The MHRA: taking patient reporting seriously

Dear All,

I've just spent a short break down in the West Country. And very nice it was, too. Now, fully rejuvenated, I felt inclined to escalate my complaints up the MHRA foodchain. To which end, I've just had this little exchange with our esteemed drugs regulator. I've emboldened the MHRA's reply, for convenience:

Dear Sean,

It's remarkable how one's memory can play tricks on one, is it not? Perhaps it was the DoH that I had that conversation with. Or the ABPI. Or my doctor. Or the NHS. Or the Samaritans. Or my colleagues. Or my blog. In any event, my primary concern is not that the MHRA overlooked an issue that I believe I raised with it, but rather that it appears to have failed to do what it purports to do; that which it appears to exist to perform; and, moroever, that which it asserted to be valuable. Perhaps we should focus on that?

In any case, thank you for your kind attention. Given the background to this particular request, perhaps I can rely on the MHRA not to brand it vexatious, on this occasion?

Best regards

Matthew Holford

From: [redacted]
To: Matthew Holford, "MHRA Information Centre" info@mhra.gsi.gov.uk
CC: [Alan Johnson], [Shailesh Vara], [Alasdair Breckenridge], [Kent Woods]
Subject: RE: Yellow Card scheme
Date: Wed, 15 Aug 2007 10:38:31 +0100

Dear Mr Holford,

I refer to your email below.

Having read through your earlier FOI requests which form the subject of my review, I have not encountered any questions which relate to the Yellow Card Scheme. You are, therefore, correct in stating that this is not under consideration in my review.

As there does not appear to be a record of you having asked a question on the Yellow Card Scheme before, I have requested the Information Centre to treat this as a new FOI request. They will acknowledge your request and refer your questions to the appropriate unit who will respond to you directly.

Kind regards,

[redacted]

From: Matthew Holford [mailto:m.holford@hotmail.co.uk]
Sent: 15 August 2007 02:46
To: MHRA Information Centre
Cc: Alan Johnson; [Shailesh Vara]; [redacted]; [Alasdair Breckenridge]; [Kent Woods]
Subject: Yellow Card scheme

Dear Sean,

It occurred to me recently that I have asked about the Yellow Card scheme, during the course of my enquiries. However, this does not appear to be under consideration, in your review.

I was keen to understand how the scheme operated, or didn't operate, as the case may be. At the time of its roll-out, back in October, 2005, Dr Patricia Wilkie, Chairman of the CSM’s Working Group on Patient Reporting, declared that direct patient reporting was essential for medicines safety monitoring. Moreover, it would be an important source of information for patients about their medicines. Meanwhile, the MHRA's CEO, Kent Woods, declared that it would provide new insight - he was right about that, at least - and that it would permit patient involvement in regulation. I would be interested to understand how those objectives are achieved? In detail, please.

Also, you may be aware that just less than half of Yellow Card reports are followed up (according to your esteemed Chairman, Professor Sir Alasdair (that's D-A-I-R) Breckenrdige). Perhaps the MHRA could explain to me how it is that this fact contributes to either Dr Wilkie's or Mr Wood's objectives?

Finally, having submitted a Yellow Card myself, following suicidal ideations experienced whilst taking fluoxetine, I regret to report that I have been one of the unlucky 51% who has received a perfunctory hard copy, but no follow up. Having no experience of the process, I would be grateful if the MHRA could explain what "follow up" means? Does it have any familial relationship with NICE's "careful and frequent monitoring," by any chance?

I find it difficult to believe that my experience is untypical. However, I don't imagine that I'm your typical dissatisfied customer, either. The MHRA's response has been slipshod at best. At worst I daren't think what it is. Either way, I'm going to find out.

Best regards


Matthew Holford

PS to Mr Johnson: is it true that the Police and Criminal Justice Act 2001 had several key provisions introduced at the behest of the Worshipful Company of Apothecaries (ie, Big Pharma)? If so, could I request just one inclusion, the next time an amendment is made to the CJA - not to be treated like a twat by government bodies? I know that this is a personal request, but I'm sure others could benefit. Thanks everso.