PACE Trial: People with ME

Caroline Dinenage Excerpts

Tuesday 20th February 2018 Westminster Hall

[The Minister for Care (Caroline Dinenage)]

It is a great pleasure to serve under your stewardship, Mr Hollobone. I congratulate the hon. Member for Glasgow North West (Carol Monaghan) on securing today’s debate. As she has articulated so beautifully, the situation is clearly very concerning. I know that she has done an enormous amount of work in this area, and has met people, both in her constituency and more widely, affected by the condition, and with expertise on the condition, to hear about its impact on individuals’ lives. As MPs, we all know people in our constituencies who are affected by the condition.

As we have heard, chronic fatigue syndrome, also known as myalgic encephalomyelitis or encephalopathy, is a debilitating and very poorly understood condition, which is estimated to affect more than 200,000 people in England. We do not understand the underlying causes of it, there is no one diagnostic test to identify it, and although patients can improve and recover, there is no cure for it. The condition, which for brevity and to avoid covering you in a thin layer of spittle, Mr Hollobone, I shall refer to in the abbreviated form CFS/ME, can stop a life in its tracks, leaving sufferers unable to carry out the most basic tasks. In the most serious cases, people can be bedbound for weeks at a time. It has a complex range of symptoms, including a very disabling, flu-like fatigue and malaise, and neurological problems. Of course, the impact on friends, families and carers can be significant as well.

It is also true that the difficulties in diagnosis mean that patients with CFS/ME often experience delays in getting the treatment and support that they need. In recognising the need for GPs to be aware of the condition, the Royal College of General Practitioners identified CFS/ME as a key area of technical knowledge that GPs should have as part of their qualifying exams, which answers a question raised by the hon. Lady.

The recommended treatments for CFS/ME, namely cognitive behavioural therapy, or CBT, and graded exercise therapy, or GET, and the evidence for them are the subject of today’s debate. Those treatments were first recommended for patients with mild or moderate CFS/ME in 2007 in the NICE guidance, in line with the best available evidence, which showed that the treatments offered benefits. The guidance sets out that there is no one form of treatment to suit every patient and that the personal needs and preferences of patients should be taken into account. Doctors should explain that no single strategy will be successful for all patients; that in common with all people receiving NHS care, CFS/ME patients have the right to refuse or withdraw from any part of their treatment; and that those with severe symptoms may require access to a wider range of support, managed by a CFS/ME specialist.

The results of the PACE trail, which examined pacing therapy, cognitive behavioural therapy, graded exercise and specialist medical care for chronic fatigue syndrome, were published four years after the NICE guidance. The trial ran from 2005 to 2011 and, contrary to what the hon. Lady said, was primarily funded by the Medical Research Council, not the DWP. Total funding was £5 million and the MRC contributed almost £3 million.

The study was undertaken by the Queen Mary University of London. It was the largest ever trial for CFS/ME, including more than 600 participants in England and Scotland. It sought to assess and compare the effectiveness of the four main treatments for CFS/ME—adaptive pacing therapy, CBT, GET and standardised specialist medical care.

The peer-reviewed trial results published in The Lancet in 2011 found, as the hon. Lady said, that 60% of patients with CFS/ME benefited from CBT and GET when provided alongside specialist medical care. CBT and GET were found to be better than pacing therapy or specialist medical care alone in improving both symptoms and disability, and a follow-up study looking at recovery after one year further supported the benefits of interventions. The trial had ethical approval from the NHS research ethics committee and had ongoing oversight from an independent trial steering committee, which included patient representatives. Trial reports were regularly provided to a data monitoring and ethics committee that had the power to halt the trial if harm was indicated. NICE considered the PACE results in 2011 and concluded that they supported its existing recommendations on both CBT and GET.

The Government are aware that the use of CBT and GET in treating CFS/ME has long been a controversial issue for patient groups, charities and some clinicians. That began with the publication of the NICE guidance 10 years ago and continued with the PACE trial. Since 2011, PACE trial data has been shared with many independent scientists as part of normal research collaboration, including the internationally respected research organisation Cochrane, which independently validated the findings. However, in the last 18 months, the attention on the trial has increased substantially, following a tribunal ruling in August 2016 ordering the release of the trial data to a member of the public, which the hon. Lady referred to. The data has since been examined more widely and critics, including some clinical academics, have suggested that it shows that CBT and GET are not as effective as the trial results suggested.

[Nicky Morgan (Loughborough) (Con)]

This is clearly a very important debate. I think both the hon. Member for Glasgow North West and the Minister would agree that it is not possible to do justice to the concerns raised by all our constituents, and the 200,000 sufferers that the Minister has identified, in half an hour. Does the Minister agree that this is a subject worthy of wider debate in the House of Commons? Constituents such as Sarah Reed, who have written to me, say that because of the belief in CBT and GET, and because academics believe in the results, many other treatments have not been pursued. Does the Minister feel angry about that?

[Caroline Dinenage]

I thank my right hon. Friend for her intervention. As has already been said, it is important that we listen to patients. As I will go on to explain, NICE is now looking at reviewing its guidance on this and, in the light of that, it may well be worth discussing the issue more fully.

[Luke Pollard (Plymouth, Sutton and Devonport) (Lab/Co-op)]

Does the Minister agree that believing patients is also important here? Patients with the condition are often not believed and concerns about the PACE trial have not been believed, and that has just loaded concerns on those individuals.

[Caroline Dinenage]

As I have already set out, sometimes it can take a really long time for this to be diagnosed. People have to keep going backwards and forwards to GPs and others with their symptoms. Many other potential conditions have to be discounted before it can be fully diagnosed, which often leaves people feeling that their symptoms are not being taken seriously or they are being dismissed. Obviously, that is massively concerning, which is why, as we have already said, it is important that patients are listened to and that clinical professionals are well-equipped to be able to recognise the symptoms and identify them.

As I said, the data has been examined more widely. Critics, including some clinical academics, have suggested that it shows CBT and GET are not as effective as the trial results suggested. In turn, the trial authors have defended their work. They have responded to criticisms in medical journals and the wider medical printed press. I know the hon. Member for Glasgow North West raised one such criticism at the oral evidence session of the Science and Technology Committee in January, concerning possible conflicts of interest of the PACE trial authors. On that point, in line with normal practice, all such conflicts were published with the trial protocol as well as the results. If she has evidence to the contrary, I would be very happy to discuss that with her afterwards.

[Carol Monaghan]

I thank the Minister for that. However, they were not disclosed to the PACE participants.

[Caroline Dinenage]

It is very important that the hon. Lady has raised that point, and I am sure it will be taken into consideration.

[Helen Whately]

ME sufferers in my constituency welcome that the NICE guidelines are being reviewed, but one problem is that when they find that the existing treatments do not work for them, there is a lack of alternatives. Does the Minister recognise that alternative treatments need to be looked into urgently and offered to patients?

[Caroline Dinenage]

I am sure that will be part of the NICE guidance. Where there is significant evidence that alternatives deserve greater investigation, I am sure NICE will look at that. I will talk about that a little more in a second.

On conflicts of interest, it is obviously important that researchers and scientists with particular expertise in one area will have worked and shared their expertise in related fields and industries, but transparency regarding conflicts of interests is vital to the integrity of the research. The NHS Health Research Authority already issues guidance on conflicting interests and I understand it will consider whether any further clarity is needed.

Clearly, the controversy around the trial is problematic for researchers, but it is most of all distressing for patients with CFS/ME, who deserve the most appropriate treatment from the NHS and to have confidence in the treatment that is being provided. That is why we welcome the NICE decision to undertake a full review of the guidance, which will examine the concerns around the PACE trial and any implications for its current recommendations. NICE develops its guidance independently to support NHS organisations and clinicians to deliver services in line with the best available evidence. It welcomes the input of stakeholders and more than 10 CFS/ME charities and organisations are already registered to support the guideline development process. All other parties who are interested can comment on the draft scope and draft guidelines at the appropriate time during the development process. Final guidance is expected in October 2020.

[Paul Blomfield (Sheffield Central) (Lab)]

The Minister makes the point that final guidance is expected in October 2020, but given the significant doubt over CBT and GET and their impact now, does she recognise the strong case for NICE to suspend the current guidance, which points people towards those potentially damaging treatments?

[Caroline Dinenage]

As an independent organisation, that will of course be a matter for NICE, taking into consideration the evidence.

I know it is a priority for the CFS/ME community that more research into identifying the underlying causes of the condition be undertaken. I would like to reassure those affected that both the MRC and the National Institute for Health Research welcome high-quality applications for research into CFS/ME, including studies to investigate its biological causes, and it will come as welcome news that the MRC is currently funding a project to examine the relationship between abnormal brain structures and symptoms of CFS/ME.

I again thank the hon. Member for Glasgow North West for raising this important issue on behalf of those affected by the condition in her own constituency and up and down the country. I hope the debate has been helpful.

Question put and agreed to.