Patient care is the primary focus of the orthopaedic profession. The enhancement of patient care has required and will continue to require orthopaedic surgeons to collaborate productively with industry to develop new medical technology and techniques that improve patient care. The relationship between orthopaedic surgeons and industry is of critical importance to the shared ultimate goal of improving patient care. Orthopaedic surgeons are well qualified to provide innovative ideas and feedback to industry, conduct research trials, serve on scientific advisory boards, and serve as faculty to teach the uses of new technology. The relationship between orthopaedic surgeons and industry is important and necessary, but it must be carefully scrutinized to avoid the pitfalls of real or perceived conflicts of interest that could ultimately affect patient care.
In late September, four orthopaedic manufacturing companies entered into Deferred Prosecution Agreements, agreeing to pay civil settlements amounting to a total of $311 million. In addition, one orthopaedic company entered into a Non-Prosecution Agreement. All will be subject to oversight by a federal monitor appointed by the U.S. Department of Justice for 18 months. The companies did not admit any wrong doing, plead guilty to any criminal charges or pay any criminal fines as part of the settlement. The federal government, through the U.S. Attorney's Office in New Jersey, has agreed not to pursue any criminal charges against the companies if they comply with the Agreements. Clearly, a spotlight has been shone on companies and orthopaedic surgeons alike.
Earlier in the year, the Fellowship of the American Association of Orthopaedic Surgeons (AAOS) adopted Standards of Professionalism on Orthopaedist-Industry Conflicts of Interest (SOPs). Of those Fellows voting (5,242), approximately 96% voted to adopt these SOPs. These SOPs establish mandatory, minimum levels of acceptable conduct for Fellows and Members of AAOS who engage in relationships with industry. They focus on how orthopaedic surgeons serve the best interests of the patient and the profession while participating in academic or commercial ventures. There are 17 standards relating to industry; it is in every surgeon's best interest to be familiar with all 17. They address such topics as consulting agreements, industry-sponsored events, inappropriate financial arrangements, CME courses and gifts from industry. Each of these standards addresses a real or perceived conflict that has the potential to influence decisions about patient care and to do so in a way that is not in the best interests of the patient or may ultimately increase risks for or even cause injury to the patient.
The AAOS SOPs emphasize the patient-physician relationship. The mandatory standards call for orthopaedic surgeons to tell patients about their relationships with industry that create real or perceived conflicts of interest and to resolve these conflicts in the best interest of the patient. Some orthopaedic surgeons may find that the SOPs validate their existing practices. Other orthopaedic surgeons may wish to revise how their practices address possible conflicts.
AAOS will begin enforcing these SOPs for acts occurring on or after Jan. 1, 2008. As with the other AAOS SOPs, allegations that a Fellow has violated any of the SOPs on Orthopaedist-Industry Conflicts of Interest may result in a formal grievance under the AAOS Professional Compliance Program. Orthopaedic surgeons found in violation of the SOPs may be censured, suspended or expelled from AAOS.
We encourage each of you to become familiar with the SOPs on Orthopaedist-Industry Conflicts of Interest and to discuss them with your colleagues. Avoiding the pitfalls of real or perceived conflicts of interest with industry enhances your personal professionalism. Maintaining productive relationships with industry that advance patient care enhances the entire orthopaedic profession.
The new AAOS SOPs on Orthopaedist-Industry Conflicts of Interest may be found at www.aaos.org/industryrelationships.
Roy Sanders, MD
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