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18-02-2013 | Article

Industry self-regulation of erectile dysfunction drug ads is dysfunctional

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medwireNews: Pharmaceutical companies' marketing of erectile dysfunction (ED) drugs violates PhRMA Guiding Principles, putting consumers at possible risk while exposing children to inappropriate content, says a study in the Journal of Health Politics, Policy and Law.

The study looked at marketing campaigns for ED drugs sold by Pfizer (sildenafil citrate), Eli Lilly (tadalafil), and Bayer Healthcare, GlaxoSmithKline, and Merck (vardenafil) from 2006 to 2010 and found they violated direct-to-consumer (DTC) advertising rules.

"There is a consistent pattern of noncompliance for each of the three drugs that they are manufacturing and marketing. And it seems to be getting worse," author Denis Arnold (University of North Carolina, Charlotte) said to medwireNews. "That's a pretty strong indication that the industry is not complying with its own standards in [DTC] advertising," which, he added, is at the expense of the public's interest in genuine health education and welfare.

Arnold and co-author Jim Oakley (Montana State University, Bozeman) found that over the 4-year span American consumers were exposed to almost 100,000 television ads for ED, equating to 500 billion total advertising impressions - of which 20% were to those under the age of 18 years and in violation of Guiding Principles.

More than 10% of "adult-themed" ED advertisements reach those under the age of 18 years, which is in violation of the 2009 Families for ED Advertising Decency Act and counter to what chief compliance officers and chief executive officers have stated. "That's a pretty significant level of failure given the executive level of commitment," Arnold observed.

According to the American Academy of Pediatrics, ads for ED drugs "give children and teens inappropriate messages about sex and sexuality."

Other compliance violations involved a failure to provide balanced information to consumers about ED drug risks and to educate about other therapeutic options. "It was quite surprising to us," Arnold said. "Risks and benefits is not just a regulatory guideline, it's a federal one. If health care education is what the industry says it is engaged in, then you need that to be balanced."

The authors propose maintaining a ban on DTC ads that already exists in the European Union while forcing American companies to comply with current rules. They also pose that the FDA approve all advertisements before being broadcast while the National Library of Medicine distribute easily understood information about the benefits, harms, and cost of the drugs that are advertised.

By Peter Sergo, medwireNews Reporter