Tuesday, March 17, 2009

Evidence Mounting that Chantix May Be Associated with Suicidal Ideation and Behavior; Anti-Smoking Movement Plays a Role in This Possible Tragedy

According to a news article published in the current issue of the Journal of the American Medical Association (JAMA), evidence is mounting that supports the conclusion that use of the smoking cessation drug varenicline (Chantix) is associated with suicidal ideation and behavior in a substantial number of treated patients (see: Kuehn BM. Studies linking smoking-cessation drug with suicide risk spark concern. JAMA 2009;301(10):1007-1008).

According to the article: "A new analysis by the US Food and Drug Administration (FDA) adds to evidence that varenicline might be associated with an increased risk of suicidal thoughts and behavior, including among patients with no psychiatric history. The results, which were published in January, follow warnings from the agency that such a link is likely, as well as label changes noting a possible risk. ... An analysis of adverse event reports submitted to the FDA between May 2006 (when varenicline was approved) and November 2007 found 116 cases of suicidal ideation and 37 cases of suicidal behavior, more than half resulting in death. Half of the patients reporting either suicide ideation or suicidal behavior had a history of psychiatric problems, 26% had no such history, and 24% had an unknown psychiatric history."

The FDA report released earlier this year did not draw any definitive conclusions regarding the link between Chantix and suicidal behavior, although the data presented were cause for great concern. The report concluded: "Together, the AERS [Adverse Effect Reporting System] data suggest a possible association between suicidal events and the use of varenicline and bupropion. Healthcare providers are reminded to closely monitor patients for neuropsychiatric symptoms (e.g., changes in behavior, agitation, depressed mood, and suicidal thoughts and behavior) while they are using varenicline and bupropion as smoking cessation aids. Healthcare providers should report any cases of suicidal ideation and/or behavior in patients taking these drugs to FDA’s MedWatch program at www.fda.gov/medwatch/. Given the well-established health risks of smoking, healthcare providers should continue to work closely with patients to assist them in quitting smoking."

The Rest of the Story

While it is unfortunate that these possible serious, adverse effects of Chantix were not detected until post-marketing surveillance, the real shame in this story is that the anti-smoking movement played a role in this potential tragedy. The movement played a role in two ways.

First, a number of tobacco control researchers and experts failed to recuse themselves from a national expert panel making recommendations for the treatment of nicotine dependence by physicians, despite having significant financial conflicts of interest by virtue of their financial relationships with Big Pharma. This panel went against the evidence base and recommended that every patient be treated with pharmaceutical agents. The panel also recommended that Chantix be used, despite the reported and well-publicized adverse effects.

The presence of these massive financial conflicts of interests creates the appearance that the expert panel was influenced by financial considerations, rather than purely scientific ones. Researchers with financial relationships with pharmaceutical companies have no business making national recommendations for the clinical treatment and approach to nicotine dependence. It is imperative that such recommendations be made by unconflicted researchers. Otherwise, financial interests rather than purely scientific and public health considerations, will enter the picture. That represents a disservice to the public interest.

Second, national and international tobacco control conferences and organizations continue to prostitute themselves by accepting sponsorship from pharmaceutical companies, thus undermining the objective discussion of appropriate smoking cessation strategies and precluding the possibility of deriving and disseminating purely evidence-based recommendations regarding the use of pharmaceutical agents such as Chantix.

Most recently, the World Conference on Tobacco or Health, held last week in Mumbai, was sponsored by Pfizer (the maker of Chantix) and Glaxo Smith Kline, which manufactures a number of smoking cessation medications.

The rest of the story is that the anti-smoking movement has contributed to this possible tragedy by allowing money to interfere with objective science in making and disseminating national and international health policy and clinical practice recommendations. We all understand that health and science, and not politics, should determine clinical practice and health policy. But neither should financial interests affect public health practice and policy. In the case of the anti-smoking movement and smoking cessation practice and policy, money has unfortunately exerted a major influence. If the connection between Chantix and suicide turns out to be real, that undue influence of financial conflicts of interest could be the biggest tragedy of all.

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