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Published 10/1/2007

SOPs: Protective not punitive

In April 2007, the AAOS fellowship adopted Standards of Professionalism (SOPs) on Orthopaedist-Industry Conflicts of Interest, with more than 95 percent of voting fellows favoring their adoption. Enforcement of the SOPs is set to begin with acts occurring on or after January 1, 2008. As part of the Academy’s educational efforts regarding the SOPs, AAOS Now executive editor G. Jake Jaquet spoke with Murray J. Goodman, MD, the chair of the BOC/BOS Professionalism Committee, to see what they mean for the fellowship.

Jaquet: What factors led to the creation of the AAOS SOPs on orthopaedist-industry conflicts of interest?

Dr. Goodman: Prior to the development of the SOPs, the media had paid a fair amount of attention to conflicts of interest between physicians and industry. You may recall the New York Times article [January 24, 2006] on the Medtronic whistle-blower suit. The suit alleged the company was giving spine physicians “excessive remuneration, unlawful perquisites and bribes in other forms for purchasing goods and medical services.” [Editor’s note: In July 2006, Medtronic agreed to pay the federal government $40 million to settle the accusations, but admitted to no liability.]

The ongoing Department of Justice (DOJ) investigation concerning orthopaedic surgeons and industry has been in the media on a regular basis as well. Even the orthopaedic publications have picked up on this; I recall one headline, “Are surgeons accepting bribes?” [American Journal of Orthopedics, March 2006, p 114, editorial by Peter D. McCann, MD.]

Certainly many surgeons were aware that the issue was on the radar screen of certain governmental regulatory agencies. Even the general public was aware of it and was questioning what was going on.

In addition, both the drug manufacturing and the medical technology industries had developed codes of ethics that they had begun promulgating to their members regarding what constituted acceptable relationships. Although AAOS already had a code of ethics that represented aspirational or ideal behavior, the newly established Professional Compliance Program presented an opportunity to craft a set of guidelines for our members as to what was right and what was not right. The SOPs are the set of minimum standards to which all fellows can look for guidance.

Jaquet: When did the work on the SOPs begin?

Dr. Goodman: We were discussing things in mid-2005, but we really got going in early 2006.

Jaquet: The concept of potential for conflict of interest is easy enough to grasp, but defining it and working out SOPs must have been difficult. Did any aspects of the SOPs prove to be particularly challenging?

Dr. Goodman: We used the Academy’s existing Code of Ethics as a starting point, then looked to create some concrete guidelines that would be clear and upon which the fellowship could model their behavior. The most basic tenet is that the patient’s interest is paramount. Our whole purpose for being in this profession is to take care of patients and make them better. Whenever a physician’s decision-making process might be influenced by financial considerations or other motivating factors, the potential exists for optimal patient care to become a secondary and not a primary goal. That is what we wanted to guard against.

So, the challenge was to look at the areas where potential conflicts could arise and define them.

Jaquet: Offhand, that would seem to be a huge task. Aren’t there chances for potential conflicts almost everywhere?

Dr. Goodman: Well, yes. But the relationship between industry and orthopaedic surgeons is a very important relationship that must continue. The basic concept is that the patient is best served by collaboration between industry and orthopaedists to develop implants and surgical procedures. You really need both sides of that team. A relationship with industry is absolutely necessary to support research and education, to train surgeons in the use of the devices, and even to help educate patients on advances in orthopaedics.

The greatest challenge was not to jeopardize that critical—and beneficial—collaboration in the attempt to define potential conflicts of interest.

Jaquet: Are there any federal or state laws related to relationships between practitioners and industry that were given attention in the development of the SOPs?

Dr. Goodman: Certainly, we wanted the SOPs to be in compliance with federal and state laws, but that wasn’t our focus. We focused more on the patient-industry-physician relationship triangle. We did ensure that the SOPs are within a safe boundary with respect to legal aspects.

Jaquet: You mentioned earlier the PhRMA Code on Interactions with Health Care Professionals and the AdvaMed Code of Ethics on Interactions with Health Care Professions—can you offer a perspective on how well these codes complement the AAOS SOPs and vice versa?

Dr. Goodman: The Academy referenced the industry codes in developing our standards so that both industry representatives and orthopaedic surgeons would have the same expectations placed on them and their behavior would thus be in sync. I think that the difference between the AAOS SOPs and the industry codes is that the latter are more involved documents, specifying more potential behaviors and violations. But I think the SOPs align with the industry codes.

Jaquet: Are any aspects of the SOPs regarding conflicts of interest more important than others for the orthopaedic surgeon to be aware of? Are there any specific areas or circumstances—consulting agreements, for example, or “perks” for attending instructional courses—of which fellows should be particularly mindful to ensure they are in full compliance with the SOPs?

Dr. Goodman: Regarding consulting fees, the arrangements must be for bona fide services that are provided for and specified in advance, in writing. And the fees must be reasonable and what is considered the general industry standard, not payment for delivering patients or payment for volume of implants. The SOPs list the criteria for such relationships.

There are basically two types of educational courses: those certified by the Accreditation Council on Continuing Medical Education (ACCME), and those sponsored by industry. Industry can contribute financially to help offset the cost of the ACCME-accredited courses, but the content and the speakers are determined by the sponsoring facility. Again, industry can help defray the cost, but it cannot dictate the content. Industry cannot provide any direct support to individual attendees at those courses.

Industry-sponsored courses, on the other hand, which do not provide CME credits, generally have as their goal training a surgeon in the use of a particular implant or technique. Such courses can be sponsored by a manufacturer or industry representative; the company can provide tuition, transportation, lodging, and modest hospitality to the person who attends that course, because he or she is learning a particular technique. These are not intended to be CME, balanced courses; they are specifically “how-to” experiences. That is why surgeons can be reimbursed for expenses incurred in attending.

All industry-sponsored events must have an educational focus and must be conducted at a venue conducive to that goal. Any aspects of social programming must represent minor hospitality in comparison to the magnitude of the educational event.

Jaquet: So, a day-and-a-half training session with a half day on the golf course…?

Dr. Goodman: The SOPs says “An orthopaedic surgeon, when attending an industry-sponsored non-CME educational event, shall accept only travel and modest hospitality, [emphasis added] including meals and receptions….” This is exactly as expressed in industry guidelines as well.

Jaquet: It would seem that in such a circumstance one might want to err on the side of caution.

Dr. Goodman: Yes. The main focus clearly has to be on education.

Jaquet: The SOPs were adopted in April, but enforcement will begin with acts occurring on or after January 1, 2008. From your perspective, is the general member aware of and compliant with the SOPs at this time?

Dr. Goodman: I think that most fellows are aware of the issue, especially with the attention drawn to it over the past couple of years. But they may need more education regarding the specifics of what constitutes an appropriate relationship with industry, particularly regarding the aspects of allowable consulting arrangements and reimbursement for educational events. The Academy’s educational efforts will include a Webinar in November and a symposium on the subject at the Annual Meeting, just to name a few. (See “Enhance your understanding of SOPs” below.)

Jaquet: Some people think the DOJ investigation of major orthopaedic device manufacturers is nearing a conclusion. Do you have any expectations about the outcome?

Dr. Goodman: I have no knowledge of anything specific that might be coming out of the DOJ investigation, but I hope it will recognize the ongoing need for collaboration between industry and medicine to benefit both patient care and product research and development. I also hope the outcome will define appropriate boundaries already covered by the AAOS SOPs.

Jaquet: Some academic institutions, Stanford, for example, have instituted policies that essentially ban relationships between the healthcare professionals they employ and industry. What ramifications will these more extreme policies have? Do they affect practice one way or another, or is this just the way life is in the academic community?

Dr. Goodman: It can be the way life is in the academic community. Certainly, as more orthopaedic residents are trained under that type of environment, it will become second nature to them. The Stanford policy is very clear, specifying that “Individuals must consciously and actively divorce clinical care decisions from any perceived or actual benefits expected from any company. It is unacceptable for patient care decisions to be influenced by the possibility of personal financial gain.” And the remainder of the Stanford guideline document is an elaboration on the specifics of that. And they draw the line very close to zero.

By reading the document, anyone who is covered by the policy has a clear and definite understanding of what is expected of them.

Similar policies have been proposed by other universities, and I’ve even heard that several state legislatures are talking about this type of regulation. Some people feel that the only way of reducing potential conflicts of interest is to completely eliminate any actual or perceived influence that financial incentives, token gifts, or even a complimentary pen or notepad might have on medical judgment. The rationale is the notion that perception becomes reality. Some recent media coverage supports this. A photo in the New York Times recently showed lunches that had been paid for by a pharmaceutical company being delivered to an internist’s office, so clearly the media is drawing attention to this. If you are totally above reproach, no one can accuse you of conflicts, and I’m sure that is behind the Stanford policy.

Jaquet: Won’t such restrictive policies put surgeons in the position of unknowingly or accidentally putting themselves at risk for a grievance under the AAOS SOPs?

Dr. Goodman: They could. But the AAOS SOPs require a complaint from one fellow against another; a petty matter is unlikely to trigger such an action. The grievance would go before the Committee on Professionalism—members of that committee are practicing orthopaedic surgeons—and have some room for interpretation.

But the media is increasingly scrutinizing these relationships and drawing attention to Congressional behavior in this regard; even college recruiters and financial aid offices have come under scrutiny by the media in the way they conduct business. So it is not just medicine; it may be beginning in medicine, but it is moving throughout business as there is more and more focus on ethics.

We hope that the AAOS SOPs on Orthopaedist-Industry Conflicts of Interest, as with some of the other SOPs the Academy has developed, will be more of an educational and behavior modification tool than a tool for enforcement. Hopefully, very few—if any—cases will come before the Committee on Professionalism. If the grievance is upheld, though, the AAOS Board of Directors may censure, suspend, or expel a member from the AAOS for a serious violation of these SOPs.

The bottom line is that patients come first. We just have to be careful because perception can become reality and we don’t want to give people the wrong idea about how we make our decisions.

G. Jake Jaquet is executive editor of AAOS Now. He can be reached at jaquet@aaos.org. The SOPs on Orthopaedist-Industry Conflicts of Interest are available at: http://www.aaos.org/member/profcomp. For more information on the SOPs, visit: http://www.aaos.org/industryrelationships