The House of Commons Health and Social Care Committee has published a report on medicinal cannabis use in the UK.
Dr Sagnik Bhattacharyya, Reader in Translational Neuroscience & Psychiatry & Consultant Psychiatrist, King’s College London and the South London & Maudsley NHS Foundation trust, said:
“This is an excellent, thoughtful and balanced report from the Health and Social Care committee. It acknowledges the changed regulatory landscape and areas of potential unmet treatment need that may be met by medicines derived from cannabinoids and related substances present in cannabis, whilst reinforcing the need for following robust processes for approval and use of such medicines based on evidence of their efficacy as well as safety and tolerability. Although medicines have great potential to treat illnesses and relieve distress/ suffering and indeed do so for billions every day, they also have considerable potential to cause side-effects and actual harm in a proportion (thankfully often a small proportion) of those who use them. Based on currently available evidence, medicines that may be derived from cannabis are likely to be no exception. Therefore, as the committee has rightly stated, there are no grounds for “making an exemption for this class of (potential) medicines”. The committee has rightly highlighted the very limited evidence base for efficacy of medicines derived from cannabis (except for Epidiolex and Sativex which are licensed for specific conditions) and underscored the urgent need for randomised clinical trials to address these knowledge gaps. Randomised clinical trials are the right mechanism to examine questions regarding efficacy as well as get a sense of safety/ tolerability for any new treatments because they provide evidence that is unbiased by expectations/ perceptions of patients as well as their clinicians rather than anecdotal and other types of observational evidence that is currently driving much of the expectation around benefit from cannabis-derived medicines. At the moment cannabis-derived medicines seem like panacea. This report hopefully will help shed light on the importance of managing expectations at the policy level. Only then can the process of evidence gathering (eg through clinical trials) by researchers/ clinicians and evidence appraisal by regulators (eg MHRA or EMA) progress in a rational manner to actually allow cannabis-derived medicines that may have a real impact on patient suffering in certain conditions see the light of the day. Unfortunately, these processes can only be accelerated up to a certain extent without having an adverse impact on the quality of decision-making.
“Where the committee could have done more is with regard to nomenclature. While it’s true that a rose is a rose by any other name, nomenclature is particularly important in the context of cannabis, which often attracts contrasting views. The committee acknowledged that cannabis is not one substance and the extract of the plant has many cannabinoids as well as other substances. There is evidence that some of those cannabinoids such as THC may actually be harmful if taken regularly in a not-insignificant proportion of people. The term ‘medicinal cannabis’ perhaps engenders and reinforces a false sense, that is not uncommon in society at large, that cannabis itself is essentially harmless. Only certain cannabinoids, either alone (such as CBD in Epidiolex) or in combination (such as THC and CBD in a particular ratio in Sativex) have been licensed as medicines. It is extremely unlikely that cannabis per se irrespective of where it is derived from and what specific constituents (eg what proportion of THC, CBD, other cannabinoids or non-cannabinoid substances) it has will be found to have medicinal use. On the other hand, it is highly likely that any additional medicinal uses of cannabinoids and non-cannabinoid substances present in cannabis will be for some of these substances either alone or in specific combination e.g. in a drug formulation. Therefore, it would have been helpful for the committee to also shed light on this aspect and suggest potential alternative names to the current term “medicinal cannabis” that may have helped avoid giving an impression that any cannabis is useful as a treatment.”
Prof David Nutt, The Edmond J Safra Chair and Head of the Centre for Neuropsychopharmacology, Division of Brain Sciences, Dept of Medicine, Imperial College London, Imperial College London, said:
“The main weakness of these recommendations is that it assumes the UK has to do it all itself – so the evidence from other countries that are ahead of us is diminished – e.g. , the over 400,000 patients on the health Canada database, and over 30,000 patients on treatment in Germany and Italy. In the UK patient advocacy groups suggest there are between 100,000 and 1,000,000 patients in the UK that may benefit from regulated, legally procured medical cannabis.
“I welcome the prioritisation of children with intractable epilepsy for clinical trials and research but am concerned however that the data from countries such as Australia, Canada, Germany, Italy, the Netherlands and the USA, that have highlighted that a significant adult epilepsy patient cohorts also benefit from being prescribed medical cannabis is ignored. Several hundred adults with epilepsy die of their illness each year.
“I support the select committee call for more research and DrugScience is developing ways to achieve this with the support of the cannabis industry and patient groups through our TWENTY21 initiative. I welcome the call for patients to be allowed to continue using non—prescribed medical cannabis as this is the only way to ensure patients with severe illnesses are entered into trials.
“I also strongly support the clear statement from the committee that doctors who believe medical cannabis is helping their patients should not be dissuaded by other factors. These doctors are welcome to contact www.DrugScience.org.uk for support and training.
Dr Dan Hawcutt, Senior Lecturer in Paediatric Pharmacology (and Consultant Paediatrician), University of Liverpool, said:
“All medicines carry the potential for harms (adverse drug reactions) as well as the benefit for which they are prescribed. This report identifies that few products available in the UK have sufficient evidence to guide prescribers, and the critical need for more research. While this will take time, the report correctly identifies how this can be minimised.”
Dr Amir Englund, Post-doctoral researcher in Psychopharmacology, Institute of Psychiatry Psychology & Neuroscience, King’s College London (IoPPN), said:
“I welcome the report from the Health and Social Care committee as it highlights many issues regarding medicinal cannabis in the UK. They rightly point out that we do not have the same evidence base for cannabis as we do for other medications and highlight that this is partly due to the scheduling cannabis and difficulties with patenting products – hence companies are less willing to invest in expensive clinical trials. The call for more funding of clinical trials is crucial as it will increase our understanding of the risks and benefits of various cannabis products for different conditions.
“While we wait for these trials to be completed an alternative may be to allow certain well-controlled products to be given to patients who have exhausted other treatment options and to perform so-called phase 4 studies, also known as post-marketing surveillance trials. This is normally done when a new drug gets approved and is available to be prescribed by doctors and aims to assess the safety and efficacy on a more long-term basis. This would allow additional access to patients as well as more quickly building up the evidence base for medicinal cannabis.
“Lastly, an important issue to address is the one of exaggerated claims of cannabis as a treatment for various conditions which circulate online and in news articles. For instance, clinical trials have found that a number of patients with epilepsy become seizure-free on medical grade CBD, however this only happens to roughly 5% of patients – which naturally becomes the focus of news stories. The other side of the coin is that some patients in these trials drop out either because they felt no improvement or were experiencing side-effects.
“We do need more evidence for medicinal cannabis and more people should be allowed to access it, however we should also measure our expectations as cannabis is not a panacea.”
Dr David Caldicott, Clinical Senior Lecturer, Faculty of Medicine, Australian National University (ANU), said:
“In a carefully worded statement, The Health and Social Care Committee have suggested that the paucity of prescriptions for medicinal cannabis in the UK related to the lack of confidence of practitioners in prescribing this controversial product. While this is globally the case, the assumption that this is exclusively due to the lack of trial data might be considered as more of an excuse than an explanation.
“In research terms, we are probably the best part of a hundred years behind where we should be in our knowledge of cannabis based products for medicinal use in humans (CBPMs). Skeptics would argue that this proves that they have no medical utility; the reality is that research has been very difficult to conduct in an environment where more broadly, cannabis has been demonized as an agent without beneficial attributes. The broader anthropological experience is at odds with this opinion, and as restrictions have been lifted, more evidence supporting the medicinal use of cannabinoids continues to emerge.
“From the report itself, it is clear that the expertise in the UK is every bit as divided as it has been elsewhere, wherever this debate has occurred. The UK has had the benefit of observing the experience of other countries in this space, but seems determined to avoid learning any of their lessons. Israel has probably the most advanced system in place, along with Canada and the Netherlands, and yet the tone of the report seems to take its cues from countries like Australia, where a reactive, impromptu series of decisions has marked a rather sorry roll-out. The Israelis believe that given the many thousands of patients deriving benefit from an unregulated market, it is ethically untenable for them not to provide a standardized product and conduct rigorous trials in parallel to compassionate access. They refer to this as the ‘medicalization’ of cannabis and have codified their prescribing guidelines into what is effectively the equivalent of a British National Formulary for medicinal cannabis prescribing, namely their ‘Green Book’. Given that it has recently been translated into English, it seems odd that such an advanced approach would not merit a mention, or inform decision makers, for this ‘Green Paper’.
“The authors correctly earmark the importance of addressing research into the promising area of intractable epilepsy, particularly in paediatric populations. The issue of pain has proven a little too difficult to grasp. Pain is the commonest reason why CBPMs are used globally, with prescribing data showing that, in jurisdictions where a functional medicinal cannabis regime is in place, patients preferentially choose to use medically supervised cannabinoid options, with fewer side effects.
“Perhaps the strongest findings of the report are in the role and responsibilities of a nascent industry in ensuring that good research can be expedited. Big Green runs the risk of tarring itself with exactly the same reputation as Big Pharma, or worse, and it could be argued that they would be wise to start out by proving that they can place patients before profit.
“The Chair of the Committee is probably correct in noting that expectations have been unfairly raised for UK patients, in what are often horrendous personal situations. In a global society, where distance can no longer be relied upon to prevent patients from comparing notes, UK patients probably assumed that they would have access similar to their counterparts in Canada, or Germany, Israel or the Netherlands. But poor communication is not limited to that for patients alone. In Australia, medicinal cannabis was rolled out without any attempt to provide independent education to medical practitioners about what the product can, or cannot do. There is an abundance of global practice and expertise in this space, and if the UK is determined not to learn from this, and to restrict compassionate, medically supervised access to those who stand most to benefit, until such a time that formal trial data becomes available, access in the UK will be delayed for many years still to come. That will not stop the therapeutic use of undifferentiated products by patients in the desperate search for relief from intractable symptoms. Instead, it will continue to propagate an environment where rogues and charlatans can take advantage of a patient group that not only deserves better, but knows what better looks like.”
* The Sixteenth Report from the House of Commons Health and Social Care Committee, Drugs policy: medicinal cannabis will be published at 00:01 UK time on Wednesday 3 July.
Dr Sagnik Bhattacharyya
SB has been investigating the effects of cannabinoids on brain function and behaviour and their therapeutic potential as well as harmful effects using experimental studies and clinical trials and observational studies in healthy people and patients for over a decade. SB’s work has been funded by the MRC (UK), NIHR, Wellcome trust, European Commission, Academy of Medical Sciences, Parkinson’s UK and Peel trust. The views expressed above are not a reflection of the views of SB’s employers nor of funders that have supported SB’s research.
Prof David Nutt: Prof Nutt is chair of DrugScience.org.uk a charity that receives unrestricted educational grants from some medical cannabis companies.
Dr Dan Hawcutt:
Dr David Caldicott: By way of conflicts, I have none. I am the author of the RACGP-accredited ‘Australian Medicinal Cannabis Course’, which we have been running for free, out of the Australian National University, since 2016.
Dr Amir Englund: I confirm no conflicts of interest related to this topic.