AAOS Bulletin - June, 2005

Collaboration and conflict: Orthopaedic surgeons and industry

Academy, industry guidelines draw a fine line

By Jeanne L. DelSignore, MD

Along the corridor outside the Orthopaedic Learning Center, a series of display cases show the evolution of orthopaedic fixation devices and joint replacement implants. From early models of bone plates, Bakelite plastic hip cups and hardware-store wood screws, through more contemporary ceramic, titanium and wire models, the display is eloquent testimony to the creativity of orthopaedic surgeons and the ongoing commitment of orthopaedic surgeons and device manufacturers to develop technologies that improve patients’ lives.

So when the Department of Justice (DOJ), through the U.S. Attorney’s Office in Newark, N.J., issued subpoenas to several orthopaedic device manufacturers, ripples of concern spread through the orthopaedic community. As one orthopaedic surgeon wrote: “If we are not willing to police ourselves, I don’t think we should be surprised when the government does it for us.”

There has long been a symbiotic relationship between orthopaedic surgeons and medical device manufacturers. Orthopaedic surgeons, in their efforts to improve patient care, have relied on device manufacturers to bring their creative ideas to fruition and to fine tune a good idea with regular improvements based on clinical feedback. Device manufacturers, in turn, rely on orthopaedic surgeons to provide both innovative ideas and feedback, to test and evaluate new designs and to use and/or endorse their products.

An ethical dilemma

At the heart of the controversy is an ethical dilemma. According to the AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons:

“The orthopaedic profession exists for the primary purpose of caring for the patient. The physician-patient relationship is the focus of all ethical concerns.”

The Code, however, also recognizes that the “practice of medicine inherently presents potential conflicts of interest” and addresses this as well:

III.C. When an orthopaedic surgeon receives anything of significant value from industry, a potential conflict exists which should be disclosed to the patient. When an orthopaedic surgeon receives inventor royalties from industry, the orthopaedic surgeon should disclose this fact to the patient if such royalties relate to the patient’s treatment. It is unethical for an orthopaedic surgeon to receive reimbursement of any kind from industry for using a particular device or medication. Reimbursement for reasonable administrative costs in conducting or participating in a scientifically sound research clinical trial is acceptable.

III.D. An orthopaedic surgeon reporting on clinical research or experience with a given procedure or device must disclose any financial interest in that procedure or device if the orthopaedic surgeon or any institution with which that orthopaedic surgeon is connected has received anything of value from its inventor or manufacturer.

The AAOS goes on to provide guidance in its Opinions on Ethics and Professionalism: Gifts and the Orthopaedic Surgeon’s Relationship with Industry. The guidelines prohibit the acceptance of cash gifts as well as the acceptance of other gifts that have either an explicit or implicit requirement that the recipient use the products or services provided by the giver.

Because the potential for a conflict of interest exists, particularly with regard to industry-sponsored educational courses, the guidelines also point out that “orthopaedic surgeons are responsible for ensuring that decisions to accept subsidies (to attend educational events sponsored by industry) are in the best interests of their patients.” In addition, the guidelines say:

Reimbursement should be limited to expenses that are strictly necessary and able to withstand public scrutiny. In no case should honoraria or reimbursement for time off to attend the course be offered or accepted. In addition, attending the course and learning the technique must not require or imply that the orthopaedic surgeon must subsequently use that technique.

The AAOS guidelines state that it is acceptable and necessary for orthopaedic surgeons to have bona fide relationships with industry. It is ethical and appropriate for orthopaedic surgeons to receive inventor royalties or other “reasonable compensation” from companies in return for consultation, research and development and true advisory services.

Such financial relationships must be disclosed to the patient when a particular device is being recommended for use. Disclosure is also required when an orthopaedic surgeon discusses or promotes devices in an educational meeting where there is a financial relationship with industry. “Token consulting or advisory arrangements cannot be used to justify compensating orthopaedic surgeons for their expertise, time, travel, lodging or other out-of-pocket expenses.”

Although these guidelines do provide some parameters for orthopaedic surgeons to judge their own and others’ actions and decisions, they are simply guidelines.

Industry guidelines

In recent years, the medical device industry has also recognized the need for guidelines. In January 2004, a new Code of Ethics was adopted by the Advanced Medical Technology Association (AdvaMed), a trade association of more than 1,100 manufacturers of medical devices, diagnostic products and medical information systems. The Code covers interactions with health care professionals in several areas, including company-sponsored meetings, third-party conferences, sales and promotional meetings, consulting arrangements, gifts, charitable donations, and reimbursement and technical information.

“Medical technology innovation depends on very close collaborative relationships between health care professionals and medical technology companies,” said Blair Childs, AdvaMed’s executive vice president, strategic planning and implementation. “Unlike drugs, which are developed in the laboratory, most medical technology is developed in a collaborative way between medical technology companies and health care professionals.”

Although the Code is voluntary, a recent survey of the AdvaMed membership found that more than half of the responding companies with ethical policies modified those policies to comply with the stricter requirements of the Code. About a quarter of responding companies had no prior ethical policy, but established one after the AdvaMed Code was introduced. Three out of four companies conducted regular training for employees, including sales representatives, marketing personnel, senior executives and general managers. In addition, shortly after the DOJ issued its subpoenas, AdvaMed updated its Code.

In some ways, the AdvaMed Code is more restrictive than the AAOS guidelines. For example, the AdvaMed Code outlines eight requirements that must be met to support the existence of a bona fide consulting arrangement. These requirements include a written, signed agreement specifying services to be provided; fair market value compensation for the services provided; a pre-identified “legitimate need and purpose” for the services, and selection based on qualifications and expertise, not volume or value of business.

The Code also limits the value of gifts to health care professionals to less than $100, except for gifts of medical textbooks or anatomical models for educational purposes, and prohibits gifts of cash or cash equivalents.

Implications for our profession

Because the DOJ subpoenas requested documents back to 2002, before the AdvaMed Code of Ethics was developed, there is some concern that the investigation might uncover some questionable arrangements.

AAOS President Stuart L. Weinstein, MD, responded to the Wall Street Journal, noting that “Optimal patient care requires collaboration between orthopaedic surgeons and industry manufacturers. This collaborative effort ensures that patients have the best surgical outcomes through the invention and testing of new technology; research and evaluation of existing technology; and continued education of orthopaedic surgeons.”

The ethical guidelines that govern our profession must be maintained. Orthopaedic residency programs are required to teach ethics, and the “Ethical Issues in Orthopaedic Surgery,” developed by AAOS, the American Orthopaedic Association and the Academic Orthopaedic Society, provides an excellent case study approach. In fact, the very first case study is on gifts from industry. In addition, the AAOS Ethics Committee is now working on a series of presentations and educational materials focusing on ethics.

The AAOS, in conjunction with the Orthopaedic Research and Education Foundation, recently (December 2004) revised its “Guidelines for Commercial Support of AAOS Programs.” The guidelines cover a few simple principles, including objectivity, transparency, control of content and direct support to faculty, authors and participants.

The guidelines outline the relationship between the Academy and industry for selected programs and projects, including scientific meetings and continuing medical education courses, publications and other self-directed educational material, musculoskeletal research, public education and public service programs. While the Academy recognizes the importance and educational benefit of industry participation in areas such as surgical skills courses, it also strives to maintain the highest standards of objectivity and retains complete responsibility, control and decision-making authority for all programs. Funding that is dependent on the inclusion or exclusion of specific medical/scientific or product content is not accepted.

Most surgeons are ethical and honest. At the same time, as one orthopaedic surgeon acknowledged, “although we try to stay objective, it’s human nature to want to do something nice for someone who does something nice for you.” The goal always is to put the patient’s interests first, to provide full disclosure whenever there is a potential conflict of interest, and to recognize that we are—and should be—held to a higher standard.

Jeanne L. DelSignore, MD, is chair of the AAOS Ethics Committee. She can be reached via e-mail at jdelsignore@handsurgeryassoc.org

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