Let’s take a step back, shall we.
It’s worth looking at what happened and when – because Alastair Benbow seems to have forgotten something…It was only in February 2003 that GSK finally submitted some clinical trial data to the MHRA showing that paroxetine caused suicidal ideation, and even then data from adult and paediatric trials were merged.
Full data from the clinical trials in children, demonstrating a causal link between paroxetine and suicidal ideation and behaviour, was finally submitted by GSK to the MHRA in May 2003 – a month before the company was due to submit an application for the drug to be licensed for use with children. [So Glaxo was still going to apply for a licence for use in children – in June 2003?]
GSK has rejected claims that it withheld information. Dr Alastair Benbow, medical director for GSK Europe, said: “We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18.”
So what Benbow is saying is that Glaxo did good – giving the MHRA, in May 2003, data from the trials and telling the MHRA there was a “potential risk”.
May 2003?
By my reckoning that’s four and a half years too late.
In October 1998 an internal, confidential SmithKline Beecham document about studies 329 and 377 was issued. Studies 329 and 377 tried to prove Seroxat/Paxil worked in children. In summary it said “… 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 [329] 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.
Someone should have faced criminal charges.
So what do you say Alastair? – is four and a half years a timely response?
I wonder how many children and adolescents died in those four and a half years between October 1998 and May 2003 becuase they took Seroxat/Paxil?
You tell me.
seroxat secrets... 