THE ORTHOPAEDIC SURGEON’S

RELATIONSHIPS WITH INDUSTRY

AAOS ETHICS COMMITTEE

Kenneth C. Thomas, MD

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Objectives• Become aware of the AAOS

Standards of Professionalism on Orthopaedic Surgeon-Industry Relationships

• Identify physician-industry conflicts of interest

• Become familiar with potential legal and ethical issues involving physician-industry relationships

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Introduction

• According to a 2006 New York Times article, an orthopaedic surgeon was paid $400,000 by a device company for 8 days of work.

• Another doctor was paid nearly $700,000 in consulting fees for nine months.

• What constitutes ethical relationships with industry?

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Introduction• The primary goal of the orthopaedic

surgeon is caring for the patient.

• Collaboration between orthopaedic surgeons and industry is essential for the advancement of orthopaedic technology.

• Relationships with industry must be done in an ethical manner and not distract from our primary goal.

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CaseChip, a sales representative, works for a new implant company that is launching a computer navigated unicompartmental knee replacement. Comstock/Thinkstock

He approaches Dr. Thomas, a busy orthopaedic surgeon who performs a large number of knee replacements.

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Chip offers Dr. Thomas a high profile consulting position with the company if he uses over 10 of his implants per month.

The position would include a generous stipend and all expenses paid travel to educational courses for the implant.

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What would you do?

What are the ethical issues?

What are the legal issues?

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Dr. Thomas refusesthe offer and explainsto Chip that he cannot receive something of value based on his use of an implant. Comstock/Thinkstock

Chip agrees and instead offers to cover the salary of a full-time research nurse to evaluate the outcomes of the new prosthesis.

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The hospital administrationdeclines to hire a research nurse that would be paid for by the implant company. iStockphoto/Thinkstock

Clearly dejected, the rep offers to fund another orthopaedic surgery residency position if the hospital uses over 10 of his implants per month.

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What would you do now?

What are the ethical issues?

What are the legal issues?

Does the change in “the deal” make an ethical difference?

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Isn’t the training of another orthopaedic surgery resident a worthwhile cause?

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Are there Mandatory Standards from the AAOS Standards of Professionalism on Orthopaedist-Industry Conflicts of Interest that are applicable?

Which specific Mandatory Standards apply?

Which guidelines from the AAOS Opinion on Ethics and Professionalism – The Orthopaedic Surgeon’s Relationship with Industry apply?

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What events have you witnessed during your residency and/or practice that may be questionable?

Should all gifts from industry be banned?

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What are acceptable relationships between orthopaedic surgeons and implant companies?

How do you determine the fair market value of consulting agreements with orthopaedic surgeons?

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Case Conclusion

Chip and the implant company are indicted for bribery and kickback schemes that took place at another area hospital.

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ReferencesAbelson R: Whistle-Blower Suit Says Device Makers-Generously Rewards Doctors. New York Times, January 24, 2006.

American Academy of Orthopaedic Surgeons: Standards of Professionalism on Orthopaedist-Industry Conflicts of Interest, Mandatory Standards 2, 6, 9, and 10. Adopted 2007.http://www3.aaos.org/member/profcomp/SOPConflictsIndustry.pdf 

American Academy of Orthopaedic Surgeons: Opinions on Ethics and Professionalism-The Orthopaedic Surgeon's Relationship with Industry, Guidelines 1, 2, and 9. Adopted 1992; revised 2004, 2005.http://www.aaos.org/about/papers/ethics/1204eth.asp American Academy of Orthopaedic Surgeons: Code of Ethics and Professionalism for Orthopaedic Surgeons, III.C. Adopted October 1988, revised 2011.http://www.aaos.org/about/papers/ethics/code.asp

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Advanced Medical Technology Association (AdvaMed): Code of Ethics on Interactions with Health Care Professionals. Adopted 2004, revised and restated 2008.http://www.advamed.org/MemberProtal/About/Code

Pharmaceutical Research and Manufacturers of America (PhRMA): Code on Interactions with Healthcare Professionals. Adopted 2002, revised 2008.http://www.phrma.org/about/principles-guidelines/code-interactions-healthcare-professionals

Orlowski J, Watseka L: The effects of pharmaceutical firm enticements on physician prescribing patterns. Chest. 1992; 102: 270-273.

Lexchin J: Interactions between physicians and the pharmaceutical industry: what does the literature say? CMAJ 1993;149: 1401-1407.

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