To: "Matthew Holford"
Subject: Reply
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
http://www.uncommonforum.com/viewtopic.php?p=348751
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