The study, funded by the Robert Wood Johnson Foundation and published in the Jan. 29 Annals of Family Medicine, claims the $4.5 billion DTC category produces ads that are more emotional than informational, and may be convincing Americans that they're sicker than they really are.
"We're seeing a dramatization of health problems that many people used to manage without prescription drugs," said the study's lead author, Dominick L. Frosch, assistant professor of general internal medicine and health services research at UCLA. "The DTC ads send the message that you need drugs to manage these problems and that, without medication, your life will be less enjoyable, more painful and maybe even out of control."
In a stunning commentary that accompanied the study, Mr. Kessler and University of California-San Francisco legal professor Douglas A. Levy wrote that the ads do not "effectively or consistently convey important information about product risks and benefits."
Dr. Kessler, now dean of the UCSF School of Medicine, was FDA commissioner under Presidents Bill Clinton and George H.W. Bush. Dr. Kessler was an opponent of DTC advertising during his tenure, but regulations were relaxed and prescription-drug advertising hit TV after he left his post. While a ban on DTC ads is now out of the question, he said, the FDA's regulation of those ads can be stronger and tighter.
"We tend to forget that pharmaceuticals are powerful agents," said Dr. Kessler, a noted ally of Sen. Ted Kennedy, D-Mass., who has the pharmaceutical industry in his crosshairs now that the Democrats have regained control of Congress. "They're not just any commodity, and advertising them based on their emotional appeal is something that has great risks."
'Not intended to be an encyclopedia'
"DTC ads are not intended to be an encyclopedia with all possible information about a product," said Dan Jaffe, exec VP, Association of National Advertisers. "The primary role of DTC advertising is to encourage consumers to discuss health issues with their doctor. There is substantial evidence that this goal is being achieved."
John Kamp, executive director of the Washington-based Coalition for Healthcare Communications, said: "We hope members of Congress read the study and respect its limits more carefully than Kessler and Levy."
The study is billed as the first to analyze the content of DTC ads on TV, assessing both their educational value and the ways in which they attempt to influence consumers. Researchers examined 38 unique TV ads for drugs that address a range of ailments, including erectile-dysfunction drug Cialis, insomnia medication Ambien and allergy drug Allegra, among others.
Using statistical analysis, the study reports that 82% of the ads made "factual claims," but far fewer provided further information about the illnesses such as causes (26%), risk factors (26%) or prevalence (25%).
Ninety-five percent of the ads made "emotional appeals," and 78% implied that use of the medication would result in social approval, the study found.
Sidney Wolfe, director of the Health Research Group at Washington-based advocacy group Public Citizen and an opponent of DTC ads, called the study helpful, adding that he hopes the findings help persuade the FDA to levy heftier fines against pharma companies that run afoul of DTC regulations.
Mr. Kamp said there is no such thing as a perfect or complete communications tool, and that includes DTC marketing. "Although interesting, this study is far from a definitive work and certainly not a basis for more stringent FDA regulation of DTC advertising," he said.