Experts force firm to cut back UK’s first large cannabis trial

PLANS to hold Britain’s first largescale trial of medicinal cannabis had to be dramatically scaled back following ethical objections, The Mail on Sunday can reveal.

Earlier this month it emerged that Harley Street firm LVL Health had obtained approval for a ‘feasibility study’ on 100 patients. The plan was to see if vaping ‘whole flower’ cannabis could alleviate chronic pain, with LVL hoping that this would lead straight to a 5,000-people trial.

The move, however, was rejected by an ethics panel.

About one in three adults in England have chronic pain – defined as lasting more than three months. Supporters of medicinal cannabis say prescription on the NHS could prevent people from selfmedicating and may be safer than opioids, the conventional treatment for chronic pain.

However, there are fears that widespread medicinal use could be used to soften criminal laws – as happened in the US.

LVL director Gregory Stoloff said their methods were robust and would yield high-quality results. But documents published online show an Oxford ethics committee had concerns about ‘the methodology’.

They questioned whether LVL would be able to recruit 5,000 patients, or to make a valid comparison with a similar number given standard NHS drugs.

Pain expert Sam Ahmedzai, a professor at Sheffield University, said the trial’s design ‘leaves a lot to be desired’. He pointed out that if the NHS group was not properly matched, the results

The new trial ‘leaves a lot to be desired’

could be misleading and that because 80 per cent of the LVL participants would have to pay £299 a month for treatment they could be more inclined to believe the cannabis was working.

But Mr Stoloff said LVL were experts at matching groups, and while the trial size could be reduced they had already had more than 5,000 enquiries.

He also said it was impossible to offer a placebo because the psychoactive effects of vaping cannabis would make it obvious which group a patient was in.

Mr Stoloff said the trial’s high expense meant LVL was not making money from the cannabis, and LVL had no interest – financial or otherwise – in recreational cannabis.

But author Alex Berenson, whose book Tell Your Children warns against legalisation, said: ‘The cannabis lobby followed a very clear playbook in the US – convince voters to approve the drug for medicinal use to create a quasi-legal industry. Then push for full legalisation.’