Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Tuesday, May 20, 2008

Dear Kent... We have a Problem!

For the past two days I have painstakingly compiled a list of comments left at the online Paxil petition. The pdf file is 172 pages long and I have only used half the comments from the petition.

For those suffering with severe withdrawal - you are not alone. If your doctor does not think it could possibly be Seroxat that is causing your withdrawal problems then print off the document and take it to him/her.

Sadly, you won't get help from the MHRA or the DoH - you see, it would be too much for them to admit that such a problem has existed and been under their noses for many years.

Kent Woods chooses not to correspond with me - he cannot hide anymore. Something has to be done. The very patients the MHRA claim to safeguard are having serious problems with Seroxat.

The pdf file has been sent to Kent Woods, CEO of the MHRA, it has also been sent to the Communications Officer at the MHRA.

You can download it here.

It makes horrific reading and you can sense the anger in some of the comments.

What makes it more disturbing is the attitude of GlaxoSmithKline CEO, John Paul (ahem) Pierre Garnier. He clearly showed yesterday in his interview with Radio Four's James Naughtie that he does not wish to discuss the problems of Seroxat. (Audio Here)

After reading through all the horrendous withdrawal stories one has to ask oneself if their was ever a motive behind the marketing, promotion and selling of Seroxat [Paxil]?

A couple of possibilities occur to me, at present:

1, GlaxoSmithKline knowingly manufactured, promoted and sold a drug that they knew would cause horrendous withdrawal effects in the consumer

or

2, They never knew - and when they found out they did nothing.

So which one?

Would a huge corporate company promote a drug knowing that it could cause these serious withdrawal effects? Well, if the recent MHRA investigation into GlaxoSmithKline is anything to go by then that is a strong possibility. The MHRA Enforcement Team found that GSK (then SKB) failed to show that Seroxat was effective in treating major depressive disorder in children. A second trial, number 377, was conducted and this also failed to show that Seroxat was effective. Both studies completed towards the end of 1998. SKB made no amendment to the SPC on the basis of these data.

An internal GSK management document (which subsequently came into the public domain) dated October 1998 says that “it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine”.

Now this suggests (1) - GlaxoSmithKline knowingly manufactured, promoted and sold a drug that they knew did not demonstrate efficacy in the consumer. So we can rule out (2) - They never knew - and when they found out they did nothing. (ie, it did suspect that its drug was dangerous and inefficacious, and when it found out, it chose to suppress what it believed to be the case).

Anyone with an ounce of common sense would therefore feel reasonably just to assume that they did exactly the same when promoting and selling Seroxat to adults.

Do we have proof of this?

Well we have proof that GlaxoSmithKline have denied that Seroxat can cause addiction so where does that leave the consumer?

Do we jump to point (1) - GlaxoSmithKline knowingly manufactured, promoted and sold a drug that they knew would cause horrendous withdrawal effects in the consumer? Or do we assume point (2) - They never knew - and when they found out they did nothing?

We have the MHRA in the UK who claim the benefits of taking Seroxat far outweigh the risks - The lists of real peoples stories of the withdrawal problems when trying to taper off Seroxat blows the MHRA statement out of the water - yet they still stand by it.

So we have a pharmaceutical company and a medicine regulator sitting on the same page regarding Seroxat being addictive.. or not as is the case.

Where does the consumer fit in?

Well, it appears that the consumer has no rights. Despite thousands of reports about severe withdrawal problems - GSK and the MHRA stand firm.Consumer reports of adverse reactions appear to be being recycled as toilet paper and used to wipe away human waste from the arses of both GSK and the MHRA. So, the consumer basically has no say in this - He/she can write about their experience of withdrawal on Seroxat but it appears nothing will be done.

Why?

GlaxoSmithKline are a money making machine - let us not lose sight of this fact. They are a business and like all businesses they wish to make money...and lots of it. To admit Seroxat can cause addiction would (in their own words) "be commercially unacceptable" and "would undermine the profile of paroxetine”[Seroxat].

But what of the UK Medicines Regulator? What motive do they have for not accepting patient reports as given? To be honest I'm as baffled as the next man when it comes to the MHRA particularly as they proudly boast on their webpage that their mission is 'Safeguarding public health'. Are they ashamed that they never did anything earlier and to act now would raise questions? Do they not like being told what to do by patients?

There is a clear problem with Seroxat withdrawal that is not listed on the Patient Information Leaflet (PIL). Seroxat CAN seriously cause debilitating side effects so much so that doctors increase the dose rather than taper the patient from it. This causes more serious side effects when the patient tries totaper off at a later date.

Personally, and I can speak from personal experience, Seroxat works in two ways.

1. It masks the feelings of depression

and

2. When trying to withdraw you can get serious problems - to counteract these problems your doctor may up your dosage.

It's a genius piece of product marketing don't you think? The initial illness can always be blamed for the problems one faces when withdrawing from Seroxat - particularly as both GSK and the MHRA stand firm that it is not addictive.

Hats off to the GSK marketing team - they've duped the regulator yet again!

What are the consequences of long-term use of Seroxat?

Nobody knows. I believe that 'Long Term' use would exceed 2 years. If long term use is found to have serious implications for the consumer then GlaxoSmithKline are going to have one hell of a ride over the coming years - and if the MHRA don't act now then they will too.

Fid (Seroxat user for 6 years - took 18 months to taper off a drug that is non-addictive)

Link - Seroxat Withdrawal Complaints

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

By Bob Fiddaman

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

AVAILABLE FOR DOWNLOAD HERE


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