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Thursday, November 27, 2008

MHRA Meeting - An Update

Back in September I attended a meeting with the MHRA to discuss the issue of SSRi withdrawal. [Minutes]

I recently contacted the MHRA for an update and have now received the following from their Communications Officer, John Watkins.



----- Original Message -----
From: Watkins, John
To: fiddaman
Sent: Thursday, November 27, 2008 4:03 PM
Subject: RE: Update





Dear Bob

On 25 November you posted something from Truthman to remind readers of the meeting you had with Kent Woods in September and to put the note of the meeting on your blog. And you have asked me what progress is being made on the issues recorded there.

Since that meeting we have had some useful discussions with those who produce the British National Formulary (BNF), about the possibility of it giving more information to doctors, particularly about management of withdrawal. As the note of the meeting makes clear, though we can make suggestions to BNF, it is for them to decide what to publish. We must wait and see.

NICE are currently updating their guidance on the treatment and management of depression in adults. The entry on their website (
http://www.nice.org.uk/Guidance/CG/WaveR/24) says that they expect to consult on a draft of the revised guidance between 24 February and 21 April. When that draft guidance is published, we will look carefully at what it does or does not say about the management of withdrawal. We will offer our views to NICE if the guidance seems inadequate but, as with the BNF, it is for NICE to decide what they publish.

We have also been in contact with David Healy and he has given us some useful thoughts about withdrawal.

Immediately under the 25 November posting of the notes of the meeting, Truthman wondered why we had agreed to meet with you. He suggested it could have been because we were aware, from a study we commissioned, that you were a prominent (and critical) voice on the web in relation to Seroxat and the MHRA. He ended by wondering whether we are more concerned about our reputation than about patients suffering on Seroxat.

We do recognise you as a prominent critic, but you have some points of view – from your own experience and those of people you are in contact with – that are worth listening to. When we recognised that, we invited you to meet with us. It was a useful meeting. You were a good advocate and put your points across well. We listened, and we said we would try to do something about them. We have been doing that and we will continue.

It’s not just you that we are listening to, and not just on the subject of SSRIs. We are genuinely and generally interested in the views of patients and the public. The MHRA’s Business Plan for 2008-09 has twelve key targets for the year. Key targets represent the highest level of public commitment from a Government Agency. One of those key targets is to “agree a two-year action plan to develop the involvement of patients and the public with a view to improving the quality of decision-making within the Agency and the level of understanding of its work, and with reference to both product-specific decisions and wider policies.” The wording is a bit bureaucratic, but you’ll get the message. And two months ago we recruited a new member of staff to concentrate entirely on patient and public engagement. This is not a PR exercise. It is because we believe that patients and the public have things to say that are worth listening to.

And the study? Your blog says that “the intention of the study was to understand the power of information online, how it is distributed and where it comes from.” Exactly. We commissioned it because we didn’t really understand what was happening in the blogosphere, what might be worth looking at and what was just noise. It concentrated on the two search terms of Seroxat and MHRA simply because it was already obvious that Seroxat was the most prominent issue in relation to MHRA and it seemed better to concentrate on a limited issue than to cast the net more widely. The picture of the web we got was complicated enough just in relation to Seroxat. We’d never have seen the wood for the trees if we hadn’t confined the search terms.

Regards,

John Watkins
MHRA



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

By Bob Fiddaman

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

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