Source: Daily Mail
The recession is being blamed for a steep rise in the number of people taking anti-depressants.
Doctors in London alone handed out nearly 3.27m prescriptions last year - a rise of 188,252 in 12 months.
Figures also show that the NHS drugs bill for treating mental health problems such as depression and anxiety is £24.3m since the beginning of last year. This is despite a reduction in the cost of anti-depressants.
One mental health charity said it was not surprised about the rise given the stresses caused by the recession. But it emphasised that pills were not the only answer.
Victoria Walsh, campaigns manager of Rethink, said: 'This shows there is a need for additional psychological therapies as anti-depressants alone are not the most effective way to deal with depression.'
The figures from the NHS Information Centre cover the 31 London primary care trusts, and refer to a wide range of anti-depressants including Prozac and Seroxat.
Read more
Fid
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Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Thursday, July 30, 2009
Wednesday, July 29, 2009
Tom Scott: FluBay Genius
There is no other word for it.
Genius.
http://www.flubay.co.uk/
Follow Tom on Twitter
----
Fid
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Genius.
http://www.flubay.co.uk/
Follow Tom on Twitter
----
Fid
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Tuesday, July 28, 2009
Government virus expert paid £116k by swine flu vaccine manufacturers GlaxoSmithKline
An eagle-eyed reader [Ruth] sent me the following story regarding Professor Sir Roy Anderson.
Anderson, it appears, has more than a vested interest in the current swine flu pandemic.
The Daily Mail reports that Anderson, who sits on the Scientific Advisory Group for Emergencies (Sage), a 20-strong task force drawing up the action plan for the virus, also sits on the board of GlaxoSmithKline,the company selling swine flu vaccines and anti-virals to the NHS.
This bears a striking similarity to Paul Blackburn, Ofsted and the Cervarix Vaccine, also manufactured by GlaxoSmithKline.
Fingers in so many pies eh Glaxo?
Fid
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Anderson, it appears, has more than a vested interest in the current swine flu pandemic.
The Daily Mail reports that Anderson, who sits on the Scientific Advisory Group for Emergencies (Sage), a 20-strong task force drawing up the action plan for the virus, also sits on the board of GlaxoSmithKline,the company selling swine flu vaccines and anti-virals to the NHS.
This bears a striking similarity to Paul Blackburn, Ofsted and the Cervarix Vaccine, also manufactured by GlaxoSmithKline.
Fingers in so many pies eh Glaxo?
Fid
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Monday, July 27, 2009
Who Killed Japanese Culture?
I've just finished reading a fascinating article from 2004. It was written by Kathryn Schulz and featured in the New York Times.
Kathryn describes in great detail how pharmaceutical companies targeted Japanese citizens with an angle based on their cultural beliefs rather than science.
Largely before 1999 Japanese citizens were, it seems, oblivious to the world of antidepressants, depression was rarely discussed, due, in part, to the cultural belief system.
Around 1999 pharmaceutical companies and their genius marketing teams used a ploy that only they could get away with. An all out attack that defies belief [at least it would have once, until I started writing about pharma]
ORDER THE PAPERBACK
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Kathryn describes in great detail how pharmaceutical companies targeted Japanese citizens with an angle based on their cultural beliefs rather than science.
Largely before 1999 Japanese citizens were, it seems, oblivious to the world of antidepressants, depression was rarely discussed, due, in part, to the cultural belief system.
Around 1999 pharmaceutical companies and their genius marketing teams used a ploy that only they could get away with. An all out attack that defies belief [at least it would have once, until I started writing about pharma]
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Saturday, July 25, 2009
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,
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
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 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,
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
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
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
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
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
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
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
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
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
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?
----
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
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?
----
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
RELATED STORIES
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
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
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
RELATED STORIES
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
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Friday, July 24, 2009
DNA Drug Sensitivity Testing
----- Original Message -----
From: fiddaman
To: Morgan, Sarah ; MHRA Information Centre ; KENT WOODS ; dhmail@dh.gsi.gov.uk ; ALASDAIR BRECKENRIDGE ; jeremy.holmes@rpsgb.org ; cmacfarlane@bnf.org ; roger.williams@ucl.ac.uk ; schaeferj@who.int ; stavek@who.int ; allanvi@who.int ; vanhiltenm@who.int
Cc: Gregor, Simon ; GISELA STUART ; David Healy ; action@mind.org.uk ; obrienm@parliament.uk ; nice@nice.org.uk ; contact@mind.org.uk
Sent: Friday, July 24, 2009 8:51 AM
Subject: DNA Drug Sensitivity Testing
Dear All,
I am sure that you are all aware that clinical factors such as age, sex, weight, general health and liver function can alter a patient's response to drugs, genetic factors being the most important.
For the past 4 years or so I have been at loggerheads with the Medicine's Healthcare and products Regulatory Agency [MHRA] regarding the safety and efficacy of Selective Serotonin Re-Uptake Inhibitors [SSRi's], in particular the safe way to withdraw or taper from these drugs.
It appears that SSRi's are the most widely reported drugs with regard to adverse drug reactions [ADR's]. It also appears that very little is being done about this problem, apart from fairly recently where the MHRA have started corresponding with the British National Formulary [BNF][1]
It's widely suggested that the MHRA's current Yellow Card Reporting system is quite flawed and that the actual number of SSRi ADR's is a lot higher than what the Yellow Card System identifies - some quarters suggest that any yellow card ADR's could possibly be multiplied by 10 to get a more precise figure of the actual problem.
There is certainly a possible solution to help patients from suffering from SSRi toxicity/withdrawal/addiction that seems to have been largely overlooked by the NHS/MHRA.
I take it you are all aware of DNA drug sensitivity testing? I also assume that you are all aware that a simple screening of patients deficient in CYP2D6 could possibly save any patient suffering and possibly reduce ADR's?
CYP2D6 acts on one-fourth of all prescription drugs, including SSRi's and tricylic antidepressants (TCA's). Approximately 10% of the population has a slow acting form of this enzyme and 7% a super-fast acting form. Thirty-five percent are carriers of a non-functional 2D6 allele, especially elevating the risk of ADRs when these individuals are taking multiple drugs. Drugs that CYP2D6 metabolizes include Prozac, Zoloft, Paxil, Effexor, 4 of the most popular SSRi's/SNRi's prescribed by doctors.
I do fully understand that to screen every single patient for this deficiency would cost the NHS an enormous amount of money but believe that it would be money well spent:
A, Time off work for the debilitating side-effects caused by these drugs.
B, A huge saving of money from prescribed medication funded by the benefits system in the UK.
C, An end to needless patient suffering. The needless suffering includes toxic poisoning, debilitating withdrawal symptoms, financial loss because of time off work and suicide ideation.
With this in mind, I wish for all of you included in this email to consider putting a DNA drug sensitivity test in place and to put aside the red-tape and money factors. This is about people, it's about a deficiency that cannot be seen by talking, it's about people who put trust in their GP's and trust in the pharmaceutical companies that manufacture the drugs they take. You ALL know this deficiency exists, you ALL know there is a solution.
You are ALL responsible for the welfare of patient safety and you ALL have a duty to protect patients.
I'd like all of you to reply to this mail. I do not wish for it to be passed on to the current Health Minister, who in turn will either cut and paste from the MHRA or NHS website with Expert Working Group Discussions et al.
I am bringing this to your attention and for the sake of humanity I want you all to do something about it. I strongly feel that by ignoring such an obvious solution is infringing basic human rights
A copy of this email will be published on my blog, Seroxat Sufferers [http://fiddaman.blogspot.com] - Any replies and/or lack of responses will also be published.
It's high-time you ALL stopped burying your heads in the sand. The talking is merely stalling. Patients need action and they need it now.
This email is also for the attention for the following people whom, for one reason or another, do not have contact email addresses:
I would be grateful if this email could be passed on to the following:
Rt Hon Andy Burnham MP, Secretary of State for Health
Gillian Merron MP, Minister of State for Public Health
Ann Keen MP, Parliamentary Under Secretary for Health Services
Sir Liam Donaldson, Government's chief medical officer
Professor Louis Appleby CBE, National Director for Mental Health
Professor Dame Carol M Black, National Director for Health and Work
David Colin-Thome OBE, National Clinical Director for Primary Care
Professor Bob Fryer CBE, National Director for Widening Participation in Learning
Surinder Sharma, National Director for Equality and Human Rights
Jonathan Mason, National Clinical Director for Pharmacy
Martin Stephens, National Clinical Director for Pharmacy
Yours
Bob Fiddaman
Author of Seroxat Sufferers
http://fiddaman.blogspot.com
BCC To interested parties
---
[1] MHRA now in discussions with BNF regarding information given to doctors regarding SSRi tapering.
http://fiddaman.blogspot.com/2009/07/correspondence-between-mhra-and-bnf.html
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
From: fiddaman
To: Morgan, Sarah ; MHRA Information Centre ; KENT WOODS ; dhmail@dh.gsi.gov.uk ; ALASDAIR BRECKENRIDGE ; jeremy.holmes@rpsgb.org ; cmacfarlane@bnf.org ; roger.williams@ucl.ac.uk ; schaeferj@who.int ; stavek@who.int ; allanvi@who.int ; vanhiltenm@who.int
Cc: Gregor, Simon ; GISELA STUART ; David Healy ; action@mind.org.uk ; obrienm@parliament.uk ; nice@nice.org.uk ; contact@mind.org.uk
Sent: Friday, July 24, 2009 8:51 AM
Subject: DNA Drug Sensitivity Testing
Dear All,
I am sure that you are all aware that clinical factors such as age, sex, weight, general health and liver function can alter a patient's response to drugs, genetic factors being the most important.
For the past 4 years or so I have been at loggerheads with the Medicine's Healthcare and products Regulatory Agency [MHRA] regarding the safety and efficacy of Selective Serotonin Re-Uptake Inhibitors [SSRi's], in particular the safe way to withdraw or taper from these drugs.
It appears that SSRi's are the most widely reported drugs with regard to adverse drug reactions [ADR's]. It also appears that very little is being done about this problem, apart from fairly recently where the MHRA have started corresponding with the British National Formulary [BNF][1]
It's widely suggested that the MHRA's current Yellow Card Reporting system is quite flawed and that the actual number of SSRi ADR's is a lot higher than what the Yellow Card System identifies - some quarters suggest that any yellow card ADR's could possibly be multiplied by 10 to get a more precise figure of the actual problem.
There is certainly a possible solution to help patients from suffering from SSRi toxicity/withdrawal/addiction that seems to have been largely overlooked by the NHS/MHRA.
I take it you are all aware of DNA drug sensitivity testing? I also assume that you are all aware that a simple screening of patients deficient in CYP2D6 could possibly save any patient suffering and possibly reduce ADR's?
CYP2D6 acts on one-fourth of all prescription drugs, including SSRi's and tricylic antidepressants (TCA's). Approximately 10% of the population has a slow acting form of this enzyme and 7% a super-fast acting form. Thirty-five percent are carriers of a non-functional 2D6 allele, especially elevating the risk of ADRs when these individuals are taking multiple drugs. Drugs that CYP2D6 metabolizes include Prozac, Zoloft, Paxil, Effexor, 4 of the most popular SSRi's/SNRi's prescribed by doctors.
I do fully understand that to screen every single patient for this deficiency would cost the NHS an enormous amount of money but believe that it would be money well spent:
A, Time off work for the debilitating side-effects caused by these drugs.
B, A huge saving of money from prescribed medication funded by the benefits system in the UK.
C, An end to needless patient suffering. The needless suffering includes toxic poisoning, debilitating withdrawal symptoms, financial loss because of time off work and suicide ideation.
With this in mind, I wish for all of you included in this email to consider putting a DNA drug sensitivity test in place and to put aside the red-tape and money factors. This is about people, it's about a deficiency that cannot be seen by talking, it's about people who put trust in their GP's and trust in the pharmaceutical companies that manufacture the drugs they take. You ALL know this deficiency exists, you ALL know there is a solution.
You are ALL responsible for the welfare of patient safety and you ALL have a duty to protect patients.
I'd like all of you to reply to this mail. I do not wish for it to be passed on to the current Health Minister, who in turn will either cut and paste from the MHRA or NHS website with Expert Working Group Discussions et al.
I am bringing this to your attention and for the sake of humanity I want you all to do something about it. I strongly feel that by ignoring such an obvious solution is infringing basic human rights
A copy of this email will be published on my blog, Seroxat Sufferers [http://fiddaman.blogspot.com] - Any replies and/or lack of responses will also be published.
It's high-time you ALL stopped burying your heads in the sand. The talking is merely stalling. Patients need action and they need it now.
This email is also for the attention for the following people whom, for one reason or another, do not have contact email addresses:
I would be grateful if this email could be passed on to the following:
Rt Hon Andy Burnham MP, Secretary of State for Health
Gillian Merron MP, Minister of State for Public Health
Ann Keen MP, Parliamentary Under Secretary for Health Services
Sir Liam Donaldson, Government's chief medical officer
Professor Louis Appleby CBE, National Director for Mental Health
Professor Dame Carol M Black, National Director for Health and Work
David Colin-Thome OBE, National Clinical Director for Primary Care
Professor Bob Fryer CBE, National Director for Widening Participation in Learning
Surinder Sharma, National Director for Equality and Human Rights
Jonathan Mason, National Clinical Director for Pharmacy
Martin Stephens, National Clinical Director for Pharmacy
Yours
Bob Fiddaman
Author of Seroxat Sufferers
http://fiddaman.blogspot.com
BCC To interested parties
---
[1] MHRA now in discussions with BNF regarding information given to doctors regarding SSRi tapering.
http://fiddaman.blogspot.com/2009/07/correspondence-between-mhra-and-bnf.html
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Thursday, July 23, 2009
GlaxoSmithSwine
Glaxo unmasked: drug firm to make £1bn from swine flu
Source: Independent Minds
GlaxoSmithKline (GSK) is to sell the vaccine for up to £6 a dose in Western countries, and the first supplies are due to arrive in Britain in September.
Andrew Witty, GSK's chief executive, refused to apologise for the boost in earnings, pointing out that GSK had invested more than $2.5bn (£1.5bn) in its vaccine development programme over the past few years.
"Swine flu is going to be positive for the performance [of the company], but only because we have put ourselves in a position to do it," he added. "And we have done that by taking very significant risks over a long time, diverting a huge amount of resources to it and doing the research that nobody else has done, so I'm not going to apologise for the fact that the company is going to make a return."
Read more HERE
----
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Tuesday, July 21, 2009
Seroxat Withdrawal - What GSK keep from the Patient.
ABC PRIMETIME LIVE - PAXIL ADDICTION
----
Click on PDF Logo to download file
GlaxoSmithKline program called “Psychnet”
Section 3: Issues Management: Managing the Discontinuation Issue.
Paxil Litigation Documents
DOCUMENT RETENTION, LETTERS TO MINISTERS, LETTERS AND EMAILS ABOUT SEROXAT AND LIST OF FOI REQUESTS
More GSK Files at http://gskfiles.blogspot.com/
----
Click on PDF Logo to download file
GlaxoSmithKline program called “Psychnet”
Section 3: Issues Management: Managing the Discontinuation Issue.
Paxil Litigation Documents
DOCUMENT RETENTION, LETTERS TO MINISTERS, LETTERS AND EMAILS ABOUT SEROXAT AND LIST OF FOI REQUESTS
More GSK Files at http://gskfiles.blogspot.com/
Any News on the Paxil Kids Yet?
Protocol Summary for 112487
Protocol Id: 112487
Secondary Ids: N/A
Title: 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.
Phase: Phase 4
FDA Regulated Intervention? No
Study Type: interventional
Oversight Authority: Japan: Ministry of Health, Labour and Welfare
Brief Summary: This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with major depressive disorder (MDD) based on the change from baseline to Week 8/end-of-study in the CDRS-R total score in a randomized, double-blind, placebo-controlled parallel-group study.
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes: To compare the efficacy of paroxetine versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with MDD based on the change from baseline to Week 8/end-of-study in the CDRS-R total score no 8 weeks.
Secondary Outcomes: To compare the safety of paroxetine versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with MDD no 8 weeks.
To assess the plasma concentrations of paroxetine administered orally at Week 8 or withdrawal in subjects with MDD. no 8 weeks.
Conditions: Major Depressive Disorder
Keywords:
children and adolescents
paroxetine
CDRS-R
selective serotonin reuptake inhibitor
Gender: Both
Minimum Age: 7 years
Maximum Age: 17 years
Central Contact: US GSK Clinical Trials Call Center
Central Contact Email: info@clinicaltrialsforgsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Responsible Party Organization: GSK
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Related Links
MHRA Investigation into Glaxosmithkline/Seroxat
Paxil Study 329
Monday, July 20, 2009
Correspondence between MHRA and BNF regarding Seroxat/SSRi withdrawal
A short time ago I requested, under the Freedom of Information, correspondence between the Medicines and Healthcare products Regulatory Agency [MHRA] and the British National Formulary [BNF]
Last September I sat with the MHRA to discuss SSRi withdrawal. The MHRA told me they would write to the BNF with regard to the withdrawal advice currently given for SSRi's.
The following file is the email correspondence between the MHRA and the BNF.
09 231 scanned correspondence
And here is the reply to my FOI
09 231 reply
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Last September I sat with the MHRA to discuss SSRi withdrawal. The MHRA told me they would write to the BNF with regard to the withdrawal advice currently given for SSRi's.
The following file is the email correspondence between the MHRA and the BNF.
09 231 scanned correspondence
And here is the reply to my FOI
09 231 reply
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Wednesday, July 15, 2009
TIME OUT
Taking some time-out from the world of blogging folks.
Don't know how long I'll be out of the loop but I need a break from all this.
Meantime, check out Seroxat Secrets and GSK : Licence To (K) ill plus all the links in my blogroll down the right hand side of the page.
I wish you all well and will write again in the near future.
Until then...
Fid
Don't know how long I'll be out of the loop but I need a break from all this.
Meantime, check out Seroxat Secrets and GSK : Licence To (K) ill plus all the links in my blogroll down the right hand side of the page.
I wish you all well and will write again in the near future.
Until then...
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Tuesday, July 14, 2009
GlaxoSmithKline agrees royalty-free licensing deal for HIV drug
The Good News:
Tuesday 14 July 2009
Source - The Guardian
Tuesday 14 July 2009
Source - The Guardian
GlaxoSmithKline has granted South Africa's Aspen the right to make its HIV drug abacavir in a royalty-free licensing deal, on the day that a group of MPs called on manufacturers to put their HIV medicines in a "patent pool" to reduce prices.
Aspen will manufacture a cheaper, generic version of abacavir, also known as Ziagen. The deal was announced by GSK chief executive Andrew Witty on a visit to Kenya today and forms part of the company's efforts to cut the cost of anti-retroviral medicines for HIV in poorer countries.
The world's second-largest drugmaker also announced a new £50m fund to support non-governmental organisations working with pregnant women to prevent mother-to-child transmission of HIV. A further £10m will go to support public-private partnership work in developing Aids medicines for children.
The Bad News:
Monday, 12 May 2008
Source - The Independent
The multinational drugs company GlaxoSmithKline (GSK) downplayed an early warning about the rising number of people who have suffered potentially fatal heart attacks following the use of its £600m anti-Aids drug, which is taken daily by tens of thousands of people around the world.
GSK was officially told of the possible risk in May 2005, three years before it issued a statement to its investors saying that the findings of an even stronger potential link between heart attacks and its antiviral drug abacavir are both “unexpected” and “unconfirmed”.
Alastair Benbow, European medical director for GSK, said that the company takes any new information about the safety of its drugs seriously but it did not want to highlight what may be “spurious observations” relating to abacavir.
----
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Aspen will manufacture a cheaper, generic version of abacavir, also known as Ziagen. The deal was announced by GSK chief executive Andrew Witty on a visit to Kenya today and forms part of the company's efforts to cut the cost of anti-retroviral medicines for HIV in poorer countries.
The world's second-largest drugmaker also announced a new £50m fund to support non-governmental organisations working with pregnant women to prevent mother-to-child transmission of HIV. A further £10m will go to support public-private partnership work in developing Aids medicines for children.
The Bad News:
Monday, 12 May 2008
Source - The Independent
The multinational drugs company GlaxoSmithKline (GSK) downplayed an early warning about the rising number of people who have suffered potentially fatal heart attacks following the use of its £600m anti-Aids drug, which is taken daily by tens of thousands of people around the world.
GSK was officially told of the possible risk in May 2005, three years before it issued a statement to its investors saying that the findings of an even stronger potential link between heart attacks and its antiviral drug abacavir are both “unexpected” and “unconfirmed”.
Alastair Benbow, European medical director for GSK, said that the company takes any new information about the safety of its drugs seriously but it did not want to highlight what may be “spurious observations” relating to abacavir.
----
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
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