Profits before People?: Ethical Standards and the Marketing of Prescription Drugs

Introduction

Introduction “It has all gone terribly wrong for the dozen or so manufacturers that make up ‘big pharma.’” is statement introduced a review of the pharmaceutical industry’s problems in a March 2005 article in e Economist.1 e once well-respected drug companies are now being subjected to fierce criticism. ey stand accused of focusing on “me-too” drugs which confer little clinical benefit over existing medicines; rushing these to market through cunning clinical trials designed to make them look better than they are; and suppressing data to the contrary. e industry is also lambasted for expensive, aggressive and misleading direct-to-consumer advertising, which sometimes creates conditions to fit the drugs, rather than the other way around.2 ere is little trust that drug companies will do the right thing: a February 2005 Kaiser Family Foundation poll of 1,200 Americans found that 70 percent agreed that drug companies put profits ahead of people.3 When the pharmaceutical company Merck announced in the fall of 2004 that it was taking its blockbuster pain drug Vioxx (rofecoxib) off the market because of evidence that its use con- 2 Profits before People? tributed to increased risks of heart attacks or strokes, some gave Merck credit for taking that action before it was mandated by the Food and Drug Administration (FDA). But many were not impressed by the company’s overall Vioxx-related performance. ere had been earlier warning signs of the risks associated with the use of Vioxx4 and Merck’s response at that time had been to continue to market the medication aggressively. By the time Merck made the decision to cease marketing Vioxx, millions of people were taking the drug, at a potential and unnecessary risk to their cardiovascular health. Vioxx was among the most heavily marketed, most widely used, and most profitable medicines, a case study of the way commercial interests can influence decisions about the marketing and use of drugs. e FDA convened a panel of experts to advise on whether to permit the marketing of Vioxx and the other two painkillers in the class of drugs known as COX-2 inhibitors (Celebrex and Bextra). After the panel endorsed continued availability of these drugs, the Center for Science in the Public Interest did background checking and found that 10 of the 32 members of the advisory group had direct financial ties with the drug companies that make these drugs (received consulting fees, speaker fees, or research money from them).5 “If the 10 advisors had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx not return to the market. e 10 advisors with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx’s return.”6 ey were permitted to participate and vote despite the obvious questions about their objectivity. It is an important sign of the times that FDA panel reports are received with some skepticism precisely because of the potential influence of drug companies on these deliberations. e pharmaceutical industry plays a key role in the American healthcare system and has had and continues to have an enormous influence on the practice of medicine. It sponsors much of the medical research being done; it produces the medicines that doctors prescribe and millions of people take; it sends out thousands of sales representatives to interact directly and frequently with physicians about the available drugs; it finances many of the continuing education programs physicians attend; it advertises drugs 3 Introduction directly to the public, who are told to “ask your doctor” about the products; it contributes heavily to political campaigns and has a strong lobbying voice at the federal and state levels. It is a powerful industry whose practices affect the health and healthcare of many millions of people. e pharmaceutical industry is now being subjected to criticism and challenge as never before in the age of scientific medicine. ere has been increased critical attention paid to the methods that the industry uses to promote its products and to influence medical decisions. Much of the criticism is coming from physicians , often focused on the ways in which industry practices affect the quality of patient care and the professionalism and integrity of healthcare providers. e cost of prescription medications has been a major focus of concern among the public, one reflected in the debate about the provisions of the Medicare drug coverage legislation passed in...