Disease Mongering in Drug Promotion: Do Governments Have a Regulatory Role?

R ay Moynihan and colleagues describe disease mongering as, " widening the boundaries of treatable illness in order to expand markets for those who sell and deliver treatments " [1]. In this article, I examine one aspect of disease mongering: activities fi nanced by drug companies to promote sales by expanding the pool of patients potentially treated by their products, when no benefi t in terms of reduced morbidity is likely. New diseases may be " created " or existing conditions redefi ned. In theory, these activities are covered by national laws governing drug promotion that forbid misleading or deceptive advertising. However, enforcement is piecemeal and largely ineffective. Drug regulation remains limited in many parts of the world. In 2004, fewer than one-sixth of countries had a well-developed system of drug regulation, and one-third had little to no regulatory capacity [2]. Although 89 countries (46%) reported active regulation of drug promotion, resources devoted to this work may be limited [3]. Full direct-to-consumer advertising (DTCA) of prescription drugs is legal in only the United States and New Zealand. However, in many other countries, unbranded disease-oriented advertising (in which no drug names are mentioned, but patients are often advised to " see your doctor ") is increasingly common. The Dutch Health-Care Inspectorate reviewed 28 product-specifi c marketing plans for prescription drugs, from ten companies, obtained through subpoenas from 1999 to 2002; 3.5% of their budgets were devoted to DTCA [4]. A market analyst reports that drug companies spent US$85 million on unbranded DTCA in Europe in 2004 [5]. Spending is expected to reach US$345.5 million by 2008. In 2005, the Australia–US free trade agreement allowed unbranded advertising in Australian media to be linked to branded information on Web sites [6]. Canada introduced more lenient policies on unbranded advertising in 1996, a shift that has occurred without legislative change [7]. A claimed benefi t of disease-awareness campaigns is that the public becomes more aware of untreated health problems and seeks effective care at an earlier stage, leading to better health [8]. For this to happen, the campaigns must address important health concerns, focus on patients likely to benefi t from diagnosis and treatment, and steer them towards appropriate care. For the individual patient, drug treatment is worth pursuing if potential benefi ts outweigh potential harm. But as healthier people are targeted, the added benefi t of drug treatment can become increasingly elusive. The …