Chantix Trial Postponement Sought by Pfizer Following Study

Pfizer is asking to delay the start of the first Chantix trial, which is scheduled to being next week over claims that the company’s stop-smoking drug caused suicidal thoughts and actions. The drug maker has requested a postponement so that it may further analyze the results of a recent clinical trial, which the drug maker suggests found that the side effects of the Chantix are comparable to a placebo.

Trial is scheduled to begin October 22 in a case filed by the family of Mark Whitely, who killed himself in 2007 while taking the prescription medication to help him quit smoking.

That case is the first scheduled for trial out of more than 2,600 Chantix lawsuits filed against Pfizer on behalf of individuals who committed suicide, attempted suicide or suffered other serious injuries as a result of sudden violent or agressive behavior that was allegedly caused by the psychological effects of the medication.

All federal complaints have been consolidated in the U.S. District Court for the Northern District of Alabama, where the cases have been centralized before U.S. District Judge Inge Johnson for pretrial proceedings and a series of “bellwether” trials, which are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be introduced throughout the litigation.

On October 16, Pfizer filed a Motion for Continuance or Stay of Proceedings (PDF) in the first trial, asking Judge Johnson to postpone the start of the trial until January 22, 2013. The drug maker indicates that the additional time is necessary to allow the parties to complete discovery and any pre-trial motion practice related to a clinical trial conducted by the drug maker at the request of the European Medicines Agency.

According to Pfizer, the results indicate that when compared to a placebo, Chantix is more effective at helping people with depression quit smoking, and reportedly provides no significant increase in the risk of psychological effects.

“Because the trial results go directly to the heart of the Plaintiff’s medical causation and punitive damages claims in Whitely and in the litigation as a whole, the results should be part of the scientific record in the first bellwether case to go to trial,” wrote attorneys for Pfizer in the Motion.

Pfizer Study Raises Questions About Chantix Side Effects

The postponement request was filed after data was received from a clinical trial done at the behest of the European Medicines Agency (EMA), which included 525 patients who had already been diagnosed with depression before starting treatment, but had no signs of psychotic behavior.

Findings of the Pfizer-sponsored study appear to contradict those of independent researchers who have concluded that there are significant increases in violence and suicidal tendencies among Chantix users, particularly when they begin first using the drug.

Chantix (varenicline) was approved in the United States in 2006, as a prescription medication to help people quit smoking.  The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine.

Within months after the medication was introduced, reports began to surface about individuals committing suicide or engaging in other unusual behavior on Chantix, which was allegedly caused by the neuropsychological effects of the medication on the brain.

In July 2009, the FDA added a “black box” label warning to the smoking cessation drug about the risks of psychological side effects, which Judge Johnson already determined last month was adequate as a matter of law to alert people about the potential psychological side effects of Chantix.

Leading up to the trial date, Pfizer has also been appealing an order requiring its Chief Executive Officer, Ian Read, to testify live. The company’s attorneys argue that Read will be extremely inconvenienced by having to testify in person, and also claim that his videotaped deposition should be sufficient. Plaintiff attorneys say Read was involved enough in Chantix before he became CEO that he should be required to appear in person for testimony.

In their motion filed this week, Pfizer indicated that if Judge Johnson is not inclined to grant a continuance of the trial date at this time, the case should at least be stayed until the Eleventh Circuit rules on Pfizer’s writ of mandamus to invalidate trial subpoenas issued for their CEO and other employees.