2007-11-21
drug wars / big pharma
I predict that Pfizer Corporation will have more problems with its experimental stop-smoking drug Chantix [Varenicline], especially as docs use it while trying to get psychiatric patients to quit.
Although clinical practitioners minimize the potential negative impact, The American Journal of Psychiatry, in its August 2007 edition, has already published two reports of problems with using Chantix for people with long-term mental disorders. Here are the links to the recent case reports: Exacerbation of Schizophrenia by Varenicline by Robert Freedman, M.D., and Varenicline-Induced Manic Episode in a Patient With Bipolar Disorder submitted by Izachak Kohen, M.D., and Neil Kremen, M.D.
The USA Food and Drug Administration, only this week, warns that healthcare professionals should monitor patients taking Chantix for behavior and mood changes. The FDA watch site also notes that "...There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment."
My own personal observations occurred with a close friend long diagnosed with schizophrenia. My friend has smoked for a few decades and, for economic reasons, really wanted to quit. He began taking Chantix as prescribed. Within a couple of days reported disorienting phenomena such as double vision and blanking out. He asked a lot more reality-testing questions ["can you hear my thoughts?"] than usual. It bothered him. In less than a month he was admitted into the psyche ward of one of Connecticut's general hospitals. I reported my observations to the clinical staff there. Although I've known the man since the 1980s, the Chief clinical psychiatrist [who, incidentally, prides himself as a researcher] and who had observed my friend less than two weeks, completely discounted my observations as total bunkus, and began to rant at me comments about Chantix that made me wonder if he were on Pfizer's payroll.
I'm not saying that he is, mind you, but he was clearly more inclined to listen to the drug company's PR propaganda than observed reality. Frankly, I suspect that his point of view is typical. Testing my newfound suspicions with pharmacists and docs where I work I found the same Pollyanna-like faith expressed in Pfizer that the community psychiatrist exhibited.
It is important to note that Pfizer's clinical studies involved less than 5,000 individuals. I doubt that any were people with long-term psychiatric disabilities or any other medical problems. The American Heart Association estimates that 25.6 million men (25.2 percent) and 22.6 million women (20.7 percent) are smokers in the USA alone. That's a mighty tempting market for Pfizer to court. But it also means the control studies population was less than 1/1,000th of a percent of that population.
Pfizer is aggressively targeting that market, both with TV adverts and easy to navigate websites like Chantix Home. They don't care about adverse impacts at all, except maybe to the company's bottom line. Even the Wall Street Journal has reported on the profit potential, yet acknowledges there seems to be a dark side.
Let's insist that the FDA, and other watchdogs, work harder at keeping this aggressive marketer [and pill pusher] in line.
For a thoughful ongoing discussion about the risks of Chantix check out Furious Seasons and the thread Pills, booze and Chantix. A German site, Boocompany, also has posts from readers who report adverse reactions including depression, psychosis and suicidal acts.
Although clinical practitioners minimize the potential negative impact, The American Journal of Psychiatry, in its August 2007 edition, has already published two reports of problems with using Chantix for people with long-term mental disorders. Here are the links to the recent case reports: Exacerbation of Schizophrenia by Varenicline by Robert Freedman, M.D., and Varenicline-Induced Manic Episode in a Patient With Bipolar Disorder submitted by Izachak Kohen, M.D., and Neil Kremen, M.D.The USA Food and Drug Administration, only this week, warns that healthcare professionals should monitor patients taking Chantix for behavior and mood changes. The FDA watch site also notes that "...There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment."
My own personal observations occurred with a close friend long diagnosed with schizophrenia. My friend has smoked for a few decades and, for economic reasons, really wanted to quit. He began taking Chantix as prescribed. Within a couple of days reported disorienting phenomena such as double vision and blanking out. He asked a lot more reality-testing questions ["can you hear my thoughts?"] than usual. It bothered him. In less than a month he was admitted into the psyche ward of one of Connecticut's general hospitals. I reported my observations to the clinical staff there. Although I've known the man since the 1980s, the Chief clinical psychiatrist [who, incidentally, prides himself as a researcher] and who had observed my friend less than two weeks, completely discounted my observations as total bunkus, and began to rant at me comments about Chantix that made me wonder if he were on Pfizer's payroll.I'm not saying that he is, mind you, but he was clearly more inclined to listen to the drug company's PR propaganda than observed reality. Frankly, I suspect that his point of view is typical. Testing my newfound suspicions with pharmacists and docs where I work I found the same Pollyanna-like faith expressed in Pfizer that the community psychiatrist exhibited.
It is important to note that Pfizer's clinical studies involved less than 5,000 individuals. I doubt that any were people with long-term psychiatric disabilities or any other medical problems. The American Heart Association estimates that 25.6 million men (25.2 percent) and 22.6 million women (20.7 percent) are smokers in the USA alone. That's a mighty tempting market for Pfizer to court. But it also means the control studies population was less than 1/1,000th of a percent of that population.
Pfizer is aggressively targeting that market, both with TV adverts and easy to navigate websites like Chantix Home. They don't care about adverse impacts at all, except maybe to the company's bottom line. Even the Wall Street Journal has reported on the profit potential, yet acknowledges there seems to be a dark side.
Let's insist that the FDA, and other watchdogs, work harder at keeping this aggressive marketer [and pill pusher] in line.
For a thoughful ongoing discussion about the risks of Chantix check out Furious Seasons and the thread Pills, booze and Chantix. A German site, Boocompany, also has posts from readers who report adverse reactions including depression, psychosis and suicidal acts.
Labels: big pharma, Chantix, drug profits, drug risks, Pfizer, psychosis
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