Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, April 05, 2007

Kent Woods CEO MHRA

Myself and long time advocate Derek Scott have had dealings with Woods of the MHRA before.

Personally, I find his attitude rather flippant.

Something stinks Mr Woods and I, Mr Scott and the countless other campaigners will not stop until you and the MHRA are impartially investigated.

We are already investigating you. You may as well come clean and admit you are a complete and utter failure at your job - Our research will find you out in the long run.


Read Richard Brook's letter of resignation to him from the SSRI 'Expert' Group


Professor Kent Woods
Chief Executive
Post-Licensing Division
Medicines and Healthcare Products
Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

12 March 2004


Dear Professor Woods
Re: SSRI Expert Group


I am writing to tender my resignation from the above group with immediate effect. As you will be aware I have had serious disagreements recently with the MHRA about the communication with patients relating to the dosage issues of Seroxat. As you know I have argued for much fuller and immediate disclosure of all findings that relate to public safety. Your letter to me on Monday evening warning me not to discuss the matter publicly was final confirmation about our fundamental differences in approach.

I was thus pleased to see the announcement today putting key information about dosages of Seroxat into the public domain. I am grateful to Lord Warner for his personal interest in this matter. Mind will be playing an active role in ensuring this information is made widely available.
However, the nature of the announcement fails to make public the fact that the clinical trial data you issued today was available to the regulator for over a decade. Despite four major regulatory reviews during this period and considerable consumer reporting and disquiet, the Committee of Safety of Medicines failed either to identify or communicate these key facts. As far as I am aware, the MHRA has not seen fit to acknowledge or address what in my view appears to be extreme negligence.

I have given careful consideration to my continuation on the Expert Group. In particular, I am aware my resignation may mean that consumers will no longer be represented on the group. However, I believe my continuation on the Expert Working Group without a frank and open admission of these important facts has become impossible. Consumers are entitled to full information both about medicines and how the regulator operates. I thus tender my resignation.

Yours sincerely
Richard Brook
Chief Executive, Mind

DOWNLOAD LETTER HERE PDF

Classic quote from Woods

"Our immediate priority has been to ensure that no further patients are harmed. We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."

This after Six men are were in intensive care after suffering a severe adverse reaction to a new biological drug in a clinical trial

The result of the 'exhaustive investigation?

MHRA clears TeGenero drug trial of manufacturing error

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