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Member WORST PILLS Visit Health Research Group’s website at BEST PILLS www.citizen.org/hrg/ Health Research Group NEWS SIDNEY M. WOLFE, M.D., EDITOR MARCH 2002 VOL. 8, NO. 3 Direct-To-Consumer Advertising—Education or Emotion Promotion? This article by Worst Pills, Best Pills tests to diagnose and drugs to treat Food and Drug Administration News Editor, Dr. Sidney Wolfe is illnesses is an important advance, (FDA) of advertising regulations reprinted from the New England confusion arises when commercially adequate? What can be done to Journal of Medicine 2002;346:524-526. driven promotional information is neutralize the negative effect of this Copyright © 2002 Massachusetts represented as educational. Two type of advertising? Medical Society. All rights reserved. articles in this issue of the Journal In an excellent review of direct- address the direct-to-consumer to-consumer promotion, Mintzes uring the past two decades, promotion of medical products and stated that “the question is not there has been an irrevers- services. Rosenthal et al. describe whether consumers should obtain D ible change in the nature of the resources allocated to direct-to- information about treatment op- the doctor-patient relationship. consumer advertising of prescrip- tions; the question is whether drug Patients are seeking much more tion drugs, as compared with other promotion—whose aim is to sell a medical information and are actively forms of promotion. Lee and product—can provide the type of participating in decisions affecting Brennan examine issues arising information consumers need.” their health. Intruding into this trend from the direct-to-consumer market- Addressing the issue of pharma- has been the rise of direct-to-con- ing of high technology medical ceutical advertising more generally sumer promotion, which, in its initial screening tests. These articles raise 30 years ago in the Journal, thrust, bypasses primary care doctors several questions. Is direct-to- Ingelfinger argued that “advertise- and other physicians. Although consumer advertising educational ments should be overtly recognized increased access by patients to or emotional? How often is it for what they are—an unabashed accurate, objective information about misleading? Is enforcement by the continued on page 18 In this Issue citalopram........................ 22 loratadine......................... 20 PROZAC .......................... 22 CLARINEX........................ 20 LUVOX ............................ 22 ranitidine ......................... 24 acetaminophen CLARITIN......................... 20 MAALOX ......................... 24 SARAFEM......................... 22 and tramadol ............... 22 clomipramine................... 22 MARPLAN ....................... 22 sertraline .......................... 22 ADIPOKINETIX ................ 21 desloratadine ................... 20 META-BURN .................... 21 SPECTRACEF.................... 23 ADRENALIN .................... 21 ELAVIL ............................. 22 moclobemide ................... 22 ST. JOHN’S WORT........... 22 ALPHADRINE .................. 21 ephedra............................ 21 NARDIL ........................... 22 TAGAMET ........................ 24 amitriptyline..................... 22 ephedrine......................... 21 norephedrine ................... 21 tramadol ......................... 22 ANAFRANIL..................... 22 EPHEDRINE 25 ................ 21 OMNICEF ........................ 24 tranylcypromine ............... 22 cefdinir ............................ 24 EPHEDROL ...................... 21 OVERDRIVE..................... 21 ULTRACET ....................... 22 cefditoren......................... 23 fluoxetine ......................... 22 PARNATE ......................... 22 ULTRAM .......................... 22 cefpodoxime .................... 24 fluvoxamine ..................... 22 paroxetine ........................ 22 VANTIN ........................... 24 CEFTIN ............................ 24 histamine-2 blockers ........ 24 PAXIL ............................... 22 ZANTAC .......................... 24 cefuroxime ....................... 24 HOLLYWOOD CUTS ...... 21 phenelzine ....................... 22 ZOLOFT .......................... 22 CELEXA ............................ 22 isocarboxazid................... 22 PHENYLKINETICS ............ 21 cephalexin ....................... 24 KEFLEX............................. 24 phenylpropanolamine ...... 21 cimetidine ........................ 24 LIPODRYL II..................... 21 PPA .................................. 21 MARCH 2002 N 17 attempt to get someone to buy parts of the brain where gut in- published. According to another something, although some useful stincts are formed, areas that study, consumers rated the safety information may be provided in the influence emotional behavior and and appeal of drugs described with process.” He suggested that such form memories.” The advertising an incomplete statement of risks advertising should be divested of its agency asserts that its “communica- more positively than similar drugs “pseudo-educational character.” tions are focused on making the described with a more complete Serious deficiencies have been hippocampus respond positively to statement of risks. documented in the educational your product...[by demonstrating] Defenses of direct-to-consumer value of advertising for prescription how your product is superior and advertising by the pharmaceutical drugs. In a survey of 1872 viewers unique.” An executive of a company industry inevitably mention that the of television advertisements, 70 that focuses on direct-to-consumer real gatekeeper is the doctor, since percent thought they had learned only the doctor can write a prescrip- little or nothing more about the tion. Even Rosenthal et al. state that health condition requiring treat- doctors will only write a prescrip- ment, and 59 percent thought they The FDA should tion for a drug when they are knew little or nothing more about “familiar with it and comfortable the drug being advertised. Another crack down harder prescribing it.” Although it is study found that whereas many beyond the scope of this editorial, it advertisements provided informa- on misleading ads. is important to examine studies tion about the name and symptoms assessing the accuracy of sources of of the disease for which the drug information that physicians use to was being promoted, few educated learn about new drugs or devices. the patients about the success rate of advertising commented that “con- There is evidence that many drug the drug, the necessary duration of sumers react emotionally, so you advertisements are not balanced or use, alternative treatments (includ- want to know how they feel about accurate, and duped gatekeepers ing behavioral changes) that could your message and what emotional may not adequately resist patients’ improve their health, or misconcep- triggers will get them to act....We exhortations to write a prescription. tions about the disease to be treated. want to identify the emotions we Since a ban on the advertising of The average number of “educational can tap into to get that customer to pharmaceutical agents is incompat- codes” (i.e., specific learning points take the desired course of action.” ible with the First Amendment, relating to a medical condition or a Another article, describing problems much stricter control by the FDA of treatment) present in the advertise- the drug industry has had in misleading advertising is necessary. ments was only 3.2 out of a possible adapting to direct-to-consumer Although expenditures for the 11. marketing, said that companies “are promotion of drugs increased from None of these deficiencies should overly focused on communicating $11 billion in 1997 to $15.7 billion in be surprising in the light of the rational attributes to customers. But 2000 (see Figure 1, next page), there characterization of advertising by consumers often choose a product is a significant decrease in the the Canadian economist Stephen on [the basis of] emotional number of actions taken by the FDA Leacock as “the science of arresting attributes....How an emotional to enforce advertising regulations— the human intelligence long enough appeal fits into fair balance in from 139 letters of warning to to get money from it.” Leacock also advertising prescription drugs companies or notices of violation in thought that, for the purpose of under the requirements and ap- 1997 to 79 in 2000 and an estimated selling, advertising “is superior to proval process of the FDA is not 73 in 2001. The FDA is grossly reality.” An advertisement, aimed at clear.” understaffed for this important the marketers of pharmaceutical Patients have dangerous oversight function: the entire products, from an agency that misperceptions about direct-to- Division of Drug Marketing, Adver- creates drug advertisements, consumer advertising. According to tising, and Communications provides some revealing insights one study, a substantial proportion (DDMAC) has had only 28 to 30 about how the process works. The of people incorrectly believed that employees since 1997. A further promotional material describes the only the safest and most effective handicap for the FDA is that it lacks hippocampus as the “prescription- drugs could be advertised directly the legal authority to impose civil writing center of the brain”—the to consumers and that the FDA monetary penalties on companies part that “processes information by required that it be allowed to review even when they

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