Pfizer pushes back on Chantix safety fears

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With an aggressive program of pushback including newspaper ads and a press briefing, Pfizer sought to turn the conversation on Chantix from side effects to smoking.

Full page ads, in the form of an open letter from Pfizer Chief Medical Officer Dr. Joseph Feczko, titled A message about Chantix (varenicline) from Pfizer, ran today in The New York Times, Wall Street Journal, USA Today, LA Times and Washington Post. The ads noted a May 16 label change “in collaboration with the FDA,” which strengthened warnings on possible neuropsychiatric side effects, advising: “We believe that the benefits of Chantix outweigh the risks, and that safety information about Chantix is appropriately reflected in the product's labeling,” and that “There are few things that provide greater health benefits than quitting smoking.”

The company is also hosting a roundtable discussion with medical and health reporters at its New York headquarters on June 5, the first of a series of such events to be held in the top 5 US markets. Attendees will hear a presentation by Pfizer medical brass, after which the company will take questions, and the event will be open to bloggers and third party organizations as well as credentialed reporters from trade, regional and national publications, said global media relations head Ray Kerins.
 
“We've done tons of one-on-one conversations and a lot of TV, but this is the first time we've invited people into our house to have an open dialogue about Chantix,” said Kerins, adding that the company will aggressively counter misrepresentations of the drug in the press nationwide through op-eds and letters to the editor.  

Pfizer has also sent out a “dear doctor” letter to 300,000 physicians, advising them of the label change, and posted it on PfizerPro.com, a website for healthcare professionals. Similar information, tailored to a consumer audience, has been posted to Chantix.com.

The moves follow a week of bad press for Chantix. After the release of a report from the nonprofit Institute for Safe Medication Practices (ISMP) flagging 988 serious adverse event reports associated with the drug for the fourth quarter of 2007 – the most for any drug – the Federal Aviation Administration instructed pilots and air traffic controllers not to take the drug and Sen. Chuck Grassley (R-IA) asked the FDA for comment on it. The ISMP said reported events included “a wide spectrum of  injuries, including serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetes, psychosis, aggression and suicide.”

Pfizer stresses that 6.5 million patients take the drug worldwide – 5.5 million of them in the US – and that smoking kills an estimated 438,000 in the US each year. The company is also highlighting the upcoming relaunch of its Get Quit patient support program. The enhanced program will feature customization options allowing users to request regular check-in emails and/or automated or live phone calls, with Mayo Clinic-certified coaches standing by through a toll-free number. In addition, the company is running randomized double blind placebo-controlled studies to better understand the utilization of the drug in specific populations including patients with schizophrenia, COPD and cardiovascular disease. 

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