Pharmaceuticals have become one of the largest and fastest-growing advertising categories in the U.S., accounting for around $2.8 billion in 2000 and over $4.2 billion in 2005.
In February, Pfizer voluntarily withdrew the direct-to-consumer (DTC) drug advertising featuring Robert Jarvik, best known for his work on the artificial heart, amidt negative media coverage and a congressional committee investigation. The main criticism stemmed from the fact that Jarvik is not a licensed physician or cardiologist, yet the ad implies that he is.
The essential question about DTC advertising is whether it is a positive force that can help inform and educate consumers about treatment options and provide guidance on medical treatment for undiagnosed conditions or is it a negative force that drives up drug costs and leads to a medicalization mentality among Americans who then expect a pill will fix anything?
Supporters of DTC feel it can alleviate long-term problems and healthcare costs by helping patients become more knowledgeable about illnesses and drugs and also increase compliance. Detractors contend that advertising is an overtly persuasive form of communication that is ill-suited to educate consumers and that it targets vulnerable consumers with emotional rather than rational information. Also, they claim that DTC drug ads fail to present balanced information on the safety and effectiveness of the products.
The FDA’s 1997 Draft Guidance allowed drug companies to run DTC ads in broadcast media without a brief summary, provided they fulfilled the following requirements. The ad must have adequate provisions for the dissemination of approved package labeling (e.g., website); not be false or misleading in any respect; present a balance between information about effectiveness and information about risk; include a detailed statement conveying all the product’s most important risk information in consumer-friendly language; and include all information relevant to the product’s indication (including limitations to use) in consumer-friendly language.
In the summer of 2003, I conducted a content analysis of DTC TV ads at the University of Georgia along with co-authors at other educational institutions. We taped 156 hours of programming, which yielded a sample of 106 ads. Our goal was to better understand the content of DTC ads and add to the knowledge about the rational or emotional nature of the appeals and the ability of these ads to comply with FDA guidelines regarding fair balance and adequate provision.
Testing Fair Balance
It is difficult to empirically test if a DTC ad meets the FDA’s definition of fair balance, because the agency does not state specific requirements. However, our study collected several pieces of data and developed a four-level classification scheme that sheds new light on how well DTC TV ads might or might not be meeting FDA guidelines.
1. Lawbreakers are those ads that do not meet the fair balance requirement. No side effects are listed if benefits were included.
2. Bare minimum will potentially not raise too many flags with FDA. Some side effects are listed, but less than 10% of ad time is given to risk information.
3. Main pack includes one or more features that increase the visibility of risk and more than 10% of ad time is risk information.
4. Proactive is the safety-oriented approach, first used by Johnson & Johnson in 2005, which presents risk and benefit information using similar creative executions. The proactive group was not expected nor explicitly coded because the issue developed after this study’s sample was selected and coded.
Rational appeals were used almost 60% of the time versus emotional appeals (40%). While critics have expressed concerns about the overuse of emotional appeals in DTC ads, it should be noted that most DTC-TV ads in the sample used a combination of rational and emotional appeals, rather than just one appeal to the exclusion of the other.
Regarding the presentation of risk information, the average 60-second DTC-TV spot contains less than eight seconds devoted to disclaimers (13% of the total ad time), and 30-second ads had 4.4 seconds of side effects disclaimers (15% of total ad time). Using our classification scheme, there were two lawbreakers (1.9%), 11 bare minimums (10.3%), 93 were in the DTC main pack (87.7%), and no ads in the proactive group.
Is DTC advertising a beneficial source of educational information for consumers or the evil drug-pushing force often portrayed by Congress and the media? As with most questions like this I would say the answer probably lies somewhere in the middle. I personally think that DTC ads could be more responsible and creative.
Pharmaceutical companies and their advertising agencies need to take the time to figure out how to convey information in a way that resonates with the consumer and what is important in his/her life.