ME: Treatment and Research

Andrew Selous Excerpts

Thursday 21st June 2018 Westminster Hall

[Carol Monaghan]

I thank the hon. Lady for her intervention. Merryn’s is not an isolated case, and neither are those of my constituents—I am sure that Members present have all heard constituents describe the same situation.

The PACE trial, which recommended CBT and GET, influences how health insurers and the DWP make their decisions. Insurance companies refuse to pay out unless a programme of GET has been undertaken, and many people who apply for benefits are told that they must carry out GET—or, indeed, that they appear well enough to work. PACE is unique in UK medical history, in that it was part-funded by the DWP. The links of some of its main authors to health insurance companies are troubling. One of those authors, Professor Michael Sharpe, states in his briefing for the debate:

“Several of the investigators had done small amounts of independent consultancy for insurance companies, but this was not relevant to the trial. The insurance companies played no part in the trial.”

I will leave hon. Members to make up their own minds about that.

Healthcare professionals worldwide are starting to take note. The US Centres for Disease Control and Prevention and the Health Council of the Netherlands have both abandoned GET. If those countries acknowledge the flaws of GET, why are ME sufferers in the UK having to fight so hard for similar acknowledgement? The ME community hopes that GET will not feature in the NICE guidelines for ME treatment after they are revised.

Some argue that CBT is provided as a treatment for many illnesses, including heart disease and cancer, and that ME patients’ rejection of it is irrational. The key difference is that cancer patients receive biomedical treatment in addition to CBT, rather than having CBT to the exclusion of biomedical interventions. Biomedical treatment for ME is woefully lacking. There are reports from the US that certain antiviral drugs improve the condition, but without properly funded research to identify biomarkers for ME, we do not have the answers.

Diagnosis is currently based on a patient presenting with known symptoms. Although there is no biomarker for ME, that does not mean there is no biomedical test for it. The two-day cardiopulmonary exercise test, which can objectively document the effects of exercise, could be used as a diagnostic tool. In simple terms, people with ME perform adequately or even well on the first day but have reduced heart and lung function on the second. That relates to the point made by the hon. Member for Alyn and Deeside (Mark Tami) about the DWP and the fact that someone’s presentation may be good one day but not the next.

That protocol involves two identical tests separated by 24 hours, the collection of gas exchange data and the use of an exercise bike to measure work output accurately. That type of testing reveals a significant performance decrease on day two among people with ME, in terms of their workload and the volume of oxygen they consume before and during exercise. Results from a single test may be interpreted as deconditioning, which may lead to harmful exercise being prescribed. However, the objective measurements of the two-day test remove the issues of self-reporting bias and the question of effort—in other words, the results cannot be faked.

Those results support the strong and consistent patient evidence of the harm that can occur as a result of inappropriate exercise programmes. However, there are moves afoot to categorise ME as a psychological condition. NHS guidelines on medically unexplained symptoms class ME as such a condition. The Royal College of Psychiatrists states:

“Medically unexplained symptoms are ‘persistent bodily complaints for which adequate examination does not reveal sufficient explanatory structural or other specified pathology.’”

[Andrew Selous (South West Bedfordshire) (Con)]

I just want to pick up on the hon. Lady’s point about ME being classified as a psychological condition. Does she agree that that is a little curious, given that the World Health Organisation states in its “International Classification of Diseases” that ME is a neurological condition? My understanding is that the United Kingdom is legally obliged to follow that classification.

[Carol Monaghan]

I thank the hon. Gentleman for his intervention. Worryingly, the WHO is looking at reclassifying ME, too—we should all be aware of that—and its current classification of ME as a neurological condition has been ignored in terms of the treatment we have offered to patients here in the UK.

The Royal College of Psychiatrists goes on to state that symptoms are

“not due to a physical illness in the body. However, they can be explained, but to do this, we need to think about causes that are not just physical.”

Under the new “Improving Access to Psychological Therapies” guidance for people with long-term conditions, patients who present with ME are classified as people with medically unexplained symptoms who should undergo CBT therapy, in conjunction with other treatments—in other words, graded exercise therapy. However, as ME is classified as a psychological condition, patients risk getting trapped in the psychological care pathway.

--- Later in debate ---

[Sir Edward Davey (Kingston and Surbiton) (LD)]

I congratulate the hon. Member for Glasgow North West (Carol Monaghan) on securing the debate and all hon. Members who will participate in it. It is essential that we speak for the millions missing, and it is great to see so many people in the Public Gallery.

What I find so shocking is that scientists seem not to want to have the debate. I hope that right hon. and hon. Members across the House find it shocking that the hon. Member for Glasgow North West was written to by a scientist and called out. I have seen scientists writing in journals such as the Journal of Health Psychology calling out the PACE trial, so the idea that the scientists who produced that work have gone unchallenged by other scientists is simply not true. A huge amount of evidence from eminent people in the science community questions the PACE trials, including the methodology, the evidence they used and how they treated their patients, as the hon. Lady said. Therefore, it has been proven not to be the case that the NICE guidelines, built on that questionable evidence, are the only way in which we should consider this disease, and she did that well in a previous debate.

It is great that the NICE guidelines are to be reviewed, but my concern is that that will take some time. I am sure that is the right process; we must get it right and ensure that the voices of ME sufferers are heard. Scoping working groups have been set up in which ME sufferers have been able to participate, and that is welcome. But I find it quite scary that the current guidelines will be in place until October 2020. I have listened to my constituents and read about those of other right hon. and hon. Members who feel that if they are prescribed according to those guidelines and go through all that, it makes them more ill. Far from helping them, it makes them deteriorate. Indeed, I have a constituent who feels that the programme she was put through set her back two or three years.

Real harm is being caused by some of the therapies recommended in the guidelines. If that is the evidence from ME sufferers—I am not a scientist, but from what I have read, that experience is widely shared—it is up to the Minister, working with the chief medical officer and others, to question whether the NICE guidelines should be suspended, at least with respect to GET. If GPs, perhaps because they have not been trained, are making medical prescriptions for treatment following NICE guidelines because Ministers and the chief medical officer have not acted, if that treatment is harming people, and if that continues until October 2020 there will, as I said in my intervention, be a case for those who are harmed to go to court and seek compensation.

No one wants that. To avoid it, surely there must be a way in which Government Ministers, working with NICE and the CMO, can issue guidelines directly to GPs and medical professionals to say, “Be careful before you prescribe GET. Ensure that you have read the evidence. Ensure that you have talked properly to the patient.” With many drugs and pharmaceuticals, there are sometimes side effects. Therapy does not work for everybody. Where is the warning in the NICE guidelines of the side effects of GET? That is serious, because people could be seriously hurt in the period between now and the conclusion of the NICE review.

I will move on to research. Looking at the work that Invest in ME Research has done, for example, setting out the calls for research in this country over two decades or more, I find it quite disturbing that those calls have been ignored. Only charities have enabled a meagre amount of research to be done. Some £5 million was set aside for the PACE trial; if we could have a small amount of that money to start real, biomedical research into ME, we would be making a step forward.

[Andrew Selous]

Does the right hon. Gentleman share my concern that, as I understand it, there are roughly two and a half times more people with ME than with multiple sclerosis, yet there is 20 times more research on multiple sclerosis than on ME and, of what little ME research there has been, the vast majority has been through psychological and behavioural studies rather than the biomedical approach?

[Sir Edward Davey]

I share the hon. Gentleman’s concern. I should say that we still need a lot of research into MS, so it is not one or the other, but given the incidence of ME, as he rightly says, the case for research into the biomedical aspects is strong. Invest in ME Research makes a number of proposals in its recent report. For example, it proposes a ring-fenced fund of £20 million a year for the next five years for biomedical research. That recommendation comes from a detailed report; it is not just plucked out of the air. That sort of figure would show that the Government mean business.

I am aware that Ministers cannot stand up at the Dispatch Box and say, “Yes, of course we will direct research money into this probe; I myself will do it.” I am not suggesting the Minister can do that today. I know he cannot. He has to work with research councils and others to direct the research. I am also aware that if researchers do not make proposals, sometimes research moneys cannot be granted.