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Thursday, May 01, 2008

MHRA Meeting with Seroxat User Group Yesterday

I've spoken with a few of the people that attended yesterdays meeting with Kent Woods, CEO of the MHRA. I've had a mixed response of the general feeling of how it all went. I strongly feel that members of the public should be allowed access to the recording that was made at the meeting as many of the answers given by Kent Woods and others present may or may not lift the lid on what the public... but more importantly what sufferers of Seroxat may or may not think of the MHRA.

I've been privy to hear the recording, whether it sees the light of day remains to be seen - personally, I think it should.

Due to legal technicalities it remains under wraps.

I won't comment on what I heard... I think it only right to leave that to Janice over at the Seroxat & SSRi User Group. Once Janice makes comment then I will link to her page and possibly add further comment myself but at this stage I feel it unfair, particularly as I was not present at the meeting.

I can say that I would have liked to have been present but due to the size in numbers and probably because I'm somewhat regarded as a 'loose cannon', I never got the invite.

Like I say... I will offer my opinion once Janice writes about it on her website.

For ALL those in attendance at yesterdays meeting I would just like to point out some comments from the former Chief Executive of the Mental Health charity M.I.N.D.

The following is taken from a transcript of Panorama's 'Taken on Trust'

JOFRE: This man has been inside the secret world of the medicines regulator. He found that for years it missed crucial safety evidence on Seroxat; a failure which must raise concerns about other medicines we take.

RICHARD BROOK: I have little confidence that the drugs they’re licensing day by day are being licensed in a way I would feel appropriate and what’s even more concerning I have very little confidence in drugs that have been regulated in the past.

JOFRE: This wider picture has only now become clear because this man – the head of Britain’s largest mental health charity - took a unique nine month journey into the heart of the regulatory system.

RICHARD BROOK: I was putting the consumer voice right to the heart of drug regulation really in the Seroxat issue. I think I was quite open-minded in the early days about what would happen, you know, I was very hopeful that my inclusion might actually make a real difference, make real change.

JOFRE: Richard Brook was invited to sit on a sit on a sixth safety review of the SSRIs. It's become known as the Expert Working Group. The government ordered it to be set up in April last year in response to mounting controversy about the drugs. Richard Brook was the first patient's representative ever to sit on one of these reviews, it gave him access to a world that's protected from scrutiny by draconian secrecy laws, a world he says where patients' interests come last.

BROOK: I think I've been totally let down really by the regulator. Actually, the most important thing here, I mean at the of the day it's we.. we're taking the medicine, it should be the most important thing and it's the least important thing, they're bottom of the list.

JOFRE: One of the first things Richard Brook discovered was how the MHRA had failed to protect some of the most vulnerable patients of all, children. Sarah Thompson was one of nearly two dozen children who contacted us after our programme in October 2002. She was just 16 when she was prescribed Seroxat for depression. Until then she'd never been suicidal or self-harmed.

JOFRE: At the very first meeting of the Expert Working Group last summer, Richard Brook was shown confidential clinical trial data from the manufacturers of Seroxat, GlaxoSmithKline, he results of extensive testing of the drug in under 18s from years earlier. It appears this was the first time the regulator had every investigated whether Seroxat was safe for children in spite of the evidence previously uncovered by Panorama.

Was there any evidence that the regulator had been concerned about the effects of Seroxat in children?

RICHARD BROOK
Expert Working Group May 2003-March 2004
No, not as far as I'm aware. I mean I've had all these reviews through the 90s and as far as I know, they'd always given the drug a clean bill of health for adults, and although it's not licensed for children, I mean they knew it was being used, from the data they had it was being used in children, it was never causing an issue for them.

----

JOFRE: In April last year we put these claims to GlaxoSmithKline. Their defence of Seroxat was robust.

And you still think that the drug could be safe for children?

Dr ALASTAIR BENBOW
Head of European Psychiatry , GlaxoSmithKline Panorama interview April 2003
Absolutely. It could be. We haven't got a license in children yet. I feel sorry for anybody who has any side effects from treatment or indeed has experienced the terrible symptoms of depression. We are trying to help people. The evidence, however, is clear, these medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm.

JOFRE: But we now know that's not true and it's surprising that Doctor Benbow said it was. Just a month later GlaxoSmithKline sent a confidential dossier to the MHRA and it was Doctor Benbow himself who went to meet them to discuss it's contents. The company was confident it would lead to a licence extension allowing Seroxat to be marketed for the treatment of certain anxiety disorders in under 18s. But the dossier contained a bombshell. GlaxoSmithKline's own clinical trial data revealed that the drug simply didn't work in depressed children. Worse still it made them up to three times more likely to self harm and attempt suicide than depressed children who were just given sugar pills. This was evidence the regulator had never seen before.

RICHARD BROOK
Expert Working Group May 2003-March 2004
It was really a shock to them. In discussions directly with me officials were saying we have defended this drug for a decade. There has never been a sign as far as we're concerned about an issue here, and suddenly we're faced with this. And as that story unfolded it becomes clearer and clearer that the sort of way the information is put into the MHRA's possession, all of that is somewhat suspect to say the least.

RICHARD BROOK: I have little confidence that the drugs they’re licensing day by day are being licensed in a way I would feel appropriate and what’s even more concerning I have very little confidence in drugs that have been regulated in the past.

And this from the then CEO of a Mental Health Charity!

I think the sooner the recording or a transcript of yesterdays meeting is made available then we can all decide on how we all feel the MHRA are handling the Seroxat issue. Meantime, we have only the word of Richard Brook.

Fid

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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