HC Deb 21 November 1995 vol 267 cc562-70

Motion made, and Question proposed, That this House do now adjourn.—[Mr. Bates.]

10.18 pm
Ms Janet Anderson (Rossendale and Darwen)

I am grateful for the opportunity this evening to highlight the plight of a number of women who have suffered the most severe injuries resulting from radiation treatment for cervical cancer. Approximately one year ago, I was invited to meet a group of women in the Manchester area who had, during a period from the late 1970s to the early 1980s, received radiation treatment for cervical cancer at the Christie hospital in Manchester.

In the normal course of events, the women would have been treated with the well-tried and trusted Manchester pack. However, they were told that they were to receive a new and different treatment which would cure their cervical cancer. The treatment was by way of a machine called a selection. It is important to point out the difference between the two treatments.

The Manchester pack can best be described as a matchbox which surrounded the tumour and emitted radiation concentrated at the tumour. The treatment spanned three days, and had been successfully tried and tested.

For women who were exposed to the selectron method, things were rather different. They were told that they were to be given a treatment which would cure their cervical cancer. This involved them being placed in a darkened room connected to a selectron machine and left there for 24 hours. We now know that, during the course of the treatment, the women received a radiation dose during 24 hours which would have previously been administered over three days with the Manchester pack. The women involved insist that at no time were they informed that they were part of an experimental treatment.

The injuries that the women incurred as a consequence of the intense radiation therapy are simply horrendous. They have suffered bowel and bladder damage and damage to their internal organs, which has made their lives intolerable. Many have had to be subjected to ostomies of almost every kind. Some injuries have been so traumatic that patients have threatened suicide, family relationships have been shattered, and children have had to be fostered while their mothers were in hospital for long periods.

The women I met were no longer able to enjoy sexual relations or to bear children. Their skins had taken on almost a translucent appearance, and they were obviously very ill. Many suffer constant pain from their injuries. I should like to refer to one of the women in particular, whose case will help to illustrate the extent of the injuries that the women suffered.

In 1987, at the age of 26, Mrs. Vicky Parker was diagnosed as having an advanced stage of cervical cancer. The best treatment was radiotherapy. But when Vicky went into Manchester's Christie hospital, she had no idea what was about to happen to her. It was to be years before she learned the truth. Her radiotherapist had informed her that she was to be treated by a selectron. Vicky said: I asked him literally hundreds of questions. At the time I had no idea that this was a new experimental treatment and that I was to be used as a guinea pig. I was told that the only side effects would be sickness and diarrhoea. According to Vicky Parker, the selectron was a complete nightmare. She said: In advertisements you see a woman apparently being treated. She is eating and looks completely at ease. The truth was a different picture altogether. Vicky spent the next 24 hours—the worst of her life—in a sealed room flat on her back with three tubes packed inside her. The selectron machine attached to the tubes fired caesium ball bearings at the tumour. Such was the strength of the radiation that, if a nurse entered the room, the pellets were automatically sucked out and the whole process stopped. For 24 hours, Vicky was unable to eat or sleep. After that, she underwent five weeks of conventional external radiotherapy.

In January 1988, the treatment stopped. Over the next few weeks, Vicky learned that the cancer had gone. She went on a long holiday with her family, and returned to work in a new job. It was a time of real celebration. She had fought cancer and won. But her celebrations were short-lived.

In September, Vicky started having pains in her bowels, and had to go back to hospital. Referred to a bowel specialist, she listened with horror as he explained that her bowel had been damaged by radiotherapy. There was no time to delay, and the endless round of bowel and bladder operations had begun. Vicky Parker never went back to work. She has been in hospital 100 times. She has had 25 operations—a colostomy, operations to repair, operations to deal with complications. She has had a thrombosis and a urostomy. She is constantly on morphine to cope with the pain.

In such circumstances, it is easy to believe that one is alone in one's experience, but in 1989, when Vicky was in and out of hospital, she met another woman on the surgical ward who was in and out of hospital for similar operations. This woman had also been treated on the selectron. It transpired, as revealed by a BBC Radio 4 "File on Four" programme in 1991, that hundreds of patients had been damaged by the experimental selectron treatment. It was shortly after that that Vicky and others founded the action group RAGE—Radiotherapy Action Group Exposure—to which I have the honour to be a parliamentary adviser.

It is hard to believe that in this country, and in this day and age, cancer patients were completely unaware that they were part of a clinical trial in which they had absolutely no say. Vicky, like all the other victims, was merely told that she would suffer some sickness and diarrhoea. Despite her in-depth questioning, she, like all the others, was not told that she was to be subjected to a most horrible experiment. In her own words, she feels that she has been "medically violated".

In October 1991, 20 RAGE victims started individual legal actions against the Christie hospital. The cases are so complicated, dealing not only with legal aspects but medical rules and ethical questions, that they are still going on. However, nothing could ever compensate the victims and their families for what has happened.

One victim, Kath Dillon, tragically died from her injuries in 1992. It was 12 months before an inquest could take place. The coroner said that internal problems that had led to her death had been caused by the treatment.

RAGE now has 3,000 members. Not all its members have had injuries through a pelvic or abdominal cancer: some have been victims of radiotherapy for breast cancer, and they have their own group, RAGE Breast. It is now apparent that it is not only women who have been abused in this way. RAGE now has a small number of men among its members who have radiotherapy injuries from treatment for prostate, bladder, testes and colon cancers.

The women are now seeking an independent investigation into radiotherapy damage and compensation. The Government have decided to audit injuries on two breast cancer cases. Surely the Minister must now agree to a simultaneous audit for all radiotherapy injuries.

Mr. Andrew Miller (Ellesmere Port and Neston)

As my hon. Friend knows, I have had a lot to do with the same group. As one of the few people in the House who has worked with radiation, albeit not in a medical sense, I claim some knowledge of the risks faced by the women in question. Does my hon. Friend agree that the issue of consent, a form for which appears to have been introduced by the Christie hospital only in 1991, is critical? Many of the women were clearly experimental guinea pigs prior to that time. It was only after the damage had been identified that people were asked to sign that form.

Ms Anderson

As ever, my hon. Friend has gone right to nub of problem. He is quite right. The whole case turns around whether the women knew they were part of an experiment. As he pointed out, the Christie did not introduce the consent form until 1991. The women that I am talking about received treatment in the late 1970s and early 1980s. I thank my hon. Friend for that well-timed intervention.

Surely the Minister must agree to a simultaneous audit for all radiotherapy injuries, and most particularly those sustained during the period of experimental treatment for cervical cancer on the selectron machine.

Finally, will the Minister tonight give us an assurance that he will agree to that, and that he will now take steps to set up a national register of victims? There are hundreds of women such as Vicky Parker and her colleagues who deserve to have their voices heard and their condition recognised. It is the responsibility of the Government to assess the scale of the problem, to give recognition to those women, and to make sure that nothing like this ever happens again.

10.28 pm
The Parliamentary Under-Secretary of State for Health (Mr. Tom Sackville)

I am grateful to the hon. Member for Rossendale and Darwen (Ms Anderson) for bringing this matter to the attention of the House. I start by expressing my deepest sympathy for the women who have suffered severe adverse effects as a result of radiotherapy treatment for cervical cancer, many of whom were treated using the selectron, as the hon. Lady said, at the Christie hospital in Manchester in the 1980s.

Let me first say something about the selectron treatment. Internal radiotherapy has been available for decades. The difference with the selectron is that, in old-style therapy, the radiation sources were inserted manually. The selectron is a way of inserting the source and removing it automatically by remote control. Such a system has the advantage of reducing staff exposure to radiation, because the radioactive sources could be withdrawn along pipes into a lead-lined safe at the foot of the bed.

In 1978, the low dose rate selectron system devised by the Christie hospital was introduced. It is now in use at other United Kingdom centres, including Edinburgh, Glasgow, Leeds, Liverpool and the Marsden.

In its early days, the correct dose on the selectron had to be calculated because stronger sources were used than in the former manual—that is, non-retractable—treatment system. It must be remembered that, although it was a higher dose of radiation than before, it was still a relatively low dose.

The treatment of women using the selectron during the 1980s was part of a randomised, controlled trial, designed to try to establish the optimum dose for patients with an early stage cancer. As I said, the selectron is still used in the treatment of cervical cancer, and the system developed at Manchester is used worldwide.

Mr. Miller

Can the Minister advise the House how the calculations were undertaken in those early clinical trials and what the dose rates were? Furthermore, does he agree that it is unacceptable that the letter from the Christie to my hon. Friend dated 26 July stated that those patients had experienced difficulties and distress? It is far more than that. Those women have had their lives destroyed; the Christie ought to admit it, and so should the Department of Health.

Mr. Sackville

The hon. Gentleman will perhaps not be surprised to learn that I do not have the information on his first, technical question. I will try to supply him with it in writing. On his second question, that was a highly regrettable series of events. As I said, we all have the deepest sympathy. Later, I will explain how I very much hope that ways will be found to avoid that situation recurring.

The selectron is still in use, and we now have the benefit of experience of doses that have been found to have acceptable levels of adverse effect. I am aware that the women who received significant adverse effects, which they believed were caused by their treatment with the selectron, are taking legal action against the Christie hospital, on the grounds that they were given insufficient information as to the nature of the treatment.

It is now clear Government policy that all patients have a right to consent to or reject treatment, and are entitled to a clear explanation of any treatment proposed, including any risks and alternatives. All treatments carry some level of risk, and patients must be allowed to decide whether they wish to continue with the treatment proposed. That is a principle that has been highlighted in the patients charter.

Some of those suing the Christie are part of a support group, RAGE National, which, with its sister group RAGE Breast, is pressing central Government for recognition and compensation for radiotherapy-related injuries. Representatives from RAGE met my noble Friend Lady Cumberlege and the chief medical officer last year to discuss its members' concerns. Following that meeting, and at the Department's behest, the Royal College of Radiologists agreed to undertake a confidential clinical review of 126 RAGE Breast members to discover what—

Ms Janet Anderson

I think that the Minister just said that Baroness Cumberlege had met RAGE National members. With respect, I think that he is confusing two groups. I do not think that it is the case that RAGE National members—the women concerned with cervical cancer—have ever succeeded in obtaining a meeting with a Minister.

Mr. Sackville

That is my information. Clearly, if it proves to be wrong, I will seek to correct it.

At the Department's behest, the Royal College of Radiologists has agreed to undertake a confidential review to discover what common factors in treatment may have led to those women suffering adverse effects. I know that members of RAGE National, which includes about 700 people in the United Kingdom who have suffered such effects, is pressing for a similar clinical review.

The review of breast cancer cases was commissioned because they are a relatively homogeneous group. Common factors are more likely to emerge than from a heterogeneous group, such as RAGE National members, who have had different cancers and undergone dissimilar radiotherapy techniques. The results of the breast review will be available soon. Once we have those results, we can then look to see whether, in the light of what has been learnt, further investigations would be appropriate.

I fully realise, of course, that many of the women who are still suffering side effects following treatment in the 1980s would wish to have their injuries recognised and consideration to be given to their claims for compensation commensurate with the degree of injury, but it is important to be clear about the way in which such claims are pursued.

First and foremost, we maintain the belief that it is right that people harmed in the course of clinical treatment should be able to seek compensation through the legal process, but that requires them to demonstrate not only that they have been harmed, but that there has been negligence and that the negligence caused the harm. Where negligence cannot be shown, however, there is no case in law for them to be compensated. From time to time, it has been suggested that that is not right, and calls have been made for the introduction of a "no fault" compensation scheme.

Hon. Members will recall that this issue has been considered in the House before, most recently in the Second Reading debate on the National Health Service (Compensation) Bill, on 1 February 1991. On that occasion, as on every other when the issue has been raised, the House concurred with the Government's view that no-fault compensation would not be helpful. I shall briefly remind hon. Members of the main reasons.

We are aware of some victims of clinical negligence who oppose no-fault compensation on the grounds that it would make it less likely that plaintiffs' non-financial concerns would be addressed. Many plaintiffs argue that their motivation for pursuing a claim is not to secure money but to obtain an explanation and an apology, and to ensure that what happened to them does not subsequently happen to others. Thus, a system designed to address financial aspects of medical accidents quickly, without regard to fault, could deflect attention from plaintiffs' most important concerns.

Another closely related issue is accountability. Our legal system holds all individuals accountable for their actions and, arguably, has a deterrent effect on malpractice. No-fault compensation could remove an incentiveto good practice, and make some health care professionals less careful.

The Government must be mindful of the potential cost implications of any no-fault compensation scheme. Costs falling on the NHS could increase substantially. For example, a scheme in New Zealand that covers accidents generally is thought to cost about 1.5 per cent. of its entire gross national product.

It has anyway yet to be shown why compensation in health care should be regarded as essentially different from negligence and compensation in other walks of life, where claims are resolved through the legal process.

Finally, there is, I believe, a fundamental misconception in the minds of many that no-fault compensation would obviate the need for legal action. Experience in the current system shows that it can be just as difficult to establish that medical treatment had caused injury as it would be to prove that someone had been negligent. Under any system of no-fault compensation, causation would still have to be shown. The level of quantum would also have to be established. Legal action would not necessarily be avoided. The process could still be very lengthy.

Mr. Miller

It is important that the Minister should cover the issue of no-fault compensation; I raised it with him in a meeting last year. The issue is surely that the hospital trust and the Department have acknowledged that, as a result of these clinical trials, some women suffered damage. The degree to which that happened in each individual case is quite varied. Some of the cases are extremely serious, as I and my hon. Friend the Member for Rossendale and Darwen have described.

If we simply leave it to the legal system to deal with the matter, it will be dealt with on a case-by-case basis— because, as the Minister pointed out, the cancers involved are very varied—and we shall not be able to deal with the overall problem. Would it not be more sensible for the Department to instruct the trusts to release all the information, not just for the legal process but—more important—in the interests of research, to prevent this from happening again?

Mr. Sackville

I shall come to the hon. Gentleman's last point later. As for the release of information, he must bear in mind the fact that legal action is pending, and the trust has a right to coduct the case as it sees fit.

I have spoken at some length about the reasons why we believe that no-fault compensation is inappropriate. The Government have concluded that where—sadly—clinical accidents have occurred, our most appropriate action is to seek to improve claims management practice within the current system, defending claims that should be defended but not causing expensive delays when claims should be settled.

In his response to the National Health Service (Compensation) Bill, the then Secretary of State for Health undertook to consider arbitration as a possible alternative to the courts for the resolution of clinical negligence claims; the Department of Health subsequently consulted widely on a possible arbitration scheme for the NHS, but the outcome was inconclusive.

Rather than dismiss the idea out of hand, however, it was decided to put it to the newly formed clinical negligence working group. That joint departmental and NHS group was set up to consider how best to help NHS trusts to manage their exposure to clinical negligence claims, which are the main cause of litigation. The group considered the proposals put to it very carefully, but its firm advice was that arbitration did not represent a significant improvement on litigation, and should not be pursued.

The group reached that conclusion for a number of reasons. It was convinced that arbitration would not appeal to plaintiffs; in particular, they were thought unlikely to commit themselves in advance to be bound by the outcome, which is a requirement of arbitration. In complex cases—and clinical negligence cases often are complex—arbitration would not necessarily be cheaper than the courts. A paper-based arbitration system, such as that put before the group, would require a better quality of written information than is often available.

The group did feel, however, that mediation offered constructive possibilities for the resolution of clinical-negligence claims, which should be explored further. That advice was put to my ministerial colleagues in the Department, and was accepted. Since then, work has focused on mediation, and I am pleased to say that a good deal of progress has been made. Pilot schemes using mediation for that purpose have been set up in two English regions—Northern and Yorkshire and Anglia and Oxford.

We believe that mediation offers a genuine alternative way of settling claims, in which the parties to the dispute come together to agree a solution. It is non-binding, but in suitable cases it is thought likely to be a humane and cost-effective way of enabling all aspects of a case to be resolved to everyone's satisfaction. Savings may be hoped for in legal costs.

Where agreement is reached, compensation will be arranged in the same way as in any other out-of-court settlement. If, in some cases, full agreement cannot be reached, mediation offers a possibility of narrowing the issues for subsequent consideration. Of course, we do not expect mediation to be a panacea, but we hope that it may prove helpful in suitable cases.

The pilot mediation schemes began operating in April, and the first mediation, which took place in September, was considered very successful by all the parties concerned. However, it will be some time before we are able to draw any firm conclusions from the schemes. When the outcome has been properly evaluated, we will decide whether mediation should be extended to the NHS as a whole.

I make it clear that we see it as a priority to minimise the risk of any adverse effects from radiotherapy, although it is recognised that most treatments have some element of inherent risk. That is why we have issued guidance to health authorities on quality assurance in radiotherapy. We want to ensure that all radiotherapy units have in place the necessary systems to ensure a quality service.

Last year, I launched a new document called "Quality Assurance in Radiotherapy" which has been disseminated throughout the national health service. In offering deepest sympathy to those who have suffered any accident as a result of this or any other cause in the course of medical treatment, it is appropriate to give a firm commitment on behalf of the NHS.

Ms Janet Anderson

I look forward to hearing that commitment. I think the Minister said that mediation is to be extended to all NHS patients. Will he confirm that, in the event of that happening, all the women who have been treated on the selectron machine and received radiotherapy injuries as a result, will also be covered?

Mr. Sackville

I said that two trials are in progress, and that we are committed to two schemes in two regions. I also said that not all accidents will be amenable to mediation. It is a question of the parties concerned finding that that is a suitable way forward which may bring a solution. Obviously, good will is needed on both sides. Although it is non-binding, it is a way to find a solution. I have said that we do not intend that trusts or any other part of the NHS should gratuitously resist claims. They should settle those that ought to be settled. All that is imprecise, because cases differ.

Before the hon. Member for Rossendale and Darwen intervened, I said that, in any discussion of a case of this sort, it is right to give a commitment on behalf of the NHS. It is that we shall constantly seek to raise the standards of quality and safety of all treatment on offer. We shall do everything in our power to ensure that events such as the tragic events that have been described never happen again.

Question put and agreed to.

Adjourned accordingly at thirteen minutes to Eleven o 'clock.