Chantix recommended to quit smoking despite safety concerns

By CARLA K. JOHNSON
08 may 2008--The federal government's new advice to doctors for helping smokers quit recommends the drug Chantix, which has recently been linked with depression and suicidal behavior. The new guidelines mention the psychiatric risks but also say the popular Pfizer Inc. drug is the most effective at helping people get off cigarettes.
The guidelines mention other options, too, and highly recommend combining counseling and medication. But doctors are encouraged to talk to all smokers who want to quit about trying medication.
Consumer advocates cautioned that the safety picture on Chantix is incomplete because it's a relatively new drug, on the market just since 2006.
"It is somewhat better than other therapies; on the other hand, it appears to have more risk," said Dr. Sidney Wolfe of the watchdog group Public Citizen. "That part of the risk-benefit equation is missing, and it's changing rapidly."
Another issue with the quit-smoking guidelines, released this week by the U.S. Public Health Service, is the lead author's past connections with Pfizer. Dr. Michael Fiore, an expert on smoking and health issues, was a consultant to the maker of Chantix. But he said he cut those ties in 2005.
Fiore's views are shaped by his past ties to the drug industry, and those ties still pose a conflict, at least one consumer advocate said. John Polito, a smoking cessation educator who runs the WhyQuit.com site advocating quitting "cold turkey," called the revised guidelines "a sales pitch" for the drug industry.
The task force overlooked research showing that quitting cold turkey works, Polito said, and studies showing Chantix is superior don't reflect how it's used "in the real world."
"People are quitting smoking to save their lives," Polito said. If Chantix's risks outweigh its benefits, "then it's insane for people to risk their lives" by using it, he said.
The guidelines are based on an extensive review of scientific evidence, were reviewed by 90 independent experts and were endorsed by 60 public health entities, Fiore said, adding that his past financial ties to the drug industry had no influence.
"Independent reviewers of it came to the conclusion that this is a document that reflects the science, and that's what we were charged to do," Fiore said.
The guideline authors analyzed 83 studies and found that Chantix helped 33 percent stay off tobacco for six months after quitting, compared with a nearly 14 percent abstinence rate for dummy pills.
The guidelines recommend combining counseling and medication as the most effective way to kick the tobacco habit, stating "both counseling and medication should be provided to patients trying to quit smoking."
Medications have not been shown to be effective in certain groups, the guidelines say. Those groups include pregnant women, smokeless tobacco users, light smokers and adolescents.
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.
Lois Biener, a researcher of tobacco use and control efforts at the University of Massachusetts in Boston, said most people who quit do so without smoking-cessation drugs.
There's little evidence that these drugs are superior in the long run to quitting without help, and while a few studies have shown some benefit, it's "way less than what is claimed" by medication advocates, Biener said.
Three of 24 panelists who wrote the guidelines reported "significant financial interests" in the pharmaceutical industry, including speaking fees and stock ownership.