Direct-to-Consumer Advertising - Education or Emotion Promotion

This article by Worst Pills, Best Pills News Editor, Dr. Sidney Wolfe is reprinted from the New England Journal of Medicine 2002;346:524-526. Copyright © 2002 Massachusetts Medical Society. All rights reserved.

During the past two decades, there has been an irreversible change in the nature of the doctor-patient relationship. Patients are seeking much more medical information and are actively participating in decisions affecting their health. Intruding into this trend has been the rise of direct-to-consumer promotion, which, in its initial thrust, bypasses primary care doctors and other physicians. Although increased access by patients to accurate, objective information about tests to diagnose and drugs to treat illnesses is an important advance, confusion arises when commercially driven promotional information is represented as educational. Two articles in this issue of the Journal address the direct-to-consumer promotion of medical products and services. Rosenthal et al. describe the resources allocated to direct-to-consumer advertising of prescription drugs, as compared with other forms of promotion. Lee and Brennan examine issues arising from the direct-to-consumer marketing of high technology medical screening tests. These articles raise several questions. Is direct-to-consumer advertising educational or emotional? How often is it misleading? Is enforcement by the Food and Drug Administration (FDA) of advertising regulations adequate? What can be done to neutralize the negative effect of this type of advertising?

In an excellent review of direct-to-consumer promotion, Mintzes stated that “the question is not whether consumers should obtain information about treatment options; the question is whether drug promotion—whose aim is to sell a product—can provide the type of information consumers need.”

Addressing the issue of pharmaceutical advertising more generally 30 years ago in the Journal, Ingelfinger argued that “advertisements should be overtly recognized for what they are—an unabashed attempt to get someone to buy something, although some useful information may be provided in the process.” He suggested that such advertising should be divested of its “pseudo-educational character.”

Serious deficiencies have been documented in the educational value of advertising for prescription drugs. In a survey of 1872 viewers of television advertisements, 70 percent thought they had learned little or nothing more about the health condition requiring treatment, and 59 percent thought they knew little or nothing more about the drug being advertised. Another study found that whereas many advertisements provided information about the name and symptoms of the disease for which the drug was being promoted, few educated the patients about the success rate of the drug, the necessary duration of use, alternative treatments (including behavioral changes) that could improve their health, or misconceptions about the disease to be treated. The average number of “educational codes” (i.e., specific learning points relating to a medical condition or a treatment) present in the advertisements was only 3.2 out of a possible 11.

None of these deficiencies should be surprising in the light of the characterization of advertising by the Canadian economist Stephen Leacock as “the science of arresting the human intelligence long enough to get money from it.” Leacock also thought that, for the purpose of selling, advertising “is superior to reality.” An advertisement, aimed at the marketers of pharmaceutical products, from an agency that creates drug advertisements, provides some revealing insights about how the process works. The promotional material describes the hippocampus as the “prescription-writing center of the brain”—the part that “processes information by connecting new concepts with the parts of the brain where gut instincts are formed, areas that influence emotional behavior and form memories.” The advertising agency asserts that its “communications are focused on making the hippocampus respond positively to your product...[by demonstrating] how your product is superior and unique.” An executive of a company that focuses on direct-to-consumer advertising commented that “consumers react emotionally, so you want to know how they feel about your message and what emotional triggers will get them to act....We want to identify the emotions we can tap into to get that customer to take the desired course of action.” Another article, describing problems the drug industry has had in adapting to direct-to-consumer marketing, said that companies “are overly focused on communicating rational attributes to customers. But consumers often choose a product on [the basis of] emotional attributes....How an emotional appeal fits into fair balance in advertising prescription drugs under the requirements and approval process of the FDA is not clear.”

Patients have dangerous misperceptions about direct-to-consumer advertising. According to one study, a substantial proportion of people incorrectly believed that only the safest and most effective drugs could be advertised directly to consumers and that the FDA required that it be allowed to review advertisements before they were published. According to another study, consumers rated the safety and appeal of drugs described with an incomplete statement of risks more positively than similar drugs described with a more complete statement of risks.

Defenses of direct-to-consumer advertising by the pharmaceutical industry inevitably mention that the real gatekeeper is the doctor, since only the doctor can write a prescription. Even Rosenthal et al. state that doctors will only write a prescription for a drug when they are “familiar with it and comfortable prescribing it.” Although it is beyond the scope of this editorial, it is important to examine studies assessing the accuracy of sources of information that physicians use to learn about new drugs or devices. There is evidence that many drug advertisements are not balanced or accurate, and duped gatekeepers may not adequately resist patients’ exhortations to write a prescription.

Since a ban on the advertising of pharmaceutical agents is incompatible with the First Amendment, much stricter control by the FDA of misleading advertising is necessary. Although expenditures for the promotion of drugs increased from $11 billion in 1997 to $15.7 billion in 2000 (see Figure 1, next page), there is a significant decrease in the number of actions taken by the FDA to enforce advertising regulations—from 139 letters of warning to companies or notices of violation in 1997 to 79 in 2000 and an estimated 73 in 2001. The FDA is grossly understaffed for this important oversight function: the entire Division of Drug Marketing, Advertising, and Communications (DDMAC) has had only 28 to 30 employees since 1997. A further handicap for the FDA is that it lacks the legal authority to impose civil monetary penalties on companies even when they repeatedly violate the law. An editorial in a December 2001 issue of Business Week commented that “pharmaceutical company advertising on TV promotes high-priced new drugs with marginal improvement over cheaper generic versions. The FDA should crack down harder on misleading ads.” In the realm of screening computed tomograpic CT scans analyzed by Lee and Brennan, enforcement is beginning to occur. FDA recently sent a notice of violation to a company, CATscan2000, for illegally promoting screening for heart disease in asymptomatic people: this form of technology has not been approved for use in such screening.

Beyond increased enforcement by the FDA, the issue of better information for patients must be addressed. The irritation felt by many physicians when patients approach them after seeing a direct-to-consumer advertisement may derive from the fact that such advertisements, with their powerful, emotion-arousing images and frequently unbalanced information on safety and effectiveness, mislead patients into believing that drugs are better than they actually are. There is a hollow ring to the statement by Pharmaceutical Research and Manufacturers of America President Alan Holmer that “direct-to-consumer advertising is an excellent way to meet the growing demand for medical information, empowering consumers by educating them about health conditions and possible treatments.”

The education of patients—or physicians—is too important to be left to the pharmaceutical industry, with its pseudo educational campaigns designed, first and foremost, to promote drugs. Public Health Service agencies such as the National Institutes of Health and the FDA, along with medical educators in schools and residency programs, must move much more forcefully to replace tainted drug company “education” with scientifically based, useful information that will stimulate better conversations between doctors and patients and lead to true empowerment.