Information contained in big blocks of fair balance text in DTC ads is lost on consumers, but simplified “facts boxes” fare better, a study found.
One concern stated in the abstract of the study, published online by the Annals of Internal Medicine, was the lack of standardized information about the benefits and harms of drug therapies. “Although [DTC] ads are often justified as serving an educational purpose, they generally fail to provide the most fundamental information consumers need to make informed decisions: data on how well the drug works,” the editors of the study wrote.
"We think DTC ads should tell people how well drugs work, both in terms of benefit and harms," said Steven Woloshin, a co-author of the study.
The study disguised names of drugs and manufacturers to avoid any preconceived notions among participants. In a symptom drug box trial, participants were shown separate versions of a print ad for Maxtor, a proton pump inhibitor, and Amcid, an H2 blocker. For each drug, participants saw either one example of an ad with regular fair balance information, or an example using a drug “facts box” instead. Facts boxes are defined in the study as one page summaries of a drug's benefits and side effects, with the central information provided in a table that shows the chance of various outcomes for people who do and do not take the drug (example here).
In the case of the H2 blocker and PPI, the drug facts box decreased the perceived magnitude of side effects—92% said the side effects were small, compared with 42% of the controlled group. The drug box group's perceptions more accurately reflected the drugs' actual side effect profiles.
In a separate test of the same drugs, participants were asked to report perceived benefits of the products. Only 16% of the drug box group reported perceived benefits of the H2 blocker to be “extremely” or “very” effective, while 46% of the control group said the drug appeared to be extremely or very effective. Conversely, the drug box group more accurately assessed the benefits of the PPI—73% said that drug was extremely or very effective, compared with 53% of the control group. In each case, perceptions among the group viewing a drug facts box were more accurate in evaluating the drugs.
The authors of the study called on FDA staff to implement facts boxes, and to produce and routinely update them internally. “Given its central role in summarizing drug information, the FDA is the most important leverage point in getting balanced drug information to physicians and consumers,” the authors conclude, adding that “billions of dollars in marketing designed to generate enthusiasm for new products [leave consumers] vulnerable to persuasive marketing techniques and selective presentations of information.”
"We are presenting this work at the FDA's risk advisory committee meeting at the end of February," said Woloshin. "We think FDA is open to reformatting [fair balance] information."
Responding to an inquiry about the possible implementation of facts boxes, PhRMA spokesperson Jennifer Wall said: “Consistent with recent DTC guidelines, PhRMA is committed to a fair balance of risk and benefit information in all DTC advertising.”
The study was authored by Lisa Schwartz, Steven Woloshin and Gilbert Welch, all members of the faculty at Dartmouth Medical School.