Healthy Skepticism Library item: 11237

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: media release

NEJM Direct-to-Consumer Ad Study Shows Drug Industry Incapable of Self-Regulation
AIDS Healthcare Foundation (US) 2007 Aug 16
http://www.aidshealth.org/index.php?option=com_content&task=view&id=1130&Itemid=193

Full text:

AIDS Healthcare Foundation-Critical of Drug Ads Including Pfizer’s Latest ‘Viva Viagra’ Campaign-Calls on FDA to Increase Oversight of Out-of-Control Drug Industry to Rein In Skyrocketing Healthcare Costs and to Protect the Public’s Health

Los Angeles, CA, August 15, 2007-AIDS Healthcare Foundation (AHF), the US’ largest HIV/AIDS healthcare provider, once again denounced direct-to-consumer (DTC) advertising by the pharmaceutical industry after an article published in the New England Journal of Medicine revealed not only an astronomical 330% increase in spending on drug ads over the past ten years ($11.4B up to $29.9B), but also the fact that-despite the industry’s own recommendation to delay ads for new drugs-most drug company ad campaigns for the most heavily promoted drugs begin within a year after FDA approval. “A Decade of Direct-to-Consumer Advertising of Prescription Drugs,” (NEJM, August 16, 2007, Julia M. Donohue, Ph.D., Marisa Cevasco, B.A., and Meredith B. Rosenthal, Ph.D.) also concludes that despite the more than tripling of DTC ad spending, regulation of the industry by the U.S. Food and Drug Administration (FDA) has grown weaker, instead of stronger. This, despite the fact that the drug industry and the FDA have come under fire over major missteps such as the Vioxx debacle and others in which heavily advertised drugs have turned out to have serious, unknown health risks.

“When it comes to direct-to-consumer advertising of pharmaceuticals, AHF believes that the only ads that are truly useful to consumers without carrying potential for harm are ‘help-seeking’ ads-ads that educate the public about a specific medical condition for which treatment is available, without highlighting a specific drug or brand,” said Dr. Homayoon Khanlou, AIDS Healthcare Foundation’s Chief of Medicine, U.S. “Patients are strongly influenced by advertising and often come in to a doctor’s office asking for a drug that may or may not not be right for them. The increased advertising referred to in the New England Journal of Medicine article interferes in the relationship between doctor and patient. Particularly after the Vioxx scandal, the FDA should be doing more to protect the public from the potential overuse-and potential harm-that could result from heavily promoting new drugs.”

AIDS Healthcare Foundation has long been against direct-to-consumer advertising of prescription drugs believing that not only does it improperly interfere with the doctor-patient relationship, but also that such advertising contributes to skyrocketing healthcare costs and poses a serious risk to public health and safety. AHF’s most recent campaign targets Pfizer Inc., the world’s largest drug company, for its marketing of Viagra, pointing to recent marketing campaigns such as a series of holiday-themed print ads and, most recently, the ‘Viva Viagra’ campaign which, they say, promote unsafe sex by marketing the drug as a ‘party drug’ encouraging its recreational use. The NEJM article concludes that most DTC spending is focused on a small number of “blockbuster” drugs used to treat chronic conditions. The article lists Viagra among the top twenty most heavily advertised pharmaceutical products with $80 million spent in 2005.

“The advertising for Viagra is so successful, it has become a household name. Commercials such as the recent ‘Viva Viagra’ ads, which associate Viagra with the party image of Las Vegas, normalize the drug to such a degree that it is no longer seen as a treatment for a medical condition. Unfortunately, physicians like myself continue to see an increase in the use of Viagra in conjunction with recreational drugs such as crystal meth, particularly among men who have sex with men. The use of this dangerous cocktail is a significant contributing factor to increases we are seeing in sexually transmitted diseases, such as syphilis and HIV,” added Dr. Khanlou. “Again, where is the FDA?”

Despite the major increase in drug industry spending on DTC, the number of regulatory actions taken by the FDA in the past ten years has decreased dramatically. According to the study, “A second indication of weakening FDA oversight of direct-to-consumer advertising in recent years is that the number of staff members who are dedicated to reviewing advertisements has remained relatively stable, whereas the use of such advertising has grown substantially. In 2002, three FDA staff members were dedicated to reviewing direct-to-consumer advertisements. In 2004, four staffers were reviewing such advertisements, even though spending on this form of advertising (and probably the volume of ads to review) had increased by 45%, from $2.9 billion to $4.2 billion.”

“Four FDA staff members to review thousands upon thousands of drug ads is irresponsible,” said Timothy Boyd, AHF’s Policy Research Coordinator. “This study makes clear that without action from the FDA the drug industry is incapable of self-regulation. AHF has repeatedly communicated with the FDA urging the government body to step up its regulatory role in drug industry advertising-to no avail. Once again, we ask the FDA to step up its oversight of drug marketing. It is the public’s health that’s at stake.”

The article goes on to conclude that despite a recent study of drug safety by the Institute of Medicine, as well as a recommendation from the industry trade and lobbying group, PhRMA, that advertising for new drugs should be delayed, “Our data show that a mandatory waiting period on advertising for new drugs would represent a dramatic departure from current industry practices.”

AIDS Healthcare Foundation (AHF) is the nation’s largest oldest and largest non-profit HIV/AIDS healthcare, research, prevention and education provider, currently providing medical care, including lifesaving treatment and services, to more than 50,000 individuals in 15 countries worldwide in the US, Africa, Latin America/Caribbean and Asia. www.aidshealth.org.