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Majority of UK MPs support drug policy reform

A new report has revealed the majority of MP’s support evidence-based drug reform.

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Majority of UK MPs support drug policy reform

A new report from the Conservative Drug Policy Reform Group (CDPRG) has shown the majority of MPs in the UK support drug policy reform, and highlights how current policy is a barrier to psychedelic research – restricting the development of new medicines.

As the rest of the world moves towards more progressive approaches to drug policy, the UK announced a ten-year crackdown on drugs. Dubbed the ‘overdose capital of Europe’, the UK’s new policy would see a record amount of funding funneled into reducing addiction and drug-related crime.

The new report from the CDPRG, ‘Making UK Drug Policy A Success: Reforming The Policy Making Process’, shows that the majority of MP’s from all parties want evidence-based reform in the UK – something the new government strategy is lacking. It also emphasises that the UK needs to rewrite its policymaking process for drugs.

The report says that the strategy, informed by the independent Dame Carol Black review, is confused between its approaches to problematic and non-problematic drug users, and “potentially places yet more burden on a criminal justice system that is already swamped by drugs-related work, serving to drive drug users even closer to their criminal supply chain and away from the treatment and security the state should offer.”

Time for evidence-based reform

The CDPRG polled MPs in June 2021, revealing that 72 per cent of Conservative MPs agree the process of making drug policy should make more use of evidence and research. 

It also showed that 85 per cent of Conservative MPs, and 90 per cent of all MPs, agree that improved cross-departmental coordination would better in helping to tackle the health crime and social problems associated with controlled drugs.

The recommendations in the report are informed by two round tables – one in collaboration with the Institute for Government and one co-chaired by Drug Science – as well as the most comprehensive analysis of UK drug policy to date. This analysis was carried out by the UK Drug Policy Commission almost ten years ago in 2012 and still remains relevant today.

CDPRG director of research, Dr Toby Webster, commented: “We’ve taken [from the analysis] the already established lessons of how drug policy should be made if it is to have a chance of achieving its stated objectives.

“The drug strategy is more complete in some areas than others – there will be a considerable amount of ongoing development, particularly in those areas for which they didn’t carry out a decent, formal, independent consultation, which is essentially everything except for treatment for addiction.

“Carol Black’s review of drugs part 2 covered the treatment of addiction very thoroughly, and it was clearly a useful resource for the team drawing up this strategy, as is reflected in the quality and detail of the recommendations they make in this area. There remains the opportunity for more formal consultation to improve the plans that are still being drawn up, and this is something we will be advocating for.

“As we engage with the ongoing development of the drug strategy, we hope to emphasise the principles of good governance that we present in our report, and we hope that this can be of some use – good policymaking processes lead to better policies, and this is what we hope to see.

“We are overall optimistic that there is an understanding that evaluating these policies properly, and having proper accountability, is key to making sure that we don’t continue the failings of the past, and we hope that this is maintained.

“We hope that the government’s commitment to evaluation and developing more sensible outcome measures leads to a willingness to admit and learn from mistakes, and change course if efforts are not working”.

The Government’s aim in its new strategy to help people reduce their reliance on addictive substances has generally been welcomed, but evidence-based drug reform groups said the new measures did not go far enough.

Drug Science urged the Government “to change its approach completely, and to adopt a rational, evidence-based approach of drug control”.

Responses also raised concerns that many of the initiatives listed are against evidence and will cause further harm.

See also  Reform organisations respond to new UK drug strategy

This sentiment from MPs and reform groups is an echo of the UK public’s views, with public polling from 2019 showing that only one in four adults believe current UK drug policy is effective at preventing harm to health and wellbeing, and three in four believe that criminal sanctions do not deter either drug use or supply. 

Additionally, a public survey carried out by YouGov earlier this year showed majority support for the rescheduling of psilocybin for research and medical purposes.

“The UK has made insufficient efforts to keep regulations up to date with the evidence base, and has been slow to respond to emerging information,” states the report.

See also  Majority in favour of changing law to boost psilocybin research in UK

Reforming the policymaking process

The report underlines the need for the UK to rewrite the policymaking process itself, saying that a methodologically flawed process sits behind the UK’s drug crisis.

Chair of the CDPRG MP Crispin Blunt says reforming this process is a “crucial foundation for producing better drug policy in years to come”.

Highlighting the inadequate capacity to carry out research that can inform policy creation as the principal problem, the report puts forward recommendations on how this can be changed.

“This is compounded by there being no specification on the extent to which policymaking must make use of evidence,” it states.

“COVID-19 has irrevocably increased awareness that the political and collective response to public health crises is best when guided by good science.”

However, the Government currently does not extend this to its drugs policy.

The 23 recommendations include suggestions to: 

  • Develop a National Drug Research Strategy
  • Establish a National Institute for Drug Science to coordinate research into substance misuse
  • Pilot schemes of new and innovative approaches such as harm reduction initiatives

They also include recommendations to ensure the Ten Year Drug Strategy is effective, suggesting that:

  • It should define specific, measurable and achievable goals, so that it can be clearly evaluated and held to account
  • It should include a robust outcome framework with evidence-based logic models informed by an open consultation 
  • It should clearly and simply outline the responsibilities of every involved department for achieving each specific commitment, and
  • It should outline the total projected expenditure including budgetary commitments of each spending department, and any funding which is to be ring-fenced for specific purposes

MP Crispin Blunt commented: “UK drug policy frequently misses its mark and our outcomes are among the worst in Europe for good reason.

“It has been apparent for some time that the way we make drug policy is not fit for purpose – indeed it is often chaotic and contradictory, barely evaluated, and with a distinct lack of senior accountability for the failures it has produced. This leads to an endless repetition of the same worn-out approaches, and outright denial from the top as they persist with strategies and legislation that has barely changed in 60 years.

“I am pleased to present our new report that shows in detail how poor policymaking has led to poor policies and poor outcomes, and recommends some steps towards improving this process.

“We are glad to see some acknowledgements of past failures in the government’s new drug strategy, and some more emphasis on data and evidence in taking the next few steps, but it remains to be seen if this will translate into concrete action.”

See also  Calls for UK Government to pilot Overdose Prevention Centres

Hindering scientific research

The new report highlights the current renaissance in psychedelic research – much of which, after 50 years of scientific censorship, is gleaning new insights into addiction and resistant mental health conditions. 

It notes the current barriers around the research of psychedelics such as psilocybin and MDMA in the UK – pointing out the multibillion market that is developing in this area across the globe.

“With over 50 psychedelics companies publicly listed across a number of exchanges, including the NYSE and NASDAQ, their combined market caps exceed $6bn,” states the report. 

“One of the largest of these companies is the UK-based Compass Pathways, but despite this and due to the harsh regulatory environment, there are currently no psychedelic companies at all listed on the London stock exchange.”

The CDPRG’s report, ‘Medicinal Use of Psilocybin’ shows there is little evidence of a social benefit to the current controls, and that there is now clear evidence these controls have actually slowed the development of new medicines.

The organisation, which has been campaigning for 24 months to reschedule psilocybin from Schedule 1 to Schedule 2, stated: “Returning to the ‘moral purpose’ and the spirit in which they were written, our drug laws should not inhibit the development of medicines.”

It continues: “The Home Office has been resistant to consulting the ACMD on the aforementioned scheduling of psilocybin for the purposes of facilitating medical research in the substance in the UK, despite the Home Office confirming that the substance (and a number of other controlled drugs) have not been subject to analysis or recent analysis of harm.

“The issue of the relationship between the Home Office, ACMD and use of evidence, in general, is contentious, with concerns that short term political priorities are taking precedence over evidence.”

To read the full report please visit: www.cdprg.co.uk

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Policy

FDA MDMA therapy advice may be a setback, but it is not the end of the road

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FDA MDMA therapy advice may be a setback, but it is not the end of the road

An advisory body to the U.S Food and Drug Administration (FDA) has recommended against the approval of Lykos Therapeutics’ MDMA-assisted therapy – but the development is not deterring the industry.

Four months ago the psychedelics industry was abuzz when Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announced it had received FDA acceptance and priority review for a New Drug Application (NDA) concerning its MDMA-assisted therapy for PTSD.

While the final decision on the matter is not expected until 11 August 2024, the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) has delivered a major blow to the development.

The committee voted “no” on the question of whether the data shows the treatment’s effecitveness as well as on the question of whether the benefits outweigh the risks, with concerns raised over trial design, data gaps, and the potential for abuse and unethical practice.

As highlighted by Lykos, the FDA is not bound by PDAC’s guidance but it does take its advice into consideration – meaning the outcome is not looking good for the FDA’s final decision later this year.

Lykos has expressed its disappointment on the vote outcome given “the urgent unmet need in PTSD”, however, the organisation has acknowledged that the committee “faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention.”

Amy Emerson, Chief Executive Officer of Lykos Therapeutics, stated: “We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system, if approved.”

Not the end of the road

While the advisory vote may not bode well, industry stakeholders believe this is not the end of the road for MDMA-assisted psychotherapy.

With the advice concerning only the Lykos trial, there may be scope for concerns raised by the committee to be addressed in further trials, as well as other MDMA analogues or therapy designs to make it to approval.

Christian Angermayer, Founder of atai Life Sciences, believes that there is still a strong chance that, with a properly conducted Phase 3 trial, MDMA-assisted therapy will get approved.

“I (still) believe MDMA is a promising drug with tremendous therapeutic potential for patients with severe mental health issues,” wrote Angermayer.

“It isn’t MDMA itself that was rejected per se, but the specific, poor data set provided by Lykos; the committee particularly cited discrepancies in clinical trial design and conduct, inadequate collection of safety and other relevant data, bias in the evaluation of patients, and cases of patient abuse during the trials.”

Rivki Stern Youdkevich, Co-founder and CEO at Shortwave Life Sciences (SWLS), which is developing psychedelic medicines for the treatment of anorexia nervosa, has said the decision is not deterring their developments.

Youdkevich commented: “We were disappointed to learn of the panel’s recommendation but we are not discouraged.

“Mental ill health is growing at an alarming rate with an increasing number of conditions affecting more people in every age group worldwide. This necessitates novel approaches to medication and treatment, as existing therapies do not suffice. So our enthusiasm for development of psychedelics-based treatments and medicine remains undiminished.

“In fact, we are doubling down on it. Shortwave Life Sciences’ goal is to become a leader in the origination, development and operation of innovative solutions in the field of mental health. Like other psychedelics drug makers, we remain unwavering in our commitment to overcome the expected challenges on the way to approval and wide acceptance of this new field as safe, effective and viable.”

Youdkevich emphasised that the FDA’s advice will not affect Shortwave’s chances of approving its drug product for anorexia nervosa.

“Specifically at Shortwave we have several strengths in our clinical and development approach which would lead us, I believe and hope, to a positive reception,” explained Youdkevich.

“Our team of experienced clinical experts led by Dr. Nadya Lisovoder designed our clinical strategy to anticipate and meet the most stringent requirements from the regulator. We are undergoing a full set of pre-clinical studies to create a robust base of evidence and research which will illuminate our clinical trials design.

“Furthermore, our by-the-book clinical trial design will be further wisened by real-time data and learnings from our partners at the Sheba Medical Center Department of Eating disorders’ Phase 1 psilocybin-assisted therapy trial for anorexia patients.

“Our anorexia programme is based on a combination of psilocybin and additional APIs. We initially designed this combination to extend the mechanism of action of the drug, giving us flexibility in dosing of the scheduled component, psilocybin. Our drug delivery method allows for efficient administration and absorption which is currently being tested, thus maximising the effect even in a potentially lower dose of psilocybin.

“Anorexia nervosa is a life-threatening disease, with the highest mortality rate of mental health conditions and with no FDA-approved medication.

“Today, treatment for anorexia nervosa is psychotherapy based, with no standardised protocol. Our novel drug product and delivery method would naturally fit into this mode of care with the aim of achieving remission in a relatively short period, and reducing the need for years of therapy and treatment. So, although psychotherapy adds complexity to the process of regulatory approval, in our case, it is the incumbent standard of care.

“We applaud and look up to the pioneers in psychedelics drug development who are the avant-garde in creating this “new field of medicine”. They are facing head on the challenges and hurdles of evaluation and acceptance into mainstream medicine.

“Our strategy at SWLS has always been to follow in the regulatory path created by the first-comers and implement their learnings vis-a-vis the regulators. Such learning may include special attention to communication at all stages and on all aspects of trial methodology design and implementation with the regulators, to the degree trial participants are novice to the drug, as well as consideration of all aspects and the possibility of conducting blind studies with psychedelic compounds.”

MDMA is gaining global traction

While it remains to be seen if MDMA-assisted therapy will gain approval in the United States in August, the compound is gaining traction as a treatment for mental health conditions including PTSD elsewhere across the world.

Canada added MDMA-assisted therapy to its Special Access Programme in 2022 for the treatment of PTSD, and in 2023 Australia rescheduled the compound to allow authorised access to the therapy for select patients living with PTSD.

In fact, just days following the FDA’s advice, a Dutch advisory committee, which conducted a multidisciplinary analysis of the health risks of MDMA to advise the Dutch Cabinet, recommended the Government should allow access to MDMA-assisted therapy for people living with PTSD.

The independent State Commission was established by the Dutch Parliament to research the legal status of MDMA and provide advice on its medical use.

The report produced by the committee specifically advises on the pros and cons of the medicinal use of MDMA for the treatment of PTSD, advising that there appears to be sufficient scientific evidence for the effectiveness and safety of this form of therapy.

The committee has now recommended developing the medical use of MDMA for PTSD as quickly as possible, advising that regulatory frameworks are established.

In a statement, Minister Pia Dijkstra, Minister for Medical Care of the Netherlands, commented: “I am pleased that the report is now available, because it provides tools to further develop the therapeutic application of MDMA.

“Research into the therapeutic use of MDMA is promising. It is possible that MDMA as a therapy-supporting medication can help, especially for mental health patients who have been dealing with their problems for years and have not been helped by the current range of therapies.

“However, more scientific, clinical research needs to be done. With regard to the recreational use of MDMA, the report emphasises the principle of Dutch drug policy, which primarily emphasises health, prevention and reducing the harmful consequences of use, for example through monitoring and testing.

“It is therefore good that this report is now available and supports the need for substantiated policy and further scientific research.”

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Policy

Psychedelics are here, now: preparing psychiatry for a psychedelic future

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Psychedelics are here, now: preparing psychiatry for a psychedelic future

An emerging body of evidence is showing psychedelics as promising treatments for mental health conditions, and psychiatry needs to be prepared for their arrival, say researchers.

Recent years have seen an increasing amount of scientific evidence pointing to the potential of psychedelics as treatments for mental health conditions such as anxiety, depression, and PTSD. So far, this evidence has led countries such as Australia, Canada, and the US to allow special access to these medicines for select patients.

In particular, MDMA and psilocybin have produced robust results – now in Phase III trials – that show their efficacy for PTSD and treatment-resistant depression, respectively. 

The developments around these two substances may lead to their approval as licenced medicines in the near future, with Lykos Therapeutics MDMA-assisted therapy for PTSD already receiving US Food and Drug Administration (FDA) acceptance and priority review for a New Drug Application (NDA), for example.

See also  UK advisory body issues rapid response on psychedelics for PTSD

In a new article published in the British Journal of Psychiatry, researchers emphasise the need for the psychiatry profession to prepare for this possible outcome, and discuss how health systems might respond to these developments.

The authors write: “Given the rapidly emerging body of evidence of efficacy for psilocybin and MDMA, people’s great need for innovative treatments and the move towards approval in some countries before licences are awarded, it seems likely that these two drugs will become a part of psychiatric practice for many in the foreseeable future. The psychiatry profession and practising psychiatrists need to prepare for this.”

Supporting patient access

Medicines must undergo rigorous, double-blind randomised controlled trials (RTCs) to reach patients under approved licensing. 

However, the authors highlight that this model poses challenges due to the high cost of trials, commercial incentives for indication testing, and socioeconomic/demographic factors impacting decisions on where a company makes a licensing application – such as population size and income.

This can mean that cancer treatments are prioritised over physiatric treatments, for example, and can lead to low- and middle-income countries waiting decades to gain access to new medicines. 

The researchers suggest that off-license administration may provide a solution.

“Already psychiatrists in many countries are using ketamine ‘off licence’ to treat people with resistant depression. There is now comparable evidence of safety and efficacy for psilocybin and MDMA to allow, with the patients’ informed consent, competent clinicians to try them out ‘off licence’ as well as in severe illnesses when other treatments have failed,” write the authors.

“One of the main arguments from patients and their carers is the distress that they cannot access treatments of proven efficacy until a company chooses to market them; these people are totally disempowered. In Australia, the issue of drug supply outside the usual drug company medicine marketing model was solved by a charity sourcing the medicines from accredited manufacturers. This model could be used elsewhere.”

The authors also highlight that ensuring patient access to psychedelics will need a country-by-country approach, taking into consideration the unique challenges of each place.

Using the UK as an example, they highlight that the Advisory Council on the Misuse of Drugs (ACMD) “appear to be acting under the misperception that a marketing authorisation generated by a pharmaceutical company is necessary to change the Schedule 1 status of these compounds in the Misuse of Drugs Regulations.”

However, the UK’s Chief Medical Officer confirmed there was ample real-world evidence to support the legalisation of medical cannabis in 2018.

“There is now indubitably better evidence for psilocybin and MDMA in their respective Australian-approved indications than there was then for medical cannabis,” the authors write, suggesting regulatory controls for psychedelics such as a register of practitioners and supervised data collection for efficacy and adverse effects.

Training psychedelic psychiatrists 

While scientific data may be mounting up and regulation changes are slowly creeping in across the globe, the roll-out of psychedelic therapies will also depend on having trained psychedelic therapists.

Lack of education and training has resulted in hesitation from NHS practitioners to prescribe medical cannabis, the authors highlight, so systematic training and relevant education will be vital if psychedelic medicines are to reach patients.

“By utilising innovative technologies, many of the educational and administrative tasks can be undertaken remotely, and we can learn from other countries, such as Australia, as to how to coordinate the delivery of excellent treatment,” the authors write.

“It is up to the gamut of professionals and organisations – for example, Royal College of Psychiatrists, the Chief Medical Officer, ACMD and other groups, to take the initiative early.”

The authors also suggest that the UK should establish a working group to explore the implementation of psychedelic therapies.

“We need to be ready for a change in the law which would signal a turning point in the provision of better treatment for some of the most incapacitating illnesses in medicine,” the authors conclude.

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Policy

UK advisory body issues rapid response on psychedelics for PTSD

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UK Government issues rapid response on psychedelic research

The UK’s independent Parliamentary Office of Science and Technology (POST) has issued a rapid response on psychedelic-assisted therapy for post traumatic stress disorder (PTSD).

The response is intended to inform policymakers on the topic as increasing research around psychedelics shows the compounds may hold promise as innovative treatments in the area of mental health.

The rapid response is the third response on psychedelics to come from POST – one of the first independent bodies of its kind in the world that sources independent analysis of public policy issues relating to science and tech for government.

Previous responses have covered depressive disorders, anxiety disorders and eating disorders.

See also  UK MPs demand answers as Drugs Minister dodges psilocybin debate

The response reads: “Research into the use of psychedelic-assisted psychotherapy for PTSD has been conducted using MDMA, ketamine, and the four ‘classical psychedelics’ (psilocybin, LSD, mescaline and DMT). These are described in POST’s rapid response article on depression.

“Generally, this approach involves ‘non-trip’ sessions with a medical professional to ensure safety, prepare the patient and build a relationship, and a minimum of one ‘trip’ session where the patient undergoes a form of talking therapy after administration of a psychedelic compound.

“Evidence from studies conducted in hundreds of participants suggests that psychedelic-assisted psychotherapy may be an effective treatment for PTSD. However, to date, there is not enough information from large clinical trials with sufficient participants comparing psychedelic-assisted psychotherapy directly to existing treatments.”

Responding to research and policy developments

POST’s responses on psychedelics have been issued following a parliamentary debate discussing psilocybin access in May 2023.

The debate saw a group of crossparty MPs call for the rescheduling of psilocybin to remove barriers to research and demand an urgent review of the evidence for psilocybin’s current status as a Schedule 1 drug under the Misuse of Drugs Regulations 2001, “with a view to rescheduling”.

The Royal College of Psychiatrists, psychedelic access non-profit Heroic Hearts UK, and other leading mental health charities, also wrote letters to the Veterans Minister and the Minister of State for Crime, Policing and Fire, urging them to champion access for patients in the UK.

The latest rapid response covers psychedelics for PTSD including Psychedelic-assisted psychotherapy for treating PTSD, MDMA, Ketamine, Classical Psychedelics and the Regulation of psychedelic drugs used in medicine.

Earlier this year, POST confirmed it intends to publish a major briefing on psychedelic drugs to treat mental health conditions in 2024.

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