Psychedelics for mental health: tripping over red tape
By Jo Neill
The last decade has seen a new focus on psychedelics as powerful medicines for treating severe mental health issues, including the use of psilocybin for conditions such as PTSD and treatment-resistant depression. However, many of these potentially life-saving treatments, including psilocybin, remain difficult to research due to overly strict drug laws. In this blog, Professor Jo Neill outlines the evidence-based case for the rescheduling of psilocybin and other drugs, including the benefits they can bring to health, national prestige, and the UK economy.
Poor mental health currently costs the UK economy upwards of £100 billion per year due to losses in productivity.
Psilocybin-assisted therapy for depression has shown more than 70% long-term efficacy.
Despite the huge potential of psilocybin and other psychedelics, current drug control laws in the UK are unnecessarily restricting research into this area.
Reforming the UK’s drug scheduling laws would bring the country in line with the US, Germany, and others, with benefits to health, British research, and the economy.
Medical psychedelic research has undergone a renaissance in recent years. Psychedelics include plant medicines such as psilocybin (the active constituent of magic mushrooms), Ayahuasca (a powerful psychedelic used by indigenous populations, often consumed as a tea), and those synthesised in the laboratory, including LSD and MDMA (ecstasy). Psilocybin is a naturally occurring molecule found in over 200 species of fungi. It is structurally similar to serotonin – a human neurotransmitter that regulates mood and perception. When administered in clinical settings with psychological support, early clinical trials show that psilocybin may be a safe and effective treatment for many mental health disorders, particularly for patients for whom other treatments have been ineffective.
Psilocybin for mental health
These medicines are, in recent small scale clinical studies, proving to be very effective for hard-to-treat psychiatric conditions, such as severe depression, anxiety and depression that occurs in terminal cancer patients, alcohol and nicotine dependence, and OCD (obsessive compulsive disorder. Most recently, evidence is emerging for efficacy in PTSD (post-traumatic stress disorder).
Our focus is on psilocybin, as the psychedelic drug with most clinical evidence for its effectiveness for severe depression. Unfortunately, researching psychedelics is particularly difficult in both human and animal studies. It is extremely costly, bureaucratic, and incurs large time delays due to its current status as a Schedule 1 drug under the Misuse of Drugs Regulations of 2001. This stems from its classification as a Class A drug under the Misuse of Drugs Act 1971, in turn based on the UN drug control conventions of 1960 and 1971. These conventions detail the scheduling of different controlled drugs at the international level. Drugs are divided into five schedules, each specifying how national governments should regulate such activities as import, export, production, supply, possession, and record keeping which apply to them, for example in research-based circumstances. At both the UK and UN level, psilocybin is currently in Schedule 1, which has the most stringent regulations, while some drugs that are in Schedule 2 – and therefore have more relaxed requirements – are heroin, fentanyl, cocaine, and ketamine.
Given the significant clinical evidence for its efficacy as a treatment for mental health conditions, we are calling for the laws in the UK to be changed to enable research with psilocybin.
For substances in Schedule 1, a Home Office licence is generally required for their production, possession, or supply. A controlled drug register must be used to record details of any Schedule 1 controlled drugs received or supplied by a pharmacy. Researchers seeking to work on potential new treatments for treatment-resistant depression (TRD) using psilocybin face burdensome additional costs and delays, stemming from its classification as a Schedule 1 substance. This is in spite of existing evidence of medical benefit and its potential as the basis for new treatments for this illness. Demonstrating this is not a theoretical issue – it already determines which research projects researchers choose to consider, which get approved, and how billions of pounds of R&D funds in the UK and international pharma industry are committed.
In order to enable this research in the UK, this Government needs to remove psilocybin from Schedule 1 of the Misuse of Drugs Regulations 2001.
Science has moved on, there is now sufficient evidence of potential medical benefit for medicines derived from psychedelics. Moving psychedelics from Schedule 1 to a lower Schedule would enable our drug regulations to continue working in the way that they were intended – allowing medical and pharmaceutical research, and continuing to guarantee secure and responsible stewardship of substances in a small number of properly regulated organisations.
By rescheduling psilocybin to Schedule 2, many opportunities can be realised. There will be benefits not just in the field of health and social care, but also economic, industrial, and financial rewards.
Benefits of rescheduling
The most obvious benefit of rescheduling will mean that research can more easily be conducted into the effectiveness of psilocybin for mental health treatments. Mental health has reached crisis levels during the COVID-19 pandemic. 21% of adults experienced depression during 27 January to 7 March 2021; an increase of 11% from pre-COVID levels (10%). Psilocybin-assisted therapy is one of the most promising innovations for the treatment of depression seen for decades, with greater than 70% long-term efficacy in small scale trials to date. These long-term effects could result in a reduction in future spending on mental health treatments, and can also contribute to workforce health and productivity. Poor mental health currently costs the UK economy upwards of £100 billion per year due to losses in productivity. By using psilocybin as a long-term strategy, it has the potential to solve these interlinked problems in one go. Research from the United States has shown that psilocybin-assisted therapies may also be used safely and be effective for substance-misuse disorders, end-of-life anxiety and obsessive-compulsive disorder.
While it could contribute to a general increase in mental health outcomes, it could also have enormous benefits for service veterans. Currently, some veterans who return from their active duty suffer from mental illnesses, most commonly PTSD. The treatments that the UK has to offer frequently aren’t effective enough, so these veterans seek help elsewhere. Many UK veterans make use of psilocybin retreats in the Netherlands – where psilocybin is legal – to self-treat their own mental health illnesses. It is not right that UK veterans who risked their lives are having to leave the country to access this treatment.
Although there are obvious benefits for mental health, rescheduling psilocybin makes economic sense too. The Government has identified Life Sciences and pharmacy as a flagship UK industry in the post-Brexit period, which rescheduling psilocybin could be a large part of. For years now, the UK has been falling behind many other countries on research and development spending. The window is closing to be an international leader, with competition from the US, Germany, and others, as there will be a ‘first in market’ advantage for whoever acts decisively to enable this research at scale. In doing so, the potential for new research jobs, both in higher education and in industry, is created, contributing further to the UK’s productivity. Changing this law has never been more pertinent.
About Jo Neill
Jo Neill is Professor of Psychopharmacology at The University of Manchester. She is Chair of the Medical Psychedelics Working Group at Drug Science, a Trustee for Heroic Hearts UK, and a scientific advisor for the Conservative Drug Policy Reform Group, Beckley Psytech, Albert Labs, and Octarine Bio. Jo is also an advisory board member of the International Therapeutic Psilocybin Rescheduling Initiative, and co-founder of b-neuro, a University-based Contract Research Organisation developing new treatments for mental illness through animal models.
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