Why are Drugs Like Chantix FDA Approved?

chantix

Chantix is the commercial name for varenicline, a quit-smoking drug developed by Pfizer and approved by the FDA in 2006. It’s the most popular smoking cessation drug and has generated $647 million in revenue for Pfizer in the past year alone. On March 9, 2015, the FDA finally warned the public that Chantix has been associated with seizures and that patients who drink while taking the drug are at higher risk of becoming aggressive and/or blacking out.

Though such warnings are usually made at the time of a label change, the FDA ordered the update to the label last September. A previous label update occurred in 2009 which included a warning, highlighted by a black box, of neuropsychiatric side effects such as depression, suicidal thoughts, agitation and hostility.

Growing awareness of the cardiovascular harm caused by Chantix goes back at least to 2011, when the New York Times Business section reported on a study of the drug by the Center for Drug Evaluation and Research in which Dr. Celia Winchell lead researcher and Dr Curt D. Furberg, senior author and a Wake Forest professor of medicine, analyzed 14 randomized clinical trials on 8200 patients. They found that one extra cardiovascular event could be expected per 28 patients treated, with serious cardiovascular events (serious stroke and heart attack) occurring at a rate of 1.06 percent of Chantix users, compared to a rate of 0.82 percent in the study population of smokers without cardiovascular history receiving placebo versus Chantix. Dr. Furberg announced in a public statement: “We have known for many years that Chantix is one of the most harmful prescription drugs on the U.S. market, based on the number of serious adverse events reported to the FDA. It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we can add serious cardiovascular events.”

Reports of harmful neuropsychiatric effects have been reported by New York Magazine, ABC News, and a site dedicated to first-hand accounts of adverse reactions to Chantix. Given what we know about Chantix, why is there not more public outrage against Pfizer and more corporate news stories warning of the dangers of Chantix, and why was it FDA approved in the first place? There are critical reports to be found if one digs deep enough, but relatively few compared to the volume of negative coverage of e-cigarettes. Imagine if e-cigs were found to be linked to seizures, depression, aggression, worsening diabetes, etc. The news would be everywhere non-stop.

One could argue that stories about e-cigs are inherently more newsworthy because they involve a more novel drug intake method, but there’s other factors involved. It’s no secret that Big Pharma companies are among the biggest advertisers on corporate news stations. According to TrueCostofHealthcare.org, from 2003 to 2013, GlaxoSmithKline spent nearly 42 billion dollars on marketing. It’s not a stretch to imagine that some of that money might go towards attacking industries such as e-cigs which hurt their profits. According to Statista, from 2008 to 2014 Pfizer spent 3.8 billion dollars on advertising. With that much money at stake and considering the growing corporate ownership of mass media, it’s more likely than not editorial decisions are influenced either directly or indirectly. The Huffington Post pointed out how Pfizer’s Chantix television advertisements are themselves problematic in the way they sidestep legal requirements and critical analysis. The messages of corporate news and advertising is also a probable explanation for why many anti-smoking activists are more likely to oppose e-cigs than smoking cessation pharmaceutical drugs which are potentially more harmful.

Pfizer is conducting an additional safety study of Chantix and will release the results of the trial in late 2015.  However, given that the drug brought in $647 million in revenue in 2014, it’s unlikely Pfizer will release data harmful enough to compel the FDA to remove the product from the market.

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One response to “Why are Drugs Like Chantix FDA Approved?

  1. Pingback: Why are Drugs Like Chantix FDA Approved? | Ecigvaporsonline·

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