PACE Trial: People with ME DebateFull Debate: Read Full Debate
Carol MonaghanMain Page: Carol Monaghan (Scottish National Party - Glasgow North West)
Department Debates - View all Carol Monaghan's debates with the Department of Health and Social Care
[Mr Philip Hollobone in the Chair]
I congratulate the hon. Lady on securing this debate. Does she agree that there is still huge concern among ME patients that the National Institute for Health and Care Excellence says it will not abandon the promotion of physio-social therapies for ME, despite the widespread scientific criticism of the PACE trial methodology, and that we must ensure that that is addressed as a matter of urgency?
My friend Jo from Leeds wrote to me:
“I’ve had CFS/ME for 25 years. I’d had it for 10 years before it was diagnosed. When I was diagnosed in Sheffield I was told there was literally no service they could refer me to and relied largely on a local support group. I was told by a Leeds GP to ‘just get on with life’ despite trying to hold down a professional job and look after a young child.”
That is a typical story of somebody with ME.
The hon. Lady is speaking very well about the challenges that this illness presents to people, but does she share my concern that in Scotland there is only one specialist, nurse-led ME facility and there are no specialist ME consultants? She raises an important point, but in terms of NHS awareness of the condition, we need to do more to ensure that people are getting the treatment that they undoubtedly need.
I, too, have been contacted by parents in my constituency. In the case of one constituent, her daughter took a year to be diagnosed and missed an entire year of school as a result. The effect on children’s lives at a very young age is palpable.
My hon. Friend makes a good case. My constituent Carol Ann McGregor has had ME since 1996 and has been bedbound for seven years. She says that she has
“lost my life, health, husband, my career and my home”.
Does my hon. Friend agree with my long-term family friend Maureen Bivard that the cover-up, and the way in which the PACE trial was carried out, amounts to a miscarriage of justice for patients?
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.
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.