Pfizer: Chantix - Quitting Smoking Can Be Dangerous to Your Health | Mother Jones

The exclusion of mentally ill subjects from drug trials, researchers say, can be justified in some cases; sometimes the people are too sick to give their consent—or they stray from the recommended course of treatment. (See our recent piece about corruption in clinical trials for the psych drug Seroquel.) Excluding them also makes it easier to evaluate trial results. But many experts say it also leaves the real-world effects of the drugs in question, since an estimated one in four Americans adults—close to 60 million people—suffer from a diagnosable mental disorder in a given year. (About 6 percent of US adults have a serious mental illness, adds the National Institute of Mental Health.)

These numbers are especially relevant for Chantix, given the higher rates of smoking among people with mental illness. In April 2010, for example, the Centers for Disease Control and Prevention reported that 43 percent of adults with depression smoke, compared with 22 percent of those who aren't depressed.

In November 2007, the FDA issued a notice that some patients taking Chantix had reported suicidal thoughts and erratic behavior. ("Posting this information," it clarified, "does not mean that the FDA has concluded there is a causal relationship between the drug products and the emerging safety issue.") Two months later, the agency ordered revised labeling, indicating that Chantix's safety for mentally ill patients had not been established. The Federal Aviation Administration, meanwhile, banned pilots and air traffic controllers from using Chantix.

But it wasn't until July 2009 that the FDA belatedly embraced the notion of testing Chantix on the mentally ill. "There is a disproportionate [number who] smoke, and they would be potentially exposed to this drug," said Dr. Curtis Rosebraugh, an FDA drug evaluation official, in a media briefing. "We have no idea if that subgroup population is at higher risk or not, and so we do want to get some sense of that."

via motherjones.com

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