Archives of Physical Medicine and Rehabilitation
Volume 90, Issue 10 , Pages 1647-1651, October 2009

Expert Opinion and Controversies in Musculoskeletal and Sports Medicine: Conflict of Interest

  • Christopher J. Standaert, MD

      Affiliations

    • Department of Rehabilitation Medicine, Orthopaedic and Sports Medicine, and Neurological Surgery, University of Washington, Seattle, WA
    • Corresponding Author InformationCorrespondence to Christopher J. Standaert, MD, 325 9th Ave, Box 359721, Seattle, WA 98104
    • ,
  • Jerome A. Schofferman, MD

      Affiliations

    • Department of SpineCare Medical Group, San Francisco Spine Institute, Daly City, CA
    • ,
  • Stanley A. Herring, MD

      Affiliations

    • Department of Rehabilitation Medicine, Orthopaedic and Sports Medicine, and Neurological Surgery, University of Washington, Seattle, WA

Article Outline

Abstract 

Standaert CJ, Schofferman JA, Herring SA. Expert opinion and controversies in musculoskeletal and sports medicine: conflict of interest.

Medical providers are faced with conflicts of interest (COIs) on a routine basis, but there is growing concern over the effects of COIs on medical care, medical education, research, product development, and other aspects of the health care system. The data clearly indicate that medical providers are subconsciously influenced by interactions with representatives of pharmaceutical and device manufacturers and that they are not very good at assessing the extent of this influence upon themselves. The data are also clear that potential bias arising from COIs is present in medical education and research. A number of professional medical associations have developed guidelines regarding interactions between medical providers and industry, and requirements for disclosure have become commonplace. The impact of these regulations and of disclosure on managing COI is unclear, however, and it is extremely important that providers manage the conflicts present on their own. A broad awareness of the effects of COIs and disclosure is necessary if providers are going to be able to offer the best care for their patients.

Key Words: Conflict of interest, Medical devices, Orthopedics, Pharmaceuticals, Rehabilitation, Spine

List of Abbreviations: COI, conflict of interest, CME, continuing medical education, IRB, institutional review board

 

THE PRACTICE OF MEDICINE has many types of COIs inherent in its underlying structure, but there is increasing public and professional concern about the potential adverse effects of financial COIs on medical care. A COI exists when a medical provider's primary obligation, which is to act in the best interest of the patient, is potentially influenced by any incentive that the provider might have to act in his or her own self-interest.1, 2 Such COIs are subconscious and too often unrecognized and underappreciated by providers. As a simple example, the very nature of seeing a patient in return for payment actually presents a COI.2 How much should the service cost? Does the patient need more services for which the physician will also be paid? If so, who decides what those services might be and how much they will cost? These scenarios are relatively straightforward, and every practitioner faces them on a routine basis. However, things can become far more complicated when financial COIs become intimately entwined in health care delivery, medical product development, CME, and research, as is increasingly the case. Clinicians should take pause when recent headlines like “Diagnosis: Greed,” “Guess Who's Educating Your Doctor?” and “The Spine as Profit Center” appear in the New York Times.3 Stories like these reflect a growing negative sentiment among the press and public regarding COIs among medical providers.

Along with concerns expressed in the press, there is also a growing body of medical literature on COIs. The scientific evidence clearly shows that medical providers are subconsciously influenced by contact with industry representatives and that all gifts, large and small, change provider beliefs and behaviors. Paradoxically, although medical providers usually recognize the potential for COI in these relationships, most deny that such contacts affect their own beliefs or behaviors.4, 5, 6 The extent of this denial is a major reason why there are difficulties changing physicians' attitudes toward these interactions, subsequently engendering the need for strict regulation. A number of professional medical associations have developed guidelines regarding physician relationships with pharmaceutical representatives, medical device manufacturers, and providers of CME. Given that many providers currently see divestment from COIs as an unacceptable or untenable option, disclosure has become a mainstay of managing COIs, and rules regarding disclosure have become much more strict. However, even the effects of disclosure have recently come under scrutiny.7, 8, 9

Back to Article Outline

Controversies 

The Effect of Conflicts of Interest on Provider Behavior 

Physicians often view their relationships with industry representatives favorably (although patients are not as generous in their perspectives), and many physicians obtain significant amounts of “medical information” from these representatives.5, 10 Data from a number of studies show that physician behavior is significantly affected by these interactions and other financial conflicts.4, 5, 6, 9, 11, 12 COIs may influence providers to use medications or devices that are more expensive when equal and less expensive alternatives exist, leading to significant increases in costs to society. There is disagreement about whether these relationships can be effectively managed so that they have no deleterious impact on patient care.

The Effect on the Health Care System of Medical Providers Interacting With Commercial Interests 

Beyond the level of the individual provider, there may be widespread effects of COIs on the health care system in general. COIs affect CME, scientific publications, and research, all of which influence the very nature of the “science” of medicine and, indirectly, the care of patients.9, 13, 14, 15 Some authors argue that the potential negative aspects of COIs are at least partially counterbalanced by the beneficial effects of entrepreneurialism among providers. Provider-driven advances may result in improved patient care, increased patient satisfaction, and better technology that would not be possible without collaboration between industry and medical providers.1, 16, 17, 18

Disclosure 

Almost by default, disclosure has become a common method by which COIs are addressed in medical journals, professional medical associations, and CME activities. However, there is research suggesting that the use of full disclosure may actually increase the potential for problems related to COI rather than reduce them.7, 8, 19 The overall effectiveness of using disclosure to manage COIs is questionable.

Back to Article Outline

Practical Approaches 

How Might Conflicts of Interest Affect Medical Care? 

COIs are pervasive in medical care. As mentioned previously, some of this is related simply to the practice of medicine being a business as well as a profession. From a broader standpoint, there is evidence for concern regarding COI in many spheres of medicine. Campbell et al13 surveyed IRB members at 100 academic institutions and found that 36% of IRB members had at least 1 relationship with industry in the prior year. Fifteen percent of their respondents had at least 1 protocol come before their IRB that was sponsored by a company with which they had a financial relationship or a competitor of that company. Ashar et al20 surveyed 1,000 internal medicine physicians and found that 37% of their respondents participated in studies or lectures sponsored by pharmaceutical companies in order to supplement their incomes. Okike et al14 assessed the relationship between COIs and the results of studies presented at the annual meetings of the Academy of Orthopaedic Surgeons in 2001 and 2002. They found that studies authored by people having a COI involving royalty, stock, consulting, or employee relationships were significantly more likely to have positive findings than those without such conflicts. Similarly, Roach et al15 looked at abstracts submitted for the Scoliosis Research Society annual meeting in 2006 and found significant differences in the proportion of favorable findings when there was a COI present related to a consulting or employee relationship compared to those in which there was no such relationship. This is all occurring in an environment in which corporate sponsorship of academic meetings and institutional education funding is commonplace.2 All of these areas play an important role in the dissemination of information to the medical community. If the very processes by which new information is made available to clinicians in the field are biased by COIs with commercial interests, how do clinicians truly obtain the best evidence with which to treat and counsel their patients?

I Am Not Really Manipulated by These Interactions, Am I? 

Unfortunately, not only is the evidence clear that clinicians are strongly influenced by contacts with industry, but it is also clear that we are poor judges of the extent of that influence on ourselves.2, 4, 7, 19 In a systematic review of the influence of physician interactions with pharmaceutical representatives on the attitudes and behavior of physicians, Wazana21 found a number of changes in physician practice behavior. It was noted that meetings with pharmaceutical representatives were associated with changes in prescribing behavior and requests to have specific medications added to hospital formularies, and that attendance at a sponsored CME event was associated with increased prescription rates of the sponsor's medication and “nonrational” prescribing. In a study of physicians attending all-expenses-paid trips to symposia sponsored by a pharmaceutical company, Orlowski and Wateska6 found significant changes in prescribing patterns regarding the sponsor's medications even though most physicians attending these symposia thought that this would not happen.

The extent of alterations in practice goes beyond pharmaceutical issues, however. A number of studies have raised concerns regarding the effects of self-referral on imaging studies. Levin et al22 found significant differences in the utilization rates of diagnostic ultrasound in the Medicare database, suggesting that self-referral may be leading to increased rates of utilization. In studying an insurance claims database over a 4-year period, Gazelle et al12 found that physicians referring to themselves or to other physicians within their own specialty utilized imaging more frequently than similar physicians referring to radiologists. In a similar study, Mitchell11 found evidence suggesting that physician self-referral arrangements and independent diagnostic testing facilities seemed to be contributing to significant increases in the utilization of highly reimbursed imaging modalities such as magnetic resonance imaging. In a separate study, Mitchell23 also found that substantial increases in utilization rates for spinal fusion surgery were associated with the entry of physician-owned specialty hospitals into the marketplace. The author thought that “the findings imply that the financial incentives linked to ownership coincided with significant changes in physicians' practice patterns.”23

It seems clear from the data that clinician decision making in a wide range of areas is affected by COIs related to industry contacts or other financial relationships. It simply does not seem valid for providers to continue to claim that they are unaffected by marketing, gifts, or financial incentives.

How Do Providers Typically Manage the Presence of Conflict of Interest From an Individual Perspective? 

Physicians seem to recognize the potential harmful effects of COIs while simultaneously holding a favorable view toward interactions with industry.5, 16 As well described by Chimonas et al,5 the presence of mutually conflicting beliefs within a single person may result in a state of cognitive dissonance in which people either act or form beliefs in a manner that is inconsistent with other beliefs that they hold. This, in turn, may lead to specific psychological defense mechanisms through which the psyche will try to reduce the dissonance, namely elimination of the conflict, rationalization, or denial.5 All 3 of these approaches will decrease the subconscious conflict. The first can be the most difficult, however, because it requires either ceasing a desired action or changing a strong, long-held belief. In medicine, this would entail the elimination of interactions with pharmaceutical representatives and the cancellation or avoidance of financial endeavors or contractual arrangements that could potentially affect clinical judgment. The second 2 are much easier for the psyche to accomplish, and physicians seem to use them adeptly in explaining their desire to maintain interactions that pose significant COIs.5, 9

There may be a number of different motivating factors that play a role in providers' decisions to maintain relationships laden with COIs. Although economics certainly appears to be one of these, Lichter9 identifies entitlement, recognition, and belonging as other “compelling” reasons. Gifts, free travel, speaking arrangements, and consultancies all have an effect on the psychological state of the provider through one of these mechanisms. These interactions also create a state of reciprocity between the provider and the commercial party; even the well-meaning provider can be manipulated through interactions that play on the need to reciprocate. In some circumstances, COIs arising from the emotional and cultural benefits of gifting and its parallels can be even more damaging than any financial inducements. It is easy to rationalize these interactions or deny their real effects, but the growing data on the economic impact of COIs make them increasingly difficult to ignore. If clinicians are going to lessen the influence of COIs on medical care, they are going to have to admit that these relationships affect them and take active steps to avoid entering into relationships or activities that raise the possibility that their actions will be biased.

Isn't There Some Benefit to Strong Relationships Between Providers and Commercial Interests? 

Despite the problems posed by COIs, there is certainly value to having medical providers involved in product development, educational programs, and in industry-sponsored drug or device trials. Medical providers in active practice certainly may have an acute awareness of a potential device that could improve patient care dramatically, and such an idea would not reach the marketplace without commercial support for development.16, 18 Without cooperation between physicians and industry, there would be no product. In the face of declining research funding from governmental agencies, it is also increasingly difficult to turn away from industrial support for important research.18 Additionally, there is some argument to be made for the motivating effect of entrepreneurialism. Shouldn't people who seek out new solutions for problems stand to benefit from the economic opportunities that arise from their work rather than having all of the financial rewards go to the institution or company that sponsored the work? Removing rewards for the individual clinician may have the effect of stifling creativity and medical progress.17 Once new products are developed, how is the rest of the medical community to be educated about their use? Clinicians with an intimate knowledge of the product would certainly seem to be in an optimal position to teach others.18

The problems with these points arise in implementation. Pursuing financial reward for the utilization of knowledge accumulated over a long career or for innovation that helps many patients is hardly wrong. However, when the financial pursuit obscures objectivity and biases opinion, significant problems emerge. Any time physicians receive material or psychological reward through their relationships with industry, it can become very difficult, if not impossible, to avoid the negative effects of these interactions. Just as a lack of opportunity to develop new ideas may limit progress, the overpenetration of biased beliefs or behaviors into the medical arena may stifle legitimate debate and impede alternative solutions. Ultimately, patient care and the financial integrity of the health care system could be threatened. Although clinicians need to be free to enter into these relationships, the effect of their doing so needs to be contained within the broader system of health care delivery and education. Without deliberate efforts to ensure that information being disseminated is clear and unbiased or that reasonable alternative viewpoints are not being suppressed as a result of conscious or subconscious bias, we can easily head down a wrong path with ample enthusiasm.

Isn't Disclosure an Effective Method of Managing Conflict of Interest? 

Disclosure is a common institutional means of addressing COI, but it may not be as effective as we tend to believe. The theory of disclosure is that when a conflict is disclosed by a presenter to a learner, the learner can make an appropriate assessment of the effect of the potential bias on the validity of the information presented. Although this idea may sound rational, it has several flaws. First, it assumes that the learner has the ability to judge the presentation for the effects of bias, which may well not be the case. It also ignores the possibility that the presenter may consciously or subconsciously exaggerate the bias in the information presented in order to account for any presumed correction by the learner.7 In reality, a number of studies on the effects of bias in information transfer indicate that learners often may not correct enough for the effects of bias and that, in some cases, the disclosure of bias may actually cause the learner to put more weight on the information, rather than less.7 For example, consider a situation in which a physician who consults or speaks for the manufacturer of a specific device strongly recommends the use of that same device to a patient. The physician discloses a financial interest in the product to the patient, but also describes extensive experience in the development and use of the device. Given that the relationship between a physician and a patient is fundamentally one of trust, this type of information may well lead the patient to have more confidence in the device rather than question the physician's motivations for suggesting its use.

Another limitation to the usefulness of disclosure is that it may actually allow the presenter more free rein to express bias than might be present without disclosure. Once disclosed, there is no reason to hide a conflict, and there is some degree of cover if the information is found to be biased. As stated by Brennan et al,19p431 “rather than eliminate the conflict, it is easier to disclose it and then proceed as though it did not exist.” Overall, disclosure may have a somewhat perverse effect of increasing the bias in information transfer and may actually prevent meaningful communication.7, 8

How Should Conflict of Interest be Managed, Particularly Regarding My Own Practice and Education? 

In order to practice medicine, providers need to manage COIs on a routine basis. To do so, we must constantly reevaluate what we are doing clinically and take steps to minimize the potential for conflicts in our work. Our goal should be to provide the best care based on the best evidence. We need to be mindful of the allure of offering the latest and greatest technology or medication because there is often inadequate proof of efficacy or safety. Given the extent to which we are influenced subconsciously, we need to be wary of interactions that put us at risk for bias, even if we do not feel the effects of the interactions ourselves. In part, this entails the elimination of contacts with representatives of the pharmaceutical and device industries that are designed to influence our behavior. We need to remember that these representatives view providers as customers who can move their products, and we should not consider any of the information they provide us as objective “medical education,” given the inherently biased process by which it is chosen for us. Similarly, the use of medication samples can affect prescribing patterns. Ideally, they should be dispensed via a mechanism that is independent from that by which they are prescribed. When used, this should be done judiciously with an awareness of the longer-term effect of their use.

Entering into consulting arrangements with industry can be ethical and valuable, but it also clearly presents the potential for COIs that can affect the care and behavior of the provider involved. Those acting as consultants need to be aware of their biased position and provide full disclosure to those with whom they work, including their patients. This may include providing patients with a detailed statement regarding commercial activities and interests and even deferring to “independent” colleagues for corroboration of significant clinical decisions that could be subject to bias arising out of the relationships in question. Clinicians seeking advice or education from others involved with relevant commercial interests need to be aware that the person in question may have unique, specific knowledge of use that comes from his or her outside work, but also that this same knowledge may be shielded from other viewpoints and presented with conscious or subconscious bias. This may require that the clinician seeking information look for multiple sources to provide appropriate perspective. Given the conflicts potentially associated with their work, those acting as consultants should remove themselves or be excluded from processes where their bias will or can be perceived as significantly affecting the outcome. This may include the elimination of active roles in educational activities and academic or organizational leadership positions.

Similarly, many physicians participate in industry-funded research. Again, this can be both ethical and useful. However, it also poses similar risks regarding potential COIs. Many of the same caveats regarding professional interactions may apply. For those performing industry-sponsored research, there are a number of issues to consider in study design and publication, including patient selection, data analysis, and full transparency.24 Whether the findings are positive or negative, the data should be presented.24 For publications, all persons listed as authors must have contributed to the work in a substantial way, and there should be no ghost authors. Disclosure regarding industry relationships and funding is mandatory. For those of us reading these studies, we need to be mindful to check the conflicts listed and be guarded in our responses to studies not part of an open registry or those for which the data are not fully provided or available for secondary review.

As a final consideration, CME activities can pose a number of challenges for clinicians. Many CME events, including annual meetings of medical specialty societies, receive significant funding from commercial interests. When present, guidelines regarding COI at CME events may have questionable enforcement. Formal guidance for individual physicians in these settings is generally minimal to absent, unfortunately. Ideally, lectures should address the evidence objectively, and speakers should be clear as to when they are presenting only expert or personal opinion. Those speakers that offer specific product endorsements or use audiovisual materials provided by a commercial interest should be entertained with caution. Industry-sponsored “educational” events, meals, and similar marketing functions should similarly be approached with some degree of wariness because of the biased nature of the information presented. We need to pay attention to disclosure and the effects it may have on a presentation and keep information in perspective with established medical practice. Ultimately, it is up to the individual clinician to decide what educational settings seem appropriate, the degree to which given information is affected by bias, and what information to discount altogether.

Back to Article Outline

Conclusions 

COIs directly affect patient care, health care costs, medical education, product development, and other aspects of the medical system. People and institutions need to be aware of the ways in which this can occur. It is essential to manage COIs effectively to minimize the deleterious risks they pose. Although this can be a challenging task given the omnipresent nature of COIs in medical practice, it is not impossible to do so adequately, particularly if this is made a priority. As a start, it can help to avoid sponsored or otherwise potentially biased “learning events,” limit contact with industry representatives, and remain skeptical of information presented by those with relevant COIs, particularly when the conclusions are not based on a sound evidence-based approach. We also need to recognize that any direct financial relationships that we may have with pharmaceutical or medical device organizations generally affect our practice habits and bias our decision making. These relationships should be approached with a full and open awareness of this. Above all, we all need to remain critical in our appraisals of medical evidence, seek out unbiased sources of information when possible, and remember that the care and trust of our patients is dependent on our ability to provide the best medical advice available. The pervasive effects of COIs cannot be ignored if we are to practice the best medicine for our patients.

Back to Article Outline

References 

  1. Bodwin MA. Medical commerce, physician entrepreneurialism, and conflicts of interest. Camb Q Healthc Ethics. 2007;16:387–397
  2. Schofferman J, Banja J. Conflicts of interest in pain medicine: practice patterns and relationships with industry. Pain. 2008;139:494–497
  3. New York Times. http://nytimes.com/Accessed October 20, 2008
  4. Brody H. The company we keep: why physicians should refuse to see pharmaceutical representatives. Ann Fam Med. 2005;3:82–86
  5. Chimonas S, Brennan TA, Rothman DJ. Physicians and drug representatives: exploring the dynamics of the relationship. J Gen Intern Med. 2007;22:184–190
  6. Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns: there's no such thing as a free lunch. Chest. 1992;102:270–273
  7. Cain DM, Loewenstein G, Moore D. The dirt on coming clean: perverse effects of disclosing conflicts of interest. J Legal Studies. 2005;34:1–25
  8. Li M, Madarasz K. When mandatory disclosure hurts: expert advice and conflicting interests. J Econ Theory. 2008;139:47–74
  9. Lichter PR. Debunking myths in physician-industry conflicts of interest. Am J Ophthalmol. 2008;146:159–171
  10. Gibbons RV, Landry FJ, Blouch DL, et al. A comparison of physicians' and patients' attitudes toward pharmaceutical industry gifts. J Gen Intern Med. 1998;13:151–154
  11. Mitchell JM. Utilization trends for advanced imaging procedures: evidence from individuals with private insurance coverage in California. Med Care. 2008;46:460–466
  12. Gazelle GS, Halpern EF, Ryan HS, Tramontano AC. Utilization of diagnostic medical imaging: comparison of radiologist referral versus same-specialty referral. Radiology. 2007;245:517–522
  13. Campbell EG, Weissman JS, Vogeli C, et al. Financial relationships between institutional review board members and industry. N Engl J Med. 2006;355:2321–2329
  14. Okike K, Kocher MS, Mehlman CT, Bhandari M. Conflict of interest in orthopaedic research: an association between findings and funding in scientific presentations. J Hand Surg [Am]. 2007;89:608–613
  15. Roach JW, Skaggs DL, Sponseller PD, MacLeod LM. Is research presented at the Scoliosis Research Society annual meeting influenced by industry funding?. Spine. 2008;33:2208–2212
  16. Garfin SR. Spine surgeons: spine industry. Eur Spine J. 2009;17:785–790
  17. Stossel TP. Regulating academic-industrial research relationships—solving problems or stifling progress?. N Engl J Med. 2005;353:1060–1065
  18. White AP, Vaccaro AR, Zdeblick T. Physician-industry relationships can be ethically established, and conflicts of interest can be ethically managed. Spine. 2007;32:S53–S57
  19. Brennan TA, Rothman DJ, Blank L, et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA. 2006;295:429–433
  20. Ashar BH, Miller RG, Getz KJ, Powe NR. Prevalence and determinants of physician participation in conducting pharmaceutical-sponsored clinical trials and lectures. J Gen Intern Med. 2004;19:1140–1145
  21. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift?. JAMA. 2000;283:373–380
  22. Levin DC, Rao VM, Maitino AJ, Parker L, Sunshine JH. Comparative increases in utilization rates of ultrasound examinations among radiologists, cardiologists, and other physicians from 1993 to 2001. J Am Coll Radiol. 2004;1:549–552
  23. Mitchell JM. Utilization changes following market entry by physician-owned specialty hospitals. Med Care Res Rev. 2007;64:395–415
  24. Segal NA, Smuck M, Sowa G, Basford JR. Considering industry-sponsored research. Am J Phys Med Rehabil. 2009;88:1–7

 No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.

 Reprints are not available from the author.

PII: S0003-9993(09)00463-8

doi:10.1016/j.apmr.2009.04.025

Archives of Physical Medicine and Rehabilitation
Volume 90, Issue 10 , Pages 1647-1651, October 2009

Article Tools