News roundup

FDA investigates direct to consumer adverts

New York Jeanne Lenzer

Testimony on direct to consumer advertising in hearings held last week by the US Food and Drug Administration was widely divergent. Consumer advocates blasted prescription drug adverts as misleading while industry representatives said that they educate the public.

Two days before the hearings, Rachel Behrman, deputy director of the agency’s Center for Drug Evaluation and Research, told the US Senate’s Special Committee on Aging that the agency believes that, “. . . done properly, prescription drug advertising can assist consumers in taking a proactive role in improving their health.”

Drug companies spent $4.1bn (£2.4bn; €3.5bn) on consumer advertising in 2004 in the US, the only nation that allows such adverts since New Zealand declared a moratorium on drug adverts from December 2004.

The FDA’s requests for public comment were focused on managing—not banning—advertising. Nonetheless, more than 200 medical professors signed a petition asking the FDA to ban the advertising, calling it misleading and “not educational” (BMJ 2005;331:1040, 5 Nov).

Mark Tosh, managing editor of DTC Perspectives, published by a consulting company that specialises in consumer marketing of pharmaceuticals, based in Florham Park, New Jersey, dismissed the doctors’ claim, saying that surveys in the past eight to nine years by Prevention Magazine provide “a lot of data saying [that consumer advertising] drives people to their doctors.”

Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, a trade group representing the industry, issued a news release on the second day of the hearings: “The educational value of [consumer] advertising is particularly important to address under-diagnosis and under-treatment of major medical conditions such as asthma, cerebral vascular disease, diabetes, and hypertension.”

The association has developed a set of voluntary guidelines to encourage accuracy and balance in advertising. But, in an earlier interview with the trade magazine Mediaweek, Mr Tauzin denounced any move to ban adverts as a “human rights abuse.” His comment refers to the legal concept in the US that corporations have the rights of humans—including “free speech.”

Peter Lurie, deputy director of Public Citizen’s Health Research Group, a non-profit making public interest organisation based in Washington, DC, wrote in his submission that misleading advertising contributed to the estimated 140 000 “serious cardiovascular events due to Vioxx [rofecoxib] alone.” He said that consumer adverts for Vioxx, totalling $160m in 2000—more than was spent promoting Pepsi or Budweiser beer that same year—contributed to the irrational use of Vioxx. Two thirds of the growth in the use of cyclo-oxygenase-2 inhibitors between 1999 and 2000 was among patients for whom the drug was unnecessary, he said.

In response to industry’s claim that adverts “educate” the public, Dr Lurie said, “It strains credulity to believe that the best way to educate patients about drugs is through the ads of a self interested industry.” Dr Lurie called on federal agencies to provide consumer medication guides.

Alex Sugerman-Brozan, attorney and director of Prescription Access Litigation, a Boston based coalition of more than 115 organisations that seek quality and affordable healthcare for all, said that consumer adverts interfere with the doctor-patient relationship. He submitted a picture of an advert for the acne drug, adapalene (Differin). The advertisement targets teens, offering them “three levels of cool” defined as three levels of free music downloads if they sign up, obtain, and refill a Differin prescription. Mr Sugerman-Brozan called for the prohibition of ads that offer free or discounted goods.

Mr Sugerman-Brozan also called for the FDA to step up enforcement, for Congress to allow the FDA to impose civil monetary penalties on violators and for the FDA to require full disclosure of risks in broadcast ads, not just a summary as has been permitted since 1997.

The American Medical Association rejected a proposal earlier this year to ban consumer adverts (BMJ 2005;331:7, 2 Jul).