Healthy Skepticism Library item: 14298

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Herper M.
Can Chantix Make A Comeback?
Forbes.com 2008 Sep 12
http://www.forbes.com/home/2008/09/11/pfizer-smoking-chantix-biz-healthcare-cx_mh_0911chantix.html

Full text:

Pfizer will restart TV advertising for its Chantix anti-smoking drug on Sunday, nine months after voluntarily putting the campaign on hold as worries about a link between the medicine and suicidal thoughts and actions grew.

The spots run 90 seconds—30 seconds more than the ones Pfizer (nyse: PFE – news – people ) ran for just four months last year—and hew to the same narrative as the old one, using a race between a tortoise and a Belgian hare to dramatize the fact that quitting smoking that 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.”

“Some people think the drug has been withdrawn from the market,” says Veronique Cardon, team leader of U.S. marketing for Chantix. “More importantly, a lot of people haven’t heard of Chantix yet.”

The new campaign shows how pharmaceutical companies are trying to adapt the marketing of their products to a climate of hair-trigger concern over drug safety. But Pfizer faces other hurdles in launching Chantix, too. Its own communications to Wall Street before Chantix went on sale described the anti-smoking market as prone to dramatic sales spikes and stomach-heaving drops.

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.

Safety controversies only make that tougher. When ads are pulled because of new and serious side effects, some reappear in a longer form with more detail about the new risks, says Ruth Day, director of the Medical Cognition Laboratory at Duke University. This also happened with ads for Celebrex (also a Pfizer drug) after it was linked to an elevated risk of heart disease.

Day would not comment on the ad without seeing it. “It is good news if the serious risks are now present physically, but are they there functionally—in a way that people will understand and remember them?” she asks.

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.

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.

Sales of Chantix last quarter were down 35% in the U.S., although that decline was offset by international sales. Pfizer says Chantix has had a strong uptake in the U.K., France, Belgium and Japan. But analysts at Natixis still expect sales to come in $50 million short of last year’s total.

Even before Chantix was launched, Pfizer was trying to guard against the possibility that patients might be disappointed—and flee the drug en masse.

“We know in this marketplace with previous launches that there can be a rapid uptake followed by a steep decline,” Ian Read, Pfizer’s head of worldwide marketing, told analysts.

Marie-Caroline Sainpy, a Pfizer senior vice president, provided a similar insight on another occasion. “It’s a market which has a history, for the few drugs which have been launched, of very rapid acceptance and very strong disappointment, and the scripts go down very rapidly,” she said.

To prevent that kind of disappointment, Pfizer 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. About 6% of patients who have Chantix are enrolled in the program, called GetQuit, and each call between a patient and counselor lasts an average of 9.5 minutes.

Laurie Olson, a vice president at Pfizer, says the program and the outreach program are both 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