Surgical Ethics: Conflicts of Interest

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Surgical EthicsConflicts of Interest

• Martin McKneally and Mark Camp
• Dept. of Surgery Joint Centre for Bioethics
• University of Toronto
• Principles of Surgery
• October 2010

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Plan of Talk

• Cases Finders fees for resident
• Celebrity endorsement
• Learning to operate
• Research project on COI
• Managing conflicts of interest
• disclose, mediate, prohibit
• Managing conflicts of obligation

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Case 1 Finders fees

• 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 companys scientific consultant advises that
  it is their standard practice to offer a
  financial incentive to solve accrual problems.
• Dr. Answers offers surgical residents a finders
  fee of 100 for each patient enrolled.

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How should we think about this?
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• The REB questions the propriety of the finders
  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?

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Why not pay the resident?

• Academic vote (yes, no, dont know)
• Views and justifications
• Obligations of residents
• Caring, learning, teaching
• Personal interests of residents
• Financial, social, professional

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If its ok for business, why isnt it ok for
surgery?

• 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

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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
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Celebrity Endorsement Case

• 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.

• 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?

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Business ethics - Celebrity endorsement
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Surgical ethics Celebrity endorsement?
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How should he think about this? Are the 4
principles a helpful framework?
Beneficence Nonmaleficence Justice Autonomy
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Conflict of Interest

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

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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

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A Framework for Management of COI

• Disclosure warning I have a financial
  interest
• Mediation oversight - CIRC
• Prohibition recuse, abstain, refuse

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Celebrity Endorsement Case - Refusal

• 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

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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

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Qualitative and Quantitative Research Study of
COI in Surgery
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Case 3 Is learning on patients a conflict of
interest for residents?
Obligation Patient
care Interest Learning surgery
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How should we think about this?
Is learning an interest or an obligation?
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Conflicts of Obligation

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

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Summary

• Cases Finders fees for resident
• Celebrity endorsement
• Learning to operate
• Research project on COI
• Managing conflicts of interest
• disclose, mediate, prohibit
• Managing conflicts of obligation

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• Acknowledgements

Paintings by Robert Pope and Joseph
Wilder Deborah McKneally, The Ravine Research
and Education Centre
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• martin.mckneally_at_utoronto.ca

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(No Transcript)
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Some Patients Rely on Trust
The Problem with Disclosure
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Disclosure is not enough

• Manage the conflict
• Objective evaluators
• Independent review
• Fair procedures

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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 Principle
s of Biomedical Ethics
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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 19993191618

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Qualitative and Quantitative Research Study of
COI in Surgery