PACE Trial: Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
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Lord Layard
My Lords, I too greatly welcome this debate. This is a terrible condition and we are talking about hundreds of thousands of people who are suffering from it. While it is clear that although there have been many studies relative to the seriousness and pervasiveness of this condition, there is far too little research into what is causing it. I want to focus on treatment, as there have been terrible misunderstandings and misconceptions put about on that score.
I want to make just four points. First, the issue of what causes the condition is often quite different from how we can best treat it. This is such a basic point but it is not fully understood by many of the people suffering from this condition. Coronary heart disease may be caused by cholesterol but we treat it with a stent. In the same way, chronic fatigue may be caused by a virus yet the best treatment available at the moment may include psychological therapy. This form of treatment implies nothing about what we believe to be the cause. People who suffer from CFS, and who in almost all cases feel that it is not psychological in origin, are surely making a mistake when they reject psychological support for their condition on the grounds that this implies something about its cause. In their own interest, they should focus on what is the best possible treatment available on the evidence.
Secondly, we have quite a lot of evidence about which treatments work. More will surely be discovered in future and some of them will surely be biological. In the mean time, we have a large amount of evidence that both CBT and graded exercise therapy enable many more people to recover than if the only treatment they have is standard medical care. My main point here is that this is so, whatever the definition of recovery. It is wrong to suggest that this all depends upon that definition; you can put the cut-off for recovery in many different places and you will always find that people who get CBT and graded exercise therapy do better than people who have only standard medical care. There are many studies preceding PACE to show this. Of course, that is the main finding of PACE, which I would say is a fine piece of work by all normal standards. Some of the criticisms are really misleading but some of them have been answered already.
I come back to this question of the change in the protocol to stress that this was made before any analysis was done of the results. It was not that they looked at the results and said, “Let’s change the recovery criteria”. The changes were made because of discussions affecting the whole research world and agreed by the trial steering committee. What is very interesting is that a separate paper has been written simply on the recovery issue, which uses five or six different criteria of recovery. Again, in the PACE study it is shown that whatever cut-off you use, you get the same difference between the outcome of CBT and graded exercise therapy. There really is not a conjuring trick going on here and it is wrong for this impression to be given to the community of people who are suffering, if that leads to them not receiving help which they could really benefit from. Instead of criticising the study, we should be rejoicing that we again have more evidence that something can be done which is better than standard medical care.
My third point has, in a way, been made before but given the strength of this evidence that we have these treatments which work, it is shocking that they are so little available. This is part of a wider story of the non-availability of psychological therapy. The survey that was done by Action for M.E. found that a large number of PCTs were providing no specialist treatment clinics for this condition—or were not providing any kind of care, let alone this most evidence-based care. That is a disgrace and I hope that the Minister can say something about that.
The treatments are not unsafe, a claim that is often put about due to the fact that, of course, some people get worse during treatment. The only argument against the treatment, if it were the case, would be if people who did not receive it were less likely to get worse. Again, the statistics are absolutely clear: the proportion of people who get worse in treatment is no higher than that for people who get worse who are not in treatment. There is no argument whatever that this is unsafe.
My fourth point is about how we can get a better deal for this large group of sufferers. Obviously, the worst possible way to get it is to turn the area into a battleground. It gives the commissioners the perfect excuse for doing nothing and gives people of good will, who might come in and try to help people with this condition, a serious disincentive for getting into this field. As we know, and has already been said, many—or certainly some—of the people who work in this area have received repeated insults and even death threats. I pay particular tribute to Sir Simon Wessely at King’s College London, who has led the field for many years in this area and has stuck to it, despite all this harassment. He and his colleagues—
Lord Wallace of Saltaire
My Lords, the noble Lord is in his seventh minute. We are very tight on time and I am worried that the Minister will not have time to reply.
Baroness Northover
My Lords, I thank the noble Countess for initiating this debate. I apologise for the fact that my noble friend Lord Howe cannot be here, as he is in the Chamber making the Mid Staffs Statement. I, too, am a last-minute replacement.
I know that the noble Countess has a particular and personal interest in the subject and I pay tribute to the way in which she continues to raise issues of concern in your Lordships’ House, as well as her unswerving commitment to improving the experience of people living with CFS/ME. I recognise how distressing and debilitating the condition can be for individuals, their carers and their families. Equally, I recognise the difficulties that many patients face in getting the treatment and care they need to help them manage their illness and, where they can, make a recovery; we have heard that this afternoon. I am sure that we all agree that the most important thing is to ensure that patients receive the treatment and care that they need.
At this point it is worth acknowledging that, while many patients feel let down by the system, many patients have had a positive experience and have worked with health and social care professionals to manage their care effectively. It is also important to acknowledge that doctors and other professionals working in this field are highly committed to providing the best possible care for their patients. We want to see people with CFS/ME being listened to when it comes to decisions about what type of treatment and care may best meet their individual needs and, across the country, many doctors are working with their patients to achieve this. I hear what my noble friend Lord Alderdice says on this.
There is no doubt that there is widespread uncertainty surrounding this condition; that has shone through in this debate. There is controversy, disagreement and divided and often polarised opinion about its causes and the best way to treat it. The kind of issues raised by the noble Countess today have surrounded the debate for many years. We have seen how passionate but how often opposed are those seeking to address these problems in the debate this afternoon.
It is an unfortunate fact that despite a great deal of worldwide research—the noble Lord, Lord Winston, made clear how extensive this is—we do not yet know definitively the cause or causes of CFS/ME: whether it is a disease; a condition, as the noble Baroness, Lady Hollins, described it; or a syndrome, as the noble Baroness, Lady Meacher, described it. The noble Lords, Lord Winston and Lord Layard, surely are right that it is concerning if researchers are in any way intimidated as they seek to clarify these problems.
CFS/ME is not alone in being mystifying. We do not know the causes of most cancers and other diseases such as Alzheimer’s. That lack of knowledge, however, has not stopped us from seeking the best forms of treatment. Many of these diseases are treated well even though we do not know their causes. I quite agree that more research is needed. In the mean time, patients want access to the best treatments that are available. So far, the only treatments that seem to have shown any benefit in clinical trials have been cognitive behaviour therapy and graded exercise therapy, but I have heard what noble Lords have said in regard to those.
This brings me to the PACE trial that has prompted today’s debate. The MRC’s decision to fund this trial was based on the fact that there was a lack of high-quality evidence to inform the treatment of CFS/ME and, in particular, on the need to evaluate the treatments that were already in use and for which there was insufficiently strong evidence from randomised controlled trials to support their effectiveness. The decision to fund this trial was based on the MRC’s usual rigorous peer- review process for clinical trials, as noble Lords have emphasised. The experts who reviewed the application were satisfied that the design put forward was of high quality, would provide useful evidence to help doctors and patients decide whether any of the four treatments to be evaluated was likely to be worth pursuing, and would help to inform decisions on the provision of treatment by the NHS. The noble Lord, Lord Winston, and others argued that this was a controlled and rigorous study. All agree that research is needed.
I shall try to address the challenges that were raised by the noble Countess, Lady Mar. She expressed concern about the selection method for participants. I assure her that having neurological symptoms, such as memory difficulties or muscle weakness, did not exclude anyone from taking part in the trial since these symptoms were medically recognised symptoms of the condition. While researchers used the Oxford definition to define the condition in the PACE trial, participants were also assessed to see whether they met the international Centers for Disease Control and Prevention criteria to see whether the effects of treatments were different in those who met this alternative definition. The independent members of the trial steering committee reviewed and agreed the plans for secondary analysis.
The noble Countess, Lady Mar, also expressed concern about the recovery statistics and other areas in relation to the protocol. As for all MRC-funded studies, it is the responsibility of the investigators and the relevant journals, guided by peer reviewers, to determine how findings are published and when. The investigators’ first paper on the outcomes of the PACE study was published in the Lancet in March 2011. A later paper was published in August 2012, which dealt with the cost-effectiveness of the interventions. Further papers will be published, including papers showing a long-term follow-up after two and a half years. The noble Baroness, Lady Hollins, made a very important point about follow-up, and no doubt the MRC will bear that in mind and will look at this debate. Follow-up in all these trials is very important.
The noble Countess, Lady Mar, asked about severely disabled patients being excluded from the trial. Patients had to be able to attend hospital for treatment, but a number needed mobility aids and others received treatment by telephone when they were too unwell to attend a clinic once they had been recruited. She also asked whether the trial data could be reanalysed. As she will know, there are ethical and legal barriers to releasing data to a member of the public without consent when these data contain medical information that might identify the patient. The main outcome data have already been independently analysed by a Cochrane Collaboration group and a paper is being prepared for publication. I know that she will look at that with interest.
An often voiced criticism is that the money spent on the PACE trial would have been better spent on research into causes. As the noble Baroness, Lady Meacher, indicated, the two are not mutually exclusive. While understanding the cause of the condition is obviously important, if potential treatments are available, it is equally important to test their effectiveness so that they can be introduced into service. Of relevance to this is that the PACE trial tested adaptive pacing therapy, which had not previously been tested in a large trial and which is supported by patient organisations. Various noble Lords have paid tribute to the quality of the research, even though the noble Countess, Lady Mar, was more sceptical.
As the noble Countess is aware, the findings of the PACE study reflect the recommendations in current NICE guidance. I understand that concerns have been expressed that patients may have their choices about care restricted because the PACE trial supports their non-recommendation by NICE or that patients may be forced into treatments they do not want because they are recommended. I assure noble Lords that clinical guidelines published by NICE help to promote consistency but recognise that patients are individuals who may require different forms of management. Clinicians are therefore free to adapt the guidelines when deciding, in consultation with their patients, the most appropriate treatment. NICE routinely reviews the need to update its guidance in order to take account of the latest available evidence. As the noble Countess is aware, CFS/ME is currently a highlighted area and a high priority for the MRC. The high-quality research stimulated by the MRC’s recent call will add to the future evidence base.
Concern has been expressed that the findings of the trial will be used to reduce the number of people with CFS/ME on state benefits. That was flagged up briefly by noble Lords. I should like to dispel straight away the idea that CFS/ME is not recognised by the Department for Work and Pensions as a potentially serious condition. For example, there are no targets for finding individuals fit for work in the work capability assessment process. The noble Baroness, Lady Meacher, raised this particular issue and asked whether patients who do not comply with the CBT or take the treatment recommended to them might have their benefits withdrawn. I can assure her that that is not the case. Entitlement to employment support allowance is not based on compliance with specific treatments and anyone claiming ESA will undergo the work capability assessment. That assessment is founded on the premise that eligibility should not be based on a person’s condition or the treatment regime for it but, rather, on the way that that condition limits their functional capability. I am happy to flag this debate to the DWP, as the noble Baroness asked me to, in regard to the availability of services.
The noble Baroness also asked me about the NHS Commissioning Board and whether it would give equal weight to a number of other diseases. I can assure her that the mandate to the NHS Commissioning Board will ensure that improvements are made to the quality of life for all people living with long-term conditions, including this one.
The noble Lord, Lord Layard, asked me about specialist treatment provided by PCTs. In the new system, clinical commissioning groups will be responsible for commissioning specialist CFS/ME services. As he knows, they comprise front-line clinicians. We certainly hope that they will therefore have a good understanding of their local communities, including patients with these problems. The NHS Commissioning Board will hold those CCGs accountable for the services that they commission, as well as providing support—for example, through the development of commissioning guides. I understand that Martin McShane, long-term conditions lead at the NHS Commissioning Board, has already met with the CFS/ME patient groups to discuss their concerns. Those discussions will inform the board’s work as things move forward.
The Government’s aim is to help individuals who are suffering from these problems both to receive appropriate treatment and to get back to work where they can do so. They also seek a better understanding of the situation that these individuals are in. The PACE trial was funded to respond to the concerns of patients, carers and doctors that more research into CFS/ME was required. Of course, we all hope that health research results in people becoming healthier and fewer suffering from these kinds of problems. This is obviously a major focus for the MRC in making its individual funding decisions.
In conclusion, I hope that the noble Countess will agree that we are sympathetic to the needs of patients with CFS/ME. I appreciate, as do other noble Lords, her many concerns. I hope that I have reassured her that we are investing in improved services for CFS/ME patients and in an expanded research programme—noble Lords have emphasised the importance of research moving forward in this area—and that this should make a difference to the lives of the many people affected by this condition. That is the Government’s priority.