The UK’s Royal College of Psychiatrists (RCPsych) has published a report that calls for more clinical testing of psychedelic medicines, as there is currently a lack of “high-quality evidence” to support their use.
The report says that this is in part because of legal restrictions around the use of psychedelics in research, including lengthy ethics approvals and complicated access pathways, which “act as significant barriers to advancing new therapeutic options, and evidence-based practice.” In particular, it is concerned about gaps in the data around safety, efficacy, and long-term use.
The report has been welcomed by Imperial College London (ICL) neuropsychopharmacologist Professor David Nutt, who nevertheless said he was disappointed that the RCPsych had stopped short of recommending a change to the scheduling status of the “most promising” psychedelics, as has occurred in Australia, arguing this would be “the most effective way to remove these research barriers and collate more evidence in this space.”
The document (PDF) focuses on well-established psychedelics like LSD, psilocybin, MDMA, and ketamine, noting that initial studies point to their potential in treating a wide range of mental illnesses, including anxiety, depression, post-traumatic stress disorder (PTSD), and substance use disorders.
Of these, only ketamine – which is a Schedule 2 or Class B drug – can be legally used for treatment outside of research settings in the UK. All the others are Schedule 1 and subject to the strictest controls under UK law.
Reimbursement authority NICE recently doubled down on its rejection of NHS use of Johnson & Johnson’s ketamine derived Spravato (esketamine) as an add-on therapy for people with serious depression that has not responded to other treatments, saying it was not cost-effective.
“New treatments are rarely developed for people with mental illness, whose needs are often overlooked, and it’s vital that this trend is reversed,” commented Professor Owen Bowden-Jones, Registrar of the RCPsych.
The College has also issued new guidance to support clinical trials and research into the use of psychedelics in combination with psychotherapy, which it says should only be carried out “within specialised clinical settings by appropriately trained practitioners with relevant experience working in this field.”
One of the report’s authors, Professor Oliver Howes, who chairs RCPsych’s Medical Psychotherapy Faculty, said “there is a risk of claims jumping ahead of the evidence” as large, rigorous clinical trials of psychedelics are only just starting to emerge.
“A system to monitor the use of these substances and how patients respond to them must also be established through multi-agency collaboration,” he added, alluding to calls in the report for the MHRA, NICE, NHS, private providers, and clinical experts to work together on developing a framework for monitoring the category.
One of RCPsych’s recommendations is to set up a centralised patient database to monitor the use of psychedelics, gather information on their safety and efficacy, and help facilitate research.
Prof Rupert McShane, a consultant psychiatrist at Oxford Health NHS Trust and associate professor of psychiatry at the University of Oxford, said Norway has recently agreed to reimburse ketamine as an option for some patients, and has experience in setting up systems for monitoring long-term use.
He also said RCPsych is right to call for multi-agency collaboration, but added that it is “a shame that the […] Medicines Repurposing Committee, which included NICE and MHRA and was designed to consider relicensing of generics, was recently disbanded following the abolition of NHS England.”
