Orthopaedic Institute of Medicine Report includes 16 recommendations
The American Orthopaedic Association (AOA) and the Orthopaedic Institute of Medicine (OIOM) have released a report on Surgeon-Industry Relationships in the Discipline of Orthopaedic Surgery. The report is the result of 22 months of study by an OIOM Task Force and includes 16 recommendations. The full report appeared in The Journal of Bone and Joint Surgery–American (July 16) and is available on the AOA website (www.aoassn.org).
The OIOM Task Force was chaired by G. Paul De Rosa, MD, and included both orthopaedic surgeons and others representing a variety of perspectives, training, and experience. Task force members included Robert L. Barrack, MD; Jonathan P. Braman, MD; Nancy M. Cummings, MD; Edward N. Hanley Jr, MD; and E. Anthony Rankin, MD, as well as surgeon-ethicist Peter Angelos, MD, PhD; cardiologist Robert Califf, MD; attorney David Hyman, JD; pathologist David Korn, MD; former industry representative Stephen Peoples, VMD; and Susan Roberts, PhD.
“The issue of surgeon-industry relationships in orthopaedic surgery is critical,” said Dr. Rankin, who previously chaired the AAOS Conflict of Interest Project Team, which developed recommendations that led to the establishment of the AAOS Disclosure Database. “This document from the OIOM puts forth recommendations and considerations designed to protect the core values of orthopaedic surgery as a discipline and to reaffirm and strengthen professionalism and integrity among orthopaedic surgeons.”
“I see this report as complementary to the Academy’s SOP on Orthopaedic Surgeon-Industry Relationships and disclosure program,” said Dr. Rankin. He noted, however, that this report concludes that “preserving the status quo is unacceptable and changes are needed.” Among other recommendations, the report calls for the orthopaedic specialty “to aspire to reduce, and eventually eliminate, industry’s financing of orthopaedic educational activities, gifts, meals, and the use of prescription drug samples.”
“We all know that self regulation is not only desired and preferred, it is also the right thing to do,” said Dr. Rankin. “I am confident that the efforts made by the AAOS, and now the AOA, in providing clarity and direction to our profession regarding appropriate physician–industry relationships will enable orthopaedists to better address this issue going forward.”
About the OIOM
The goal of the OIOM is to deliver unbiased education, information, and recommendations on issues critical to the profession of orthopaedics and the care of patients with musculoskeletal disease or injury that also impact other disciplines/specialties and/or healthcare providers. The first OIOM study was Emergency Department Call Coverage, downloadable at www.aoassn.org
The OIOM is managed by the American Orthopaedic Association, but no organization, including the AOA, can alter or approve/reject the final work product to ensure an independent perspective.
From the report…
The following are among the recommendations from the OIOM:
- Payment for consulting with industry, by providing advice, expertise, or other services in the context of product development should be fee-for-service or hourly consulting fees based on fair market value and well-defined contractual obligations with pre-specified timelines and deliverables.
- Orthopaedics surgeons should only participate in research that meaningfully contributes to the professional literature, are adequately powered to examine clinically important endpoints, and have a study design, operational structure, and oversight mechanism to minimize bias and ensure patient safety. The analysis and reporting of research data must be independent of industry influence, particularly if the research is industry-funded.
- Funds from industry for residency, fellowship, and other training programs should be distributed through unbiased, independent, third party organizations or through central administration of the institution. Residency and fellowship training programs should stop accepting individual-focused grants from companies and require companies to submit funding through either of the aforementioned approaches.
- Industry funds should not be used to develop clinical practice guidelines. When forming guideline committees, individual and composite numbers of financial ties to industry should be evaluated and minimized to avoid actual or perceived industry influence on the resultant guidelines.