Industrial Interests and Surgeons' Obligations

A spirited debate on the role of industry funding in surgery was the highlight of the winter quarter dinner meeting of the St. Michael's Hospital surgery department. A background paper provided to the speakers by orthopaedic resident Mark Camp described how the US Federal government, concerned about the escalating cost of 700,000 hip and knee replacements per year, initiated an investigation by the Department of Justice. Criminal charges were filed against four major orthopaedic manufacturers for violating federal anti-kickback statutes. US $800 million had been paid to orthopaedic consultants as royalties or consulting fees for teaching, research, training sales representatives in the operating room and travel. Fines of $310 million have been paid under a deferred prosecution agreement, and criminal prosecution of individual surgeons is threatened.

Tim Daniels

Orthopaedic surgeon Tim Daniels, who organized the meeting, introduced the speakers and the topic. He told us that 90% of the $21 billion pharmaceutical marketing budget is directed at physicians. Research funding for multicentred trials in the US is heavily weighted toward industry. Private foundations provide $10 billion, federal funds $29 billion, and industry $60 billion. NIH funding for research has remained static as the burden of disease increases. 94% of US physicians have some relationship with industry. The Food and Drug Administration cannot find enough unconflicted physicians to fill its advisory boards. Awareness of abuse, kickbacks and biased publications is eroding public trust in the profession. If funding by industry were prohibited, the gap will never be filled by public or private sources. Industry has an important role, but its governance is currently under critical review.

Doug Thomson, Executive Director of the Canadian Orthopaedic Association (COA) and former industry CEO, set the stage, asking: "How far is too far in the surgeon- industry relationship?" He showed a flurry of news headlines describing bribes, kickbacks, and confusion about conflict of interest management. He quoted the Royal College Surgical Ethics Curriculum and clarified the values guiding the ethic of business, where "financial rewards are culturally accepted for enhancing profits". He cited the standards of the COA and advocated a publicly accessible website for publishing an "open book account" of all industry payments to physicians. This accounting was mandated by the US court for Zimmer, Biomet, Depuy, and Smith & Nephew, as part of the court's preliminary settlements with these orthopaedic manufacturers. The Cleveland Clinic, under the leadership of its innovative and entrepreneurial CEO, cardiac surgeon Toby Cosgrove, will now voluntarily publish all industry payments to its physicians and surgeons.

Allan Gross

Orthopaedic surgeon and Blue Jays team doctor Allan Gross claimed that "we've come so far by doing it just right". He offered the evidence that some surgeons voluntarily divert industry funds to third party oversight by their department, hospital or training program director, and they contribute directly from their salaries to support research. He described the critical importance to industry of surgeon designers, who uniquely know the field conditions that will determine the usefulness of a medical device. They should be compensated through royalties or contracts - if and only if they participate in the design. Surgeon consultants' legitimate role should be paid by reasonable fees on an hourly or annual basis for the development of courses, skill centres and for preceptorships and direct surgeon-to-surgeon case consultation and reviews. He decried the misuse of royalties or annual fees when they are used as a kickback to promote the company's business interests, and the use of lavish resorts for education, describing these as efforts to recruit surgeons, fellows and residents to be future customers.

Solly Benatar

Physician bioethicist Solly Benatar, Emeritus Professor of Medicine at the University of Cape Town and a faculty member of the University of Toronto's Joint Centre for Bioethics took us to the 30,000 foot level. Based on the writing of Eliot Freidson, (1) he argued that the logic of professionalism, rather than commercialism, consumerism, bureaucracy or law should guide our management of this issue. The logic of professionalism is based on trust in the knowledge, dedication and self-regulation of professionals, whereas market logic is based on freedom, rational choice, competition and consumerism. Professionalism is being eroded by expansion of self-interest and expanded control of research by the financial interests of industry. The conflict illustrated in Solly's nearby figure pulls us away from surgery as a calling to a valued social service and toward personal entrepreneurial (2) self-interested striving, a highly valued activity in the market ideology and logic. Quoting Edmund Pellegrino, his suggested solutions include "reconfiguring medical economics to foster the classical ideals of commitment to individuals, public good, and altruism"; and "strengthening of institutional ethics, taking into account the roles and legitimate interests and obligations of diverse parties". He cited the recent examples of erosion of professionalism such as the revelation of kickbacks ("payment for collaboration, especially for illicit profits" Canadian Oxford Dictionary) and falsification of conflict of interest disclosure forms at prominent American universities. During a vigorous discussion period, Solly made reference to the imaginative and challenging 'Health Impact Fund' project (under the leadership of Thomas Pogge) to reshape pharmaceutical industry activites in a manner that enables development of drugs with potentially major beneficial effects on the health of large numbers of underserved people without reducing pharmaeuctical company earnings.

The surgeons expressed enthusiastic appreciation for the insights and the stimulating discourse provided by all of the participants, as exemplified by Jim Waddell's comments:

"This discussion was illuminating for all of us and though it focused primarily on orthopaedic surgery because of topicality, the dilemma about industry-physician relations is common in all areas of medicine and surgery. I don't see this as a black and white issue - certainly I'm not naïve enough to think that all physicians are good and all of industry is bad. There is a partnership between physicians and industry that is essential to the wellbeing of both. The problem as I see it is that the ethics of business and the ethics of professionalism are different. That doesn't make the ethics of one good and the ethics of the other bad - just different. What's desperately needed is some type of interface between the two groups that satisfies the ethical needs of both, rewards people fairly for their intellectual property and ensures continued advances in medical care through responsible product development."

M.M.

(1) Freidson, Eliot. Professionalism: The Third Logic Chicago: University of Chicago Press, 2001.

(2) An entrepreneur is "a person who starts or manages a commercial enterprise, especially one involving initiative and financial risk". (Canadian Oxford Dictionary)