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Case 5

Direct-to-Consumer Advertising for Pharmaceuticals: Is It Ethical?*

What do Ozempic and Prolia have in common? They are both gold medal winners for their direct-to-consumer advertising (DTCA) in the pharmaceutical industry.1 Although their brand-name recognition does not rival that of Coca-Cola, their names are familiar to consumers across the nation. As flag bearers of the DTCA efforts of the pharmaceutical industry, they are at the forefront of the DTCA debate. At this writing, the United States and New Zealand are the only developed countries that permit DTCA of pharma drugs. While over the years there has been discussion about opening up the United Kingdom and the European Union to such marketing practices, there has been little progress on that front. In fact, during a tell all television interview of Prince Harry and Meghan Markle by Oprah Winfrey in 2021, British viewers seemed to be more shocked by the prescription drug advertisements during the telecast than the big reveals about the British Royal Family.2 Why debate DTCA? In his testimony before the Senate Commerce Subcommittee on Consumer Affairs, Dr. Sidney Wolfe, director of the Public Citizens Health Research Group, expressed the following concern: There is little doubt that false and misleading ad advertising to patients and physicians can result in prescriptions being written for drugs that are more dangerous and/or less effective than perceived by either the doctor or the patient.3

Beyond safety concerns, there are also concerns over the additional costs that consumers bear with DTCA, as well as the emotional impact and tone of images used in the advertising. For the past six years, the American Medical Association has called for a ban on DTCA prac-tices for prescription drugs and medical devices with concerns that the growing proliferation of ads is driving demand for expensive treatments, despite the effective-ness of less costly alternatives.4

The findings of a CMI/Compas survey of 104 physi-cians across multiple specialties underscore these concerns: 89 percent of the physicians indicated that a patient requested a prescription because of seeing a DTCA and 43 percent of the physicians reported changing their prescribing as a result.5 Only 20 percent agreed (5 percent strongly and 15 percent somewhat) that DTCA improves the relationship between a clinician and the patient.6

However, it seems that consum-ers feel differently. In 2019, the research arm of the Food & Drug Administration (FDA) published research based on a survey of more than 1,700 U.S. adults and found that most patients do not believe DTCA has a negative influence on the patient-provider interaction. A majority (76 percent) said they were likely to ask a health-care provider about adver-tised drugs and 26 percent of that group had already done so.7 On the positive side, DTCA can help patients. In the CMI/Compas Survey, 48 percent of the same physicians agreed (5 percent strongly and 43 percent somewhat) that DTCA educates patients, and 52 percent agreed (9 percent strongly and 43 percent somewhat) that DTCA lessened the stigma of some diseases.8

Dr. Richard Dolinar, an endocri-nologist, says that the ads empower consumers: Direct-to-consumer advertising is getting patients with diabetes into my office sooner so they can be treated.9

Professor

Dhaval Dave of Bentley University conducted a study for the National Bureau of Economic Research (NBER) and found that advertising directed at consumers can expand the total market for drug treatment by educating consum-ers with regard to treatment options for their symptoms, by facilitating contact between the patient and the physicians, and by reminding patients who already have prescribed medications to adhere to their drug therapy.10 With strong arguments for and against DTCA, many people find their opinions evolving. John LaMattina, the former president of Pfizer Global Research and Development, is an expert on the pharmaceutical indus-try. In a Forbes article titled Maybe Its Time for Drug Companies to Drop TV Ads, he questioned whether the negatives of DTCA are starting to outweigh the benefits.11 He was an early supporter of DTCA based on its educa-tion value for the consumer and he still believes that some benefits remain; however, he now thinks that the ads are having too many negative effects due to industry missteps. For example, some of the commercials are not age appro-priate for children and so are subject to tighter industry standards.12

Researchers Denis Arnold and James Oakley

found that, over a four-year period, five major pharmaceu-tical companies violated industry standards in their mar-keting of erectile dysfunction drugs, leading to children being exposed to sexually themed advertising more than one billion times.13

Another issue LaMattina raised is that

the endless listing of negative side effects creates problems. He quotes Elizabeth Rosenthals New York Times article:14 When the Food and Drug Administration in the 1990s first mandated that drug makers list medicines side effects in order to advertise prescription drugs, there

was a firestorm of protest from the industry. Now the litany of side effects that follows every promotion is so mind-numbingdrowsiness, insomnia, loss of appe-tite, weight gainas to make the message meaningless.

It seems that the message is that the potential benefits of DTCA must be balanced with the potential for harms. In fact, this is what a recent literature review of studies on DTCA concluded.15

The review showed that the benefits

of exposure to DTCA include patients enhanced infor-mation-seeking, increased patient requests for appropriate prescriptions, and patients perceptions of higher-quality interactions with prescribers. Harms of DTCA, however, included patients receiving drug prescriptions that were not appropriate for them or that the patients did not need, and the potential for DTCA to interfere with medical adherence in some populations, such as those with mental illness.16

Questions for Discussion

1. What are the ethical issues related to DTCA?

2. Should DTCA be judged by the same criteria as other advertising? If not, how should it be judged differently?

3. What public policy changes would you advocate regarding DTCA? Should the United States and New Zealand ban them? Should the United Kingdom and the European Union (EU) allow them?

4. How will changes in technology and viewing habits change the DTCA issue?