Quitting Smoking Can Be Dangerous to Your Health

How Pfizer and the FDA dropped the ball on a blockbuster anti-smoking pill.

Late one morning in June 2008, 57-year-old Southern California real estate agent Linda Ware was driving with her cousin along a desolate highway near Lancaster when she began hallucinating. Envisioning in the distance a sign that read “God Is in the Realm,” she pulled over suddenly and ordered her cousin out of the car. Then, just as abruptly, Ware burst out laughing and—before her cousin could do anything—pulled back onto the road again.

This was weird behavior, to say the least. Although Ware suffered from depression, as her daughter Cary Ussery later told me, she’d never acted like this. A few days earlier, however, she had started taking Chantix, a pill meant to help her quit smoking by suppressing the effects of nicotine on the brain.

The day after the driving incident, a family friend found Ware slumped by her bed, dead from a fatal cocktail of prescription drugs, a suicide note at her side.

While Chantix has helped some smokers kick the habit, its record has been plagued by tragedy ever since it was first approved by the Food and Drug Administration in May 2006. By mid-2009, the agency had received reports of nearly 300 suicide attempts—about a third were successful—and close to 5,000 serious psychiatric events in all, including symptoms like psychosis, blackouts, and aggression. Hundreds more reports have streamed in since.

While people with mental health problems are overrepresented among smokers (and, therefore, potential Chantix users), a review of the drug’s history shows that Pfizer, its manufacturer, never tested Chantix on people with psychiatric problems—including people with a recent history of depression. FDA regulators, for their part, approved Chantix after a sped-up “priority review” process; the agency didn’t bother asking Pfizer to do a follow-up study on mentally ill Chantix users, even though its own safety reviewer reported that the exclusion of these smokers may have undermined the clinical trials.

Only after three years and reports of thousands of serious side effects did the FDA finally ask Pfizer to conduct trials on this group; it also slapped a black-box warning, the agency’s strongest alert, on the medication. But by that time, claims of problems with the drug had triggered a torrent of lawsuits.

Some 1,000 cases are now pending in federal court, and plaintiffs’ lawyers expect they’ll bring at least 1,000 others. About half of the current batch is related to suicides or suicide attempts, the lawyers say.The lawsuits argue that Pfizer—the world’s largest pharmaceutical company, with sales of more than $60 billion this year—neglected to test Chantix adequately prior to its release, hid evidence of potentially serious side effects, and failed to sufficiently warn consumers of its risks. Pfizer counters that it “acted responsibly and appropriately at all times in connection with the development, approval, and marketing.” The FDA also says it acted properly. “The agency does not feel any mistakes were made,” says spokeswoman Sandy Walsh. “We can never speculate as to what may happen with a drug once it goes into widespread use after approval.”

But the agency’s failure to insist that psychiatric patients be included in the clinical trials points to a potentially serious flaw in FDA safety practices. While the mentally ill are commonly excluded from drug trials, they are a key part of Pfizer’s target market in this case. “You need to think about who is going to be taking the drug,” says Dr. Karen Lasser, a Boston University physician and researcher who has studied the link between mental illness and smoking and says she was baffled by the oversight.

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