Clozapine and biological safety of the patient

The National Institute for Biological Standards and Control did not have the information requested.

name removed 23 Oct 2012

Dear National Biological Standards Board,

I am making a formal Freedom of Information Request for data on Clozapine and biological safety.

On the internet there are many resources on Clozapine varying from enthusiastically embracing Clozapine as the best drug for schizophrenia sufferers to a report of a Coroner stating that Clozapine had been instrumental as part of the reason for why a person had died.

There are several studies where scientists have determined that death is a known side-effect - albeit extreme - of Clozapine administration.

In view of this, I wish to know what the National Biological Standards Board have considered regarding Clozapine as you are the centre of the Health Protection Agency, and people's lives are potentially being put at danger - as to whether or not they happen to be affected in whatever way by Clozapine.

Why is a drug which is so dangerous actually allowed to be prescribed at all?

How many drugs are as dangerous as Clozapine that patients have to be registered into the National Clozaril programme?
Which other drugs have a similar national registration programme?

How many antipsychotic drugs are regarded as potentially toxic?

Which ones are they?

What precautions must be taken by clinicians to ensure that patients have maximum safety?

In view of the fact that mental health patients may be under Section of the Mental Health Act 1983/2007, and have no option but to take these drugs, how many mental health patients are being drugged against their will?

And are any of these compulsory patients being part of a trial of Clozapine?

Are mental health patients told that they are part of a trial if they are compulsorily detained? And if not, why not?

Thank you very much for your help

Yours sincerely,

[first name removed] [last name removed]

Freedom Of Information,

Dear Ms [last name removed],

The Freedom of Information team acknowledges your request for information.

You will receive a response within 20 working days.

Kind regards,

Neville

Please reply to [NIBSC request email]

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name removed 23 Oct 2012

Dear Freedom Of Information,

Thank you very much for your reply. I look forward to receiving the response to my FOI Request via this website http://whatdotheyknow.com .

With best wishes,

Yours sincerely,

[first name removed] [last name removed]

name removed 23 Oct 2012

Dear Neville,

Thank you very much for your kind help,

With best wishes,

[first name removed] [last name removed]

Campaigner for Justice, Truth and Liberty

Freedom Of Information,

1 Attachment

 

 

Dear Ms [last name removed]

 

Please find attached the Health Protection Agency’s response to your
request for information.

 

Feel free to contact me if you require further clarification.

 

Kind regards

 

 

Freedom of Information Officer

 

 

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name removed 23 Oct 2012

Dear Neville,Freedom Of Information,

Thank you very much for your response which I place within this formal application for Internal Review of my orginal FOI.

I attach below my original request and your response.

My query relates to the definitions of what is and what is not "biogical safety" of the patient.

The question of Clozapine being a "molecular" drug does not disguise the essential fact that it is the HUMAN BIOLOGY of a person who is to be affected by this "molecular" drug, and thereby by its very nature is it also, indistinguishably, a BIOLOGICAL DRUG AND AGENT.

For it is not inanimate. It is not a corpse. It is a living human being who is being administered this drug, Clozapine, and therefore most certainly Clozapine is A BIOLOGICAL DRUG AS IT WORKS ON THE HUMAN'S OWN BIOLOGICAL SYSTEM.

To say anything different would be simply ridiculous.

It is not as though Clozapine were to be used in NON-human medicine - and again even if it were to be used in veterinary medicine it is about LIVE ORGANISMS - not dead corpses.

Thus I would be most grateful if the relevant Data Controller - whoever that is deemed to be either in the HPA or the NISBC - National Institute for Biological Standards and Control can investigate my serious concerns that if indeed the NISBC NEVER investigated Clozapine then potentially their inaction has led to the worries about the safety of Clozapine in any event - as per the Coroner's Decision of December 2011 re Catherine Bell's death was specifically linked to Clozapine.

If the HPA and the NISBC cannot - or will not - or unable to release sensitive documentation regarding Clozapine, I wish to be given the full rationale as to why such a potentially toxic substance is allowed to be administered at all.

I am alarmed for public safety in the alternative.

With many thanks for your personal help and kindness,

With best wishes,

[first name removed] [last name removed]

Campaigner for Liberty, Truth and Justice

HTML version of an attachment to the Freedom of Information request 'Clozapine and biological safety of the patient'.
By email

Ref: 12/01/09/nc/007
Health Protection Agency

Public Information Access

61 Colindale Avenue
London

NW9 5EQ

Tel +44 (0)20 8327 6920

Fax +44 (0)20 8327 6633
6 February 2012

www.hpa.org.uk
Email: [NIBSC request email]

Dear Ms [last name removed]
Re: Clozapine and biological safety of the patient

Thank you for your email dated 8 January 2012 addressed to the National Biological Standards Board regarding Clozapine and biological safety of the patient. In accordance with section 1 (1) (a) of the Freedom of Information Act 2000, I can confirm that the Health Protection Agency (HPA) does not hold the information you have requested.

Clopazine is a small molecular drug rather than a biological medicine so the National Institute for Biological Standards and Control (NIBSC) which is a HPA Centre have not had, and would not have, any involvement with this. Please note, the National Biological Standards Board was abolished with its functions transferred to the HPA.

I hope you have found this information helpful. If you have any queries regarding the information that has been supplied to you, please refer them in the first instance to myself. If you are dissatisfied with this response and would like a copy of the HPA complaints procedure then please contact Mr George Stafford, Complaints Manager at: Health Protection Agency, 61 Colindale Avenue, London NW9 5EQ.

Please note that you have the right to an independent review by the Information
Commissioner’s Office if a complaint cannot be resolved through the HPA complaints procedure. The Information Commissioner’s Office can be contacted by writing to Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire
SK9 5AF.

Yours sincerely,
Freedom of Information Officer
Health Protection Agency
[NIBSC request email]

Freedom Of Information,

Dear Ms [last name removed]
The Health Protection acknowledges your request for an internal review.

Kind regards

Freedom of Information Officer

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Freedom Of Information,

1 Attachment

  • Attachment

    Internal review case 055 Clozapine and the biological safety of the patient.pdf

    27K Download View as HTML

Dear Ms [last name removed]

 

Please find attached the Health Protection Agency’s internal review
response to your request for information. Please feel free to contact me
if you require further clarification.

 

Kind regards

 

Gloria Akinyemi

 

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name removed 23 Oct 2012

29 February 2012

Dear Mr Stafford, HPA, Mr Lansley Secretary of State for Health, Department of Health, Mr Turner MP for the Isle of Wight,

I am very grateful to you for checking through your data. Once I realised that the NPSIS no longer existed, I requested the data from the HPA which had taken over the functions of NPSIS.

Does the HPA ever communicate with the MHRA about Clozapine?

If not, why not?

And if so, is there any data showing what commumications about Clozapine there have been between the MHRA and the HPA and the Department of Health and Secrretary of State for Health?

I ask this in relation to a drug of known toxicity which has the potential to heal but also to cause serious injury, and possibly death.

As such, I am very surprised to learn that the HPA has not data on this at all.

If you do have ANY data even if it is only emails between different organisations regarding Clozapine, I would be most grateful to have the details - not the personal emails of anyone - but just the known details of what Clozapine really can do - its toxicity is needed to be understood in order for Health Protection Agency AND the Department of Health to take measures to protect the public from harm, not just the MHRA through its Yellow Card scheme, I aver.

Thank you very much for your help,

Yours sincerely,

[first name removed] [last name removed]

Campaigner for legal reform, liberty, truth and justice

Ref: 12/02/06/lh/055

"Dear Ms [last name removed]

Re: Internal review for Clozapine and Biological Safety of the Patient

Thank you for your email of the 6 February 2012 in which you requested an internal review of our response to your Freedom of Information request regarding Clozapine and the biological safety of the patient.
I have now completed the review. I have examined the available information and consulted staff members who contributed information to the original response. I have considered whether the correct procedures were followed and assessed the reasons why information was withheld from you.

My findings are set out below.

Health Protection Agency (HPA) informed you that in relation to your request for information regarding Clozapine and the biological safety of the patient, under section 1 (1) (a) of the Freedom of Information Act, the HPA did not hold any of the information you had requested.

The HPA explained to you that Clozapine is a molecular drug rather than a biological medicine. The HPA explained that it is not involved in the testing of Clozapine, and can not provide information on the issues you have raised. The HPA also stated that National Biological Standards Board (NPSIS) to which you sent your letter had been abolished and its functions had been incorporated into the HPA.

You requested an internal review of the response you received from the HPA. You argued about the effects of Clozapine on the human body, and asked for the release of all sensitive documentation held regarding Clozapine by NPSIS and the HPA.

The HPA does not hold the information that you requested. I am satisfied that The HPA properly considered the request for information and conclude the response you received was appropriate.

This completes the HPA internal review process.
You may also be interested in examining further information on Clozapine at the Medicine Health Care Regulatory Agency website www.mhra.gov.uk.

Please note that you have the right to an independent review by the Information Commissioner’s Office. The Information Commissioner’s Office can be contacted by writing to: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.

Yours sincerely,

George Stafford

Head of Public Information Access"

Yours sincerely,

[first name removed] [last name removed]