Monsanto Roundup Lawsuit

Tuesday, April 29, 2008

The Evidence GSK won't let the MHRA release

Exactly what did the MHRA look at that convinced them GSK were up to no good regarding the Seroxat paediatric studies?

What convinced them that GSK did indeed manipulate the studies just so they could market the drug?

Did the ghostwriters commit an offence? Fraud maybe? If so, what is to become of them? Will they be let off the hook under some perverse EU Law?

Will Martin Keller face charges of any sort or is he deemed out of the UK jurisdiction? Would he ever be questioned? Hopefully the MHRA Enforcement Team won't be privy to any such investigation - can you imagine it?

MHRA - "So Mr Keller, do you have anything to say?"
MHRA - "Okay"

Sounds sarcastic but that is basically what the MHRA's Enforcement Team did to the GSK 'suspects' - only they never even got the chance to speak to them!

So back to study 329, which undoubtedly was the crux of the Enforcement Teams evidence. Was there anything in that study that we (the public) have not yet seen? Was it more shocking to read than the documents we (the public) have had access to over the past few years? Was it so disgustingly shocking that it sickened the Enforcement Team at the MHRA? So vile that it made the MHRA Chairman, Alasdair Breckenridge shudder at the thought that his former employees GSK could ever do such a manipulative thing? Did it shock Ian Hudson, the Director of Licensing at the MHRA who previously held the post at GlaxoSmithKline (then SKB) of no less than WORLD SAFETY OFFICER and who has gone on record stating that he had '...a significant interest in Paxil [Seroxat]'

Incidentally... The MHRA's Enforcement Team chose not to interview Messrs Hudson & Breckenridge. Not content with allowing the GSK suspects to walk free, they also turned a blind eye to two of their own members who could 'possibly' have shed some light on Paxil Study 329 - in particular Ian Hudson who... and I'll say it again - has gone on record stating that whilst he was employed at GSK (then SKB) as WORLD SAFETY OFFICER he had '..a significant interest in Paxil [Seroxat]'

So what was so alarmingly shocking? Was it the fact that GSK had manipulated the data in such a way that they had probably convinced themselves that any child actually administering a Seroxat tablet would be safe?

The Clinical Psych Blog writes eloquently about the whole subject with the post of the year
' Paxil, Lies, and the Lying Researchers Who Tell Them '

I posted yesterday making the statement that I was totally pissed off... and someone should be held accountable - not one person has held up their hand and admitted failure - there has been no apologies and WE (the patients) are supposed to just take it on the chin?

Will the parents that have lost children to Seroxat be expected to take it on the chin too? Someone owes them one almighty fucking explaination as to why this was allowed to happen! Do you think they want to hear about some fucked up law that allows... for want of a better phrase - a suicidal pill onto the market?

Wake up - smell the fucking coffee. This is scandalous and nobody seems to give a flying fuck about the lives that have been lost to Seroxat. The bodies that lay in graves - the ashes that sit in urns. Children, Kids, Adolescents (label them how you want) have lost their lives - Can anyone even begin to imagine just exactly what their parents are going through right now - right at this very moment in time?

I want the MHRA members - from the CEO right through to the admin team to close their eyes for 30 seconds. I want them to imagine their children playing in the park, falling over and running to them for a cuddle... 'Kiss it better daddy', 'Mommy make the pain go away' - you getting the picture? I want you to imagine reading your child a bedtime story, bathing them, holding them in your arms and telling them how much you love them. I want you to imagine them going through adolescence and bringing their first boyfriend/girlfriend home to meet you. I want you to imagine the look of surprise on their face as you throw a surprise 18th birthday party for them.

It's all beautiful isn't it.

Now imagine if your child had committed suicide as a result of taking a drug that a UK regulator had allowed onto the market.

Would you be pissed off?

Would you want answers?

Would you be happy at a four year investigation that let off the manufacturers of the drug that had been part of the reason why your child had taken their own life?

Thankfully, none of my children have ever taken this drug - I will never allow them to take any SSRi - I doubt very much if any employee of the MHRA would allow their children to take one either... come to think of it I doubt very much if any employee of the MHRA would allow their children to take an SSRi type drug when they are fully grown adults too!

Someone left a comment under my last post Comment from John Watkins of the MHRA - It deserves to be read:

They wrote:

I think you hit the nail on the head there ..

"The Patients are bearing full responsibility for everyone else failures" ..

This is exactly what has happened.

Although this meeting is a step in the right direction..

It's a little too late if you ask me..

6 panorama programmes exposing patients devastating seroxat experiences, corruption, lies and deceit ..and the the MHRA does not communicate with patients..

10, 000 signatures on a paxil(seroxat) protest petiton online ..and the MHRA does not validate patients voices...

An American paxil protest, three day vigil outside of GSK in Philidelphia and the MHRA does not listen to patients concerns...

A protest outside the MHRA by mental health charites , including MIND and patient advocates and the MHRA ignores the plight of those affected by Seroxat..

Countless studies and articles indicating the dangers of Seroxat and the MHRA continues to promote it as a safe and effective treatment...

The World Health Organisations report that Seroxat is the hardest of all drugs to come off.. and the MHRA continue to permit GSK to sell this TOXIC SHIT to the public...

Thousands of documented online videos, documentaries, websites and blogs screaming about Seroxat side effects and Seroxat withdrawal and the MHRA still denies this drug is dangerous...

Numerous news articles condemning GSK and their role in the Seroxat scandal, suppression of data etc and the MHRA slaps them on the wrist ..

This has gone beyond a joke..Mr Woods if you are reading this...You have A LOT of explaining to do...

Not least to the grieving familes of kids (and adults) who killed themselves on Seroxat because of your regulatory incompetence...

But also to those whom are still affected , those whom are still enslaved on this disgusting poison which you market as medicine and also to those who are still trying to pick up the pieces after Seroxat withdrawal..

An experience of unimaginable horror, one which you could not ever comprehend even in your worst nightmare...

Yes .. there is a lot of explaining to do Mr woods...

At the very least you owe the thousands of Seroxat victims and seroxat suvivors some justice and closure...

If you can't even offer that, then you are have failed the public and I think you should resign...


I agree in the main with what the anonymous reader left - I disagree with the line 'I think it's a little late if you ask me...'

I think it is a bold move by the MHRA to meet with Seroxat campaigners - I think it is a massive middle finger up to GSK.. I am still undecided whether I think anything will come of todays meeting with Kent Woods, the CEO of the MHRA. I'll wait until I have spoken with Janice Simmons.

Now getting back to the actual 329 study. A paper has just been wrote and published in the International Journal of Risk & Safety in Medicine. The subject matter is the Paxil 329 study.

This is probably an insight into what the MHRA Enforcement Team went on - although why it took them four years to come to any sort of conclusion remains a complete and utter mystery.

Robyn at Healthy Skepticism sent me a rather interesting pdf file relating to the paper just released in the International Journal of Risk & Safety in Medicine. As mentioned earlier Clinical Psych writes about it HERE. The original Paxil 329 documents can be obtained HERE.

I have the proof copy that has recently appeared in the journal. I will quote one para here for you all:

There was no significant efficacy difference between paroxetine and placebo on the two primary outcomes or six secondary outcomes in the original protocol. At least 19 additional outcomes were tested. Study 329 was positive on 4 of 27 known outcomes (15%). There was a significantly higher rate of SAEs with paroxetine than with placebo. Consequently, study 329 was negative for efficacy and positive for harm.

A copy has now been made available on Ed Silvermans Pharmalot

Now what of the adults taking Seroxat? Are the MHRA going to ignore the warning signs yet again then carry out yet another four year investigation before giving the new CEO of GSK, Andrew Witty, a slap on the wrists later down the line?

Act now.

Listen... and act upon what we (the patients) have to say.

More importantly - the proof is in the pudding. Take a course of Seroxat and make me a liar.

I dare ya.


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

By Bob Fiddaman

ISBN: 978-1-84991-120-7