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Pharmaceutical Industry Disclosure Practices


CME and the pharmaceutical industry:
two worlds, three views, four steps
by David A. Davis, Canadian Medical Association Journal (July 20, 2004; 171 (2) 149)


Imagine you have following two courses to choose from. Course A is a 3-day event sponsored by ABCPharma. Called Diabetes Today, it is a series of lectures held at an upscale resort. Registration is only $125, the accommodation fee is sizably reduced, and the course promises to provide a much-needed break from practice. Course B is sponsored by "McRonto University" (the new medical school in Oakville, Ont.) and will be held at a reasonably priced hotel in town. It costs $325 for two and a half days, plus full-fare accommodation. The topic - managing diabetic patients with comorbidities - will be covered in multiple formats, including case-based workshops. The choice should be fairly easy: course B, given its better format, more clearly defined objectives and apparent freedom from the influence of the pharmaceutical industry, easily trumps course A - at least in the mind of the ethical, self-directed, evidence-based physician. Or does it?

The role of "big pharma" in continuing medical education (CME) is undoubtedly one of the major professional issues in medicine today. Let us approach it from three different vantage points: that of the pharmaceutical industry, of medical schools, and of physicians and their patients. "Big pharma" involvement in CME is a mixed picture. On the one hand, the pharmaceutical industry has its own interests - it's a business, after all - and there are lots of examples of so-called educational events whose real objective is to change prescribing behaviour.1,2 On the other hand, a code of marketing practices does exist,3 many pharmaceutical companies are scrupulous about distinguishing between CME and promotion, and - at the end of the day - many discoveries that extend lives and reduce suffering are made in the research departments of pharmaceutical
companies.

Now for the involvement of medical schools. The role of an ethical provider of CME such as "McRonto University" is, to a greater extent than one might imagine, a mixed picture of pharmaceutical and nonindustry funding. Although separate data do not exist for Canadian schools, the biannual survey of the Society for Academic Continuing Medical Education4 captures data from the United States and Canada. This survey reflects a growing trend among medical-school providers of CME: over the period 1993-2001, while medical schools reported a modest 25% increase in the number of courses and a doubling of registration fees, they disclosed a quintuplingof commercial support for CME. Does this matter? Does increased industry funding necessarily lead to bias in medical-school CME?

Research indicates that industry funding can skew CME content in various ways to match the goals of industry.2,5,6 This skewing may be felt in the subtle influence of industry on the selection of topics (do medical-school CME curricula devote as much time to the diagnosisof hypertension as it does to its treatment?) or, at a more general level, in what receives support and what does not (courses on social pathologies are less common than those, say, on diseases with specifically "medical" management). Given that the primary driver of physicians' involvement in CME is an interest in their patients' welfare, and that the main interest of industry is to promote profitability,7,8 increased industry funding of CME raises many questions, among them: What can we do about a possible skewing effect? Need we do anything? Here we come to the third vantage point. In determining the appropriate boundaries between the pharmaceutical industry and medical schools and, by extrapolation, between industry and CME more globally, we must not forget what CME is all about: physician-learners and their patients. This vantage point must inform the steps we take to ensure that physicians make informed decisions about CME. In that vein, let us take the following steps:

1. Increase the decision-making capacity of physicians. We need to assure ourselves that physicians have adequate undergraduate, postgraduate and continuing training in critical appraisal and ethical decision-making. This assurance implies both teaching and testing. Let's do both. Let's do them better.

2. Broaden the definition of "full disclosure."It may not be enough to ask the physician-speaker to "disclose" industry connections at the beginning of a talk. All CME providers, medical school and industry included, might
consider indicating the full amount that industry (and other sources) have contributed to programming, so that physician-learners can discern the degree of pharmaceutical or other support. This is not a new concept.9

3. Level the playing field. Some have called for greater government and professional support for continuing professional development, to balance the influence of industry.10 Although support from these quarters also has the potential to introduce bias, the diversification of funding sources has in fact begun: the support of the Ontario Ministry of Health and Long-Term Care and of the Ontario Medical Association for the Guidelines Advisory Committee11 is an example, as is the federal government's Primary Health Care Transition Fund12 initiative with the Association of Canadian Medical Colleges. This could be just the beginning.

4. Organize dialogue, develop guidelines, give the process legs and teeth. Who will continue the dialogue, and how? Who will develop Canada-wide guidelines and see to their application? Although guidelines do exist at the local level (the University of Toronto's are arguably the most stringent in the country13) and overall accreditation guidelines are in place,14 there is wide variability in their application. Clearly, we need a national body to take on the challenge of containing, examining and regulating the issues for all Canadian health care such as the Committee on Accreditation for Continuing Medical Education (a collaborative accreditation process of t the Canadian Medical Association), the Association of Canadian Medical Colleges, the Royal College of Physicians and Surgeons of Canada and the College of Family Physicians of Canada, among other groups. Are there more steps to take in the process? Of course. But if we want physicians to have the necessary information, skills and confidence to make informed decisions (for example, in choosing between course A and B), and thus to be better able to balance learning needs and patient concerns, these four action items might be a start.

References
1. Relman AS. Defending professional independence: ACCME's proposed new guidelines for commercial support of CME. JAMA2003;289:2418-20.
2. Wazana A. Physicians and the pharmaceutical industry. Is a gift ever just a gift? JAMA2000;283:373-80.
3. Code of marketing practices. Ottawa: Canada's Research-Based Pharmaceutical Companies; revised Jan 2004. Available: www.canadapharma.org/Industry_Publications/Code/Code_of_marketing-ENJan2004.pdf (accessed 2004 April 6).
4. Society for Academic Continuing Medical Education. Biennial survey. Available: www.sacme.org/Biennial_Survey/default.htm (accessed 2004 April 6).
5. Lexchin J. Interactions between physicians and the pharmaceutical industry: What does the literature say? CMAJ1993;149(10):1401-7.
6. Relman AS, Angell M. America's other drug problem. N Republic2002;27-41.
7. Coyle SL; Ethics and Human Rights Committee, American College of Physicians-American Society of Internal Medicine. Physician-industry relations.
Part 1: individual physicians. Ann Intern Med2002;136(5):396-402. 8. Coyle SL; Ethics and Human Rights Committee, American College of Physicians-American Society of Internal Medicine. Physician-industry relations. Part 2: organizational issues. Ann Intern Med2002;136(5):403-6.
9. Steward DE. A proposal to enhance the disclosure of potential conflict of interest for continuing medical education events. Teach Learn Med2003;15(4):267-9.
10. What's wrong with CME? [editorial] CMAJ2004;170(6):917.
11. Guideline Advisory Committee. Recommended clinical practice guidelines.
Available: www.gacguidelines.ca (accessed 2004 April 6).
12. Health Canada. Primary Care Transition Fund. Available: www.hc-sc.gc.ca/phctf-fassp (accessed 2004 April 6).
13. Policy on support of University of Toronto sponsored continuing education activities
from commercial sources. Toronto: University of Toronto; 1999. Available:
www.library.utoronto.ca/medicine/staff_info/Commercial_Support.pdf (ac-
cessed 2004 April 6).
14. Accreditation Council for Continuing Medical Education. Standards for com-
mercial support. Standards to ensure the independence of CME activities. Available:
www.accme.org/incoming/174_Standards%20for%20Commercial%20Support
_April%202004.pdf (accessed 2004 April 6).


Pharmaceutical Industry Donations & Continuing Medical Education
Pharmaceutical Industry Donations & Policy Think Tanks and Advocacy Groups
Pharmaceutical Industry Support for Patient Groups/Promotion of Prescription Drugs
Pharmaceutical Industry Donations & Charitable Conduits to Doctors
Pharmaceutical Industry Donations & Influencing Prescribing Guidelines

Pharmaceutical Industry Disclosure Practices