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

ORDER THE PAPERBACK
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Improved Paxil Pediatric Settlement Hits "YouTube" Like a Bad Dream For Glaxo

Video Informs Parents That Clock Is Ticking On $48 Million Payback Fund; Unclaimed Money Will Revert Back to Drug Maker

Source: YubaNet.com

While the maker of Paxil and Paxil CR, GlaxoSmithKline (GSK), was required by law to announce the settlement terms of a parent-driven class action lawsuit in October 2006, it was not required to publicize the fact that those terms were greatly improved and simplified in April 2007. Because of legal actions taken by Public Citizen, many more parents whose children took Paxil before the age of 18 could benefit from the settlement if they only knew about it.

Public Citizen posted a YouTube video to tell these parents that there is a $48 million dollar fund created by GSK to pay them back. Even without receipts, parents can recover up to $100. Any money that is not claimed prior to the August 31, 2007 deadline will revert back to the drug company.

GSK and the FDA warned doctors only last year that Paxil increased suicidal thoughts in this age group, and yet this "popular" anti-depressant has been prescribed to children and teenagers since 1992. Parents believed this information was known and withheld by the company, which opted to settle the case rather than go to trial and be forced to answer some very difficult questions.

Watch the video, spread the word and help parents get the refund they deserve. Visit http://www.paxilpayback.org/

Jim Thomson CEO, The Centre for Mental Health - The final

To be honest I've become quite bored of Mr Thomson and his rants and think I have gave him enough space on here to vent his misdirected anger. The readers of this blog have all seen the mails - I was going to respond to them publically but then thought... what is the point?

It seems Jim Thomson and whoever he is part of, be it Depression Alliance, Innervate or the Centre for Mental Health, likes to have the last say.

I'm done with him now - Seroxat Secrets, who Jim seems to get worked up about, continues to press him for answers so what does Jim do? He emails me!

I have nothing to do with the Seroxat Secrets web page other than both I and its author share the same passion - one which is to expose GlaxoSmithKline.

If any of you want to learn more about Jim Thomson then you can read his biography here

His myspace page can be found here

I suspect many of the readers (whom I only have a small audience if Jim is to be believed) have also become bored by it all. My aim was to allow Thomson to have his say, something his websites do not allow.

Read through the correspondence and see who is the one who appears to be 'losing the plot'

Jim is a fan of music.... there is a wonderful chorus in a Deacon Blue song which I keep hearing over and over again in my head as I read through the correspondence between Jim and I.

And I'll sail her up the west coast
Through villages and towns
I'll be on my holidays
They'll be doing their rounds
They'll ask me how I got her I'll say I saved my money
They'll say isn't she pretty that ship called dignity

I think Jim should look up the word 'Dignity'

I've now added his email address to my spam filter.

There will no doubt be more unearthing over at Seroxat Secrets.

THERE WILL NOT be anymore time or space given to Thomson on this blog

And a message for you Jim. I decline you offer of a meeting where you would like to meet me face to face, eyeball to eyeball - to be honest I found that quite threatening and if it gives your ego a massive boost I feel very intimidated by you. Apart from that I could never accept a 'freebie' off you Jim - that would change me into something that I despise.

Now if you wouldn't mind Sir... this site has bigger fish to fry

Bob

Jim Thomson CEO, The Centre for Mental Health - The Emails Part 4

... and they keep on coming


This one from 11.01am

----- Original Message -----
From: jim thomson
To: 'fiddaman'
Cc: 'STUART, Gisela' ; 'Amelia' ; mhtml:%7B4F2932A1-7C6B-4867-AEC4-6B41014FDB7F%7Dmid://00000070/!x-usc:mailto:chris.manning@primhe.org
Sent: Tuesday, June 05, 2007 11:01 AM
Subject: RE: I almost forgot


But interestingly, Bob, no comments from you about the points I made below, and which clearly contradict your view of me as being a puppet of big pharma. I trust your M.P. (who I see you copied in on your non-reply) will take the opportunity to view the Hansard pages relating to my evidence, and come to her own conclusions regarding the fairness of your concerted attacks on me (and those of your acquaintances on other blogs.)

While it behoves a Member of Parliament to represent all of her/his constituents, I am sure that Ms Stuart, particularly given her time at the DoH, will be well able to sort the wheat from the chaff, and no doubt conclude that there are forces at work here that probably do not have the public interest at heart.

Ms Stuart, for your benefit, I have copied this to two other people that Mr Fiddiman and others have targeted for their singularly vile personal attacks, because they and I do not toe their particular party line. I will email you presently explaining who these people are and who I am.



Jim Thomson is CEO for The Centre for Mental Health who proudly boast on their website:

What are you working on right now and do you need any help. Email us with a short desciption of your project and the kind of input you're looking for.

Jim Thomson CEO, The Centre for Mental Health - The Emails Part 3

Sent to me at 9.54am

He never copied in his two friends this time.

----- Original Message -----
From: jim thomson
To: 'fiddaman'
Sent: Tuesday, June 05, 2007 9:54 AM
Subject: I almost forgot


Sorry….. Bob,

I almost forgot. Why is it that you draw attention via your blog (damn, that counter is STILL running slowly today) to the ranting dwarf’s submissions to the Health Select Committee inquiry, yet you conveniently neglect to mention my submissions to same. Come on, fair play and all that guff ….. ….Bob……

You must have read my comments (made under oath, as it happens.) I would have thought you’d be congratulating me on two in particular – the one calling for routine and ongoing post-marketing clinical trials….and the one calling for a revamped system to report adverse effects of medications.

I’ve had a good look through the blog….Bob…. but not a dicky bird. No mention at all of these recommendations and the contribution they would make to increasing patient safety. Why is that, Bob? Strangely enough, the wizened dwarf doesn’t ever mention them either. Funny that.

Thankfully, the Committee was listening, the recommendations I made (and another that would cost big pharma billions of dollars if implemented) made it into the minutes and the final report. That’s democracy in action – just in case you don’t recognise the concept….Bob.

Toodle Pip,

Jim


I sent a copy of this email to Gisela Stuart, who, it seemed Jim referred to as the 'ranting dwarf' and the 'wizened dwarf'


Jim Thomson is CEO for The Centre for Mental Health who proudly boast on their website:

Mental health is "everyone's business". The Government's particular role is to enable the opportunities and environment that sustainably and enduringly support this proven fact.

Jim Thomson CEO, The Centre for Mental Health - The Emails Part 2

This one I recieved at 9.38am

----- Original Message -----
From: jim thomson
To: 'fiddaman'
Cc: 'Amelia' ; chris.manning@primhe.org
Sent: Tuesday, June 05, 2007 9:38 AM
Subject: RE: recent exchange


Morning Bob (damn, that makes me smile every time I write it – just can’t help visualising Rowan Atkinson.)

have indeed read your blog this very morning (and what a fine sunny one it is.) I see you plan to respond in detail to my last email. Splendid – my day just gets better and better. I look forward to it. As an aside, Bob (there’s that smile again) why is it that you didn’t respond straight away to the points I raised – and specifically the invitation to meet face-to-face? Could it be that I sent the email after office hours? As we all know, Lawyers and PR agencies tend to keep strict hours. In any event, when it comes, I’m sure your response will be entertaining. I wonder if it will be like some of your offerings – written in perfect English, or like the others – written in abject colloquial English. A more suspicious or conspiratorial man than I might suspect that more than one hand is at work here. Perish the thought, eh?

While writing, I must commend you on criticising my lack of professionalism in suggesting that there might be more to your little blog than you would like your readers to know. Imagine my shock when I realised that you recognised the concept of professionalism. Who’d have thought it?

Of course, the other belly laugh was when you stated that I had done “some research of my own.” Let me get this straight…. You are allowed to say whatever you please about me to your thousands of readers (though, I have to say, Tuesdays must be quiet – your web counter has gone up by six this morning, and five of them have been me checking back to see if you’ve replied yet. Could it be that your scribblings are not as fervently followed as you think?) but I am not allowed to investigate who is dragging my name through the mud? Is that the deal here? You can say what you like about me and others? You can put my photograph on your blog? Yet you wail and gnash your teeth when, for example, the MHRA makes a tiny clerical error deleting your name and address from a form letter? Dual standards old chum, dual standards. And before you justify your behaviour by saying that all is fair in the crusade for truth and justice, or that you are doing this for patients, let’s get one thing straight. I (and others) know why you are doing this and now, following my email yesterday, you know that I know. Makes it interesting, eh? Oh, and for the record, I didn’t do any research. I was having a chicken mayo bagel when the information dropped into my lap. And no (yawns) it didn’t fly in from big pharma.

So, Bob (smiles), let’s have that meeting. Surely it’s the offer you’ve been waiting for. The opportunity to convince three prominent people working in mental health, of your case. That MUST be worth the trip. Hell, we’ll even come to you if you like. What are you waiting for.

Oh, and just so that you know that I’m not avoiding the question…. Who pays my salary? Right now, Bob (etc) no-one. Kind of knocks a big hole in your argument, n’est pas?

Best,

Jim


P.S. Come on Bob, it’s gone half-nine. Those nice folks down at the agency must have finished their croissants by now, surely………

Jim Thomson is CEO for The Centre for Mental Health who proudly boast on their website:

People are best served by all concerned with mental health working collaboratively. All those with a voice in mental health have a right to be heard.

Jim Thomson CEO, The Centre for Mental Health - The Emails

It seems Jim Thomson has been busy looking in at my blog this morning (you will see evidence in the emails he sent me earlier and last night)

Make of these what you will

This is one he sent last night:

----- Original Message -----
From: jim thomson
To: 'fiddaman'
Cc: 'Amelia' ; chris.manning@primhe.org
Sent: Monday, June 04, 2007 6:15 PM
Subject: RE: recent exchange

Hi Bob,

Thanks for letting me know. And thanks so much for ignoring the “without commentary from you” request. I figured you wouldn’t be able to resist it….

I trust the DVD business is going well? Or is it poetry? I forget. And perhaps you could ask your oppo how the Dundee fresh meat market is going…..

In any event, I will ignore your extremely clumsy summation of our exchange. It is beneath contempt. But I will offer this. You gave me the opportunity to say what I wished on your blog. In return, I offer you the chance to meet, face to face, with me. I will ask Chris and Amelia to do the same. I’ll even pay the bar bill. Face to face, eyeball to eyeball, no holds barred. I tell you what….I’ll provide the laptop and you get to provide the after-dinner movie. But please do make sure that it has a BBFC certification – I do hate those moody DVDs. Don’t you?

In the meantime, I am particularly gratified that you and your chums seem to think that now it is acceptable to question my anti-counterfeiting creds. Of course, it matters little to you that patients with prostate cancer, serious psychoses and major stroke/cardiovascular problems… are being harmed by taking fake medicines (all three in the last seven days – or don’t you read the news???) It is clearly MUCH more important that the conspiracy theory continues to gather pace. God forbid that the interests of someone with a terminal illness should get in the way of a good story or an even better lawsuit.

Go on, take me up on the offer. It’s good to talk. And, unlike some “expert witnesses”, I don’t charge a Monkey a time for my opinion. You people crack me up… but I am willing to be convinced of your motives….face to face.

I await your availability. Personally, I am ready to clear my diary. Can you say the same?

Jim

P.S. Congratulations on making the trip to OZ – quite an achievement for someone with your stated medical issues.


Jim Thomson is CEO for The Centre for Mental Health who proudly boast on their website:

"The Centre is a collaboration of all who share our values, bringing together and galvanising interested individuals, mental health organisations and leaders, patient groups, the media, corporate sector partners, and statutory agencies. It is designed to provide a beehive for policy and service development, giving everyone in mental health a voice. "

More of Jim's emails coming soon.

Bob

SO MANY QUESTIONS...NOT ENOUGH ANSWERS

Gentlemen - it seems, as you know, that GSK has looked at some of its Seroxat data again... and I'm sure it has nothing to do with Dr Breggin's report becoming public several weeks ago - nothing at all..........

I notice that the MHRA continues to support the use of the drug in the UK - when even GSK itself is backing off:

"GSK added warnings acknowledging that patients on the drug may experience persistently worse depression, or may experience emergent suicidality or symptoms that might be precursors to worsening depression or suicidality and these symptoms may be severe, abrupt in onset, or were not part of the patient's presenting symptoms."

The company advises doctors: "Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication."It seems that this data is anything between 10 and 15 years old (perhaps Dr Hudson, you could tell us EXACTLY how long GSK have been sitting on this data)

Anyway - who's to blame for this terrible situation....

GSK for not analysing the data properly in the first place?

GSK for analysing the data and then HIDING the results for so long?

GSK for lying to the MHRA and the public?

The MHRA for ignoring the huge amount of anecdotal evidence about the lack of safety of seroxat?

The MHRA for dragging its feet while 'investigating' GSK?

The MHRA for not wanting to stir up any trouble for its paymasters?

Ian Hudson for appearing to be complicit in what can only be described as a cover up?

Kent Woods for being as much use to the public as chocolate fireguard?

The Government for allowing the MHRA to continue to function in its present form?

So many questions - so few answers.

You see, the problem is, that I don't know the answers - but I'm sure that someone out there does....

Yours

Roger Cleghorn