Just as the first trial was to begin over accusations that its Chantix pill for quitting smoking caused a suicide, Pfizer has agreed to a settlement, according to a spokesman for the drugmaker, who declined to disclose the terms. The case was being closely watched because it was considered a bellwether - a potential indicator for how the overall litigation may proceed.
The case involved an Alabama man named Mark Whitely who committed suicide five years ago, shortly after taking the controversial pill. Safety concerns have plagued Chantix almost since the pill was approved in 2006 and, consequently, have frustrated Pfizer, which had high hopes the drug would generate impressive - and much-needed - sales.
Instead, a stream of media stories about psychiatric and cardiovascular side effects have dampened expectations (see this and this). In the first half of this year, Chantix generated just $350 million in revenue, a 10 percent drop from the same six-month period a year earlier (see page 42). And with some 2,600 lawsuits stacked up in court, Pfizer's legal bills are going to eat up a chunk of sales.
The settlement comes after Pfizer tried to delay the start of the case earlier this week when new clinical trial data was released showing the drug is safe for smokers with depression (read this). But US District Court Judge Inge Johnson denied the gambit, noting that Pfizer was in a position to control when the results were publicly released (read this).
The Whitely trial also generated attention when the drugmaker appealed an order by Johnson, who had recently granted a request by lawyers for Whitely's family that Pfizer ceo Ian Read and two other execs take the witness stand. Pfizer argued that civil procedure "prohibits service of subpoenas on a corporate party’s officer more than 100 miles from the courthouse” (back story).
The next trial is not scheduled until January 22 and involves a man who claims Chantix caused him to have suicidal thoughts. Whether Read will be asked again to testify remains to be seen, but it is likely the same arguments over an appearance will occur, even though his deposition was videotaped.
Last year, the FDA declared that Chantix benefits outweigh ther risks after reviewing the results of two epidemiological studies that compared the controversial Chantix smoking-cessation pill with NicoDerm patches. The decision came three years after the drugmaker added warnings its anti-smoking drug is connected to suicidal thoughts and behavior (look here).
cig smoke thx to jo naylor on flickr