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Thursday, April 22, 2010

The Evidence, However, Is Clear...The Seroxat Scandal Introduction





Introduction

On Friday the 7th of April, 2006, I began, what I thought at the time, to be a mini protest against the Medicines Healthcare products and Regulatory Agency [MHRA] and the second largest pharmaceutical company in the world, GlaxoSmithKline [GSK]. The world of blogging [1] was new to me but it seemed a good outlet to get ones voice heard and a short way to cut through the red tape that exists at government level here in the UK. I wasn't happy with the way an antidepressant called Seroxat, manufactured by GlaxoSmithKline, was being widely prescribed and its serious adverse side-effects were being largely ignored by both the medical profession and the UK Medicine regulator, the MHRA.

The MHRA was founded in 2003 by merging the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). The MCA was created by the UK Medicines Act 1968, in the wake of the thalidomide disaster. [2] The Thalidomide tragedy occurred over fifty years ago, when it came onto the market. The years that followed saw it causing serious deformities in children whose mothers had taken the drug during pregnancy. Many of them died. Both the pharmaceuticals industry and legislators learned lessons from this tragedy. The safety tests that a new drug is required to undergo before it can be administered to humans were made much more stringent... or so we were led to believe.


40 years on and prescription drugs are still slipping through the system and into the bloodstreams of humans. Some would say that the whole Seroxat scandal is on a par with the thalidomide disaster, I would suggest, with respect, that it is far worse than that, worse because we actually have a regulator in place who have ignored the pleas of patients, articles and even doctors that have claimed Seroxat has ruined their lives or the lives of their patients. Of course children born with abnormalities is far worse than those suffering withdrawal, those poor children were dragged into this world with defects, it is because of them that we have a drugs regulator in place. The Seroxat scandal should have been quickly nipped in the bud by the regulator, instead the denial continues and patients still suffer. This is what sets it aside to the thalidomide disaster. We have people in place to help us and they are clearly not.

Emails to the CEO of the MHRA, Prof. Kent Woods were being ignored. Freedom of Information requests [FOI's] to the MHRA were being returned to me with exemption rules and/or a vagueness that defied belief. Something just didn't sit right with me. My suspicions regarding the MHRA and their closeness to the pharma industry stemmed from a documentary aired on BBC TV almost two years before I started blogging. BBC's Panorama [1] had already aired two programmes regarding Seroxat and their third, 'Taken on Trust', delved deeper into how prescription drugs are regulated in the UK. The programmes investigative reporter, Shelley Jofre, exposed huge failings in the MHRA and revealed how patients' lives had been put at risk. It focused on one drug, a drug whose controversy was raising daily here in the UK. That drug was GlaxoSmithKline's Seroxat. The first documentary, 'The Secrets of Seroxat' was aired in 2002 and saw 65,000 people ring the BBC helpline and they received over 1,500 emails. This prompted Shelley to make a follow-up programme called 'Emails from the Edge', which was broadcast on BBC TV on the 11th May 2003.

'Taken on Trust', her third and I believe the most powerful of the four, is mentioned above. Her fourth and final instalment [thus far] of the whole Seroxat scandal was called 'Secrets of the Drug Trials', she showed how GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials. This was aired in 2007.



What is Seroxat?

In 2006 the patient information leaflet [PIL] for Seroxat reads:

“Seroxat treats depression and anxiety disorders. Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of against the possible unwanted affects, before starting treatment.”


and

“Seroxat is a treatment for adults with depression and anxiety disorders. It is not fully understood how Seroxat and other SSRI’s work but they may help by increasing the level of serotonin in the brain.”


All seems above board with these statements but it wasn't always like that. The PIL from 1996 did everything but relay warnings and they [GSK] were adamant that there was an illness that Seroxat could treat.

1996 PIL:

What is “Seroxat”?

“Everyone has a substance called Serotonin in their body. Low levels of Serotonin are thought to be a cause of Depression and other related conditions. This medicine works by bringing the levels of serotonin back to normal.”


The statement by GSK is utter nonsense and it has never been scientifically proven, it is merely a theory that low levels of serotonin cause depression yet GSK claim that Seroxat works by bringing the levels of serotonin back to normal. How can a medicine act on a theory?

The PIL continued with:

Seroxat works by relieving symptoms of depression and any associated anxiety. It also treats obsessions , compulsions and panic attacks. These tablets are not addictive. Most people find that Seroxat does not affect their daily lives.


We now know that this broad statement by GSK was wrong. They carefully worded sections simply by adding a word, for instance, 'Most people find that Seroxat does not affect their daily lives .' - By adding the word 'Most', GSK had cleverly spun the fact that some people find that Seroxat does affect their daily lives. It's a marketing trick to keep the consumer from the truth. Can you imagine if, in 1996, the wording would have read something like this: “Some people find that Seroxat does affect their daily lives.” It would have been a marketing disaster and could possibly have been detrimental to GlaxoSmithKline making billions of pounds with their drug, Seroxat.

It was research like this that led me to believe that not only I was being duped but so were millions of others worldwide. This was the reason that I started to bang the drum.

I took Seroxat for 6 years, the last 22 months I tapered using an oral syringe and a liquid form of Seroxat. On month 19, I went cold turkey. [See Chapter 2] The following 3 months were the worst moments of my life.

The first chapter of this book takes you through my six years on Seroxat. It is a snapshot of how this one drug completely changed my character. Many of the personal events I mention throughout this book are hazy at best. Seroxat, I believe, has left me impaired in as much that my memory is not what it used to be, nor is my sleep. My life has changed as a result of taking Seroxat. I have lost many things along the way, both physical and mental. Seroxat depersonalised me.

It's time for change here in the UK.

It's time to stand up and be counted.

The Evidence, However, Is Clear…The Seroxat Scandal
ISBN: 978-1-84991-120-7
Chipmunka Publishing.

Download the E-Book HERE

Paperback coming later this year.




Fid

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