Pharmaceutical Industry Financial Support for Medical Education: Benefit,or Undue Influence?

May D. , “Selling Drugs by ‘Educating’ Physicians”, Journal of Medical Education 36, no. 1 (1961): 1–23; Silverman M. and Lee P. R. , Pills, Profits, and Politics (Berkeley: University of California Press, 1974).

Brody H. , Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry (Lanham, MD: Rowman and Littlefield, 2007); Angell M. , The Truth about the Drug Companies: How They Deceive Us and What to Do about It (New York: Random House, 2004); Kassirer J. P. , On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health (New York: Oxford University Press, 2005); Avorn J. , Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (New York: Knopf, 2004); Abramson J. , Overdo America: The Broken Promise of American Medicine (New York: HarperCollins, 2004); Weber L. J. , Profits Before People? Ethical Standards and the Marketing of Prescription Drugs (Bloomington: Indiana University Press, 2006).

ACCME Annual Data Report 2006, available at <http://www.accme.org/dir_docs/doc_upload/f51ed7d8-e3b4-479a-a9d8-57b6efedc27a_uploaddocument.pdf> (last visited May 20, 2009).

One defense of current industry involvement was authored by the then-president of the Pharmaceutical Research and Manufacturers of America (PhRMA); Holmer A. F. , “Industry Strongly Supports Continuing Medical Education,” JAMA 285, no. 15 (2001): 2012–2014. For the claim that physicians with the closest ties to industry are therefore the best-informed presenters of CME, see brief of the Washington Legal Foundation opposing new ACCME guidelines (infra note 37 and accompanying text).

Torrey E. F. , “The Going Rate on Shrinks: Big Pharma and the Buying of Psychiatry,” American Prospect, July 15, 2002, at 15–16.

Id., at 15.

Id., at 16.

Harris G. , “Psychiatrists Top List in Drug Maker Gifts,” New York Times, June 27, 2007, at A14.

See AAFP, “Assembly Partners,” available at <http://www.aafp.org/online/en/home/cme/aafpcourses/conferences/assembly.html> (last visited May 20, 2009). Note that as a matter of course, Web pages for the annual scientific assembly are taken down within a few months after completion of the meeting, to be replaced later on by advance announcements for the next year's meeting; the URL may change from one year to the next.

AAFP, “Exhibitor Information”, available at <http://www.aafp.org/online/en/home/cme/aafpcourses/conferences/assembly/exhibits.html> (last visited May 20, 2009). Note that this quote was taken from the link posted in 2007.

AAFP, “Attendee Demographics”, available at <http://www.aafp.org/online/en/home/cme/aafpcourses/conferences/assembly/exhibits/interested/benefits/demographics.html>; “Attendee Buying Power,” available at <http://www.aafp.org/online/en/home/cme/aafpcourses/conferences/assembly/exhibits/interested/benefits/buying.html> (last visited May 20, 2009).

AAFP, “Marketing Opportunities,” available at <http://www.aafp.org/online/en/home/cme/aafpcourses/conferences/assembly/exhibits/current/marketing.html> (last visited May 20, 2009).

For a description of the organization, No Free Lunch, see <http://www.nofreelunch.org> (last visited May 20, 2009); for news reports of the attempts to erect booths at meetings, see <http://nofreelunch.org/news.htm> (last visited May 20, 2009).

See Brody , supra note 2, at 23–50.

Erde E. L. , “Conflicts of Interest in Medicine: A Philosophical and Ethical Morphology,” in Speece R. G. Shimm D. S. and Buchanan A. E. , eds., Conflicts of Interest in Clinical Practice and Research (New York: Oxford University Press, 1996): at 12–41.

Id.

Epstein R. A. , “Conflicts of Interest in Health Care: Who Guards the Guardians?” Perspectives in Biology and Medicine 50, no. 1 (2007): 72–88.

I argue elsewhere that this tendency toward mutual reinforcement of rationalization can be traced back to deliberate advertising strategies adopted by the industry as far back as the 1950s; see Brody , supra note 2, at 146–147. An early perceptive statement of this problem follows: “The degree to which the profession, mainly composed of honourable and decent people, can practice such self deceit [that is, the view that they can accept gifts and benefits from industry while their judgment remains untouched] is quite extraordinary.” See Rawlins M. D. , “Doctors and the Drug Makers”, The Lancet 2, no. 8397 (1984): 814. A recent study on the extent to which this rationalization pervades physicians' thinking is Chimonas S. Brennan T. A. and Rothman D. J. , “Physicians and Drug Representatives: Exploring the Dynamics of the Relationship,” Journal of General Internal Medicine 22, no. 2 (2007): 184–190.

See generally Brody , supra note 2. An excellent source of evidence-based information about the influence of pharmaceutical marketing is <http://www.drugpromo.info> (last visited August 17, 2007).

Walker L. , “ROI for Meetings Beats Detailing and DTC”, Medical Meetings website, July 1, 2001, available at <http://meetingsnet.com/medicalmeetings/ar/meetings_roi_meetings_beats/index.html> (last visited May 20, 2009). The same figure was repeated in a more recent press account; see Healy M. , “In Short, Marketing Works,” Los Angeles Times, August 6, 2007.

See ACCME Annual Report 2006, supra note 3.

ACCME Annual Report 2004, available at <http://www.accme.org/dir_docs/doc_upload/2130a818-1c9f-400b-9d54-56b3f8f9a2f6_uploaddocument.pdf> (last visited May 20, 2009). More precisely, this portion of commercial support came from “firms that manufacture products regulated by the FDA,” that is, pharmaceutical, biologic/vaccine, and biotechnology companies.

See Brody , supra note 2, at 204–205. These figures represent 2003, the latest year of data available at the time that the detailed breakdown was carried out.

Relman A. S. , “Separating Continuing Medical Education from Pharmaceutical Marketing,” JAMA 285, no. 15 (2001): 2009–2012.

Elliott C. , “Pharma Goes to the Laundry: Public Relations and the Business of Medical Education,” Hastings Center Report 34, no. 5 (September–October 2004): 18–23.

See Brody , supra note 2, at 215–220.

For a review of the evidence that industry-sponsored trials are often biased, and that the industry often suppresses trial data that are unfavorable to sales, see Brody , supra note 2, at 97–138. A research trial sponsored by the industry is more than four times more likely than a neutral trial to reach conclusions favorable to sales of the drug. See Lexchin J. Bero L. A. Djulbegovik B. and Clark O. , “Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review,” BMJ 326, no. 7400 (2003): 1167–1170.

See Elliott , supra note 25, at 21. The reference to the academic researcher signing the article produced by the MECC refers to the practice of ghostwriting, in which a drug firm has an article written it its own specifications to transmit its preferred commercial message, an academic physician attaches his name as sole author (for a fee usually of around $1000), and the article is submitted to a medical journal with no evidence of industry authorship. For more on ghostwriting, see Brody, supra note 2, at 130–135.

Bowman M. A. , “The Impact of Drug Company Funding on the Content of Continuing Medical Education,” Mobius 6, no. 1 (1986): 66–69; Bowman M. A. and Pearle D. L. , “Changes in Drug Prescribing Patterns Related to Commercial Company Funding of Continuing Medical Education,” Journal of Continuing Education in the Health Professions 8, no. 1 (1988): 13–20. See also Lexchin J. , “Interactions between Physicians and the Pharmaceutical Industry: What Does the Literature Say?” Canadian Medical Association Journal 149, no. 10 (1993): 1401–1407; Dieperink M. E. and Drogemuller L. , “Industry-Sponsored Grand Rounds and Prescribing Behavior,” JAMA 285, no. 11 (2001): 1443–1444; and Spingarn R. W. Berlin J. A. and Strom B. L. , “When Pharmaceutical Manufacturers' Employees Present Grand Rounds, What Do Residents Remember?” Academic Medicine 71, no. 1 (1996): 86–88.

Sierles F. S. Brodkey A. C. and Cleary L. M. , “Medical Students' Exposure to and Attitudes about Drug Company Interactions: A National Survey,” JAMA 294, no. 9 (2005): 1034–1042.

See Elliott , supra note 25, at 22.

Bok D. , Universities in the Marketplace: The Commercialization of Higher Education (Princeton: Princeton University Press, 2003): at 206.

See Brody , supra note 2, at 287–298.

See Elliott , supra note 25, at 22.

See Brody , supra note 2, at 287–298. Also see Schafer A. , “Biomedical Conflicts of Interest: A Defence of the Sequestration Thesis,” Journal of Medical Ethics 30, no. 1 (2004): 8–24.

ACCME, ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME Activities, available at <http://www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725-80a1504e520c_uploaddocument.pdf> (last visited May 20, 2009).

See Washington Legal Foundation Press Release, available at <http://www.wlf.org/upload/1-30-03ACCME.pdf> (last visited May 20, 2009). When I last searched, the actual comment to the ACCME had been removed from the WLF Web site. The issue of freedom of commercial speech is too complex to be adequately addressed here. See, for example, Chen P. , “Education or Promotion? Industry-Sponsored Continuing Medical education (CME) as a Center for the Core/Commercial Speech Debate,” Food and Drug Law Journal 58 (2003): 473–509. I was pleased to read in Notes on the subject a proposed legal approach which seems to me to match well the ethical principles involved — that the responsibility of the government to regulate commercial speech increases to the extent that the commercial entity owns such a monopoly of resources that it effectively prevents dissenting points of view from being heard. See “Notes: Dissent, Corporate Cartels, and the Commercial Speech Doctrine”, Harvard Law Review 120 (2007): 1892–1913.

Office of the Inspector General, “Compliance Program Guidelines for Pharmaceutical Manufacturers,” Department of Health and Human Services, Washington, D.C., April 2003. Federal law is implicated, according to the report, so long as any physician in the CME audience is ordering prescriptions that are reimbursed by federal programs such as Medicare or Medicaid. It is argued that a company violates antikickback laws if it provides anything of value to the CME provider, in the expectation that in exchange, it will receive an increase in sales. The report basically describes an auditing strategy, and reassures companies that they will pass any audit so long as they maintain a clear organizational barrier between the part of the company that provides CME funding and the part of the company involved in advertising and marketing.

See Brody , supra note 2, at 209–211 for this argument.

Committee on Finance, U.S. Senate, “Committee Staff Report to the Chairman and Ranking Member: Use of Educational Grants by Pharmaceutical Manufacturers”, April 2007, at 2, available at <http://www.finance.senate.gov/press/Bpress/2007press/prb042507a.pdf> (last visited May 20, 2009).

ACCME, ACCME Policy Updates, August 2007, at 10, available at <http://www.accme.org/dir_docs/doc_upload/31835cb6-55ea-47cb-919f-7c28787b1917_uploaddocument.pdf> (last visited May 20, 2009).

For an example of such critical commentary, see <http://carlatpsychiatry.blogspot.com/2007/08/accmes-new-policies-translated.html> (last visited May 20, 2009).

I am indebted here to an anonymous reviewer of an earlier draft of this paper for suggesting counter-arguments to my position as expressed above.

Schafer A. , “Biomedical Conflicts of Interest: A Defence of the Sequestration Thesis — Learning from the Cases of Nancy Olivieri and David Healy,” Journal of Medical Ethics 30, no. 1 (2004): 8–24. Schafer uses the term “sequestration thesis” to refer to the position that in the text above I call the “divestment strategy”; see Brody , supra note 2, at 287–298.

On the problems with Vioxx and related COX-2 drugs, see Brody , supra note 2, at 106–113.

As this paper was being edited for publication, the Institute of Medicine released its report on conflicts of interest, which strongly endorsed a divestment strategy for CME, proposing that all industry funding be eliminated following a two-year transitional planning period: Lo B. and Field M. J. , eds., Conflicts of Iinterest in Medical Research, Education, and Practice (Washington, D. C.: National Academies Press, 2009).