coverage in the Gooznews Blog, in which Merrill Goozner noted that the report "stopped short of calling for prohibiting faculty members from consulting or speaking on behalf of drug and device companies, or for eliminating industry’s role in financing continuing medical education (CME)." On the other hand, the Postscript blog by the Prescription Project noted the AAMC report without much comment.

ADDENDUM (30 April, 2008) - On theRetired Doc's Thoughts blog, Dr James Gaulte is also skeptical, "My non-insider take is that there will be a flurry of high profile (within the institutions at least) announcements of 'no more free lunches' and much self congratulation and talk of professionalism but somehow I doubt the faculty will give up the lucrative lecture gigs although a veneer of word smithed propriety and oversight will be grafted onto it."

1 comment:

insider said...

Does Academia need a Committee of Truth and Reconciliation to assist in the process of forgiving and forgetting past entanglements with Big Pharma?