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Sunday, October 23, 2011

Japanese Paxil Study in Children Proves Very Little

How Glaxo recruited 7-17 year old children for their Japanese Paxil study


Back in 2009 I reported on how GlaxoSmithKline Japan were trialing out Paxil/Seroxat in children and adolescents. Over the following months I sought to find out why such a study was taking place, it seemed odd, to say the least, that GlaxoSmithKline were trying to prove their drug was safe in children and adolescents when it was blatantly obvious that it was not safe and effective.

The clinical trial, aimed at 7-17 year olds, went ahead, an 8 week trial which, it appears, was for the sole purpose of trying to prove one thing, at least that's the impression I get when reading the results.

What did Glaxo wish to push the boat out for? Well, my assumption, because I'm allowed to assume, is that Glaxo will use the results of this study to spin the suicidal ideation in kids claims that they hid in the earlier Paxil 329 study.

The 2009 study, which was completed earlier this year, shows a quite remarkable change.

You've guessed it folks.

Take a look at the following table:



You will note that the psychiatric disorders shows there were 3 reports on placebo whilst none were reported for Paxil. I't's hardly convincing seeing as there were only 29 subjects taking Paxil but I'm sure GlaxoSmithKline will use this to their advantage.

However, it would appear that the study proves nothing. Paxil was only slightly superior compared to placebo but it's all irrelevant anyhow.

Personally, I feel the only reason this study took place was to highlight the suicidal thoughts or lack of - Glaxo will no doubt spin this in future medical journals...or rather key opinion leaders handpicked by Glaxo will.

With just 29 subjects on Paxil they would have been lucky to pick up just one (3 per hundred is about 1 per 33). The low number of participants in the active treatment group pretty well ensured they most likely would not see emergent drug induced suicidality.

The study, like 329, has been manipulated, that's my opinion anyway, I'm still allowed an opinion aren't I?

If you look at the original exclusion criteria for this study you will see that it is not based on real-world prescribing. Remember just 1 subject in a hundred becoming suicidal because of the drug equates to 1000 subjects per million. And nobody knows for certain how many of those will go on to kill themselves - we do know that there have been many.

Each subject in this trial were asked a series of questions to determine if they were experiencing adverse reactions, the questions were, it appears, based on the CDRS-R rating scale

The CDRS-R is a brief rating scale based on a semi-structured interview with the child (or an adult informant who knows the child well). Designed for 6- to 12-year olds, and successfully used with adolescents, it can be administered in just 15 to 20 minutes and easily scored in a few minutes more. The interviewer rates 17 symptom areas (including those that serve as DSM-IV criteria for a diagnosis of depression): [SOURCE]

Impaired Schoolwork
Difficulty Having Fun
Social Withdrawal
Appetite Disturbance
Sleep Disturbance
Excessive Fatigue
Physical Complaints
Irritability
Excessive Guilt
Low Self-Esteem
Depressed Feelings
Morbid Ideation
Suicidal Ideation
Excessive Weeping
Depressed Facial Affect
Listless Speech
Hypoactivity

Most of these symptom areas are rated on a 7-point scale so the CDRS-R can capture slight but notable changes in a child's symptoms. This makes the scale ideal for monitoring symptoms during illness or remission. Other additions to the scale include suggested interview prompts and guidelines for integrating information from multiple informants.

Japanese Medwatch were concerned about this particular study, so concerned that they wrote the following to GSK Japan:


Click to read




The results of the trial have now been published online and can be viewed HERE

I anticipate they will appear [polished and spun] in medical journals soon.

Previous coverage of the Japanese Paxil Trials:


Monday, January 12, 2009 - GSK Just won't stop trying to push paroxetine on children!

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

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

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

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

Friday, May 13, 2011 - Glaxo remain tight-lipped on new Japanese Paxil study in children.

Wednesday, May 18, 2011 - GSK JAPAN - PAXIL STUDY IN KIDS UPDATE

Monday, May 23, 2011 - Are GlaxoSmithKline Japan Putting Children At Danger With Paxil Trial?


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ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE
OR UK FROM CHIPMUNKA PUBLISHING

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