A new study published in Annals of Internal Medicine has shown that adding a simple fact box to adverts for prescription drugs considerably improves consumer awareness of the risks and benefits of the medication. In this study, people who examined an advert with a drug fact box were more likely to choose the most efficacious drug than were participants who assessed an advert with an in-depth summary of the drug characteristics.
The FDA requires that direct-to-consumer adverts include a ‘brief summary’ of all the risks listed in the drug’s FDA-approved prescribing information. This summary can amount to more than a page of dense text, however, and although companies are supposed to use easy-to-understand language, the text can seem pretty impenetrable. Writing of the current system, the study authors Schwartz et al. say that “the U.S. public currently lacks accessible and accurate information about prescription drug efficacy and side effects. Instead, people are exposed to billions of dollars in marketing designed to generate enthusiasm for new products, leaving them vulnerable to persuasive marketing techniques and selective presentations of information”.
Schwartz et al. assessed whether using a ‘drug facts box’ – a 1-page round-up of a drug’s benefits and side effects, with key information on the chance of various outcomes provided in a table – improved knowledge of the risks and benefits associated with a medication and helped patients make informed treatment choices.
This study was split into two randomised trials that assessed two types of fact box: one box on how a drug treats current symptoms and one on how a drug prevents the onset of symptoms.
In the symptom drug box trial, the authors tested adverts for a fake proton-pump inhibitor (PPI) – Maxtor – and an imaginary histamine-2 (H2) blocker – Amcid. These two types of drug are used to treat symptoms of heartburn and have similar adverse effects, but clinical data show that PPIs clearly outperform H2 blockers. All 231 participants received the same ‘ad image page’ (the colorful front page) and then also received either the symptom fact box (drug box group) or a brief summary (control group).
In the prevention drug box trial, the authors used adverts for a statin – Concor – and clopidogrel – Pridclo – for prevention of future cardiovascular events. Such events are relatively rare, so the drugs have small absolute effects and are, therefore, not appropriate for many individuals. The 219 study participants were randomly assigned to receive either adverts with a brief summary or adverts with a drug box.
In the symptom drug box trial, more participants in the drug box group than in the control group were able to accurately recount the risks of the two heartburn drugs. In addition, the perceptions of individuals in the drug box group more accurately reflected the actual efficacy of the drugs. When asked which drug they would prefer to take, 68% of the drug box group chose the PPI – objectively the more effective drug – compared with 31% of the control group.
Participants in the prevention drug box trial who received the drug box adverts were more likely to understand the side effects of the two drugs. Also, most of the patients in the drug box group were able to accurately quantify the small reduction in the risk of cardiovascular events provided by the two drugs, whereas more than half of the participants in the control group overestimated the benefits of the drugs by a factor of 10 or more. Individuals in the drug box group were, therefore, more likely to conclude than the side effects associated with the drugs outweighed the small benefits provided.
The authors write: “Some may wonder whether we simply proved the obvious: one group was provided with the ‘right answers’, whereas the other was not. However, that is precisely the goal of the drug box—it provides the data needed to make informed decisions. Without these data, people can only guess, and their guesses are most likely based on the information that appears in the ads.”
Schwartz LM et al. (2009) Communicating Drug Benefits and Harms With a Drug Facts Box: Two Randomized Trials. Ann Intern Med Early-release article: 17 February 2009