FIDDAMAN BLOG: February 2007

Wednesday, February 28, 2007

The Hansard Society and Pharma

The Hansard Society is an independent, non-partisan educational charity, which exists to promote effective parliamentary democracy.

Notice the three supporters I have highlighted and click on them.

Hardly suprising is it that our Government won't act on any issues you and I may have with Pharmaceutical companies!

Bob

Corporate Supporters of the Hansard Society 2005/6
Accenture
ASDA
Anglo American Plc
Barclays
BG Group
BP
BT
Corporation of London
Dod’s Parliamentary Communications
Eli Lilly <---- Click on them Ellwood and Atfield
EON UK
Faculty of Advocates
First Division Association
GlaxoSmithKline <---- Click on them GKN
HBOS
IBM UK Ltd
KPMG
The Law Society of Scotland
Marks & Spencer
MBDA
McGrigors Public Policy
MORI
MORI Scotland
News International Plc
National Assembly for Wales
Ofcom
Pfizer Ltd <---- Click on them PWC
Quintus
Rio Tinto Plc
Royal Bank of Scotland
Scottish Enterprise
Scottish Parliament
Shell UK
The Standard Life Assurance Company
Unilever
Weber Shandwick
Zurich Financial Services

Tuesday, February 27, 2007

2nd Chance to Members of Parliament

Today, I sent out a second series of emails to MP's - it was quite an exhaustive task having to cut and paste the email addresses from HERE but none the less something that had to be done.

Quite a few of the email addresses bounced back as they are no longer in use or are full, however, the majority managed to get through and all morning I have been recieving reciepts stating that my email has been read.... ONLY ONE thus far was deleted without being read.

I have a list of emails deleted without being read from my first series of emails I sent out.

Anyway, here is the email I sent:

Dear recipients,

You may recall that sometime last week I sent you all an email regarding Glaxosmithkline and the MHRA.

I sent this email to every existing MP and not one of you replied, indeed thus far 12 of you deleted the email without reading it first!

This is not a local issue, it is a national one and one that affects ALL of your constituents.

I urge you all to speak with Paul Flynn MP regarding matters relating to Glaxosmithkline and the MHRA.

I have created a blog site and I will be using it to highlight any of you who delete this message without reading it - hence the read reciept inclusion.

I am one voice of many and it seems there are only two members of Parliament, namely Paul Flynn MP and Stewart Hosie MP who are voicing our opinions. I urge you ALL to look into this matter regarding Glaxosmithkline and the MHRA and to start using your voice for your constituents, many of whom are unaware that the prescribed drug, Seroxat, could be causing either them or their loved ones serious damage.

Thank you for taking the time in reading this email. If you have any further queries please do not hesitate to contact me at fiddaman64@blueyonder.co.uk.

My blog SEROXAT SUFFERS - STAND UP AND BE COUNTED can be found at: http://fiddaman.blogspot.com

Yours sincerely

Mr Robert Fiddaman
UK

Should prove interesting

Bob

Monday, February 26, 2007

EMAILS TO MP's UPDATE

On Thursday the 22nd Feb 2007 I sent out a series of emails to well over 100 MP's. As yet, the only responses I have had have been auto responders. 10 - YES 10, MP's have deleted my emails without reading them. I'll give it a week or so then publically shame them.

Not one response folks

...now what did I say earlier about that gravy train....

Bob

Saturday, February 24, 2007

Members of Parliament

Two days ago I emailed well over 100 Members of Parliament. I urged them to read information on this site and other sites doing the rounds on the internet.

I set the emails up with a read request, basically confirmation that they had read my mail.

As yet, the only responses I have recieved have been auto responders and quite unbelievably 4 Members of Parliament deleted my email without reading it.

In a week or so I will be naming and shaming those Members of Parliament who deleted my mail without first reading it - I will aslo highlight the constituency they control.

The whole GSK/MHRA debacle is a national scandal, it seems Members of Parliament have more important issues and couldn't really give a toss if these two powerful corporations quite literally get away with murder.

Members of Parliament are voted in by YOU. It is their duty to deal with issues you present to them. They can continue to ignore the bigger issues if they so desire, they can continue to ride the 'gravy train' and claim their expenses (Which comes out of the pockets of you and I).

Through research we have learned that there are certain MP's who hold shares in Glaxomithkline - there are more than likely other MP's who hold shares with GSK but have not declared that fact. Believe me, WE WILL find out and they will be brought to task.

The lack of silence coming from the Houses of Parliament sickens me to the core. It's high time this 'gravy train' was stopped and these MP's were reminded just WHO voted them into power and what they were voted in for.

To find your local MP and to email them, click HERE

There are two Members of Parliament who deserve a mention here for taking this issue seriously. Both Stewart Hosie MP for Dundee and Paul Flynn MP for Newport West have been supportive of our campaign.

Now get this...

WE know that GLAXOSMITHKLINE recently wrote to 'certain' Members of Parliament urging them NOT to sign any Early Day Motions regarding GSK.... hardly suprising is it that my emails are being ignored by the very same people we put our faith in when it comes to local elections.

This whole thing leaves me with a really bad taste in my mouth

Bob

Thursday, February 22, 2007

The question is..... WHY?

Why an investigation within the agency?

Why not hand the investigation over to the Police?

How can a regulator with a history of negligence regulate itself?

How can an agency investigate a company when two of it's members are former employees of that company?

Bob

Tuesday, February 20, 2007

Monday, February 19, 2007

WILL YOU GET THE SUGAR PILL OR THE NEW INVESTIGATIONAL DRUG?

DOES IT MATTER?

HOPE YOU SLEEP WELL TONIGHT MR BENBOW

Paroxetine (SEROXAT) From Wikipedia, the free encyclopedia

Side effects

General side effects are mostly present during the first 1-4 weeks while the body adapts to the drug. Almost all SSRIs are known to cause either one or more of these symptoms. A person receiving paroxetine treatment may experience a few, all, or none of the following side-effects, and most side-effects will disappear or lessen with continued treatment, though some may last throughout the duration.

Apathy

Pupil dilation

Nausea

Teratogenicity: Pregnant women are advised not to take the drug due to possible fetal heart defects.[11]

Drowsiness

Headache

Changes in weight and appetite

Changes in sexual behaviour

Increased feelings of depression and anxiety (initially)

Dry mouth

Aggressive behavior (esp. in children)

Possible suicidal behavior

Possible congenital malformations

Rash

Restlessness or Akathisia
Itch

Sodium depletion

Sweating

Suicide

Muscle weakness

Muscle ache

Uncharacteristic levels of aggression

Serotonin syndrome

Individuals experiencing any of the following symptoms should contact their doctor immediately:

Jaw, neck, and back muscle spasms

Fever, chills, sore throat, or flu-like symptoms

Yellowing of the skin or eyes

Black, tarry stools (this can indicate upper GI bleeding)

Paroxetine and other SSRIs have been shown to cause sexual side effects in most patients, both males and females[12]. Although usually reversible, these sexual side effects can sometimes last for months, years or possibly indefinitely even after the drug has been completely withdrawn. This disorder is known as Post SSRI Sexual Dysfunction.

Secrets of the Drug Trials: Seroxat and the Dangers of Antidepressant Medications

By Moira Fraser

The GlaxoSmithKline Seroxat case highlights the need for transparency regarding antidepressant research. Still, not enough is known about the potential dangers associated with antidepressant medication. Continued research is needed but more importantly its outcomes must be candidly communicated.

Key issues around the prescribing of medication for children and young people need to be addressed. While European guidelines state that talking therapy should be the first line of treatment, in reality children and young people can wait up to a year before treatment due to long waiting lists. Considerable investment is needed to provide effective counselling and psychotherapy services for children and young people. Among teenagers, rates of depression and anxiety have increased by 70% in the past 25 years. Without adequate provision of this kind of service, these rates will continue to rise.

For some young people, it may be necessary to prescribe antidepressant medication when other treatments do not work. In this instance, only medication authorised by the Medicines and Healthcare products Regulatory Agency should be prescribed, and responsibility should sit with experienced health care professionals who can closely monitor the young person and their response to the treatment.

If you’d like to learn more about clinical trials research, just visit our clinical trials database, which lists full details of all drug trials currently tracked by the US government.

I was hooked on happy pills

FROM THE BELFAST TELEGRAPH

I was hooked on happy pills

Kirsty Morrison was on one of the Tube trains hit by terrorist bombs on July 7, 2005. Tormented by flashbacks, she was prescribed antidepressants - and that's when her problems really began.

ON the morning of July 7, 2005, I stepped on to a Piccadilly Line Tube train and began my regular subterranean journey across London. Little did I know that this was to be the start of a journey that has not yet found its end. It was the Tube train on which a 19-year-old man decided to blow himself up, killing 26 innocent people and injuring hundreds of others.

I was one of the 'lucky' ones. I was physically unscathed and walked away from that scene of devastation intact, or so I thought. The psychological injuries were buried deep within my brain and went unnoticed for weeks. Something in my mind had snapped during those 30 long minutes buried in a dark, smoke-filled carriage. The moment responsible for the lasting damage was a split second in which I had thought I might die. I contained the turmoil for two months, but finally it escaped, exploding and screaming in the middle of the night. The horrors emerged and took over my days. I sat at home trembling, unable to sleep, eat or work.

I started to see a psychiatrist who diagnosed me with post- traumatic stress disorder (PTSD). He explained the mechanisms inside my head that were causing the chaos. With comprehension came relief - I couldn't stop it, but I could, at least, understand.

Initially, I hoped it would pass within weeks. But for two months, I was unable to work. Then my shrink dropped the bombshell. "It will be at least a year until you get back to your old self; and even then, you might not be the same," he said. He suggested that perhaps I should try some antidepressants. "Your brain will sort itself out in the background and they will take away the pain," he said. I contemplated for a week, then succumbed to the temptation of a quick-fix solution.

The pressure was on to get back to work and I was desperate to retrieve a semblance of normality. His professional opinion was swallowed without question along with a daily dose of 20mg of Citalopram, one of a group of drugs called selective serotonin re-uptake inhibitors (SSRIs), which includes Prozac and Seroxat. Naively, I was hoping to be bouncing off the walls within weeks. Instead, I was plunged into life-questioning darkness.

Later, I read that this can be common during the first weeks of taking SSRIs; some people even try to kill themselves. I mentioned it to my shrink. He thought it was unrelated.

One year on and an anniversary later, I felt in control of my life and ready to ditch the drugs. The side effects had been minimal, but I wouldn't feel that I had won this fight until I was doing it unaided. "Take it slowly, " everyone said, "you can't just suddenly stop." Over three long months, I cut down by five milligrams at a time. Each reduction was followed by an identical cycle. Two weeks of nothing, then an exponential week of spiralling mania.

I was then plummeted into two familiar weeks of self-loathing and misery. My own little manic-depressive cycle, condensed into less than a month.

Initially, I thought that the PTSD was back, but my GP was reassuring. " It could be a recurrence, but it is more likely to be the side effects of reducing the medication," he said.

The only advice that he had to offer was to increase the dose if it all became too much. But the decision had been made - I was on this road to stay, and a diversion into the sunshine was never an option. So, sticking to the lowered dose, I battened down the hatches and waited for the storm to pass.

Eventually, the clouds lifted and stability returned to my battered brain. Three five-milligram reductions later, I was shattered but undeterred. The time had come to hit zero.

I took my last pill and waited with trepidation. I had no idea of what was to come - no one had ever warned me. Two weeks went by and I nervously wondered whether I had already been through the worst. Quietly, though, the heavy head returned and I sensed the drug-fuelled apathy. There was going to be a final hurdle after all.

On the Monday, I began to feel weary and cold, and the chill found its way to my bones. I couldn't concentrate or keep still; I was shivering to my core. The week continued with lethargy and exhaustion and my appetite started to fade. On Wednesday night, I woke suddenly, startled by a shudder. It was freezing and dark and my body was convulsed with fitful shakes. I hauled myself out of bed and piled on the layers - jumpers, socks and even a hat. I turned the heating up high and flung a blanket over my bed, all to no avail. This was the cold turkey of heroin addicts; it felt like a scene from a movie. Eventually, it subsided, but it was quickly replaced with biting nausea. I forced myself from my nest, staggered to the bathroom and was violently sick.

I warmed up slowly over the next few days, but the nausea and fatigue remained. I was snappy and irritable. My head thumped with relentless pain. When I moved, it took me a moment to catch up. I forced myself to eat, although I had no urge, but usually it passed through me without touching the sides.

There was small comfort. They were clearly not caused by PTSD. It was not a recurrence - it was my body in shock, trying to cope without the presence of the drugs.

My curiosity got the better of me and I wanted to know whether others had been through the same. If so, how many, and why had I not been warned? When I examined the information leaflet, I found it listed reams of possible side effects when taking the drugs, but only a scant few lines warning of 'mild' withdrawal symptoms such as headaches, dizziness and nausea. There was no detailed guidance, either, on how to come off them.

The potential side effects caused by coming off Seroxat are well documented. In a Panorama programme in 2000, Dr David Healy, an expert on Seroxat, said: "If they (SSRIs) aren't the right drug for you, they can cause problems. They can make you suicidal, or throw you into a state of mental turmoil. And even if they are the right drugs for you, in some cases they can leave you hooked."

The makers of Seroxat, GlaxoSmithKline, deny that the drug is addictive, but their patient leaflet does contain a detailed warning about possible withdrawal symptoms.

Professor David Taylor is head of pharmacy at the Maudsley Hospital and runs a national medication helpline. From statistics gathered over the past 10 years, he has become convinced that all antidepressants cause some level of withdrawal. A controlled study in 2000, by Dr David Michelson of Lilly Research Laboratories, showed that the incidence of SSRI discontinuation syndrome ranged from between 35% and 86%. Taylor admits that it is difficult to get accurate figures since many cases go unreported, but he believes it is more than 50% for some drugs.

He said that one of the key reasons for this lack of information is that, in order to be granted a licence, manufacturers are only obliged to study any side effects that occur while taking the medication. Hence, nine out of 10 clinical trials do not look at the effects of stopping the medication, despite the fact that they can be far more distressing for patients than the ones that they warn about.

When I contacted Professor Taylor's helpline, they reassured me that my symptoms were "completely normal" when coming off SSRIs. They said that doctors could be wary of talking about withdrawal in case it put people off taking medication that could help them.

Professor Taylor says there is truth in this, but he thinks that there is also a lack of awareness. He believes that "patients should be allowed to weigh up the benefits for themselves".

He stresses that withdrawal "can be extremely unpleasant, especially when people are exposed without any prior warning".

He thinks that the lack of information is because of pharmaceutical firms' incompetence rather than an effort to hide the facts. When SSRIs were launched, he told me, there was no research into withdrawal. When problems were identified, he says, "we just didn't shout loud enough".

Three weeks on and I hope that I am through the worst of it. But the exhaustion continues and I still can't hold down much food. I can't say whether I would have taken Citalopram had I been told of the risks.

Neither do I know whether it helped me in my recovery from PTSD. What I do know is that I would rather have been made aware of all the risks before I decided to put those pills into my mouth.

Your faith in their hands

Peter R. Breggin, MD Reposts

Paxil Special Report I Court Filing Makes Public My Previously Suppressed Analysis of Paxil's Effects

Peter R. Breggin, MD

Published in Ethical Human Psychology and Psychiatry 8, 77-84, 2006

Product liability cases against drug companies like GlaxoSmithKline are often settled with an agreement that the potentially incriminating data found in the drug company files will be sealed or kept secret. In the case of Lacuzong v. GlaxoSmithKline, my report disclosed extensive manipulation of data concerning Paxil's adverse effects, including rates of suicidality, psychomotor agitation (akathisia), and over-stimulation.

In a subsequent lawsuit against the company, my report was unsealed and is now available to the public. I placed the entire report on my website and published three scientific articles based on it. This is the first of the three articles.

As a medical expert, I was empowered by the court to examine hundreds of cartons of drug company files contained in GSK's sealed record room. These files included Food and Drug Administration (FDA) correspondence and all of the company's worldwide clinical trials and drug reports for Paxil.

Read complete article here

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Paxil Special Report II How GlaxoSmithKline Suppressed Data on Paxil-Induced Akathisia: Implications for Suicidality and Violence

Peter R. Breggin, MD

Published in Ethical Human Psychology and Psychiatry 8, 91-100, 2006

Since the publication of my first special report concerning how the manufacturer of Paxil hid and manipulated data concerning Paxil-induced suicide, in May 2006 the drug company GlaxoSmithKline issued a letter to Healthcare Providers confirming that depressed adults of all ages taking the antidepressant have an increased rate of suicidality compared to depressed adults taking placebo. This special report is the second in a series demonstrating that GlaxoSmithKline hid or manipulated data that years ago indicated that Paxil increases the risk of suicidality and other dangerous adverse mental effects of the drug.

Read complete article here

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Paxil Special Report III Drug Company Suppressed Data on Paroxetine-Induced Stimulation: Implications for Violence and Suicide

Peter R. Breggin, MD

Published in Ethical Human Psychology and Psychiatry 8, 255-263, 2006

This third report focuses on the role of Paxil-induced central nervous system stimulation in causing violence and suicide and the manner in which GSK obscured or disguised the antidepressant's stimulating effects. Akathisia can be viewed as a form of central nervous system stimulation, and therefore this current report dovetails with the second report.

Read complete article here

Sunday, February 18, 2007

ADULT SEROXAT SUICIDAL THOUGHTS ACKNOWLEDGED AT ONLINE PHARMACY

Good to see that drugstore.com acknowledges the fact that adults can get suicidal thoughts when taking Seroxat/Paxil.

Before using WARNING: ANTIDEPRESSANT MEDICINES MAY INCREASE THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS IN CHILDREN AND ADOLESCENTS, AND POSSIBLY ADULTS, WHO HAVE SEVERE DEPRESSION OR CERTAIN OTHER MENTAL OR MOOD DISORDERS.

An FDA directive?

Seroxat turned Janice's life into a 'living nightmare'

Article from the Sunderland Echo - 16th Feb 2007

A MUM left isolated and suicidal today reveals her fears about a controversial drug used by thousands of Wearsiders.

Janice Leonard spent 12 years battling to free herself from a "living nightmare" after being prescribed the anti-depressant Seroxat.

It was hailed a wonder drug when it was launched more than a decade ago, but Mrs Leonard, 53, claims it left her prisoner in her own home.

She said: "I couldn't go out any where. I couldn't see anyone. It was horrendous."

More than 50,000 prescriptions for Seroxat were handed out in the North East in just 12 months, and it is one of the most common anti-depressants available through doctors in Sunderland.

But Mrs Leonard, a florist, believes not enough is being done to let people know about the side-effects.She said: "When I was put on Seroxat they told me there'd be no side-effects.

"But they didn't tell me I wouldn't able to drive a car or that I wouldn't be able to go to work at the end of the street without calling a taxi. It was a living nightmare."

Suffering a difficult time after the death of her father, Mrs Leonard, of West Boldon, was prescribed the drug by her doctor. She had previously been taking anti-depressants after suffering severe post-natal depression.

But just 12 months after starting on the medication, she found herself spiralling into a pit of depression and even having suicidal thoughts.She added: "I was afraid of everything. It was like I had been frozen. But I don't blame the doctors. They'd been told this was a marvellous drug, that it was going to change everything."

Married to Ian, 55, Mrs Leonard spent more than three years trying to get off the drug.In the end, she used Prozac and Valium to help handle her depression and free herself from Seroxat.

She also received help and support from the Council for Involuntary Tranquillisation and Addiction (CITA).

She added: "I want people to know they can get through it, but more really needs to be known about what Seroxat can do."

A recent BBC Panorama programme claimed people can get hooked on the drug, while pop star Robbie Williams, who recently admitted himself into a U.S. rehab centre is also alleged to have used the anti-depressant.

A spokeswoman for CITA said: "We believe withdrawal from this drug can be terrible. Whatever good was done by the person taking it is undone when they try to get off it."

Makers GlaxoSmithKline, which maintains that Seroxat is a safe and effective drug that has already helped millions of people, says there is no reliable evidence available to suggest it is addictive.A spokesman for GSK told the Echo: "Patients are advised to speak to their doctor when considering whether to stop taking Seroxat (paroxetine).

"The majority do not suffer symptoms on stopping treatment and most find that any symptoms they do experience are mild and go away on their own within two weeks. "However, for some these symptoms may be more severe, or go on for longer." A CITA helpline is available between 10am and 1pm weekdays, tel. 0151 932 0102.

$10,000 Funding Offer - WHO ARE YOU?

The World Health Organisation, the drugs company and the $10,000 funding offer

· Patients' group 'was asked to act as covert channel'

· UN body denies attempt to bend donation rules

Michael Day and Sarah BoseleyFriday February 16, 2007

The Guardian

The World Health Organisation is facing allegations that it attempted to secure a $10,000 (£5,100) donation from a drugs company by asking a patients' group to act as a covert channel for the funds, in the light of documents published today. The alleged arrangement would have broken the WHO's own rules on accepting money from the pharmaceutical industry.

Emails between Benedetto Saraceno, the WHO's director of mental health and substance abuse, and the European Parkinson's Disease Association appear to suggest that the WHO was willing to take $10,000 from Britain's biggest drug company, GlaxoSmithKline, to help pay for the preparation of a report on neurological disorders, for which GSK makes drugs.

However, Dr Saraceno made it clear that the money must pass through the coffers of the EPDA first because of the rules on WHO accepting drug industry funding.

"Unfortunately WHO cannot receive funds from the pharmaceutical industry," he wrote to Mary Baker of the EPDA in June 2006.

"Our legal office will reject the donation. WHO can only receive funds from government agencies, NGOs, foundations and scientific institutions or professional organisations. Therefore I suggest that this money should be given to EPDA and eventually EPDA can send the funds to WHO which will give an invoice (and acknowledge contribution) to EPDA, but not to GSK."

He added: "This is in line with what we have done so far with other contributions to the report which are all coming from other professional organisations."

The email exchange, detailed in today's British Medical Journal, is likely to reignite the debate over the extent of the reliance on pharmaceutical funding by health organisations. A part of the United Nations, the WHO has long suffered from underfunding and never has enough money for the wide range of services that it provides. The WHO produces guidelines on all kinds of health issues across the globe.

In this case, GSK appears to have been appalled at the lack of transparency on the part of the WHO and withdrew its offer.

In June 2006 Alastair Benbow, a vice president of the company, wrote to Ms Baker: "Unless I am misreading something here it sounds like they [the WHO] will accept funding from you but not from the industry. Worse than this, they will accept funding from you even if they know it originally came from us in order to bypass their own rules. This is hypocritical in the extreme. It makes a complete mockery of attempts at transparency, which should be welcome and which the WHO have called for."

Dr Saraceno strongly denies that he was suggesting breaking the rules. He claims that his email to Ms Baker was "clumsily worded" and that he had "never intended to solicit donations from the pharmaceutical industry through the patient organisation".

After Dr Saraceno was shown Dr Benbow's email, he sent a further one to her in which he attempted to explain his position, saying that he had never asked her organisation to raise funds from the pharmaceutical industry and stating that he would prefer to decline the $10,000 "in order to avoid a perception of conflict of interests for WHO".

A spokesman for the WHO said: "It's astonishing that the BMJ thinks there's a story here. Dr Saraceno sent a second email saying that he had not meant to ask for money. So I don't think there's anything to answer."

Ms Baker, however, had a different perspective on events. "There is absolutely no doubt in my mind that Dr Saraceno knew the $10,000 was coming from GSK and that he was intending to disguise its origins by getting the EPDA to accept it first before passing it on."

Saturday, February 17, 2007

Sharise Gatchell

I've recently added the Sharise Gatchell tribute webpage to the links section. The page was created by her sister.

For those of you that don't know, Sharise's mother appeared on the Panorama programme 'Secret Emails' - It made me sad and angry that yet another victim had been hoodwinked by both GSK and the MHRA. How do these people sleep at night?

Anyway, the page is a fitting tribute to a youngster whose life was tragically cut short on the 25th May 2003.

Please take some time to pay a visit to the site... we owe it to ourselves.

Her site can be found here: http://www.sharisegatchell.com/

Bob

Here is the speech that Stephnie Gatchell made at the Brighton convention September 04 regarding Seroxat.

Being up here this evening, is to say the least, extremely difficult for me. At the same time, I'm immensely grateful for this opportunity.

We moved permanently from South Africa to the UK in 1999, seeking better opportunities and security for our son and daughter.

Sharise was a shy , somewhat introverted 14 year old and an amazingly talented artist.

On the 25th of May 2003, aged 18, she hanged herself from the loft hatch in our house.
We were away for the bankholiday weekend in Scotland. Sharise hated long car trips....

2 DAYS...2 DAYS later on the 27th of May, GSK FINALLY decided to hand over the required trial data to the MHRA, and 2 weeks later the announcement came that SSRI'S should no longer be prescribed to under 18's....

For Sharise it was just too little, too late... She took one Seroxat pill daily, for 17 days...

I'm urgently appealing to you to do the following:

Firstly, to totally ban Seroxat for use in especially new patients. It is obvious that GSK needs to go back to the drawing board....

Secondly, I'm asking, no begging you, NOT to allow GP's to prescribe mind altering drugs such as SSRI's?

They are simply NOT experienced enough to make accurate diagnoses of certain types of depresson, a crucial skill when prescribing SSRI's, and definitely NOT in the 10 minutes or so that they spend with patients... My very strong views come from personal experience.

Sharise was first prescribed Seroxat during a consultation with a specialist for delayed menstruation, aged 16... During the consultation she became emotional. The doctor asked her in my presence:

"Do you sometimes feel like ending it all?"

She replied:"Yes."

He still proceeded in prescribing Seroxat , already surrounded by controversy regarding self harm and suicide even then. A situation he , being in the medical profession should've been aware of?

I had complete faith in his judgement, had no prior knowledge of it, didn't know it wasn't licensed for use in children, and was re-assured that it wasn't addictive!

Sharise almost instantly underwent a major personality change. She was definitely less inhibited which helped with her social life, but she was also agitated, lost all interest in her school work, gained weight, had irregular sleeping patterns and seemed generally demotivated.

Gone was the almost obsessive regard she had for her health as a vegetarian. The change in her was obvious as she previously was an exteremly diligent pupil.

To my absolute horror I discovered that she was selfharming.... cutting her arms!!!!
NEVER, EVER before did she do anything selfdestructive !!

Desperately worried, I begged her to stop using Seroxat. It was obvious to me that it was having an incredibly negative effect on her. She reluctantly did ,shortly after...somehow she seemed to 'enjoy' the 'new' Sharise....

She was never the same again....

She felt awful again and saw a 2nd doctor who prescribed Cipramil after I explained the Seroxat ordeal and insisted that we tried something else. Apparently no notes of this very important conversation was made... A month later Sharise decided that it wasn't helping at all, and stopped taking it.

In desperation she discussed using Seroxat again...I was adamant that she should avoid it.
Being 18 and no longer needing my consent ,she asked the final doctor for it, and received...
She kept it secret from us, hiding the pills underneath her bed, where we discovered it after her death.

I feel DEEPLY let down by the medical profession....

I find it impossible to understand why, the final doctor did not ask a few basic, logical questions ie:

Why did you stop using Seroxat the first time?
Have you ever selfharmed?
Do you ever feel suicidal?

It is WRONG not to have notify parents or friends when someone starts using SSRI's...
How can an already unstable ,hormonal teenager be prescribed mind altering drugs and her family not be warned to look for danger signs?

It is common knowledge that the first few weeks on SSRI'S is the most dangerous time...

Her doctor made her follow -up appointment 3 weeks later! Again 2 days too late.....

Her doctor mentioned during the Inquest that she had no reason to suspect that Sharise was in a really bad state because she seemed chirpy! Prior to taking Seroxat she was depressed, but nothing like what followed.....Seroxat deepened her depression!

REASONS WHY GP'S SHOULD NOT PRESCRIBE SSRI's:

The many questions after Sharise's death lead me to correspond with a retired South African doctor , Dr. Tinus Uys, who tragically lost his 27 year old son , under similar circumstances....
His investigations lead to the discovery of Prof. Kay Redfield- Jamison's outstanding work:
"Night falls fast-understanding suicide"

Here are some of his conclusions:

Firstly, the age group cut-off point of 18 years in the use of SSRI's is absurd. Sharise's and his son's cases are fine examples.

It is NOT about age but about correct diagnoses.

Bipolar depression needs a totally different aproach, because here, SSRI'S can be highly dangerous.

Bipolar depression is more common than is recognized,and even found in toddlers. If you do not ask the right questions, you will miss it.

If Bipolar depression is treated with a SSRI, it can lead to the Switch- phenomenon and result in Mixed- Bipolar depression, the form described by the Prof. as among the most dangerous of psychopathological conditions.....

I'm convinced that this is what happened to Sharise....

NO PERSON suffering from Bipolar depression, should EVER be given SSRI'S, whether they are 15 or 44!!! Bipolar depression should be treated with mood stabilisers. Please note that SSRI'S such as EFEXOR is the most dangerous regarding this problem.

ALL this is existing knowledge which seems to be ignored world wide for some reason????
Allowing GP's to prescribe SSRI'S is simply irresponsible !

I applaud the MHRA for banning the use in children, and urge them NOT to make an exception of Prozac? The human brain is after all only fully developed in the early 20's !
Surely, it MUST be madness to bombard a child's growing brain with mind altering chemicals on a daily basis?

Two days before she died , Sharise woke up in an unusually good mood after spending about a week in the abyss. She said to me:" It's SO nice to feel good again! You know Mommy, I'm sure I'm a Manic- depressive, I'm either way up, or down." That day she went on a spending spree and even shoplifted! That very evening I was chased out of her room in a rage! The 2 weeks before her death she was extremely agitated. Days were spent in her room, comfort eating and not sleeping properly.

We left for Scotland feeling uneasy and suspicious.So much so, that we returned a day earlier than planned. She seemed what can best be described as 'void' and 'hostile'.
In a last e-mail to a friend she said that she as feeling terrible and like she was going crazy...
She meant every word... She left the empty Seroxat packet on her pillow next to her last note...She WANTED me to find it, WHY?

It is not a question of HOW Seroxat has affected our lives, but rather of how has it NOT???
Our lives have been TOTALLY... devastated by her loss

There is absolutely NO area that hasn't been affected. NOTHING is the same anymore... Not holidays or birthdays, Christmas.....nothing. We are constantly being tormented by the most horror-filled flashbacks of that awful, awful night....

And then... there is the unbearable pain of her permanent absence...... Her brother Warren, (who isn't religious) summed it up in a recent e-mail to me. He wrote:

"I so wish that there really was a Satan, so that I could sell my soul for a chat with Sharise..."

As for GSK and anyone who has ever aided them in spinning their web of deceit...their unscrupulous behaviour has been despicable !!!!
How they can look themselves and the families of those destroyed in the eyes is beyond me !!
Surely they must be parents themselves??? It is selfish human greed at it's lowest form....

How unimaginably wrenching ,to lose one's child because drug companies conceal the truth, so as not to impede profit maximization !!! GSK's reputation is tarnished beyond repair and they will have to pay dearly for their excessive greed....there where it hurts the most...in their pockets!!

Please restore my faith in mankind?
Please do what is right??
Thank you

Stephnie Gatchell

I really have no comment to make about this speech... my only hope is that those responsible will one day be tried in a court of law and punished

Bob

Friday, February 16, 2007

The Serotonin Myth (Taken from an Aboriginal Website)

Taken from Mulubinba Moments:

Mulubinba is the Aboriginal name for the site of Newcastle, Australia.

Named by the Awabakal people after the indigenous fern - Mulubin

The Serotonin Myth

A myth is a story (either fictional or partially factual) which is used to explain a natural phenomenon or to illustrate a moral or cautionary lesson.

If you go along to your doctor complaining of depression there is a fair chance that you will hear about serotonin. Perhaps the older term "chemical imbalance in the brain" will get a mention too. The idea is that the low levels of serotonin in the brain cause the symptoms of depression. Serotonin is a neurotransmitter which means that it is a chemical that nerve cells use to message one another. If it is in short supply then the brain nerve cells that are dependent on it will not function very well. Many of those cells help to maintain happiness, so when they fail we become unhappy. And if we can just give the serotonin a boost all will be well again. It is a good story - simple, easy to understand, seemingly scientific. But it is a myth....

There is evidence that serotonin is somehow linked to depression, not the least of which is the fact that most of the drugs which help depression do appear to boost serotonin levels. However the truth of the matter is that doctors do not really fully understand the neurochemical basis of depression or indeed most of human behaviour.

Some people object to using a neurochemical model to explain human feelings and behavior because they believe it denies the reality of free will, and that idea challenges some very important ideas regarding morality, ethics and religious belief. Humans clearly do not function as puppets with the strings being pulled by chemicals such as serotonin. Free will is something we all experience and use most of the time. But of course the operation of free will is limited by biological factors. We all have the choice of eating or fasting but most of us could not voluntarily maintain a total fast for much longer than a day, mainly due to the biological drive to eat, which eventually becomes stronger than our willpower. People with drug addiction have a similar problem - while the decision to use drugs is ascribed to a weakness of willpower the biological drive is often more powerful than the will to eat! In depression a person's ability to make choices is hampered by the biological factors of their illness, but it is far more complicated than just a low serotonin level.

However like ancient myths the serotonin myth serves some important purposes.

Explanation. Myths explain things that need explaining. Most of the explanations of ancient mythology have been superseded by scientific explanations so a modern myth has to be based on a scientific model to have any credibility. Being only partially factual does not matter to a myth.

Morality. Myths provide moral guidance. People with depression often feel guilt and feel that they have done something to deserve their situation. They are often blamed by others for not "snapping out of it". Unfortunately there is a stigma attached to mental illness. Presenting it as a chemical deficiency (like diabetes) excludes blame guilt and morality, which is a good thing.

Action. Myths provide guidance in decision making. The serotonin myth helps guide people to make a sensible decision which is to get treatment for their depression. Drugs which boost serotonin are lifesaving and even cognitive behavioral based therapies sometimes get explained in terms of the fact that these therapies will boost serotonin levels and thus help resolve the depression.

For many people ancient myths are now regarded as "wrong" because the explanations they provide have been replaced by better explanations. But such a judgement ignores the valuable role these stories served in their own time. Similarly I have no doubt that one day the serotonin explanation will be regarded as wrong. However that does not matter to us now as the serotonin story still has much to offer in the treatment of depression.

Thursday, February 15, 2007

MY COMPLAINT TO THE MHRA

On Wednesday 14th February, I wrote to the MHRA asking for an email address for the Communications Directorate as I wished to lodge an official complaint regarding the answers I had recieved from them for a FOI request. Unbelievably, I had to go through Richard Goldfinch first, email the information desk or send the mail by post!!!

Read on

----- Original Message -----
From: Goldfinch, Richard
To: fiddaman64
Sent: Tuesday, February 13, 2007 3:43 PM
Subject: RE: Communications Directorate

Dear Mr Fiddaman

I attach a copy of the MHRA complaints procedure. If you don't want to email info@mhra.gsi.gov.uk, you should send by post:

Very Well. I shall make a formal complaint via yourself in this email.

As you are aware I have been making various FOI requests to the MHRA over the past two years or so - the last, FOI 07/002 was answered by Tim Berridge, a copy of his answer was also sent to you and two others, namely, Muriel Passmore and Ingrid Calvert. None of my previous requests have ever been 'CC'd' to Muriel Passmore and Ingrid Calvert and I would firstly, like to know why these steps were taken, secondly, I would like to know whom these people are and thirdly, I would like to know why Mr Tim Berridge refuses to answer any of the follow-up questions I put to him about FOI 07/002

This is merely part of my complaint regarding FOI 07/002.

I asked three questions, two of which were answered, the third was 'shelved' under the exemption rule contained in the FOIA, section 21.

It took 20 working days exactly to answer two questions, I find this totally unacceptable, you may remember Mr Goldfinch I had to write you twice to remind you?

Anyway, to the crux of the problem I have with the answers of Mr Tim Berridge and his lack of communication at my follow-up questions.

I asked:

1. Did GSK provide the MHRA background documents giving details about the imbalance of serotonin in the brain?

Mr Berridge replied:

Yes, a lot of this information has arisen from our knowledge of other antidepressants and from animal studies and animal models. To the best of my knowledge, this has never been directly proven in humans

I am glad to see we now have it on record that GSK did indeed provide the MHRA documents giving details about the imbalance of serotonin in the brain, I am somewhat confused though because to my knowledge, based purely on my own research, there is NO or never has been any scientific study into the imbalance of serotonin in the brain. The last line of your answer to question (1) you state 'To the best of my knowledge, this has never been directly proven in humans'. Now call me flippant or naive but what on earth are the MHRA doing granting a licence to GSK for a drug that they (GSK) claim, and I quote here from the Seroxat patient information leaflet "...People who are depressed or anxious have lower levels of serotonin than others." To make a broad statement like that surely must mean that there have been some 'human' experiments carried out by GSK regarding the imbalance of serotonin. Is this claim by GSK on the Seroxat patient information leaflet something the MHRA have overlooked or do the MHRA actually agree with GSK that people who are depressed or anxious have lower levels of serotonin than others?

Moving on to question (2) of my Freedom of Information request:

2. Did GSK provide the MHRA documents with figures for the effect the drug had in changing the imbalanced state?

Mr Berridge replied:

No. To my knowledge, it would not be possible to conduct such a trial in humans.

Once again I bring to your attention the Seroxat patient information leaflet that states "...People who are depressed or anxious have lower levels of serotonin than others."

Finally, Mr Goldfinch

I asked:

3. Please forward me documents that GSK supplied the MHRA during the application procedure for Seroxat that relate to the 'correcting effect' regarding people with lower levels of serotonin.

The reccomendation I recieved from Mr Berridge after he threw the exemption rule Section 21 at me was laughable.

He wrote:

Answer: Under the Freedom of Information Act (FOIA) certain exemptions apply to the information we can make available. The information you have requested concerning the 'correcting effect’ is subject to the exemption contained in the FOIA, namely Section 21 - 'information accessible to the applicant by other means.' The trials conducted by GSK on paroxetine can be found on their website (http://ctr.gsk.co.uk/Summary/paroxetine/studylist.asp).

Here we have a company, Glaxo SmithKline, who are currently under investigation by the MHRA regarding Seroxat and a member of the MHRA refers me to thier webpage to read about the very same trials that are being investigated by the MHRA!

At first I had to double check - was I hallucinating? Did I just read that?

You have to admit Mr Goldfinch, to point me to the very same company you are investigating borders on the absurd. I do not believe Glaxo SmithKline have published ALL the trial data and certainly not the negative trial data. Both you and I know that Glaxo SmithKline have witheld information from the public to booster sales of Seroxat, they have done this without a care for the health and safety of patients... worse still Mr Goldfinch, the MHRA, the very same body put into action to stop this sort of behaviour have stood by and let them do it!

You will no doubt throw yet another exemption rule at me regarding this current investigation. Three years Mr Goldfinch... three long years and still Glaxo SmithKline manufacture and sell Seroxat. One only has to Google the word 'SEROXAT' to be faced with horror story after horror story about the patients the MHRA has allowed to suffer. You need to pull out all the stops to end this investigation Mr Goldfinch. You have a suspect and you take three years? - if our Police force acted the way the MHRA did then we would have murderers running amok on the streets of Britain.

Please answer my questions, I have a right to know. Glaxo SmithKline have peddled Seroxat for many years despite the thousands, probably millions worldwide, of horror stories of children and adults.

BBC recently ran a programme about Seroxat, their fourth one! Does this not tell the MHRA that there is something drastically wrong within the walls of GSK?

With two former employees of GSK working for the MHRA I suspect you may personally find it 'difficult' to give an honest answer.

So, there you have it Mr Goldfinch - in a nutshell I am sick and tired of the lack of transparency the MHRA are showing me - I am exhausted but will not surrender and will continue to campaign and help others who have struggled... and still are... with Seroxat.

You may gloss over my rant about the ongoing investigation but please do not ignore the questions I have put to you regarding the answers I recieved from Mr Tim Berridge and please do not tell me whether or not I can relay information I have recieved regarding a FOI request to other people. This matter is of public interest so in future do not add any copyright notice in future correspondence to me.

I look forward to your reply but suspect I shall once again be stonewalled by the MHRA

Regards

Mr Robert Fiddaman

Tuesday, February 13, 2007

ROBBIE WILLIAMS ADDICTED TO ANTIDEPRESSANTS

Robbie Williams marked his 33rd birthday today by checking into rehab.

The pop star is said to be addicted to anti-depressants.

In a statement, his spokeswoman confirmed: "Robbie Williams has today been admitted into a treatment centre in America for his dependency on prescription drugs."

While she would not reveal where, he is believed to be at the exclusive but "hardcore" Meadows clinic in Arizona - where outside contact is banned, along with alcohol, sugar, cigarettes and caffeine.

Unlike other centres - including The Priory, which he has already tried - the £2,000-a-night Meadows has a tough, no-frills approach.

It is officially a Level 1 Psychiatric Acute Hospital and specialises in a "12-step" treatment of serious disorders, from schizophrenia to heroin addiction.

The news follows a string of setbacks for the former Take That star, who has confessed to bouts of depression as well as drug and alcohol habits.

American model Lisa D'Amato, who says she had a relationship with Williams, was recently quoted as saying that he used anti-depressants.

She told a newspaper: "It was clear he was struggling with his mind. He doesn't drink but he needs antidepressants to get him through the day. A lot of the time he seemed on edge."
Last year, Williams appeared in the BBC documentary The Secret Life Of The Manic Depressive, where he confessed to beginning to take anti-depressants a year after becoming sober.

Now ladies and gentlemen read the following from http://www.johannhari.com/archive/article.php?id=24

What better anniversary gift could we have than Robbie Williams's acknowledgement that Seroxat is beautiful? Speaking on Sarah Cox's radio show last week, he revealed that SSRIs have pulled him back from depression. "I took too much ecstasy, to tell you the truth," he said. "When you take E, your brain releases an awful amount of serotonin the chemical in the brain that broadly correlates with happiness and it makes you go, Great.' Use it all up and your brain's got nothing to bathe in." SSRIs have restored his serotonin to normal levels (or as normal as it gets for a billionaire rock-god).

Are you listening Glaxo SmithKline?

Are you listening Dr Ian Hudson, Alistair Benbow?

Speaking on BBC One's Panorama programme, Dr Alastair Benbow, head of European clinical psychiatry at GlaxoSmithKline, admitted that people could have misunderstood the information on patient leaflets which said the drug was not addictive.

TRANSPARENT? MY ARSE!

----- Original Message -----
From: fiddaman64
To: Berridge, Tim
Cc: Gisela
Sent: Tuesday, February 13, 2007 7:37 AM
Subject: Re: FOI 07/002

Dear Mr Berridge,

I would be grateful if you could answer my emails. I know you have read them as I have recieved a read reciept. Please have the courtesy to answer the follow up questions I have put to you regarding your answers to my FOI request 07/002. (Below) I am still astounded that you referred me to GSK's website to obtain the information I requested, particularly as they are supposed to be under investigation by the MHRA... and have been so for the past three years.

Please live up to your name and be 'transparent' with me.

Regards

Robert Fiddaman

----- Original Message -----
From: fiddaman64
To: Berridge, Tim
Cc: Gisela
Sent: Sunday, February 11, 2007 8:24 AM
Subject: Re: FOI 07/002

Dear Mr Berridge,

Is it your intention to answer the issues I raised regarding the answers I recieved regarding my FOI request 07/002? (See below)

----- Original Message -----
From: Berridge, Tim
To: fiddaman64
Cc: Passmore, Muriel ; Calvert, Ingrid ; Goldfinch, Richard
Sent: Wednesday, January 31, 2007 3:31 PM
Subject: FW: FOI 07/002

Dear Mr Fiddaman,

Please see attached response to your FOI request.

Kind regards

Mr Tim Berridge Licensing Division MHRA

Tel: 0207084 2391 Fax: 0207084 2170

Dear Mr Berridge,

Firstly I would like to thank you for your response, although why it took 20 working days to basically answer two questions still remains a mystery. I was also concerned to see that you had copied in three other people, Richard Goldfinch I know of but the other two, namely, Muriel Passmore and Ingrid Calvert, I cannot recollect ever seeing their names before in my correspondence with the MHRA. Could you tell me firstly, why these two were copied in on your email to me and secondly what division of the MHRA do they work in (if they work within the MHRA that is)

Now onto my Freedom of Information request and the answers provided by you.

I asked:

1. Did GSK provide the MHRA background documents giving details about the imbalance of serotonin in the brain?

You replied:

I am glad to see we now have it on record that GSK did indeed provide the MHRA documents giving details about the imbalance of serotonin in the brain, I am somewhat confused though because to my knowledge, based purely on my own research, there is NO or never has been any scientific study into the imbalance of serotonin in the brain. The last line of your answer to question )1) you state 'To the best of my knowledge, this has never been directly proven in humans'. Now call me flippant or naive but what on earth are the MHRA doing granting a licence to GSK for a drug that they (GSK) claim, and I quote here from the Seroxat patient information leaflet "...People who are depressed or anxious have lower levels of serotonin than others." To make a broad statement like that surely must mean that there have been some 'human' experiments carried out by GSK regarding the imbalance of serotonin. Is this claim by GSK on the Seroxat patient information leaflet something the MHRA have overlooked or do the MHRA actually agree with GSK that people who are depressed or anxious have lower levels of serotonin than others?

Moving on to question (2) of my Freedom of Information request:

2. Did GSK provide the MHRA documents with figures for the effect the drug had in changing the imbalanced state?

You replied:

No. To my knowledge, it would not be possible to conduct such a trial in humans.

Once again I bring to your attention the Seroxat patient information leaflet that states "...People who are depressed or anxious have lower levels of serotonin than others."

Could you or any other expert tell me how GlaxoSmithKline arrived at this assumption bearing in mind that, in your own words Mr Berridge, you told me '...it would not be possible to conduct such a trial in humans'

Thirdly, I approach question (3) and its answer by you with a sense of bewilderment.

I asked:

3. Please forward me documents that GSK supplied the MHRA during the application procedure for Seroxat that relate to the 'correcting effect' regarding people with lower levels of serotonin

Your reply was basically no answer, using instead the exemption rule contained in the FOIA, section 21 - Information accessible to the applicant by other means.

Whilst I have to accept this I was however totally flabbergasted that you suggest that I go to the website of GSK to read of the trials conducted by GSK on Paroxetine/Seroxat.

Flabbergasted because the MHRA are currently investigating GSK regarding the clinical trials of Paroxetine/Seroxat. I, as a member of the public, have grave concerns over anything that comes out of GSK, particularly their 'published' Seroxat clinical trial data.

Why then would someone from the MHRA direct me to a website of a company who are currently under investigation by the MHRA? It just defies belief and all logic.

Finally, a colleague of mine noticed that answers to FOI requests from the MHRA are now carrying a copyright notice at the foot of the response. Are you suggesting to me that whatever information I receive from you via the FOI should remain for my eyes only?

Like you, I have taken the liberty of copying in people in this email, some you or your peers will be aware of, others you will not. I trust I am not breaking any copyright rules here.

Regards
Mr Robert Fiddaman

Sunday, February 11, 2007

GLAXO SMITHKLINE SCANDAL

PANORAMA - SEROXAT - THE SECRET EMAILS

Friday, February 09, 2007

The Real Causes of Depression (February 2007)

Article by Dorothy Rowe

The Real Causes of Depression (February 2007)

Saga February 2007

The Real Causes of Depression

How many times have you heard it said, ‘Depression is caused by a chemical imbalance in the brain’? If you’ve been depressed and consulted a doctor it’s very likely you’ve been told this in tones of absolute certainty. If you’ve been prescribed one of the SSRI antidepressants like Prozac or Sexoxat you were probably told that this drug would replace the serotonin that was missing from your brain. The SSRI drugs certainly do put serotonin in the brain, but there wasn’t any missing in the first place. There never has been any evidence that any brain chemical was depleted when a person was depressed. However, psychiatrists kept hoping that one day their hypothesis that depression was caused by a chemical imbalance would be proved to be right. Now, thirty years after the hypothesis was first produced, the Royal College of Psychiatrists and the Institute of Psychiatry have accepted that depression isn’t caused by a chemical imbalance. But you’ll find this out only if you visit their websites. They haven’t issued a press release saying, ‘We were wrong.’

On the Institute of Psychiatry’s website there is a lengthy notice about an important conference on depression which will be held in April 2007. The preamble to this notice reads, ‘Depression cannot be described any longer as a simple disorder of the brain, but rather as a series of behavioural and biological changes that span mind, brain, genes, body – and indeed affects both psychological and physical health.’

The website of the Royal College of Psychiatrists has dropped all references to chemical imbalance causing depression. If you look at the very detailed and informative pamphlet on depression made available on the website, under the heading, ‘Why does it [depression] happen?’, there is a statement which says that sometimes there’s an obvious reason for becoming depressed and sometimes there isn’t. It’s different for different people. Then there’s a list of the things that can lead you to be depressed. These are: things that happen in our lives, such as a bereavement, a divorce or losing a job; circumstances, such as having no friends, being stressed or physically run down; physical illness, such as having a life threatening illness like cancer or a chronic disease like arthritis or bronchitis; personality which ‘may be because of our genes, because of experiences in our early life, or both’; alcohol ‘It often isn’t clear which came first – the drinking or the depression’; gender ‘Women seem to get depressed more than men do. It may be that men are less likely to admit their feelings and bottle them up, or express them in aggression or through drinking heavily. Women are likely to have the double stress of having to work and look after children’; and genes - depression can run in families.

All of these causes have to do with how we see ourselves and our world and how we live our lives. This includes the possibility that genes are involved. For many years geneticists have been saying that a single gene cannot be the cause of complex behaviour, but only recently have psychiatrists stopped talking about ‘a depression gene’ or ‘a schizophrenic gene’. Genes and the multitude of proteins which genes express interact in very complex ways. Specialists in physical illness whose genetic basis has been identified know only too well that the outcome of the disease in each individual depends on how the individual interprets his situation. If cystic fibrosis, an inherited disease which shortens life significantly, is identified in the first four years of a child’s life AND the parents meticulously follow a daily programme of helping the child to clear his lungs, AND if the child as he grows doesn’t fail to carry out this daily programme, then he can look forward to a life of normal span. We all know that nicotine and alcohol can kill us, but many people continue to smoke and drink to excess. It’s not what happens to us that determines our behaviour, but how we interpret what happens to us.

Moreover, developmental psychologists studying newborn babies have shown that babies born to depressed mothers become distressed and then apathetic when their mother fails to respond to the baby’s attempts to engage his mother in those little conversations which undepressed mothers have with their babies all the time. Also, when parents try to inculcate a sense of guilt in their children in order to teach them to be socially responsible, the lessons can be learnt far too well and the child becomes an expert in feeling guilty. Many depressed people have told me that as children they had felt responsible for their father deserting the family or their mother dying, and that their guilt for their failure remained as keen as ever. Depression does run in families, but it’s not through the genes

Many people will continue to believe that their depression has a physical cause. The one great advantage to this belief, is that you don’t have to feel responsible for your depression. However, there is one great disadvantage. There’s no physical cure. Psychiatrists don’t talk of curing depression but of managing it in a way similar to the way doctors manage a chronic illness like diabetes or epilepsy. If you see your depression as being the outcome of how you see yourself and your world and how you live your life then you are saying that, while you didn’t set out to make yourself depressed, this is the outcome of what you have actually done. We often get results we didn’t plan for. Having to take responsibility for yourself can seem like a tremendous disadvantage, but there is a great advantage. If you don’t understand how you created your depression, then by learning more about yourself you can uncreate it. In the same way many people diagnosed schizophrenic have recovered by coming to understand themselves

The different experiences which psychiatrists call mental illness or mental disorder begin with an overwhelming fear and a feeling that your very self is shattering, even disappearing. This happens when you discover that there is a serious discrepancy between what you thought you life was and what it actually is. Mental illnesses are not illnesses but defences to hold the person together when he feels that he is falling apart. These desperate defences are terrible to endure but, if we are willing to learn, they can teach us that we need to change the way we live our life. It isn’t always easy to change how we see ourselves and our world but, as the testimonies of many people show, it is in our power to do so.

http://www.rcpsych.ac.uk/ http://www.iop.kcl.ac.uk/apps/depression/introduction.aspx

Saturday, February 03, 2007

CAMPAIGNER WRITES TO MP

Below is a letter from fellow campaigner, Derek Scott, penned to Stewart Hosie MP for Dundee East. Derek pretty much sums up the way a lot of us are feeling about this issue.

Dear Mr Stewart Hosie MP for Dundee East,

I write further to my last letter dated 19th November 2006, which incidentally has as yet gone unanswered by your constituency office (see attached). As you are aware I have continually campaigned for the banning of Seroxat. If there was any doubt that this should occur one need only look to the excellent BBC Panorama documentary ‘Secret of the Drug Trials’ aired on Monday 29th January 2007 (please find enclosed CD containing the documentary). This is now the fourth in the series of BBC Panorama documentaries focusing on the defective antidepressant Seroxat. The question has to be asked as to when the Government is going to intervene to prevent further death and suffering of mentally ill citizens of the United Kingdom? The focal point of the latest BBC Panorama documentary was on pediatric clinical trial 329 (that I previously provided to you!) which illustrated that the antidepressant drug Seroxat failed in comparison to placebo in terms of efficacy, indeed the placebo was more effective. Worse Seroxat was shown to actually exacerbate depression and anxiety increasing the risk of suicide! When the FDA asked GlaxoSmithKline to reanalyse Paroxetine raw clinical trial data in 2006, this reanalysis established that the risk of suicidality was actually six times greater for children (three times greater for adults).

GlaxoSmithKline knew in 1998 (see attached clinical trial 329 in its entirety) that study 329 suggested that children and adolescents were at an increased risk of suicide in comparison to a non drug (placebo) but who concealed that information from Dr’s to the detriment of the lives of patients prescribed the defective antidepressant Seroxat. The purposeful concealment of study 329 by GlaxoSmithKline unquestionably means that innumerable innocent and vulnerable children have been murdered by Britain’s largest pharmaceutical company GSK, but let us not forget that adults too suffer exactly the same adverse drug and withdrawal reactions to Seroxat as their younger counterparts, something BBC Panorama ‘Seroxat Taken on Trust’ and previous documentaries on the subject have reiterated time and again since 2002.

The more the story unfolds the scarier things seem to become. If manufacturers of pharmaceutical drugs are routinely concealing clinical trial data that are commercially unfavourable this means that we, the consumers of medicinal products are at ever greater risk of suffering from severe adverse drug reactions. Clinical trials of TGN1412 that went spectacularly wrong in 2006 and which could in the future cost four young adults their lives, their immune systems having been forever altered by a defective compound means that those clinical trial participants (human guinea pigs) could develop life threatening illnesses such as cancer at a later date. The Government drug regulatory agency the MHRA authorized the trial of TGN1412 and should be held accountable, but not just over that novel compound, but also over the defective antidepressant Seroxat which it licensed in 1991.

The warning signs have been glaring the Committee on Safety of Medicines (CSM) in the face in 6 failed safety reviews of SSRI antidepressants, yet Seroxat was deemed to be safe and effective in adults following the Committee on Safety of Medicines Expert Working Group Safety Review of SSRI Antidepressants when the report was finally published in December 2004. The reanalysis of SSRI antidepressants by the FDA in 2006 which suggested a 6 fold increase in the risk of suicidal thoughts and acts in children and a 3 fold increase in the risk of such serious adverse drug reactions in adults should herald a complete ban of Seroxat and a reanalysis of other medicines of the SSRI class by an independent agency out-with the CSM or MHRA. The MHRA cannot be trusted to be impartial since both the chairman and director of licensing are previous employees of GSK, Sir Professor Alasdair Breckenridge and Dr Ian Hudson respectively.

Clearly the Government and its drug regulator the MHRA are in collusion with the pharmaceutical industry? Paul Flynn MP for Newport West authored Early Day Motion 767 and which suggests that Members of Parliament had been written to by GlaxoSmithKline urging them to oppose Early Day Motions critical of their conduct in the concealment of pediatric Paroxetine clinical trial 329, I quote below

EDM 767 “CONDUCT OF GLAXOSMITHKLINE 30.01.2007 Flynn, Paul

That this House questions the propriety and courtesy of the action of GlaxoSmithKline (GSK) in writing to hon. Members with constituency interests in GSK urging them to oppose Motions for Early Day (EDMs) critical of their conduct, then denying originators of the EDMs details of the content of their messages when requested.”

If the Government and its drug regulatory agency cannot be trusted, who can consumers trust? It is self evident that there is a despicable collusion between Government, the drug regulator MHRA and the pharmaceutical industry. Clinical trial 329 that you have before you advises that and I quote a segment directly from that study”

TARGET: "To effectively manage the dissemination of these data in order to minimise any potential negative commercial impact."

The target of GlaxoSmithKline in 1998 was to effectively manage the dissemination of the clinical trial data contained within clinical trial 329 in order to minimize any potential negative commercial impact on their billion dollar adult marketing of the antidepressant Seroxat. To discover that there is UK Government and drug regulator collusion via Paul Flynn MP for Newport West’s Early Day Motion 767 is beyond comprehension unless you hypothesise that the Labour party has been funded by GlaxoSmithKline and most likely other pharmaceutical companies and hence why GlaxoSmithKline wrote to Members of Parliament urging them to oppose EDM’s critical of their conduct exposed by BBC Panorama ‘Secrets of the Drug Trials’ in the concealment of Pediatric Paroxetine clinical trial 329.

Shelly Jofre the BBC Panorama investigative reporter in all four Seroxat documentaries asked US lawyer Karen Barth Menzies what she made of the claim: “Remarkable safety and efficacy”. She replied to the question that, “it was a lie, and fraud”.

The evidence is clear, Seroxat is a deadly antidepressant medicine and that the manufacturer knew this fact, and worse that drug regulators and governments (UK and US) were in collusion with the manufacturer GlaxoSmithKline. Shelly Jofre, Professor David Healy and various lawyers who have pursued the issues for years have to be commended for their perseverance.

What must now occur, and I concur with Charles Medawar of Social Audit Ltd., on this are three fold:

1.) The GMC (General Medical Council) should investigate and rule over the conduct (or rather misconduct) of Dr Alastair Benbow the Head of European Clinical Psychiatry at the pharmaceutical company GlaxoSmithKline.
2.) GlaxoSmithKline should be prosecuted by the Department of Health Enforcement Officers, it has been 3 years now since Lord Warner declared that and I quote from a 2004 letter addressed to me by Ian Luke former MP for Dundee East, “GSK were being investigated by the enforcement officers of the Health Department over the withholding of testing results at the final stage of the development of Seroxat. If any criminal intent is found then legal action will ensue.”
3.) An urgent and proper enquiry is required over the effectiveness of the MHRA something the Parliamentary Health Select Committee Report of the Influence of the Pharmaceutical Industry advised in 2005.

The latest BBC Panorama documentary ‘Secrets of The Drug Trials’ makes clear the importance of the main criticism of the MHRA made by the Health Select Committee in its final report of ‘The Influence of the Pharmaceutical Industry 2005’:

During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs. We recommend that there be an independent review of the MHRA

As the spokesperson and founder of the Online Seroxat Support Group we call on the UK Government to implement the aforementioned three points and to do as the Health Select Committee recommended in 2005, that of a completely independent review of the MHRA.

I look forward to receiving correspondence from your constituency office that the points brought up in this letter will be acted upon with immediate effect.

Yours Sincerely
Derek Scott
BSc Behavioural Science (Hons)

Friday, February 02, 2007

POLYGRAPH

Lie detector test redirects here. For other uses, see Lie detector test (disambiguation)
For the early automatic-signing device, see Autopen

Polygraph results are sometimes recorded on a chart recorder

A polygraph (commonly yet incorrectly referred to as a lie detector) is a device that measures and records several physiological variables such as blood pressure, heart rate, respiration and skin conductivity while the subject is asked a series of questions.

The measurements are posited to be indicators of anxiety that accompanies the telling of lies. Thus, measured anxiety is equated with telling untruths. However, if the subject exhibits anxiety for other reasons, or can control his anxiety level voluntarily, a measured response can result in unreliable conclusions.

A polygraph test is also questionably used as a psychophysiological detection of deception (PDD) examination.

So, just in case you were unsure about a polygraph.

Zantac Lawsuit

Wednesday, February 28, 2007

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