Published 3/1/2003
Chris Przybyszewski

Working together without crossing the line

Be “ethical,” be “professional,” AAOS past president says

They were big questions asked in a simple way: Do orthopaedic surgeons need industry to create new and improved treatments for their patients? Do industry engineers need orthopaedic surgeons to create new and improved products?

“As an orthopaedic surgeon, I believe that we need each other,” answered Charles A. Rockwood Jr., MD, AAOS past president and professor and chairman emeritus of the department of orthopaedics at the University of Texas Medical School at San Antonio.

Dr. Rockwood was speaking on “Ethics, Orthopaedics, and Industry” at the University of Memphis’ FedEx Institute of Technology in Memphis, Tenn., as part of the InMotion Musculo­skeletal Institute’s quarterly musculoskeletal lecture series.

The critical component is that surgeons must keep these relationships “ethical” and “professional.” Dr. Rockwood speaks with both authority and experience. He has helped several companies develop products, most notably shoulder implant systems.

Dr. Rockwood owns portions of the patents and continues to collect royalties from multiple products on the market.

Crossing the line is trouble
“Some [orthopaedic device] companies have gotten in trouble, and the reason they got in trouble is because they had physicians who were not doing much work, but were getting lots of money for using (certain) prostheses,” claimed Dr. Rockwood.

It was those breaches, according to Dr. Rockwood, that may have triggered Department of Justice involvement in the orthopaedics industry, including punitive fines and extensive oversight. “If physicians and industry had kept ethics as one of their goals, we wouldn’t be in this position today,” he said.

Guidelines are there
In reviewing the general history of ethics in the medical profession, Dr. Rockwood reminded his audience of the guidelines established by the American Medical Association (AMA) in 1956, which stated simply that “Physicians may not take money except for direct patient care.” Nearly 30 years later, in 1985, The New England Journal of Medicine required authors to disclose the financial sources for their research funding, and the following year, both the AAOS and the Journal of Bone & Joint Surgery instituted similar policies.

Ethics guidelines were expanded by the AMA (1990) and the AAOS (1991) to include disclosure requirements for all educational presenters. In 1992, the AAOS published an official policy on ethics, relating directly to orthopaedic surgeons’ relationships with industry. Since that time, AAOS has stipulated concisely and consistently that all public presentations by surgeons be accompanied by a disclosure announcement.

In 2007, the AAOS fellowship adopted Standards of Professionalism on Orthopaedist-Industry Conflicts of Interest, which set forth 17 mandatory standards, dealing with the relationships between industry and orthopaedic surgeons.

For its part, industry has also developed and, over the years, strengthened various codes of ethics. Recently, both major trade associations—the Pharmaceutical Research and Manufacturers of America (PhRMA) and AdvaMed, the Advanced Medical Technology Association—updated their ethical codes to clarify and distinguish between appropriate and inappropriate activity between healthcare professionals and member companies.

These policies are designed not only to instruct surgeons and commercial companies and their vendors on ethical behavior, but also to cultivate an atmosphere of partnership with industry that keeps good science and patient care at the forefront of every conversation.

Cooperative efforts benefit patients
Dr. Rockwood iterated the reasons that orthopaedic surgeons and industry researchers need each other. For example, industry partners generously provided both funds and equipment to train new generations of orthopaedic surgeons, particularly in fellowship programs. Industry support has been critical for basic and clinical research, with industry funding frequently covering the gap between a researcher’s needs and his or her ability to secure private or government funding. Through research and design partnerships, that support has included manufacturing and distribution of devices and the training of surgeons on the use of new devices.

Likewise, Dr. Rockwood suggested strongly that industry needs orthopaedic surgeons, who are the creators of new treatments based on individual clinical experience. “How else [will industry] come up with ideas to create a new prosthesis?” he asked. “Surgeons are the ones who dream up new prostheses, new gadgets, new tools.”

The relationship is effective, then, but only if controlled in an ethical and professional way, said Dr. Rockwood, who used his own career as one model to follow. “I do not have a contract for services,” he asserted. “I do not receive an honorarium for time away for teaching. The only money I receive [from industry partners] is from patents and royalties.”

Avoiding “sticky” situations
Veering away from these simple guidelines can get one into situations that Dr. Rockwood called ‘sticky,’ such as offering or accepting travel expenses to meetings, tickets to entertainment opportunities, golf outings at resorts, or even outright cash in exchange for using certain medical devices.

“When payment is intended to encourage the healthcare provider to select a particular manufacturer, it raises ethical and legal issues,” he says. Among the many risks of this behavior is the possibility of violating the Medicare antikickback statute that stipulates payment by industry sources must not be intended to compensate the physician for using a specific device. Rather, the physician should only receive payment for the treatment of the patient.

As a consequence of the settlements reached with the Department of Justice, the five largest orthopaedic device companies now have government-employed “monitors” who approve all monies leaving the companies for research, development, and educational purposes.

That’s been problematic, according to Dr. Rockwood. “All those companies have been suffering.” Delays in normal research and development activities, which translates into slowed discoveries and fewer products moving to market, have occurred.

A second consequence of the settlements is that industry funds in support of medical education may no longer be channeled directly to nonprofits and schools. The companies have sought other ways to distribute the funds, including the use of a disinterested third party.

Aside from these issues, however, is the impact that the investigation and subsequent publicity and disclosure may have on the physician-patient relationship. Could disclosure compromise that trust or make the patient question the doctor’s use of a particular device? According to Dr. Rockwood, the more important question is about the surgeon’s ability.

“How do you know your prosthesis fits [a particular patient]?” he asked. “It doesn’t make a whole heck of a lot of difference which prosthesis it is. Given the right surgeon, it is going to work.”

Chris Przybyszewski is director of grants and communications at the InMotion Musculoskeletal Institute. He can be reached at chris@inmotionmemphis.org