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Friday, April 03, 2009

Japan/GSK - 329 All Over Again!


"If a serial killer kills his second victim, he is already thinking of his third. If he gets away with it, his hunger continues."

I have wrote about the current Paxil clinical trials in Japan previously on this blog. In fact, my first post about this saw my blog being hit from GSK, from Philadelphia to the UK.

I wish to write about it again because this latest clinical trial makes no sense at all. It serves no purpose and can only cause more harm than good.

It is universally agreed that Paxil is about as useful as a chocolate fireguard in children and adolescents so for the life of me I cannot understand why GlaxoSmithKline are currently running a trial in Japan regarding Paxil and 7 to 17 year old children.

I wrote to the Japanese Embassy back in January about this issue. They never replied.

Glaxo don't seem to be hiding the fact that they are once again trying to market Paxil on kids. From their own website - "A randomised, double-blind, placebo controlled, parallel group , flexible dose study to evaluate the efficacy and safety of Paxil® Tablets in children and adolescents with Major Depressive Disorder."

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, so what next?

Japan grants a license for Paxil or Paxil is used 'off-label' for patients between the ages of 7 and 17.

Articles will be sent out to Japanese doctors and psychiatrists claiming some sort of fantastic study that shows Paxil helps this age group [efficacy]

What criteria will doctors in Japan use when an 8 year old walks into a surgery with his parents who claim that their son has been having difficulties at school, has become withdrawn, is misbehaving? If Paxil is approved, chances are the doctor [probably previously dined and dashed by GSK reps] will prescribe the child Paxil.

"If a serial killer kills his second victim, he is already thinking of his third. If he gets away with it, his hunger continues."

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.

"If a serial killer kills his second victim, he is already thinking of his third. If he gets away with it, his hunger continues."

They manipulated the data in Study 329, they had their wrists slapped. Now, it seems, they are at it again, this time in a major economic power. Japan has the world's second largest economy by nominal GDP and the third largest in purchasing power parity. [1]

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." [2]

Why then are they currently running a trial for paroxetine in an age group that they clearly state is 'not approved for the treatment of patients younger than 18'?



Incidentally, Bloomberg ran the following article on the 28th June, 2007. "Japan Says Suicidal Cases Rise Among Paxil Users."


'HARI KARI'



Fid

1. http://en.wikipedia.org/wiki/Gross_domestic_product

2. http://us.gsk.com/html/media-news/news-paroxetine.html

Related links:

Glaxo - Turning Japanese!

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

GSK Just won't stop trying to push paroxetine on children!

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

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