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MHRA IS A REPREHENSIBLE AND DISHONEST ORGANISATION AND HAS SCANT REGARD FOR PATIENT SAFETY & WELLBEING!
My quest for answers regarding Co-proxamol began in June 2008 under a Labour administration and unfortunately nothing has changed with this government. None of my questions have been answered with honesty and it appears that most MP’s in successive governments believes that every word issued by MHRA to be true.
Since November 2015 the NHS via local CCG’s have managed to obliterate the “Named Patient safeguard” which was assured by the MHRA during 2004 – 2007. This decision will result in thousands of UK patients (and millions globally) living with the horrendous side effects caused by the alternate analgesia or living with unmedicated pain for the rest of their lives.
All the patients who were classed as a ‘Named Patient’ had all previously proved beyond any doubt that all alternative pain relief had been useless to them in order for them to be placed on the list in the first place! Why has this government allowed this to happen?
The Department of Health have failed to work with the manufacturer to ensure a consistent supply of Dextropropoxyphene was available in order to enable the ‘Named Patient Scheme’ to continue
Despite my best efforts there appears to have been no cohesion at all between the NHS departments, MMG’s CCG’s DOH, MHRA, ACMD, or the Home Office.
I’ve previously contacted these departments the APPG Secretariat, and many of the organisations who originally disputed the MHRA’s decision to remove the licence for Co-proxamol at the end of 2007. My MP Paul Maynard answered my request by simply quoting the misinformation from MHRA and declined my request for a meeting at one of his surgeries. I’ve also submitted several ‘Freedom of Information’ requests since my prescription for Co-proxamol was cancelled during November 2015.
Please take the time to read the Following : -
My Original Search for Proof That Oxycodone Is More Dangerous To Patients than Co-Proxamol (Submitted To MHRA, CCG, and DOH)
*There must have been a reason why MHRA deliberately removed a completely safe (when tolerated and used correctly) drug from the market while continuing to grant additional ‘Marketing Authorisations’ for two drugs which were known to have serious consequences for patients.
The Attached PhotoTable (6) comes from an American FDA study taken between 1969 and 2005 and would have been available during 2005 when MHRA made their catastrophic decision to remove the MA's (Licence) for Co-proxamol.
1st January 2008 the remaining 17 Marketing Authorisations for Co-proxamol were removed.
Between 2005 and 2015 MHRA issued an additional 138 ‘Marketing Authorisations’ for Oxycodone. According to the FDA report above there were 10671 more adverse event reports, 3256 more overdose reports, 437 more suicide reports, 5041 more abuse & dependence reports, and the total number of death reports increased by 5059 when Oxycodone was compared with Propoxyphene (Co-proxamol)!
THIS STUDY WAS COMPLETED BY 2005 WHEN THE UK GOVERNMENT ACCEPTED THE RESULTS OF THE FLAWED CSM / MHRA CALL FOR EVIDENCE REPORT WHICH HAD A RESPONSE OF A MEAGRE 14.7%
WHY WOULD MHRA ADVISE THE GOVERNMENT TO BAN AN EFFECTIVE DRUG AND THEN PROCEED TO ISSUE ADDITIONAL MA’s FOR TWO DRUGS WHICH HAD BEEN PROVED TO BE FAR MORE HARMFUL TO PATIENTS?
DID CAROLINE FLINT MP HVE A PROBLEM WITH DUE DILLIGENCE?
Most of the 1.7 million patients previously prescribed Co-proxamol have had to have other medications added to their prescription list to counter the severe side effects of the alternate analgesia resulting in increased costs to the NHS. Since my prescription was removed in November 2015 I have had to have many additional visits to my GP in my unsucsessful attempt to find a suitable alternative drug, again increasing the costs to the NHS!
November 2015 CCGs informed their members to switch patients to alternative medication after fears that the annual spend would far outreach the £3.2 million spent in 2014 on Co-proxamol. This decision was based on financial savings NOT MEDICAL NEED!
The vast majority of patients used Co-proxamol responsibly and in normal use the drug posed no threat to life and had considerably fewer side effects than any of the other pain killing drugs.
MHRA refused to accept any of the positive responses they received from Patients, MP’s, or ‘Medical Professionals’.
Oxycodone was prescribed more than a million times in England (2012 – 2013), a rise of 39 per cent since 2010.
2009/2010 - 788,607 2010/2011 - 919,177 2011/2012 - 1.01million 2012/2013 - 1.09million
The price NHS has to pay for Oxycodone (Part VIIIA products).
Drug Quantity Basic Price Category
Oxycodone 10mg /
Naloxone 5mg 56 £42.32 C
Oxycodone 10mg capsules 56 £22.86 C
Modified-release tablets 56 £25.04 C
MHRA’s reasoning for the removal of the MA’s was: - 300-400 deaths per year. Deaths from the alternate drugs have increased dramatically since the removal of co-proxamol!
• MISINFORMATION Hawton and colleagues showed that as prescriptions for co-proxamol markedly declined during the withdrawal phase (2005-7), there was a corresponding reduction in deaths due to poisoning with the drug (Hawton, Bergen et al., 2009) and also fewer non-fatal poisonings (Hawton, Bergen et al., 2011). Encouragingly, there was no substantial increase in poisoning deaths involving other analgesics used in place of co-proxamol.
** [Hawton, Bergen et al., 2009, Hawton, Bergen et al., 2011, and Hawton, Bergen et al., 2012]
• More recently the research team have evaluated the longer-term impact of the initiative, including following full withdrawal of co-proxamol from 2008 to 2010 (Hawton, Bergen et al., 2012). This showed a similar picture, with a further decrease in deaths due to co-proxamol poisoning, such that over the six-year period from the beginning of the initial withdrawal there were about 600 fewer deaths, with again no indication that deaths due to overdoses with other analgesics increased significantly.
[The further decrease in deaths were due to the fact that most GP’s weren't prepared to accept the threat of litigation placed on them by their insurer’s and union and refused to prescribe]
None of the above statements appear to correspond with the figures in the attached image (Co-proxamol Suicide Rates 1998 to 2007)
Hawtons study was supported by a grant from the Department of Health for England. Views expressed in this paper are those of the authors, and not necessarily those of the Department of Health. Keith Hawton is supported by Oxfordshire Mental Healthcare NHS Trust, and Sue Simkin by Oxfordshire Research and Development Consortium Strategic Research Fund.
This initiative did not stop in the UK.
Following presentation of the Oxford team’s findings by Hawton to the European Medicines Agency (EMEA), the EMEA recommended to the European Union (EU) that non-prescribing of dextropropoxyphene should become policy throughout the EU. The decision was endorsed in June 2010.
• The UK and EU initiative prompted the US Food and Drug Administration to take action in 2010 to withdraw dextropropoxyphene in the USA.
• In 2010 Health Canada did likewise in Canada, as did the equivalent authorities in New Zealand, Singapore and Taiwan. Thus it is anticipated that the work of Hawton and his team will contribute to the saving of lives in many countries, not just in the UK.
[There wasn’t any reduction in deaths, just an increase in addiction]
Deaths involving all types of paracetamol continued to fall, with 255 deaths in 2009 compared with 410 in 2005. The biggest impact on this decline was deaths with a mention of co-proxamol (paracetamol and dextropropoxyphene), where the figures have fallen 84 per cent between 2005 and 2009. However, over the same period deaths that mention co-codamol (paracetamol and codeine) have increased by 23 per cent and deaths involving codeine taken alone have doubled.
Deaths in the UK 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 (+187)
• Deaths from Oxycodone rose from 11 in 2005 to 53 in 2014
• Deaths from Codeine rose from 44 in 2005 to 136 in 2014 (+ 92)
• Deaths from Fentanyl rose from 3 in 2005 to 40 in 2014 (+ 37)
• Deaths from Buprenorphine rose from 5 in 2005 to 24 in 2014 (+ 19) Total increase + 397
[The Suicide Toll Was Already Falling]
This chart clearly shows a 5% reduction in Co-proxamol Suicides prior to the ban being announced!
Year Co-proxamol †
Suicide, open Suicide, open, accidental
1998 298 (21) 354 (16)
1999 298 (21) 359 (16)
2000 296 (23) 345 (16)
2001 268 (21) 322 (15)
2002 217 (18) 265 (13)
2003 196 (16) 226 (12)
2004 204 (16 ) 249 (12)
2005 70 (6) 86 (5)
2006 69 (7) 83 (5)
2007 53 (6) 63 (3)
†Percentage of drug poisoning deaths shown in brackets.
In addition to the misery MHRA has inflicted on the patients the Government had been left to pick up the bill for the ridiculous price increases over the years 2005 £2.70 for 100 tablets 2015 £49.50. This resulted in co-proxamol being withdrawn from prescribing completely on the NHS. The only way I could receive Co-proxamol now would be on a private prescription at a cost of £130.00 for 100 tablets (my last quote from Boots chemist).
• PATIENTS AROUND THE WORLD HAVE BEEN FORCED TO SUFFER THE SEVERE SIDE EFFECTS FROM THE ALTERNATE DRUGS!
• GOVERNMENTS AROUND THE WORLD HAVE BEEN FORCED TO PAY FOR THE LUDICROUS PRICE INCREASES, AND DEAL WITH THE ADDICTION PROBLEMS THAT WERE BOUND TO FOLLOW!
Who Has Gained From This Debacle?
* My continuing search for new information about the Co-proxamol ban has resulted in my opinion changing within past few months regarding the MHRA!
I have recently discovered that the most likely reason for the removal of the ‘Marketing Authorisations were probably financial. Their reasoning for the removal of the MA’s was: - 300-400 deaths per year.
As Co-proxamol had been on the market for over 50 years the income MHRA received from the remaining 17 ‘Marketing Authorisation’ holders had diminished by 2005.
MHRA have issued many more ‘Marketing Authorisations’ for alternate analgesia during the period from 2005 to 2014. Once again they appear to seek increases in their income while totally ignoring patient safety & wellbeing.
How do you increase your income from one hundred thousand pounds to fifteen million pounds? (This would be my guestimate and could be higher) BAN CO-PROXAMOL!
MONETARY IMPACT OF CO-PROXAMOL WITHDRAWAL
My FOI Questions to MHRA: - 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
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. This is the total received in application fees for these new marketing authorisations and does not include any subsequent licence variations or service fees. (The figure of fifteen million is my guestimate of application fees, licence variations, and service fees for Oxycodone and Tramadol plus any additional MA’s issued for other drugs that replaced Co-proxamol)
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 and are far more lucrative than the initial marketing authorisations)!
There have been significant financial gains for MHRA with the additional Marketing Authorisations (MA’s) being issued by them. Unfortunately this has seriously impacted on the 1.7 million patients in the UK who were receiving prescriptions prior to 2005, and more recently the 60,000 patients who were prescribed Co-proxamol on the ‘Named Patient’ scheme until 2015.
When the decision was made to remove the licence there were approximately 1.7 million patients taking Co-proxamol in the UK; the overdose death rate, assuming their figures were correct equated to just 0.02% OF PATIENTS WOULD HAVE BEEN AT RISK of death (intentional or accidental)! This was an extremely low risk to patients.
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 ANY OTHER PAIN KILLING DRUG.
The MHRA, EMA, and FDA have deliberately removed a completely safe (when tolerated and used correctly) drug from the market while continuing to grant ‘Marketing Authorisations’ for two drugs which were known to have serious consequences for patients when these decisions were made!
THERE IS A REASON THE SLANG TERM FOR OXYCODONE IS HILLBILLY HEROIN!
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