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Sunday, April 09, 2006

EMAIL TO THE OBSERVER (Sun 9th April 2006)

Below is an email I have sent to Jo Revill, Health Editor of The Observer



----- Original Message -----
From: fiddaman64
To: editor@guardianunlimited.co.uk
Sent: Sunday, April 09, 2006 9:23 AM
Subject: FAO: Jo Revill - re: Drug trial firm knew of risk

Dear Jo,

I read with great interest your article 'Drug trial firm knew of risk' and would like to bring to your attention a series of cover-ups from Pharmaceutrical giants, Glaxo SmithKline (GSK) and the Medicines and Healthcare products Regulatory Agency (MHRA).

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.

The report shows how they knowingly suppressed data which basically showed that Seroxat showed a higher rate of suicidal ideation and aggressiveness.

The MHRA are made up of medical experts, two of which are former employees of GSK, namely Dr Ian Hudson and Sir Alistair Breckenridge. In October 2005, Prof. Kent Woods, Chief Executive of the MHRA, wrote me to give me assurances that Seroxat was safe and that there was no conflict of interests within the MHRA. He also assured me that both Dr Ian Hudson and Sir Alistair Breckenridge never sat on the panel when Seroxat was being reviewed by the MHRA.

Both Dr Ian Hudson and Sir Alistair Breckenridge must have known about the suppressed data yet failed to mention this despite reported suicides and aggression in the news media.

I have included the 31 page document for your perusal and you will see from it's content that GSK knowingly witheld vital information from the MHRA.

This is scandalous and goes against all medical ethics.

Emails to Prof. Kent Woods from myself and members of the Online Seroxat Support Group of which I am a moderator, are being ignored.

It needs somebody like yourself to highlight these issues with your reporting - maybe then we will get answers.

Founder member of the Online Seroxat Support Group, Mr Derek Scott, requested from Prof. Kent Woods the Informed Consent Document!! Under the FOI (Freedom of Information Act 2000). Mr Woods rather flippant response was:


Dear Mr Scott

Approval of the Informed Consent document does not form part of the clinical trial authorisation process performed by the MHRA under the legislation. That is the task of a Research Ethics Committee, to which the research sponsors make a separate application.

Regards
Kent Woods
CEO

We believe this to be a lie and as we speak are in touch with the Research Ethics Committee - maybe you could throw some light on Prof. Kent Woods response?

Meantime, Seroxat is still being prescribed to patients and adverse effects are still being reported - The MHRA are NOT doing their duty.

I sincerely hope you can help us in our plight to get answers from the MHRA Jo.

I shall be adding this email to you to my blog
http://fiddaman.blogspot.com/ which is full of information regarding the MHRA/EMEA and GSK.

Meantime, I look forward to your reply.

Mr Robert Fiddaman (Group Moderator for the Online Seroxat Support Group)
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