Minneapolis, MNWhile Pfizer continues to put a positive spin on Chantix, and the risk of suicide, at least one doctor acknowledges the risk of any medication that directly targets brain chemistry, given that the latter is such an individual thing, there is little room to predict how one person will fare on a drug, when compared against another.
For example, there will be one former smoker for whom Chantix proved effective, helping them kick a habit that before then seemed to be unbreakable. It was hard, and the side effects were unpleasant but manageable, and at the end of the day it worked. This story has been told many times.
But so has the following story, this time told by a woman from Minnesota. We'll call her Delores.
Delores writes that she began taking Chantix to quit smoking at the end of February. She read the warnings, which included a range of side effects, but none suggested increased depression, "or suicidal ideation. The drug worked miracles, smoking was horrible, and I successfully quit after about 1 1/2 weeks." She says the directions were to continue taking Chantix for 12 weeks, to be sure that the habit had been sufficiently kicked.
"But I started getting extremely irritable and 'down'," Delores says. "I've always suffered from extreme PMS symptoms—and here in Minnesota many of us get the end-of-winter-blues, awaiting more daylight and nice weather."
Delores also began to experience troubling nightmares, "and this began to concern me. I was having dreams of things I would never even think about, things that have never crossed my mind. For example, I dreamt of shadows coming out of my legs that were some sort of demon or devilish thing. I knew that the only way to get rid of these shadows was to cut my legs off." Poor Delores awoke the next morning, the dream still vivid in her mind, and panicked at the thought as to what she might have done. "This was my final straw," she says. "I thought it must be the Chantix. At this point I stopped taking it and began hearing people talk about their crazy dreams while taking it, too."
A few days went by and Delores' craving for cigarettes returned. "I thought, 'well, I'll give it another try…maybe it was a fluke.'" Five days later Delores quarreled with her mother, "which for us is no surprise," she says. "But this time I just snapped."
This is where Delores' story gets troubling.
"I decided to take a drive to clear my head. I ended up driving about 70 miles from my home. I was frustrated that I had gotten lost (it was 4am). I pulled off the road after passing the same farmer's field five times. At this point it's like I completely gave up…"
Delores took a pocketknife from her car, went into the woods and slit her wrists. Worse, she happened to be in a remote location in a field not readily visible from the unmarked, gravel road. "I severed the main artery, three tendons and two nerves in my left hand, and one tendon in my right. By the grace of God someone saw my car in the field and called 911. A police officer got to me at 1pm…" Delores was told she had been unconscious for about nine hours. "It is a miracle I am alive."
Delores goes on to say that she had never been one who wanted to hurt herself. "I have the most amazing and supportive friends and family, whom are all baffled. I have doctors telling me they have no idea. I seem to be 'normal' and had a random, intense impulse. I'm very strong, and have never considered suicide an option.
"This leads me to believe one thing...the Chantix."
On June 5th Pfizer, the manufacturer of Chantix, invited media to its headquarters to attend an event billed as a roundtable discussion on Chantix. What felt more like a press conference to participants who were there, Pfizer is reported to have articulated the following: that smoking is a serious health problem that kills people; most of the adverse events that have been reported recently are already on the Chantix label; smokers who are trying to quit can be depressed and irritable; and paying close attention to adverse-event reports helps the US Food and Drug Administration (FDA) and Pfizer enhance drug safety.
To the last point, Pfizer cautioned that post-market observational studies and adverse incident reports are not the gold standard inherent with clinical trials. The point was also made that the acknowledged incidents of suicide were inherent with real-world use, and not with clinical tests.
It should be noted that during clinical trials for Chantix, participants were carefully screened, and benefited from professional counseling as an adjunct to their attempt to quit smoking. And while the success rate for Chantix was seen to be better than Zyban, its closest rival, the vast majority of Chantix trial participants were unsuccessful in staying away from cigarettes.
Meantime, the adverse event reports just keep coming, and so too are the lawsuits…