Direct-to-Consumer Advertising and the Demise of the Ideal Model of Health Care
White, Ronald F., Independent Review
In recent years, pharmaceutical companies have begun to market expensive new drugs directly to consumers via television ads. These new drugs target some of our most common medical problems, such as allergies, heartburn, erectile dysfunction, and attention-deficit disorder. Those same corporations, however, have come under fire for mass-marketing drugs previously approved by the U.S. Food and Drug Administration (FDA), but later deemed to be unsafe, including Rezulin, Fen-Phen, Vioxx, and Baycol. In 2001, Bayer Pharmaceutical's Baycol, a cholesterol-lowering drug, was withdrawn from the market under the cloud of approximately eight thousand pending lawsuits. Some critics of the FDA complain that the review process is too slow and deliberate, whereas others insist that it is too fast and reckless.
On June 15, 2005, Bristol-Myers Squibb announced a self-imposed ban on direct-to-consumer (DTC) advertising of new drugs until those drugs have been on the market for a year. For that first year, marketing efforts would emphasize direct-to-physician (DTP) advertising. Meanwhile, the American Medical Association continues to push the FDA for stricter governmental regulation of DTC advertising, and the American health-care system as a whole remains in a state of crisis. What's really going on here?
The maze of regulations that envelopes the sale of pharmaceutical products in the United States has its roots in a longstanding, yet subtle, ideology that pervades the health-care industry as a whole: the belief that the provision of health care is not a business and that the distribution of its products and services requires paternalistic oversight by duty-bound physicians and government regulators. The dogged defenders of this ideology usually adopt the following premises as support for a system of medical paternalism: (1) health is a fundamental necessity; (2) the consumer often cannot adequately assess the absence or presence of disease; (3) treatment requires specialized expertise; (4) misdiagnosis, mistreatment, or nontreatment may have profound consequences; and (5) ill people are frequently rendered especially vulnerable to exploitation by their disease (Berger et al. 2001, 199). Often implicit is the hidden premise that "objective science" in the form of FDA-regulated clinical trials protects the public from unsafe or ineffective medical treatment.
The primary conclusion drawn from these premises is that health care, by its very nature, is not really a business, so it is exempt from the kind of moral scrutiny afforded other corporate entities. Until recently, this argument has gone unchallenged for the most part and has even been reaffirmed by medical ethicists. Despite fervent effort by the defenders of the status quo, however, market forces have begun to undermine this pervasive ideology. The rise of DTC advertising in the United States is an early sign of an impending revolution in health care.
In reality, health care has always been an economic activity that involves the exchange of products and services. Modern medicine's hallmark has been the rapid rise in the number of persons who earn paychecks in that sector. In the United States, the health-care delivery system now employs at least 10 million, including 798,000 medical doctors and 208,000 pharmacists (Shi and Singh 2004, 3-4). U.S. healthcare costs have spiraled. In 1960, they accounted for only 5 percent of our gross domestic product (GDP); in 2000, however, they accounted for at least 13 percent (AHRQ 2002, 1). Rising health-care costs have contributed to high-profile bankruptcies in the auto industry and elsewhere.
Despite these stark realities, the keepers of the status quo benefit greatly from maintaining the system. The various interest groups--whose lobbyists stalk the halls of Congress representing physicians, pharmacists, and drug companies--deploy a variety of cloaking devices to hide the health-care system's economic foundations. …