HC Deb 25 March 1998 vol 309 cc456-63 12.28 pm
Mr. Tim Collins (Westmorland and Lonsdale)

Last September, I visited a constituent of mine, Mrs. Spence, who lives in Kendal at the heart of my constituency, at her request. When I saw her, I found a lady in constant pain and completely bed-ridden, apart from access occasionally to a wheelchair, whose life had been ruined by the pain she suffers 24 hours a day. That was not always the case. In her younger years, she was a tennis player and ballroom dancer, and even marched on trade union marches when she lived in London. Today, her entire life has been ruined by the condition that is known as adhesive arachnoiditis.

In describing the condition to me, Mrs. Spence said, "It is like having a hot poker placed in your spine and spreading all over your body. It is like having a group of worms in your legs and feeling that they are wriggling around inside." She constantly feels that she has to punch her legs to try to stop the pain.

Mrs. Spence's husband, Brian, who has been a support to her throughout her life, sits up night after night looking after her, trying to control her pain and to help her. She is on constant medication. That includes a course of morphine tablets, but she has also been given liquid morphine; she often has to take it in liquid form when the pain breaks through the barrier of the tablets. She cannot put her feet on the floor without experiencing extreme discomfort. In 1980, she was told that, unless she used a wheelchair, she would be unlikely ever to leave her home again.

All that appears to stem from two occasions—one in 1971 and the other in 1973—when Mrs. Spence was injected in her spine with a chemical called Myodil. It is worth pausing to reflect on the purpose of the chemical. It is a radiopaque dye that is used when people have X-rays of their spines to enable all the substances within the spinal column to be shown more clearly on the X-ray. When she was given the chemical, she was placed on a table, injected and upended so that it sloshed up and down her spinal column. It appears that the chemical is a very sticky substance, and it bound together many of the nerve endings in the back of her spine. The consequence is constant discomfort and agony.

Mrs. Spence is not alone. I am grateful to my hon. Friend the Member for Tunbridge Wells (Mr. Norman) for drawing to my attention the case of his constituent, Mr. Peter Crawford, who is also confined to a wheelchair and suffers continuous pain requiring 24-hour care. My hon. Friend the Member for Faversham and Mid-Kent (Mr. Rowe) has told me of similar instances in his constituency. I believe that right hon. and hon. Members on both sides of the House have constituents who suffer from the condition.

In September, the Minister of State, Department of Health, Baroness Jay, wrote a letter to my hon. Friend the Member for Hertsmere (Mr. Clappison) in which she described adhesive arachnoiditis as "a rather uncommon … condition". To some extent, I wish that that was true, but none of us knows.

I tabled a parliamentary question, which received an answer from the Under-Secretary of State for Health. I asked how many cases of adhesive arachnoiditis have been diagnosed in the last 20 years". The reply was: The information requested is not available"—[Official Report, 12 January 1998; Vol. 304, c. 152.] That was largely because adhesive arachnoiditis is not a notifiable disease. It is not infectious, and statistics are not kept, so, sadly, none of us knows how extensive the condition is. However, there are some world experts in the sector.

One in particular is Dr. Charles Burton, the senior medical director of the department of neuroaugmentive surgery in Minnesota, a department which he founded. He is a distinguished person. Among other things, he served as a panel chairman of the United States Food and Drug Administration and was a founder of the North American Spine Society. He is probably the world's leading expert on this condition.

Recently, Dr. Burton wrote a paper, in which he says: Despite the availability of a wealth of published scientific information on the subject, it has not been well appreciated by the medical profession that the advanced forms of arachnoiditis may be associated with incapacitating pain, disability, or even death. In addition, the global incidence of severe arachnoiditis has only recently become more evident owing to the formation of patient self-help groups in the United States, England, and Australia. These organizations have shown that arachnoiditis represents a worldwide public health problem of considerable magnitude. He has said that the condition is as bad as terminal cancer without the prospect of death to end the suffering. The difficulty is that there is a history to that use of the chemical and its side effects. I have an article that appeared in January 1954 in The Journal of Bone and Joint Surgery, which was the official publication of the American Orthopaedic Association and the British Orthopaedic Association, and was printed both in Boston and London. The article is entitled "Arachnoiditis following the use of iodized oil." It starts: It is the purpose of this paper to present clinical and experimental data which suggested to us that pantopaque"— the material that I am talking about— and other iodized materials may contribute to severe and disabling arachnoiditis. An article in The Lancet as long ago as 1956 indicated similar problems relating to the chemical.

It is worth noting also that Dr. Burton points out in his paper: In Sweden and a number of other countries throughout the world (including the former Soviet Union) … on the basis of animal studies or clinical observation", these substances were removed from clinical practice … as early as 1948", yet in this country Myodil was used as standard practice for many decades: from the 1940s to the 1980s. Indeed, Myodil was never refused a product licence of right under the Medicines Act 1968. It was always granted those licences every five years until the late 1980s, when its manufacturer, Glaxo Wellcome, decided for its own reasons to withdraw the product from use.

The difficulty is that Myodil is an extremely unpleasant substance. Glaxo Wellcome issued guidance on its use about 20 years ago, which said that it should not be injected with anything other than a glass syringe because it would melt the rubber or plastic of any other type of syringe. There is evidence of the chemical being spilled on to a laboratory floor and melting the tiles, yet, in this country, the chemical was regularly injected into the spinal column of people as a normal and accepted part of medical practice. That was against a pattern of well-known scientific research throughout the world showing that there were problems with it.

I am delighted to note that, last month, Baroness Jay, who I believe is responsible for these matters in another place, wrote to Mrs. Ursula Coxhead of the Myodil Action Group: The Department of Health does recognise the association between the use of Myodil in myelography and the development of arachnoiditis in some patients. That is a very important statement, because it has taken a long time for the Government—whether Conservative or Labour—to accept any link between the two. She adds: Warnings about the possibility of post-myelography arachnoiditis were included in the product information for Myodil many years ago. That may be true, but those warnings consisted largely of exhortations to medical practitioners to remove the chemical immediately after it had been injected. In many cases—certainly in that of Mrs. Spence—that was not done, but, even where the chemical was removed in some cases, the evidence is that it was not possible to remove it all and that it did sustained and long-term damage.

That is why I and many sufferers of the condition have called for an inquiry. It is clear that there is prima facie evidence of, at best, something dramatically wrong and, at worst, serious and consistent malpractice. It is also clear that there is a division in medical opinion, which the Minister may mention in her reply. I accept that there is not yet a medical consensus on the causes of the condition or its linkage with Myodil, although it is strongly felt by some leading global experts, and the evidence appears to be accumulating.

I was disappointed when the Minister replied to my written question of 5 November last year: We have no plans to institute an inquiry into this issue."—[Official Report, 12 November 1997; Vol. 300, c. 596] I hope that she will reconsider. I pay tribute to a Newcastle newspaper that does not cover much of my constituency, but is significant in the north—The Journal—which has been running a sustained campaign on the issue. Let me quote briefly from an editorial last month which sets out the case very clearly. It states: This is not a small claim for a minor injury. Myodil has ruined lives. It is a case which must come to court, not only to fix compensation for sufferers, but also to throw some light on what happened when Myodil was being used. This will have to emerge in the courtroom because of the Government's steadfast refusal to hold an inquiry into the circumstances surrounding the drug's use. This obstructive attitude is unforgivable. Those people enduring the daily agony from the Myodil treatment at least deserve to feel that lessons might be learned from what went wrong. Such an inquiry might also result in information about the extent of the problem. Health ministers admit they have no idea how many people are suffering from the problem they refuse to investigate. Let me stress that it is not a partisan issue and that the current Government are taking exactly the same stance as their predecessors. In that respect, they are no worse—or better—than the previous Government. However, some of those concerned about the issue find it sad that, in opposition, the Government took a rather different view. In a press release issued in February 1993, under the heading "Blunkett calls for emergency action on arachnoiditis" the shadow Health Secretary, now the Secretary of State for Education and Employment, referred to needless tragedy" and the damage caused to innocent people's health and the need for a clear statement of precisely what action has been taken". He called for specific steps, including: No-fault compensation should be paid … A full enquiry should be established … All invasive procedures carried out in the course of spinal treatment should be immediately replaced with safer practices such as Magnetic Resonance Imaging. That is what the then shadow Health Secretary, now a member of the Cabinet, called for in opposition. That is what those suffering from the condition seek from the Government today.

We are considering a chilling chain of incidents. There is scientific evidence, published as long ago as the 1950s, that the chemical has devastating side effects. There is also evidence of concealment within the medical profession. My constituent tells me that in 1994 she obtained medical notes dating as far back as 1973 which demonstrated that two separate doctors and a neurosurgeon diagnosed her as suffering from adhesive arachnoiditis, but she was not told until she obtained those notes that she was suffering from anything other than a variation of arthritis of the spine.

There is evidence that Myodil was a nasty chemical and that a very large and wealthy company has taken a hostile attitude. It takes the view that, as anybody needing a myelography had a back problem, all subsequent problems must have stemmed from that. There is also evidence that, sadly, successive Governments followed the advice of their officials that it would be too difficult to have an inquiry and get to the root of the problem.

I am sure that the Minister will have looked into the matter and that she has in front of her an elegant speech drafted by her hard-working officials—no doubt the same officials who advised previous Governments. After she has read her speech, I ask her not to dismiss the issue from her mind, but to search her heart and consider whether the impulse for justice that brought her and hon. Members representing all parties to the House, and which is the purpose and function of this place, would be best served by having an open, full and public inquiry to establish the medical facts, who knew what when and where blame lies and to address the issue of compensation for people whose lives have been blighted beyond belief. They will never recover, but they may be able to have a little more comfort in their dying years if they receive some compensation.

12.44 pm
The Minister for Public Health (Ms Tessa Jowell)

I begin by congratulating the hon. Member for Westmorland and Lonsdale (Mr. Collins) on introducing the debate, on the elegance and eloquence of his speech, and on the care with which he is representing his constituent's interest in the matter.

Let me also make it clear to the House that my brother holds a senior position on the board of Glaxo Wellcome. In the context of my ministerial duties, I do not participate in discussions concerning the pharmaceutical industry. I raised the question of my having any conflict of interest in replying to today's debate with the permanent secretary, who feels there is no conflict of interest, and I have written to the hon. Gentleman accordingly.

The hon. Gentleman is absolutely right to say that arachnoiditis is not a party issue. Members on both sides of the House have constituents who are raising precisely the same concerns as he has raised today on behalf of Mrs. Spence. Many such people afflicted with awful and chronic illness turn their own adversity to the advantage of others by highlighting through their circumstances the broader lessons to be learned. We pay tribute to their efforts.

I assure the hon. Gentleman that I have listened very carefully to the points that he has raised. Let me begin by putting the issue of the treatment of people who suffer from arachnoiditis into its broader context by setting out the Government's proposals for developing, strengthening and rebuilding our national health service that were clearly set out in the White Paper "The new national health service—modern and dependable" which made clear our concern to develop proper support and services for people who suffer long-term, life-limiting conditions and disabilities such as arachnoiditis.

Many people suffer from conditions that will never be completely cured. Therefore, it is important for the health service to ensure that they are properly supported. We shall focus on recuperation and rehabilitation, recognising that the management of chronic pain and other palliative care is an important part of enabling people with such conditions to live as independently and actively as possible. The Government will expect co-operation, not competition, in the planning and delivery of health and social care at local level.

As the hon. Gentleman made clear, co-operation will be crucial in providing the right support for people suffering from conditions such as arachnoiditis. I hope that he accepts that all the action that the Government are taking following the publication of the White Paper and the public health Green Paper make clear our determination to rebuild public confidence in the national health service as a public service accountable to patients, open to the public and shaped by their views and experiences.

It may help if I briefly summarise the issues that the disease raises for the Government. The hon. Gentleman has made very clear the extent to which arachnoiditis is an uncommon and distressing condition, characterised by chronic inflammation and thickening of the arachnoid membrane. That membrane apparently looks like a spider's web—hence its name. It covers and protects the brain and the spinal cord.

It is particularly distressing that arachnoiditis may be a subsequent complication of an earlier injury. It is a progressive condition, for which there is no known cure. It traps nerves as they leave the spinal cord, and at the lower end of the spinal canal; it may cause a great deal of low back, neck and leg pain—and in some cases, this becomes a neurological disability.

The sad fact is that a mercifully small number of people are seriously affected by arachnoiditis. We know, as the hon. Gentleman stressed in the case of Mrs. Spence—other hon. Members will testify to the experience of other constituents—that the pain from this condition can cause misery for the individual concerned and for his or her family.

The White Paper sets out our approach to service development in the context of evidence-based service frameworks which will focus much more strongly on the quality of care. That was often neglected by the previous Administration under the internal market. The election of a Labour Government, with our commitment to rebuilding a national health service, marks an important move away from focusing solely on quantity of treatment and towards a much greater preoccupation at every stage with the quality of treatment. Pain management is developing across the country and is supported by an increasing commitment by the professions to evidence-based pain services. Quality is absolutely integral to the effectiveness of those services. I hope that that will be good news for patients.

The National Institute for Clinical Excellence will actively contribute to the development of services across the NHS by co-ordinating programmes to improve clinical standards, by issuing guidance on the clinical and cost-effectiveness of clinical practice, and by supporting clinical audit development work, making sure that quality is measured at every stage of the process.

Effective pain relief, a key component of high-quality care for people with arachnoiditis, will be one of the topics that may in due course form part of the national institute's work. Attention has recently focused on the Audit Commission's report "Anaesthesia Under Examination", which highlighted the need for commissioners and trusts to obtain better data about clinical activity and service standards, so that resources can be matched more closely to need. The Audit Commission has made a number of extremely sensible recommendations for improving the efficiency of pain clinics—recommendations which I am sure managers and professionals throughout the NHS will take on board, because they are evidently of benefit to patients.

As I said, arachnoiditis is caused by injury to the arachnoid membrane. That may result from many causes, such as infection, haemorrhage, trauma, surgery, and the diagnostic procedure known as myelography. Patients with arachnoiditis may have more than one predisposing cause.

Myelography, the cause with which the hon. Gentleman is particularly concerned, is an X-ray of the spinal cord cavity involving a lumbar puncture to inject the contrast agent or dye used into the subarachnoid space. The contrast agent or dye may then be visualised by X-ray. Myelography is used to diagnose serious conditions such as spinal cancer or a prolapsed disc. It is not a procedure used on patients who are otherwise fit and healthy. As with many difficult clinical decisions, the risks of not being able to diagnose what may be a life-threatening illness have to be set against the risks involved in the procedure itself. It is never a clinical decision to be undertaken lightly; it is undertaken only after careful consideration of all the factors involved.

As the hon. Gentleman will be well aware, no clinical intervention is completely free of risk. That is why we look to doctors to use their knowledge, skill and experience to weigh carefully the likely benefits of any procedure, such as an X-ray investigation, against the anticipated risks for the patient. It is also why we support doctors' efforts to maintain those skills. There should also be discussion with patients so that they are aware of any risks that may accompany the treatment.

Mr. Collins

Of course the Minister is right to say that we must place our trust in the medical profession; equally, that profession is subject to public accountability. Will she deal with the case for a public inquiry, which her party supported when in opposition? Now that it is in government, does her party still support the idea?

Ms Jowell

I shall be coming to the case that the hon. Gentleman made for a public inquiry.

In the past, Myodil was linked to the development of post-myelography arachnoiditis in some patients, especially when there were technical difficulties in carrying out the X-ray procedure. Myodil was withdrawn by Glaxo from the market in late 1987 for commercial reasons. Arachnoiditis was a known, if rare, side-effect of Myodil, and the appropriate warnings were given in the product information, with the advice to remove as much of it as possible after the X-ray procedure. The number of patients who suffered from that complication is unfortunately not known.

Myodil is an old product which was available before licensing procedures were in place in the UK. Following the thalidomide tragedy, the Medicines Act 1968 was introduced, and implemented in 1971. Products already available on the market were given a product licence of right and were systematically reviewed by the Committee on Safety of Medicines for safety, quality and efficacy. Myodil was reviewed under those procedures, and a reviewed licence was given early in 1987. It was therefore handled under the normal procedures for the licensing of medicines.

Things have moved on; patients today are much more involved in discussions and subsequent decisions about their care. Like any medicinal products, the contrast dyes used in myelograms come with product information supplied by the manufacturer. All medicinal products are subject to stringent assessment of safety, quality and efficacy before being licensed, and are closely monitored after licensing to detect any previously unrecognised adverse effects or any change in the balance of risks and benefits. This post-marketing assessment of drug safety is known as pharmacovigilance.

Things have also moved on in the area of diagnoses. Today, many patients who require diagnostic procedures of this nature have to undergo a non-invasive magnetic resonance imaging scan instead of myelography. But not all patients are suitable for MRI scanning, so myelography is still an important procedure. For such patients, newer, water-soluble dyes are available and are less likely to be associated with arachnoiditis.

On the hon. Gentleman's call for an inquiry, I reiterate the parliamentary answer that I supplied some months ago: we have no plans to hold an inquiry, and I hope that he understands that it would not be proper for me to comment on matters that may yet become the subject of legal proceedings. I have, however, asked officials to set up a meeting with the Myodil Action Group. Baroness Jay, who has ministerial responsibility for this matter, has agreed to chair the meeting.

I hope that, having raised this issue in the context of concern for his constituents, the hon. Gentleman accepts the responses that I have given to his questions.