Written evidence submitted by Karen Gray, Joanne Griffiths, Margaret Huxley and Elaine Levy (CLL0021)

Dear Health and Social Care Committee,

We write to ask you as part of this on going inquiry into the coronavirus:lessons learnt, to accept our written evidence and if you can to investigate the unnecessary suffering, due to Covid of the children/Adults (age 1-49) with Intractable epilepsy who take CBD/THC privately prescribed medication,, and the parents/family on going mental persecution.

As you know it will be two years in November since the law changed to allow prescription cannabis. Yet since the law changed not one new NHS prescription has been written for cbd/thc products. Many of us took part in the review into the barriers and two trials had been advised, one a randomised controlled trial and the second an observational alternative for those children/adults already on a cannabis based drug. It stated - [ 69.For patients who cannot be enrolled into standard RCTs, we need a mechanism that will further support the generation of new evidence and that draws together a detailed and consistent set of data on the most affected, including those children and young adults who are currently in receipt of a CBPM.

NHS England and NHS Improvement and NIHR in conjunction with the specialist network will work together to determine an appropriate alternative study design that will enable evidence generation for those patients who cannot be enrolled into a standard RCT. This scope of study should include those children and young adults who are currently in receipt of a CBPM.]

The problem we have is that the children/adults have been prescribed these medications by specialist private doctors, using the guidance put out in November 2018, and after parents/carers sought out second opinions that the Rt Hon Matt Hancock suggested was needed in his parliamentary speech. Since then further guidance has been written in December 2019 which has become a further barrier in obtaining these medications through the NHS. Now we are told that the NHS England, NHS Improvement, and Department of Health and Social Care want the  patients with intractable epilepsy who use these medications to go through a “wash out” period of these medications and enter RCTs. This is highly dangerous and could cause brain damage or death, but definitely increased seizures and suffering.

Knowing full well that parents are struggling to pay the huge costs of the medication every month due to them being mainly funded by fundraising events, and the impact Covid has had on those efforts, we feel the parents are now being given no other options. One child ended up intubated due to parents being furloughed and running out of funds during lockdown and hugely increased seizures. Kindly someone donated enough money for one month of cannabis medication and that child was back home four days later. This is what we now need to avoid as many areas go into lockdown again. Another child has been denied funding or an NHS prescription and has been given an “End of life care plan” when the time comes that the parents can no longer afford to purchase the cannabis oil. This is absolutely unethical. Furthermore, two children have been left with NO NHS neurologists due to this continued situation and lack of prescribing. (Non to date) Children and adults with epilepsy are being put at risk, despite the Rt Hon Matt Hancock telling parents on the 19th March 2019 that in several months time these cannabis based medications would be available in the normal way via the NHS.

The parents/Carers that have obtained private prescriptions did so due to their being no other option left for their children/loved ones. The law had been changed allowing the NHS clinicians to prescribe medical cannabis however they refused to do so or the Hospital Trusts block the prescribing. Even the GP shared care guidance put out by NICE is now blocked by the new December 2019 NHS England guidance and local CCG policies which are creating a postcode lottery situation. This situation needs to be urgently rectified to alleviate the financial suffering of all concerned. 

We have asked the Health Secretary to fund these privately prescribed bedrocan/other oils that now three other children get via NHS funding, using the coronavirus bill and other powers at his disposal to prevent another child/adult running out of their cannabis medication. This help has been refused, leaving us in a desperate situation with Covid cases on the rise, no way to fundraise, and parents loosing their jobs. All this is endangering the life of the children/Adults with severe forms of Intractable epilepsy, many that have been on their privately prescribed cannabis medication successfully for over 19 months. In fact my son saw the private neurologist on 5th March 2019 and received his medication in the April. Having experience of these drugs being removed, after having run out of a full extract Canadian oil in September 2018, and after the Trust neglected to sign off on the government panel application, filled in by my sons NHS neurologist, he became desperately ill with increased seizures, some over 25 minutes long. He was then given compassionate access to Epidiolex which failed to work and he nearly lost his life having 200-300 tonic and drop seizures per day. (EEG evidence recorded this and has since recorded the improvement of his seizures since using bedrolite and bedica, bedrocan oils)

We have also been in contact with Epilepsy Action regarding the ongoing situation for families who are currently accessing cannabis-based medicines privately. They share our concerns about the lack of an ‘alternative study’ for those who are currently accessing cannabis-based medicines privately with evidence of efficacy and for whom the RCT style trials agreed in principle through the NIHR are not suitable.

Epilepsy Action continue to support calls for an ‘alternative study’ to be brought forward at pace, in parallel to RCT trials. As previously stated, this approach has been recommended by NHSE/I and touted by the Department of Health and Social Care. This would allow people with severe and treatment resistant epilepsies who are currently benefitting from private prescriptions of unlicensed cannabis-based medicines to access these products through the NHS, with necessary ongoing clinical observations. This need is made even more acute by the additional and ongoing pressures of the COVID-19 pandemic.

The parents that form End Our Pain would be happy to share with you their continued difficulties and I have included below recent correspondence from the Department of Health and Social Care on the matter along with old correspondence from Alette Addison in October 2019, along with the recent response on the matter from Edward Argar. As you will see from all this, we are now left feeling strung along, and worried about the future health of our children/loved ones.

We hope you can help

Joanne Griffiths

On behalf of End Our Pain parents

Our ref: DE-1247665

Dear Mrs Griffiths, 
  
Thank you for your correspondence of 1 August to Matt Hancock about medicinal cannabis. I have been asked to reply and I apologise for the delayed response. 

I understand your frustration and was sorry to read of the difficulties that your son and other children and young adults with refractory epilepsy have faced. Whilst the Department cannot comment on individual cases, I have sought to clarify the points raised in your correspondence.

Firstly, the NHS has commissioning responsibility for specialist neuroscience services for children and young people. It is not the responsibility of clinical commissioning groups. The fact that the NHS has commissioning responsibility does not mean that any particular treatment will necessarily be funded. The NHS does not commission Bedrolite and Bedica products for children with these conditions. These products are not licensed for treating children (or, indeed, any patient group) and have not been recommended by the National Institute for Health and Care Excellence for routine commissioning in the NHS.

The NHS has published guidance on the use of unlicensed cannabis-based products for medicinal use (CBPMs) in a letter to clinicians, which can be found at www.england.nhs.uk by searching for ‘guidance to clinicians for prescribing cannabis based products for medicinal use’.

The NHS has also published methods on the decision-making process for funding new treatments falling within its direct commissioning responsibilities. It is important that the process is fair and transparent and considers the relative benefit and cost of new treatments, and that it considers all potentially eligible patients.

However, the fact that the treatment is not commissioned by the NHS in England does not mean it is impossible for patients to receive that treatment on the NHS. If a specialist NHS clinician considers that, in their professional judgement and considering relevant evidence and guidance, the treatment is appropriate and the hospital trust agrees, then a prescription could be made. Our understanding is that no NHS trust or specialist clinician operating within the NHS has been found to exercise that judgement and prescribe accordingly.

The lack of evidence to support routine prescribing of unlicensed medicinal cannabis on the NHS remains the greatest barrier. The Government has asked the industry to produce the evidence on the quality, safety and efficacy of these unlicensed products. To date, with few exceptions, the industry has failed to do this. That is why the Government is committed, through the National Institute for Health Research (NIHR), to support the establishment of clinical trials on the use of cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC) in the treatment of refractory epilepsy. I appreciate that you may be frustrated that these trials have taken longer than expected to commence, but the Government remains committed to see these established as quickly as possible.

The NHS and the NIHR have confirmed in principle support for two randomised controlled trials on early onset and genetic-generalised epilepsy. These will compare medicines containing only CBD and CBD plus THC to a placebo. The aim is to design a safe and scientifically robust trial for adults and children with severe epilepsy, including those patients currently using CBPMs. This will require a ‘washout’ period for existing drugs before trials commence. This and other details will be explained further to patient groups in due course.

As with any new medicine, a robust and high-quality clinical evidence base will be required to inform any future commissioning and funding decisions. This trial will be critical to ensuring that the evidence base for CBPMs can be developed to a sufficient standard to help make future commissioning decisions for the many hundreds of patients in the UK with refractory epilepsy.

A new Refractory Epilepsy Specialist Clinical Advisory Service (RESCAS) was established following last year’s review into the barriers to accessing medicinal cannabis on the NHS. This is in response to the request to provide additional advice and support to clinicians who were considering prescribing CBPMs for the treatment of refractory epilepsy, particularly for children. This multidisciplinary team is able to provide advice impartially, based on its clinical knowledge and experience. It complements local services, but clinical responsibility for the care of patients discussed at RESCAS will remain with the referring paediatric neurology team. If you have not already done so, you may wish to discuss with your son’s NHS clinical team whether a referral would be appropriate.

I hope this reply is helpful.

Yours sincerely, 
  
Anthony Moses 

Ministerial Correspondence and Public Enquiries
Department of Health and Social Care