Code of Conduct
keeping industry at arm's length 

Dennis Jeanes
Manager, Communications & Advocacy
Canadian Orthopaedic Association

"Some of the guys here in Saskatoon go golfing with some of the equipment reps, who are our good friends. Whenever I see them at the club, the first thing they do is come running over to say, 'I'm paying my own green fees,'" chuckles Dr. Bill Dust, a professor of orthopaedic surgery at the University of Saskatchewan. "I don't know if it's because I'm always pushing for professional ethics, but now if companies want to do something here, they actually come and ask me - which may or may not be the beginning of a tradition. Certainly, locally, everybody's far more conscious of ethics and conflicts of interest than they used to be."

Attitudes about proper surgeon/industry relations are indeed changing. And much of the impetus for that change - actually more of a sharp kick in the seat of the pants - goes back almost two years. That's when four of the US's largest makers of hip and knee implants were publicly disgraced by accusations of criminal conspiracy to violate federal anti-kickback laws and collectively agreed to pay $390 million in financial penalties to settle the case. (A fifth big manufacturer cooperated with the Justice Department investigation and was never charged with any wrongdoing; it did, however, accept the same industry-wide reforms imposed on the four other device-makers.) 

In addition to the fines, there were also court-ordered in-house monitors, who would, for 18 months at company expense, review all payments made to surgeons and ask pointed questions about those payments. As a further humiliation, each company had to submit for government approval a needs-assessment detailing every conceivable task for which it might engage surgeons in the coming year. Under such unprecedented public scrutiny, industry had no choice but to change its ways and develop guidelines for what was permissible and what was not. To paraphrase Barack Obama, the corporate culture had to assimilate into its thinking the fierce urgency of "no."

Just how far the pendulum has swung in the US can be gauged by the unprecedented steps taken by several device-makers at this year's Annual Meeting of the American Association of Orthopedic Surgeons. According to publicly circulated memos, some industry representatives were to close shop at day's end and remain in their hotel rooms. After-hours fraternization with surgeons was strictly forbidden. Redemption can be a hard and lonely road.

Not surprisingly, the fallout from the scandal was felt here in Canada and about a year ago, prompted both industry association, MEDEC, and the Canadian Orthopaedic Association to revise their own respective codes of conduct (available online at www.medec.org/code_of_conduct and
www.coa-aco.org/en/library/health_policy/code_of_ethics.html).

"People understand 'no' better than they understand 'a little bit,'" says Dust, who advised on updating the COA's code on industry relations and conflicts of interest. "If you leave a little wiggle room, there will always be the few who abuse it. The only thing that everybody understands is 'No, you can't do it.' We need to develop for a while the mindset that the purest thing, and the most defensible, is 'no.'" 

At this juncture, a quick refresher on conflict of interest might be useful: Conflict of interest exists in every aspect of human affairs, including medicine and science. Physicians have a fiduciary duty to place their patients' interests above their personal interests. There is nothing inherently unethical in finding oneself in a position of conflict of interest, as long as that conflict is acknowledged and patients' interests are given priority. Problems arise when physicians do not recognize the seductive interference - and corrosive effect - of secondary gain. Another, more subtle, problem arises when there is an appearance of interference with fiduciary duty even though no such interference occurs.

"There have been lots of social humanities studies done," says Bill Dust, "that show even with small gifts, there is an expectation of reciprocity - even if they are given with 'no strings attached.' It's what our parents taught us as kids. If somebody gave you something nice, you were taught to say thank you and feel good about that person." The bottom line is, if a surgeon accepts money from industry for anything, they will be open to allegations (true or not) that they are being bought.

Thus, the code of ethics was developed to protect a surgeon's reputation as much as possible when collaborating with industry. Under the revised guidelines, to prevent perceived conflict of interest, the COA will no longer accredit CPD programs where a surgeon's travel costs (such as airfare, hotel, meals) are covered directly by industry. Also, direct financial aid (textbooks, meals, travel) from industry to residents and fellows is banned. And there are provisions in the code recognizing the important relationship between surgeons and industry for product development, research and consultancy. To counter the siren song of new unproven technology, says Dust, surgeons are encouraged to seek impartial second opinions from their peers, and they should be willing to invest their own money to learn about the innovation if they truly consider it valuable. After all, why should surgeons expect someone else to pay for their education?

"Ethical standards change with time. There's an ebb and flow," says Dr. Rod Martin, a professor of orthopaedic surgery at Newfoundland's Memorial University. "My own views have changed over the years. In the past there have been industry-sponsored events that were light on content and heavy on social. Those types of events are gone now, and thank heavens for that." And yet just saying no to industry, he observes, isn't very practical, and there is a traditional "symbiotic relationship" between surgeons and industry that needs to be preserved because it "results in superior patient care through the use of improved techniques and devices."

Martin has no problem with the profession's using industry funds to educate surgeons, fellows and residents. Indeed, he feels industry has a responsibility to help do so - as long as the money is an unrestricted grant and administered in a transparent fashion by a third party such as a program director or hospital department: "Residents learn from staff guys how industry funding can be used in the most unbiased and ethical manner. Ultimately, the program chief must be able to decide which educational events are appropriate for the resident and what would give the best return for each individual's unique level of training."

Orthopaedics, says Martin, is not a discipline that lends itself very well to online learning and remote videoconferencing. Teaching must "incorporate the touch and feel of the instruments on bone or bone models, and this kind of education is often not available outside of industry." As a frequent course instructor, he sees no conflict in accepting a meal while providing these services and notes that "the honoraria paid to do this do not make up for the shortfall in income, but I believe it's important to give back to the profession, which is why I, and many others, participate in these courses.

"I think the COA has given us ethics guidelines that still allow us as surgeons to morally and ethically feel good about our interactions with industry and, at the same time, establish the appropriate boundaries."

Meanwhile in the US, in a bid to avoid any possible appearance of conflict of interest, one device-maker has opted to funnel all its sponsorship money through the AAOS, which has set up a separate trust to administer the flow of funds and to adjudicate their dispersal. The corporation thus remains at arm's length and very clearly has no influence on how the money is spent. "It's a blueprint that could be useful for us here in Canada," says Doug Thomson, CEO of the COA. "We have relations with industry, and I think we can play a role with regards to CPD, resident training, fellowships and new product marketing. The COA could play a stewardship role."

By contrast, Thomson is less enthusiastic about a current movement afoot in the US that is calling for a ban on industry funding for Annual Meetings: "I don't think it's practical at this time. If such a ban were to occur here, it would have a very negative impact on the way we conduct out Annual Meeting, since industry contributions are a key component of meeting revenue."

He notes that the COA's industry partners for Annual Meetings stopped participating years ago in so-called "consumptive activities." Nor is any industry money used to cover overhead costs for the meeting. Now corporate funding is directed to very specific educational events. But there's more to industry participation than just money, says Thomson: "I think industry brings something special to the Annual Meeting. They're involved in hands-on workshops that the COA simply doesn't have the resources to provide."

Coming back to the notion of the COA as a steward looking out for surgeons' interests, Thomson points out that not only "does it fit in with our role of championing surgeons, but it also provides protection for industry. For example, we could set up a consultant's bureau or a speaker's bureau, so if a company required a consultant in any particular specialty, the COA could act as a broker, with a standard fee schedule for specific activities. Money would flow though a COA-managed trust, subject to standard accounting practices. It would all be very clean, very transparent."