Wednesday, 25 July 2007

"FOI Review - Seroxat"

My latest jolly exchange with the MHRA, copied to Alan Johnson (the incumbent Secretary of State for Health, though for how much longer is debateable), Shailesh Vara (my MP), and the Information Commissioner's Office:

Dear ,

I have received your letter and attachments of 10 July, and I would respond as below. However, please be clear that while you have identified this series of communications to concern Seroxat, they at least equally concern the MHRA's conduct, with Seroxat being used as a case study:

FOI 07/040 - my request of 1 February and the MHRA's response of 21 February

I understand that there is a limit to the information that the MHRA is able to provide, in the context of an ongoing investigation. Having looked at this question in conjunction with the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended), I have come to the conclusion that the information made available to the public is scant - it is difficult to establish a reasoned view of the conduct of the Company, even where one assumes that the 2004 Regulations apply in terms of the bar on retrospective application. The extent to which the MHRA wishes to publicize its belief that the Company has complied with the relevant legislation in certain respects, whilst continuing to investigate other areas, would be a matter for the MHRA.

FOI 07/104 - my requests of 27 March and the MHRA's response of 23 April

I raised several questions in my emails, most of which have been dealt with, although I do have a couple of outstanding queries. Thus, I am still unclear as to what the Company considered "significantly more affective" to constitute. Mr Fawbert suggested that I contact the Company for this information, which I have done, on several occasions. However, the Company appears unwilling to communicate with me, though I can't imagine why. As such, I would be keen for the MHRA to approach the Company, because I would be keen to understand what the Company thought the benefit of the drug was, if only in the US. Presumably the MHRA has the authority to compel a response - if it doesn't, I would be grateful if you could clarify that, because I would be keen to have a more complete understanding of the limits of the MHRA's authority.

Also, given the lack of information in the public domain, mentioned above, I am disappointed to note that where a member of the public wishes to conduct his/her own investigation into the conduct of a company or its regulator, (s)he will be precluded from doing so, with the FOIA being cited as authority.

FOI 07/105 - my request of 30 March and the MHRA's undated reply

It is reasonably clear from the MHRA's reply that it felt the Government had taken the appropriate course. However, with respect, I asked what the MHRA's response was to the allegations made by the HSC, and not the Government's. Also, while the legislation is no doubt rigourously drafted, at all times, I don't imagine that any regulator is precluded from introducing additional procedures where it perceives a need.

I believe I am correct in stating that the MHRA has no written internal procedures, nor does the MHRA publish and enforce an industry Rulebook, for the benefit of its members? For what it's worth, if I am correct in this understanding, then I consider this to be an appalling state of affairs. I believe I am also correct in stating that I asked for detailed information concerning the way that assessments were carried out (in a separate request, which it does not appear that you are considering in your review). As to the first point, I am keen to understand why? As to the second point, I believe this to be critical in my understanding of the MHRA's commitment to safeguarding public health.

In short, I believe it appropriate that I should be permitted to understand the rules that the MHRA purports to operate by. I fail to understand the secrecy.

FOI 07/130 - my request of 24 April and the MHRA's response of 22 May

I accept the explanations put forward by Mr Fawbert, concerning the changes to the PIL. However, you will note, perhaps, that this ties in with the question concerning the withholding of trials data, touched upon in FOI 07/040. Dr Benbow's comments are at odds with the 1998-2000 UK exercize, which Mr Fawbert mentions in his response to FOI 07/104, and with the Company's internal dialogue, dated October, 1998. I was interested to undersand whether the MHRA, as regulator, concerned itself with this incongruence, a point also covered under FOI 07/140?

FOI 07/131 - my request of 23 April and the MHRA's response of 22 May

I believe I sent a follow-up mail to Mr Fawbert's reply (indeed, I imagine I tend to regard these things as a dialogue, rather than simple, one-off requests for information, as you will probably have noted), in which I suggested that, owing to the risk of suicide, it would be appropriate for the largescale study mentioned to be carried out. As I recall, I also took issue with Mr Fawbert's claim that suicide was symptomatic of depression, or that depression causes suicide.

Perhaps the MHRA regards this as a semantic argument, but depression does not cause death in the same way that cancer does, as such I am still struggling to understand the acceptance of the increased suicide risk acknowledged to be created by Seroxat, given the apparent absence of an identified benefit.

Incidentally, the link that Mr Fawbert provided, for further information on the Licensing process (, does not appear to work.

FOI 07/140 and 142 - my request of 29 and 30 April and the MHRA's responses of 3 May

My queries concern Dr Benbow's claims, my wish to understand why these are so clearly at odds with official perception of the risks and with my ongoing concern regarding the absence of any clear definition of "efficacy" or "benefit", as those words pertain to Seroxat. I am concerned that such key questions were stonewalled.

I believe that is everything, aside from the issue of "vexatious" requests. Mr Goldfinch may not have understood where I was going with my enquiries, but then he should have asked, shouldn't he? He is a public servant, much as Mr Johnson is. "Another to go to Mr Holford"? Perhaps Mr Goldfinch would not be so flippant, if he understood better what I had experienced, coincidental to SSRI useage?

Best regards

Subject: FOI Review - Seroxat Date: Mon, 9 Jul 2007 12:22:06 +0100
Dear ,

I have now managed to locate your earlier FOI requests on our database. There are 12 requests, 10 of which relate to Seroxat. Of these 10, 7 have been replied to and it appears that you have not received a reply to 3 of the requests.

Your email of 22 June 2007 raises a number of complaints about the MHRA's failure to provide you with some of the requested information. As you may appreciate, it would be very difficult to conduct an effective review of the MHRA's responses to your requests based on general complaints, nor would I want to run the risk of linking your complaints to the incorrect FOI requests. I propose, therefore, to send you hard copies of your requests and the responses sent to you from the MHRA. I will not send you papers relating to the 3 requests for which you have not received a reply, however, I will address these in my review.

I would be grateful if you could consider your requests and the replies received and then identify the specific areas that you would like reviewed. Grounds for review may include the failure to answer a question, or disagreement with the application of a FOI exemption applied etc.

Could you please provide me with your postal address so that I can send you the hard copies.

Many thanks,

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