The FDA Strikes Back: Criminal Probe of Glaxo Seeks to Chill Data Manipulation

The FDA's investigation of whether GlaxoSmithKline (GSK) broke the law by concealing heart attack data on its diabetes drug Avandia will expose two competing dynamics: 1. Whether such a probe will unfairly chill robust, legitimate scientific debate between the FDA and the drug companies it regulates. 2. The fact that the FDA has regarded GSK as a scofflaw since 2005, when it sent U.S. marshals to raid and ultimately shut down one of its factories in Puerto Rico.

Regardless of whether GSK executives really did make false statements to federal officials (a crime which fetches up to five years in prison if convicted), the drug industry will be horrified if charges are brought. Since 2007, GSK has published all its trial data on Avandia online. The only reason the Cleveland Clinic's Dr. Steve Nissen was able to do his critical meta-study showing more heart attacks with the drug was because he downloaded that data from GSK.

While GSK has been accused of hiding documents from the FDA, GSK's side of the story is that its unpublished study information did not show any signal for heart attacks, and that it had included the data with its Periodic Safety Update Report, submitted to the FDA.

Companies could conclude that merely communicating scientific information to the FDA creates criminal liability under the false statements statute, and stop doing so. That would be terrible, given how difficult some of this data is to interpret. The fact is that the FDA needs companies and their experts to interpret some of this data for them, so that the FDA can compare their version of events to independent scientists'.

The FDA, however, may be seeking revenge against GSK. From their point of view, the company sat on data for 10 years that showed an increase in heart attacks on Avandia, and didn't make that clear to the FDA. It was only this year that its own scientists concluded GSK fudged data that the FDA had used to make decisions on Avandia. GSK's maneuvering made the FDA look foolish.

Worse, the FDA doubtless remembers that it was GSK that repeatedly failed to bring a factory up to scratch where it made Paxil and Avandamet, a drug that uses Avandia as an ingredient. The FDA got federal court warrants and U.S. marshals busted the plant. The FDA used unusually harsh language (for the FDA, at least) to make sure everyone knew this was GSK's fault. It said at the time:

FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing ... GSK has voluntarily recalled some of the affected lots of Paxil CR and Avandamet; however, it has failed to recall all affected lots of these products. This failure on the part of GSK resulted in today's seizures by federal authorities.

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