Meeting date: Wednesday, May 16, 2018
Meeting of the Parliament 16 May 2018
Agenda: Portfolio Question Time, Erasmus+, Business Motion, Parliamentary Bureau Motions, Decision Time, Focused Ultrasound Device
- Portfolio Question Time
- Business Motion
- Parliamentary Bureau Motions
- Decision Time
- Focused Ultrasound Device
Focused Ultrasound Device
The final item of business is a members’ business debate on motion S5M-10550, in the name of Rhoda Grant, on the campaign for a focused ultrasound device. The debate will be concluded without any question being put.
That the Parliament notes the support for Ninewells Hospital’s campaign to raise funds for the purchase of a £1.5 million focus ultrasound device, which it believes would benefit all patients in Scotland, including in the Highlands and Islands; notes that this piece of medical technology can be used with the existing MRI scanning facility to allow surgeons to perform very small incisions within the brain using ultrasound beams; considers that this can be useful for patients with essential tremor and Parkinson’s disease, and potentially for people with multiple sclerosis who have severe tremor, and understands that there is only one focused ultrasound device in the UK and that some patients will have to wait until 2022 for this treatment due to the significant waiting list at St Mary’s Hospital in London.17:03
I have brought this motion to the chamber because of my constituent Mary Ramsay, who is in the public gallery tonight. Before I met her, I knew nothing about essential tremor, the condition that she was born with, which is basically a syndrome that causes uncontrollable shaking. As a child, she was referred to numerous specialists and was given, she says, “every tablet known to man”. Due to the lack of understanding of her condition, she was then told that it was all in her mind. Mary was 48 years old when she received a definitive diagnosis. Although the condition is not life threatening, it can have a detrimental impact on someone’s life. Depending on its severity, the condition can stop someone doing ordinary things, which means that sufferers often retreat into themselves and become depressed.
Mary was bullied—she was physically and verbally abused. She could not do basic things such as thread a needle or drink a full glass of milk. Eating with others became a nightmare, so she retreated into herself. As a result of her experience, she would like compulsory disability training to take place in schools in order to build understanding.
The scale of the condition is not widely known, but it is estimated that approximately 1 million people in the United Kingdom have it. It is difficult to be precise, because many people withdraw into themselves and away from the public as they find it difficult to deal with the impact, and they become isolated as a result. Mary is a pretty strong individual, and she kept going. As an adult, she found the National Tremor Foundation. Until that point, she had felt that she was the only one with the condition, so it was fantastic for her to get in touch with others.
Mary would not be fobbed off and she insisted on seeing a specialist, who recommended deep brain stimulation. She went for it and had surgery to put electrodes in her brain. When you meet Mary today, she is pretty invincible. She says that she was as quiet as a mouse before she had her surgery, and now she is the mouse that roared. She was not happy to get the treatment only for herself, and she has now started to campaign for others. She had to go to Newcastle for her treatment. There is only one Scottish DBS centre in Glasgow, and it has a long waiting list. That spurred her on to help others, with her aim being to have more treatment available in Scotland.
There is a new treatment for the tremor that does away with the need for invasive surgery, and the aim is to make it available in Ninewells in Dundee. That would not help Mary, as she has already had the electrodes implanted for deep brain stimulation, but it would help others avoid surgery. The treatment could benefit not only people who have essential tremor but people with Parkinson’s, multiple sclerosis and other conditions that lead to tremor. The new treatment is magnetic resonance-guided focused ultrasound surgery—there is an acronym, for that, which is MRgFUS, but it is almost as hard to say as the name itself.
The treatment is awaiting approval from the National Institute for Health and Care Excellence, but it is thought that approval for essential tremor will be given next month. There will be a proviso, which is that patients should be followed up in the long term to assess the longevity of the treatment’s effect. It has already been approved in the USA and in other parts of Europe for treatment of essential tremor and Parkinson’s. In addition, 16 patients in the UK have benefited from the treatment, which has been successful in reducing tremor in every single one of those cases.
Having the treatment available in Scotland would make us leaders in the UK and in the world. There is one other treatment centre in the UK, at St Mary’s in London, which has a five-year waiting list. Distance and waiting time therefore puts treatment out of reach for Scottish patients. The treatment would be a game changer for those who are currently suffering in silence, and it would allow them to live their lives. I also understand that it can be used to improve the quality of life for those with inoperable brain tumours—something that the late Tessa Jowell fought for.
The treatment works by targeting the brain areas that produce the tremor with sound waves—ultrasound—using magnetic resonance imaging. Patients are awake throughout and require no anaesthetic. A small lesion is created by heating up the brain tissue with ultrasound waves, and the effect on the patient’s tremor is both painless and immediate. It is a day-case treatment that requires no hospital stay—-it is revolutionary.
The treatment is minimally invasive. It has the same immediate and long-term effects as invasive alternatives such as deep brain stimulation but without the infection risk, and it does not require permanent electrical hardware or revision operations in the future. Currently, there are risks with DBS: a one in 1,000 risk of death, a one in 100 risk of stroke and a one in 30 risk of brain haemorrhage. More than 1,200 patients worldwide have had the new treatment without experiencing any significant comparable complications to date. The new treatment is also a third of the cost of DBS.
There are more than 1 million people with essential tremor in Britain, around 250,000 of whom are severely disabled by their tremor. Dr Peter Bain, who is a consultant neurologist and a founding trustee at the National Tremor Foundation, co-ordinates the trial of focused ultrasound surgery. He says that the new technique is the biggest breakthrough in functional neurosurgery in the past 20 years.
Ninewells is ideally placed to take this on. There is already a fundraising appeal in place, led by the University of Dundee, which needs £2.3 million to purchase the equipment. The equipment would pay for itself by allowing people to lead their lives, get back to work and play an active part in society and by cutting the cost of the treatment. It is an opportunity for Scottish patients to receive state-of-the-art, minimally invasive neurosurgery for some of the commonest causes of tremor and to establish Scotland as one of a handful of countries worldwide that are using the technology for research into treatments for brain drug delivery and brain tumour surgery.
As I said, the only treatment centre in the UK is at St Mary's in London, which has a waiting list of five years. Without our own treatment centre, not only will Scottish patients with tremor have to wait, there is a significant risk that the treatment will eventually be available only to those who can afford to pay for it. Therefore, we need to make sure that the treatment comes to Scotland.17:11
I congratulate Rhoda Grant on securing this evening’s debate, and l am pleased to be participating in it. Like Rhoda Grant, I welcome the fundraising campaign to raise the money that is required to purchase a focused ultrasound device for Scotland’s national health service that has the potential to benefit patients across our country. I commend all those who are involved in the campaign and all those who have supported it, especially Mary Ramsay. I was sad not to be able to meet her this afternoon.
It is a concern to all of us and to so many Scottish patients who could benefit from the device that we are seeing waits of up to five years to access it in the unit at St Mary’s in London, which currently has the only one in the UK. Having a device in Scotland would obviously lessen the significant stresses and costs for patients in having to travel to London for treatment and the extra pressure that that places on their family members.
The focused ultrasound device is a piece of cutting-edge technology that allows doctors to use high-intensity sound waves to destroy tissue causing mistimed electrical signals inside the brain in the thalamus. Treatment is performed in imaging departments rather than operating theatres. The use of ultrasound in the brain to treat patients with neurological conditions that lead to tremors means far fewer side effects and risks than there with the traditional treatments of drugs or brain surgery. As Rhoda Grant said, the costs of the treatment are estimated to be a third of the costs of equivalent brain surgery.
Professor Gedroyc, who is a consultant radiologist at Imperial College Healthcare NHS Trust, has described the device as a
“game-changer for patients with ... movement disorders because we can cure them with a treatment which is completely non-invasive and we don't have to give unpleasant drugs.”
He is one of the many radiologists and neurologists who believe that the device has huge potential, and it is hoped that its use will soon be increased across the country to transform the lives of many people with a range of neurological conditions.
One of the main challenges for all health services in developed countries but certainly for our NHS is how to access and bring forward quickly the ever-increasing number of new drugs, technologies and devices that patients, understandably, want to be able to use, when resources are finite and there are so many competing demands across the NHS. The device at St. Mary’s was funded wholly by the Imperial Health Charity, which funds major equipment purchases and is a great example of a charitable foundation making a real difference to patients’ lives. I hope that we can see the fundraising campaign succeed in delivering a focused ultrasound device for Scotland
Again, I welcome the debate and the campaign, and I look forward to hearing from the minister how the Scottish Government believes that Scotland can secure a focused ultrasound device, as it clearly offers so much promise for patients with essential tremor, Parkinson’s and other life-limiting neurological conditions.17:14
I warmly congratulate Rhoda Grant on securing this evening’s debate and on her informative and well-researched speech, and I welcome Mary Ramsay to the public gallery. Her bravery throughout her early life circumstances led to her setting up a Scottish support group with the National Tremor Foundation, providing advice, guidance and support to others with her condition.
The purpose and objective of this evening’s debate is to raise awareness of essential tremor and the need for developing treatment options in Scotland. As the Mayo Clinic makes clear,
“Essential tremor is a ... neurological ... disorder that causes involuntary and rhythmic shaking. It can affect almost any part of your body, but the trembling occurs most often in your hands—especially when you do simple tasks, such as drinking from a glass or tying shoelaces.”
Although it is often confused with Parkinson’s disease, the conditions vary in key ways, such as the timing of the tremors and the associated conditions. Parkinson’s is also linked with stooped posture, slow movement and shuffling gait. The parts of the body affected can also differ. Essential tremor mainly affects the hands, head and voice, while Parkinson’s starts in the hands and can go on to affect the legs, chin and other parts of the body.
Mary Ramsay could be described as a doughty fighter. Her life has not been easy. Imagine someone being told as a 20-year-old that they could not have children due to their condition? Yet she now has three children and 10 grandchildren. She has been campaigning for disability rights for about 40 years, but despite her long fight she is still frustrated by the gaps in service. People with essential tremor regularly contact Mary and express their disappointment with available treatments.
For Mary, deep brain stimulation was a godsend, giving her courage to speak out on behalf of others with disabilities, not just tremor. However, the surgery that Mary underwent is invasive and can have serious side effects, as we have heard from Rhoda Grant. It is no surprise that many are reluctant to undergo such a daunting procedure.
MRI-guided focused ultrasound surgery is a new treatment that is utilised to alleviate tremor. The incisionless treatment has the same immediate and long-term effect as invasive deep brain stimulation but, in contrast, it does not require permanent electrical hardware, or revision operations in the future. As we have heard, however, that alternative procedure is currently available only in London, with long waiting lists.
I compliment the team at Ninewells hospital in Dundee, who have visited the London surgery team at Imperial College Healthcare NHS Trust in order to see the new surgery and the use of the high-intensity ultrasound device. The London team have expressed support for the introduction of that novel technology to Scotland and have offered to visit the Ninewells team to guide them through the first few procedures.
Mr Selwyn Lucas, a 52-year old painter and decorator from St Austell in Cornwall, was one of the first people to receive the treatment as part of the trial in the UK. For more than 20 years, he lived with a tremor in his right hand; it had grown progressively worse in the five years before he was treated. Commenting on the trial he said:
“Since the treatment I have been able to write my own name for the first time in many years and taken my wife out for a lovely meal without fear of embarrassing myself. I will also be able to go back to using my right hand which will allow me to take on more painting and decorating jobs.”
As we have heard, £2.3 million is required to bring the new technology to Scotland, of which £1.5 million is to purchase a high-frequency machine for essential tremor treatment, £500,000 is for a low-frequency machine to treat brain tumours, and £300,000 is for running costs up front. So far, £400,000 has been raised by a robust fundraising campaign led by the University of Dundee, but the costs would be a crucial investment in Scottish healthcare. Bringing the treatment to Dundee would be an opportunity for Scottish patients to receive state-of-the-art neurosurgery for some of the commonest types of tremor, including essential tremor, Parkinson’s and multiple sclerosis.
In addition, this is a chance to establish Scotland as one of only a handful of countries in Europe and worldwide that are using that technology for research into treatments for brain drug delivery and brain tumour surgery.
The chairman of the National Tremor Foundation, who himself lives with essential tremor, said:
“in my opinion the costs involved in setting up this equipment would be recouped many, many times over in years to come. The opportunity of assistance for people young and old to carry out their studies, work, pursue their ambitions and carry on with their everyday lives as a result of this treatment can only benefit the Scottish economy in the long run.”
I congratulate Rhoda Grant again. I am delighted that Mary Ramsay is here. I thank everyone who has helped to highlight this important issue to the Parliament.17:19
I am delighted to have the opportunity to take part in the debate, and I thank Rhoda Grant for securing it. I thank Rhoda Grant, Dave Stewart and Miles Briggs for telling me a lot more about this problem than I knew before. The fact that I have had the opportunity to research it before this evening is one of the benefits of having these debates, so I thank them for their contributions and for allowing me to learn more.
I take the opportunity to voice my support for the campaign to install a focused ultrasound device in Dundee.
I commend all those who have campaigned tirelessly on this issue, including Mary Ramsay, who I met this afternoon. As I found out this afternoon, Mary Ramsay is an eloquent and persvase—[Interruption.] I am sorry, I meant to say persuasive. I knew that I would get that wrong. I am nervous because you are behind me in the gallery, Mary. I hope that you do not mind that I did not make that comment through the chair, Presiding Officer.
I was just wondering whether Mary could teach me how to make members nervous.
As we have heard, £0.5 million has already been raised by the public to secure a focused ultrasound device. I welcome that and I believe that the Scottish Government really should be stepping up to fund the balance.
The case for purchasing a focused ultrasound device appears to be a simple one. Waiting lists could well be shortened and patient load could be lightened. If the Scottish Government commits to purchasing the device and putting it in Dundee, those benefits could be realised.
When I spoke to Mary Ramsay this afternoon, I learned how Highlanders who have essential tremor have to travel to Newcastle for treatment, because there is a four-year waiting list in Glasgow for deep-brain stimulation.
According to the National Tremor Foundation, focused ultrasound treatment is a lifeline for patients. A recent study showed that hand tremors improved by 75 per cent and quality of life improved by 65 per cent. That is a huge step forward.
Before today’s debate, I read many patients’ stories and learned about the remarkable recoveries that have been brought about by the treatment. In one example, which is similar to the one that David Stewart mentioned, a patient described how the tremors in their right arm had completely disappeared after the procedure and they said that the treatment
“has frankly given me back my life; my only regret is that I did not have the treatment sooner.”
That statement should be enough to make the case for why the treatment should be available in Scotland. That the treatment might also affect our ability to treat Parkinson’s disease, epilepsy, the early stages of prostate cancer and, possibly, breast cancer, makes that case even more compelling.
As we know, politicians can talk and talk and talk, but let us try to avoid that. We could avoid it if the Government delivered a focused ultrasound device in Dundee. The question for the Government is whether to delay or deliver, to chat or to act. I say, let us act.17:22
I remind the chamber that I am the parliamentary liaison officer to the Cabinet Secretary for Health and Sport.
I was not intending to speak, Presiding Officer—as you know, I pressed my button during the debate—but I want to take the opportunity, from the SNP back benches, to thank Rhoda Grant for bringing the issue to the chamber and, of course, to thank Mary Ramsay for what sounds like an absolutely tireless campaign.
As Edward Mountain said, as I have sat listening to the debate, I have been educated. I suppose that the point of campaigns is to let us find out a wee bit about what is going on in different areas. There can be no doubt that minimally invasive treatment, where appropriate, is a good thing. I believe that that is in line with Scottish Government policy. I know that the health secretary has talked about these things many times in the chamber before.
As others have said, I like the idea of Scotland being a leader in this area; that is a good thing, given that no treatment centres are readily available. That can maybe link into wider challenges in the health service, such as the ageing population and the different types of treatment that people are looking for.
I am just learning about this subject today. As I said, that is the purpose of campaigns. I know that all these decisions have to be checked and balanced against the available evidence. I look forward to hearing the cabinet secretary’s response to what she has heard.
You will be glad to hear that I do not need to take up my whole time, Presiding Officer. The purpose of my standing up was to put on the record my thanks to the campaign for getting this issue to the chamber and letting me hear about another treatment.17:24
I am very grateful to Rhoda Grant for bringing the motion to Parliament today. I join with others in welcoming Mary Ramsay to the public gallery and pay tribute to the work that she has undertaken in raising awareness of essential tremor and the debilitating impact of the condition. I also thank her for highlighting and raising interest in a new type of experimental treatment for those living with essential tremor.
As the members who have been involved in today’s debate will know, the adoption of innovative medical technologies into the NHS has the potential to offer new ways to treat conditions. Some of those technologies have the potential to provide transformative improvements in the health and quality of life of patients.
However, as I am sure members will agree, it is imperative that before any new procedure is adopted into the NHS, it is first subject to rigorous clinical assessment to establish patient safety and efficacy. That is vital for clinicians and the patients who are in their care. It will support informed conversations between clinicians and their patients about the range of treatment options that might be available to them and the likely risks and benefits. With that knowledge, clinicians can offer the best information about the different treatment options, which will support shared decision making between clinicians and patients about their care.
In the case of the new technology and procedure that is the subject of the motion—magnetic resonance image-guided ultrasound for the treatment of essential tremor—current expert opinion has very recently been issued, albeit in draft form, by the National Institute for Health and Care Excellence. That guidance follows an assessment by NICE of the available clinical research evidence. The final guidance will be published in June, but the draft guidance is already available.
NICE has concluded that the available evidence suggests that the procedure does not give rise to major safety concerns. However, NICE has also concluded that the evidence of its clinical efficacy is presently too limited to recommend that it be used in practice in the NHS, unless there are special arrangements in place or it is used for the purposes of research.
As members might be aware, NICE assesses the safety and efficacy of interventional procedures—including the one that is at issue here—on behalf of the NHS in Scotland, England and Wales. NICE provides advice on the suitability of the adoption of new procedures into the NHS based on its assessment of the evidence. The processes and methods that are used by NICE are designed to ensure that its guidance is expert, robust and developed in an open, transparent and timely way. Consequently, NICE guidance is authoritative, protects the safety of patients and supports clinicians—and the NHS as a whole—in managing clinical innovation appropriately.
Given the latest opinion from NICE that the evidence of efficacy is too limited, adoption as a commissioned national service for the treatment of essential tremor, or the other conditions that are mentioned in the motion, cannot be considered at the current time. Better evidence that demonstrates efficacy will be needed from all the nations across the UK. Where NICE has outlined special conditions for the use of a procedure, such conditions must be followed. In this case, the draft guidance mandates that clinicians must inform patients that there are special conditions attached to the use of the procedure—it can be used in research trials but it is not for routine clinical use—as current evidence of efficacy is limited.
I can well appreciate that that situation might be disappointing. However, I am aware that a number of clinical research studies in other countries are under way on the use of MRI-guided ultrasound for essential tremor.
Obviously, the treatment is new and research needs to be carried out, but the research that has been carried out so far shows that the treatment could be a game changer. Would it not be good if Scotland could lead the way in the research? The University of Dundee is involved in the research, alongside Ninewells hospital. We could carry out the research procedure, but also lead the way in allowing that treatment to be available in Scotland.
I am just coming on to that very point.
Research is in progress internationally that will improve the range of evidence on the safety and efficacy of the technology, and NICE will pay attention to that. The Scottish Government will also keep the situation under close review. Should new clinical evidence be generated from anywhere that demonstrates effectiveness and materially changes the clinical assessment by NICE, our position would of course be re-evaluated. That evidence would be expected to include a review of the clinical and cost effectiveness of the device, as well as its position in the current established treatment pathways.
With that in mind, as Rhoda Grant and many others have mentioned, and as members will be aware, since it is noted in the motion, the University of Dundee and NHS Tayside are exploring the possibility of purchasing MRI-guided ultrasound technology. That is in order that they might join—and add to—the international research effort to evaluate the use of such technology for the treatment of movement disorders. I am encouraged by the university’s plans to explore the possibilities of undertaking such research work, since that could provide opportunities for patients in Scotland to participate in clinical trials of the technology, and hence meet the requirements of the NICE guidance, albeit that that is in draft form at the moment.
Given that clinical efficacy of the technology is still unproven, it will be for the University of Dundee to assess it and decide whether to invest in it for research. However, should a facility be established in Dundee, the Scottish Government, through the chief scientist’s office, would welcome a high-quality application to its competitive grant funding scheme for clinical research projects that aim to evaluate such technology further. As usual, applications would be independently and rigorously assessed, using the CSO’s established processes. That is important, because it would mean that the application would undergo robust evaluation. An application would not be just about the appropriateness of the funding stream, but would undergo recognised evaluation processes that are important for establishing evidence.
In addition, the CSO’s financial contribution to the National Institute of Health Research opens up opportunities for larger-scale funding from the NIHR’s schemes for clinical research. Furthermore, like all research-active health boards, NHS Tayside has some discretion about the clinical research activities that it supports, using the research support funding that is provided by the Scottish Government though NHS research Scotland. It could therefore utilise some of that infrastructure funding to support trials of the technology if it chooses to do so. NHS research Scotland support is also available to facilitate the siting of both commercial and non-commercial trials and the recruitment of patients to them. Should the University of Dundee be successful in purchasing it, there will therefore be a range of opportunities and support, through the CSO and NHS research Scotland, to facilitate clinical research on that technology and on the procedure.
In bringing all that together, I can say that there will be an opportunity for Scotland, but that the proper processes will have to be gone through so that the evidence and evaluation of the technology will be robust and recognised internationally. I encourage the various partners to come forward through the routes that I have mentioned.
I will finish by reiterating that the Scottish Government is committed to having safe and effective care and treatment, which put the patient at their centre. In order to have that, we must ensure that decisions about the adoption of new technologies, interventional procedures or services into the NHS are based on the best available evidence. Although the clinical efficacy of MRI-guided ultrasound for movement disorders has not yet been demonstrated, I certainly hope that the clinical trials evidence that is being accrued internationally—and that I hope will happen in Scotland in due course—might enable a wider range of options with established safety and efficacy to be offered to patients who are in the situation in which Mrs Ramsay used to be. I aspire to that for Scotland.
I thank members for their contributions to the debate. I hope that they have found what I have had to say useful. There is still some work to be done by the various partners in progressing the technology, but, again, I thank Rhoda Grant for raising this important issue through her motion.Meeting closed at 17:33.