This is an HTML version of an attachment to the Freedom of Information request 'Clozapine use in patients with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG'.









 
FOI 12/144 
 
Dear Mrs xxxxxxxx 
 
Thank you for your request of 22 March. It is part of an ongoing series of 
correspondence regarding Clozapine. Your new request was: 
 
“I am writing in abject horror - Clozapine is a KNOWN CARCINOGEN according to CDN 
ISOTOPES. 
 
https://www.cdnisotopes.com/msds/en/D-3917.pdf 
I am requesting an urgent investigation into the safety of this substance, for how can 

ANY KNOWN CARCINOGEN BE FORCED INTO UNWILLING AND UNWITTING PEOPLE, 
SOME OF WHOM ARE COMPULSORILY MEDICATED AGAINST THEIR WILL, WITHOUT 
THEIR CONSENT AND WITHOUT ANY KNOWLEDGE THAT THIS TOXIC SUBSTANCE 

CAN CAUSE CANCER? 
  

Please make an urgent investigation into Clozapine. I understand that it is a very 
controversial drug and in December 2011 the Coroner's Decision regarding Catherine 

Bell referred specifically to Clozapine. 
  

I fear that we may have a "Thalidomide" on our hands or a "mattress grade" silicon 
breast implants potentially killing people, not now, but in a few years' time when 
people might not realise the actual connection between the drug and cancer. 

  
How many people have died from cancer SINCE being on Clozapine?  Has anyone 

ever checked? 
  

I would like there to be an urgent parliamentary debate about the safety of Clozapine 
because it surely cannot be the case that a Carcinogen stops being a Carcinogen 

when it enters the body?” 
 
This request is one of a series of FOIA requests you have sent to the Agency on 
various issues. Thus far, three of these requests have also subsequently been the 
subject of internal reviews.  
 
You also raised the same or similar issues via direct correspondence, formal 
complaints etc, and with other organisations, apparently cross copying everyone into 
every email –whether or not it is intended that that organisation is expected to 
respond- thus confusing matters. The emails themselves are lengthy and often 
include the email trail of everything that has gone before, but which still need to be 
read through each time, in their entirety, to see if there are any substantially new 
issues raised and, if so, where in the body of the correspondence they might be, 
before deciding whether or not a reply is appropriate or necessary and then drafting 
the reply. The length of the emails, combined with the lack of clarity and the 
repetitive nature of the correspondence in itself constitutes a distraction from the 
Agency’s core function of safeguarding public health as much time is spent unpicking 









 
their content to try to come to a reasonable interpretation of what information, if any, 
is actually being requested 
 
Furthermore, your requests frequently ask the Agency to take or participate in 
actions, speculate or give opinions, none of which activities is within the remit of the 
FOIA. The FOIA exists –exemptions allowing- to provide requesters with information 
“held” by the Authority. We do not consider that the FOIA is a suitable vehicle for the 
continuation of discussions with a public authority that should be pursued and settled 
by other, more appropriate, means - such as requesting an urgent Parliamentary 
debate. 
 
We also note that replies often serve merely to generate further requests or 
correspondence, so the actual number of requests themselves does not necessarily 
capture the totality of the burden placed on the MHRA in answering them 
 
This letter is, to advise you of the provisions of Section 14 of the Freedom of 
Information (FOI) Act.  
“Vexatious or repeated requests  
14. – (1) Section 1  
(1) Does not oblige a public authority to comply with a request for information if 
the request is vexatious.  
(2) Where a public authority has previously complied with a request for 
information which was made by any person, it is not obliged to comply with 
subsequent identical or substantially similar request from that person unless a 
reasonable interval has elapsed between compliance with the previous request 
and the making of the current request.”  
 
Guidance from the Information Commissioner’s Office defines “vexatiousness” thus:-  
 
“…a request (which may be the latest in a series of requests) can be treated as 
vexatious where:  
•  It would impose a significant burden on the public authority in terms of 
expense or distraction; and meets at least one of the following criteria.  
•  It clearly does not have any serious purpose or value.  
•  It is designed to cause disruption or annoyance.  
•  It has the effect of harassing the public authority.  
•  It can otherwise fairly be characterised as obsessive or manifestly 
unreasonable.”  
 
We have no doubt that the issues you have raised with the Agency arise from matters 
about which you genuinely feel concerned. Furthermore, we do not consider that 
there is any deliberate attempt on your part to waste the Agency’s time. However, we 
believe that the Agency has given adequately full responses to the questions you 
raise, and continued requests will simply go over substantially the same ground, with 
minor variations according to how you choose to frame them. It seems likely at this 
juncture that no matter how much effort the Agency invests in responding to your 
queries, we will be unlikely to reach a point that promises to satisfy your concerns. 









 
We also have to weigh up the fact that dealing with them is taking up a substantial 
amount of staff time, places an unreasonable burden on the Agency’s resources, and 
diverts and delays staff from other important work. 
 
Consequently we will not be answering this request by virtue of the application of 
Section 14. Section 14 will be considered on a case by case basis, and if future 
requests are substantially different they will be dealt with as normal. 
 
It would also be of great benefit, not least to yourself, if you could in future bear the 
following in mind when making FOIA requests to the Agency. 
 
•  Consider what information it is reasonable and realistic that we be expected to 
hold. 
 
•  Where possible, be specific about what information it is you actually want – we 
do not necessarily need to know why you want it or what you intend to do with 
it, and certainly not in great detail. If we need to clarify we will get back to 
you. 
 
•  Unless it provides a context that is helpful in allowing us to identify what you 
are requesting, we do not need to see everything that has gone before, every 
time you contact us - this only serves to confuse matters and possibly delay 
an answer, as we then need to read everything again  each time. 
 
•  Internal reviews should only be requested to consider the handling of an 
answered request, not to raise new issues. If you have new questions to ask 
you should submit these in a new and separate FOIA request. If you submit 
what you consider to be further new requests for information within 
correspondence relating to an ongoing or concluded reply there is a danger it 
will not get picked up as such and subsequently missed. 
 
•  Where you have copied an email to numerous organisations, it would be very 
helpful to know which one is being asked to consider which issue 
 
If you are dissatisfied with the handling of your request, you have the right to ask for 
an internal review. Internal review requests should be submitted within two months 
of the date of receipt of the response to your original letter and should be addressed 
to: 
 
Communications Directorate, Medicines and Healthcare products Regulatory Agency, 
151 Buckingham Palace Road, London, SW1W 9SZ.  
 
If you have any queries about this email, please contact us.  Please remember to 
quote the reference number above in any future communications.  
 
If you are not content with the outcome of the internal review, you have the right to 
apply directly to the Information Commissioner for a decision. The Information 









 
Commissioner can be contacted at: Information Commissioner’s Office, Wycliffe 
House, Water Lane, Wilmslow, Cheshire, SK9 5AF 
 
 
 
 
Kind regards 
 
Central Enquiry Point 
Information Services 
Medicines and Healthcare products Regulatory Agency 
 
020 3080 6000