Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, January 15, 2009

Email to Japanese Embassy regarding New GSK paroxetine study in Children. ClinicalTrials.gov Identifier: NCT00812812

Dear Sir/Madam,

May I bring to your utmost attention an undergoing recruiting campaign by pharmaceutical giants, GlaxoSmithKline, in your country.

GSK Japan are recruiting children from the ages of 7 to 17 "To compare the efficacy of paroxetine versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents..."

This is surprising as by GSK's own admission they have already stated that "Paroxetine is not approved for the treatment of patients younger than 18 years of age." - http://www.gsk.com/media/paroxetine.htm


One has to beg the question why they are recruiting in Japan to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with major depressive disorder (MDD) - http://clinicaltrials.gov/ct2/show/NCT00812812?intr=paroxetine&rank=2&flds=Xabcg


As far as I am aware, Japanese human beings aged 7 to 17 have the same make-up as human beings of that age range from the UK, USA etc.

A few news stories regarding paroxetine, GSK and efficacy in children may broaden your mind. These can be found here:

BBC: Glaxo Hid Safety Concerns Related to Seroxat (Paxil) - http://www.newsinferno.com/archives/1409


MHRA Investigation into Glaxosmithkline/ Seroxat 6 March 2008 - http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON014155&RevisionSelectionMethod=LatestReleased


Paxil Study 329: Paroxetine vs Imipramine vs Placebo in Adolecents - http://www.healthyskepticism.org/documents/PaxilStudy329.php


----

I would be grateful if you could acknowledge receipt of this email and tell me of your intentions.

Thank you for reading.

Yours sincerely

Bob Fiddaman



Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

1 comment:


Please contact me if you would like a guest post considered for publication on my blog.