§ Motion made, and Question proposed, That this House do now adjourn.—[Mr. Andrew Mitchell.]
§ 10.2 pm
§ Mr. Barry Field (Isle of Wight)
I thank you, Madam Speaker, for granting me this Adjournment debate this evening. You appear to be in rude health. Clearly, the Easter recess has done you good.
This is the first occasion since my arrival in the House on which I have had an Adjournment debate on a national issue. Hitherto, all my Adjournment debates have been exclusive to my constituency. I have two admissions to make. First, I had never heard of arachnoiditis until it was raised in my constituency by the chairman of the Arachnoiditis Self Help Group. I believe that I was in good company, because none of the journalists on the local television, radio or newspapers had heard of it, either.
I understand that arachnoiditis is the inflammation of the delicate membranes surrounding the spine and nerve routes. They become inflamed, thicken and adhere to other tissues, such as nerves. The condition has been associated with spinal infection or injuries, including spinal surgery, the most common of which is for slipped discs. It is allegedly caused by injections to the spine in connection with procedures such as myelography. It was the fact that the Isle of Wight consultant who is responsible for myelographies told our local newspaper that, because of the risks involved, he would not dream of having one himself, that drew the matter to my attention and to that of a number of others.
The second admission that I have to make is that, until I put my back out—fortunately only on one occasion—I did not realise the sheer unspeakable agony of a back complaint. There is no respite from it, whether one stands up or tries lying on a bed or even on a hard surface such as a floor.
I see that the Minister, who also appears to be in his customary rude health, is in his place. I do not know whether he has ever suffered from a back complaint. I have noticed that, since his translation from the Whips Office, he has developed red box stoop but, apart from that, he has always seemed to me to be a bouncy and healthy Minister; but if he has had the unfortunate experience of putting his back out, he will know precisely why I have initiated the debate.
I pay tribute to my constituent, Mr. Ron Sheppard, who is the chairman of the Arachnoiditis Self Help Group. He has worked tirelessly for the cause, and his breakthrough came when the Parliamentary Under-Secretary of State, my noble Friend Baroness Cumberlege, wrote to me on 5 March:it is possible that any procedure involving puncturing the membrane around the spinal cord could lead to the introduction of harmful bacteria and hence cause inflammation such as arachnoiditis.I thank my noble Friend Baroness Cumberlege, through my hon. Friend, for cutting through all the red tape and bureaucracy and giving the brave little band of back sufferers the answer straight down the line. That is a triumph for open government.
The first great concern is that people still feel that they are not properly counselled about the risks involved in myelography. My noble Friend continues in her letter:In many situations, MRI"—magnetic resonance imaging—925will be a suitable alternative to a myelogram. Currently, clinicians have to consider for individual patients the balance between the risks of myelography and the risks of waiting for the availability of an MRI scan. The patient should be involved in this decision through informed consent.The self-help group has a number of letters from people all over the country who say that they were never properly counselled concerning the risks involved. I have asked the chairman to select a sample to illustrate my point; I am sure that the Minister will take my word for it that I could provide the originals of those letters and many more besides. The first is from the chairman, Ron Sheppard, who says:I was never warned of any risk before myelography".Mrs. Rogers of Sussex writes:At no time was I warned there may be side effects".Mrs. Ince of London states:never at any point was I informed of the dangers of the said procedure.Mrs. Paton of Cornwall says:No-one seems to tell you anything".It has been put to me—I am sure that my hon. Friend the Minister will be sympathetic to the point—that when one is suffering the unspeakable and excruciating agony of this back disorder, one will sign one's life away to anyone who will promise one relief from it. I hope that my hon. Friend will take that point on board and that, perhaps as a result of this Adjournment debate, we will see the introduction of a large, bold-typeface warning about the risks involved in such treatment, to be signed in duplicate by patients, with one copy to be taken away by them and the other to be placed on their file, so that in future there can be no doubt whatever that patients have been properly counselled in such circumstances.
As Baroness Cumberlege said in her letter, MRI scans have an important part to play in the alternative therapy that will be available in future. I understand that, in September 1992, the Royal College of Radiologists issued a report, which is brought to the attention of the Secretary of State for Health personally, estimating that MRI scanner needs of the United Kingdom amount to approximately 225, and that there are currently 90 in operation. I am pleased to say that one is made available regularly on the Isle of Wight, and it plays an important part in the diagnostic health care of my constituents.
When my hon. Friend the Minister replies to the debate, he will no doubt point out that, in 1991, the Secretary of State for Health announced a three-year rolling programme for MRI scanners. However, the problem is urgent, and one reason for this debate is to call for an accelerated programme. Indeed, with fundholding, these matters are being discussed actively with consultants and general practitioners throughout the country. In my constituency, Mr. Paul Bingham of the Isle of Wight health commission published an article in the "Public Health Quarterly" to provoke discussion on the use of MRI scanners in future.
An article in today's Times states that my hon. Friend the Minister will announce next week an increase in the limit for regions and national health service trusts from £50,000 to £250,000 for leasing medical equipment and building new developments. Having spent my first Parliament campaigning against the wretched Ryrie rules, I am delighted that, in my right hon. Friend the Prime Minister, I have at long last found a champion for their 926 total abolition. If the article in The Times is true, next week's announcement will hopefully be the manifestation of that abolition.
I want my hon. Friend to go further than that. The provision of pound for pound has been an area of great success in the Government. Every £1 raised locally is matched by El from the taxpayer's pocket. Such a scheme for MRI scanners would be welcomed by the general public. Many district health authorities already operate such schemes, but if they were encouraged by the Department of Health, that would be a very welcome initiative.
We can all decide which good causes to support, but none of us has a choice about when we are ill. That is why our national health service is so precious to us all. I hope that the Minister will pick up this baton and run with it till we have a result. Such a scheme would accelerate the introduction of this wonderful "Tomorrow's World" technology throughout the health service, and it would be just the kind of dynamic challenge that my right hon. Friend the Secretary of State for Health had in mind in involving private financing in the health service.
I have some questions for the Minister. Are there any central records of the number of myelograms being carried out? What more can be done to ensure that GPs are aware of arachnoiditis and so ensure its proper diagnosis? Are there any proposals for looking into alternative pain management to avoid spinal injections? Has the Department of Health considered the work of Professor Jayson at Manchester hospital, who has been researching the condition and is president of the self-help group? Has the Medical Research Council a part to play in considering the problem?
I understand that Ron Sheppard has written to the Select Committee on Health asking whether the whole problem can be examined. I know that the Minister will, as always, be as helpful as possible when he replies to the debate, and that he will do his best to continue that ray of hope brought into the lives of so many sufferers by the letter from Baroness Cumberlege. I hope that my small contribution tonight will encourage those who have suffered for so long, and that I may have convinced the Minister that arachnoiditis really is a pain in the back.
§ The Parliamentary Under-Secretary of State for Health (Mr. Tom Sackville)
I congratulate my hon. Friend the Member for Isle of Wight (Mr. Field) on his very full and lucid account of the serious problems faced by people who suffer from arachnoiditis. I acknowledge the close interest that he has taken in the matter.
I am only too familiar with the problems facing people with arachnoiditis. I have been made aware of just how great the suffering can be by my constituents and through the Department. Perhaps it would be helpful to hon. Members if I briefly describe it.
Arachnoiditis is an uncommon condition which is characterised by chronic inflammation and thickening of the sub-arachnoid space, which covers and protects the brain and spinal cord. It may develop for several reasons. These include meningitis, suba-rachnoid haemorrhage, tumours, trauma from injury or surgery and irritants, including the contrast agents used in myelography. The condition traps nerves as they leave the spinal cord.
927 Arachnoiditis at the lower end of the spinal canal may cause a great deal of low back and leg pain, although there is no distinctive syndrome.
Any trauma to the spine, including surgical invasive procedures, may lead in some cases to the development of arachnoiditis. Patients with this condition may have more than one predisposing cause. For example, myelography involves trauma to the spinal cavity to introduce a needle through which a contrast medium, which is an irritant, is injected, and is not uncommonly followed by a spine operation. Epidural injections involve the introduction of a needle to the epidural space. It does not penetrate the arachnoid membrane, nor is a contrast agent injected, but arachnoiditis has been reported following epidural injections.
Myelography is a diagnostic procedure. It involves the introduction of a contrast medium into the spinal column through a needle inserted into the lower spine. Once the contrast agent has been injected, several radiographs are then taken which provide views of the spinal cavity.
Myodil was the United Kingdom trade name for the contrast medium, which was an oily contrast agent for myelograms. It was introduced in 1941. It quickly became the standard contrast medium for myelography until the general acceptance of non-ionic water soluble contrast media during the 1980s. Myodil has not been marketed since 1987, when it was withdrawn from the market by its manufacturers.
Myodil was first marketed in the 1940s and was, therefore, issued a product licence of right when the licensing of medicinal products was introduced under the Medicines Act 1968. At the time of first licensing, the product information warned of the occurrence of post-myelography arachnoiditis in some patients. At the time of the review of the product licence of right, that warning was strengthened. It is the responsibility of doctors who use a product to ensure that they are fully familiar with the benefits and risks of any procedure or treatment.
Potentially, any medicine may cause side effects which may be minor or more serious. The Committee on Safety of Medicines carefully monitors all issues of drug safety and, where necessary, provides advice to doctors, dentists and pharmacists. Prescribing information and advice about side effects is available to doctors in the data sheets of an individual product, which are issued by the manufacturer of the product, and in the British National Formulary which the Department provides to all prescribers.
The incidence of clinically significant arachnoiditis associated with Myodil myelography is difficult to assess but has been estimated to be approximately 1 per cent. However, the relative contribution of Myodil, compared to other factors also known to be associated with arachnoiditis, is less certain.
I am aware that legal proceedings are currently in progress between a substantial number of patients, who claim to have suffered damage as a result of the use of Myodil, and Glaxo, the manufacturers of this product. The Department—in this case the Medicines Control Agency—complied with a High Court Order for discovery of documents relating to Myodil in 1991 but has had no further involvement in the case. My hon. Friend will understand that, in view of the judicial proceedings, 1 am unable to comment further.
§ Mr. Ian McCartney (Makerfield)
In a general debate, it is interesting that all three major parties in the House are represented by their Front-Bench spokespersons. The reason for that is that we have received literally hundreds of letters from sufferers of arachnoiditis about the pain they are suffering and their inability to get adequate answers to the issues which have been raised.
On 25 March, I wrote to the Secretary of State for Health about a meeting of departmental officials, the Under-Secretary of State for Health, the Secretary of State for Health, hon. Members on both sides of the House and representatives of the action group to see whether we could consider in detail some of the complaints that have been raised about the Department.
I have had no confirmation so far from the Department of an agreement in principle to the meeting. Perhaps the Minister will say before the debate concludes whether in principle the Department is agreed that the meeting should take place and, on that basis, when it is likely to take place.
§ Mr. Sackville
I can give the hon. Gentleman, and the hon. Member for Rochdale (Ms Lynne), an assurance that we shall arrange a meeting at a time of their convenience.
I shall now make some general comments about injuries sustained as a result of medical treatment. If a patient suffers injury as a result of medical treatment, he or she can go to court to claim compensation. If the claim is against the national health service, to be successful the patient must succeed in proving that there has been negligence on the part of the NHS.
Where a patient suffers an injury as a result of negligent care or treatment provided by the NHS, it is right that compensation should be paid to that patient. However, the individual who is accused of being negligent also has the right to defend his or her professional reputation. Unless the alleged negligent action is so obvious as to be beyond doubt, as in other walks of life, if the injured person wishes to pursue the case, the dispute is resolved through the courts.
In a case such as that concerning Myodil, the Government's position has always been that it is a matter to be resolved between the drug companies and individuals, if necessary through the courts.
Magnetic resonance imaging, known as MRI, is a relatively new method of imaging, which has come into clinical use over the past 10 years. It is a non-invasive technique that enables good images of spinal cavity to be obtained but differs from myelography in not using ionising radiation. In many situations, MRI will be a suitable alternative to a myelogram, but there will be some situations in which myelography is preferable. For instance, some patients are unable to tolerate the enclosed conditions which are a feature of MRI.
There are about 78 MRI units in England—the number has already grown—but these are not sufficient to take on the present myelography work load; so it would not be practical to discontinue myelography entirely. I am glad to remind my hon. Friend that the then Secretary of State for Health announced early in 1992 a three-year programme of capital funding for medical equipment, including whole body scanners. Several scanners were purchased for England in the financial year 1992–93, and we expect that rather more will be acquired in the current financial year.
Clincians associated with treatment of the spine would wish to avoid invasive procedures wherever possible, and consultants would not go along with it if there were always 929 alternatives available. In the context of the current provision of MRI, clinicians have to consider for individual patients the balance between the risks of myelography and the risks of waiting for the availability of an MRI scan. The patient should be involved in that decision, through the process of securing informed consent.
Patients are entitled to receive sufficient information in a way that they can understand about the proposed management, any possible alternatives and any substantial risks. Patients must then be allowed to decide whether they agree to the treatment. This important principle of achieving informed consent has been highlighted in the patients charter.
As part of the recent NHS reforms, hospitals are responsible for providing efficient and effective health services to meet the needs identified by Health Authorities. In this context, and against the background of the imperative to minimise doses of ionising radiation in diagnostic radiology, provider units will decide whether they will make MRI available. Conversely, health authorities as purchasers of health care will decide how best to use their resources in order to meet the needs of their population. If purchasers are not willing to purchase myelography, it is open to hospitals to provide MRI as an alternative.
It is a sad fact that people have been seriously affected by arachnoiditis—the exact causes of which may be uncertain in individual cases. There is no known cure for 930 arachnoiditis, which can result in severe pain, and adequate pain relief should be an important part of treatment. Services specifically for the relief of pain are available in a number of hospitals.
To summarise, any invasive procedure in the spine carries a risk of causing arachnoiditis. Myelography is one such procedure, but an alternative—MRI—is becoming increasingly available. MRI can replace many invasive diagnostic procedures, including myelography, with the added advantage of avoiding ionising radiation. CT scanners were introduced about a decade before MRI and are now readily accessible; I hope that MRI will become similarly more accessible in the future.
I conclude by congratulating my hon. Friend on highlighting the problem and making more people familiar with the word. I take his point that warnings must be issued and that patients must be made aware of the degree of risk, which is uncertain but which exists.
When I started replying to letters on the subject, as a sufferer of back pain myself—although not of severe back pain—I realised how enormously distressing is the condition. It can dominate and even ruin people's lives. I hope that the programme of acquiring MRI scanners will accelerate and that—as my hon. Friend said—hospitals will take advantage of new flexibility in the way that they finance such acquisitions. I hope that the growth in the number of MRI scanners will help more people in future. Once again, I thank my hon. Friend for bringing the matter to the attention of the House.
§ Question put and agreed to.
§ Adjourned accordingly at twenty-seven minutes past Ten o'clock.