More government watchdogs appear to be boarding the Paxil investigation train. The Justice Department is coordinating a probe that includes Colorado's Justice folks and the Boston U.S. attorney's office. GlaxoSmithKline had already disclosed the Colorado investigation and confirmed the rest in today's Wall Street Journal. Investigators are gathering documents and depositions about Paxil's potential link to suicidal behavior, at least in part from plaintiff's lawyers representing families suing the drugmaker, and about GSK's portrayal of those risks to doctors and the FDA, the WSJ says.
Glaxo says it's cooperating with the investigation and that it can't comment further. In the past, the company has said that it "acted properly and responsibly" in testing Paxil and passing on trial data to regulators.
According to the WSJ, the probe is particularly focused on Glaxo's submissions to the FDA about Paxil and suicidality when the drug's approval was pending. Investigators also were anxious to get their hands on some documents, under court seal, that disputed GSK's research conclusions on suicidality risks. GSK gave the Justice Department those documents, stipulating that they not be passed along to the FDA.
You'll recall that last week, Sen. Charles Grassley demanded an FDA investigation of Paxil's 1992 approval. That followed a years-long U.K. investigation that recently ended with no charges against GSK because British laws on data-sharing are unclear.
- read the Wall Street Journal story