Charity launches real-world medical cannabis study

A medical charity aims to inject some hard data into the often fractious debate into the value of medicinal cannabis, with the help of a 20,000-patient pilot study in the UK.

Drug Science – headed by the former Chair of the Advisory Council on the Misuse of Drugs Prof David Nutt – has set up a partnership between patient groups and medical cannabis companies to launch the national registry study.

Called Project TWENTY21, the pilot intends to enrol the 20,000 subjects by the end of 2021 and take a real-world approach to generating data on the safety, efficacy and cost-effectiveness of medical cannabis products.

Last November, NHS England decided that medicinal cannabis products could legally be prescribed in the UK by a hospital doctor who is registered to do so, for three specific indications which don’t respond to other therapies.

That includes children with rare, severe forms of epilepsy, adults with vomiting or nausea caused by chemotherapy, and adults with muscle symptoms caused by multiple sclerosis. However, it doesn’t include chronic pain, one of the main uses of cannabis products, and campaigners have said this makes the programme too restrictive.

Moreover there are also claims that the new framework is making it much too hard for even eligible patients to access medicinal cannabis, with a lack of clarity over the criteria used to make judgments on access.

As a lack of clinical evidence is the main reason for rejecting cases, Project TWENTY21 wants to fill the data void, and will include a much larger spectrum of patients from the off, including those with chronic pain and other diseases like multiple sclerosis, and improve access to therapies.

David Nutt

“Cannabis was a medicine in the UK for over a century until 1971 when it was banned for political reasons,” according to Nutt. “Since then hundreds of thousands of patients have been forced to break the law to get a treatment that most find preferable to their previous prescription medicines.”

Just this week, a mother in Scotland was visited by police after admitting smuggling cannabis oil into the UK for her son, who has a rare form of epilepsy. She told the BBC she now fears child protection proceedings.

Meanwhile, Emma Appleby – whose daughter Teagan also has severe epilepsy – had £2,500-worth of cannabis oil seized by UK customs earlier this month even though she had a private prescription, on the grounds that she did not have an import licence. The supplies were eventually returned but the case demonstrates that the current framework is not operating effectively.

“Despite the UK making cannabis a medicine in November 2018 there have as yet been only a handful of prescriptions on the NHS,” says Nutt.

The patient registry approach also sidesteps the current access protocol and effectively means that patients will be able to get access to treatment for the purposes of the research, without breaking the law.

“It will also provide a solid clinical database from which experience of and confidence in, medical cannabis prescribing will develop, providing a foundation for other medical prescribers to build on.”

Project TWENTY21 will be run by a working group drawn from the United Patients Alliance (UPA), several academic researchers and medical cannabis companies including Althea which recently entered the UK market.