Photo: Facebook/Keep Billy Alive
Charlotte Caldwell’s 15-year-old son Billy has suffered severe, life-threatening epileptic seizures since he was a baby. He was at the centre of a years-long legal battle to be prescribed medical cannabis after doctors in North America used CBD whole plant extract to get his seizures under control.
While Billy’s treatment effectively legalised medical cannabis in the UK in late 2018, campaigners like Caldwell believe more clinical trials are necessary in order for NHS doctors to feel comfortable prescribing the medication, so that medical cannabis can become more accessible, and ultimately covered by the UK’s taxpayer-funded National Health Service. They are fighting to relieve the financial burden on vulnerable and chronically ill patients who are currently obliged to seek private prescriptions.
In 2020, a Care Quality Commission report found that 259 cannabis-based medical products (CBMPs) had been prescribed privately in the UK in 2019, and only 18 CBMPs had been prescribed through the NHS. Although not a direct comparison, in contrast California had nearly one million medical cannabis patients in 2018.
In the UK, cannabis is illegal for recreational use. Medical use of cannabis is legal when prescribed by a registered specialist doctor. However, due to significant lack of research and clinical trials, finding an NHS doctor willing to prescribe medical cannabis is incredibly difficult.
Caldwell and her team from the I Am Billy Foundation will meet with a junior minister in the UK Department of Health and other health officials this week to make their case.
“This is about pioneering for the patients. We can do this, in a way whereby it will get comfortable with the government because it’s the only way this is going to go. We have got to start gathering the evidence. The efficacy and the safety of the medicine is paramount,” Caldwell told VICE World News.
Billy was born on the 26th of July, 2005 in County Tyrone, Northern Ireland; a seemingly healthy baby boy, with big baby blues. “He looked like E.T.,” Caldwell told VICE World News. “They had the towel around him and all you could see was these two big, massive blue eyes like saucers”.
But Billy was only four months old when Charlotte noticed something unusual about his behaviour. “I looked into his crib, and he was just lying very still with his eyes wide open, staring at the ceiling. He wasn’t crying, but I thought it was a really strange expression.” She picked him up, rubbed his back and placed him back in the crib. Again, Billy began to stare with that same, blank expression.
Doctors advised that he be sent to a specialist in the county’s main hospital. During the ambulance ride, Billy experienced his first grand mal seizure or tonic-clonic seizure.
A tonic-clonic seizure occurs in two stages. Tonic stage: loss of consciousness, stiffened body, and often collapse. Clonic stage: jerking limbs, loss of control over bladder or bowel, and difficulty breathing.
“I obviously had heard about epilepsy and seizures, but I didn’t know this was what he was having,” Caldwell said. “He went bright red just like a tomato. He was seizing. His whole body. It was horrifying. The local hospital to this other hospital was a 55-minute drive, and I think it must have been the longest 55 minutes in my entire life.”
This was only the beginning of what has become Billy’s lifelong battle with epilepsy. The seizure that had started in the ambulance continued for a terrifying seven and a half hours. Once the nurses were able to stabilise Billy, and stop the seizures, Caldwell was allowed to see him. “It was like somebody had just knocked me out and I was in some horrific nightmare, because here was this little tiny E.T. in the middle of this massive hospital bed with machines all around him”.
Despite Billy being on a variety of anti-epilepsy drugs, the seizures continued. After three days in the hospital, he was transferred to Royal Victoria Hospital Belfast, where a clinician spoke to Caldwell and warned her that her son wouldn’t likely make it to his first birthday. Charlotte took Billy home expecting him to not even make it past six months.
But she also refused to give up. And she began searching for a solution. She was determined to keep her “little wizard” alive. Eventually, she located a doctor in Chicago who she and Billy, then two years old, flew out to meet. The doctor was successfully able to wean Billy off his anti-epileptic medication cocktail, get him on a ketogenic diet (a high fat, controlled protein and limited carbohydrate diet), and leave him, for the first time in his young life, seizure-free. Caldwell and her son stayed in Chicago as he underwent intense physiotherapy, where he learned to sit, walk, crawl and stand. For the next eight years, life returned a degree of normalcy for Caldwell and Billy.
But in June 2016, when Billy was almost 11, the seizures returned with a vengeance. Attributing the seizures’ return to puberty, Billy’s body was starting to change. The seizures were stronger, longer, and more frequent. Caldwell watched all those years of therapy crumble before her own eyes.
Caldwell sought out the same doctor from Chicago who had then relocated to Los Angeles. There, they carried out a number of diagnostic tests on Billy and eventually referred him to a medical cannabis expert.
Under UK law at the time, Caldwell was only able to access a prescription that was based on, and had proven efficacy through clinical trials. She found a paediatric neurologist at the Children’s Hospital in Toronto, Canada that had been running clinical trials of medical cannabis.
Billy was prescribed CBD whole plant extract, microdosed over a period of weeks up to his target weight. Within weeks, Billy’s seizures became less intense and less frequent.
The UK Department of Health said that the Caldwells were unable to return to the UK with Billy’s medicine unless the NHS or a private consultant agreed to support Billy’s prescription. If they were to return home without a supporting doctor, they would be arrested.
In June 2018, Charlotte and Billy returned to London Heathrow Airport and Billy’s medicine was confiscated. Only a few days later, Billy was rushed to the hospital in a full-scale grand mal seizure that was unshakeable. Caldwell was prepared to say goodbye to her son.
The NHS staff did all they could do with hands tied behind their back. The only medication that was going to save Billy’s life was confiscated and locked away at the UK Home Office.
After serious negotiations between Caldwell’s foundation and the treating doctor, Billy’s medicine was returned to the family the following morning. “‘I am going to get your little boy’s medicine back,’” Caldwell recalled the doctor’s words.
Only a few days later, Billy was discharged from the hospital, greeted by the world’s press. Later that week, the Home Secretary Sajid Javid told the story in parliament about how Billy had gotten his medicine, and that the UK would conduct research into whether cannabis did indeed have medical benefits for those living with epilepsy. Without ever meaning to, Caldwell and Billy had effectively legalised medical cannabis in the United Kingdom.
But the fight was long from finished.
Medical cannabis is legal in the UK, but with very limited prescription options. The issue faced by medical cannabis patients today lies in the lack of clinical trials. NHS doctors are much less likely to prescribe or support a medical cannabis prescription without proven and consistent efficacy.
Dr Mikael Sodergren is the Managing Director & Academic Lead at Sapphire Medical Clinics, the first officially registered medical cannabis clinic in the UK. “We don’t have a very good molecular understanding of the mechanism of action of CBD in epilepsy,” he told VICE World News. “We know that [CBD] signals through a number of different molecular pathways and we know that the endocannabinoid system in the brain has its specific receptors. It’s through the effect of these molecular signalling pathways that we see a reduction in seizures”.
There have been a number of different therapeutic effects of medical cannabis, but they are still preclinical, and not entirely backed up by trials. “We just don’t have the clinical data to be able to prove that in randomised trials, yet those trials haven’t been done. It’s not that they’re negative. It’s just they haven’t been done,” Sodergren said.
Caldwell’s fight was never solely about her son, but for the countless others in the UK who don’t have the resources to fight on their own.
“We need to gather real world evidence, evidence for the efficacy. It’s imperative that we show the efficacy and safety of this medicine and relieve the financial burden of some of these patients who are some of the most vulnerable, chronically ill patients of our society from some of the most deprived areas of our society,” Caldwell said.
You can find out more about Billy and Charlotte’s story at their foundation’s website: IAmBilly.uk.