Monsanto Roundup Lawsuit


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

Wednesday, April 30, 2008

Keller has an awful lot to answer for!

There are approx 226 papers/letters that cite the 'Keller Paper'


Papers that unequivocally report study 329 as positive on the basis of the Keller paper.



This was the same man who patted BBC Journalist Shelly Jofre on the head like she were a small puppy when she approached him at a seminar.


The papers can be found at Healthy Skepticism (Word Doc)

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

GSK Australia - Clearly Behind the times

"Aropax corrects the chemical imbalance and so helps relieve the symptoms of depression."
http://www.gsk.com.au/products_prescription-medicines_detail.aspx?view=64

The Irish equivalent of the MHRA, the Irish Medical Board, recently banned GlaxoSmithKline from claiming that paroxetine corrects a chemical imbalance even in their patient information leaflets [HERE].

Should the Australian equivalent of the MHRA do the same or do Australians have different enzymes from Europeans?

In fact I am unsure whether or not this is the stance of the MHRA?

Is the chemical imbalance theory fact or merely a theory?

If indeed it is a theory .. and only a theory, what the hell are GSK Australia playing out by making such a false and misleading claim?, If indeed it is misleading and false?

I've wrote about this before.

Maybe an email to the TGA will help?

Fid

----- Original Message -----
From: fiddaman
To: TGA.Advertising@tga.gov.au
Sent: Wednesday, April 30, 2008 1:00 PM
Subject: GSK claim - False and misleading


Dear Sir/Madam,

I wish to complain strongly about the claims GSK Australia are making on their webpage. - http://www.gsk.com.au/products_prescription-medicines_detail.aspx?view=64

They claim that:

"Aropax corrects the chemical imbalance and so helps relieve the symptoms of depression."

This is false and misleading according to this paper from Plos Medicine. http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0020392

I trust you will take this matter very seriously?

Sincerely

Mr Bob Fiddaman,
UK

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

Man in police axe attack took Seroxat

Source: The Garstang Courier

A GARSTANG man who threatened to kill police officers with a woodcutter's axe has been told he must attend domestic violence and alcohol abuse rehabilitation sessions.

John Southwell, of Croston Road, pleaded guilty to a charge of affray at Lancaster Magistrates Court last week, following an incident at his home on Saturday, April 19.Joanna Stephenson, prosecuting, told the court that the 59-year-old's wife, Mary, had called police to the property that evening.She said: "At about lunchtime, Mr Southwell had been drinking bottles of Stella. He then went to the British Legion for a drink. He drank about six bottles before going out, and had taken Seroxat, an anti-depressant.

Magistrates took into account Southwell's previous good character and early guilty plea before sentencing him to a community-based penalty.

FULL STORY HERE


**COMING SOON

A review of yesterdays meeting with MHRA CEO Kent Woods.

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, April 29, 2008

The Evidence GSK won't let the MHRA release

Exactly what did the MHRA look at that convinced them GSK were up to no good regarding the Seroxat paediatric studies?

What convinced them that GSK did indeed manipulate the studies just so they could market the drug?

Did the ghostwriters commit an offence? Fraud maybe? If so, what is to become of them? Will they be let off the hook under some perverse EU Law?

Will Martin Keller face charges of any sort or is he deemed out of the UK jurisdiction? Would he ever be questioned? Hopefully the MHRA Enforcement Team won't be privy to any such investigation - can you imagine it?

MHRA - "So Mr Keller, do you have anything to say?"
KELLER - "No"
MHRA - "Okay"

Sounds sarcastic but that is basically what the MHRA's Enforcement Team did to the GSK 'suspects' - only they never even got the chance to speak to them!

So back to study 329, which undoubtedly was the crux of the Enforcement Teams evidence. Was there anything in that study that we (the public) have not yet seen? Was it more shocking to read than the documents we (the public) have had access to over the past few years? Was it so disgustingly shocking that it sickened the Enforcement Team at the MHRA? So vile that it made the MHRA Chairman, Alasdair Breckenridge shudder at the thought that his former employees GSK could ever do such a manipulative thing? Did it shock Ian Hudson, the Director of Licensing at the MHRA who previously held the post at GlaxoSmithKline (then SKB) of no less than WORLD SAFETY OFFICER and who has gone on record stating that he had '...a significant interest in Paxil [Seroxat]'

Incidentally... The MHRA's Enforcement Team chose not to interview Messrs Hudson & Breckenridge. Not content with allowing the GSK suspects to walk free, they also turned a blind eye to two of their own members who could 'possibly' have shed some light on Paxil Study 329 - in particular Ian Hudson who... and I'll say it again - has gone on record stating that whilst he was employed at GSK (then SKB) as WORLD SAFETY OFFICER he had '..a significant interest in Paxil [Seroxat]'

So what was so alarmingly shocking? Was it the fact that GSK had manipulated the data in such a way that they had probably convinced themselves that any child actually administering a Seroxat tablet would be safe?

The Clinical Psych Blog writes eloquently about the whole subject with the post of the year
' Paxil, Lies, and the Lying Researchers Who Tell Them '

I posted yesterday making the statement that I was totally pissed off... and someone should be held accountable - not one person has held up their hand and admitted failure - there has been no apologies and WE (the patients) are supposed to just take it on the chin?

Will the parents that have lost children to Seroxat be expected to take it on the chin too? Someone owes them one almighty fucking explaination as to why this was allowed to happen! Do you think they want to hear about some fucked up law that allows... for want of a better phrase - a suicidal pill onto the market?

Wake up - smell the fucking coffee. This is scandalous and nobody seems to give a flying fuck about the lives that have been lost to Seroxat. The bodies that lay in graves - the ashes that sit in urns. Children, Kids, Adolescents (label them how you want) have lost their lives - Can anyone even begin to imagine just exactly what their parents are going through right now - right at this very moment in time?

I want the MHRA members - from the CEO right through to the admin team to close their eyes for 30 seconds. I want them to imagine their children playing in the park, falling over and running to them for a cuddle... 'Kiss it better daddy', 'Mommy make the pain go away' - you getting the picture? I want you to imagine reading your child a bedtime story, bathing them, holding them in your arms and telling them how much you love them. I want you to imagine them going through adolescence and bringing their first boyfriend/girlfriend home to meet you. I want you to imagine the look of surprise on their face as you throw a surprise 18th birthday party for them.

It's all beautiful isn't it.

Now imagine if your child had committed suicide as a result of taking a drug that a UK regulator had allowed onto the market.

Would you be pissed off?

Would you want answers?

Would you be happy at a four year investigation that let off the manufacturers of the drug that had been part of the reason why your child had taken their own life?

Thankfully, none of my children have ever taken this drug - I will never allow them to take any SSRi - I doubt very much if any employee of the MHRA would allow their children to take one either... come to think of it I doubt very much if any employee of the MHRA would allow their children to take an SSRi type drug when they are fully grown adults too!

Someone left a comment under my last post Comment from John Watkins of the MHRA - It deserves to be read:

They wrote:

I think you hit the nail on the head there ..

"The Patients are bearing full responsibility for everyone else failures" ..

This is exactly what has happened.

Although this meeting is a step in the right direction..

It's a little too late if you ask me..

6 panorama programmes exposing patients devastating seroxat experiences, corruption, lies and deceit ..and the the MHRA does not communicate with patients..

10, 000 signatures on a paxil(seroxat) protest petiton online ..and the MHRA does not validate patients voices...

An American paxil protest, three day vigil outside of GSK in Philidelphia and the MHRA does not listen to patients concerns...

A protest outside the MHRA by mental health charites , including MIND and patient advocates and the MHRA ignores the plight of those affected by Seroxat..

Countless studies and articles indicating the dangers of Seroxat and the MHRA continues to promote it as a safe and effective treatment...

The World Health Organisations report that Seroxat is the hardest of all drugs to come off.. and the MHRA continue to permit GSK to sell this TOXIC SHIT to the public...

Thousands of documented online videos, documentaries, websites and blogs screaming about Seroxat side effects and Seroxat withdrawal and the MHRA still denies this drug is dangerous...

Numerous news articles condemning GSK and their role in the Seroxat scandal, suppression of data etc and the MHRA slaps them on the wrist ..

This has gone beyond a joke..Mr Woods if you are reading this...You have A LOT of explaining to do...

Not least to the grieving familes of kids (and adults) who killed themselves on Seroxat because of your regulatory incompetence...

But also to those whom are still affected , those whom are still enslaved on this disgusting poison which you market as medicine and also to those who are still trying to pick up the pieces after Seroxat withdrawal..

An experience of unimaginable horror, one which you could not ever comprehend even in your worst nightmare...

Yes .. there is a lot of explaining to do Mr woods...

At the very least you owe the thousands of Seroxat victims and seroxat suvivors some justice and closure...

If you can't even offer that, then you are have failed the public and I think you should resign...

----

I agree in the main with what the anonymous reader left - I disagree with the line 'I think it's a little late if you ask me...'

I think it is a bold move by the MHRA to meet with Seroxat campaigners - I think it is a massive middle finger up to GSK.. I am still undecided whether I think anything will come of todays meeting with Kent Woods, the CEO of the MHRA. I'll wait until I have spoken with Janice Simmons.

Now getting back to the actual 329 study. A paper has just been wrote and published in the International Journal of Risk & Safety in Medicine. The subject matter is the Paxil 329 study.

This is probably an insight into what the MHRA Enforcement Team went on - although why it took them four years to come to any sort of conclusion remains a complete and utter mystery.

Robyn at Healthy Skepticism sent me a rather interesting pdf file relating to the paper just released in the International Journal of Risk & Safety in Medicine. As mentioned earlier Clinical Psych writes about it HERE. The original Paxil 329 documents can be obtained HERE.

I have the proof copy that has recently appeared in the journal. I will quote one para here for you all:


There was no significant efficacy difference between paroxetine and placebo on the two primary outcomes or six secondary outcomes in the original protocol. At least 19 additional outcomes were tested. Study 329 was positive on 4 of 27 known outcomes (15%). There was a significantly higher rate of SAEs with paroxetine than with placebo. Consequently, study 329 was negative for efficacy and positive for harm.

A copy has now been made available on Ed Silvermans Pharmalot

Now what of the adults taking Seroxat? Are the MHRA going to ignore the warning signs yet again then carry out yet another four year investigation before giving the new CEO of GSK, Andrew Witty, a slap on the wrists later down the line?

Act now.

Listen... and act upon what we (the patients) have to say.

More importantly - the proof is in the pudding. Take a course of Seroxat and make me a liar.

I dare ya.

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

Comment from John Watkins of the MHRA

I have had permission to add this comment to my blog from John Watkins of the MHRA. It refers to my post 'Seroxat, Who should be held accountable?' where I questioned whether Kent Woods meeting with Janice Simmons at the end of this month was merely a token gesture?

Dear Bob,

I read on your blog for 28 April that you were “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?”

Allow me to put the record straight on this. The date for the meeting was suggested to me by Janice. It was convenient for her and for others who would come with her. I told her that Kent Woods’ diary for the day would only allow an hour and asked whether she would prefer to look for another date when there could be more time for a meeting. On balance, Janice preferred to use the date she had suggested.

Let me assure you that this meeting will be more than a token gesture and that Kent would have been happy to have had a longer meeting.

Regards,

John Watkins MHRA

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'm pissed off - totally and utterly pissed off.

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

Sunday, April 27, 2008

One Mans Paxil Hell hits youtube

I want those responsible to take a good look at this video and to read what the creator added:

This video, gives you a glimpse into one mans tormented mind. ME!Paxil: 40mg for 8 years. From 40mg to hell in 60 days. Like many, My Dr. never told me to taper off.After a year of torment and almost loosing my sight, family and life! I'm back on paxil. Now that I can think again, I made this to let others know they are not alone. What you don't know WILL hurt you!. Loved ones will never understand the misery of SSRI withdrawal. God Speed!

I cannot add anything. He pretty much sums up my time on withdrawal.

Remember folks - Seroxat is safe if you are over 25!




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

EU rejects widow’s complaints over Seroxat risk concerns

Source: Irish Examiner

Hat tip to Stuart for sending me this.

EU rejects widow’s complaints over Seroxat risk concerns

By Seán McCárthaigh

THE European Ombudsman has rejected complaints by the widow of a Corkman who died by suicide that EU bodies failed to adequately review concerns she raised about the safety of the anti-depressant drug, Seroxat. However, the ruling only came after the European Commission and the European Medicines Agency (EMEA) addressed warnings by the EU ombudsman that they had possibly been guilty of maladministration in their dealings with Nuria O’Mahony.

The nurse from Bandon, Co Cork, maintains that her husband, Niall, 39, took his own life as a result of taking Seroxat. The father-of-three was found dead on December 26, 2003 — within two weeks after he first began taking the controversial drug.

Ms O’Mahony, a nurse at Cork University Hospital, complained to the European Ombudsman in 2005 there was a lack of information by the commission and the EMEA when she questioned their decisions to authorise the use of Seroxat.

A month earlier, the commission instructed EU states that Seroxat information should include a warning about its use in children and adolescents.

However, it ruled that the benefit-risk balance of the drug remained favourable for use by adults.

Ms O’Mahony said GlaxoSmithKline failed to release all its clinical trial data on Seroxat to medical licensing authorities and complained the commission and EMEA had failed to inform her how much of this data had been seen before they issued their recommendations.

She also claimed they had not given her a fair hearing on her concerns about the safety and suicide risks of Seroxat

Yesterday, she expressed gratitude for the help from the EU Ombudsman which resulted in the commission providing information which she had not previously been given.

“However, many questions remain unanswered about the safety of Seroxat and what steps the EU authorities have taken to see all available data on the drug,” said Ms O’Mahony.

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

Saturday, April 26, 2008

...they knew but did nothing!

Thanks to Steph Gatchell for alerting me to this video.




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, April 25, 2008

GlaxoSmithKline v Lundbeck Pharmaceuticals

When GlaxoSmithKline saw the ads running for Lundbecks Cipramil they nearly had a seizure

Complaint: An advertisement for Lundbeck Pharmaceuticals, promoting Cipramil, was published in the New Ethicals Catalogue. The headline stated "This is the only kind of interaction your depressed patient needs…Cipramil® See the difference…". This text surrounded the portrayal of a mother smiling into the face of her daughter.

The Complainant GlaxoSmithKline, was represented by Ms Edith Gersten and Mr Txema Sanz.


The Advertiser, Lundbeck Pharmaceuticals was represented by Ms Ruth Stokes.

The Complainant said:

"Further to our correspondence dated 17 April 2001, ASA complaint number 2001/88-AWAP 01/9. GlaxoSmithKline NZ wishes to formally register a complaint regarding a promotional advertisement for Cipramil, a Selective Serotonin Re-uptake Inhibitor (SSRI) used for the treatment of depression, published by Zuellig Pharma on behalf of Lundbeck Pharmaceuticals, in the May 2001 issue of the New Ethicals Catalogue. This complaint is in addition to our complaint of a previous version of this advertisement that appeared in the November 2000 issue of New Ethicals Catalogue. Lundbeck used misleading advertising and were found to be in breach of several ASA codes. Unfortunately, Lundbeck have chosen to ignore the ASA code again by using unreferenced and unsubstantiated claims.

Lundbeck have submitted an advertisement without a TAPS number and have blatantly disregarded the guidelines set by the ASA in their last ruling.


Since the New Ethicals Catalogue is published 6-monthly and is widely retained on doctor's desks. It is impossible to withdraw the advert from this particular publication. GlaxoSmithKline would therefore like to see the following corrective measures taken by Lundbeck:


* That all of Lundbeck's promotional material be scrutinised and approved by Mr. Nigel Andrews, the TAPS adjudicator to ensure that breaches of the code such as this one, will not and cannot occur again.


* That the offending advert for Cipramil be withdrawn from any other industry and medical publication immediately.


* That a corrective letter be published in all major industry publications including New Ethicals Journal, New Zealand GP, New Zealand Doctor and Pharmacy Today. We would like to see the letter appearing in at least 3 consecutive editions to ensure that all prescribers and dispensaries were aware of the issue.


* That ADIS International be advised of the ramifications of not abiding by the TAPS system and its regulations.

The new advertisement depicts a woman who appears to be dancing with a young girl. The advertisement contains the caption “This is the only kind of interaction your depressed patient needs”. We have enclosed a copy of the advert for your reference.


GlaxoSmithKline is of the opinion that this claim is misleading, unqualified and all encompassing with regard to the superiority profile of Cipramil against other antidepressants in its class, namely SSRI's.


FULL SUMMARY DECISION HERE

Okay, this is old news but just shows you how far one will go to protect their assets... or in this case, their SSRi.

I had to laugh at the last para "GlaxoSmithKline is of the opinion that this claim is misleading, unqualified and all encompassing with regard to the superiority profile of Cipramil against other antidepressants in its class, namely SSRI's."

Misleading?

Unqualified?

Hmmm.

Now, let me point you to an article that appeared in an Australian newspaper about a year or so later.

Sponsor's advert a happy coincidence

It's the biggest event on Britain's charity circuit and now it's coming to Australia.


Comic Relief, which raises close to $1billion biennially, hopes to be "the most significant charitable fundraiser in Australia by 2003".

But it is also providing an opportunity for drug manufacturer GlaxoSmithKline, whose campaign of support for Comic Relief has some similarities to its advertising for one of Australia's top-selling anti-depressant drugs.

"Love that Aropax smile," reads a six-page fold-out ad that appeared in doctors' news magazines at the end of last year. It is trimmed in bright orange and features a formerly depressed mother joking with an orange segment in her mouth, and her giggling, orange-clad daughter.

Earlier this year the company took out ads in the same publications, touting its $200,000 donation to Comic Relief and announcing a fund-raising program in which its drug sales people would visit doctors dressed as clowns.


The notices bore no direct reference to Aropax, but nevertheless had an orange backdrop and they continued the smiling theme. "We're dropping in to make you smile for a very worthy cause," the company explained.

The creative director of advertising agency Belgiovane Williams Mackay, Rob Belgiovane, said GlaxoSmithKline's Comic Relief and Aropax ads were "both selling the notion of happiness - one the natural way, the other the anti-depressant way".


Now pardon the use of my Garnier like tongue here but... What a fucking liberty!

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

Thursday, April 24, 2008

GSK Investigation - Simply not good enough


It's laughable that the public won't be allowed to find out who the 'suspects' were. Is this further embarrassment upon the MHRA or are they breathing a sigh of relief?

I buy into the fact that the MHRA are totally pissed off in the way GSK have totally embarrassed them but at the same time I have little sympathy for them. Why should I?

There has been no public announcement that GSK have responded to Woods - the pdf file is tucked away on the MHRA website. Why?

Is it just left to the patient advocates again to bring this to the attention of the public?

Why wasn't there a press release from the MHRA?

If I had been made to look a complete incompetent fool I would certainly want to get my point across. Instead we have a letter to Garnier
'You naughty boy, go and stand in the corner then explain your reasons why you did what you did'

Garnier sulks then gets someone else to write his explanation. No admission of any wrong doing - in fact the letter from Krall does everything but admit fault.

The 4 year investigation found that GSK were morally wrong to do what they did. Morals don't account for much with Pharma. GSK could not be prosecuted due to some perverse EU law - a law, that it seems, they used to their benefit. A law that protected them to do what they did.

The MHRA criminal investigation... because at the end of the day it WAS a criminal one, needs to be seriously looked at by impartial investigators - at this moment in time patient advocates, bloggers et al seem to be those impartial investigators. We continue to make noises that make those in power feel uncomfortable.

The funding the MHRA receive from pharma is basically to finance the drugs they review. But the data they review would pass any rigorous review because it is data that pharma want the MHRA to see. It's akin to an advertisement for a book. You've seen the blurbs on the posters... normally followed by a quote from a national newspaper - 'HIS BEST NOVEL TO DATE' etc. The book publisher won't add the comment from a book critic that said
'I FOUND THE BOOK WEAK AND BORING'

Why?

Because they want the book to make money... and lots of it.

This is how medicines are regulated - The MHRA are basically going on 'HIS BEST NOVEL TO DATE' because they are unaware of
'I FOUND THE BOOK WEAK AND BORING'

It's the best analogy I can offer. Once that 'book' hits the shelves critics (in this case patient advocates) will make their own minds up - it's a personal experience thing. Their word will reach far and wide and eventually book sales will slump.

Meantime the book publisher and/or marketing team are left with egg on their face but hey they made a mint out of it before those pesky critics got in the way.

I digress.

The criminal investigation into GlaxoSmithKline was mis-managed. Suspects should have been arrested regardless of whether or not the MHRA enforcement team thought they would talk.

We can see now by Kralls letter why they wasn't arrested.

Mud sticks and if arrests were made then it would have become public knowledge. The fact that they were only suspects gives them the protection of anonymity, GSK's lawyers would have already foreseen this so why didn't the enforcement team and the MHRA lawyers? Maybe they did and felt the need to protect.

There has to be a reason why the suspects were not arrested. The whole 'they would have remained silent' just does not wash with me. Like any criminal investigation team be it internal or external there has to be an interrogation at some point, I'm not talking about beating a suspect with wet towels until they confess. An interrogation of any suspect advances a criminal investigation or at least eliminates suspicion.

The MHRA took it on good faith that the Seroxat data was kosher. The MHRA enforcement team took it on good faith that the suspects would remain silent if questioned under caution. On both occasions they handled GSK with kid gloves - on both occasions they have been made to look incompetent.


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

Wednesday, April 23, 2008

Letter from GSK Chief Medical Officer to MHRA - 18 March 2008































Download pdf file HERE



Kent Woods response to letter HERE





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, April 22, 2008

Prescription Suicide.

These 5 videos go out to the MHRA and Pharmaceutical Companies.

We have documented evidence, anecdotal evidence, evidence used in a court of law and now a former pharma rep speaks out.

What more do you want?

PART ONE

PART TWO

PART THREE

PART FOUR

PART FIVE

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 21, 2008

BMJ Letters & A plea to Kent Woods MHRA CEO

Thanks to the Truthman for alerting me to this group of letters published on the BMJ website in 2002

The whole thread can be found here

Some rather interesting ones:

The thread started was a Consultant Physician from Waterford Regional Hospital in Ireland. He writes...

The "dizziness" associated with paroxetine withdrawal has happened to me on two seperate occasions of dose-reduction, and within two days on each occasion. The nearest description I can apply to the sensation is the feeling of having one's head inflated by an air pump,without evidence of any such appliance in the immediate vicinity. Cipramil, an alternative SSRI, does not produce this spaceman sensation, when my dosage is reduced.

This was later followed by a comment left by someone whom I think is a general practitioner from Heacham Group Practice...

At last a recognition of what most general practitioners and community mental health workers have recognised for some time; withdrawal from paroxetine is much more likely than other SSRI's to produce a characteristic and often severe syndrome. We belief that the figure is considerably higher than the 7% quoted. Paroxetine is, however, an extremely effective and useful drug, and what should now follow is a wide debate, (with appropriate research), to address the following questions;-

1)How common is the withdrawal syndrome?
2)In what proportion of patients is it severe?
3)What regime should be used for withdrawing the drug?
4)How is the syndrome best treated, other than re- starting paroxetine, e.g. should an alternative SSRI be used?
5)Are there particular patient characteristics which predispose them to the syndrome?

Failing satisfactory answers to these questions will inevitably lead to the substitution of alternative therapies.


Alfonso Carvajal, a clinical pharmacologist from Spain adds...

In fact, I think withdrawal symptoms with paroxetine are more frequent, more severe and more difficult to treat than currently believed. I have tried to stop paroxetine in a female patient by reducing the dose during a long period: three weeks on a 3/4 of the current dose (20 mg); three weeks on 1/2 and, finally, other three weeks on 1/4. After finishing the medication, symtoms have appeared, being the more prominents insomnia, bad dreams and restlesness. It is worrisome that these symptoms resemble those of depression. I agree that it is necessary to find out better strategies to stop this medication but important as well, to have into account, before starting this medication, the appearence of a difficult to treat withdrawal syndrome.

A heartfelt response from Dawn Rider of the United States followed with...

I am encouraged to finally see the FDA take action on this extremely urgent matter. I have been communicating with hundreds of people across the United States and throughout Europe who have been attempting to warn the public about the dangers of not only Paroxetine, but other SSRI/SNRI drugs.

These are people who were prescribed Paroxetine (or one of the other SSRI/SNRI drugs), without any warning of the addictive nature, or severe side effects upon withdrawal that all too often accompany these drugs.

I can only hope that similar action will be taken against all drugs that are within the SSRI/SNRI classification of drugs. The population so adversely affected by these drugs may appear to be nominal when written up as a percentage in the drug labeling insert, but in reality- with so many now being prescribed these new "wonder" drugs for everything from mild depression to PMS, there are millions now using these drugs, most without proper follow up care. The "small percentage" factor now translates into thousands, possibly hundreds of thousands who are so adversely affected.

I know from personal experience. I have never taken any of these drugs, but we lost our fourteen year old son to suicide, which I firmly believe was brought on by his own adverse reaction to Prozac, and I have watched my husband suffer terribly in attempting to withdraw from Paxil. I would venture to guess that those who are adversely affected by these drugs are much higher than even the 7-10% that is now being proposed.

I encourage you to investigate further into the hundreds of thousands of other "anecdotal" evidences from those using the other SSRI/SNRI drugs. If you don't take the responsibility to do this now, the reality will manifest itself, as has been the case with Paroxetine. There are simply too many people now who are beginning to realize that they were denied the opportunity of "Informed Clinical Consent". These people are not laboratory rats who should be subjected to such experimentation. Listen to what they have to say!

Oh, and one more thing, until there is absolute proof positive that one has a "serotonin imbalance", it would be best if this theory ceased to be pushed upon the public as fact. Until there is a method in place to determine what is a "normal" serotonin level in a patient, and a method to determine how much that level should be tampered with to achieve the desired results, the pharmaceutical firms should cease comparing patients diagnosed with depression, anxiety, bi-polar disorder or any other number of "mental health disorders" to those diagnosed with diabetes. You can measure the level of insulin needed to obtain the correct balance needed for someone with diabetes. Not so with serotonin.


Now Mr Woods, CEO of the MHRA has a meeting with Janice Simmons from the Seroxat & SSRi User Group at the end of this month. Janice has similar emails sent in by concerned patients. I urge Kent Woods not to pass them off as anecdotal. If GP's, Consultant Physicians, Clinical Pharmacologists and Leading Experts on SSRis were complaining about withdrawal as early as 2002 then why wasn't they listened to?

The thread continues here Mr Woods. If you want to learn about withdrawal then read it. If you want to experience withdrawal may I suggest, like all good chefs, you try the product. Prove that we are wrong - show us that if you are over 25 there really is no problem withdrawing from Seroxat.

This is a problem Mr Woods, a severe problem that has been ignored for too long. Like Dawn Rider states in her reply (above) "... These people are not laboratory rats who should be subjected to such experimentation. Listen to what they have to say!"

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, April 18, 2008

Steptoe & Johnson - Who are they? What do they want?

Everyone has a right to surf the internet. It seems this blog is attracting all sorts.

Steptoe & Johnson visit on a daily basis, sometimes seconds after the MHRA and GlaxoSmithKline have logged in to this site. Coincidence?

So who are Steptoe & Johnson? One would think Wilfred Brambell had teamed up with the lead singer of AC/DC.

A quick Google search brings up the following.

Steptoe & Johnson LLP: An International Law Firm
Steptoe & Johnson LLP provides counsel and representation of clients before governmental agencies, successful advocacy in litigation and arbitration...

UK Site
http://www.steptoe.com/

I don't know why they are taking a particular interest in this blog, the only thing I can think of is Seroxat. So what is their interest in Seroxat?

It seems they have been interested in Seroxat for a few years now.

This from the MHRA files section:

From:
Sent: 15 December 2005
14:59
To: Pharmacovigilance,
Cc: Subject: Request for Information

Dear Sirs
Attention: Pharmacovigilance Team

I wish to make a request for information pursuant to the Freedom of Information Act 2000 for the following information:

1. please identify the statute(s) and regulations which obligate the pharmaceutical industry to report suspected serious adverse drug reactions to the MHRA, and which include a definition of "serious" adverse drug reactions; and

2. a Drug Analysis Print for paroxetine which lists all of the adverse drug reactions which have been reported to the MHRA (and the former MCA) by all sources (including those reported by the marketing application holder) up to 1 May 2001.

I would prefer to receive the information electronically via email, but you may otherwise post the requested information to my attention at: Steptoe & Johnson, Clements House, 14-18 Gresham Street, London EC2V 7JE.

Please do not hesitate to contact me via email or telephone if you have any questions.

Thank you.

So exactly who are Steptoe & Johnson? Who are they working for? What is their interest in this blog? What is there interest in Seroxat? More importantly why are they interested in all the adverse drug reactions that have been reported to the MHRA regarding Paroxetine?

Answers on a postcard please.

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

Thursday, April 17, 2008

Dr Ian Hudson MHRA - why wasn't he interviewed?




Here is Dr Ian Hudsons public declaration of interests.




Now wasn't he the World Safety Officer at SKB?




What two prescribed drugs have recently prompted both the FDA and the MHRA to write to JP Garnier at GlaxoSmithKline?




Avandia & Seroxat.




And the MHRA refused to interview Hudson. This is just absurd!






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

Dr Ian Hudson (MHRA) In the Red!

Many thanks to Derek Scott of the Online Seroxat Support Group for digging through his archives and finding this little gem.

You may recall previous posts on here regarding Dr Ian Hudson of the MHRA. For those that don't know Dr Hudson was employed by GlaxoSmithKline (SKB). He has also gone on record stating that he had a significant involvement in Seroxat.

Dr Ian Hudson was not interviewed by the MHRA enforcement officers - as yet, it is not known why. I have recently requested this information from the MHRA.

My good friend Derek Scott has vast amount of Seroxat articles. He recently sent me this, it needs to be seen not only by patients but by the MHRA as well.

The title of this post is 'Dr Ian Hudson (MHRA) In the Red' - The relevant part of this information is in red.

07 March 2007

Source: The Courier

A DUNDEE MP is calling for the controversial anti-depressant Seroxat to be suspended for all new patients in the light of growing evidence linking the drug to suicidal tendencies.

Dundee East MP Stewart Hosie met the medicines trade body, the Association of British Pharmaceutical Industries, to outline his concerns about the drug.

A recent US Food and Drug Administration report found a six-fold increase in the risk of suicidal thoughts and acts in children and a three-fold increase in adults after Seroxat treatment.

It is the latest in a long line of damning reports over the drug’s dangerous effect on an unacceptably high number of adults and children, and Mr Hosie has criticised ministers for “dragging their heels over the strong evidence regarding Seroxat.”

He has also joined a growing number of cross-party MPs in criticising the body responsible for licensing the drug, the Medicines and Healthcare products Regulatory Agency (MHRA), for being too close to the pharmaceutical industry.

Speaking after his meeting with the pharmaceutical industries association, Mr Hosie said, “From what I have heard during the meeting, it is my understanding that many people within the pharmaceutical industry share my concerns about the apparent close relationship between the MHRA and the companies it regulates.

“The MHRA is currently funded by industry fees but I feel that it is important for the government to set up some kind of positive mechanism outside the industry to create a perceptible distance.”

However, the MHRA said that a working relationship with the industry was vital, and that appropriate safeguards were in place to ensure industry funding did not impede its regulatory independence.

A spokesperson added, “The funding of MHRA is a political decision, taken by ministers of successive governments. The current Government policy is that they have no plans to change the current system.”

The concern over industry links at the MHRA is inexorably linked to the debate over continued licensing of Seroxat.

MPs and campaigners have misgivings about certain members of the company’s executive board being too close to the company which manufacturers the drug—pharmaceutical giant GlaxoSmithKline (GSK).

MHRA chairman Professor Alistair Breckenridge once sat on the scientific advisory committee of GSK subsidiary SmithKline Beecham, while MHRA head of licensing Dr Ian Hudson was formerly director of safety at the firm.

On a public declaration of interests submitted to the European Medicines Agency (EMEA), Dr Hudson admits that he previously had “significant involvement in a number of SB products—especially Avandia, Hycamtin and Paroxetine (aka Seroxat).”

FULL STORY HERE

The article itself is old news. It's a story that has been told time and time again. Interestingly, I never knew Hudson had a significant interest in Avandia as well as 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

SSRi Withdrawal Support Needed

Blogging about this problem may have opened the eyes of GP's, partners watching loved ones go through withdrawal hell etc... but what is needed is some form of hotline or even individual classes set up around the country to help those suffering with SSRi withdrawal.

First acknowledgement is needed that withdrawal is a severe problem with SSRi's. WE know it is as WE have suffered this. Our problem lies with the regulator and manufacturers of these drugs.

As long as comments are abound from Pharma spokespersons such as Mary Anne Rhyne (GSK) then there will be a huge amount of un-needed suffering.

"If discontinuation reactions occur in patients stopping Paxil, the majority will experience symptoms that are mild to moderate in intensity, and are usually limited to two weeks"

If Pharma were to come out and acknowledge the severe withdrawal symptoms that would be a start. An alcoholic needs to acknowledge he/she is an alcoholic before they can even begin on that road to recovery - same way a drug addict does. If either the alcoholic or drug addict were told that the effects of their chosen vice were 'mild to moderate' then there would be no call for support groups would there?

Obviously, it is common knowledge that alcohol and illegal drugs (some legal) are bad for you. The point of this blog and I'm sure many others... along with websites, is to bring about awareness, not for those suffering but for those who have never suffered, for those that watch loved ones go through the suffering. It is also about making the regulator aware that these are not just anecdotal stories. Something needs to be done and it needs to be done NOW.

Janice Simmons of the Seroxat & SSRi User Group has been calling for support groups for years now. Hopefully her meeting with Kent Woods, CEO of the MHRA, will be a starting point to get these groups into swing. People need help and they are not getting it. It's time for change... DO IT TODAY.

To learn more of the proposed withdrawal support groups contact Janice Simmons via her website: Seroxat & SSRi User Group.

Or contact her direct via email HERE

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, April 16, 2008

Counterfeit Drugs - I'm worried.. YOU should be too

I recently asked the MHRA (under the FOI Act) a question regarding counterfeit drugs here in the UK.

Back in March I watched a documentary called The Fake Trade. I was quite aghast at the ease that fake drugs can reach our shelves. It prompted me to read up about this serious problem. First stop was the MHRA website.

From there I learned that there had been nine known reported cases where fake drugs have reached pharmacy and patient levels. This may seem a low number but if you think that those nine reported cases had reached just nine patients then that is nine too many. However, the number of patients that may have taken these counterfeit drugs is far greater than nine. Far greater!

This from the Daily Mirror:

There have been nine known cases of fake medicine being sold in the UK, which doesn't sound like much of a problem until it's explained that with each case representing 100,000 doses, the number of fake prescription drugs winding up on UK chemists' shelves is more like 900,000.

That's almost one million. Quite a problem I think you would agree.

So, I wrote the MHRA with the following question:

1. There have been nine known reported cases where fake drugs have reached pharmacy and patient levels. Approx how many patients administered these fake drugs?

The MHRA have recently answered:


Dear Mr. Fiddaman,

In response to your request under the Freedom of Information Act, the following information can be provided.

As correctly stated, since August 2004 counterfeit medicines have been discovered in the UK regulated supply chain and recalled on nine occasions.


It is not known how many of these counterfeit products reached the market and therefore it is impossible to calculate the number of patients affected.

Kind Regards,
Central Enquiry Point


Impossible to answer?

This is quite a problem and the MHRA reply to a very serious question with 'impossible to answer'

I have wrote back. I'm not particularly happy about this. You shouldn't be either.


Dear MHRA,

Thank you for the reply. I feel this needs to be followed up.

I don't know whether or not you are aware but I am trying to 'mend bridges' between the MHRA and myself.

May I say that the answer you gave in reply to my FOI request appears to be less than caring.

Why do you not know approx how many patients were affected by these counterfeit drugs?

What efforts were made to try an ascertain how many patients may have been affected by these counterfeit drugs?

What measures are put in place to estimate how many patients could be affected by counterfeit drugs?

Surely there must be some sort of plan? If not, why?

Do the public need to be concerned if any counterfeit drugs make it to the shelves in the future? If not, then can you allay their fears?

When you state the words '...impossible to calculate the number of patients affected', it sounds to me as you do not wish to make any efforts to try? Or am I barking up the wrong tree?

Regards

Bob Fiddaman

Seroxat Sufferers

http://fiddaman.blogspot.com

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 14, 2008

The Mole from within Mr Woods

8. 14 April 17:31 N3 Service Provider, Peterborough, United Kingdom
9. 14 April 17:35 Exponential-e Customer Allocation, London, London, City of, United Kingdom
10. 14 April 17:35 N3 Service Provider, Peterborough, United Kingdom

Post about the DoH, minutes later they are looking in at this blog, 4 minutes later someone from the MHRA is looking in.

I refer you all to this post... particularly you Mr Woods.

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

DoH 'We must now consider this matter to be closed'

Yup, the good old Department of Health (DoH) have wrote me and told me in no uncertain terms that they no longer wish to discuss Seroxat with me. It's a pity, all I asked was one question... What is the benefit of Seroxat?

They couldn't/wouldn't answer - maybe because they can't or maybe because they just don't know!

Here is the 'final' email I received from them earlier today.

Dear Mr Fiddaman,

Thank you for your further email of 14 March to the Department of Health about Seroxat.

Several previous replies have set out the Department's position in full and I can add nothing to these responses.

As such we must now consider this matter to be closed. Any further emails will be logged, but you may not receive a reply.

Yours sincerely,

Edward Corbett
Customer Service Centre


Amazing isn't it?

It's like asking a math teacher - 'What is 8 + 8?'

To which he replies ' Today is Monday'

He isn't lying because today is Monday - he's just avoiding the question. Something the DoH have clearly done.

I'm glad they think that this matter is closed.

Nice for someone to have closure.


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

The Parallels of Scientific Misconduct

Dr Aubrey Blumsohn over at Scientific Misconduct has a rather interesting set of posts recently added to his blog.

Although not Seroxat related there are some parallels to the recent investigation of GlaxoSmithKline by the MHRA.

They key to Aubreys posts is basically 'accountability' where he focuses on an individual named Professor Eastell.

Eastell is the Head of the Academic Unit of Bone Metabolism at the University of Sheffield and Honorary Consultant in the Metabolic Bone Centre at Sheffield Teaching Hospital´s NHS Trust.

This from Jennifer Washburn at slate.com (Dec. 22, 2005)

Did a British university sell out to Procter & Gamble?

Earlier this month, Sheffield University in Britain offered $252,000 to one of its senior medical professors, Aubrey Blumsohn. According to a copy of a proposed settlement released by Blumsohn, the university promised to pay him if he would agree to leave his post and not make "any detrimental or derogatory statements" about Sheffield or its employees.

...In the summer of 2002, Blumsohn, a senior lecturer and bone metabolism specialist, and Dr. Richard Eastell, Sheffield's research dean, signed a $250,000 research contract with Procter & Gamble. Blumsohn and Eastell were to evaluate the effectiveness of P&G's osteoporosis drug, Actonel. The goal was not to win FDA approval; Actonel was already being widely prescribed. Instead, the Sheffield study would shed further light on how Actonel affects women's bones and their susceptibility to fractures. According to Blumsohn, Eastell had already reviewed blood and urine samples from two previous P&G clinical trials of Actonel. Now Blumsohn was supposed to evaluate a third trial, with the aim of providing a final analysis of all three.

But in the past, it seemed, P&G had not allowed Eastell to perform his own data analysis. In an e-mail that Eastell wrote to P&G and copied Blumsohn on, he confessed that while presenting a paper at the International Osteoporosis Foundation, he had been unable to respond to questions about his own research posed by a fellow academic. "I think that to avoid criticism in the future it would be good if we could say that we had done the analyses independently," Eastell wrote in the e-mail. He suggested that Blumsohn be entrusted with the independent analysis, so he could vouch for results that would be published under both their names.

Blumsohn and his staff reviewed thousands of blood and urine samples from women with osteoporosis. At this stage, they were "blinded" from knowing which patients had taken Actonel and which had taken a placebo. This helped to ensure objectivity. But when he finished examining the samples in December 2002, Blumsohn says he asked P&G to release the codes for the raw data so he could independently interpret the results.

Blumsohn requested the data access codes for 18 months, as numerous e-mails and other records document (here's one). P&G officials wrote back refusing to permit independent access to the data. However, in a written statement, the company denied that it withheld necessary data. "We have appropriately shared our clinical data with both investigators and regulatory authorities, and have conducted our business with the highest of standards."


...the company denied that it withheld necessary data. "We have appropriately shared our clinical data with both investigators and regulatory authorities, and have conducted our business with the highest of standards."

Ring any bells?

The MHRA involvement seems like a state of Déjà vu considering recent events regarding the hidden data of the Seroxat by GSK.

Dr Blumsohn, like myself, has been banging the drum loudly about a prescribed drug, in this case Actonel. Like me, Blumsohn has merely been trying to raise awareness. Actonel Media Case Reports can be read here and the MHRA's 'investigation' can be downloaded in pdf form here.

It reads:

The Sheffield dispute was discussed inthe UK Parliament in December 2005, and was transmitted by the Health Minister to the UK drugs regulator (the Medicine and Healthcare Products Regulatory Agency, MHRA) for “investigation.” The MHRAis itself accused of failing to examine or to secure raw data in drug licensing applications, simply accepting the word of industry with blind faith (6, 14). Since this was precisely the problem in Sheffield, its disinclination to investigate was hardly surprising.

No investigation (or at least anythingfitting that definition) took place. TheMHRA failed to produce any report, declined to accept any documentary evidence (17, MHRA response to FOIrequest #06/115), stated that the matter was of “low priority” (17), and that the agency does not have any procedure for investigating research misconduct (17,MHRA response to FOI #06/188). Further, it claimed that the drug regulator has no remit, nor any necessary obligation to be interested in the integrity of the scientific literature about drugs (17, MHRA FOI#06/188) unless related to licensing (and collected using documentation appropriate for licensing). It even argued that it is“illegal” for a scientist to have data pertaining to information written in his name without the consent of the company“owning” that data (17, MHRA FOI#06/115).

It refused to compare data itwas sent from Sheffield with the original data it should have received and examined as part of the licensing process forActonel. Initially, this refusal was on the basis that it would be “too much work”(17, MHRA FOI #06/059). Later, it admitted that it had not in fact seen or retained raw data prior to approving the drug (17, MHRA FOI #05/404). With governments setting the standard for scientific conduct, it is hardly surprising that independent science has encountered such difficulties.

For some time now Aubrey has voiced his opinion regarding pharma giants Procter and Gamble and the drug Actonel including, and here I quote, "... the serious implications of the failed but rather sad attempts at coverup and delay by "regulators".

That line in itself prompted me to post about this matter on here. Its parallels are plainly obvious.

Fid

Related Links

Actonel Case Media Reports
Did a British university sell out to Procter & Gamble?
Money and accountability (Procter and Gamble)
The Scientific Misconduct Wiki (Procter and Gamble)

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, April 13, 2008

Garnier (GSK) Warned Yet Again!

...This time over Avandia

How many warnings are needed before action is taken?

VIA FEDERAL EXPRESS

Jean-Pierre Garnier, Ph.D.
Chief Executive Officer
GlaxoSmithKline
Five Moore Drive
Research Triangle Park, NC 27709


Dear Dr. Garnier:

On August 20 through November 13, 2007, an inspection was conducted at your corporate headquarters, located at Five Moore Drive in Research Triangle Park, NC, by the United States Food and Drug Administration (FDA). The inspection focused on your firm's compliance with Postmarketing Adverse Drug Experience (PADE) reporting requirements and other postmarketing reporting requirements relating to Avandia (rosiglitazone maleate), approved by FDA on May 25, 1999, under NDA 21-071.

Our inspection revealed that your firm failed to report data relating to clinical experience, along with other data and information, for Avandia, as required under Section 505(k)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355(k)(1)] and Title 21 of the Code of Federal Regulations (21 CFR) Sections 314.80 and 314.81. In particular, the inspection found that your firm failed to report multiple postmarketing studies involving Avandia in mandatory Periodic and/or NDA Annual Reports. Failure to comply with Section 505(k) of the Act is a prohibited act under Section 301(e) of the Act [21 U.S.C. § 331(e)].

The deviations observed during the inspection demonstrating your firm's failure to comply with 21 CFR §§ 314.80 and 314.81 include the following:

DOWNLOAD THE PDF FILE FROM THE FDA WEBSITE HERE

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

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