DTC Special Feature: Which color is it?
A recent study of DTC advertising appearing in the Journal of General Internal Medicine concluded that few broadcast ads are compliant with FDA’s guidelines. The reality, though, might not be so cut and dried.
Tucked a third of the way into the May issue of the Journal of General Internal Medicine, in between articles about behavioral risk factors in the chronically ill and improving flu vaccine rates by using EHR portal messages, doctors across the land recently came across something they rarely encounter in a medical journal: a peer-reviewed study of direct to consumer broadcast advertising. Opinion pieces on DTC in journals aren’t uncommon, but the authors of “Direct-to-consumer broadcast advertisements for pharmaceuticals: off-label promotion and adherence to FDA guidelines” went a step further by analyzing ads for regulatory compliance – every broadcast ad, in fact, that aired between January 2015 and July 2016, for a total of 97 ads and 60 drug products.
Those authors did not seem very impressed. Their own conclusion: “Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.”
“Personally, I do not think DTC advertising should be legal in the United States,” says Joseph Ross, M.D., a professor of medicine and public health at the Yale School of Medicine and co-author of the DTC study article. “I have not seen good evidence that it is associated with better informed patients and caregivers. In contrast, the studies I have seen suggest that it’s associated with higher rates of use of medications for less appropriate patients, meaning that it leads to both overdiagnosis and overtreatment of patients.”
What did the authors mean by low quality of information? In two words, quantitative data; they point out in the article that none of the ads they reviewed described drug risks quantitatively, and only a quarter described drug benefits quantitatively.
“The benefits were rarely quantified in a way that would allow a patient or caregiver to better understand whether they are likely to achieve a better outcome by taking the medication,” Dr. Ross told Med Ad News. “For this, one would need to focus on absolute risk differences or, better yet (although it is unlikely), characterize number needed to treat (i.e., 45 people need to take this medicine for one person to benefit). Most ads had little data on benefit. When they did, it was presented as relative risk (people on average got 20 percent better). And there was no quantitative data for safety or adverse events.”
Dr. Ross also brings up the issue of cost. “Because we rarely, if ever, see advertising for drugs available as generics, DTC advertising promotes use of higher cost medications when cheaper, generic alternatives, that work equally well, are available.”
And then there is off-label marketing. According to the study authors, ads for five diabetes products “suggested non-FDA-approved – or off-label – uses, all of which were for weight loss and/or reduction in systolic blood pressure.” As an example of what “suggested” means, they cited language from an ad for Novo Nordisk’s Victoza – “Victoza is not approved for weight loss. In our largest study, when added to metformin, people lost on average up to 6.2 pounds” – and AstraZeneca’s Farxiga – “And although it’s not a weight loss or blood pressure drug, Farxiga may help you lose weight and may even lower blood pressure when used with certain diabetes medicines.”
Does FDA consider statements like that to be off-label marketing? No, says Hensley Evans, principal at the sales and marketing consultancy ZS Associates.
“Off-label promotion would mean that they were suggesting that Victoza be used for weight loss in patients who have not been diagnosed with Type 2 diabetes, and it does not appear that there is any intent to do that,” Evans told Med Ad News. “Since they are pretty clearly saying in each case that the drug is not approved for weight loss, I would not call this off-label promotion. Additionally, most new campaigns are pre-cleared with the FDA ahead of time, and while direction back from the FDA is not always clear in all aspects, they are generally very specific with regard to claims.”
As to quality of information, Evans offers a very different perspective than the authors of the study, pointing out that they don’t offer any data showing that quantitative information makes ads easier to understand for the average consumer. “Based on my own experience and given the very low overall numeracy of the U.S. population, adding quantitative data makes it more likely that consumers might be misled by the data, not less likely,” she says. “‘Low-quality’” seems to be a very subjective term.”
None of that, of course, should be taken to mean that pharma brand managers have perfected the art of balancing their messages, or that they can not do better.
“I do think that the industry can constantly seek to improve the clarity and understandability of its DTC advertising,” Evans told Med Ad News. “Many advertisers do make significant investments in consumer research to help structure messaging to ensure that consumers can and do understand both the benefits and the risks. The medical, regulatory and legal review processes through which DTC advertising is reviewed internally by manufacturers is typically quite rigorous, and manufacturers are consistently working to improve their processes and make their ads effective while complying with FDA guidelines.”
But are those guidelines clear enough? One point on which the study authors and Evans agree is that FDA’s regulations on DTC are quite subjective. And in fact, the study authors take on that subjectivity in one of the key conclusions of their article: “By creating clearer, more objective requirements, the FDA could better regulate broadcast DTC advertising.”
Until that day comes, though, brand managers will try to stretch the boundaries – and the JGIM study suggests that adding a bit of heft to the medical/regulatory/legal review team may be in order.
“For many companies, a key objective is to produce and deliver high-quality, compliant promotional materials/advertisements, with speed to market as a key metric and success factor,” says Karl Kraft, VP, marketing operations and med/reg/legal, TGaS Advisors. “Marketers will continue to push the envelope on what they can and can’t do regarding promotion, but a seasoned MRL review team will effectively interpret FDA guidelines to ensure their organization remains compliant. The results of this study suggest a gap in the interpretation of FDA guidelines for DTC advertising. Moving forward, organizations will need to ensure the right people and processes are in place to deliver both effective and FDA compliant DTC ads.”
So the JGIM study may not be cause for brand managers to rend their garments, but it should at least serve as a wake-up call.
“We live in an era of fake news,” says Jay Carter, senior VP, director of business development, AbelsonTaylor. “Fact checking is therefore essential, whether in the lay or medical press. I work on the front-line of the efforts to create effective and responsible DTC promotion. It’s a lot like making sausage. It can get messy.
“Reading [the] study on DTC adherence to FDA guidance in the Journal of General Internal Medicine reminded me of the prevalence of fake news in our society. While my first inclination was to view the study as picayune, I was quickly reminded that fact-checking is essential in today’s society, and that the study is likely a sincere effort to shed light on how well the industry adheres to FDA regs. That is surely a good thing.
“That doesn’t mean that there isn’t an agenda. In 2015 AMA officially called for a ban on DTC promotion of prescription drugs and medical devices. I strongly suspect the authors of this study share this view. Just as we evaluate content from Fox News or the Washington Post, readers of studies like these need to keep the editorial agendas in mind. All in all, I’m grateful for the insights. But I’ll continue to hold my nose while making the sausage that is DTC advertising.”
Top pharma brands by DTC ad spend
$ in millions
Rank Brand 2017 2016
1 Humira $429 $439
2 Lyrica $350 $392
3 Xeljanz $273 $259
4 Eliquis $227 $301
5 Keytruda $209 $67
6 Taltz $207 $82
6 Chantix $207 $157
8 Trulicity $195 $142
9 Cosentyx $174 $147
10 Entresto $159 $124
Source: Kantar Media
Top pharma brands by DTC TV spend
$ in millions
Rank Brand 2017 2016
1 Humira $341 $344
2 Lyrica $216 $221
3 Xeljanz $167 $139
4 Trulicity $145 $58
5 Eliquis $142 $174
6 Keytruda $127 N/A
7 Xarelto $120 $84
8 Taltz $116 N/A
9 Breo $103 $103
10 Cosentyx $100 $87
Top pharma companies by DTC ad spend
$ in millions
Rank Company 2017 2016
1 Pfizer $1,312 $1,413
2 Lilly $480 $396
3 AbbVie $467 $498
4 Allergan $420 $484
5 Merck $371 $389
Industry-wide $6,128 $6,423
Source: Kantar Media