A study published last week finds that direct-to-consumer (DTC) advertisements on the four major television networks are increasingly emphasizing lifestyle over information.
The findings — published in the May/June issue of the Annals of Family Medicine — raise questions not just about potential conflicts with existing FDA and PhRMA guidelines on such advertising, but also about the potential for misleading information hurting more people.
Andy Lazris, MD
“Direct-to-consumer marketing is a nightmare,” said Andy Lazris, MD. Lazris is an internist and geriatrician in Maryland with a special interest in shared decision-making and risk communication. He believes the ads use imagery and statistics in misleading and potentially harmful ways.
“Everyone on the ads appears healthy, happy, dancing, and they get better. So people are led to believe a) the drug will be effective (which is often not the case), and b) that they should replace their old therapy with the newer one because it’s better (again, which is often not the case).
“And if they give you any numbers at all they’re almost always the deceptive relative numbers that look really good, not the more realistic absolute numbers. So the benefits are over-exaggerated, the harms are downplayed or missed, and that’s how patients can get hurt.”
FDA and PhRMA Guidelines: A tale of two thresholds
The FDA requires all DTC advertising:
- to be accurate and not misleading.
- to reflect balance between harms and benefits.
- to make claims only supported by substantial evidence.
PhRMA (Pharmaceutical Research and Manufacturers of America — the pharmaceutical industry trade group) requires ads to:
- educate patients about treatment options.
- increase awareness about diseases.
- motivate patients to consult their doctors.
- increase likelihood patients will receive appropriate care.
You’ll notice the FDA wording is unambiguous (see words in bold) and geared toward requisite information needed to make an informed choice.
The PhRMA wording (see underlined), on the other hand, is quite ambiguous and open to interpretation. It’s a much lower bar, making it easier to produce an ad and claim it educates, motivates, and increases awareness. Just how, or to what extent, is highly debatable.
Does the study suggest these guidelines are being met?
The study published last week evaluated the content of prescription drug ads aired during primetime over a 13-week period in late 2016. It was able to make rough comparisons with a similar study published in 2004. Here are some of the major findings:
- Portrayals of drugs enhancing lifestyle (or the untreated condition compromising lifestyle) increased.
- Emotionally positive framing of drugs helping people gain control and/or social approval (or the untreated condition leading to the opposite) increased.
- Factual information, biological explanations, and discussions of causes, prevalence or risk factors all decreased.
In the 2004 study, just over half the ads portrayed the advertised drug as enabling healthy lifestyle activities (ie. biking, yoga, going to the farmer’s market, or spending time with family or friends). The 2016 sample found this sort of portrayal had jumped to over two-thirds of ads.
Janelle Applequist, PhD
“The increased emphasis on drug benefits, and the overall reduction in educational content is an important shift,” said co-author Janelle Applequist, PhD, an assistant professor at the University of South Florida whose primary research interest is health communication and advertising in the pharmaceutical industry.
“Especially when you consider that the FDA’s rationale for permitting these ads in the first place has been educational. So the take home message from this study is the greater need for literacy training. It’s up to patients to make themselves aware of the nature of these ads, be proactive in researching the claims, and discuss risks at length with their doctor.”
But another take-home message looms even larger: that the FDA guidelines for DTC advertising are clearly not being met, and it’s quite likely the more lax PhRMA “self-regulatory principles” aren’t being met either.
Applequist points out that several ads for Lyrica, Humira, and Xeljanz rely heavily on before-and-after portrayals in which the before is a “gloomy and negative depiction” prior to the treatment, contrasted with a “happier and more fulfilling life” after the treatment.
This Lyrica ad is a good example. As you watch it, ask yourself if it meets the FDA criteria for backing up claims of benefit with evidence, portraying harms vs. benefits in a balanced way, and being more accurate than misleading.
[embedded content]
Although some might argue that nearly half the one-minute commercial is dedicated to a listing of side effects and cautions — and that this should fulfill the FDA’s call for accuracy and mentioning harms — this stands in stark contrast to the complete lack of evidence to support the touted benefits.
Furthermore, research has established that imagery is much more likely to be remembered than words; it’s called the Picture-Superiority Effect, and drug advertising relies upon it heavily.
The above video is a good example. The “before” imagery show us the faces of defeated women who can’t walk the dog, keep their life organized, or even do their kids’ laundry. But the imagery after taking Lyrica is of women in control, motivated, smiling, socializing, and deeply engaged in their work and families.
It’s this latter imagery that is much more likely to stay with viewers, rather than the dry, monotone listing of cautions. In other words, it wouldn’t work as a radio ad.
“Doctors are not immune to being deceived”
“Before we had direct-to-consumer marketing I didn’t see this miracle or breakthrough mentality,” said internist Lazris, who’s a co-author of the book, ‘Interpreting Health Benefits and Risks: A Practical Guide to Facilitating Doctor-Patient Communication.’ “There wasn’t this magical belief that there’s this ‘miracle drug’ out there. Doctors and patients were more reasonable. But now it’s changed completely.”
As we wrote last year, direct-to-consumer marketing of prescription drugs was approved in the U.S. in 1997 (the only other country where this is allowed is New Zealand, where it was approved in 1981) “before the internet emerged as the most far-reaching marketing tool of our time.” According to Kantar media drug companies spent just over $6 billion on DTC advertising in 2017, a 64% jump since 2012.
But Lazris sees the trend as a double-edged sword — increasing the risks for harm, on the one hand, but also providing an opportunity to dispel misinformation.
“I’ll tell you what disturbs me most of all,” said Lazris about our roughly 20-year experience with DTC advertising of prescription drugs.
“It’s not just how much it’s impacting patients, but how much it’s affecting doctors. I can’t tell you how often doctors are influenced by the drug reps that walk into their office, or by the ads they see on TV. Doctors are not immune to being deceived, and it seems like every new drug that comes out becomes ‘the drug’ for a lot of doctors. And they end up convincing patients to go on these drugs. So they end up pushing some very dangerous and potentially harmful treatments.”
Lazris’ concern is supported by research that shows that — although the vast majority of physicians are against DTC marketing of prescription drugs — such marketing does, indeed, contribute to doctors prescribing more drugs.
Despite this, Lazris also sees an opportunity.
“I’ve come to look at it differently. When something new comes out I’ll dig in and study the actual risks and benefits. So when my patients come in and ask about drugs they’ve seen advertised I can say: ‘Great! Now let me tell you what this drug really does and doesn’t do!’ It gives me an opportunity to have a doctor-patient relationship. Because now they know I look into these issues, I’ll answer their questions, and that I care.
“And guess what? When I do this, it’s been my experience that my patients don’t push me to go on the drugs.”
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