IT'S A FREEDOM OF INFORMATION REQUEST YOU INCOMPETENT HALF-WIT. YOU CANNOT FORCE ME TO KEEP QUIET ABOUT SOMETHING THAT IS AVAILABLE TO MEMBERS OF THE PUBLIC VIA YOUR FREEDOM OF INFORMATION SERVICE.
AND WHILST WE ARE ON THE SUBJECT OF COPYRIGHT LAW - PERHAPS YOU WOULD LIKE TO RE-VAMP YOUR WEBPAGE AND REMOVE MY ADDRESS DETAILS BECAUSE THAT INFRINGES MY PRIVACY AS IS SET OUT IN THE DATA PROTECTION ACT.
Dear Mr Fiddaman,
Thank you for your FOI request of 21 February 2007 about Paxil which has been passed to me for reply. You have raised a number of questions and I will answer them in the order in which you raised them.
1. Were the MHRA aware of the FDA's findings in May 2006?
Yes. GSK submitted the same data to the MHRA at the same time as they submitted them to the FDA.
2. Will the MHRA now be making an official statement regarding the increased rate of suicidality in depressed adults as measured in controlled clinical trials.
A Dear Doctor letter was sent to all doctors in May 2006 to inform them of new analyses by the Committee on Safety of Medicines and at European level. This letter is available on the MHRA website.
3. Will the MHRA be making the public aware that Depressed people are 6.4 times more likely to become suicidal while taking an antidepressant than while taking a sugar pill?
The full GSK analysis is already in the public domain on the GSK website.
4. Will criminal charges be brought against GSK for witholding this evidence?
The MHRA is investigating whether GlaxoSmithKline PLC withheld information from the MHRA relating to paediatric clinical trials of their drug Seroxat (the UK brand name for paroxetine). The investigation is still in progress.
5. Will there be an independant review of the MHRA and its members? and 6. Will there be any criminal charges brought against the MHRA?
The Agency does not hold any information as to whether or not an independent review of its activities and performance is to be held, or criminal charges brought against it.
Vigilance and Risk Management of Medicines Division
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