We are delighted to announce the publication of a major new report, Medicinal Use of Psilocybin, in collaboration with the free market think tank the Adam Smith Institute. The report calls for the rescheduling of psilocybin, the active compound in magic mushrooms, which could help avert a looming mental health crisis. The paper, by Dr. James Rucker, David King, Jesse Schnall, Daniel D’Hotman, Timmy Davis and Prof. Jo Neill, has been sent to the Home Office accompanied by statements of support from leading scientists.
“A cross-hatching of prohibitive scheduling […] has led to a scientific blackout lasting nigh on fifty years, precluding new treatments and, with them, the prospect of a better life for millions of people.”
Crispin Blunt, Chairman of the CDPRG
The authors argue that psilocybin’s current inclusion in Schedule 1 of the 2001 Regulations follows an outdated assumption of harmfulness, implicit in its Class A status, which is not supported by the current evidence base. Controlled drugs may be rescheduled by a Statutory Instrument implemented by the Home Secretary, on the advice of the Advisory Council on the Misuse of Drugs (ACMD), without affecting existing legal controls on non-medical or scientific use, and there is a precedent for rescheduling controlled drugs before market authorization.
● Progress in the treatment of depression has been slow. Prior to the approval of esketamine by the European Commission in late 2019, the last major advancement in the treatment of depression came over 30 years ago with the licensing of SSRIs.
● Psilocybin will fundamentally improve the treatment of mental health conditions. Psilocybin works in a different way to traditional antidepressants and psychological therapies, by directly increasing activity and changing patterns of connectivity in brain regions strongly associated with ongoing depression and anxiety.
● Psilocybin’s current Schedule 1 status is at odds with its low toxicity. Compass Pathways recently completed the largest ever randomised study of psilocybin, in collaboration with Dr James Rucker and Professor Allan Young at King’s College London. The study found that psilocybin caused no statistically significant worsening of cognitive and emotional measures, no serious adverse events and no adverse events that led to withdrawal from the study. This is the strongest evidence yet for the basic safety profile of psilocybin, and the best evidence yet to justify ongoing, large scale research in patient populations.
● Moving psilocybin to Schedule 2 could kick-start the UK’s flagging mental health research field. The UK presently has no active pharmaceutical laboratories doing central nervous system research and development outside of universities since Eli Lilly closed their site in Surrey in March 2020.
Major depression is common and deadly. It is associated with nearly half of all suicides in the UK and is a leading cause of disability and socioeconomic burden worldwide. About a third of people suffering with major depression don’t get better with standard drug and psychological treatments. Good quality, small scale clinical trials have indicated that psilocybin therapy is an effective new treatment for those people.
We now need to perform large scale trials to confirm this. However, psilocybin is designated a ‘Schedule 1’ drug by the UK Government. This makes large scale clinical trials very difficult and very expensive to conduct. Schedule 1 designation is unnecessary because psilocybin is not dangerous and not addictive when compared to other drugs. Therefore, we are asking the UK Government to review the Schedule of psilocybin, so that we can work more efficiently to bring a potential new treatment to patients who are suffering, and dying, every day with major depression.
Dr. James Rucker, Honorary Consultant Psychiatrist and Senior Clinical Lecturer in mood disorders and psychopharmacology at the Centre for Affective Disorders at the Institute of Psychiatry, Psychology & Neuroscience at King’s College London and the South London and Maudsley NHS Foundation Trust.
“There are more than a million depressed adults in the UK today whose illness does not get better with antidepressants. Almost one in three of these people will attempt suicide. My mother was one of them - she took her own life in 2013 after struggling with mental illness for decades. I speak from experience when I say that the impact on patients and their families is tremendous. Meanwhile, pharmaceutical interest in developing new drugs for depression has completely dried up - with one notable exception. Psilocybin-assisted therapies are being investigated, and the evidence suggests that they may work where other treatments have failed.
One might think that the UK Government would be supporting this vital research however possible, but the opposite is true. Despite substantial evidence of safety, and with no known association between psilocybin and crime, it is controlled by UK law under the strictest possible regulations. While these regulations do not prohibit research, they make it far more difficult. Parliament has known about these barriers to research for 20 years, but no progress has been made. We cannot afford to wait any longer. The Government has an ethical duty to support mental health research by rescheduling psilocybin, urgently.”
David King, Director of Research at the Conservative Drug Policy Reform Group (CDPRG) and a final year graduate medical student at King's College London. (Corresponding Author)
“Every person deserves access to good healthcare. Rescheduling psilocybin is safe, effective and achievable today. When we discover a tool to help people who are suffering, we must use it. When the law no longer reflects the evidence, we must change it.”
Dr. Jesse Schnall, medical doctor in Melbourne, Australia, former visiting student, University of Oxford.
“People with mental health issues deserve the same high quality care as any patient. But for some people, including many former service men and women with PTSD, all existing treatments fail. Psilocybin has shown great potential to help these patients. Yet its Schedule 1 status is holding back research. Rescheduling psilocybin would restore fairness to the regulatory environment, and give British scientists every chance of providing a new therapy that can reduce suffering for those who are in need.”
Dr. Daniel D’Hotman, Australian Rhodes Scholar and medical doctor, currently completing a DPhil on the ethics and politics of using AI for suicide prevention at the University of Oxford.
“Modern research is showing psilocybin to be a safe and effective psychiatric intervention, lending scientific credence to the voices of those who have espoused its psychotherapeutic properties for decades. Depression has been the target chosen to indicate its promise but psilocybin’s potential lies in its applicability across numerous clinical categories; a list including depression, post traumatic stress disorder, alcohol use disorder, nicotine addiction, obsessive compulsive disorder and anorexia nervosa is by no means exhaustive. While psilocybin remains in Schedule 1 these lines of research and others are unjustifiably stifled. The expedited rescheduling of psilocybin could save and improve numerous lives, alleviating the suffering of millions of individuals living with myriad mental health conditions, as well as furthering the UK’s reputation as leading the world in psychedelic research."
Timmy Davis, Psilocybin Rescheduling Project Manager and researcher at the Conservative Drug Policy Reform Group (CDPRG) and is undertaking psychoanalytic training with the SITE for Contemporary Psychoanalysis.
“Psychedelic Medicine can provide an effective therapy for many hard to treat conditions, such as PTSD, refractory depression, addiction, and potentially many other disorders. More research is urgently required to enable our understanding of how these drugs work and how they can best be used for patient benefit. Current drug scheduling restrictions hinder this research, creating time delays, significant costs, and unnecessary bureaucracy. None of these restrictions applies to Schedule 2 drugs. Rescheduling will enable Psychedelics Research, and ensure that the UK’s Life Sciences sector becomes an international leader.”
Prof. Jo Neill, Professor of Psychopharmacology in the Manchester Pharmacy School at the University of Manchester.