Brand of the Year 2008

"It's easy to quit smoking," Mark Twain is said to have said. "I've done it a thousand times." Twain could joke about the insidiousness of nicotine addiction more than a century ago, but lately society has lost its sense of humor about cigarette smoking—along with its sympathy for smokers. They are casually dismissed as "slow suicides," their health problems shrugged off as their just desserts.

The medical group (left): Cristina Russ, Larry Samuels, Doug Vanderburg, Deborah Petrowsky, Martina Flammer (group leader), Anjan Chatterjee. The marketing group (right): Dina Klugman, Karen McDonald, Chris Hogan, Veronique Cardon (group leader), James Humphries, Deborah Hamel, Amrish Luthra.

Smoking is the single most preventable cause of morbidity and mortality in the developed world. According to the Centers for Disease Control and Prevention (CDC), an estimated 440,000 Americans die from smoking-related illness every year, and nearly 20 percent of the 44.6 million adult smokers have at least one serious smoking-related disease. All this adds up to an annual $157 billion in economic losses.

So, even if Pfizer's Chantix (varenicline) did nothing more than help an estimated million or so smokers (so far) break their addiction, it would be a strong contender for Pharmaceutical Executive's Brand of the Year. But, in fact, Pfizer's entire approach to branding the drug is itself worth admiring for several reasons:

Medicalizing smoking We live in an anti-tobacco time. Smoking bans are spreading, cigarette taxes are increasing, and health warnings grow more graphic by the day. But in another sense, society has yet to get serious about smoking—it is still generally viewed as a lifestyle choice, even a moral failure. Chantix is promoting a more enlightened, scientific view of smoking as a serious, difficult-to-treat addiction—and spreading the word not only to smokers but also to physicians.

Focusing on the goal Drug companies are traditionally better at selling pills than at coordinating treatments—a fact that has done much to harm the industry's reputation. For Chantix, Pfizer has addressed this issue with an intensive consumer-focused strategy—including a 52-week program of patient education and support intended to maximize success rates.

Narrowing the focus Some of the recent public uproar over drug safety is due to the blockbuster model's focus on expanding the consumer pool. If Vioxx, for example, had been used only by patients with severe arthritis and who had problems tolerating other pain meds, it would probably still be on the market. Pfizer has taken a major step toward pharma's future by trying to limit the use of Chantix to informed, motivated patients—and making information about the drug's limitations not just a disclaimer, but an essential aspect of marketing.

If Gardasil, our Brand of the Year in 2007, was Merck at its best, Chantix is Pfizer at its best, restoring luster to its reputation as a sophisticated marketer of consumer-oriented drugs. What's more, this first-in-class product is the first potential blockbuster discovered in its own lab since Viagra. And Pfizer's fine-tuned launch, which focuses less on quantity of prescriptions than on quality of treatment, is a strong sign that the firm is moving fast to embrace new branding and business models.

Best in brand launch

No Silver Bullet

Smoking cessation is a market that pharma has largely avoided. Though there are some 1.3 billion smokers worldwide, global sales of aids for quitting barely hit $1 billion in 2005. Survey after survey shows that seven out of 10 smokers want to stop, and about half of all daily smokers are actively trying to stop. Yet by many estimates, only one out of 12 quitters remains abstinent after six months, a stat that drops to one out of 20 at one year and declines from there. The average smoker makes six to nine attempts before getting it right.

Market research told the Chantix team that attitudes toward smoking cessation are rife with cynicism and defeatism. One self-proclaimed quick fix after another has gone bust, leaving a bad taste for consumers and the media alike. Boasting a novel mechanism of action, Chantix proved its clear superiority over the competition in clinical trials. Yet Chantix is still no silver bullet—a fact placed front and center in its branding strategy.

"Smoking is a chronic relapsing condition and an addiction," said Veronique Cardon, group leader of the Chantix US marketing team. "We wanted to be very careful never to overpromise or position Chantix as a magic pill."

Nicotine-replacement therapies—patches, gums, lozenges, and nasal sprays—deliver a 5 to 10 percent success rate. A course of psychological or other counseling does about as well. Zyban (bupropion), the first smoking-cessation drug, was introduced a decade ago and pushed success rates to about 16 percent, according to some studies. In Pfizer trials, the success rate of Chantix, at one year, reached 22 percent.

"We desperately needed new medications," said Neal Benowitz, an expert in nicotine addiction at the University of California–San Francisco who advised Pfizer on its clinical trials. "If you were going to pick one first-line drug, this would be it."

Best in brand extension

The Eureka Moment

The man behind Chantix is chemist Jotham Coe. He quit nicotine 20 years ago at age 30, then watched the death of his father from emphysema and his uncle from lung cancer, both caused by smoking.

Coe joined Pfizer's antismoking project in 1995. He focused on cytisine, a substance derived from plants that has a molecular structure similar to nicotine's and competes with nicotine for the brain's dopamine receptors. Coe hoped that if he could tweak the structure of cytisine just right, it could beat nicotine to the punch.

The eureka moment came a year later, after dozens of dead ends. Frustrated, he took a step back and began reviewing earlier work on morphine-related chemicals (because they are built like cytisine). There he hit upon a paper published in the seventies that said a morphine molecule seemed to have anti-addictive effects when a nitrogen atom was removed. Sure enough, the same nitrogen sleight of hand in cytisine neutralized nicotine. By 1997, Coe had a new molecular entity, dubbed varenicline, ready for clinical trials.

The beauty of varenicline is the double duty it performs as both an agonist and an antagonist of a key nicotine receptor, says Martina Flammer, MD, senior medical director for Chantix, US and global. "It releases dopamine, but at a much lower level than nicotine. This takes away the urge to smoke. At the same time, it shields the receptor from nicotine, so that if you do smoke, you don't get the same pleasure."

Over the next eight years, Pfizer tested varenicline in some 5,000 patients in six clinical trials. Five of the six were classic placebo trials with smokers who had averaged 21 cigarettes a day for 25 years. The drugmaker was so confident in its product that it also went head-to-head against Zyban.

Unlike many smoking-cessation studies, Pfizer followed patients for a year, tracking relapses. "We chose the most stringent endpoint out there," said Flammer.

Chantix scored a clean sweep. In one 1,025-volunteer study, 44 percent of the subjects taking Chantix were not smoking after 12 weeks, compared with 29.5 percent on Zyban and 18 percent on placebo. After a year, these rates fell by about half: 22 percent, 16 percent, and 8.4 percent, respectively. (A second, nearly identical study got nearly identical results.) In a third study, 1,900 smokers in seven countries were given Chantix for 12 weeks, at which point 65 percent were tobacco-free. These 1,236 quitters were then followed for another 12 weeks, half on Chantix and half on placebo. At the 24-week mark, 70.5 percent of those on Chantix were still not smoking, compared with 49.6 percent of the placebo group.

"The research was very robust," said Andrea King, an associate professor of psychiatry at the University of Chicago who played no role in the studies.

Best in brand resilience

FDA fast-tracked the drug and approved it in May 2006—the first new anti-smoking drug in a decade. With Edelman handling the PR, word spread quickly. By the first week of July, the Journal of the American Medical Association had reported Chantix trial results and the Wall Street Journal had run a front-page story. Pharma blogger John Mack praised the strategy as a "case study in [how] pharmaceutical marketers [can] build their brands using public relations followed by advertising." In addition, Mack wrote, "it's not all positive news, which makes it even more credible."

The negative news consisted mainly of pointing out that the trial results might inflate the drug's real-world effectiveness, because the volunteers were all "highly motivated"—and excluded people with a history of depression or substance abuse. What critics missed was that Pfizer was aiming to maximize the real-world effectiveness of Chantix by ensuring that consumers use it in almost clinical trial–like way.

A Pill and a Plan

The decision to brand Chantix as "a Pill and a Plan" was the brainchild of Marketing Team Group Leader Veronique Cardon. The launch had to establish credibility with skeptical patients and doctors by promoting a realistic understanding of nicotine addiction—and of "treatment" as requiring not just the drug but the hard work of behavior change. Even pre-approval, an unbranded Consider Quitting print and online campaign identified consumers who were highly motivated—and most likely to succeed on the drug. A 52-week online program called Get Quit—complete with patient ed, e-mail check-ins, phone support, even a personal coach—went live before the first script was written.

Best in brand comeback

The last thing Pfizer needed was to sell a lot of Chantix in a short period to people hoping for miracles. "It was important to shape patient expectations," Cardon said. "The message had to be: 'You are taking a medication that is powerful and will help you stop smoking, but you also have to work hard to make behavior changes. And there will be bumps in the road.'"

Doctors can be a tougher audience. "Healthcare practitioners' attitude has become, 'I have no empathy and no time for you if you smoke. And if you ask, I will make you feel very guilty for smoking,'" said Cardon. "The patient, of course, shuts down immediately."

Pfizer's professional campaign, featuring the image of a giant broken cigarette, had to break through this resistance. The sales force had go-slow orders, initially detailing only to the highest-prescribing primary-care physicians. For doctors too busy to coach their patients, Get Quit was a safety net. Theone thing reps did not offer was a single free sample—a first for Pfizer, according to Flammer—so as not to lower the motivational bar. Because Pfizer backs the PhRMA Code's six-month moratorium on consumer advertising for newly marketed drugs, Chantix DTC wasn't set to debut until December 2006. In the end, though, Pfizer delayed its consumer blitz until late September 2007; the company depended on PR, a series of unbranded ads, and Get Quit to spark interest. The results exceeded Pfizer's projections, with $168 million in revenue in the first half of 2007.

With McCann HumanCare, the agency that also handles Viagra DTC, Pfizer rolled out a $75 million tortoise-and-hare-themed campaign in print, TV, online, and out-of-home, tagged "On the road to quitting, it's all about getting there." The campaign has attracted criticism for its cutie-patootie imagery. But the ads were among the year's most-recalled and clearly defied the anti-smoking fear-based approach.

"We chose to use the fable of the tortoise and the hare because...the imagery resonated strongly with smokers," said Pfizer PR's Jeanne Traflet. "People described them as engaging and inspiring. They also said the message of a steady, determined approach to quitting smoking was realistic."

Cheaper Than Cigarettes

Pfizer honcho Ian Read crowed to the Wall Street Journal last year that Chantix was "the company's fastest launch ever," outpacing even Viagra. He may have been exaggerating just a bit. After all, the rollout was geared to a slow, steady uptake of motivated consumers. But even with the soft launch, in just 18 months, 4.5 million, or 10 percent, of US smokers have already taken the three-month course.

This is major mojo, given that only one-fourth of managed care organizations (MCOs) reimburse or even discount smoking-cessation products. Payers have had little incentive to shell out for products whose long-term quit rates are in the single digits. Medicare Part D is more generous, covering prescription aids and some counseling.

If the Chantix pill-and-plan program works as well in the real world as in clinical trials, Pfizer may get Chantix on formularies by arguing that it is the first truly effective treatment. "The success rate is encouraging to MCOs," said Cardon. And the rates of Get Quit enrollees are even 25 percent higher.

Paying out of pocket for a drug may be the best screening device for attracting motivated consumers. Pfizer set the US price at $3.24 a day (two tablets)—cheaper than a pack of cigarettes. A full treatment course is 12 weeks; consumers who reach that goal without relapsing are advised to play it safe by going another 12 weeks.

"It's the difference between putting money into making yourself sick or putting money into making yourself healthy," said Pfizer marketing director Terri O'Gorman.

Chantix pulled in $603 million in sales through the third quarter of 2007, and it looked to be on track to hit the billion-dollar mark this year, ahead of most analysts' predictions. And given the high prevalence of smokers in emerging markets worldwide, Pfizer was justified in thinking on a megablockbuster scale. You could almost see that giant hole that will be left by Lipitor's patent loss begin to fill up with cash.

And then this dream scenario turned into a drugmaker's worst nightmare.

Adverse Events, 2008-Style

On Sept. 19, ABC News did a segment on the freak death of Carter Albrecht, a Dallas musician with the band Edie Brickell and New Bohemians. After a night of drinking, Albrecht went on a tear, smacking his girlfriend around, then banging on a neighbor's door. Suspecting an intruder, the man fired a warning shot, killing Albrecht. According to his girlfriend, Albrecht had just started taking Chantix when his nervous system went wrong: nightmares, hallucinations, violent behavior.

The media went on a tear of its own. The Dallas medical examiner ruled that Chantix was not responsible for Albrecht's behavior—the level of alcohol in Albrecht's blood was reportedly three times the legal limit. But this did little to put the controversy to rest, since he had inexplicably failed to use the Chantix assay Pfizer had sent him.

Pfizer did its best to get in front of the story. The data from six studies in 5,000 people showed no incidence of violent behavior; there was no difference between the Chantix and the placebo groups in the rate of neuropsychiatric adverse events. But other than national newspapers, the media often showed little interest in the data—or a realistic view of smoking. That nicotine withdrawal itself causes serious psychological effects; that smoking can mask depression, anxiety, and other symptoms that emerge only upon quitting—facts like these were glossed over. Once again, nicotine addiction was not taken seriously. "No-Smoke Pill on Sale Despite Death Link," read one headline.

With Chantix users approaching 5 million worldwide, reports of neuropsychiatric adverse events began piling up at FDA. In October, a Sky TV editor killed himself a month after starting on the drug, sparking a similar news cycle in Britain. In November, FDA warned doctors to closely monitor Chantix patients. "We're beginning to look at this as an emerging safety issue," said FDA spokesperson Rita Chappelle.

Needless to say, the blogosphere has been ablaze with information, misinformation, and disinformation about Chantix from bloggers and forum posters. The anti-pharma agendas were out in full force, only too eager to hail "another Vioxx" and spin conspiracy theories about data cover-ups.

But for now, Pfizer has dodged the bullet. In January, the firm updated the label with a warning about neuropsychiatric symptoms. And in a press release, the company had to leave the door to this controversy slightly open. "In some reports, however, an association [between the adverse events and the drug] could not be excluded," it said. A few days later, Pfizer released its fourth-quarter financials. Surprising analysts predicting a drop in prescriptions, Chantix sales remained on track, surging to $280 million—just under $900 million for its first full year on the market.

For the Chantix team—whose branding strategy focused on changing patient behavior—to be hit with an unexpected controversy about uncontrollable patient behavior may be a bitter irony. Still, their confidence in their product remains unshaken. "People need to understand the difference between adverse events—which may have nothing to do with the drug—and side effects," said Martina Flammer. "We're not seeing a higher rate of side effects in the postmarketing reports than in the clinical trials." Looking ahead, she dismisses any talk of black-box warnings.

And while it is unwise to underestimate the public's capacity for irrationality about drug safety, Pfizer may know something the bloggers don't. "Every day we get e-mails, calls, and letters from patients who have stopped smoking after taking Chantix—when nothing else had ever worked," said Veronique Cardon. "That is a great achievement."

Finding a way to brand that message may be the Chantix team's next assignment.