The Science of DTC

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Consumer drug advertising is back—if it was ever really gone—nattily attired in a starched lab coat. After an apocalyptic post-Vioxx pause, when many marketers folded their wallets, held their breaths and privately wondered if they shouldn't just chuck consumer advertising altogether, DTC spend is rising again, if only very slowly, posting a 4.9% gain to $4.65 billion for 2005, according to TNS Media Intelligence. The FDA's Division of Drug Marketing, Advertising and Communications staff is now buried under a mountain of promotional materials submitted for pre-approval. And drug advertisers, a cautious bunch in the best of times, are showing sparks of innovation as they interpret the PhRMA guidelines on DTC. This is not the consumer advertising of old. Driven by renewed FDA scrutiny of drug ads, the consumer backlash against DTC and technological shifts, marketers are rethinking DTC. 

Gone are the beaches and fields, the happy people living lives free of pain. The clichés du jour in today's drug advertising are doctors and celebrities addressing the viewer dead-on and dispensing risk information with little subtlety. 

But beyond the glut of stethoscopes, drug advertisers have seized the opportunity afforded them by the DTC scare to broaden the marketing mix and to ask what makes patients tick—how do people process risk and benefit information in ads? Do they understand whether or not a given product is for them? 

Getting into patients' heads
Merck's marketing division, led by Charlotte McKines, executive director of marketing communications, is looking for answers to these questions. Under the direction of Ed Slaughter, who ran Prevention magazine's DTC study, Merck is studying how consumers read broadcast drug ads, with a view toward sharing the insights gleaned with the FDA and competitors. Slaughter, consumer marketing manager at Merck, says the study will examine consumers' recall and understanding of essential information in TV ads, along with viewers' ability to discern whether or not they are in the patient population for a given drug. “We're trying to cut to the issues at hand in DTC advertising,” says Slaughter. “Every time an FDA official gets up and speaks at a conference, they say, ‘If anybody has any data on this, we'd love to see it.' This is an attempt to move the ball forward and answer that in a scientific, data-driven way.”

Merck is tweaking its study design and will launch a pilot test soon. The study will include sufferers of a disease for which the product advertised is indicated, along with a smaller control group. Subjects will view a clutter-reel exposure—a barrage of advertising including a drug spot along with a series of unrelated promotions, mimicking how viewers take in ads during commercial breaks at home. Initial test ads will feature variables such as distracting visuals. Viewers will then be quizzed on the product, the condition it treats, its risks and benefits. 

The idea is to make better, more balanced advertising that gets a green light from DDMAC faster. Having mandated pre-submission of ads to the FDA for years, Merck has long wrestled with how to speed up the process. Now that Merck's habit is in fashion and the agency is inundated with submissions, providing proof of balance and readability is that much more vital. Once the company has a proven protocol, it can test multiple versions of executions for newly approved products or those for which there is a new indication or a new claim, determine which is most effective and submit it, together with data backing that up, to the FDA. “If you have hard data, that also facilitates decision-making around the advertising,” says Slaughter.

Merck approached the agency with the idea last summer and has requested technical assistance on its study design, ensuring that their research complements ongoing DDMAC research. “They're a data-driven organization, we're a data-driven organization,” says Slaughter. “So let's get some data into the decision-making process.”

Chunking: not just for tuna
Merck isn't alone in researching consumer understanding of advertising, of course. Duke University's Department of Psychology has scrutinized distracting visuals in advertising—even counting the number of times the Nasonex bee flaps its wings while risk information is being delivered. (There is four times as much flapping as during benefit information. The ad has since been altered, the bee's movements calmed.) The university also examined the role of risk information, finding that good placement—information in the middle to mid-end of an ad is lost on viewers—can bring a 100% improvement in the viewer's understanding of the drug's potential risks. They looked at the speed of narration in 2005 Ambien and Lunesta ads, finding that viewer understanding of risk was lost on the Ambien spot, in which the narrator speeds up during that section. (The new Ambien CR ads, they note, are more even-keeled.) And Duke researchers found that “chunking” of information—presenting facts in bite-size snippets instead of unloading a rapid-fire barrage of risks on the viewer—aids understanding and retention. 

Other factors affecting intake include the likability and evocativeness of actors, patients or doctors appearing in ads. Viewers, it seems, mimic the behavior of characters. When a patient appears attentive, as in last year's ground-breaking Ortho Evra spot, we are more likely to pay attention. When characters are warm, we respond with warmth.

Speaking at a Drug Information Association (DIA) conference in New York last month, Ruth Day, associate professor and director of the JD/MA program in psych at Duke, pointed to an intimate spot for AstraZeneca's Nexium, in which an older couple finish each other's sentences as they talk about the drug, as an example of the personalization factor. The couple has depth and “presents a positive affect.” Their interaction draws the viewer in. They present risk and benefit information in a conversational fashion, giving each point room to breathe and be absorbed. “That does lead to acceptance of side effects,” says Day, who advocates an “evidence-based” approach to advertising. “You need to look at the location of risk information, the speed at which it's delivered and competing information on risks and benefits.”

Clarity is an even greater concern when you factor in health literacy issues. At the DIA conference, Pfizer's Lisa Dieter spoke about the company's Principles for Clear Health Communication, noting that 93 million US consumers—including 7.8 million seniors—have only the most basic literacy skills, while 11 million are illiterate in English. Tasks like signing a form, adding amounts on a deposit slip, searching a short text for drug interactions and even using a TV guide can prove challenging for these patients. Another 30 million Americans are below basic literacy.

Even the highest-functioning readers are hard-pressed to slog through the dense, highly technical text in a typical brief summary. To improve readability, Pfizer adopted its Principles, mandating that communications should explain a drug's purpose and limit content to avoid clutter; involve the reader; make text easier to read through use of active words, conversational style, chunking and road signs; make the look of the content more inviting through use of white space, good contrast and elimination of ghosting and other competing visuals; and select realistic visuals that motivate patients to take action. The company's new consumer-friendly risk information format for print ads, wherein easy-to-read chunks of information are presented in bullet-point-happy bubbles, was one result of those principles. The format debuted in Lipitor ads at the end of the year.

The challenge of television
Pfizer is rolling out its brief summary format across all products, pending FDA approval, and is now looking to broadcast. 

“TV is challenging, because a lot is going on in a 60-second spot,” says Jim Maffezzoli, leader for Pfizer's consumer strategy team. “There's a lot of moving parts.” Pfizer is looking at the impact of tone, pacing and placement of risk information on understanding, recall and persuasion in TV ads, with a view toward standardizing best practices as it has in other media. The firm is also bringing its agency partners in on the process. Agency heads were summoned to Pfizer HQ last month for a briefing on the standards and the work in progress.

The firm is also looking to follow up on its disease-awareness spots for cholesterol and ED with unbranded advertising for other disease states. Employing diverse marketing strategies and media is crucial to understanding, just as Pfizer has found that employing a broad marketing mix is key to commercial performance. “We know people use four or five different information sources before raising something with a doctor,” says Maffezzoli. “Where the consumer is getting information can vary by disease state or brand and over time as media habits change, so we try to tailor our communications accordingly.”

For all the kvetching that went on at pharmaceutical firms about the use of disease education ads prescribed by FDA and PhRMA, they're hard to miss these days. Pfizer has launched its “Make the Call” and “My Heart Health” efforts, for ED and cholesterol, respectively, while its ED category rivals GSK and Schering-Plough have launched their “Men's Facts” campaign. Unbranded ads, critics say, are a waste of money from the standpoint of a challenger brand and can only truly benefit the category leader, but companies seem to have concluded that they can't afford not to do disease-awareness advertising at a time of DTC backlash—particularly in controversial categories like ED and depression.
Similarly, where many marketers privately grumbled over PhRMA's encouragement to pre-clear ads with DDMAC before running them, the agency is now awash in promotional materials.

After a sharp contraction in late 2003 and early 2004—one largely caused by the sudden disappearance of COX-2 ads and Prevacid moving from TV to print—spending is again on the rise, even as most of the largest firms spend less. Network TV spending was static at $1.6 billion for 2005, and companies spent less on national newspapers, online (-12%) and Hispanic media (far less, with Hispanic network TV down 22%), while spending on Sunday magazines shot up by 65% and outdoor advertising rose 49%. Newspaper, cable TV and magazine advertising also posted respectable double-digit increases.

With the true blockbuster behemoths thinning out, the mass-market big spenders are fewer. “Companies are cautiously supporting DTC outreach when it makes sense for the brand and the category,” says Andrew Schirmer, EVP and managing director for McCann HumanCare. “You're not seeing as many of the $200-million-plus spends that were happening with Nexium and Vioxx and Claritin in the old days, but there are more than enough spending $20 million to $50 million.” 

“It's a much more complex world,” says David Kweskin, SVP at TNS Media Intelligence. “There's no pullback, but they're doing smarter DTC and making more of an effort to understand the emotionality that surrounds advertising, so that it's not about the product alone but how the disease state affects lifestyle.”

Trials and triangles
It took the threat of congressional action to get companies to the table and resolve the long-running, on-again-off-again effort to establish industry guidelines on DTC. Even then, at the height of the DTC backlash, talks were contentious, but members have found they can live with PhRMA's Guiding Principles on DTC Advertisements since their unveiling in August. The deluge of pre-submitted promotions at the FDA suggests they're complying, as does the unexpectedly large volume of disease-awareness spots.

Bristol-Myers Squibb, Pfizer and now AstraZeneca have even improved on them. BMS adopted a one-year moratorium on advertising of new products. Pfizer followed up with a six-month moratorium and stricter restrictions on the advertising of sensitive health topics like ED.

In February, AstraZeneca issued its own interpretation of the guidelines. The company not only declined to take on a voluntary moratorium—it blasted the notion. “We do not believe a moratorium or other curtailments would be beneficial to consumers,” said an AstraZeneca white paper entitled “The Responsible Path.” AstraZeneca's position is that companies must maintain the flexibility to promote lifesaving drugs as they become available, while respecting the PhRMA guidelines' prescription to educate doctors on a new drug before going to consumers with it. 

Is there a doctor in the frame?
Advertisers have adapted to the post-Vioxx environment, executing creative with a more somber, straightforward tone and more explicit risk information. But even as they have shed the feel-good clichés of yesteryear, they've adopted new ones. Schirmer's presentation to prospective McCann HumanCare clients includes a slide with the words “Is there a doctor in my spot?”

“My ultimate fear is that in an effort to be careful, we end up being boring, and if we do that, our objectives can't be met,” says Schirmer, voicing the collective anxiety of agency creatives.

With superiority claims under FDA scrutiny, Grey Worldwide EVP and managing partner Bob Burruss cites a pervasive belief that it's impossible to differentiate products without head-to-head clinical trials.
Some are nonetheless finding innovative ways to use DTC. AstraZeneca, for example, is experimenting with mass-market TV as a compliance tool with ads for Toprol-XL. The campaign, by CommonHealth's Quantum, features patients rationalizing missed doses and a doctor explaining why it's important to follow the script and take your medication regularly.

Doctor-patient dialogue features prominently in many recent executions, and that's a good thing, says Unit Seven chairman and CEO Loreen Babcock. “It's reminded people how important that conversation is with a health professional,” says Babcock. “The doctor-patient relationship is the cornerstone of everything that's going on in the marketplace.

Schirmer points to “Schoolhouse Rocks,” the '70s series of PSAs aimed at educating kids on the fundamentals of history, biology, physics and government, as a case study in responsible, effective education. “Why was it so successful? Because it took the same stuff that bored the crap out of kids and served it up in an engaging way, in a format that was acceptable to them,” says Schirmer. “You didn't have an outcry against turning education into cartoons. It was accepted, because it delivered information to the audience in an engaging way. We're dealing with an audience that is confused by complex health topics and, at the end of the day, we hope to drive them to have that discussion with someone who has a lot more education than they do. The question is how you pave that path.” 
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