Pfizer's Full-Court Press to Save Chantix

In the wake of more of the same-more adverse event reports, more bad press, more patient and doctor fears, and more analysts eyeballing falling scripts and slashing projected sales-Pfizer has launched an exceptionally aggressive advertising and public relations campaign to defend Chantix.

Using every possible medium, from print to email to face time with reporters, the drug giant is aiming to shift public attention to the novel drug’s often-ignored benefit: it works better than any of the many other smoking-cessation techniques. Pfizer also hopes to change the channel from Chantix’s risks to smoking’s risks.

Whether these tactics-and the sheer presence of information about Chantix-will perpetuate reasonable risk/benefit discussions between doctors and patients remains to be seen. But in some important corners, Pfizer’s campaign may have the opposite of its intended effect. Rather than reassuring Wall Street that the company is out in front of the controversy, the outsize scope of the campaign has some analysts wondering if in fact all of this is prepping the public for when the other shoe drops.

The first-in-class targeted therapy-a nicotinic receptor partial agonist-both reduces cravings for, and decreases the pleasurable effects of, cigarettes. In clinical trials nearly 50 percent of patients on Chantix quit smoking for 12 weeks-an unprecedented success-although about half relapsed over the next 12 weeks.

But given that the drug boasts a novel mechanism of action that works on neurons in the brain, Pfizer has been faulted for not anticipating the eruption of a wide range of neuropsychiatric symptoms in small groups of patients once the lifestyle drug was mass-marketed. From the first, the firm downplayed adverse events reports, even presenting the drug’s risk profile as positive at its August 2006 launch. Since then a troubling list of CNS-related events has been reported by Chantix users, such as depression, aggressive behavior, sudden drowsiness, and, most ominously, suicidality. With FDA on its back, Pfizer dropped DTC ads last January and has changed the label three times, finally adding a bolded warning.

The breakthrough anti-smoking drug, which had been fast-tracked for approval by FDA, was used by more than 5 million smokers by January 2008 and, despite its aura of uncertainty, appeared to be on its way to blockbuster status with sales of $883 million last year. Analysts estimated that Pfizer’s leading new drug could hit $2.25 billion by 2012, when the company is due to lose as much as $13 billion in profits as Lipitor’s patent gets shredded.

Yet since January, new prescriptions for Chantix have dropped by half, according to Wolters Kluwer Health data reported before the current turmoil. Ironically, according to a more current analysis by ImpactRx, this downward trend was in fact beginning to turn in March

The current dustup began mid-May with a report by the Institute for Safe Medication Practices, a non-rofit watchdog group outside Philadelphia, concluding that “use of Chantix among persons operating aircrafts, trains, buses and other vehicles could cause serious injury.”
 A rash of new heart-related complaints was also detected.

The report prompted the Federal Aviation Administration and the Federal Motor Carrier Safety Administration to ban the use of the drug by pilots, air controllers, and truckers.

These new regs in turn prompted a barrage of negative headlines. What’s more, pharma’s congressional bete noir, Iowa Republican Sen. Charles Grassley, got wind of the report’s headline news that more adverse events had been reported about Chantix last year than any other drug. Now Grassley is investigating FDA’s decision to approve the first-ever designer drug to target smoking addiction.

That’s when Pfizer kicked its formidable damage-control machine into high gear. According to Pfizer spokesman Ray Kerins, the campaign includes:
• Full page ads in the nation’s five largest newspaper. Framed as an open letter from Pfizer Chief Medical Officer Dr. Joseph Feczko, it struck the two key notes-Chantix’s benefits and smoking’s risks. “We believe that the benefits of Chantix outweigh the risks, and that safety information about Chantix is appropriately reflected in the product's labeling,” Feczko wrote, and: “There are few things that provide greater health benefits than quitting smoking.”
• Five roundtable discussions with medical and health reporters, bloggers, and advocates in the nation’s five top markets, starting tomorrow at its New York headquarters.
• A “dear doctor” letter to 300,000 physicians.
• The relaunch of its Get Quit patient support program providing users with regular check-in emails and phone calls, with Mayo Clinic-certified coaches available at a toll-free number.
• Unbranded TV commercials promoting the lifesaving benefits of quitting smoking
So how does all this go down with financial analysts? “In the current safety-conscious environment, it is unclear whether additional regulatory action will be taken [such as a black box warning or even a withdrawal from the market],” Tim Anderson, senior analyst at Sanford Bernstein, wrote in a May 21 analysis. “What is clearer, however, is that [previous] sales forecasts for Chantix could be too high by as much as $500 million to $1 billion by 2012.” Anderson’s own forecast for 2008 sales has dropped from $1.14 billion to $909 million; his 2012 forecast has dropped from $1.65 billion to $720 million.

A best-case scenario suggests that Chantix will remain right on the verge of blockbuster status for the next few years before falling off (the smoking-cessation sales trajectory is much shorter than that of most drugs.)

Miller Tabac’s Les Funtleyder shared with Pharm Exec his decidedly more visceral reaction. “I was kind of stunned to see a full-page defense of Chantix by their chief medical officer in the Wall Street Journal,” he said. “That’s not exactly their prescribing audience,”

Funtleyder also sees Pfizer’s plans to educate the public about how to think about Chantix’s risk/benefit profile as an exercise in futility. More ominously, the analyst said, “To be honest, the campaign struck me as out of proportion to what the new safety issues and the few media stories warranted. So that makes me more, not less, concerned. Is this an attempt to prepare us for some really serious problems with Chantix up ahead?”

Repeated requests for comment went unanswered by Pfizer.