MHRA WEBSITE

Amazingly if you google the words 'Fiddaman' and 'MHRA' then scroll down the page to:

[PDF] Mr Charles Medawar
File Format: PDF/Adobe Acrobat - View as HTMLMr Robert Fiddaman. MHRA Reference: FOI 06/011. 23 February 2006. Dear Mr Fiddaman ...www.mhra.gov.uk/home/groups/ es-foi/documents/foidisclosure/con2023334.pdf - Similar pages

(ADDRESS HAS BEEN REMOVED DUE TO IT REAPPEARING ON THE INTERNET ELSEWHERE) - Lets hope the person who republished it has the decency to take it down!

Quite why Charles Medawar's name appears is a mystery - an even bigger mystery is that this is a file available for download on the MHRA website.


The file in question is a letter they sent to my home address with answers to questions I put to them earlier this year.

They will have you believe that my name and address have been deleted from the file but if you download the file here: http://www.mhra.gov.uk/home/groups/es-foi/documents/foidisclosure/con2023334.pdf then simply open it and cut and paste the contents into microsoft word - HEY PRESTO! My name and address appears on top of the letter.

This was apparently a confidential letter sent from the MHRA, who remember, strictly adhere the the 'Civil Service Code' and act with integrity, impartiality and honesty.

Not only are they violating my rights, the answers to all three questions (below) do not fit in with Dr Breggin's recent findings, see here: http://www.breggin.com/Breggin%20Paxil%20Lacuzong%20Report%20Filed%20with%20Court.pdf

I have removed my address - but if you do as instructed (above) you will see how the MHRA have made yet another balls up in their filing system.

This ladies & gentlemen are the body of people who regulate the drugs we take!!




Mr Robert Fiddaman


MHRA Reference: FOI 06/011

23 February 2006

Dear Mr Fiddaman

I am writing to you further to your recent correspondence with your MP Gisela Stuart. Ms Stuart has in turn written to Jacqueline Kennedy who has asked that the Medicines and Healthcare products Regulatory Agency respond to your questions under the Freedom of Information (FOI) Act.

Please find below our responses to the questions that you asked relating to paroxetine (Seroxat):

1. How many suicides/suicidal acts coded under the heading of placebo occurred within a 30 day period rather than simply post treatment and how many occurred after 30 days?

In the adult-placebo-controlled trials for paroxetine there were a total of four completed suicides: one in the paroxetine group (on therapy) and three in the placebo group (all in the post-treatment period)

In the first case the patient had made a suicide attempt during the study and a further attempt 14 days after last dose of medication. They committed suicide 33 days after the last dose of study medication.

In the second case the patient committed suicide 17 days after their study medication was stopped. They had received ECT therapy 3 days earlier.

In the third case the patient committed suicide 19 days after their study medication was stopped.

2. How many did involve subjects put on another antidepressant and how many did not involve subjects put on nother antidepressants?

From the case narratives reviewed it does not appear that any of the individuals in these three placebo suicides were receiving an antidepressant drug around the time they died. In one of the cases the individual had received a course of Electroconvulsive therapy (ECT) 3 days prior to the date that they committed suicide.

3. How many cases did the company not now because they had lost contact with the patient?

There is a requirement for all clinical trials to be conducted in accordance with the internationally recognised principles of good clinical practice (GCP), which helps ensure that all trials are conducted to the appropriate high standard and that risks to patients and healthy volunteers are minimised. It is recognised that in any trial a certain percentage of patients will be lost to follow-up, i.e. fail to return for a scheduled follow up visit and never return for further evaluation. Often despite repeated attempts by the investigators to contact them it is not possible to obtain information on what happens to these patients. Therefore, it is not possible for us to provide information on the number of these patients lost to follow-up who may have committed suicides or made suicide attempts.

If you have a query about this letter, please contact me. 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 request. 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 quoting reference. After that, if you remain dissatisfied, you may ask the Information Commissioner at

The Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

to make a decision on whether or not we have interpreted the FOIA correctly.

Yours sincerely
Dr Julie Williams

Therapeutic Team Leader
Pharmacovigilance Risk Assessment Unit
Post Licensing Division
Cc Ms Sarah Wark MHRA/PL