It is the obligation of every physician to put the best interest of the patient above all other considerations. Patients seeking care from orthopaedic surgeons are often vulnerable; their clarity, judgment, and decision-making capacity are skewed by pain and suffering. The invasive nature of surgery—combined with the urgent and potentially life-threatening nature of many orthopaedic conditions—requires an unwavering commitment from the surgeon to maintain the centrality of the patient's welfare in decision-making and justify the patient's trust. The challenge facing the discipline of orthopaedic surgery, and the profession of medicine in general, is to sustain the undeniable value of surgeon innovation, research, and teaching in collaboration with the biopharmaceutical and device industry (industry) while eliminating gratuitous relationships that are inappropriate, can skew professional judgments and increase cost to the health-care system without adding value, and, most important, can undermine public trust in the discipline and in the medical profession more broadly.
Recognizing the need for guidance that is unique to the discipline of orthopaedic surgery, the American Orthopaedic Association (AOA) established a Task Force on Orthopaedic Surgeon-Industry Relationships in 2010 under the aegis of its Orthopaedic Institute of Medicine (OIOM). The purpose of the Task Force was to assemble a diverse group of individuals with different perspectives to discuss and explore, in an unbiased manner, the critical topic of industry relations with orthopaedic surgeons.
The OIOM Task Force recognizes that a financial conflict of interest exists in the discipline of orthopaedic surgery. Orthopaedic surgeons are uniquely qualified to inform product development, which ultimately provides more and better options for patient care. Relationships with industry are valuable and productive when they are ethical, transparent, and managed appropriately. Positive change can be accomplished through a thorough examination of current relationships with industry and elimination of those that are gratuitous in nature; a reaffirmation of altruism and other core values of medical professionalism; a recommitment to ethical standards of conduct; and a repeated emphasis of these values and standards in all phases of orthopaedic education.
The OIOM Task Force has put forth in this document many recommendations and considerations that are designed to protect the core values of the discipline of orthopaedic surgery and underscore the need to reaffirm and strengthen professionalism and integrity among its members along the entire arc of their careers. The sixteen specific recommendations emphasized in this report are viewed as the next steps in moving the discipline of orthopaedic surgery closer to the goal of maximizing relationships with industry that are respectful of the values of both partners and patients and are beneficial to patients, while eliminating those relationships that are gratuitous and entered into primarily to generate physician revenue.
The OIOM believes it appropriate and timely to provide leadership to the orthopaedic discipline regarding the increasing prevalence of orthopaedists’ relationships with industry, which have been driven by extraordinary advancements in science and technology and their translation into new and improved orthopaedic devices and instrumentation. Ironically, industry is dependent on the orthopaedic community for the optimization of products, device instrumentation, and techniques, and for their utilization and subsequent promotion to the orthopaedic community. The discipline of orthopaedic surgery must maintain its autonomy and self-regulate by educating its trainees and young professionals in the core values and principles of the profession, as well as in the science, technology, and art of the discipline by insisting on lifelong learning and personal assessment throughout their professional lives, and by making certain that they retain the freedom to care for the sick and infirm according to their best professional judgment and existing best evidence. Failure to regulate ourselves will inevitably lead to increasingly intrusive external regulation. Most important, the OIOM avers that the self-regulation called for is the right thing to do for the patient.
Note: Members of the task force include G. Paul DeRosa, MD; Peter Angelos, MD, PhD; Robert L. Barrack, MD; Jonathan P. Braman, MD; Robert M. Califf, MD; Nancy M. Cummings, MD; Edward N. Hanley, Jr., MD; David M. Hyman, JD; David Korn, MD; Stephen J. Peoples, VMD, MS; E. Anthony Rankin, MD; C. McCollister Evarts, MD; and Susan Roberts, PhD.