This article is part of Big Pharma, Bad Medicine, a forum on the impact of the pharmaceutical industry on medical training and science, and the responsibilities of physicians.
Marcia Angell notes that industry-funded continuing medical education (CME) is marketing masquerading as education. I will focus on this critique because, in fact, CME is the pharmaceutical industrys most important marketing tool. Through a largely unnoticed process that plays out over a course of years, the pharmaceutical industry uses CMEwhich, unlike other forms of drug promotion, is not regulated by the Food and Drug Administration (FDA)to prepare the market for new drugs, expand existing markets, position products against competitors, and promote unproven uses of treatments.
Heres how it works. Pharmaceutical-company employees, or specialized vendor services, identify opinion leadersinfluential (or up-and-coming) health-care professionals at academic medical centers. Physicians are the primary target, but as nurse-practitioners and physician assistants become increasingly important in primary care, these hidden prescribers are also being targeted. Industrys influence on NPs and PAs has not received enough attention; for example, the recently passed Physician Payments Sunshine Act requires that pharmaceutical companies disclose payments made to physicians, but not those made to other prescribers.
Selected opinion leaders are wooed, perhaps over an expensive one-on-one meal with a company researcher or executivenot someone identified with marketing. In the course of discussing the opinion leaders work, the industry representative will elicit his or her opinions on a variety of topics, including the disease state of interest. Opinion leaders whose perspectives align with a companys marketing goals are then courted. A company may nurture relationships with targeted health-care professionals over many years and will pay them to educate their peers at CME events and other settings.
Industry-paid speakers frequently deny espousing marketing messages. Ive heard many physicians justify their pharma-funded speaking gigs by saying, I never emphasize their product or, triumphantly, I dont even mention their drug! But these comments only highlight their sales skills. Pharma doesnt hire doctors to sell drugs; thats a drug reps job. Pharma hires physicians to sell diseases.
The process of selling what industry calls a disease state begins many years before a drug is submitted to the FDA for approval. Specific marketing messages for a product may be developed seven to ten years before a drug goes on sale. Pre-approval marketing messages assigned to opinion leaders might emphasize the _under-diagnosis of a targeted condition, stress the serious consequences of delayed treatment, or trumpet the importance of a new receptor or novel mechanism of action.
A classic way to expand the market for a drug is to invent a disease state or exaggerate the importance or prevalence of an existing condition. Heres a fictitious example of the latter.
The gurgles and rumbles of an empty stomach are called, in medical-speak, borborygmi (it is one of the few onomatopoeic medical words). Lets imagine that a company is developing a drug that prevents borborygmi. The first step would be to encourage people to take the disease state seriously. Marketing messages developed while the drug is still undergoing testing might include:
• While the occasional growling stomach is not a cause for concern, regular episodes could indicate the presence of CLASS (Chronic Loud Atypical Stomach Sounds).
• CLASS is not always benign. The distinction between normal stomach rumbling and a symptom of a serious disease can only be made by a physician.
• CLASS sufferers may limit their travel, work, and recreational activities out of embarrassment; some may become reclusive, fearing social stigmatization.
• CLASS can lead to overeating and obesity because sufferers may eat constantly to prevent audible stomach rumbling.
A pharmaceutical company may then begin to recruit physicians to act as mouthpieces for specific marketing messages. A gastroenterologist may be recruited to explain to prescribers that every person with stomach rumbling should be examined to rule out a malabsorption disease. Another physician may be recruited to report that 12 percent of the population has undiagnosed CLASS, and that some patients have become homebound because of the condition. A third could announce that CLASS is a new risk factor for obesity and associated health problems.
Sets of physicians are then invited to medical meetings, including CME events, to educate health-care professionals around the country about CLASS: it is no laughing matter, but rather a common, under-diagnosed condition with potentially serious consequences. Because the disease-state blitz begins years before a product arrives on the market, audiences are unlikely to connect a drug to the sudden upsurge of presentations on the disease it is intended to cure.
Although it is illegal for pharmaceutical companies to promote a drug before it is approved, nothing bars pharma-funded physicians from exaggerating the prevalence, severity, or importance of a disease state at a CME event in the name of education. By the time the new drug launches, the disease state is well-established; ideally, CLASS is accepted as a reimbursable diagnosis, and medical students are taught to treat what once was known to be a harmless manifestation of normal gastrointestinal function.
Other companies that want a piece of the CLASS market may create me-too drugs, and then hire opinion leaders to differentiate their new products from existing ones. When more than one treatment is available, opinion leaders might be assigned to highlight the deficiencies of competitive therapies; compare mechanisms of action (only drug X suppresses CLASS-associated disordered gastric rhythms); or invent diagnostic distinctions by, for example, dividing borborygmi into two subtypes, one of which is tailor-made for a new drug.
Opinion leaders are supported by industry only as long as what they say advances marketing goals. A prescriber who expresses doubts about an assigned products efficacy, concerns about its risks, or enthusiasm for a nonmarketable lifestyle change (say, exercise) as a superior therapy, will be dropped from a companys speakers list.
Industry-paid speakers are pushing a product, even if they dont realize it, and health-care professionals at industry-funded CME events are listening to marketing messages, even if they, too, are oblivious to this fact. As Angell points out, by paying for CME and other forms of education, companies are simply buying access to prescribers. Lawyers, accountants, and other professionals pay for their continuing education. It is time for doctors, nurses, and physician assistants to pick up their own tab.
Adriane Fugh-Berman, Associate Professor of Physiology and Family Medicine at Georgetown University Medical Center, directs Pharmedout.org, which will be hosting a conference on industry funding of continuing medical education on June 25, 2010.