1. THE ORTHOPAEDIC SURGEON’S RELATIONSHIPS WITH INDUSTRY AAOS ETHICS COMMITTEE Kenneth C. Thomas, MD 1

2. 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 2

3. 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? 3

4. 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. 4

5. Case Chip, 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. 5

6. 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. 6

7. What would you do? What are the ethical issues? What are the legal issues? 7

8. Dr. Thomas refuses the offer and explains to 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. 8

9. The hospital administration declines 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. 9

10. 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? 10

11. Isn’t the training of another orthopaedic surgery resident a worthwhile cause? 11

12. 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? 12

13. What events have you witnessed during your residency and/or practice that may be questionable? Should all gifts from industry be banned? 13

14. What are acceptable relationships between orthopaedic surgeons and implant companies? How do you determine the fair market value of consulting agreements with orthopaedic surgeons? 14

15. Case Conclusion Chip and the implant company are indicted for bribery and kickback schemes that took place at another area hospital. 15

16. References Abelson 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 16

17. 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. 17