COI is continuing medical education (CME), espe- cially because currently industry funds 40â60% of. CME. COIs have the potential to bias physicians in practice ...
Pain Medicine 2011; 12: 1713–1719 Wiley Periodicals, Inc.
The Medical–Industrial Complex, Professional Medical Associations, and Continuing Medical Education pme_1282
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Abstract Financial relationships among the biomedical industries, physicians, and professional medical associations (PMAs) can be professional, ethical, mutually beneficial, and, most importantly, can lead to improved medical care. However, such relationships, by their very nature, present conflicts of interest (COIs). One of the greatest concerns regarding COI is continuing medical education (CME), especially because currently industry funds 40–60% of CME. COIs have the potential to bias physicians in practice, educators, and those in leadership positions of PMAs and well as the staff of a PMA. These conflicts lead to the potential to bias the content and type of CME presentations and thereby influence physicians’ practice patterns and patient care. Physicians are generally aware of the potential for bias when industry contributes funding for CME, but they are most often unable to detect the bias. This may because it is very subtle and/or the educators themselves may not realize that they have been influenced by their relationships with industry. Following Accreditation Council for Continuing Medical Education guidelines and mandating disclosure that is transparent and complete have become the fallback positions to manage COIs, but such disclosure does not really mitigate the conflict. The eventual and best solutions to ensure evidencebased education are complete divestment by educators and leaders of PMAs, minimal and highly controlled industry funding of PMAs, blind pooling of any industry contributions to PMAs and CME, strict verification of disclosures, clear separation of marketing from education at CME events, and strict oversight of presentations for the presence of bias.
that might influence patient care. This concern of undue influence has been focused on relationships between individual physicians and industry, but most recently financial interactions between industry and PMAs are gaining increased attention and scrutiny, especially with respect to continuing medical education (CME) [1–5]. Physicians must obtain CME to remain current. CME should be intellectually rigorous, driven by peer-reviewed published data, and free of bias. Bias can be introduced into CME by individual speakers and by the PMA that organizes a medical conference. Educators who have financial or other relationships with industry may have an unconscious bias toward that company and its products that is reflected in their presentations. The influence of industry funding on PMAs might be reflected in their choices of symposium topics or speakers as well as whether and where to sell advertising [6]. Industry has long known that CME events, especially the annual meeting (AM) of a PMA, provide excellent venues for marketing their drugs and devices. There are obvious forms of marketing such as the exhibit hall. There are also the displays of company names or logos on signs, banners, lanyards, bags, and Internet kiosks that attendees will see over and over during the meeting. A more subtle type of marketing can occur during lectures, poster exhibits, and “satellite symposia” when presenters or an entire symposium emphasize a sponsoring company’s drug, device, or a condition for which that company has an approved treatment. It is important to be clear that relationships that physicians or PMAs have with industry are not inherently negative, unprofessional, or unethical. On the contrary, true intellectual collaboration is necessary for the development and evaluation of new medications and devices that might ultimately benefit patients [6–8]. That said, such relationships are conflicted by their very nature and therefore have the potential to create bias. Their potential value does not mitigate this effect.
Introduction There is concern among physicians, journal editors, the media, legislators, and the biomedical industries themselves about the effects of financial conflicts of interest (COIs) in medicine. Financial relationships that physicians and professional medical associations (PMAs) have with medical device makers and pharmaceutical companies (collectively “industry”) have the potential to create bias
COI: Definitions A COI in medicine exists when secondary interests have the potential to influence the primary interests of a clinician, researcher, educator, or PMA (modified from Ref. 9). The primary interest of physicians is the optimal care of patients. The primary interest of educators is to 1713
Schofferman teach objectively based on medical evidence. A primary role of a PMA is to promote the highest quality of care for patients through (among other things) the education of its members. On the other hand, cynical as this might sound, the primary interest of industry is profit. Another definition of COI in medicine, the “perception definition,” suggests that a COI exists if a reasonable observer might find it plausible that a physician could be (not necessarily would be) swayed by a particular secondary interest [1,10,11]. This definition is particularly important to legislators, the public, and the media [5]. There are many types of secondary interests that can exert influence upon medical care [11]. However, none is as pervasive and problematic as the financial entanglements among educators, PMAs, CME, and industry [6,12].
Most physicians believe they can resist the influence of their conflicts by virtue of their intelligence, integrity, intellect, and scientific training [11,14,18]. However, compelling research has demonstrated they cannot [14,18,20,21]. Physicians are as susceptible to marketing as anybody and cannot totally avoid the unconscious effect of receipt of a “gift” [14,17,21]. Most physicians, however, tend to overestimate their ability to resist marketing efforts and fail to appreciate that they can be subtly influenced. The disconnect between physicians’ belief that they are impervious to overt and covert marketing and the scientific evidence that they are quite vulnerable has been proven to be a significant obstacle in overcoming the COI problem in medicine. Another disconnect is that physicians who emphasize evidence-based practice can ignore the scientific evidence of influence. Potential Effects of COI on Individual Physicians and Educators
Mechanisms of Action of COIs on Individuals A COI has the potential to create bias. Bias has the potential to influence beliefs and behaviors. When bias influences a clinician, it can affect patient care, and that is the crux of the matter. When individual clinicians are influenced, the effect is somewhat limited. However, when educators are influenced, the effect is multiplied many fold because educators interact with many learners [12]. It must be stressed that bias and influence created by COI are not intentional, but are an unconscious neuropsychosocial response to which everyone is susceptible [13]. Two models that attempt to explain the effects of COI have gained favor in behavioral economics. One is based on the fact that individuals unconsciously default to their own self-serving best interests. This innate human characteristic can subvert our conscious control and rational decision-making process [14–16]. The second, the reciprocity model, is based on a feature of social exchange— the need to reciprocate for “gifts” and favors [13,14,16,17]. In this context, “gift” includes recent and even past remuneration for services such as lecturing, consulting, or research; material gifts; and even nonmaterial “gifts” such as special recognition or flattery. In addition to the psychosocial aspects, there may be a biological basis for at least part of the human need to reciprocate. Using functional magnetic resonance imaging, Harvey et al. showed activation of certain neural networks in the brain under experimental circumstances that investigated “the need to reciprocate.” The authors stated that “. . . the influence was covert and the subjects were not consciously changing their judgment” [13]. Social scientists are gaining an increased understanding about gifting and reward. It is well established that even small gifts or visits by pharmaceutical representatives influence physician prescribing behavior [14,18,19]. The relationship that is established by all forms of gifting is more important than the size of the gift. Industry is well aware of this dynamic. 1714
The influence of gifting and other forms of marketing on physician prescribing patterns have been clearly demonstrated [14,18]. It has been estimated that for every dollar spent on marketing to physicians, industry gets a return of $3.56, so it is money well spent [1]. Why all the fuss? Advertising abounds. It is a free market economy. There are ads and signage everywhere. But there is a difference. Most conventional marketing is directed at the end user. Physicians are not the end user of medical products and drugs. Instead, they are the agents who are entrusted to make recommendations to the end user, the patient, based on medical evidence [1,17]. Patients do not have the necessary knowledge to make a fully informed decision and so must trust doctors. If a patient feels his/her physician might be influenced by industry marketing through contributions to CME, that trust has been violated. In a recent Consumer Reports survey, 69% of those taking prescription medications felt that pharmaceutical companies have too much influence on what doctors prescribe [22]. Dual Mechanisms of Action of COI on PMAs The mission of a PMA is to improve the quality of care of patients through the education, research, and advocacy of and for its physician members. In addition, PMAs produce educational material for the public and are the public face of their members. Financial COIs can influence a PMA through the physicians in its leadership positions and through PMA staff who are tasked to maintain financial stability in the face of increased costs. It is expensive for a PMA to carry out its mission, and for many, their expenses exceed revenue from dues, CME tuitions, and personal donations. As a result, many PMAs depend on industry funding for a significant portion of their operating budget [1]. Industry revenue comes in various forms, but for many PMAs, the greatest portion of industry money is associated with the AM. Among other things, industry purchases exhibit hall space, buys advertising
Commentary opportunities, sponsors “satellite symposia,” and pays the registration costs for their sales representatives. Other forms of industry support include donations of money and materials as well as providing research grants. The reliance on industry funding has created a serious COI for most PMAs. A PMA is not an autonomous organism. It is led by physicians and staff, and both groups are subject to influence. While serving in their leadership capacity, physicians have the fiduciary responsibility to make decisions that best enable the organization to fulfill its mission while remaining financially solvent. Overreliance on industry funding creates the potential for these physicians, in their collective leadership role, to unconsciously make CME decisions that favor companies that make financial contributions to the PMA. At the same time, these leaders are susceptible to their own personal conflicts such as those already discussed. The administrative staff of a PMA must work to provide for the mission while maintaining financial solvency. These individuals are therefore subject to be influenced by industry funding. Only through awareness of these layers of conflict and their power to influence at several levels simultaneously can one come to the best decisions for the PMA, the individual physicians, and eventually for patients. Does Industry Funding Influence CME? There are several issues to address. Does industry funding lead to bias? Do attendees believe that commercial support increases the chance of bias? Is bias detectable by listeners? Most importantly, does bias influence the practice decisions of listeners and thereby affect patient care? Industry funds as much as 60% of CME in the United States in one form or another. Certainly, when industry spends this much money related to CME, a reasonable observer might find it plausible that there is the potential and possibly the expectation to influence. Although the hard evidence that bias is present when industry contributes to CME is weak, beliefs and opinions that there is the potential for bias are quite strong. The Institute of Medicine (IOM), U.S. Senate Finance Committee, The Macy Foundation, and most thought leaders who write on this subject agree that industry funding of CME creates an opportunity for bias and therefore should be minimized [1–2,6,23–28]. The IOM concluded that “industry influence on choice of topics and content is not rare” [28]. Even the Accreditation Council for Continuing Medical Education (ACCME) has stated that the potential for financial gain by educators “creates an incentive to influence the content of the CME—an incentive to insert commercial bias” [25]. In an interview with Dr. Bernard Marlow, director of continuing professional development at the College of Family Physicians of Canada, he stated that specially trained peer reviewers observed bias in 15–20% of the CME programs they reviewed [23]. The same news article cited Carlat who analyzed 15 articles produced by ACCME and found significant instances of bias [23].
In most instances, such bias, when present, is subtle. Speakers at major CME conferences rarely, if ever, intentionally present biased information. A problem is that most educators do not recognize that they may have been influenced and might unconsciously be presenting biased information. During industry-sponsored CME conferences or in lectures by industry-sponsored speakers, drugs of a sponsor are likely to be cited more often than those of competitors while side effects are minimized. There may be underreporting or even omission of unfavorable research studies, overemphasis on positive studies, and perhaps an overreliance on the speaker’s personal experience. Other examples include the use of brand rather than generic names, the order of in which drug options are discussed, the implication that a particular drug works better despite a lack of comparative data, or the failure to discuss alternative treatments that do not include drugs or devices [29]. The role of industry funding and bias in research and publications is beyond the scope of this article, but obviously if there is research or publication bias, the bias would be introduced in presentations by any speaker who depends on published evidence to create a talk. Physician learners now appear to accept that industry support at least leads to the potential for bias. In 2003, Rutledge reported a survey of 1,137 physicians in the UK [30]. Only 40% thought that industry involvement created a COI, and 86% thought that industry funding did not create bias in their own drug selection [30]. Things have changed. In 2011, 88% of physicians acknowledged that industry funding of CME might introduce bias and felt that greater amounts of support carried greater risk [31]. More interestingly, only 42% of respondents would be agreeable to increased tuition in order to decrease industry support. Despite the knowledge that bias can be present, it does not appear that listeners perceive bias. Kawczak et al. analyzed information from a large CME database at a single academic institution to see if there was a correlation among the degree of perceived bias, the type of CME activity, and the presence or absence of commercial support [32]. They found no evidence that industry support created the perception of bias by the learners, nor did they find a difference in perceived bias whether industry support was or was not present. They concluded that rigid adherence to ACCME guidelines appeared to ensure that industry support does not create the perception of bias in the learners. Steinman used a questionnaire to query attendees at 213 single universitysponsored live CME events with different degrees of industry support to determine if attendees detected bias [29]. They found that a median of 97% of attendees did not detect bias and there was no correlation between degree of industry funding and perception of bias. The authors point out that their university had gone to great lengths to minimize the potential for industry influence. As a result, bias may have been eliminated before hand, and their results might not be generalizable to other sponsors of CME events. 1715
Schofferman The results of these studies are somewhat distressing and difficult to reconcile. The disconnect between attendees knowing that bias might be present when there is industry support, the knowledge that bias is often present, and the fact that learners do not perceive bias suggests that bias can be quite subtle. Learners who are not experts certainly would be less able and likely to detect it or be able to avoid its influence when it is (dis)guised as education. Such marketing in the form of education can come from individual educators and from the PMA or other organizing body, despite adherence to ACCME guidance. The bias that can affect a PMA has been discussed [6,12]. Meeting chairs and members of the meeting committee might have relationships with industry. The individual’s COIs might influence the choices of symposia topics, speakers, and original scientific presentations. Industry will sponsor symposia, especially satellite symposia topics that are specifically directed toward a medical problem for which the company has an approved drug or device, and during the symposium, there may be little or no mention of alternatives. Most importantly, bias and influence during medical education does influence physician practice. Again, the influence is unconscious. Physicians attending a CME conference supported by industry are more likely to use the sponsoring company’s product [33]. Steinman cites an extensive literature that suggests industry marketing strategies rely heavily on physician education in a variety of formats to boost drug sales [29]. Other forms of marketing during CME events are obvious. Some start before the meeting even begins. PMAs sell mailing lists of pre-registered attendees who then receive mailings about products or satellite symposia. PMAs sell marketing rights that permit companies to put their name, product’s name, and logo on airport and bus banners, hotel key cards, name tag lanyards, bags, conference daily “news papers,” and internet kiosks. A PMA will sell hotel room numbers for night “drop offs,” and sponsor physicians who make “robo calls” to the hotel rooms of attendees. There are free satellite symposia, often outside regular meeting times or during lunch or dinner time, which are industry-sponsored events. Meals or snacks might be offered in the exhibit hall. Routes to posters might require attendees to pass through the exhibit hall. Industry would not spend these large sums of money on marketing if it were not effective.
to produce higher quality meetings to compete for physicians’ CME dollars. The “most up to date” argument offers that educators who work closely with industry are most knowledgeable about the latest technology and drugs and therefore are best suited to teach. However, “most recent” does not necessarily equate with better or best. In addition, once sufficient research about newer drugs and devices has been peer-reviewed and published, there would be many well-qualified and experienced clinicians without industry ties to explain their benefits and risks. Others argue that ACCME guidelines are sufficient to minimize the influence of industry. They are not. Steinbrook feels that ACCME guidelines should be “a floor, not a ceiling” [22]. The ACCME guidelines do offer reasonable disclosure rules as well as guidance for review of CME content for bias by event organizers. But as we have seen, such rules do not substantively change the subtle biases and influence of industry-related speakers and sponsorships. Nakayama argues that industry and physicians share the same goals of patient welfare, patient safety, and running a profitable business [37]. While on the surface this is true, industry has the fiduciary responsibility to place profit first, while physicians must place patient welfare and quality of care above all. He goes on to state that industry consultants, including those who educate other physicians, provide a valuable service and should be appropriately paid. Although this argument is valid, payment should be at fair market value and for true work-product, not sham consulting or speaking arrangements. Even then, such relationships are conflicted by definition. Nakayama also opines that marketing to physicians is necessary to get approved products to patients. Of course, industry has the right and perhaps the fiscal responsibility to market to physicians, but marketing should be clearly identifiable as such, and not occur covertly in the guise of CME or non-CME industry courses. Harrington and Califf, who disclosed their multiple relationships with industry, argued that the exclusion of industry from CME will “. . . deprive practitioners of ready access to critical knowledge about the proper use of medical products” [36]. I would offer that proper use of medications and products can be taught and learned effectively by educators who are independent and free from any taint of potential bias. Learners should obtain their information about new products from objective and peer-reviewed sources rather than from a company financed or supported speaker or a non-CME educational event.
In Defense of Industry support of CME
Disclosure
A minority of authors and physicians defend industry support of CME [1,5,34–37]. Brody presented some of the more common arguments [1]. The cost argument suggests that it is very expensive to put on a CME conference, and if there were no industry funding, tuition would have to be increased substantially. On the other hand, if tuitions were increased, physicians would attend fewer meetings, which would engender competition among CME providers
Two methods available to manage COI are divestment and disclosure [1,6,25,38]. A divestment strategy calls for a physician to be completely free of financial relationships with industry [1,6,38]. Certainly, divestment is preferred, but it may be difficult to accomplish and even to convince some educators and leaders of its necessity, importance, and eventual value. Strategies for divestment among educators and PMA leaders are met with significant
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Commentary resistance. Disclosure is simpler to accomplish and far less divisive, and, as a result, it has become the most common strategy for “managing” COIs. However, disclosure presents problems of its own and may not be as valuable as it would initially appear [39–45]. In theory, disclosure should allow the learner to better appraise lectures and literature, and then decide if there is bias. However, as we have seen, learner detection of bias is not reliable [32]. Nevertheless and despite its limitations, specific, comprehensive, verifiable, and uniform disclosure rules are necessary for individuals and for PMAs [45].
NASS finances have remained sound. While there has been a gradual erosion of industry financial support in the forms of donations, sponsorships, and grants, there have been increases in revenue from other industry sources such as increased exhibit booth fees, print advertising, unrestricted educational grants, and exhibitor registration. In addition, dues were raised slightly. Membership has grown, and attendance at CME events continues to increase.
The North American Spine Society COI Story
Changes are coming slowly, but surely. The Society of General Internal Medicine conducts its AM without industry support. To do this required significant changes in format [46]. Rothman et al. proposed practical and achievable steps for controlling COI and CME [6]. They emphasized that the overriding principle for CME activities is that education must be clearly separate and distinguishable from marketing. For example, because an exhibit hall is obviously marketing, attendees must be able to access posters, other scientific materials, lectures, and food without having to pass through the hall. If attendees wish to visit the hall, they can choose to do so. It is important to remember that industry needs exposure to physicians as much or more than PMAs need such extensive industry funding.
It is easy to suggest changes in relationships between industry, PMAs, and CME, but the reality of implementing effective strategies while maintaining the financial viability of the PMA is more difficult [6,46]. But it is being done. The North American Spine Society (NASS) (disclosure: I am on the board of directors and the ethics committee of NASS) has gradually and successfully implemented such a plan [47]. NASS instituted a program of tiered divestment based on the level of leadership. It has been successful and well accepted, although initially there was significant resistance. The requirements are described in the NASS disclosure and divestment policy [47]. The board of directors (BOD), guidelines committee, co-chairs of the AMs, editorin-chief of the NASS journal, chair of the ethics committee, and several other influential committee chairs are required to divest fully from all industry relationships except for some carefully scrutinized and vetted intellectual property rights (e.g., inventions). Divestment must begin one year prior to starting service and continue for two years after the term of office is completed. Less divestment is required of those in less influential positions. All questions are resolved by a fully divested conflict of interest review committee. Disclosure is full and transparent. All those in any committee or other leadership position, educators at every CME event, authors of all NASS publications, and authors who submit original scientific abstracts for CME events are required to fully disclose their relationships with industry. Disclosure requires specific dollar amounts, which are transferred confidentially by staff to tabular form and published in the AM brochure and online. Disclosure is done online yearly and amended if there are significant changes in leadership position or industry relationship. There is no disclosure requirement for general members. There have been minimal repercussions as a result of the disclosure and divestment policies. NASS has more than 7,000 members. Soon after the implementation of the policies, 11 resigned from the association and 14 resigned from committees. During the same time period, there was an increase in the number of new applicants. There has been no decrease in the number of abstracts submitted to the AM for consideration, nor has there been difficulty getting faculty.
Recommendations for Change
There should be elimination of company names or logos on hotel keys, lanyards, tote bags, etc. The use of phone calls to hotel rooms and distribution of under the door fliers that advertise satellite symposia should stop. AM program chairs should be completely divested from any industry ties. PMAs should not accept funding that allows industry to conduct satellite symposia during the AM. Steinbrook makes several additional suggestions. Physicians should pay fair value for attending a CME event. CME providers should stop using faculty who are consultants or speakers for industry. PMAs should limit industry support for CME to contributions to a “central depository of funds” to which a PMA BOD or CME planners are blinded [22]. PMAs will need to change significantly. They should work to minimize and eventually eliminate industry funding, except for advertising in journals or exhibit hall. All donations, educational support, and other funding from industry should be pooled into a central depository, and the BOD and major committee members can be blinded to the individual contributors. Leadership of PMAs must fully disclose all industry relationships, and divestment should become a near-term goal. To accomplish this, some PMAs may need to scale back some of their ambitious plans. They may need to increase dues to cover the actual costs or running the organization. Conclusion Relationships between industry and both individual physicians and PMAs can be important to advances in medical 1717
Schofferman care, but they present COIs. Although such relationships can often be mutually beneficial, they have the potential to induce bias. CME events, particularly a PMA’s AM, provide excellent marketing opportunities. Industry markets in both obvious and subtle ways during CME events. Both methods appear to be quite effective. Educators who teach at CME events and who have relationships with industry may subconsciously introduce bias into their presentations. It is important for best patient care that physicians receive their CME from unbiased sources. In order to accomplish this, educators should be free of any ties to industry and PMAs should refrain from selling rights to market (except perhaps for exhibit halls and journal ads) and to conduct satellite symposia. The goals would be that educators and leadership of PMAs are fully divested from industry, PMAs would minimize their reliance on industry funds and when funding is necessary to supplement the AM, it would be in the form of unrestricted educational grants. The experience of NASS appears to confirm that these things are very possible to accomplish and still allow a PMA to continue to fund its mission. JEROME SCHOFFERMAN, MD SpineCare Medical Group, San Francisco Spine Institute Daly City and San Francisco, California, USA
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