by Jeanne Hambleton © 2007 – Fibromite
NFA Leader Against Pain – Advocate
Dateline: November 2007
(This is a long document for which I make no apologies. It has entailed much work but it is my hope that readers will be encouraged to take action. No copyright infringement is intended as this is not written for financial gain but for guidance and in the hope of some action and hopefully ‘without prejudice’.)
The painkiller, which so many UK fibromites and millions of other people rush to take to relieve pain, co-proxamol, is scheduled to be withdrawn from general prescription from New Year’s Day. Only named patients, who have tried alternatives and failed to find relief from other drugs, will be considered by some GPs for a special prescription. It is hoped this may continued after the end of 2007 subject to the availability of stocks, as some manufacturers have already stopped producing this drug.
As a writer and reporter I claim no medical qualifications but to help people understand the problems surrounding the distribution of co-proxamol, or lack of it, I have drawn together, from a number of sources, background information and comments from those who have a special interest in the withdrawal of co-proxamol.
Already many patients are being told that this medication can only be prescribed under special circumstances – your GP must decide you are a suitable and trustworthy patient and that you will read and abide by the instructions. Alcohol and co-proxamol are literally a deadly combination and can be fatal. This is the reason given by the “powers that be” for withdrawing co-proxamol, which is a combination of the analgesics, dextropropoxyphene and paracetamol. There is little doubt that by the end of the year obtaining co-proxamol on prescription may be more difficult – unless things change. I am told that some years ago paracetamol faced withdrawal in a similar battle – which was won!
HOUSE OF COMMON DEBATE
Many people who take co-proxamol have been complaining about the withdrawal of this painkiller, which was highlighted in the House of Commons in a debate way back in 2005 following an announcement in the press early that year. The debate appears to continue with no solution in sight as we enter the final stages of withdrawal – one month away.
In 2005 according to the Hansard report on the debates in the House, Anne Begg, Labour MP for Aberdeen South, called for an Adjournment Debate on the availability of co-proxamol. The MP said she had a personal interest as she had been prescribed these tablets for some years and took four a day. A number of her constituents who relied on the drug had contacted her about the withdrawal – hence the debate.
Hansard reported that Anne Begg spoke about specific patients who relied heavily on co-proxamol. In some cases the painkiller was the relief that enabled patients to carry on working, sleep well and keep mobile. She related stories with which many of you will be familiar – patients being taken off co-proxamol and given alternative painkillers. Patients found they were unable to sleep well, felt unwell all the time and were unable to continue at work.
The MP told the House that the drug was not being withdrawn because it was ineffective – those using the drug found it very effective. It was not due to side effects – patients felt it gave them less problems than alternative analgesics or other drugs. Co-proxamol had not been connected with the incidence of strokes, heart attacks or other major health problems.
The then Secretary of State for Health had confirmed to Anne Begg, “That some people might abuse the drug and use it to commit suicide,” said the Hansard report. The Department of Health claimed between 400 and 500 suicides annually were connected with co-proxamol.
The MP reported that all drugs carry some sort of risk, which in theory could mean practically every drug would be unavailable. Those relying on co-proxamol were upset that the drug had been singled out for withdrawal. Anne Begg said there had been a similar debate about paracetamol several years earlier and this remained controversial for a long period.
Co-proxamol users claimed this drug was superior and that it led to a feeling of wellbeing. It was said this was due to destropropoxyphene, which is used in the medication.
Anne Begg said GPs were recommended to prescribe paracetamol or a non-steroidal anti-inflammatory medication such as ibrufen. However ibrufen was not without risks for those with gastric problems. The alternatives went on to include a very strong analgesic, which has severe side effects to amytriptyline, a drug often prescribed for patients who have been involved in suicide attempt.
News of the withdrawal of co-proxamol was originally announced in January 2005 but it had taken six months for this to be debated by MPs. Anne Begg claimed this was because patients who had been offered a change in prescription had taken time to discover the alternatives did not work. She made reference to informed choices and referred to other drugs effective in dealing with arthritic pains and fibromyalgia, that had been withdrawn due to other dangers to health.
The MP said although she did not normally go against medical opinion, with co-proxamol she felt the Government should reconsider the advice of one of its committees. She expressed concern and recommended the Government should review the prescribing arrangements for co-proxamol and asked why some responsible patients should be penalized. GPs should be able to prescribe co-proxamol to a patient who was aware of the risks if misused or left accessible to others. It was suggested a change in the packaging in smaller quantities could help – this had been done with paracetamol. A strip of 10 tablets might be considered an overdose, where eight co-proxamol would be safer said Anne Begg.
In response to a request from the press it was reported the Medicines and Healthcare products Regulatory Agency had said co-proxamol would be available to patients on their “own responsibility” subject to clinical needs. But this report did not coincide with feedback from patients said the MP.
Hansard reported that the Parliamentary Under-Secretary, Department of Health, Caroline Flint said the Department had, at that stage, received 130 letters from Members of Parliament writing on behalf of their constituents.
Caroline Flint claimed the co-proxamol decision was made after a full risk-benefit assessment, extensive public consultation and with the Committee on Safety of Medicines advice. Other specialists and experts were invited to comment including the Government’s Independent Scientific Advisory Committee on Medicine Safety. The Parliamentary Under-Secretary said co-proxamol, that was said to be very toxic, could result in an overdose from only a few tablets beyond the recommended dose. Patients could die before they arrived at hospital, as unlike paracetamol, there is no antidote for co-proxamol poisoning.
There had been a comprehensive review in 2004 by the Committee on Safety of Medicines, said Caroline Flint and the public was invited to provide comments on the advantages and risks over a 12-week period. Hansard reported that many large organisations including healthcare professionals, patient groups and stakeholders had received letters. Having considered the evidence the CSM felt the risks outweighed the benefits and manufacturers were recommended by the MRHA to withdraw the drug over a period of 36 months – by December 2007.
Caroline Flint reported a reduction in the amount of co-proxamol being prescribed, with the 50% of the total reduction made in the first six months following the announcement about the withdrawal. It was reported by Hansard that one doctor had decreased the number of patients using co-proxamol from over 400 to just 20 but the GP did acknowledge there was currently no acceptable option for this small minority of his patients.
It was reported co-proxamol had been available for some 40 years and many patients who were distressed about the withdrawal, had written expressing this view. It was said co-proxamol would be available on a named basis only at the end of the withdrawal period. The MHRA will ensure GPs are aware of this and this should resolve the supply question.
The Parliamentary Under-Secretary confirmed GPs would still be able to prescribe co-proxamol if there is a clinical need and if no satisfactory alternative could be used. There will however be a much stronger focus on “risk benefit judgment for the particular patient”.
Caroline Flint said the Department of Health would support the decision but would accept there could be a need to allow co-proxamol to be prescribed for some patients where there was a clinical need. Responding to a question on the availability of future supplies, the MP said it would be necessary to decide about the future for the minority who are prescribed co-proxamol as the only acceptable painkiller to bring relief.
The Parliamentary Under-Secretary hoped Arthritis Care and similar groups would feel reassured by her comments and her “acceptance of the possibility that co-proxamol will continue to be prescribed where there is a clear clinical need because alternative treatments are unsuitable”.
She added that the Government is sensitive to the problem and accept that pain management is a complex matter.
Hansard (the Official Report) is the edited verbatim report of proceedings in both Houses of Parliament. Reports contain Written Ministerial Statements and Written Answers. Daily Debates are published on the following website the next working day at 8 am. http://www.publications.parliament.uk/pa/pahansard.htm
Arthritis Care who have been opposed to the withdrawal of this drug since it was first announced, had been working with some MPs to have the issue raised in Parliament again this year.
The Arthritis Care website believed the named patient basis only was not a satisfactory way to ensure those who need the painkiller would receive it. The charity continues to argue for a review of how best to make co-proxamol available long term.
On their website Arthritis Care have invited those in pain, who had been transferred from co-proxamol to another drug, to contact them with comments in the efficiency of the alternative, to help further this cause. Telephone 0207 380 6547 or contact –
The Arthritis Care website shows that MPs Anne Begg and Howard Stoate are working with the organisation to press for a review on the withdrawal of co-proxamol.
Reporting on the current situation the campaign website states, “The MHRA anticipates that after 2007, co-proxamol will be available on a ‘named patient’ basis only, subject to stocks.
THE BACKGROUND AND PLAN OF ACTION
When the MRHA announced the withdrawal of co-proxamol on January 31 2005 it was stated, “A recent consultation looking at evidence for the safety and effectiveness of co-proxamol found that the benefits of the medicine did not outweigh the risks and that it should be gradually withdrawn from clinical use. Co-proxamol is associated with 300-400 intentional and accidental fatal overdoses each year.”
It is estimated that 1.7 million GP patients each year receive 7.5 million prescriptions for co-proxamol.
At that time the Chairman of the Committee on Safety of Medicines (CSM), Professor Gordon Duff said, “Co-proxamol will be phased out of the market place gradually to give patients time to discuss their treatment with their doctor and change to a suitable alternative. There is no need for panic or concern and if patients have been taking co-proxamol continuously for a long time they should not stop without consulting their doctor.”
In January 2005 the Chairman of the Medicines and Healthcare products Regulatory Agency (MHRA), Sir Alasdair Breckenridge said, “Whilst the risks of co-proxamol are well known to health professionals, the latest evidence is that the measures to strengthen the labelling of co-proxamol have been ineffective in reducing the high fatality rate involving both intentional and accidental overdose. The MHRA and CSM have considered further evidence gathered during a public request for information on the risks and benefits of co-proxamol and have decided that the benefits of the continued availability of co-proxamol do not outweigh the risks and that co-proxamol should be withdrawn from the market.”
At the same time The Times newspaper reported it had learnt and printed the following,
“One of Britain’s most commonly used drugs is to be withdrawn over concerns about the high risk of accidental death from slight overdose and its frequent use in suicides.
“Co-proxamol, prescribed to hundreds of thousands of Britons every year, is to be the subject of a staggered withdrawal because of evidence that it can cause death if patients exceed the maximum recommended dosage by as little as two tablets……
“A recent study found that the medication, whose effects are increased by alcohol, was responsible for 18 per cent of all drug-related deaths and 5 per cent of all suicides. David Kelly, the Government’s weapons adviser, is believed to have taken up to three packets of co-proxamol shortly before his death in 2003.
“Last year eight million prescriptions were issued in England and Wales for co-proxamol, which has been a mainstay in British healthcare for more than 40 years.”
In March 2005 Dr Martin Kittel of Windsor launched a website about co-proxamol in which he claimed no widespread consultation had taken place and that doctors were as surprised as patients when the announcement was made.
The Doctor suggested, “Unless something extraordinary happens, co-proxamol will be withdrawn from the market and millions of patients suffering chronic pain will have to switch to another drug.”
The site, http://www.coproxamol.org.uk/ which was funded by the Doctor, is apparently no longer available.
Prior to the site’s disappearance, Dr. Kittel suggested the choice of alternative drugs was very limited and many patients would be left without an equally effective pain killer or will have to take higher does of alternatives, which may lead to other complications including constipation.
He pointed out that, “Co-proxamol by experience is just a lot more effective than other equal drugs and for many patients causes less side effects. Co-proxamol is highly cost effective and its withdrawal will not only harm patients, but also harm the health service. The NHS will pay a lot more for equally effective pain relief, strapping it of cash badly needed in fighting other diseases. Arthritis sufferers recently had to change drugs, when Cox 2 inhibitors were related to heart disease and one of them was withdrawn (Vioxx).”
Dr. Kittel stresses the website is not funded by any drug company and he urges all co-proxamol users to write to the local councillors, parish, district and county, MPs, and MEPs, asking the Houses of Parliament for a review on the withdrawal of co-proxamol before the scheduled withdrawal at the end of 2007. The simple website he recommends identifying your MP, using only your postcode, can be found on: –
Alternatively your Yellow Pages telephone book (Members of Parliament – Political Organisations and Representatives) should give you your MP’s address to post a letter.
When writing to your MP on-line, it may be helpful if you first type what you want to say off-line and then copy and paste it in the letter/message area when you enter the above website. This will save “on-line time”.
PATIENTS’ POINTS OF VIEW
Some time ago I looked at the Patient UK website and searched for co-proxamol. The site has since been “redeveloped” and although there are supposed to be two references to the painkiller, they were not easily available.
In March one patient had written, “The situation of co-proxamol withdrawal is a very woeful one and it seems immoral and unethical to allow people to suffer by removing this medication from their lives when there is no suitable alternative to be found. This drug has been in use for many years by millions and its effects and side effects are well documented.
“I agree that this matter is now one to be fought about at the highest level of Government possible (i.e. letters to MPs etc. – especially those who are medically trained).
“I suggest that those users who have been taking this medication for many years with no ill effects; for whom there can be found no suitable alternative; whose quality of life is enhanced by the freedom from pain that it can bring and who are not found to be suffering from any accompanying depressive illness or disposition to drug abuse or attempting/completing suicide; and for whom there are no contradictions medically due to polypharmaceutical complications or existing medical conditions, should be given the option of doing the following:
“Sign a document declaring that they have been fully informed about the possible risks involved in taking this particular medication and that in the event of any unfortunate consequences as a result of taking co-proxamol in the way normally prescribed by a medical practitioner, they will not hold the prescribing doctor (or the General Practice where the doctor may be working) to be legally liable.
“This medicolegal course of action is undertaken every day in the case of people giving their consent to surgical procedures under anesthetic by signing a document permitting surgery (and the need for any further treatment if necessary whilst under anesthetic).
“Of course, in the case of medical negligence – if found proven – there may be case for blame, thus by signing a similar document concerning one’s daily medications there would be created a situation for some thinking and debate.
“However, I believe that this may be a suitable way around this difficult matter and am sure that many patients who are finding co-proxamol to be a life enhancing aid in the daily difficulties of chronic medical conditions causing much pain and distress, would be happy to give their consent to taking some responsibility for informed participation in their medical treatment – instead of having, as it were, the ‘rug pulled out from under them’ – for such is the effect of this draconian measure concerning the issue of prescribing co-proxamol for many years and then suddenly stopping.
“In some cases there has not even been a gradual period of readjustment to other analgesia given – leaving patients in a worse state than before. This goes against the doctors’ ethical code of “first, do[ing] no harm.”
“In a ‘worst case scenario’ it is possible that some patients, unable to find adequate alternative pain-relief would fall into depressive states (chronic pain can do this) and some, even, eventually resort to attempting/completing suicide – thus the declared medical objective of reducing the number of deaths from prescribing this drug might well end up causing a higher number from not prescribing it. Hardly an intelligent, desirable solution to the problem.
“If then, as a patient you find this medication to be essential to your life, please do fight for your rights to as pain free an existence as possible and get writing to your GP practice managers and Members of Parliament.”
TV DOCTOR ADDS HIS SUPPORT
Dr. Hilary Jones, the GMTV medical professional, also came out in support of the battle to save co-proxamol.
In an interview with Jim Pollard of Arthritis News, Dr. Hilary said many of his patients were asking what alternative painkillers they can use but he did not have the answer. His patients said other painkillers make them sick and were not as effective. Dr. Hilary, who had taken co-proxamol, claimed the painkiller was a safe drug.
Like others Dr. Hilary urged those in need of co-proxamol to write to their MPs to have the decision reversed.
The article outlining Dr. Hilary’ views on co-proxamol appeared in the August/September 2006 issue of Arthritis News.
In September 2007 when supplies of co-proxamol seemed to suddenly become unavailable the complaints came thick and fast. To help I launched an e-petition but those who complained failed to support this. Whether a rush in the last month will have any effects, remains to be seen.
It is somewhat out of date now, as it seems supplies seem to be currently available. If you feel strongly enough to launch your own e-petition asking about the future of co-proxamol, please let me know and I will sign it and mention it on my weblog.
I did in fact submit a further e-petition but this was rejected – the web team may have thought it was too political. Nevertheless the contents of the e-petition are certainly worth reading.
It does in fact present the perfect ‘excuse’ should a GP feel he does not wish to prescribe this painkiller for you. Had it been accepted it would have read:
Will the Prime Minister Gordon Brown please reverse the ban on prescribing the 50 year old painkiller CO-PROXAMOL due to come into effect in December 2007 and instead make it controlled drug under Schedule 3 of the Misuse of Drugs Act 1971, before it is too late and it all becomes a shambles.
Dr. Howard Stoate (MP Dartford) speaking in a House of Commons debate in May 2007, according to TheyWorkForYou.com and the Hansard report, suggested co-proxamol should become a controlled painkiller, as the GP would then be free to prescribe it without having to walk a legal tightrope to do so. 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 he said.
THE PRESS RELEASE
In August 2007 I contacted the Press Office of the MHRA (Medicines and Healthcare products Regulatory Agency www.mhra.gov.uk/) and apart from a long and detailed background to the decision – an increase in the number of suicides with folk taking co-proxamol and the dangers of alcohol with this painkiller – the Press Officer wrote:
We recognise, however, that there is a small group of patients who are likely to find it very difficult to change or where there is an identified clinical need; when alternatives appear not to be effective or suitable. For these patients, continued provision of co-proxamol through normal prescribing may continue until the cancellation of the licenses at the end of 2007. After this time there is a provision for the supply of unlicensed co-proxamol, on the responsibility of the prescriber which in effect means it will still be available, for as long as you need it, should your doctor deem it suitable for you. If you wish to go down this route may I suggest you discuss this possibility with your doctor?
So is there light at the end of the tunnel?
SO BE IT
We are now on count down to December 2007 at the end of this week and understandably the big date for this month for most folk is the 25th – and on the 31st when co-proxamol is due to disappear, people will be celebrating the arrival of New Year.
It will be interesting to see the public reaction if suddenly co-proxamol is no longer being prescribed in January.
Try as he might, my dear GP always tell me my painkiller is being discontinued and I should use this or that…I quote MP Caroline Flint’s promises in the House of Commons saying that one manufacturer WILL continue to manufacture and supply co-proxamol. I give him my affirmation that I am a responsible fibromite and as a long-term reliable fibromite I am able to be a named patient and have co-proxamol. The dear man eventually gives in, bless him.
I think I would be up the wall now with my 3 fractures in my pelvic bone and fractured wrist without co-proxamol…either that or I would be in the divorce courts for sure…
I imagine many more doctors will be offering alternatives and there will come a time when it is no longer economically viable for the one remaining manufacturer to continue making co-proxomal together with the pressure from the powers that be. That is, unless we can all become named patients and are prescribed co-proxamol regardless of what we might have to sign to say we will behave responsibly and not overdose.
It is beyond my understanding why some medical quango has not produced a suitably worded form for us to sign relieving our GPs of any responsibility legally.
Is it not time that for those suffering with fibromyalgia, chronic fatigue, ME, arthritis and other long-term pain problems take up the challenge before it is too late?
I believe there has been no recent mention about co-proxamol in the House since May 2007. It must be good time to write to your MP and encourage others who take this painkiller to do the same. There is a chance that you may save co-proxamol from being withdrawn from general prescription. Tell your MP about your pain and suffering – why you need this painkiller (fibromyalgia?) to be available to you – they need to know – but do not forget the message – we need a review on the withdrawal of co-proxamol, a change of policy, a U turn.
If your MP is a member of the All Party Parliamentary Group on Fibromyalgia (APPG for FMS), ask him or her to raise this at their next meeting and to take the question of a review forward for debate. This would also apply to arthritis, ME and all long term chronic pain.
To find the name of your MP look in your telephone book, or Yellow Pages or try TheyWorkForYou.com and search for ALL MPs.
As of October 2007 the MPs who are members of the All Party Parliamentary Group for Fibromyalgia are: Rob Wilson (chairman); Dr Nick Palmer (vice chairman); Philip Davies (treasurer); Ian Austin (secretary).
Members: Russell Brown, Paul Clark, Gerry Sutcliffe, Adrian Bailey, Natascha Engel,
Rosie Cooper, Jim Devine, Ian Lucas, Andrew Dismore, Richard Burden, David Cameron,
Robert Key, Graham Brady, Tim Boswell, Shailesh Vara, Dr Julian Lewis, Andrew Pelling,
John Gummer, Henry Bellingham and Norman Lamb.
I am sure you all know what to write about – co-proxamol, a review and funding desperately needed for fibromyalgia research.
Between ourselves the email address of most MPs is their surname firstname.lastname@example.org – ie email@example.com. However there are exceptions. Try this website for a lot more detail. The alphabetical list of MPs will lead you to websites, biographies and email addresses.
Not wishing to sound like a wet blanket (I have never listened to a wet blanket, have you?) all MPs are generally only required to reply to correspondence from their constituents – those who voted them in locally. I have been rebuffed (knocked back) several times even with press enquiries. If they are a member of the APPG, you should mention this and stress this is why you are asking the questions – as a member of the APPG for FMS – and in the hope they will answer it – and copy your request to your own MP and let him know who else you have written to.
It might be a good idea to copy your emails to MPs Anne Begg and Howard Stoate who have already raised questions in the House about co-proxamol. It is said Anne Begg has taken co-proxamol. Your emails will give the MPs some ammunition to raise this problem again.
This Doctor is according to the website was the Vice Chairman of the APPG for Medical Research.
ALL PARTY PARLIAMENTARY GROUP FOR FIBROMYALGIA
May I suggest you look among the names of the members of this APPG for FMS and you will see a certain distinguished name? I understand he has been a member of this Group for a considerable time – before other commitments made big demands on his time. With enough pressure he just might help – who knows.
Lastly as recently as October 2007 the chairman of this APPG Rob Wilson had written questions heard in the House, according to the Hansard report and TheyWorkForYou.com.
He asked the Secretary of State for Health
(1) what recent steps his Department has taken to raise awareness of fibromyalgia among (a) the general public and (b) health professionals;
(2) what progress is being made in improving NHS (a) diagnosis and (b) treatment of fibromyalgia;
(3) what recent representations he has had and received on fibromyalgia.
Hansard source reported that Ann Keen (Parliamentary Under-Secretary (Health Services), Department of Health) had replied saying,
• “We have made no assessment of the progress being made by the National Health Service into improving the diagnosis and treatment of fibromyalgia.
• “We have taken no recent steps to raise awareness of fibromyalgia among the general public and health professionals.
• “We have received three recent Downing Street e-petitions on fibromyalgia, as well as correspondence from individuals and their members of Parliament.”
What kind of answer is that when the Government is trying to get fibromites back in the work place to reduce the benefit bills?
One other fact to emerge from this reply is that the e-petitions are obviously reaching the Department of Health even if they appear to be ignoring them. I wonder does the PM ever see them?
Better get writing to your MPs in double quick time, even if you are an ex-pat somewhere else in the world.
Do let me have your comments – have you written?
I have read and re-read this until I am seeing double – please excuse any typos – fibro fog is the culprit!
Jeanne Hambleton © November 2007