Tuesday, 11 September 2007

More opaque than an opaque thing... Part V

The AG's office replied, but I can't be bothered to post the email. The upshot is that the AG's office knows nothing, and doesn't know who does.
Dated: Wednesday, 12 September, 2007

I thought I'd try the AG's office. Just for a laugh, you know. Copied to Deats, Johnson, Vara, CPS:

Dear Sir or Madam,

I'm very keen to understand the position, on this question. Perhaps the Attorney General's Office is able to clarify, or direct me to somebody more appropriate?

The issue at stake is what conduct constitutes an offence under Regulation 50 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). It is my contention that the suppressing of negative trials data (ie, data that does not demonstrate safety/efficacy of a drug), which may or may not be widespread (although the suppression of original data most certainly is widespread, on the ground that it is "proprietary information") causes the provision of "false or misleading" data, when only positive data is presented to the regulator at the time of the marketing authorization application.

The above is my understanding of the process - I have tried to clarify with the MHRA, but regrettably it felt unable to discuss its assessment process with me. As such, I apologize for any material inaccuracies.

Best regards



Dear (redacted),

Perhaps you will never have to consider the question. However, please do not concern yourself, as the Head of the Intelligence and Enforcement Unit, at the MHRA, is currently considering the matter, and I have no doubt that the Secretary of State is similarly occupied, given the seriousness of the implications, and the role of the DoH in promoting the Worshipful Company.

Best regards


From: "Freedom of Information Unit"
To: (redacted)
Subject: Freedom of Information Act Request (Ref 1025)
Date: Tue, 11 Sep 2007 16:04:17 +0100


Dear (redacted),

I refer to your request under the above legislation for information about guidance held by the CPS concerning Medicines for Human Use (Clinical Trials) Regulations 2004, and in particular the contravention of Regulation 50.

I am writing to advise you that the Crown Prosecution Service does not hold the information requested. The CPS does not hold any guidance concerning this topic.

If you are unhappy with the decisions made in relation to your request from the Crown Prosecution Service you may ask for an internal review. You should contact the Freedom of Information Unit (Appeals), 50 Ludgate Hill, London, EC4M 7EX, if you wish to complain.

If you are not content with the outcome of your complaint, you may apply directly to the Information Commissioner for a decision. Generally, the ICO cannot make a decision unless you have exhausted the complaints procedure provided by the Crown Prosecution Service. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane

Yours Sincerely,

Information Management Unit
[Crown Prosecution Service]

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