Friday, 31 August 2007

The MHRA - taking patient reporting seriously - Part III

The MHRA excelled itself with the speed of its reply (emboldened). My response is at the bottom:

From: (redacted)
To: (redacted)
Subject: RE: FOI 07 246
Date: Fri, 31 Aug 2007 12:52:17 +0100


Thank you for your further email of 30 August 2007.

As I said in my last reply, the purpose of the Yellow Card Scheme is to provide the MHRA and CHM with information on adverse drug reactions (ADRs) so that they can take necessary action to protect public health, and update product information where appropriate. Information on all ADR reports that we receive is available to patients and the public on our website and under the Freedom of Information Act.

The MHRA sends regular communications to health professionals about changes to the safety profile of medicines including "Dear Doctor letters", and in August 2007 we launched a new bulletin "Drug Safety Update," sent to all health professionals and available on the MHRA website.

I have nothing further to add to my previous reply dated 30 August 2007 and consider this correspondence closed. As I said in my last reply, issues relating to the Yellow Card you submitted will be handled in your complaint.

Yours sincerely


Dear (redacted),

Your previous mail was certainly full of information and tightly worded, and I can see that you would not wish to add to it. I imagine that (redacted) felt the same way, when he branded my repeated requests for clarification on certain points "vexatious". I am not on a fishing trip, (redacted), the MHRA's answers are just unclear to me, that's all.

However, while the excellence of the Yellow Card scheme (indeed, the MHRA regulatory practises, in general), is not in doubt from the perspective of providing information to the MHRA and CHM, I am still a little confused about the mechanics of getting that information to the patient, other than via the GP. Given my experience of the MHRA's willingness to provide basic details of its regulatory activities to me, you will, perhaps, forgive me if I am skeptical on the question of transparency.

As it happens, my own issue is not with respect to the information that I received, although nothing quite prepares one for that sensation of "not wanting to go on," when it hits. Much less is one prepared for what happens next.

The position, then, is this: we have a drug that has acknowledged side effects, which are severe by anybody's estimation. This drug has question marks over its efficacy that the MHRA is seemingly unable, or unwilling, to dispel (although it is keen to dismiss them). We have a system of assessment, which by Prof Breckenridge's own admission (please see the HSC's Report), seemingly amounts to rubber stamping the submitting company's application portfolio (I think he used the word "trust" somewhere, in this respect - you will find that there is a distinct absence of that commodity outside the relationship between the Worshipful Company and the MHRA). We have a system for reporting side effects that is seemingly, by accident or design, only capable of moving information in one direction, at any speed.

I regret to advise you that the vast majority of that summary is derived from the MHRA's answers to my questions, over the past six months, or so. And then, when a patient experiences the (acknowledged) side effects, (s)he may well find that (s)he is advised that this had nothing to do with the drug, based on nothing whatsoever, in my case, seeing as I have no history of mental illness, prior to my experience 2/3 years ago.

Your system, (redacted), is working perfectly, as far as I can establish. Everybody is doing their job to their utmost capabilities, and I congratulate them for that. I do. From the bottom of my heart. However, things are going wrong, and it is patients who are bearing the fall out - it is the patients' fault, in short.

I wish to know what the benefit of Seroxat is, and then, I suspect, we can dispense with the discussion about side effects, and reporting, because it will be irrelevant. I am already satisifed that the MHRA is incompetent, based on its ability to discuss side effects at length, but to be unable to discuss efficacy for more than a few paras. How does the MHRA know that Seroxat is efficacious? Because Smithkline Beecham told the MCA so? It rather looks that way, from the outside, which is all that counts.

Best regards


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