Feeling very humble this morning

Last night I was out on the town – well not really, more like out at Waterston’s in High Street Kensington for the official launch of – The Pill That Steals Lives – a new book by Katinka Blackford Newman.

Of course the book is one thing (and I think you should go and buy a copy) but for me the highlight of the evening was meeting so many people who are campaigning to raise awareness of the problems that anti depressants can cause.

I say problems, but in reality the stories I heard were beyond belief and so very harrowing that I all I could do was to sit there quietly in tears… I urge you to read David Carmichael‘s story. It seems I got away with it. What I went through was nothing compared to what happened to some.

The pain and suffering in the room last night was matched only a sense of quiet anger and frustration. Anger at the drug companies for not stepping up and admitting what’s wrong with their ‘product’ and doing something about it, and frustration that we still don’t have our voices heard above the noise that is generated by the establishment. I was humbled by the great work others have done and continue to do.

And speaking of getting our voices heard – please have a look at AntiDepAware – it’s a great resource that we should all be supporting.

In the UK, the good news is that it looks like GSK want to go court. I for one think this would be a fantastic thing – the chance to bring everything out in the open and re-ignite the whole SSRI debate and put a spotlight on the arguments about what’s wrong with their entire business model – from the way they fix drug trials – to the way they market their drugs – to the suffering they have caused. A trial in the High Court in London will ensure our voices are heard.

I’m ready – bring it on.

 

 

Seroxat Group action – latest news

Great news about the Seroxat Withdrawal Group Litigation in England… we are on our way to trial! AT LAST!!

I’m sure if you read Bob Fiddaman’s blog you know already – see here – but I thought I’d wait until we had passed the time limit for GSK to appeal Mr Justice Foskett’s judgement to proceed with the Seroxat Withdrawal Group Litigation. That time has passed and there was no appeal… we are on our way to trial! AT LAST!!


If you happen to be one of the group claimants and you HAVE NOT received forms from Fortitude Law in the past 2 weeks, then you should contact Fortitude Law via email at lcorr@fortitudelaw.uk or telephone on 0203 667 3775 without delay.


I think I’ll say it again, just because I can … ‘Judgment has been received from the Honourable Mr. Justice Foskett to proceed with the Seroxat Withdrawal Group Litigation’. 

I think there must be quite a few people on the other side who really thought this had gone away, but I can tell them now to look out – it hasn’t gone away and it’s all too real. I’ve said before that, for me, a trial is the only to resolve this issue

The publicity of a High Court hearing will mean the mainstream press  will be free to report on ALL the evidence presented. Now… I’m thinking that this will mean a lot of GSK documents that have until now remained secret will become very public knowledge. You see a case like this, while common in the USA, is unheard of in the UK and the publicity it will generate will be huge. And all those once-secret documents and the information they hold will be available the world over for future claimants to use. I think a whole new raft of claims will be kick-started in the USA alone. I wonder what GSK’s share price will look like after all this? And how institutional investors will view a company that breaks the law and lies & cheats its way to profit?

In the 21st century, ethos & culture – the way a company actually conducts its business – are as important to a PLC as having a blockbuster product to sell. Ethos & culture are intrinsic parts of a modern corporate brand, going way beyond the generic, meaningless mission statement that we see from GSK.

I’d like to finish on a personal note. Perhaps, after all these years, I’m getting nearer to closure. For me, that simply means people will believe what happened to me was real.

More importantly, I hope that Doctors will understand what happened to me was real – and perhaps then we can start to help others who are going through the horrors of withdrawing from Seroxat/Paxil today.

 

 

What is GlaxoSmithKline still hiding from us – what is so important about the missing 9 pages?

Last week news broke in the New Scientist that Glaxo’s own researchers had been responsible for “an inappropriate analysis” of clinical trials that “obscured” suicide risks associated with Seroxat/Paxil for 15 years (see the court documents released last month).

Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.

An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it’s “virtually impossible” that GSK simply misunderstood the data.

Glenmullen’s report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public.

Read that last sentence again – “… the judge agreed to make parts of it public…”

What was released to the public was 83 pages of Dr Glemullen’ report – 9 pages have been withheld.

Over now to United States Senator Chuck Grassley, I think.

Senator Grassley has written to Mr. Christopher Viehbacher, President of GlaxoSmithKline (United States) asking for the missing nine pages. The full letter is here.

Part of it reads:

It is my understanding that 9 pages of Dr. Glenmullen’s report are not available publicly. Accordingly, please respond to the following questions and request for information. Please repeat each enumerated question and follow it with your response.

1. When did GSK first learn that Paxil was associated with an increased suicide risk?

2. When did GSK first report to FDA that Paxil was associated with an increased suicide risk?

3. When did GSK first notify patients and doctors that Paxil was associated with an increased suicide risk? Please provide all pertinent documents and communications.

4. Please provide the Committee with the complete, unredacted version of Dr. Glenmullen’s report. Along with that report, please provide the appendix and all documents that are referred to in the report, in the order that they are referenced.

5. Please provide the Committee with the accompanying children and adolescents report.

Now, I think at this point we should turn to Professor David Healy.

As an expert witness in the Schell/Tobin case, Professor Healy had been granted access to Glaxo’s archives and made shocking discoveries, so much so that on the 7 June 2000, he wrote to Dr June Raine of the UK’s Licensing body the MHRA.

“… All of their [GSK] healthy volunteer studies were supposed to have been made available to me but not all were. Of the ones that were missing there was trace correspondence left in once indicating that the investigator had never witnessed such a level of problems in a study with healthy volunteers. Another study was a single dose study which in a dose dependent fashion yielded a 75% rate of severe adverse events most of which involved the central nervous system. There were other disturbing indications from one of the other missing studies”.

“My testimony in this case also bore witness to sealed studies and other unreported data. It commented on the Montgomery Baldwin Study which yielded a projected rate of 45 suicide attempts in a group of recurrent brief depressive disordered patients on paroxetine per annum versus 12 on placebo. The figures were not statistically significant in great part one has to suggest because the company had terminated the study early. This termination and subsequent non-publication I would imagine the jury will have found and others will find significant.

In conclusion, Professor Healy wrote:

I think what will also be clear is that SmithKline Beecham recognised the presence of withdrawal syndromes in their volunteers from the early to mid 1980s. That withdrawal syndromes occurred at a much higher rate than occur on benzodiazepines. Nevertheless they applied for and have received from you and other regulators a licence to claim that their drug is effective in the prophylaxis of depression and these claims have been based on designs which almost certainly are designs better suited to show the presence of a withdrawal syndrome than designs suited to demonstrate prophylaxis in depressive disorders. A great number of people have in recent years been told that when they begin to feel ill on discontinuing treatment that this is the recrudescence of their mood disorder rather than a discontinuation syndrome from their drug. I would imagine that a great many such people and others on their behalf will feel extraordinarily let down and angry when faced with the evidence that I’ve been faced with”.

Anyone see a pattern forming here?

Senator Grassley has given GlaxoSmithKline until February 14 to respond to his letter…

GlaxoSmithKline hid suicide risks in clinical trial data… what do you think?

This from The New Scientist.

AN INAPPROPRIATE analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years, suggest court documents (897kb, requires Acrobat Reader) released last month. Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.

An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it’s “virtually impossible” that GSK simply misunderstood the data – a claim the company describes as “absolutely false”.

Glenmullen’s report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public.

The analysis focuses on the “washout” phase preceding a trial, when subjects stop taking most or all medications to avoid confusion with results from the trial itself. Because the washout occurs before patients randomly receive either the drug or the placebo control, adverse events during this time can’t be attributable to the trial and so are seldom if ever included in final results.

However, GSK researchers submitting data on Paxil to the US Food and Drug Administration in the late 1980s and early 1990s included suicides and suicide attempts from the washout period in the results for the placebo arms of trials, but not from the Paxil arms. Glenmullen alleges that these extra “placebo” suicides negated suicides attributed to Paxil in the trials, making the drug appear safer than it really was. He says that if the washout results had been excluded, the data would have showed that Paxil increased eightfold the risk of suicidal behaviour in adults.

GSK spokeswoman Mary Anne Rhyne says inclusion of the washout data “was intended to present the full picture of events that occurred in all phases of the clinical trials – starting from the time patients were enrolled, before they were randomised”. She says that even without the washout data, Paxil still came out as safe as the placebo in this trial. She accused Glenmullen of incorrectly analysing the data to reach the opposite conclusion, but didn’t respond to a request for numerical proof that Glenmullen’s verdict was wrong.

Glenmullen suggests that the FDA would have acted differently had the use of the washout data been made more explicit. Rhyne says that material still under seal shows the FDA to be fully aware of how the washout data was being used. But Glenmullen quotes Martin Brecher, the FDA official who reviewed Paxil’s safety, as agreeing during a pre-trial hearing that the use of the washout data was “scientifically illegitimate”.

Independent researchers say it was wrong to use washout data as GSK did. “I can’t imagine circumstances in which it would be appropriate,” says Bruce Psaty of the University of Washington in Seattle.

IN AN UPDATE FROM PHARMALOT: Chuck Grassley of the Senate Finance Committee has just written Glaxo seeking nine pages that weren’t made available with the unsealed documents. Here is the letter.

Seroxat increases suicidal thinking – it’s official – but what about addiction and withdrawal?

Seroxat increases suicidal thoughts – it’s official, or at least it will be official
from October this year. But only if you’re 25 years old or younger…

… if you’re older, even by a month or just a day, then you’re safe – so they
tell us and GlaxoSmithKline always tells us the truth, don’t you agree?

But no mention of withdrawal or addiction.

WARNINGS of the dangers of suicidal thoughts and behaviour are to be
included in the packages of anti-depressants in the UK. Warnings will be
carried in the patient information leaflet in the packets from October this
year.

The direction was issued yesterday (Tuesday) by the Government’s
Medicines and Healthcare Products Regulatory Agency. (MHRA)

A notice has been sent to drug manufacturers. It mentions a review by
the Food and Drugs Agency in America, which looked at bupropion,
citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine,
mirtazapine, nefazodone, paroxetine, sertraline and venlaxfaxine.

The review found no risk of higher sucidality in the general
population but said younger people were at higher risk and that there
were no differences in the risk between antidepressant classes.

A statement released by the MHRA says that the wording of warnings has
been agreed by the EU as has the time table for implementation.

The agreed wording reads:

“Thoughts of suicide and worsening of your depression or anxiety
disorder. If you are depressed and/or have anxiety disorders, you can
sometimes have thoughts of harming or killing yourself. These may be
increased when first starting antidepressants, since these medicines
all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

If you have previously had thoughts about killing or harming yourself.

If you are a young adult.

Information from clinical trials has shown an increased risk of
suicidal behaviour in young adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you
are depressed or have an anxiety disorder and ask them to read this
leaflet. You might ask them to tell you if they think your depression
or anxiety is getting worse or if they are worried about changes in
your behaviour.”

The news was greeted as a victory by anti-drugs campaigner, Janice
Simmons, a grandmother from Great Stukeley in Huntingdon.

Mrs Simmons told The Hunts Post on Tuesday: “I’ve won. This is the
result of eight years’ work. Warnings of suicidal thoughts and
behaviour will now be carried on all anti-depressants.”

Mrs Simmons, 57, began her campaign after she discovered that her
second husband, John had been prescribed Seroxat years before she met
him and since become addicted to anti-depressants. Her help-group –
the Seroxat User Group – has had tens of thousands of hits on its
website. Mrs Simmons has gathered information from across the world.
She has begun a dossier of case histories of tragic effects on people
who have been prescribed anti-depressants.

This year she had a meeting with the Prime Minister, Gordon Brown to
discuss the problem. However, she has always conceded that the drugs
can help some people.

One of the issues Mrs Simmons discussed with Gordon Brown was the
length of time (four years) that the MHRA has taken to investigate
allegations against the manufacturer of Seroxat, GlaxoSmithKline
.

It is alleged that the drugs giant withheld information that Seroxat
could cause suicide in under 18s. The allegations have always been
denied and GSK has said that Seroxat was never licensed for children.

Too little too late is what I say

An insider explains why Glaxo bought Reliant Pharma…

More from Cafe Pharma here.

The inside track?

“Talked with a home office insider he said that the main reason they went after Reliant is to postpone layoffs until the fall of 2009 when we lose a ton of patents. They want to squeeze every dollar out of the portfolio and keep the reps focused for the next 2 years. Just be prepared for late 2009, if nothing new gets approved it will all hit the fan.”

and another sales rep comments:

“Hey idiots – Lovaza is only indicated for patients with TGs greater than 500. How many patients actually fit this description? approx 5-15% of the cholesterol market, so any doc RXing it for tgs below 500 is ‘going off label’ (which is their right). The problem you will face at GSK is that your reps have the high power microscope of the gov’t on them and Reliant did not. Reliant was a scumbag company which openly promoted off label usage and was not a part of Phrma (even selling it for the pleotropic effects is off label). What does this mean? Well the GSK reps will have to watch what they say even more carefully and any reliant reps (all 4 of them) who manage to pass a competency test will find themselves held to a higher standard and be washed out. Unless you garner another indication your sales will soon plateau and eventually decline once Reliant is out of the picture.”

So now that Glaxo has bought Reliant (and Lovaza), I wonder how long it’ll be before we discover that Lovaza can treat many other illnesses.

How long until the rigged clinical trials start appearing that demonstrate just that?

Oh the irony of it – Glaxo buys Reliant Pharma for $1.65billion…

I see that GlaxoSmithKline is going to pay $1.65 billion to buy U.S.-based Reliant Pharmaceuticals, a privately held drug maker that specializes in cardiovascular remedies…

That’s handy, because Glaxo’s drug Avandia seems to cause heart attacks – at least that’s what the FDA thinks and it has recently forced Glaxo to amend Avandia’s existing black box warning to add the FDA’s conclusion that a meta-analysis of short-term studies showed an association between Avandia and an increase in myocardial ischemic events – that’s heart attacks in plain English.

That all gives the Reliant deal a kind of symmetry, don’t you think?

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