n disappointing news for Pfizer, a study found that its controversial Chantix pill for quitting smoking failed to show any benefit over nicotine patches and lozenges among people trying to kick their habit.
Although the study did not question the effectiveness of the product, the findings may represent another hurdle in the quest to transform Chantix into a blockbuster seller. Ever since it was approved a decade ago, Chantix has been dogged by safety concerns, lawsuits, and languishing sales.
The study, which was published in the Journal of the American Medical Association, compared three approaches to quitting smoking in which 1,086 patients either used a nicotine patch, the Chantix pill, or a combination of a patch and nicotine lozenge.
The findings, which relied on lab tests to gauge carbon monoxide levels, did not find any statistically significant differences between the products at either six months or one year. At six months, for instance, the quit rate was 23 percent for the patch; 24 percent for Chantix; and 27 percent for a patch and lozenges. And at one year, the quit rate was 21 percent, 19 percent, and 20 percent, respectively.
Although equally effective as the other options, Chantix did yield higher side effect rates — about 29 percent of the patients experienced nausea, 23 percent reported having vivid dreams, and 22 percent suffered insomnia, according to the study.
Not surprisingly, the results greatly exceed so-called cold turkey quit rates that do not involve a medical intervention, which are usually between 3 percent and 5 percent. But the researchers said they were surprised by the outcome because previous studies found that both Chantix and the combination of a patch and lozenge were more effective than a patch alone.
Nonetheless, all of the approaches provide a “significant boost” compared with what would happen if someone tried to quit smoking without help, said Dr. Michael Fiore, who heads the University of Wisconsin Center for Tobacco Research and Intervention, and a coauthor of the JAMA study. He noted, by the way, that this was the first time that all three approaches had been contrasted in a head-to-head comparative study.
“This expands the options that physicians and smokers have,” said Fiore. “But one study doesn’t mean we throw out the prior research. We do need to respect this as a signal and replicate it in future studies. But it may also reflect that American smokers are changing over and smoking fewer cigarettes a day. Possibly, with those lighter smokers, they may not need as an intensive medication option.”
A Pfizer spokeswoman wrote us that “double-blind, randomized, placebo-controlled trials are more robust in evaluating the relative efficacy of a drug than open-label studies,” such as the JAMA study. And she pointed to such a study showing Chantix was more effective than a nicotine patch.
Even so, the results may pose yet another challenge to Pfizer, given that Chantix already carries a so-called Black Box warning – the most serious type of health alert – on its product labeling. The warning refers to side effects such as psychiatric risks, aggressiveness, suicidal thoughts, and hostility. Last year, a safety alert was added about a risk of seizures and to cut back on drinking alcohol while taking the drug.
The serious side effects spawned horrendous publicity and numerous lawsuits, which the drug maker spent hundreds of millions of dollars to settle. Two years ago, Pfizer unsuccessfully attempted to have the Black Box warning removed. Meanwhile, sales are sputtering, from $846 million in 2008 to $647 million in 2014. During the first nine months of last year, Chantix sales were $561 million compared with $640 in the same period the year before (see page 42).