Five perspectives on the surgeon-industry relationship
In March 2005, the U.S. Department of Justice (DOJ) issued subpoenas to several orthopaedic device makers, seeking information about their relationships with surgeons. Although the issue of industry-surgeon collaborations has often been discussed, the DOJ’s action brought “conflict of interest” into sharp focus. At the 2006 fall meeting of the American Association of Hip and Knee Surgeons, a clinician, an academician, a lawyer, an industry executive vice-president and an AAOS leader each brought a unique perspective to the debate.
Panelists included Lawrence D. Dorr, MD, medical director of the Arthritis Institutes in Los Angeles and Inglewood, Calif; Stuart L. Weinstein, MD, Ignacio V. Ponseti Professor of Orthopaedic Surgery at the University of Iowa; Robert Pristave, JD, partner, McGuireWoods LLP; Ned Lipes, executive vice president, Stryker Corp., and Richard F. Kyle, MD, AAOS president.
Changing the nature of man
The past four decades have been the “most exciting” time in medicine, according to Dr. Dorr. “Patients can live fulfilled lives because of the operations we’ve developed,” he said, noting that prior to 1960, orthopaedic surgeons could treat fractures and infections and do tendon transfers for polio, but little else.
But individuals such as Sir John Charnley, Paul Harrington, MD, and Frank Gunston, MD, working in their laboratories and sometimes in their garages, developed and produced devices that changed orthopaedics. A decade later, companies began to realize the potential of orthopaedic devices, and by the 1980s, the field “exploded, like Silicone Valley,” said Dr. Dorr. Surgeon champions, working with industry, were directly involved in device development, designing implants that are still in use.
A change in style from champions to consulting teams in the 1990s and a more recent emphasis on process rather than individuals has not negated the need for involvement by orthopaedic surgeons. “Orthopaedic surgeons must continue to work with industry because it is the only way the field will advance. But it must be done within moral, ethical standards,” concluded Dr. Dorr.
Pervasive in academia
Academics, noted Dr. Weinstein, have many roles: clinicians, researchers, educators, leaders. In each role, conflicts of interest threaten the professionalism of the orthopaedic surgeon.
Because patients who see clinicians at academic centers have specific expectations, academic orthopaedists must follow the same rules as those in private practice—always putting the patient’s best interests first, said Dr. Weinstein. This rule also underlies any clinical decisions, particularly because there are very few Level I studies in orthopaedics and most decisions are based on a surgeon’s clinical experience.
“The federal government provides approximately $25 billion in funding for biomedical research,” said Dr. Weinstein. “Private foundations raise $8 billion to $10 billion each year. But in 2000, industry provided more than $55 billion in research funding. Nearly 75 percent of the literature on total hip arthroplasty was funded by industry.”
Institutional policies vary widely, Dr. Weinstein pointed out, and a careful reading may reveal that many researchers are in violation of their institutions’ ethical guidelines. “With industry-sponsored research, one has to ask, ‘Is there bias? Who owns the data?’” said Dr. Weinstein.
As educators, orthopaedic surgeons in academia serve as role models to the next generation. “Habits learned in training persist in practice,” quoted Dr. Weinstein. “We need to teach objectivity and scientific integrity to our residents, to incorporate discussions of ethics and professionalism early on, and to continue that dialogue throughout their medical training.”
From a legal standpoint
Addressing the recent investigations into the device industry, Mr. Pristave stated that “the government always wins, because no company will go to trial. None will take the risk of losing, because if you lose, you will be barred from participation in Medicare.”
In such a hostile climate, he advised, physicians should focus on developing consulting contracts that will meet the government’s criteria. “Lawyers think in terms of hours and work effort,” he said, “so a compensation structure based on an hourly fee for documented work is probably the best arrangement.” In ascending risk order, other compensation arrangements include a flat annual fee in return for delivering a list of services, a percentage of sales (royalties), company stock options and joint ventures.
Warning that state laws are often broader than federal regulations, he advised attendees to meet as many “safe harbor” requirements as possible when working with industry. These include establishing compensation in advance and basing it on fair market value, rather than volume.
Unfortunately, he said, physicians may not realize what companies are saying internally. Citing the Medtronic settlement, he noted that an internal memo, uncovered during discovery, was key to the government’s claim that the company had established “sham” consulting agreements with several physicians.
The industry perspective
“Collaboration throughout the product development process is vital,” said Mr. Lipes. “Developing implants without surgeon input is like designing a race car or a fighter plane without input from a driver or pilot.”
The role of the surgeon is particularly significant in three areas: new concept development, design and testing, and training and education. But whether a product will succeed, he noted, depends on improved patient outcomes.
“Every time I’m in the operating room with a surgeon,” recalled Mr. Lipes, “I walk out with half-a-dozen ideas on what we could do better to make a product more useful or effective.” No product, he said, would gain wide acceptance unless it delivered better clinical results.
Surgeons who have the opportunity to work with industry should select their partners carefully, he advised. “Talk to colleagues, make sure there’s a fit between you and the culture or personality of the company, and structure the financial arrangement carefully.”
AdvaMed, the industry trade association, has established a voluntary code of ethics that provides guidance in several areas and covers a broad range of interactions. Under this code, any consulting agreement must meet several tests, including specification of a legitimate need and purpose for the surgeon’s participation. “Increasing sales or usage is not a legitimate need,” said Mr. Lipes.
“We have not solved every problem,” he concluded, “and our patients are more demanding than ever. We need each other to advance care and improve outcomes.”
Keeping patients first
“Conflicts of interest exist,” pointed out Dr. Kyle. “It’s how you manage them that’s important.” Collaborations between physicians and industry are needed to advance and improve patient care. But “the patient’s best interest must come first,” said Dr. Kyle.
“Whenever possible, conflicts must be eliminated,” he continued. Resolution of conflicts of must always be in the patient’s best interest.”
The AAOS is addressing the need for professional self-regulation through the development of Standards of Professionalism (SOPs), said Dr. Kyle. The SOPs establish minimum mandatory standards of behavior. The newest SOPs, which will be considered at the 2007 AAOS Annual Meeting, cover orthopaedist-industry conflicts of interest. These standards, in conjunction with the AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, establish clear boundaries for any cooperative venture.
“We can see real-time collaboration between surgeons and industry in the development of new technologies and treatments for soldiers injured in the war on terror,” said Dr. Kyle. “Such efforts are absolutely critical to advance patient care.”