The excellent Evelyn Pringle has been given access to more of the documents that we learned about in the recent Panorama programme ‘Secrets of the drug trials’.
She is able to explore the issues raised in the programme in much more depth, including the controversial Study 329 ‘authored’ by ‘Marty’ Keller and Neal Ryan. (Under FDA rules at the time, if the company conducted tests on Paxil with children, Glaxo could get a 6-month extension on its patent, which meant enormous profits. To that end, hundreds of children were recruited from around the world for several pediatric studies with the largest conducted in the US, known as Study 329).
In an email dated October 14, 1998, written by the Paxil product director in the UK we learn: “The results of the studies [377 and 329] were disappointing. The possibility of obtaining a safety statement from this data was considered but rejected.”
In other words, Glaxo knew it could not get a license to treat children in the UK. Another comment in the email says: “The best which could have been achieved was a statement that although safety data was reassuring, efficacy had not been demonstrated.”
Back in October, 1998, another document labeled, “SB Confidential – For Internal Use Only,” clearly shows that Glaxo had decided not to try to get Paxil approved for children because studies found the drug ineffective and states: “Data from these 2 studies [377 and 329] are insufficiently robust to support a label change and will therefore not be submitted to the regulatory authorities.” It further states: “Based on the current data from Studies 377 and 329, and following consultation with SB country regulatory and marketing groups, no regulatory submissions will be made to obtain either efficacy or safety statements relating to adolescent depression at this time”.
The document also explains the rationale for not attempting to obtain a safety statement on Paxil at that time as follows:
i) regulatory agencies would not approve a statement indicating that there are no safety issues in adolescents, as this could be seen as promoting off-label use
ii) it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.
But as we all know today, this ‘little setback’ wasn’t going to stop Glaxo promoting paxil for kids – it didn’t seem to matter to the company that Seroxat was not safe and hadn’t actually been shown to work.