CO-PROXAMOL ALIENATION AND POWERLESSNESS OF THE INDIVIDUAL (Kafkaesque)

[Whowillgiveastuff]

My quest for answers regarding Co-proxamol began in June 2008 under a Labour administration and unfortunately nothing has changed with this government.

There had been a total lack of consideration for patients (DUE DILIGENCE) by the UK Government during the period 2004 to 2007 which has continued with the NHS, DOH, PrescQIPP, MP’s, and Ministers in successive governments ever since. They have all believed that every word issued by MHRA to be true when the facts were available to prove MHRA’s information regarding Co-proxamol was clearly, and totally untrue in 2005 when the ban was first announced!

None of my questions have been answered with honesty and it appears that no one in successive governments have been prepared to challenge MHRA regarding Co-proxamol

QWhat Caused the Demise of Co-proxamol (Best Ever Analgesic for RA Sufferers) and MHRA’s So Called ‘Named Patient Scheme’?

AThe pure avariciousness of MHRA and a total lack of DUE DILLIGENCE by the UK Government during the period 2004 to 2007.

FACTS

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. Again they appear to seek increases in their income while totally ignoring patient safety & well-being.

How do you increase your income from one hundred thousand pounds to fifteen million pounds? (This would be my guestimate and could be (and certainly will be in future years) 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

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. This is the total received in application fees for the 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 which are far more lucrative than the initial marketing authorisations!

In order to resolve this issue I compromised and requested them to research the first 60 MA's they issued for Oxycodone since 2005 via a new FOI request FOI 17/046

MHRA Reply

Dear Mr xxxx xxxxxx,

Thank you for your email of 25 January 2017, requesting under the Freedom of Information (FOI) Act the research of the first 60 MA's MHRA have issued for Oxycodone since 2005. We confirm that the answer to your question is £1,068,399

We now consider this request closed.

This proved that licence variations and service fees are a ‘Gift That Keeps on Giving’ a continuous income for MHRA which are far more lucrative than the initial marketing authorisations! When you consider that just 60 additional ‘MA’s' raised over an additional million pounds between 2008 and 2015, the next question MHRA should answer is ‘how many additional MA’s for all analgesic products have been issued since the ban on Co-proxamol was announced in January 2005’? (If I was to ask this question I’m sure section 12 would be invoked again)!

The money grubbing tactics of MHRA began 18 months prior to the ban being implemented. I found the first of many additional authorisation for Tramadol granted to Bristol Laboratories Limited on 27thJune 2006 50mg Capsules PL 17907/0110.

According to an FDA report produced between 1969 and 2005 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)!

Oxycodone was prescribed more than a million times in England (2012 – 2013), a rise of 39 per cent since 2010.

OXYCODONE PRESCRIPTIONS

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

2012/2013 - 1.09million

MHRA ARE GETTING RICHER AS THE PATIENTS’ HEALTH IS DETERIORATING!

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

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

If there is just one patient living in the Newport West constituency you are lucky to have the only MP (Paul Flynn) who would be prepared challenge the MHRA. I would be grateful if you could bring this information to his attention. Despite all this relevant information my MP refuses to meet with me at one of his surgeries.

[Eiram50]

This is maybe because it's been a long, rough day but although what you e written is very interesting , I'm not clear what your actual question that you want answered is?

Is it the need to have answered simply why co proxamol was stopped in its prescription and that it seemed a money making exercise versus being in the best interest of the public ? Is it that, as you state, the best drug for RA sufferers and therefore should've remained available ?

Wanted to understand what was the actual question ( and driver)

[Whowillgiveastuff in reply to Eiram50]

Unfortunately my MP refuses to offer any assistance regarding this situation and there is now only one MP remaining who is prepared to state the truth about the corruption within MHRA. As I don’t reside in his constituency I'm unable to seek his advice.

My question is the final paragraph, "If there is just one patient living in the Newport West constituency you are lucky to have the only MP (Paul Flynn) who would be prepared challenge the MHRA. I would be grateful if you could bring this information to his attention."

[Eiram50 in reply to Whowillgiveastuff]

Yes, I understand. I'm unsure though as to what you hope to achieve and why?

[helixhelix in reply to Eiram50]

I guess it's the announcement a day or so ago that copraxamol will be removed from NHS list completely now. It's been restricted for a while as was alleged not to be any more effective than others and had high number of deaths associated with it. However some feel this was about money (making it & saving it) not patient safety. And they want it back.

[Eiram50 in reply to helixhelix]

Thanks HH

Think I was having a foggy day yesterday! Having said this, I was reading over the reasons for this and there does seem to be some evidence to support the removal from market?

I'm not sure there's anything of substance to support that it was "the best drug for RA sufferers" either.

Thanks for the response. Have a good day.

Marie

[Whowillgiveastuff in reply to Eiram50]

I feel that I have been able to prove beyond any doubt that MHRA’s advice to government to ban Co-proxamol was in order to increase their income and NOT FOR DRUG SAFETY CONCERNS!

This extract from the 'Parliamentary Debate' States why Co-proxamol should not have been banned!

72000 patients who had proved they could not tolerate any of the alternate analgesia have been left to suffer horrendous side effects and lack of pain conrtol!

PLEASE TAKE THE TIME TO READ.

publications.parliament.uk/...

17 Jan 2007: Column 343WH (4.40 pm)

Dr. Howard Stoate (Dartford) (Lab): Thank you, Mr. Cummings, for giving me an opportunity to take part in this debate. I congratulate my hon. Friend the Member for Aberdeen, South (Miss Begg) on securing it and on her excellent speech. She has been a tireless campaigner on this issue, and my colleagues in the medical profession, as well as the 72,000 patients who continue to use co-proxamol, owe her a debt of gratitude for the work that she has done in raising the profile of the subject. I concur with almost everything that she said today, but I shall come back to that later.

I would like to begin by reading a quote from a consultant rheumatologist from Wearside who has been working in the field for more than 20 years and is, therefore, well placed to comment on the merits of the decision of the Medicines and Healthcare products Regulatory Agency to withdraw co-proxamol:

“There is absolutely no doubt that co-proxamol is an invaluable drug for patients with chronic rheumatic pain. Its withdrawal has caused enormous distress for a large number of patients who have found it to be safe, effective and free of the side-effects of other analgesics such as constipation and impaired cognition...Large numbers of rheumatologists and patients have come to the conclusion that co-proxamol is superior to other simple analgesics.”

His is by no means a lone voice. It is apparent from the medical press that the frustration that he feels is shared by hundreds of consultants and general practitioners throughout the country.

Indeed, the poll carried out by the medical magazine Pulse of GPs and consultant rheumatologists in October 2006, to which my hon. Friend referred, found that 70 per cent of GPs and 94 per cent of rheumatologists wanted the MHRA to revisit its decision to ban co-proxamol.

Why are clinicians so strongly opposed to the MHRA’s decision? After all, a review by the Committee on Safety of Medicines found that the painkiller is the second most common prescription drug associated with fatal overdoses, with around 300 to 400 people dying each year as a result of accidentally or deliberately taking too many tablets. Similarly, a study published in the British Journal of Clinical Pharmacology in 2005 found that an overdose of co-proxamol was more than 10 times more likely to be fatal than one of co-dydramol or co-codamol.

Perhaps the main reason why GPs and specialists are so unhappy with the MHRA’s decision is co-proxamol’s proven track record as an effective painkiller and the absence of any suitable alternative for certain patients.

A GP who is a prescribing lead in south London stated:

“The problem is that every practice has a number of people who have no alternative analgesic. I’m aware of several patients who tried everything else and nothing works.”

A GP from Hampshire made the following point:

“There is a small but persistent group of patients who are adamant that, for one reason or another, only co-proxamol works for them. It may well be too small a group to be able to pick up in clinical trials comparing efficacy versus other agents, but they are persistent, unchanging and deserve to be heard. I don’t think that they are addicted or lying because none of the ones that I am aware of belong to what you might describe as ‘the usual suspects’.”

17 Jan 2007: Column 344WH

One other reason for the continued popularity of co-proxamol is that it has the reputation of being a well-tolerated, low-side-effect drug. For example, an experienced Norfolk GP stated that it is “a low side effect drug. In twenty years of practice I have seen more side effects from co-dydramol and co-codamol and more lives wrecked by dihydrocodeine addiction.”

Other practitioners have also expressed surprise that the MHRA chose to take such a tough line on co-proxamol when so many other commonly used drugs such as warfarin, digoxin and aspirin are also potentially lethal in an overdose.

However, the thing that disappoints practitioners the most about the MHRA’s decision is that it has taken away the freedom of clinicians to decide for themselves whether the use of co-proxamol is in the best interests of their patients. In effect, the MHRA is saying to practitioners that it does not trust them to make the right decision on behalf of their patients, and that clearly runs counter to the Government’s policy of devolving more power and clinical responsibility to front-line health professionals.

The decision also flies in the face of the Government’s stated policy of giving patients greater opportunity to influence how their treatment is planned and managed, particularly patients with chronic conditions such as arthritis who often have a clear understanding of what they need to do to manage their condition effectively.

Ministers and the MHRA would do well to take heed of what the president of the British Society for Rheumatology, Dr. Andrew Bamji, said on the matter:

“It is unreasonable to withdraw a drug from those who understand the risk.”

That just about sums it up. In other words, as long as the practitioner is satisfied that co-proxamol is the most suitable drug for a patient, and he or she is confident that the patient is fully aware of the potential risks involved in taking it and will follow their advice on how to take it sensibly, they should be free to prescribe it—without, I emphasise, having to walk a legal tightrope to do so.

That is the problem with the compromise solution that has been put forward by the MHRA. Offering doctors the opportunity to prescribe on a named-patient basis what will, in effect, be an unlicensed drug after December 2007 is not viable. Few GPs, if any, will wish to expose themselves to the possible threat of litigation by doing so, however strong the patient’s need for the drug. In practice, the solution amounts to a comprehensive ban.

A more sensible way forward, as my hon. Friend said, is to make co-proxamol a controlled drug under schedule 3 of the Misuse of Drugs Act 1971. The advantage of doing that is that the potential risks involved in prescribing would be flagged up, but GPs could still prescribe the drug when necessary, and it would be clearly acknowledged in doctors’ minds that extra precautions and closer monitoring of patients would be advisable.

Schedule 3 status would also send a clear message that co-proxamol is not a first-line drug and that it should be used only after careful consideration of all the available alternatives. It would also give pharmacists the opportunity to reinforce guidance to patients who are on the drug and to ensure that they fully understand the risks and benefits of taking it.

The MHRA must trust GPs—who are, of course, in dialogue with their patients—to exercise clinical judgment when it comes to the prescription of co-proxamol. In view of the potential risks, the decision will not be easy for GPs to make, but we should not forget that they are highly trained, and well paid, to make decisions on a daily basis that require them to tread the fine line between therapeutic benefits and the disadvantages and side effects of drugs.

The MHRA should have the courage to rethink its decision to withdraw co-proxamol. I hope that, following today’s debate, Ministers will agree to lobby the agency for an immediate review of its position.

___________________________

When the government accepted the advice from MHRA the cost of this drug increased from £2.70 per 100 tablets to £49.50 when it was finally removed from the prescribing list in 2015!

Fortunately the drug ban in India has been reversed and is now back in production at less than £2.00 per 100 tablets!

I have recently been in contact with the Parliamentary Health Committee and the Ombudsman in the hope have having the decision reversed in the UK.