Direct-to-consumer advertising and the demise of the ideal model of health care.

• Author: White, Ronald F.

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 In 2001, Bayer Pharmaceutical's Baycol, a cholesterol-lowering drug, was withdrawn from the market under the cloud of approximately eight thousand pending lawsuits.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. The most obvious device has been our third-party payment system, which has numbed the system's price sensitivity. In this misrepresented system, health-care sellers have been able to charge noncompetitive prices for their goods and services with impunity, in the guise that their transactions are not ordinary business activity.

At the cultural level, the obfuscation is much more subtle. How did Americans end up with a health-care system steeped in euphemisms, in which health-care buyers (disguised as "patients") are routinely prescribed expensive patent-protected medical treatment by its sellers (disguised as "providers") in the absence of antecedent bargaining over prices? And why do physicians, dentists, surgeons, hospitals, and pharmaceutical companies routinely exchange ideology disguised as "information" behind a smokescreen of arcane "scientific" language that most buyers cannot decode without professional translators? Of course, the most basic question is: Why do we tolerate a high-priced health-care system infested with artificial monopolies and shrouded in opacity?

The answer to all these questions is that the realities of health care have been obscured by an ideology that masks multiple layers of what business ethicists would otherwise call conflict of interest. The FDA, which regulates pharmaceutical products, contributes significantly to the preservation of this deeply rooted ideology that masks the economics of health care and at the same time surreptitiously lines the pockets of health-care providers.

The most prolific source of this culturally based self-deception can be traced to the Hippocratic, Judeo-Christian, and Western liberal ideologies, which together portray the health-care industry as a physician-directed coterie of charitable "professions" that operate outside of the laws of economics. This ideology has also been influenced by endemic scientism, which fosters the cultural belief that medicine is an applied science, like engineering, and that we can rely on those objective and altruistic scientists to construct a risk-flee society. Consequently, most of what constitutes traditional medical ethics today systematically ignores the presence of a lumbering elephant in the room: virtually everyone involved in the provision of health care today gets a hefty paycheck signed by a corporation.

After years of interminable debate by medical ethicists over issues purged of underlying economic reality--abortion, reproductive assistance, euthanasia, and stem-cell research--the time seems ripe for a more realistic approach. Americans should acknowledge that health care is an industry and therefore should be subjected to the kind of scrutiny other businesses receive. As a case study, I focus my discussion here on DTC advertising of pharmaceutical products. I suggest that as long as we choose to ignore the elephant in plain sight, we will not be able to make sense of prescription-drug laws, DTC advertising, and the health-care crisis in the United States. Our socially constructed inability to distinguish between truth and mere ideology has perpetuated the status quo and impedes meaningful reform of the health-care system.

I begin by briefly describing the pharmaceutical elephant, explaining why the Hippocratic, Judeo-Christian, and some Western liberal medical models fail to elucidate the real ethical issues associated with marketing medicines. In the end, I suggest that meaningful health-care reform requires that we abandon the status quo, admit that health care is a business, and hold the various health-care providers to the same moral and legal standards that we apply to other businesses. In short, I argue that business ethics provides a more plausible, reality-based approach to DTC advertising, and perhaps to most other issues, than does traditional medical ethics.

The Pharmaceutical Elephant

Let us begin with a broad description of the elephant in the room, that obvious behemoth among us whose existence we simply refuse to acknowledge.

1. Health care has always been an industry, or a coterie of highly profitable industries, including insurance corporations, hospitals, and the pharmaceutical industry.

2. Since the early twentieth century, health-care business institutions in the United States have wielded great social, economic, and political clout through professional organizations, corporations, industrywide political action committees (PACs), and so forth. In recent years, pharmaceutical corporations have become especially prosperous and well situated politically among the various components of the healthcare industry. Surprise! They act like other corporations outside of the health-care system.

3. Government directly or indirectly influences the health-care industry's competitive environment. In recent years, government has been especially hospitable to the pharmaceutical industry. This hospitality is basically "corporate welfare" disguised as "regulation," which includes generous patent protection for twenty years or more, governmentally funded research, cooperative regulatory agencies, and mountains of industry-friendly legislation.

4. There is a health-care crisis in the United States. The medical profession, the...