Joint Meeting of the Group with the APPG on Mental Health: 15th September 2020

APPG for Drug Policy Reform meeting in collaboration with the APPG on Mental Health on the topic of Psilocybin

15 September 2020, 10:00-11:10, Online Meeting

Parliamentarians RSVPed attending:

Lord David Ramsbotham
Sam Tarry MP
Stuart Anderson MP
Rob Roberts MP
Jeff Smith MP
Tommy Sheppard MP
Ronnie Cowan MP
Crispin Blunt MP
Baroness Molly Meacher

Others RSVPed attending:

Gregory Sutherland
Lavinia Trehane
Karen Tyrell
Claire Poyton
Natasha Mutebi

Speakers:

Dr James Rucker, Consultant psychiatrist and Psychedelic Trials Group lead at King’s College London.
Michael Bourne, A participant who received a psilocybin for treatment resistant depression in a clinical trial at Imperial College.
Ainslie Course, Vice President, Cluster Busters.
Prof Joanna Neill, Professor of Psychopharmacology, University of Manchester.
Rudi Fortson QC, independent practising Barrister since 1976.
Dave King, Director of research, Conservative Drug Policy Reform Group.

Apologies

George Freeman
James Gray
Baroness Sally Hamwee
Nadia Whittome
Debbie Abrahams

Meeting minutes

Introduction by Jeff Smith MP

Jeff Smith MP introduces himself as co-chair of both APPG for Mental Health and Drug Policy Reform and MP for Manchester Whittington.

The APPG Mental Health aims to ensure that mental health stays firmly on the agenda.

The APPG Drug Policy Reform thinks there should be an end to the Global War on Drugs.

This meeting brings together both to discuss the very interesting emerging evidence on the use of psilocybin in mental health treatment.

Jeff introduces each speaker:

Jeff Introduces co-chair of the APPG on Drug Policy Reform Crispin Blunt MP, who will be chairing the discussion and Q&A.

Presentations - chaired by Jeff Smith MP

Jeff Smith MP introduces:

Dr James Rucker:

Starts by contextualising the problem. Every 40 seconds someone succeeds in taking their own life. Suicide is the biggest killer of men under the age of 50 in the UK and one of the biggest Killers of women. Half of all suicides are related to depression.
There are no new treatments for depression and many that are being used are unacceptable to patients, have side effects, or both.
Prior to the 1971 psilocybin was used as a medical treatment in the UK and USA. Evidence from that time shows that 80% of those who received the treatment showed clinical improvement. After just one or two treatments.
Psilocybin was caught up in the War on Drugs leading to its designation as not for medical use even though it did have a medical use.
This stopped prescriptions unless the medical personnel had a home office license - this stopped all new research.
He has completed good quality but small scale clinical trials with psilocybin despite its schedule 1 status which suggest it is likely to be much better than other treatments when given in a controlled setting.
It could be used for addictions, post traumatic stress disorder, anxiety disorders and other disorders - that are costly, disabling and also associated with high rates of suicide.
Schedule 1 makes research much more expensive and difficult to conduct. This should not be the case as psilocybin is not addictive or dangerous.
Easing restrictions will give the UK a jump start in this area, bringing real world benefits to patients, as well as the UK research and biosciences industry.
This is the most promising treatment in a generation.
The UK is poised to lead the way if the government reconsiders psilocybin’s schedule 1 status.

Dr James Rucker introduces Michael Bourne

Michael Bourne:

He suffered for decades from depression and tried everything - 3 different talking therapies and antidepressants before hearing about the clinical trial for depression at Imperial
He felt he had nothing to lose, without high expectations, maybe feel better for a couple of days - it has actually transformed his life and he hasn’t taken antidepressants since.
It’s like all the best psychotherapies given intensely in one go by the psychotherapist in your own mind.
Sitting at Kings Cross before her trial he was wondering why they were all so happy and what was he missing, after the trial he was talking to strangers and enjoying himself, remembering happy memories and feeling better. This lasted for over a year.
His partner and therapist thought he was transformed and no longer needed more psychotherapy sessions.
He says it is a crime that people who go through depression can’t get this treatment.
Rates of depression are rising because of Covid-19 and if the normal treatments are all we can give they have no chance.

Michael Bourne introduces Ainslie Course

Ainslie Course:

Representative of non-profit cluster busters and a 35 year survivor of cluster headaches aka suicide headaches. They support and advocate for research and a cure, educating on the condition and bringing awareness.
Many sufferers respond well to psilocybin after exhausting all other pharmaceutical options which sometimes have side effects and fail to alleviate symptoms.
It does not only improve the physical symptoms but also the psychological repercussions of those symptoms.
Course shows an image to elucidate why cluster headaches are considered the most painful condition a human can endure. The image is the cranial scan of a 56 year old male who suffered cluster headaches for 9 years despite treatment with conventional medication. He fired multiple metallic pellets into his symptomatic right eye, luckily he survived without cognitive deficit.
This is one example of many others, and explains without words why this condition has a suicide rate 20 times higher than the national average.
Cluster Busters supports the rescheduling of psilocybin in the UK and abroad.

Jeff Smith MP introduces Prof Joanna Neill

Prof Joanna Neill:

Neill has been working in drug discovery and new medicines all her career, as an early stage researcher using animal models - we have come nowhere in finding new treatments for patients, big pharma pulled out 10 years ago and psychiatry has hit a brick wall up until the psychedelic renaissance.
As James and everyone has said these are enormously important but we need large scale research.
This research is massively hindered by Schedule 1 - the home office says all you need to do is apply for a controlled drug license. This is only partly true.
Having applied for a license herself and conducted research into this she has identified 4 key issues.
Researchers are capable of keeping dangerous chemicals secure - cocaine and ketamine and heroin are all schedule 2 and do not have the same restrictions.
License costs £3000, plus you need cameras, safes, trained personnel.
Each building and site needs its own license - James needed 6 licenses before even being able to get the drug to patients.
This is all tax payer money
Another barrier is the delay - 6 months is standard, this is no good for phd researchers or others.
Bureaucracy is disabling research too - filling in one form takes over a week, you need lots of information which is not easily accessible.
Then there is the stigma - everyone is incredibly nervous when you mention you are studying a Schedule 1 drug and this creates delays and extra hurdles that are not associated directly with the obtainment of licenses from the Home Office.
Rescheduling psilocybin or giving research exemptions seems like a very simple ask that would remove these four barriers and enable research to be undertaken.

Jeff Smith MP introduces Matt

Matt:

Served in Afghanistan during a 6 year army career.
You are taught about PTSD but don’t understand it until you’ve experienced it.
The first couple of weeks after discharge he was losing sleep and fixated on various extremely intense experiences.
After reaching out to his GP he realised the safety net was not there, it took 7 months before he received antidepressants, then Cognitive Behavioural Therapy after a year.
He heard about it during service in the US, hearing stories of the substantial effects.
His research showed that it could be effective for him but the schedule 1 status made it scary as possessing could lead to jail time, so he travelled to amsterdam to self medicate.
The symptoms of PTSD affected all areas of his life.
12 hours after the psilocybin the effects had disappeared and he was able to be comfortable in crowds and around other people - he was able to consider his symptoms and experiences in different ways.
There is a lot of stigma in the military around drugs, but psilocybin should not be considered in the same way as it is not addictive and you cannot overdose on it, it is not recreational and tolerance builds quickly.
Veterans are already self medicating with alcohol and other substances which don't help.
Lot of veterans die by suicide, having access to this medicine could potentially save some lives.

Jeff Smith MP introduces Rudi Fortson QC

Rudi Fortson QC:

The current problems posed by the Misuse of Drugs Act 1971 in relation to conducting research on psychedelic compounds stem from the fact that current legislators are disengaged from the original intentions behind the authoring of the Act.
The MDA 1971 was in fact designed to afford policymakers flexibility in terms of reassessing the scheduling of particular substances, for instance so as to ensure that the MDA would not unnecessarily stand in the way of research.
The emphasis is on “restriction” within the wording of the MDA, in relation to verbs such as “supply” and “possession,” rather than on the “banning” of the substances outright, which is a choice designed to allow legislators a common-sense approach with room for maneuver according to the needs of the day, when granting or refusing a particular license. Clauses like “unlawful, except for research or other special purposes” allow for the granting of supply/possession/use in unexpected circumstances that may arise, e.g. in Billy Caldwell’s medical cannabis case.
Drugs thought to have limited or no medicinal value were put in Schedule 1, but it was never intended that they should stay there if medicinal value was found, or that their being in Schedule 1 would itself be a barrier to investigating their medicinal value.
A move to Schedule 2 would not automatically make it easier to develop a compound currently in Schedule 1 into a widespread medicine because there are multiple other policies in place to prevent this, like the Human Medicines Regulations 2012. Being in Schedule 1 increases the timeframes and costs of research, but doesn’t add anything whatsoever to the rigorousness of the scientific testing required to make a medicinal product of the compound, compared to being in Schedule 2.
People tend to look at the MDA without regard for medicines legislation which is itself very complicated, but to move psilocybin to Schedule 2 may speed up many of the concerns raised this morning, and could be brought about relatively quickly and easily by way of secondary legislation.

Jeff Smith MP introduces David King.

David King:

Psilocybin is as strictly regulated today as it was 50 years ago, but the original legislation was based on sensationalist media reportage, unsubstantiated reports of unsafe medical practices in the USA and without consideration of the ways it was being used safely and effectively by clinical researchers around the world. There was virtually no Parliamentary Debate concerning the regulatory status of psilocybin; it was not widely known about when it was scheduled with very little scrutiny.
Today we have a lot of evidence that psilocybin is associated with very low potential harms, and that there’s a tremendous value in the research of psilocybin and other Schedule 1 drugs backed in a similar way.
We propose that psilocybin and related drugs of high research value are urgently rescheduled to Schedule 2, with statutory limits in place to restrict unlicensed access to ethically approved research studies.
This would immediately improve availability for research without risking the diversion of drugs or inappropriate prescribing.
King recommends the Home Office commission the Advisory Council on the Misuse of Drugs to review the status of psilocybin, issuing a statutory instrument under negative procedure. This would allow decades of regulatory blocks to be lifted in weeks.
There is no evidence that rescheduling psilocybin to Schedule 2 would cause any harm to the British public. However, there is substantial evidence that doing so would benefit our research institute institutions, our life sciences sector, and ultimately British patients; every single day that passes by while the government neglects this opportunity to reduce research barriers, 18 British citizens take their own lives. It is not ethically economically or politically justifiable to wait any longer.
The Home Office will say that it is already looking into regulatory barriers, but no Commission has yet been made to the HMP to review the scheduling status of psilocybin and related drugs. There is nothing in the ACMD work plan that directly addresses the issues discussed today.

Questions and discussion session with speakers and audience - chaired by Crispin Blunt MP

Crispin Blunt MP gives concluding remarks.

Thanks to the speakers and organisers as well as the attendees.

This webinar gives us the ability to get the evidence into the hands of the ministers - Jo Churchill has requested such a presentation. A recording and transcription can be given to the decision makers so that they will then be pushing their officials to get on and produce the necessary administrative software to make sure that they can be addressed by the ministers responsible for making progress on this relatively straightforward issue.

Crispin Blunt MP opens the floor for questions and comments.

Ronnie Cowan MP:

I have spent some time thinking about medicinal cannabis and did not know what psilocybin was - magic mushrooms, the penny dropped. We don’t know why it was banned in 1971 with Nixon.

I disagree with Crispin - the home office is a problem, the health department is a problem, they don't get it. Something could be done if we change the mindset of the few people who can do something about this.

My question is - is there some place in the world that has got this right?

Prof Joanna Neill responds:

There is a doctor in Switzerland who can use LSD for his patients - he has to be approved on a patient by patient basis.

Dr James Rucker responds:

The problems stems from the UN conventions which countries around the world mimic, as well as media demonization. There is a Schedule 1 cycle whereby research is not authorised, because the drug is legally denoted as not for medical use. So why would you want to research it, no one wants to fund it.

The only way to counter it is to make a health related argument with clinical research but that is exactly what Schedule 1 stops us from doing, which is why we want relaxation of Schedule 1.

David King responds:

Canada has recently granted compassionate access to a number of patients. There are other countries where because of different laws, psilocybin based therapies are available.

Crispin Blunt MP:

Thank you for the question, it brings up how we may press the arguments home.

One is the veterans mental health support, Matt speaks for 2500 of his fellow veterans who have PTSD from recent conflicts and are beyond conventional treatments. The UK owes its armed forces effective treatments, plus those suffering from depression and the end of life group in Canada - charities that represent each group can help us reinforce the arguments we are making here. There is no evidence for not making this change. All we need to do is get Ministers to ask the necessary question to the ACMD, get the advice and move matters on.

Any more questions?

Baroness Molly Meacher asks a question:

Do we know that psilocybin won’t come up against the same problems as medical cannabis? Very few people got a medical cannabis prescription, because of prejudice and stigma, is the rescheduling to schedule 2 be the goal we are going for? What about schedule 4? Or outside of the scheduling? Have we got our ask right?

Prof Joanna Neill responds:

This is a short term goal to enable the research which is what we have to do. I work with drug science and we are looking at psychedelics registries to provide real world evidence so that we are ahead of the curve when psilocybin becomes a medicine.

David King responds:

There are some key differences between the situations of psilocybin and medical cannabis. There are thousands of formulations of medical cannabis that work for different patient groups but it is difficult to obtain data because of the complexity of the plant. Whereas in the case of psilocybin, which is a single compound, we don't want lots of prescribing but rather to open up the possibility of preclinical, experimental and clinical research in order to develop our understanding of how it can be used clinically - the goal is market authorisation and the standard process.

Rudi Fortson QC responds:

What I am interested in is why is licensing so problematic? We are dealing with accredited scientists working in respected institutions - why should it be so expensive and result in long delays? If we could get to the bottom of that then matters would improve substantially. So maybe it does require a body to conduct some form of inquiry or investigation into the workings of the department responsible for licensing to find out what the issues really are.

Crispin Blunt MP responds:

There does seem to be a change in culture going on - they are beginning to think that licensing for these things should be coming from the department of health. Some lessons have been learnt from medical cannabis - that you need to think the whole thing through before a decision.

I think we can get change here by presenting the evidence, drug policy issues need to be brought to ministers and opportunities pointed out.

Rudi Fortson QC:

I suspect the problem is one of mindset.

Crispin Blunt MP:

Yes the home office is about enforcement and prevention and the department of health is about opportunity and treatment and health.

Dr James Rucker:

There is a misconception that rescheduling will short circuit the medical licensing procedure - it wont, they are separate processes - the medical cannabis perspective is different for a number of reasons.

Crispin Blunt MP:

I want to get this argument into the hands of ministers - we need the transcript and or the videos so that they can engage with the arguments in their own time. Lots of the ministers’ interests have been engaged by the panel and the presenters. Thank you for your time, hopefully we can make progress for the vast amount of people who can benefit greatly from all this.

Ronnie Cowan MP:

I am happy to put a question to the Home office or Health department.

Crispin Blunt MP closes the meeting.

Frank WarburtonDecember 16, 2020