It’s been 10 years since it was first “time for Claritin,” and DTC advertising as we know it was born. A decade after the FDA issued its draft guidance on broadcast DTC, it seems strange to imagine a time when spots for Lipitor, Lunesta and Nexium did not pepper our morning commutes and our evenings on the couch—just as it’s difficult to imagine a world in which we could not simply fire up the laptop and troll the Web for information about a family malady.

Consumer drug ads have been woven deeply into the fabric of our daily lives. And just as the Internet has made us more active participants in our own health, so has drug advertising contributed to our sense of agency. But a mere 10 years ago, doctors held a virtual monopoly on drug information, and if you were looking to market a new treatment, your choices were limited to detailing, sales aids and journal ads.

Consumer drug advertising was then, and remains still, controversial. Drug ads, doomsayers said, would undermine physicians’ authority and drive consumers to lobby doctors for medications they knew nothing about. Those fears haven’t played out, though the Vioxx debacle, rightly or wrongly, has provided critics with a case example of ads broadening the market beyond the intended indication. Moreover, as the public face of the industry, mass advertising has become a lighting rod, channeling ire about access and affordability issues and presenting a useful bogeyman for ambitious pols looking to strike a populist pose.

But for all the guttural noises emanating from Washington about DTC these days, consumer advertising isn’t going anywhere. It has become broadly accepted knowledge, backed by the Prevention and FDA studies, that drug ads help drive patients to take action on health issues and contribute positively to the patient-physician dialogue. Attitudes and expectations about the role of the patient in healthcare have changed. And a look back at the days before broadcast DTC yields a picture of a regulatory morass no one would want to return to.

There were, in fact, more than a few efforts at consumer drug advertising well before 1997. The first consumer print ad for a prescription drug, for Merck’s Pneumovax, appeared in Reader’s Digest in 1981. Two years later, Boots Pharmaceuticals ran the first TV drug ad in the US—a spot for ibuprofen brand Rufen featuring the British company’s dapper CEO with a chalkboard, boasting that his drug was cheaper than Motrin. Under pressure from doctors, the FDA made the firm pull the ad because it did not include prescribing information—even though it made no efficacy claims—and instated a two-year moratorium on consumer ads.

FDA confusion on the rules around drug ads didn’t deter some manufacturers from pushing forth through the late 1980s and early 1990s with print ads for HRT and allergy drugs, and early disease awareness TV ads from the makers of Seldane and Rogaine. One company even ran a two-minute branded TV spot with 90 seconds of product information. And major print campaigns ran for Ciba-Geigy’s Estraderm, Wyeth’s Premarin and Glaxo Wellcome’s Imitrex.

By the mid-1990s, HIV/AIDS patient groups were demanding access to the same medical information that doctors had, and HIV drug manufacturers began running branded ads in publications for those patients. Under pressure from multiple parties and advised by their lawyers that they couldn’t win a First Amendment case against advertisers, FDA officials relented and drew up a draft guidance allowing broadcast advertising. “They said, ‘The fact is, this is going to happen with or without our support, so we might as well try and shape it some way,’” says Mike Guarini, president, North America, for Ogilvy Healthworld.

And that’s where the game-changing Claritin campaign came in.

‘Blue skies’ for mass advertising
The brand that jump-started broadcast consumer advertising was already on the air when, on Aug. 8, 1997, the FDA gave companies the green light to air product claims in ads for prescription drugs. The initial spots Schering-Plough had been running for the allergy drug would today be called reminder ads, as they didn’t tell viewers what Claritin was or what it did, instead advising simply that “It’s time for Claritin” and imploring them to ask their doctor about it.

Despite their irritating vagueness, those early ads worked. “We had incredibly high name recognition in those markets the ads ran in, and a comparative increase in new prescriptions,” recalls Steve Andrzejewski, then product director on Claritin for Schering-Plough. With those metrics, the Claritin team was able to win buy-in from skeptical senior execs and expand the campaign when Washington cleared the way. And having established name recognition and cemented the “Blue skies” imagery through the pilots, Schering-Plough had already laid the groundwork for the first of the monster consumer campaigns.

Claritin was an ideal test subject for consumer advertising. As one of two prescription medications in the antihistamine category (along with Aventis’ Allegra), the drug was fairly novel, with a superior non-sedating claim. And Schering-Plough was, says CommonHealth president Matt Giegerich, an aggressive client with “marketing testosterone.”

‘Marketing testosterone’
“They really understood the dynamics of the antihistamine marketplace and they knew it was incredibly promotion-sensitive,” says Giegerich, who was then launching CommonHealth consumer unit Quantum and handled the brand in tandem with his colleague Dave Chapman on professional advertising. The challenge was to get the masses of allergy sufferers using drowsiness-inspiring OTC treatments to consider a prescription alternative. Side effects were relatively low-risk, self-diagnosis was easy and the potential was enormous. “They knew if they hit hard on the professional side, they would dominate share, and if they drove a lot of new patients to their doctors to ask about prescription alternatives, they’d be getting the lion’s share of that growth,” says Giegerich.

Schering-Plough took the plunge in a big way. Claritin ad spend topped $142 million in measured media in 1998, according to TNS Media Intelligence. Buoyed by strong prescription growth, the brand continued to receive strong support across five line extensions and blazed a number of new trails in consumer advertising including the use of celebrity spokespeople (former Good Morning America anchor Joan Lunden and Major League Baseball star Mike Piazza), a combination of branded and unbranded ads and a rich media mix. “We learned a little bit from every campaign we put out there and did continual market segmentation research to understand our audience,” says Andrzejewski, who is now chief commercial officer at King Pharmaceuticals. “We perfected it as time went on.”

The dawn of broadcast DTC was met with a ferocious physician backlash. “My personal doctors were really angry with me because I was part of this,” recalls Anne Devereux, CEO of TBWA WorldHealth and LLNS. “One even didn’t want to treat me. You don’t hear that anymore, because they’re relieved that for so many of the higher risk diseases, patients are hearing more about them and taking them more seriously. But in the early days, it was perceived as a total threat to physician authority.”

Looking back, it’s hard to see what all the fuss was about, but broadcast drug ads wrought a significant shift in the patient-physician dynamic. “When broadcast was approved, you had this complete symbiotic relationship between doctor and patient,” says Devereux. “Then, patients started to feel empowered by things they saw on TV, and managed care forced physicians to see more patients in a shorter period of time, so if a patient felt strongly about something, she had to become her own advocate.”

Complicating things, some of the early DTC work was not particularly well-targeted. Devereux recalls hearing of patients with depression asking their doctors about Claritin because they’d seen the reminder ads and associated the blue skies motif with happiness.

“A lot of people early on were seduced by the great numbers you could reach through mass advertising,” says Dorothy Wetzel, the former Pfizer DTC guru who is now SVP management supervisor at Saatchi & Saatchi. “Now, they’re realizing those big numbers can actually have a negative spillover effect because if you’re reaching people who don’t need the product, they tend to get annoyed at the ads.”

Physicians and consumers weren’t the only ones skeptical of DTC early on. “There was a lot of wrangling with senior management,” says longtime Merck marketer Len Tacconi, now president of Discovery Health Media Enterprises. “There were people who got the vision and were inspired by it, and then there were those who were like, ‘Why are you here and how can we make you go away?…You’re diverting a lot of money and attention away from our true audience—the physician.’”

The return-on-investment data bore out the value of DTC, but the Vioxx scare seemed to validate one common criticism—that consumer ads might seduce many patients for whom a drug might not be necessary, or even safe. While the DTC guidelines released in 2005 by the Pharmaceutical Research and Manufacturers of America  went a long way toward demonstrating that the industry can self-police advertising (the number of DDMAC-issued warning letters on broadcast promotions since: zilch), the changing of the guard in Washington promises plenty more efforts to curb DTC in the coming months. But for the most part, the industry seems cautiously optimistic that these will amount to little more than congressional grandstanding—or that any changes will ultimately benefit industry by clarifying the ground rules.

“These debates—about access to care, the cost of drugs and the implications of DTC—have been knocking around since the beginning,” says Ogilvy Healthworld’s Guarini. “Certainly, some Democrats will want to address healthcare. That’s fine, and we’ll have a balanced debate and some things will change. It might be chaotic and upsetting at first, but in the long run, it’s about getting patients in doctors’ offices, getting them diagnosed and on medication.”

Some see the pendulum swinging back—not toward journal ads and sales aids, but rather to a more holistic orientation which reunites consumer and professional messaging. “We went from a fully professionally oriented industry that spent all of its money on physicians to one that spent a huge amount on consumers,” says Meg Columbia-Walsh, managing partner, president consumer and e-business at CommonHealth. “We were following the packaged-goods model, and that was a good thing, because it taught us how to target markets and articulate positioning to different targets. As a result, it changed the culture to a more information-seeking one that gives people more choices. Now, there’s a shift toward a more conservative middle, and it’s going to fall into two areas: improving the doctor-patient dialogue and compliance and persistency.”

This shift is being driven by divergent technological trends. The paucity of new mass-market drugs in development and the burgeoning number of specialized treatments is fueling a need for better targeting. Meanwhile, media fragmentation is devaluing traditional mass-advertising, and the proliferation of new marketing channels—eCRM, viral and social marketing, mobile marketing, direct TV, etc.—is enabling it. But using those marketing channels effectively requires close synchronization of patient and physician messaging.

“We had this separation of church and state,” says TBWA/LLNS’ Devereux. “It used to be that we’d figure out the consumer insight and the strongest communication of the data and build the detail and the DTC, and very often, these two lines of communication were very different. The physician is trained to be data-driven and analytical, so he wouldn’t accept the quality-of-life argument. Now they understand that the best drug with the best data isn’t going to be effective without understanding patient priorities.”

The culture of medicine is changing, as medical schools teach students how to talk—and listen—to their patients. “DTC has helped drive that,” says Devereux. And a parallel shift is taking place at healthcare advertising agencies, many of which are scrambling to meld their various consumer and professional specialties, and at pharmaceutical companies, some of which now forbid their consumer and professional marketing arms from planning campaigns separately. “It’s not all of them, and it’s not necessarily the large ones, but it’s the smart ones,” says Columbia-Walsh. “The silo days are over,” adds Devereux.

Personalized marketing
Saatchi’s Wetzel sees an age of “environmentally sensitive” marketing, in which “less is left behind,” as messaging is more carefully crafted to appeal to multiple constituencies in tandem—consumers, physicians, regulators, patient and professional groups. The buzz these days is around microsegmentation and a personalized marketing to match the emerging personalized medicine.

But don’t count out the good, old-fashioned “big TV and glossy blast” just yet. There’s still a vital role for traditional mass advertising, says Andrew Schirmer, EVP and managing director of McCann HumanCare. “It’s very sexy to talk about viral and CRM,” says Schirmer, “and of course, we need to look at those things as we go forward, but not as a replacement for mass advertising where appropriate. Because the big difference for DTC is that I can cast a wide net, because people suffering from that affliction are going to see it, and I don’t care if millions more see it.”