"The code is more what you'd call 'guidelines' than actual rules," quipped actor Geoffrey Rush in the 2003 blockbuster, "Pirates of the Caribbean," referring to an oft-broken and morally flexible 'code'. But the same could just as easily be said about the pharmaceutical industry's own code governing direct-to-consumer (DTC) advertising, claims a new study published in the Journal of Health Politics, Policy and Law.
While pharmaceutical advertising now seems relatively normal, if not ubiquitous, in the US, it hasn't always been that way. In 1997, the US Food and Drug Administration (FDA) eased a decades-long restriction on marketing, allowing companies once again to reach the public. But that newfound freedom came with a catch in the form of the "fair balance" standard. Companies could market the products, but would have to devote equal time to both the benefits and the risks associated with the drug.
But another set of guidelines came into effect a few years later-a voluntary set born out of a growing perception that companies had a responsibility to market their products responsibly, and to a higher standard than is set by FDA. The primary guideline used is PhRMA's "Guiding Principles," a set of 18 principles that the trade group said should guide all advertising aimed at consumers.
Among them: respect for the seriousness of the condition, accuracy of the advertising, fostering responsible communications between patient and provider, making FDA aware of all advertisements before publication, the availability of other treatment options, a clear association of the product with the condition to as to reduce off-label implications, and appropriate for the age the advertisement is likely to be seen by.
Signatories to the code are required to self-certify that they are in compliance with the guidelines, and PhRMA maintains an office of compliance that investigates allegations of deficient advertising practices by its members and is capable of punitive actions.
But Are They Effective?
These principles were seen by some as an effort to stave off potentially more restrictive regulations on the part of FDA, including study authors Denis Arnold and Jim Oakley of UNC Charlotte and Montana State University.
"If pharmaceutical companies are not adhering to principles that they themselves developed and promulgated in conjunction with PhRMA, then governmental regulation may turn out to be a more suitable response to criticisms of pharmaceutical advertising than industry self-policing," they wrote.
The authors go on to say that, in their view, the principles are more to "reduce reputational risk and potential sanctions." Without any external oversight or meaningful sanctions, they added, self-regulation is nothing if not "unreliable."
But for Arnold and Oakley, these points raise a testable question: Are the guidelines actually effective?
Arnold and Oakley assessed the principles' effectiveness by looking at all DTC regulations for one type of advertisement almost anyone who has ever watched television is likely to be familiar with: erectile dysfunction advertisements for Viagra, Cialis and Levitra.
Between 2006 and 2010-the timeframe of the study-the sponsors of the three products collectively spent more than $1.4 billion on DTC advertising, the vast majority of which ($1.1 billion) went toward television advertisements.
But why study erectile dysfunction? Principle 16 of PhRMA's guideline explains that advertisements "should be targeted to avoid audiences that are not age appropriate for the message involved." In other words, an advertisement for Viagra would run afoul of this principle if it were to be aired during a show targeted to young children.
The researchers saw this as one area in which the principle could be empirically evaluated, particularly given the enormous amount of advertising conducted in the area relative to other products, such as sexually transmitted disease therapies.
Ads Viewed 102 Billion Times-by Children
The five marketers of erectile dysfunction therapies-Pfizer, Eli Lilly, Bayer, GlaxoSmithKline and Merck-were confirmed by the authors as being "signatory companies" to PhRMA's guiding principles.
In all, the authors looked at a total of 24 commercials and 17 different print advertisements, which were then cross-referenced to Nielsen monitoring data to determine whether they ran during time slots where they could be considered violative of PhRMA's guidelines.
Under PhRMA's guidelines, at least 90% of the audience should be 18 or older if the erectile dysfunction advertisement is to be properly targeted.
Arnold and Oakley, however, found widespread violations of this practice. Through 2009, most companies were at least making a reasonable effort to prevent their advertisements from being seen by those under the age of 18, with between 80% and 95% of all ads being proper.
But in Q1 2009, violation rates began to skyrocket, led by aggressive marketing by Viagra the quarter before. Soon, violations for Cialis exceeded 70%, and 60% for both Levitra and Cialis, and remained elevated through the end of 2009.
"We estimate that Viagra commercials were viewed by children approximately 30 billion times, Cialis approximately 38 billion times, and Levitra approximately 34 billion times during the four-year period we studied," the authors wrote-102 billion times in all.
The authors said that despite their repeated attempts to contact PhRMA's reporting hotline, their efforts were rebuffed and they either failed to get through (10/11 attempts to send a facsimile failed, by their account) or never received a response (multiple confirmed-receipt letters).
A response from PhRMA was not available at the time of publication.
To Arnold and Oakley, the findings of the study are indicative of a larger problem.
"Pharmaceutical industry self-regulation has the potential to enhance public health via public health education while reducing transactions costs for individual companies," the authors write. "While current industry guidelines on DTCA may be imperfect, if the guidelines were consistently followed by signatory companies, they have the potential to better balance these competing interests."
At present, they argue, pharmaceutical companies' engagement in this scheme only serves to "block" other forms of regulation that would otherwise shield the public from these improper advertisements, to say nothing of allowing parents to avoid countless awkward conversations.
The authors go on to recommend that PhRMA or other regulatory bodies-the US Food and Drug Administration, even-move toward a more robust system with some degree of accountability for participants, which they say would promote higher degrees of compliance.