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

martin.mckneally@utoronto.ca

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