Study 329 is probably the most famous clinical trial ever. It is one of the few to attract a Fraud action and is certainly the only one with a $3 Billion fine linked to it. See A Milestone in Drug Safety.
The study began recruiting adolescents to Paxil, imipramine or placebo in 1994 and finished up in 1998. Later in 1998, SmithKline Beecham, the marketers of Paxil (they hadn’t discovered it), acknowledged in an internal document that the study had shown that Paxil didn’t work for children. This lack of benefit was something they were not inclined to share with the outside world. Instead they decided then they would pick the good bits out of the study and publish these.
The good bits led to a publication in 2001 – Keller and 21 others – in the Journal of the American Association of Child and Adolescent Psychiatry, which boasted that it was the journal with the highest impact factor in child psychiatry.
The authorship line was KoL-to-die-for-country.
At the time most of us were still innocent. Few would have guessed that no one on the authorship line might have had any meaningful input to the paper. Few would have guessed that none of the “authors” except perhaps the company personnel had seen the data.
The real author in the sense that most people in the street would recognize as authorship was Sally Laden. The study made Sally perhaps the most famous medical writer ever. But even she had not seen the data.
This is a woman who concedes that “There are some data that no spin can overcome”. Not having access to the data may make it easier in tricky cases.
The Keller and 21 others paper was published in July 2001. A month previously the Tobin trial in Cheyenne Wyoming returned a verdict against GSK (formerly SKB) and Paxil in a multiple homicide-suicide case.
The Tobin verdict and the facts that GSK was then the biggest pharmaceutical company in the world, and was notionally based in Britain, and that Paxil was the biggest selling antidepressant in the world, engaged BBC’s leading investigative program, Panorama.
Up till then, in 50 years, Panorama had never repeated a topic but they made four programs about Paxil – Seroxat,
All the programs are available on Study329.org along with their transcripts.
At the heart of these programs was Shelley Jofre who showed that you don’t need medical expertise to sift the wheat from the chaff of most medical studies. She read the Keller paper within weeks of its publication and immediately smelt a rat.
The rest is a history that will reach a major landmark around September 14th when BMJ publish Restoring Study 329, a year after it was submitted to them and two years after work started on the Restoration.
The Panorama programs are now available on Study329.org.
As is The Famous Grouse lecture which covers the History of 329 and the Black Box Warnings.
Yet more will be added over the next few weeks.
The BMJ paper, when published, will sit there alongside the Keller and 21 others paper.
Mickey Nardo – 1boringoldman – one of the authors of the Restoration will be have a series of posts linked to the publication outlining how and why we cannot afford to glaze over when experts mention clinical trials – RCTs. We need to grab our chance for a Shelley Jofre moment with both hands. His posts will in addition be reproduced here.
The posts here and later on RxISK.org are available for comment and there is a contact us button on Study329.org.