In a previous post, I described how Pfizer dragged its feet in reporting to the FDA suicides associated with the use of it stop-smoking drug, Chantix. But in fairness, I suppose I should point out that not everybody who takes Chantix kills himself.

Sometimes they kill other people instead. And sometimes, they do both.

(N.B.: The active ingredient in Chantix is called varenicline. Outside the USA, the same drug is marketed as Champix.)

In September of 2008, 62-year-old Kenneth Heath of Canaan, Vermont, shot and killed his mother for no apparent reason when she came to check on him at his home. Heath, who had a history of mental problems, had begun taking Chantix several weeks previously. Two days before the shooting, his mother became concerned by his increasingly odd behavior and took him to the hospital, where doctors advised him to discontinue the drug. Attorneys for both the prosecution and the defense agreed that Chantix had affected Mr. Heath’s mental state, and he pleaded no contest to a charge of voluntary manslaughter.

In May of 2009, 34-year-old Sean Wain of Economy, Pennsylvania, murdered his wife of fourteen years with a shotgun blast before turning the gun on himself, leaving their four small children orphaned. Neighbors and the family pastor said they had seen no sign of any marital discord prior to the shootings. Mr. Wain had begun taking Chantix a week or two earlier.

In July of last year, 33-year-old delivery driver Andrew Case stabbed his wife Vicki to death, then smothered their two little girls before hanging himself. Mr. Case had begun taking Champix two weeks earlier.

A study published in PLoS One provides further evidence of a link between Chantix and violence. Thomas J Moore of the Institute for Safe Medication Practices and his colleagues analyzed adverse drug event reports submitted to the FDA for the period beginning in 2004 and ending with the third quarter of 2009. Only drugs for which at least 200 adverse events were reported were included in their analysis – a total of 484 drugs in all. For each of these drugs, Moore et al. tabulated the incidence of violence case reports, which they defined as physical abuse, physical assault, homicidal ideation, and homicide.  

For the majority of these 484 drugs, there were no violence case reports. For most of the rest, there were only one or two such reports. Varenicline stood out from the pack with a whopping 408 violence case reports, or 21% of the total. The proportion of violence case reported for varenicline was eighteen times the average for all other drugs.

Why is anybody surprised? If this stuff really can kill your desire to smoke, what the Hell else is it doing to your brain? Who knows? Certainly not Pfizer, or the docs who prescribe this stuff.

In fairness, I should point out that some of the people who committed suicide or homicide after taking Chantix had mental problems even before they started on the stuff (although many of them did not) and so what? It stands to reason that people who already have mental problems will tend to be the ones who are most likely to be pushed over the edge into madness.

And it’s not as if mental problems are unknown among smokers. In fact, smokers are more likely to suffer from mental problems than the general population, and yet the clinical trials which formed the basis for FDA approval of Chantix (all of which were paid for by Pfizer) specifically excluded anyone suffering from a history of alcohol or drug abuse, major depression, panic disorder, bipolar disorder, or psychosis. They also excluded anyone with a history of cancer, COPD, cardiovascular disease… the list goes on and on.

The whole point of a clinical trial is, or ought to be, to determine if a drug produces significant benefits which are broadly applicable to the general population. But not only did the FDA let them get away with excluding people with all of the aforementioned conditions, they didn’t even require Pfizer to warn consumers that the safety and effectiveness of Chantix had not been determined for anyone suffering from any of these conditions.

And it’s icing on the cake to point out that there are no data that show this stuff is any better than quitting cold turkey, outside of highly artificial clinical situations which have no relevance to real life. Only about one out of twelve study participants did better with Chantix than they would have with a placebo, and this was after excluding one-third of prospective study participants and providing the rest with stop-smoking support beyond the wildest dreams of the average quitter.

Over 46 million Americans have quit smoking. 90% of those who quit did so cold turkey. And yet, guidelines published by the Office of the Surgeon General state that, in the absence of specific contraindications, people should not try to quit without pharmaceutical assistance.

Oh, by the way, the panel report that contains those guidelines mentions that Dr. Michael C. Fiore, the panel chair, holds an endowed professorship at the University of Wisconsin funded by GlaxoSmithKline, the makers of Wellbutrin, Commit lozenges, Committed Quitters, NiQuitin/Nicoderm/Nicabate, and Nicorette – all drugs whose use is recommended by the report.

The whole notion of a stop-smoking drug creeps me out, anyway. How about a change-a-flat-tire-in-the-pouring-rain drug? How about a move-your-sofa drug? Am I the only one who is disturbed by this vision of ourselves as beings who have no need for self-control, self-discipline, or free will? Just pump us full of the right drugs and we’ll do whatever our masters want.

In response to the PLoS study, a spokesperson for Pfizer told Ed Silverman of Pharmalot, “There is no reliable scientific evidence that Chantix causes violent thoughts or actions. We have not had the opportunity to review this study or its underlying data. As the authors themselves acknowledge, however, the study has many limitations, and these limitations are obviously very significant.”

Where do they find people who can make statements like that with a straight face? Don’t these guys just kill you?

Photo via Wikimedia Commons