How this devoted mother's tireless battle to save her 11-year-old son from crippling epilepsy led to him becoming the first Briton to be prescribed cannabis on the NHS

• Billy Caldwell was born with a severe form of epilepsy and learning disabilities
• The 11-year-old suffers from seizures which can't be controlled by medication
• He has become the first Briton to be prescribed medical marijuana on the NHS

By Charlotte Hobbs

As a baby, Billy Caldwell was so desperately unwell that doctors declared he wouldn't see his first birthday. Born with a severe form of epilepsy and learning disabilities, he has cheated death thousands of times.

Billy, now aged 11, suffers from particularly vicious seizures which cannot be controlled by medication. But after years of ineffective treatment and – at its worst – suffering up to 100 fits a day, his condition is finally under control.

Last week, Billy became the first Briton to be prescribed medical marijuana on the NHS. The liquid cannabis oil – a natural plant extract – has led to him not suffering a single seizure in three months. What makes his story even more unusual is that the medication is not licensed for prescription here due to its links with narcotic cannabis.

The landmark case is likely to pave the way for more epilepsy sufferers to demand such treatment. Indeed, Billy's GP has called for the Government to open the debate and back further research into medical use of cannabis.

Billy Caldwell (pictured with his mother Charlotte) suffers from particularly vicious seizures which cannot be controlled by medication

DESPERATE SEARCH FOR HELP

Billy, from Castlederg, Co Tyrone, Northern Ireland, was originally prescribed cannabis oil in the US after his desperate mother Charlotte took him to a world-renowned paediatric epilepsy specialist in California. Medical use of marijuana has been legal there since 1996.

Dr Douglas Nordli, co-director of the Neurosciences Institute at Children's Hospital Los Angeles (CHLA), formulated a comprehensive care plan and spent several weeks perfecting the correct dose for Billy.

The results were remarkable. 'He went from having 25 seizures a month to about eight – and he's not had one for three months,' says Charlotte.

But back home a few weeks later, and with promises of help from local doctors falling flat and Billy's supply of cannabis oil running out, she was terrified for her son's health. In desperation, she begged her GP for help.

Realising the 'unique and unusual' situation, Dr Brendan O'Hare agreed to write a repeat prescription – and a pharmaceutical firm in Dublin supplied the medication.

As a result Charlotte, 49, who is Billy's full-time carer, will be able to collect the drug from her local pharmacist. Billy takes two types of cannabis oil. The first is cannabidiol (CBD), a derivative of cannabis which the UK watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), allows doctors to prescribe.

But he also has an oil containing the compound tetrahydrocannabinolic acid (THCA), which, when exposed to heat, forms the psychoactive component of cannabis.

THCA is, strictly speaking, illegal in the UK. It is categorised as a Class B drug alongside amphetamines and barbiturates. However, when given in medicinal form – and not burned – THCA does not have the narcotic effect that smoking cannabis has.

Epilepsy, which affects more than 500,000 Britons, is a fault in the electrical activity of the brain. Experts believe compounds in cannabis help to control seizures, although it is not yet fully understood why this happens. Billy has four 0.6ml doses of both flavourless liquids a day, administered under his tongue with a syringe. Although Charlotte claims that Billy's British neurologists 'gave up on him', she is careful to point out that 'his treatment has been medically supervised the whole way along'.

This is the mixture of blackcurrant juice and cannabis oil (left) used to medicate 11-year-old Billy while a poster was created to promote their fundraising efforts (right)

She first took her son to the US when he was two, after becoming exasperated that NHS doctors were unable to control his seizures, and that they simply offered him powerful morphine because 'he wasn't going to survive'.

Unwilling to accept this, Charlotte searched the internet to find the best specialist in the world. She discovered Dr Nordli, who has written more than 70 studies into treatment of epilepsy.

Billy was prescribed medication that brought his condition under control and he was seizure-free between 2007 until late last year, when Charlotte woke up one morning to find him having a fit in bed.

She immediately contacted Dr Nordli again and began fundraising, setting up a Facebook group to seek sponsorship.

In November she flew back to California with Billy where the specialist suggested prescribing him cannabis oil. Charlotte says: 'I wasn't shocked. I'd read about it online as a treatment they were using in America. I've never taken cannabis and never would. But this is a medicine, and I was willing to try anything. I knew that the next seizure Billy had could kill him. When Billy has a fit, he starts to struggle to breathe, his eyes become wide and he looks like he's staring, and he nods his head. It doesn't seem dramatic but every one damages his brain.'

After Billy suffered another severe seizure, Dr Nordli put him into medically induced coma for five days to save him from further brain damage.

As Billy recovered, Dr Nordli added THCA to his regime and set about the painstaking process of adjusting the dose. Too high a dose can actually trigger seizures. It is for this reason that treatment must be supervised by medical professionals. But, to everyone's relief, it worked. 'That massive seizure was the last one he had,' says Charlotte. 'Finally, something was working.'

THE MOUNTING EVIDENCE

After three months in LA, Billy was stable enough to return home. Charlotte was given a two-month supply of THCA cannabis oil, which she declared to customs on arrival in Dublin. She says: 'I walked up to them and told them what was in my bag. I showed them the documentation from the hospital that showed it was for medical use. They waved me through.'

She adds: 'I went to our GP at Easter and begged him for help. Billy's medication was running out, and he agreed to prescribe it.'

A LANDMARK CASE... BUT WE NEED MORE RESEARCH  

By Dr Ellie Cannon  

This is a landmark first case of using medical marijuana in the UK under medical supervision.

The regulatory body, the MHRA, has approved the prescription of drugs containing cannabidiol for medical purposes, and the GP who prescribed this did so as a one-off.

The GP felt he was prescribing this in the best interests of the patient. We make decisions like this with other unlicensed medications: it is the responsibility of one doctor acting for one patient to make this judgment call.

I have used the same call myself with patients who have been prescribed medicines abroad that are not used here, where there is a good history that they have worked and have been safe.

What could be groundbreaking about this case is the impact now on marijuana use in terms of legislation and research.

We still do not know how cannabis oil can have this positive effect: this is only one case but may be held as evidence to push forward research and usage. Campaigners believe there are too many obstacles to looking at cannabis use properly.

Lobbyists on both sides have polarised the debate. It is seen as either a miracle cure or a dangerous drug.

Cases such as this illustrate that we need to look for the middle ground, and explore research, safe use and the potential to benefit patients.

Dr O'Hare stresses that he prescribed the oil to Billy on ethical grounds – and because the dose had been set by a specialist, Dr Nordli. 'I couldn't stand by and risk him suffering fits because his medication had run out. The way I see it is that I prescribe diamorphine, which is essentially pure heroin, to terminally ill patients because it helps their pain. This is a similar scenario. We really to have a debate on this matter and get political approval, as many patients could benefit.'

Billy's THCA oil has been sourced by pharmaceutical start-up GreenLight Medicines. It is working with University College Dublin and the Royal College of Surgeons in Ireland on exploring the 'full potential of cannabis and cannabinoids as a medicine'.

GreenLight chief executive Dr James Linden claims there is 'increasing evidence' that cannabinoids are an 'effective form of treatment' for many illnesses, including MS, arthritis, epilepsy and cancer.

In Billy's case, GreenLight acted as an intermediary, finding 'a medical cannabis company in Canada, approved by their health service' which agreed to send new medication to Charlotte. Although THCA is a controlled substance, because Billy has been prescribed it by the NHS, this is entirely legal, they claim.

A large trial carried out across 11 US epilepsy centres, published in the Lancet Neurology journal in 2015, found that 214 patients who received cannabis oil for 12 weeks saw their seizures decrease by an average of 54 per cent. All the patients had epilepsy that did not respond to currently available treatments.

Last year, a cross-party group of MPs and peers led an inquiry into the drug's potential to help patients. The group took evidence from more than 600 patients and medical professionals and commissioned a consultant neurologist, Professor Mike Barnes, to review published research on the drug's potential to alleviate medical problems.

He found 'good evidence' that cannabis can help with chronic pain, muscle spasms often associated with MS, the management of anxiety, and nausea and vomiting, particularly when caused as a side effect of chemotherapy.

'I'VE GOT MY BOY BACK'

In December, an Irish government Bill was passed to make cannabis, including THCA, available in Ireland for medicinal use. However, there are no such plans at this time to follow suit in England – barring specific request from scientists undertaking research.

Experts warn the success of cannabis oil varies from patient to patient. 'It will not be a miracle cure for everyone,' says Dr Colin Doherty, consultant neurologist at St James's Hospital in Dublin.

'Ten per cent will see their seizures go away, 35 per cent will see an improvement, and the rest will experience no improvement.

'There is also no widespread data on its safety. But it is a useful addition to the armoury in fighting epilepsy. The jury is also still out on whether adding THCA is necessary.'

But Charlotte has no doubt about the huge benefit the medication has had on Billy. 'This treatment has given Billy back to me,' she says. 'He's been more than 90 days without a seizure now. We don't know what will happen in the future – he isn't cured. But it is incredible that the illness is being kept at bay by this little bottle of oil.'