HISTORICAL & LEGAL CONTEXT
Cannabis and Epilepsy: How It’s Helping Patients in the UK
1.1 RESCHEDULING MEDICAL CANNABIS
1 November 2018: The UK government reclassified cannabis-based medicinal products (CBPMs) from Schedule 1 to Schedule 2 of the Misuse of Drugs Act, permitting specialist doctors to prescribe it legally .
Cases of Alfie Dingley and Billy Caldwell, children with severe drug-resistant epilepsy who benefitted enormously from cannabis treatments abroad, helped drive this change .
1.2 LEGAL PRESCRIBING FRAMEWORK
Initiation of CBPMs must be by a specialist on the GMC register, typically tertiary paediatric neurologists for epilepsy .
While GPs or nurse prescribers may continue via shared care, the specialist oversees prescribing and medico-legal responsibility .
Epidyolex (plant-derived CBD) is licensed and NHS-approved for rare epilepsies (Lennox-Gastaut, Dravet, tuberous sclerosis) .
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2. SCIENTIFIC EVIDENCE
2.1 CBD MONOTHERAPY (Epidyolex)
Meta-analysis of clinical trials in Lennox-Gastaut and Dravet syndromes shows 50%+ reduction in seizures in about 37% of patients vs 21% with placebo; ~20% mean reduction in seizure frequency .
Adverse events: high frequency (~88% vs 72%), issues include drowsiness, diarrhea, raised liver enzymes .
2.2 FULL-SPECTRUM CBPMs (CBD + THC)
Open-label case series (35 children) from the UK registry:
65.7% had ≥50% seizure reduction.
CBD+THC combo achieved 94% ≥50% seizure reduction vs 31.6% for CBD isolate .
Mild/moderate side effects occurred in ~45.7% .
UK qualitative study: carers report dramatic improvements in quality of life with CBPMs; benefits outweigh risks .
Observational data: 80% average reduction in monthly seizures in children using full-spectrum oils ; anecdotal 97% reduction in seizure frequency reported by Cannabis Health .
Argentine adult focal epilepsy trial: 32% had > 80% seizure reduction; 87% had ≥ 50% reduction with CBD add-on .
2.3 NEED FOR RCTs
NICE and NHS England highlight limited evidence, especially for full-spectrum CBPMs; demand more gold-standard RCTs .
A major double-blind RCT launching in 2025 will involve 500 UK patients (children & adults) using CBD, CBD+THC or placebo over 24 weeks, targeting refractory epilepsy .
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3. REAL-LIFE PATIENT EXPERIENCES
3.1 NHS VS PRIVATE ACCESS PATIENT STORIES
Patient Treatment Outcome
Alfie Dingley – early pioneer Full-spectrum THC oil in Netherlands → 90% seizure reduction; halted at home due to illegality → resumed after legal change; still reliant on private supply .
Louis Petit – drug-resistant epilepsy Moved to Netherlands, began cannabis → seizure-free > 4 years and now studying art; ongoing monthly cost ~£1,500; NHS-funded prescription pending .
3.2 CARERS’ STRUGGLES
Families report desperation, high costs (~£1,800–£2,000/month), and risky smuggling when supply is interrupted .
Only ~4 NHS-funded paediatric prescriptions exist vs ~28,000 private ones (June 2023) .
Lack of paediatric specialists: only 1–2 doctors prescribe full-spectrum CBPMs, with waiting lists of hundreds .
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4. SYSTEMIC AND POLICY ISSUES
4.1 PRESCRIBING BARRIERS
Resistance from clinicians: concerns over limited RCT data, long-term safety, THC effects on developing brain .
BPNA guidance labels evidence as insufficient; specialist support remains scarce .
4.2 NHS FUNDING SHORTFALL
CBPMs remain mostly unlicensed; NHS only covers under exceptional case-by-case reviews .
Individual funding requests are opaque and slow; many families must depend on private prescriptions, fundraising, or charities like Intractable .
4.3 PRIVATE SECTOR EXPANSION
~89,000 private prescriptions issued, compared to <5 on NHS .
Clinics like Curaleaf, Mamedica, Sapphire are gaining ground; many offer CBPMs including flower, vaporisers, oils .
Concerns over aggressive marketing and minimal screening, raising issues around recreational vs medical use .
4.4 DATA COLLECTION & GOVERNANCE
In April 2022 NHS England launched a CBPM Patient Registry to track prescribing and outcomes .
RESCAS (Refractory Epilepsy Specialist Clinical Advisory Service) advises tertiary neurologists nationwide .
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5. RISKS, SIDE EFFECTS & SAFETY
5.1 ADVERSE EVENTS
CBD side effects: drowsiness, decreased appetite, diarrhea, elevated liver enzymes .
Full-spectrum CBPMs report mild/moderate side effects in ~45%, including sedation and gastrointestinal issues .
5.2 LONG-TERM HEALTH CONCERNS
Insufficient data on THC’s impact on cognition, mental health, endocrine function.
Concerns from NICE and clinicians about neurodevelopmental effects in children .
Commercial CBD (OTC) is capped at 10 mg/day due to uncertain long-term liver effects .
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6. FUTURE DIRECTIONS
6.1 ONGOING AND UPCOMING TRIALS
2025 NHS-backed RCT (CBD vs CBD+THC vs placebo) across ~500 adults and children with refractory epilepsy .
CANPAIN MHRA-approved study (chronic pain) indicates expanding research infrastructure .
6.2 POLICY PROPOSALS
NHS England recommends establishing paediatric neurology prescribing frameworks, better GP integration, funding pathways, and registry data use .
Calls from advocates to revise NICE guidance, support full-spectrum prescribing, and bolster clinician education via Medical Cannabis Clinicians Society .
6.3 PATIENT GROUP ACTION
Advocacy by charities like Epilepsy Action, End Our Pain, Medcan Family Foundation, Intractable pushing for equitable access .
Documentary “D is for Distance” (Louis Petit) amplifies stories of families impacted .
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7. SUMMARY & CONCLUSIONS
1. Strong anecdotal evidence: Many families report dramatic reductions in seizure frequency, especially with full-spectrum CBPMs.
2. Clinically approved CBD (Epidyolex) demonstrates moderate efficacy in rare syndromes but has limitations.
3. Evidence gaps remain: large-scale RCTs are limited, and full-spectrum products lack formal trials.
4. Access barriers: NHS prescribing is minimal, costly, and slow— pushed aside in favour of private routes.
5. Safety caution: Short-term adverse events are common; long-term THC effects unknown, particularly in developing brains.
6. Research momentum: 2025 RCTs and growing registry data may reshape guidelines and reduce prescribing hesitation.
7. Policy push: Advocates want wider prescribing rights, funding clarity, more specialists, and NICE guideline updates.
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8. PATIENT PERSPECTIVE & POLICY IMPLICATIONS
Financial pressure: Families spend up to £1,800–2,000 monthly on vital CBPMs .
Emotional toll: Parents face anxiety, guilt, and fear of running out; also legal strain over sourcing .
Health inequality: Those unable to afford private prescriptions are left without access to life-changing treatment.
Governance need: Calls for transparent NHS policy, stronger paediatric prescribing, registry use, and clinician training.
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9. WHAT TO WATCH NEXT
2025 NIH‑backed RCT results: Will be pivotal for full‑spectrum CBPM acceptance.
NICE guidance: Potential update as evidence emerges from trials and registries.
NHS prescription numbers: Any increase in NHS-funded cases would signal a policy shift.
New specialist clinics: More UK clinics prescribing to paediatric cases may ease access issues.
Cannabis and Epilepsy: How It’s Helping Patients in the UK
