Questionable Impotence Ads Gain FDA Attention

Questionable Impotence Ads Gain FDA Attention

February 20th, 2013 // 5:24 pm @


Several years ago, the drugmakers that sell impotence pills convinced Congress that federal regulations were not required to ensure objectionable ads would not be seen by children. However, a new study charges that industry efforts to regulate direct-to-consumer advertising have been a “ruse” designed to deflect criticism and block Congress from intervening.

From 2006 to 2010, when DTC advertising for erectile dysfunction pills rose 62 percent, to $324.3 million, the study found a “consistent pattern” in which drugmakers failed to comply with so-called guiding principles that were propagated by the Pharmaceutical Research & Manufacturers of America, the industry trade group.

Originally, PhRMA instituted 15 principles for DTC advertising in 2006, but the list was revised and expanded three years later. The principles cover accuracy; patient education; readability; availability of treatment options; assistance for uninsured or underinsured patients, and avoiding audiences for which messages may be inappropriate, among other things (here are the principles).

Both times, PhRMA cited its principles as reasons that Congress should not pass a law that would have restricted the time of day that TV ads for impotence pills could be aired. Instead, drugmakers convinced lawmakers such a move would be unnecessary because they complied with industry principles which, after the revision, said that at least 90 percent of the audience for the ads would be 18 years or older.

But the study says that did not happen. Instead, consumers were exposed to approximately 500 billion TV ad impressions for impotence pills since 2006, and more than 100 billion were seen by children – those under the age of 18, which violated the Guiding Principles. And the study found the 90 percent goal was not met for any quarter during the years that TV ad materials were studied.

Specifically, the researchers found that ads for Cialis, which is sold by Eli Lilly (LLY), consistently violated six principles, partially complied with two principles and fully complied with one principle. And Pfizer’s Viagra DTC campaign consistently violated five principles, partially complied with one principle and fully complied with two principles.

Similarly, GlaxoSmithKline’s Levitra ads consistently violated five principles, partially complied with three principles and fully complied with one principle. Merck (MRK) and Bayer Healthcare also market Levitra but in other countries, and the study focused on US DTC advertising. Glaxo (GSK) is responsible for Levitra marketing in the US.

The researchers found that, at no point, did the drugs comply with the guideline at a rate better than 50 percent for the total category. Cialis was the most consistently compliant, with violation rates ranging from 33.7 percent to 55.7 percent. Viagra’s violation rate ranged from 56.9 percent to 64.4 percent, and Levitra ranged from 56.6 percent to 72.2 percent.

Here is the study.

“Our conclusions provide evidence to support the idea that self-regulation can be utilized as a way to prevent new governmental regulations while allowing companies to engage in practices consonant with their independent strategic aims through a collective blocking strategy,” write the researchers in the Journal of Health Politics, Policy and Law.

“Cumulatively, our data shows that ED marketing campaigns fail to responsibly educate consumers about health conditions and appropriate treatments,” says lead author Denis Arnold, an associate professor of management and Surtman Distinguished Scholar in business ethics in the Belk College of Business at UNC Charlotte, in a statement.

“Instead of facilitating a balancing of interests between company profits and public health, the illusion of industry self-regulation is primarily serving the interest of pharmaceutical companies at the expense of the public’s interest in genuine health education and welfare.” And the study notes that PhRMA has played the role of facilitator. (We should note that the researchers examined nine of the 18 principles, since they believed they could not independently verify all of them).

What to do? The researchers suggest more regulation is in order. These might include restrictions on ads that can reach children; requiring ads to address treatment options other than medicines along with comparative costs; requiring FDA approval of ads before being broadcast for the first time, and assessing fees for each ad that is broadcast, which would provide funding for the National Library of Medicine to distribute simple information about benefits, harms and costs.

We asked the drugmakers and PhRMA for responses and will update you accordingly. Meanwhile, a Lilly spokeswoman sent us this: “We’re actually looking into this study and checking with our media buyers regarding the violations mentioned in the article. Lilly takes this very seriously. The main goal of all of our direct-to-consumer ads is to educate and inform, and we have been able to do that in a responsible and thoughtful way with the Cialis ads through the years. As with all of our direct-to-consumer materials, these commercials are straightforward and sincere and the content is open and honest about ED, which is in line with our corporate brand. Also, the ads provide men with important benefit and risk information, consistent with FDA guidelines, allowing men to make a decision about whether to consult with their physician about Cialis.”

And Pfizer sent us this: “We have not reviewed the analysis, but we take great care in choosing when and where we advertise because we want the right message to reach the right person at the right time. Viagra ads air only during programs that have greater than 90 percent adult viewership. We believe that both healthcare providers and patients need information about the benefits and risks of available treatment options. We believe it is our responsibility to communicate clear information about medical conditions and treatments so patients can work with their healthcare professionals to make informed decisions about their health and get appropriate prevention, diagnosis, treatment and wellness information. DTC advertising is one way of communicating information to patients.”

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