Anne Begg (Aberdeen South, Labour)
Thank you, Mr. Cummings—you did indeed pronounce co-proxamol correctly. I, too, hope to pronounce the various medical terms correctly.
I am delighted to have secured this debate. I am also delighted that my hon. Friend Dr. Stoate is here. I hope that he will catch your eye, Mr. Cummings, so that he, too, can contribute. I hope to speak from the perspective of a patient who has taken co-proxamol, but my hon. Friend is a doctor and knows all the fancy medical terms. I would also like to thank Arthritis Care and the British Society for Rheumatology for their help in preparing for this debate. Without their help and detailed knowledge of the subject, I would certainly not be as well informed as I am.
I am glad to see the Minister in her place. She has drawn the short straw, because she was also the Minister who deputised in a similar debate that I secured some 18 months ago, on
At the time of the last debate, the Minister and many in the medical profession assured those of us who were taking co-proxamol that equally effective alternatives would be found. For instance, I was told that full-strength paracetamol would be just as effective as an analgesic as co-proxamol. That is simply not true; when my GP contacted me to say that he would no longer repeat my co-proxamol prescription, I, like many, went along with his advice. I stopped taking it and have not gone back to it.
I have not secured this debate for my own sake; I have found alternatives, although the alternative of paracetamol supplemented with dihydrocodeine is probably more powerful than co-proxamol. If I had a free choice, I would go back to co-proxamol, but that obviously also depends on the outcome of today's debate.
Last summer, there were problems with the supply of the drug—probably because of confusion over its status, which meant that some pharmacists were not reordering it. Stocks diminished as a result. I understand that the problem has been sorted out, certainly in the short term. However, such problems will arise later this year and in the foreseeable future.
As things stand, prescriptions of co-proxamol under existing rules will end in December 2007. Thereafter, it will be prescribed to far fewer people, and only on a named-patient basis. Less of the drug will be required, and the manufacturers will take commercial decisions on that basis.
I have secured this debate to persuade Ministers at the Department of Health that their concerns about the high incidence of suicide among those using co-proxamol can be addressed without a full ban. The action taken during 2005-06 to reduce prescription of co-proxamol has been effective, so it will reduce the number of suicides. The statistic cited for the number of suicides per year among those using co-proxamol dates from 2001. I suspect that in the past two years that number has dropped as a result of the huge reduction in the prescriptions of the drug from 434,250—almost half a million—in January 2005 to just over 70,000 in August 2006. Only 1,350 of those were new prescriptions.
I have a copy of the paper considered by the Committee on Safety of Medicines in reaching its decision; an individual requested one under freedom of information legislation. That paper lists a complete ban as only one of five options. The Medicines and Healthcare products Regulatory Agency said that it decided in favour of a full ban because information and communication programmes had failed to alert prescribers and patients of the dangers of the drug. What the paper presented to the committee actually said was that the programmes had failed at national level as they had
"been piecemeal activities rather than a concerted campaign using several vehicles simultaneously."
The paper goes further in its conclusions, saying that
"it is possible on pharmacokinetic grounds that co-proxamol may only have a full therapeutic effect with chronic dosing. There may therefore be some justification for co-proxamol remaining a therapeutic option for the management of chronic pain."
Another conclusion in the paper, on the clinical effectiveness of co-proxamol, was based on the contention that there were no robust data to prove that. Co-proxamol is an old drug that has been around since the 1950s. It has never been subject to testing to find out exactly how it works, as is done on modern drugs. Such testing has not been carried out even today. There are no robust data, because there are no data.
The conclusion drawn could quite easily have been the opposite—that there were no robust data, and that that proved that the drug was not effective. There are no robust data proving that full-strength paracetamol is as effective as co-proxamol either. From my experience, it most certainly is not.
It is difficult for me, as a lay person looking at the papers on which the MHRA based its decision, to find the justification for a full ban. There were alternatives to that. However, it took that decision and created huge confusion. At the time, some GPs assumed that they had to get all their patients off co-proxamol as quickly as possible. Indeed, during my July 2005 debate, the Minister quoted an article in Pulse magazine from May 2005 about a GP who, concerned at the risks of co-proxamol, had managed to reduce the number of patients on the drug from 438 to 20.
However, an article in an issue of Pulse magazine from October last year—a copy of which was thrust under my nose by my brother, who happens to be a GP—had the headline "GPs demand U-turn on co-proxamol ban". The magazine reported its own survey, which showed that 70 per cent. of GPs and 94 per cent. of rheumatologists demanded that the MHRA revisit its decision. Although the spokesman for the MHRA accepted that there was
"a small group of patients with a clinical need for co-proxamol as alternatives appear not to be effective or suitable",
he said that the licence for the drug would still be withdrawn in December 2007.
I have asked for this debate so that we can get a sensible solution for that small group of patients—the 20 to whom the GP in the Pulse article of May 2005 still prescribed co-proxamol even after he had tried to remove the drug from all his patients.
I certainly do not argue that we should return to the levels of co-proxamol prescription that preceded the original decision of the MHRA; the drug was too widely available then, and often prescribed for acute pain. My own experience was that it never worked for acute pain. If I had a headache, I always took paracetamol, which worked. Co-proxamol did not. However, co-proxamol has proved effective in dealing with chronic pain, and I can back that up from my own experience. It is not just that co-proxamol is effective; many patients claim that it actually works.
I have received a large number of e-mails supporting my position from all over the country, not only from my constituency. One came from Jonathan Russell, my constituent who instigated my original debate, as a result of which he was able to get his GP to re-prescribe co-proxamol. He writes explaining what a difference that has made. He has a full and active life despite having ankylosing spondylitis.
A correspondent from Ayrshire says that he is "getting a better understanding" of how and why co-proxamol works so well and why pain tests fail to identify that. He says:
"Co-proxamol enables me to cope with more pain but with far fewer side effects than anything else. So physically I am in much better shape and far less prone to despair or depression."
I have too many e-mails to read them all out, but another correspondent asked me to ask the Ministers concerned
"why they felt that they had to ruin all our lives by withdrawing the medication when they could have made a more humane decision to not prescribe to any new patients."
There are strong feelings among patients about the effectiveness of the drug.
To achieve an acceptable balance between a significant reduction and availability where there is a clear clinical need, Arthritis Care and the British Society for Rheumatology propose that co-proxamol be made a controlled drug under schedule 3 of the Misuse of Drugs Act 1971, which I hope my hon. Friend the Member for Dartford will explain; that co-proxamol prescriptions should be initiated at specialist level, but that GPs should be able to make repeat prescriptions; that the MHRA should conduct a co-ordinated and comprehensive education campaign, aimed at prescribers, about appropriate and inappropriate use of the drug; that prescriptions be restricted to second-line usage; and that prescriptions be restricted for chronic, rather than acute, pain.
I hope that the Minister has some good news for the hundreds of people who have found co-proxamol the most effective drug in dealing with their chronic pain. They are looking to her to remove worry and to ensure that they continue to have access to the one drug that has made their life bearable.
If only I could cross my fingers, I would. I hope that the Minister has heard my appeal and responds sympathetically.
Howard Stoate (Dartford, Labour)
Thank you, Mr. Cummings, for giving me an opportunity to take part in this debate. I congratulate my hon. Friend 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'."
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.
Caroline Flint (Minister of State (Public Health), Department of Health; Don Valley, Labour)
I have had an opportunity to have an informal discussion with my hon. Friend, and I have taken several of her queries to the Department to try to establish what progress has been made since the last Adjournment debate on the matter, and to pick up on some points raised by her and by my hon. Friend Dr. Stoate.
I know that this will not be information for my hon. Friends, but I would like to put on the record, as information for the House, a reminder of why we are where we are today in respect of the withdrawal of co-proxamol.
Co-proxamol is a combination product consisting of paracetamol at a lower than recommended dose and a weak opiate. In 2003, growing concern about the safety of co-proxamol was prompted by UK research showing that it accounted for almost one fifth of drug-related suicides, and that it was second only to tricyclic antidepressants as an agent of fatal drug overdose. Furthermore, co-proxamol is involved in 300 to 400 self-poisoning deaths each year. Many of those deaths involve people taking co-proxamol that has not been prescribed to them; for example, troubled teenagers who come across tablets in their granny's medicine cabinet.
That leads to an important issue that is not directly about co-proxamol. I spent part of last summer with some community matrons in my constituency. Each of them carried a bag in order to retrieve unused prescribed medicines that were sitting in cabinets in people's homes. That raises important questions about effective prescribing and the storage in our relatives' cabinets of drugs that may be dangerous.
Co-proxamol is potentially very toxic, and toxic overdose can occur with only a few tablets more than the recommended daily dose. Unlike paracetamol, with which there is also danger of overdose, there is limited opportunity for the effective treatment of co-proxamol poisoning. Sadly, victims often die before they reach the hospital. The impact, I understand, is rapid. In that sense, it is in a class of its own when compared with something such as paracetamol, without taking away from any of the dangers of overdose from paracetamol.
As a result of the concerns, in 2004 the Committee on Safety of Medicines conducted a rigorous review of the available evidence on the risks and benefits of co-proxamol. It highlighted the lack of evidence that co-proxamol is any more effective than full-dose paracetamol either for short-term use or for chronic conditions. During the review, there was a public call for evidence on the risks and benefits of co-proxamol. The CSM carefully considered the evidence of efficacy for chronic pain and concluded, as I have said, that there was insufficient evidence to justify a marketing authorisation for chronic pain. In particular, there are no robust studies of sufficient duration; I understand that the studies are no greater than 48 hours. In particular, in cases of long-term prescribing there was not the evidence to show why the drug should be prescribed or to demonstrate the efficacy of prescribing it. There is another issue about whether poor efficacy might prompt patients unintentionally to overdose and whether that accounts for a fifth of deaths. I am not taking away from what my hon. Friends have said and from what individuals feel about the efficacy of the drug, but there is a question mark over whether that is tempting people to take more than they are prescribed, which leads to unintentional death.
Paul Flynn (Newport West, Labour)
It is right to take those deaths seriously. They were running at 300 a year, and deaths from paracetamol and co-proxamol combined were between 500 and 600 a year. Those deaths were avoidable. It was right for the MHRA to act, but before any change in policy, and although one sympathises with anyone who can find one drug to offer pain relief and is not satisfied with others, there must be a rigorous examination of whether alternatives are available and what the results of any withdrawal of co-proxamol will have on suicide. As the Minister said, the drugs were widely available and in almost everybody's medicine cabinet, and people who took two or three over the prescribed limit lost their lives. In other cases, the effects, like those of paracetamol, are irreversible. There was a terrible, regular scourge of deaths, suicides and accidents involving the drugs. The CSM was right to act, but it might well have gone too far.
Caroline Flint (Minister of State (Public Health), Department of Health; Don Valley, Labour)
I know that in the past my hon. Friend has asked questions about the prescription of alternatives to co-proxamol. At that time, the Minister of State, Department of Health, my right hon. Friend Ms Winterton, said that the guidance provided refers to a number of alternatives that can be used. The chief medical officer has communicated that to health care professionals, too. In particular, we have provided advice on the withdrawal of co-proxamol and the alternatives that should be considered. Despite the withdrawal, we have an inbuilt flexibility to continue to prescribe in certain circumstances for people for whom co-proxamol seems to be the only answer.
The information gathered as part of the review did not provide sufficient evidence on efficacy, in particular, for the continued provision of co-proxamol when that was weighed up against the public health concerns. The review noted that the previous strengthened warnings to doctors and patients about the hazards of co-proxamol had proved ineffective. I note the point made by my hon. Friend the Member for Aberdeen, South about whether the national campaigns are too piecemeal and not effective, but we communicate in part directly with health professionals. Over and above what we do nationally about patients and the public, we have sophisticated methods of communicating directly with health professionals. Even with that direct line of communication, it was felt that those health professionals were not taking the matter as seriously as they should have been through the normal measures. It was believed that the risks of co-proxamol outweighed the benefits of allowing the medicine to remain on the market.
During the review, the CSM considered strengthening warnings on the product information, restricting the pack size, an education and communication programme to alter prescribing behaviours, restricting the indication for the treatment of chronic pain, restricting prescriptions for second-line use, restricting prescriptions to specialist use only and rescheduling co-proxamol as a controlled drug. All the issues that my hon. Friends raised were considered as part of the discussions, but the CSM felt and advised that none of the measures was capable of effectively minimising the risk.
We all take the prevention of suicide seriously: 4,500 people take their own life in England every year—I am sorry that I do not have the figures for Wales for my hon. Friend Paul Flynn—and we have a national suicide prevention strategy. It was extremely encouraging to see in April 2006 that progress is being made on our national suicide targets. The third annual report showed that the most recent suicide rate, for the three years from 2002 to 2004, has been reduced by 6.6 per cent. from the 1995 to 1997 base line. The report outlined areas where progress was being made, including in the phased withdrawal of co-proxamol. As I said, it is a cause of accidental as well as deliberate harm. It is estimated that a fifth of the co-proxamol self-poisoning deaths each year were unintentional. On that basis alone, we can assume that more than 100 lives have been saved to date as a result of the action to withdraw co-proxamol.
There are many alternatives to co-proxamol and that is reflected in the steady fall in the prescribing of that medicine. Over the phased withdrawal period, we expected to see prescribing decline. Co-proxamol prescriptions have fallen from more than 7.2 million in 2004 to approximately 1.5 million in 2006—about an 80 per cent. drop in usage over the past two years. Northern Ireland has phased out co-proxamol altogether.
That steady decline in usage has doubtless been supported with pain management guidance from the CSM and the National Prescribing Centre, which demonstrates that health care professionals and patients are making informed choices about appropriate pain relief. However, I recognise that a small group of patients are finding it difficult to change from co-proxamol or that alternatives appear not to be effective or suitable.
Before the CSM review, co-proxamol was widely used. As I have said, there were 7.2 million prescriptions in England in 2004. We received 367 letters during the past two years from patients concerned by the decision. However, that number of letters represents a small minority given the overall benefits that we think will be gained by the withdrawal of co-proxamol. For those patients, the continued provision of co-proxamol through normal prescribing may continue until the end of 2007. We have confirmed with manufacturers that the manufacture of co-proxamol will continue after that date. The main manufacturer has informed us that it is its firm intention to continue to manufacture co-proxamol following the cancellation of the licences, so supplies will be assured.
There will be scope, as always, for the prescription of unlicensed co-proxamol. Clear provision in legislation gives the right to prescribers to prescribe off-label or unlicensed medicines if it is judged to be in the best interests of the patient. If there is clear clinical need, it will still be possible to prescribe co-proxamol, but in a more targeted way with a stronger focus on the risk-benefit judgment for the patient—and the patient will be involved in the decision.
That, I think, is the best way forward. My worry about going down the route suggested by my hon. Friends, which was considered by the CSM in its review, is that it might lead to a regression, prescribing the drug when it might not be necessary rather than prescribing it only for the small minority for whom co-proxamol seems to be the only answer. There is flexibility in the system for it to continue to be prescribed.
It being Five o'clock, the motion for the Adjournment of the sitting lapsed, without Question put.