Pfizer has restarted TV advertising for its Chantix anti-smoking drug. Earlier it had been put on hold following concerns that it could lead to suicidal tendencies.
The spots run 90 seconds, 30 seconds more than the ones Pfizer ran for just four months last year. As with the old narratives, the new ones too use a race between a tortoise and a Belgian hare to say that quitting smoking favors the slow and steady--and that Chantix can help.
Side-effect information takes up 41 seconds of the advertisement, with about 20 seconds devoted to a warning that patients taking Chantix should stop taking it if they experience agitation, suicidal thoughts or suicidal behavior. Pfizer says the role of Chantix in those symptoms is "not known."
The drug's success is particularly important as it tries to match the success of older medications like Lipitor, which loses patent protection in just three years. Pfizer shares have fallen 25% in 12 months.
Chantix, launched in May 2006, is the only drug designed specifically to combat nicotine addiction ever sold in the U.S. Previous stop-smoking aids either contain nicotine, like gums and patches, or are re-purposed antidepressants. Chantix is more effective than Zyban, an antidepressant, but the large majority of patients still don't succeed in stopping smoking. Doctors say there is a huge need for new options. In 2007, Pfizer booked Chantix sales of $883 million.
That early success came without the support of any direct-to-consumer advertising. Drug industry critics had suggested drugs be marketed for a year before advertising began, and Pfizer did exactly that, running the first of its tortoise and hare ads for Chantix in September 2007.
But as soon as the ads started, so did the controversy did. An up-and-coming musician who was taking Chantix was shot on Sept. 3, 2007 after a night of strange behavior; he had also been drinking. The case drew national attention.
Last November, the Food and Drug Administration issued an alert saying it was looking into neurological and psychological side effects for Chantix. In January, Pfizer and the FDA added concerns about those side effects to the drug's label, which serves as a guide for doctors and the basis for claims in advertising. At that point, Pfizer stopped airing ads that advertised Chantix by name.
Then in May, the Institute for Safe Medicine Practices issued a report linking Chantix to more side effects, including traffic accidents. Federal regulators warned first pilots, then truckers, not to take the drug.
Psychiatric side effects are a particular concern for an anti-smoking drug because the mentally ill are more likely to smoke than other people. The vast majority of schizophrenics use tobacco, and 40% of cigarettes are sold to people suffering from mental illness.
Pfizer itself paired Chantix with a support program that costs about a quarter of every $120 Chantix prescription. Pfizer pays 16 counselors trained at a special Mayo clinic program to respond to Chantix customers who are feeling the urge to smoke.
Laurie Olson, a vice president at Pfizer, says it is all about helping patients face the "daunting" task of quitting. "We need to empower patients," she says.
Not everyone agrees that Chantix is the way to provide that empowerment.
Elliot Wineburg, who runs the Stop Smoking Medical Center in New York, says Chantix is "not anywhere near the number one technique available." He uses nicotine replacement, antidepressants and hypnotherapy first and says he has only needed to turn to Chantix once.
But some doctors defend Chantix.
"It would be a major public disservice if the few people with negative experiences get in the way of the smokers who are dying early from their inability to quit," says Carlos Roberto Jaén, head of family and community medicine at the University of Texas Health Science Center at San Antonio. He has no financial ties to Pfizer.
Pfizer says that some cases where there were neurological and psychiatric symptoms associated with Chantix may have been complicated by nicotine withdrawal. An analysis of neurological and psychiatric effects in placebo-controlled Chantix studies of 5,000 patients will be presented at a medical meeting in Rome later this month.