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17 Jan 2007 : Column 341WH—continued

The paper goes further in its conclusions, saying that

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

he said that the licence for the drug would still be withdrawn in December 2007.

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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:

I have too many e-mails to read them all out, but another correspondent asked me to ask the Ministers concerned

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.

John Cummings (in the Chair): I call Howard Stoate, with the permission of the initiator of the debate and the Minister.

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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:

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:

A GP from Hampshire made the following point:

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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

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:

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
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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.

4.47 pm

The Minister of State, Department of Health (Caroline Flint): I congratulate my hon. Friend the Member for Aberdeen, South (Miss Begg) on securing this debate. I am once again substituting for the Minister who leads in this area. At present, it is my noble Friend Lord Hunt of Kings Heath.

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 the Member for Dartford (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.

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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) (Lab): 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: 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 the Member for Doncaster, Central (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.

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