"It's not about what they tell you, it's about what they don't."
~ Bob Fiddaman, Author, Blogger, Researcher, Recipient of two Human Rights awards
Sunday, June 21, 2009
"Promptly" or "Reasonably Practical"? MHRA Semantics
Dobbin clearly highlights the frustrations when dealing with the semantics of the UK Medicine Regulator [MHRA]
It's well worth a read as it focuses on the MHRA investigation into GlaxoSmithKline regarding the suppression of important data that, in essence, could have saved lives.
As you may recall, GlaxoSmithKline were investigated by the MHRA, an investigation that took over 4 years to complete. Basically, the MHRA concluded that GlaxoSmithKline could not be prosecuted because of a weakness in the law. Instead, Jean Pierre Garnier, the then CEO of Glaxo, was issued with a schoolboy reprimand from the CEO of the MHRA, Kent Woods.
Personally, and they already know my thoughts on this, I believe the investigation was pretty abysmal. Arrests should have been made regardless of whether Glaxo employees would have chosen to talk to MHRA investigators. Glaxo have once again been let off the hook.
Dobbin, now believes the MHRA are playing around with words such as 'Reasonably Practical' and 'Promptly'
I have a pdf copy of the letter should any of you wish to view it [click on mailbox, right hand side of this blog]
Here is the letter:
The Rt. Hon. Alan Johnson MP
Secretary of State
Department of Health
Richmond House
79 Whitehall
London
SW1A 2NS
Tuesday 12th May 2009
Dear Alan,
Further to my previous unanswered correspondence of 28/04/09, I would like to bring your attention to matters arising from my P.Q. 264951 and the subsequent clarifications provided by the Department of Health and the MHRA.
The MHRA investigated the Pharmaceutical Company Glaxo Smith Kline for withholding safety information concerning their product SEROXAT; specifically Glaxo Smith Kline concealed increased rates of suicide in children given SEROXAT. The MHRA concluded that Glaxo Smith Kline should not be prosecuted because of a weakness in the law.
The Health Minister Dawn Primarolo M.P. announced that the law would be strengthened to make sure this could not happen again. On the 3rd of April 2008 Dawn Primarolo M.P. stated, in answer to a Parliamentary Question by myself:
The MHRA plans further stringent regulations to place obligations on companies to report safety issues timeously.
The MHRA produced a draft amendment to the law which used the word “promptly.” After a consultation process the amendment was altered to “reasonably practicable.”
My Parliamentary Questions 261391 and 264951 were intended to establish the wording of the amendment and the meaning of these words. When I asked the Department of Health for further clarification of the answers I was given I was put in touch with Dr Julie Williams of the MHRA and then Beryl Keeley of the MHRA.
There was then an additional complication, in order to place the words “reasonably practicable” in their full context it was necessary to obtain and juxtapose three separate documents.
i) The Medicines for Human Use (Marketing Authorisations etc) Regulations 1994.
ii) Medicines (Codifications Amendments etc) Regulations 2002.
iii) SI 2008 Amendment Regulations (3097)
According to Beryl Keeley ‘consolidated regulations’ do exist but they are not available to M.P.’s. This is the first point I want to bring to your attention; that the most complete and up to date copy of legislation should be available to M.P.’s, so that they can carry out their work.
In response to my main question, the meaning of the words “reasonably practicable”, Beryl Keeley directed me to an MHRA Explanatory Memorandum on the 2008 Amendments. Paragraph 8.5 states:
On balance, use of “as soon as reasonably practicable” can be argued to give those required to comply a clearer understanding than the insertion of the word promptly. There is more case law around use of this phrase and it is more commonly used in offence-creating legislation.”
However, when I asked Beryl Keeley for the reference to the case law to which the memorandum refers she was “unable to identify any.” In other words there is no pharmaceutical case law on which to base the introduction of the words “as soon as reasonably practicable” or which could clarify the meaning of these words.
“Reasonably practicable” is in my opinion a vague and subjective phrase. It could easily be interpreted by a pharmaceutical company to mean a long process which could extend into years.
In my opinion the wording suggested by MIND in response to the consultation would have been appropriate. MIND suggested “quickly, as soon as it comes to light”, also “urgently”, or a defined period of time.
There have been no prosecutions of pharmaceutical companies for withholding safety information since 1992, according to a recent answer to a parliamentary question. To the best of my knowledge there were no prosecutions prior to 1992 either.
In my opinion the withholding of safety information by pharmaceutical manufacturers has been widespread and has resulted in thousands of deaths and drug injuries. A clear example is the benzodiazepine tranquillisers such as Valium and Ativan which were claimed by the manufacturers to be safe and non-addictive.
The 2008 amendments were an opportunity to have closed at least one loophole in the regulations and provide some improved protection to the public. My second point is that this amendment was introduced by the MHRA on the basis of case law that does not exist, and that the amendment is weak and should be corrected.
Thirdly, I would like to point out that in my opinion the MHRA have not handled this matter effectively. The MHRA was heavily criticised by the Health Select Committee enquiry 2004-5, “The Influence of the Pharmaceutical Industry,” the MHRA was seen as too closely connected to the pharmaceutical industry. My third point is that this connection remains the case and that this change to the law should have been carried out by Parliament, not the MHRA.
I would appreciate it if you could answer this letter personally.
Yours sincerely,
Jim Dobbin MP
Chair of the All-Party Parliamentary Group on Involuntary Tranquilliser Addiction
cc. Phil Woolas MP
MIND
----
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Thursday, June 04, 2009
European Election Farce
Just returned from the polling station where I was to cast my vote.
No polling card was sent to my address and I never even had to produce an ID to tell the two sat at the table who I was.
Told them my address, they checked... then checked again.
I don't exist.
Funny, I said, as I voted last year in the local elections.
The guy sat at the table to my left said, it was quite rare for this to happen - he also told me that many people had turned up who hadn't received a polling card - One, he said, was sent to a three year old!
Now I don't exist, do you think I will be able to get away without paying my council tax?
Welcome to the 21st century.
Britain at it's bloody best!
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Tuesday, January 27, 2009
PM Gordon Brown in bed with Pharma
Amazing isn't it?
Further evidence that this government is in bed with pharma.
Money talks folks.
Full story here
Fid
Hat-Tip - Steph Gatchell
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Sunday, July 06, 2008
Boss of drug firm behind cervical cancer jabs for schoolgirls is on board of Ofsted
...But critics fear GSK’s place on the Ofsted board has given it instant moral authority and has commercially strengthened its position at a time when children are being targeted by the pharmaceutical industry.
Source: Daily Mail
By Eileen Fairweather
Schools Secretary Ed Balls is at the centre of a controversy over the appointment of a top executive with a drugs company to the board of education watchdog Ofsted.
Paul Blackburn, 53, is a senior vice-president at GlaxoSmithKline, which is being sued by hundreds of parents and patients who claim its drugs have caused suicide and psychosis.
His appointment came two weeks before the company won a reported £100million contract to vaccinate all schoolgirls of 12 and 13 against the sexually transmitted virus linked to cervical cancer. Family campaigners argued that the jabs would ‘normalise’ childhood sex.
Mr Blackburn’s new role has been met with such disquiet that one childcare expert boycotted an Ofsted conference on Friday, and urged others to make a similar stand.
Announcing the appointment, Mr Balls, one of Gordon Brown’s closest advisers, said Mr Blackburn had a ‘passion’ for helping children.
But critics fear GSK’s place on the Ofsted board has given it instant moral authority and has commercially strengthened its position at a time when children are being targeted by the pharmaceutical industry.
They point to the rise in the use of prescription pills to improve behaviour and aid memory and concentration. Some have been linked to depression and violence in children.
Labour MP Graham Stringer said: ‘It (GSK) is looking at new markets to create and I am disturbed that someone from Glaxo is considered appropriate for a position with Ofsted.’
Others said the appointment demonstrated an unhealthily cosy relationship between the Government and GSK, the world’s second biggest pharmaceutical company, formerly known as Glaxo Wellcome.
Last year its chief executive Jean Pierre Garnier was appointed by Gordon Brown to his new Business Council, while Children’s Minister Margaret Hodge made the company’s chairman a member of the Higher Education Funding Council. But the latest appointment places the drugs multinational at the heart of childcare.
Labour and GSK are also linked through the cash-for-honours controversy. Although GSK stresses it does not make donations to political parties, it has invested heavily in a firm run by a man who has.
In 2004 Labour awarded a peerage to party donor Dr Paul Drayson, founder of vaccine firm PowderJect pharmaceuticals, and made him Minister for Defence Procurement. It later emerged that Glaxo Wellcome had invested £175million in PowderJect.
Mr Blackburn was one of four businessmen installed on the Ofsted board last month. ‘They bring with them a breadth of private sector experience and a passion to help improve the lives of children and learners,’ said Mr Balls.
As well as setting Ofsted’s ‘strategic priorities’, the 12-strong non-executive board is required to ‘safeguard and promote the rights and welfare of children’.
Mr Blackburn is financial controller at GSK. Mr Balls’s department insisted he was appointed to Ofsted on merit and was not representing GSK, but questions were last night raised about his suitability. Child protection expert Liz Davies asked whether he would understand ‘key childcare issues such as why new systems are failing to keep children safe from harm.’
As well as regulating education, Ofsted is responsible for monitoring children in care.
Outlining his reasons for pulling out of the Ofsted conference he was due to address, childcare expert Phil Frampton blamed GSK’s history of testing drugs on children in care.
The New York health authority recently investigated claims that drugs were tested on 100 babies and toddlers with HIV at the city’s Incarnation Children’s Centre. GSK was one of the firms that supplied the drugs.
At the time it insisted that all trials followed stringent standards and complied with local laws and regulations.
But Mr Frampton – who called Mr Blackburn’s appointment ‘really outrageous’ – said: ‘Drug trials using children in care are a modern form of child slavery, only more insidious.
'Do we want the modern Bodysnatchers at the heart of the care system using their position on Ofsted as a cover for their global exploitation of children in care?’
In 2000 Glaxo Wellcome was accused of extraordinary ‘obfuscation’ by Ireland’s senate after a commission unsuccessfully sought files concerning vaccine trials it conducted in the Sixties and Seventies on children in care homes. At the time the firm said: ‘Glaxo Wellcome regrets any distress that may have been caused to individuals involved in these trials.’
Last night GSK rejected criticism of Mr Blackburn’s appointment and described Mr Frampton’s comments as ‘without foundation’. It added: ‘GSK acts properly and responsibly in the conduct of all its clinical trials, including those related to children.’
GSK faces class actions in Britain and the US by hundreds of families whose children allegedly became suicidal, psychotic or addicted after taking its anti-depressant Seroxat. The company was accused of concealing its adverse effects on children for more than a decade.
Legal action in the US recently forced GSK to publish studies showing that children on Seroxat are twice as likely to have suicidal thoughts as those on a dummy pill. Although GSK says: ‘Seroxat has never been approved by EU or US regulators as a medicine for those under 18,’ many doctors legally give it to children in a practice known as ‘off label’ prescribing.
Schools and the state childcare boom present a lucrative market for drugs including those to treat obesity, unplanned pregnancies, sexually transmitted diseases and Attention Deficit Hyperactivity Disorder (ADHD).
GSK markets an anti-ADHD drug in the United States – amphetamine Dexedrine – and may yet try to market it or a similar drug in Britain.
It recommends Dexedrine for ‘stabilising’ patients from three years to 16 who exhibit ‘distractibility, short attention span and hyperactivity’. Critics say this could describe any normal toddler or hormonal teen, and drugs should be a last resort.
Since 2006, the US Food and Drug Administration has made ADHD drugs manufacturers provide warnings of potentially fatal reactions in those with weak hearts, and the risk of ‘psychotic or manic symptoms, for example hallucinations, delusional thinking, or mania in children and adolescents without a prior history’.
The FDA has linked ADHD drugs to 25 deaths in the US, and they are allegedly linked to the deaths of seven in Britain.
Ofsted said in a statement: ‘The Ofsted Board determines the strategic direction for Ofsted and ensures that its functions are performed efficiently and effectively, but has no operational responsibilities.
‘Paul Blackburn was selected to become a non-executive member of the Ofsted Board for his financial expertise and experience. He is appointed as an individual and does not represent GlaxoSmithKline.’
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Wednesday, July 02, 2008
Gordon Brown & The GSK Connection
Today news appeared in the Herald Tribune that Gordon Brown is appointing three top executives as new advisers on his national business council. He says Andrew Witty, chief executive of drug developer GlaxoSmithKline PLC, BT Group PLC chief executive Ian Livingston and Paul Walsh, chief executive of drinks producer Diageo PLC, will join the panel.
Around about the same time last year Brown recruited Jean-Paul Garnier, GlaxoSmithKline chief to serve on the Business Council!
I'd like to add the promise that Gordon Brown made to Janice Simmons when she met with him last year. This from The Huntington Post:
DRUGS giant GlaxoSmithKline will be prosecuted if an investigation finds the company withheld information that the drug Seroxat has a higher suicide risk for under 18s. This promise was made by Gordon Brown on Thursday at a Downing Street meeting with a campaigner from Huntingdon.
Looks like we are all saved then!
Brown - You never came through with that promise did you? GlaxoSmithKline were NOT prosecuted. Instead, you recruit their fucking CEO to your business council!
Fid
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Monday, April 28, 2008
Seroxat - Who should be held accountable?
I wake every morning with an inbox full of mail from comments left by disgruntled patients pointing me to various stories across the Internet relating to Seroxat suicide and/or withdrawal problems. I read about how the MHRA promised to make prosecutions either to GSK as a whole or to individuals - they never did. It's difficult to prosecute someone if you don't arrest them first!
I've been accused of being a Scientologist, a conspiracist, having a hidden agenda and even been accused of working for a firm of solicitors!
I've had photographs of me holidaying in Australia sent to Mental Health Charity CEO's, Gisela Stuart MP, Hugh James Solicitors and even the MHRA - It wouldn't surprise me if the same photos had been sent to GSK's lawyers - quite what this individual who is sending these photos plans to achieve is beyond me. I know who he is - his name is not worth mentioning on this blog.
I, like many others, have been campaigning tirelessly for the last four years, hoping that one day other folk will be safeguarded by our regulator, hoping they will sit up and take notice of patient voices, hoping they will sit up and read the studies that show Seroxat to be a drug that causes serious withdrawal problems in both the young and old (that's ALL ages!)
I'm frustrated because my short term memory is shot to pieces, frustrated because of the outcome of the MHRA's recent four year investigation into GlaxoSmithKline ended with just a slap on the wrists for their CEO, JP Garnier, frustrated because the MHRA Enforcement Team treated GSK and the 'suspects' with kid gloves.
I'm pissed off at our governmental policies - How could they allow a law so perverse that would let a pharmaceutical company present only the good data to a regulator?
I was enlightened to hear that the CEO of the MHRA, Kent Woods, had agreed to a meeting with Seroxat campaigner Janice Simmons at the end of this month but disappointed to learn that he has offered her only one hour of his time. Is it merely a token gesture by Woods?
The DoH are pretty much on the same page as the MHRA - Despite thousands of complaints about Seroxat they still won't budge in their beleif.
What do we have to do?
The tired excuse that it was the depression that was linked to the suicidal thoughts and NOT the drug has really worn thin. Remember these were healthy volunteer studies.
Maybe we should have some volunteers step forward at the MHRA and/or DoH?
Try a month on Seroxat - say 40mg per day. Then come off it. Let's see if you have any adverse withdrawal reaction. If there is nothing wrong with it then this shouldn't be a problem. Of course one individual can be different from the others so we would want at least 12 healthy volunteers from the MHRA and/or DoH. Maybe Woods and Primarolo can show their leadership skills here and put themselves forward?
Will they step up to the plate?
Or maybe Alasdair Breckenridge, Chairman of the MHRA - He's robustly defended Seroxat at every given opportunity - would he care to volunteer to try it for a month or so?
What about the Director of Licensing at the MHRA, Ian Hudson? Would he want to step up to the plate? He was after all the former World Safety officer and GSK (Then SKB) and has stated that he had a 'significant interest in Seroxat' during his spell at SKB. Step up to the plate Mr Hudson and prove us all to be liars.
What of Alistair Benbow, Head of Psychiatry at GSK? We all know his position on Seroxat. Would he care to take up the challenge?
Mary Anne Rhyne of GSK - She made the bold statement that it takes maybe two weeks to withdraw from Seroxat - would she like to step up to the plate?
Doesn't every good chef taste his own food before he sends it out into his restaurant?
If the chef's food is less than desirable then usually a critic will lambast it... it seems the patients are lambasting it yet the regulator (food inspector) is turning a blind eye. Why?
It took me 18 months to wean down from 40mg per day to 22mg per day but hey... don't let that put you off. If you are so cocksure about the safety of this drug then why don't you all step up to the plate and prove me wrong? You are all healthy right?
The benefits of this drug far outweigh the risks - is withdrawal for 18 months not a risk? Maybe in the perverse minds of pharma and regulators it's a benefit! Who knows how these people think.
I'm pissed off today. I know this will be read and passed on to Kent Woods... or at least I hope it will. Because someone must be held accountable for this, one person must hold up their hands in submission and say 'We've failed' - Now who has the guts to do it?
Dare you play a game of Russian Roulette with patient advocates?
Anyone care for a Seroxat?
Oral syringes will be provided when withdrawing.
Fid
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Friday, March 14, 2008
Say No More...
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Dear Dawn Primarolo...
Nowhere in the letter does it mention what the benefit of Seroxat is.
She may also want to do her homework regarding the safety and efficacy because the age groups she claims that Seroxat works in is NOT in line with those at the MHRA!
May I remind her:
A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
What chance do we have when
a, The Minister of State, Dawn Primarolo, cannot even get to grips with a basic question?
and
b, The Department of Health are not on the same page as the MHRA when it comes to the risk of taking Seroxat.
So what is it?
18?
19?
25?
29?
This isn't Family Fortunes you know. You don't get a prize for guessing the right answer.
I thought the MHRA wre evasive but fuck me backwards! Dawn Primarolo just takes the biscuit!
Now Dawn, What the fuck is the benefit of Seroxat?
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
MP 'John Lewis List' v Fid List
Air conditioning unit: £299.99/Leave Window Open FREE
Bed: £1,000/£200
Bedside cabinet: £100/£15 Charity Shop
Book case/shelf: £200/Don't have one
Bookcase/cabinet: £500/FREE off my sister
Carpet: £35 per square metre/£400 2 rooms + fitting
Carpet fitting: £6.50 per square metre/see above
Coffee maker/machine: £100/FREE, I make my own coffee
Coffee table: £250/No room in flat for a table
Dining armchairs: £150 each/No room in flat for dining room chairs
Dining chairs: £90 each/Eat dinner on my lap
Dining table: £600/No room in flat for table
Dishwasher: £375/Wash dishes myself, it keeps my feet firmly on the ground.
Drawer chest (5): £500/£25 from charity shop
Dressing table: £500/Don't own one
Food mixer: £200/My stomach mixes the contents of any food I eat
Free-standing mirror: £300/I own a small shaving mirror - £1.00
Fridge/freezer: £550/£99
Gas cooker: £650/Have electric cooker - £120
Hi-fi/stereo: £750/£199
Installation of new bathroom: £6,335/Council Property, Est Cost £300
Installation of new kitchen: £10,000/What?
Lamp table: £200/A lamp has a special table?
Nest of tables: £200/How many tables does one person need?
Recordable DVD player: £270/£35 Yamada (Cheap but it does the job)
Rugs: £300/Don't own any
Shredder: £50/An MP with a shredder? Thought they had laptops that went missing?
Sideboard: £795/Kinell! How big is this second home of theirs?
Suite of furniture: £2,000/ FREE, Had my sisters old one
Television set: £750/£120
Tumble dryer: £250/I use Fresh air
Underlay (basic): £6.99 per square metre/Came FREE with fitting
Wardrobe: £700/£25 from charity shop
Washer-dryer: £500/Washer dryer and a tumble dryer too? My machine cost £250
Washing machine: £350/What in the name of Bo Diddley!
Wooden flooring/carpets: £35 per square metre/Huh?
Workstation: £150/£40
Am I happy?
Yes, I don't have to take Seroxat anymore and I have never forgotten my roots.
MP's on the other hand...
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Wednesday, March 12, 2008
New EDM Tabled Condemning the MHRA
EDM 1147
SEROXAT
Flynn, Paul
That this House deprecates the gullibility of the Medicines and Healthcare Regulatory Agency (MHRA) in assuming that GlaxoSmithKline (GSK) would observe high ethical and scientific standards above its own financial interests in promoting the drug Seroxat; is astonished that the MHRA spent £1 million in their dilatory four year investigation of the drug before establishing that the law does not require GSK to report the ill-effects of Seroxat in children; is alarmed at possible conflicts of interests as the MHRA Chairman and several senior employees have been paid to work for and with GSK and that five of the 20 members of the MHRA oversight body currently depend on research grants from GSK; and calls for the establishment of a fully independent regulatory body free from the funding, influence and control of the pharmaceutical industry.
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Tuesday, March 04, 2008
Benefits of Seroxat? DoH answer... or do they?
In classic MHRA/GlaxoSmithKline style they answer me - totally avoiding the question:
----- Original Message -----
From: dhmail@dh.gsi.gov.uk
To: fiddaman64
Sent: Tuesday, March 04, 2008 2:29 PM
Subject: Response to your Query : - Ref:DE00000283875 - Anti-depressants
Our ref: REDACTED
Dear Mr Fiddaman,
Thank you for your email of 26 February to the Department of Health about a recently published study on antidepressants. New guidance on the treatment of depression will be issued by National Institute for Health and Clinical Excellence later in the year, and this new study will be considered as the guidance is prepared. Until then, the message to patients and doctors remains the same - antidepressants are an appropriate treatment for moderate or severe depression.
The Department is, however, expanding the availability of psychological therapies as an alternative to drugs with extra investment and plans to train an extra 3,600 psychological therapists. The evidence shows that these therapies are effective and often preferred by patients.
I hope this reply is helpful.
Yours sincerely,
Edward Corbett
Customer Service Centre.
----
I hope this reply is helpful?
Yup, about as helpful as sending me a man with no arms to groom my dog!
So, what is the benefit of Seroxat? I may go and ask the brick wall at the foot of my garden!
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Thursday, February 28, 2008
Early Day Motion - SSRI ANTI-DEPRESSANTS
That this House welcomes the Department of Health's announcement to increase the provision of talking therapy for depression; notes Professor Irving Kirsch's study of the manufacturer's trials of the SSRI anti-depressants Prozac, Seroxat and Efexor and his conclusion that these drugs are not effective; notes that there is zero cost-effectiveness to drugs that do not work; further notes that large numbers of people are involuntary addicted to these drugs and suffer bizarre and severe side effects which leave them unable to work; calls upon the National Institute of Health and Clinical Excellence to review the approval of these drugs; calls upon the Government to provide withdrawal clinics for people addicted to prescribed drugs; further calls upon the Government to provide appropriate rehabilitation to bring these people back into the workforce; urges the Government to organise controlled withdrawal of these drugs from the market; and further urges the Government to investigate how the manufacturers and distributors obtained product licences and to implement the recommendations of the Fourth Report of the Health Committee, Session 2004-05, on the Influence of the Pharmaceutical Industry, HC42-1, including an independent review of the UK drug licensing authority the Medicines and Healthcare Products Regulatory Agency.
LINK
Finally, the penny has dropped!
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Wednesday, February 27, 2008
The Three Little Pigs

The Three Little Pigs
Once upon a time there were three little pigs, Kent, Dawn and Justice, and the time came for them to leave home and seek their fortunes.
Before they left, their mother told them “Whatever you do , do it the best that you can because that's the way to get along in the world.”
The first little pig, Kent, who was CEO of the UK Medicines Regulator, the MHRA, built his house out of straw because it was the easiest thing to do.
The second little pig, Dawn, who was the Minister of Health in the UK, built her house out of sticks. This was a little bit stronger than a straw house.
The third little pig, Justice, who represented Seroxat patients globally, built his house out of bricks.
One night the big bad wolf, otherwise known as GlaxoSmithKline or GSK, and who dearly loved to eat fat little piggies, came along and saw the first little pig in his house of straw. He said “Let me in, Let me in, little pig or I'll huff and I'll puff and I'll blow your house in!”
“Not by the hair of my chinny chin chin”, said Kent the little pig.
But of course the wolf did blow the house in and ate the first little pig.
The house was destroyed and the MHRA infiltrated by the big bad wolf (GlaxoSmithKline)
The wolf then came to the house of sticks.
“Let me in ,Let me in little pig or I'll huff and I'll puff and I'll blow your house in”
“Not by the hair of my chinny chin chin”, said Dawn the little pig.
But the wolf blew that house in too, and ate the second little pig.
The house was destroyed and the Minister of Health became embroiled by the big bad wolf (GlaxoSmithKline)
The wolf then came to the house of bricks.
“Let me in , let me in” cried the wolf
“Or I'll huff and I'll puff till I blow your house in”.
“Not by the hair of my chinny chin chin” said Justice the pig.
Well, the wolf huffed and puffed but he could not blow down that brick house.
But the wolf was a sly old wolf and he climbed up on the roof to look for a way into the brick house.
The little pig Justice saw the wolf climb up on the roof and lit a roaring fire in the fireplace and placed on it a large kettle of water.
When the wolf finally found the hole in the chimney he crawled down and KERSPLASH right into that kettle of water and that was the end of the troubles for Justice with the big bad wolf.
The next day the little pig Justice invited his mother over . She said “You see Justice, it is just as I told you. The way to get along in the world is to do things as well as you can.”
The third little pig Justice, represented by Seroxat patients globally lived happily ever after.
The two pigs Kent and Dawn, whose houses were destroyed, both went away into the woods to lick their wounds.
The moral of this story?
Never mess with people whose lives you have fucked!
The irony of this story?
For years Seroxat sufferers have met with brick walls when asking questions to Pigs 1 & 2
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Tuesday, February 26, 2008
Any comment from the MHRA or DoH?
Anyone care to comment? Benbow? Breckenridge? Woods? The Doh? Gisela Stuart MP? The MHRA?
Fid
Prozac pills 'do not work' - THE SUN
ANTI-depressant pills such as Prozac do not work on most patients, medics claimed yesterday. A major study by the University of Hull analysed the four main antidepressants — Prozac (also known as Fluoxetine), Venlafaxine, Nefazodone and Paroxetine...
DUMMY PILLS 'AS GOOD AS PROZAC' - The Mirror
Taking some types of antidepressant may be a waste of time, say researchers. Researchers used Freedom of Information laws to analysis American data on modern anti-depressants such as Prozac, Effexor and Seroxat...
Papers say 'the drugs don't work' - BBC News
The message across many front pages is clear - 'the drugs don't work'...
Hardly anyone helped by anti-depressants: study - The Ottawa Citizen
Researchers who pooled data from all clinical trials -- published or not -- submitted to American drug regulators for four "new-generation" anti-depressants that include Prozac and Paxil found the drugs provided virtually no benefit over placebos for moderate depression, and only a small difference for the severely depressed.
Antidepressant drugs not effective for most patients -- official study - CNN Money
Prozac and other antidepressant drugs in the same class do not work according to a major review released today, reports The Guardian...
Depression drugs don’t work, finds data review - The Times Online
Millions of people taking commonly prescribed antidepressants such as Prozac and Seroxat might as well be taking a placebo, according to the first study to include unpublished evidence.
Anti-depressants 'not much of a help' - The Cheers
For the depressed, this might come as a big blow- according to a new study the 'happy pills' or anti-depressants they take, have little or no impact. In the study, the research team focused on drugs in the class known as Selective Serotonin Reuptake Inhibitors (SSRIs), which work by increasing levels of the mood controlling chemical serotonin in the brain. These included fluoxetine (Prozac), venlafaxine (Efexor) and paroxetine (Seroxat).
Prozac is no better than a placebo, shows 'fantastically important' study - Daily Mail
The drugs studied - including Prozac, Seroxat and Efexor - were little more effective than placebos in improving the mental health in the majority of cases, ...
Talking Back To Prozac - CBS News
The pattern they saw from the trial results of fluoxetine (Prozac), paroxetine (Seroxat), venlafaxine (Effexor) and nefazodone (Serzone) was consistent. "Using complete data sets (including unpublished data) and a substantially larger data set of this type than has been previously reported, we find the overall effect of new-generation antidepressant medication is below recommended criteria for clinical significance,"
Dummy Pills Can Aid Depression As Much As Prozac, Claims Study - The Daily Record
Researchers found little difference in mildly depressed patients who took the antidepressants Prozac, Effexor, Serzone and Seroxat/Paxil and those who took a dummy pill, or placebo.
Millions taking Prozac 'may as well be taking a placebo' - study - Irish Independent
MILLIONS of people taking commonly prescribed anti-depressants such as Prozac and Seroxat might as well be taking a dummy pill, a study suggests today.
Prozac, used by 40m people, does not work say scientists - The Guardian
A spokesman for GlaxoSmithKline, which makes Seroxat, said the authors had failed to acknowledge the "very positive" benefits of the treatment and their conclusions were "at odds with what has been seen in actual clinical practice". (snigger)
New study implies anti-depressants ineffective - RTE News
Researchers reviewed a series of studies, both published and unpublished, on four anti-depressants, examining the question of whether a person's response to these drugs hinged on how depressed they were before getting treatment. The drugs are all so-called selective serotonin reuptake inhibitors, or SSRIs.
GPs urged to cut number of antidepressant prescriptions - Management in Practice
A charity is calling for GPs to reduce the number of antidepressant prescriptions after a new study found some of the latest brands have limited benefits. These included studies on Prozac, Efexor, and Seroxat
Study casts doubt over anti-depressants - ABC Online Australia
A major new study has cast doubt on whether anti-depressant drugs taken by millions around the world do any good at all. The research was published in the online journal, Public Library of Science Medicine. Critics of the pharmaceutical industry predict shock waves for what's become a global billion dollar business.
Why antidepressants don't work - Marie Claire
The researchers claim prescription drugs help only a small number of severely depressed individuals, although the makers of Prozac and Seroxat, unsurprisingly, are disputing the claims.
Psych Drug Shocker: Antidepressant Drugs Work No Better than Placebo; Big Pharma Hoax Finally Exposed - The Westender Brisbane Australia
The researchers obtained data on all the clinical trials submitted to the FDA for the licensing of fluoxetine, venlafaxine, nefazodone, and paroxetine. They then used meta-analytic techniques to investigate whether the initial severity of depression affected the HRSD improvement scores for the drug and placebo groups in these trials.
Antidepressants 'not working' - Channel 4 (UK)
Research suggests new-generation antidepressants are often no more effective than dummy pills. They included antidepressants regularly prescribed in the UK, including fluoxetine (Prozac), venlafaxine (Efexor) and paroxetine (Seroxat).
A new study suggests that anti-depressants such as Prozac, prescribed to millions of people all over the world, could be largely ineffective. - Radio New Zealand
Marjorie Wallace, head of the British mental health charity Sane, said that if these results were confirmed they could be "very disturbing". But the makers of Prozac and Seroxat, two of the commonest anti-depressants, said they disagreed with the findings. (Hmmm)
Antidepressants 'not working' - ITN UK
They said even trials suggesting benefit for severely depressed people did not provide evidence of clear clinical benefit. They included antidepressants regularly prescribed in the UK, including fluoxetine (Prozac), venlafaxine (Efexor) and paroxetine (Seroxat).
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Monday, February 25, 2008
Dept of Health, MP & Alisdair Breckenridge
From: fiddaman
To: STUART, Gisela
Cc: REDACTED@guardian.co.uk
Sent: Monday, February 25, 2008 6:49 AM
Subject: Dept of Health & Alisdair Breckenridge MHRA
Dear Gisela Stuart MP,
Still nothing regarding request you sent Dept of Health over a month ago. Be grateful if you could pick up the phone and ask Dawn Primarolo directly what the benefit of Seroxat is then relay answer to me.
The Dept of Health WILL NOT find the answer on my blog so they have no need to visit it (which they have been doing this past month)
I'd also like you to write to the MHRA for me because they are now refusing to answer any of my queries on the grounds that (and here I quote) "We see no point in answering questions where you have prejudged the veracity of any answers".
This does not fall under any protocol or MHRA ruling or amendment so therefore I would like you to write them and ask them the following:
1. Was the MHRA Chairman, Alisdair Breckenridge unaware at the time of his statement on BBC TV's Panorama that the clinical trial results actually DID show that there was a high rate of suicide attempts in adults during the first ten weeks? If so, why?
2. Would Alisdair Breckenridge or the MHRA be prepared to now state that based on fresh new evidence, we believe that Seroxat DOES cause suicide in adults? If no, why?
3. As the Glenmullen report clearly shows there is a high risk of suicide in adults over the age of 25, do you think it reasonable that either Alistair Breckenridge or the MHRA publically apologise to all those patients and patients families whom have suffered at the hands of this drug?
I would also be grateful if you could send me a copy of this request.
You can email the MHRA Information Centre here: REDACTED@mhra.gsi.gov.uk
Regards
Bob Fiddaman
Quinton
cc The Guardian
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Monday, February 18, 2008
Health Minster, Rt Hon Dawn Primarolo
Gisela Stuart kept her email to me brief:
I have written to Dawn Primorolo and she will respond.I will forward the letter to you in due course.
Yours
Gisela Stuart
Low and behold - Guess who has been visiting this blog today?
17. 18 February 13:38 DEPARTMENT OF HEALTH, Newark, Nottinghamshire, United Kingdom
19. 18 February 13:41 DEPARTMENT OF HEALTH, Newark, Nottinghamshire, United Kingdom
21. 18 February 13:42 DEPARTMENT OF HEALTH, Newark, Nottinghamshire, United Kingdom
23. 18 February 13:43 DEPARTMENT OF HEALTH, Newark, Nottinghamshire, United Kingdom
25. 18 February 13:48 DEPARTMENT OF HEALTH, Newark, Nottinghamshire, United Kingdom
40. 18 February 14:58 DEPARTMENT OF HEALTH, Newark, Nottinghamshire, United Kingdom
41. 18 February 14:59 DEPARTMENT OF HEALTH, Newark, Nottinghamshire, United Kingdom
42. 18 February 15:02 DEPARTMENT OF HEALTH, Newark, Nottinghamshire, United Kingdom
44. 18 February 15:35 DEPARTMENT OF HEALTH, Newark, Nottinghamshire, United Kingdom
45. 18 February 15:52 DEPARTMENT OF HEALTH, Newark, Nottinghamshire, United Kingdom
Well Dear Minister for Health,
You will NOT find the answer on here. You could always ask the MHRA - though they seen unable (ill-equipt) to answer it too. Why not try The University of St. Andrews, they've also been looking in today:
33. 18 February 14:26 The University of St. Andrews, United Kingdom
34. 18 February 14:26 The University of St. Andrews, United Kingdom
35. 18 February 14:27 The University of St. Andrews, United Kingdom
36. 18 February 14:28 The University of St. Andrews, United Kingdom
What's the connection I hear?
A strong candidate could be this man - Alisdair Breckenridge
Alasdair Breckenridge was born and brought up in Scotland. He received his secondary education in Cupar, Fife before proceeding to study medicine at the University of St Andrew's in 1954. He had a distinguished undergraduate record and qualified in 1961 as the best medical graduate of the year. He did his preregistration house jobs in Dundee but left Scotland in 1962 to work in London and was never to work again in Scotland although he remained (and still remains) spiritually a Scotsman.
I'm sure you know him?
I've wrote about him before on this blog - In fact I recently wrote to the MHRA about him - See Dear MHRA... Re: Alisdair Breckenridge lying on national Television
Now, you have my attention Minister, would you please answer the question my MP sent to you almost a month ago!
WHAT IS THE BENEFIT OF SEROXAT?
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Sunday, February 17, 2008
MP for Bartley Green,Edgbaston,Harborne and Quinton slow to respond
Dear Gisela Stuart MP,
On the 22nd Jan 2008, I asked you if you would ask the Health Minster, Rt Hon Dawn Primarolo, what the benefit of Seroxat was.
I have still not had a reply and seeing as it has been almost one month since this request I am therefore requesting that you arrange an appointment for me to speak with her either by telephone or in person - failing this, you could always request to talk with her yourself.. or maybe even just pick up the phone and ask her what the benefit of Seroxat is?
You maybe aware of the termilogy currently used by both GlaxoSmithKline and the MHRA when speaking of Seroxat... 'The benefits far outweigh the risks'. Seeing as we know what the risks are I am sure you, as a human being, would like to know exactly what the benefits are?
The MHRA cannot give us answers, neither, so it seems, can GlaxoSmithKline.
It's a simple enough question and one that should be simple enough to answer, if indeed there is any benefit in taking Seroxat?
The time it is taking to answer such a simple question only highlights the fact that research to find an answer has proved futile. If this is the case then I would like to ask Why is Seroxat still being prescribed seeing as not one person (including the manufacturer, GSK) can state what the benefit is of taking this drug.
The fact that I have waited almost one month for an answer has driven me to post this email to you on my blog, Seroxat Sufferers therefore nobody has been blind copied in on this particular email.
In the interests of the British public may I suggest you pick up the phone and call the Health Minster, Rt Hon Dawn Primarolo and ask her 'What is the benefit of Seroxat?'
Meantime, I would be grateful if you would forward this email onto the Prime Minister, Gordon Brown.
Regards
Bob Fiddaman
Seroxat Sufferers
Tuesday, February 12, 2008
Email to Australian Prime Minister Kevin Rudd
Email Address: REDACTED
Postal Address: REDACTED
Subject: Aropax & GlaxoSmithKline
Comment:
Dear Sir,
Firstly I would like to introduce myself. My name is Bob Fiddaman and I currently reside in Birmingham, UK.
For the past four years I have been an advocate in warning the public about the dangers of Paroxetine (Aropax in Australia)I have had much communication with the Medicines Healthcare products Regulatory Agency (MHRA) here in the UK regarding issues about the side effects and suicidal tendancies that this particular SSRi can cause.
To cut a very long story short, the MHRA know who I am through countless Freedom of Information requests to them and for highlighting correspondence on my blog SEROXAT SUFFERERS (http://fiddaman.blogspot.com)
As you are probably aware the recent European Directive, supported by the MHRA, has requested that suicide warnings be placed on ALL antidepressants in the UK. Strangely, this only applies to patients 25 years of age or under.
As you can clearly see in this document (http://media.newscientist.com/data/images/ns/av/mg19726424600D1.pdf) the suicide attempts not only occured in patients under the age of 25 - infact there were more suicide attempts from the age of 26 upwards. These seemed to occur within the first ten weeks of taking Seroxat (Aropax).
The pdf link is an analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, and suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989.
I feel the need to bring this to your attention for you to at least read through the documents and to arrive at a decision that may safeguard the health of Australian citizens.
A copy of this is also being sent to the TGA.
Basically, the documents will show you how GlaxoSmithKline have manipulated medicine regulators around the world with their "bad numbers". They have known since 1989 that Seroxat (Aropax) had an 8 fold increase of patients taking it... patients of ALL ages.
I sincerely hope that you can give this your utmost attention. I know I am not a citizen of Australia but I have a passion for human life... as you will see through reading the 74 page document - GlaxoSmithKline do not!
Warm regards
Bob Fiddaman
ADDRESS REDACTED
UK
EMAIL: REDACTED
Sunday, February 10, 2008
Dear MHRA... Re: Alisdair Breckenridge lying on national Television
To: MHRA Information Centre
Cc: alasdair.breckenridge@mhra.gsi.gov.uk ; kent.woods@mhra.gsi.gov.uk
Sent: Sunday, February 10, 2008 3:50 PM
Subject: Suicide attempts
Dear Sirs,
Please find attached a graph taken from the recently opened documents in the O’Neal v. SmithKline Beecham d/b/a GlaxoSmithKline case in the United States.
As you are aware the recent European Directive, supported by the MHRA has requested that suicide warnings be placed on ALL antidepressants in the UK. Strangely, this only applies to patients 25 years of age or under.
As you can clearly see in the graph attached, the suicide attempts not only occured in patients under the age of 25 - infact there were more suicide attempts from the age of 26 upwards. These seemed to occur within the first ten weeks of taking Seroxat (Paxil).
The Chair of the MHRA, Alisdair Breckenridge has publically stated that '...these drugs DO NOT cause suicide, they DO NOT cause suicidal thoughts in adults' (see video panorama 04.17 - http://youtube.com/watch?v=TozBgI5LyGc)
Three questions for you
1. Was Alisdair Breckenridge unaware at the time of his statement that the clinical trial results actually DID show that there was a high rate of suicide attempts in adults during the first ten weeks? If so, why?
2. Would Alisdair Breckenridge or the MHRA be prepared to now state that based on fresh new evidence, we believe that Seroxat DOES cause suicide in adults? If no, why?
3. As you are aware myself and others have been saying for the past four years or so that we beleive Seroxat does/can cause suicide in adults. If proved correct would you think it reasonable to publically apologise to all those patients and patients families whom have suffered at the hands of this drug?
Regards
Mr Robert Fiddaman
Seroxat Sufferers
http://fiddaman.blogspot.com
cc: Various colleagues, MP's and media
*For the purpose of this blog, the attachement I refer to in this email can be viewed here
Friday, January 18, 2008
MHRA and Gisela Stuart MP asked to respond to...
Check out the time I sent the email.
----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Cc: STUART, Gisela
Sent: Friday, January 18, 2008 3:56 PM
Subject: Effectiveness Of Antidepressants Questioned
Dear Sirs, Madam,
Would anyone at the MHRA or within government be prepared to make a statement about the following links on this page?
http://fiddaman.blogspot.com/2008/01/for-glaxosmithkline-and-all-other.html
Regards
Bob Fiddaman
Please note: This email will be published on the www
----
They can't say they couldn't access the links from this site because...
4. 18 January 15:58 Exponential-e Customer Allocation, London, London, City of, United Kingdom
5. 18 January 15:59 Exponential-e Customer Allocation, London, London, City of, United Kingdom
6. 18 January 16:00 Exponential-e Customer Allocation, London, London, City of, United Kingdom
7. 18 January 16:20 Exponential-e Customer Allocation, London, London, City of, United Kingdom
8. 18 January 16:24 Exponential-e Customer Allocation, London, London, City of, United Kingdom
Exponential-e Customer Allocation is the server/ISP used by the MHRA
Fid
Praise the Lord for Websats :)




