Dear Mr Goldfinch,
Well, I'm inclined to refer you to the 1998 US PIL, again, where Seroxat is "significantly more affective [sic] than placebo..." The Company, then, if only in the US, regarded the drug, not as negligbly better than placebo, which I understand is the case, but significantly better. On what ground? If, alternatively, the drug is not any better, or negligibly better, than placebo, shouldn't people be taking placebos, instead, given that sugar pills presumably don't give rise to suicidality, and so on?
I don't understand your line of argument, to be honest. There has to be a benefit to Seroxat, and if that benefit is a mere 2 Hamilton points(1), which is the case, I understand, then suicidality is not an acceptable side effect, and the drug should not be on the market, I would contest. So, what is the benefit of the drug? As to peer-reviewed journals, and published trials, I have two words for you: "Marty Keller".
I am delighted that you regard my requests as vexatious, but contest that they are, other than subjectively, from your perspective. You are aware that I have complained, and you know why, because I have explained that to you. I have nothing else to say on that matter.
From: "MHRA Information Centre"
To: "Matthew Holford"
Date: Fri, 8 Jun 2007 15:24:25 +0100
Dear Mr Holford
Thank you for your email of 8th May. Please note that an applicant only has to demonstrate that the drug is more effective than a placebo and there is no requirement to demonstrate any scale of impact nor is there any requirement to show comparative benefits over any other type of treatment or other drug. It is the responsibility of NICE to advise prescribers on the comparative efficacy of treatments for a particular condition. The benefit of a particular drug is assessed by carrying out placebo controlled clinical trials in large numbers of patients. As I have pointed out to you before, summaries of these are published in the scientific literature in peer-reviewed academic journals and you can ask a library to conduct a literature search for these.
Thank you for copying the MHRA in on your correspondence with Mr Chapman of the ICO. It is apposite as we are refusing to reply to your emails of 22 May to Stephen Fawbert or your emails to the MHRA of 29th May, 31st May and 3rd June (and any other emails you may have sent or may send in the future on the same or substantially similar subjects), on the grounds that the requests have now become vexatious. Clearly, you feel that you have not had the answers you wanted to receive, but this is not the same as not being answered, and we have given such information as we are able, from what we actually hold. Consequently, there is nothing further we can add in this regard.
If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your requests. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address.
After that, if you remain dissatisfied, you may write to the Information Commissioner at;
The Information Commissioner's Office
They will make a decision on whether or not we have interpreted the FOIA correctly in withholding information from you.
(1) The reference to the benefit being 2 points, as opposed to 10 points (see my previoius post), is explained thus: I have read that Seroxat was adjudged to have moved trialists 10 Hamilton points (this based on a meta analysis of the "positive" trials, ie, the ones that were published). Placebo, meanwhile, moved the patients 8 Hamilton points. The difference between drug and placebo (and thus the real benefit of taking the drug, over placebo), is, then, 2 Hamilton points, which is regarded as "clinically negligible," I understand.