Post on 18-Jan-2016
Surgical Ethics:Conflicts of Interest
Martin McKneally and Mark CampDept. of Surgery & Joint Centre for
BioethicsUniversity of Toronto
Principles of SurgeryOctober 2010
Plan of Talk
Cases: Finder’s fees for resident
Celebrity endorsementLearning to operate
Research project on COI
Managing conflicts of interest:
disclose, mediate, prohibit
Managing conflicts of obligation
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
How should we think about this?
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?
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?
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?
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
“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?
Business ethics -
Celebrity endorsement
Surgical ethics –
Celebrity endorsement?
How should he think about this?
Are the 4 principles a helpful framework?
Beneficence
Nonmaleficence
Justice
Autonomy
Conflict of Interest
A situation in which the self-interest of an individual is in conflict with an obligation.
George Khushf
in Surgical Ethics
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
A Framework for Management of COI
Disclosure: warning – “I have a financial interest…”
Mediation: oversight - CIRC
Prohibition:recuse, abstain, refuse
“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
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”
Qualitative and Quantitative Research Study of COI in Surgery
Case 3: Is learning on patients a conflict of interest for residents?
Obligation: Patient
care
Interest: Learning surgery
How should we think about this?
Is learning an interest or an obligation?
Conflicts of Obligation
Teachers, residents, and patients share a societal obligation to educate.
*Managing Conflicts of Obligation:
Safeguarding the patient
Scheduling fairly
Substituting competently
Summary
Cases: Finder’s fees for resident
Celebrity endorsementLearning to operate
Research project on COI
Managing conflicts of interest: disclose, mediate,
prohibit
Managing conflicts of obligation
Acknowledgements
Paintings by Robert Pope and Joseph Wilder
Deborah McKneally, The Ravine Research and Education Centre
Some Patients Rely on Trust
The Problem with Disclosure
Disclosure is not enough
Manage the conflict
Objective evaluators
Independent review
Fair procedures
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 & ChildressPrinciples of Biomedical Ethics
Alternatives to Evidence Based Medicine
Basis Marker __Measure____
Eminence Radiance Luminometer
Eloquence Smoothness Teflometer
Vehemence Stridency Audiometer
Confidence* Bravado Sweat test
Evidence Randomized trial Meta-analysis
*applies only to surgeons Isaacs & Fitzgerald
BMJ 1999;319:1618
Qualitative and Quantitative Research Study of COI in Surgery