I have taken the unusual step in copying in both your CEO, Kent Woods and your Head of Pharmacovigilance Risk Management, Sarah Morgan. I have also blind copied interested parties in on this particular request as I feel any response you may give may put their minds at ease that we are being protected from harmful drugs.
What I am about to present to you is something that you may or may not already be aware of. If you are already aware then I would find it very strange as to why no public announcement has been made by the MHRA regarding the issue I am about to present to you.
This is more applicable to Sarah as she is the Head of Pharmacovigilance Risk Management and, as such, the responsibility falls, in the main, on her shoulders, for alerting the powers that be and, to an extent, the British public about serious matters that may arise regarding prescription drugs that may be harmful to a populous of those taking them [however small that populous may be]
Attached is a study ‘ Polymorphisms in the CYP 2D6 Gene: Association with Plasma Concentrations of Fluoxetine and Paroxetine’, by Corinne Charlier, PhD, Franck Broly, PhD, Michel Lhermitte, Emmanuel Pinto, Marc Ansseau, and Guy Plomteux.
Sarah will be in a much better position than I, and probably to anyone else at the MHRA, to offer her evaluation of the study.
I have met with both Sarah and Kent at a meeting last September where the issue of SSRi withdrawal was discussed. As yet, nothing has materialised from that meeting with regard to informing doctors, the BNF and to arrange a meeting with Dr. David Healy. I know these things take time but as each hour passes more and more consumers of these products are going through needless suffering. I am in no position to speed up the process, that, ladies and gentlemen, lays solely on you.
I digress.
As you will see from the attached PDF, there is a far more serious problem that needs to be brought to the table and addressed immediately.
The paper throws light on what happens to patients when they are prescribed a dose over 20mg of paroxetine. It’s a given that anything over 20mg of paroxetine is not beneficial to a patient, yet we all know that this is still happening throughout the UK.
Please correct me if I am wrong with the following:
Paroxetine uses a liver enzyme called 2D6 – to reduce the drug so that the body can clear it. If drugs are not cleared properly – with each dose taken the drug concentration in the blood will continue to increase to toxic levels. The thing that makes paroxetine quite unique and unsafe is that whilst it needs this 2D6 enzyme for metabolic reduction and clearance – it also acts as a inhibitor of production of the enzyme, basically, it shuts down the livers ability to produce the enzyme so that it cannot further metabolise the drug.
I take it that we all agree that there is no further clinical benefit in doses above 20 mg of paroxetine – there is also much greater increase for adverse reactions as the body cannot deal with or eliminate this increase in paroxetine drug quickly enough. For people who already have a genetic deficiency in production of 2D6 (about 8-10% of the white population) i.e.; their liver cannot/does not produce the enzyme – the drug is basically a death sentence for 8-10% of the white population.
My question to you all is thus:
What do the MHRA plan to do to warn people?
Regards
Bob Fiddaman
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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