Before he became the newly chastened Governor of New York who has been bludgeoned into proposing a 21% pay increase for the hard working legislators of the Empire State, Eliot Spitzer was the hard charging Attorney General who twice failed by a whisper in being named Time Magazine’s “Man of the Year.” 

I believe that one of Spitzer's most successful cases was his 2004 law suit against the drug company Glaxo Smith Kline. Spitzer's litigation alleged that Glaxo’s promotion of its drug Paxil for the treatment of childhood depression failed to disclose its own studies that suggested a possible link between the use of Paxil and suicide or, in the legalese of a 1998 internal Glaxo memo, “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.”  Although Glaxo’s CEO initially spluttered about having met the requirements of the FDA and that the company was within its First Amendment rights, within days and in the face of tanking stock price (evidently the Street did not reward companies that conceal data about how their product might cause teenagers to commit suicide), Glaxo ran up the white flag.   To its credit, the industry trade group, Pharma, began a voluntary process by which companies would be pushed to record all of its clinical data.

The federal agency who should have been watching Glaxo was the FDA, but from 2001 to 2004, the FDA was firmly in the hands of the deregulators. The General Counsel and de facto Chair of the FDA was a former tobacco and drug company litigator who never met an FDA regulation he didn’t hate.  Because the FDA did nothing, it was up to Eliot Spitzer to do the job.

All of this is the background to the welcome news that appeared in yesterday’s front page headline in the New York Times.  The FDA is “now requiring drug makers to study closely whether patients become suicidal during clinical trials.”  The story goes on to say “the seeds for the new federal effort were planted four years ago…” which by my count is 2004 – the year of Spitzer’s Paxil initiative.

Three belated cheers for the FDA.

And one huge “thank you” to Eliot Spitzer.