GSK paroxetine study

I'll be reproducing some of these over the coming weeks.

Downloadable from the GSK website

Patient 083.003.1090

Study Medication: Paroxetine
Cause of Death: Suicide (by hanging)

This 58 year old female had hypertension on entry to the study. She had been receiving metoprolol 100mg daily and amiloride plus hydrochlorothiazide from day 54.

She had suffered five or six previous episodes of depression for which she had received treatment with bi/tri/tetracyclic antidepressants and benzodiazepines. The duration of the present episode of depression was recorded as 1 to 3 months. She had received previous treatment for this episode with bi/tri/tetracyclic antidepressants, which were stopped on day 1, and benzodiazepines, which were stopped on day 4.

The patient received 20mg paroxetine from days 0 to 8. She also received temazepam 20mg, twice or three times daily, from day 0, and chloral hydrate 500mg daily from day 1.

The patient experienced a moderately decreased appetite and mild dryness of the mouth from day 2; both events were considered to be probably related to study treatment.

The patient did not have any double flagged changes in vital signs data and only baseline laboratory assessments were performed. On day 8 the patient committed suicide by hanging (preferred term: emotional lability).

The investigator considered this to be unrelated to study treatment.
CONFIDENTIAL Seroxat Article 31 - Consolidated Response Document - January 04

****

Here are some paroxetine deaths and 'incidents' you won't find on GSK's website.

Fid

Hat tip: The Truthman

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

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Pride

The Claret & Blue machine keeps on rollin'

Blackburn V Aston Villa
Uploaded by Globajeez

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New Worries About Gardasil Safety

CBS Evening News Exclusive:

Vaccine-Safety Group Study Shows Higher Instance Of Medical Side-Effects Than Another Vaccine.

There are new concerns about Gardasil, the vaccine that prevents a virus that caused cervical cancer. It's approved for girls as young as nine. And five million have received it since it was approved two years ago. The FDA and its maker insist it's safe. But CBS News investigative correspondent Sharyl Attkisson has exclusive information on some very serious side effects.

Full story here

Hat Tip: Susan [If Your'e Going Through Hell Blog]

Link - Your Daughter... Merck's Lab Rat

Fid

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

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Antidepressant Labels to Carry New Warning of Life-Threatening Side Effect

Source LA Times

The LA Times reported on Feb 5th that the FDA has ordered a wide range of antidepressants to carry new warnings of an unusual but potentially deadly side effect seen most often in the first few weeks of treatment or when a patient increases dosages. The labels of two classes of new-generation medications for depression -- selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) must now notify patients that malignant neuroleptic syndrome has been linked to the use of these drugs.

Among the drug companies ordered to revise their labels to alert patients of the danger were those making Celexa, Cymbalta, Effexor, Lexapro, Paxil, Pexeva, Pristiq, Prozac, Venlafaxine and Zoloft. The orders were dated Feb. 4, but disseminated this morning in a public notice of FDA actions.

Here's the letter the FDA sent to GlaxoSmithKline regarding Paxil and malignant neuroleptic syndrome.

Full story here

Hat tip Ruth Francis

Related Links - Furious Seasons

Fid

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

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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OBSCENE SALARIES FOR PHARMA HEADS

Source: FiercePharma May 19, 2008

1. Miles White - Abbott - $33.4M

2. Fred Hassan - Schering-Plough - $30.1M

3. Bill Weldon - Johnson & Johnson - $25.1M

4. Bob Essner - Wyeth - $24.1M

5. Robert Parkinson - Baxter - $17.6M

6. Daniel Vasella - Novartis - $15.5M

7. Richard Clark - Merck - $14.5M

8. Frank Baldino - Cephalon - $13.5M

9. Sidney Taurel - Eli Lilly - $13M

10. Jeff Kindler - Pfizer - $12.6M

11. Jim Cornelius - Bristol-Myers Squibb - $11.3

12. Franz Humer - Roche - $11.1M

13. Robert Coury - Mylan - $8.5M

14. Jean-Pierre Garnier - GlaxoSmithKline - $6M

15. Werner Wenning - Bayer - $4.77M

16. David Brennan - AstraZeneca - $4.3M

17. Gerard Le Fur - Sanofi-Aventis - $3.27M

No wonder Prime Minister, Gordon Brown, invited them to his den earlier this year!

Fid

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

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Ending the Atrocities of the FDA; Life Extension Urges Immediate Petition Action for Health Freedom

Aricle on naturalnews.com

"The same Senate committee investigating the Ketek® scandal uncovered another study with falsified data. These fake data were used to support the approval of a popular antidepressant drug used by millions of human beings.

According to a report authored by a Harvard medical doctor, when the Paxil® application was submitted to an FDA advisory committee in 1991, the drug company improperly put people who had previously attempted suicide into the placebo group, so that it would appear that the Paxil® group would have the same rate or an even lower rate of suicide than the placebo recipients. This was done to make it appear that there was no increased risk of suicidal behavior in those taking Paxil® compared with placebo.

It took until 2006 for the manufacturer to send a letter to doctors admitting that the risk of suicidal behavior was 6.7 times higher in study subjects taking Paxil® compared with placebo.(10)

Suicide is the 11th leading cause of death in the United States.(11) It killed over 32,000 people in the United States in 2004. The number of suicides attributed to drugs like Paxil® (selective serotonin-reuptake inhibitors) could be in the hundreds of thousands during the 13 years it was fraudulently marketed.(8,9)"

FULL ARTICLE HERE

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

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Manie - Top Geezer

Now here's a nice little story and a two finger salute to GlaxoSmithKline too.

Young Manie, who entered this world with a rare heart defect because of Paxil use during his mother's pregnancy, has taken up Tae Kwon Do, a Korean martial art.

Manie was born with Transposition of the Great Arteries(TGA), basically his aorta and pulmonary arteries in his heart are switched. He had open heart surgery when he was 8 days old, a procedure that lasted 12 hours.

He's a brave little fella and despite all he has had to suffer and all that he still suffers, he has now taken up Tae Kwon Do. The phrase, 'We Shall Overcome' springs to mind here.

Let's hope he saves some of his best moves for all those concerned with the marketing of Paxil in the States.

Way to go top fella.



Link - http://bigpharmavictim.blogspot.com/

Fid

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

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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The UK Yellow Card Test

This is a simple test for anyone that lives in the UK.

Pop in to your chemist, be it Boots or your local.

Approach counter.

Ask sales assistant for a yellow card.

Then report back here and tell me of the blank expression on the sales assistant's face.

After talking with a fellow campaigner the other day on the phone I ventured to a pharmacy and asked the sales assistant if she could give me a yellow card.

She looked at me as if I was an alien!

The Yellow Card Scheme - A total sham

Fid

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

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Thousands 'have taken fake drugs'

Source: BBC

Thirty-thousand packs of fake life-saving drugs may have been consumed by NHS patients, the BBC has learned.

A senior official from the government's medicines watchdog said the case must lead to tightening of the law.

The Medicines Health products Regulatory Authority (MHRA) issued four emergency drugs recall notices in June 2007 - its highest state of alert.

An MHRA official told BBC File On 4 30,000 out of a batch of 70,000 fake drugs were still unaccounted for.

Three medicines, Casodex (bicalutamide) for prostate cancer, Plavix (clopidogrel) which treats strokes and heart conditions and Zyprexa (olanzapine) to control schizophrenia, had to be removed from pharmacies and warehouses across the UK in the recall 18 months ago.

Pills seized

The MHRA triggered four Class One recalls - its highest alert - in the space of a few days after it discovered thousands of packs of counterfeit drugs had entered the NHS supply chain.

Mick Deats, its head of enforcement, told File On 4: "It's not something done lightly, in fact it was the first time Class One recalls were ever carried out in the UK."

He added: "On all of the recalls in 2007, the meds involved had between 50% and 80% of the correct pharmaceutical ingredient in them."

A UK wholesaler had spotted discrepancies in packaging of stock bought elsewhere in Europe, but by the time that was picked up, thousands of drugs had been distributed to chemist shops, doctors and hospitals.

New law

Mr Deats said: "We think about 70,000 packs were in the batch of which we seized about 40,000. Thirty-two thousand went out to pharmacy level and some got to patients and a recall was conducted where some of those were recovered. "

"It ran into the thousands that came back. Nevertheless, a significant amount got out to patient level and that is why Class One recalls had to be conducted to try to receive, quarantine or seize as much of it as we could."

Asked what happened to the 30,000 packs unaccounted for, Mr Deats said: "They would have been consumed by the patients."

Mr Deats told the BBC: "It's extremely rare to see counterfeit medicines in the regulated supply chain. It's a tiny fraction of a proportion."

He said this was no consolation to those who had taken the drug. "That's why this case has been taken so seriously which, we hope, will lead to changes in the law in the UK and we'll take the offenders to court"

----

I wonder what the side-effects are on the fake Zyprexa?

Fid

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

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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GORDON BROWN PM - UP PHARMA'S ARSE!

The facts:

The British economy will shrink by 2.8 per cent this year in the worst performance of any developed economy.

As of today, British companies have confirmed the loss of 83,368 jobs in the past four months.

The wave of wildcat strike action that swept across the UK last week continued today as contract workers at the Sellafield nuclear site joined the protest against foreign labour.

Government figures show 136 suspected illegal immigrants arrested at 2012 site between April and December 2008. More than 100 workers suspected of being illegal immigrants were caught working on the Olympic site last year.

The number of people losing their homes is rising so steeply that it is now greater than at the worst point of the recession nine years ago, according to unpublished government figures for England and Wales.

Confidence among Britain's embattled manufacturers slumped to a near-record low last month as the recession battered industry and bosses embarked on a massive post-Christmas jobs cull.

Sterling falls to $1.36, its lowest level for 25 years.

The demand for mental health services will rise in the wake of the financial crisis.

Pretty grim huh?

Here's what the UK Prime Minister, Gordon Brown, decides to do.

Gordon Brown has summoned senior industry figures, such as Andrew Witty, chief executive of GlaxoSmithKline, and David Brennan, his opposite number at AstraZeneca, to a meeting at No10 to discuss ways of protecting pharmaceuticals and biotechnology companies, their revenues and their jobs, as the economy deteriorates rapidly.

Fuck the small businesses, fuck the masses facing eviction, fuck the British workers losing jobs so corporate companies can employ immigrants for a lower rate of pay.

You have fucked up Brown and you have fucked up an a humongous scale.

You look after Pharma, Brown, we shall have to fend for ourselves. [Like we always have done]

Where is Robin Hood when you need him!

Fid

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

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Birmingham 2nd Feb 2009 - Snow :-)

View from my place.

Snaps taken on a Samsung mobile phone.

Brrrrr

Click on each photo to enlarge

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

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Are you allergic to people?

Public service ads or just a sales pitch?

The Wayback Machine is a useful tool in finding various articles that could possibly embarrass pharmaceutical companies such as GlaxoSmithKline. It allows you to trawl through websites that no longer exist, many of which have been taken down to avoid any further embarrassment to outlandish advertising campaigns such as the one I'd like to expose right now.

In and around 1999 posters were popping up all over the United States, many were pasted onto bus shelters and street corners. The poster was of a young man staring into a cup of coffee, looking despondent. Opposite him were a seemingly happy couple. The tagline for the poster read: "Imagine being allergic to people"

The poster carried the name of a website to visit - aptly named, allergictopeople.com.

The site is no longer up but the Wayback machine offers the chance to view it.

The poster appears on the website with the text:

You know what it's like to be allergic to cats, or dust, or pollen. You sneeze, you itch, you're physically ill. Now, imagine that you felt allergic to people. You blush, sweat, shake — even find it hard to breathe. That's what social anxiety disorder feels like. Over ten million Americans1 suffer from social anxiety disorder, an excessive, persistent, disabling fear of embarrassment or humiliation in social, work, or performance situations.

The good news is that this disorder is treatable. People can overcome social anxiety disorder. So if you feel like you're "allergic to people," talk to your doctor or other health professional.

For a free informative brochure about Social Anxiety Disorder, call 1-800-934-6276.

More information on Social Anxiety Disorder is available from the following sources:

The Sources are:

Freedom From Fear

Anxiety Disorders Association of America

American Psychiatric Association

----

What the website does not tell you is where the funding came from for the apparent allergy to people 'illness.'

SmithKline Beecham

Their antidepressant, Paxil [Seroxat] had just recently been approved by the Food and Drug Administration for the treatment of debilitating shyness, formally known as social anxiety disorder.

You would have to be from the planet Zog not to see the motive behind SmithKline's financial backing of the "Imagine being allergic to people" campaign.

At the time SmithKline insisted that helping the afflicted, not boosting sales, is the goal of the poster blitz. "We find that less than 5 percent of patients are really treated today," says Barry Brand, product director for Paxil. "There's tremendous need out there." The company, he adds, is adamant about deterring frivolous use. "We don't want this to be a pill that you take for shyness," continues Brand. "We don't want you to think, 'Oh, I'll take a Paxil and I'll feel good.' "

Interesting that Barry Brand should say that.

What did Glaxo want you to think when you took Paxil then?

Maybe what many people since 1999 have since stated.

Oh, I'll take Paxil and I'll feel crap!

Barry Brand is now CEO of CeNeRx BioPharma, Inc.
**Disgraced Psychiatrist, Chuck Nemeroff, has had dealings with Cenerx in the past... although he failed to disclose that particular conflict of interest!

Fid





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

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman