1. Surgical Ethics: Conflicts of Interest Martin McKneally and Mark Camp Dept. of Surgery & Joint Centre for Bioethics University of Toronto Principles of Surgery October 2010

2. Plan of Talk Cases: Finder’s fees for resident Celebrity endorsement Learning to operate Research project on COI Managing conflicts of interest: disclose, mediate, prohibit Managing conflicts of obligation

3. Dr. Answers has obtained a grant to assess a new antimicrobial prophylaxis regimen. Accrual is slow, because the regimen requires preoperative treatment. Patients are difficult to identify, contact, inform, and enter into the study under the same-day surgery program. The company’s scientific consultant advises that it is their standard practice to offer a financial incentive to solve accrual problems. Dr. Answers offers surgical residents a finder’s fee of $100 for each patient enrolled. Case 1: Finders’ fees

4. How should we think about this?

5. The REB questions the propriety of the finder’s fee, arguing that the research program may foster an unprofessional attitude toward research and patient care. The residents feel that they can maintain their objectivity, and gain needed supplemental income. If you were the resident representative on the REB, what advice would you give to its members?

6. Academic vote (yes, no, don’t know) Views and justifications Obligations of residents Caring, learning, teaching Personal interests of residents Financial, social, professional Why not pay the resident?

7. Ethic of business Incentives in Business reliable products/services profit, bonuses reasonable price persuasive advertising return to shareholders Ethic of surgery Incentives in Surgery trustworthiness fees, salaries competence publications, grants commitment promotion If it’s ok for business, why isn’t it ok for surgery?

8. Case 2: Celebrity Endorsement “I was visited by the vice president of a major manufacturing company, who presented me with a new prosthesis that his engineers allegedly had developed according to my philosophy. The prosthesis was to be called the Sarmiento Total Hip Prosthesis.” Augusto Sarmiento Past President, AAOS

9. “Before I had a chance to say that I did not know I had a unique philosophy he handed me a check, payable to me in the amount of $250,000.” Celebrity Endorsement Case Dr Sarmiento is highly regarded in his field; he has a two year waiting list. He was not involved in the design. How should he decide whether to accept the offer?

10. Business ethics - Celebrity endorsement

11. Surgical ethics – Celebrity endorsement?

12. How should he think about this? Are the 4 principles a helpful framework? Beneficence Nonmaleficence Justice Autonomy

13. Conflict of Interest A situation in which the self-interest of an individual is in conflict with an obligation. George Khushf in Surgical Ethics

14. Obligations and interests Our obligations could include: –Patients –research –education –cost-containment –integrity of profession Interests could include: –wealth –career advancement –fame –personal The best interests of the patient is our paramount obligation

15. A Framework for Management of COI Disclosure:warning – “I have a financial interest…” Mediation:oversight - CIRC Prohibition:recuse, abstain, refuse

16. “I rejected the offer, and found the prosthesis advertised in various journals a few months later. I inquired from the local representative as to who was the physician behind the concept. He responded that the implant represented the unique philosophy of a very distinguished orthopaedist from a medical school on the East Coast.” Augusto Sarmiento Celebrity Endorsement Case - Refusal

17. Example of surgeon-industry relationships Celebrity Surgeon KB –Total paid by Zimmer in 2007: $1.8 million –Total expenses (Meals, Flights, Lodging): –$73,000 No royalties received or patents held by surgeon Full time clinical practice He received $1,727,000 in undisclosed payments in 2007, based on a “Consulting Agreement”

18. Qualitative and Quantitative Research Study of COI in Surgery

19. Case 3: Is learning on patients a conflict of interest for residents? Obligation: Patient care Interest: Learning surgery

20. How should we think about this? Is learning an interest or an obligation?

21. Conflicts of Obligation Teachers, residents, and patients share a societal obligation to educate. *Managing Conflicts of Obligation: Safeguarding the patient Scheduling fairly Substituting competently

22. Summary Cases: Finder’s fees for resident Celebrity endorsement Learning to operate Research project on COI Managing conflicts of interest: disclose, mediate, prohibit Managing conflicts of obligation

23. Acknowledgements Paintings by Robert Pope and Joseph Wilder Deborah McKneally, The Ravine Research and Education Centre

24. martin.mckneally@utoronto.ca

26. Some Patients Rely on Trust The Problem with Disclosure

27. Disclosure is not enough Manage the conflict Objective evaluators Independent review Fair procedures

28. Learned & Helping Professions Medicine, Law, Theology, Teaching Professions maintain self-regulating organizations that control entry by certifying that candidates have necessary knowledge and skills that [patients, clients, parishioners, students] lack, and that morally must be used to benefit society. Beauchamps & Childress Principles of Biomedical Ethics

29. Alternatives to Evidence Based Medicine BasisMarker__Measure____ EminenceRadiance Luminometer EloquenceSmoothness Teflometer VehemenceStridency Audiometer Confidence*Bravado Sweat test EvidenceRandomized trial Meta-analysis *applies only to surgeonsIsaacs & Fitzgerald BMJ 1999;319:1618

30. Qualitative and Quantitative Research Study of COI in Surgery