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I am delighted to have the opportunity to call an Adjournment debate on the availability of co-proxamol, which is a mild analgesic that is used to treat those who have mild to moderate chronic pain. The debate stems from the advice that was given to general practitioners in January this year by the Committee on Safety of Medicines, which recommended that co-proxamol should be withdrawn entirely over the next six to 12 months.
I must declare an interest: I have been prescribed the drug, which I have used regularly for some years, and I take four co-proxamol a day. However, I am not here tonight because I use the drug and might be affected. I am here because a number of my constituents who use the drug contacted me when the withdrawal of co-proxamol was first announced in the press because they are worried about what might happen. When my constituent, Jonathan Russell, who has ankylosing spondylitis, came to one of my constituency surgeries, I began to take an even greater interest in the debate.
Jonathan has been taking co-proxamol, which he has found to be an effective response to his chronic condition. I have known him for a number of years in his professional capacity: he is a social worker who works with disabled people and gets them into employment and he leads an extremely active life. He contends that he can lead his busy life because of co-proxamol, which allows him a good night's sleep and also keeps him supple.
When Jonathan heard about the concerns associated with co-proxamol, he went to his GP, who took him off the drug. Over the past few months, he has tried various other drugs, which are supposed to be as good as, if not better than, co-proxamol, but he has told me that none of them are working. Indeed, some of the new drugs are making him feel very unwell and not allowing him to get the night's sleep that he requires, which is affecting his ability to work.
The desperation caused by his not feeling well and the fear that he can never return to co-proxamol drove Jonathan to seek an appointment with me and to complain. He is not the type of person who normally complains—he deals with a chronic condition extremely well and with an extremely cheery disposition. The effect that the withdrawal of co-proxamol has had on his life must be extremely serious for him to complain. He has learned to live with and manage his pain, which is the meaning of chronic pain, but he cannot do so without access to co-proxamol. The effects of the other drugs mean that he has been unable to loosen up in the morning and that he has been late into work. Indeed, he is afraid that he may have to give up work if he cannot continue to use what he regards as a mild, effective drug that has no side effects.
Why has the withdrawal of co-proxamol been proposed? Is it because the drug is ineffective? The answer appears to be, "No"—patients report that it is extremely effective. Is it because the drug has serious side effects? The answer is also, "No"—patients who use co-proxamol feel that out of all analgesics and other alternative drugs, whether they are COX-2 inhibitors or non-steroidal anti-inflammatories, it is the drug with the fewest side effects. Has co-proxamol been withdrawn because it increases the likelihood of a heart attack, a stroke or any other major health problem in the individual who is taking the drug? Again, the answer is "No"—the alternative drugs, which I shall discuss later are associated with a higher risk of such major health problems.
The reason why co-proxamol has been withdrawn, as was confirmed to me in a letter from the Secretary of State for Health, is that some people might abuse the drug and use it to commit suicide—not that the drug leads to people having suicidal impulses but that it is a mechanism for those who want to commit suicide. The Department of Health says that between 400 to 500 suicides a year are associated with co-proxamol, and that is why it has to take action.
Co-proxamol is quite different from most other drugs that have been withdrawn from the market. In those cases, there is usually an associated health risk for those who take the drug; in this case, the associated health risk is to those who may not have been prescribed the drug but take it in order to commit suicide or those who have been prescribed it but take it in overdose and therefore unconsciously or unwittingly commit suicide.
People who are on co-proxamol are aggrieved about the different approach that has been taken to that drug which means that they are losing an effective analgesic not because of anything that they do in terms of their behaviour or prescribing practices but because of what others might do. If that thinking was applied to all drugs, almost all would probably have to be taken off the market, because all drugs have some kind of associated risk; certainly, many opiates can be used to commit suicide.
Several years ago, we had the same debate about paracetamol. It is interesting that the advice that GPs have been given by the Committee on Safety of Medicines is that paracetamol, the drug that was controversial a few years ago, is just as effective as an analgesic. In medical terms, it might well be, but the people who use co-proxamol believe, from their own experience, that it is a superior drug. What is different about it is that it contains destropropoxyphene, which can give people a high and be mildly addictive. It is probably that feeling of well-being that people get that makes them believe that it is a drug. But that is not a reason for withdrawing co-proxamol; many drugs, including opiates, will give people a sense of well-being.
The advice to GPs goes on to suggest that if paracetamol is not enough they should consider prescribing a non-steroidal anti-inflammatory such as ibuprofen. There have recently been reports about the risk factors inherent in ibuprofen. We also know that other non-steroidal anti-inflammatories can cause gastro-intestinal bleeds, so they are not risk-free drugs. If that is not enough, GPs are advised that perhaps they could think of prescribing dihydrocodeine, which is a very strong analgesic but has severe side effects—it makes people feel very sleepy and leads to constipation. The alternative drugs that are proposed to replace co-proxamol are not without associated side effects or risks.
The advice recognises that for some people none of this may work, and in such cases taking antidepressants such as amytriptyline is suggested. That is bizarre, because that class of drug is indicated in more suicide attempts than co-proxamol, since antidepressant drugs are generally used by those who may be more likely to have suicidal tendencies in the first place.
Why has it taken six months for us to get this far and have a debate in the House? It is probably because problems are only now beginning to appear. In some cases, patients who were on co-proxamol went to their GP, who prescribed something different and, six months later, they are realising that none of the alternative drugs work. That happened in the case of my constituent, Jonathan Russell. He has found that nothing else works. He has tried everything else and concluded that co-proxamol was the best drug for him.
The second group of patients comprises people such as me. I have not been to my GP but I know about the risks and that, at some point, I shall have to address the matter. However, that will be sometime in the future and I shall worry about it then. Many patients on co-proxamol may fall into that category. Perhaps some are not aware of what is going to happen. As time goes on and more practices determine their strategy on prescribing co-proxamol, that group, like my constituent Jonathan, will become more distressed.
People who are working in health are worried that not only co-proxamol is affected. If the suggestion had been that co-proxamol should be withdrawn from use, there would be less concern. However, many drugs that are used as alternatives to or alongside co-proxamol for chronic pain, especially the anti-inflammatories that are prescribed for people with arthritis, have large question marks over their use and the associated risks. Some have been withdrawn.
For example, the COX-2 inhibitors have proved remarkably effective in dealing with arthritic pain. Again, I speak from personal experience because I was on Vioxx. It was withdrawn and I went back on to co-proxamol. That was ironic because Vioxx was extremely effective and, when I took it, I did not need co-proxamol—as an anti-inflammatory, Vioxx reduced the pain and I did not need the analgesic effects of co-proxamol. Withdrawal of some of the COX-2 inhibitors has meant that people are more reliant than they had been on co-proxamol.
We must consider the exact risk that we ask patients to take. Almost all drugs have some associated risk and side effects, which can differ in different people. It is important that, when patients and GPs make decisions together on the most effective drugs for dealing with pain, they can make an informed choice. It should be up to them to weigh up the risks and benefits associated with their drug. If a drug is extremely effective, as the COX-2 inhibitors seemed to be, would patients be willing to put up with the associated increased risk of heart attack if they could be almost pain free for the next 20 years? Patients, with their doctors, should be allowed to make that informed choice.
Groups such as Arthritis Care have been keen to emphasise that informed choice. It is not a case of asking for all drugs to be available to all people at all times but of making a correct choice. I pay tribute to Arthritis Care. After I had applied for the Adjournment debate, I realised that I needed a little more background information about what patient groups felt about the withdrawal of co-proxamol and whether the issue was more widespread than the case of my constituent. Arthritis Care has been extremely helpful in providing me with a great deal of background information.
Groups such as Arthritis Care do not ask for co-proxamol to be freely available. It recognises that the Committee on Safety of Medicines has to take account of the public health aspects of any drug's use and misuse. It has to take account of misuse, even by those who have not been prescribed the drug.
I am normally supportive of medical opinion. I am unlikely to go against informed medical opinion and it is therefore strange for me to be in the position of asking the Government to reconsider the advice from one of its committees, which has been established to provide such advice. I have always supported the work of the National Institute for Health and Clinical Excellence, and I believe that we must have independent committees to consider these issues.
It is important that the Government look again at the prescribing arrangements for co-proxamol. Why should a person who lives alone and who takes four co-proxamols a day—which is well below a dangerous dose—be denied a drug with minimal side effects that he or she finds effective, just because other users cannot keep their drugs secure and might allow them to get into the hands of people who want to use them for the wrong reasons? There is a middle way. Arthritis Care does not necessarily want co-proxamol to be made available as a front-line drug. It would like GPs to be given the chance to find another suitable drug. If they cannot, however, it would like them to be able to prescribe co-proxamol, perhaps having sat down with the patient and provided a demonstration, either written or otherwise, to ensure that they are aware of the risks inherent in the drug, and of the risks involved if the drug is misused or left lying around.
Perhaps we could also consider changing the packaging of the drug, as was done with paracetamol. Co-proxamol is packaged in strips of 10 at the moment, which constitutes an overdose, whereas eight would be a safe dose. Perhaps we could consider packaging it in strips of eight. I hope that the Minister will take those suggestions on board.
In the past couple of days, I have noticed a difference in approach. In response to a media request, the Medicines and Healthcare products Regulatory Agency has now said that
"prescribers will be able to continue to prescribe co-proxamol on their own responsibility if the clinical need is justified."
That is not what patients are being told, however. The least that the Minister could do tonight would be to clarify the situation with regard to the availability of co-proxamol. Is it to be withdrawn completely? Is it to be available only while stocks last? Or will it continue to be available under certain conditions? If it is to continue to be available, that information needs to be well publicised. Organisations such as Arthritis Care which have large numbers of members who use co-proxamol will be delighted to have the issue clarified. There is confusion at the moment, and a great deal of distress in the wider community, and I hope that the Minister will be able to give us some reassurance tonight.
I congratulate my hon. Friend Miss Begg on securing this debate. This is an important issue, and her questions on health and health care issues are always thoughtful and thought-provoking. I acknowledge that the relationship between a GP and a patient in relation to pain management is a very personal one. Each individual needs to describe how pain is affecting them personally, and the response can change from one person to another. As my hon. Friend has rightly said, this is also a very complex issue.
My hon. Friend has brought to our attention the concerns of her constituent, Jonathan Russell, about the withdrawal of co-proxamol. The Department has received about 130 letters from Members of Parliament writing on behalf of their constituents about this issue. My hon. Friend also mentioned Arthritis Care, and I would like to acknowledge the good work that that organisation does to support those who suffer from arthritis. It provides an experienced and knowledgeable voice on the issue of patients' rights, and also works with health professionals. The decision to withdraw co-proxamol was not an easy one to make and followed an extensive risk-benefit assessment, a wide public consultation and advice from the Committee on Safety of Medicines. The Government's independent scientific advisory committee on medicine safety also contributed, as did other experts.
Co-proxamol is a combination of a weak opiate painkiller with a relatively low dose of paracetamol and has been available since 1965, before the current system of medicines regulation existed. As a long-established medicine, it has not been subjected to modern standards of clinical research—clinical trials then were often either poorly designed or of very short duration and on the whole did not produce definitive results. As such there is a lack of evidence that co-proxamol is more effective than full-dose paracetamol. Despite the lack of evidence, many prescribers considered it to be a useful alternative to non-steroidal anti-inflammatory drugs such as ibuprofen and more potent opiates in situations in which paracetamol alone is ineffective.
On the other hand, the dangers of a co-proxamol overdose, especially when taken with alcohol, are well established and, I am afraid, cannot be ignored. Co-proxamol is involved in 300 to 400 self-poisoning deaths each year, of which around a fifth are accidental. Many deaths involve people taking co-proxamol that has not been prescribed to them. Co-proxamol can be very toxic, and overdose can occur with only a few tablets more than the recommended daily dose. Toxicity from co-proxamol overdose is extremely rapid compared with that from other pain-relieving medicines, so, sadly, victims often die before they reach hospital. Unlike paracetamol, there is no effective antidote to co-proxamol poisoning. Importantly, paracetamol is considered to have a comparatively good safety profile—the onset of toxic effects is slow, allowing more time for effective treatment.
Advice from the CSM aimed at the reduction of co-proxamol toxicity and fatal overdose dates back as early as 1985. You can therefore see, Mr. Deputy Speaker, that the issue has been discussed for a considerable time. Sadly, this advice has not been effective in preventing the deaths that occur each year following a co-proxamol overdose. The growing concern was prompted by recently published UK research using data from the Office for National Statistics showing that co-proxamol alone now accounts for almost one fifth of drug-related suicides and is second only to tricyclic antidepressants as an agent of fatal drug overdose. Concerns have also been raised by Sweden in the European Parliament.
In light of the lack of evidence that co-proxamol is any more effective than full- dose paracetamol in pain management, and its high toxicity in overdose, the expert advice of the Committee on Safety of Medicines was sought. During 2004, the CSM comprehensively reviewed all the available evidence regarding the risks and benefits of co-proxamol. A public call for evidence on the risks and benefits of co-proxamol was also conducted for 12 weeks in 2004. The Medicines and Healthcare products Regulatory Agency wrote directly to a large number of organisations representing healthcare professionals, patient groups and other stakeholders as well as publishing the request for information on the MHRA website. Comments from patients and members of the public, as well as health care professionals, were welcomed. The CSM reviewed all the responses to this call for evidence and also international evidence on the safety of co-proxamol. During this review, the CSM noted that previously strengthened warnings to doctors and patients on the hazards of co-proxamol have unfortunately proved ineffective.
After considering the wide range of available evidence and the options for action to reduce the risk of overdose—for example, prescriber and patient education, smaller packet sizes and restricted indications, as my hon. Friend outlined—the CSM determined that the risks of co-proxamol outweighed the benefits of allowing the medicine to remain on the market. Following advice from the CSM, the MHRA has therefore agreed with the manufacturers to withdraw co-proxamol over an extended period of time in order to allow long-term users an opportunity to adopt suitable alternative pain management strategies. The CSM advised that the withdrawal of co-proxamol should be phased over a period of up to 36 months, or to an earlier timetable to be agreed with manufacturers. Most manufacturers have indicated that they intend to withdraw the drug over a period of approximately six to 12 months. A few have indicated that they wish to phase the withdrawal until the end of 2007.
Over that period, we expect to see the prescribing of co-proxamol decline as patients are moved to suitable alternatives. To help doctors find the best options for individual patients, the MHRA has issued CSM pain management guidance. Available data on sales at wholesale level suggest that the sale of co-proxamol is slowing down steadily. There has been as much as a 10 per cent. month-on-month decline since June 2004, and total supply has more than halved in the six months since the announcement was made. An article in the May edition of Pulse was authored by a GP who has reduced the number of patients in his care on co-proxamol from 438 to 20. That demonstrates that good GP care and discussing the various issues with patients can effect a change to an alternative that works.
It being Seven o'clock, the motion for the Adjournment of the House lapsed, without Question put.
Motion made, and Question proposed, That this House do now adjourn.—[Tony Cunningham.]
Sensitive discussion that takes into account all the options can effect a smooth transition to an alternative. However, the GP in question does acknowledge that, for a minority of his patients, other alternatives have not proved an option. However, a reduction from 438 to 20 is a significant one.
To judge by what my hon. Friend said earlier, it appears that stocks will run out, so even for the minority who found co-proxamol the most effective remedy—they include my constituent—there will be an end date by which the drug will be completely off the market. Is that correct?
I will address that point shortly, as I want to clarify the situation for the minority of patients who have agreed with, in most cases, their GP that there is a clinical need to continue with the prescribing of co-proxamol.
Many local formularies, including in Northern Ireland, have already phased out co-proxamol altogether. It has been on the market for 40 years and it is clear that some patients have been established on this medicine for a long time, so I realise that the action that has been taken must be very distressing. The Department has received many letters from patients who are upset at its withdrawal. I have sympathy for them, but I am encouraged by the progress that has already been made in shifting to other forms of pain management. The decision to withdraw co-proxamol from the market has tested medicines regulation to the extreme. However, weighed against the difficulties caused to individual users is the clear public health gain in removing a medicine that has been widely implicated in accidental and non-accidental overdose.
At the end of the phased withdrawal, and following the cancellation or withdrawal of licences for existing products, provision will remain for the supply of unlicensed preparations. I understand that the drug will continue to be available on a named patient basis, and that the MHRA will communicate that fact clearly. Its doing so should deal with the question of supply, but I will check this point for my hon. Friend and I am happy to write to her about it.
Individual patient use of co-proxamol preparations could continue, with responsibility for such use falling primarily on the prescriber, who is usually the GP. In this way, where a clinical need exists and alternatives have proved unsuccessful, it will still be possible to prescribe co-proxamol, but in a more targeted way than in the past, and with a stronger focus on the risk-benefit judgment for the particular patient. I hope that that judgment will be reached through a strong relationship between patient and prescriber that establishes the patient's needs and their need to use this drug.
In making a risk analysis and a public benefit analysis of the withdrawal of co-proxamol, will she also consider the following point, which she will probably be unable to deal with this evening? Those who previously used co-proxamol, and who were active and in work, might lose their job and be unable to work as a result of its withdrawal and their failing to find an equally effective alternative. My constituents' fear is that they will therefore be a burden on the state, instead of contributing to it.
It is important that all the alternatives are looked at. We need to ensure, in respect not just of co-proxamol but of other drugs, that GPs have the most up-to-date and most effective pain management care for their patients. Sometimes drugs become a matter of custom and practice, because it is the one thing that the general practitioner knows about, so he or she continues to prescribe it despite evidence that there are better alternatives. I understand what my hon. Friend is saying: I will reflect on what she said and write to her on that issue.
What I am saying this evening is that the primary issue is that we stand by the decisions made by the Committee on Safety of Medicines, while at the same time recognising that, for a minority who have gone through all the alternatives, there may be a clinical need to continue with the prescribing of co-proxamol.
My hon. Friend is a Minister in the Department of Health, so the calculation may be done on health grounds, but there may be social costs to the withdrawal of the drug, which may not have been factored in with respect to the health costs of keeping the drug going. There could be costs to society if people fail to get an effective drug and co-proxamol is withdrawn.
I understand what my hon. Friend is saying. Yes, we have to weigh up all the different factors. However, the information that I provided earlier this evening about the impact of this particular drug on the number of people who die through either accidental or planned overdose is a very serious issue. I understand that all drugs have risks, but we face huge challenges that cannot be overcome through treatment if someone overdoses by accident. Some people, unfortunately, seek to commit suicide, but they may rethink that option if they have a chance of getting treatment—after being saved, as it were. That raises many questions about co-proxamol. From the evidence that I have seen, the option of having treatment, thereby saving life, is much reduced by the accidental or intentional use of this drug when it leads to an overdose. We have to take all those factors into consideration.
As I have already said, it is a complex issue that has focused the minds of many people in establishing what is the best thing to do. No one lightly takes removing a drug from the market when it has become part and parcel of how many people, whether they are in or out of work, cope with their daily lives. I referred earlier to an article in Pulse, which made it clear that GPs are engaging with patients in a sensitive way in planning the withdrawal of co-proxamol in favour of alternatives. The fact that there has been a decline, from 438 to 20, in the number of people who cannot deal with any alternative drug shows that progress can be made, although we must be mindful of the minority for whom alternative treatment may not be an option. There is a process that must be gone through but, as I said, GPs or prescribers retain the ability to prescribe co-proxamol.
I shall write to my hon. Friend about some of the issues that she has raised, and particularly about the question of stocks. Clearly, it is important to determine what the future holds for those people for whom co-proxamol is the only drug that can give them the relief that they need.
I welcome the opportunity to hold this debate. Sometimes, regulation must balance the preferences of the few with the needs of the many, but that is not to say that we do not take account of the individual requirements that my hon. Friend has expressed so ably. I hope that she and organisations such as Arthritis Care are reassured by my acceptance of the possibility that co-proxamol will continue to be prescribed where there is a clear clinical need because alternative treatments are unsuitable.
The Government are sensitive to the problem and accept that pain management is a complex matter. We expect health professionals to engage fully with patients on the range of drugs that are available to manage their pain, and we know that patients have considerable interest in complementary and alternative medicines for the management of pain.
The way forward is to ensure that the relationship between health professionals and patients is developed. It is not good enough for GPs or prescribers to sign off a patient on drugs for many years without any discussion of pain management. The relationship must be a progressive one: it may change with time, but both patient and prescriber must feel that they have attempted to make the best possible progress.
Question put and agreed to.
Adjourned accordingly at ten minutes past Seven o'clock.