**EXCLUSIVE VIDEO: LAWYERS DISCUSS THE RECENT GLAXO V KILKER CASE

This is pretty riveting stuff - I only wish they could do this on national TV with an audience and I do hope that one day GlaxoSmithKline actually go the distance with an appeal and lose... instead of settling the case.

There are an awful amount of Internal documents from the Kilker case that have been sealed, they will remain sealed if Glaxo settle the appeal - which, they probably will.

Personally, I think this is appalling behaviour by GlaxoSmithKline. Lyam Kilker was born with heart defects [3 different heart defects as it happens] - A jury found GlaxoSmithKline's Paxil [Seroxat] to be the causation of his heart defects. Glaxo appeal the decision - yet settle other 'birth defect cases'. Meantime, the family of Lyam Kilker are plunged into another long wait which, I think, will result in an out of court settlement some time down the line.

It's one thing to manufacture a drug that harms a child, but to then punish the family and child because they won at trial is pretty despicable even by GlaxoSmithKline's standards.

Everyone, even GSK, have a right to appeal but we all know what the outcome of this tragic case is going to be - Glaxo will settle, they cannot afford for the sealed documents to be made public property.

My heart goes out to Lyam Kilker and his loving family. All his mother is guilty of is taken Paxil for what can only be deemed as mild depression. She never knew the damage it could cause her fetus because GlaxoSmithKline never told her... more importantly, they never told her doctor.

The case of Lyam Kilker was a 'test' case - basically Glaxo dipping their toes in the water to see how hot it is. It appears their toes were scolded.

Expect settlements with the other 630 birth defect cases they dispute.

Did they know of the dangers of pregnant women taking Paxil?

Watch the video.

The first 30 seconds is audio only, while the team prepare to go on air. The video is uncut and exclusive to Seroxat Sufferers blog.




Special thanks to the production team at Law Journal TV for passing this on to me and granting me permission to use on Seroxat Sufferers.

After watching the video, take a look at the files that have been made public from the recent Kilker v GSK trial, including a testimony from Ex-GSK executive Jane Nieman which was pretty damning for GlaxoSmithKline.

**Footnote

The MHRA have access to the documents. They refuse to act on them. A strong message of support for GlaxoSmithKline it would appear.

Fid

SEROXAT SUFFERERS STAND UP AND BE COUNTED
Beware of Obsessive freaks posting as me


Original Image: whitman-ma.gov



"This petition is to bring criminal charges against GlaxoSmithKline. The medication they made has caused numerous deaths not to mention birth defects. Many babies have died or been born with horrible birth defects caused by the use of Paxil [Seroxat]. Information that Paxil caused birth defects was hidden therefore taking the right to make an informed decision was taken away from Mothers. GlaxoSmithKline needs to be held criminally accountable for their misinformation and blantant lies. It is for all these babies to have justice."

SIGN THE PETITION HERE

JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY

KILKER v GLAXOSMITHKLINE COURT DOCUMENTS

TO ACCESS FILES VISIT SEROXAT SUFFERERS BLOG HERE

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Fid

SEROXAT SUFFERERS STAND UP AND BE COUNTED
Beware of Obsessive freaks posting as me.

Department of Health and the CYP2D6 Deficiency

DE00000433477

Dear Mr Fiddaman,

Thank you for your email dated 24 July to the Department of Health expressing your view that patients should be tested for deficiency in CYP 2D6 before being treated with Selective Serotonin Reuptake Inhibitors (SSRIs). I have been asked to reply.

I understand that you have had correspondence with the Medicines and Healthcare products Regulatory Agency (MHRA) on this issue, and that you are aware of the conclusions of the Committee on Safety of Medicines' Expert Working Group on the Safety of SSRIs that a number of different factors, including genetic variation, could potentially impact the effectiveness and safety of SSRIs for individual patients.

Before a test for CYP 2D6 deficiency could be recommended for routine clinical use, there would need to be evidence from specific clinical trials which demonstrated the value of such a test in predicting which patients would suffer adverse reactions. Research of this nature has been very limited and we currently do not have good evidence to suggest that people who are CYP 2D6 deficient are at higher risk of adverse reactions to SSRIs. A recently published article on this subject - Pharmacogenetics of Selective Serotonin Reuptake Inhibitors and Associated Adverse Drug Reactions (Pharmacotherapy 2009;29(7):822-831) - has reviewed the available evidence for a genetic basis of adverse reactions to SSRIs. The review highlights the large number of genetic variations which could affect the response of the individual to SSRIs, and the authors conclude that ‘no clear associations have been established between CYP 2D6 and the risk of adverse reactions’.

It is important that patients are monitored for adverse effects of SSRIs, whatever the underlying reason is for them experiencing the adverse effects. There are warnings present in the product information in line with this. Where there is evidence that the effect of paroxetine on CYP 2D6 has clinically relevant impact on patient safety - in the area of interactions between paroxetine and other drugs - there are detailed warnings in the product information.

The impact of genetic variation is important for the effectiveness and safety of many drugs, but the science of pharmacogenetics still has limited application in clinical practice. The MHRA is working with other European regulatory authorities and the European Medicines Agency to identify where there are screening mechanisms available to identify patients who will gain the greatest benefit from a particular medicine, or who may have an increased risk of adverse reactions.

You may be interested to know that the Department recently awarded Liverpool University and Professor Munir Pirmohamed the first NHS Chair in Pharmacogenetics. Professor Pirmohamed leads a team of clinicians, scientists and nurses in identifying genetic variations that dictate a patient’s positive or negative response to a drug.

The Chair will complement a £10million Centre for Personalised Medicines created at Liverpool University . In addition to contributing to research on pharmacogenetics, the remit of the NHS Pharmacogenetics Chair includes helping to establish a UK Pharmacogenetics Forum.

The Department had previously targeted funding for pharmacogenetics, and funded six research projects at a cost of around £4million. The focus of the research is on existing medicines, the pharmacogenetics of which are unlikely to be addressed without public sector funding. This included research on certain generic medicines used in the NHS, such as warfarin, an anti-clotting drug used to treat thrombotic disorders, and drugs involved in epilepsy and hypothermia or drugs that have been implicated in toxicity.

I hope this is helpful.

Yours sincerely,

Martin Gatty
Customer Service Centre
Department of Health

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Bob Fiddaman

Author of Seroxat Sufferers Blog

Paxil Study 329 All Over Again?

Something has been bugging me about the Paxil NCT00812812 trial currently being run by GlaxoSmithKline in Japan. Enough to keep me awake at night to ponder the 112487 trial Protocol and its content, in particular, the exclusion criteria.

For those of you who don't know, the Paxil NCT00812812 trial, underway at this moment in time, is for children from the age of 7 upwards to 17 - Yes, you read it correct, CHILDREN!

It's hard to fathom out why GSK would be yet again trying to target children with a drug that, by their own admission, is NOT safe in this particular age group. One can only assume that GSK believe the genetic make-up of Japanese subjects is significantly different to those of the Western population, unless of course they have other reasons for wanting to gain a license for use of Paxil in children?

Just because this is Japan does not mean that we should ignore what GSK's intentions are here. They wish for children to take a drug that is dangerous and harmful - it's safe to assume that isn't it?

The criteria for inclusion into this trial stipulates that the subjects must be between the ages of 7 to 17 - in other words, Children. It also stipulates that the subjects must have Major Depressive Disorder [MDD]. They measure the level of depression according to the DSM-IV-TR criteria - Depressive disorders: MDD, single episode (296.2), MDD, recurrent (296.3). To the layman, this means children who have major depression.

The exclusion list for this trial is lengthy to say the least and it would appear that GSK want the 'best' of a 'bad' bunch.

Exclusion Criteria
run-in period: A subject will not be eligible for inclusion to this study if any of the following criteria applies at start of run-in period:
Patients who in the investigator's judgment presented with a clinically predominant Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific phobia, PTSD, OCD, Panic disorder, etc)
Patients with any history of a psychotic episode or psychotic disorder (including schizophrenia ), or complication of these diseases.
Patients with a history of a bipolar disorder, or complication of these diseases.
Patients with Attention-Deficit, or Hyperactivity Disorder
Patients with Mental Retardation or Pervasive Development Disorder
Patients diagnosed with Substance Abuse or Dependence within 12 weeks prior to the Screening visit
Patients with past treatment experience with the investigational drug (i.e. paroxetine)
Patients treated with electroconvulsive therapy in the immediate 12 weeks prior to the Screening visit
Patients with past history of serotonin syndrome and neuroleptic malignant syndrome.
Patients with CDRS-R score of "suicidal ideation" of 3 or greater. Or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the chief investigator (subinvestigator), are at significant risk for harming self.
Patients with past history of suicide attempt, self harm(excluding "no suicidal intent " ), or an intentional overdose (excluding obviously unintentional overdose)
Patients who have been treated with other clinical trial investigational drug (including post-marketing clinical trial) in the immediate past 3 months of the Week -2 visit.
Patients who have taken antidepressant medication 1 week prior to screening.
Patients with complicated disease of glaucoma.
Patients with convulsive disorders such as epilepsy or past history of these diseases.
Patients regularly using drugs (e.g. NSAIDs) that would increase the risk of hemorrhage, or patients with bleeding tendency or hemorrhagic diathesis.
Patients with severe renal and hepatic disorder.
Patients with serious organic disorder in the brain.
Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody.
Patients with a current history of carcinoma or malignant tumor, or complication of these diseases.
Female patients who are pregnant, lactating, or who might be pregnant, or who wish to be pregnant during the study period
Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study.
Patients with clinical significant co morbid impulsivity symptoms.(e.g. Personality Disorder, Conduct Disorder)
treatment period: Subjects for whom any of the following categories apply at Week 0 (start of the treatment period) will not be progressed to the treatment phase.
Patients with CDRS-R score of "suicidal ideation" of 3 or greater, or patients who, in the opinion of the chief investigator (sub investigator), are at significant risk for harming self
Patients with variation of the CDRS-R total raw summary score at Week 0 of +/-25% or greater compared to that of Week -2.
Patients with drug compliance of Drug 1 (run-in placebo) from Week -2 to Week 0 less than 80%.
Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study.

Quite a list, I'm sure you would agree?

Forget the scientific talk, it's aimed to confuse. What one has to do here is read between the lines to see exactly what GlaxoSmithKline want from this trial.

The last exclusion listed is quite open-ended wouldn't you agree?

Why list such a vague exclusion after naming all other exclusions?

"Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study."

This could mean anything and could possibly mean that any subject that could be detrimental into getting Paxil a license will be removed from the trial. That's my train of thought anyway. Am I right to question the motive behind this vague statement? One only has to study the Paxil 329 study to see how GSK massaged data to gain a license for children all those years ago. A license that was obtained by fraudulently manipulating figures - something GSK have never been held accountable for... unless a slap on the wrists counts as a punishment?

Does the whole world need to be reminded of the infamous SmithKline Beecham Paxil 329 study again?

Are they trying to gain a license for Paxil in children in Japan because of the language barrier?
　
CYP450-2D6 is a phrase some of you may not have heard of before and, I believe, it's one that GSK don't want you to hear about either.

To cut a long story short, anyone who is deficient in the CYP450-2D6 Cytochrome can be at danger if they take Paxil. There is no easier way to say it folks.

This, I believe, bothers GSK with regard to Paxil, so much so that it was announced in March 2006 that GSK had 'solved' the Structure of Human Cytochrome P450 2D6 [1]

The 2D6 deficiency differs from culture to culture. In Asia approx 60% of the Asian population (Thai, Chinese & Japanese) are poorer than normal metabolizers of drugs such as Paxil, which primarily use the 2D6 enzyme.[2] Which begs the question if the final exclusion, ["Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study."] - actually means this population of 60%?

If GSK are going to pre-screen for this deficiency then any positive outcome of the trial will be cleverly disguised as an out and out success - 'The 'best' of a 'bad' bunch remember? Unless of course GSK step up to the plate and state clearly that 2D6 deficient subjects were removed from the trial?

So in essence, GSK want a bunch of kids with MDD. They don't want these kids to have any of the illnesses, traits, habits included on their exclusion list - anything that may cause a negative finding during the trial.

So, let's predict that the Paxil NCT00812812 trial is a success for GSK. They are granted a license for Paxil, moreover for use of Paxil in Japanese children. How many children will then be prescribed Paxil by GP's, healthcare professionals who will use the same criteria as GSK did for the trial?

Take a look at the exclusion criteria again. Imagine if you will the scenario of a distraught mother with her 16 year old son. She has gone to see her Japanese doctor because her son is showing signs of major depressive disorder. The exclusions for this trial need to be changed into questions for doctors to ask patients before they prescribe them Paxil. In this scenario, do you think the doctor would ask the mother of this child the following questions:

Is your son 2D6 deficient?
Does your son have predominant Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific phobia, PTSD, OCD, Panic disorder, etc?
Has your son ever had any history of a psychotic episode or psychotic disorder (including schizophrenia ), or complication of these diseases?
Does your son have a history of a bipolar disorder, or complication of these diseases?
Does he have Attention-Deficit, or Hyperactivity Disorder?
Does he have Mental Retardation or Pervasive Development Disorder?
Has your son ever taken any drugs that have led to Substance Abuse or Dependence?
Has he ever been treated with Paxil before?
Has he, in the past 12 weeks been treated with electroconvulsive therapy?
Does he have a past history of serotonin syndrome and neuroleptic malignant syndrome?
Does he have a CDRS-R score of "suicidal ideation" of 3 or greater. Or did his C-SSRS assessment suggest that they he has been a significant risk for harming himself or has actually harmed himself?
Does he have a past history of suicide attempt, self harm(excluding "no suicidal intent " ), or an intentional overdose (excluding obviously unintentional overdose)?
Does he have glaucoma?
Does he have convulsive disorders such as epilepsy or past history of these diseases?
Is he using drugs (e.g. NSAIDs) that would increase the risk of hemorrhage, or has he had bleeding tendency or hemorrhagic diathesis?
Does he have severe renal and hepatic disorder?
Does he have a serious organic disorder in the brain?
Does he have chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody?
Does he have a current history of carcinoma or malignant tumor, or complication of these diseases?
Does he have clinical significant co morbid impulsivity symptoms.(e.g. Personality Disorder, Conduct Disorder)?
Finally, one question the doctor WILL NOT be able to ask this mother would be
Has he, in the opinion of a 'specialist', been judged as not appropriate for Paxil?
　
A huge list of questions for any doctor but ones that should be asked if Paxil is granted a license for use in children in Japan. If it's good enough for GlaxoSmithKline to exclude subjects from the trial because they don't meet the criteria then it's fair to say that doctors should be concerned and ask the patient or the patient's parents the above questions.

Two questions I have put to GlaxoSmithKline in an email are thus:
　
1- What exactly does the exclusion criterion "Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study" mean? What other criteria might this include not already listed. Could it possibly mean that children & adolescents will be pre-screened, by genetic testing to be sure that they are not deficient in the CYP450-2D6 enzyme that Paxil desperately needs to be safely cleared from a persons system. Will these kids not be included in the study?

2- Does the long list of exclusion criteria really represent the real world of kids that will be prescribed this drug in Japan,if it is approved. Will doctors use this same list of criteria when deciding to prescribe Paxil to their young Japanese patients?
　
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You have to ask yourselves if GlaxoSmithKline used the same criteria in other trials for Paxil other than trials for children. Whatever or whomever they excluded in all of the Paxil trials should be made abundantly clear to doctors before any prescription is ever wrote for Paxil - that's fair game isn't it?
　
Paxil has been proven to be as useful in children as a one-legged man at an arse kicking contest and as dangerous as giving them a loaded gun. I predict the results of this current trial will be favourable to GlaxoSmithKline. I also predict that doctor's will not be made aware of reasons NOT to give Paxil to children [Exclusions]

To put it bluntly and to use an analogy:

Here we have a rollercoaster in an amusement park, a rollercoaster that was condemned because it was faulty. The greedy amusement park owner wishes to re-open the rollercoaster, despite knowing how dangerous it is - so he has trial runs to prove to the public that children with ginger hair will be safe. Absurd isn't it - and nobody in their right mind would deem this acceptable behaviour. Yet here we have GlaxoSmithKline, the faultless pharmaceutical company who are deluded enough to believe that they have never done any wrong where Seroxat/Paxil is concerned. They are re-launching the rollercoaster... but first they need a license and they will do everything in their power to gain that license.

I hope I'm wrong.
　
Bob Fiddaman
Author of Seroxat/Paxil Sufferers
http://fiddaman.blogspot.com

[1] Structure of Human Cytochrome P450 2D6 solved by GlaxoSmithKline with the use of Fludigm Technology - http://www.analytica-world.com/news/e/53265/
[2] Bernard eta al, J Pharm Sci 96-2007

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Japan/GSK - 329 All Over Again!

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!

Email to Ministry of Health - Japan

Japan Says Suicidal Cases Rise Among Paxil Users