The movement to make physician-industry payments more transparent gained momentum over the past several years, with states like Massachusetts and Vermont passing versions of the Sunshine Act in 2008 and 2009, respectively. As one article recently noted, after these state laws passed, “there were running jokes in the exhibition halls of surgical society meetings around the country” about the fact that surgeons from “these states were barred from drinking the free cans of Diet Coke that device companies might hand out at their booth seemed ludicrous.”
However, the jokes started to fade when the Physician Payment Sunshine Act was adopted in the Affordable Care Act (ACA) in March 2010. This provision requires physicians to disclose any gift worth more than $10. It also provided for the creation of a national, publicly accessible database that would list physicians’ names, addresses and the nature and value of all gifts received from industry.
While we certainly applaud any efforts to make physician-payments more transparent, so that the public can fully understand the value such relationships provide in creating new treatments, enhancing patient care, and improving patient outcomes, some members of the healthcare industry are concerned about the negative impact the Sunshine Act will have on them. In particular, the database will have a far-reaching affect on surgeons.
Although many surgeons agree that bias can be present from such payments, they argue that medical devices are vastly different from pharmaceutical products. In addition, at the 12th World Congress of Endoscopic Surgery last year, experts voiced concerns rippling through the surgical community that “losing or denying industry support might hurt graduate and continuing medical education (CME), the leadership of specialty surgical societies, and the development of minimally invasive surgery as a whole.”
Minimally Invasive Surgery Is Unique
National surgical meetings like those hosted by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) are among the best places to look at conflict of interest in surgery. “Without industry support, these meetings likely would not exist.” In fact, Gerald Fried, MD, the Steinberg-Bernstein Chair of Minimally Invasive Surgery and Innovation at McGill University Health Centre, in Montreal, noted that industry funding “really impacts the whole running of SAGES or [the Canadian Association of General Surgeons] or any specialty society.”
The article however, used old data about funding of CME programs from industry. Commercial support of CME has been significantly reduced over the past several years, and now makes up less than half of all CME funding. Specifically, since 2007, commercial support has declined $355 million or 29.3%. Moreover, the total percent of commercial support as part of the overall CME budget dropped from 47.5% (2007) to 39.0% in 2009. Fewer companies are funding CME programs as well.
Nevertheless, Dr. Fried was right in asking: “Can you imagine if we took all that money and it was not available for CME activities?” The small groups of critics who call for an end to commercial support of CME generally have no answer to this question. Some assert that physicians could pay more for CME. Others suggest that government (which never funds CME) could cover the costs. Another idea is for hospitals and institutions to begin offering more courses. All of these ideas are unrealistic and do not address the significant resources, staff, and regulatory/legal issues that CME providers deal with on a day-to-day basis.
But those of us who have seen the beneficial impact of commercially supported CME programs—such as improvement in use of NIH guidelines for Hypertension or improved use of evidence based practices in COPD—know that removing commercial funding of CME, like Dr. Fried noted, “would have a huge impact,” on physician training and patient outcomes.
Michael Holzman, MD, associate professor of surgery and medical director of the Minimally Invasive Surgery Center at Vanderbilt University Medical Center, in Nashville, Tenn., agreed. “Without [industry], I don’t know what we could do for CME. It would become very expensive.”
As the article explained, “much of the research presented at meetings is made possible only through industry support. Most academic investigators, or at least their departments, receive funding from one or several device companies. Some investigators even admit they owe their entire academic careers to research funded by industry.”
Larry Whelan, MD, chief of colon and rectal surgery at St. Luke’s-Roosevelt Hospital in New York City, estimates that the “minimally invasive surgical literature would literally be several orders of magnitude smaller” without the industry research support that has been provided over the past two decades. This support has included educational grants to hospitals and researchers as well as money given to societies for distribution to grant winners.
Dr. Whelan asserted that, “the government will never have the means to support this kind of work, and that the vast majority of this research would simply not get funded by the [National Cancer Institute] or [National Institutes of Health].” As a result, Dr. Whelan recognized that, “without device companies pushing device research and development, everyday surgical instruments would be several generations behind, and this is particularly true for minimally invasive surgery.”
In fact, Dr. Whelan noted that he could not “think of another field in general surgery in which the growth has been so closely tied to industry.” He further noted that, “there is so much that goes on with this interaction, it’s hard to imagine the academic landscape without these relationships in place.”
Effects of Conflicts of Interest
Consequently, Dr. Fried noted that, “the world of CME is greatly benefitted by the resources that industry gives for research and education.” However, he mentioned that some evidence shows physicians can be biased as a result of these interactions. He did not however discuss three studies from last year, which produced substantial data that demonstrate a lack of commercial bias in industry-sponsored CME (Cleveland Clinic; Medscape, and UCSF).
Moreover, the article unfortunately tried to make a connection between the alleged “gifts” that surgeons receive, and the influence they may have on physicians prescribing habits or clinical decisions. This line of reasoning is extremely problematic for two reasons. First, it neglects to mention the recently adopted AdvaMed Code of Ethics, which puts in place strict prohibitions against any gifts whatsoever. Second, the article’s use of the Wazana study is flawed because the study explicitly stated that of the publications reviewed “…no studies used patient outcome measures.” In other words, there is no evidence that gifts (when they were given) harmed patients.
Managing Perception
The article noted that physicians need to be concerned about the perception of bias [and] have to manage that perception as well. In this section, the authors did mention the AdvaMed Code of Ethics, implemented in 2009, which touched on nearly every interaction between industry and surgeons. Consequently, one of the consequences from the “perception of bias” was that a group of device companies in February announced they would be pulling funding on more than 200 minimally invasive surgery fellowships around the country, which represented as much as one-fourth of the surgical fellowship training force.
To address the significant shortage in surgical fellows this created, a group of academic surgeons scrambled to put together the nonprofit Foundation for Surgical Fellowships to provide a buffer layer between industry and the fellowships they funded. Bruce Schirmer, MD, who is vice chairman of surgery at the University of Virginia in Charlottesville and was involved in setting up the foundation, called it “insurance against a conflict-of-interest disaster.” The foundation adds a layer of bureaucracy and cost, but will keep minimally invasive surgery fellowships from being targeted by critics.
Surgical societies have responded as well by adopting policies recommended by the Institute of Medicine, which state that society presidents and officers be completely free from conflicts of interest, beginning at least two years before they take office.
Discussion
The problem with increased conflict-of-interest concerns is that they will have a chilling effect throughout the entire surgical community, “from cutting resident courses and symposia to stricter guidelines that reduce the number of clinical and animal studies.” It will also create an atmosphere where both industry and physicians may become reluctant to work together as closely as they did in the past, leading to less discovery and innovation in medical devices, which will only harm patients.
As Dr. Whelan concisely pointed out, “industry is afraid, and is trying to make sure it’s protected in terms of liability. Physicians are reluctant to agree to industry-sponsored studies or support if that involvement can be misconstrued.” This clearly leads to less being done.
To address these issues, the article recommends that surgeons first be transparent and not accept anything from industry that doesn’t contribute to patient care. Next, they recommend that physicians understand the principles behind the American Medical Association’s Code of Medical Ethics as well as any other guidelines at the level of their institution. Having understood the principles, surgeons should assess their projects, publications, and business relationships from a conflict-of-interest perspective.
The main areas that may be looked at are ownership or director-level roles in biomedical companies or medical facilities, the level of industry-sponsored research and any consultantships and legal work performed.
Conclusion
In the end, the authors note that the much larger issue is how surgeons as a group should respond. Many surgeons feel the first step is differentiating surgery from drug development. Others believe part of the process is educating and talking to patients to show them why the work surgeons do with industry is important and why surgeons are proud of the work they’ve done with industry.
If this is not done, surgeons and device companies run the risk for being lumped together with other industries, where any interaction between surgeons and companies is seen as negative. Ultimately, they noted that surgeons must act now because Congress is trying to act for them.