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Dear Sirs,
As I understand it, you are the drug regulatory authority for Japan, i.e.; the equivalent of the UK drug regulator, the MHRA and the American drug regulator, the FDA.
I would like to bring to your attention a trial currently on-going in Japan. A clinical trial that defies all logic and, I believe, one that is putting the children on it, at risk.
I am referring to the Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study) - Link here - http://clinicaltrials.gov/ct2/show/NCT00812812
I have recently wrote to GlaxoSmithKline to ask them what their motives are behind this current trial - link - http://fiddaman.blogspot.com/2010/05/email-to-glaxosmithkline-re-paxil-study.html
I ask you the same question.
What are the motives behind this trial?
Paroxetine has already been deemed 'unsafe' for children.
The inclusion criteria for this study is even more alarming. Basically the trial has recruited Kids 7-17 yrs who amongst other things, have been diagnosed with major depression and have not exhibited any past suicidal ideation – and have not had drug abuse issues…..etc etc.
The very last exclusion on the list - “Patients in the opinion of the chief investigator (sub-investigator) judged as not eligible for the study”.
In other words, they are loading a study with children who they think will do well. The results will no doubt be favourable.
I am unsure whether or not GlaxoSmithKline have had to seek permission from you to run such a trial in your country, if they have, then why have you granted them permission?
This study should NOT be taking place. By GSK's own admission, "Paroxetine is not approved for the treatment of patients younger than 18 years of age. Please refer to the approved prescribing information for additional warnings and information."
Back in January 2009 I wrote to the Japanese Embassy to alert them of this clinical trial, they never responded. I also wrote to the Japanese Health Minister in April of 2009 - once again, I never received any response from them.
Interestingly only about 1% of the Japanese population are considered poor metabolizers (PM) of 2D6 – but about 60% are considered to be of the intermediate metabolizer type (IM). (Bernard 2006). IMs are slower than the (normal) extensive metabolizer (EM) type and can also suffer severe adverse reactions at lower doses. I wouldn’t put it past GlaxoSmithKline to secretly run 2D6 genotyping and exclude the PM and IM types. After all, the last exclusion criteria (above) seems to be intentionally written vaguely enough to allow them to exclude based on genotype without disclosing that they had performed the test.
I would like an answer to this email in writing.
Interested parties have been blind copied in on this email
Bob Fiddaman
Author of Seroxat Sufferers
Author of the book, The Evidence, However, Is Clear...The Seroxat Scandal
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Fid
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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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