Doctors worried by Chantix in ‘07

EXCLUSIVE:

Department of Veterans Affairs doctors began raising red flags last year about whether the smoking-cessation drug Chantix was causing severe psychotic episodes among veterans, prompting a quiet investigation last fall but no warning for many months to the 32,000 retired service members prescribed the medication, according to internal agency documents reviewed by The Washington Times.

“Early reports” from doctors at VA medical centers were flowing in throughout 2007, well before the U.S. government and drug maker Pfizer Inc. issued public warnings late last year and earlier this year that Chantix had been linked to psychotic behavior, hallucinations and suicides, VA officials said.

By late November, VA officials began collecting data showing nearly one out of every 1,000 veterans taking the drug had been hospitalized for severe psychosis, a rate noticeably higher than for veterans trying to stop smoking with alternative treatments like nicotine replacement, the documents show.

VA officials told The Times that they decided to proceed with their normal process of studying their data for several months to determine whether the trend was “statistically significant” and did not issue immediate warnings.

In the interim, more veterans were prescribed the drug, including some suffering from post-traumatic stress disorder (PTSD) who were enrolled in a medical experiment in which VA officials acknowledged Monday that the number of severe side affects averaged nearly one problem for every two veterans taking Chantix. VA officials said they wished in retrospect that their warnings had been issued sooner and they are examining how to improve their communications process.

The House Veterans Affairs Committee is set to investigate the VA’s conduct in prescribing Chantix at hearings Wednesday, and the committee’s chairman said Monday that the inaction detailed in the documents obtained by The Times raised serious, new questions about whether the agency cared enough about the veterans it treats.

“When questioned, the VA immediately wants to defend ‘the process,’” said Rep. Bob Filner, California Democrat. “When is the VA going to understand that it is not about the process, but about the veteran? Veterans don´t want to hear the VA defend its process. It´s time for the VA to defend our veterans, our heroes.”

Doctors treating veterans were reporting last year into a medical surveillance database maintained by the VA numerous instances in which the patients were taking Chantix when they were hospitalized for serious psychotic episodes. By October, the VA changed its tracking of Chantix side effects to include psychosis because of the concerns raised by doctors. A month later, the VA began a formal review that took nearly four months to complete, gleaning from the database all reports of psychotic behavior that required hospitalization.

That review found that among 27 patients taking Chantix who were admitted to VA hospitals for psychiatric problems since the drug was approved for the market in 2006, 11 had attempted suicide, one attempted homicide, nine had suicidal thoughts, and six were suffering from hallucinations, according to an internal report completed on March 18.

Results “show a greater crude rate of severe psychosis with varenicline compared to nicotine or nicotine/bupropion but do not reach statistical significance,” the report concluded. “These data show a signal for potential increased psychosis and warrant further examination to determine actual incidence and potential causality compared to control.”

The study was never released to the public, but VA officials agreed to let The Times review it.

The VA internal analysis examined more than 100 hospitalizations for psychiatric episodes of VA patients who had just begun trying to quit smoking by taking either varenicline (Chantix), nicotine-replacement therapy, or nicotine-replacement therapy along with bupropion. It looked back at the time period between September 2006 and September 2007.

VA officials noted that patients in the other groups also were admitted to hospitals for similar episodes, including 73 veterans who were trying the nicotine-replacement therapy and seven who were trying nicotine-replacement therapy and bupropion.

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