7 Years... RIP Big Man

Stuart Adamson

11th April 1958 - 16 December 2001

BIG MAN

Such pleasure you gave me with your prose
Now you have been flung just akin to the rose.
The hills seem so distant, the clouds have departed
Into the valleys of the broken hearted.


With your back against the wall all you saw was pain
Not even the Big Man could find strength to abstain.
The perils of booze was clear, the despair became threefold
Now all that’s left is memoirs of a chronicle left untold.


It must have been so lonesome, you must have felt so sad,
Trying to evaluate the good from the bad.
The choice was not yours, which I can recognize
So short your years devoid of compromise.


The angels are singing, home came their own
Upon the hills with your name cast in stone.
Thanks for all you gave me in that all you knew
But most of all Big Man thanks for being you

© BOB FIDDAMAN

Fid

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Antidepressants May Damage More Sex Lives

"Dr. Cigdem Tanrikut a Massachusetts General Hospital urologist, reported last month at the annual meeting of the American Society for Reproductive Medicine that when 35 normal, healthy men were put on Paxil for five weeks, up to 35 percent of them reported new problems with erections and up to 47 percent reported difficulty ejaculating while on the medication."

FULL STORY

Comment:

Problem after problem yet it still remains on the market. One would have thought that the 'norm' would be to pull a product from the shelves until it had been rigorously re-tested for the infinite amount of adverse reports coming in about it. But here we are in 2008, some 20 years after it's launch and it is still being prescribed.

Perversely, Glaxo can use this latest report as marketing spin, Seroxat can be promoted as a cure for premature ejaculation. Like all good marketing teams they can turn this negativity into spin.

For a drug that supposedly helps people with an array of mental health problems it sure does create a lot of problems along the way.

What can be more frustrating than not being able to gain an erection...and even if one does, what's even more frustrating is the wolf will knock at the door but his rat-a-tat-tat will go unnoticed.

Frustration:

1. a. The act of frustrating or an instance of being frustrated.
b. The state of being frustrated.

2. Something that serves to frustrate.

I think we can agree that frustration can bring about anger and maybe infidelity too. Women like to be pleasured by their partners, if their partners cannot even get aroused then suspicion steps up to the plate - it's human nature.

Seroxat was quickly launched because Glaxo [then SmithKline Beecham SKB] saw a lucrative gap in the market. Prozac was getting a bad rap from some quarters and SKB saw this as a great time to push a drug that, it seems, had not been fully tested. The minute adverse reports started appearing should have been a wake-up call for the regulators but they sat back and largely ignored patients.

It's clear now, through the power of the Internet and media, that Seroxat has been responsible for children and adults killing themselves, for causing severe withdrawal problems, it may even be responsible for causing acts of violence. It is abundantly clear to me that Seroxat is not the saviour that SKB would have liked us all to believe when they pushed it on to the shelves all those years ago. Back then, they blamed Pharma rivals, Lilly, for muck spreading. It seems when anyone speaks out against this particular SSRi GlaxoSmithKline have either defended it with ghost written articles from fraudulent psychiatrists, defended it by using spokespersons employed by them or threatened people with legal action if they dare speak out against it.

In and out of court in the United States they have settled Paxil [Seroxat] litigation by paying claimants but restricting what these claimants can tell the press with gagging orders. Court documents have been sealed under file to keep the truth from the public, files that could sway your doctor's decision whether or not to prescribe you Seroxat.

And here we have the likes of me, banging the drum to tell our regulator [MHRA] that there is a problem with Seroxat [and SSRi's in general]. On that front, I am pleased that Kent Woods, the CEO of the MHRA, is now aware of the problems as are his staff at MHRA HQ. Some may say that he should have known years ago, my thoughts on this are crystal clear, the MHRA's Yellow Card reporting system DOES NOT work. It is old fashioned and about as useful as an electric blanket made from chocolate.

One cannot miss the fact that the MHRA have failed along the way to take patient reporting seriously. Their board are stuck in the 1960's, still sticking to MCA [Later to become MHRA] policies. The MHRA need an injection of new blood, new talent, open minded folk who will listen and act upon patient reports, fears. The MHRA HQ in London quite literally has cobwebs growing on cobwebs. It's hard to verbally attack stubborn people because the more you attack and tell them that they are wrong, the more stubborn they become. Sir Alasdair Breckenridge, Chairman of the MHRA, is a classic example. He, along with others at the MHRA, are stuck in a time warp where secrecy should be kept within the walls of MHRA HQ because that secrecy hides the failings and poor operations of these stubborn individuals.

So, here we have another paper regarding SSRi's and sexual dysfunction, another paper with another adverse reaction. It won't ruffle the fathers of GlaxoSmithKline, same way telling a murderous psychopath that killing is wrong, I see GSK as an entity, an entity that is a walking, talking psychopath. I see certain members of the MHRA board as diciples for Pharma who, over the years, have been brainwashed into believing that patient opinion means nothing. It's time for those individuals to sweep off the dust and step into the 21st century and come to terms with the fact that it is we who experience the effects of these drugs and not the Pharmacology Departments at Pharmaceutical companies such as GlaxoSmithKline.

There is... and always has been a problem with Seroxat.

Fid

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Seroxat discontinuation [SKB - "They last up to two weeks"]

Two videos for GlaxoSmithKline here. An example of what your drug, Seroxat/Paxil can do to people... but I'm guessing that you already know?

...and two months later...

Excerpt from SmithKline Beecham Internal file - Section 3 Issues Management:

Discontinuation Symptoms with Seroxat/Paxil

Discontinuation symptoms following Seroxat/Paxil use are predictable

They occur within the first week of stopping medication

They last up to two weeks

They are unlikely to be confused with relapse or recurrance

Not content with the above nonsense, SmithKline Beecham then go on to blame Pharmaceutical rivals, Lilly, for the fuelling of publications and discussion about Seroxat discontinuation. Page 8

At least back then they were blaming their rivals... they now seem to blame the patient or doctor. They have never once held their hands up and took responsibility.

GSK [formerly SmithKline Beecham] proudly boast the following:

"We have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer."

..and I've just saw a pig fly past my window!

Fid

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FOR GLAXO!

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Effectiveness of paroxetine in the treatment of acute major depression in adults

Among adults with moderate to severe major depression in the clinical trials we reviewed, paroxetine was not superior to placebo in terms of overall treatment effectiveness and acceptability.

2008 paper






Paroxetine Effectiveness - CMAj 2008

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ANALYSE THIS GLAXO!

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Glaxo accusing Lilly and Pfizer of marketing ploys?

Tell me now, because my memory is quite distorted but didn't GSK first tout Seroxat as a drug to cure shyness?

The words, pot, kettle and black spring to mind.

It's like one big game for the boys isn't it. It seems the main objective in this particular paper is to slag off Lilly and Pfizer.

The 'discontinuation syndrome' issue is downplayed time and time again in this file, rather than see this as an issue, it seems, GSK, then SKB, would rather play 'My dick is bigger than your dick' with Lilly and Pfizer.

Then we have this utter nonsense:

Discontinuation symptoms with Seroxat tend to occur with 2-5 days and resolve within 2 weeks?

Are you kidding me?

Point 6 of this paper claims: "Discontinuation events are not a major clinical issue, but are being used as a commercial smokescreen by Lilly in an attempt to retain market share"

NO GLAXO, They are being reported by patients worldwide, this has nothing to do with competition with Lilly. If anyone is using a commercial smokescreen it is YOU with this utter garbage about Seroxat discontinuation symptoms resolving themselves with 2weeks!

So, we can take it from this particular file that your reps went on the road and told doctors over dinner [dine & dash] that Seroxat was the dogs bollocks.

You knew there were discontinuation problems with Seroxat but you played them down by accusing Lilly of using a commercial smokescreen. Was that how the conversations went with your reps and doctors?

Face it Glaxo, you hoodwinked a nation, you hoodwinked my doctor, you put me through a personal hell regarding withdrawal, you also put these people through a personal hell, all because you were playing the 'big dick' game with Lilly and Pfizer.

I understand that SKB/GSK was/is a business and all businesses prime goal is to make money. Where YOU have messed up here Glaxo is by promoting and marketing a drug that has caused needless suffering. What is even more shameful is that you have sat on this information for years, meantime, patients have gone to their doctors, complained of zaps, aggression, intolerance to loud noises, suicidal thoughts, homicidal thoughts and a whole host of others. Their doctors, merely increase the dose, which in turn increases the Stirling silver for you.

You have duped the medicine regulators in the UK regarding what I like to term, the withdrawal issue on Seroxat, withdrawal as you know means dependence, dependence in turn would suggest addiction - that is the only reason you use 'Discontinuation Syndrome' isn't it Glaxo?

The game is up Glaxo. Seroxat made you an obscene amount of money, a profit of despair for hundreds of thousands of your customers. Even now, some of your customers have been free from the stranglehold of Seroxat, they still suffer. Long term use of Seroxat has never been investigated has it Glaxo? Whist you reaped the rewards we [your customers] put our faith in you. You abused that faith by turning the tables on your rivals in the Pharma sector. Your cash cow made you blind, it made you forget what medicine is all about. £££ signs drove you on, not the fact that you had manufactured a tablet to actually help people.

There are some callous people in this world, in my opinion, there are none more callous than you. Ruining people's lives and denying that you had any part in it is a despicable act, putting the onus on doctors to cover your own ass is pretty shameful too. I hope Andrew Witty reads this, I hope JP Garnier spends his retirement money [money the consumers gave him] without a conscience.

We may be the small people Glaxo, we may be David and you our Goliath but slowly and surely we are knocking down the walls of suppression, slowly but surely we are winning over the medicine regulators.

Our day will come Glaxo and the day I see you hang your heads in shame will be the day I stop writing about your unethical practices.

Fid

Previously Unseen GSK Internal Files

The following files have been uploaded to Christopher Lane's website.

This Paxil Fact File, containing confidential information, was drafted and distributed by SmithKline Beecham in 1998--for internal use only.

Christopher discusses the consequences of this material in his recent book, Shyness: How Normal Behavior Became a Sickness (Yale, December 2008) and that the book also reprints a litany of unpublished, internal, and similarly damaging internal documents at the American Psychiatric Association over how social phobia and 111 other new disorders came to be approved in 1980 for the third edition of its diagnostic manual (DSM-III).

PaxilFactFileForeword

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PaxilFactFileSection1

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GSK.confidential.2001

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Paxilcr Pm

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Section2.Social.anx

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Section3.Issues.management

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Paxil.litigation

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How GSK Spun Seroxat

Revealed: secret plan to push happy pills

Source: The Observer

Britain's largest drug company drew up a secret plan to double sales of the controversial anti-depressant Seroxat by marketing it as a cure for a raft of less serious mental conditions, The Observer can reveal today.

The contents of the 250-page document have alarmed health campaigners who accuse the firm, GlaxoSmithKline (GSK), of putting profit before the therapeutic needs of patients by attempting to broaden the market for the drug which has been linked to a spate of suicides.

The revelation is likely to prompt further concerns about the role and influence of the pharmaceutical industry, which has come under severe scrutiny in recent months. The document is now being investigated by a parliamentary inquiry into the drugs industry. The internal report carries a section which outlines how GSK planned to double sales of 'selective serotonin reuptake inhibitors (SSRI)' - the industry term for anti-depressants - by winning the marketing war against Seroxat's chief rival, Prozac, manufacured by Eli Lilly.

Written in 1998 and subsequently updated in following years, the section is entitled: 'Towards the second billion - all SSRIs are not the same' and discusses strategies to see off the threat posed by Prozac.

The document outlined how GSK intended to market Seroxat for a range of conditions other than clinical depression. Chief among these was a condition the company identified as social anxiety disorder, although other forms of anxiety were also discussed internally.

'What this document makes clear is that a number of different forms of anxiety were being targeted in a systematic way. The thrust was to move sales beyond the $1 billion to $2 billion mark by pushing it to people who were not clinically depressed,' said Professor David Healy, a psycho-pharmacologist at Cardiff University, who has given evidence to the House of Commons Health Select Committee.

Richard Brook, chief executive of Mind, the mental health charity which submitted the document to the committee, told the MPs it was 'all about developing new conditions for that drug and demolishing the arguments of other competitors about why their drug was not any good'.

In addition the document shows GSK made a great virtue of the fact that Seroxat had a relatively short 'half-life' compared with Prozac, an argument which has subsequently proven deeply controversial.

A half-life is the scientific term for how long it takes for the concentration of a drug to drop by 50 per cent in a patient's bloodstream. The company suggested Seroxat's short half-life meant patients could come on and off the drug easily, compared with those on Prozac, even to the extent that they could take 'treatment holidays'. 'There was an argument that a short half life was really good news,' Brook said.

'But five years later, Seroxat has withdrawal issues. It's the short half life that causes the problems. The substances get into the body so quickly it causes some sort of dependency reaction. So one of the things the company was saying was a benefit was actually a problem.'

In its submission to the parliamentary committee Mind said the original trial data submitted to the UK regulators by GSK showed the claim was at best 'naive and at worst seriously misleading'. It added that 'the Seroxat file is highly illustrative of using marketing information as facts'.

Concerns about the addictive properties of Seroxat saw the government ban its prescription to people under the age of 18 last year. This followed a review which found children taking it were more likely to self-harm or commit suicide.

A spokesman for GSK said Seroxat could be marketed at new conditions only after stringent testing. 'Medical authorities around the world have required that GSK study each condition separately in order to prove benefit in each condition specifically.'

Coming Soon to this blog - Some of the above files

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The effect of rate of antidepressant

This recent paper was sent to me by a reader and friend of Seroxat Sufferers. I think it clearly shows just how difficult SSri's are to taper from, in particular, Seroxat [paroxetine]

The effect of rate of antidepressant tapering on the incidence of discontinuation symptoms: a randomised study

Abstract

Twenty eight patients treated with selective serotonin reuptake
inhibitors /venlafaxine were randomized to a three-day (short) or 14-day(longer)anti–depressant taper and openly assessed after a five to seven day drug-free washout, and again after seven days treatment with a new anti–depressant of the treating clinician’s choice. A ‘discontinuation syndrome’ (3 new symptoms on the Discontinuation Emergent Signs and Symptoms checklist) occurred in 46% of patients with a similar frequency in those with short (7/15) versus longer (6/13) taper. Patients initially on short half-life anti–depressants had significantly greater increases in discontinuation and depressive symptoms than those stopping fluoxetine. Four patients, all on paroxetine, developed emergent suicidal ideation after taper. These results support the importance of half-life in determining discontinuation symptoms and suggest that there is little advantage to a two-week taper over a three day taper when switching antidepressants. Antidepressant discontinuation in depressed patients can be associated with worsening depression and increased suicidality.

The paper can be downloaded here. Pay particular attention to:

"We found that the increase in discontinuation symptoms was less
marked with fluoxetine than other shorter half-life SSRIs and that
the highest incidence of a discontinuation syndrome occurred with paroxetine."

Fid

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

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Drug Treatments for Social Anxiety

Source Christopher Lane

In the 1970s, when it first developed Paxil as an antidepressant, GlaxoSmithKline (then SmithKline Beecham) was so unimpressed by the results that it considered shelving the drug.

But in 2000, the year after Paxil received FDA approval to treat social anxiety disorder, GSK spent $92 million pushing Paxil as the remedy—almost $3 million more on advertising than Pfizer spent that year on Viagra.

Paid consultants (some receiving fees from up to 17 different drug companies) were prepared to say that almost one American in five experiences social anxiety disorder in particular, and nearly one-third of the country suffers from some form of anxiety disorder.

That first figure was based on a study involving randomized telephone calls to 526 urban Canadians. Their self-reported levels of social anxiety resulted in percentages ranging from 1.9% to 18.7%. The higher figure was widely reported in subsequent literature, as a claim about the likely social anxiety prevalence rates in the U.S overall.

GSK has spent over $165 million in class action lawsuits since Paxil received FDA approval in March 1999 (Business News, March 28, 2006; Washington Drug Letter, April 3, 2006).

GSK continues to call the drug “safe and well-tolerated,” even after acknowledging, in a confidential memo quoted in Shyness, that one-in-five patients suffers mild-to-serious side effects from Paxil.

Information about some of those side effects was withheld from the public.

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

By Bob Fiddaman

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GSK Internal Documents [Seroxat]

Christopher Lane, author of the book, Shyness: How Normal Behavior Became a Sickness, has uploaded two unseen GSK internal documents, at least I've never seen these particular two before.

It looks like they are part of the infamous money bag documents that leaked out some time ago.

They make a very interesting read in as much one can see that GSK, then SmithKline Beecham, really wanted to promote Seroxat because they knew they were on to a nice little earner.

The Foreword was written by Paul N Jenner MD, he writes:

Seroxat/Paxil has shown outstanding success since its first launch in 1991 and now represents one of SmithKline Beecham's biggest and most important assets. Worldwide internal flash sales in 1997 exceeded £1 billion, and history was made in the US when Paxil became SB's US's first billion-dollar product. Through our highly skilled sales and marketing efforts we have demonstrated that we can overtake fluoxetine and sertraline to become number one and achieve our aim of marketing the world's biggest selling antidepressant. This has already happened in a number of markets, and the promise of new indications and further reinforcement of Seroxat/Paxil's unique positioning as the best agent for treating depression and depression with associated anxiety symptoms brings this goal ever closer.

Thank you for all your efforts to date. As we enter the new millennium, we look forward to making Seroxat/Paxil's SB's first £2 billion product.

Paul N Jenner
Director and Vice President
Neuroscience
World Strategic Product Development

****

As you can see, there is no mention of how this drug can help people, it is merely a memo of sorts to the employees of SKB thanking them for their efforts. This is all about money, it has nothing to do with how safe the product is.

It's interesting to learn that Paul N Jenner's name also appears on the publication - WO/1999/003469, TREATMENT AND PREVENTION OF CARDIAC DISORDERS USING SELECTIVE SEROTONIN RE-UPTAKE INHIBITORS (SSRI)

The claims of this publication are:

Claims 1. A method for treating and/or preventing cardiac disorders in human or non-human animals, which method comprises administering an effective, non-toxic amount of an SSRI or a pharmaceutically acceptable salt thereof, to a human or non-human animal in need thereof.

2. Use of an SSRI or a pharmaceutically acceptable salt thereof in the manufacture of a medicament for use in the treatment of and/or prevention of cardiac disorders.

3. A method according to claim 1 or use according to claim 2 wherein the SSRI is selected from the group consisting of paroxetine, fluoxetine, citalopram and fluvoxamine.

4. A pharmaceutical composition for use in the treatment and/or prevention of cardiac disorders which comprises an effective amount of an SSRI or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier.

The second file available on Christopher Lane's site is entitled 'Towards the Second Billion -- All SSRIs Are Not the Same'.

The most interesting find, for me at least, was the wording of the last paragraph:

Seroxat/Paxil - efficacy across the depression - anxiety spectrum

It is well accepted that psychiatric patients do not present with neat clusters of symptoms. Rather the clinician often has to play 'detective' in eliciting which symptoms predominate and thereby understand what the primary diagnosis might be. The efficacy of Seroxat/Paxil across a wide range of symptoms and often overlapping diagnoses helps substantially in removing the potential for confusion and inappropriate management. This positioning has been very successful in many markets.

This is all one huge game. I have said it all along, I made my feelings crystal clear to Kent Woods, CEO of the MHRA when we met back in September. The onus is put on doctors, doctors that have inadequate training when it comes to spotting whether someone is deeply depressed or merely just feeling a little down. SKB's internal document shows how doctors all over the world are being manipulated and used as pawns in one of the biggest scams in the history of medicine.

Men, women and children have died as a result of taking Seroxat. Babies have been harmed, families have been ripped apart, needless withdrawal suffering continues to this day because SKB put profit before patient safety.

Seroxat is still being prescribed all over the world, the evidence that has been presented to the FDA, TGA and MHRA clearly shows that SKB's mission wasn't to make people better, it was merely to make billions of pounds.

This is utterly shameful. I spit in the direction of SKB/GSK for the wanton disregard of human life they have shown regarding Seroxat.

I have sick in my mouth as I write this. SKB/GSK disgust me!

Fid

Hat Tip - Furious Seasons

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

By Bob Fiddaman

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An open letter to Andrew Witty... Top Dog at GSK

Dear Mr. Witty,

Welcome to GSK, it's been a while but I feel i must congratulate you on your appointment as the 'Top Dog' at GSK. You have quite a reputation to live up to with your predecessor, Jean Paul... [ahem] Pierre, Garnier.

First of all Mr. Witty, you have my commiserations. Old JP left you right in the brown stuff didn't he? He must be so embarrassed at his failure...I'm sure the payoff softened the blow though.

Now, Mr. Witty, let's move on to matters at hand. Let's talk about Seroxat, the drug your company manufacture/manufactured and bestowed on the public.

Are you aware Mr. Witty that your company manufactured a drug that completely ruined my life? Are you aware that GSK's Seroxat is STILL being prescribed to children because of the failure of your company to issue stringent warnings to doctors that Seroxat SHOULD NEVER be given to children or people under a certain age? What is that age Andy? Do you know without reaching for guidance from your clinical psychiatry unit at GSK?

Are you aware of the withdrawal problems your drug is causing Mr. Witty? Do you think we are all liars and have some form of a re-occurring depression Mr.Witty?

How long have you been top dog at GSK Andrew? Are you cleaning up the mess old JP left behind? Want to make a statement about Seroxat? Do you want to tell your consumers the benefit of taking Seroxat as opposed to the risks?

Do you want to come clean about the Paxil 329 study or can you live with JP's opinion that your company did nothing wrong? Do you have children Mr. Witty, would you allow your children to pop a Seroxat tablet?

Did your office smell of excrement when you took over from JP? Was it fumigated, was the wallpaper stripped because the stench was unbearable Andy?

Your company have been hiding facts haven't they Mr. Witty?

How would you like to meet with me? We can share a coffee at Starbucks and you can sit there and patronise me for half an hour or so. You can spin the same crap that your spokespersons spin when commenting about a fatality due to the drug that you manufacture.

You have been awfully quiet regarding the Seroxat issue Andrew, does it not matter to you that the company you represent manufacture defective drugs? They are defective don't you think Mr. Witty?

Do you want to explain to the thousands of people that have suffered at the hands of your drug, Seroxat, that it is their illness causing the problem and not your drug?

You have an opportunity to clear the stench from GSK HQ Mr. Witty, quite how you can endure the smell that old JP left behind impresses me Andy.

I never thought there could be anyone as stubborn and ignorant as JP Garnier when it comes to the Seroxat issue. You are amazing, you haven't once came out in the public eye to speak about it.

What drives you Andrew? Are you in this purely for the monetary gain or do you plan to make changes for the benefit of your consumers?

Do you wish to sit down with me Andrew? Do you wish to sit there and listen to my personal withdrawal hell?

Come talk to me Mr. Witty. I can tell you exactly where you are going wrong and why Seroxat is your Achilles heel.

The truth will always out Andrew, you have an opportunity to advance that truth... if you have the courage to do so that is.

Talk to me Mr. Witty. Your company's lawyers have my address.

Fid

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


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