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266 Robert F. Orsetti, Susan Alpert, Maureen Doyle-Schar√, and Michael Saxton chapter 23 Industry Support of Continuing Medical Education and Continuing Professional Development: A Perspective on the Past and Implications for the Future of Pharmaceutical and Device Company Support In recent years the pharmaceutical and medical device industries have adopted new procedures and policies such as the PhRMA and AdvaMed codes to support continuing medical education (CME) activities that contribute to physician knowledge, application of skills, improved patient care, and the advancement of medical science . Despite such e√orts, some view commercial support of CME as a disguised extension of marketing and promotion that is reflected in inappropriate , biased, subjective, and often scienti fically unsupported influence on CME participants at considerable cost to the public in the form of high-cost medications and procedures. Bowman and Pearle∞ were among the first to question the appropriateness of commercial support of CME, in 1988. They expressed concern about the steady and increasing rate of commercial support of CME in the absence of regulation from the mid-1970s through the late 1980s. Prior to that time the pharmaceutical and later the device industries earmarked product support funding primarily for marketing and sales campaigns, with occasional and modest support of academic medical education. This chapter traces the evolution of industry policy and practice in support of CME from the early 1970s through to the present, while also describing the introduction and strengthening of regulations that have improved and standardized the development and delivery of CME. Prominent policy-making organizations and projections about the future direction and form of CME are discussed. The Pharmaceutical Industry in the 1970s The pharmaceutical industry entered the 1970s with then blockbuster cardiovascular, central nervous system, anti-infective, and anti-inflammatory medications, and some of the major pharmaceutical companies used ever-increasing marketing budgets to expand their product outreach through educational o√erings for physicians. That was a time largely without regulations pertaining to medical education. Still in its infancy, the Accreditation Council for Continuing Medical Education (ACCME), under the guidance of Richard Wilbur, MD, focused on setting standards and guidelines to upgrade and demonstrate the accountability of the medical education enterprise in the United States.≤ The ACCME along with the American Medical Association (AMA) wished to ensure that individual physicians were keeping up to date in their medical practices and, as such, paid little attention to industry activities. As long as industry remained in compliance with the advertising and promotion Industry Support of CME & CPD/ Orsetti, Alpert, Doyle-Schar√, & Saxton 267 components of the Food, Drug, and Cosmetic Act (FDCA),≥ it could self-sponsor and support medical education at will. Because of the rapid release of new and unfamiliar classes of medications, physicians welcomed the opportunity to be educated by the pharmaceutical industry, its clinicians, and its research scientists. Prior to the growth of industrysupported live educational activities, symposia, clinical papers, scientific exhibits, and other activities at nonsupported, annual association meetings, occasional monographs, newsletters, and sales representatives were the main sources of physician education. Physicians, especially high-volume prescribers , were key targets of industry education, with few programs designed for other health-care professionals. To that end, industry sought to build and strengthen relationships with clinical thought leaders and recognized authors and faculty . These individuals assisted their industry colleagues in planning and sta≈ng educational programs designed, for the most part, to convey messages tied directly to product marketing campaigns . In virtually all instances, funds were allocated from marketing product budgets, with product managers and directors intimately involved in the planning process. Selection of subject areas, content, faculty, and location were typically within the purview of the marketing department. In a few companies, the units responsible for these activities and other forms of medical communications (such as publications ) reported to the medical department; but, in this setting, marketing had the final word. Medical, regulatory, and legal sta√s reviewed and approved content for release to ensure compliance with Food and Drug Administration (FDA) advertising and promotion requirements. Education became an extension of the marketing e√ort without much concern for independence, objectivity , fair balance, or scientific method. The current benchmarks for validation of best practices in CME—needs assessment, learning objectives, adult learning principles, and outcome evaluation—were years away from being required in supported activities. Few sta√ members were trained educators. Many had meeting planning and medical writing and communication experience , and some simply learned by doing. While most educational activities were live...

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