Clozapine and Amisulpride

name removed 23 Oct 2012

Dear Medicines and Healthcare products Regulatory Agency,

I am making an FOI specifically about Clozapine and Amisulpride.

How many people died in 2011 as a result of taking Clozapine?

How many people died in 2011 as a result of taking Amisulpride?

How many people died in 2011 where Clozapine was a contributory factor?

How many people died in 2011 where Amisulpride was a contributory factor?

How many people developed a heart condition on account of taking Clozapine in 2011?

How many people developed a heart condition on account of taking Amisulpride in 2011?

How many people were taking Clozapine in 2011 who were removed from the Clozaril national programme on account of significant side-effects? How many of these had a heart condition?

Thank you very much for your help,

Yours sincerely,

[first name removed] [last name removed]

MHRA Central Enquiry Point, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Regulation of medical devices:

[9]http://www.mhra.gov.uk/Howweregulate/Dev...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Coming soon: We will be conducting a survey of our Enquiry Point, seeking
your views on the service we provide and any enhancements you would like
to see. Click here for further information: [10]Central Enquiry Point.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Howweregulate/Dev...
10. http://www.mhra.gov.uk/Contactus/Central...

MHRA Central Enquiry Point, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 12/024

Dear Enquirer,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 18 January 2012.

I confirm that your request is being handled under the Freedom of
Information Act and you should receive a reply within 20 working days
from our date of receipt.

If you need to contact us again about this request, please quote the
reference number above.

Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

show quoted sections

name removed 23 Oct 2012

Dear MHRA Central Enquiry Point,

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

Yours sincerely,

[first name removed] [last name removed]

MHRA Central Enquiry Point, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Regulation of medical devices:

[9]http://www.mhra.gov.uk/Howweregulate/Dev...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Coming soon: We will be conducting a survey of our Enquiry Point, seeking
your views on the service we provide and any enhancements you would like
to see. Click here for further information: [10]Central Enquiry Point.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Howweregulate/Dev...
10. http://www.mhra.gov.uk/Contactus/Central...

MHRA Central Enquiry Point, Medicines and Healthcare Products Regulatory Agency

4 Attachments

Dear Ms [last name removed],

Thank you for your recent enquiry to the MHRA.

Please find attached response to your FOI 12/024.


Please contact us again if you require further assistance.

Kind Regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000`

show quoted sections

name removed 23 Oct 2012

Dear Medicines and Healthcare products Regulatory Agency, Mr Andrew Turner, MP for the Isle of Wight, Mr Cameron Prime Minister, Mr Lansley, Secretary of State for Health, and Lord Howe, Parliamentary Under Secretary for Quality to the Department of Health,

I am writing to request an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'Clozapine and Amisulpride'.

I am very concerned about Clozapine and wish to be given the details of ALL deaths where the Coroners have given DECISIONS about deaths where patients were given Clozapine and where it was deemed to be a possible factor in death.

Where are the Coroners' Decisions?

And although you mention that there are supposed to be PILs given to patients on Clozapine there are also details NOT given to the patients.

Therefore please may I have ALL DETAILS GIVEN TO PATIENTS AND THE DATA NOT GIVEN TO PATIENTS?

It cannot be right to withhold essential data such as trials and the known toxicity of Clozapine as found around the world.

Are there any countries which BAN Clozapine?

Has Clozapine ever been banned by any country and if so, when? and has any country ever un-banned the use of Clozapine, and if so, when?

Who is liable in law if the drug is licensed for use, and the doctor prescribes it and then the patient dies?

All of these questions are vital for a national moratorium on the use of Antipsychotics and Clozapine.

A full history of my FOI request and all correspondence is available on the Internet at this address:
http://www.whatdotheyknow.com/request/cl...

Good luck with the legal reform of the entire Health and Social Care networks in the UK. And please abolish the Mental Capacity Act and Section 44 which seeks to demonise and "criminalise" potentially 6 million carers in the UK.

We have crossed the Rubicon,

Yours sincerely,

[first name removed] [last name removed]

Campaigner for legal reform, liberty, truth and justice

MHRA Central Enquiry Point, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Regulation of medical devices:

[9]http://www.mhra.gov.uk/Howweregulate/Dev...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Howweregulate/Dev...

Jones, Sue, Medicines and Healthcare Products Regulatory Agency

1 Attachment

 
 
Dear Mrs [last name removed]
 
I attach the report relating to your request for a review of your enquiry
FOI 12 -024.  I have noted in paragraph 3.3 that you have raised new
questions which should be treated as a new FOI request - I am copying to
the Central Enquiry Point to register this as a new FOI request
accordingly.
 
Yours sincerely
 
Sue Jones
MHRA Policy Division
 
 
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

name removed 23 Oct 2012

13 March 2012

Dear Ms Jones,MHRA, Mr Turner MP for the Isle of Wight,

Thank you for your Internal Review, and thank you for creating a new FOI Request from paragraph 3.3.

I would be most grateful, also. to know specifically what the seriousness or otherwise the status of a patient with the combination of atrophied frontal lobes as found on Cat Scans, regular pattern of sinus tachycardia and right heart atrial enlargement as found on ECG actually is.

NOBODY HAS TOLD ME.

I have gone to NHS Direct but found nothing.

I have gone to NICE but found nothing.

I have gone to the Department of Health but found nothing.

Does ANYONE actually have an answer? Or does literally nobody know?

Is it a condition that is serious or one that is minor and inconsequential?

Please tell me.

Thank you again,

With best wishes,

[first name removed] [last name removed]

Campaigner for liberty, truth and justice

Yours sincerely,

[first name removed] [last name removed]

MHRA Central Enquiry Point, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Our Ref: FOI 12/135
       
Dear Enquirer,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 12 March 2012.
       
I confirm that your request is being handled under the Freedom of
Information Act and you should receive a reply within 20 working days from
our date of receipt.
 
If you need to contact us again about this request, please quote the
reference number above.
       
 
Kind Regards,
 
Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000
 

show quoted sections

Ben Harris left an annotation ()

[name removed] has told us that she has referred this request to the Information Commissioner.

--
Ben Harris, WhatDoTheyKnow volunteer.