Academy calls for appropriate disclosure, educational context

On Oct. 31, 2007, to comply with settlement agreements reached with the US Attorney of New Jersey (Department of Justice or DOJ), five major orthopaedic hip and knee implant manufacturers disclosed the names and certain financial information about the physicians with whom they have consulting or other relationships. The disclosures include the name, city and state of residence, and amounts paid to physicians and other entities that have financial relationships with the implant manufacturers in 2007.

In addition, by the end of November, the implant manufacturers are expected to disclose “any costs of additional indirect payments,” such as the estimated costs for registered or unregistered securities, meals, entertainment, travel, gifts, and in-kind services.

Within the orthopaedic community, the broad definitions used by the DOJ of “consultant,” “consulting agreement,” and “payment” raised concerns that, without an educational context, the disclosure information may be confusing to patients and the public.

AAOS leadership
Immediately after the settlements were announced on Sept. 27, 2007, the AAOS notified all fellows and members of their terms. (See “Money and monitors: What the settlements mean” on page 41.)

During the weeks between Sept. 27 and Oct. 31, AAOS leadership and staff continued to monitor the situation and to maintain open lines of communication with fellows and members with varying viewpoints, as well as with orthopaedic specialty societies and government representatives. In addition, the AAOS retained outside counsel to provide advice on relating to the US Attorney’s office.

During all meetings, teleconferences, and discussions, the AAOS recognized the primacy of the physician-patient relationship and the benefits that accrue to patients through ethical collaborations between orthopaedic surgeons and implant manufacturers. Concerns about privacy rights, confidentiality, and the potential for misunderstanding were also addressed.

Position on disclosure
As a result of these discussions, the AAOS developed the following position: “Financial disclosures that display only the name of the physician and an aggregate dollar amount received without educational context may be confusing and misleading to the public and patients. AAOS believes that financial disclosures of implant manufacturer payments should be divided into separate categories, such as royalty payments, consulting agreements, funding for the conduct of research, funding for the support of medical education, and that these terms should be defined so that patients and the public can understand them.”

This philosophy is reflected in the Academy’s recently developed Orthopaedic Surgeon’s Disclosure Program. The database defines several areas in which potential conflicts of interest might exist—ranging from board and consulting positions to royalties, honoraria, research or institutional support, stock ownership, and other financial or material support. (See “AAOS introduces new disclosure program,” AAOS Now, October 2007.)

When royalty payments for intellectual property are lumped with research grants, fellowships, and educational honoraria, the resulting figure can be substantial, but not necessarily reflective of inappropriate or unethical behavior.

In a meeting with US Attorney Christopher J. Christie, the AAOS—represented by President James H. Beaty, MD; First Vice-President E. Anthony Rankin, MD; Chief Executive Officer Karen L. Hackett, CAE, FACHE, and outside counsel Kathleen (Katie) McDermott—requested that the disclosures include both an educational context and financial categories of payment. Although the AAOS position was “treated with respect,” it was not adopted.

The meeting did, however, allow the Academy to discuss its role and mission to serve the profession, champion the interests of patients, and advance the highest quality musculoskeletal health. Because the DOJ investigation is reported to be ongoing and the provisions of the settlement agreements will be implemented over the next 18 months, the Academy wants to engage in ongoing dialogue with the US Attorney.

Putting patients first…now and always
“The priority of AAOS members is the care and well being of their patients,” said Dr. Beaty in his statement to the media in regard to the Oct. 31 disclosures by the implant manufacturers. “We are committed to making sure that patients and the public have confidence that partnerships between companies and physicians put the interests of patients first.…

“AAOS holds its members to extremely high ethical standards to ensure that even the appearance of a conflict of interest does not jeopardize the trust that patients place in our doctors,” he continued. He acknowledged the Academy’s commitment to strengthening ethical standards for the profession, particularly with the Standards of Professionalism on Orthopaedist-Industry Conflicts of Interest, and noted that “There is no place for even the appearance of illegal and unethical arrangements where compensation to a physician greatly exceeds the value of the services to the company. These arrangements erode public trust and confidence.”

In recognizing that many AAOS fellows work in partnership with implant manufacturers to provide consulting advice, conduct research, and educate their colleagues and the public, Dr. Beaty reaffirmed the important contributions to patient well-being that have resulted from partnerships between orthopaedists and implant manufacturers. “The United Sates is a world leader in the development of new orthopaedic technologies and techniques in large part because orthopaedic surgeons have used their unique knowledge and skills in collaboration and partnership with implant manufacturers,” he said.

The AAOS has also developed educational materials for members and patients, which can be used to establish an appropriate context and facilitate discussion and understanding of the many ways that orthopaedists and implant manufacturers can work together in ethical ways to advance patient care. (See “Resources” below .)

“AAOS believes that orthopaedic surgeons will continue to share their unique knowledge and skills to develop new devices and technologies for the betterment of our patients,” said Dr. Beaty. “Our priority has been and will always be our patients.”

Mary Ann Porucznik is managing editor of AAOS Now. She can be reached at porucznik@aaos.org

Resources
The AAOS Web site, www.aaos.org/industryrelationships, includes links to a variety of materials that can be used to educate patients, referring physicians, and the public about appropriate relationships between physicians and implant manufacturers and other commercial companies.

The Patient Discussion Guide provides facts and information that may be useful in answering patients’ questions. The guide includes a copy of the AAOS Standards of Professionalism on Orthopaedist-Industry Conflicts of Interest.

A model Patient Disclosure Letter is also provided that orthopaedic surgeons can tailor for use in disclosing financial arrangements and/or consulting agreements.

Because these disclosures may have an impact on patient care and physician relationships, the AAOS has established a disclosure hotline at industryconflicts@aaos.org Members are encouraged to share their experiences—both positive and negative—regarding these disclosures on this hotline.

As part of the ongoing education effort in support of the Standards of Professionalism (SOPs) on Orthopaedist-Industry Conflicts of Interest, the AAOS broadcast an educational online seminar (“Orthopaedists at risk: Navigating industry relationships”), on Nov. 13, 2007.

The seminar will be available online at www.aaos.org/industryrelationships

These issues will also be addressed as part of the Annual Meeting symposium on “The Evolving Orthopaedic Surgeon-Industry Relationship,” scheduled for Friday, March 7, 2008, at 8 a.m. in San Francisco’s Moscone Center Gateway Ballroom.