“FDA questions Pfizer Study of Chantix Psychiatric Effects”

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Pfizer is petitioning the FDA to remove the black box warning for Chantix which focuses on neuropsychiatric side-effects like suicidality and depression. The regulators have pushed back, however, arguing that Pfizer’s studies are potentially biased and did not adequately capture adverse events.

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2 COMMENTS

  1. This is simply incredible! I follow Chantix closely and am astounded at the degree of Pfizer involvement in every study. A telling study was done by an epidemiologist at UCSD, normally a bastion of corruption, greed, and hubris. He found that since the introduction of Chantix, quit rates have

    Based on responses from more than 39,000 smokers, overall use of pharmacotherapy increased from 28.7 percent of smokers trying to quit in 2003 to 31.1 percent in 2010-11, representing a 2.4 percent increase.

    This slight increase in the use of cessation aides, however, did not translate into more smokers breaking the habit. In 2003, approximately 4.5 percent of smokers reported successfully quitting for at least a year, compared with 4.7 percent in 2010-11.

    That’s a 1% increase on a paltry percentage. Still paltry. And what have individuals, health insurers, and medicare/caid shelled out for this result?

    Not to mention the horrible and sometimes permanent changes to one’s mental state.

    I took it for a while about a year after undiagnosed akathisia had driven me to smoke. I would have snorted Ajax if I thought it would help. I became dependent right away. On Chantix, the obvious need to kill myself asap would swoop down from the heavens and perch in my brain. It was a TERRIBLE visitation, delivering an expansive sense of hopelessness and eternal loss with the certainty of a right hook to the head. My IdiotDoctor® hadn’t told me of any side effects, but something inspired me to look at the insert. I didn’t talk to my doctor for months after that. I did begin to see the value of looking at the inserts.

  2. Er, not every study. Pfizer didn’t fund the epidemiologist’s study, which is here:
    https://health.ucsd.edu/news/releases/Pages/2015-08-17-smoking-aid-doesnt-boost-number-of-people-who-quit.aspx

    Two years before, this came of out UCSD’s shillboy, Robert Anthenelli. And it had smokers who smoked as few as ten cigarettes per day. That’s like studying alcoholics who drink 3 beers per day.
    https://health.ucsd.edu/news/releases/Pages/2013-09-16-varenicline-helps-smokers-with-depression.aspx
    Anthenelli is a scientific advisor to Pfizer, Inc., manufacturer of Varenicline. He receives no personal income and his services have been contracted by The Regents to Pfizer. As a result of this contractual arrangement, Anthenelli receives funding to support research and other University activities.