FDA to study TV drug ads' influence on U.S. consumers

Controversial since they debuted in 1997, DTC ads are thought by many to require more oversight.

By Susan J. Landers — Posted Feb. 2, 2009

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Are direct-to-consumer television ads the best way for consumers to absorb information? Maybe TV viewers don't even hear the laundry lists of potential side effects. Perhaps they are distracted by the accompanying scenes of happy people doing fun things or snoozing contentedly.

The Food and Drug Administration has outlined a novel study designed to measure participants' recall and comprehension of risk and benefit information in television ads.

The agency will produce ads for a fictitious blood pressure medication and recruit 2,400 participants to view them and report on the messages they take away. The study design was announced in the Dec. 30, 2008, Federal Register, and the agency is gathering comments until Jan. 29. The FDA's intention to conduct the study was first announced in 2007.

The action is expected to provide preliminary data on how the agency might set standards for DTC ads that conform to those called for by Congress, said Kathryn Aikin, PhD, social science analyst in the agency's Division of Drug Marketing, Advertising and Communications. "The data should help us plan whether additional research is needed to develop the standards called for in the FDA Amendments Act of 2007."

DTC advertisements have prompted debate among physicians and others ever since 1997, when they were first allowed on the airways and in print. Some find the ads raise legitimate issues about diseases and conditions. Many others, though, would like them to just go away for several reasons -- for instance, the time physicians and patients waste talking about unneeded medications during office visits.

A major objection to the ads centers on how information is presented. "Direct-to-consumer ads often portray drugs through rose-colored glasses by including more information about a drug's benefits than risks," AMA President Nancy H. Nielsen, MD, PhD, told a congressional oversight committee in May, 2008. "Imbalances in these ads can diminish patient understanding of certain drug risks and increase the need for an ongoing dialogue between patients and physicians about the benefits and risks of prescription drugs."

The American Medical Association developed a set of recommendations to ensure that ads provide a service to patients and physicians by providing objective benefit and risk information. The AMA also would like the FDA to review and preapprove the ads before they appear on TV and in magazines, and also would prefer that the ads not appear until physicians have been educated about the product.

A step toward improved regulations?

The AMA commended the FDA on its plan to conduct the study when the agency announced its 2007 proposal. "We agree with the agency that the results of this study should help improve how television advertisements present a drug's risks and benefits," wrote Michael D. Maves, MD, MBA, the Association's executive vice president and chief executive officer. "The AMA looks forward to the completion of this important study and, as necessary, the translation of its results into more effective DTC regulations."

Another big player in the TV ads debate is the Pharmaceutical Research and Manufacturers of America, which represents large drug and device manufacturers. A PhRMA spokesperson indicated that the proposal was still being considered for comment as of late January.

Several experts, however, wonder whether the study is worthwhile -- especially given the scarcity of funds in the federal budget.

The FDA is missing the fundamental question, said Steven Woloshin, MD, associate professor of medicine at the Dartmouth (N.H.) Institute for Health Policy and Clinical Practice. He described the issue this way: "Do patients understand how well the drugs work and do the ads help them have a better understanding?" He conducts research on enhancing the quality of medical communications.

"Given the scarce resources, is this the best way for [the agency] to be spending its money?" asked Peter Lurie, MD, MPH, deputy director of the Health Research Group at Public Citizen, a nonprofit consumer advocacy group in Washington, D.C.

"The questions are certainly interesting and the methodology thought-provoking, but ... in terms of enforcement, I'm not sure how much it will help," he said. Dr. Lurie has testified before Congress that the federal government should do more to stop misleading ads from reaching consumers.

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Boxes deliver drug facts in comprehendible way

When it comes to a convenient and understandable way to convey drug risk and benefit information to consumers, Steven Woloshin, MD, associate professor of medicine at the Dartmouth (N.H.) Institute for Health Policy and Clinical Practice, and his colleagues believe they have an answer. They have developed and tested a "drugs fact box," which conveys that data.

The boxes provide information on what the drug is for, who might consider taking it and who should not take it. In addition, they include recommended testing -- for example, a yearly checkup or blood test, and other steps patients should consider taking regarding the drug's particular indication. The boxes also relate highlights of study findings that include whether the drug helped, common side effects and other important things to know.

When consumers were shown the boxes in a trial, they had an "overwhelmingly positive reaction," Dr. Woloshin said. "People were hungry for this." Studies on the drug facts boxes have been published in the April 2004 Health Affairs and in the Oct. 2007 Medical Decision Making.

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External links

"Docket No. FDA-2007-N-0451, Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Broadcast Advertisements," Federal Register, Dec. 30, 2008 (link)

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