Monday 29 April 2019

Yes, that’s next Monday. 

That’s four days away.

It’s the day that the trial starts in the UK… I’m talking about the High Court action against GlaxoSmithKline that is being taken by a group of UK patients who are determined to finally have their day in court confronting GlaxoSmithKline.

It has been a long slog with many false starts but we have finally, finally made it. 

Over the years there were times I really did think that we would never get to court. But we have and I for one am ready.

And this time GSK, it’s personal.

Let’s shine a light under this particular stone and let the press and public see what GSK has been trying to keep hidden for all too long.

Throughout the many years the group has been pursuing its case, it has been unedifying to watch GSK and their lawyers squirm and obfuscate as they tried to avoid this trial. But that’s only part of it – along with GSK’s refusal to ever admit Seroxat could be a dangerous drug for many people to take; along with their illegal drug marketing activities; along with their hidden trial results, there’s one thing I never quite understood.

Why, oh why, did GSK never produce Seroxat tablets in small doses – say 0.5mg and 1mg? 

This simple step would have helped many hundreds of thousands of patients worldwide to more safely wean themselves off the drug. Instead we had to use liquid Seroxat in order to slowly reduce doses by tiny amounts. 

Of course the liquid version was more expensive and so more difficult to get doctors to prescribe.

Anyway back to Monday… this from Fortitude Law who are representing the claimants in the Group:

Following the halt of the Seroxat Group Action in 2010 when public funding was withdrawn, Claimants determined to continue with their claims for compensation have turned to Fortitude Law. We are now set to return to Court and confront GlaxoSmithKline (UK) Ltd. with evidence of the harm they suffered as a consequence of having become dependent upon the antidepressant, Seroxat. Fortitude Law is working with Counsel Jacqueline Perry QC and Niazi Fetto, 2 Temple Garden Chambers, London to represent 105 Claimants in their High Court claims.

Patients were reassured by their GPs that unlike other antidepressants, they would be able to stop taking Seroxat whenever they wanted. Instead, over 6,000 individuals advised their GPs that each time they reduced their dose they suffered bizarre and debilitating symptoms not previously experienced. These symptoms often included impulsive suicidal thoughts, thoughts of self harm and uncharacteristic aggressive behaviour. Their withdrawal symptoms were so severe that the only way they could be avoided was to return to their previous daily dose. Several of the current Claimants were minors at the time they were prescribed Seroxat for transient mental healthcare problems.

Moreover, women who became dependent upon Seroxat delayed or decided not to start their families upon learning that Seroxat had the potential to harm their unborn infant ‘in utero’.

Several Group Actions have been settled in the US following Court proceedings related to harm caused to individuals who had become dependent upon Paxil (Seroxat in the UK) – an FDA approved and prescribed antidepressant.

“It is ironic” says Claimant Bob Fiddaman “this British company has compensated Americans for the harm caused to adults and children who became dependent upon its antidepressant Paxil (Seroxat) yet UK citizens have had to fight for years to have their case heard. We may now only be a group of 105 Claimants but we are determined to gain compensation for the harm caused to us.”

To see the genesis of this litigation, which first commenced with the BBC’s Panorama Programme ‘Secrets of Seroxat’ first shown in 2002, visit news.bbc.co.uk/2/hi/programmes/panorama/2310197.stm

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What makes Prof David Baldwin such a bad doctor?

So David Baldwin still insists that the vast majority of patients can stop Seroxat in a couple of weeks and they won’t experience anything more than unpleasant symptoms…

However, the All Party Parliamentary Group for Prescribed Drug Dependence review suggests half of patients have withdrawal symptoms and for half of these the symptoms will be severe.

Patients should be properly warned, it says. Official guidance says symptoms are usually mild and clear up in a week. But the reality is it’s not uncommon for side-effects to last for weeks, months or years in some cases.

The review authors, Dr James Davies, from the University of Roehampton, and Prof John Read, from the University of East London, say about four million people in England may experience symptoms when withdrawing from antidepressants, and about 1.8 million may experience these as severe.

Dr Davies said: “This new review of the research reveals what many patients have known for years – that withdrawal from antidepressants often causes severe, debilitating symptoms which can last for weeks, months or longer.”

“Existing NICE [National Institute for Clinical Excellence] guidelines fail to acknowledge how common withdrawal is and wrongly suggest that it usually resolves within one week. This leads many doctors to misdiagnose withdrawal symptoms, often as relapse, resulting in much unnecessary and harmful long-term prescribing.”

Surely by 2018 we have got to the point where doctors such as Baldwin can no longer ignore the fact that these drugs do a lot of damage to a lot of people. 

1.8 million people.

Everything in the garden isn’t rosy – but Baldwin thinks it is. 

He allows no room for discussion – what happened to me and so many others during withdrawal from anti depressants has no place in Baldwin’s world and that is what makes him such a bad doctor. 

Prof David Baldwin, Prof Wendy Burn & the Royal College of Psychiatrists.

So, I came on this via twitter. It features Prof David Baldwin, Prof Wendy Burn and the Royal College of Psychiatrists.

I think it’s time to get my soapbox out again… 

I take issue with quite a few things in this story, the most outrageous claim being the assertion made by Baldwin & Burn that “… In the vast majority of patients, any unpleasant symptoms experienced on discontinuing anti-depressants have resolved within two weeks of stopping treatment…”

It is very worrying that in 2018 two very high profile mental health professionals can make a statement that is quite so wrong – and dangerous. I really did think we had got beyond this kind of muddle-headed stupidity. And as for Baldwin representing the Royal College of Psychiatrists on an Public Health England expert panel reviewing prescription drug addiction – well, words fail me on that one.

Why would they say something like this? Do they have an agenda? Are there any conflicts of interest that could possibly be in play? 

Or are are they just plain stupid? I have to ask this, as I’m the expert – at least I presume I am – as I guess that Baldwin and Burn have never taken Seroxat and then had to suffer the hell of withdrawal as they tried to stop taking it. I’m not talking about a few “unpleasant symptoms” that “resolved in two weeks” but rather almost two years of absolute horror – physical and emotional – as I slowly reduced the amount of Seroxat I took. 

And I’m not the only one. I suggest that Baldwin and Burn read some of the comments on this blog or take a look at the Facebook group ‘Paroxetine Paxil Seroxat SSRI Withdrawal’ – or maybe just open their eyes and do some research of their own. Maybe even design some proper research. I would think that with Prof Baldwin’s contacts with drug companies perhaps he could get them to pay for the study… or maybe not in this case!

And if we are going to talk about “the vast majority of patients” then it should be in the context that the vast majority of patients do, in fact, often have terrible problems trying to come off Seroxat and other anti-depressants. 

I would ask Baldwin (and Burn) to understand and admit that SSRI withdrawal is a very real problem for many millions of people around the world. Listen to your own colleagues such as Prof Healy or Prof Read – because I know you still don’t really like it when patients talk back at you and have the temerity to question your ‘knowledge’. 

Yes, I am still angry after all these years and no I don’t think I am fully recovered even today, so please forgive me if you see this as just more “vile taunts” or yet another part of “a sustained campaign of abuse”. But I would suggest that the first step for doctors like Baldwin and Burn (and many in the Royal College of Psychiatrists) is to acknowledge the anger of patients who have been so badly let down by the medical establishment and the drug manufacturers, often working in tandem in pursuit of profit – both corporate and personal. 

Then listen to us. 

On a personal level, I think it’s a good thing that Baldwin has resigned from the PHE review panel. His opinions are clearly suspect and his knowledge lacking – and there are further question marks over his close financial ties to drug manufacturers. 

The Daily Mail summed it up like this “A government drugs adviser has been forced out of his position after a sustained campaign of abuse saw him branded ‘worse than Hitler’ and a ‘pharma-whore’, it emerged last night. Professor David Baldwin was subjected to the vile taunts after he wrote an open letter to a newspaper playing down the side-effects of coming off anti-depressants”.

A more measured piece was this from The Times

Me – I think the man’s a fool and wonder what his real motive was for resigning. 

Absolutely nothing to do with ties to drug companies I should hope.

A history of SSRIs

This is a re-post from something I wrote in March 2007 – on reflection, perhaps it should be more accurately entitled A History of SSRIs and the Damage they do to Patients.

I think there may well be a lot of discussion in the coming months about Seroxat dependency and the terrible withdrawal symptoms that many people have to endure as they try to stop taking Seroxat and so I think that the download – A History of SSRIs  is more relevant today than ever.

Looking at my original post, I was remiss as I didn’t credit the author of the download – so belated apologies to Prof David Healy (I think it’s his piece).

Now read on:

Over the years I have collected a few interesting documents and I think it’s just plain selfish to keep them to myself so I’m starting to share them with you.

The one for download here – A History of SSRIs is exactly what it says it is… a history of SSRIs.

You can read about the first SSRI – Zelmid – which was patented in 1972 and made it to market in 1982 before any of the others. I suppose not many of you remember Zelmid though as it was discovered in rare cases to cause a serious neurological disorder called Guillain-Barré Syndrome. This potentially fatal disorder led to the immediate removal of the drug from the market.

But Astra had already begun the development of a derivative of Zelmid, called alaproclate, when Zelmid ran into trouble. Alaproclate was being investigated for both depression and Alzheimer’s disease. But it caused liver problems in one strain of laboratory mice and this was enough to lead Astra to drop it. Shortly after this, Astra introduced an innovative antipsychotic, remoxipride, which looked like it would have significantly fewer side effects than older agents. Several months after its launch, however, remoxipride was reported to cause aplastic anemia in a small number of people and it too was withdrawn.

Notice a pattern here?

And did you know this about Prozac? As Eli Lilly were trying to launch Prozac in Germany they came up against a slight problem with the view of the German regulators on fluoxetine (Prozac) as of May 1984: “Considering the benefit and the risk, we think this preparation totally unsuitable for the treatment of depression”.

A History of SSRIs is an enlightening document – with a large section on Seroxat…

 

 

What I believe

I believe Seroxat is defective and dangerous.

I believe that Glaxo has hidden clinical trial data that shows exactly how dangerous a drug it is.

I believe that Seroxat is addictive.

I believe that Seroxat can cause anger, aggression and violence.

I believe that something must be done to help people who suffer terrible problems with withdrawal, as they desperately try to stop taking Seroxat.

I believe that doctors have taken large sums of money from Glaxo to lie about the efficacy and safety of the drug.

I believe that GlaxoSmithKline puts profits before patients – their wealth before our health.

I took Seroxat for 9 years and it took me 22 months to withdraw from the drug little by little.

Believe me – I know what I’m talking about.

Stephen Whitehead, ABPI – missing the point completely

I read this article in the New Statesman today and made me really quite annoyed…

It featured a letter written to the New Statesman by the CEO of the Association of the British Pharmaceutical Industry (ABPI), Stephen Whitehead, as a response to issues Ben Goldacre’s new book, Bad Pharma.

It’s amazing just how stupid a response it is – in fact I have to ask if Stephen has actually bothered to read the book at all or if the’s just gone into classic big Pharma knee jerk mode (after all, Stephen did spend 10 years of his career working at Glaxo and Eli Lily).

But no matter, as the New Statesman has printed Ben’s reply to the response.

However the comment I really found strange from Stephen Whitehead was this “…references to companies (GSK, Lilly, Pfizer) being fined are all examples from the US and simply not relevant to the UK market…”

GSK’s fine was, to remind you, the largest healthcare fraud settlement in history at $3bn.

How it isn’t relevant to the UK is beyond me – because what we’re talking about here is not just illegal marketing of drugs – not just bribing doctors to prescribe GSK products – what we’re talking about here are dead people.

Patients died because they were taking drugs that weren’t safe, drugs that weren’t even approved for their treatment.

In the case of Avandia, the drug is so dangerous that it can no longer be prescribed in Europe – it had to be withdrawn from the market because of high levels of heart attack, heart failure and stroke in patients. It had to be withdrawn from the market because it killed too many people.

How’s that “simply not relevant” to patients in the UK, Stephen?

Should we trust GlaxoSmithKline – and Andrew Witty…?

Trust GlaxoSmithKline?

Trust GSK? – you must be mad.

Sarah Boseley in The Guardian writes:

“The British drugs company GlaxoSmithKline is to open up the detailed data from its clinical trials to the scrutiny of scientists in a bid to help the discovery of new medicines and end the suspicions of critics that it has secrets to hide.

In a speech today [11 Oct] to the Wellcome Trust in London, the chief executive, Andrew Witty, will say openness to the public and active collaboration with scientists and firms outside GSK are essential to finding new drugs to treat the diseases plaguing the world, from novel antibiotics to cures for malaria and tuberculosis.

He told the Guardian GSK had already done much to advance transparency in clinical research, including publishing a summary of every drug trial – whether a success or not – on its website

Said Sir Mark Walport, director of the Wellcome Trust – “In its commitment towards more openness and collaboration, GSK is setting an example of how the pharmaceutical industry must adapt to help drive forward medical advances. Real breakthroughs do not come out of nowhere, but are borne of scientists sharing their knowledge and learning from each other. GSK’s moves are bold and innovative, a very positive sign of its commitment to tackle some of the greatest health challenges facing the world today.”

But hold on a minute – Dr Ben Goldacre’s not sure about GSK :

“But we should judge drug companies by their actions, not by their promises, especially when similar promises have been made in the past, and then broken.

In 1998 GlaxoWellcome promised to set up a clinical trials register, amidst outcry over withheld trial results. But when the company merged with SKB to create GSK, in 2002, this register was unceremonially deleted from the internet. This tragic story is described in an excellent open access article on this history of attempts to get access to hidden data, by Iain Chalmers.

Then, in 2003, GSK were caught withholding clinical trial data showing that their drug seroxat increases the risk of suicide in young people. As part of the settlement on fraud charges, in the US in 2004, GSK were forced to promise to post all trial results on a public website. But in 2012 GSK paid a new $3bn fine for criminal and civil fraud: this included charges over withholding data on the diabetes drug Avandia, as late as 2007, well after this earlier promise of transparency was made”.

That’s a pretty poor record, I’m sure you’ll agree.

As far as GSK is concerned, talk is cheap and promises are routinely broken with no compunction whatsoever.

 

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