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Friday, May 13, 2011

Glaxo remain tight-lipped on new Japanese Paxil study in children.

Some of you may remember I highlighted sometime ago on this blog that GlaxoSmithKline Japan were carrying out studies with Paxil/Seroxat in children. [See links at foot of this article]

Naturally I was, like many others, appalled at Glaxo's need to carry out such a study, particularly as they had already deemed Paxil unfit [unsafe and ineffective] for this particular age group. [7-17 years]

It seems I wasn't alone in voicing my concerns.

The following is a letter sent to GlaxoSmithKline from Yakugai Ombudsperson Medwatcher Japan and Toshihiro Suzuki, Representative. It's dated July 16 2009.

Demand for Publication of Information Related to Post-Marketing Clinical Trials on Children and Adolescents Using the Antidepressant Paxil.

I. Purpose of the Demand

We are requesting the following information on "Clinical Evaluation of Efficacy and Safety of Paxil Tablets in Children and Adolescents with Major Depressive Disorder: Placebo-Controlled, Double-Blind, Parallel Group Study."

(1) The justification for determining the conduct of this study to be necessary and valid (how and why the conduct of the trial was determined to be necessary and valid)

(2) In particular, if the premise of conducting the clinical study is that effects can be expected for Japanese children, what information was used as justification for making that determination

(3) The most recent version of the study protocol (including records of previous revisions)

(4) Subject recruitment status (the names of the sites participating in the study to date, the number of people recruited at each site, and the Patient Information Sheet used at each site)

(5) Information on adverse events reported to date (information on number of emergent cases and clinical course of individual cases, etc.)

Both the Yakugai Ombudsperson and Suzuki added:

"We strongly desire the disclosure of detailed information and a public re-examination of the question of whether it is truly necessary and valid to conduct a new clinical trial with Japanese children on a drug whose efficacy could not be confirmed in overseas clinical trials and which furthermore is suggested to potentially increase the risk of suicide."

I echo their sentiments. Are GlaxoSmithKline suggesting that it may be okay for Japanese children to take Paxil? I cannot quite grasp why Glaxo would carry out such a study on this age group.

The letter can be viewed in PDF format here:

According to the GlaxoSmithKline web page, the study is now completed. However, the results of that study still remain a mystery.

I emailed GlaxoSmithKline this morning to ask them for the conclusion of study NCT00812812, I anticipated either silence from them or a reply stating that under some twisted pharmaceutical law they are not allowed to divulge such information.

I was wrong. Their response was even more elusive:

Dear Mr. Fiddaman,

Please be advised that we have sent your request to our Business Representatives in regards to your question. Someone will contact you in the next few days.

No time like the present - I phoned them and asked if they could give me the results of the trial, they informed me that my request had been passed on to a "business representative" - they also asked me if I was a doctor or patient, I told them I was a former patient and writer and added that I write specifically about paroxetine [Paxil]

When asked if the trial results would be made public within the next 48 hours, I was told, "We don't know, we have to wait until the business representative gets back to us."

Jeez, it would be easier to ask Shania Twain if she wanted to play a game of hide the salami with me - at least I'd get a definitive answer!

Rather than wait for their "Paxil has benefited millions of people world-wide" type of response I thought I'd press ahead with this post, if only to highlight that Glaxo are [once again] not being transparent with regard to clinical trials with Paxil and children!


Here are the links where I previously wrote about this study:

Thursday, January 15, 2009 - Email to Japanese Embassy regarding New GSK paroxetine study in Children. Identifier: NCT00812812

Friday, April 03, 2009 - Japan/GSK - 329 All Over Again!

Friday, April 03, 2009 - Email to Ministry of Health - Japan

Saturday, July 25, 2009 - Paxil Study 329 All Over Again?

Friday, May 21, 2010 - Email To GlaxoSmithKline Re; Paxil Study In Children

Friday, September 24, 2010 - HEY, GLAXO!... LEAVE THOSE KIDS ALONE


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