With the upsetting case of Alfie Dingley dominating news headlines ("Home Office denies medical cannabis pleas for boy age six"), the UK Government is being asked to reconsider its approach to medicinal cannabis. But what would this mean for manufacturers, healthcare professionals, and, most importantly, potential patients?
If, like me, you have been following the case of Alfie Dingley in the news, you'll be familiar with the debate that is raging over the use of medicinal cannabis in the UK. Of course, we can all have an opinion on the somewhat tricky (and extremely nuanced) topic of drug decriminalisation - but what is the Government's stance, and are attitudes shifting? And if they are, what would any change mean for pharmaceutical companies, manufacturers, healthcare professionals, and, most importantly, for patients?
Alfie, aged six, suffers with a rare form of epilepsy (only nine other children in the world suffer with the same condition), and can have between 20 and 30 violent seizures a day. In September last year, Alfie's mother, Hannah, took him to the Netherlands to take a cannabis based medication (prescribed by a paediatric neurologist there), which saw his seizures reduce in number, duration and severity; he went 24 days without an attack.
It was on that basis that Alfie's family requested a licence from the UK Government, which would allow him legally to take cannabis oil to treat his epilepsy, and it was this request that has sparked furious debate.
During the debate over Alfie's requested licence, a spokesperson for the Home Office stated that cannabis 'is not recognised in the UK as having any medicinal benefit' and emphasised the importance of thoroughly testing medicines to 'ensure that they meet rigorous standards before being placed on the market, so that doctors and patients are assured of their efficacy, quality and safety'.
Lord Dear (independent crossbencher and former Chief Constable of the West Midlands) told the House of Lords that the current legal classification of the drug as having no therapeutic value had been 'roundly rebuffed' by other countries. Calling on the Government to look urgently at the licensing of the drug for medicinal use, Lord Dear contrasted the UK's approach with numerous EU countries, US states, Canada and Israel, who all allow 'under medical supervision licensed use of cannabis'. Policing Minister, Nick Hurd, has also commented that 'we are aware that the position is shifting in other countries - we monitor that closely'.
The World Health Organisation is presently reviewing cannabis use, and Baroness Williams assured peers that the Government was keeping 'a very close eye on the outcome of that review' to take 'a view on it in due course'.
Despite the above, Alfie's request for a licence was denied on the basis of current legislation, which states that Cannabis (as a Schedule 1 drug) cannot be practically prescribed, administered or supplied to the public, and can only be used for research under a licence. The Government is now considering whether a clinical trial – which would be led by Alfie's medical team, based on 'sufficient and rigorous evidence' – could provide another option. In the meantime, Alfie has unfortunately been readmitted to hospital.
But what does this show about the Government's stance on medicinal cannabis? Society's and individual attitudes towards the decriminalisation of drugs seem to be shifting, but policy also has a part to play; there are arguments that the UK's attitude is lagging behind other European and American countries (adding to concerns that, following Brexit, patients in the UK will access the latest treatments some years later than those in the EU).
Clinical and Legal issues when bringing a drug to market
If Alfie were placed on a clinical trial which yielded successful results, this would likely pave the way for further advancements in the use of cannabis oil as medicine. But there would be many issues to consider in the meantime:
Legally: new regulations would have to be considered and implemented;
Practically: manufacturers would need to boost output, and would need to review published information such as patient information leaflets;
Medically: patients would need to be monitored and side effects noted and reported;
Statistically: data would need to be collected and analysed.
Ethically: the risks of such treatment will be relatively unknown (very little UK data would be available) and this would cause concern for healthcare professionals, providers (and their insurers). Patient consent would need to be managed extremely carefully (with all possible adverse reactions covered).
However, for those potential patients who are suffering, it would probably be a risk they would happily take.