Zantac Lawsuit


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

Saturday, April 08, 2006

YOU CAN RUN ... BUT YOU CAN'T HIDE PROF. WOODS

Despite sending the following email to Prof. Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) - He has still failed to respond.

You can run... but you can't hide

I demand answers

Dear Prof.Woods.You may recall sometime ago I wrote you about my concerns over the running of the MHRA and the anti-depressant drug, Seroxat. I was grateful for your lengthy response to me Ref: (Witheld)

As you are probably aware a recent previously sealed court document was opened in the United States which is damning for Glaxo SmithKline. It clearly shows that they witheld vital information during the clinical trials for Seroxat.

In your previous lengthy response to me you gave me assurances that the MHRA's responses were both transparent and impartial. You also added that members of the MHRA are subject to the Civil Service Code and that code required all members to conduct themselves with integrity, impartiality and honesty.

You added further that the Europe-wide review of the risks and benefits of Seroxat undertaken by the then CPMP concluded that no strong evidence had been found to support an increased risk of suicidal behaviour. You also went on to say that the Expert Working Group concluded that there was no clear evidence of an increased risk in self-harm and suicidal thoughts in young adults of 18 years or over.

With the evidence attached to this email I would like to know if you still stand by your original letter to me.

I would also like to point out to you that I am well aware that Dr Ian Hudson and Sir Alistair Breckenridge have never sat on a review board regarding Seroxat. My question to you Prof. Woods is plain and simple and one that will cast doubt upon the MHRA's 'Civil Service Code'

Dr Ian Hudson and Sir Alistair Breckenridge were both employed by Glaxo SmithKline - both must have known about the suppressed data (attached) yet both decided not to mention it to other members of the MHRA. My question is, Why?

Meantime, Seroxat continues to be prescribed to both adults and children when clearly it is a drug that was shown in the trials that could cause suicide/suicidal thoughts and/or aggression.

I put it to you that both Dr Ian Hudson and Sir Alistair Breckenridge have not acted with integrity, impartiality or honesty in fact quite the contrary.

You now have clear evidence of this yet you, the Chief Executive of the MHRA, still refuse to acknowledge that this drug is defective and that the board of the MHRA have all acted subject to the 'Civil Service Code'

I trust that you, as the Chief Executive, will take action once your investigations are complete and I urge you to send out directives to GP's to stop prescribing this defective drug to new patients. It must be done with immediate effect before there is more blood on GSK's/MHRA's hands.

Meantime, I look forward to your reply

Yours sincerely

Robert Fiddaman

(Group Moderator of the Online Seroxat Support Group)

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