Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Wednesday, August 31, 2011

Patrick McGorry, Clinical Trials and the Flaws



A thought just occurred to me regarding Aussie shrink Patrick 'DeLorean' McGorry and his heavily criticised early intervention program.

For those that have never heard of McGorry he is the Australian psychiatrist who basically can predict if a child will fall foul of a "mental illness" in future years. This is based on family history and...well, erm... likelihood. In other words it's a guessing game.

Anyway, whilst browsing the Clinical trials website it occurred to me that many, if not all pharmaceutical companies, have an exclusion criteria when carrying out clinical trials. An example would be a recently completed Paxil trial. Some of exclusion criteria was:

Patients with a history or complication of another (non-MDD) mental disorder (schizophrenia, etc.)
Patients with a history or complication of manic episodes

Patients diagnosed as having an attentional deficit disorder or hyperactivity disorder

Patients with a 3 or more-point score of "suicide" (HAM-D Item 3) or with a strong suicidal tendency by C-SSRS and investigator clinical judgement.

The full exclusion criteria for this particular trial can be read HERE.

Anyway, the point I am making here is thus:

If Paddy McGorry believes he can predict if a child will fall foul of a psychosis like illness and he firmly believes his early intervention program is fool proof then what of future exclusion criteria in clinical trials?

Surely if, in the above instance, those deemed to have been diagnosed with "ADHD" could not be part of certain clinical trials then what of McGorry's line of kids he has waiting to tick boxes to see if they will fall foul of such a disorder in future years?

Pharma can't have their cake and eat it. Maybe they should contact McGorry to pre-test all the children they add to their clinical trials.

**ring ring ring ring

"Hello, Paddy McGorry speaking."

"Hello Paddy, GSK here. We was just wondering if you could screen a bunch of kids for us to see if they will fall foul of a mental disorder sometime in the future."

**KA CHING

"Of course, send them over."


Maybe with the DeLorean Intervention Program, McGorry may just stop kids being picked for trials by pharmaceutical companies who, despite knowing their psychiatric medication is not safe for kids, continue to find ways to use it on kids.

If McGorry's program is so fool proof then why don't pharmaceutical companies use it before accepting children and teens onto their clinical trials?

I think my argument is valid, don't you?

Your move Paddy.




More about McGorry HERE.


Fid


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Tuesday, August 30, 2011

CCHR Canada - Another Emotional Journey

Toronto - 27th Aug 2011


I've not long got back from Toronto. CCHR Canada invited me out to give a talk about my advocacy work.

It's extremely difficult to get up in front of people and talk about the reasons why I do what I do, CCHR, wherever they are based, have a unique ability to make one feel at ease. The Canadian ball busting branch of CCHR are no different.

Once again, I was made to feel very special by this kick-ass movement. Landing in Toronto on Thursday, being taken for dinner, of the sticky rib variety then off out with one of the sisterhood, Lori Farquhar-Bryenton, to sup on a few Canadian samples of light ale. We discussed many things and I just felt so 'right'. Lori is now officially my Canadian drinking buddy.

Canada holds a very special place in my heart. Regular readers of this blog will know the story of Oakville teen, Sara Carlin, who hanged herself whilst on Paxil. Sara's story really reached out to me, it was a bond that I just cannot explain but I knew one day I would get to finally pay my respects to her. That's a private moment and one that I won't share on this blog. Sufficed to say, I did what I needed to do and now feel much better for it.

The CCHR gala, an annual event, was held at Lakeshore, a former psychiatric unit, only CCHR could muster up such a genius location. The whole event was kicked off by the new Chill EB video made in collaboration with CCHR International. It was the first time this had been aired to a live audience and I have to say it gave me goose bumps and was greeted enthusiastically by the sell out audience.

Guest speakers for the night was myself and Anthony Stephan of Truehope. Anthony gave a passionate talk to the audience about his life and his work which resulted in a standing ovation. He's an accomplished speaker and much of his work has tried to be shot down by the Canadian health regulator, Health Canada - they failed.

My talk was pretty much off the cuff [no script]. I really enjoyed speaking and felt only a slight twinge of nervousness but that was soon washed away. It's surreal for me to be given such a standing, I'm just a council tenant from Birmingham who decided to write a blog back in 2006, to be plummeted into a world of folk that are pretty much all on the same page as I gives me such an adrenaline rush. To be treated like someone special is kind of difficult for me to accept too but it is accepted graciously because it means people are reading my work, more importantly they are listening to the voices of Sara Carlin, Matthew Steubing, Candice Downing, Sharise Gatchell, Toran Henry, Shane Clancy. That is the most important thing for me. These beautiful children should not have been taken from their family and friends and it is only with the great courage of their parents, family and friends that myself, and others like me, will give them what they deserve - a voice. CCHR also give the lost a voice, they also take preventative action so that loved ones are made aware of the dangers of these bullets in a pack. I am in no doubt that medication caused the aforementioned to take their own lives, no doubt at all. I wish I had never met the parents of the children above. The only reason I have is because of their loss. I would sacrifice my friendship with all of them just so they could have their babies back.

Other children are taking these meds, many are falling by the wayside and I will, along with CCHR, do my utmost to continue spreading awareness about the dangers of these drugs, the greedy bastards who make them and the limp-wristed cowards that grant them a licence. I've not changed in my stance against using psych meds on kids. I used to bang the drum loudly about Seroxat [Paxil] - hooking up with CCHR opened my eyes, they kind of fine-tuned me, if you will.

I have met so many great people in Canada, hooking up with the Carlin family was sad...yet uplifting. Paying a visit to the offices of Oakville MP, Terence Young, was also a great highlight for me.

I'm not going to let Sara Carlin's memory be forgotten. Those responsible for her death know exactly who they are, it is they that will have to live with that - I may just remind them occasionally.

Same goes for other children lost to this wanton abuse and denial of those responsible for the safety of prescribing medication to the vulnerable.

I'm in my sixth year of blogging now, my archives are full of sad stories, full of devastation...yet it is voices that are reaching out, warning others about the dangers.

I'm just a small voice...but I've hooked up with an even bigger one in CCHR.

I stand united by their side.

Here's to the next 6 years of psychopharmaceutical monopoly ass kicking!






Wednesday, August 24, 2011

Double Whammy For Lundbeck



Things aren't looking to good for Danish pharmaceutical giants Lundbeck these days.

An announcement yesterday that a secretly recorded meeting between Lundbeck and the parents of Shane Clancy is about to hit the Internet may or may not have them running in a tizzy. If that doesn't then today's announcement by the FDA should see them frantically calling the Lundbeck spin doctors to play down the latest risk associated with their antidepressant citalopram [Cipramil, Celexa]

According to an announcement today by the FDA, citalopram has now been associated with abnormal heart rhythms when taken in high doses!

No mention of that when Lundbeck officials spoke with Leonie Fennell and Tony Donnelly earlier this month...plenty of denial and deflection though. I'd love to tell you more [as I have heard the full audio recording] but I shall refrain. The recording is coming soon.

In the meantime, Cipramil, which is Britian's best selling SSRi, has yet again made the news for all the wrong reasons.

It would be safer to eat a cholesterol sandwich than stick an SSRi in your mouth - easier to wean off too.

Your move Lundbeck.

**Coughs - "Is citalopram a teratogen?"


Here's a taster of that meeting:



Fid


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AUSTRALIAN ORDERS HERE




Tuesday, August 23, 2011

Audio Recording of Meeting With Lundbeck to Hit the Internet

Tony Donnelly and Leonie Fennell, parents of Cipramil victim, Shane Clancy




Courage (also bravery, fortitude, or intrepidity) is the ability to confront fear, pain, danger, uncertainty, or intimidation. [Source]

On August 15 2011, the parents of Shane Clancy travelled to Denmark to confront Lundbeck, the pharmaceutical company that manufacture Cipramil [citalopram] and Lexapro [escitalopram]

Back in 2009 Shane attacked a group of teens [killing one] before stabbing himself 19 times.

Armed with a hidden video camera and audio recorder, Tony Donnelly and Leonie Fennell, Shane's parents, recorded their meeting with Lundbeck.

I have been privy to hear the full recording, it's explosive and is likely to cause a bit of a stink.

A pre-cursor to the audio recording, video footage, appears on Leonie Fennell's blog [HERE]

I have the utmost respect for any parent who confronts the might of the pharmaceutical industry. Their bravery boils down to an act of unselfishness in wanting to create awareness to others about the dangers of taking SSRi mediction.

Tony and Leonie...I salute you.

Fid


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE




Monday, August 22, 2011

Who Moved The Goalposts on Patrick McGorry's Clinical Trial

The DeLorean v Google Cache


So, Former Australian of the year Patrick McGorry has published a rebuttal on his blog to all the criticism he has received.

It's a response to an article by Jill Stark that appeared in The Age, a popular Australian newspaper.

McGorry writes:

The article is entirely based on misleadingly linking two entirely separate events. These events are: the decision of Orygen Youth Health Research Centre (for which I am Executive Director) not to proceed with an already ethically approved trial of the medication.

I'm glad he has raised the ethical issue.

If you look at the Australian New Zealand Clinical Trials Registry listing you will see that it was changed to say that ethics approval had been received on 8 July 2010: [FIG 1]

Yet on the 16 Aug 2011 there was no mention of this - [FIG2]

I find it strange that the criteria for a clinical trial can change, almost overnight, when one of it's supporters comes under fire from his peers

So, one has to ask why McGorry's claim that his trial was 'ethically approved' only appeared on Sunday night, hours after he had been slammed by the Australian press? The Google cache is a journalist's DeLorean Mr McGorry. It may also be your downfall.

FIG 1 How the clinical trial looks today


FIG 2 How the clinical trial looked on Aug 16, 2011

A glitch in the flux capacitor, perhaps?


Fid


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AUSTRALIAN ORDERS HERE




Sunday, August 21, 2011

McGorry Seroquel Drug Trial - The Complaint

Former Australian of the Year, Patrick McGorry
Jill Stark's superb exposĂ© on Australian psychiatrist Patrick McGorry has caused a storm down under. 

McGorry, with the financial assistance of Seroquel manufacturer Astra Zeneca, wanted to carry out a clinical trial [of sorts] with children, amongst others, who had not yet been diagnosed with a psychotic illness.

Psychiatrists, psychologists and researchers from all over the world lodged a complaint when they heard of the planned trial.

McGorry pulled the trial and now denies that the complaint had anything to do with his decision. If the 9 page complaint didn't change McGorry's mind...then what did?



McGorry appeared an Australia's Lateline 24 hours prior to Jill Stark's article went to press



Related Articles:

Patrick McGorry: "Hey... Paddy... Leave Those Kids Alone"

Patrick McGorry - Torn Asunder Down Under

Early Intervention, McGorry, Politics & TV Shows

Psychiatrist Patrick McGorry Slams His Critics [Diddums]

Is Australia's "Number One Man" Misleading The Public?

Pre-Mental Disorder Screening and Drugging - THE PHARMACEUTICAL DELOREAN

Patrick McGorry's Delorean Pulls Over For New Passenger

Patrick McGorry and Co Under Fire

Hickierie Dickory Doc - McGorry Turns Back the Clock

Psychiatrist's Assessment of Patrick McGorry

Patrick McGorry's "Back to the Future" 2008 Study

Australian Doctor Magazine Sees Patrick McGorry Defend His Position

Are The Wheels Coming Off Patrick McGorry's DeLorean?

 Professor Graham Burrows - The "Cosmetic Psychiatrist?" [Updated 7.34pm]

 Patrick McGorry Responds to Criticism by Allen Frances

Australian Member of Parliament, Martin Whitely, also speaks out against McGorry's Headspace initiative HERE.

Patrick McGorry's Headstrong DeLorean Posse Part I 



Can someone ask Paddy to define better?


 




Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE








Saturday, August 20, 2011

Was McGorry Forced To Pull AstraZeneca Funded Trial on Children?

Australian psychiatrist/soothsayer, Patrick McGorry


Jill Stark has a revealing article about Prof. Patrick McGorry running in tomorrow's edition of 'The Age'. Because of the time difference UK/Australia...or maybe because I've been pushed into the future 'DeLorean' style, that article is now available online.

Stark's investigation shows how McGorry planned to carry out a trial using the antipsychotic Seroquel on children as young as 15. The trial, funded by AstraZeneca, was to "investigate whether the drug would decrease or delay the risk of people aged between 15 and 40 with early signs of mental illness developing a psychotic disorder such as schizophrenia", writes Stark.

Psychiatrists, psychologists and researchers from all over the world lodged a complaint when they heard of the planned trial, resulting in the trial being pulled.

I cannot quite grasp why anyone would want to give someone a mind altering drug to see if it would deter an onset of an illness that the subject may or may not get. It defies logic. Then again, when have pharmaceutical companies applied any logic when it comes to medicating children with disorders invented by those nutty professors in white coats?

McGorry claims the decision to scrap the trial was made in June and is unrelated to the complaint. Yeh right, and I've just witnessed a pig fly past my window and an owl and a pussycat rowing a pea green boat!

Stark's article can be read in full HERE

It seems more and more people are now speaking out against McGorry's soothsayer ways, something the citizens commission on human rights [CCHR] have been doing for years. Long may it continue.


Related Articles:

Patrick McGorry: "Hey... Paddy... Leave Those Kids Alone"

Patrick McGorry - Torn Asunder Down Under

Early Intervention, McGorry, Politics & TV Shows

Psychiatrist Patrick McGorry Slams His Critics [Diddums]

Is Australia's "Number One Man" Misleading The Public?

Pre-Mental Disorder Screening & Drugging - THE PHARMACEUTICAL DELOREAN

Patrick McGorry's Delorean Pulls Over For New Passenger

Patrick McGorry & Co Under Fire

Hickierie Dickory Doc - McGorry Turns Back the Clock

Psychiatrist's Assessment of Patrick McGorry

Patrick McGorry's "Back to the Future" 2008 Study

Australian Doctor Magazine Sees Patrick McGorry Defend His Position

Are The Wheels Coming Off Patrick McGorry's DeLorean?

Professor Graham Burrows - The "Cosmetic Psychiatrist?" [Updated 7.34pm]

Patrick McGorry Responds to Criticism by Allen Frances

Australian Member of Parliament, Martin Whitely, also speaks out against McGorry's Headspace initiative HERE.

Patrick McGorry's Headstrong DeLorean Posse Part I



Fid


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE
OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE




Lundbeck Open Doors To Grieving Parents

Tony Donnelly and Leonie Fennell, parents of Cipramil victim, Shane Clancy


Last week Danish pharmaceutical giant, Lundbeck, opened its doors to Leonie Fennell and Tony Donnelly, the parents of 22 year old Shane Clancy.

Shane had been taking Lundbeck's antidepressant, Cipramil [known as Celexa in the US] for just 17 days before ending his life in bizarre fashion by attacking three people [killing one] before stabbing himself 19 times.

The resulting inquest returned an open verdict, a finding by a coroner's jury of death without stating the cause.

Both Tony and Leonie are convinced that Cipramil played a major part in Shane's decision making that day, research by experts would suggest that they have a point. Lundbeck, on the other hand, deny that their drugs citalopram and escitalopram can cause suicide.

It takes immense courage to face the murderer of your child, Tony and Leonie believe Lundbeck manufactured a product that resulted in their child brutally killing himself.

With this in mind they both travelled to Copenhagen earlier this week and met with Lundbeck officials, Dr. Madsen and a Public Relations Officer, Anders Schroll. It was the second anniversary of Shane's death.

Tony and Leonie also handed out 1500 leaflets outside the Lundbeck building [Fig1]

Leonie has wrote a precursor regarding this meeting, she has much much to come over the coming weeks on her blog.

It would appear that Shane's parents asked some hard hitting questions, many of which were deflected by Lundbeck's spokespersons Madsen and Schroll. It's one thing to open your door, but another to be less than forthcoming with the truth when answering questions put to you by your guests.

I have a deep admiration for anyone that takes on the might of the pharmaceutical industry. Leonie and Tony could have done what Lundbeck wanted, they could have accepted Shane's death and moved on with their lives but for them to 'move on' it is incumbent for them to seek the truth. That truth has not been forthcoming and I suspect Tony and Leonie are in this for the long haul.

Lundbeck won't like that.

Leonie's account of her meeting with Lundbeck is a must read, if only to see how their probing questions were deflected and...well, not really answered at all.

Full story HERE

Related:

Interview with Leonie Fennell [FIDCAST]


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman  - US and CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE







Friday, August 19, 2011

Professor McGorry Defends Early Intervention DeLorean Program

Australian Psychiatrist, Patrick McGorry. A soothsayer who can predict the future  mental health of children.


Australian soothsayer Patrick McGorry has been defending his early intervention program by appearing on Lateline, an Australian Broadcasting Corporation current affairs programme.

McGorry, who I have highlighted on this blog many times, claims the early intervention model he promotes has been proven to reduce mental illness symptoms and reduce costs to the health system.

'Proven' is past tense by the way.

Most notably, McGorry stated:

'What the studies actually show is there is no need to use anti-psychotic medications as first line in these patients [at high risk of developing psychosis].'

NB: The phrase 'first line' signals that he is not completely backing away from the use of antipsychotics in at-risk patients.

Also notable was the patronising but predictable dismissal by McGorry, Mendoza, and Crosbie of criticism as envy, in-fighting, bizarre, ignorant, self-defeating.... [I've seen playground bullies with better tactical skills]

Here's the transcript of his performance on Lateline


Related Articles:

Patrick McGorry: "Hey... Paddy... Leave Those Kids Alone"

Patrick McGorry - Torn Asunder Down Under

Early Intervention, McGorry, Politics & TV Shows

Psychiatrist Patrick McGorry Slams His Critics [Diddums]

Is Australia's "Number One Man" Misleading The Public?

Pre-Mental Disorder Screening & Drugging - THE PHARMACEUTICAL DELOREAN

Patrick McGorry's Delorean Pulls Over For New Passenger

Patrick McGorry & Co Under Fire

Hickierie Dickory Doc - McGorry Turns Back the Clock

Psychiatrist's Assessment of Patrick McGorry

Patrick McGorry's "Back to the Future" 2008 Study

Australian Doctor Magazine Sees Patrick McGorry Defend His Position

Are The Wheels Coming Off Patrick McGorry's DeLorean?

Professor Graham Burrows - The "Cosmetic Psychiatrist?" [Updated 7.34pm]

Patrick McGorry Responds to Criticism by Allen Frances

Australian Member of Parliament, Martin Whitely, also speaks out against McGorry's Headspace initiative HERE.

Patrick McGorry's Headstrong DeLorean Posse Part I


OTHER LINKS

Jill Stark did an excellent article about criticism of Patrick McGorry in The Sunday Age on 7 August. The Age is Melbourne's main newspaper, and the article was apparently on the front page, so the article would have been at least glanced at by many people. Six letters (including one from McGorry) were published in response:

McGorry accused of conflict of interest

The Big Issue: Mental Health

Not surprisingly, McGorry also responded with a piece on his website:
Merchants of doubt do no favours for people with mental illnesses


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE









Thursday, August 18, 2011

Big Pharma—Define 'Better'



This needs airplay.

The message is simplistic. Word is getting out.

Maximum respect to Chill EB

Please feel free to share on your Facebook walls and Twitter accounts.

There is power in music...and in video:

From the CCHR stable of drug busting advocates.


Chill EB...I salute You!


CCHR...You already know what I think about you.




"The pen of Chill EB is mightier than the sword of the psychopharma monopoly." - Bob Fiddaman, 2011



Fid
ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING
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4 Easy Steps That Highlight GSK Suppression

1. Sign up to the GlaxoSmithKline Facebook page.
[Do this by clicking the 'Like' button.]

2. Open comments under the "Glaxo "Builds Bonnie Babies" advertising hoarding opposite Kings Cross Station, London in 1921, UK" thread.
3. Ask them a question about one of their products. 
4. Sit back and watch consumer queries get deleted. Here's some snapshots.




GSK DELETE MOST OF THE ABOVE MESSAGES



Just one more for good measure... this has not appeared on GSK's Facebook page...yet.







Wednesday, August 17, 2011

GlaxoSmithKline Facebook Update

Well, it would appear that Glaxo are offering advice to pregnant mothers taking Paxil on their Facebook page. When I say 'advice' I mean they are referring someone to "talk to their doctor".

A subscriber to the page wrote:[1]

Hi , A friend of mine is taking paroxetine and she is thinking of having a baby. Is paroxetine a teratogen?
Glaxo responded with:
Hi Joanne – We are not allowed to discuss product information or offer advice to individuals about medicines. Please ask your friend to speak to her healthcare provider if she has any concerns about her medication.
This is similar to the 'advice' they give to patients who contact them asking for help withdrawing from Seroxat [known as Paxil in the US] - [Back story]

Oh, and they removed my advice to the concerned patient. [2]



[1]

[2]


Plus ca change, plus c'est la meme chose.


Fid 


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING 


AUSTRALIAN ORDERS HERE



Tuesday, August 16, 2011

Facebook 1 Pharma 0



Facebook, the popular social networking website have delivered a major blow to the pharmaceutical industry. Up until now pharmaceutical companies were allowed to create accounts where they could restrict comments from followers. Many companies, such as GlaxoSmithKline, signed up to Facebook and told everyone how good their drugs were...no criticism was allowed.


An article in The Washington Post from August 12 reports on how most drug company pages will have to have open 'Walls' starting Monday [yesterday] So, I just 'Liked' GlaxoSmithKline's page and low and behold comments can now be left. Ho hum, where do I begin?

The Washington Post writes:

Companies are worried that open Walls mean risks, and many are reconsidering their engagement on Facebook. On Friday, AstraZeneca, which sells the antidepressant Seroquel, shut down a page devoted to depression. Johnson & Johnson said it will close four of its pages Monday. Other companies said they will monitor their pages more closely once the changes take effect. The industry is concerned that users might write about bad side effects, promote off-label use or make inappropriate statements about a product, and that the comments could raise concerns from government regulators.
Awwww diddums, "The industry is concerned that users might write about bad side effects." - Doesn't your heart just bleed for the poor widdle pharmaceutical industwee. Pfizer are on there too. [HERE]

So, if there is anything you want to ask the relevant pharmaceutical industry regarding any of their drugs you have issue with...now's your chance folks. Let's see how long the 'big boys' keep their pages open.

All's fair in love and war.




Fid 


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AUSTRALIAN ORDERS HERE





Saturday, August 13, 2011

GSK Respond - "Dr Benbow is no longer with GlaxoSmithKline."



Some of you may know that I have been requesting information from British pharmaceutical giant GlaxoSmithKline regarding comments made by their employee Alastair Benbow on national TV and to BBC investigative journalist Shelley Jofre.

A recent document that surfaced shows an exchange of words between Benbow and Jofre from October 2002. This actual transcript shows Jofre press Benbow for an answer regarding Seroxat withdrawal, much of the transcript never made the final edit.

My request to GSK was thus:


To whom it may concern,

1. In a 2002 interview with BBC TV's Shelley Jofre, GlaxoSmithKline spokesperson, Alastair Benbow, claimed that, "... the majority of patients who experience withdrawal symptoms - and the majority of patients actually do not experience any withdrawal symptoms - of those that do the majority of those symptoms are mild to moderate in nature and will go away without any treatment within two weeks." He was, of course, referring to the antidepressant Seroxat. Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim.

2. Furthermore, in the same interview, Dr Benbow claimed, "maybe that a small proportion of patients do get more severe symptoms...". Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim. The full transcript, which has recently been released, was part of disclosure and used in litigation against GSK in the United States and is attached for your perusal.

Yours sincerely,

Bob Fiddaman


On Thursday August 11, I wrote a scathing article and published it on my blog. An hour or so before I published the article I announced on Twitter, "**Exclusive - GSK's Andrew Witty in Patient Aftercare Snub - Keep your eye on the Seroxat Sufferers blog" [Fig 1]

Fig 1

At 4.47pm, just 13 minutes before I was due to publish my article, GSK replied to my request, a request that I had sent them three times!

When I say replied, it was basically GSK side-stepping what I had asked for.


Here's the reply:


Dear Mr Fiddaman,

Thank you for contacting the Medical Information Department at GlaxoSmithKline regarding our product Seroxat* (paroxetine hydrochloride hemihydrate) and thank you for providing us the transcript of the Panorama interview.

You have requested information on study/studies that substantiate some selected quotes from Dr Alastair Benbow with regard to Seroxat during that interview back in 2002. Dr Benbow is no longer with GlaxoSmithKline and therefore it would be inappropriate to attribute substantiation data to him without any consultation. However, the tenor of what is quoted is supported 9 years later in the current prescribing information for Seroxat, namely that:

· in clinical trials adverse events seen on discontinuation occurred in 30% of patients treated with paroxetine compared to 20% of patients treated with placebo;

and

· generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity;

and

· generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more)

For your information some of the clinical trial data for paroxetine in terms of nature and frequency of withdrawal reactions are available in the public arena and discussed via the information presented on p126 of the CSM EWG report of 2004. Lastly, and as before, information about GSK’s clinical trials is available on the GSK Clinical Trial Register at GSK.com.


You will notice GSK's selective choice of words, such as, “generally” and “most”. What I actually requested were the studies that could back up Benbow's claims. So I wrote back the following:


Dear GSK,

With respect, you have not provided me with the information I requested.

Your employee, Alastair Benbow made the statements on national TV.

I would like to see the evidence that backs his claims.

If I wanted a snapshot of a patient information leaflet I would have downloaded one. You are not being transparent here.

Best

Bob Fiddaman


As yet, GSK have not replied to me.

It is interesting to learn that Alastair Benbow is no longer with GSK, quiet convenient that the one person who has the answers to why he said what he did no longer remains as GlaxoSmithKline's spokesperson.

So, in essence, I have requested studies that back up Benbow's claims - GSK cut and paste information off the Seroxat patient information leaflet and send it to me.

Clearly not good enough! I'll keep you posted should GSK ever send me the evidence that supports Benbow's claims.

Back story: **Exclusive - GSK's Andrew Witty in Patient Aftercare Snub



Fid 

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Thursday, August 11, 2011

**Exclusive - GSK's Andrew Witty in Patient Aftercare Snub




I'm on a quest around the world to find Bigfoot.

I'd originally set out to see if GlaxoSmithKline would actually help patients affected by Seroxat... but I decided to keep my goals realistic.

Here's why.



A short time ago I highlighted the plight of "Zoe", a Seroxat sufferer who has been screaming for help in getting off her daily dose of Seroxat.

Zoe, you see, wants to try and kick her Seroxat addiction into touch. She's currently down to 2.4mgs and is having to use the sickly oral suspension that comes complete with an oral syringe.

She drops by 0.5mgs per week, anything higher is intolerable. It was myself who recommended to Zoe that 0.5mg would be slightly easier than a whole 1mg.

I've previously suffered the addictive qualities of Seroxat. It took me 18 to19 months to taper from 40mg per day to 22mg per day...in the end I went cold turkey. The 'two weeks' of tapering quoted by Alastair Benbow and Mary Anne Rhyne, both GlaxoSmithKline spokespersons, was poor advice based on...um...well, it's not known what their claims were based on. I have been asking GSK via the Freedom of Information Act but, despite two requests, they have failed to answer me. More about that later.

I gave Zoe the suggestion because neither her psychiatrist or doctor could recommend a tapering regime for her, neither could GlaxoSmithKline. Zoe had contacted them and asked for help... they told her to 'talk to her doctor.' When I say 'they' told her, I actually meant they got one of their highly paid lawyers to speak with her on the phone. Classy huh? Even more astonishing was this lawyer's apparent ability to predict the future. Zoe pressed him about the current UK Seroxat litigation, he replied by telling her there would be a major announcement about that soon. [Still waiting Mr Blabbermouth]

You see, there is no advice that GlaxoSmithKline can offer because they just don't know. The Seroxat clinical trials went on, at a guess, for approximately two years. Any person, today that goes over two years on Seroxat are basically venturing into the land of the unknown.

Another patient who contacted me [who wishes to remain anonymous] also wrote to GSK asking for help. Here's their reply:

Click on image to enlarge

The frustrated patient wrote back an angry response to GSK:

I recently E mailed you concerning my terrible experience while discontinuing , and after Taking your so called wonder drug Seroxat !!

And I must say that I am not impressed with your response !! And that I refuse to sign the consent form to give you access to contact my GP and investigate my medical files !! why you may ask ?? I’ll tell you !! you only wish to investigate for your own benefit !! and have absolutely no intention or interest in helping myself or anyone else in my situation !! You manufacture these products so must have a resolution to put things right when they go wrong as they have !! DO YOU ?

The reply continued with...

Mr Witty and Mr Benbow should be thoroughly Ashamed of themselves for defending this Drug !! I hope you pass on this letter to them so they can read for themselves what SEROXAT has done to Me...

Benbow, not shy in front of TV camera's, accepts there may be patients who take longer to 'discontinue', Glaxo's spin for 'withdrawal'. He does not tell us why though, nor does he tell us how. Why? Because he doesn't know.

A university student also contacted me, he, just like the above two patients, was trying to taper from Seroxat. Things got so bad for this particular patient that even a reduction of 1ml per month on the liquid form of Seroxat was proving to be too difficult.

He was given a reduction plan by his local prescribed medication support service, a service ironically run by the NHS. He told me, "I think part of the problem was making a reduction and then waiting for my brain to adjust. This method seems to attempt to get around that problem, and seems be set out over a realistic time span."



The current advice on the Seroxat patient information leaflet is to taper by 10mg per week. The above tapering plan appears to show that Glaxo's advice is way too ambitious - The above withdrawal plan, for the patient who is stuck on 10mg, is expected to last a staggering 71 weeks!

Don't you find it astonishing that the NHS acknowledge that SSRi withdrawal is severe, or at least this one small centre does, yet the manufacturers of these drugs and those that are supposed to regulate them, don't?

The Pwll Glas Resource Centre is a small centre servicing a small town [Mold] and the Prescribed Medicine Support Service is only a small part of what they do. The centre is mainly where Community Psychiatric Nurses [CPN's] are based and deal predominantly with mental health problems and run Cognitive Behaviour Therapy counselling services. I wonder if they have contacted the manufacturers of these drugs and asked for help in getting their patients off them, I wonder if they were told to refer to the patient information leaflets? It's utterly absurd that we have an acknowledgement from a small centre in a small town which is run by the NHS, yet we have no acknowledgement from our own government, medicine regulators and pharmaceutical industry!

71 weeks is 1.3 years. An astonishing length of time to taper off a drug that Glaxo claim takes just 2 weeks!

I'm neither shocked or surprised at the attitude of GlaxoSmithKline with regard to the above three patients and for the hundreds of thousands who are guided by Glaxo's advice on the patient information leaflets. This isn't the first time they have shirked their responsibilities, it won't be the last.

In 2009 a jury concluded by a majority of 10-2 that Seroxat was the causation in Lyam Kilker being born with heart defects. Internal documents to surface from that trial showed how Glaxo knew as early as 2001 that Seroxat may cause pregnant women to give birth to children with defects. The internal document showed how a woman had wrote to Glaxo in May 2001, she wrote:

**Paxil is the US brand name for Seroxat.
"I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I've been taking Paxil, which is truly a miracle drug. I've been panic-free with this drug and have been able to go on with a normal life.

"I was married in October of 2000. My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

"The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time).

"To say the least, I was absolutely distraught with this news. I thought this was something that I did [...] because I stayed on the Paxil for selfish reasons.

"I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies.

"My husband and I are ready to try again to get pregnant in the next monthor two. I am so nervous. I don't want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront. And I will somehow stop taking it for the time being.

"Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me. I just want to continue to have a normal life and have the child that I always wanted.

"Please contact me as soon as possible ... Please don't forget about me."

The same woman sent a second email on June 1 2001, this time she wrote:

"This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.

"I am in no way insinuating your product did this to my child. I love the product, and I don't think I could have gotten through my panic attacks without the wonderful help of this miracle drug.

"I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.

"Please, if you do not have this information, where is this information held? Does anyone do studies like this? Please, any information you may give me would be great. Thanks again for your help."

Glaxo responded to the distraught woman five days later on June 6 2001:

"Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition.

"Because patient care is individualised, we encourage patients to direct questions about their medical condition and treatment to their physician.

"We believe that because your physician knows your medical history, he or she is best suited to answer your questions.

"Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department ..."

Once again, Glaxo were telling a patient to talk to their doctor!

What they didn't tell either this woman or her doctor was the discussions they had after they had received her emails.

An internal document shows them blaming their own drug Paxil [the US brand name for Seroxat]

Case number A0348482B", dated 13 June 2001, states: "Relatedness assessment to medication – almost certain."

Still, Glaxo never told this woman or her doctor! One has to ask the question why?

During testimony presented to a Pennsylvania jury, Glaxo officials indicated in 2001 that they were “almost certain” that Paxil caused a heart defect in an unborn fetus. Former Glaxo drug-safety executive Jane Nieman testified that the determination was made by an unidentified Glaxo employee in the company’s database after the mother emailed the company inquiring if there was a connection between her use of Paxil and the birth defect.

In fact, Sean Tracey, the lawyer representing the Kilker family, said in his opening statement of the trial that Glaxo executive, Bonnie Rossello, wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. She wrote, “If neg results. can bury.” This statement by Rossello was to do with withdrawal.

Do you see a pattern forming here?

Janice Simmons, who operates the Seroxat User Group, has amassed over 60,000 emails from Seroxat patients, most of them are struggling to get off Seroxat. Janice cannot tell them how to combat the side effects such as; electric zaps, suicidal thoughts, intolerance to sudden loud noises, bouts of crying, headaches and visionary disturbances etc.

So, Janice decided to request a meeting with GlaxoSmithKline's CEO, Andrew Witty. To her surprise, GSK’s UK medical director Dr Pim Kon wrote back asking what she wished to discuss...adding that they cannot give advice to patients, they need to seek that from their healthcare professionals. [Yawn]

Janice informed Dr Kon that she wished to discuss the issue of Seroxat withdrawal. Kon wrote back telling Janice that they was not allowed to discuss personal matters with patients and that they should 'talk to their doctor'. [Another yawn]

Is that  building in Brent surrounded by mountains? The echo is unmistakably obvious. YODEL-AY-EE-OOOO


Kon added that the Seroxat patient information leaflet had been updated with information about [ahem] 'discontinuation' .

Dr Pim Kon is no stranger to controversy. Last year she told the InPharma magazine that European regulators [EMA] were wrong to withdraw its diabetes drug Avandia from the market. Avandia was suspended by the EMA last year because of high levels of heart attack, heart failure and strokes in patients

Let's take a gander at Glaxo's Seroxat withdrawal advice:

Do not stop taking Seroxat until your doctor tells you to.

When stopping Seroxat, your doctor will help you to reduce your dose slowly over a number of weeks or months - this should help reduce the chance of withdrawal effects. One way of doing this is to gradually reduce the dose of Seroxat you take by 10 mg a week.

10 mg per week? Ah, I can see why they have plucked this amount out of thin air. The maximum dosage for mild depression is 20mg, if you drop by 10mg per week Glaxo have their "It takes the majority of patients two weeks to discontinue." I'm reminded of a song by Ian Dury and the Blockheads, "There Ain't Half Been Some Clever Bastards" - (Dury, Jankel - 1979)

INTERLUDE



Janice wrote back to Kon and asked if GSK could provide her with any studies that GSK had carried out on withdrawal from Seroxat to back up GSK's statement that 'it may be helpful to reduce by 10mg per week and withdraw over the course of 2 weeks. - Kon, after a period of two weeks, has failed to provide Janice with any such evidence.

So, it's a given that I am not fond of GlaxoSmithKline, in particular their spokespersons Mary Anne Rhyne and Alastair Benbow. I'm not particularly fond of their highly paid lawyers either, have any of them ever seen the movie The Devil's Advocate? Keep on telling yourselves that you are doing a great job folks. You know, I'd really like to see things from your point of view but I can't seem to get my head that far up your arses!.

Here's the paradox. GSK refuse to help patients who contact them with regard to difficulties weaning off Seroxat. They quote the ABPI Code of Practice and tell the patient to 'talk to their doctor'. The doctor either thinks their patient is still suffering from the original illness or knows that the drug is addictive but still prescribes it anyway! A recent survey showed that almost 80% of doctors routinely prescribe drugs to which they believe the patient may be addicted! GSK's lawyers support them [GSK] to the hilt despite witnessing the devastation this drug has caused. Round and round we all go, caught in the psychopharmaceutical trap folks. It's a merry-go-round that isn't very merry at all. We want to get off but the pharmaceutical industry, doctors, psychiatrists and lawyers won't let us, they just keep on spinning the ride and the truth.

By Glaxo's own admission, Seroxat can cause withdrawal problems for some. Yet they have defended every single accusation that Seroxat has caused problems for their consumers, instead they blame the original illness or other mitigating factors, anything but the very same drug they say 'can' cause withdrawal problems for some people. Glaxo's Seroxat now carries a warning for pregnant mothers, yet every single mother whose child has been born with defects get no admission of liability from Glaxo. Glaxo's wonder pill can also cause suicide, once again they have never once admitted liability for any suicide on Seroxat. They defend this medication yet say all of the above are possible. That's like a chef presenting you with a steak, the steak may kill you or give you botulism but the Chef, although admitting that the steak he cooked could be harmful, will deny any wrongdoing if you pursue the matter, he, in actual fact, will blame everything...but the steak. It's GSK having their cake and eating it.



The Olive Branch snapped in half.

Had Witty been brave enough to meet with Janice Simmons I would have just loved to have been present. I would have liked him to help people come to terms with their Seroxat addiction, I would have liked him to acknowledge that people, like Zoe, need help and I would have liked his company to pay for that help by way of offering her, and people like her, a placement on a detox program.

I would have also have liked Andrew Witty to help those who have been off Seroxat for sometime but have been left with long term side effects. Long term effects that they, once again, deny.

Now, Witty, and indeed all of Glaxo's spokespersons, can continue down the road they've all been stuck on for all these years and deny Seroxat causes a myriad of side effects or they can start helping those that their product has harmed.

Any response along the lines of, "Seroxat is not addictive" or "Seroxat has benefited millions of people worldwide" would have been seen as an attempt of impunity and would have been greeted with a two finger salute, by me at least. It would also have been acknowledged that the only reason GSK roll out these boring statements is to protect themselves from litigation.

On the subject of litigation, I would have liked Andrew Witty to give those that have been harmed by his company's drug some closure. Let them be allowed to turn around to all those finger pointers and say, "I told you it was a side effect and not the 'real' me."

I guess any admittance would have had repercussions on the benefits system here in the UK too. Any acknowledgement that Seroxat can debilitate people during withdrawal and even years after stopping it could see a deluge of disability claims. The government wouldn't want that now, would they? And with Mr Witty appointed as Lead Non-Executive Board Member for the Department for Business, Innovation and Skills in 2010, I can only assume that they would take a dim view if he were to admit his company's product harmed people to the point where they could not function properly. I can only begin to imagine the amount of money Mr Witty is saving the UK government by not announcing that his company's product has caused so much pain and misery to thousands of UK residents. Of course, he will argue that it has helped "millions of people worldwide", which doesn't really address the outstanding issue, does it?

You see Mr Witty, I've got the staying power of an energy saving light bulb. I can, and will continue to highlight articles in the press regarding your company. I'll also continue to offer readers of this blog court documents if and when they become available, documents from the USA where your attorneys have struck deals with claimants, only to be silenced by gagging orders because, it would appear, you want the truth suppressed.

I'm like one of those little bunnies that play the drums in the TV adverts, I can keep on going because I've been loaded with the Duracell batteries and not the normal ones, capice?

Oh, and please don't quote the safety reviews carried out by the 'expert' working committees either. An expert would be able to tell me and the thousands of others how to wean off your product without having to experience the intolerable side effects for days, weeks, months and years on end. The committees are basically the MHRA with a few 'outsiders' thrown in to show there is no conflict of interest...we all know there is though.

Any association with the MHRA is seen, by me at least, as a total embarrassment. Both the expert working group and MHRA are clueless and, it would appear, they have no desire to change. You could, however recommend a decent shampoo for employees of the MHRA, their scalps must be terribly itchy with all that sand their heads have been buried in all these years. Not to mention the kind of 'expert' witnesses Glaxo's lawyers have called upon to defend their product in the current UK Seroxat litgation. Remind me who Rashmi Shah used to work for again please?


  • Dr. Rashmi Shah is the owner of Rashmi Shah Consultancy Ltd, located in Slough, Berkshire, UK.
  • Shah was employed by the MHRA between 1987 and 2004. Positions held were: Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.
  • An employee of the MHRA for 17 years.

The regulator and Pharma, as one. Snug as a bug on a rug.

Let's not forget the head of licensing at the MHRA, Dr Ian Hudson, whom were his previous employers?

SmithKline Beecham!

And his role at SmithKline Beecham?

World Safety Officer!

In fact, one of Hudson's significant involvements was with paroxetine, that's Seroxat for those that don't know. [Source]

Is it any wonder the MHRA give Seroxat a clean bill of health each time it is reviewed?

Their Chairman's embarrassing performance in front of TV camera's trying to defend Seroxat was plain to see for the millions that tuned in BBC's Panorama exposĂ©. And who is their Chairman?

Alasdair Breckenridge.

His former employers?

GlaxoSmithKline [Formerly SmithKline Beecham]

To coin a phrase, "This crap just writes itself."



You want to improve Glaxo's image? Make a stand, be the first pharmaceutical company to hold up their hands and say, "You know what, the customers are right...they do need our help." I guess that would boil down to an admission of guilt though. When was the last time Glaxo ever admitted any wrong-doing...apart from when they were forced to?

An apology would have been nice but I can't say for sure if it would have been accepted by the likes of the Gatchell, Carlin and Keegan families, whom have each lost a precious life because they actually believed it when they were told their teenage children would be okay taking your product.

It takes a big man to step up to the plate, are you that man Mr Witty? Obviously not.

Can you imagine how good it would have felt if you, Mr Witty, were part of the solution?

Alas, it appears you are not up to the challenge. Why am I not surprised! Maybe you are allergic to people? Isn't that how Glaxo first promoted Seroxat in the US with a huge poster campaign? [SOURCE]

Seroxat is rarely prescribed any more in the UK, recent figures show that it is, in fact, the least prescribed SSRi in the UK today - why is that?

Don't bother answering...we all know why, don't we?

I am left wondering how your company came up with the idea to treat depression, anxiety and shyness. Did you ever think about how one could be diagnosed? It amazes me that psychiatrists and doctor's can diagnose a patient without any form of removal of bodily fluids. Nothing was taken from my brain when I was prescribed Seroxat nor did I have to urinate into a jar or have blood taken to show I had the blues.

One would think that a manufacturer of a product would act upon a defective product, particularly if that product was to be used by millions of people. Then again, sadly, the UK public aren't even considered when it comes to your company acknowledging Seroxat withdrawal. Readers of this blog will be surprised to know that GlaxoSmithKline have made over 3,000 out-of-court settlements in America, all those settlements were to do with the withdrawal issue. A settlement means no liability, once again Glaxo can refer those left suffering to their doctors.

Glaxo launched Seroxat in direct competition to Eli Lilly's Prozac. Lilly, being Lilly, saw this as a threat. So battle did commence.

According to this recently surfaced internal file, GlaxoSmithKline [then SmithKline Beecham] knew of two studies that Lilly had carried out, those studies showed that Seroxat showed significantly higher rates of withdrawal problems when compared to Prozac.

How did GSK handle this?

Well, instead of addressing Lilly's findings they decided to play down the issue of Seroxat withdrawal. The fact that Seroxat withdrawal problems were significantly higher than Prozac saw Glaxo's team pull together the following plan.

Click to enlarge
Click to enlarge

You will note the date of the memo is July 1997, that's 14 years ago!

It would appear, Mr Witty, that your company were already debunking the withdrawal problem with spin way back then.

Personally, I believe your company royally ballsed up by not carrying out any extensive studies into the protracted withdrawal of your product, choosing instead to set money aside for future out of court settlements to consumers that had to go through the legal system to get some kind of justice after being harmed by your drug. Money well spent for Glaxo, probably all part of the insurance cover your company takes out when they launch a product. I believe that money would have been better used on a withdrawal study, then again you already knew about the withdrawal problems early on, didn't you...well maybe you didn't but your predecessor, JP Garnier, must have known, right?

Is it any wonder that you have decided not to manufacture or invest any more of your billions into antidepressant medication?

"You don't need a weatherman to know which way the wind blows" - Bob Dylan

I'd also be grateful if you could ask your company's spokespersons to put a lid on making statements every time another child or teenager dies whilst on your product. Statements with the tired out phrases, "we utterly refute" and "Seroxat has benefited millions of people worldwide" really do nothing to ease the pain of the parents, brothers and sisters left behind.

It would be real nice if you could chase up a couple of Freedom of Information requests, they are just basically questions, I understand that, even by using the FOIA, you are not obliged to answer... be worth your while if you did though. I will understand if you don't want to - any answers would kind of leave a door open to further probing of Seroxat, wouldn't it?

GSK Customer Relations - UK


The following request I make under the Freedom of Information Act.



To whom it may concern,

1. In a 2002 interview with BBC TV's Shelley Jofre, GlaxoSmithKline spokesperson, Alastair Benbow, claimed that, "... the majority of patients who experience withdrawal symptoms - and the majority of patients actually do not experience any withdrawal symptoms - of those that do the majority of those symptoms are mild to moderate in nature and will go away without any treatment within two weeks." He was, of course, referring to the antidepressant Seroxat. Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim.

2. Furthermore, in the same interview, Dr Benbow claimed, "maybe that a small proportion of patients do get more severe symptoms...". Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim.

The full transcript, which has recently been released, was part of disclosure and used in litigation against GSK in the United States and is attached for your perusal.

Yours sincerely,

Bob Fiddaman

And this one to GSK Australia:

I've recently learned that GSK Australia rolled out the a plus project in 2002 The project, as I understand, was for the promotion of the antidepressant Aropax.

My questions, submitted to you under the FOIA, are thus:

1. How many patients were enrolled in the a plus project?
2. How many of the patients were under the age of 18?
3. Did the starter packs just contain packets of Aropax with 20mg tablets or were there starter packs with lower doses?
4. What were the qualifications and training of the counsellors on the a plus project?
5. What were the sales trends of Aropax in Australia before, during and after the a plus project?
6.How much did GlaxoSmithKline pay individual key opinion leaders, including (but not limited to) Professor Graham Burrows and Professor Bruce Singh? What were the services for which each was paid?
7. What were the goals of the a plus project?
8. How long did the a plus project run for?
9. How many adverse reactions were reported for Aropax during the project?
10. Were participants on the a plus project ever followed up or did GlaxoSmithKline Australia lose touch with the participants once the project had finished?
11. Why was the project ended?
12. Was the a plus project deemed a success by GlaxoSmithKline?.
13. Has GlaxoSmithKline or its subsidiaries ever offered similar counselling sessions to patients taking other drugs manufactured by the company?
14. How much did GlaxoSmithKline pay for sponsorship of the Depression Awareness Journal around the time of the a plus project?

Mr Bob Fiddaman

Chase these FOI requests for me Mr Witty, there's a good chap.


Finally, could you ask GSK Japan to justify the money they have recently spent on a Seroxat clinical trial aimed at 7-17 year old children.

Oh, don't bother screaming like a big girl to your lawyers. I'm merely asking for things and making a mockery of your company and their stance toward making people do more, feel better and live longer. Ironic that you have never changed that motto despite all those that have been harmed by your drugs.

I'm ashamed that GlaxoSmithKline are a British company. I'm astounded that you continue to refuse to help patients who are suffering at the hands of your product. To me that's an intention to inflict emotional distress, you merely hide behind the Association of the British Pharmaceutical Industry code of practice, a great weapon of mass deflection you have there Mr Witty. Ooh look I just did a play on words, "Weapon of mass deflection." [Scroll up and play Ian Dury again if you feel inclined]


Our current government, in fact any party voted in, see you as the jewel in the crown.

One only has to look at the 2001 Pharmaceutical Industry Competitiveness Task Force Final Report to see how the industry is revered.

Page 20 - 'The UK benefits in the following ways from the pharmaceutical industry...

Returns to UK shareholders, tax revenues accruing to the UK Exchequer and benefits arising from terms of trade.

I can only guess that if they were to ever mess with GSK, you could always move your business elsewhere. That's quite a grip of the gonads Glaxo have on the UK economy.


Looks like I have chosen my unpaid career as someone who will continue to write about you and your company until you put things right. Any threatening letters by your lawyers will be copied and re-published on this blog.

I'd copy in the press with this post but seeing as you have one of the Murdoch's on your board at GSK I can only assume that they will only print what you want them to. Remind me, what exactly is James Murdoch's role at GSK? Did he have any input into your promotion/protection of the MMR Jabs? There are many that are suggesting he did. [Rupert Murdoch, Brian Deer, Dr Andrew Wakefield and fabricated lies]

Tut tut - children the targets yet again!

I guess it will all come out in the wash eh Mr Witty? - Just like your product, Ribena, you know, the one that you said was "Full of Vitamin C", when actually it wasn't! [SOURCE]

It's entirely up to you whether you wish to reply, I doubt you will.



**Inserts Duracell battery and proceeds to bang the drum.









Bob Fiddaman
Former Seroxat addict
Left with long term adverse reactions due to ingesting Seroxat for 6 years

"When stopping Seroxat, your doctor will help you to reduce your dose slowly over a number of weeks or months - this should help reduce the chance of withdrawal effects. One way of doing this is to gradually reduce the dose of Seroxat you take by 10 mg a week." - Seroxat Patient Information Leaflet 2010










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