A Modest Proposal
How many of you read the printed ingredients and nutrition fact boxes found on packaged foods to help you decide which of two similar products you ought to buy? What if the same concept was applied to direct-to-consumer (DTC) prescription drug ads? Do you think that it would be easier to determine which of two similar medications may be best for you? Well, researchers at Dartmouth Medical School think so! And, they are urging the US Food and Drug administration to adopt a similar concept for all DTC advertising.
Based on results from two randomized, clinical studies, the Dartmouth team proposed that numerical tables that quantify the benefits of a drug (compared with placebo) and also the odds of developing certain side effects should be included on DTC advertisements including television, print and web-based ads. In those studies, patients were shown drug ads that did and did not include a fact box. Participants looked at ads (with and without fact boxes) for two similar prescription heartburn medications and two widely prescribed cardiovascular drugs. The trial using the heartburn medications was designed to evaluate consumer decision-making about drugs that are used to treat symptoms whereas the cardiovascular medications trial was used to evaluate decision-making about the use of preventative medications that reduce the risk of future events, e.g., heartache or stroke.
Overall, the researchers said, the addition of facts boxes to prescription drug ads allowed consumers to make better decisions about the choices of drugs for their symptoms and were better informed about the benefits of drugs that could be used for prevention. For example, when asked which drug they would choose for heartburn 68 percent of those who had seen ads with facts boxes picked what the researchers referred to as "the superior drug," as compared with 31 percent of those who had seen ads without facts boxes. Also, about 80 percent of the facts-box group, as compared with 38 percent from the non-fact-box group, knew that both drugs had similar side effects. After looking at cardiovascular drug ads with or without fact-boxes, 72 percent of those who saw ads with facts boxes correctly described the risk reduction associated with both drugs whereas only 9% of non-fact-box participants were able to do this.
DTC advertising is big business—last year the pharmaceutical industry spent approximately $4.8 billion on television and print ads alone. While DTC advertising is known to influence prescription drug sales, it is also somewhat controversial suggested Dr. David L. Katz, director of the Prevention Research Center at Yale University School of Medicine "Direct-to-consumer drug advertising is controversial in medical circles, largely out of concern that drug companies will talk patients into preferences not in their best interest, "But I often encounter the opposite problem in my patients. After hearing the litany of potential side effects of a drug, they absolutely refuse to take it," Katz said. Nevertheless, he and the Dartmouth researchers agree that better-informed patients make better drug choices.
Drs. Woloshin and Schwartz, leaders of the Dartmouth team, are scheduled to present their findings tomorrow to an FDA advisory panel on “risk communication.” The panel is tasked with examining how best to provide consumers with data about prescription drugs using printed matter.
Adding fact-boxes to print, television or web-based ads won’t substantially increase the cost of creating and producing them. Also, rather than hurt prescription drug sales—what most pharmaceutical companies are worried about—the new approach may be good for the industry. According to Robert Ehrlich, who heads DTC Perspectives, a company that specializes in pharmaceutical marketing, “If there is high benefit and low risk, doctors will prescribe more of the drugs. If there is low benefit and high risks than the drug should probably not be on the market,” said Ehrlich.
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Until next time...
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The newest culprit in the direct-to-consumer (DTC) television ad cat and mouse game between pharmaceutical manufacturers and US regulators is Cordis, a medical device subsidiary of Johnson & Johnson. The ad in question deals with promotion of the use of a 
