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CFS/ME

Steve Hinks made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency

This request has an unknown status. We're waiting for Steve Hinks to read a recent response and update the status.

From: Steve Hinks

13 December 2011

Dear Medicines and Healthcare products Regulatory Agency,

in the last 2 week your webpage reported that there was no link
between CFS and the HPV vaccine. In particular it mentioned a
specific newspaper report in daily newspapers concerning a girl
with 'coma like symptoms' and stated that this case is being
closely monitored and that specialists had been consulted and that
they had reported that there is no link between CFS and the HPV
vaccine.

Please name these specialists, their qualifications, experience and
knowledge of this specific case (by the way they were commenting on
the case of Lucy Hinks). No one from the MRHA has contacted her
family and it should be noted that the NHS who originally reported
this case made several mistakes in the Yellow Card submitted. Her
father has since submitted an accurate Yellow Card.

Yours faithfully,

Steve Hinks (Lucy's dad)

Link to this

From: MHRA Central Enquiry Point
Medicines and Healthcare products Regulatory Agency

13 December 2011

Dear Enquirer,

Thank you for your enquiry to the Central Enquiry Point at 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
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time of 20 working days. For further information about our service and how
we handle different types of request, please view the information
published at the ‘Central Enquiry Point’ section of our website at the
following link:

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

If you have not heard from us after 20 working days then please contact us
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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
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This email and any files transmitted with it are confidential. If you are
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show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
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References

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

Link to this

From: MHRA Central Enquiry Point
Medicines and Healthcare products Regulatory Agency

14 December 2011

Our Ref: FOI 11/484

Dear Mr Hinks,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 14 December 2011.

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.

Yours Sincerely

Central Enquiry Point
Information Services
MHRA
151 Buckingham Palace Road
London
SW1W 9SZ

show quoted sections

Link to this

From: MHRA Central Enquiry Point
Medicines and Healthcare products Regulatory Agency

11 January 2012


Attachment FOI 11 484 11.01.12.doc
119K Download View as HTML


Dear Steve Hinks,

Thank you for your recent enquiry to the MHRA.

Attached is the response to your FOI request.

Please contact us again if you need further assistance with this, or any
other queries.

Kind Regards,

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

show quoted sections

Link to this

From: Steve Hinks

11 January 2012

Dear MHRA Central Enquiry Point,

Please investigate again - I provide further information:

On 5 December 2011 K Darke reported on NHS Choices the following
comment:

There have been recent reports in the press regarding a 13-year-old
girl who has been in a 'waking' coma since having her third HPV
vaccination. The girl was reported to have chronic fatigue syndrome
(CFS).

The Medicines and Healthcare products Regulatory Agency (MHRA) has
kept this issue under close review and its advice, endorsed by
independent experts, is that the vaccine is not a cause of CFS.

See the MHRA website for a full report on the safety of HPV vaccine
www.mhra.gov.uk/Safetyinformation/DrugSa...

I don't know who K Darke is but I certainly believe he/she is not a
member of the public. I suspect he/she is an employee of the MRHA
or NHS.

I have at least one other witness that saw this web page and
reported it to me in writing.

Yours sincerely,

Steve Hinks

Link to this

From: MHRA Central Enquiry Point
Medicines and Healthcare products Regulatory Agency

11 January 2012

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

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

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

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

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: [7]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/Med...
4. http://www.mhra.gov.uk/Howweregulate/Dev...
5. http://www.mhra.gov.uk/Safetyinformation...
6. http://www.mhra.gov.uk/Howweregulate/Med...
7. http://www.mhra.gov.uk/Contactus/Central...

Link to this

From: MHRA Central Enquiry Point
Medicines and Healthcare products Regulatory Agency

19 January 2012


Attachment FOI 11 484 2 19.01.12.doc
130K Download View as HTML


Dear Steve Hinks,
       
Thank you for your recent enquiry to the MHRA.

Attached is the response to the follow up query in relation to FOI 11/484.
<<FOI 11 484_2 19.01.12.doc>>
Please contact us again if you need further assistance with this, or any
other queries.
       
       
Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 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:
[1]www.mhra.gov.uk/Contactus/CentralEnquiryPoint/index.htmPoint.

show quoted sections

Link to this

From: Steve Hinks

6 February 2012

Dear Medicines and Healthcare products Regulatory Agency,

Please pass this on to the person who conducts Freedom of
Information reviews.

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

On the 13th December I submitted a request to the MHRA making
reference to a report on their webpage to my daughters case. It
stated "the MHRA has kept this issue under close review and its
advice, endorsed by independent experts, is that the vaccine is not
the cause of CFS. This is a safe vaccine". I requested the names of
the specialists (independent experts), their qualifications,
experience and knowledge of this specific case. I was advised "we
have no records of such a statement on our website". I provided
further information and was told "the report referred to by K Darke
within the correspondence is the two year safety review conducted
in July 2010". This again is not the report I was referring to
which definitely appeared on the MHRA web page and was witnessed by
at least one friend who wrote to me to inform me of its existence.
Although I was not able to prove otherwise I have now stumbled
across the exact same report on another Department of Health web
page at
www.immunisation.dh.gov.uk/cervical-canc....
This is definitely the report which also appeared on the MHRA web
page. I am seriously concerned that dishonesty and cheating is
going on within the DH and MHRA - I have already obtained evidence
that Professor David Salisbury has required the MHRA to have the
Cervarix EMC Medicine Guide firstly removed from the NHS Choices
website and then modified because he doesn't agree with it. This is
unethical. I thought these were supposed to be the manufacturers
medicine guides "approved" by the MHRA. It is clearly wrong that
the man in charge of immunisations in the UK and hell bent on a
high uptake of vaccine is allowed to dilute the safety rules. It is
already incredible that this man is able to lead a national
immunisation campaign which totally disregards these safety rules
denying parents and girls their right to make an informed choice.

I would expect that this matter is fully and thoroughly
investigated, appropriate actions put in place to correct matters
and controls to prevent re-occurence.

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

Yours faithfully,

Steve Hinks

Link to this

From: MHRA Central Enquiry Point
Medicines and Healthcare products Regulatory Agency

6 February 2012

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.

If you'd like to give us your views about the service provided by the
Central Enquiry Point, then please take part in our short survey by
following the link below.  Your views are very important to us and will
shape how we develop the service over the coming months.

[10]https://www.surveymonkey.com/s/7TV3BSM 

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. https://www.surveymonkey.com/s/7TV3BSM

Link to this

Steve Hinks left an annotation ( 6 February 2012)

In my last request the web address of thge DH website was truncated. To find the specific page you can insert 'coma' into the site search engine or use the full address which is:
www.immunisation.dh.gov/ (followed by) cervical-cancer-jabs-coma-coverage-should-not-cause-concern/

Link to this

From: Jones, Sue
Medicines and Healthcare products Regulatory Agency

29 February 2012


Attachment FOIReview 11 484.pdf
107K Download View as HTML


 
 
 
Dear Mr Hinks
 
Further to your request of 6th February for a review of your Freedom of
Information Act (FOIA) request number 11-484, this review has now been
completed and I attach a full report.
 
Yours sincerely
 
Sue Jones
MHRA Corporate, Policy & Government
151 Buckingham Palace Road
London SW1W 9SZ
Please do not print this message unless you have to
 
 
 
 
 

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.

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