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"Seven million dollars for twelve days work"

Martin McKneally
Martin McKneally
Orthopaedic resident and bioethics student Mark Camp drew my attention to this startling revelation on the website of the Zimmer Orthopedic Instrument Company. It was the highest of over 200 disclosures of physician remuneration listed. These disclosures are now required by a court order, following a US Department of Justice investigation of kickbacks. (http://www.zimmer.com/ web/enUS/pdf/Company_Consultants 10.pdf) Prominent surgeons are being rewarded for endorsing or advising equipment companies at a level that competes with Tiger Woods' endorsement income. Richard Reznick's column in this issue examines our relationship with industry and gives useful references and recommendations. In this column I will try to outline some steps that might be helpful in achieving the fine balance that Richard recommends. I have published a more complete explanation of this problem elsewhere. (1)

Trust is what is at stake. Our profession is trusted because we maintain high standards. We are justifiably trusted to be technically competent and tirelessly committed to assuring that our patients receive the best care we can provide. "The ethic of surgery can be summarized in one word: trustworthiness. In the fee-for-service system, we have long been accustomed to managing the inherent conflict between our financial incentive to perform operations and our fiduciary duty to prioritize the interests of patients who may be best served by nonoperative treatment. Almost unconsciously we follow a well-developed code of virtuous conduct ingrained through residency and reinforced by collegial standards and community respect." (1)

When private interests and profit might interfere with a professional obligation, the situation is defined as a conflict of interest. Most conflicts are currently managed by disclosure, the generally accepted approach to minimal conflicts. Disclosure is now commonly accepted in our journals and our meetings as adequate management. Semi-transparent statements that an author or speaker "has a financial relationship" with a manufacturer, though widely accepted by ethics committees and journals, are insufficient explanations of management of major conflicts of interests, such as those Mark pointed out.

Mediation by an independent third party is a more effective and publicly defensible approach to major conflicts. Since the tragic death of Jesse Gelsinger at the University of Pennsylvania, conflict of interest committees analogous in some ways to research ethics boards have been introduced at many universities, hospitals and clinics in the United States.

"Jesse died of a massive systemic inflammatory response after receiving the ornithine transcarbamylase gene delivered through an adenovirus vector. Undisclosed lethal toxicity in animal studies and deviation from the treatment protocol were linked to his physician's financial interests in the vector, sold shortly afterward for $13.5 million USD." (1) Mediation is also implemented by impartial data managers, statistical analysts, safety monitoring boards, review committees, editors and peer reviewers.

Prohibition is the most severe and definitive form of management. It is problematic because only industry can provide the capacity for production, evaluation, and distribution of new technology. Our department's iconic Nobel laureate Frederick Banting naively resisted advice to patent insulin. He erroneously believed that it would "violate his Hippocratic oath". Bringing production of insulin to the scale needed by the world's diabetics required licensing of the production method to Eli Lilly. Industry in turn needs the Banting level scientists and the patients who are attracted to our health science centres.

Medical students and clinician-teachers need more education about management of conflicts of interest. These are woefully underemphasized in research ethics courses and clinical ethics lectures. Research ethics courses are underpowered or absent from surgical curricula. Clinical ethics lectures (including my own) generally have had a blind spot on this particular subject. Similarly, industry needs training and oversight as it tries to self-regulate.

Like the financial markets, self-regulation of the biomedical industry is vulnerable to the faults of human frailty that lead to rule-bending, self-deception and misrepresentation when profit is the primary interest. Journals and the lay press provide some guidance and incentive, but journals are vulnerable to seduction because of their financial dependence on advertising and the large orders for articles and supplements for promotion of pharmaceuticals and devices that are described in their scientific reports.

There will be a symposium and debate about industry's role in education sponsored by St. Michael's Hospital Department of Surgery on November 17 at the Pantages Hotel at 4:30 p.m. Speakers from industry, the Joint Centre for Bioethics and the Surgery Department will explore this important issue in a collegial setting. A summary of this symposium will be published in the Winter issue of the Spotlight.

(1) McKneally MF. Beyond disclosure: managing conflicts of interest to strengthen trust in our profession. Journal of Thoracic & Cardiovascular Surgery. Feb. 2007;133(2):300-2

Martin McKneally


Letters to the Editor are welcomed to keep the community informed of opinions, events and the activities of our surgeons, friends and alumni.

Good Afternoon Dr. McKneally,

I just received my copy of the spring / summer Surgical Spotlight, and found your article "A Systems Approach to Surgery" fascinating. I also found your article linked via CTSnet very interesting as I was involved in the triage and transferring of the SARS and Non SARS emergency patients during that time. The "open fracture in a transplant patient ....." brought back memories and expressed exactly how we addressed all our patients at CritiCall. As you know, for us, despite any challenges imposed during an incident, the patients always come first.

Given our commonality in "system thinking" I thought you would be interested in an update on the many exciting changes happening with our program. You may recall we began the CritiCall Program & Provincial Bed Registry in the mid 90s - fully voluntary by hospitals / physicians. Now under the Critical Care Secretariat and facilitating more than 16,000 referrals per year, we are mandated and developing patient referral frameworks with our LHIN partners and healthcare stakeholders. Too many exciting changes to list but I have attached an article, released today in Hospital News, that will give you an idea. It continues to be a great system for Ontario emergency patients and for the healthcare workers caring for them.

http://www.hospitalnews.com/modules/magazines/mag. asp?ID=3&IID=110&AID=1408

Karen Bachynski is Provincial Adult Acute Care Liaison Disaster & Emergency Preparedness Liaison Ontario CritiCall Program

To the Editor,

For some time now I have marveled at the accomplishments of old friends and colleagues as displayed on the pages of "The Surgical Spotlight". I look forward to its arrival. It is humbling to see what has been accomplished. Nonetheless, the accomplishment of this publication also requires recognition. So... thank you Martin. Thank you for a job well done that is greatly appreciated by a former U of T person. I miss the academic environment greatly and you provide me with memories and considerable joy reviewing the current accomplishments of a faculty I truly admire.

Dr. Todd is a Senior Medical Officer at the CMPA. He served as Professor of Thoracic Surgery and Head of the Thoracic Division at Toronto General Hospital.

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