Pfizer tells its side of Chantix story

Today, Pfizer opened its HQ doors to journalists for a "roundtable" discussion of Chantix, the embattled stop-smoking drug. The company said it wanted to correct publicly misunderstandings about the med, which has attracted a lot of attention lately for safety questions.

Here's the background: Since January, the drug's label has carried a new warning about the risk of suicidal thinking. Just last week, a report linked Chantix to a host of side effects from accidents to seizures. The FDA received more than 1,000 adverse-event reports about the drug just during the fourth quarter of last year. Since the safety questions arose, new prescriptions have dropped by about 40 percent.

What was Pfizer's message? That smoking itself has some serious side effects, for one thing. That the adverse events reported are almost all listed already on the drug's label. That the number of reports at the end of 2007 might have been inflated by a burst of media coverage of Chantix's potential to cause psychiatric side effects. Plus, the company's execs said, quitting smoking can make people depressed and irritable, and that studies have shown smokers to be at higher risk of committing suicide.

In a separate interview with the Associated Press, Pfizer Senior Medical Director Dr. Martina Flammer said patients with a history of mental illness can use Chantix--though they should tell their doctors first. "[T]here is no indication that there is any reason why Chantix should not be taken in this population," she said. Apparently she was trying to defuse some criticism that the Chantix trials didn't include patients who'd suffered from mental illness. The company is now conducting additional studies, including people with schizophrenia and other pre-existing health problems. Plus, Pfizer is funding some follow-up investigations of severe adverse events in Chantix patients with depression, schizophrenia and alcoholism.

- read the Forbes story [1]
- see the WSJ Health Blog post [2]
- check out Pharmalot's take [3]