Chantix Promoted By US Government in Guidelines Written by Former Pfizer ConsultantMay 8, 2008 | Parker Waichman LLP
Health officials in the federal government are urging smokers to use Chantix as part of their efforts to stop smoking - despite the drug's association to suicidal thoughts and behavior. New smoking cessation guidelines, published by the US Public Health Service, do note that Chantix has been linked with suicide and other psychiatric side effects. But they promote the Pfizer drug as the method most likely to help smokers wanting to quit. The new guidelines are creating controversy, not only because of the strong Chantix recommendation, but also due to the fact that their lead author, Dr. Michael Fiore, has ties to Pfizer.
Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.
In the US, 34 Chantix users have reportedly committed suicide. According to an FDA Nov. 20 Early Communication, the agency said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases was not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, the FDA said it was working with Pfizer to finalize a Medication Guide for patients. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency's highest safety alert.
Considering the recent FDA notices, it is not surprising that the US Public Health Service's Chantix recommendation is raising eyebrows. Critics say Chantix has not been on the market long enough to known the true extent of its suicide risks, or what other side effects it might carry.
Other critics have said that Dr. Fiore's involvement makes the guidelines little more than a Chantix sales pitch. Fiore was once a paid consultant to Pfizer. Though he says he cut ties with Pfizer in 2005, critics say those ties could still cause him to be biased in favor of Chantix.
According to the Associated Press, the new guidelines encourage doctors to speak with their smoking patients about Chantix, and claim it works better than other methods or drugs. The guidelines say doctors should consider asking about their patients' psychiatric history before prescribing Chantix. Doctors also should monitor patients for changes in mood and behavior while on the drug.
But some smoking experts question claims that Chantix is more effective than other smoking cessation methods. Lois Biener, a researcher of tobacco use and smoking cessation efforts at the University of Massachusetts in Boston, told the Associated Press that most people who quit do so without smoking essation drugs. While a few studies have shown some benefit, it's "way less than what is claimed" by medication advocates, Biener said.