A teenager is facing a return of life-threatening epileptic seizures within weeks after the NHS refused to fund his cannabis drug.
Four years after a historic campaign to have medicinal cannabis legalised in Britain the Mirror can reveal there is now a block on the NHS offering the lifesaving drugs.
The life of 19-year-old Louis Petit has been blighted by violent seizures which left him bed-ridden and unable to talk properly.
He moved to Holland with his mum for four years ago to access the drug Bedrolite, where it can be purchased cheaper than privately in the UK.
Mum Emma crowdfunded, had money donated from family and spent her life savings on Bedrolite.
Once Louis was weaned off his old NHS drugs and was using Bedrolite only his seizures - which can cause permanent brain damage - stopped completely.
He has now been seizure free for 19 months. He has completely regained his health and been accepted on to a university degree course in London.
However the family are now out of funds and Louis’ supply of medication is due to run out in August.
Louis told the Mirror: “I’ll lose my life again if I’m taken off cannabis and start having seizures again.”
A Mirror investigation has uncovered how despite the law change - and following NHS prescriptions for the three most high profile child cases - NHS England has now halted funding the unlicensed medicines in a secret U-turn.
NHS England says individual hospitals must fund any such ‘high cost’ unlicensed prescriptions but trusts fear that agreeing to pay for one will set a precedent and bankrupt them.
We can reveal 90 children are having NHS prescriptions denied for the only drug found to halt their life-threatening seizures.
Louis told the Mirror: “Before I was on cannabis I was on a lot of harder drugs that were harder to come off than heroin.
“They stopped me from processing information, I was completely unaware. I couldn’t remember anything. I couldn’t have proper conversations and I would drift in and out.
“Once I was taken off those drugs and on to cannabis that has much weaker side effects... it feels like I’ve woken up from a coma.
“Now I’m about to start my life and go to art school. I just want to live my life as a normal adult but I can’t do that if I don’t get the cannabis medication.”
Louis’ seizures did not start until he was 12 so his neurological development has not been harmed as much as other severely epileptic children, who are often left severely disabled.
Before discovering Bedrolite Louis would have a dozen attacks, one after another. He would spend days in hospital being given powerful anti-epileptic drugs, which left him unable to remember his words.
In his last school term before leaving the UK for Holland Louis was only at school for seven days and spent most of his time bedridden, watching films.
Despite the disruption to his schooling, talented artist Louis was offered an unconditional university place at London’s City and Guilds Art School for this year.
The family made plans to move back in to their central London flat after a panel of expert neurologists at Kings College Hospital ruled that it would be unethical for the NHS not to fund his prescription.
However his Independent Funding Request (IFR) from the trust was then rejected out of hand by NHS England.
Emma, who is suffering from complex PTSD linked to fears her son’s seizures may return, said: “He can’t wait to go to university but what’s happening now is like his life is in danger again.
“That axe is hanging over our heads again.”
Official Government guidance states that exceptional cases for funding can be made to NHS England or a regional Clinical Commissioning Group (CCG), by hospital trusts, through the standard NHS process for ‘high cost’ unlicensed drugs.
However NHS England internal advice is that unlicensed cannabis drugs such as Bedrolite are “not eligible” for this Independent Funding Review (IFR) process.
That is despite latest official published guidance stating that trusts could be reimbursed for unlicensed medicinal cannabis through the IFR process.
Kings College Hospital told Louis it cannot afford to take on the £26,000 annual cost for his Bedrolite.
One of the three patients granted an NHS prescription was Billy Caldwell whose mother shamed the Government in to legalising medicinal cannabis.
Mum Charlotte Caldwell made headlines in June 2018 after announcing she would smuggle then 12-year-old Billy’s medicinal cannabis in from Canada, via Heathrow Airport.
Within a week pressure on Mr Javid forced him to use an exceptional power as Home Secretary to order the seven 40ml bottles be returned to her.
The publicity campaign that followed saw Mr Javid announce a month later that medicinal cannabis would be legalised in Britain.
Another of those three patients is Alfie Dingley, from Kenilworth, Warks, who suffered up to 150 seizures a week until Bedrolite “transformed” his life.
Mum Hannah Deacon, who formed the support group MedCan to help other parents of epileptic children, said her ten-year-old has now been free of seizures for two years.
“This is a national scandal,” she told the Mirror.
“People think this issue has gone away and it really hasn’t. At the centre of it are some of the most vulnerable people.
“This medicine was made legal in 2018. My son has a prescription and two other children have prescriptions. So if it’s not safe then why did that happen?
“The Government says we want more data but that’s not helping children now. Children need help now.
“If a doctor is happy with that then there should be a route to funding that medicine. and there just isn’t at the moment.
“We hear heartbreaking stories from mums saying ‘my doctors told me to go home and just keep my child comfortable and hope for the best’.
“It is just disgraceful when there is a product that is unlicensed, yes, but lots of children get prescribed unlicensed medicines all the time.
“It’s not uncommon and there’s millions of pounds spent every year on unlicensed medicines within the NHS.
“My son Alfie hasn’t been in hospital for over three and a half years since he’s had his NHS prescription and he was in hospital every week having hundreds of seizures which was costing hundred of thousands of pounds.”
Peter Carroll, co-founder of End Our Pain, said: “This is a national scandal.
“How can it be that a law change achieved by the campaigning efforts of families with children with severe epilepsy has resulted in a situation in which all but three children are having to find private doctors to prescribe and then pay up to £2,000 a month to buy the medicine.”
Louis’ NHS £26,000 a year prescription cost is dwarfed by how much his hospital inpatient stays would cost the taxpayer if his seizures return.
This year the family raised £10,000 for his drugs through a JustGiving page but have spent most of it already. He is expected to run out of Bedrolite supplies in August.
US experts have now discovered Louis is the only known patient in the world with a specific genetic variant that causes the seizures.
Leading international neurologists have written to the NHS, backing his case for a Bedrolite prescription.
Emma, a TV film editor before moving to Holland, said: “It’s a gene that’s associated with neurological development but it’s really nasty because it is associated with people dying within 10 years.
“In a study of mice where this gene was knocked out they suffered seizures and early death.
“I think it’s extraordinary that these drugs have been put on the excluded list with no announcement.”
Daniel Jennings, policy officer at Epilepsy Action, said: “Young people like Louis don’t have time to wait.
“Since the law change in 2018, we have been calling for the Government to urgently deliver on its promise to provide a way for these children to access funding for medicines which are helping them.
“As Louis’ case illustrates they have not yet done this for the majority of families affected.”
An NHS England spokesman said: “Decisions on whether to prescribe unlicensed medicines are made by clinicians and hospitals can choose to fund them when they are in the best interest of their patients.”
A spokesman for King’s College London NHS Foundation Trust said: “We are in regular contact with NHS England as well as the patient and his family and are unable to comment further.”
Bedrolite, made by Target Pharmacy, is about to start being manufactured in Scotland after the Government struck a deal to secure its UK supply chain following Brexit.
A spokeswoman for the Department of Health and Social Care said: “Specialist doctors are allowed to prescribe cannabis-based products, where clinically appropriate and in the best interests of patients.
“Licensed cannabis-based medicines are funded by the NHS where there is clear evidence of their quality, safety and effectiveness.
“We are working closely with regulatory, research and NHS partners to establish clinical trials to test the safety and efficacy of more cannabis-based products for medicinal use to inform future NHS funding decisions.”
Visit here to support Louis’ crowdfunding appeal for Bedrolite supplies.
Families of epileptic children can visit www.medcansupport.co.uk for information on support available.
What is medicinal cannabis?
Unlike recreational cannabis these products are processed to pharmaceutical standards.
Some contain just one highly purified extract of the plant and one such drug called Epidyolex is the only one licenced and approved for routine use on the NHS.
Several hundred NHS prescriptions have been approved and it is still the only medicinal cannabis to be approved by NICE for epilepsy since the 2018 law change.
It is only suitable for fewer than 2,000 of the 37,000 UK patients with drug resistant epilepsy, in particular those suffering with rare conditions Lennox Gastaut Syndrome or Dravet Syndrome.
What drugs have been blocked?
The cannabis plant contains over 260 chemicals which each have a different effect on the human body.
Most medicinal cannabis products are “whole plant” - such as Bedrolite and Bedica - and many more patients need these full spectrum drugs to stop seizures.
No whole plant drugs are approved by UK regulators despite making up 50% of medical cannabis prescriptions in countries such as Germany.
Why can't patients get the drugs?
The NHS has many advantages over other health systems but one disadvantage is that it can be very rigid and risk-averse when approving new drugs.
Families say this system ignores the greater risk of not allowing access to such experimental drugs in these rare life-threatening cases.
Some whole-plant cannabis drugs contain combinations of 160 cannabinoids, modified to find the perfect dose for a patient to halt seizures.
These different combinations all effectively create a new drug so they must all go through separate human clinical trials to be granted NHS approval. This would be unworkable as a single patient cannot make up a randomised controlled trial (RCT).
This means there is a lack of the RCTs to show that these drugs work demanded by UK regulators.
Also drugs such as Epidyolex take around a decade to develop through all phases of RCTs.
The UK is playing catch up due to an almost complete halt on RCTs on medicinal cannabis until it was legalised in 2018.
Many severely ill children cannot afford to wait for completion of these RCT processes for their drug to be licensed in Britain.
What could be done to help these severely epileptic children?
At least 50 research studies using observational data have shown unlicensed cannabis drugs can have miraculous results in patients such as Louis.
An NHS report in 2019 recommended such observational “real life” data be used more by UK regulators to help inform decisions to enable experimental drugs to be prescribed.
However campaigners insist this is not happening and UK regulators still rely heavily on full RCTs.
UK regulators could place greater emphasis on observational studies - as happens in countries such as the US, Canada, Australia and Germany - to allow these drugs to demonstrate their effectiveness.
The Medicines and Healthcare products Regulatory Agency (MHRA), which is the regulator that licences drugs in Britain, told the Mirror it has not mandated a requirement for RCTs and said it has issued guidance to encourage the use of “real-world data”.
Will the NHS Fund them?
Potentially many hundreds of children with epilepsy may benefit from unlicensed medicinal cannabis.
Different parts of the NHS are refusing to take on that up front prescription cost from their budget - despite it being an overall NHS saving if it prevents regular hospital inpatient stays.
Specialist hospitals are reluctant to take on the £26,000 annual per patient cost for Bedrolite for fear many more patients will then approach them for a prescription. However prescribing it more often would bring the per-patient cost down.
Officially exceptional cases for funding of high cost unlicensed drugs can be made by hospital trusts to NHS England or a regional Clinical Commissioning Group (CCG).
The Mirror has found that NHS England has now issued internal advice that drugs such as Bedrolite are not eligible for this Independent Funding Review (IFR) process.
Some NHS consultants want to prescribe but are now being stopped by this funding blockage.
Can the Government step in?
Bedrolite, made by Target Pharmacy, is about to start being manufactured in Scotland after the Government struck a deal to secure its UK supply chain following Brexit.
However despite the moral arguments, Government is reluctant to bring on board costs to the cash-strapped NHS that are currently being shouldered by ‘self-payers’.
