Part 3 of a series.  Please read part 1, DTC advertising, and its history with the FDA, and part 2, Economic and commercial impact of DTC advertising.

In the first two parts of this article, we explored the historical and legal contexts of direct-to-consumer (DTC) advertising, the effects of these ads on prescribing behavior, and the economic incentives to advertise.

In this final installment, we will examine what patients and physicians really think about these ads and offer one possible way to minimize the potentially harmful effects of DTC advertising.

Perceptions about DTC Advertising

Patient perceptions about DTC advertising are dynamic and have become less favorable over time. The FDA carried out a series of surveys in 1999 and 2002 to determine what patients thought about consumer advertising. In both years, the agency interviewed more than 900 patients. Overwhelmingly, in both surveys the most common source of DTC advertising was television (>90%). Over the course of three years, patients’ attitudes about DTC became less positive. The percentage of patients who said that they liked seeing prescription drug advertisements fell from 52% in 1999 to 32% in 2002. Also, the percentage of patients who thought that advertisements helped them to make better decisions about their health fell from 47% to 32%. And finally, when asked if advertisements helped them to have better discussions with their doctors, 62% of patients agreed in 1999 compared to 43% in 2002. The lobbying group, Pharmaceutical Research and Manufacturers of America (PhRMA), claims that its ads are beneficial because they help patients to make better healthcare decisions. However, given these survey results, this does not appear to be true.

The FDA results are not unique. Another survey study from Colorado in 2004 also examined patients’ and physicians’ opinions about DTC advertising. In their study, only 29% of patients felt that DTC advertising was a positive trend in healthcare. Furthermore, only a fraction of consumers (28.6%) felt that DTC ads made them better informed about their health. Of note, these patient surveys were conducted during and immediately after the Vioxx scandal. A more recent survey is needed to see if these attitudes have held up over time.

Physicians had more mixed views about DTC advertising. Whereas 29% of patients thought DTC ads were a positive trend, only 9.8% of physicians agreed. Despite this negative opinion, data from the FDA physician survey in 2002 showed that physicians actually thought that DTC ads improved the clinical encounter. Half of the surveyed physicians (53%) felt that these ads allowed them to have better discussions with their patients. Also, 73% thought that patients who had seen these ads asked more thoughtful questions, and 45% felt that the time they spent with their patients was used more effectively as opposed to 35% who disagreed. The discrepancy between patient and physician perceptions about the utility of these ads demonstrates that there is a fundamental gap between what patients want and what they actually receive in the clinical encounter. Given the mixed results from these survey studies, it remains unclear how much impact, if any, these advertisements actually have on the doctor-patient relationship and effective clinical decision-making.

“Advertising is information”: Pros and cons of DTC advertising

DTC advertising is inherently controversial, with business interests on one side and consumer groups and physicians cautiously on the other. DTC ads do make patients more aware of available treatments and may indeed improve communication between patients and doctors. On the other hand, though, these ads do cause an increase in prescription writing that may or may not be beneficial, do not fully illustrate the risks alongside the benefits, and may confuse patients about what are acceptable standards of care.

On the eve of the FDA’s remarkable reversal to allow broadcast DTC ads in 1997, Nancy Buc, a spokeswoman for Wyeth-Ayerst Laboratories (makers of Zosyn, Protonix, and Ativan) was quoted as saying, “Advertising is information.” Is this information educational and valuable? PhRMA agrees. In their 2008 press release on the matter, the organization contended that without the “active dissemination of information about medicines to both physicians and consumers,” the gap between necessary care and the care that patients actually received would widen.

So what information are consumers getting from these ads? According to the FDA surveys, not much. When consumers were asked if advertisements provided enough information about risks, only 31% agreed in 1999 and 32% in 2002. Regarding information about benefits, a selling point that one would think would be over-emphasized, only a minority of consumers agreed that DTC ads gave enough (39% in 1999 and 41% in 2002). The paucity of substantive information about drug indications, side effects, duration of treatment, or alternative non-medical therapies is glossed over with images of celebrities, cartoons, and ex-presidents all encouraging us to “talk to our doctors.”

Perhaps the biggest criticism of DTC advertising is that the bulk of these ads air within a year of FDA approval. The approval process, based on small studies involving only hundreds of patients over weeks to months, may not detect infrequent adverse events. However, clinical trials conducted over longer time frames with larger groups of patients are not feasible and are prohibitively expensive. As a result, the FDA relies on post-marketing surveillance to ensure that a drug that was considered safe actually is. Scott Lassman, senior assistant general counsel of PhRMA said that “when a drug is approved, the FDA has already made an assessment that it is safe.”

One only has to look at the Vioxx scandal to see how wrong that statement is. When the FDA approved Vioxx in May 1999, Merck heralded the drug as a godsend for patients with osteoarthritis. Within a year, the $161 million marketing campaign began. However, early in 2000, the results of the VIGOR study (VIoxx GI Outcomes Research) were published, which showed an increase in cardiovascular events associated with Vioxx. Later, in 2001, the APPROVe study (Adenomatous Polyp PRevention On Vioxx) also showed a similar increase in patients taking Vioxx for more than eighteen months. Amidst these two trials were allegations that Merck had intentionally withheld poor outcomes data from the FDA to make the drug appear safer than it really was. In September 2004, Merck voluntarily withdrew the drug. Shortly thereafter, the lawsuits began.

The future of DTC advertising: A way out?

Direct-to-consumer advertising is here to stay and will most likely only increase in the coming years. Advertising has been afforded First Amendment protection under the doctrine of commercial free speech, and there are few in the public or in Congress who are willing to challenge that. Attempts by individual members of Congress, notably Rep. Henry Waxman and Senators Edward Kennedy and Michael Enzi, to give the FDA more regulatory power, have so far been unsuccessful. One potential solution would be a moratorium on advertising for the first few years that a drug is on the market. This would allow time for post-marketing data collection on adverse events before the drug is widely advertised to the public. There is support for this idea, both in the federal government and in industry. However, whereas the FDA would prefer a two-year limit, individual pharmaceutical companies are asking for only six months to one year.

The bottom line: drug companies are businesses. They make a product that impacts the health of the consumer and they can charge a premium for that product. We should not expect drug companies to be altruistic in their motives or in their advertising. As a medical profession, we should be wary of exaggerated claims and should place the same amount of scrutiny on ads for prescription drug as we would on any other advertisements. Also, as physicians, we should not be hesitant or annoyed to discuss these ads when patients bring up the topic in our offices. They may have genuine concerns and questions about their health that we should honor. Yes, prescription drug ads are far from perfect, but they can serve a purpose in the larger context of patient education if they are indeed fair, balanced, and honest. Hopefully, DTC advertising will make consumers not just more informed, but better informed.

Ishmael Bradley is a resident physician and Section Editor of Clinical Correlations, where this post originally appeared.

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