Off Label Prescription Drugs - Unlicensed to Kill

It's that time of year when reality dawns. I sit here playing AC/DC, they played their first night in the UK last night and hit my hometown next week. My son and I will be attending, it will be our last time out together as he is heading off soon for a journey that will be 'eye opening' to say the least. Intensive training for 28 weeks then a future of tours with the British Army.

I'd love to give him the send off he deserves... I shall leave that to AC/DC. Anyway, I digress.

I wish to have a rant about off label prescriptions, more importantly, why I think this practice is unethical, dangerous and criminal.

For those that don't know, a doctor can prescribe drugs to patients that the MHRA have otherwise told him/her not to. This is called 'Off Label Prescribing' and leaves both the MHRA and pharmaceutical companies in the clear should the patient have adverse reactions to the drug... or worse still, die from taking it.

It's a powerful tool for both pharma and the MHRA because it lays no blame on them and they can use it as an excuse when questioned about the safety and efficacy of any given drug.

A classic example is witnessed in this video here. Chairman of the MHRA, Alasdair Breckenridge, clearly puts the onus on doctors regarding prescriptions being written for Seroxat and taken by children [0.56 Secs]

Breckenridge: "Remember Seroxat has never been licenced in children, it has never been licenced in children at all. But nevertheless, practitioners have, on their own behest, have used it extensively... our best evidence is that some 7,000 children a year were.. um children and adolescents... were receiving Seroxat."

I use Seroxat and Breckenridge as an example here because it is what I write about and because I have no video evidence of any MHRA member talking about any other SSRi.

Read more

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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OFF TOPIC. An angry rant

Firstly, I want to go on record here and state that I am not a racist, in fact I have more asian friends than I do white friends.

Tonight I have learned that British troops from the 2nd Battalion The Royal Anglian Regiment returned home and paraded through the streets of Luton, Bedfordshire, UK.

These soldiers have returned from Iraq and have put their lives on the line. They will have witnessed things that the majority of us will never witness in our lifetime.

What do they come back to?

A group of Muslim protesters, waving placards with slogans such as, "Anglian Soldiers: Butchers of Basra" and "Anglian Soldiers: cowards, killers, extremists".

The British soldiers were also shouted at by this moronic minority, "Murderers", "Rapists".

Defence Secretary John Hutton said: "I can only condemn the tiny minority who used this opportunity to make, whatever their personal views, utterly ridiculous and insulting comments to these brave men and women."

Condemning their actions is not good enough. Lock them up.

Can you imagine a group of white protesters carrying placards with vile slogans on that were aimed at Muslims?

Are the Police surprised that this protest fuelled anger today?

I am appalled at this behaviour. Why on earth was this demonstration allowed? By allowing this 'demonstration' the Police were merely allowing the touch paper to be lit.

If this group of Muslims are that pissed off at British soldiers, if they are ashamed of the country that they live in, then why don't they put their money where their slogans are and go and live elsewhere!

How dare they call our soldiers cowards. I haven't heard of any British soldier walking up to an innocent whilst loaded with explosives.

Speak out against this behaviour and you are labelled a racist. What the hell is going on here in the UK?

This mindless minority should have had their placards removed along with their testicles and then should have been put on a plane and given an option of what country they wanted to defend.

I have nothing against religions, if people want to beleive in fairy tales that is up to them. What an insult to all those British soldiers that have died or lost limbs in Iraq and Afghanistan.

To make matters worse and to show just how perverse this country is, two arrests were made. The two arrested didn't particularly like what this minority were shouting and showed their anger.

What a fucked up Britain we live in!

Rant over.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Virgin Media - A Rant

This is just a typical example of a fucked up Britain.

Yesterday I received 5 phone calls from my cable company.

Caller: Hello, this is Virgin Media, can we have your password please?

Fid: Um, sorry, I'm not going to give any Tom, Dick or Harry my password who claims to be from Virgin Media.

Caller: But we need your password to discuss this matter.

Fid: What matter?

Caller: We need your password

Fid: I'm not in the position of giving you my password, you could be anyone, how do I know you are Virgin Media?

Caller: Okay.

**Hangs up.


This happened 5 times... on a Saturday!


So, I call Virgin Media, I have no problem giving them my password if it is I who calls them.

They can confirm that an outside company now makes 'courtesy calls' to Virgin Media customers to remind them that their bill is due.

I ask when my bill is due.

March 10th Sir, they tell me!

18 days away!



Fid

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

GP Sales Representative - GlaxoSmithKline

Seems they have vacancies in Australia! Click on the highlighted links

http://www.tannermenzies.com/page/jobs?id=427667


GP Sales Representative - GlaxoSmithKline

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A career as a GP Sales Representative will see you putting the goals and visions of the company on the frontline. You’re main responsibilities will include:

Initiating and developing strong relationships with GP’s and pharmacists
Promoting a portfolio of leading prescription medicines
Effective planning and time management of a set territory

GSK are committed to developing their people and provide continuous product and sales training that will allow you to excel in your career. It is essential you are a highly motivated individual who takes pride in developing strong relationships with your customers, who also has the ability to not only educate but influence your customers. The nature of the role of a GP Sales Representative demands you to be organised and happy to work autonomously as you are out on the road. It is also essential to be an exceptional team player who is committed to developing strong working relationships with your peers.

Ideally you will currently be working as a Sales Representative or potentially you are a nurse seeking a new, exciting and challenge career change. A degree in Science or a related area is highly advantageous and recent graduates are encouraged to apply.

The role is challenging and exciting and in return, you will be rewarded with an excellent package including a competitive base salary, performance related bonus, fully maintained company car and full product training.


To enquire further, please contact Nikki Norbury in our Sydney office on 02 8298 3803. When responding, please quote 35-720500. Confidentiality is assured.

Anyone with morals need not apply

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

Keep The Wolf From The Door With Seroxat...

... but don't expect to pro-create.

Want to be regarded as some sort of stallion?[1] Take Seroxat, you will satisfy your partner but probably not yourself!

Oh, and don't expect your partner to fall pregnant if you do manage to release that sexual tension because Seroxat can make men infertile![2]

So any women looking for a man that has the staying power of a stallion? Ask any future partners if they take Seroxat... but don't expect to start a family with them.

Any man who is considering a vasectomy, try Seroxat, hey, it saves the indignity of getting your meat and two veg out and having a needle administered into your testicles.

Paroxetine can also be used in the treatment of premature ejaculation [3] - Once again though, this has flown under the radar of the medicine regulators as it is prescribed 'off-label' [4]

So, GlaxoSmithKline are aware that it is being prescribed 'off label' for premature ejaculation just as they knew Seroxat was being prescribed 'off-label' to children. They didn't speak out against the use of it in children until they were basically forced to so why would they speak out for Seroxat being prescribed off-label for premature ejaculation? More importantly, the MHRA must be aware it is being prescribed off-label for premature ejaculation, so why are they not speaking out against it being prescribed for this purpose?

Seroxat has been promoted as some sort of miracle pill that can cure many things. The chemical imbalance marketing strategy was genius. The team at GSK who are responsible for marketing the drug could probably convince The Pope to buy a years supply of condoms! I'm sure if GSK manufactured condoms, the marketing team would profess that they could delay ejaculation... in fact I'm surprised GSK haven't yet ventured down this road. Maybe they could market a condom laced with the active ingredient paroxetine then claim that their condoms are a bit like Duracell batteries and once you 'slip on the sheath' you will last longer...much longer!

Take it from me [Oooh err, Freudian slip], it is more frustrating for a man when he can't leave Bill Clinton's calling card than it is making instant custard!

All you women who want a man of the street
But you dont know which way you wanna turn
Just keep a coming and put your hand out to me
cause Im the one whos gonna make you burn

Im gonna take you down - down, down, down
So dont you fool around
Im gonna pull it, pull it, pull the trigger

Shoot to thrill, play to kill
Too many women with too many pills
Shoot to thrill, play to kill
I got my gun at the ready, gonna fire at will

Yeah

Im like evil, I get under your skin
Just like a bomb thats ready to blow
cause Im illegal, I got everything
That all you women might need to know

Im gonna take you down - yeah, down, down, down
So dont you fool around
Im gonna pull it, pull it, pull the trigger

Shoot to thrill, play to kill
Too many women with too many pills
Shoot to thrill, play to kill
I got my gun at the ready, gonna fire at will
cause I shoot to thrill, and Im ready to kill
I cant get enough, I cant get the thrill
I shoot to thrill, play to kill
Yeah, pull the trigger

Pull it, pull it, pull it, pull the trigger

Oh

Shoot to thrill, play to kill
Too many women, with too many pills
I said, shoot to thrill, play to kill
I got my gun at the ready, gonna fire at will
cause I shoot to thrill, and Im ready to kill
And I cant get enough, and I cant get my thrill
cause I shoot to thrill, play it again

Yeah

Shoot you down

Yeah
Im gonna get you to the bottom and shoot you
Im gonna shoot you
Oh hoo yeah yeah yeah

Im gonna shoot you down yeah yeah
Im gonna get you down
Yeah yeah yeah yeah
Shoot you, shoot you, shoot you, shoot you down
Shoot you, shoot you, shoot you down

Oh, oh, oh, oh, oh, oh, ooooooh

Im gonna shoot to thrill
Play to kill
Shoot to thrill

Yeah, ooh yeah

Young, Young & Johnson (AC/DC)

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

GSK to report organization grants

Had to laugh when I read the latest PR exercise from GlaxoSmithKline. It makes them out to be transparent but it's oh so obvious that their hand has been forced by Sen. Grassley just as it was by Elliot Spitzer when they were forced to publish their clinical trials data online.

The latest effort to stifle bloggers, government officials and various media sources is nothing more than a publicity stunt.

We are already aware of the grants GSK have given to the likes of Keller and other Seroxat Gunslingers and also to 'experts' who 'big up' Seroxat.

I can just hear the spokesperson from GSK now... "We put all our information online that is readily available to the public."

Be nice if they put information on their website as to why they have made countless settlements out of court then placed gagging orders on those affected by Seroxat!

So next time GSK claim to be transparent, ask them why they place gagging orders on individuals they settle out of court with.

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

GSK Duped Norwegian Medicinal Agency it seems.

Not content with duping the FDA and the MHRA, evidence has now come to light that GlaxoSmithKline had not reported to and had misrepresented the frequency of adverse reactions that were noted in the early clinical trials [Paroxetine] – to the Norwegian Medicinal Agency! {1}

The authors write:

Adverse drug reactions are of particular interest when they have been clandestine for many years. We were admitted access to unpublished data through the Civil Ombudsman’s unusual decision to advise the Norwegian Ministry of Health to let us examine files in the archives of the Norwegian Medicinal Agency. We found that reports of a series of randomized controlled studies evaluating the efficacy and safety of paroxetine already existed at the time of the first application for marketing authorization. Common to these studies were that they were small, were of short duration and were mostly published individually. Some of them have remained unpublished and no thorough meta-analysis has been carried out either for efficacy data or for adverse event data. The main published conclusions from these studies are that paroxetine is a safe and effective medication for the treatment of major depression.2–7

During the widely clinical use of paroxetine, more adverse drug reactions have become evident than were evident when the drug was first licensed in 1989. Our hypothesis was that some of these adverse drug reactions were already documented in the initial clinical trials forming part of the application for marketing authorization, but that no adequate pooling or meta-analysis of the data was carried out. We therefore wanted to explore the usefulness of gathering information about the occurrence of adverse reactions to a drug by means of randomized controlled trials at the time of first application for marketing authorization and to analyse these data by a meta analysis.

Purpose

We wanted to determine to what extent adverse drug effects associated with a selective serotonin reuptake inhibitor (SSRI) were known but not assessed before application for registration of paroxetine.

Methods With a special permit from the Norwegian Ministry of Health, we obtained reports from 82 clinical trials presented by the paroxetine license holder in 1989. There were 17 double blind, placebo controlled clinical trials with parallel design with 903 patients on paroxetine and 592 on placebo. Altogether 32 adverse effects showed a risk difference (RD) between paroxetine and control groups of more than 0.5%.We did a meta-analysis for each of these adverse effects. We then compared the outcome with the frequencies stated in the Summary of Product Characteristics (SPC) at the time of registration and those reported in the current SPC.

Results

At the time of registration 19 of the adverse effects were statistically significant. Only eight of these adverse effects were listed as being common in the first SPC from 1989. Five out of the nineteen adverse effects are not mentioned in the current SPC. Among them are headache with RD 5.4%, decreased libido RD 2.6%, nervousness RD 2.0% and paresthesia (brain zaps) RD 1.7%.

Conclusions

Frequently occurring adverse reactions that are included in today’s SPC for paroxetine were evident and documented already in the early studies accompanying the application for marketing authorization in 1989. Some other adverse effects observed then are still not mentioned in the SPC of today. Meta-analyses of adverse effects should be mandatory at the stage of first registration of a drug.

{1} Aursnes I, Gjertsen MK. Common adverse events associated with an SSRI: meta-analysis of early paroxetine data. Pharmacoepidemiol Drug Saf. 2008 Jul;17(7):707-13

I see from my webstats that GlaxoSmithKline from Hertford, UK, have been looking in today.

I have a message for you:

You manufactured and marketed a drug that I took. Because you never reported these adverse events at the time I took it, I put my faith in you, I trusted you. I have since learned that you not only duped me but our regulator too, and now it seems, the Norwegian regulator!

It's my mission to make sure you don't dupe others, be they regulators, doctors or more importantly, patients.

Do you want me to go away Glaxo?

See me as your confessional box, although I won't be telling you to go away and say three Hail Mary's for your sins.

I'm here to stay.

GET USED TO IT.

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

Clearing up the mess for GlaxoSmithKline

A Fiddy Rant

It seems that GlaxoSmithKline will never acknowledge that Seroxat has addictive qualities in some patients - my guess is that they know that it does but to admit it would be corporate disaster and would open the floodgates to them being sued by the thousands of patients who have suffered horrendous addiction problems with their 'miracle pill'.

Some of the comments by GlaxoSmithKline employees over the years just add fuel to the fire for those suffering addiction and a GP is more likely to believe a GSK sales rep who has just wined and dined him/her or given him/her gifts than he/she is to believe a patient complaining of symptoms that they normally would hear from a Heroin user.

So if GlaxoSmithKline won't... or can't do anything about it then I think it's high time campaigners such as myself did.

Will the MHRA help?

Up until the investigation 'result' I would have said no. But I am of the opinion that the MHRA are so pissed off with GlaxoSmithKline for making them look incompetent that the possibility of acknowledging and tackling this addiction problem may well be feasible. Am I living a false hope?

I am not the biggest fan of the MHRA, they would be the first to acknowledge that the 'Fiddaman' guy has been writing on his blog again, slagging us off. If it makes them aware then I have achieved something. I know GlaxoSmithKline pay regular visits to this little old blog , as have Ofsted and a whole bunch of vastly overpaid lawyers.

It is easy to turn the other cheek and ignore critics slamming you - GlaxoSmithKline are used to it and to an extent so are the MHRA but there has been a change, at least with the MHRA. They recently had a meeting with Seroxat campaigners regarding the four year investigation into GlaxoSmithKline and their liaising skills are getting better. Far be it for me to 'big-up' the MHRA, they have a huge mountain to climb before they regain any confidence from me and no Mori -Poll will make me think that they have reached the point where they have my utmost respect.

I do, however, believe that the tide is turning for the second biggest Pharmaceutical Company in the world. For too long they have had things their way. One only has to look at people blogging about them. This corporate company is slowly but surely being pinned down. They or their fat cat lawyers may read this and smirk, they may feel they are untouchable but there is a new breed of bloggers out in the blogsphere these days - these people, like me, are pissed off and they are not afraid to say so.

So back to the point, which is pretty much the title of this rant, 'Clearing up the mess for GlaxoSmithKline'.

There are people in the UK that are suffering with withdrawal/addiction problems with Seroxat. If this were not true I would be served some sort of threatening letter by GlaxoSmithKline's lawyers to ask me to retract that statement. For a sufferer to watch a Glaxo employee play down risks on Panorama or to read the words of a Glaxo employee playing down the withdrawal effects is quite torturous.

I want the following:

• Acknowledgement that there is an addiction problem with Seroxat
• Special clinics to be set up to help those suffering with addiction
• GlaxoSmithKline to pay for the up keep of these clinics
• The clinics to be manned by people that know about the horrors of withdrawal
• A withdrawal program to be written and verified by former Seroxat sufferers

This may seem like some sort of patient Utopia but it is something that needs to be done and it need to be done RIGHT NOW!

So, there you have it. I may not get what I want, but at least GlaxoSmithKline and their lawyers know exactly what it is I want now.

This would cut out patients having to go through the courts only to be given a paltry payment and then a gagging order for all the shit they have had to endure at the hands of, what I deem, a defective drug.

Ball is in their court

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

The NHS on antidepressants

Quite laughable and contradictory if you ask me.

Information from NHS Foundation Trust

The page is entitled 'How SSRIs (probably) work'

Probably?

Straight away I have a tendency to take the information given with a pinch of salt.

The NHS giving information on how SSRi's probably work?

It's a bit like a car dealer telling you that the car you are about to buy will probably get you from A to B and you probably will be safe despite the engine not being thoroughly tested. Oh, and you will probably be safe wearing a seat belt with this particular model sir because it's probably passed all the test regulations!

How can the NHS get away with such vagueness? How have the MHRA got away with it for years? How have GlaxoSmithKline got away with it regarding Seroxat?

I'm sitting here with a wry smile on my face - there is nothing more left to do than to smile at the hypocrisy of it all.

The NHS site How SSRi's (probably) work kicks off with a marvellous piece of patronization.

It states:

In order to try to understand a little about how drugs work, it is best to first learn a few facts about the brain. Each human being has:

One head

One brain

Thanks for clearing that up - What would we do without you?

They then go on to explain to the layman (or the paupers) about brain cells and nerve fibres. They then tell us that... and I quote, 'the brain is an extraordinarily complex part of the body.'

Really?

Who needs to study a beginners course in psychology when we have the wisdom of the NHS!!!

Next up for us mere mortals is an explanation of synapses.

They state:

Synapses are very important because;-

There are a lot of them

Thank you oh wise ones. I sit in utter disbelief at your confound wisdom.

They then tell us what happens when a brain cell decides to send a message to another cell in order to make something happen.

This is all highly educational. There's talk of transmitters, electrical impulses, nerve fibres, and receptors.

Then our good friend Serotonin or 5-HT makes an appearance.

The NHS explain:

In the body, 5-HT is involved with blood pressure and gut control.
In the brain, it controls mood, emotions, sleep/wake, feeding, temperature regulation, etc.

More so they tell us what happens if problems get out of balance:

Too much serotonin and you feel sick, less hungry, get headaches or migraines
Too little and you feel depressed, drowsy etc.

Hmmm

In 2007 the MHRA told us “A variety of factors can contribute to an individual’s predisposition to depression. Although it is believed that depression may be caused by a biochemical imbalance and it is recognised that serotonin plays a role in the development of depression it is considered that there is more than one final common pathway in the aetiology of depression, and we are not aware of an internationally agreed ’proper chemical balance of serotonin in the brain’ that would prevent or reduce the likelihood of experiencing depression."

They added

"As the precise role that serotonin plays in depression is still subject to ongoing research we really are not best placed to provide you with a response on this particular issue.”

Hang on - The NHS say:

Too much serotonin and you feel sick, less hungry, get headaches or migraines
Too little and you feel depressed, drowsy etc.

Whilst the MHRA state:

"As the precise role that serotonin plays in depression is still subject to ongoing research we really are not best placed to provide you with a response on this particular issue.”

So what about GlaxoSmithKline? What exactly is their take on the whole serotonin issue?

In 1997 the patient information leaflet [PIL] that accompanied Seroxat told us that Seroxat:

"...boosts the levels of serotonin in your brain and that’s what makes you stop feeling depressed"

9 years later, GlaxoSmithKline had moved the goalposts. The patient information leaflet read:

"...It is not fully understood how Seroxat and other SSRIs work…"

Even more confusing is GlaxoSmithKline's Australian web page. It's now 2008 and they tell us:

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

Back to the NHS - Here they explain depression:

"In depression, it is known that there are reduced levels of serotonin and noradrenaline. These reduced levels lead to a lowering of mood. The full reasons are not fully known but stress may well play a part in causing this."

It is known that there are reduced levels of serotonin? The full reasons are not fully known...?

Thanks. That's clear as day!

Section 6 of the NHS page is entitled:

'HOW SSRI ANTIDEPRESSANTS PROBABLY WORK'

*Coughs*

Don't you just love the way they cover themselves [Probably]?

Face it. The NHS, the MHRA and GSK have not got a clue how this drug works, more importantly they went into this with eyes shut firmly and when the brown stuff hit the fan their eyes remained shut. People have died as a result of their probabilities, people have...and still are suffering because they cannot decide how the hell a drug works.

This is like some recurring nightmare. I may buy myself a chemistry set and manufacture a pill. I will tell the MHRA that it corrects the chemical imbalance of the brain - I'm sure it will get a licence, though Ian Hudson may be a stumbling block as he is head of licensing at the MHRA - he used to work at GSK [then SKB] and may see my new pill as a threat to his former employees miracle pill.

Hey, if it gets passed by the MHRA and later down the line I claim that it is not known whether or not it actually corrects the imbalance of serotonin then I'll still be sitting pretty. The MHRA won't remove it from the shelves even though I was adamant that it corrected the imbalance when I first told them but now I wasn't so sure?

Section 8 of the NHS page - 'DO THE SSRIs WORK, AND FOR HOW LONG?'

"We do not know for certain what happens after five years. Many people may be advised to carry on with an antidepressant for longer but that is a decision for you and your doctor to make."

Gee thanks. Talk about washing your hands of a problem!

Personally, I was on Seroxat for 6 years and now I read 'We do not know for certain what happens after five years'

So where does that leave me?

I have short term memory problems and an undesirable sleep problem - both of which I never had before taking Seroxat. I take it that the NHS don't know why I have this problem? Would they lean toward prolonged use of Seroxat? I think a court of law would don't you?

What kind of half assed system are we under here?

We have the NHS giving out messages contradicted by the MHRA who in turn are contradicted by GlaxoSmithKline!

It's an utter farce. A health system giving out information that is not scientific fact, a medicines regulator ignoring the problem of SSRi withdrawal and a manufacturer being allowed to do as it pleases. What a nightmare!

The Health Minister role in the UK changes like the wind - I have no idea who the current one is. Whoever it is I hope you sleep well.

The CEO of the MHRA is Kent Woods. I hope he sleeps well.

The CEO of GlaxoSmithKline is Andrew Witty. I hear rumours that on taking over his new role he turned to Garnier and said 'That's another fine mess you've got me into' - I hope he sleeps well.

I'd be embarrassed to show my face to any of my friends or family if I were any of the above.

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

CORPORATE MURDER BY GLAXOSMITHKLINE?

The following rant contains language of an adult nature


They have quite literally gotten away with murder.

They withheld vital clinical trial results back from the regulators, results that could possibly have saved lives.

They chose not to release this data because it would have dramatically hit sales of Seroxat, they chose not to release this data because under law, a fucked up law at that, they were allowed to.

4 years investigating GlaxoSmithKline - yes they have been found to be negligent, yes they held back vital evidence that could have saved lives, yes they sat back and allowed GP's to prescribe this horrendous drug to children (albeit off label)

The MHRA were told about this - it took them 4 long years to come to the conclusion that GlaxoSmithKline actually were holding back evidence.

I have been telling Kent Woods and his bunch of fucking merry men this for years.

Why didn't the MHRA Chairman, Alasdair Breckenridge inform Woods & Co that something underhand was going on at GlaxoSmithKline, after all HE WAS EMPLOYED BY THEM!

Why didn't Head of Licensing at the MHRA, Dr Ian Hudson, Tell Woods & Co that something underhand was going on at GlaxoSmithKline, HE WAS ALSO EMPLOYED BY THEM!

Now ladies and gentlemen at the MHRA. How long are you going to take apologising to all those children whose lives have been ruined by this bastard drug? Or apologising to the parents who have lost children because of this bastard drug?

From your investigation, you have stated that you won't/can't criminally charge GlaxoSmithKline - so maybe you should take full responsibity? You did after all turn a blind eye and allow off label prescribing of this drug didn't you?

I must be psychic, I kind of predicted the result of this sham of an investigation.

WHEN ARE THE MHRA GOING TO ACTUALLY FUCKING LISTEN TO THE PATIENTS?

Angry?

You fucking better beleive I am!

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

You ever wondered why JP Garnier looks smug?

I've often wondered why GlaxoSmithKline CEO, JP Garnier looks remarkably smug for someone faced with so much shit. Falling shares, bad drugs, shedding his workforce, recent bad press regarding impartial studies etc.

Maybe the huge salary he demands is enough to keep him smiling through? Or maybe it is the knowledge that no matter how many Members of Parliament sign EDM's or voice their constituents feelings in the Houses of Parliament, he knows deep down that his close friendship with PM Gordon Brown will safeguard him.

Seroxat & SSRi User Group Founder, Janice Simmons, met with Gordon Brown last year, she asked him:

I am sure you are aware that GSK are being investigated for withholding information regarding seroxat being dangerous for children in that it caused self harm/suicide, which led to the drug being banned for under 18’s in 2003.

Can you please tell us why the MHRA are holding this investigation and why it has not been passed to the CPS? Why it has been 4 years since the investigation was instigated and still no conclusion?

We have in our possession a letter from SmithKline Beecham dated 1995, which reads: ‘with regard to behavioural side effects associated with Seroxat, you may be interested in the following information relating to emergence of aggressive behaviour and also of agitation with Seroxat.’

Gordon Brown replied "this investigation is being treated as a very serious investigation and I understand that over 1 million documents are being looked at. If GSK are found guilty prosecutions could be made.’

It's hardly endearing stuff from Brown is it?

Do we really think anything will be done?

How can we beleive that it will.

Let's see what I'm driving at here:

PM announces make-up of new Business Council

The Prime Minister has announced the creation of a Business Council for Britain comprising senior representatives of UK-based businesses, to advise him on issues that affect enterprise, business and the long term productivity and competitiveness of the economy.

The Council will be chaired by Mervyn Davies of the Standard Chartered Bank and will be attended by the Prime Minister and Secretaries of State of the main economic departments will attend. Other Secretaries of State will attend the meetings at the invitation of the Council.

The full list of members of the council is:

Sir Richard Branson: Founder, Virgin Group
Damon Buffini: Managing Partner, Permira
Sir William Castell: Chair, Wellcome Trust
Mervyn Davies: Chairman, Standard Chartered Bank
Sir Rod Eddington: Director, News Corporation
Dr Jean Pierre Garnier: Chief Executive Officer (CEO), Glaxo SmithKline
Stephen Green: Chairman, HSBC
Tony Hayward: CEO, BP
Sir Terry Leahy: CEO, Tesco
Sir John Parker: Chair, National Grid
Sir John Rose: CEO, Rolls Royce
Stuart Rose: CEO, Marks and Spencer
Arun Sarin: CEO, Vodafone
Dame Marjorie Scardino: CEO, Pearson
Sir Alan Sugar: Chair and CEO, Amstrad

Need I say anymore?

The gravy train keeps rolling and rolling.

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

Makers of Sugar Pills Disappointed With Findings

Wally Winka's Sweet Factory, the makers of popular dummy pills, (Placebos) said they were 'disapppointed' at the recent study regarding antidepressants being as effective as their product.

A recent study showed that a huge meta-analysis of 47 published and unpublished clinical trials of five well-known anti-depressants, including Prozac and Seroxat, suggested that only a small group of severely depressed people stand to benefit from them. In other words, most patients might as well be swallowing placebos.

A spokesperson for Wally Winka's Sweet Factory told a packed press conference, "We beleive that this study may have caused unnecessary alarm and concern for consumers of our placebos." He added, "Our placebos have benefited millions of people worldwide".

Dr Alistair Crippen, Head of Safety at Wally Winka's Sweet Factory, said, "The evidence, however, is clear, these placebos are not linked with suicide, these placebos are not linked with an increased rate of self harm." He went on to say, "We are not misleading our consumers. The information on the placebo packets and in the information we supply to retailers, is based on fact."

CEO of the regulator who monitors the food we Brits consume, Prof. Kent D' Nial, told us, "The safety of the Wally Winka's placebos is kept under close continual review by us."

Wally Winka himself protested 'There has been no reports of side effects with our placebos, unlike the many reports for the antidepressant Seroxat, okay consuming our products may cause weight gain but compared to Seroxat we feel our brand of placebos has been wrongly condemned. Our placebos do not cause the following: Allergic reaction, chills, face edema (abnormal amount of fluid in the facial tissue), infection, moniliasis (infection caused by Candida (yeast like fungi), neck pain, overdose. Cardiovascular: Bradycardia (abnormal slowness of the heartbeat), conduction abnormalities (abnormal transfer of sound waves, heat, nerve influences, or electricity), ECG abnormal, hypotension (lowered blood pressure), migraine, ventricular extrasystoles (a premature contraction of the heart)."

He continued, "Neither do they cause Acne, alopecia (absence of hair from the body where it is normally present), dry skin, ecchymosis (blood under the skin, usually looks or appears like a bruise), eczema (an inflammatory skin disease characterized by lesions varying greatly in character, at times watery discharge and the development of scales and crust), furunculosis (a number of painful nodules formed in the skin, caused by bacteria, which enter through the hair follicles or glands, its formation is favored by digestive derangement and local irritation), herpes simplex, urticaria (reaction of the skin to certain drugs, marked by the appearance of smooth, slightly elevated patches, which are redder or paler than the surrounding skin and often includes severe itching)."

Winka paused for breath before adding, "To my knowledge our placebos will never cause Bruxism (grinding of the teeth especially during sleep), buccal cavity disorders (cavity running from the cheeks to the lips), dysphagia (inflammation of the esophagus), eructation (the act of belching or casting up wind from the stomach), gastroentertitis (inflammation of the stomach or intestines), gastrointestinal flu, glossitis (inflammation of the tongue), increased salivation, liver function test abnormal, mouth ulceration, vomiting and diarrhea, rectal hemorrhage."

"More so", he continued, "do they cause Anemia, leukopenia (reduction in the number of leukocytes in the blood), lymphadenopathy (disease of the lymphnodes), purpura (condition charactized by the presence of blood just under the skin, can appear any where over the body), WBC abnormality (white blood cell abnormality)?"

Finally, Winka added, "To tar our placebos with the same brush as a product that has had reports of Akinesia (the temporary paralysis of a muscle, can include intense pain), alcohol abuse, amnesia, ataxia (failure of muscular coordination or irregularity of muscle action), convulsion, depersonalization, hallucinations, hyperkinesia (abnormally increased mobility, abnormally increased motor function or activity), hypertonia (a condition of excessive tone, tension or activity, can include increased blood pressure), incoordination, lack of emotion, manic reaction, paranoid reaction, and thinking abnormal is, I beleive, totally wrong"

He ended his statement with, "Our placebos have brought joy to millions of people worldwide and do not carry the same risks of taking antidepressants"

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

Message to MHRA from Seroxat Sufferers Reader

Jane left a new comment regarding my post about the MHRA - MHRA - "We see no point in answering questions where you have prejudged the veracity of any answers"


Dear Bob,

I am disappointed to see no one felt it necessary to answer your questions. Maybe they felt you had pre-judged their answer, but do they not realize this is a public site and anyone has access? I found your site googling Paxil after my doctor wrote me a prescription for this medication. I must say, I won't be filling the prescription based on the fact, MHRA cannot provide any answers as to what the benefit might be.

Thank you for this site - what an eye opener!


I can see the defence of GSK, The MHRA and doctors that have been brainwashed by pharmaceutical reps: It is wrong that your site is stopping people from taking important medication - but it IS NOT this site. It is the MHRA's and the Department of Health's reluctance to answer one basic fundemental question. What is the benefit of Seroxat?

The Dept of Health have had a month to answer - they have no doubt been in touch with the MHRA but I'm still to recieve an answer. My MP thinks I should give people time to answer questions - notice the plural? One question - What is the benefit of Seroxat?

We are constantly told by the MHRA that the 'benefits' far outweigh the risks - we know what the risks are but are yet to learn what these 'so-called' benefits are.

I don't know the answer to this question so the MHRA cannot spin the "We see no point in answering questions where you have prejudged the veracity of any answers" line at me can they?

Now it seems a patient (Jane) was today given a prescription for Seroxat - she, like any human being is entitled to, did some research and stumbled upon this blog. Once here she read the MHRA correspondence. Because they cannot answer a basic question she decided not to go through with dispensing the prescription.

So GSK have lost a potential customer (addict). Ironically, the MHRA's silence is actually protecting the British public! Hats off to you Kent.

I'm pleased that Jane stumbled upon this site.

Pleased that she won't have to go through the horrific withdrawal.

Pleased that she won't think she is burning from within.

Pleased she won't feel like commiting an act of violence upon someone.

Pleased that she won't have to experience head and body zaps that Head of European Psychiatry for GlaxoSmithKline Alistair Benbow puts down to 'dizziness'.

Pleased that she won't feel the urge to walk from room to room because she cannot sit still because something inside her body won't let her sit still.

Pleased that she won't contribute to her short term memory loss by popping one of these pills.

Pleased for her loved ones because they won't have to witness her turning from a normal human being into someone that nobody recognises.

Pleased because she won't feel the urge to kill herself.

Pleased because she won't have to go through the ordeal of explaining to people that she does not know what is wrong with her.

Pleased that she won't have to lobby a Member of Parliament who is too busy signing Early Day Motions for more TV coverage of cricket to give a toss about her/his constituent.

Pleased because she won't have to bombard the MHRA with questions only to be told "We see no point in answering questions where you have prejudged the veracity of any answers".

Pleased that she will be able to live the rest of her life knowing that she can wake in the morning and decide to have an extra hour in bed and not have to rise because her sleep has been ruined by chemicals that ficticiously replace a ficticious chemical imbalance.

Pleased she won't get to the stage where she has to use an oral syringe and push vile tasting liquid into her mouth because she would find it impossible to shave her Seroxat tablets with a blade.

Pleased that she won't have to put up with people thinking she is a 'psycho' who could 'explode' at any given time.


You getting all this down Kent?

These are the risks - Kind of 'outweighing' the benefits (What are the benefits?) don't you think?

Pleased that she sought the truth... and found it.

It appears to me that this blog, along with many others are doing the jobs of MP's, The Dept of Health and the Medicine's Regulator! Meantime, the aforementioned get paid wads of cash to bury their heads in the sand in the hope that people will stop asking questions if they (MHRA et al) remain silent.

Not a chance in Hell

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

Side-effects 'should be reported'

Source: BBC News

You just have to laugh at the audacity of The MHRA. Some of the statements in the above news story from the BBC website are just laughable!

This gem from June Raine at the MHRA:

"If you suspect that you have had a side-effect to your medicine, please tell us about it via the Yellow Card scheme."

Tell me, what is the point? You may listen to patients and read yellow card reports but you do precious little about it!

You can't even answer a simple question - that being, What is the benefit of Seroxat?

Well? What is the benefit?

MHRA - A complete and utter joke - merely there to help Pharma sell their wares

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

GlaxoSmithKline Statement - A Closer Look

GlaxoSmithKline Statement - BBC Panorama

January 29, 2007

LONDON, Jan. 29, 2007 - This statement has been issued in anticipation of the BBC Panorama programme, ‘Secrets of The Drugs Trials’ which is to be aired on Monday 29th January.

GlaxoSmithKline (GSK) has provided a written response to the allegations it understands are to be made in the above programme. GSK has not seen the programme but strongly denies suggestions that it has acted in any way improperly. The company has no confidence that its responses will be accurately, or appropriately, represented in the programme, or in the BBC’s publicity materials. GSK therefore wishes to make the following points that include a summary of the information provided to the programme:

We are extremely concerned that Panorama, will again, through misleading and deliberately provocative commentary, alarm patients about using their anti-depressant medication, with potentially serious consequences.

In other words we are using the patient here to defend our corner. On each of the 4 (count them) Panorama programmes aired about Seroxat, there has always been a warning not to suddenly stop taking your medication. What Glaxo are saying here is possibly more frightening thus trying to show the patient that they really are a caring company.

Patients concerned by issues raised in the programme should seek advice from their doctor.

The very same doctor that your reps have convinced Seroxat works?

Depression is a severe and disabling condition. A well-recognised, tragic outcome of the disease, particularly among young people, is suicide. Careful monitoring of all patients is essential, regardless of whether they are taking medication or not.

I put it to you that taking Seroxat is a severe and disabling condition. A well recognised outcome of the drug, amongst all age groups is suicidal thoughts and/or aggression. Another thing, I've heard and read the careful monitoring line numerous times. How can a family practitioner 'carefully monitor' a patient when that patient leaves his/her surgery to go home? More to the point - goes home with a packet of pills known to give rise to suicidal thoughts?

In developing Seroxat, GSK has always been strongly conscious of the duty it owes to the millions of patients, including those under the age of 18, who suffer from depression and we refute any allegation that we have failed in this duty. GSK conducted nine studies, over eight years, to examine the use of Seroxat in treating patients under the age of 18 with depression and other psychiatric disorders, as treatment options for these vulnerable patients are extremely limited.

Top line is a gem isn't it? The rest of this paragraph gets down to the nitty gritty but we shall move on to the next paragraph because this is where it gets confusing.

GSK utterly rejects any suggestion that it has improperly withheld drug trial information. Results from its paediatrics studies were documented and submitted to regulators in accordance with regulatory requirements. Results were also presented publicly, published in scientific journals and are available on GSK’s website.

We know different now though huh? This statement was made in 2007 - just over a year later court documents were unsealed that clearly show this part of your statement to be incorrect. I love the terminology used in this paragraph: "submitted to regulators in accordance with regulatory requirements." The regulatory requirements being that you only have to submit a summary of the trial results... not only that but you can choose which parts of the summary you wish the regulators to see (ie; the positive results).

You also state that results were presented publicly and published in scientific journals and are also available on your website. Again, only the results that you wish the public to see, the same 'results' that you sent to the regulators, the same results that you sent to your opinion leaders. All favourable results and we know that not all the results were favourable don't we?

No suicides were reported in any of the nine paediatric trials conducted by GSK.

But there was a high volume of suicide attempts was there not? Funny how you skate over this issue. Or have you covered yourself by stating earlier: "Depression is a severe and disabling condition. A well-recognised, tragic outcome of the disease, particularly among young people, is suicide." It's clever spin I'll give you that...so clever it is actually hard to argue against. I guess that's why so many people have hired the services of lawyers.

When reviewed individually, none of these trials were considered by GSK or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide.

Independent? I'd hardly call the opinion leaders you hired 'Independent'. They are afterall (or have been) on the GlaxoSmithKline payroll list are/have they not? Was Breggin not an 'independent investigaor? What about Glenmullen? Was he not also an 'independent' investigator? Or do you only consider favourable results?

Only when all the data became available, at the end of the research programme, and were analysed together was an increased rate of suicidal thinking or attempted suicide revealed in those paediatric patients taking Seroxat .

Oh what a remarkable coincidence! Now you tell us about the suicide attempts and thoughts. Did you not know back then (1989) that there was an increased rate? All you had to do was read the data. The graph here (taken from your own internal memo) will show you the suicidal thought rates in not on children but adults too)

GSK brought this analysis to the attention of the regulatory authorities, including in the UK.

Why wasn't the results of this analysis given to the regulatory authorities first time around? Once again, the clever spin you use can be used as a defence here: "Results from its paediatrics studies were documented and submitted to regulators in accordance with regulatory requirements." In other words you didn't have to give the regulatory authorities the negative results did you? This loophole more or less guaranteed you a license for Seroxat. The fact that you didn't have to submit the negative results is neither here or there. It's really a question of ethics. You, as a multi-million pound company, had a drug that could rival Eli Lilly's Prozac, a drug that around the time Seroxat was about to be launched, was lambasted in the media for causing suicide and suicidal ideation. This was music to the ears for GlaxoSmithKline was it not? You had decided to manufacture a drug that could compete with your biggest threat, that being Eli Lilly. You decide (despite evidence that Seroxat also could cause suicide and suicidal ideation) to send favourable results to the regulator and to opinion leaders. So what do you do? You send them all the favourable results in summary form. You leave out the results of suicide and suicidal ideation... well you 'ham' it up with your bad numbers so it looks favourable. The demise of Lilly's Prozac opened the door for Seroxat and Lilly's downfall could now be used in your marketing strategy but only if you could prove that Seroxat didn't have the side effects that Lilly's Prozac did. So, you hold back the negative results don't you? Why publish them now there seemed to be a lucrative gap in the market?

GSK does not promote its medicines for indications for which they are not approved.The company strongly refutes any suggestion that Seroxat was promoted to UK doctors for use outside the terms of the UK marketing authorisation, whether through clinical experts (“Key Opinion Leaders”) or any other route.

The key opinion leaders line is wearing thin. Why did you not hire the services of a leading SSRi expert? David Healy for example? Was it because an actual expert like Healy would want to see the raw data unlike Dr Martin Keller who for all intents and purposes just put his name to a favourable report about Seroxat? So why didn't you ask the World's leading expert on SSRi's? Surely this would have been the route to take. OK I can accept that there probably was no leading expert around at the time of your launch but... and here is the crux... why didn't you seek the advice of an SSRi expert when patients started complaining of withdrawal? We know the answer to that don't we?

Seroxat has never been approved by EU or US regulators as a medicine for those under 18 years of age.

Yeh this was a line spun out by your ex-employee and now Chairman of the UK medicines regulator, Alisdair Breckenridge, in the prevoius Panorama programme aired than the one discussed here. He commented: "Our best evidence is that some 7,000 children a year were ... or children and adolescents were recieving Seroxat" Now if a drug, that has never been approved for this age group, is being prescribed (allbeit on the behest of a doctor) then shouldn't GlaxoSmithKline have issued a warning? Something along the lines of 'STOP! What you are doing is highly dangerous. We have evidence that suggests that Seroxat can cause suicidal thoughts in this age group. Why didn't you? 7,000 prescriptions a year may only be loose change to GlaxoSmithKline but those 7,000 (I beleive the figure to be actually higher - much higher) children, adolescents, young adults - call them what you will - could have been saved from the horrific symptoms of withdrawal had you spoke out. You didn't and that's what pisses so many folk off.

GSK’s UK product labelling has been entirely consistent with that position, and at the time of the events in question, this label stated: “the use of Seroxat in children is not recommended, as safety and efficacy have not been established in this population.”

How many children do GlaxoSmithKline know that are 25? Is it not the position of the MHRA that ALL antidepressants should now carry a warning on the patient information leaflet stating that they could cause suicidal thoughts? They beleive (wrongly, in my opinion) that SSRi's are effective if you are above the age of 25. Let's just condense your labelling at 'that time' shall we?

“the use of Seroxat in children is not recommended, as safety and efficacy have not been established in this population.”

I will ask you again - Do GlaxoSmithKline know of any child aged 25? Come to think of it do they know of any child who is 18,19,20,21,22,23 or 24? You messed up big time on the labelling but in good old Glaxo fashion cover yourselves by putting the onus on the family practitioner who has also never seen the raw data.

Another question for you: Why, did your European medical director for GlaxoSmithKline, Alistair Benbow state in 2003 that he thought Seroxat was safe for children? Why did he state on national television: "Absolutely, it could be, we haven't got a license in children yet." A license in children 'yet'? This is suggestive that you were indeed trying to gain a license for children does it not?

Any decision to prescribe a medicine outside its authorised indications, in the EU or the US, is made by a doctor on the basis of his/her clinical judgement and the interests of their patient.

Thus putting the blame on the family practitioner. You did after all warn them that safety and efficacy had not been proven in this population. In hindsight don't you think a more 'clear' statement should have been made? Something along the lines of 'Seroxat MUST NOT be prescribed to any persons under the age of 25', surely there would have been a clearer understanding with a statement like this rather than 'the use of Seroxat is not recommended in children...'

But no - you had to protect that 'lucrative gap' I spoke about earlier didn't you?

The final paragraph of your statement reads thus:

GSK, in 2004, further demonstrated its commitment to data transparency by creating an unsurpassed on-line database, called the Clinical Trial Register (CTR). This is a record of detailed summaries of more than 2,800 clinical trials conducted in 50 countries to study 52 GSK prescription medicines and vaccines which is available to the public at http://ctr.gsk.co.uk

Demonstrated its commitment? What utter bullshit! You were FORCED to create an online database by Elliot Spitzer when you were found guilty of fraud. It was part of the settlement you made wasn't it? And we all know that you STILL are not forthcoming with the raw data. Again you use summaries. Hell, I could summarize the benefits of anything you wish to throw at me. We can all paint pretty pictures and hide the truth!

Face it - the invetion of the internet has been GlaxoSmithKline's achilles heel. Rob Robinson's Paxil Protest started the ball rolling - here we had a patient (over the age of 25) who decided to fight back because he knew the drug you were selling killed people. You knew it too but did nothing about it and that is utterly shameful.

More 'Fiddy Rants' can be read HERE and also now available on OpEd News

Glaxo spokeswoman Mary Anne Rhyne

Now and again there are sheer moments of comedy that leave one doubled up and in a complete state of apoplexy. I have just had such a moment when reading a comment from Glaxo spokeswoman Mary Anne Rhyne. It hit me smack in the face, the preverbal 'meeting with a steam train head on'. It is a moment of pure genius from Glaxo's spin Princess - it defies any sense of logic and never has the phrase 'pot, kettle & black been more appropriate.

It comes from yet another report on the Glenmullen story - I have to admit I'd not seen this quote before, it's better than Benbow's 'Patients have nothing to fear taking Seroxat'... Yes, it's that good, that contradictory.

You ready for it?

Now, I must first warn you to put down any cups with hot beverages inside. Chew whatever is in your mouth and swallow and sit down comfortably.

Here is her take on Glenmullen's report:

"Glenmullen has carefully selected excerpts from GSK documents and made his own interpretations, without looking at the totality of the data." (1)

You stopped laughing yet?

Now, forgive me if I am wrong... I don't think I am but didn't GlaxoSmithKline's so-called opinion leaders do exactly the fucking same? You know those chaps... oh and one woman, I would have called her a lady but... well I guess you know my feelings toward people who take vast amounts of money that is basically blood money.

So Princess Rhyne of GlaxoSmithKline (Hey that rhymes) - what exactly did these people do when you... or your company, presented them with summarisations of the Paxil data?

Dr Andrew Leon
Dr Charles Nemeroff
Dr David Dunner
Dr David Shaffer
Dr Fredrick Goodwin
Dr John Mann,
Dr John March
Dr John Rush
Dr Martin Keller
Dr Neal Ryan
Dr Mark Olfsen
Dr Robert Gibbons
Dr Graham Emslie
Dr Karen Wagner

Let's just go over the statement to the press again shall we?

"Glenmullen has carefully selected excerpts from GSK documents and made his own interpretations, without looking at the totality of the data." (1)

You lot are just laughable. We've recently had Garnier slagging off scientists and the media because basically they don't agree with him and now Princess Rhyne of GlaxoSmithKline tells us all that the one man who blew the lid on her beloved company didn't look at the totality of the data!

MHRA Priorities

Two Men Fined For Selling Erectile Dysfunction Drugs, UK

FULL STORY

The Medicines and Healthcare products Regulatory Agency successfully prosecuted two men on 7 February 2008 at Bradford Magistrates Court for selling unlicensed medicines. David Tetley, (61) retired, and Stephen Evans, (49) unemployed, of 554 Leeds Road, Idle, Bradford, BD10 8JH, they pleaded guilty to the illegal sale and supply of Kamagra, Kamagra Oral Jelly and Loveagra.

Wooooooooooooo - That's it Prof. Woods - you go after the big boys. You pissed at Messrs Tetley and Evans from Bradford because they don't pay your wages? Or maybe the people that DO pay your wages (Pharma) were pissed that Tetley and Evans were selling drugs and wanted you to crack down before it snowballed? Pharma can't have competition now can it Prof. Woods?

I just love some of the statements from the MHRA in this story.

Here's a classic:

Mick Deats, Head of Enforcement and Intelligence says "This successful prosecution highlights the robust action the MHRA takes against anyone, even first time offenders such as Tetley and Evans, who commit offences under medicines legislation".

Medicines legislation? Does such a thing exist here in the UK? Jeez, you could have fooled me.

Another great line from this story is:

The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe.

HAHAHAHAHAH - What comic genius wrote that? Did he/she ever work alongside Gervais, Coogan, Milligan or Cleese?

Did you start investigating Tetley and Evans over four years ago Prof. Woods? Or was the arrest and conviction much quicker than that? I suspect it was. Am I right Prof. Woods?

I won't email you because you choose not to answer my emails Prof.Woods. Hey remember when you actually DID answer my emails back in 2006 Kent me old mucka?

Did you think back then that I could be brushed aside with comments such as “I have already given you a full account of the Agency’s position in this matter and there is nothing to add to it.” This being your response to an email I sent you regarding Pete Breggin's findings that basically stated that Seroxat was a shit drug.

Did you anticipate the severity of the whole Seroxat Scandal back then Prof Woods? Or did you think you were untouchable? Do you still think you are Prof. Woods?

So here we are Kent - some years down the line. I'm still campaigning whilst you are still in denial. My oh my how this Seroxat campaign has grown. You know of the other websites and campaigners don't you Prof. Woods?

Ironic isn't it mate - There's you STILL in a job and here's me STILL out of work due mainly to a drug that you and your band of merry men seem to endorse at any given opportunity.

I have to applaud you Kent. You are closing down small internet sites that sell Viagra quicker than a GSK rep's retort to 'Is this drug addictive?' You must be so proud at what you have achieved at the MHRA Prof. Woods. I still see your good friends are still in a position at the MHRA - Breckenridge and Hudson - you know who they are don't you Prof. Woods? Sure you do - they are the two that were offered jobs at the MHRA when they both decided to leave GlaxoSmithKline... or SmithKline Beecham as it was known then.

It's all very cosy for you isn't it Kent? Well, I guess it was until myself and others started poking our noses in. Don't be mad at us Kent. We just want justice... and a regulator.

Good day to you sir.

Fid

SEROXAT GUNSLINGERS

From left to right

Top Row: Dr Andrew Leon, Dr Charles Nemeroff, Dr David Dunner, Dr David Shaffer
2nd Row: Dr Fredrick Goodwin, Dr John Mann, Dr John March, Dr John Rush
3rd Row: Dr Martin Keller, Dr Neal Ryan, Dr Mark Olfsen, Dr Robert Gibbons

4th RowDr June Raine, Dr Graham Emslie, David Stout, Dr Karen Wagner
5th Row: Dr Alistair Benbow, Dr Ian Hudson, JP Garnier, Prof. Alisdair Breckenridge
Bottom Row: Prof. Kent Woods, The FDA, GlaxoSmithKline, The MHRA

ARE THEY RESPONSIBLE FOR THE LIST IN THE FOLLOWING VIDEO?
YOU DECIDE

Dear MHRA... Re: Alisdair Breckenridge lying on national Television

From: fiddaman
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

Implementation of warnings on suicidal thoughts and behaviour with antidepressants by MHRA

...but this does not apply to anyone over the age of 25


The MHRA has notified companies that hold authorisations for antidepressant products that they will shortly be receiving letters requesting Type II variations to update the warnings on suicidal thoughts and behaviour in line with European agreements. The Pharmacovigilance Working Party (PhVWP) had considered the results of a meta-analysis of adult clinical trial data for SSRIs and other antidepressants recently completed by the FDA. It agreed that the ‘EU core SPC for SSRIs and related substances’ of October 2005 should be modified with regard to suicidality and should now be extended to cover all antidepressants. In particular, the wording should be updated with respect to the increased risk to young adults and the need for close monitoring of patients, and it will be applicable to all antidepressants, not only SSRIs. The timetable for implementation has also been agreed at European level to ensure that healthcare professionals, patients and their carers receive this important safety information as soon as possible.

Wording on ALL antidepressants PDF


So if you take antidepressants and are over the age of 25 the MHRA think you are not at risk!

I wonder if this release has anything to do with the current MHRA investigation into GlaxoSmithKline regarding them witholding clinical trial data?

More than likely will be their statement if they find GSK guilty.

I can just hear the MHRA now

'We have agreed to change the wording on the patient information leaflets on ALL antidepressants'

This is JUST NOT GOOD ENOUGH!

Forgive me if I don't break open the Champagne. A step in the right direction it is but there is much more work to be done - this is merely papering over the cracks and is over one year behind what the FDA already did in America regarding black box warnings.

Don't take the plaudits too serious yet Mr Woods - there are still many of us over the age of 25 who disagree with this pathetic 'age ruling'