The Orthopaedic Surgeon and Manufacturing Industry Relationship: Ethical Guidelines
February 1, 2000 4 minutes read
The Orthopaedic Surgeon and Manufacturing Industry Relationship: Ethical Guidelines
Abstract & Commentary
Synopsis: Industry and physician relationships are common, but require heightened scrutiny as potential for abuse and the need to educate younger physicians on appropriate relationships must be recognized. Regardless, putting the patient’s concerns first above vested interests is essential.
Source: Lim EVA, Aquino NJ. The orthopaedic surgeon and manufacturing industry relationship. Clin Orthop 1999; 368:279-286.
Lim and aquino have produced an excellent synopsis of the common areas of involvement with the physician and the manufacturing industry. They present compelling information that is brutally honest and they ask some difficult questions for the clinician. The ethical question of proper relationships has always been present; however, Lim and Aquino note that, with the current economic pressures on physicians, the temptation or need for increasing relationships is greater than in the past.
Lim and Aquino note three common avenues for involvement with the manufacturing industry: 1) receiving gifts from industry, 2) industry support of educational and research endeavors, and 3) royalties, stock options, and retainer fees from industry. Receiving gifts from industry, no matter how small or seemingly inconsequential, can still have an influence and can be a potential for abuse. Lim and Aquino note that larger gifts, such as golf outings or paid trips to company manufacturing facilities, do not appear to have any direct benefit for the patient. They go on to note that most physicians would argue that accepting a gift does not gain their influence and that physicians hold themselves to a higher moral ground. Lim and Aquino point out the great potential for abuse in such scenarios.
Industry support of education is a long-accepted practice in medicine. Education in the use of orthopaedic gadgetry or education on new medications is frequently wrapped around trips and resorts. Frequently, resident education relies on providing resources, most commonly meals, to allow access of the physicians to the product. Lim and Aquino note the potential for a conflict of interest in such scenarios and the need to decrease the relative dependence on industry to fund meetings, conferences, and research.
Lastly, the involvement of royalties, stock options, and retainer fees from industry also has potential for abuse. Lim and Aquino refer to Article IIIC from the American Academy of Orthopaedic Surgeons, "When an orthopaedic surgeon receives anything of value including royalties from a manufacturer, the orthopaedic surgeon must disclose this fact to the patient and colleagues."1 Lim and Aquino go on to note that the disclosure must be full and thorough, and point out the significant potential for abuse and (with the Stark amendment) fraud.2
Lim and Aquino summarize that any ethical relationship with industry requires: 1) putting the patient’s concerns first above vested personal or physician interests; 2) an awareness of a potential for abuse; and 3) a level of awareness of the relationship and the need to educate residents and younger physicians on proper behavior to maintain ethical standards.
Comment by Robert C. Schenck, Jr., MD
Lim and Aquino have written a useful synopsis outlining the relationships and potential for abuse that can exist between the physician and the manufacturing industry. Although this "ethical guideline" was written for the intended purpose of educating orthopaedic surgeons, it is applicable to most physicians’ relationships with medical industry, be they pharmaceutical companies or, as seen in sports medicine, the various vendors involved in the care of the athlete. The topic often makes the physician uncomfortable. The need for proper behavior and maintenance of ethics for years have rested on the individual. With increasing economic pressures including, but not limited to, decreasing income streams, the temptation for blurring of the lines between right and wrong is much more common. Furthermore, seeing other local physicians or colleagues involved in such a relationship may give one the false sense of justification, or "everyone is doing it." Lim and Aquino mention the need to create policy regarding ethical behavior or even "policing" of behavior to maintain our ethical standards. Many state licensure boards require yearly CME credit in the area of ethics (state of Texas, for one). These ethical decisions are frequently difficult and Lim and Aquino recommend in any relationship with industry to place the patient’s concerns first above vested interests. When in doubt, "do the right thing." v
References
1. American Academy of Orthopaedic Surgeons. Code of Ethics for Orthopaedic Surgeons. Rosemont, Ill.: American Academy of Orthopaedic Surgeons; Adopted October 1988, Amended October 1991.
2. http://www.house.gov/stark/accomplishments.html.
Relationships between the physician and manufacturing industry involve one of three common pathways. Which of the following would not apply?
a. Subsidy for education or research.
b. Inexpensive gifts have no influence on physicians.
c. Stock options, royalties, and retainer fees.
d. All-expense-paid trips and other gifts.
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