Firstly we must go back to October 1998 to an internal, confidential SmithKline Beecham document about studies 329 and 377. In summary it says “… the data do not support a label claim for the treatment of Adolescent Depression… efficacy had not been demonstrated.”
Specifically about Study 329 “…the study failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures.” In other words – it didn’t work.
About Study 377 we read “… failed demonstrate [sic] any separation of Seroxat/Paxil from placebo.” In other words – it didn’t work.
“Data from these 2 studies are insufficiently robust to support a label change and will therefore not be submitted to the regulatory authorities.”
Feel free to download a copy of this document and read the rest of the interesting conclusions (especially page 6) – SB internal –
Now we move on to March 1999, to a fuller manuscript of Study 329 being prepared for publication. This was written by Sally K Laden but was attributed to Marty Keller, Neil Ryan and colleagues. (I believe this is what is known as ghostwriting).
Please download a copy of this manuscript – Sally/Marty draft 3 –
If you go page 4 you will see the conclusion reads “Paroxetine is a safe and effective treatment of major depressive disorder in the adolescent patient.”
You can see that Sally/Marty’s spin has quickly moved on from that of SmithKline Beecham only 5 months previously. In fact you might be forgiven for wondering how these two different conclusions could be reached from the same data…
Now on to March 2001 – internally at least SmithKline Beecham seem to have understood what the data from Study 329 really said. In an email to Cohn and Wolfe, the company said: “Originally we planned to do extensive media relations surrounding this study  until we viewed the results. essentially the study did not really show Paxil was effective in treating adolescent depression, which is not something we want to publicize.”
Download a copy here – SB to Cohn Wolfe –
However, by August 2001 SmithKline Beecham Paxil Product Management was writing to all sales representatives selling paxil and telling them about Marty Keller’s “cutting edge, landmark study which was the first to compare efficacy of an SSRI and a TCA with placebo in the treatment of major depression in adolescents. Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression.”
Download this memo here – Sales reps memo –
As I said none of this is new. The last Panorama programme, Secrets of the Drug Trials was where all of this first broke.
Just a thought – I wonder if this is the kind of data that the big pharma apologists would have us rely on?