Mentally Ill Excluded in Chantix Clinical Trials

Washington, DCThe reality that Chantix was fast-tracked for approval by the US Food and Drug Administration (FDA), together with the FDA's failure to require Chantix manufacturer Pfizer to include depressed and mentally ill patients in the product's clinical trials, has left experts and advocates baffled, according to fairwarning.org in a story appearing in the December 19 issue of the Houston Chronicle. The risk for Chantix suicide as a major adverse reaction, say Chantix critics, is hardly surprising.

Fairwarning.org reminds us that Chantix appeared to be so promising from the outset that the FDA, for reasons unexplained, gave Pfizer the green light for an accelerated approval without initial requirement for follow-up studies on mentally ill patients. The absence of depressed or mentally ill patients from clinical trials is also a curiosity, given that most people who continue to smoke tend to suffer from depression, anxiety, or some other form of emotional instability or mental illness.

As a result, the primary constituent for Chantix smoking cessation was never consulted. Critics have alleged previously that excluding depressed or emotionally unstable participants, together with the inclusion of companion counseling during the clinical trial window, afforded trial participants the best chance for success, and gave Pfizer the best opportunity for a positive outcome.

Fairwarning.org recounts the heartbreaking story of Linda Ware, who began taking Chantix in 2008 in an attempt to stop smoking. Within days, Ware is reported to have experienced episodes of hallucination. While driving with a cousin in a remote rural area, Ware is reported to have seen a sign by the side of the road that said 'Gold is in the Realm,' after which she abruptly stopped the car, ordered her passenger out, then just as abruptly broke into uproarious laughter.

Ware's daughter told fairwarning.org that while her mother suffered from depression, there had never been prior examples of such bizarre behavior from her mother.

One day later, Ware, who worked as a real estate agent in Cypress, California, was found dead in her room, accompanied by a suicide note and empty pill bottles.

Between May 2006—when Chantix was approved by the FDA—and mid-2009, the nation's drug agency had received reports of nearly 100 actual suicides, 200 attempted suicides and somewhere in the neighborhood of 5,000 reports of serious psychiatric events. This year, according to fairwarning.org, there have been hundreds of additional reports.

While the FDA has since mandated Pfizer to conduct clinical trials on the mentally ill for Chantix and suicide, as well as various other Chantix side effects, the requirement came three years after Chantix was approved without such information.

Chantix manufacturer Pfizer stands behind its product and the process involved in bringing Chantix to market. Pfizer, according to fairwarning.org, "acted responsibly and appropriately at all times in connection with the development, approval, and marketing" of the drug.

The FDA, likewise, says it acted properly. "The agency does not feel any mistakes were made," said FDA spokeswoman Sandy Walsh in a statement. "We can never speculate as to what may happen with a drug once it goes into widespread use after approval."

It should be noted that mentally ill patients are normally excluded from clinical trials. However, fairwarning.org reported that the FDA's own safety reviewer noted that excluding the mentally ill might have undermined clinical trial results.

Given the disproportionate number of smokers that fall within the mentally ill profile, the exclusion baffles experts like Dr. Karen Lasser, a researcher at Boston University who studies the link between mental illness and smoking.

"You need to think about who is going to be taking the drug," she said in comments obtained by fairwarning.org. Chantix warnings now include a black box warning for, among other Chantix side effects, Chantix suicide and Chantix aggression. Many sectors, such as the airline industry and the military, have outlawed the use of Chantix by pilots and anyone who operates heavy machinery or firearms. More than 1,000 lawsuits are either percolating through or headed for the courts.