Does Direct-to-Consumer Prescription Drug Advertising Do More Harm Than Good?

IN RESPONSE:

We share Dr. Vitry's concerns about DTCA of prescription drugs: It can generate exaggerated beliefs about drug efficacy and encourage the medicalization of ordinary experiences. The drug facts box directly addresses these concerns by providing balanced data about drug efficacy and harms, and by including a section called “Other things to consider doing,” highlights nondrug treatment options. The Amcid box, for example, suggests dietary changes, such as eating smaller meals or avoiding alcohol before bedtime. Our findings demonstrated that the drug facts box approach worked, even in the presence of advertising images. Enthusiasm for Amcid was much lower in the drug facts box group than in the control group: 16% versus 46% rated Amcid as “extremely” or “very” effective.

We do not agree, however, that drug facts boxes legitimize DTCA of prescription drugs. Instead, drug facts boxes ensure that advertisements have at least some educational value (given that a DTCA ban is unlikely). If boxes were written independently by U.S. Food and Drug Administration (FDA) reviewers using a transparent, reproducible process, consumers and physicians would have ready access to balanced, understandable information about prescription drug performance.

Although we studied the effect of drug facts boxes as a replacement for the current “brief summary” in DTCAs, the boxes could also have an important role outside of advertisements. Boxes serve as a kind of executive summary of the FDA's review documents and thus highlight what the FDA knew at the time of drug approval. Boxes could be posted on the Web sites of the FDA, consumers, the Centers for Medicare & Medicaid Services, and the National Library of Medicine, as well as in medical journals.

Dr. Vitry's last points are about the role of patient values in medical decision making. To decide whether drug benefits outweigh harms, persons need more than facts; they need perspective. Physicians can and should help here. Regarding the drugs in our study, a physician could point out that clopidogrel's minimal effect on a composite outcome is not nearly as important as the statin's reduction in cardiovascular mortality. We hope that the drug facts boxes will enhance meaningful patient–physician discussion and foster shared decision making by making key information about what drugs do—and don't do—accessible.