According to an article at MSNBC.com, a “breakdown” in surveillance of the adverse effects of Chantix has led to an underestimate of the potential harm caused by the drug, with an additional 150 Chantix-associated suicides having not been reported to the FDA.
According to the article: “Hundreds of reports of suicides, psychotic reactions and other serious problems tied to the popular stop-smoking drug Chantix were left out of a crucial government safety review because Pfizer Inc., the drug’s manufacturer, submitted years of data through ‘improper channels.’ Some 150 suicides — more than doubling those previously known — were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices.”
“’We’ve had a major breakdown in safety surveillance,’ said Thomas J. Moore, the ISMP senior scientist who analyzed the data. The serious problems — including reports of completed suicides, suicide attempts, aggression and hostility and depression — had been mixed among some 26,000 records of non-serious side effects such as nausea and rashes, with some dating back to 2006, the year Chantix, or varenicline, was approved. They echo previous claims that the drug can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and sudden, violent outbursts. ‘It’s really chilling,’ said Moore, who analyzed 26 Chantix reactions in a paper published in the September 2010 issue of the Journal of Pharmacotherapy. ‘This seems to unleash something in people. It can be violence to anything around.’" …
“Moore, who has served as an expert witness in court regarding Chantix, said it's the riskiest drug among those analyzed from the FDA's adverse event reports. In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities logged as any other drug, he said. … 'To us, it raises questions about whether this drug is safe for widespread clinical use,' Moore said. 'Does this tip the balance?'"
According to the article, there have now been a total of 272 suicides associated with Chantix use. Pfizer continues to deny that there is a causal link between the drug and these suicides.
The Rest of the Story
The most interesting aspect of this story is why anti-smoking groups that have called for a ban on electronic cigarettes, for which there have been adverse reports of zero suicides or deaths, are not calling for the removal of Chantix from the market, in light of the 272 suicides that are potentially linked to almost immediate neuropsychiatric effects of the drug.
The argument in favor of keeping Chantix on the market is that the benefit of its use in smoking cessation outweighs these potential side effects. That’s fine, but why doesn’t the same reasoning hold for electronic cigarettes. Given that e-cigarettes are helping thousands of people to quit smoking or cut down substantially on the amount that they smoke, shouldn’t they remain on the market? Don’t these benefits outweigh the risks, especially when there are no known risks, as not a single severe adverse event has been reported despite more than four years of widespread use?
The answer appears to be two-fold. First, the anti-smoking groups advancing this inconsistent policy on smoking cessation aids are all funded by Big Pharma. Most, if not all of them, have received money from Pfizer itself.
Second, there is an ideological block in the tobacco control movement which does not allow these groups to possibly view as favorable a product which simulates smoking behavior, even if it may save lives.
I believe that some form of relatively safe nicotine delivery in the form of a cigarette-like device is going to be the most important intervention of our time to reduce smoking-attributable morbidity and mortality. Just last week, Philip Morris International purchased rights to a product which delivers nicotine vapor through a device similar to an electronic cigarette, except that there is no electricity or heat involved. Instead, a chemical reaction takes place which results in the release of nicotine vapor, which is inhaled by the user.
Ironically, it is the anti-smoking groups which stand as the main roadblock between these interventions and their use in preventing smoking-related disease. You see, it’s not acceptable to quit smoking unless you quit smoking in the way we tell you to quit smoking. Doing so in a manner that simulates smoking is not OK. You must use the least effective of approaches: pharmaceutical agents that only address the pharmacologic aspects of smoking addiction, not the critical physical, behavioral, and social aspects of the addiction.
It might be the least effective method, but at least the financial relationship between the anti-smoking groups and pharmaceutical companies are not threatened. I have demonstrated how much money influences the anti-smoking groups, and nowhere is that money talking more than in the area of approaches to smoking cessation.
ADDENDUM (June 2, 2011 - 4:53 pm): I was just informed by Altria Client Services that it was Philip Morris International that acquired the rights to the technology described above, not Altria. I apologize for the error.