Viewpoint: The Elephant in Medical Professionalism’s Kitchen
Hafferty, Fred PhD
Dr. Hafferty is professor, Department of Behavioral Sciences, University of Minnesota Medical School—Duluth, Duluth, Minnesota.
Correspondence should be addressed to Dr. Hafferty, Department of Behavioral Sciences, University of Minnesota Medical School—Duluth, Duluth, Minnesota, telephone: (218) 724-3456; e-mail: (firstname.lastname@example.org)
The rise of the corporation within health care during the 1980s and early 1990s was met by organized medicine with a deluge of editorials, articles, and books that identified a singular enemy—commercialism—and depicted it as corrosive of, and antithetical to, medical professionalism. Medicine’s ire proved prognostic as scores of highly publicized corporate-medical scandals began to crater the landscape of a rapidly emerging “medical marketplace.”
Medicine’s main weapon in this counteroffensive was a renewed call to medical professionalism. Numerous organizations hosted conferences and underwrote initiatives to define, measure, and ultimately inculcate professionalism as a core medical competency. Nonetheless, an examination of medicine’s overall response to the threat of commercialism reveals inconsistencies and schisms between these praiseworthy efforts and a parallel absence of action at the community practitioner and peer-review levels.
The most recent salvo in this war on commercialism is a policy proposal by influential medical leaders who call for an end to the market incentives linking academic health centers and medical schools with industry. These forthright proposals nevertheless appear once again not to address the heartbeat of professional social control: community-based peer review, including a vigorous and proactive role by state medical boards.
The author concludes by examining the implications of a professionalism bereft of peer review and explores the societal-level responsibilities of organized medicine to protect, nurture, and expand the role of the physician to maintain the values and ideals of professionalism against the countervailing social forces of the free market and bureaucracy.
In spite of all that organized medicine has accomplished over the past two decades in reinvigorating medical professionalism, this work remains fundamentally—and in some ways dishearteningly—incomplete. Critical shortfalls are the lack of emphasis on professionalism within the work of state medical boards and the absence of a vigorous and proactive professionalism ethic at the community practitioner and peer-review levels. These constitute a hamartia that, if left unaddressed, will eventually calcify, and in doing so signify a death knoll not only to medicine’s occupational status as a profession but, even more significantly, to the only way of organizing work (professionalism) that can resist and counter market forces and bureaucratic structures.
The recent ascendancy of commercial forces within clinical and research medicine (from the 1970s on) has altered the very identity (and some would claim “soul”) of medicine. Driven by what would become this nation’s longest-running bull stock market (1982–1999), investors discovered medicine as an investment opportunity and poured billions of dollars into companies that promised to revolutionize how medicine was organized, delivered, and ultimately defined and valued within this newly anointed “medical marketplace.”
Examples abound. In 1987, a small and obscure hospital chain began its corporate life with two hospitals in El Paso, Texas. A scant 10 years later (1997) this company merged with Hospital Company of America, went public (sold stock), acquired hundreds of hospital and related properties, and transformed itself into this nation’s ninth largest employer, Columbia/HCA. In 1997, that company’s market value ranking (#49) placed it one notch behind Eastman Kodak (#48) and ahead of such nationally known companies as Allstate, Bell Atlantic, Wells Fargo, Home Depot, and Texaco—most of whom had been in business for decades.1 Although Columbia/HCA’s meteoric rise to fame and fortune is notable, it is not unique. Whatever the business plan or marketing niche, the constant across all examples was Wall Street, as numerous physicians-turned-entrepreneurs lent their visions, expertise, hubris, and sometimes even their names (e.g., drkoop.com) to what was being heralded as “the new health care revolution.”
Organized medicine, long silent on matters of professional identity, prerogatives, and responsibilities, rose up in protest. Editorials, commentaries, articles, and books began to blanket the medical literature heralding what one team of authors labeled the “epic clash of cultures between commercial and professional traditions in the United States.”2 The offender, almost universally identified and condemned, was “commercialism.” The principal threat, medicine claimed, was to its own work ethic of selflessness and altruism.3–9 Concerns about the corruption of academic medicine would soon follow.10–20 During this same time period, similar questions were being raised about the commercialization of higher education21,22 and about other professions such as law.23,24
Organized medicine’s response to these outpourings of concern and warning was nothing short of remarkable. A number of medical organizations and specialty groups sprang into action, lead by the American Board of Internal Medicine and its foundation.25 Old definitions of professionalism were dusted off and new definitions explored.26 Competencies were established (most clearly and forcefully at the graduate medical education level), and measurement tools elaborated.27–29 Medical schools and residency programs rushed to create new curricula to foster professionalism.30–41
These efforts, while admirable in their own right, seemed to have little effect as the tide and tarnish of medical commercialism continued their corrosive spread. As health care companies grew, so did corporate scandals. Columbia/HCA was convicted of Medicare fraud, paid a record penalty of nearly $1.7 billion, and promptly changed its name to HCA.42 More recently, TAP Pharmaceutical Products, Inc., agreed to a settlement of more than $1 billion for illegally marketing and pricing its prostate cancer drug Lupron.43–47 Other drug companies promoted similar pricing scams to their physician customers.48–53 Industry giant Pfizer was fined $430 million for illegally promoting the antiseizure medication Neurontin for off-label prescribing purposes.54–60
The transgressors of record may have been corporations, but as we will explore below, the agents-of-action were much closer to home.
The Missing Element
As organizations lined up to pay their fines, one player was missing, at least at the level of public pronouncements—the physician. What about all of those doctors who took kickbacks from Columbia/HCA for referrals?42,61 What about the oncologists who purchased Lupron at highly discounted prices (sometimes free) and pocketed the spread between what they paid TAP (if anything) and what they submitted for reimbursement? What about the veritable army of physician speakers (i.e., “opinion-leaders”) who were being paid considerable sums of money by Warner-Lambert to spread the word about Neurontin’s off-label benefits (e.g., attention deficit disorder, Lou Gehrig’s disease, neuropathic pain, restless leg syndrome, and drug and alcohol withdrawal seizures among others) at CME courses, hospital dinners, and weekend retreats? According to court documents, one university neurology professor received more than $300,000 for pro-Neurontin presentations given between 1994–1997. Other academicians received in excess of $100,000.61 Meanwhile, Warner-Lambert was “reimbursing” (a term favored within the culture of medicine) physicians for allowing company representatives to accompany those doctors into exam rooms to meet with patients, to review charts, and to make medication recommendations.62 “Anything for a buck” appeared to displace “First, do no harm” as the ethic-of-record for modern medicine.
News and industry reports of such activities, however egregious they might appear at first blush, proved to be, in the greater scheme of things, “merely background.” On June 18, 1997, The Wall Street Journal ran a front-page story (“First Do No Harm: Second, Peddle a Box of All-Fabric Bleach—Doctors Upset Over Lower Pay are Selling Amway Products: Not Everyone Gets Rich”)63 that sent shock waves through organized medicine.64 The AMA’s House of Delegates, amidst considerable internal debate (thereby insuring significant loopholes/exemptions in the final product), moved to pass an Opinion to address physicians’ sale of medical and nonmedical products from their offices. Subsequent reports noted that these commercial transgressions were not limited to medicine’s proverbial “one or two bad apples.” The AMA newspaper, American Medical News, reported “tens of thousands of physicians are now joining the ranks of network marketers by becoming ‘distributors’ of products offered by such firms as Amway, Rexall and NuSkin.”65
Physicians’ commercial practices, however, were not confined to the sale of products. Community physicians, in large numbers, also were delivering/selling their patients to contract research organizations (CROs) for participation in clinical trials. The practice is both wide-spread and lucrative. Physician can be “reimbursed” in amounts ranging from $1,000 per patient for common disease conditions to as much as $40,000 if the underlying disease condition is sufficiently rare. Furthermore, these practices are quite permissible as far as state licensing boards are concerned.66–70 To this core we can add the proliferation of “boutique medicine,” “concierge care” and “retainer” medical practices,71–76 the sale of “clinical brands” of cosmetics,77 gift certificates for plastic surgery and related procedures,78 and the participation of physicians on reality TV shows such as The Swan79,80 (where surgical procedures are transformed into “entertainment” and physicians into media celebrities)—all of which exist with nary a breath of professional disapproval. Symbolizing the marriage of medicine and Wall Street, stock analysts now religiously read medical research journals, attend national research meetings, and curry the favor of physician-clinician/researchers, all with the hope of garnishing prior-to-market insights into the prospects of clinical trial drugs and early-stage medical technologies.81 Other more enterprising institutional investors hire physicians as “consultants” to selectively gain access to insider information.82
Amidst all of this activity lurks our elephant—ubiquitous, yet seemingly invisible. Regardless of one’s choice of definitional standards or point of focus, two points stand beyond dispute. The problem of medical commercialism is neither restricted to a renegade fringe of physicians nor to a narrow domain of medical work (e.g., plastic/cosmetic surgery to “enhance” sexual organs). Medicine’s traditional “one or two bad apples” has morphed into a mega-orchard of physician clinicians and researchers, brimming with commercial proclivities, penchants, and practices.
There are at least three sets of disconnects within U.S. medicine that reveal particular issues of unprofessional commercialism.
Silence of definitions, charters, and measurement tools
The first disconnect lies within the overall emphasis on “professionalism” within organized medicine today, as indicated by the various “products”—the codes, charters, opinions, competencies, and even the definitions and measurement tools—produced by various medical organizations. However earnest and genuine, these products remain relatively silent on the commercial behaviors of rank and file. It is as if organized medicine is more than willing to denounce commercialism as antithetical to medical professionalism as long as definitions, charters, and measurement tools do not get in the way of physicians making money. Yet the issue of how physicians make their money—and the distinctions between professionally appropriate and inappropriate ways to do so, as opposed to legal versus illegal—are precisely what the conflict between commercialism and professionalism is all about. While some may define the problem as one of physician liability under federal antikickback and claims laws,83 the core issue is much more foundational. The problem is not one of legalities. The problem is about medicine’s status and soul as a profession.
Silence of state medical boards
A second (and related) disconnect is located between the above meta-concerns and the policies and practices of state medical boards.83 For example, there is a considerable gap between the principles detailed in the AMA’s Code of Medical Ethics: Current Opinions with Annotations,84 for example, and what takes place at the state board level. Commercial behaviors clearly identified as unprofessional by the AMA are rarely so identified in state board statutes, and if they do appear, they are not sufficiently developed.83 This problem is further compounded when states with applicable statutes purposely choose to focus their adjudicatory efforts on issues other than unprofessional commercialism. With a history of chronic underfunding, and a related disinclination to operate proactively, state boards are much more likely to focus on “the big three” (sexual abuse/assault of patients, physician abuse of alcohol/drugs, and improper scripting of controlled substances) than on other types of transgressions.83 Even within this restricted focus, the track record of state boards is not one of exemplary vigilance. Periodically, state boards are raked over the public coals for their failure to discipline physicians—even when the physicians have been involved in patient abuse or physician drug abuse.85–87 Sir Donald Irvine has raised similar concerns about the lack of peer review and licensure in the United Kingdom.88
Silence of formal educational policy
A third disconnect takes place at the level of medical education and exists in that space between formal educational policy and practices, and the types of learning (formal, informal, and hidden)89–92 that engulf students on a daily basis. Three examples (focusing on professionalism in general and the influence of industry in particular) illustrate this gap.
The first example highlights the move to “competencies” and the stark difference between accreditation practices at the level of graduate medical education (GME) versus undergraduate medical education (UME). The Accreditation Council for Graduate Medical Education (ACGME) centers its accreditation practices around six core competencies—one of which is professionalism.93 The Liaison Committee on Medical Education, on the other hand, calls upon medical schools to document student development toward competencies,93a but in doing so only references standards developed by other groups, such as the Association of American Medical Colleges (AAMC)’s own Medical School Objectives Project (MSOP), the ACGME’s core competencies, and the list of “roles” developed regarding Canadian GME accreditation (CanMEDS 2000). Professionalism is not mentioned, nor is it included in, for example, the AAMC’s MSOP report.94 In short, the only mechanism formally specified for addressing issues of professionalism in medical education is at the GME level. Nonetheless, when we turn to issues of commercialism and the influence of industry, even GME is relatively silent. The only mention of unprofessional commercialism in the ACGME’s competency documents is located in the description of its “professionalism” competency and calls for “commitment to ethical principles” pertaining to “business practices” (along with issues of confidentiality, informed consent and other topics).95 Currently, the ACGME is more than halfway into its 10-year project to specify best practices regarding the definition and assessment of its six competencies; thus it is very possible that the finished product will formally address issues of industry influence. Nonetheless, what we presently have is more anticipation than promise. One cannot help but speculate that the absence of unprofessional commercialism and conflict of interest items within tools used to assess professionalism in medical students and residents may reflect a belief that those issues are more likely to involve faculty than students. In other words, the absence of these items may reflect a belief that students are not capable of engaging in conflict of interest behaviors. Whether this is true or not, there appear to be few standards addressing unprofessional commercialism and conflict of interest in place for medical students and residents.
The second example is to briefly examine the “policy proposal” recently published (January 25, 2006) focusing on “health industry practices that create conflicts of interest” within medical schools and academic health centers (AHCs).96 Among its many virtues, this proposal punctures two key myths about commercial conflicts-of-interest. The first is that there is a meaningful distinction, in terms of influencing physician behaviors, between “large” and “small” gifts. The second is that disclosure of financial conflicts is sufficient to protect patient interests. This proposal unflinchingly calls for a ban on all gift-giving from pharmaceutical and medical device makers to physicians, and that prohibits AHC faculty from participating in speaker’s bureaus. This is not your run-of-the-mill policy proposal. However, we need to be clear about who and what are not covered by this proposal, with particular attention to a key term—“faculty.” The text implies university faculty, but we know that these individuals comprise only one segment of the overall teaching cadre in medical education. What about all those community physicians that serve as clinical teachers, preceptors, and role models? Do they have free reign to continue with their commercial endeavors and enterprises? After all, medical training is infamous for the sniping wars that go on between university faculty and community physicians—between “ivory tower” and “real world” medicine (as some community physicians see it) or between “cutting edge” and “backwater” medicine (as some faculty see it). It is within such sniping that students encounter powerful messages (and learn lifelong lessons) about when and where rules and norms about ethics and professionalism do—and do not—apply. Great care needs to be taken to ensure that these policy proposals, admirable as they are, do not become the site of inconsistent and countervailing messages as well as unintended consequences.
Many of these same issues can be explored within the context of policies and programs adopted by individual schools. A recently published overview of policies adopted by Yale University School of Medicine is an excellent place to start.97
There also is a small measure of irony within this discussion of medical students, residents, and conflict of interest policies. University faculty are now becoming more aware of any new institutional policies of this ilk.98 So, too, will the public—the JAMA article,96 for example, received significant local,99 national,100–102 and international103 news coverage. The population least likely to be aware of any such policy proposals are medical students, whose general withdrawal from “current events” and “news of the day,” as they are swept along by their training, is legion.
Finally, we need to be cognizant of one additional social-psychological wrinkle when seeking to remediate unprofessional commercialism and conflicts of interest within medical education settings. Both practicing physicians104,105 and medical students96 are resolute in believing that while industry practices may indeed effect clinical decision making, any such influence occurs only for “the other guy.” In other words, how are our educational interventions going to quell this troubling disconnect when those who need to learn about the issues exhibit such hubris, lack of humility, and just plain denial? Currently there are no interventions present, or called for, in the above-reviewed materials that are designed to rouse medical students and practicing physicians and unequivocally affirm that they, too, are part of the problem.
Our third example broadens our framework and focuses on the rise of the research juggernaut within medical schools and AHCs. The rise of the R0-1 translational-researcher-god within academic medicine is a hallmark of our times.106–109 The overall learning environments of AHCs and teaching hospitals are awash with commercial ventures, as researchers and clinicians alike scurry to develop commercial products replete with patents, copyrights, and product-exclusivity contracts.8,10,21,110–123 This push for “revenue maximization” has caused some medical schools to ease restrictions on outside faculty ventures.14 The negative impact that funding sources can have on research conduct12,15,124–130 and research findings107,111,124,131–137 are well documented. As such, we need to acknowledge the potential effect of industry on medical students’ socialization that is occurring via an industry-infused research milieu that is quickly engulfing medical learning environments. The fact is that medical students and residents—even if they have no intention of becoming researchers—will be exposed during their clinical training (at least) to the clinical medicine equivalent of “research-rules-of-the road,” governing how scientific investigation “really takes place” as opposed to how it is formally depicted in “textbook research.” This gap between ideal and real will be a source of learning for students, as will be the rationales researchers give for why relations with industry are necessary and good. Once again, none of this speaks to the problem of “insider hubris”—where medical students and clinicians believe they, among all their peers, stand above outside “contamination.”104,105
Summing up about education
In summary, whether our focus is clinical practice or research, what we find, upon examination, are troubling gaps between formal policy and/or “rules” and the various types of influences and learning environments medical students and residents encounter during their training. Community physicians and preceptors are no less influential role models than medical school faculty, and they certainly can—and do—participate in gift-giving, research, speakers bureaus, and related activities, all of which are accompanied by convincing rationales for why these practices exist, why they embrace these practices, and why the rules of “ivory tower medicine” do not apply to the “real world” of practicing clinicians. And woe to those organizations that try to eliminate traditional perks such as outside consulting. The recent upheaval at the National Institutes of Health over regulations to prohibit outside consulting is a perfect case in point.119,138,139 In short, the educational milieu of U.S. medicine is awash with the spirit and practice of commercialism. A scant twenty years ago, medical leaders joined ranks in uniformly denouncing an ethic of commercialism. Today, medical editorials are just as likely to label commercialism as “simply a fact of life of medicine in this era.”117 What started as anathema now is being labeled as inevitable or even necessary for the practice of “good research” and “good medicine.”
Medicine stands today at a critical juncture. The evil that once launched a thousand editorials no longer appears as ominous—or at least as professionally suspect and unjustifiable—as it once did. In turn, and acting as both a cause and consequence, tens of thousands of physicians ply their commercial wares unfettered by concerns about professional sanctions. What, then, are we to conclude? Is commercialism—really and truly—antithetical to professionalism? One would think so—at least according to traditional claims and definitions.140 If so, then what about the blatantly commercial behaviors of medical organizations and rank and file physicians? Should we place transgressors within some kind of adjudicatory cross-hairs? On the other hand, perhaps these are different times and call for different conclusions? Do we try to uphold traditional definitions and standards, or alternatively, do we try to craft new (although some might say, watered down) understandings of what it means to be a professional within the milieus of contemporary medical practice and research?
One current and special issue is whether the JAMA policy proposal advanced by Brennan, Rothman, Blank, and colleagues96 will usher in a whole new chapter in medicine’s professionalism project or whether this and similar (e.g., Yale’s97) policies will become the site of ideal-versus-real disjunctures and begin to ooze a stream of unanticipated consequences. The upside involves both the potential for broader organizational commitments to an ethic of professionalism, as well as continued discussions and debates within the medical community about issues of professionalism. As I have argued elsewhere,141 professionalism is not a “thing” that exists independent of social action and social actors. As a theoretical construct and operational entity, professionalism is a product of—and a factor in—social interactions, be they among social actors, or between individuals and organizations. There can be no true professionalism shorn of discussion and debate.
There remain significant downsides as well. Even if we imagine, for the sake of discussion, that medical schools and AHCs can rid themselves of commercial contaminants (including the above-mentioned “infectious” role of nonuniversity clinical faculty), there remain significant threats to professionalism. A “cleansing” of medical school and learning environments is not enough. Students still need to learn about the whys and wherefores of the professionalism-commercialism conundrum. Otherwise, we have a Garden of Eden effect, where student innocents, unbesmirched by the sins of commercialism during training, go into the real world of medical practice and find themselves unable to effectively cope with the types of unprofessional commercial practices and rationales that practicing clinicians and/or researchers encounter on a daily basis. Students need not only to learn what is right but also what is wrong, even if there is no wrong within their immediate training environments.
This dissonance between the ideal and real is a fundamental reason why the cleansing of undergraduate and graduate medical training environments must be the first of several remedial steps. The ultimate solution to the professionalism problem, however, resides not with enforcement-from-above, such as within the policies and decrees of medical schools, AHCs, the LCME, and/or the ACGME. The solution lies, as it always has, at the level of self and peer review. There can be no professionalism short of its manifestation at the physician, physician–peer, and physician–patient levels. Professionalism-from-above, while necessary, is not sufficient. Traditional definitions of professionalism have always emphasized its internalized nature. Professional control, first and foremost, has always been about self-control. It is a product of socialization, something internally embraced, and not externally mandated, even if the external source is a medical school or training program. Ultimately, peer review is the heart and self-review (e.g., reflection) the soul of medical professionalism.
None of these calls-to-action will be either easy or straightforward. The fact that we have 50-plus state review boards means that any effort to take remedially coordinated steps must happen on 50-plus fronts. This is a daunting barrier to system-wide reform. Nonetheless, and assuming that medical education can effectively clean house, one possible course of action might be to formally link medical schools and AHCs with their geographically proximate state boards. Here, the intent would be to translate effective school-based policies into policies and practices that effectively target unprofessional commercialism at a local and peer-based level.
What, then, about the law? After all, physicians have the legal right to undertake virtually all of the commercial and entrepreneurial practices labeled above as unprofessional. This point is true—but ultimately immaterial. At root, professionalism is not about law. It is about ethics and the standards of work set by a specific occupation group. A professionalism that is law-based is professionalism in name only.
There remains, however, one more layer of concern.
The issue of medicine’s continued status as a profession—however deeply and earnestly felt by medical insiders—is but a small window into a much broader and more profound set of issues. Medicine is not the only profession, but it is the prototype profession, and as such, has become the organizational entity most watched and critically examined around issues of discretionary decision making, occupational autonomy, and the right and ability to control credentialing and the recruitment and training of new practitioners. In what would be his last major statement on professions,140 sociologist Eliot Freidson labeled professionalism “the third logic” and detailed how controls by occupation groups with specialized knowledge and skills (professions) serve as a countervailing force to (1) control by the consumer/buyer (free market) and (2) control by managers (bureaucracy). Freidson also identified five “critical contingencies for establishing and supporting professionalism”—the fifth being “an ideology servicing some transcendent value” (emphasis mine, to introduce a theme that will be apparent in a moment).
While Freidson explicitly denied that any one of these critical contingencies was more important or essential to modern life than the other, and while he detailed the downsides of each, he remained quite troubled by the potential decline of the expert’s control over his or her labors. Such a demise, Freidson noted, would leave all work exposed to the vagaries and deceptions found in unregulated markets or to the administrative and hierarchical stranglehold of bureaucratic structures, both of which are forms of authority that German social theorist Max Weber felt would lead to an “iron cage of servitude.”142
This is the broader context within which medicine functions, and this is the level that medical schools and AHCs ultimately must address as they go about crafting their policies and pedagogical programs regarding industry and conflicts of interest. Yes, it is important for medical students, residents, and practicing clinicians to distance themselves from conflicts of interest and knowledge that may be compromised by corporate influences. However, as just indicated, the issues are much broader and more profound than the particulars of specific threats to physician clinical decision making.
One outcome of medicine’s “professionalism project” has been an increased willingness of the profession to formally refer to its social contract with society.143–146 For medicine, the social contract means a promise to do good work and to carrying out that work for the welfare of patients. However, in rushing to rediscover medicine’s soul, there are some within medicine who have got the “professionalism thing” backwards. Ultimately, professionalism is not defined by the good deeds of physicians and/or the benefits to society wrought by organized medicine. Instead, the values and ideals of professionalism evince their constituent meanings within the broader context of contemporary social life and within the clamor and commotion of those countervailing social forces (free market and bureaucratic) that seek to define and limit issues of agency, which concern the purposeful action by volitional agents who help to shape the broader social structures they inhabit.
Medicine has been the standard-bearer of professionalism for most of the 20th century, and during this epoch it has benefited greatly (as an occupation and at the level of individual clinicians) from this status. However, this is “crunch time.” The carrion wrought by the market and by the strictures of bureaucratic rationality now sits visible at the gate of the medical community. This putrescence, however, is not about formularies, report cards, or incentivized (usually money) clinical decision making. It is about the value of expert decision making in a world that seems hell-bent on reducing human interactions and social life to the “logic” of the market or to the “principles” of organizational rule making.
Social theorist Emile Durkheim was right.147 Professionalism is about protecting the public from the powerful. This is medicine’s social contract. History is watching.
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