Isn’t it Time to Stop Accepting Handouts for our Educational Efforts?
By KM Tan, MD
The drip-drip-drip method of torture mistakenly attributed to the Chinese but more accurately Italian in origin1 has proven pervasive and persuasive over the past year as more and more reports of prominent and preeminent physicians failing to report substantial amounts of money from pharmaceutical and medical equipment companies hit the media.
The raison d’être of drug companies is to maximize profits for their shareholders. This has led to an ongoing ethical conflict between marketing departments whose sole purpose is to increase sales versus the pharmaceutical companies’ educational departments where distinct separation of provided commercial support from the intent and content of educational interventions is considered paramount.
Most highly paid speaking engagements offered to internationally and nationally renowned physician researchers at top universities appear, unfortunately, to be paid from the marketing departments of pharmaceutical companies. It is becoming depressingly obvious that large and substantial payments are conveniently not reported to universities as policy requires. This has, predictably, not only tainted their reputations but also raised questions about the quality of the research activities.
Consider the case of Charles Nemeroff, MD, Chair of the Psychiatry Department at Emory University as reported in the New York Review of Books. He failed to disclose, per university policy, that for over 250 educational presentations to physician audiences he had received more than $1.2 million between 2000 and 2006 from several pharmaceutical companies, primarily GlaxoSmithKline.2 Dr Nemeroff was simultaneously the principal investigator of a five-year $4 million grant from the National Institute of Mental Health to study several GlaxoSmithKline drugs. Federal rules call upon him to report any amounts over $10,000 to the National Institute, a regulation conveniently overlooked.
Particularly egregious was the fact that Dr Nemeroff was investigated by Emory University in 2004 and was cited for multiple policy violations as a result of which he promised to report any remuneration in excess of $10,000 from any one company. He reported $9999 from GlaxoSmithKline that year while, apparently, actually receiving $171,031.3 In late December 2008, Dr Nemeroff was permanently relieved of his position as Chair of Psychiatry at Emory. However, the damage is done, raising questions about his research activities, his multiple educational presentations, and his influence worldwide as co-editor of the Textbook of Psychopharmacology (Arlington,VA: American Psychiatric Press; 1998).
Dr Nemeroff’s case is not a study in isolation. Reported in The New York Times is another world-renowned psychiatrist, Joseph Biederman, MD, of Harvard University, whose research has resulted in an exponential increase in the use of powerful antipsychotic medications for children as young as two years of age. He also failed to report more than $1.6 million in consulting fees from pharmaceutical companies from 2000 to 2007.3,4 Two other colleagues in the same department failed to report similar substantial income as well.4
That such preeminent and sophisticated scientists apparently chose to cover up their conflicts of interest is a sad commentary on the state of ethics in our medical profession.
Awareness of these episodes is a result of a congressional inquiry through the efforts of Senator Charles Grassley (R-IA) of the Senate Finance Committee who is now turning his investigation from psychiatrists to cardiologists. There are already multiple examples of questionable ethical behaviors involving cardiologists and orthopedic surgeons where surgical device makers appear to have a cozy relationship with physicians promoting their products. I would venture no medical specialty would be off limits.
Continuing education for physicians is a multibillion-dollar enterprise generously supported by pharmaceutical and medical device companies historically, amounting to approximately 60% of a total outlay of $2.7 billion in 2007. Increasing fears that the firewalls promulgated by the Accreditation Council on Continuing Medical Education (ACCME) are proving porous are buttressed by the stories related above and have led to an increasing consensus for the complete separation of commercial support from educational interventions.
In November 2007, the Josiah Macy, Jr, Foundation released a report5 on continuing education in the health professions reflecting the conclusions of a group of preeminent medical educators that commercial support for continuing education risks distorting educational content and invites bias, raises concerns about the vows of health professionals to place patient interests uppermost, endangers professional commitment to evidence-based decision making, validates and reinforces an entitlement mindset among health professionals that continuing education should be paid for by others and impedes the adoption of more effective modes of learning. The report calls for a ban on commercial support for accredited organizations that provide continuing education and recommends that faculty of academic centers should not serve on speakers’ bureaus or as paid spokespersons for pharmaceutical or device manufacturers. In addition, the report decries the common practice of publishing articles, reviews, and editorials under the names of prominent academics that have been ghost written by industry employees and recommends its prohibition.5
In April of 2008, a task force on industry funding of medical education from the American Association of Medical Colleges called on all medical schools to ban drug company food and gifts and to strongly discourage faculty from serving on speakers’ bureaus.6
Finally, the Council on Ethical and Judicial Affairs of the American Medical Association recommended the discontinuance of commercial support for medical education,7 a heroic stand soundly defeated by the June 2008 House of Delegates, perhaps a reflection of the entitlement mindset mentioned in the Macy report.
Stanford University, one of the leading providers of radiology CME, has historically held elaborate vendor-supported receptions linked to large meetings, including International Symposia on multidetector row CT, PET/CT and molecular imaging, neuroradiology, etc. These receptions have been noted for “full-sized CT ice sculptures, ‘mad-scientist’-inspired hors d’oeuvres, and dancers/acrobats in colorful costumes, futuristic helmets, and roller skates,”9 A new policy (http://cme.stanford.edu/documents/cme_commercial_support_policy.pdf), effective September 1 2008, changes everything. Under this new policy, no exhibits are allowed. According to Philip Pizzo, MD, “If company support has been linked either directly or indirectly to marketing goals, I expect that the funding support will decline.”9 Stanford University has been a leader in reforming interactions between industry and the medical profession, in research, in education, and in clinical care, and has restricted commercial funding since 2006 with its Industry Interactions Policy (available at: http://med.stanford.edu/coi/siip/), which addresses the issues raised here. (Philip Pizzo, MD, personal communication. 2009 Apr 30).a
Cleveland Clinic has also started publicly reporting the business relationships that any of its 1800 staff physicians and scientists have with pharmaceutical companies and device makers.9 This is an understandable reaction to the increasing and ongoing furor on conflicts of interest that occur when physicians work closely with pharmaceutical companies and device companies in research and development, yet artfully neglect to have appropriate financial disclosures available to all and sundry.
The Permanente Medical Group (TPMG) adopted a strong revised conflict of interest policy for its physicians effective January 2005, whereby physicians are prohibited from receiving anything from commercial vendors; this includes funding for CME programs directed at TPMG physicians. The medical group has allocated sufficient funds to cover the shortfall resulting from the loss of commercial support. Sharon Levine, MD, Associate Executive Director, TPMG, faults the assumption that if you cap the amount of money you receive as a gift or a gratuity that somehow caps the level of influence. Rather, she points out, the social science literature is replete with research that supports the premise that it is not the size of the gift, but the gifting itself that creates the desire to reciprocate.10
Because of the increasing scrutiny and with multiple examples of questionable practices and given the risk of eroding the trust of our patients, perhaps it is time to consider whether all physicians and employees in Kaiser Permanente will need to build on the foundation that TPMG and other medical groups, notably the Northwest Permanente Medical Group and the Colorado Permanente Medical Group have started: the separation of commercial support from our educational endeavors nationwide would be a great start.
a Memo from Phillip A Pizzo, MD, Dean, Stanford University School of Medicine.
References
1. Innes B. History of Torture. New York: St Martin’s Press; 1998.
2. Harris G. Top psychiatrist didn’t report drug maker’s pay, Files show. The New York Times. 2008 Oct 4;Sect A:1.
3. Angell M. Drug companies and doctors: a story of corruption. New York Review of Books 2009 Jan 15;56(1): 8-12.
4. Harris G, Carey B. Researchers fail to reveal full drug pay. The New York Times, 2008 Jun 8; Sect A:1.
5. Fletcher SW. Continuing Education in the Health Professions: Improving Healthcare through Lifelong Learning [monograph on the Internet]. Josiah Macy Jr Foundation 2007 Nov [cited 2009 Apr 6]. Available from: www.josiahmacyfoundation.org/documents/pub_ContEd_inHealthProf.pdf.
6. AAMC Calls for Strict Limits on Industry Support of Medical Education: Association Leadership Approves New Guidelines [News release on the Internet]. Washington, DC: Association for American Medical Colleges; 2008 Jun 19 [cited 2009 Apr 8]. Available from: www.aamc.org/newsroom/pressrel/2008/080619.htm.
7. Industry Support of Professional Education in Medicine, REPORT OF THE COUNCIL ON ETHICAL AND JUDICIAL AFFAIRS (CEJA Report 1-A-08) [monograph on the Internet]. Chicago (IL): American Medical Association; 2008 Jun [cited 2009 Apr 8]. Available from: www.ama-assn.org/ama1/pub/upload/mm/369/ceja-cme_1i08.pdf.
8. Boughton B. Elite medical facilities ban commercial support of CME. Diagn Imaging [serial on the Internet]. 2008 Nov [cited 2009 Apr 7];30(11):[about 3 p]. Available from: www.diagnosticimaging.com/display/article/113619/1348486.
9. Abelson R. Doctors show their hand. The New York Times, Dec 3,2008; Sect B:1.
10. No free lunch: TPMG a leader with a conflict of interest policy. TPMG forum [serial on the Internet]. 2008 Jul-Aug [cited 2009 15 Apr];20(4):[about 3 pages]. Available from: http://cl.kp.org/portal/site/ncal/template.FRAME/menuitem.edbcbd56bff107f8401fdf702a71eea0/? url=http%3A%2F%2Fcl.kp.org%2Fpkc%2Fncal%2Fclib%2Fnews%2Ftpmg_forum%2Fjul_aug_2008%2Findex.htm? epi_baseMenuID=null&epi_menuItemID=null&epi_menuID=null. (Password protected.)
