Psilocybin Treatments

The evidential basis for psilocybin’s current status as a schedule 1 substance has never been reviewed since it was first controlled more than 50 years ago, and there is an urgent and medically justified need to reschedule psilocybin under the Misuse of Drugs Regulations 2001. It is unethical to deny that any longer. A review of the evidence of psilocybin’s harms and utility should be undertaken immediately, with a view to rescheduling it.

The use of psychedelics in medicine is not novel; they have been used throughout human history to treat the sick, from peyote ceremonies in Mexico to ayahuasca in the Amazon basin, and the San Pedro cactus in Peru. The earliest evidence of psychedelic use can be found in a cave in the Tassili-N’Ajjer region of the Sahara desert in Algeria, with a mural depicting what is referred to as the “mushroom man” or “mushroom shaman”, a bee-headed figure with mushrooms identified as Psilocybe mairei, native to the region, sprouting from his body. The mural has been dated as being between 7,000 and 9,000 years old.

The Selva Pascuala mural in a cave in Spain features mushrooms that researchers believe to be Psilocybe hispanica, a local species of psychedelic mushroom, and is dated as being approximately 6,000 years old. We can also date back to the 13th century western scientists first discussing the use of psychedelics in healthcare in Latin America. None of this is new.

Modern psychedelic research began when Albert Hofmann first synthesized lysergic acid diethylamide, or LSD, in 1938, causing something of an explosion in interest among psychiatrists and psychologists, with studies from the period showing the safety and efficacy of psychedelics, including psilocybin, in treating a whole range of psychiatric conditions. However, all that progress was stalled by the counter-cultural movement of the 1960s, which ultimately led to the criminalisation of the drugs. Since then we have been in stasis, until in recent years something like a psychedelic renaissance has taken place among researchers.

Today, there are serious and considerable barriers to legitimate research associated with the schedule 1 regulations. While current legislation does not preclude scientific research with the drugs, it does make them significantly more difficult, time-consuming and costly to study. I will share with the House just one example of this, from Rudy, a psychology PhD student whose thesis is investigating psychopharmaceutical treatments for addiction—a noble avenue of study, as I am sure we would all agree.

Rudy was first motivated to undertake this research after reading incredible findings that psilocybin administration was associated with sustained nicotine cessation in humans, with 80% of participants abstinent after 6 months. Rudy wanted to see whether those results could be replicated to treat other addiction disorders. However, he ran into problems due to the schedule 1 status of psilocybin. He says that

“in order to undertake my research, I would have had to spend upwards of £20,000 applying for Home Office Schedule 1 licences and retrofitting my laboratory to the correct security standards. Meanwhile, I can work with heroin, cocaine, and methamphetamine with no qualms. In light of this, I had to modify my experiment to instead investigate the effects of ketamine. I find it shocking that this government is willing to throw life science research under the bus and push life scientists out of this country with an outdated and downright illegitimate understanding of the medical benefits psilocybin can provide. Please do what you can to fix this!”

That is just one example. At a recent seminar at the Royal Society of Chemistry with some of the country’s most eminent neuroscientists, psychopharmacologists and psychiatrists, I spoke to countless researchers who have run into the same issues, making their research either needlessly more expensive or so prohibitively difficult to do that it has had to be abandoned. There is a huge credibility gap between psychiatry and politics for that reason; psychiatrists cannot understand why, at a time when we claim to be listening to the experts in the field of health, and when this country is facing a mental health crisis, we in Westminster are satisfied with doing nothing on this issue.

Why do we set up expert bodies and not listen to them? It is dangerous, immoral and unethical, and it is frankly offensive to both psychiatrists and their patients that we seem to think that as politicians we know better because of some moral panic 50 years ago. Multi-criteria decision analysis shows the comparative harms of various different kinds of drugs. Psilocybin is physiologically non-toxic and consistently found to be one of the safest controlled drugs, with the broader category of psychedelic compounds it falls into considered relatively safe physiologically and not drugs of dependence. The idea that psychedelics, including psilocybin, are dangerous is a myth, created and perpetuated to justify keeping them illegal.

Psychiatrists tell me that psychedelics are the best clinical tool and the best bit of psychiatric equipment they have, altering states of consciousness to allow for deeper processing and exploration of trauma and opening a therapeutic window where treatment can work, versus sub-optimal treatments with maintenance medications and substandard psychotherapies.

Moving on to patients, there is not a single other field where we would accept a 90% failure rate as acceptable, yet in mental health treatment that is where we are. There are a number of mental health conditions, including borderline personality disorder, that we seem to be satisfied with having no proper treatments or cures for. Psilocybin has been shown in numerous studies globally to have a profound and lasting effect over placebos for a range of different mental health conditions including treatment-resistant depression, post-traumatic stress disorder, anorexia nervosa and addiction.

I want to talk first about one of those conditions, PTSD. I have referred previously to living with PTSD, and that is where my interest in the potential promise of psilocybin as a treatment first began—so please consider this a declaration of interest, Mr Deputy Speaker. I was first diagnosed almost two years ago, after being the victim of a crime, and I cannot overstate the impact it has had on my life.

PTSD is a condition that I can expect to live alongside potentially indefinitely, and that can only ever be managed. It is a condition that has, for me, proved almost fatal. I manage it through a combination of a powerful serotonin and norepinephrine reuptake inhibitor, Venlafaxine, taken daily, benzodiazepines taken for sleep and to stave off a dissociative episode if I am triggered by something, and regular therapy, following an almost month-long period as a psychiatric inpatient, having been sectioned in 2021 for my own safety. I am not telling the House this for sympathy, but because I hope my experience can be illustrative of just how debilitating a condition such as PTSD is.

We all know that being an MP can be a difficult job at the best of times. However, I ask hon. Members to consider for a moment what it is like living with a condition such as PTSD and the myriad subtle and unsubtle ways my body lets me down: having to put my best face on and go into a meeting after a panic attack; having the energy to make it through our long working hours after a virtually sleepless night plagued by night terrors, where I try to fight my attacker off me and wake up covered in bruises; seeing someone who looks like my attacker on a tube platform and feeling a terror so acute that I want to jump in front of the oncoming train to make it stop; going for walks until I am exhausted and my feet are bleeding in order to burn through the nervous energy that fizzes up inside me; finding myself in dangerous situations and being more vulnerable as a result; hearing a car going past playing the song that was playing when my PTSD began and vomiting; dissociating and losing time; being angry, messy and erratic; crying at everything and nothing; being snappy with my loved ones and becoming convinced that ending my own life would be a kindness to all those who have had to deal with me throughout the worst period of my PTSD, from my staff to my family. Even at its best, it is a living hell. There is nothing I would not give, nothing I would not do, to go back to who I was before my diagnosis.

My experience is not unique. This is the reality of living with a serious mental health condition. I am making it through as best I can because of the love and support of friends, colleagues and psychiatric intervention, but I know that, just as I am a million miles better than I have been, and there are many more good days than bad these days, I could easily relapse because of something I can neither plan for nor prevent.

I am hopeful that this sort of treatment may offer a light at the end of a very dark tunnel and finally give me my life back. The evidence shows that psilocybin, as with other psychedelics, can be such an effective treatment for PTSD that following a successful course of psychedelic-assisted therapy, many patients no longer even fulfil the diagnostic criteria any more—they are all but cured. But this Home Office, and its scheduling policy, which says against all the evidence that this is not allowed, is stopping that. It feels like institutional cruelty to condemn us to our misery when there are proven safe and effective treatment options if only the Government would let us access them.

Just as that is one story—my own experience—consider the millions of people in this country and around the world living with the same, with no hope that things can or will ever get better. Depression is one of the most socially, medically and economically burdensome diseases of the modern world. It is the single largest cause of global disability and the leading contributor to suicide. An average of 18 people take their own lives every day. Up to one third of people with depression do not respond to multiple courses of medication; an estimated 1.2 million adults in the UK live with treatment-resistant depression.

The direct treatment and unemployment costs to the UK associated with depression in 2020 have been estimated at £10 billion. The human and economic burden of that condition is profound, and there are clear benefits to supporting development of therapies that may be effective where all other treatments have failed. Mental health costs the UK £117.9 billion a year—around 5% of GDP—yet that is not nearly enough money to address our current crisis. Waiting lists for specialist treatment are often years long. There is both a moral and economic imperative for the Government to act.

We are being left behind as a nation. Some US states have legalised the use of psilocybin in mental health treatment. In 2018 it was granted “breakthrough therapy” status for depression by the United States Food and Drug Administration, expediting the research and approval process, with expected approval by the FDA in 2024. In Australia, from 1 July this year,

“medicines containing the psychedelic substances psilocybin and MDMA can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions.”

In Canada, healthcare practitioners may be able to access psilocybin for emergency treatment under a special access program when a clinical trial is not available or suitable.

We have charitable organisations in this country, such as Heroic Hearts, which take veterans abroad to be able to access treatment that they should be able to get in this country on our NHS. We have scientists, including the brilliant Dr Ben Sessa, leaving the country to pursue research and treatment abroad. That is utterly, utterly shameful. The real-world data from those countries will only make avoiding change in the UK even less justifiable.

The motion would make no difference to the laws around recreational use or supply of psilocybin or magic mushrooms. Further, there is no evidence of diversion of schedule 2 substances from clinical research. Use of psilocybin-containing mushrooms is low, and there is no evidence of users developing a dependency. As psilocybin mushrooms grow wild throughout the United Kingdom, psilocybin does not represent an opportunity for profit-motivated gangs and criminal individuals. These proposals do not risk increasing drug-related harms but will allow us to assess and access the benefits of psilocybin as a substance.

Of all of the psychedelic compounds that show promise in this area, psilocybin has the lowest risk profile across all metrics, so there is little reason not to reschedule it but plenty of reasons to make the change as soon as possible. The overwhelming scientific consensus is that psilocybin does not pose a major risk to the individual, to public health or to social order. Its schedule 1 designation is not morally, medically or economically appropriate.

We are supported in our call today not only by politicians from across the House, but by the Royal College of Psychiatrists, the Campaign Against Living Miserably, the Conservative Drug Policy Reform Group, Drug Science, Heroic Hearts, Clusterbusters and SANE, among many other organisations. I thank the Backbench Business Committee for having the political courage and will—those are, sadly, too often lacking in this place —to grant us this important debate so that we may move ahead on rescheduling psilocybin. Now it is the Government’s turn to show that political courage and will.

Psilocybin’s current status as a schedule 1 drug is incommensurate with the evidence of its harm and utility. I beg the Government to support our motion and finally, finally right the historic wrong of its scheduling.

I wanted to give the forewarned drugs Minister the opportunity, in responding to the debate, to show that His Majesty’s Government understand the potential improvement to mental health treatment, and that they are straining every bureaucratic and regulatory sinew to follow up the strongly indicative research evidence to date about its potential. I put that in terms in the previous debate. I said:

“I do not want or expect an answer this evening; these matters demand careful consideration. There will shortly be an application to the Backbench Business Committee, supported by more than a score of colleagues from across the House, for time for a fuller consideration. I hope by the time that debate is secured we can enjoy the news that this Minister is taking the available opportunities of his very tough policy inheritance.”—[Official Report, 14 March 2023; Vol. 729, c. 805.]

It is now two months since that debate and almost six years since the Advisory Council on the Misuse of Drugs was first commissioned to look at the problem, so it is frustrating, to put it mildly, that it is the drugs Minister’s colleague who has been put forward to reply to this debate. I have the highest regard for the Minister for Immigration, my right hon. Friend the Member for Newark (Robert Jenrick), and the quality of his attention to detail on issues he has been responsible for, such as planning, which is of immense importance to my constituency of Reigate, but this issue needs the policy Minister across the complexities engaged, and with the authority and confidence of his colleagues to carry them with his strategy, to enable the benefits that only bureaucratic inertia prevents.

Where is the drugs Minister? Having told him in terms of today’s opportunity and the date of this debate, when I had notice of it from the Backbench Business Committee, and of my expectation that he would have spent those ensuing two months engaged with these issues and able to come to the House today, what are we to make of his absence? What has he prioritised over Parliament, with notice? Does it remain his view that this issue is not a priority? Has he nothing new to say? Has he so little regard for the people who are raising this that he has prioritised the apparent visit scheduled for today, having initially tried to palm it off on the Minister for medicine, my hon. Friend the Member for Colchester (Will Quince), in the Department of Health and Social Care?

The Immigration Minister is now having to reply to this debate, and I already know the speech he is going to give on officials’ advice. The irony is that it should be the Minister for medicine replying to this debate, but the Department of Health and Social Care does not own this policy—the Home Office does—and that is part of the reason our drugs policy is in such an unforgivable mess. I am not sure who should be more insulted and put out by the drugs Minister’s dereliction of parliamentary duty: my right hon. Friend answering, with no new defence to offer, or myself, who tried to create this opportunity and deliver an incentive to his colleague to get the necessary focus to clear the bureaucratic hurdles to enabling this potential medicine.

What we can certainly conclude is that this Home Office, with the collective responsibility of all Government Ministers, can now be held accountable for the delay in delivering psychedelic-assisted psychotherapy and psychiatry as a new mental health treatment in the United Kingdom. Having heard the powerful opening speech from the hon. Member for Warrington North, it must be clear to any reasonable person that the duty on His Majesty’s Government to act and act now has been established.

The hon. Member for Warrington North, with personal courage of the highest order, has used her own massive trauma to advance the public interest engaged. She speaks for tens of thousands suffering from apparently untreatable, life-changing mental health trauma. How can my right hon. Friend the Minister look our parliamentary colleague in the eye and read his prepared script? She also speaks for 1.2 million of our fellow citizens with depression. One hundred and twenty five people end their battle every week by killing themselves. Knowing what they know, that makes the Government guilty of joint enterprise in those decisions, because we could and should now be on a path to avert them.

The hon. Lady speaks for about 2,500 veterans of Iraq and Afghanistan who have PTSD from their service that is currently untreatable. She speaks for Scotty, the ex-paratrooper medically discharged after 15 years of service who presented himself with military dignity on my train home last week to his fellow passengers. He gave his Army number and his service record of five tours in Iraq and Afghanistan as he asked for food, not money, understanding his health condition to be untreatable. He was apparently medically discharged after 15 years’ service due to an untreatable mental health condition and a borderline personality disorder. His dignity in these appalling circumstances, when simply under the care of his GP, being prescribed every kind of chemical cosh going but with no hope of cure, was humbling. It is the absence of hope that I found so distressing.

The current cost of depression alone to the United Kingdom economy is estimated to be about £110 billion a year—5% of our GDP. Even if psilocybin delivered a fraction of what is hoped, the benefits to the economy would be immense, and giving hope to those suffering without it today would be priceless. The ask is simple: that psilocybin be placed in the same schedule as heroin and cocaine through an urgent review by the Advisory Council on the Misuse of Drugs of the evidence of its harms. The original controls were not based on a review of the available evidence but simply on the fact that no product had yet reached market, which itself is an accident of history. No review has ever been conducted since, for over half a century. In what other area of policy would that be acceptable? Where it has been assessed—in Australia and the United States, for example—change has happened.

It is especially shocking that psilocybin has never been subject to analysis of harm and utility, when the Government admit they are aware of the many studies regarding its potential therapeutic applications. Adding insult to injury, the Government have confirmed that they have no plans to commission the Advisory Council on the Misuse of Drugs to assess the scheduling of psilocybin because it is “not currently a priority”. The potential treatment of thousands, if not hundreds of thousands, of mental health patients is not a priority—really? Does the word “scandalous” do that position justice? If psilocybin treated a physical health condition such as cancer or epilepsy, Government inertia not to swiftly lift barriers to research and treatment would not be tolerated, given the level of clinical potential and safety.

Let us not forget that in the last four months alone, His Majesty’s Government have commissioned the ACMD to conduct rapid reviews of the evidence of the harms of both nitrous oxide and monkey dust. In the case of nitrous oxide, it took the ACMD four weeks to reply. It took the Home Office about four hours to formally ignore that advice, but we know it is possible to commission a rapid review of harms, so why not do so for psilocybin? The Royal College of Psychiatrists and various mental health charities wrote to the drugs Minister to say:

“It is unethical to wait any longer. Psilocybin’s schedule 1 designation is not morally, medically or economically appropriate.”

Now let me address the speech that we shall hear from the Immigration Minister. He will explain that research trials are possible under schedule 1. While research into schedule 1 drugs is possible, only a tiny fraction of the possible research actually takes place, almost all of which is conducted by large pharmaceutical companies trying to bring drugs to market. This red tape not only discourages competition, as only very big companies can afford to conduct the research; it also means that, as the research is unnecessarily expensive, it will be the taxpayer who ultimately picks up the bill through higher drug prices for the NHS. Moreover, leading UK academics have had to relocate to North America and Australia, where the research is easier, which is leading to a brain drain in this vital bioscience area, despite our desire to be a science superpower. Put simply, the Home Office is the enemy of the Prime Minister’s aim to make Britain a centre of global bioscience.

The Immigration Minister, reading his script, will explain that barriers to research are already being investigated and that the ACMD is currently undertaking a review of the barriers to research into controlled drugs beyond cannabinoids. We are told that the drugs Minister is apparently pressing for urgency on psilocybin, but it was six years ago, in 2017, that the Government first asked the ACMD to review this. There is no current deadline for the completion of the current report. In 2017, the Government rejected the ACMD’s recommendations, just as they did with nitrous oxide recently.

In the meantime, since 2017, 40,000 people with depression and trauma have taken their own lives. As butchers’ bills for Government inaction go, I hope that statistic alone will gain some attention. Are the Government hoping that this issue will simply go away? Let me tell them: it will not. Under the current procedures, even if the ACMD is supportive of rescheduling, the Government will still need to issue a further review to reschedule psilocybin under statute to the same schedule as heroin and cocaine, as the current review does not look at the evidence of harms for rescheduling specifically, meaning more delay, more deaths and more misery for those people suffering from depression, who will eventually get treated with pharmacology accompanying psychotherapy and psychiatry.

The Government have also taken the view that specific compounds will be rescheduled once a drug containing psilocybin reaches market authorisation. Nowhere in law, nor in the standard scheduling operating procedures for the ACMD, is that required. In truth, there are three routes to rescheduling: one is that market authorisation triggers a review of the scheduling of that product rather than the generic compound, as was the case with Sativex in 2018, but rescheduling can also take place through the ACMD self-commissioning a review of the evidence or the Home Office commissioning an ACMD review of the evidence. Waiting for a product to reach market authorisation produces a Catch-22 situation where a product cannot be researched in the first place because the barriers of schedule 1 are too high. More importantly, rescheduling only patented products could create a pharmaceutical monopoly on a compound that grows naturally in the United Kingdom, increasing waiting times for patients and costs to the NHS and, ultimately, the taxpayer.

The Home Office has the power to commission a review of the evidence, and there is precedent for commissioning such a review in cannabis-based products for medicinal use. Indeed, in 2018, the wretched situation of just two epileptic children enabled change to start the deployment of cannabis-based medicines, but the regulatory treatment of the psychedelics—psilocybin in particular—remains unaddressed. Perhaps the Minister might like to have a go at advancing an explanation of why 1.2 million people with depression can go hang, compared with the very deserving but relatively few epileptic children.

There is some good news, in that thanks to the Chancellor’s Budget measures, psychedelics will benefit from the expedited approvals of medicines via the Medicines and Healthcare products Regulatory Agency announced in the Budget. While welcome, that would still leave UK patients without access until approval has been achieved abroad, leaving the UK trailing behind Canada, Australia and the United States. In this scenario, the United Kingdom has become a world bioscience follower and not a leader, with the Home Office seeking to deny competitive advantage to our prestigious universities and research companies—indeed, to impose disadvantage on them.

Finally, psilocybin has been consistently found to be one of the safest controlled drugs. It is physiologically non-toxic, and there is no evidence of diversion from schedule 2 substances of whatever danger from clinical research of any kind. Use of psilocybin-containing mushrooms is low, and there is no evidence of users developing a dependency. Psilocybin mushrooms grow wild throughout the United Kingdom, meaning that psilocybin does not represent an opportunity for profit-motivated gangs and criminal individuals. To argue that they might conceivably cause excessive damage to the population, especially when the ask is for medical use under medical supervision, is nonsense—not least when tobacco and alcohol are already legal.

If the Home Office is not prepared to act, it is surely now crucial that the ACMD demonstrates its independence and a proactive approach by prioritising the wellbeing of patients in the UK, particularly given that it is chaired by a practising psychiatrist who enjoys the support of his royal college. But today, Madam Deputy Speaker, it is perhaps time to reveal the Home Office’s true regard for the advice and guidance of the regulatory body responsible for advice on drugs policy, set under statute by this House. That body reports its total expenditure in 2019-20, the last year for which figures are available, as £46,067.34. That is to guide the Government on drugs harms that cost the country an estimated £20 billion a year. It is perhaps unsurprising that proactive advice from the ACMD is somewhat rare.

Surely now the Minister, who has so kindly stood in for his colleague, is appreciating the scale of the hospital pass he has received this afternoon. Add in the modest consideration that the size of the psychedelics market is set to grow to $10 billion by 2027, and the fact that today’s proposition enjoys four to one support with the public and has the potential to revolutionise the lives of millions, and the Minister is invited to defend the Government’s position, which is unethical, immoral and wholly counter to the national interest, however we express it. It will not stand the test of time—change it now.

We need to do so much more to support people who take these prescribed drugs. There is also a huge amount—at least £500 million a year—spent on prescribed drugs for people where the prescription has gone beyond the period in the guidance. They should not be receiving these drugs, but they are doing so and it is costing the taxpayer half a billion pounds a year. We can think of the knock-on effects in terms of the health costs, and my hon. Friend the Member for Reigate mentioned huge figures there, the welfare costs and the human cost. We need to go beyond these pills. We need to get to an approach to mental health that does not only rely on what he calls the chemical cosh.

I have some concerns about psilocybin being the next big thing or the next SSRI, treated and imagined as if it will be some sort of silver bullet—another pill and another shortcut to what is a profoundly complex set of mental health circumstances, which derive in many cases from trauma and deep-rooted adverse social and emotional conditions that cannot just be wished away by the administration of a new pill.

I find myself in the strange position not only of agreeing with my hon. Friend—actually, I do agree with him on many important matters, just not on others—but of taking inspiration from places such as Oregon and Colorado that I regard as unhelpful places, given the other things they are up to; they are the leading jurisdictions promoting assisted suicide, of which I strongly disapprove. I notice that Australia is also in the gang, and presumably Canada, if it is not so already, will be full steam ahead for psilocybin. Liberals do not get everything wrong, I suppose is my conclusion, because these places are paving the way and in this case we should follow them.