Editorial: Is It Time to End Surgeon-Industry Consulting?

The relationship between our profession and the device industry is an awkward topic for many orthopaedic surgeons. Perhaps some of our squeamishness derives from the chronic, often-sensationalized overexposure the subject receives in the lay press [2, 3, 14].

But maybe it is not the media presentation, but rather the reality of the story, that causes distress among surgeons. Confronting the uncomfortable here may do us some good. This month in Clinical Orthopaedics and Related Research^®, Jonathan N. Grauer MD and colleagues from Yale University [15] provide the first analysis of commercial payments to orthopaedic surgeons released under the new disclosure rules mandated in 2013 by the Physician Payments Sunshine Act. Grauer and colleagues show that a small number of orthopaedic surgeons receive most of the money that flows from commercial sources [15]. A substantial portion of that money was paid as industry gifts to surgeons and consulting deals. Those payments should end.

While only a small percentage of surgeons receive most of the consulting dollars that change hands, the media covers those transactions as though big-ticket consulting were normative among orthopaedic surgeons. Importantly, perceptions of widespread corruption go beyond the public and the media; our elected officials have articulated many of the same concerns [10]. The good news: If a few hundred surgeon-consultants were to change how they approach consulting —or cease doing it—public and government perceptions of our specialty likely would improve dramatically.

In 2007, the US Department of Justice (DOJ) collected settlements in excess of USD 300 million from four implant manufacturers as part of a deferred-prosecution agreement pertaining to violations of the antikickback statute. The DOJ was particularly concerned about consulting agreements in which little or no work was performed, but rather through which corporations bought surgeons’ brand loyalty [5]. Surgeons feared individual prosecutions, which never came; instead, the settlements resulted in the first large-scale public reporting of surgeons’ names and dollar amounts received. The deferred-prosecution agreement had a chilling effect on a business the DOJ believed was driven by surgeons whose consulting deals were, in effect “decisions predicated on how much money they could make—choosing which device to implant by going to the highest bidder” [5].

Enter the Sunshine Act and its publicly reported database, the Open Payments Program (http://www.cms.gov/openpayments/). The very name implies that dark transactions remain despite the 2007 DOJ intervention. Under this program, certain payments from implant and pharmaceutical manufacturers to individual physicians and teaching hospitals must be made available through the Centers for Medicare & Medicaid Services (CMS) to the public. If sunshine, as they say, is the best disinfectant, what does that make this part of our profession? While physicians remain by and large comfortable with their pharmaceutical-industry relationships [11], patients are much less sanguine, and indicate that they would not be as likely to trust—or take prescriptions from—physicians who take gifts from manufacturers [8].

Certainly many physicians did not receive the Sunshine Act with great warmth [13]. The American Medical Association and dozens of other societies representing hundreds of thousands of doctors—including the American Association of Orthopaedic Surgeons (AAOS)—protested the need to report the cost of books and reprints given to physicians by industry. They argued that capturing these transactions under the Sunshine Act would “harm patient care” [1], apparently indifferent to the promotional purpose behind these gifts [4], the evidence of their effectiveness at achieving the aims of the commercial source [16], and the ironic image this projects of doctors who can’t afford to buy or be bothered to find valid sources of medical information without the helping hand of industry.

Even so, the Sunshine Act is not perfect. Fairness dictates that physicians be allowed a reasonable period of time to correct errors in the database, but when the Open Payments system went live, the mechanism through which individuals could dispute transactions attributed to them was clunky [6]. This resulted in billions of dollars of deidentified payments, which are impossible for a user of the CMS website to interpret. Another problem is that it is too easy for an unsophisticated user to draw misleading conclusions from averaging the available data.

It is for this reason that thoughtful analyses like those of Dr. Grauer’s team in this month’s CORR^® are so important. Grauer and colleagues found that more than 95% of the money went to just 10% of surgeons who received payments during that period, a fact that has not changed much since 2007 [9], and one that points to this reality: A few surgeons’ industry partnerships influence perceptions that patients, the media, and our elected officials form about all those who practice our specialty [3, 10, 14]. While most of the money—nearly 70%—paid surgeons for their intellectual property, which perhaps is the easiest kind of transaction to justify to outside observers, that still left almost USD 14 million in consulting fees going to a small number of surgeons during just a few months, and nearly USD 6 million for “nonconsulting services,” mainly food and drink.

Rather than getting uncomfortable every time this topic gets dragged into the sunshine, perhaps we should approach these relationships differently. Surely an orthopaedic surgeon can pay for his or her own meals. Why let a patient imagine that a surgeon’s implant choice could be influenced by a steak dinner? Five years ago, thought leaders in our specialty, including at least one past president of the AAOS, suggested that surgeons should avoid these kinds of gifts [7], yet surgeons continue to accept them. This should stop.

But the far larger issue—in dollars and credibility—remains those consulting relationships. They result in legitimate research being called into question [12], and while consultants may feel that their roles entail important educational components—speakers’ bureaus, hands-on courses—these activities are widely and correctly perceived as marketing [2]. Indeed, prior to 2007, according to the DOJ, much of the money was actually spent marketing to those getting paid: That is, buying their loyalty with payments that amounted to kickbacks [5]. To what degree, if at all, anything has changed in this regard since then remains unclear. Certainly, the appearances here are a large part of our reality. The public senses, because the media reports it, that the main goal of consulting payments is “to influence prescribing practices” [17]. Even after the 2007 DOJ settlements, a US senator chairing a senate special committee on aging began his session with “unethical payments are not anecdotal but rather have been pervasive and industry-wide for too long…both the medical device industry and the physicians who take their money are equal participants and are equally culpable” [10].

The time has come to end or severely curtail consulting relationships between orthopaedic surgeons and industry. For those commercial projects where hiring surgeon-consultants is absolutely necessary, the surgeon’s contributions and his or her fair-market value should be assessed by a disinterested third party, as others have suggested [7]. Industry-funded research grants remain necessary and appropriate, provided that robust data-integrity safeguards are maintained, and provided that surgeons disclose their industry partnerships to their patients. Surgeons with great ideas should protect their intellectual property and continue to bring their ideas to market, partnering with industry when it is helpful to do so, and, again, providing full disclosure of the surgeon’s own commercial interests to patients.

But gifts of food or entertainment, payments for participation in speakers’ bureaus, and most consulting relationships with orthopaedic industry should end. Future surgeons will look back and wonder why we ever allowed them to begin.