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Doctors worried by Chantix in '07

Quiet investigation preceded warnings by months

By Audrey Hudson and Amy Fagan | Tuesday, July 8, 2008

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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.