Producers are doing a ‘disservice’ to patients by not funding clinical trials, says expert

Cannabis producers are doing a ‘disservice’ to patients by not investing in the clinical trials needed to improve access, an industry insider has said.

Manufacturers should be putting money behind the research needed to build the evidence base for medicinal cannabis, according to Hannah Simon, director of Sana Healthcare, a importer and distributor of cannabis medicines in the UK.

Simon believes producers are doing a ‘disservice’ to patients by not investing in clinical trials.

She was speaking last week, during a panel discussion hosted by PLEA (Patient-led Engagement for Access) for Medical Cannabis Awareness Week on Tuesday 1 November. 

The webinar, Medical Cannabis Research on Paediatric Epilepsy was held on the fourth anniversary of the historic legalisation of medical cannabis in the UK. It explored the barriers still preventing children with treatment-resistant epilepsy from being prescribed cannabis in both the public and private sectors. 

It covered the existing research that has been done around the efficacy of cannabis for seizure reduction, including a paper published by Drug Science, which found seizure frequency fell by 86% in children with intractable epilepsy who were using whole-plant cannabis. 

They same researchers calculated that the treatment has a 96% chance of reducing seizures in another child with the same condition. 

Addressing safety concerns 

A lack of scientific evidence from clinical trials is continually cited by policymakers as the reason why the prescribing of cannabis cannot be more widely rolled out through the NHS. 

The challenges of Randomised control trials (RCTs) in relation to whole-plant cannabis research have been widely discussed among experts. Due to its complexity, cannabis, which contains over 100 different cannabinoids alone, doesn’t easily lend itself to these form of trials, which are usually carried out on an isolated compound.

But in Simon’s view, if the goal is to improve patient access the sector needs to address the concerns of clinicians. 

“It keeps coming back to safety concerns. The risk profile is something we need to address, rather than efficacy, which I do feel there is sufficient evidence for,” she said.

“For me there is space for RCTs on particular products, to gather safety and toxicity data if nothing else.”

She added: “Clinicians are the gatekeepers to patient access, so if we want to improve patient access we need to address their concerns head on.”

Opportunities for research

RCTs are typically expensive to run and have a lengthy approval process, but Simon highlighted that there are a number of research initiatives in the UK which companies could be taking advantage of.

The Innovative Licensing and Access Pathway (ILAP) is an initiative of the National Institute of Health Research (NIRH) which is designed to support innovative approaches to the ‘safe, timely and efficient development of medicines’.

It is open to both commercial and non-commercial developers and aims to speed up the time it takes to get a medicine to market in order to improve patient access.

“ILAP holds the organisation’s hand through submitting the dossier and designing the trials and is therefore supposed to expedite the process,” explained Simon.

“Furthermore the NIHR has also committed an amount of funding to innovation in the biotech space, so they will subsidise clinical trials which they think have longevity… they are looking at this as part of a view to position the UK as an epicentre of medical research.”

She added: “So, there are a number of initiatives that the cannabis sector could be taking advantage of and isn’t [currently]. The manufacturers, the people who are making the drugs, are not doing the research that the clinical communities are calling for. I think to some extent they are doing patients a disservice by not doing that.”

Calls for compassionate access 

Even with these innovations, it is likely to be some time before cannabis medicines are widely available on the NHS. In the meantime, families are struggling to continue to fund their children’s prescriptions privately.

Matt Hughes, co-founder of Medcan Support which helps parents and carers of children with epilepsy, called for some form of compassionate access scheme for these patients. 

“We are going to be in the private sector for a long time, we know that, but families just can’t afford it. A bottle of Bedrolite starts at £150 and that lasts just a few days,” he commented.

“Given the current economic climate and all our bills going up, we definitely need some form of compassionate access.”

Emma Matthews, mum to Louis, 19, who is prescribed medical cannabis privately at a cost of £1,400 a month echoed this, adding: “We can’t wait for trials, we just can’t afford it.”

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