More research is needed to justify use of 'medicinal' cannabis: UK agencies
A concerted campaign to unlock the use of cannabis to treat severe childhood epilepsy prompted the British authorities last year to sanction its use in certain patients, when other medicines have failed, after consultation with a specialist doctor. On Thursday, NHS England and cost-effectiveness watchdog NICE unveiled their preliminary recommendations on the adoption of cannabis-derived medicines for a variety of conditions. In short, they want more research to justify the medical use of cannabis.
NHS England issued a review that underscored a paucity of long-term safety and efficacy of medicinal cannabis, acknowledging that clinicians have found that some patients with severe treatment-resistant epilepsy do respond to cannabis-based therapy and that observational data suggest cannabis therapy can diminish seizure frequency, resulting in fewer trips to emergency rooms and a better quality of life.
While medicinal cannabis was being considered on a case-by-case basis since last November, the lack of randomized control trial (RCT) data is a major hurdle to prescribing, in addition to the cost of acquiring the product, which is not readily attainable on the NHS or by NHS Trusts.
Consequently, the NHS recommended two clinical trials be set up.
In parallel, NICE recommended further research into the use of cannabis-based products in indications such as fibromyalgia, chronic pain, nausea and vomiting and spasticity.
The agency also highlighted that it was unable to make a recommendation for the use of cannabis-derived medicines in severe treatment-resistant epilepsy, citing a lack of clear evidence of benefit. (GW Pharma’s FDA-approved cannabis-derived drug for epilepsy, Epidiolex, is under European review.)
“For those affected by severe epilepsies, hope is often in short supply. We recognise how disappointing the draft recommendations will be for many. Having already waited almost a year for this guidance, the prospect of waiting many years more for trials to be completed is unacceptable,” Simon Wigglesworth, deputy chief executive at UK-based Epilepsy Action, told Endpoints News.
On the basis of a lack of cost-effectiveness, NICE also advocated against the use of GW Pharma’s $GWPH approved cannabis-derived spray Sativex in patients with spasticity. In addition, NICE said that that other cannabis-based medicinal products should not be offered to treat spasticity unless as part of a clinical trial. NICE did, however, endorse the use of synthetic cannabis treatment nabilone, as an add-on treatment for adults with chemotherapy-induced nausea and vomiting that haven’t responded to conventional medicine.
“We recognise that some people will be disappointed…However, we were concerned when we began developing this guidance that a robust evidence base for these mostly unlicensed products was probably lacking,” Paul Chrisp, director of the Centre for Guidelines at NICE, said in a statement. “Having now considered all the available evidence it’s therefore not surprising that the committee has not been able to make many positive recommendations about their use.”
While the UK is slowly building the evidence case to evaluate the potential medicinal properties of cannabis — in the United States, researchers have found that gaining access to cannabis for medical research has been a frustrating, uphill battle. A majority of US states have sanctioned the use of cannabis in a medical and/or recreational capacity — but at the federal level, it remains a schedule 1 substance considered to have no medicinal value.
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