Medicinal Use of Psilocybin: Reducing restrictions on research and treatment

The Adam Smith Institute, in conjunction with the Conservative Drug Policy Reform Group (CDPRG), has published a new report outlining the medical potential of psilocybin and the need to reduce restrictions on research and treatment written by Dr James Rucker, Dr Jesse Schnall, Dr Daniel D’Hotman, David King, Timmy Davis, and Professor Joanna Neill:

• Psilocybin is a compound found in over 100 species of fungi. In humans, it induces temporary changes in mood, perception and cognition via activation of serotonin receptors in the brain. It is associated with a low potential for harm relative to other classes of psychoactive drugs: it has very low toxicity, its use is not associated with the development of physical dependence, nor with acquisitive or other crime, and deaths attributed to its abuse are extraordinarily rare. It is listed in Class A of the Misuse of Drugs Act 1971 and in Schedule 1 of the Misuse of Drugs Regulations 2001. There is overwhelming scientific consensus that the current legal status of psilocybin is not evidence-based, but rather grounded in overstated historical assumptions of harm.

• Depression is among the most significant social, economic and medical challenges in the UK. It is the greatest contributing factor to suicide, a leading cause of disability, and it costs the economy £10 billion annually. Existing therapies are not adequate for approximately 30% of patients; 1.2 million British residents are estimated to be living with treatment-resistant depression. Since very few advances have been made in the treatment of depression in several decades, there is an urgent need to support research into novel therapies for treatment-resistant cases.

• Psilocybin is being investigated as a novel therapy for treatment-resistant depression and other difficult-to-manage mental health conditions, including obsessive-compulsive disorder, substance misuse disorders, and end-of-life anxiety. In 2018, the British life sciences company Compass Pathways received FDA ‘Breakthrough Therapy’ designation for psilocybin. Evidence from completed early phase trials indicates that psilocybin can be used safely and feasibly, is well tolerated by patients, and that it is likely to have lasting therapeutic benefits. However, robust evidence on efficacy can only be generated by large-scale phase 3 controlled clinical trials. Compass intend to start phase 3 at UK sites in the near future. These trials will be greatly enabled by rescheduling.

• Although trials are successfully being undertaken, Schedule 1 regulations are a major barrier, increasing the costs, difficulties and duration of research. Schedule 1 research typically requires multiple Home Office licenses per study, incurring significant administrative costs and delays. Compliance with Schedule 1 safe custody and security regulations add further substantial burdens of cost and time. In practice, these requirements necessitate contracting specialised pharmacies to do what could otherwise be done by hospital pharmacies at trial sites. Additionally, stigma associated with Schedule 1 negatively impacts funding, ethical approval, and collaboration. These barriers, which are well known among the research community and have been recognised in Parliamentary reports for at least twenty years, prevent many studies from taking place and substantially complicate those that do.

• A scheduling review is undertaken as part of the normal process when a medicinal product achieves market authorisation, but significant savings could be made by moving psilocybin to Schedule 2 prior to the commencement of phase 3 trials. This would have wide-ranging benefits: to legitimate commercial drug development through reduced barriers to research; to the taxpayer through decreased expenditure of Government research grants; and to the NHS and British patients through lower end-costs of treatment and earlier completion of trials. Greater regulatory support for psilocybin research will ensure the UK’s reputation as a global centre of excellence in this area, attract commercial investment and international expertise, and prevent a ‘brain-drain’ of British research and innovation to other jurisdictions. Immediate action will yield the greatest benefits to the UK.

• In November 2018, a precedent was set for moving controlled drugs (cannabis-based products for medicinal use (CBPM)) from Schedule 1 to Schedule 2 prior to market authorisation as a medicine. At the time, the Home Office wrote: “The rescheduling may lead to increased UK research [...] as these products can be tested more easily.” “This may lead to economic benefits for UK businesses and health benefits to patients if this research leads to new and improved [medicinal products].” “In principle, research is ongoing and could lead to more effective treatment, lower costs, better understanding and management of risks, and improved health and wellbeing, over the medium term.” The current Chief Medical Adviser to the UK Government, Prof Chris Whitty, later stated that moving CBPM to Schedule 2 was “the single most important thing that could be done by Government” to support the development of an evidence base.

• Likewise, rescheduling would be the most significant and immediate way that Government could support ongoing research with psilocybin. Psilocybin could be rescheduled with statutory limits restricting access to ethically-approved research studies only – unless a product has market authorisation – thus preventing wider prescribing on an unlicensed basis. This would be unprecedented in UK law, but would serve to support scientific development without risking inappropriate prescribing. 

• The major source of diverted medicinal drugs is by prescription prior to diversion. Moving psilocybin to Schedule 2 for research purposes is unlikely to increase the risk of diversion because the drug is administered to participants under clinical supervision, rather than being prescribed for use in the community. This is in line with ACMD advice that “the risk of diversion and misuse in a research setting is likely to be minimal.”

• The proposed research-only model of rescheduling would support legitimate scientific and commercial development while maintaining stricter controls on psilocybin than on other controlled drugs associated with greater potential for harm, including diamorphine (heroin), methamphetamine, and cocaine. It would not affect existing legal controls on criminal use or supply. This model may also serve as a basis for future scheduling decisions; there are other Schedule 1 drugs under investigation as treatments for mental health conditions for which there are similar clinical arguments to support rescheduling, albeit with less immediate urgency. 

• The ongoing ACMD review on barriers to research with Schedule 1 drugs is vital. We also welcome the current work to establish a Standard Operating Procedure (SOP) for scheduling decisions. However, the primary emphasis of the review on barriers to research is on synthetic cannabinoids and it is currently unclear whether the SOP will be used to review historical scheduling decisions. Since neither report is expected to be published until 2021, nor to directly provide recommendations on psilocybin, there is no known work currently commissioned by the Home Office that addresses the urgent issues identified in this report.

• We recommend that the Home Office commission a high-priority ACMD review into the access-restricted rescheduling of psilocybin under the Misuse of Drugs Regulations 2001.

Testing Times: The urgent need to decentralise COVID-19 diagnostic testing in the United Kingdom

The ASI’s latest paper, written by ASI Head of Research Matthew Lesh, makes the case for decentralising COVID-19 diagnostic testing in the United Kingdom:

• COVID-19 is the biggest public health emergency in modern history. There have already been over 875,000 confirmed cases and 43,500 deaths worldwide. These numbers are expected to grow exponentially in the coming weeks, potentially resulting in millions of cases and hundreds of thousands of deaths. 

• The United Kingdom is experiencing a substantial growth in cases and deaths. Over 2,350 people confirmed to have died after contracting the virus. This number is doubling approximately every 3 days, putting the UK on a similar trajectory to the worst affected regions in the world.

• Testing is a key tool to combat infectious diseases. It allows doctors to identify the needs of patients, public health authorities to trace and isolate cases to minimise spread, and epidemiologists to track the spread of an outbreak. It is also essential for healthcare workers to return to the frontline.

• The UK has fallen to the bottom quarter of OECD countries for COVID-19 diagnostic testing, on a per capita basis. South Korea has tested four times as many people as the UK, Germany almost three times and the United States now almost twice as many, per capita.

• The early decision to centralise testing to a single Public Health England (PHE) laboratory has hampered the ability to increase testing in the UK. Testing has now been expanded to 12 labs operated by PHE as well as a limited number of NHS laboratories.

• The most successful countries in testing COVID-19 – such as Germany, South Korea, and more recently, the United States of America – have decentralised testing and embraced a mixture of public, non-government and private laboratories.

• Since March 16, the United Kingdom has just over doubled daily testing capacity. In the same time, the United States has increased daily testing by a factor of 21.

• The private sector has shown an extensive willingness to support the Government’s efforts to tackle COVID-19, including the rapid design and manufacture of ventilators and agreeing to transfer beds and staff in independent hospitals to the NHS.

  • If the UK Government wants to meet its testing targets and save lives, it must:

  • fast-track approval for private sector laboratories to conduct COVID-19 testing; 

  • substantially expand usage of NHS and university laboratories to conduct COVID-19 testing; 

  • undertake rapid approval of private sector developed tests, including mutual recognition of tests approved by other regulatory bodies such as the FDA;

  • reduce testing red tape, including any requirements that initial positive tests must be retested centrally by PHE; and

  • explicitly call on companies to help make testing kits and develop lab capacity for COVID-19 testing, modelled on the successful call for businesses to make ventilators.

Up in Smoke: Unlocking Tobacco Harm Reduction

A new paper by Daniel Pryor, a Research Economist and Head of Programmes at the Adam Smith Institute, argues that the United Kingdom defends vaping and argues that the UK should redouble efforts to unlock further tobacco harm reduction:

• The United Kingdom is a world leader in encouraging smokers to switch to alternative, less harmful nicotine products.

• Britain’s success is closely linked to the broad, evidence-based consensus in favour of e-cigarettes as a smoking cessation tool. Public Health England has declared that vaping is “at least 95% less harmful”. 

• There is a very strong correlation between the reduction in cigarette usage and the increase in e-cigarette usage in recent years. According to PHE estimates, up to 57,000 more people have quit a year due to e-cigarettes.  

• The available evidence does not substantiate recent concerns about e-cigarettes. The vast majority of e-cigarette users are former (53%) or current ‘dual users’ (39%) of cigarettes. Relatively few young people in the UK have taken up vaping and less than 1% of young people who have never smoked have tried vaping products. Furthermore, safety risks related to illicit products have not and are unlikely to become a concern in the UK.

• There is a need for further progress in harm reduction: there are 8.56 million smokers in Great Britain, 4.37 million smokers have tried e-cigarettes but gone back to smoking, while 2.88 million smokers have yet to try a reduced-risk product.

• There is widespread misinformation about the relative risk of e-cigarettes. Over two-fifths (43%) of UK smokers do not believe that e-cigarettes are less harmful than tobacco cigarettes.

• The most common reason for e-cigarette users returning to smoking is that vaping “didn’t feel like smoking a cigarette.”

• Leaving the European Union presents an opportunity for the UK to liberalise the treatment of reduced risk products, including harnessing the potential of alternative reduced-risk products such as heated tobacco and oral nicotine pouches, and ensuring high levels of public awareness about the relative risk levels of different products.

• If the Government wants to turbocharge tobacco harm reduction and achieve its stated goal of a ‘smoke-free’ society by 2030, they should:

  • (1) Develop an evidence-based set of generic health claims that can be used by regulated e-cigarette marketers to advertise products;

  • (2) Commission independent research to develop the evidence base in relation to heated tobacco products, with a view to allowing accurate communication of this information by marketers;

  • (3) Reform counterproductive elements of the EU Tobacco Products Directive post-Brexit;

  • (4) Implement risk-based taxation to incentivise switching to reduced-risk products, building on the creation of a separate taxation category for heated tobacco;

  • (5) Legalise snus post-Brexit with a sensible regulatory framework;

  • (6) Encourage the NHS to take a leadership role in promoting tobacco harm reduction across trusts;

  • (7) Allow cigarette pack inserts that exclusively advertise reduced-risk products.

Room for improvement: How drug consumption rooms save lives

A new report by Jarryd Bartle, a drug policy consultant and university lecturer, calls for Britain to introduce life-saving Drug Consumption Rooms:

• Drug consumption rooms are an evidence-based harm reduction intervention which allow people who use illicit drugs to do so within a medically supervised environment.

• The use of drug consumption rooms in other jurisdictions has been shown to reduce drug-related deaths, reduce health burdens and decrease public injection and syringe litter.

• Supervised Drug Consumption Rooms are effective at engaging hard to reach, highly marginalised populations with drug treatment, healthcare and other services. People in treatment use less illegal heroin and other drugs, potentially reducing the scale of the illegal drugs market.

• Concerns that drug consumption rooms will increase drug use, attract substance users to an area or increase local crime are not supported by research.

• A large majority (89%) of drug users are willing to use a drug consumption room.

  The UK is falling behind the rest of the world, including countries such as Australia, Canada, Denmark and France which are increasingly adopting drug consumption rooms as part of drug harm reduction strategies. 

• This paper recommends that the UK prioritises the introduction of an integrated drug consumption room in an area identified as being of increased risk of drug-related harms.

• Drug consumption rooms currently sit in a legal gray zone, leading to a lack of willingness by local authorities to introduce this proven harm reduction strategy. This could be addressed by:

  • 1. An explicit statement by the Home Office that the operation of DCRs is a matter for local authorities; specific rules could then be agreed by police forces, the Crown Prosecution Service (CPS), health bodies and local authorities; and

  • 2. The UK Parliament passing legislation that makes it explicitly legal to take controlled substances within such facilities in specified circumstances.

Making​ ​Sense​ ​of​ ​the​ ​NHS

Exactly how much the Treasury should provide the NHS is a political decision, based on the state of the UK economy, international comparatives, the coherence of NHS strategy and the competing demands for support. But there is wide agreement that exactly how those funds should be allocated should not be a political decision.

The cross-party convention proposed by Norman Lamb, or the Royal Commission proposed by Lord Saatchi, could help create this division of responsibilities. They should consider five major NHS structural changes to realise its potential:

• NHS England is too big to manage. It needs to be split into six autonomous NHS Regions—run as independent public corporations like the Bank of England or BBC, not by a vast central Whitehall staff.

• The limits of NHS provision—at present open-ended—must be identified. Only then can resources be focused on their most urgent uses.

• Patient co-payments, common in almost every other healthcare system (and already current in NHS dentistry and prescriptions), needs to be extended, with care, to reduce marginal and unnecessary demand on NHS services.

• Our ageing population means that the number of GPs and geriatricians must be increased, particularly geriatricians, whose numbers are outstripped by demand.

• The 12% of the UK population with mental health issues need greater prioritisation and specialist resource.

The benefits of this clearer, more manageable strategy include:

• Improved morale, recruitment and retention of a workforce that feels more valued and able to achieve identified aims, rather than having to deal with continual crisis.

• Localised autonomy to innovate, reduce waste and learn from others.               

• Better balance of NHS resources with demand, which is outstripping supply because (a) they are free, (b) an older population needs more geriatrician care, (c) mental health needs more specialists and (d) a wealthier population demands more healthcare in general.

• Improving the quality of healthcare and balancing the books by focusing money, personnel and equipment on their most cost-effective uses. More skills need to be pushed down the line: consultants to primary care, GPs to nurses and pharmacists.

Read the full paper here.

Instrumental Variables: How the UK can become a world leader in medical innovation

A little under a year ago, the New York Times reported on do-it-yourself insulin pumps. Tech savvy people, mostly parents to diabetics, were pairing glucose sensors with insulin pumps. These would allow caregivers to constantly monitor glucose levels. Some even made what are, in effect, artificial pancreas, with the glucose sensor triggering the insulin pump, automating insulin delivery.

In September, the FDA approved MiniMed 670G, a mostly automated insulin pump, for sale to the general public. The device was made available spring 2017. The device is only available in the US, and Medtronic, the device manufacturer, has stated there is no timeline to bring it to other markets—diabetics can only access the years old previous version.

Automated insulin pumps illustrate two important aspects of drug and medical device regulation. First, existing regulatory systems have been slow to adapt to changes in the development of new medical devices, and medical innovation more broadly. Second, safe and effective medical devices are often unavailable in the UK, while British newspapers abound with stories of life-saving drugs unavailable in Britain.

Brexit gives the UK the opportunity to tackle both challenges and to become a leader in medical innovation. The European Medicines Agency (EMA), as well as the Medicines & Healthcare products Regulatory Agency (MHRA), the UK’s own regulatory body, were both designed for a different era.

They were created for big medicine, when large, multi-national corporations were the primary drivers of innovation. The world is in the early stages of changes in the nature of medical innovation. The era of big medicine will soon be behind us. To take full advantage of the coming changes in the structure of innovation, regulatory policy must adapt.

The UK has two advantages which could allow it to lead the charge in medical innovation.

First, the UK has a well-educated population, even relative to other developed countries, scoring near the top of the pack in maths and science, according to the multi-national TIMSS exams. It also has disproportionately strong higher education, with more universities in the world top 10, top 50, and top 500 than any country except for the US, according to most rankings. It has the human capital 2 necessary to be at the cutting edge of innovation.

Second, Brexit caused a large regulatory shock. Most regulatory changes take substantial time because of slow moving bureaucracies. Because of Brexit, the UK must make rapid changes. The question is, what type of changes should they make?

Read the whole paper.

Reforming the National Health Service

In this report, retired industrial line manager and entrepreneur Chris Davies reflects on his experience of four decades of NHS care, and details the numerous occasions on which Britain's health service has failed him. He argues that the NHS is a fifties-style nationalized service that does “time wasting and inconvenience on a monumental scale" and is fundamentally incapable of serving its customers effectively. Davies goes on to advocate reforms far more radical than anything yet contemplated by the British government: his blueprint would see the entire NHS estate sold to competing, private groups; it would establish a national insurance fund financed by the proceeds of those sales and by employer and employee contributions; and it would introduce a co-payments system whereby patients had to pay 20 percent of medical bills themselves, up to reasonable annual limit.

Read this report.

Depoliticizing the NHS

This paper documents the bewildering and counter-productive range of political initiatives and interference which has wreaked such havoc on our nation's healthcare system.

The paper's proposal is for a distinguished panel of health professionals to be appointed to run the NHS, to allocate its budget, determine its priorities, and operate it according to medical needs rather than political aims. A YouGov poll taken on the subject shows massive popular support for precisely such a proposal, with 69 percent in favour and only 12 percent against.

The NHS budget would be set by Parliament every five years, and up-rated each year in line with inflation. The ASI's YouGov poll showed that this idea, too, enjoys widespread popular support, with 74 percent in favour. The suggestion that "the NHS has become a political football" receives 72 percent backing.

Read the paper here.