Chantix Problems on a Number of Fronts: Tobacco Researcher

Boston, MAA leading tobacco researcher has some things to say about Chantix and Chantix side effects. Michael Siegel is a former practicing physician and today serves as a professor in Social and Behavioral Sciences with Boston University School of Public Health. In his blog Professor Siegel raises the specter of Chantix suicide, together with the possibility that Chantix and suicide may not have had to exist in the same sentence were it not for a seemingly powerful lobby.

Most are aware by now of the potential for harm with Chantix. The smoking cessation drug was approved and released the market with much fanfare just a few short years ago. Since then any positive reports on the drug by patients who have found success with Chantix have been offset by reports of suicide ideation, many resulting in actual suicides.

It has been noted previously that Chantix was approved with results from a clinical trial involving, allegedly, handpicked participants with few of the health concerns generally associated with the smoking community. What's more, trial participants are said to have benefitted from regular monitoring and counseling—something which may not have been available to the lion's share of Chantix clients in the field.

It has been reported that Chantix patients will now benefit from increased monitoring and observation, to help ensure the Chantix regimen is working to combat the patient's nicotine dependence, without incurring a greater risk to the patient's health.

Professor Siegel raises a far more significant issue. In his blog the noted tobacco researcher cites a number of tobacco control researchers and experts for failing to recuse themselves from an expert panel making far-reaching recommendations for the treatment of nicotine dependence by physicians—even in the face of financial conflicts given existing relationships with pharmaceutical companies.

Many physicians, for example, receive compensation from pharmaceutical companies for speaking, consulting or helping to research their products.

Spiegel accuses the panel of voting against the base of evidence presented to the panel, by recommending that every patient be treated with pharmaceutical drugs. This panel, according to Spiegel, also voted in favor of Chantix use in spite of the emerging concerns.

That's one example of a back-story that has not served the public interest well, according to Spiegel.

The other concern, notes the professor, has to do with the acceptance of sponsorship from the tobacco industry for international tobacco control conferences and organizations. Specifically, he references the World Conference on Tobacco or Health, which was sponsored by Pfizer and GlaxoSmithKline. The latter puts out a number of smoking cessation products. The former is the company responsible for Chantix.

As for Chantix in particular, a report appearing in the Journal of the American Medical Association (JAMA) this spring cited mounting evidence that varenicline (Chantix) is associated with suicidal ideation and behaviors in a number of Chantix patients. Citing a January 2009 analysis by the US Food and Drug Administration (FDA), the Kuehn BM. Studies report support the FDA findings that a Chantix link to suicidal ideation is likely.

"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," according to the FDA analysis. "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."

Siegel notes that the FDA report failed to draw any definitive conslusions with regard to Chantix and suicidal behavior, although the data was a cause for concern nonetheless.

"Together, the AERS [Adverse Effect Reporting System] data suggest a possible association between suicidal events and the use of varenicline and bupropion," says the FDA report. "Healthcare providers are reminded to closely monitor patients for neuropsychiatric symptoms (i.e. 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…

"Given the well-established health risks of smoking, healthcare providers should continue to work closely with patients to assist them in quitting smoking," concludes the FDA.

Few would argue that quitting smoking is one of the hardest habits to break. By design, Chantix was intended to ease that process. However a dark side of the drug appears to be emerging: Chantix and suicide. Of all the Chantix side effects currently associated with the drug, Chantix and suicide is by far the most worrisome. And aside from label updates that will further inform physicians and patients as to the riks of Chantix together with recommendations for improved monitoring and observation, there are no plans to remove or reduce Chantix from the market. To wit, many experts believe Chantix will rebound and sales will improve—in spite of the risks.