§ Mr. Jeremy Corbyn (Islington, North)I am pleased to raise a subject that many Members are keen to debate—I took part in a similar debate earlier this year. An early-day motion tabled by a Liberal Democrat Member, which has all-party support, seeks compensation for women who suffer the terrible effects of radiotherapy damage and the permanent pain and injury that accompanies it.
On 15 February this year, a debate on breast cancer services was initiated by my hon. Friend the Member for Edinburgh, Leith (Mr. Chisholm). He informed the House about a petition of more than 200,000 signatures from Scotland alone about the need for better treatment. That debate referred to the work of the all-party group on breast cancer, which demonstrates that, unfortunately, one in 12 women in Britain are likely to suffer breast cancer and only 40 per cent. will be able to see a specialist oncologist.
Although today's debate deals with compensation, the wider issue of accessibility to quality diagnosis and treatment of breast cancer is particularly important. I quote from the reply to the debate on 15 February by the Under-Secretary of State for Health, the hon. Member for Bolton, West (Mr. Sackville), who, in reply to the hon. Member for Colchester, North (Mr. Jenkin), mentioned the
damage unwittingly done through the use of excessive radiation on treatment. I assure him that there are initiatives to minimise the risk of any further slip in quality assurance and plans are in hand to ensure that all radiation units are subject to the strictest guidelines so that the unnecessary and disastrous damage to which he referred cannot occur in future.Later in his speech, he said:It is well known that too many cancer sufferers, especially women with breast cancer, are not diagnosed swiftly enough. They are not seen sufficiently quickly by people with the appropriate level of expertise, which means that treatment can be delayed. Whatever the clinical effect of waiting for diagnosis and then waiting for treatment may be—it can be serious—the emotional effect is clearly considerable and we need to take action."—[Official Report, 15 February 1995; Vol. 254, c. 953–54.]I assure the House that we shall return to that issue in future.The figures relating to people suffering from breast cancer are truly horrendous: 25,000 cases per year are diagnosed and 15,000 die—or 300 deaths a week. Britain has one of the highest death rates in the world from breast cancer and one of the highest occurrences of that disease. The incidence rate is much lower in other countries. There many reasons for that and there is not sufficient time to discuss them today, but they need to be studied.
The treatment has been described as a lottery. I have been trying to raise this subject because of the serious problems faced by hundreds of women in Britain who suffer from permanent, progressive and disabling injuries after radiotherapy treatment for breast cancer.
The issue is not new. The Select Committee on Health examined it in detail in its report on breast cancer. I recommend that the Minister rereads the evidence taken on 30 March from Radiotherapy Action Group Exposure and the very thorough memo that RAGE drafted for the Select Committee on 15 January, setting out its aims and objectives and what it saw as the way forward.
634 Since its invention, the dangers of radiotherapy have been fully recorded and recognised, yet hundreds of women have been treated without informed consent or warning of its dangers. It is routinely prescribed, often without consultation and purely as a precautionary treatment. There is very little recognition in the medical profession of the true extent of the injuries caused by radiotherapy.
RAGE helped me a great deal in preparing the debate, and I pay the strongest possible tribute to that organisation for its work and for the hope that it has given many of its members and supporters round the country. It was formed in July 1991 and aims
To identify sufferers, collectively record their particular circumstances and draw attention widely to their injuries.It lists as its objectives:To seek independent inquiry. To seek remedial action, including compensation. To urge the upgrading of radiotherapy practice and seek national quality standards. To provide support.It is doing that extremely well.The work of RAGE took off as a result of the withdrawal at trial of Lady Ironside's High Court action for medical negligence. A handful of the victims met to discuss the situation and it immediately became apparent that there was a common pattern of injury among them. While RAGE cannot pretend to represent every woman who has ever had radiotherapy treatment or every sufferer from breast cancer, it certainly has a large membership and wide support, so it represents an authentic voice of people who are suffering because of such treatment.
There is something seriously and unaccountably wrong with the radiotherapy treatment techniques and procedures being applied in the United Kingdom. All the work of RAGE has been done by women in constant and dreadful nerve pain, whose personal and professional lives have been shattered. Some members of RAGE have had their limbs amputated and almost all have been left with only one usable arm. For the rest of their lives, in addition to being under the cloud of the possible recurrence of cancer, they will become progressively disabled.
I find it a humbling experience to talk to victims of breast cancer for whom, although their cancer has been treated, the permanent damage and injury and the constant pain means that they may never get a night's sleep or a day free from pain for the rest of their lives. As a man, I find their plight hard to contemplate. I am sure that many women will understand what I am saying and the requests that I am making today.
The Government should give urgent consideration to what is happening to those women and to giving them the compensation that they so desperately need and deserve. It is not just my view, but one shared by Professor Karol Sikora, professor of clinical oncology at Hammersmith hospital and a leading pioneer in the fight against breast cancer.
The members of RAGE have all contracted breast cancer and have experience of the treatment protocol and of receiving radiotherapy treatment of the brachialplexus at one of the 53 treatment centres in the United Kingdom, as it is invariably prescribed as a precautionary measure following surgery. While the women, as patients, were generally made aware of the temporary nature of the side effects such as sickness and nausea, they were not made aware of the risk of serious and permanent injury involving arm paralysis and other disabling consequential effects that have been identified.
635 The Department of Health should look seriously at the facilities that are made available to support people going through the treatment process. While consultants and doctors give medical advice and try to explain the possible effects, there is a need for women who are feeling desperately anxious and often isolated to receive that advice in a supportive environment. Unfortunately, that does not often happen. The debate earlier this year drew attention to the lack of specialist centres and the fact that many women are misdiagnosed because there is not sufficient expertise in all areas of the medical profession. The Minister conceded that point.
Some of the consequential effects are lymphoedema, lung burn leading to severe breathing difficulties, deadened bones—often leading to spontaneous fracture—heart damage, jaw bone pain, amputation of an arm as a last resort, skin burn and psoriasis. The onset of injury has occurred as long as 20 years after the treatment.
I hope that the Minister will listen to this carefully. It is important that the information collected by RAGE shows that there are clusters of cases at certain hospitals in certain years. In some hospitals, they coincided with a cost-cutting exercise to treat more women in the same time scale. Women were treated in 15 fractions instead of 25 to 30 fractions, thus enabling doctors to treat twice as many patients. Many RAGE members sustained injuries while being treated in 30 fractions. British hospitals use higher doses per fraction compared with other European countries and the USA. The records show a higher recovery rate, and that would be justified.
Britain's record of deaths from breast cancer is among the most horrifying in the world. In the United States, the issue has been taken seriously. A committee was already established, and President Clinton convened a special conference to examine the issue and the problems faced by women throughout the United States. We also must acknowledge the need for serious examination.
The marked clustering of injured women in certain hospitals in certain years—while other centres have experienced no cases—seems to suggest faulty protocols, inevitably at the cluster hospitals. Injury does not have to be inevitable. It is also worrying that the number of radiotherapy injuries after breast cancer reported to RAGE have increased, not declined, in recent years. The lack of a national reporting system makes it difficult to see the total picture. The Government have sought to dismiss the increase in notifications, claiming that it can be attributed to more women learning of the existence of RAGE. That may be so, but if there were national analysis and reporting, that argument would disappear. I ask the Minister to consider establishing such a system as a matter of urgency.
It is often said that it is difficult to identify causation, but that is not necessarily so. RAGE's work in increasing awareness of radiotherapy injuries has led to causation being unequivocally identified and admitted in the majority of cases. The Government's present position is that victims must seek compensation through the courts. Replying to Lorna Patch of RAGE on 7 August, the Minister stated, on compensation:
I can only repeat that the Government's position remains that the basis for seeking compensation is by proof of negligence through the courts.That is unacceptable, because one must be very rich to pursue compensation that way. It costs around £200,000 to mount an effective case to prove medical negligence in 636 the High Court, which is totally beyond the means of almost everyone in this country. It would certainly be beyond the means of an individual who has suffered as a result of breast cancer, lost her income and, more importantly, forgone any prospect of future income. The individual might try to obtain legal aid, but there is a legal threshold of the probability of success and one must also pass a poverty threshold. The Government must instead produce a compensation package.The injurious effects of altering the time dose fractionation plan were known to practitioners as early as 1966–29 years ago. The alteration continued at the Royal Marsden hospital until as late as 1982, 16 years after its injurious effects were first known, as a measure to increase productivity. RAGE members to whom I have spoken—and this comes through in all their documentation—had no prior warning before radiotherapy of the risk of permanent injury. As a result of such injury, entitlement to statutory benefits and state pensions has often been eroded, exacerbated by lack of Department of Social Security recognition of the type of injuries.
The compensation package suggested by RAGE—which I and a large number of hon. Members in all parts of the House endorse—is an annual figure for extra expenses, such as splints, slings, medication and hospital transportation; a sum to cover the net cost to date, net of any disability benefit or attendance allowance; and a payment to cover loss of earnings to date and to retirement. Victims can be women of all ages and classes. Many of them may have been in high-paid jobs, while others might have looked for career development and additional qualifications that would have improved their life style—and that potential has been cut by the inability to pursue their career.
Those calculations, however, take no account of the constant, nagging pain that victims suffer and their inability to lead a normal life and to pursue ordinary leisure pursuits. Where the loss of an arm is involved, the victim is unable even to pick up her child or grandchild—something that the rest of the population takes for granted as normal behaviour. Loss of mobility is an important factor.
The Department of Health is about to publish an audit conducted by the Royal College of Radiologists on the practices of its own members, to establish how such injuries occurred. RAGE was denied an independent, multidisciplinary inquiry. I hope that the audit will go some way to supporting the arguments constantly made on causation and for proper compensation. There is strong support for an independent inquiry that is not dominated by the medical profession, but takes evidence from its members—in the way that a Select Committee does.
We should be concerned to study the causes of breast cancer in Britain and why the incidence is so high, examine facilities for diagnoses and treatment, and look at increasing and making more readily available specialist treatment centres so that breast cancer can be detected earlier and be properly treated. We should ensure also that women who receive radiotherapy are made fully aware of what it involves, the dangers and possible side effects, which may not appear for many years.
We should also acknowledge the dreadful damage done to many women by mistakes, misdosage and a failure to explain possible after effects. The least we can do is to 637 ensure that women who have suffered so grievously in the past receive proper compensation, ensure that such suffering does not recur and try to conquer that awful illness.
§ The Parliamentary Under-Secretary of State for Health (Mr. Tom Sackville)I am grateful to the hon. Member for Islington, North (Mr. Corbyn) for bringing the issue to the attention of the House. I want to express my deepest sympathy to the women who have suffered side effects as a result of radiotherapy for breast cancer. I know that they can endure severe, debilitating pain and even bone fractures, as the hon. Gentleman said. In some cases, the injury to the arm is such that the women cannot continue their careers or undertake ordinary daily tasks without help. We must aim at discovering the reason for those strong reactions to treatment that, for most women, is effective and has few long-term side effects.
Radiotherapy dose and treatment techniques are determined by the clinician in charge. However, all patients have a right to consent to or reject treatment, and all are entitled to a clear explanation of any treatment proposed—including of any risks and alternatives. All treatments carry some risk, and patients must be allowed to decide whether they wish to continue with the treatment proposed. That important principle has been highlighted in the patients charter and it is departmental policy.
Any health professional will take any steps possible to avoid adverse effects, and significant cases are published so that all doctors may learn lessons from them. It is important to define factors that cause adverse effects in particular patients so that they may be avoided. It is possible that, in future, research will allow a patient's sensitivity to radiation to be assessed before treatment, to allow the treatment to be individually tailored. Unfortunately, adverse effects from radiotherapy are frequently incurable because the effect on the tissue cannot be reversed by surgery. The effects of radiotherapy are drastic because that is the nature of the treatment: it is designed to kill tumour cells and in doing so will kill a proportion of normal cells as well.
As the hon. Gentleman knows, representatives from RAGE Breast, the organisation representing many of the women suffering severe side effects, met Lady Cumberlege and the Department's chief medical officer last year to discuss the concerns of their members. Following the meeting, discussions took place between the Department of Health, the Royal College of Radiologists and RAGE at which it was agreed that the royal college would undertake a confidential clinical review of consenting RAGE members, funded by the Department of Health.
The aim of the review was to discover what common factors in treatment may have lead to these women suffering such effects. It is a relatively homogenous group and we hope that the audit will yield useful information about common factors in treatment that might have led to the adverse effects. Armed with this information, we can then assess the need for further studies.
Two hundred and forty-nine patients—all of whom are now members of RAGE—treated at 15 centres in the 14 years between 1980 and 1993 were invited to 638 participate; 126 consented to do so. A conservative estimate of the total number of patients receiving radiotherapy for breast cancer at these centres over the same period is 65,000. The clinical review has now been completed and the report will be published on 6 December. Following that, each participating RAGE member will receive a personalised assessment of his or her case.
At the behest of the Department of Health, the Royal College of Radiologists has developed guidelines for the care of women who have suffered tissue damage following radiotherapy for breast cancer. They were sent to the NHS in October this year. Additionally, the Department has funded the production of factsheets—prepared by the cancer charity BACUP and other charities—for women about to undergo radiotherapy, and for women experiencing short and long-term effects following it.
As for quality assurance systems, the ionising radiation regulations are intended to prevent unnecessary or excessive exposures to medical radiation. The Secretary of State's inspectorate investigates cases of suspected breach. There are four inspectors who are Department of Health officials. The introduction of dose-reducing strategies continues and is part of a thrust to reduce radiation doses to as low as reasonably practicable in order to achieve the required diagnostic or therapeutic purpose.
Guidance notes for the protection of persons against ionising radiations arising from medical or dental use were issued in 1988. In July 1991, guidance was issued to health authorities on quality assurance in radiotherapy. It sets out 18 requirements to be satisfied to ensure that quality is maintained. The guidance has been considered in two sites—the Bristol oncology centre and the Christie hospital in Manchester. Both centres completed their assessments, and their findings were disseminated by way of a document called "Quality Assurance in Radiotherapy", which I launched at a conference in May last year. The document will act as a quality assurance model for the wider NHS; it will be for each radiotherapy department to produce a quality manual showing how the requirements of the guidance are to be met and detailing procedures in the department.
I fully realise that many of the women suffering side effects would wish to have their injuries recognised and consideration given to their claims for compensation, commensurate with their injuries. It is important to be clear about how such claims are pursued. First, we believe it right that people harmed in the course of clinical treatment should be able to seek compensation through the usual legal process. But that does require them to demonstrate not only that they have been harmed but that there has been negligence, and that the negligence caused the harm. When negligence cannot be shown, there is no case in law for compensation.
From time to time it has been suggested that this is not right, and there have often been calls for the introduction of a system of no-fault compensation. Hon. Members will recall that this issue has been considered in the House before, most recently on Second Reading of 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 view that a no-fault compensation scheme would not be helpful.
Perhaps I should remind the House of the reasons for that conclusion. We are sensitive to the fact that some of the victims of medical accidents oppose no-fault 639 compensation on the ground 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 mainly to deal quickly with the financial aspects of medical accidents, without regard to fault, would deflect attention from plaintiffs' most important concerns.
Another issue is accountability. Our legal system holds all individuals accountable for their actions, which arguably has a deterrent effect on malpractice. No-fault compensation could remove or weaken it.
We must also be mindful of the possible cost implications of a no-fault compensation scheme. Costs falling on the NHS could increase greatly. For instance, a scheme in New Zealand which covers accidents generally is thought to cost at least 1.5 per cent. of its gross national product. Given that we spend about 6 per cent. of our GDP on health, hon. Members can imagine the possible impact on our health budget.
Proponents of no-fault compensation have yet to show 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 usual legal process.
Finally—
§ Mrs. Maria Fyfe (Glasgow, Maryhill)I am sorry that the Minister seems to be approaching the end of his speech because I had hoped to hear a quick word about the sums devoted to research into breast cancer, and the efforts to detect it in women under the age of 50. He probably knows that current mammography methods are not suitable for women under 50, who are clearly an important group.
640 The Minister has expressed his worries about NHS budgets. Clearly, if enough money were spent on research in the first place, fewer women would suffer from breast cancer.
Finally, it would seem from the Minister's argument that only women with money in the bank will be able to claim compensation at all.
§ Mr. SackvilleAlthough I have outlined some of the reasons why no-fault compensation has been thought inappropriate, we have recently accepted that a system should be tried for mediation in such cases. The Minister of State recently agreed to set up pilot mediation schemes that may make it easier to reach agreement. We have no wish gratuitously to defend certain cases or to cause any unnecessary delays.
The Calman review was set up precisely to ensure that best examples of cancer treatment in this country should be disseminated throughout the system. In particular, we should ensure that more patients see specialists and that those with rare or difficult-to-treat cancers do not always end up in local cancer departments. They should be referred to tertiary specialist cancer centres, possibly on a regional basis, so that people with the qualifications to treat cancer can diagnose and treat the more difficult cases referred to them.
Following the general agreement that we need to take such steps to improve cancer care, I hope to see more widespread best practice. I offer the House a commitment today on behalf of the NHS: we will do everything possible to ensure that accidents of this sort are avoided in the future.
§ It being Two o'clock, the motion for the Adjournment of the House lapsed, without Question put.
§ Sitting suspended, pursuant to Standing Order No. 10 (Wednesday sittings), till half-past Two o'clock.