Eurotunnel: Payment

Carol Monaghan Excerpts

Monday 4th March 2019 Commons Chamber

[Matt Hancock]

I think I have mentioned that the point of this settlement was to ensure the unhindered supply of medicines, which is very much a matter for me as Health Secretary. People watching these proceedings will also be astonished that the Labour party can argue against a settlement such as this when it is refusing to vote for the deal that could ensure that we have a smooth and orderly exit and that the plans and the contingency plans for a no-deal Brexit are not necessary. Mr Speaker, the hon. Gentleman should vote for the deal, too.

[Carol Monaghan (Glasgow North West) (SNP)]

I do not know what is more embarrassing: that the Secretary of State has the brass neck to sit there this afternoon, or that his entire Front-Bench team are nodding along with his “Jackanory” stories.

Since the Secretary of State insists that this is about the supply of medicines, I am going to ask him, for the second time in a fortnight, about radioisotopes. Last time he said that there was no problem because we could fly them in. Can he now tell us how we can get radioisotopes supplied to us if we are not a member of Euratom?

[Matt Hancock]

Access to radioisotopes is precisely through the aviation route—that is exactly what I said to the hon. Lady last time, and I say it to her again today.

Oral Answers to Questions

Carol Monaghan Excerpts

Tuesday 19th February 2019 Commons Chamber

[Matt Hancock]

Yes, my right hon. Friend puts it extremely well, because he reminds us of who we are here to serve when discussing questions of health and of cancer. He is right to raise this matter, and I can absolutely confirm what he asks for: we will deliver in Stephen’s memory and in the memory of others who have died. That is what gives us the strength to carry on and try to deliver and improve services for everybody.

[Carol Monaghan (Glasgow North West) (SNP)]

The Secretary of State talked earlier about a six-week stockpile of medicines, but radioisotopes for cancer diagnosis and treatment cannot be stockpiled. I have asked many times about the future arrangements for radioisotopes post-Brexit, so will the Secretary of State detail them now?

[Matt Hancock]

In the event of a problem at the Dover-Calais strait, we will bring in radioisotopes by air, and we have already contracted an aircraft to ensure that that happens. That part of the planning is well advanced.

Appropriate ME Treatment

Carol Monaghan Excerpts

Thursday 24th January 2019 Commons Chamber

[Carol Monaghan (Glasgow North West) (SNP)]

This debate is long overdue and much anticipated, and I thank the Members who have remained in the House on a Thursday afternoon to contribute to it.

There have been previous debates on ME, including one called by the then Member of Parliament for Great Yarmouth, Anthony Wright. That debate took place 20 years ago, and in 20 years little has changed for those living with ME. There is currently no cure, and many with the condition experience inadequate care and support. An estimated quarter of a million people in the UK suffer from it, and we are letting those people down. Many adults with ME cannot maintain employment or relationships, while children frequently fall behind at school. The ignorance surrounding the condition makes it harder for people to access benefits, and assessors from the Department for Work and Pensions often decide that sufferers are fit for work.

ME has specific characteristics—severe fatigue, debilitating muscle and joint pain, and extreme sensitivity to light and sound—but an important marker for the condition is that mental and physical activities can make the symptoms more acute. Some people with severe ME spend their days in darkened rooms, unable even to watch TV or listen to music. Touch is intolerable. Many are tube fed. For these individuals, ME is a life sentence, but it is a life spent existing, not living.

[Mr Jim Cunningham (Coventry South) (Lab)]

Will the hon. Lady give way?

[Carol Monaghan]

Very briefly.

[Mr Cunningham]

I fully support the motion, because it alludes to some of the complaints that ME sufferers have brought to my surgeries. This is a timely debate, and what the hon. Lady has said so far is quite right.

[Carol Monaghan]

I thank the hon. Gentleman.

This condition is largely unknown, because those affected are often hidden away. I commend the ME community for lobbying so successfully to ensure so many Members are here this afternoon. Ultimately, what that community wants is better treatment and care for people with ME.

[Paula Sherriff (Dewsbury) (Lab)]

Will the hon. Lady give way, on that point?

[Carol Monaghan]

Again, very briefly.

[Paula Sherriff]

I congratulate the hon. Lady on her sterling work on this issue. It is my privilege to represent Lucy, a lovely teenage girl in my constituency who has ME. Her parents have requested me to ask the House to ensure that biomedical research shapes all aspects of support—in which case it must be funded—and to reiterate that ME is a physiological condition, although it is often treated as a psychological condition. Lucy was asked if she needed to get around. She was told to just get up and walk, but she needs a wheelchair. Much more awareness is needed generally.

[Carol Monaghan]

Yes, ME receives far less research funding than other similarly prevalent conditions. That, I fear, reflects the attitude of some in the medical community who consider it to be behavioural rather than a pathological condition.

[Mr Robert Goodwill (Scarborough and Whitby) (Con)]

Will the hon. Lady give way?

[Carol Monaghan]

I shall have to keep going. I apologise, but a great many Members want to speak.

The psychological view of ME led to the controversial and now debunked PACE trial—PACE is “Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation”. The researchers reported that with cognitive behavioural therapy and graded exercise therapy—in which patients were encouraged to attempt increasing levels of exercise—approximately 60% of patients “improved” and 22% “recovered”. The treatments were labelled safe. Patient groups, however, were saying the opposite. Many who were able to walk when they embarked on a course of graded exercise dropped out of the treatment in wheelchairs or bedbound. Furthermore, patients were pressurised to describe improvements that they did not feel. As the trial progressed and the results did not meet the authors’ expectations, they simply lowered the threshold to define improvement. In some cases, those whose condition had deteriorated were classed as “recovered”. That is simply not good science.

The recommendation of graded exercise has caused untold physical damage to thousands of people. In fact, a 2018 survey found that 89% of ME sufferers experienced worsened symptoms after increasing activity. If graded exercise were a drug, it would have lost its licence.

The blatant ongoing refusal to accept ME as physiological doubtless explains the lack of proper research. Of course it is the Medical Research Council that allocates funds, but the Government can demonstrate their true commitment to improving the lives of ME sufferers. The Scottish Government have committed £90,000 for a PhD scholarship to support research into the causes, diagnosis and treatment of ME, and I would ask that the UK Government follow this lead.

During the debate in June, the Minister for public health, the hon. Member for Winchester (Steve Brine), who is in his place, said that £2.62 million had been spent on ME research since 2011. Let me be very clear: this money was spent on behavioural studies. We need money to be spent on biomedical research, and we are looking for a solid commitment from the Minister.

Until we have developed effective treatments, however, we must ensure suitable care plans are in place to respond to patients’ varying needs. Many US agencies are now removing their recommendations for graded exercise. However the National Institute for Health and Care Excellence guidelines continue to advocate this, despite patient surveys consistently indicating its harm. The risks are not acknowledged in the guidelines, undermining patients’ ability to give informed consent, and some patients are being threatened with being sectioned if they do not commit to a programme of graded exercise.

[Mr Goodwill]

Will the hon. Lady give way?

[Carol Monaghan]

Very briefly.

[Mr Goodwill]

Many consider the NICE guidelines to be completely inappropriate. Does the hon. Lady agree that the timescale for that review, which will end in 2020, is far too long for these patients?

[Carol Monaghan]

Actually, NICE has taken a very positive step in reviewing the guidelines—it is listening to the community—but until they are published in 2020, we need NICE to make a public statement about the potential harm of graded exercise; patients must be made aware of the risk. It is a big ask to request that the Minister talks to NICE and encourages it to make that statement, so that this information can be added to the current guidelines while we are waiting for updated guidelines in 2020.

Care programmes for people vary greatly. Some with ME describe medical professionals who are sympathetic, but others talk of being disbelieved and forced down treatment paths to which they have not consented. Coverage of ME in many medical textbooks remains potentially misleading and inadequate, even non-existent. Health professionals must be equipped with clear guidance on diagnosing ME early and accurately, and with appropriate basic management advice.

At the end of last June’s debate, the Minister for public health resolved that

“as a result of the debate I will redouble my efforts to”

raise awareness among medical professionals concerning ME, and said that

“as part of my role as Minister for primary care, all GPs certainly should be aware of ME”.—[Official Report, 21 June 2018; Vol. 643, c. 229WH.]

That was a welcome statement; I would now like to understand what concrete steps have been taken since that promise was made. Furthermore, I would ask the Minister to ensure that ME clinics and treatment centres are aware of the risks of graded exercise and are not forcing this on patients.

Some of the worst cases we hear about are children with ME. ME affects an estimated 25,000 children in the UK. Many experience significant distress when disbelieved by medical and teaching staff, often when these professionals do not understand how ME affects the child’s ability to attend school.

[Dr Matthew Offord (Hendon) (Con)]

Is the hon. Lady aware that one in five families looking after children with ME have been referred to child protection services?

[Carol Monaghan]

Yes. The statistics are terrible, but I want to describe one such case, which is really quite harrowing. It involves a girl, B, whose name cannot be disclosed. B became ill at the age of eight. A diagnosis of probable ME was made, but it was suggested that the underlying issues were psychological. To show willing, her parents took her to a child psychiatrist, who then involved social services. B’s parents were warned that if they did not fully comply, child protection proceedings would be initiated. Social services specified graded exercise, despite being warned of the dangers. As a result, B deteriorated rapidly until she became wheelchair-bound. Under threat of court action, B’s parents were then forced to take her to a children’s hospital, having been warned that they were “not under arrest just yet.”

B’s parents found what they presumed to be a safer option in an ME unit run by a consultant who appeared to view ME as an organic illness, but this was disastrous. B arrived wheelchair-bound but still able to sit upright and read and write, but under the activity programme, she deteriorated. Her mother was banned from visiting, but other parents in the unit observed B unattended in the wheelchair, in constant pain, unable to sit upright, with her head hanging down the side and crying in distress. This treatment continued for five months. Her parents were threatened that if B did not progress, she would be transferred to a psychiatric unit or placed in foster care. Desperate, they turned to Dr Nigel Speight and the Young ME Sufferers Trust. B was finally allowed home, and her name was eventually removed from the at-risk register. However, by the age of 15, she was bedridden, paralysed, unable to feed or wash herself and utterly dependent on carers. Doctors, psychiatrists and social services all failed her when she was eight. As the hon. Member for Hendon (Dr Offord) suggested, this is the case for one in five families living with a child with ME.

A firm diagnosis of ME protects the child from these proceedings, but unfortunately, paediatricians are often reluctant to give this, simply because they do not understand the condition. This leaves the child open to social service intervention. Often, paediatricians phone a so-called expert on ME, who immediately prescribes graded exercise, without even seeing the child in person. I say to the Minister that this is a national disgrace and it needs urgent action. Children who are already blighted by ME must not be subjected to this trauma. I ask him to consider this issue with the utmost seriousness, and to give the House an assurance that parents will not be prosecuted simply for caring for a sick child.

ME has been disregarded for far too long, and it can be fatal. In the UK, there have been two patients, Sophia Mirza and Merryn Crofts, whose deaths have been attributed by coroners to ME. However, the actual number of deaths due to ME may be much higher, and we cannot wait for more. The ME community have waited decades for their voices to be not only heard but believed. The Government have the power to make radical changes, and I invite the Minister to meet groups of patients who would welcome the opportunity to describe their experience. Little progress has been made in the 20 years since the 1999 debate. Surely, Minister, in the 21st century we can do better for those suffering from this devastating illness.

[Several hon. Members rose—]

--- Later in debate ---

[Carol Monaghan]

I thank all Members who have stayed behind once again on a Thursday afternoon, particularly the Members who sponsored the debate, and especially the right hon. Member for Loughborough (Nicky Morgan) and the hon. Member for Ceredigion (Ben Lake). I also thank the ME community for their lobbying and presence here today in the Gallery, and the Backbench Business Committee for granting the debate. We had some very clear asks for the Minister, which he has responded to in part. On the question of medical research, I am sure that many researchers will have heard what he said. However, it is notable that although there is some excellent biomedical research going on just now, it is being funded by charities, and not by the Government. The Government need to take this seriously.

Question put and agreed to.

Resolved,

That this House calls on the Government to provide increased funding for biomedical research for the diagnosis and treatment of ME; supports the suspension of Graded Exercise Therapy and Cognitive Behaviour Therapy as means of treatment; supports updated training of GPs and medical professionals to ensure that they are equipped with clear guidance on the diagnosis of ME and appropriate management advice to reflect international consensus on best practice; and is concerned about the current trends of subjecting ME families to unjustified child protection procedures.

[Karen Lee]

On a point of order, Madam Deputy Speaker. I did actually mention the film “Unrest”, and I am sure that Hansard will bear me out on that. My constituents would never forgive me if I did not point that out.

Childhood Obesity Strategy: Chapter 2

Carol Monaghan Excerpts

Monday 25th June 2018 Commons Chamber

[Steve Brine]

Yes, and may I thank the Chair of the Select Committee for the work she has done on this? Ever since we came into Parliament together she has been championing this issue—long before it was fashionable, I might add—and she has really led the line with her Select Committee inquiry on it, to which I and other Ministers joining me on the Front Bench today, including the Minister for Digital and the Creative Industries, my hon. Friend the Member for Stourbridge (Margot James), gave evidence. With most, if not all, of the consultations we are not hanging about; they will be getting under way this year.

[Carol Monaghan (Glasgow North West) (SNP)]

This is a ticking time bomb that needs to be dealt with properly. We know that children from deprived backgrounds are twice as likely to suffer from obesity, so I first want to ask the Minister how this ties in with his plans to tackle poverty. The Scottish Government’s ambition to halve obesity in Scotland by 2030 and initiatives such as the Daily Mile are extremely important in addressing this. Those initiatives have received the backing of Jamie Oliver, who has stated that Scotland

“has picked up the baton that Westminster dropped”.

The Scottish Government will support small and medium-sized enterprises that have innovative ideas for junk food alternatives. What support will the UK Government be giving to companies founded to offer alternatives to fatty foods? Does the Minister agree that restricting the powers of the Scottish Parliament to lead the way on legislation on food safety, labelling and health claims could severely restrict Scotland’s ability to lead the way in this area?

[Steve Brine]

I thank the hon. Lady for what I think was her welcome for this. Looking at the letter on the comprehensive strategy to tackle child obesity that was sent to the Prime Minister on 25 April and signed by her leader, the First Minister of Scotland, I have ticked alongside the bullet points and I reckon that 80% or possibly 90% of the things that her leader has asked for are in this plan. She has asked about inequality, for example, and we have the lowest levels of inequality in 30 years. I am not going to get into the devolution arguments, but I will say that we welcome the North Star policy that the Scottish Government have announced, with the support of Jamie Oliver—who, I might add, has been very supportive and helpful throughout this process. We matched that, but the difference is that we have a plan for how we are going to get there.

ME: Treatment and Research

Carol Monaghan Excerpts

Thursday 21st June 2018 Westminster Hall

[Carol Monaghan (Glasgow North West) (SNP)]

I beg to move,

That this House has considered myalgic encephalomyelitis treatment and research.

It is a pleasure to serve under your chairmanship, Mr Rosindell. I thank the Backbench Business Committee for giving Members the opportunity to hold this debate.

It is estimated that around a quarter of a million people in the UK suffer from myalgic encephalomyelitis—ME. It costs the UK around £3.3 billion per annum. Although the exact cause of the disease is unknown, numerous patients report that their ME developed following a viral infection. ME is characterised by flu-like symptoms that can vary in severity from headaches and muscle aches to debilitating pain, extreme sensitivity to light and sound, and memory and concentration problems. For some, even touch is intolerable and they require tube feeding. Despite the number of people affected and the devastating effect of the disease on sufferers and their families, it is very much a hidden illness, which is characterised by some as yuppie flu and misunderstood by doctors, the public and politicians alike.

[Mr Jim Cunningham (Coventry South) (Lab)]

The hon. Lady is quite right that doctors do not research this enough and do not have adequate training to suss it out, for want of a better term. More importantly, less than 1% of children are badly affected. Does she agree that, very often, employers do not understand the illness?

[Carol Monaghan]

I agree entirely with the hon. Gentleman. It is a tragic situation when children are not able to attend school and social services become involved because they consider there to be a problem with those children’s care.

[Mark Tami (Alyn and Deeside) (Lab)]

It is particularly difficult for those who attend benefits assessments on a day when the symptoms are not as bad, because there is no acceptance that the illness can be very bad on some days, but not quite as bad on other days. Does the hon. Lady agree the benefits system must look at the longer term picture, rather than the short term?

[Carol Monaghan]

I will come on to interactions with the Department for Work and Pensions. ME patients report that energy levels vary. Sometimes, going to such an appointment can wipe out someone for many weeks afterwards. If that person were to attend the appointment the following day, their condition would be very different.

[Jeremy Quin (Horsham) (Con)]

I am delighted that the hon. Lady has secured this debate. She referred to the seriousness of ME and how many people are affected. Does she agree that for it to be taken seriously and proportionately to its scale and impact, that needs to be reflected in every area, including the amount of medical research that is devoted to ME? It is certainly a point that my constituents are concerned should be raised in this debate.

[Carol Monaghan]

ME receives practically no biomedical research funding, which I will come back to. Because of the misunderstanding of the condition, the treatments available are often more damaging to the person than no treatment at all.

Merryn Crofts was just 15 when she experienced hives and swelling in her joints after a family holiday in Majorca. Tests revealed that she had contracted glandular fever. Despite dozens of medical appointments, Merryn’s condition deteriorated; she suffered breathing problems, exhaustion and excruciating hypersensitivity to touch, light and sound. She was eventually diagnosed with ME. This once bright young woman was forced to wear an eye mask and suffered from severe migraines, brain fog, slurred speech and persistent infections. Stomach problems and difficulties swallowing meant that her weight plummeted to just 5½ stone. Merryn was eventually fitted with an intravenous nutrition line but was given a terminal diagnosis in 2016. Merryn wrote in her blog:

“Having severe ME, is like being trapped in your own body every single day. There is no rest, you are bedbound all day every day. It snatches the most simple things away from you like being able to wash yourself, even in bed. Being cared for in every way possible. In terrible pain, from everything. Not being able to talk on the phone or have visitors, and feeling worse about saying no every time someone asks again. Months and months in hospital. Severe infections. Breathing problems. Low immunity. Problems anywhere and everywhere in the body. Paralysis. Severe hypersensitivity. The list is endless, and if I was physically able to type I would carry on. Spread awareness and remember all of us and all of those who have lost their lives.”

Merryn died on 23 May 2017, just days after her 21st birthday.

Why is the treatment for people with ME so poor? The lack of understanding shown by some healthcare professionals of a person’s suffering is one of the greatest frustrations to the ME community. Much of that stemmed from the publication of the controversial PACE trial. The treatments investigated in the PACE trial were based on the hypothesis that ME patients harbour “unhelpful” convictions about having a disease and that the continuation of their symptoms is the result of deconditioning.

The PACE trial compared different treatments, including cognitive behaviour therapy—CBT—and graded exercise therapy, or GET. The results that were published in The Lancet in 2011 seemed to show that GET and CBT could bring about some improvements in a person with ME. Although that may seem positive, if we dig a little deeper we discover that the parameters for recovery were changed midway through the trial and the results depended on self-reporting. Patients have told me that they were pressurised to describe improvements they really did not feel. One participant in the original trial said:

“After repeatedly being asked how severe...my symptoms were. ..I started to feel like I had to put a...positive spin on my...answers. I could not be honest about just how bad it was, as that would...tell the doctors I wasn’t trying and I wasn’t being positive enough.”

[Robert Courts (Witney) (Con)]

The hon. Lady is making a powerful speech and is drawing attention to this much misunderstood but very serious condition. My constituents will be grateful to her for that. She made some powerful comments on the PACE trial; will she comment on the way that NICE guidelines have an impact on how the condition is viewed?

[Carol Monaghan]

I will come on to the NICE guidelines. They are under review, and all politicians can help with that. I have already written to NICE about the issue and I will ask the Minister about that later.

We now know that 13% of the participants in the PACE trial qualified at baseline as “recovered” or “within the normal range” for one of the study’s two primary measures—self-reported physical function—even though they were classified on the same measure as disabled enough to enter the study. That anomaly, which occurred because the investigators weakened key outcome thresholds after data collection, invalidates any claim that patients recovered or got back to normal. The overlap in entry and outcome criteria is only one of the trial’s unacceptable features.

For patients, the impact of PACE is severe. The recommendation of GET as a treatment for ME has provoked a backlash from patient groups, who report that many people with ME end up more severely disabled after a course of GET than before. I have spoken to people living with ME who have tried to do GET because they are so desperate to get better and have ended up in a wheelchair or bedbound as a result of this programme.

[Patrick Grady (Glasgow North) (SNP)]

I congratulate my hon. Friend on securing the debate. The turnout shows the significance of this issue to all our constituents. Her point about GET is important. It seems perverse that people should be forced to take a course of treatment that patently makes their condition worse. Does she agree that that must be reviewed?

[Carol Monaghan]

Indeed. Many people have written to me about their experience of GET, but some of the most upsetting examples are of children who were forced through a programme of GET and ended up with life-changing disabilities as a result.

[Liz McInnes (Heywood and Middleton) (Lab)]

I am grateful to the hon. Lady for mentioning my constituent, Merryn Crofts, whom I will speak about later. Merryn’s mum, Clare, said to me that Merryn was put on GET and that it made her condition worse. Everything that the hon. Lady says is backed up by the testimony that Clare gave me—I just wanted to share that with her.

[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.

[Michelle Donelan (Chippenham) (Con)]

I am co-chair of the all-party group on Lyme disease. Does the hon. Lady agree that there are many similarities between Lyme disease and ME, in that patients may be misdiagnosed and may not know where to turn, and that we need to invest in research in both those important areas?

[Carol Monaghan]

There are many conditions that we now think could be grouped under the wide umbrella of auto-immune conditions. Lyme disease, multiple sclerosis, rheumatoid arthritis and ME may all be in that group, but without research we do not know.

Some people consider ME to be a psychological condition, despite the fact that people with ME are not allowed to be blood or organ donors. Unfortunately, those who hold such beliefs often are in influential positions and have a blinkered view of the condition. I wonder what they have to fear from proper biomedical research into ME. If such research showed they were correct, their views would be vindicated. However, if it threw up new information that had an impact on ME treatment and care, as medical professionals they should surely support that.

[Sir Henry Bellingham (North West Norfolk) (Con)]

I congratulate the hon. Lady on securing the debate. Is she aware that the UK charity Invest in ME Research recently opened a centre of excellence for ME research at Norwich Research Park? That was funded by patients and carers, who raised a staggering £800,000 for what will be groundbreaking, world-class research.

[Carol Monaghan]

I was not aware of that specific centre, but I am aware that almost all the biomedical research currently taking place in the UK is funded by charities and patient groups, rather than by the Government or research councils.

Interestingly, Professor Sharpe, one of the authors of the PACE trial whom I already mentioned, emailed me this week and told me that my behaviour is “unbecoming of an MP”. I say to Professor Sharpe that if listening to my constituents, investigating their concerns and taking action as a result is “unbecoming”, I stand guilty. [Hon. Members: “Hear, hear!”] If Members of Parliament are not willing to stand up for the most vulnerable in society, what hope do any of us have?

[Scott Mann (North Cornwall) (Con)]

The hon. Lady is making an exceptionally good point about this whole challenge, and the number of Members in the Chamber is testimony to her leading an exceptional debate. Many of my constituents have written to me about this issue. Is the thrust not that the ME community needs to be listened to more broadly in the review by the National Institute for Health and Care Excellence?

[Carol Monaghan]

NICE has said that it will review its guidelines and talk to patient groups and ME charities in doing that. We must continue to urge it to ensure that that is the case, because those best placed to talk about the impact of the current guidelines and what should be in future guidelines are those living with ME.

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

Should not graded exercise therapy be removed as a treatment option even before the NICE guidelines are reviewed, given the evidence that people are being harmed by it? The Minister is hearing that evidence today. Is there not a possibility that in future a court could compensate ME sufferers if they continue to be prescribed GET, given that we, the Minister and medical professionals know the evidence?

[Carol Monaghan]

One of the big issues we have is the real lack of awareness among many in the healthcare profession. I do not want to criticise people in healthcare, and in particular GPs, who have to cover many different conditions, but that highlights why GP education and ME awareness must be increased. It is not an uncommon condition, so we really need to look at that.

What do we need to do now? First, we need properly funded biomedical research into the causes of ME and the treatment of those with ME. I recently asked a series of written questions about the level of funding into biomedical research, and frankly the answers did not fill me with confidence. Less than £1 is spent annually on each ME patient in the UK. It gets worse, because the response states that that was not solely Government funding but, as has been mentioned, from a combination of funders including many ME charities. The Scottish Government have just announced £90,000 for a PhD studentship to support research into the causes, diagnosis and treatment of ME. It would be most welcome for people across the UK if the UK Government were to follow that lead.

I am pleased that NICE is reviewing its guidelines, but, as was just said, GPs are still recommending exercise as a treatment. I ask the Minister: how is the Department of Health and Social Care supporting training for medical practitioners on ME care and treatment? The new NICE guidelines will not be published until 2020, so what representations will he make to NICE to ensure that damaging exercise therapy does not remain the main course of treatment?

In the debate on ME in February, I asked the Minister for Care, the hon. Member for Gosport (Caroline Dinenage), about working with her colleagues in the Department for Work and Pensions to ensure that new guidelines are drawn up for dealing with people with ME. What progress has been made on that? Most importantly, will the Minister support proper funding for biomedical research into the diagnosis and treatment of ME? I understand that money is not usually ring-fenced for particular conditions, but, considering how poorly funded biomedical ME research has been up to now, what steps will the Government take to address that?

I thank all hon. Members who have delayed returning to their constituencies to speak up for those with ME. Their support is appreciated and welcomed by those here today, and by the wider ME community. I also thank the ME charities and campaigners who have briefed us all so thoroughly, and the Countess of Mar for her relentless campaign for improved treatments for ME.

ME is a condition that it is all too easy for us to ignore. Those afflicted by it are often unseen by society, but many hon. Members are in the Chamber because they have been approached by affected constituents. I thank all of those who have brought the condition to our attention. ME has a devastating impact not just on its 250,000 sufferers but on families and carers, too—it has a far wider impact. Ultimately, as politicians we must remember that statistics are simply patients with the tears wiped away.

--- Later in debate ---

[Jim Shannon (Strangford) (DUP)]

It is a pleasure to speak in this debate. I congratulate the hon. Member for Glasgow North West (Carol Monaghan) on advancing a comprehensive and compassionate case on behalf of ME sufferers and I congratulate her on encapsulating the issues so well. Her constituents will be very proud of her; she can be assured of that.

As someone who has had the opportunity to speak on behalf of ME sufferers over the years, before I came here in 2010, one frustration of my former life as a councillor and as a Member of the Northern Ireland Assembly was that if I put “ME” on a disability living allowance form, as it was then, that I was filling in for a constituent, and went to the GP and said, “I need a wee letter to support this person who has ME”, they would say, “They have what?”, and I would have to explain. That is in the past now, thank goodness, and I can honestly say that in the past few years there has been a better understanding from GPs and doctors in my constituency. They have come round from not understanding ME to understanding it, so when someone needs a form to be filled in, it is filled in right; if they need a support letter, that happens too. That is very important.

It was my pleasure to support the hon. Member for Glasgow North West at the Backbench Business Committee, so I wanted to make a contribution today.

[Carol Monaghan]

I should have paid tribute to all hon. Members who supported my application for the debate, and who came along to make representations to the Backbench Business Committee, like the hon. Gentleman. I see several of them present, and I thank them.

[Jim Shannon]

We are always very pleased to support the hon. Lady’s proposals to the Backbench Business Committee.

This is an emotive issue. Many constituents have contacted me in anger, frustration and hurt as they simply feel that their illness is not understood and that successive Governments and some in the Department of Health and Social Care have shown no desire to gain an understanding—I say that respectfully, and I understand that some might say that healthcare is devolved. That is not the case for everyone, but it is certainly how many of my constituents have said that they feel.

We are fortunate to have a Minister who has a deep interest in this subject matter. He is in deep conversation with his Parliamentary Private Secretary, the hon. Member for South Suffolk (James Cartlidge), at the moment, but I am sure he will turn round shortly and be aware of my contribution. I am sure that he will respond constructively.

I want to thank MEAction, Action for ME, the ME Association, the ME Trust, Blue Ribbon for the Awareness of ME, the Centre for Welfare Reform, Forward-ME, ME Research UK, the Welsh Association of ME and CFS Support and Hope 4 ME Fibro NI in particular. All those organisations—there are lots of them—have furnished us with lots of information, and I thank them. I particularly thank one constituent, Sally Burch, who ensured that I had all the details and information to help me. She comes to see me regularly and fills me in on all the details.

ME is a chronic fluctuating neurological condition that causes symptoms that physically affect many bodily systems, commonly the nervous and immune systems, and affects an estimated 250,000 adults and children in the UK, as other hon. Members have said—it is not just an illness in adults. Approximately 7,000 people in Northern Ireland and about 17 million people worldwide have ME.

--- Later in debate ---

[Kerry McCarthy]

Yes. This is the problem we see over and over again with NICE: how do we value quality of life? We can look at the economic opportunities that are also lost if someone has to spend a lifetime on benefits rather than working and paying taxes, but there is so much more that they could perhaps have contributed to society and that opportunity has simply been lost.

In the time that is left to me today, I will mention the benefits system. We have already heard from other Members about it. Time and time again, we see that the assessments for employment and support allowance and for the personal independence payment just cannot cope with people who have fluctuating conditions, or with people who might be able to pass a test but who feel absolutely dreadful afterwards.

My friend scored zero on the test because she was trying to be as honest as possible, and if she was asked whether she could walk up a flight of stairs, she would reply that she could. However, on a bad day it would probably take her an awfully long time and she would collapse in a heap at the top. Actually, one of the reasons she was turned down when she went for the face-to-face assessment was that the examiners said, “Well, you look very presentable and you’ve washed your hair.” I know that she is bedridden for days at a time and cannot wash her hair, but clearly if she drags herself out for an assessment and is well enough to attend it on a particular day, she will try not to look like she has just got out of bed.

[Carol Monaghan]

Does the hon. Member agree that such questions are entirely unsuitable for people with many conditions but particularly for ME sufferers? “Can you walk up a flight of stairs?” “Yes, but it wipes me out for three weeks afterwards.” The examiners are not interested in the “but”. That does not figure in the questions.

[Kerry McCarthy]

Yes, we need a system that is sensitive to the people who are taking the test, rather than being a series of tick-box exercises—yes or no.

Action for ME gave some interesting evidence to the Work and Pensions Committee when it conducted an inquiry into ESA and PIP towards the end of last year. Action for ME cited one case study of a man who, as well as having ME, is registered blind; he can only just perceive some light. He said, “I’m not disabled by blindness. In comparison to living with ME, my blindness is just an inconvenience.” When it came to the assessment, of course, his blindness scored maximum points, but his ME did not register at all. He said, “Actually, with my blindness I can still go out and walk my dog, but it’s the ME that means I’m housebound. With blindness, I can use audiobooks, but my ME means that I just can’t concentrate for any period of time.” But one condition is accepted as a disabling condition, while the other is not. There is a perception that ME is just about being tired all the time but, as one ME campaigner said:

“The difference between ME and just feeling tired is the same as the difference between having a shower and drowning.”

I was going to mention the case of Merryn Crofts, but my hon. Friend the Member for Heywood and Middleton (Liz McInnes) is here and she is her MP. That is clearly an incredibly tragic case—the second person in the UK to have ME recorded as the reason for death on her death certificate.

Instead, I will conclude by mentioning the documentary “Unrest”, a screening of which I attended. Jennifer Brea, a 28-year-old ME sufferer, documented her condition with a camera when doctors told her that her illness was all in her head. Using Skype, she connected with others around the globe suffering with ME, and documented their plight. It is a powerful and moving documentary about the realities of life for many people with severe ME, and I would encourage anyone who is looking to gain a better understanding of the illness to watch it.

[Stephen Kerr (Stirling) (Con)]

It is a pleasure to serve under your chairmanship, Mr Rosindell. I pay tribute to the hon. Member for Glasgow North West (Carol Monaghan) for this campaign, which she is doing a superb job of leading. I cannot remember the name of the academic who wrote to her reproaching her for the stance she has taken in the campaign, but I say to her, I think on behalf of us all, that she is doing exactly what an MP should be doing, and shame on anyone who says otherwise.

I specifically compliment the hon. Lady on her presence at the recent Edinburgh event with the hashtag #MillionsMissing—a global day of action. The purpose of that event was to raise awareness, to highlight the need for support for ME sufferers, and to call for investment in healthcare and biomedical research, which is an excellent summary of the purpose of today’s debate. As has been mentioned, every participant in that event was invited to bring a pair of shoes, but what touched me deeply in the event publicity was that those pairs of shoes symbolised the millions of patients who are missing from their lives because of this devastating disease. The phrase “missing from their lives” deeply touched me.

I rise to speak just for a few minutes to highlight the experience of those who are affected by ME. As my hon. Friend the Member for Cheltenham (Alex Chalk) said, their evidence is compelling and should be a primary consideration. It has been upsetting for me to hear how many people, including those in the medical profession, are unaware, or lack a detailed understanding, of ME. Many persist in believing that the disease is some form of mental illness or neurological disorder. A constituent in Stirling told me that as recently as 2011 they were told, “There is no such thing as ME,” after collapsing at work. She has since been diagnosed with severe ME.

There are many distressing stories about the treatment of people suffering from ME. Another of my constituents was told repeatedly by different doctors that her ME was a psychological problem, and was referred on multiple occasions for psychological assessments. It took her two and a half years to get a proper ME diagnosis.

[Carol Monaghan]

Does the hon. Gentleman share my concern about the aspect of “medically unexplained symptoms” diverting ME down the psychological path?

[Stephen Kerr]

I absolutely agree, and I thank the hon. Lady for her intervention.

I cannot speak too highly of Helen Hyland, a constituent of mine, who has done so much to raise awareness of the condition across the UK in her role within the ME Association. She has also done so much to educate me as her Member of Parliament about this disease. Soon after my election as the Member of Parliament for Stirling, Helen reached out to inform me of what I could do to help the campaign. I am grateful that my office and I have been able to work with her to highlight ME to GPs in Stirling. I am not sure how they have responded to a letter from their Member of Parliament advising them to be careful about how they diagnose those who have the symptoms of ME; I am sure that is a different story.

Helen has been involved with the ME Association since her husband took his own life, a year after being diagnosed with ME. The way she told her children, who were very small at the time, of her husband’s passing outlines how hard ME is to cope with. She said:

“Imagine a Dr Who monster getting inside and taking over Daddy’s head and body. The harder Daddy fights, the harder the monster fights back. The monster always wins”.

For people with ME and those around them, the diagnosis is crucially important. To be told that they have a medically recognised condition is validation for them, yet there is still so little known about this illness. There is no easy way of diagnosing it, no clear treatment, and no known cure. That has to change. Along with many others, I will continue to support the ME Association and any campaign that pledges itself to combating ME.

I will now turn to the first-hand account of a lady called Jules Smith, who wrote to me and asked me to make her voice heard in this afternoon’s debate. I will do that because her story, as touching as it is, is not her story alone, but the story of many others. She wrote to me:

“For over ten years I was a therapist and devoted my life to helping others as best I could.

I first became ill about 8 years ago but kept going and put it down to general aches and pains. I finally had to give up what I loved in November 2016 with a final diagnosis of severe ME in May 2017.

I’ve been to psychology to be told it’s all in my head, pain management to be told to push through the pain and physiotherapy who told me my muscles were so weak there was nothing they could do!

I’ve been on so many prescribed medications and vitamins; last year I was taking in excess of 22 tablets a day and yet I would still crash.

I am 90% house and bed bound and my GP has exhausted all avenues for me therefore—as I was told—‘you must try and manage your illness as best you can.’

I had been told that graded exercise therapy would help me starting off by stretching then low impact sports like walking. I’m an ex-runner who was capable of running a 10k every week so I was familiar with pushing through the pain barrier and grading my exercise but it has made me more severe. I feel like my life is just wasting away; I get all my prescription medications on repeat, I get a telephone appointment with my GP every once in a while, and that’s it!

My husband works long shifts with the Scottish Prison Service and I’m home alone for at least 10 hours a day; sometimes I have to crawl on my hands and knees to get to the bathroom and I can go days on end without being able to bathe or shower as I’m just too exhausted to move!

I feel like so many others that we are just left to rot; I feel like my mental health is now suffering as I become more and more isolated from society and there’s no one to help me and many others just like me.

I am severely fatigued to the point that I cannot stand upright otherwise I get so dizzy I’m about to faint. I also have severe laboured breathing but there’s nothing recommended but rest and resting doesn’t cure ME.

I don’t wallow in self-pity. I spend what time I can online being an advocate for Action for ME and Millions Missing Scotland and whenever I can, I offer support to other members of the social media groups I am in and share my stories and experiences.

I have a devoted and caring husband who does everything he physically can to look after me but it’s tough when I’m home alone for so long with no care.

I try to do what I can to keep my spirits up but on days when I crash for no reason and I can’t watch TV, or read a book, I have to have my curtains drawn and be in a darkroom. Sometimes I even need soft silicone earplugs to block out any noise as I get cognitive dysfunction too!

This is not living Stephen this is just existing!”

I thank Jules for allowing me to share her story in the debate. I am grateful and feel privileged that I was allowed to let her voice be heard today in Parliament.

--- Later in debate ---

[Steve Brine]

He is nodding. It is important that we raise awareness and educate people, including me, about the condition and its impact on people’s lives.

I will now turn to the two issues that have primarily been debated today, research and treatment. On research, the Government invest more than £1.7 billion a year in health research via the National Institute for Health Research and the Medical Research Council through UK Research and Innovation. The NIHR and MRC welcome high-quality applications for research into all aspects of CFS and ME, which would certainly include the biomedical research that the hon. Member for Glasgow North West spoke about in her opening remarks.

Since 2011, the MRC has funded seven projects on CFS/ME totalling £2.62 million, and it is ready to support further applications of the highest scientific quality, which is required to make those scientific breakthroughs. My hon. Friend the Member for North West Norfolk (Sir Henry Bellingham) is no longer in his place, but he spoke about the Norwich Research Park—didn’t he push that a few times?—which sounds very promising. I look forward to hearing more about it, and I feel certain that he will tell me.

The MRC has had an open cross-board highlight notice on ME since 2003. It was updated in 2011 alongside a bespoke funding call in that year. ME research remains an area of high strategic importance for the MRC. Applications that focus on the underpinning mechanisms of ME are encouraged, with priority areas including immune dysregulation—[Interruption.] Sorry, I am distracted by someone shouting about stopping something outside—I think he is saying, “Stop ME!”. The priority areas include pain, improved sub-phenotyping and stratification of ME, and mechanisms of ME in children and young people.

A number of people mentioned the late Baroness Jowell. I was very privileged to meet her. I did so just the once, but I was left in no doubt about her resolve on the issue of brain tumours. Let me say in reference to her and to the research environment that, as my Parliamentary Private Secretary, my hon. Friend the Member for South Suffolk (James Cartlidge), reminded me, that journey started around the time of a Westminster Hall debate. Perhaps that is a good sign.

Our challenge with brain tumour research is the lack of high-quality research proposals that have come forward. The late Baroness Jowell was passionate about stimulating the research community to get that situation changed, and we have latched on to that. That is one of her great legacies. I would hazard a guess that her greatest legacy is yet to be reached, but that is one reason it is important to mention her today.

The NIHR has, since 2011, provided £3.37 million of funding for projects and training on ME. That might not be termed biomedical research, but as with other disorders, given that the cause and mechanisms of the condition are still poorly understood, it is important that we carry out both biomedical research, to further our understanding, and applied health research, to improve the treatment offered to people with ME now and to help to improve their symptoms and quality of life.

The NIHR and the MRC recognise that ME is a debilitating condition and are working with the UK CFS/ME Research Collaborative, which was mentioned towards the end of the debate, and with patient representatives on how best they can support a joined-up approach to encourage high-quality research into this complex disorder. I mentioned that Baroness Jowell is a good example of how to start such research. They hope to be able to update colleagues on those discussions by the end of the year, and I for one will look keenly for that update.

For Members who do not know about that important collaboration, it was set up in 2013 to promote high-quality basic and applied research into ME. The CMRC brings together researchers, major funders and charities, and provides them with a mechanism for working together in a co-ordinated and collaborative way, increasing awareness of ME in the research community—that is so important if we are going to stimulate applications—highlighting priorities for research funding and increasing such funding. Both the NIHR and the MRC sit as observers on the CMRC board.

Everyone who contributed to the debate spoke passionately, but the hon. Member for Ealing North spoke particularly passionately, and I liked his point about humanity. This is a matter of good Christian humanity in many ways.

The Royal College of General Practitioners oversees GP training in England. It provides an online course for GPs and other primary care practitioners that includes an overview of the presentation, diagnosis, assessment and ongoing management of ME. The course highlights common misconceptions about ME and considers the challenges that surround that complex condition for patients, carers and primary care professionals. It is produced as part of the METRIC study, which is funded by the NIHR.

Of course GPs can always know more and learn more, but let me speak up for them for a moment. They are called “general practitioners”. Be a GP for a day—it is incredibly difficult to know everything about everything and to be a master of all. General practice is, though, where most patients with ME are likely to be managed, certainly in the first instance. The condition is identified as a key area of clinical knowledge in the RCGP applied knowledge test content guide. The AKT is a summative assessment of the knowledge base that underpins general practice in England and a key part of GPs’ qualifying exams.

Although I understand hon. Members’ points about raising awareness among medical professionals, and as a result of the debate I will redouble my efforts to do that as part of my role as Minister for primary care, all GPs certainly should be aware of ME, and should maintain their clinical knowledge of it and other conditions, as part of their commitment to continuing professional development. Indeed, I have resolved—I have already sent a note to myself—to send a copy of the report of the debate to Professor Helen Stokes-Lampard, who currently leads the RCGP, and to ask for the college’s latest thinking about this subject.

Before any medical condition can begin to be treated, it must be diagnosed. That goes to the heart of our challenge. As the symptoms of ME often resemble those of many other debilitating illnesses—we heard about Lyme disease—there is no test with which to make an accurate diagnosis. ME, therefore, is not always easy to diagnose, to put it mildly. Diagnosis relies on clinical observation of symptoms by healthcare professionals. We understand that that can be frustrating, to put it mildly, for patients—and, it must be said, for their clinicians.

People with ME should be referred to a specialist service, where care should be based on their needs, on the type, complexity and severity of their symptoms, and on the presence of co-morbidities. That decision should be made jointly by the patient and their healthcare professionals. As the shadow Minister said, referral to specialist ME care should be offered within six months of presentation to people with milder symptoms, within three to four months of presentation to people with moderate symptoms, and immediately to people with severe symptoms. Clinicians are responsible for advising patients about available treatment options.

Of course I am aware that access to services for those with severe ME is a big and ongoing issue. Under the Health and Social Care Act 2012, the configuration of services is a matter for local NHS commissioners, who have to be best placed to deliver services for their area. A number of Members referred to the report of the chief medical officer’s independent working group on ME, which was published in 2002. Following that, a central investment programme of £8.5 million was established to address the service gaps across England—I am responsible for the NHS in England. That included the establishment of 13 centres of expertise across the country, 36 multidisciplinary community teams for adults and 11 specialist teams for children and young people, and facilitation of access to advice on clinical management for patients, families and health professionals.

Linked to that—the Department is, of course, now called the Department of Health and Social Care—the vast majority of people with severe ME and their families will come into contact with social care services at some point. The Care Act 2014 requires a local authority to carry out a needs assessment where an adult or carer appears to have care and support needs. The local authority must then decide whether the person has eligible needs by considering the outcomes they want to achieve, their needs, and how those impact on their overall wellbeing. Where a person is assessed as having eligible care and support needs, those must be met by their local authority.

Let me say some more about children and young people, who were mentioned by a number of Members. There is a powerful moment in “Unrest” where a young lady is celebrating her birthday. She says, “I remember my 16th birthday in this bed, and my 17th birthday, and my 18th birthday”—and she goes on through; I think she was celebrating her 22nd birthday in the film. Although access to services was raised, I know that access to education is also a huge issue for children and young people with ME.

All schools have a legal duty to make arrangements to support pupils with a medical condition in school. Guidance to schools states that they should put in place arrangements that show an understanding of how medical conditions affect a pupil’s ability to learn and give parents and young people confidence in the school’s ability to provide effective support for their condition. Children and young people with ME should have an individual healthcare plan, which should normally be drawn up in partnership with the school, healthcare professionals, parents and the young person, and should be tailored to their needs.

Schools and other services should work together to ensure that children and young people with ME receive an education that is flexible and appropriate. That could mean programmes of study that rely on part-time attendance, in combination with alternative provision or home schooling, which was mentioned. Consideration should also be given to how children and young people are integrated back into school after a period of absence, when they are feeling better and, hopefully, more able physically to cope.

A lot was said about NICE guidelines, which are clearly a sensitive topic and a source of much unhappiness among Members and the wider ME community. According to NICE guidelines, recommended treatments for ME include cognitive behavioural therapy and graded exercise therapy. I know that many patients disagree with those treatments, and we heard powerful testimony about that. The NICE guideline is clear that there is no one form of treatment to suit every patient; that the personal needs and preferences of the patient should be taken into account; that doctors should explain that no single strategy will be successful for all patients; and that, in common with all people receiving NHS care, ME patients have the right to refuse or withdraw from any part of their treatment that they do not agree with or they think is doing them harm.

As we heard, the NICE guideline is being updated—a jolly good job, too. NICE will look at the current evidence base, including the PACE trial, which has been debated at length in the House before. Of course, we welcome NICE’s decision to undertake a full review of ME guidelines. Many of the ME charities we have heard about today are registered to take part in the guideline development process, but NICE is the independent expert body responsible for developing robust, evidence-based guidance for the NHS to design services that are in line with the best available evidence, and no one should hide from the evidence. It would be inappropriate and wrong for Ministers to interfere with the process, but I feel sure that NICE will be listening to the debate and taking a keen interest in it.

[Carol Monaghan]

The Minister has rightly said that any patient has the right to withdraw from medical treatment. However, when the DWP is saying that patients must undertake graded exercise therapy, and when health insurance companies are saying that they must undertake graded exercise therapy, it puts the patient in a very difficult position.

[Steve Brine]

I fully appreciate that point—the hon. Lady put it on the record very well earlier—which takes us on very neatly to welfare benefits.

The hon. Members who requested the debate also flagged the issue of benefits. I know they would like, and are having, an ongoing conversation with the DWP. I am clearly not a DWP Minister—they wanted a Health Minister to respond to the debate, and that is what they have. The DWP obviously recognises that ME is a real and disabling condition. Entitlement to benefits depends on the disabling effects of the condition, which of course must be taken on an individual basis. When assessing claimants, healthcare professionals are expected to be mindful of the fact that many illnesses—including ME—produce symptoms that vary in intensity over time, and they are instructed not to base their opinion solely on the situation observed at the assessment. The DWP assures me that all healthcare professionals are required to read an evidence-based protocol on ME as part of their training, as well as engaging in a programme of continuing medical education that includes modules on the condition.

From what I have heard today, Members clearly feel that that is not happening— certainly not in a consistent way. I will take an action from the debate to send a copy of what has been said to the relevant Minister—I believe it is the Minister for Disabled People, Health and Work, my hon. Friend the Member for Truro and Falmouth (Sarah Newton)—at the DWP. However, I encourage members of the all-party group to seek more and continuing engagement with the DWP on this issue. I will certainly follow that up with them.

Once again, I thank the hon. Member for Glasgow North West, who opened the debate, and her colleagues who secured the debate through the Backbench Business Committee for raising the issues of ME research and treatment on behalf of those affected—their constituents and mine. I welcome this and all other opportunities to raise awareness within the House. Ultimately, raising awareness is what we can do, and that can lead to action and real change, as we saw within the brain tumour community.

I thank the ME charities—they are very active in my part of the world, in Hampshire—for their continuing work in this area. What has been fascinating today, as always with debates in my portfolio, is that I have not heard one single person mention their party political colours. There really is no politics in ME, and nor should there be. I want to see us come together at our true, cross-party best to focus on the needs of people with ME and see if we can move the research agenda forward in this area.

I think the hon. Member for Glasgow North West said in her opening remarks that professionals should welcome research, because evidence-based treatment is ultimately the basis of their training. I welcome such research. I echo what has been said, and on the email that she read out earlier—clearly, I have not seen it and have only heard her reporting of it; I think she will give it to me afterwards—I hope that that will be the second apology received as a result of my remarks today. I look forward to being copied into that.

As I said earlier, the NIHR and MRC are speaking to the UK CFS/ME Research Collaborative and patient representatives about how they can best support a joined-up approach to high-quality research into this complex disorder. I hope they will update colleagues about those discussions later in the year. I will end with what Jennifer said right at the end of “Unrest”:

“every book I read…said, ‘when you fall ill, either you...find the cure or die trying.’ It always ends in triumph or tragedy. But that’s not my story—at least not yet.”

That is how she put it.

[Carol Monaghan]

I thank hon. Members once again—Thursday afternoon is not an easy time to stay behind for a debate, and I really appreciate the fact that they have done so. I also appreciate the great support from the people in the Public Gallery, many of whom are living with ME. It has been tough enough for us to sit here for three hours, so it must have been a hard slog for them. I hope they do not feel the impact of the debate too badly over the next few days.

I have been following the debate on Twitter, and it has been interesting to see the messages of support coming in for individual Members. People really are watching and were interested and encouraged by what they heard. Although we are talking about treatment and diagnosis in the UK, the repercussions are far wider. Messages of support have been coming in from Norway, Canada, the United States and right across Europe. ME affects people worldwide, and I hope the debate has given them some hope.

The debate was about more than just raising awareness. Members asked specific questions, and I am glad the Minister said that he would work with the DWP to draw up guidelines for people with ME. We will all watch that with interest, and perhaps some parliamentary questions will go in as a result.

I was also a bit disappointed. The Minister, who is a compassionate person, talked about funding, and I think he said that the Medical Research Council is putting £2.6 million into ME research. Unfortunately, that is not for biomedical research—or little of it is. I quickly googled and found that a new research programme is taking place at Bath University, but, once again, it is at the department of psychology. That is where we have the trouble: it is not a psychology department that needs to be doing research, but a medicine or biomedical sciences department.

Members have spoken passionately on the ME community’s behalf, and once again I thank everyone here this afternoon. I do not see this as the end. The fight for people with ME both here and across the world continues.

Question put and agreed to.

Resolved,

That this House has considered myalgic encephalomyelitis treatment and research.

Oral Answers to Questions

Carol Monaghan Excerpts

Tuesday 19th June 2018 Commons Chamber

[Mr Hunt]

Of course I am happy to meet my hon. Friend. I recognise that this is one of the things that we are not good at at the moment. We have fantastic research, with amazing new drugs developed in this country, but our uptake can be painfully slow, and that is of course something that we want to put right.

[Carol Monaghan (Glasgow North West) (SNP)]

ME affects approximately a quarter of a million people across the UK, and while there has been substantial psychological research into the condition, there has been very little biomedical research. What funding will the Secretary of State make available specifically for biomedical research into the treatment and diagnosis of ME?

[Mr Hunt]

I am grateful to the hon. Lady for raising that issue. She is introducing a debate on it in Westminster Hall on Thursday. I have met a number of families who have suffered very badly as a result of ME, and we would all like better research, so I hope that her campaign is successful.

Oral Answers to Questions

Carol Monaghan Excerpts

Tuesday 8th May 2018 Commons Chamber

[Jackie Doyle-Price]

I am happy to associate myself with the comments of my hon. Friend and those of the Prime Minister. We should leave no stone unturned in making sure that we recruit enough paediatricians to support the service. I reiterate that every effort will be made to ensure that that happens.

[Carol Monaghan (Glasgow North West) (SNP)]

22. Scotland recruits many health professionals from overseas, and that is particularly important for the delivery of healthcare in rural areas. Does the Minister agree that Scotland needs overseas doctors and nurses? What representations has she made to the Minister for Immigration regarding the lifting of the tier 2 visa cap?

[Jackie Doyle-Price]

The hon. Lady will understand that the impact on the workforce is of as much interest to us south of the border as it is to her. We continue to engage in representations with colleagues to address such matters.

Surgical Mesh

Carol Monaghan Excerpts

Thursday 19th April 2018 Commons Chamber

[Carol Monaghan (Glasgow North West) (SNP)]

I congratulate the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) on securing this debate and on the power of work that she has done on behalf of the women affected by mesh. I also pay tribute to the chair of the all-party parliamentary group on surgical mesh implants, the hon. Member for Pontypridd (Owen Smith), for his work. I declare an interest as a member and vice-chair of the group. In the run-up to this debate, I have been contacted by many constituents whose lives have been devastated by mesh. Because of the sensitivity of the topic and the embarrassment that many women feel, it is a major step for them to come forward and speak so bravely about their experiences. For these women, what started as a slight leakage of urine and an embarrassing discomfort has escalated into life-changing disabilities, and I want to use this speech as an opportunity to raise some of their cases.

My constituent, Karen, underwent a hysterectomy in 2008. The following year, she suffered a significant prolapse and was given a pelvic organ mesh. After that procedure, she began to suffer from severe incontinence, which affected her ability to work. She mentioned this to the consultant, who said that there was a simple procedure that would help. She had that procedure, but was given no further information about the risks and possible complications. In 2011, she started to experience severe pain and was referred to a new consultant, who told her that the pain had nothing to do with her implant. She finally had the implant removed in 2013, but has been left severely disabled and now has to use a wheelchair when she travels long distances. This has been a real problem for her because, she says, people talk to the person who is with her, rather than to her. She therefore feels as though she has been dehumanised as a result of this as well. Had Karen been told what the mesh procedures entailed, she would never have agreed to have the implant. She and a group of survivors in Scotland have set up a Facebook group. It started with 17 women, but it now has more than 500 members.

Another constituent, Jean, had her implant inserted in 2006, but she realised from day one that it had not worked and that she was still incontinent. She says:

“The full side effects of having polypropylene plastic TVT-O are as yet unknown. What is known is removal is complicated and carries its own risks, due to the fact that the mesh implanted in the woman’s pelvic region is designed to be permanent. In cases where a surgeon does a partial removal and leaves the rest then the long term result can be further degradation and an acceleration of mesh debris into the body. To remove the Monarc sling that I have, a surgeon has to cut through many structures including bone and muscle, and is known to be nearly impossible to remove safely without further damage.”

In fact, one consultant has described mesh removal as being like trying to remove warm chewing gum from someone’s hair.

At the most drastic end of the scale, some women now face losing their organs as a result of this procedure. This has happened to Claire, a mum of three, who says:

“I had a mesh implant in September 2011 for stress incontinence. I woke with excruciating pain and struggled to walk. I had the mesh removed in July 2015 but unfortunately the damage I suffered is severe. I am now disabled for life. I use crutches for short distance, wheelchair for longer. My nerves are severely damaged, I have autoimmune issues, foreign body reactions, currently use anal irrigation system for my bowel as it can’t work on its own. Next for me is to have my bladder and bowel removed. Mesh products are simply not fit for use in the human body. These procedures need to be stopped now.”

Cathleen, from Benbecula, a constituent of my hon. Friend the Member for Na h-Eileanan an Iar (Angus Brendan MacNeil), has said:

“The Government is currently banning the use of plastic because of damage to the environment, destroying sea life and leaching into the food chain. Why on earth place such plastics into the human body when I like many others have suffered mesh erosion as my body rejected the polypropylene?”

The issue that is raised repeatedly in all these cases is the lack of information given to patients. Some were told that the procedure was simple; others were told that a little piece of tape or a sling would be inserted. None was told about side effects or complications. Most were not offered non-mesh procedures, which might cost slightly more in the short term but which would have massive savings in the long term because these women would not need to live on benefits, having had to give up work, with all the other problems that that entails.

In Scotland, the suspension of mesh has been welcomed, but because the regulation of such devices is still a reserved issue, we need the MHRA to stop recommending the use of mesh before it can be banned outright. Medical devices do not go through the same rigorous level of testing as drugs, and the effects are often not experienced immediately. This is why it is so important to carry out an audit of the women who have had the procedure. I welcome the review of surgical devices announced by the Government, as well as the announcement that they will conduct a full registry of all mesh procedures. However, it should be noted that the number of women affected may well be far higher than estimated. Many women who experience problems are told that their issues are not mesh-related. Are those women’s problems being captured in the current mesh figures?

[Gordon Marsden (Blackpool South) (Lab)]

I, too, have constituents who have been affected by this, and one of them has written to me to say:

“I had this operation carried out—it was only effective for a few months and had failed, leaving me with constant discomfort…The operation itself was a long one and I have so far managed to put up with this discomfort as I really don’t want further surgery.”

Does the hon. Lady—and indeed the Minister—have any thoughts on how many people might be going under the radar because they are in a similar situation to my constituent?

[Carol Monaghan]

I thank the hon. Gentleman for his intervention. That concern has been raised time and again in the all-party group. We believe that many of the women affected are not being captured in the figures, and it is important that we should carry out an audit to find out what is going on. That audit should include GP visits and visits to consultants. They should all be part of it.

Mesh implants have been described as the “gold standard” treatment for incontinence and as a “minor procedure” that would change lives. Sadly, the procedure did change many lives, and crucially, the device manufacturers who have marketed mesh so aggressively are making a profit on it. For the women affected, the manufacturers’ profits have come at a heavy price. My hon. Friend the Member for Argyll and Bute (Brendan O’Hara) has been working closely with a constituent, Nancy from Dunoon, who was left suicidal after having mesh implants several years ago. Four months ago, Nancy underwent an operation to have the mesh removed, and I am sure the whole House will join me in wishing her a full and speedy recovery. She has said that

“if they’d discovered this kind of serious fault in a car, they’d have recalled them all and stopped making them. So why didn’t they do that with mesh?”

It is important that we now have a complete suspension of mesh implants. Also, a number of Members have mentioned that physiotherapy should be offered as standard for new mothers, to give them other methods of dealing with slight incontinence and to help them to restore their core after birth. Many mesh survivors are now calling for a sunshine payment Act, as there is in America, that lists all industry funding, sponsorship or grants received by GPs and surgeons. This would show any conflicts of interest, and it would help with all medical issues, not just mesh. Finally, I would like to pay tribute to the campaigners from Sling the Mesh and from Scottish Mesh Survivors for all their work in bringing this issue to the attention of the wider public and to the attention of us here in this place.

PACE Trial: People with ME

Carol Monaghan Excerpts

Tuesday 20th February 2018 Westminster Hall

[Carol Monaghan (Glasgow North West) (SNP)]

I beg to move,

That this House has considered the PACE trial and its effect on people with ME.

It is a pleasure to serve under your chairmanship, Mr Hollobone.

“The doctor doesn’t see me crawl on the floor. The doctor doesn’t know I don’t shower every day or brush my teeth twice a day like everyone else. He isn’t aware of my frequent sore throats, my poor balance, my difficulties with reading, my muscle twitches, or my sound intolerance, and he certainly wasn’t here to nurse me when once I was too weak to eat.”

Those are the words of a junior doctor living with ME, who alongside nearly 1,000 others has contacted me prior to this debate.

Myalgic encephalomyelitis, or ME, has been described in many ways, but labels such as chronic fatigue syndrome or post-viral fatigue syndrome simply do not come close to the living hell experienced by many ME sufferers—a hell that is made worse by the lack of understanding that is faced when seeking help.

ME is estimated to affect about 250,000 people in the UK and is classified by the World Health Organisation as a disease of the central nervous system. Symptoms can include debilitating muscle pain, severe headaches that are often made worse by light or noise, significant impairment of short-term memory and post-exertion malaise that can last days and even weeks.

[Jim Shannon (Strangford) (DUP)]

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?

[Carol Monaghan]

I thank the hon. Gentleman for his intervention. I will come on to the NICE guidelines later in my speech.

Although ME is a pathological, not psychological, condition, much about it remains a mystery. The reasons for that are twofold. First, many sufferers are housebound and therefore easy for society to ignore. Secondly, there is a lack of awareness among medical professionals and as a result a woeful lack of quality research. What we do know is that ME is often triggered by a viral infection such as flu, but, unlike healthy individuals, people living with ME do not recover. Into that research drought entered the PACE trial—pacing, graded activity and cognitive behaviour therapy; a randomised evaluation.

The trial was unique in medical research. It was funded by the Department for Work and Pensions to the tune of £5 million, a point to which I will return. From the very start the PACE trial was flawed. In contravention of the World Health Organisation classification, it assumed that ME was psychological and sufferers could recover if they chose so to do. Thus the PACE trial was framed in psychological terms.

[Mr Jim Cunningham (Coventry South) (Lab)]

I thank the hon. Lady for securing this important debate. Does she agree with me that a lot of employers do not really understand how people with ME suffer and that that can affect their employment? It can also affect housewives.

[Carol Monaghan]

Absolutely. The public perceive it as mere tiredness, but it is so much more than that. The debilitating pain that ME sufferers experience is something that we all should be aware of.

The participants in the PACE trial received a range of different treatments, including cognitive behaviour therapy and graded exercise therapy, where patients were encouraged to become physically active and then increase the activity’s intensity. Unbelievably for a trial this large, none of the groups was given specific medical interventions. The results were published in The Lancet in 2011, with the contentious claim that CBT and GET brought 30% of patients back to normal, while 60% improved. The media reported that all ME sufferers had to do to recover was exercise. However, the report was immediately questioned by the patient community. How could exercise, the very thing that was known to worsen symptoms, actually help?

[Alex Sobel (Leeds North West) (Lab/Co-op)]

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.

[Carol Monaghan]

I thank the hon. Gentleman for his intervention. It is typical, because the PACE trial had such publicity and was lauded by many as the answer. One participant in the original trial has contacted me:

“I was determined to be a part of the...trial because I wanted to get better—so if this ‘treatment’ could make me better I wanted to give it the chance to do so. I was assigned Graded Exercise Therapy. It never occurred to me that it would actually make me more ill. Nor did it occur to me that decline would not be documented, and that despite patients not recovering (or in some cases worsening), they would publish that the treatment was successful...It was stressed that I would only get better if I tried harder, and even though the graded exercise was clearly making me worse, my struggle and pain was dismissed.”

[Rachael Maskell (York Central) (Lab/Co-op)]

As a former physiotherapist, I recognise that all therapeutic interventions must be patient-led—led by people with the lived experience. Does the hon. Lady agree?

[Carol Monaghan]

Absolutely. In fact, I will be calling for the patient voice to be heard in any treatments.

Calls to publish the raw data—basic protocol in good research—were ignored. Queen Mary University spent an estimated £200,000 on keeping the data hidden. Finally, after a long battle, patients won a court order to force the PACE authors to release the data. It was discovered that the authors had altered the way in which they measured improvement and recovery, to increase the apparent benefit of the therapies. Re-analysis showed that the improvement rate fell from 60% to 21% and the recovery rate fell from 22% to just 7%.

The method of patient reporting has also been questioned. As one participant says:

“After repeatedly being asked how severe...my symptoms were—in the context of…it’s just me not trying hard enough...I started to feel like I had to put a...positive spin on my...answers. I could not be honest about just how bad it was, as that would...tell the doctors I wasn’t trying and I wasn’t being positive enough. When I was completing questionnaires...I remember second guessing myself and thinking for every answer: ‘Is it really that bad? Am I just not looking at things positively enough?’”

[John Howell (Henley) (Con)]

I thank the hon. Lady for securing this debate. The PACE trials have been roundly condemned by many scientists as being totally inappropriate. Does she have a feel for what an appropriate trial might have found?

[Carol Monaghan]

Yes. I will come on to how an appropriate trial could be done. First, I will mention the self-reporting that was a part of the trial. Questionnaires provided the data and measures of success. There were no physiological or scientific measurements. For patients the damage was done. I am a science teacher by profession and I always told my pupils that there are a number of stages to any scientific investigation: “Start with a hypothesis. Decide how you will test this theory, what measurements you will make, how you will record your results and how you will use these results to draw your conclusions. Those conclusions, which might be different from the original hypothesis, must be based on the evidence you have gathered.”

That did not happen in the PACE trial, which relied on patient self-reporting, rather than measurable physiological parameters. Furthermore, when the results were not as expected, rather than revise the original hypothesis, the investigators simply changed the success criteria. Thus patients participating in GET who had deteriorated during the study were considered recovered.

There are, of course, ways of measuring the physiological impact of exercise. The two-day cardiopulmonary exercise test can objectively measure post-exertional malaise. We know that a person with ME can perform adequately—sometimes even well—on the first day, but can have greatly reduced cardiopulmonary function on the second. The test requires the participant to exercise on a static bicycle, and allows data on oxygen consumption, workload and gas exchange to be measured. Two identical tests, separated by 24 hours, must be carried out to properly measure the impact of exercise. Results from a single test could be interpreted as a lack of fitness. Two tests change that to something quite different. A healthy person will perform better the second time; an ME sufferer will most likely be worse.

Of course, the failure of the PACE trial to do that could simply be put down to bad science, but unfortunately I believe that there is far more to it. One wonders why the DWP would fund such a trial, unless it was seen as a way of removing people from long-term benefits and reducing the welfare bill.

[John Lamont (Berwickshire, Roxburgh and Selkirk) (Con)]

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.

--- Later in debate ---

[Carol Monaghan]

This is a worldwide issue. The PACE trial results have affected people all over the world. In my folder, I have examples of people from Australia, the United States and Canada. Although there are no specialist centres in Scotland, the ones in England are recommending graded exercise therapy, which is making people worse. We need to deal with the issue.

[Helen Whately (Faversham and Mid Kent) (Con)]

Will the hon. Lady give way?

[Carol Monaghan]

I will make some progress. The PACE trial was used to inform NICE guidelines, which has meant that symptoms have been disregarded, and sufferers are considered to be attention-seeking hypochondriacs or even, in the case of some female patients, hysterical. Although in some ways the lack of belief has been the most difficult thing for sufferers and their families, the impact of the PACE trial and the resulting NICE guidelines is far further reaching. Many sufferers have reported major difficulties in accessing financial support. Employment and support allowance assessments do not consider the impact of exertion on a person’s ability to function on subsequent days, and personal independence payment assessments, which consider ME to be psychological following the PACE report, mean that sufferers struggle to access that entitlement and simply rely on family members.

Conflicts of interest in the trial are also deeply worrying. The former chief medical adviser to the DWP sat on the trial’s steering committee, and ultimately the results of the trial have been used to penalise those with ME. When we consider the relationship between key PACE investigators and major health insurance companies such as Unum, the trial takes on a far more sinister slant. Sufferers have reported that their health insurance company would pay out only if they undertook a programme of GET—an impossible task, as the insurance giants knew.

It is not only adults who are affected. Children with the disease have been subject to care proceedings because of widespread misunderstanding among health workers. ME has been mistaken for school phobia, neglect or even abuse.

[Layla Moran (Oxford West and Abingdon) (LD)]

Will the hon. Lady give way?

[Carol Monaghan]

I will in a moment. One mother contacted me, saying:

“Our 12 year old son was seen at specialist ME centre by a consultant who prescribed GET. In one year this ‘programme’ caused our youngster’s body to develop higher and higher levels of inflammation, he began limping, was in continual pain from not only the ME headaches but joint and foot pain. The comments were ‘well he managed to limp into my office’, ‘you were very active, now since the virus you are very inactive, so you will have this pain due to lack of exercise’.

GET caused his body’s immune system to go into overdrive. My son developed Juvenile Idiopathic Arthritis. This was treated by a paediatric Rheumatology Consultant who was shocked it had been left so long and told my son that his toes would be permanently swollen even after treatment as the bones had grown abnormally during the inflammation”.

[Layla Moran]

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.

--- Later in debate ---

[Carol Monaghan]

Many parents who try to home school their children also face local authority intervention, trying to get the children back to school. We must listen to patients.

This disease is very easy to ignore. All too often, those living with ME are housebound, and suffer from what they refer to as “brain fog”, which makes it difficult to mount an organised campaign. That means that much about ME remains unknown. There is some evidence that it could be grouped with auto-immune conditions such as multiple sclerosis and rheumatoid arthritis. Some people have reported that certain anti-viral drugs improve their condition, but without properly conducted scientific research, we do not have the answers. Ultimately, the impact of the PACE trial on those with ME has been devastating.

[Alison Thewliss (Glasgow Central) (SNP)]

rose—

[Luke Graham (Ochil and South Perthshire) (Con)]

rose—

[Carol Monaghan]

I give way to my hon. Friend.

[Alison Thewliss]

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?

[Carol Monaghan]

I think that when the full details of the trial become known, it will be considered one of the biggest medical scandals of the 21st century.

[Luke Graham]

Will the hon. Lady give way?

[Carol Monaghan]

I am just going to finish off. I am pleased that NICE is reviewing its guidelines on ME and has removed the recommendations to embark on harmful exercise, but I was contacted only last week by a lady who had been told recently by her GP to exercise her way to health. That highlights the huge need for education and for raising awareness among both the public and medical practitioners.

I ask the Minister: can the next set of guidelines be drawn up through listening to those living with ME? What plans does she have to introduce compulsory training for medical practitioners on ME care and treatment? Can she assure me that specialist ME treatment centres are not advertising graded exercise therapy as a method of recovery? Will she support proper funding for ME research? Lastly, will she work with DWP colleagues to ensure that new guidelines are drawn up for dealing with people with ME?

Finally, I thank the Countess of Mar and the ME Association for helping me to prepare for today. I also thank those living with ME, whose voices are not being heard.

--- Later in debate ---

[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.

Hormone Pregnancy Tests

Carol Monaghan Excerpts

Thursday 13th October 2016 Commons Chamber

[Hannah Bardell (Livingston) (SNP)]

I speak on behalf of my constituent, Mrs Wilma Ord, her daughter Kirsteen and the many hundreds of thousands of women and families who have been affected by the drug Primodos. It is a sad and tragic irony that this debate follows another hugely important debate on baby loss, in a week when we remember parents and families who have lost their little ones.

Miscarriages, cerebral palsy, brain damage and children being born without limbs are just some of the alleged side effects that the hormone pregnancy drug Primodos can inflict. Dubbed the forgotten thalidomide, Primodos was a drug given to women in the 1950s, ’60s and ’70s to establish whether women were pregnant. Many believe that it caused damage and deformities in thousands of babies in the UK and across the world. Primodos, as prescribed, was 40 times stronger than the average oral contraceptive pill. Recorded tests undertaken by the producing drug company Schering, now known as Bayer, in 1966 found that Primodos was potentially “embryo lethal” and “embryotoxic”. The Medicines and Healthcare Products Regulatory Agency has stated:

“The regulatory and social environments have changed greatly since the 1970s and as a result no medicines are recommended for use in pregnancy unless considered essential.”

I urge the Minister to keep those points in mind throughout this debate and while considering the role he has to play in ensuring the integrity of the inquiry that was set up last year to establish whether there is a link between Primodos and the birth defects.

Before I touch on the detail of the inquiry, I want to pay tribute to my constituent, Mrs Wilma Ord and her daughter Kirsteen, who are here in the Gallery today, along with many other families whose lives have been affected by this issue. They have made long journeys from around the country at their own expense. Wilma has visited me and my staff a number of times and I will speak more about her story later. Marie Lyon, who has been mentioned, has done a power of work and is an inspiration to me and my staff on a daily basis.

I also pay tribute to my colleague and friend, the hon. Member for Bolton South East (Yasmin Qureshi). She has been fighting on this issue for many years. Sometimes we must put party politics to one side for the greater good. Today is one of those days when politicians of all colours stand together in unity to fight for justice for those who have been silenced or who cannot speak for themselves.

On the scope of the inquiry, in October 2014, the former Minister for Life Sciences, the hon. Member for Mid Norfolk (George Freeman), ordered an independent review of all papers and evidence linking hormone pregnancy tests to birth defects, following wide-scale concerns raised over many years by many Members of the House. I have been following recent developments in the progress of that inquiry and have grave concerns about its scope and the way in which it is being conducted. In summary, I am concerned about conflicts of interest, as there is a lack of clarity on the framework, including the scope of work and the decision makers; the evidence being presented to the group; the lack of focus on regulatory failures; and, finally and most importantly, transparency and openness.

On the conflicts of interest, my concerns are severe yet simple. Panel members have been asked to self-declare their interests. We know of one instance of an undeclared interest that went unnoticed until highlighted to the individual. That suggests that no proper checks are in place to ensure that declarations are made. There is no clarity on how or whether such conflicts of interests are declared or investigated, or on how it is decided whether they are conflicts of interest. There is a lack of clarity on who is responsible, if anyone.

It was thought appropriate to invite an expert panel member as a visiting expert who was later removed from the working group because of his previous associations with the drug manufacturer. I am concerned about the logic in deciding, first, to invite him as an expert and then to remove him because of a conflict of interests. Who is making those decisions and why are they being made?

I and other members of the all-party group on oral hormone pregnancy tests were told in a letter from the chair of the expert working group that

“no core members of the Expert Working Group have declared any interests in Bayer”.

What is a core member? How has the information given been verified? Is it acceptable for non-core members to be associated with Bayer? The letter also states that there are “participant categories”, but again there is no explanation available of what that means or who decided those categories. It further states that all recommendations about who ought to sit on the working group

“were considered and where appropriate, endorsed by the Chair, taking into consideration the expertise required for the Expert Working Group and following consultation with the MHRA Executive”.

What expertise does the chair consider is required? Is it up to only the chair to decide or is it decided in conjunction with the MHRA? Are they the correct people to decide, particularly in the light of what I have just said about decision making?

I know from a particularly odd experience of my own concerning a panel member —the hon. Member for Bolton South East also mentioned this situation; we are unsure whether the person in question is a core member—that there is a potential conflict of interest. Earlier this year when we convened with Marie Lyon we came across a website for something named “bumps/UKTIS”—that stands for UK Teratology Information Service. It purports to be funded by Public Health England. It was with some concern that we read an article on that site on the apparent safety of Primodos. By way of example, I quote just one section, which states:

“Although older smaller studies suggested a possible association between oral hormonal pregnancy tests and congenital malformation, subsequent larger prospective controlled studies showed no increased risk.”

That is doublespeak at its worst.

Upon noticing the article, I telephoned the number on the website to ask about its content and share my concerns. The gentleman with whom I spoke assured me that the head of UKTIS, who wrote the article and whom he named during the call, had lots of knowledge on the subject on account of her sitting on the expert working group. The content of the article has also been tweeted on numerous occasions. Members may imagine my dismay not only upon reading the article, which suggests to the public that the drugs are safe—as we all know, that at best remains uncertain—but upon then learning that a member of the working group was behind its content.

The review’s scope is to

“examine the evidence to assess whether there are grounds for accepting a link between the use of HPTs and the conditions experienced by some patients.”

Given that, will the Minister consider how independent and impartial the expert working group truly is or can be? Is the situation I have outlined not in fact a clear conflict of interests? Is that particular member of the working group a “core member”, expected to make a decision on whether there is a link between hormone pregnancy tests and birth defects in babies? I would suggest from her tweets that her decision is already clear. That would appear to undermine the whole purpose of the formation of the working group.

Given the obvious conflict of interest, I wrote to the chair of the inquiry panel, who I thought had a duty to check on such conflicts, for confirmation that that group member had declared an interest. I also asked what measures were taken to decide that no conflict existed. I suggested that, if it was not declared by the panel member, it should be investigated, and asked whether it was investigated. Given that one member had already been asked to leave the panel following an unveiled conflict, I looked for assurance that checks and balance were in place. I wrote and sent my letter at the end of August and am yet to receive a response.

Given the gravity of my concerns, combined with other alarming evidence that all hon. Members have seen, I get a sense not only that something is amiss with the inquiry, but that it smacks of a continued cover-up on a significant scale. I do not use those words lightly. My final question on conflicts is this: how can we have confidence in the membership of the working group, and have the members been carefully considered to ensure an appropriate balance and expertise while maintaining impartiality?

The letter from the chair that sought to reassure the all-party parliamentary group members about the documentation being considered by the group raised more questions than it answered. We were told that

“members, invited experts and observers were recently given access to all of the documents the MHRA had so far used in preparing the assessments…These are the documents that have been used as a basis for the MHRA papers for the first four meetings including 11th August meeting.”

In case anyone missed that, I will say it again: the documents given to the expert working group panel have been used by the MHRA to prepare assessments. What exactly does that mean? It strikes of the MHRA cherry-picking what the panel members get to see. Frankly, that is not acceptable. How can it make decisions based only on MHRA-chosen information when there is a vast amount of information available on Primodos? How does that fit with the order from the hon. Member for Mid Norfolk for a review of all of the evidence and papers?

I fully appreciate that I have delved into significant detail, which we occasionally lack in the House, but I hope the significance of it is not lost on the Minister when he considers the numerous documents found in the Germany and Kew archives, some of which I have seen and will describe later. Furthermore, articles published in Der Spiegel in July released damning information about Bayer and Primodos and Duogynon, as it is known in Germany. The article is exceptionally detailed and includes the many failings of Bayer and the deliberate suppression of evidence. I will of course be more than happy to share the documents with the Minister.

My concern with the lack of focus of the inquiry into regulatory failures relates to my concern about the evidence provided to the working group. By way of example, let me share the experience of my constituent Mrs Wilma Ord and her daughter Kirsteen. Mrs Ord came to see me when I was first elected. She had been pregnant in 1970 and gave birth to her daughter Kirsteen, who was born with multiple defects, including cerebral palsy, profound deafness, asthma and bone density issues. Mrs Ord had taken Primodos to test whether she was pregnant. Her medical records, which she brought to my office, show a gap between 27 November 1968 and 27 January 1971. In other words, there is no evidence of her ever being pregnant or being prescribed Primodos by her GP.

Having tried desperately to track down her missing medical records, my constituent received a letter from NHS Scotland, which states:

“I refer to missing notes for the period 1969 to 1970...I have done a full investigation and contacted all the previous GP practices you gave me and also checked our offsite storage...but with no success. Unfortunately we have no way of knowing when or where these notes were lost or mislaid at a practice”.

Evidence I have seen—I do not know whether it has been provided to the expert working group members—shows that Schering knew of GP concerns from the 1960s about the adverse effect of Primodos experienced by their patients. I have also seen documents showing that Schering sought legal advice, and that it was told that it would be more than likely to be found guilty of negligence by a trial judge.

I have seen a document saying that Schering should try to “buy off” a family who were attempting to take legal action against it because there was no telling how many more cases there would be. I have seen a document with my own eyes dated 13 March 1964 clearly stating that, for GP doctors worried about adverse reactions, it would be best for them to destroy any evidence or records to protect themselves “however wrong that was”. I ask the Minister to think again about where Mrs Ord’s missing medical records may have gone, and about the adequacy or relevance of the documents that are actually being shared with the expert working group.

[Carol Monaghan (Glasgow North West) (SNP)]

I am listening to my hon. Friend with great interest as a scientist who will always make decisions based on evidence. It seems there is a lot of evidence missing, both in terms of documentation and scientific research. Does she agree that one of the big issues for many people affected is that they feel responsible themselves? Some people have not done all the work her constituent has done and the burden they are carrying is really quite severe at this point.