3.4.2 Relationships Between Physicians and Industry
Jeff Blackmer, MD, MHSc, FRCPC
- To understand the inherent conflict of interest present when physicians interact with members of industry
- To understand the ways in which industry influences physicians
- To be able to recognize conflicts of interest and resolve them in the best interests of the patient
You are the newly appointed Program Director for a residency training program in a large tertiary medical teaching centre. You have just met with a representative from a multinational pharmaceutical company to discuss issues of funding and residency education. She has expressed an interest in having increased involvement with your training program and its residents.
Specifically, she would like to purchase textbooks for the incoming first-year postgraduate (PGY1) residents each year to ensure that they have proper educational materials. These books are likely to cost $400 each, and there are three new residents admitted to the program every year. The representative would like to sponsor an educational session for the residents and medical staff in your department once a month at a local gourmet restaurant. These sessions would consist of dinner and drinks for physicians and their spouses, followed by a presentation by a local physician hired by the company who would discuss one of the company's products. Finally, the representative would like to provide an unrestricted continuing medical education (CME) grant for the department to facilitate bringing in an external speaker to talk about a topic of the department's choosing each year.
- Should you, as the new Program Director, have any concerns?
- Where is the potential for conflict of interest in this scenario?
- Does industry target physicians in training specifically, and if so, why?
- With reference to the Canadian Medical Association policy "Guidelines for Physicians in Interaction with Industry"(2007),"1 how should the Program Director approach:
- the offer to buy textbooks for the new residents?
- the offer to hold educational sessions?
- the offer of an unrestricted educational grant?
The relationship between physicians and representatives of private industry (including pharmaceutical companies, medical equipment manufacturers, radiological supply services and baby formula makers) is long-standing. Currently, particularly in Canada, little or no case law exists in this area. Some regulatory authorities have become involved in the area, but the situation is inconsistent across the country. The pharmaceutical industry itself is voluntarily self-regulated through Rx&D, a national representative association with voluntary membership to which not all companies belong.2 Physicians are guided by the Canadian Medical Association (CMA) policy "Guidelines for Physicians in Interaction with Industry"(2007)."1 Adherence to this policy is also voluntary, and there are no sanctions for non-compliance. In the United States, the law has been more stringent, with involvement from the Office of the Inspector General and fines in the millions of dollars for companies who have broken antitrust legislation.
According to the CMA policy, "The primary objective of professional interactions between physicians and industry should be the advancement of the health of Canadians."1 However, in reality, that is not always the case. Because both physicians and industry stand to gain, directly or indirectly, from this relationship, and because this gain has the potential to impact the patient-physician relationship, the possibility of a conflict of interest is extremely high.
The primary obligation of physicians is to provide the best care possible to each of their individual patients. Physicians naturally have secondary interests, including making a living from their income, advancing academically, and pursuing research and educational interests. These secondary interests are perfectly acceptable — as long as they do not interfere with the primacy of the patient-physician relationship. When they do, a conflict of interest has occurred. For such a conflict to be ethically problematic, one does not have to prove that it is impacting physician behaviour 3-5 — the very fact that the possibility of such an impact exists is ethically problematic in and of itself.
It is no secret that private companies are interested in making money. In most cases, they will market products directly to consumers. In the case of medications and other medical devices, they need to have a physician prescribe their product. Therefore, the marketing (and the millions of dollars a year that go along with it) will be geared toward physicians. This marketing can take the form of advertising, samples, sponsored continuing medical education (CME), educational materials, gifts, conferences and so on. It is all intended to directly influence physicians so that they will prescribe a particular company's product to their patients.
In spite of the recent tightening of some of the relevant guidelines, this marketing continues to take place. And physicians who say they are not influenced by it are ignoring the overwhelming scientific evidence that shows that they are influenced. Interestingly, the majority of physicians say that they are not influenced by industry largesse, although they feel that their colleagues are influenced.
Clearly, there are benefits to encouraging properly regulated physician-industry interaction. As public money for both research and CME has been continually cut, private companies have helped make up the shortfall, albeit with research and education that tends to be highly directed toward their products. Recently, provincial medical associations have been attempting to address the CME issue by negotiating for public funding for physicians to attend conferences. There is also little doubt that most of the pharmaceutical discoveries of the past few decades could not have taken place without funding from private industry and without physician involvement in the research and development of these products.
Efforts at regulation have been mixed at best. By and large, physicians are left to decide for themselves what constitutes an appropriate relationship and what is a blatant conflict. Is it OK to accept a pen? If so, what about a swimming pool or an addition to the house — both of which have been previously funded for doctors by drug companies. Where is the line that physicians have to cross where acceptable becomes unacceptable? Some have argued that this is up to the individual physician. Others say that any gift or incentive is acceptable because physicians can't be bought. And there is a school of thought that says that no gift is acceptable regardless of the value. This final line of thinking is supported by the social and medical science literature on gift-giving and reciprocity, which has shown that recipients of gifts are more likely to take a positive view toward the giver and are likely to want to reciprocate for the gift, either consciously or subconsciously.
Katz et al., as well as others, have examined the influence of gifts on prescribing behaviour.3-5 In particular, they demonstrate that, no matter the size of the gift, research supports that gift-giving has the power to influence behaviour. In addition, gift exchanges create a human tendency to engage in relationships of obligation and reciprocation.
The CMA guidelines are intended to provide physicians with information and direction when they interact with industry representatives. For instance, funding to attend CME events would not be considered acceptable unless the physician was part of the faculty for the event. Funding for industry-sponsored research should not exceed what the physician would normally bill clinically during this time to reduce the potential for enrolling patients for whom the study was not in their best interest or for prioritizing study patients.
In this case, the new Program Director needs to tread carefully. Textbooks would reasonably be considered gifts by most and should be directed to the program library and not to individual residents (article 44, CMA policy).1 Sponsored dinners should be modest in content or what the attendees would normally pay for themselves (article 32, CMA policy).1 Spouses should pay for attending the event, unless they are also physicians. The associated CME must be independent and geared toward the learning needs of the participants, not simply an advertisement for a new product, and speakers should be chosen by the CME planners (article 22, CMA policy).1 However, unrestricted educational grants to facilitate CME efforts are allowable, particularly when the department chooses the topic and speaker.
- Canadian Medical Association. Guidelines for Physicians in Interaction with Industry”(2007) http://policybase.cma.ca/dbtw-wpd/PolicyPDF/PD08-01.pdf
- Rx&D [Canada’s Research-Based Pharmaceutical Companies]. Code of conduct — January 2008. Principles and integrity. Available from: https://www.cag-acg.org/images/about/rx_dcodeofconduct2008.pdf
- Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. American Journal of Bioethics: AJOB 2003; 3(3): 39–46.
- Brennan TA, Rothman DJ, Blank L, Blumenthal D, Chimonas SC, et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA: Journal of the American Medical Association 2006; 295: 429–33.
- Angell M. The truth about drug companies: how they deceive us and what to do about it. New York: Random House Publishing; 2004.