Psilocybin Treatments

Charlotte Nichols Excerpts

Thursday 18th May 2023 Commons Chamber

[Charlotte Nichols (Warrington North) (Lab)]

I beg to move,

That this House welcomes the development of treatment options in mental health; further notes there have been no new pharmacological treatments for depression, with the exception of Esketamine, in over 30 years; recognises that psilocybin, a naturally occurring compound, has the potential to revolutionise the treatment of many of the world’s most hard to treat psychiatric conditions such as depression, PTSD, OCD, addiction and anorexia nervosa; recognises that no review of the evidence for psilocybin’s current status under UK law has ever been conducted; regrets that psilocybin is currently more controlled than heroin under the most stringent class and schedule under UK law which is significantly stalling research; and calls on the Government to take steps to conduct an urgent review of the evidence for psilocybin’s current status as Schedule 1 under the Misuse of Drugs Regulations 2001 with a view to rescheduling, initially for research purposes only, in order to facilitate the development of new mental health treatments and enable human brain research for the benefit of researchers, patients and the life sciences sector in the UK, and to deliver His Majesty’s Government’s commitment to be world-leading in its approach, with evidence-led and data-driven interventions, and building the evidence base where necessary.

Psilocybin is a psychoactive substance found in more than 50 species of fungi, including many native varieties of mushroom that grow wild across the UK. There is a certain irony in the fact that this debate follows on from the debate on access to nature, because in many respects our debate is also about that.

Psilocybin is a naturally occurring substance and produces a window of neuroplasticity that lasts for a number of hours. When administered in a controlled environment with psychotherapeutic intent by trained professionals, psilocybin could be a powerful and effective tool to help treat society’s most complex mental health conditions, and that is what we call on the Government to make possible.

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.

[Madam Deputy Speaker (Dame Eleanor Laing)]

I think the whole House will wish to commend the hon. Lady for her courage in bringing this matter before the House and for the way in which she has put her case this afternoon.

--- Later in debate ---

[Robert Jenrick]

I am afraid I do not know the precise departmental visit that my right hon. Friend the Member for Croydon South is on. But knowing him, if he was here, he would certainly wish to be part of this debate and to continue the conversation that he has had with hon. Friend the Member for Reigate. It is only because of other departmental business that he was not able to join us today.

I want to begin by recognising, as others have done, the personal interest that the hon. Member for Warrington North has in this topic. I concur with your comments, Madam Deputy Speaker, that the hon. Member spoke with great conviction and very deeply. I have heard her speak on other subjects that we have a shared interest in, such as the fight against antisemitism, with the same eloquence and bravery that she showed today.

It may be helpful at the outset to remind the House that medicines policy, including the availability of medicines for prescribing, is led by the Department of Health and Social Care. Medicines are licensed and regulated by the Medicines and Healthcare products Regulatory Agency. However, the Home Office is responsible for controlled drugs legislation. Our controlled drugs licensing regime supports research and clinical trials in the UK. The two Departments work together on issues connected to controlled drugs in healthcare. I will endeavour to set out the Government’s position this afternoon.

Controlled drugs legislation seeks to prevent criminality while permitting access for legitimate use, including for medicines development. The Misuse of Drugs Regulations 2001 enable the use of controlled drugs in healthcare. The Home Office’s controlled drugs licensing regime enables the possession, supply, production, import and export of controlled drugs to support industry, pharmaceutical research and healthcare. These controls are subject to review in light of any emerging evidence and in consultation with the Advisory Council on the Misuse of Drugs, which has been referenced many times this afternoon.

There is an established process for medicines, including those that contain controlled drugs, to be developed, evaluated in clinical trials and licensed, based on an assessment of their quality, safety and efficacy by the MHRA. The MHRA supports the safe and scientifically sound conduct of clinical trials in this area, and provides regulatory and scientific advice to companies at all stages of developing medicines. Should a company submit an application for a marketing authorisation, otherwise known as product licence, it will ultimately be a decision for the MHRA whether to license a product based on a psychedelic drug as a therapy.

[Charlotte Nichols]

The Minister refers to marketing authorisation. In this case, psilocybin, as we have discussed, is something that grows in mushrooms across the UK. Is the Minister suggesting that people would be able to access psilocybin only if it were in another substance?

[Robert Jenrick]

I am by no means an expert in this field, but I think I am suggesting that were this to be a drug that is licensed, it would need to go through the MHRA process in the usual way.

I would like to come to a point made by the hon. Lady earlier around the costs involved in a first-time application for a controlled drug licence of the kind we have been discussing. She quoted a substantial figure, which would be concerning as it would be prohibitively costly for smaller manufacturers or researchers. The figures that I have been quoted are that first-time application for a licence costs £3,700 and a standard renewal costs £326. I will write to the hon. Lady with those figures and if she contests them in any way, then I or the Minister for Crime, Policing and Fire, my right hon. Friend the Member for Croydon South (Chris Philp) will be happy to respond.

--- Later in debate ---

[Robert Jenrick]

My hon. Friend has made his point very powerfully. Of course the Government’s ambition is to ensure that NICE, the MHRA and all our regulators work in the most research-friendly manner, and that applies to mental health treatments as much as to anything else.

If a manufacturer is successful in being granted a marketing authorisation by the MHRA for a medicine containing psilocybin, the Home Office is committed to swift action to remove psilocybin from schedule 1 and make it available for prescribing, subject to advice from the Advisory Council on the Misuse of Drugs on the appropriate scheduling and safeguards for the medicine. The same scrutiny should be applied to all potential medicines to ensure patient safety. While it is legally possible to enable prescribing in advance of marketing authorisation, the Government currently have no plans to move to that position.

[Charlotte Nichols]

The Minister keeps referring to medicines containing psilocybin. He does not seem to understand that psilocybin is the medicine, in and of itself. It does not need to be added to something else to make it work. This is why we are running into the issue. The Government keep telling us about a licensing regime in which there is a requirement to add something to the compound in order to make it some sort of novel substance, rather than looking at the substance that already exists and, as we have said, has been used for thousands of years with demonstrated safety and efficacy. Will the Minister talk about psilocybin, rather than medicines containing psilocybin?

[Robert Jenrick]

I understand the hon. Lady’s point. As I have said, the Government are funding research into psilocybin and its effect on patients with certain conditions. What we are discussing today is the Home Office’s role in ensuring that that research, as it emerges, can be considered as part of our drugs legalisation framework.

The Government have commissioned the ACMD to consider how better to enable research with respect to all schedule 1 drugs, and that includes the potential to extend schedule 2 status for research purposes to all schedule 1 drugs including psilocybin. This, I believe, is the point that my right hon. Friend the Minister for Crime, Policing and Fire made in the Adjournment debate, and he has written to the ACMD asking it to consider, in particular, the potential options available to extend schedule 2 status for research purposes to all schedule 1 drugs. He highlighted psilocybin specifically in his letter. If the hon. Member for Warrington North, my hon. Friend the Member for Reigate or, indeed, other interested Members have not seen it, I shall be happy to ensure that they receive a copy and can see the instructions that my right hon. Friend has given to the ACMD. My hon. Friend the Member for Reigate asked earlier about the likely timetable for any advice from the ACMD. I have been told that, while the ACMD is independent of Government, it is understood that its consideration is well advanced, and we should expect its advice in the near future.

The approach that we have taken in this regard should deliver much of what my hon. Friend and others are requesting. I should make a distinction: prescribing will remain unavailable outside a clinical trial. It is not for the Home Office to determine medicines policy, and I am sure that my hon. Friend and others will accept the general principle that medicines should be assessed on the basis of their safety, quality and efficacy before being made available to patients.

The two Departments continue to support the ACMD’s review. The chief scientific adviser to the Home Office recently convened a discussion with her counterpart in the Department of Health and Social Care and the Government’s chief medical officer on this precise subject. I understand that they had a very positive discussion and I know that they will be advocating for the best outcome for researchers and, of course, patients. When the ACMD provides its advice, the Government will consider it carefully before deciding how to proceed.

I thank Members for their contributions to the debate. I can assure my hon. Friend the Member for Reigate and others that the Government have heard what they have to say. I will ensure that my right hon. Friend the Minister for Crime, Policing and Fire is fully apprised of what was said in the debate, so that he and others can continue their conversation on this issue.

I reassure the whole House that the Government agree with the intent of much of what has been debated today, but rather than developing a bespoke approach for psilocybin alone, we consider our approach to be more ambitious. We want to tackle this issue across all categories of section 1 drugs to reduce barriers to legitimate research, rather than focusing on individual drugs. Equally, we must keep a firm focus on the need to tackle drug misuse, which causes such harm across our society. Both are vitally important aims, and we will continue working to strike the right balance in the interests of the public.

[Charlotte Nichols]

I thank all Members who came to support the debate. Like my hon. Friend the Member for Reigate (Crispin Blunt)—he is a friend—I am disappointed in the Government’s response; yet again, we see a real lack of urgency from them on this issue. As we have heard, the ACMD review has been ongoing since 2017. In that time, at least 40,000 people have taken their own lives.

I am grateful for the fact that the Minister said he will take back the content of today’s discussion to the Minister for Crime, Policing and Fire, the right hon. Member for Croydon South (Chris Philp), who should have been here today but unfortunately was not, because I am really keen that we should finally progress this issue. I thank all Members who took part in the debate to make the case clearly and cogently to the Government that we cannot accept their inertia any longer.

Question put and agreed to.

Resolved,

That this House welcomes the development of treatment options in mental health; further notes there have been no new pharmacological treatments for depression, with the exception of Esketamine, in over 30 years; recognises that psilocybin, a naturally occurring compound, has the potential to revolutionise the treatment of many of the world’s most hard to treat psychiatric conditions such as depression, PTSD, OCD, addiction and anorexia nervosa; recognises that no review of the evidence for psilocybin’s current status under UK law has ever been conducted; regrets that psilocybin is currently more controlled than heroin under the most stringent class and schedule under UK law which is significantly stalling research; and calls on the Government to take steps to conduct an urgent review of the evidence for psilocybin’s current status as Schedule 1 under the Misuse of Drugs Regulations 2001 with a view to rescheduling, initially for research purposes only, in order to facilitate the development of new mental health treatments and enable human brain research for the benefit of researchers, patients and the life sciences sector in the UK, and to deliver His Majesty’s Government’s commitment to be world-leading in its approach, with evidence-led and data-driven interventions, and building the evidence base where necessary.