Monsanto Roundup Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Friday, July 31, 2009

The Mothers Act Disease Mongering Campaign

By Evie Pringle


Part I

"The Mothers Act represents the ultimate example of disease mongering at its worst because the eight-year attempt to pass this federal legislation has evolved into profiteering never before exhibited so conspicuously." READ MORE

Part II

"Although the mandatory screening language was removed from the Mothers Act last year, due to strong opposition, the words and actions by the bill's supporters demonstrate that the screening dragnet was always the main component of this disease mongering campaign. The language in the previous bill stated in part: "To ensure that new mothers and their families are educated about postpartum depression, screened for symptoms, and provided with essential services." READ MORE

Part III

"In an article titled, "Disorders Made To Order," in the July 2002 issue of Mother Jones Magazine, Brendan Koerner described the "modus operandi" of marketing a disease rather than selling a drug, "typical of the post-Prozac era." READ MORE

Part IV Coming soon.

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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BRIAN JOHNSON ON BBC'S 'TOP GEAR'

Unrelated post but seeing as I have an interest in all things AC/DC, I thought I'd share this.




And here is a track from the concert in Moscow he refers to in the interview.



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Thursday, July 30, 2009

Popular Breast Cancer Drug Used with Seroxat & Other SSRi's Puts Women At Risk


Source Newswire

A new analysis finds that women in New Jersey who take the breast cancer drug tamoxifen in conjunction with certain popular antidepressants may be at a higher risk for a breast cancer recurrence.

In May, Medco Health Solutions, Inc and Indiana University School of Medicine released a study revealing that women using tamoxifen to prevent a recurrence of breast cancer who also use certain selective serotonin reuptake inhibitors (SSRI), for example Prozac(R) (fluoxetine), Paxil/Seroxat(R) (paroxetine) and Zoloft(R) (sertraline), have up to twice the chance of having a recurrence of the disease.

FULL SHOCKING STORY HERE

Fid


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Recession 'drives thousands to use anti-depressant pills'

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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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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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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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]

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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,
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

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

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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




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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

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Fid

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Tuesday, July 21, 2009

Seroxat Withdrawal - What GSK keep from the Patient.

ABC PRIMETIME LIVE - PAXIL ADDICTION


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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/




Fid

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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

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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

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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



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Tuesday, July 14, 2009

GlaxoSmithKline agrees royalty-free licensing deal for HIV drug

The Good News:

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.

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Fid

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Monday, July 13, 2009

Announcing the Release of the Recently Revised Confessions of an Rx Drug Pusher




The Story of an Industry Insider

“Confessions of an Rx Drug Pusher is a powerful book. Olsen knows her drug facts, she knows the ins and outs of pharma selling, and she knows the tragedy and pain of personal trauma from the effects of psychiatric drugs. Confessions blends all three and I most highly recommend the book!” --John Breeding, PhD, Psychologist

A successful, fifteen-year-veteran pharmaceutical rep from 1985 – 2000, Gwen Olsen worked for McNeil Pharmaceutical, Syntex Laboratories, Bristol-Myers Squibb, Abbott Labs and Forest Laboratories. She was a hospital rep and specialist rep the majority of her career, educating residents in hospital teaching settings and selling drugs to doctors in obstetrics and gynecology, cardiology, neurology, endocrinology and psychiatry. Her award winning book, Confessions of an Rx Drug Pusher, is an expose and autobiographical journey into the tragic loss of her beloved niece to suicide, and the behind-the-scene tactics of “disease mongering” and deceptive marketing practices that are used to sell dangerous prescription drugs.



A Unique Perspective

“Gwen Olsen is ‘outing’ this massively corrupt industry from a tenured insider's perspective. She convincingly illustrates everything I've known and suspected about Big Pharma's money-making agendas--and more! This book is a must read!” --Abram Hoffer, M.D., Orthomolecular Psychiatrist

Gwen has a unique industry insider’s perspective of the current US healthcare dilemma, and utilizes both her experience and the insight she received in her extensive sales training with Pharma to illuminate current marketing trends and illustrate how greed and conflicts of interest make the system itself the biggest health risk to American consumers.



A Natural Health and Chiropractic Advocate

“I am excited to share that I personally know dozens of patients who have made informed decisions about their health through reading your book, bringing information to their physicians, and, in some cases, finding new physicians to work alongside their chiropractors and naturopaths to help them safely get off the deadly medications they were once prescribed. I can not thank you enough for the lives you save. You are an inspiring leader who will impact lives for generations to come.” --B.J. Hardick, D.C.

In 2000, Gwen left pharmaceuticals and entered the natural foods industry. For several years she worked as an area account manager for Nature’s Way and later as a regional sales manager for Gaia Herbs. Gwen is genuinely interested in alternative health therapies and has extensively studied nutrition, chiropractic, homeopathy, vitamins, herbs and aromatherapy. She has published articles in the Well Being Journal and online with Natural News and HealthNewsDigest.com.



A Captivating Speaker

“Judging by the long lines at your book-signing table, you really resonated with what people are experiencing and needing. My "Aha" moment occurred after I heard you and saw the results on the audience. People need to use their anger, frustration, and confusion and become more self-empowered and take more responsibility for what is happening to them. Thank you! --Ray Goddard, D.C.

Gwen is a passionate mental health activist, writer and dynamic speaker who devotes much of her time to mental health and child advocacy. Gwen volunteered as a Court Appointed Special Advocate (CASA) for the Texas Travis County court system from 1995 to 2000, serving as an advocate for abused and neglected children in foster care. A 2007 Human Rights Award recipient, she is a highly sought after international speaker and media resource, and has testified numerous times before Congress and the FDA. Herself a victim and survivor of life-changing prescription drug adverse events, Gwen motivates audiences of all ages to become proactive about taking charge of their health and refusing to be just another statistic!



I am returning to the speaking circuit! To book a speaking event or an interview, please contact Gwen Olsen at 512-219-5030, www.gwenolsen.com or golsen@austin.rr.com.



For bulk and group discounts on book purchases please contact www.iuniverse.com or for

International Orders: Call 00-1-402-323-7800


Our children and I thank you for your continued support!

----

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Saturday, July 11, 2009

Seroxat Patient Information Leaflet - Vague. FOI to MHRA

----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Sent: Saturday, July 11, 2009 9:31 AM
Subject: FOI


Dear MHRA Team,

Whilst reading through the Patient Information Leaflet for Seroxat liquid - attached - I came across a line that is quite vague in its description, i.e.; there is no explanation.


The line in question is thus: [see red]

"If you feel restless and feel like you can’t sit or stand still, tell your doctor. Increasing the dose of Seroxat may make these feelings worse."

I don't know if the MHRA have the answer but why would increasing the dose of Seroxat make 'these feelings' worse?

The line would suggest that GlaxoSmithKline have evidence that shows an increase in Seroxat would make 'these feelings' worse. Could you provide me with such evidence please?



So,

Request under the FOI:

1. Why would an increase in Seroxat make the feelings of restlessness and not being able to sit or stand still worse?

and

2, Could you please provide the data that suggests this?



Many thanks

Bob Fiddaman

Seroxat Sufferers
http://fiddaman.blogspot.com

----

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Thursday, July 09, 2009

Paxil can lead to cognitive impairment in older people

By Darla Carter
dcarter@courier-journal.com

They're used for some of the most common ailments around — allergies, nausea, depression, itching, urinary incontinence and lack of sleep, just to name a few.

But they also could affect your mental sharpness, especially if you're over the age of 65.

The culprit: drugs, such as Benadryl, Detrol and Paxil, that have so-called "anticholinergic effects," or put another way, can affect cognitive performance.

Dr. Malaz Boustani of Indiana University co-authored a paper about the drugs recently. He thinks more people need to be aware that medications with anticholinergic effects can lead to cognitive impairment in older people, though it's unclear whether there's a long-term impact on the brain.

FULL STORY - Courier Journal

Fid

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Girls used as Guinea Pigs in HPV Trials Admits GSK

Source: American Chronicle

July 05, 2009

Christina England

We have always suspected it and now they admit it,GSK are using young girls (as young as 9 in some areas) as human Guinea Pigs in HPV vaccine Cervarix trials. This was only discovered after reading a document that was meant for 'Scientific Background and Informational Purposes only'

Damning article for GSK

Read more about Cervarix:



GSK - A Catalogue of Disasters!

Glaxo: "Promote More, Feel Better and Live a Life of Luxury"

Glaxo Goes Head-to-Head on HPV

Teenage Girls Sue Over GSK's Cancer Jab, Cervarix!

GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine

HPV Vaccine Video on Youtube

Concerns over GSK's Cervarix vaccine

UP YOURS GLAXO!

Mindy Merck & Gail Glaxo Dilemma

LOLA'S LAND PROMOTING HPV VACCINE

GlaxoSmithKline's Cervarix. Is Your Daughter Safe?

More debate on GSK's Cervarix

Cervical Cancer, Ofsted & GlaxoSmithKline

Is Cervarix and Gardasil Safe ? Humorous and very blunt answer.

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Wednesday, July 08, 2009

Let Us Pray - Our Lord Angus of AC/DC

Taken from Hampden Park, Glasgow




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Tuesday, July 07, 2009

How Michael Jackson Was Failed

Source: Examiner.com

Anorexia, drug addiction and body dysmorphia: The American medical system failed Michael Jackson.

A superstar suffering from anorexia, drug addiction and body dysmorphia disorder, and the American medical system, in every way possible, failed Michael Jackson and the American public. And if the man who was, perhaps, the most famous person in the world can be failed by our out-of-control medical system, what chance do the rest of us have?

Michael Jackson weighed a reported 112 pounds at the time of his death. According to the Santa Barbara (California) Sheriff’s Department arrest report in 2005, Jackson’s height was 5 feet and 11 inches. That would make his body mass index a skeletal 15.6 at the time of his death. How low is that? The World Health Organization says that a BMI of 16.0 is the weight one might die of starvation. Amazingly, Jackson was reputed to have been gaining weight for his upcoming concert tour.

READ MORE

Fid

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SWINE FLU ADVERSE REACTION "PRIORITY" REPORTING


With an apparent pandemic of swine flu, the Medicines and Healthcare products Regulatory Agency [MHRA] have issued a letter to Healthcare professionals with regard to reporting of any adverse reactions to the vaccines, Tamiflu [Roche] and Relenza [GlaxoSmithKline].

The letter, which can be downloaded here, announces the 'special' web-based portal, which the MHRA have named, 'The Swine Flu ADR Portal.'

Two ways of looking at this:

1, The MHRA expect a large number of reports because the vaccines will be widely used

or

2, The MHRA have their suspicions about these vaccines so want to keep a close eye on the adverse reactions.

Now call me a cynic...

Fid

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Monday, July 06, 2009

ANTIDEPRESSANTS - TRUTH vs LIES

Three videos to watch.

Video one is from Gwen Olsen. Gwen spent more than a decade as a sales rep in the pharmaceutical industry working for health care giants such as Johnson & Johnson, Bristol-Myers Squibb and Abbott Laboratories.

Video two is from BBC's Panorama, 'Taken on Trust' and features Glaxo's Head of European Clinical Psychiatry, Dr Alastair Benbow and MHRA Chairman and former employee of Glaxo, Sir Alasdair Breckenridge.

Video three is food for thought. I don't expect pharma or regulators to pass comment.

You can draw your own conclusions...








Fid


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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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This post is dedicated to the memories of Sara Carlin and Sharise Gatchell and to the countless others who have lost their lives to antidepressant medication.


Sunday, July 05, 2009

The Corrupt Industry

Fascinating article one of my good friends sent me this morning.

This article was written in 1986 and comes from the New Internationalist, issue number 165.

So 23 years ago there was already a concern about Pharma.

How far have we come?

The corrupt industry
Bribery and corruption, fraud in the testing of drugs, criminal negligence in the manufacture of drugs, dubious advertising claims - the pharmaceutical industry has a worse record of law breaking than any other industry. Dr John Braithwaite of Canberra's Australian National University explains why there should be such a high concentration of sinners - as well as saints.

The pharmaceutical industry has contributed more to the well-being of humanity than any other. Arguably among other achievements it has helped to remove tuberculosis, gastroenteritis and diphtheria from among the ten leading causes of death in the western world. Yet the avoidable suffering caused by pharmaceutical companies, particularly to the poor of the world, seems at times beyond comprehension.

As both a consumer activist and a student of business ethics I have been struck by the large numbers of pharmaceutical executives I have met who, in their commitment to socially responsible business conduct, were so much more impressive than the average industrial decision maker. Yet corporate crime is a bigger problem in the pharmaceutical industry than any other. The pharmaceutical industry is a paradox of corruption and conscience.

By corruption, I mean first of all the paying of bribes. Every scholar who has surveyed the comparative evidence on bribery in international trade has concluded that pharmaceuticals is one of the most corrupt, if not the most corrupt, of industries. My own research1 found evidence of substantial bribery by 19 of the 20 largest American pharmaceutical companies. There is evidence of bribes being paid to every type of government official who could conceivably affect the interests of pharmaceutical companies: bribes to cabinet ministers to get drugs approved for marketing, bribes to social security bureaucrats who fix prices for subsidised drugs; to health inspectors who check pharmaceutical manufacturing plants; to customs officials, hospital administrators, tax assessors, political parties, and others.

But a much greater threat to world health than corruption is fraud in the safety testing of drugs. Rats die in trials on new drugs and are replaced with live animals; rats which develop tumors are replaced with healthy rats; doctors who are being paid $1,000 a patient to test a new product pour the pills down the toilet, making up the results in a way which tells the company what it wants to hear.2

But it is the less blatant forms of fraud against health authorities which have caused the greatest loss of life - companies telling half-truths to governments about the severity of side effects or covering up adverse reaction reports from concerned doctors. Last year Eli Lilly was fined $25,000 in the United States after it was charged with covering up deaths and illnesses caused by its anti-arthritic drug, benoxaprofen. The drug was withdrawn from sale in 1982 after it was found to be associated with 61 deaths in Britain and unknown numbers elsewhere. In 1984, Smith Kline was fined $100,000 on charges of covering up adverse reactions to their product Selacryn, which was associated with 36 deaths in the US. Similar allegations of covering up adverse reactions are being made against A. H. Robins in the litigation over the Dalkon Shield intrauterine device. A former company lawyer has testified that he was ordered by his superiors to shred sensitive evidence.

Beyond bribery and fraud, misrepresentation in advertising, breaches of laws which ensure the sterility and purity of products and antitrust offences, have all been widespread.

The reason for the paradox of corruption and conscience in the pharmaceutical industry is first that it attracts a lot of idealistic people keen to work on ways of solving health problems, but second that the realities of the pharmaceuticals' market make the temptation for corporate crime unusually acute.

The pharmaceutical industry is very much like the aerospace and defence industries - the future of a company often depends on securing the support of a small number of people who can unlock a big market for a single product which has already cost the company a fortune to develop. Just as aerospace companies face great temptations to bribe defence chiefs to secure one big sale of their new supersonic fighter, pharmaceutical executives confront massive win-lose decision points when national health authorities decide whether to approve their new drug for marketing.

Often the product will have cost $50 million of company funds to develop. A single national market might recover that entire up-front expenditure. Equally, a single pricing decision by a social security bureaucrat on a company's leading product will often decide whether the national subsidiary will run at a profit or a loss for the year. In this way companies which sell pills are different from those which sell breakfast cereals. The temptation to dishonestly secure the one big sale of cornflakes is not common; so one does not see the culture of corruption which characterizes the pharmaceutical industry.

How do honest people survive in an industry where so much unethical and downright criminal conduct occurs? They survive because they have no contact with it and mostly no knowledge of it. Organizational complexity in a large corporation makes it quite possible for the left hand not to know what its right hand is doing. And if the right hand is engaged in fraud and bribery, then organizational complexity is exaggerated to prevent knowledge of wrongdoing from spreading to other parts of the firm. The left hand would probably rather not know about it in any case.

Some American pharmaceutical companies take this to extraordinary lengths: they have 'vice-presidents responsible for going to jail' whose job it is to act as a scapegoat for corporate crime, to have the buck stop with them rather than taint the chief executive with knowledge of illegality.

But mostly the ways of protecting pharmaceutical executives from their own consciences are more straightforward. The quality control manager is an honest person who takes pride in producing a product which is always sterile, pure and made exactly to specifications. She or he is very busy at this important task and doesn't take time to find out that these pills are being promoted in Brazil for totally inappropriate conditions or that the specifications she so meticulously follows are partially based on fraudulent testing. Moreover, the corporate culture has taught her that the activities of the Brazilian subsidiary are none of her business.

The difference between socially responsible and corrupt companies is that in the former, ethical questions are everyone's business. In a socially responsible company there are mechanisms for a researcher who discovers a dangerous side-effect to blow the whistle within the company if his superiors cover up the discovery; the researcher can complain to an ethics committee of the board or an internal ombudsman if the Brazilian subsidiary ignores new information on the product.

However most pharmaceutical companies do not look to break down the barriers which protect the ethical majority of executives from their own consciences. That leaves it up to external critics to prick the consciences of the decent corporate employees. For it is insiders who, in the long run, are in the best position to prevent the day-to-day predations of the industry.

The international consumer movement, organized under the umbrella of Health Action International (see page 25), has been the most important of these outside forces.

The consumer movement has become increasingly sophisticated in the way it approaches the industry. There is now a realisation that most pharmaceutical industry executives do have consciences which can be stirred; and there are a great many 'sleepers', covert supporters of the consumer movement's campaigns. Further, because any pharmaceutical company is uniquely dependent on its reputation to sell products to doctors and hospital administrators in a way that companies which sell cornflakes or cigarettes are not, it is highly sensitive to publicity and community campaigns which tarnish its image.

So there are grounds for optimism that consumer activism can deliver reform. Indeed, there is already growing evidence of a willingness of the transnational pharmaceutical companies to respond constructively to the criticisms put publicly by activist groups.

Apart from internal critics and the threat of damage from unwelcome publicity, a further control mechanism to protect public interest is criminal law. It is an under-utilized weapon which can break down the barriers protecting honest executives from their own consciences. Criminal law is also the tonic needed for the consciences of many government officials. After all, with bribery it takes two to tango.

My research found that when bribes are paid to Latin American health ministers to secure government approval of a new product, the proposition is put as one of speeding up the inevitable approval of a product which will prevent much suffering or death. That is, the Minister's conscience is protected because he accepts the company's view that he is acting in the public interest by taking the bribe.

Criminal prosecutions would highlight publicly that when decisions on drug approvals are made on the basis of bribes rather than scientific assessment, lives will be lost, not saved. Fraud and crude misrepresentations in advertising for wonder drugs can have cruel repercussions on the community's health. It is up to the community to enforce the criminal prosecutions needed to jolt the industry into reassessing misplaced priorities. Healthy people are more important than healthy corporate ledgers. And the two need not conflict.

John Braithwaite is Senior Research Fellow, School of Social Sciences, Australian National University as well as author of Inequality, Crime and Public Policy and Corporate Crime in the Pharmaceutical Industry.


1 Corporate Crime in the Pharmacautical Industry, Routledge & Kegan Paul. 1984.
2 These practices are illustrated with many specific examples from North America, Europe and Japan in Corporate Crime in the Pharmaceutical Industry


SOURCE

Fid


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GSK's Alli Linked to Liver Failure!


Source: Sunday Mail
Hat-Tip - Ruth

A slimming pill that triggered massive sales when it was launched earlier this year is being investigated amid fears it is linked to liver damage.

Alli, which blocks the absorption of fat in the gut, is the first diet pill of its kind to be available without prescription.

Its main ingredient is the drug orlistat. But now the US medicine watchdog, the Food and Drug Administration (FDA), is investigating a series of alerts from patients who developed problems while taking orlistat.

The UK drugs regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has also received 31 reports of side effects linked to orlistat since Alli was launched in April.

But it was not able to say if those were from patients taking Alli or the stronger pill Xenical – which also contains orlistat but is available only on prescription.

Since Xenical became available in 2001, 24 patients taking it have died, one of liver failure and the others from heart attacks, gall bladder inflammation, multi-organ failure and lung clots. There were also five cases of sudden death where the cause was unclear. In total, the MHRA has received 1,252 reports from patients of potential side effects from Xenical, including heart problems, gastrointestinal issues and skin complaints. Nearly 100 were connected with liver problems.

On the day Alli was launched in the UK, £1million worth of pills were sold. But it has already provoked controversy. Manufacturer GlaxoSmithKline (GSK) claims it can boost weight loss by up to 50 per cent, helping dieters lose an extra 1lb for every 2lb shed.

Read More

Related Links:

This size-8 girl was able to buy diet pills [Alli] at her local chemists

Alli pimping - GSK's new Ally

Diet drug Xenical renamed Alli, still a cancer worry

Angry Aussie slams Alli

GlaxoSmithKline Complaints Dept

Alli - The Poem

Experts wary of new diet pill

GSK - The Alli Spin

GSK 'Crossing the line with Alli

GSK's Alli and The Obesity Society

GSK's Alli

GlaxoSmithKline's 'Belly' laugh

Lose Weight with GSK's Alli...

Fid


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Friday, July 03, 2009

"Off-Label" Prescribing

Phil Dawdy over at Furious Seasons has an interesting post this morning. Antipsychotic Use Up 1,000 Percent In Canadian Kids, highlights the number of children taking medications known as atypical antipsychotics in Canada has increased tenfold over the past decade.

This interested me as I've recently been in correspondence with the MHRA with regard to "off-label" prescribing. A practise, I believe, is the crux of the non-acceptance by doctors that SSRi withdrawal is an issue.

If a doctor deems it fit to prescribe an SSRi to a child, despite that particular drug being banned for use in that age group, then what hope do adults have when complaining to their doctor about a whole host of problems they have when tapering?

Conversations with the MHRA has proved baffling as it seems they are powerless to stop this practise of "off-label" prescribing.

I don't actually know who has the authority to stop it? Surely this is hugely problematic.

The MHRA have recently uploaded a 'Drug Safety Update' (April 2009 edition) where "off-label" prescribing is highlighted. It still does not throw any light on this subject other than basically telling the doctor that they are responsible for the drugs they prescribe... at least that's the way I see it?

What we have here is:

1. Pharmaceutical Product
2. MHRA Rules [ie; Not recommended for persons under the age of -------- Fill blank]
3. GP's

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Thursday, July 02, 2009

Emory University - "Double Standards"

It seems the top brass at Emory University don't like to be associated with blogs these days... unless of course the author/s cover them in garlands that is.

Doug Bremner, who writes the insightful, 'Before You Take That Pill' blog has been told by Emory to remove their name. Bremner, who is ironically a professor of psychiatry and radiology at Emory, recently added the post, 'I Am Removing the Name of My University From This Blog.'

What strikes me here is that Emory officials seem to be ashamed of their tainted past. Remember it was Emory who remained quiet over Charles Nemeroff and his money making ties to the pharmaceutical industry, in particular, GlaxoSmithKline. Nemeroff failed to tell Emory about $500,000 he received from drug maker GlaxoSmithKline PLC while heading a government-funded research project studying Glaxo drugs.

Here we have two men in Bremner and Nemeroff. One who fails to tell Emory what he is doing, whilst the other proudly tells his readers of his connections with Emory.

Emory University, it appears, is nothing more than a pharmaceutical rep breeding ground. One would imagine that it is okay for Emory students to peddle in illegal drugs... as long as Emory officials don't know about it!

It's laughable.

Although I'm not all too happy with Bremner's company he keeps, he doesn't deserve this - which in essence, is nothing more than bullying.

Emory have shot themselves in the foot and gained further bad publicity with this latest attempt to stifle voices.

I hereby award them the Seroxat Sufferers Dumbass Award.

EMORY, YOU ARE DUMB ASSES!



Fid
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Please contact me if you would like a guest post considered for publication on my blog.