The Orthopaedic Surgeon and Industry

Ethics and Industry Incentives

Abstract

Physicians may receive various gifts and incentives from companies that make pharmaceuticals and medical devices. Although such incentives may benefit patients and physicians, they often pose serious conflicts of interest that violate a physician's professional responsibility. The physician-patient relationship is predicated on the physician acting in the best interest of the patient. The application of medical knowledge to complex clinical circumstances is difficult, even without biased sources of information and internal conflicts attributable to financial incentives. Yet, industry resources often are dedicated to the dissemination of information and incentives aimed to influence decisions not necessarily aimed at the goals of the patient. Physicians often are unaware of the nature of the incentives and commonly deny their demonstrated impact. Any incentive that is designed to impede, rather than enhance, the clinician's ability to make optimal patient care decisions is unethical for a physician to accept. These incentives should play no role in the practice of orthopaedic surgery.

Physicians may receive various gifts and incentives from companies that make pharmaceuticals and medical devices. These gifts may range from trinkets designed to prompt name recognition to honoraria and consultant arrangements aimed at inducing clinicians to try new products or to enhance use of a company's wares. Given the recent reduction in fees, such supplemental resources may be needed to support practice components valued by patients or to facilitate physician attendance at essential continuing medical education activities. In addition, industry supported clinical and basic science research can lead to significant advancements in patient care. However, industry incentives may create conflicts of interest that violate a physician's professional responsibility. What are the ethical issues and how should an orthopedic surgeon decide whether to accept industry incentives?

Case Report

A representative of a company that is releasing a new hip prosthesis approaches an orthopaedic surgeon who performs approximately 200 total hip replacements each year. After demonstrating the new prosthesis and suggesting its many potential advantages, the representative explains that because the surgeon is an influential member of the local orthopaedic community, the company would like to extend an offer to the orthopaedic surgeon to become a consultant for the company. As compensation for providing general guidance about product development, the physician would receive a stipend as a consultant. In addition, he or she would join the company's speakers' bureau and have the opportunity to deliver hip replacement surgery "how to" lectures. The company will develop a personalized set of slides for these talks. Each speaking engagement includes first class travel and accommodations. The orthopaedic surgeon also will receive an honorarium. Should he or she accept the offer?

Comment

To consider this question, it is essential to ponder the fundamental tenets of the physician-patient relationship. This relationship is predicated on the physician acting in the best interest of the patient. This principle, often termed beneficence, means that a physician must take into account a patient's clinical factors and preferences in deciding on the best course of treatment for the patient. Issues that might be relevant to such a consideration would include the patient's precise clinical condition and overall prognosis, the available medical therapies for the condition, and the patient's goals. It should be noted that this list does not refer to what is best for the physician. Industry incentives create a system that may, and in many cases aim to corrupt the physician's decision making mechanism in choosing the best treatment for a particular patient. Such incentives intercalate the physician's interest into the decision making process. This creates a conflict of interest.

How does a physician choose the medical treatment or device that will work best for a particular patient? This decision may be predicated on evidence from the medical literature or may be based on the clinician's experience. For instance, clinical trials may show that one treatment is better than another or that one type of prosthesis has greater durability or economy. All too often, however, there is no clinical trial to guide physician behavior. In this case, the clinician must rely on other sources of information to make medical decisions. These information sources include retrospective studies, colleagues, local or regional influence leaders, professional society statements, continuing medical education presentations, or information from industry. Each of these sources has its inherent benefits and detractions. For example, groups of colleagues traditionally may have approached cases in a particular way that is not consistent with the most up-to-date data or technology. Similarly, local influence leaders may retain undisclosed potential conflicts of interest. It is the clinician's duty to select the best available sources of information to facilitate care of his or her patients.

Prior evaluation of information promoted by the pharmaceutical industry suggests that clinical information from this source must be treated as potentially biased. One study of pharmaceutical advertisements in leading medical journals found that many advertisements would not withstand the review requirements of research articles in those same journals, despite the fact that the advertisements and articles were nestled side-by-side on the journal pages.⁷ Evaluations of the accuracy of information provided by pharmaceutical sales representatives⁸ and pharmaceutical materials⁶ revealed substantial inaccuracies in the information provided. These findings argue that clinicians should search for sources of information that have undergone peer review or emanate from sources without likely conflicts of interest.

Even more troubling then dealing with potentially flawed sources of medical information is the difficulty of combating one's intrinsic biases. Receiving financial gain, directly or indirectly, from using a particular pharmaceutical or device may affect one's judgement in making a choice. This is particularly true in the field of orthopaedic surgery, which has generated few randomized clinical trials to guide the clinician. Many physicians may respond to the potential for biased decision making attributable to conflicts of interest by rationalizing that they are unaffected by such influences. However, a study of pulmonologists showed not only that physicians' prescribing patterns are affected by pharmaceutical company incentives, but that clinicians often were unaware of the effect that such information had on their own behavior.⁴ The fundamental concept of blinded peer review in science is the understanding that potential sources of bias exist in any evaluation mechanism. These sources must be identified and minimized to execute any objective evaluation. The potential for biased judgement is particularly great when direct financial gain hangs in the balance. The enormous size of the direct physician marketing budgets of major pharmaceutical companies reveals that industry is aware of the power of such financial incentives.

The search for objective information to best treat patients is of paramount importance in the practice of medicine. It should come as no surprise that the American Academy of Orthopedic Surgeons states as part of the "Principles of Medical Ethics in Orthopedic Surgery": "The practice of medicine inherently presents potential conflicts of interest. Whenever a conflict of interest arises, it must be resolved in the best interest of the patient. The orthopedic surgeon should exercise all reasonable alternatives to insure that the most appropriate care is provided to the patient."¹ The American Medical Association aims at the root of conflicts of interest, specifying that "Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted."² The American Medical Association and the American Academy of Orthopaedic Surgeons policies go on to state that no gifts should be accepted if there are "strings attached."^2,3

In the case presented, there is the implication that the physician stands to gain by switching to the new prosthesis made by this manufacturer. This incentive is not based on any benefit to the patient. However, it is also carefully crafted not to link the use of the prosthesis to any cash payment. The latter situation would not only be clearly unethical, but it even reaches the lesser standard of being frankly illegal.⁵ It is important to understand the unstated intent of the incentive: to sway the physician toward using the prosthesis, whether the medical literature or the physician's clinical experience would lead to this decision. The physician's role as a consultant in the case presented is particularly troublesome because it is vague. The specific duties to be performed by the physician as a consultant and the time commitment required were not defined. Was the physician selected by the company for this opportunity because of his or her expertise in product design or because of his or her large arthroplasty practice? This type of physician-industry consulting relationship may not only be unethical, but may be a violation of the federal Anti-Kickback Statute.⁵

This raises the question of whether it would be ethical for the physician in the case to accept the incentive if he or she would have chosen to use this device without the incentive. There are at least three problems with accepting the incentive under such circumstances. First, as noted above, prior work has shown that incentives influence physician judgement even when physicians are unaware of their effect.⁵ Thus, it is impractical to construct a requirement that an incentive is ethical only if it does not affect physician judgement. In aiming to promote objective decision making, clinicians strive to identify and diminish sources of potential bias. The industry offer is a prime example of a potential conflict of interest. The second issue is that the industry link may (consciously or unconsciously) prevent or hinder the physician from testing out new prostheses or from changing his or her opinion concerning the best prosthesis as new research becomes available. Third, from an outsider's view, it would be troubling to know that a physician who must choose the device that is best for his or her patient would receive substantial remuneration from a company that makes one of the devices. How would patients view this if it were revealed?

Even the disclosure of potential conflicts of interest to patients does not relieve the physician of the responsibility of making choices that are in the patient's best interest. Thus, a physician who receives an incentive to use a particular device (perhaps because she or he is an influential leader in a particular institution or region) cannot absolve receipt of this incentive simply by disclosing to a patient that an "honorarium" was received. This is because patients may not fully understand the implications of a physician receiving an incentive to use a particular device. Most patients enter the physician-patient relationship under the assumption that the physician will do what is in the best interest of the patient; thus, the patient would be unlikely to suspect that an industry incentive would affect a decision so important as their clinician's choice of prosthesis. Furthermore, even if the patient were to understand and accept such a bias in the physician's decision making, the physician violates his or her professional responsibility by permitting his or her own interests to trump what is best for the patient. This situation is analogous to the scientist whose project is funded by private industry presenting scientific data at a professional society meeting. The scientist's disclosure is made to warn the audience about potential bias in the scientist's reasoning; the disclosure does not release the scientist of responsibility for biased science or presentation.

However, there are numerous circumstances in which physicians might rightfully receive remuneration for choosing a specific device. Consider, for example, the clinician who helped to develop a specific device that she or he thinks is the best available device for the purpose. (It would be problematic if all other specialists and the medical literature weighed in against the device, but this is a problem with the intrinsic influence of personal incentives.) Collaboration between expert clinicians and industry is a major source of medical innovation. In this situation, it is appropriate for the physician to receive a royalty each time the device is used. This clinician would have an ethical obligation to reveal to the patient that he receives such a royalty. He would explain that he receives the royalty because he helped to develop the device and that, in his opinion, the device is the best available.

This discussion lumps together all sorts of financial incentives designed to influence physician opinion in medical practice decisions. Any incentive that is designed to expose the clinician to biased information or to impede, rather than enhance, the clinician's ability to make optimal patient care decisions is unethical for a physician to accept.³ This prohibition would not apply to unrestricted educational grants (such as sponsored presentations within a physician training program or at a continuing medical education conference) in which the aim is to promote an unbiased flow of information. It also would not apply to incidental gifts, such as pens or reflex hammers, which are so small that they are unlikely to unduly influence physician decision making.^2,3 (Although, even the latter may be perceived by an outsider as suggesting that industry has a foothold in influencing physician decision making.) How large a gift is too large to not affect a physician's decision making is a matter of judgment, but the remarkable capacity of the human mind to tolerate cognitive dissonance should not be forgotten.

This discussion is not predicated on the assumption that all interaction with industry is negative or prohibited. Indeed, many of the most important advances in medicine in the past decade were borne of academic-industry partnerships. Research collaboration between academics and industry can be extremely productive as long as appropriate protections over independence (such as permitting publication whether the findings are salutary) are scrupulously maintained. Industry sponsorship of clinical trials is also an important tool promoting advancement in medicine. In research and clinical collaboration, the goal of objectivity in decision making always must be preserved.

This conclusion is captured in the American Academy of Orthopaedic Surgeons' "Principles of Medical Ethics" when it states: "The orthopaedic profession exists for the primary purpose of caring for the patient."¹ This requires that decision making focus on what is best for the patient and not what is best for the surgeon. Financial incentives may impede such decision making and have no role in the practice of orthopaedic surgery.