There Is a Role for Industry-Sponsored Education in Cardiology

Abstract

HomeCirculationVol. 121, No. 20There Is a Role for Industry-Sponsored Education in Cardiology Free AccessArticle CommentaryPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessArticle CommentaryPDF/EPUBThere Is a Role for Industry-Sponsored Education in Cardiology Robert A. Harrington and Robert M. Califf Robert A. HarringtonRobert A. Harrington From the Duke Clinical Research Institute and the Duke Translational Medicine Institute, Durham, NC. Search for more papers by this author and Robert M. CaliffRobert M. Califf From the Duke Clinical Research Institute and the Duke Translational Medicine Institute, Durham, NC. Search for more papers by this author Originally published25 May 2010https://doi.org/10.1161/CIRCULATIONAHA.109.868026Circulation. 2010;121:2221–2227Education: “The process or art of imparting knowledge, skill and judgment; Facts, skills and ideas that have been learnt, either formally or informally.”—Wikipedia1The term profession is applied to those persons who have specialized and technical skill or knowledge which they apply, for a fee, to certain tasks that ordinary and unqualified people cannot ordinarily undertake. The term derives from the Latin: “to swear (an oath) …”.—Wikipedia2Let’s consider how we as cardiovascular medicine specialists spend our days in the care of people with cardiovascular disease. In the office or making rounds in the hospital, we prescribe drugs and order diagnostic tests; in the noninvasive laboratory, we obtain and interpret images of the heart; in the electrophysiology and cardiac catheterization laboratories, we program and implant devices in patients. When antithrombotic and fibrinolytic drugs are administered, and primary percutaneous coronary intervention is done using balloon catheters and intracoronary stents, lives are saved among patients with acute myocardial infarction.Response by Avorn and Choudhry see p 2221The mortality risk from heart failure decreases and quality of life increases from the proper and appropriate use of angiotensin-converting enzyme inhibitors and β-blockers. Lipid lowering through the use of statin drugs saves lives and reduces serious cardiovascular complications such as myocardial infarction and stroke when properly prescribed to patients with a variety of manifestations of atherosclerotic vascular diseases. According to a recent publication by Ford and colleagues,3 deaths due to coronary heart disease in the United States declined substantially from 1980 to 2000, resulting in >340 000 fewer deaths in 2000. The authors attributed approximately half of this decline to changes in cardiac risk factors and half to the application of evidence-based therapies. An underlying theme in all of this is that the pharmaceutical, biotechnology, and device industries produce an enormous amount of public good through their investment in drug and device discovery, development, and research.Likewise, education of the clinical practice community ensures that clinicians are familiar with the latest developments and advances in cardiac care so that they might be offered to our patients. Failure to implement evidence-based prescribing carries significant consequences for patients. Peterson and colleagues4 have shown that among patients with acute coronary syndromes, a 10% increase in guideline adherence translates to a corresponding decrease in in-hospital mortality. The mortality risk of patients with acute coronary syndromes has dropped by >30% in the past 15 years.5Had this amazing application of technology to benefit people with cardiovascular disease been dependent on a medical products industry that operated in a vacuum, without facile interchange with medical practitioners, progress would have been much slower. The combination of the aggressive nature of an industry driven by a societal obligation to return value to its shareholders and the near abdication by academic medical centers of their responsibility for continuing education of medical practitioners has produced an imbalanced system that is in need of correction, but we should be wary of unintended consequences of well-intentioned reforms. The “elephant in the room” is a reimbursement policy that rewards doctors and hospitals for using expensive technology; this policy has resulted in a system that is facile in transferring knowledge about new technologies but profligate in applying those expensive technologies when simpler approaches would do as well or better.Our principal thesis is that greater balance is needed than currently exists, and it must be achieved by constricting the role of industry funding, changing the payment system, and holding academic centers and professional societies accountable for educating physicians with appropriate independence. Recently, the Association of American Medical Colleges (AAMC) called for renewed attention and focus on the issues facing continuing medical education (CME).6 Although it is critical that medical schools reengage in this critical element of medical education, the draconian exclusion of industry from participation in the educational system is counterproductive, because it will deprive practitioners of ready access to critical knowledge about the proper use of medical products. Similarly, it will hamper the participation of American physicians in the development of new therapies by impeding much-needed communication between those who develop, manufacture, and distribute innovative new products and the practitioners who use them.Framing the DebateThere are legitimate societal concerns that relationships between the medical products industry and the clinical delivery industry need to be carefully defined and governed by behavioral standards so that each group can best serve its mission, whether that means returning value to shareholders or providing health care to patients. Although the interests of the medical products industry should be aligned with those of the practice community, these interests should not be superimposable, because the care of patients requires consideration of many factors beyond a pure financial model based on return on investment.The estimated economic costs for the care of heart disease and stroke in the United States exceed $300 billion annually.3 A recent article by Gawande7 in the New Yorker pointed out the societal harm that occurs when cardiovascular specialists, among others, turn a profession into a pure business model. Indeed, our current understanding of the effect of profit seeking by practitioners on our national economy raises the question of which is more of an “industry”: Those who make medical products or those who make money by applying those products to patients.7 Although we believe that reform of the CME system can be a vital part of reframing medicine as a profession rather than strictly as a business, we also believe that it is naïve to assume that we can completely separate economics and clinical care; we will argue that this is not even in the best interest of our patients.Research and education make up 2 parts of the tripartite mission of the clinical cardiovascular professional. Innovation requires investment of time, energy, and financial resources. Major progress in the diagnostics and therapeutics of modern medicine has been driven by the market-based reality of a financial return. The continued advancement of cardiovascular care and science depends, in part, on defining a legitimate and appropriate working relationship between clinicians and the industry. Thus, to develop new, effective therapies, the profit motive is needed, but to translate the therapies into better health, equilibrium is needed; the system should balance education about the intricacies of applying medical technologies with education about when to apply medical technologies in the best interest of the patient or the healthcare delivery system. In fact, the medical errors literature now refers to 2 distinct types of errors: Errors in the application of the correct plan and errors in the plan itself. The former error (application) is very much in the domain of the medical products industry (imagine defibrillator use without qualified industry consultants), but the latter error (formulating the plan) is much more common and should be off-limits to the medical products industry, because it clearly falls within the purview of the profession and its key knowledge repositories, professional societies and academic medical centers/health systems.Medical Education: Learning About Medical Diagnostics and TherapeuticsTraditional medical education, including cardiovascular specialty education, can be thought about in 3 broad categories: Undergraduate, graduate, and postgraduate. During medical school, the undergraduate category, students are typically not exposed to the complexities of drug and device development. Much of the first 2 years of medical school in most curricula focuses on understanding the basic sciences and the underlying pathophysiology of diseases. Little attention is paid to the realities and challenges of how medical products are actually developed and evaluated in a highly regulated environment. Nor, with the exception of an introduction to basic statistics, are most medical students exposed to a detailed, quantitative approach to evidence that allows them to critically assess new information that arises from clinical investigation or to concepts of probabilistic reasoning and decision making that are so critical to proper application of therapies in practice.During the apprenticeship part of medical school, students spend time in the clinical care setting, where they are expected to apply their understanding of science to the care of patients. During these 2 years, the emphasis is on learning how to take a medical history, perform a physical examination, interpret basic laboratory findings, and arrive at a diagnostic and therapeutic plan. It is during these years that students need to begin to understand and appreciate the development and application of medical products. Unfortunately, few if any medical schools and training programs approach this part of medical education in a systematic way, educating their students on sales and marketing theory and techniques or on how sales representatives are trained to interact with physicians. Considering that most students will spend the majority of their future professional lives ordering, prescribing, and implanting products, it is remarkable that so little attention is paid to this aspect of education. A critical element of system reform will require an overhaul of our outdated undergraduate medical education system.During the residency and fellowship years (the graduate medical education years), there is again little to no systematic or organized attention paid to understanding how drugs and devices are developed, studied, approved, and entered into the medical marketplace. Yet it is during these years of clinical training that new physicians have extensive exposure to both the good and the bad of industry-supported education. In most cardiovascular training programs in the United States, many conferences are supported directly or indirectly by the medical products industry. Some of these conferences grant CME credit and so fall under the rules/regulations of the Accreditation Council for CME (ACCME). We will discuss these in more detail. Other conferences are more informal, do not grant CME credit, and vary greatly in their quality, including their bias. At their best, these conferences can serve as a vehicle to transmit timely information, including new research, on medical products. At their worst, they are marketing events with little emphasis on objective science. It is a mistake to assume that all industry-supported conferences are of poor quality, and such an assumption can deprive trainees of valuable learning opportunities.The Medical Products Industry in US SocietyThe development of medical products in the United States is a highly regulated activity for drugs, biologics, and devices (diagnostic and therapeutic). The Federal Food, Drug, and Cosmetic Act outlines the laws that the US Food and Drug Administration is expected to enforce.8 Medical products are expected to be “safe and effective” before being approved for use. Federal law requires the medical products industry to abide by Food and Drug Administration regulations in developing new diagnostic and therapeutic products. Regulations and guidance documents govern all aspects of product development, research, reporting of results, marketing of products, dissemination of information to consumers and healthcare providers, and interactions among company representatives (many of whom are physicians) and healthcare professionals.9 The specifics of the regulations differ between drugs and devices, but general principles apply to both. Essentially, medical product companies (“sponsors”) become repositories of an enormous amount of data about their products. Although the manufacturing of the product is a critical skill, it is the knowledge of the product that confers its economic value, and attempts to apply a technology without access to this knowledge would be foolish. This has been referred to as being part of a “knowledge-based” industry/economy.10 Indeed, the medical products industry has a legal obligation to ensure that those who use its products have adequate knowledge to use them appropriately, and the industry is at substantial risk of product liability if this does not happen.Industry and Cardiovascular Clinician RelationsLet’s now return to our opening example of how cardiovascular clinicians spend their day in the care of patients with cardiovascular disease. If much of what will transpire over the course of a day involves the use of various medical products, then what is needed are methods by which there can be a knowledge transfer (education) between the industry and cardiovascular clinicians. Although there are academics who have been involved with a product’s development and a broader group of clinicians who have been intimately engaged in the research evaluating a product, there is no denying that industry scientists are very knowledgeable about the product and its uses. The challenge, as well as the opportunity, in the development of educational materials about a medical product is how best to tap into industry experts while appropriately limiting their inherent bias and focus on their own product engendered by both financial conflict and employee loyalty.This tension is not new. Podolsky and Greene reviewed the historical issues in a 2008 perspective published in JAMA, noting that “… the history of industry involvement in medical education involved tensions between promotion and education dating back to the origins of the wonder drugs, from antibiotics to antipsychotics.”11 They pointed out that prominent physicians in the 1950s worried whether the profession was capable of regulating its own education.12 The worry centered on the industry’s very clever use of marketing disguised as education. The authors pointed out that formal CME grew out of these concerns as a way of regulating professionalism and providing some control over the content of postgraduate medical education.13 In fact, Podolsky and Greene noted that “arguments from academia, industry and organized medicine articulated in 1958 persist in almost untouched form in 2008.”11The themes of freedom from bias, independent selection of content, and a separation of marketing from education have been present in this debate for almost 50 years. In 1960, the Pharmaceutical Manufacturers Association and the Association of American Medical Colleges issued “Guides for Medical Education Efforts by the Drug Industry,” supporting the notion that industry-supported education was to be free of commercial influence, insisting that “the final choice of individual speakers should be made by the medical school concerned, in the interest of providing the best possible source of information on a specific subject.”14Although the intention to separate commercial influence from the education of physicians has a long track record, we are obviously still debating the topic 5 decades later. The Food and Drug Administration provided a draft guidance document on the subject of “Industry-Supported Scientific and Educational Activities” in 1997,15 and more recently, both the AAMC and the Institute of Medicine issued position papers on the topic.16,17 The American Medical Student Association supports a campaign known as PharmFree, which “promotes the conscientious, explicit and judicious use of the current best evidence in clinical care. Information used by physicians in making clinical decisions should be comprehensive, transparent in its methodology and results, and independent from institutions and individuals with a financial interest in physician prescribing. Physicians should not seek education from industry marketing efforts, whether they are in the form of advertisements, sales pitches from representatives, or sponsored lectures by paid physicians.”18There is no question that egregious behavior has occurred in the relationships between clinicians, both academic and private practice–based, and the medical products industry.19,20 Speakers bureaus, although potentially a useful educational activity and source of up-to-date medical information, have evolved to a largely commercial activity with carefully prepared slide sets and messages to be delivered that are crafted in company-led speaker training sessions. Part of this is due to Food and Drug Administration requirements that company-sponsored speakers bureau slides be consistent with product labeling, but much of it is due to the sponsors’ desire to ensure consistency in product messages. Such activities are not consistent with the educational goals/missions of the cardiovascular profession and should not be supported outside the realm of independent CME activities (more on this below).Some physicians derive a substantial part of their income by making dinner presentations, most often outside the realm of regulated CME. Although there is undoubtedly some benefit to meeting informally with colleagues and exchanging ideas and information over a meal, many of these activities are little more than marketing exercises. For decades, conferences in major academic centers or smaller community hospitals were accompanied by breakfast or lunch provided by an industry sponsor. Did that make the education bad? Or did it send inappropriate messages of influence on the part of the sponsoring organization? “Ghost and guest” authorship continues to be a byproduct of commercial support for medical education and remains inappropriate in all forms.21,22There are important themes and lessons to be learned here. All of these modes of knowledge exchange are potentially both useful and appropriate. The intention to deliver new product information via academic and clinical peers is a critical part of professional education and should be supported appropriately by the medical products industry. But given the enormous financial stakes in our current healthcare system and the emphasis on the sales-trained and sales-oriented pharmaceutical/device representative as the key interface between prescribing clinicians and the company, the relationships have become distorted, with the lines between advertising and education blurred and indistinguishable. Let’s talk specifically about postgraduate professional education or CME.Continuing Medical EducationMuch of the debate over the appropriate role (if any) for industry support of medical education centers around the industry’s heavy financial support for CME activities. As noted in the AAMC’s report on industry funding of medical education, “An effective and principled partnership between academic medical centers and various health industries is critical in order to realize fully the benefits of biomedical research.”16 The majority of states require CME for physician licensing. In 2007, more than 1 million hours of CME were offered through accredited providers.23 That same year, industry grants provided almost half the $2.5 billion generated through accredited CME programs. There is little question that CME is big business, with universities, professional societies, and for-profit medical education companies all competing for these educational funds. The problem is not industry support of education per se but the manner in which it has evolved, steeped in the methods of advertising and product placement.The ACCME oversees the delivery of CME in the United States and, as such, provides guidance for the role of industry support of CME.24 These standards are designed to ensure that CME activities (identification of needs, design and delivery, selection of faculty, resolution of conflicts of interest) are free of commercial bias. The recently issued AAMC statement addresses the role of academic medical centers and faculty in the CME process.16 In that document, the AAMC acknowledges the legitimacy of industry support of postgraduate medical education and of the ACCME as the regulating entity overseeing these activities in the United States. The AAMC report clearly stresses that academic medical centers need to conduct postgraduate medical education in accordance with ACCME policies and standards. It also clearly states that industry-supported education for physicians should be conducted under the auspices of the CME regulations. Some academic medical centers have adopted new policies to more appropriately create firewalls between faculty and industry influences. Some of these were addressed in a recent American Medical Association report on financial relationships with industry in CME.25 One notable example in all of this is the Memorial Sloan-Kettering Cancer Center’s decision to forego all industry support for its CME programs.26 More experience and research are needed on all of these changes to better understand the overall impact on the quality of CME.As with many other organized professional medical associations or public interest groups, the American College of Cardiology and the American Heart Association offer an extensive set of educational activities to members and other interested cardiovascular professionals. These offerings include live meetings, World Wide Web–based education, self-assessment programs, journal articles, and audio learning. Some of this is made possible through industry grants. Both the American College of Cardiology and American Heart Association have extensive guidelines about the use of industry funding for CME activities that are consistent with both organizations being accredited CME providers through the ACCME.27,28Some authors have recently called for a severe limitation on industry funding for professional society educational efforts in an attempt to better manage “real and perceived” conflicts of interest.29 Whether or not this is feasible in the current economic environment is unclear, but it is also highly dependent on what members desire from their professional organizations. In his presidential address to the American College of Rheumatology in October 2004, Wofsy noted that “since 1998, our annual budget has increased by 75%, while dues have increased only 6%. The expanded programs include, for example, enhanced educational offerings at the annual meeting and elsewhere, practice management seminars, scholarships for trainees to attend our meetings, and major new initiatives to provide assistance to rheumatologists at the local level.”30 Likewise, industry funding to support education within the American College of Cardiology and American Heart Association has resulted in a markedly expanded set of learning opportunities that would be unlikely to be developed without those funds. Given the investment of time, energy, and resources to bring a therapy to market, it is a reasonable societal expectation that the industry that will profit ought to “give back” some of that profit to assist in the professional education surrounding new developments in a field and to increase the likelihood that its products will be used appropriately to defer their own liability risk.It is of interest that among the authors of the JAMA paper that called for diminished support from the industry to professional medical associations are medical journal editors.29 Medical journals are full of advertisements for medical products. The American Medical Association (JAMA and affiliated journals) reported more than $31 million in advertising revenue in its 2008 annual report.31 Journal editors claim that ads are readily distinguishable from peer-reviewed articles. This again raises the question of whether the challenge is industry support or the transparency of that support. If the journals’ approach is considered acceptable by leading members of the medical community, ought there not to be an equally appropriate and transparent manner by which other modes of education can be supported without suffering the negative effects of industry influence and control? The central thesis of the journal editors is that journals play a legitimate “honest broker” role because they have a transparent and time-proven structure of peer review and editorial oversight to sort marketing and knowledge transfer into different pages on the journal. We accept this argument, even though it sometimes fails.32,33 In the case of 1 leading journal, both the editorial oversight of knowledge transfer and the publisher role of making advertising decisions are housed in 1 individual.We need to develop a similar honest-broker model for CME, and there are 2 candidates for the broker: Professional societies and academic medical centers. Both have nonprofit status in our society, signifying that their primary mission is not to return value to shareholders but to seek societal good by upholding the professions that they represent and educate. We believe that both groups need improvement in fulfilling this aspect of their missions. Professional societies are heavily dependent on industry money for educational activities, and more balance is needed, particularly in the specialties in which the financial stakes are high, such as cardiovascular medicine. The American College of Cardiology has recently taken important steps to limit even the appearance of bias in the manner in which funding for its annual meeting is used,34 and continued reform is under way. The engagement of the professional societies is highly preferable to a model of for-profit CME.Academic medical centers have simply chosen to focus their available dollars on other issues, particularly basic biomedical sciences, and have put little genuine, dedicated effort into CME, even for those who practice at their own hospitals and clinics. At our own university, the total support of the CME office is less than the cost of several transgenic mouse cages per year, and yet our health system includes more than 2600 doctors, not to mention numerous other medical professionals.If one accepts that knowledge transfer must occur between medical products companies and the practitioners who use those products, then it stands to reason that the industry should build the cost of education about the use of its products into its pricing model, as does every other industry. But this contribution should be more than matched by out-of-pocket support for CME by practitioners, by health systems in which practitioners practice, and by payers who count on informed practitioners for their clients’ well-being. It is time for medical schools and academic health centers to correct their educational portfolio imbalances and embrace their societal responsibility to provide high-quality ongoing education for the practitioners whom they both train and employ as members of their faculty and medical staffs.Two individuals from the Office of the Inspector General recently presented their view of the role of industry support for CME.35 They described the federal government’s concern about industry influence and what it may mean for the delivery of quality care. They also described the challenges of a system that depends on industry funding for CME and offered several alternative models for consideration. Although these are not novel suggestions, the notions of pooled funding support, enhanced professional society oversight, and accreditation of individual activities all have merit and deserve consideration.Recommendations for Appropriate Engagement With Industry Over Medical EducationWe recommend the following: Medical education, undergraduate through postgraduate, should be treated as a social benefit, with the expectation that key stakeholders invest in it. All groups who benefit from a well-educated healthcare community, including medical professionals, the medical products industry, the government, private foundations, academic medical centers, and the insurance industry, should contribute to the funding of medical education.Medical schools, health systems, hospitals, and medical practices should establish rules of behavior for interacting with industry for their faculty, staff, and students; this includes methods for accepting funds for educational support that are highly transparent and free from commercial control, influence, and bias.Appropriate firewalls should be put in place to ensure independence of content development, faculty selection, and delivery methods when academic medical centers receive industry funds for CME programs.Conferences held in a training environment (students, residents, fellows, etc) should follow a standard set of rules regardless of whether or not these are formal CME events.Beginning with undergraduate medical education, pra