You may remember that back in July I wrote about the Yugoslavia paroxetine (Seroxat UK, Paxil US) trial (here and here)
In 1988 GSK, then SmithKline Beecham (SKB) sponsored clinical trials in Yugoslavia. The purpose of the trials was to show how Paxil (known as Seroxat in the UK) could, when stopped, cause a relapse in depression. SKB never took into account that those relapsing (after stopping Paxil) could have been suffering withdrawal symptoms.
With the results they wanted, SKB then provided the FDA with apparent evidence that showed patients staying on Paxil continued to enjoy a normal, "depression free" life, but that those abandoning the drug would suffer relapse back into a depressive state.
Seeing as Glaxo are a British pharmaceutical company I decided to write to the British drug regulator (MHRA) to request, under the freedom of information act, information relating to Glaxo's trials in Yugoslavia.
My email to them read...
Dear Sir/Madam,
Pursuant to the federal Freedom of Information Act, I request access to and copies of a a clinical trial in Yugoslavia that commenced in 1988.
The trial was, as far as I am aware, sponsored by SmithKline Beecham (SKB) and was known as the "Yugoslavia trial" or "relapse trial."
I am specifically requesting the protocol for this particular clinical trial and whether or not that protocol included information and/or guidance on Paxil withdrawal.
I look forward to your reply within 20 business days, as the statute requires.
Thank you for your assistance.
Sincerely,
--
Bob Fiddaman
The MHRA have now answered this request.
Are you holding your breath folks?
The current Chief Executive of the MHRA is Dr. Ian Hudson. Before joining the MHRA, Hudson was the World Safety Officer for GlaxoSmithKline (then SKB)
Later this year GlaxoSmithKline will be defending allegations in the UK regarding Seroxat withdrawal. One of Glaxo's experts to be called will be Dr. Rashmi Shah. Shah was employed by the MHRA between 1987 and 2004. Positions held were Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.
You can draw your own conclusions.
Bob Fiddaman.
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