My involvement with Study 329 began as an expert witness in the Tobin trial in 2001, where GSK and Paxil were found guilty of homicide. This verdict against the notionally British pharmaceutical company, then the biggest in the world, and its best-selling drug engaged BBC’s Panorama team with Shelley Jofre as the Lips. Jofre focussed on Study 329 and brought the famous document to light showing that GSK opted to pick out the good bits of this study and market these. This document led to the Black Box Warning on Antidepressants, fraud charges against GSK, and later a $3 billion fine.
I was also involved as an expert witness with Baum-Hedlund, especially Cindy Hall, on a series of SSRI suicide and withdrawal cases and these legal cases began to paint a picture of company ghostwriting that in the case of Study 329 was pursued by Leemon McHenry and Jon Jureidini. My involvement is written up in Let Them Eat Prozac.
The emerging picture of ghostwritten publications with lack of access to trial data, and the fact that controlled trials often give exactly the wrong answer, led to the creation with Dee Mangin, and Joanna Le Noury of RxISK.org which launched in 2012. This aims at empowering people in their relationships with doctors and pharmaceutical companies and restoring the magic to medicine by making it clear that through good teamwork this is where we can bring about good outcomes even though using poisons.
In the Rewrite of Study 329, I have spent my time making sure Joanna Le Noury has all the coffee she needs to be able to concentrate on the almost impossible task of accessing GSK data through what was dubbed the GSK periscope.
Bangor University, School of Medical Sciences