MPs Call for Urgency Over Medicinal Cannabis Trials

Peter Russell

July 03, 2019

Expectations that recent changes to government policy would lead to easier availability of medicinal cannabis were unfairly raised, MPs said.

An inquiry by the Health and Social Care Committee found that medicinal cannabis products remain unlicensed because of "major gaps" in research.

It called for the Government and the pharmaceutical sector to ensure that clinical trials into medicinal cannabis go ahead, and that there should be a greater sense of urgency about exploring its potential in the treatment of intractable childhood epilepsy.

"In research terms, we are probably the best part of 100 years behind where we should be in our knowledge of cannabis based products for medicinal use in humans," commented Dr David Caldicott, clinical senior lecturer at the Australian National University.

Change to the Law

Efforts by the families of Alfie Dingley and Billy Caldwell to access medicinal cannabis led to a change in government policy. In November 2018 medicinal cannabis was changed from Schedule 1 to Schedule 2 of the Misuse of Drugs Regulation 2001. That allowed specialist doctors to prescribe it, and for products to be made available for further research.

MPs said that the rescheduling was widely welcomed but was accompanied by "a failure to communicate what this would mean in practice for the availability of medicinal cannabis".

The inquiry found that very few prescriptions have since been issued for medicinal cannabis. This was because most of these products are not licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA), and are not approved by the National Institute for Health and Care Excellence (NICE).

The campaign group End Our Pain said it was not aware of any prescription being written for any patient since November 2018.

Clinical Trials

The inquiry said that a robust evidence base was needed so that patients and clinicians could evaluate the risks and benefits of medicinal cannabis use. Without this research, medicinal cannabis products would remain unlicensed for the many areas where patients wished to know if they could be effective.

Patients should therefore have the opportunity to take part in robust research, including randomised double blind controlled trials, to establish a body of evidence, MPs said.

The Committee welcomed the broad call for research proposals into medicinal cannabis products by the National Institute of Health Research (NIHR).

It noted that clinical trials were very difficult prior to the rescheduling of medicinal cannabis but that some pharmaceutical companies remained resistant to making their products available for research.

The Department of Health and Social Care should 'name and shame' companies which were not doing all they could to make their products available, the inquiry said.

"Current and future patients could benefit greatly from a swift move to carry out robust research into medicinal cannabis products," the Committee concluded. "We call on the Government to support the research community and industry to take this forward."

MPs also called on the Government to "desist from confiscating prescribed medicinal cannabis obtained overseas under specialist supervision".

Dr Sarah Wollaston MP, chair of the Health and Social Care Committee, said: "Although the recent changes to Government policy were welcomed, there was a failure to communicate what this would mean in practice for the availability of medicinal cannabis.

"Expectations were unfairly raised that these products would become widely and readily available, and there needs to be far clearer communication that this is not the case.

"However, recent changes to the scheduling do make it easier to conduct robust research into medicinal cannabis, which would build a stronger evidence base so that patients can weigh up any risks and benefits of treatment. At present there are too many gaps in the evidence to allow most forms of medicinal cannabis to be licensed for use and approved by NICE. We welcome the calls for research proposals from the NIHR and we recommend that intractable childhood epilepsy should be a priority."

Reaction to the Report

Genevieve Edwards, director of external affairs at the MS Society, said: "The Committee is right that the law change on medicinal cannabis has so far only led to raised expectations and misinformation. Evidence shows that cannabis can help ease pain and muscle spasms – MS symptoms which are relentless, painful and disabling.

"Yet people with MS are frustrated and disappointed that it’s still easier to buy cannabis on the street than it is to get an NHS prescription.

"We now need to see a concrete plan from the UK Government and industry to remove the barriers that are denying people an effective treatment. A focus on further research can’t become an excuse for inaction for the people with MS who could benefit now."

Dr Dan Hawcutt, a consultant paediatrician, and senior lecturer in paediatric pharmacology at the University of Liverpool, commented: "This report identifies that few products available in the UK have sufficient evidence to guide prescribers, and the critical need for more research."

Dr Amir Englund, post-doctoral researcher in psychopharmacology at King's College London, welcomed the MPs' report. He said: "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 [of] 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."

A Government spokesperson said: "We will carefully consider this report and its recommendations alongside the outcome of the NHS England review into the use of cannabis-based products for medicinal use in the NHS. 

"In doing so, the Government will consider any further action we might take to strengthen the evidence base and improve access to cannabis-based products for medicinal use where specialist doctors determine it is clinically appropriate."

Drugs Policy: Medicinal Cannabis, Health and Social Care Committee, Report

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