Why Was the Japanese Paxil Pediatric Study Terminated?

Regular readers of this blog will know how I broke the news back in 2009 regarding GlaxoSmithKline's attempts to push Paxil [known as Seroxat in UK] on kids in Japan.

I was so outraged at this that I wrote to the Japanese Embassy and the Japanese Ministry of Health, more or less to give them a detailed view of how GSK had previously claimed Paxil was safe for kids to take...when in actual fact they knew that it wasn't.

I never heard back from either one of them.

I also contacted GlaxoSmithKline in 2010, you can see the email I sent to them here.

In 2008, one year before I broke the news, Glaxo were recruiting kids for a clinical study. I say Glaxo, they, in actual fact were sponsoring the study.

The study was designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily.

Oral paroxetine is a sickly orange syrup, I've been on it myself. It was the only safe way to taper from this highly addictive antidepressant.

And just who were being used as the guinea pigs in Japan?

One look at the inclusion study criteria would have showed you.

Ages Eligible for Study:7 Years to 17 Years.

Yup, that's right folks. Despite being dragged through numerous courts in the US where evidence was shown that Glaxo manipulated previous clinical trials in children, here they were again back in 2008 recruiting more kids.

A marketing campaign went out in the form of a poster... which I just happened to obtain from a source at Medwatcher Japan. Medwatcher were also furious at this particular clinical trial involving kids and Paxil.

Take a good look at the imagery used in the recruitment poster.

If a picture paints a thousand words, eh?


Well, folks... **drum roll** - the trial has been terminated.

**Cue a spectacular display of fireworks**

According to GSK's clinical trial database the study was terminated in 2011. They give no reasons as to why this study was terminated.

What we do know is that 56 kids were enrolled. 29 were in the Paxil group whilst the remaining 27 were in the placebo group.

The study results claimed that there were 3 reports of suicidal ideation in the placebo group but none in the Paxil group. [More about this later]

The subjects enrolled had to have a diagnosis of a depressive disorder before being allowed into the study.

So, it would appear that 3 of the kids taking placebo had suicidal ideation. Not one report in the Paxil group. Glaxo must have loved this.

Unfortunately for the Glaxo sponsored trial, Paxil didn't really show much efficacy.

Open the Outcome Measures on the Clinical Trials website and it tells us how Paxil failed.

Paxil didn't reduce the depression scores of the children sufficiently to be considered effective and the primary purpose of this study was efficacy. In this study all participants had to have a depression score of 45 or greater to be included. A 50% reduction on the CDRS-R is required to consider children have responded to treatment.

So, not only did Paxil not reach the standard for efficacy but in comparison to, let's say, fluoxetine, it would be seen to be less effective.

In the Fluoxetine studies [1] [2] the average decrease was 28.9%. In this Japanese study, the decrease was only 16.9% therefore the kids would not be considered to have responded to Paxil treatment.

No wonder the study was terminated, right?

It would appear that GlaxoSmithKline didn't want to expose the fact that Paxil is less effective than that of their competitor.

Another interesting finding from the Japanese study was the participants only had to have been free from any antidepressant for 1 week prior to the trial commencement.

Anyone who's anyone will know that one week off an antidepressant is hardly a time to get the champagne corks popping and decorate rooms with bunting and balloons. Any number of these participants could have been suffering withdrawal even before they were entered into the Japanese trial. Any of these patients suffering withdrawal, which remember can mimic depression, would have had immediate relief if they were selected for the Paxil arm of the trial. As the phases of the trial progressed they would have, obviously, reaped the benefits of Paxil but not for their apparent depression, their benefits from Paxil would have merely meant they would not be going through withdrawal anymore.

Take the three patients from the placebo arm of the study who, according to the results, suffered suicidal ideation, and we may just find that these three were also taking antidepressants a week or so before they entered the Japanese study.

Could their suicidal ideation have been caused by the withdrawal effects of the medication they were taking prior to the Japanese study?

Glaxo pretty much shot themselves in the foot with this study, a study that should never have taken place given the findings of the Paxil 329 study.

So, once the Japanese trial was over did the sponsors, GlaxoSmithKline, do any follow-up to see if these kids were okay? The doses used in the study were between 10mg and 40mg, the latter being enough to put a horse into a coma.

The withdrawal phase of the Japanese study lasted three weeks. Two weeks later the participants were contacted to see how they were.

Can you imagine a 7 year old child on 40mg of Paxil a day just having three weeks to taper? Even if the 7 year old was on a lower dose it's still mind-boggling how one adult human could give someone so young a pill known to increase suicidal thoughts, known to increase completion of suicide.

What on earth were GlaxoSmithKline thinking by using kids in a study for Paxil?

The Japanese public, particularly the children and adolescents, just don't know what a lucky escape they've had from this truly awful abomination of an antidepressant.

Bob Fiddaman

[1] Psychometric Properties of the Children's Depression Rating Scale–Revised in Adolescents - J Child Adolesc Psychopharmacol. 2010 December; 20(6): 513–516.
[2] Early Prediction of Acute Antidepressant Treatment Response and Remission in Pediatric Major Depressive Disorder - J Am Acad Child Adolesc Psychiatry. 2009 January; 48(1): 71.

Back stories:

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

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

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

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

Paxil - Multiple Symptoms, One Solution

So, we all know how Glaxo failed to show the efficacy and safety of Paxil use in kids, we all know how they buried data and hired a ghostwriter to dupe doctor's, journal editor's and parents of kids. Basically, a suicide link was seen in the clinical trials, Glaxo covered it up. We all know how Glaxo reps were given carte blanche by executives at Glaxo to pay doctor's large sums of money, carefully disguised as preceptorship's and/or fees for attending and sitting on advisory boards. All this on top of the lavish weekend breaks for doctor's and, in some instances, their partners.

That's business, eh folks?

The following is a letter from the FDA's Division of Drug Marketing, Advertising and Communications [DDMAC] to GlaxoSmithKline warning them about their promotional activities regarding Paxil and children.

Remember, Glaxo had not got a licence for Paxil in children, none the less they saw fit to push it on them in the despicable way.

Basically, Glaxo distributed a T-shirt during a Health Fair function at the Children's Advocacy Center of Brevard in Brevard, Florida. The front of the T-shirt saw the logo and name of the Children's Advocacy Center, while the back of the T-shirt saw the claim "Multiple Symptoms, One Solution" followed by the Paxil logo.

Here's the letter, courtesy of the Drug Industry Document Archive, from the FDA to Eloise R. Scott, D.V.M. Associate Director, U.S. Regulatory Affairs at Glaxo, formerly Smithktine Beecham Pharmaceuticals.

Fid

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

AUSTRALIAN ORDERS HERE

Sitting Back in Anger

There are those that do then there are those that...well, that just sit there shrugging their shoulders not giving a toss.

There is a global problem with children being prescribed mind-altering drugs, in fact the increase in drug prescriptions stranglely does not run concurrent with the increase in apparent mental disorders. The drugs, the system, is being manipulated.

Put a bunch of children on courses of powerful antipsychotics, chances are their reactions to them will mimic the traits of a depressive or someone who shows a lack of interest. Solution? Feed them more drugs.

The term "chemical cosh" has been used by many people to describe these drugs, they whip the child into submission - Go and sit in the corner and be quiet, I'm not putting up with your tantrums today.

It's all well and good writing blogs about this problem or posting videos to Twitter and Facebook, chances are that only a small number of people on friend lists will retweet or share on the social networking websites. People these days seem more moved by a dog being mistreated or a cat being thrown into a bin by a passer-by. There's public outrage [and rightly so] at seals being clubbed to death or secretly filmed videos of animals being mistreated by the travelling circus. I've seen campaigns on Facebook that range from the ridiculous to the sublime and seen grown adults post links to the various games on Facebook, "You have been invited to play Mafia Wars." Hey, each to their own, whatever gets you through the day, I'm not knocking the fact that you wish to escape from reality, we all need that escapism at some point in our lives.

There are far too many shoulder shruggers, The why should it bother me, my kids are fine type. Sometimes we, as adults, have to step out of our own bubbles to see the true state of humanity. Yeh, it sucks, it's depressing and why should we take on other people's problems when we have so much crap in our own lives?

Nice take on life folks.

There are those that do then there are those that sit back and watch those that do. "You are doing great work", "Thanks for highlighting this", "Thanks for posting, I'll read after I have planted the seeds in my garden on Farmville."


I'm of the opinion that the people that highlight these stories about the ever-increasing drugging of children do not want the thanks, they'd much prefer people to do something about it. Recognition is nice but what is it worth if your message gets lost amidst the back-slapping and high fives? By all means thank those that highlight these stories but please remember what you are thanking them for then ask yourself what you can do about the reason why you thanked them.

There is a trend for those that do, they never stop at one story, they continue to highlight the plight of children being drugged because they know they have to. Repetition is the key.

Next, we have the haters. Those people that just don't like to see good triumph over evil, the anonymous knuckleheads who are so hellbent on discrediting that they fail to realise that they are no better than the white-coated buffoons that hand out these drugs, the pharmaceutical companies that manufacture them and the independent bodies that, apparently, regulate them.

Yesterday saw me join a bunch of folk for a demonstration in my hometown of Birmingham. It was to protest against the use of ECT, otherwise known as Electroconvulsive therapy. Two incidents that struck me were thus:

Scene: Standing outside Maple House where there was a symposium for psychiatrists who were gathered to discuss the benefits of ECT.

A psychiatrist, who bore a striking resemblance to comedian Billy Connolly, came outside for a cigarette break, he couldn't help but look in the direction of the protesters as we were only about 5 yards away from him. He, like so many before him, had the usual smirk on his face, the patronising kind that suggests that he knows best. He looks toward our direction and says, "So, I hear you are Scientologists", then exhaled cigarette smoke in one of those laughing fashions. "Well, I'm not", I replied. His bottom lip quivered, he shuffled, shrugged his shoulders and eventually said, "Good for you." Hey great Mr Psychiatry man, if you are going to make a broad statement toward a crowd then, at the very least, have some form of defence if you are wrong. Then again, they do like to label people eh?

Scene: Standing around the corner from Maple House holding a banner.

A member of the public stops and asks me what ECT stands for. I explain and he shakes his head before coming back with, "I thought they stopped doing that in the age of the witch.". He then walked away, hopefully better educated for that brief minute we spoke.

Two incidents, two very contrasting points of view.

One has to throw a stone to get the pool to ripple, I do my bit and many other bloggers out there do the same. The Citizen's Commission on Human Rights [CCHR] have been doing it for many years, their stones being boulders. They don't stop at isolated cases, they add more coal to the fire because the train track is never ending, boy, do I know that feeling.

This post isn't about singing the praises of CCHR, they pretty much know how I feel about their organisation. This post is one that wishes to tap into the conscience of those that feel that there IS a problem but there isn't much they can do about it. They are wrong, they need to start making the pool ripple because psychiatry, the pharmaceutical industry, medicine regulators and those haters will continue to induce harm to children around the world.








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


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The Parental Consent Act - The Petition

Dear readers,

I'd be really grateful if you could head on over to a petition that I am fully behind. Although this is an American petition, it's purpose is to send out a crystal clear message to those who feel psychiatric drugs are safe to use in children.

The madness must stop, you can help by signing the petition.

Here's part of the blurb:

This petition is in support of The Parental Consent Act, a federal bill introduced by Congressman Ron Paul, which prohibits federal funds being used to establish or implement any mandatory or universal mental health/psychiatric screening of schoolchildren. It also establishes a parent's right to refuse mental health screening of their child. This is a crucial bill which must be passed to guarantee parental rights. We urge everyone to sign the petition in support of this bill. 

SIGN HERE 

For more information on The Parental Consent Act please visit Ablechild, an organisation co-founded by a good friend, Sheila Matthews.





Fid


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

AUSTRALIAN ORDERS HERE