Loss of Co-proxamol Leads To A Life Of Relentless Side Effects And Substandard Pain Relief!

James Kelly made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

Once again I have been forced into a life of living hell! MHRA are directly responsible for my situation for a second time. I have had to endure this situation since my prescription for Co-proxamol was withdrawn during November 2015.

Between 2005 and 2007 all patients receiving prescriptions for co-proxamol were forced to trial alternate analgesia. *Hundreds of patients contacted MHRA regarding the severe side effects they were suffering along with substandard pain relief during this period!
*http://webarchive.nationalarchives.gov.u...

None of the 1.75 million patients prescribed Co-proxamol were consulted in your review!
ONS figures are expected to show Tramadol deaths will increase again in 2015 when the figures are released in September. (This would place Tramadol more dangerous than Co-proxamol was in 2007)

Your Reasoning: - 300-400 deaths per year

The figure of between 300-400 deaths per year was difficult to establish when using Office of National Statistic figures: often alcohol and other drugs were used in conjunction with co-proxamol. At the time of stating this figure, there were approximately 1.7 million patients taking co-proxamol; the death rate, even if correct, equated to just 0.02% of patients affected. The vast majority of patients had taken Co-proxamol responsibly and, in normal use, co-proxamol posed no threat to life and had considerably fewer side effects than other pain killing drugs.

As it appeared that MHRA had no regard for patient’s well-being, I can only assume other factors must be responsible for your previous decision making. This is why I’m seeking answers with a FOI request.

There were approximately 16 licence holders (MA’s) for Co-proxamol at the end of 2007

1. What was the monetary loss to MHRA when these MA’s were cancelled?

2. What was the potential monetary loss to MHRA between 2008 and 2015? (Renewals Etc.)

3. How many MA’s were held for the following drugs when the phased withdrawal for Co-proxamol was first announced in January 2005? Codeine, Co-codamol, Dihydrocodeine, and Tramadol

4. How many MA’s were held in January 2015?

5. What was the monetary Gain to MHRA between 2008 and 2015 resulting from any increases in the number of MA's issued? (Including Renewals Etc.).

Yours faithfully,

James Kelly

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. 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 requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 16/451
       
Dear Mr Kelly,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 13 September 2016. 
       
We 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     

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [1][MHRA request email]
[2]Stay connected

 

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 16/451

Dear Mr Kelly

Re:  Monetary impact of Co-proxamol withdrawal                      
       

Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency (MHRA).

I enclose the information you have requested according to our licensing
records.

1.            What was the monetary loss to MHRA when these MA’s were
cancelled?

Zero

 

2.            What was the potential monetary loss to MHRA between 2008
and 2015? (Renewals Etc.)

This has been calculated to be approximately £100,000

 

3.            How many MA’s were held for the following drugs when the
phased withdrawal for Co-proxamol was first announced in January 2005?
Codeine, Co-codamol, Dihydrocodeine, and Tramadol

389 (288 for any codeine or dihydrocodeine containing products and 101
tramadol products)

 

4.            How many MA’s were held in January 2015?

285 – (186 codeine or dihydrocodeine + 99 tramadol)

 

5.            What was the monetary Gain to MHRA between 2008 and 2015
resulting from any increases in the number of MA's issued? (Including
Renewals Etc.).

Zero.  (There was a net decrease in numbers of MAs during this period).

 

Copyright notice
The information supplied in response to your request is the copyright of
MHRA and/or a third party or parties, and has been supplied for your
personal use only. You may not sell, resell or otherwise use any
information provided without prior agreement from the copyright holder.
For full details on our copyright policy please visit:

[1]http://www.nationalarchives.gov.uk/infor...

 

If you have a query about this email, please contact us. If you are
unhappy with our decision, you may ask for it to be reviewed. That review
will be undertaken by a senior member of the Agency who has not previously
been involved in your request. If you wish to pursue that option please
write to the Communications Directorate, 4-T, Medicines and Healthcare
products Regulatory Agency, (via this email address). After that, if you
remain dissatisfied, you may ask the Information Commissioner at

 

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

to make a decision on whether or not we have interpreted the FOIA
correctly in withholding information from you.

 

Yours sincerely

 

Customer Services

Communications division

Medicines and Healthcare products Regulatory Agency

151 Buckingham Palace Road, London, SW1W 9SZ

Telephone: 020 3080 6000

Email: [2][MHRA request email]

Stay connected: mhra.gov.uk/stayconnected

 

 

 

 

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Dear MHRA Customer Services,
Thank you for your prompt reply, as you have stated "there was a net decrease in numbers of MAs during this period" I can only assume that alternative analgesia MA's have been issued between 2005 and 2015.
Is it possible to request additional information to include oxycodone to be added to the list 'How many MA’s were held in January 2005 and January 2015?'
Yours sincerely,

James Kelly

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. 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 requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

show quoted sections

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 16/459
       
Dear Mr Kelly,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 28th August 2016.
       
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,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

show quoted sections

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 16/459

Dear Mr Kelly

Re:   Monetary impact of Co-proxamol withdrawal                                  

Thank you for your follow-on enquiry to the Medicines and Healthcare products Regulatory Agency (MHRA).

I enclose the information you have requested according to our licensing records.

How many MA’s were held for OXYCODONE drugs when the phased withdrawal for Co-proxamol was first announced in January 2005?

13

How many MA’s were held in January 2015?

151

(I should point out that in 2008 the patent protection for oxycodone expired which will have contributed to the increased numbers of oxycodone products during the same period).

What was the monetary Gain to MHRA between 2008 and 2015 resulting from any increases in the number of MA's issued? (Including Renewals Etc.).

Approximately £1,550,000. This is the total received in application fees for these new marketing authorisations and does not include any subsequent licence variations or service fees.

In order to provide you with all of the information that you have requested i.e. all fee income from these licences, would require checking the records for each of the 151 products.

Section 12 of the Act makes provision for public authorities to refuse requests for information where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
We estimate that it will take us in excess of 24 working hours to retrieve and extract the information to fulfil your request. Therefore, we have only provided the application fee information.

You may wish to refine your request by narrowing its scope by being more specific about what information you particularly wish to obtain, including any dates or period of time relevant to the information required.

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: MHRA Customer Services ([MHRA request email]).

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

NB  Information is not supplied on products currently under assessment.

Copyright notice
The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder. For full details on our copyright policy please visit:
http://www.nationalarchives.gov.uk/infor...

Yours sincerely

Customer Services
Communications division
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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Dear MHRA Customer Services,
Re your reply: - In order to provide you with all of the information that you have requested i.e. all fee income from these licences, would require checking the records for each of the 151 products.

As you were able to provide an approximate loss regarding *Co-proxamol I would have thought it would have been reasonable to assume that with your charges being constant for renewals etc. it should have been possible to supply an approximate figure multiplying one figure by 151

*2. What was the potential monetary loss to MHRA between 2008
and 2015? (Renewals Etc.) This has been calculated to be approximately £100,000

Yours sincerely,

James Kelly

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. 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 requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

show quoted sections

Dear MHRA Customer Services,

Clarify Re your reply: - In order to provide you with all of the information that you have requested i.e. all fee income from these licences, would require checking the records for each of the 151 products.

As you were able to provide an approximate loss regarding *Co-proxamol I would have thought it would have been reasonable to assume that with your charges being a constant for renewals etc. it should have been possible to supply an approximate figure for Oxycodone. By multiplying one figure by 138 which was the additional MA’s issued for Oxycodone between 2008 and 2015, and then subtract the £100,000 for the loss of revenue from Co-proxamol.

*Q1. What was the monetary loss to MHRA when these MA’s were cancelled? Zero
Q2. What was the potential monetary loss to MHRA between 2008 and 2015? (Renewals Etc.)
This has been calculated to be approximately £100,000

Yours sincerely,

James Kelly

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Mr Kelly,

 

Thank you for your email.

 

In reply to your comments, medicine licensing fees vary depending on the
complexity of the application and in the case of these oxycodone products,
the initial fees for each product varied from £2,700 to £29,000. In
addition every product will have a different history of variations to the
licence (most variations will also incur a fee and these also vary
considerably depending on the complexity of the changes being requested)
and the volume of periodic fees may also differ, depending on whether a
licence remained active or was cancelled during this period. We estimated
that it would take at least 15 minutes to check the records for each
licence and produce an estimate which is why we exempted this information
under Section 12 of the Freedom of Information Act.  The figure for loss
following the co-proxamol cancellations was simpler to estimate because no
initial fees were involved.

 

 

Kind Regards,

 

Customer Services

Communications division

Medicines and Healthcare Products Regulatory Agency

151 Buckingham Palace Road, London, SW1W 9SZ

Telephone: 020 3080 6000

Email: [MHRA request email]

Stay connected

 

 

 

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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 'Loss of Co-proxamol Leads To A Life Of Relentless Side Effects And Substandard Pain Relief!'.

It’s my opinion that MHRA produces more income from increases in the number of variations to the licence than the initial MA fees for each product.

Obviously you appear to be embarrassed by this amount and seem to be hiding behind Section 12 of the Freedom of Information Act.

Surely a rough guestimate could have been achieved by adding the variation figures from the two extremes (£2,700 and £29,000) dividing the result by two then multiplying this figure by the number of additional MA’s issued since 2005. This would only have taken two hours of additional work according to your figures.

Deaths from all of the alternate analgesia have increased alarmingly since the MA’s for Co-proxamol were removed!
• Deaths from Tramadol rose from 53 in 2005 to 240 in 2014
• Deaths from Oxycodone rose from 11 in 2005 to 53 in 2014
• Deaths from Codeine rose from 44 in 2005 to 136 in 2014
• Deaths from Fentanyl rose from 3 in 2005 to 40 in 2014
• Deaths from Buprenorphine rose from 5 in 2005 to 24 in 2014
• THE ONLY BENEFIT OF BANNING CO-PROXAMOL HAS BEEN THE MANY MILLIONS OF POUNDS ADDED TO THE COFFERS OF MHRA! MHRA are responsible for forcing patients on to far more dangerous and less effective drugs.

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

Yours faithfully,

James Kelly

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. 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 requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

show quoted sections

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 16/546
       
Dear Mr Kelly,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 20th October 2016.
       
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,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

show quoted sections

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Mr Kelly,

 

The internal review that you have requested (our reference FOI 16/546) has
been completed and summarised as follows:

 

Section 12 of the Act makes provision for public authorities to refuse
requests for information where the cost of dealing with them would exceed
the appropriate limit, which for central government is set at £600. This
represents the estimated cost of one person spending 24 working hours in
determining whether the department holds the information, locating,
retrieving and extracting the information.

 

 

We consider that Section 12 has been correctly applied in this instance
because of the complexity of fees and the number of licences involved.  We
are not able to provide an ‘guestimate’, nor is it ‘information held’ by
the agency as defined in the Act.

However we do hold an accurate figure for the income from initial licence
fees for oxycodone products authorised between 2008 and 2015 and this
figure could have been released with an explanation as to why to get a
total to include service fees and variation fees would take more than 24
hours to produce.

 

The total for initial application fees received between 2008 and 2015 for
new oxycodone products was £1,391,139.

 

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

 

Customer Services

Communications division

Medicines and Healthcare Products Regulatory Agency

151 Buckingham Palace Road, London, SW1W 9SZ

Telephone: 020 3080 6000

Email: [1][MHRA request email]

Stay connected: mhra.gov.uk/stayconnected

 

 

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