Clinical evidence re. effectiveness of co-proxamol

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Dr Munir Pirmohamed, Professor of Molecular and Clinical Pharmacology at the University of Liverpool, in reply to an enquiry:-

“Codeine is a pro-drug and it is converted in the body to morphine which is what leads to the pain relief.  This conversion is undertaken by an enzyme called CYP2D6, which is absent in about 7-8% of the UK population. Thus, if you lack the enzyme, you cannot convert codeine to morphine, you do not get pain relief. 

In relation to dextropropoxyphene: (a) it is not a pro-drug and is supposed to act directly; (b) it is not broken down by the same enzyme as codeine (CYP2D6) and thus will not be liable to the same issues as codeine; and (c) it is broken down by another enzyme called CYP3A4, which varies in the body, but all people have the enzyme.”

in other words, if you are genetically unable to produce the enzyme to metabolise it, codeine will do nothing for you.  We have to make clear co-proxamol, being easily metabolised and direct acting, is a valuable treatment or we will lose it!

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13 Replies

  • Posted

    Hi Helen,

    There must be a better way of getting this information out there! Last October I sent a PDF file to the local newspaper (no response). Thursday 4th May I spent half a day at Media City trying to get the attention of a BBC Journalist, after leaving my details I did receive a call back on Friday requesting information which I supplied. At least I now have a name so I will get back to them next week If I haven’t received a response.

    GOOD LUCK WITH YOUR LATEST EFFORT! 

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    • Posted

      Hi Jim - I'm getting the same feeling; either no reply or referring me back to my GP (who is brilliant, but won't be able to prescribe what's unavailable)!  No-one seems to want to listen and I applaud your efforts with the media, I got no reply from Radio 5 so will try Radio 4.  Why isn't anyone else protesting?  Are they too incapacitated with pain?  Have they found a workable alternative?  Because the silence is what worries me most...

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    • Posted

      still suffering in silence, after trying every painkiller out there with no luck I'm now on buprenorphine patches, they help a bit, but nothing like a couple of co-proxamols.  I think it is scandalous that they have withdrawn this drug, and whoever decided to do it should be taken to court and jailed for all the misery they have caused and are still causing. What can we do?

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    • Posted

      Hi Helen,

      I’ve Just Revamped My Blog (COPROXAMOLBAN) Feel free to copy & paste it to Your MP (Or anyone else).

      This Blog still has links to the original 3 BBC Breakfast segments on Co-proxamol from August 2008 as well as the 2 links for the Parliamentary amendment debates (2005 and 2007) by Anne Begg.

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    • Posted

      Hi Patti - that sounds as awful as I feared: yes, I've been on evry painkiller up to and including morphine and nothing works as well as co-proxamol.  There seems to be a refusal to accept that what patients (and their GPs) are saying is true; I wish I knew who to write to but will get back to you if I get any useful names.  For the moment, pester your GP, as it is still available to prescribe where no other medication has proved effective, which fits your situation exactly.  Don't take no for an answer and offer to accept full liability for the prescription.  Write a letter for your Local Area Team and give that to your doctor to forward (this is what I have done).  Unbearable pain is not acceptable, so please don't give up, H

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  • Posted

    Hi Helen, I've done all those things, begged my doctor (new one because my old one who prescribed CoProxamol for me retired last June, which is when my problems began) she didnt even know what co-proxamol was, and the surgery wasnt willing to take any chances on prescribing it, have written to my MP, NICE and the Rheumatoid association, all I get back is a standard letter saying nothing of any use.  There was even a petition out there but less than 200 people signed it.................

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    • Posted

      Hi Patti - Lesley Cookson (chief prescribing officer) is one to try; as I've shared above, where there is clinical need, GPs are entitled to prescribe.

      Underline the effect on your quality of life, make it clear to the new GP that you were much better on co-proxamol and don't take no for an answer :-(

      Wishing you luck, H

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  • Posted

    From Lesley Cookson, Chief Prescribing officer:-

    Many thanks for your correspondence sent to the Customer Contact Centre regarding NHS England’s recent announcement to review some prescription items, including co-proxamal.

     

    The cost for all prescriptions dispensed in primary care in 2015, not including any dispensing costs or fees, was £9.27 billion, a 4.7% increase on the previous year. Due to the increasing cost, from April 2017, NHS England will lead a review of low value prescription items and develop new guidance for CCGs. CCGs are responsible for planning the right services to meet the needs of local people, buying local health services including community health care and hospital services, and checking that the services are delivering the best possible care and treatment for those who need them.

     

    The purpose of this review is to develop guidance at a national level that will support CCGs locally to manage their resources and reduce the differing approaches and regional variation in prescribing across England. It will be based on the latest clinical evidence, including from NICE, and take account of the changing healthcare and societal environment.

     

    Whilst seeking to set out the overall clinical evidence as to the efficacy of certain medicines, it will also recognise the needs of particular groups and individuals, which can best be addressed by the individual clinician when caring and prescribing medicines for their patient. Please be assured that careful consideration will be given to ensure that particular groups of people are not disproportionately affected, and that principles of best practice clinical prescribing are followed.

     There is hope!

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  • Posted

    Are you making any progress in accessing Co-Proxamol ? My GP says the CCG say she can no longer prescribe it.
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  • Posted

    I havent been able to get a prescription now for over a year and I have disintegrated from walking with one stick almost painlessly to going everywhere in a wheelchair in pain.  I have tried just about every painkiller under the sun and no joy, finally got prescribed Buprenorphine Patches 15mg, they help a bit but nothing like Co-Proxamol.  Its a pity we cant sue the government for banning this medication just because of a few silly people overdosing on it.
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    • Posted

      Buprenorphine Patches 15mg,This Drug is far more dangerous and addictive than Co-proxamol!

      MHRA have issued 138 additional Marketing Authorisations for OXYCODONE (Often Described as Hillbilly Heroin) since 2005 when they first announced the withdrawl of Co-proxamol.

      An FDA Report report prepared between 1969 and 2005 Proved this Drug was  responsible for 982 suicides in the USA compared to Just 437 for Propoxyphene (Co-proxamol).

      Significant new information has appeared through my recent FOI requests that have been answered. [FOI 16/546] 20th October 2016 and [FOI 17/046] 9th February 2017.

      MONETARY IMPACT OF CO-PROXAMOL WITHDRAWAL

      My FOI Questions to MHRA [FOI 16/546]: - Co-proxamol, what was the monetary loss to MHRA when these MA’s were cancelled?

      MHRA response: - Zero

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

      MHRA response: - This has been calculated to be approximately £100,000

      Alternate Analgesia                             

      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

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

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

      My attempt at obtaining an answer to this question was cunningly circumvented by them using Section 12 of the Freedom of Information Act. Licence variations and service fees are a continuous income for MHRA which are far more lucrative than the initial marketing authorisations!

      When I combine the response from my latest FOI requests with my initial research I feel that MHRA certainly have a case to answer!

      They persuaded the UK government to accept a flawed CSM /MHRA report that had received a meagre response of just 14.7%.

      OXYCODONE PRESCRIPTIONS ISSUED

      2009/2010 - 788,607   2010/2011 - 919,177   2011/2012 - 1.01million    2012/2013 - 1.09million

      MHRA ARE GETTING RICHER AS THE PATIENTS’ HEALTH CONTINUES TO DETERIORATE, AND THE ESCALATION OF OPIATE ADDICTION CONTINUES TO RISE!

      Oxycodone 10mg capsules in 2017 is £22.86 for 56 tablets

      *The price of Co-proxamol in 2005 was £2.70 for 100 tablets.

       MHRA are nothing more than a REPREHENSIBLE MONEY GRUBBING ORGANISATION IN CAHOOTS WITH BIG PHARMA [/b]and are totally devoid of a moral conscience regarding patient safety and wellbeing. They are totally responsible making life intolerable for millions of patients of patients globally!

      I have submitted a further FOI Request this week;" Increasing Use Of Dangerous Opiates."

      Dear Medicines and Healthcare products Regulatory Agency,

      I would be grateful if you could suply the following information. How many MA’s were held for: - 

      1. Fentanyl, 

      2. Fentanyl Citrate, 

      3. Buprenorphine 

      4. Naloxone 

      When the phased withdrawal for Co-proxamol was first announced in January 2005?

      How many MA’s were held in January 2017?

      How many MA’s for the drugs listed have been cancelled or withdrawn during the period 2005 and 2017?

      What was the monetary Gain to MHRA between January 2005 and 2017 resulting from the additional number of MA's issued for these drugs?

      I have no doubt that many more millions of pounds will have been added to MHRA's Coffers!

       

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  • Posted

    Dear Helen, since co-proxamol was stopped My life has literally stopped in it's tracks.I am no wimp to where pain is concerned but now I have given up hope, my heart is broken at the nonsensical heartless way people have been treated and made to suffer all the indignities that pain can cause I did my bit whilst doing my duty in the military and ended up as a war pensioner to protect the very people that have taken upon themselves to let the rest of us suffer I hope that they can sleep at nights, please do not judge me too harshly as I wish only peace and happiness to all men and women. 

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    • Posted

      Hi Colin,

      I hope you can gain some reassurance that new facts regarding MHRA’s disgraceful behaviour are emerging all the time!

      I'm waiting for a response from the ‘Ombudsman’ and the ‘House of Commons Health Committee’.

      Copy Email     

      House of Commons Health Committee,                                               

                                                                                                                 

      25th September 2017

      Dear Dr Wollaston and colleagues   

      My quest for answers regarding Co-proxamol began in June 2008 under a Labour administration and

      I have been astounded that no one in the NHS, DOH, or successive governments has ever challenged the outright misinformation MHRA have reiterated time & again concerning Co-proxamol? It's my firm belief that MHRA is guilty of ignoring patient safety and well-being purely for financial gain.

      Remuneration and pension interests of the thirteen most senior managers at MHRA range from £105,000 to £210,000

      It would be obvious to assume MHRA couldn't afford to pay the exorbitant salaries from drugs which could only generate a low income.

      This was certainly the case with Co-proxamol its financial contribution to MHRA had declined to a total of just one hundred thousand pounds for the period 2005 and 2015!

      Dr Ian Hudson Chief Executive 

      2016 Salary, Performance pay, and Pension related benefits amounted to a total of £220,000 - £225,000!

      Dr June Raine, CBE Director of Vigilance & Risk Management of Medicines 2016 Salary, Performance pay, and Pension related benefits amounted to a total of £165.000 - £170,000!

      On 9th August 2017 I submitted a further FOI  request [FOI 17/356]     ‘Increasing Use Of Dangerous Opiates’ (Internal Review Requested 8th September 2017): 

      Dear Medicines and Healthcare products Regulatory Agency, I would be grateful if you could supply the following information,  How many MA’s were held for

      1. Fentanyl, (Including Fentanyl Citrate)                         + 75

      2. Buprenorphine                                                            + 85

      3. Naloxone                                                                    + 24

      TOTAL                                                              184 Additional MA's Issued

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

      How many MA’s were held in January 2017?

      How many MA’s for the drugs listed have been cancelled or withdrawn during the period 2005 and 2017?

      What was the monetary Gain to MHRA between January 2005 and 2017 resulting from the additional number of MA's issued for these drugs?

      MHRA Response: - 

      I can confirm that the MHRA can provide some of the information that you have requested. The information we can provide is concerning the number of MAs at certain dates, as follows: 

       

      * FENTANYL (including fentanyl citrate):  92 MAs currently granted at 1 Jan 2017; 19 at 1 Jan 2005; 9 cancelled after 1/1/05

      * BUPRENORPHINE:  103 MAs currently granted at 1 Jan 2017, 18 at 1 Jan 2005; 12 cancelled after 1/1/05

      * NALOXONE:  35 MAs currently granted at 1 Jan 2017, 11 at 1 Jan 2005; 14 cancelled after 1/1/05

      The question regarding 'monetary gain' is exempt under Section 12 of the Freedom of Information Act (unreasonable use of resources) and we cannot process your request any further on that question. 

      Following my previous FOI requests [FOI 16/546 FOI 17/046] I wasn't surprised when MHRA invoked ‘Section 12 of the Freedom of Information Act’ regarding my question 'monetary gain'.

      Fortunately I can assume the additional 184 MA’s would generate a similar increase in revenue to the 138 additional MA’s MHRA issued for Oxycodone which I calculate to be a further £4,000,000 +. This would put MHRA's Total Gain at over Eight Million Pounds!

      As Naloxone is used to treat a narcotic overdose in emergency situations the additional 24 MA’s issued would indicate that the alternate analgesics are more dangerous than Co-proxamol and MHRA have gained financially from the additional opiates dispensed and the cure for overdose.

      It remains my firm belief that MHRA often uses ‘Section 12 of the Freedom of Information Act’ in order to avoid any embarrassing questions which would show them in a negative way.

      I'm sure someone in the organisation would have known exactly how much their financial gain was worth or certainly have been able to supply reasonable estimates to my FOI requests without invoking ‘Section 12’.

      Co-proxamol had been a completely safe (when tolerated and used correctly) and economical drug which had been used by patients for over 50 years, my FOI request [FOI 16/546] outlined the MONETARY IMPACT OF CO-PROXAMOL WITHDRAWAL. 

      MHRA Total Losses from the Cancelation of MA’s For Co-proxamol 2005 to 2015                                                                                       £100,000           

      MHRA Total Gains up to 2015.

      Additional Application Fees (MA's issued) for Oxycodone     £1,550,000.00   

      Subsequent licence variations and service fees (First 60).    £1,068,399.00 * 

      Additional Licence Variation and service Fees (78) 

      [Average of first 60]                                                               £1,388,868.00 **

      Total Gain                                                                             £4,007.267.00                                                                             

      *This Figure is only for the first 60 MA’s issued! There was an additional 138 Ma’s issued for Oxycodone between 2005 and 2015 and many more for other analgesics! 

      ** Average Cost £17806 per MA 138 – 60 = 78 remaining MA’s              £1,388,868.00

      Was The European Ban Coincidence, Conspiracy, or Corruption? The European Commission issued their decision on 14 June 2010.

      Unfortunately these facts have only come to my attention during August 2017 and are certainly relevant to why this well tolerated and effective drug had been banned globally!

      It appears that the two main instigators of the UK ban on Dextropropoxyphene containing products in the UK were probably responsible for the European ban!

      Dr. June Raine was elected in 2005 to chair the CHMP’s (EMA) Working Party and in 2012 as the first chair of the Pharmacovigilance Risk Assessment Committee. She is also a member of the WHO Advisory Committee on Safety of Medicinal Products.

      Dr. Ian Hudson Head of Licencing at MHRA was also a member of CHMP EMA's drugs evaluation committee. Dr. Hudson had been a member of the scientific advisory committee since 2004.

      As the NHS has had to bear the excessive additional costs to operate MHRA’s ‘Named Patient Scheme’ along with the increased costs for the inferior medication thrust upon patients and the additional prescriptions added to combat the severe side effects of the alternate drugs I feel that doctors Ian Hudson, and June Raine should be brought before the committee to explain MHRA’s huge financial gains, at the direct costs increases to the NHS! 

      I hope your committee will consider all aspects of my 'Official Complaint' to MHRA (No Response To Date) and to the attached PDF file. I look forward to receiving your comments and prompt response.

       

      Yours sincerely, 

      xxxx

      I will post any updated information as soon as I receive replies from the ‘Ombudsman’ and ‘Health Committee’

      Best Wishes

      Jim

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