Connect with us

Policy

New UK guidance on real-world data is good news for psychedelics

The MHRA has confirmed that greater use of real-world data from clinical trials could get medicines to patients much quicker.

Published

on

New UK guidance on real-world data is good news for psychedelics

The new guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) stating that the use of real-world data from clinical trials could help with quicker regulatory approval for new medicines is welcome news for the psychedelic industry.

The new guidance from the MHRA has outlined how the use of real-world data for clinical trials could help with quicker regulatory approval for new medicines and improve clinical trial recruitment.

The announcement follows consultation with pharmaceutical industry stakeholders, patient organisations, trade associations and academic researchers, among others. 

Commenting on the new guidance, MHRA Chief Executive, Dr June Raine, said that real-world data can “make a huge difference when it comes to bringing medicines through clinical trials to patients.”

See also  Reform organisations respond to new UK drug strategy

Currently, the UK’s gold standard method of assessing medicines for regulatory approval is randomised controlled trials (RCTs). This method is considered the most scientifically rigorous as it utilises placebo groups, large sample sizes and double-blinding.

The method, however, can have its limitations as not only is it extremely costly (sometimes costing millions of pounds), but the stringent controls in these trials do not always reflect the real world. 

For psychedelic medicines, using real world data as an addition to RTCs would allow for reduced costs and quicker access to medicines for patients.

Leading psychedelic researchers, including Dr Robin Carhart-Harris, professor David Nutt and Dr David Erritzoe, et al, earlier this year pointed out that supplementing RTCs with real-world data and digital health solutions could “better support the discovery of optimal and personalised treatment protocols and parameters.”

With real-world data, data sets are routinely collected from patients through electronic patient health records, and disease and patient registries. This kind of data is used to monitor medicine and medical device safety, however, it is rarely used to demonstrate the effectiveness of a medical intervention before it is approved.

Most recently, one instance when real-world evidence has been utilised for a new medical intervention is for COVID-19 vaccines. As vaccine trials usually take years to complete, including real-world data can help assess efficacy much quicker.

As noted by the British Medical Journal: “Well conducted real world studies of vaccine effectiveness are an important complement to randomized controlled trials.”

With the current mental health crisis, there is a desperate need for quick access to new and effective medicines for patients with resistant conditions, and a number of psychedelics have shown promise in this area.

See also  Findings give new insight into how psychedelics help mental health

The new guidance has been welcomed by UK psychedelics companies, including Albert Labs, a member of Psychedelic Health’s editorial board, which is developing psilocybin medicine to treat cancer-related distress.

CEO, Graeme McFarlane, commented: “The new guidance from MHRA in respect of  the value Real World Evidence brings clinically to the regulators accelerated access strategy for patients is welcome news and underscores the approach Albert Labs is taking as a leading psychedelic manufacturer, fully supported by the UK regulatory authorities in the acceleration of clinical development in areas of both unmet need and importance to UK public health.”

See also  UK’s Albert Labs receives conditional approval for CSE listing

Non-profit drug reform organisation, Drug Science, which has been carrying out Europe’s largest patient registry for medical cannabis, Project Twenty 21, and which is campaigning for the rescheduling of psilocybin for research purposes, has also welcomed the news.

David Badcock, chief executive of Drug Science, commented: “When one considers the obstacles that prevent researchers from conducting safe, large scale trials, it becomes clear why Real World Data is so valuable.

“Our own Project Twenty 21 uses exactly this kind of data. It’s one of the largest observational studies of its kind in the world. And it indicates the real world effectiveness of medicinal cannabis for improving patients general health and quality of life.

“That’s why Drug Science believes the MHRA’s guidance is a welcome step in the right direction. There is still much more to do here, but our hope is it will lead to increased acceptance of important evidence.”

[activecampaign form=52]

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Policy

Now is the time for psychedelic access, says campaigner

Published

on

Now is the time for psychedelic access, says campaigner

Activists in Oakland recently filed a ballot put forward by Dave Hodges seeking to legalise safe and legal access to psychedelics for therapeutic uses. 

In the face of critics, Hodges has said now is the time for safe access to psychedelics.

The Psychedelic Wellness & Healing Initiative would enable the sale, possession and use of psychedelics for therapeutic purposes if passed. Psychedelics that would be allowed under the ballot include Psilocybin, MDMA, DMT, and Mescaline.

If passed, the initiative would give doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of problems, including obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), depression, anxiety, addiction, suicidality and traumatic brain injury (TBI), among others.

Hodges has said: “Now is the time for safe, controlled medical access for patients in need. The way to solve the problem is not by continuing to ignore it.” 

Hodges’ solution is to create a structure for use that includes proper dosages and access to experts who can help users benefit from appropriate treatment.

The updated initiative language emphasises safety, and gives doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of conditions.

Research by the University of Michigan and Columbia University shows non-LSD hallucinogenic use on the rise and Hodges has stated that increase means that the initiative providing guidelines for use is needed more than ever. 

Hodges said he hopes Californians will read the initiative, share their thoughts about it over the holiday week and offer feedback via the initiative website, PW4CA.com, by 27 November, 2023, the deadline for modifications.

“Now is the time to provide medical and therapeutic access to psychedelics,” Hodges said. “The way to do this is through the initiative.”

Continue Reading

Policy

Transform Drugs releases groundbreaking book: How to regulate psychedelics

Published

on

Transform Drugs releases book: How to regulate psychedelics

UK charity Transform Drug Policy Foundation has published a new book ‘How to Regulate Psychedelics: A Practical Guide’ that sets out how psychedelics can be legalised and regulated for non-medical adult use.

While an increasing amount of research is pointing to the potentially beneficial effects of psychedelic treatment on mental health conditions, many people across the globe are using psychedelics outside of the clinical setting.

The book includes a set of proposals for post-prohibition policies, covering psychedelics including psilocybin, LSD, DMT and Mescaline. 

Previously, Transform’s guides on regulating stimulants and cannabis have been used to advise governments around the world on drug policy. This book seeks to inform the debates on psychedelic drug reforms taking place across the world.

Co-author and Public Affairs and Policy Manager at Transform Drug Policy Foundation, Ester Kincová, stated: “Despite psychedelic drugs being illegal, their non-medical use within society has been steadily increasing. 

“Punitive enforcement has not decreased use or eliminated supply, but it has made use more unsafe. 

“Legalising and regulating psychedelics is a pragmatic move to reduce harm. This is no longer a theoretical debate, states in the US are already recognising the need and  making moves to regulate for non-medical adult use.”

Scientific Chair of Drug Science, Professor David Nutt, added: “Once again Transform have come up with a well thought out and practical plan for the regulation of another group of currently illegal drugs – in this case psychedelics. 

“Their ideas would be both easy to implement and to engage with and will, if adopted, radically enhance the safe use of these remarkable agents.”

Proposals for regulation

The book includes a four-tiered regulation model “that attempts to manage the variety of psychedelic preparations and the different ways in which they are used”.

These include:

  • Private use, home cultivation, foraging and not-for-profit sharing.
  • Membership-based non-for-profit associations for plant-based products.
  • Licensed production and retail adaptable to different products and environments
  • Regulated commercial guided or supervised use

Additionally, a decriminalisation model is proposed which suggests that possession for personal use should no longer be an offence of any kind or be subject to any sanctions; Drugs for personal use should not be confiscated; cultivation of small amounts of plant-based drugs for personal use should be decriminalised, among other suggestions.

The book also includes topics such as embedding social justice, equity and human rights into policy design, how to think about psychedelics regulation, why regulate psychedelics and why now, and psychedelics and the UN drug treaties.

To read the book, please visit transformdrugs.org/.

Continue Reading

Policy

Oakland ballot seeks to legalise medical psychedelics

Published

on

Oakland ballot seeks to legalise medical psychedelics

Activists in Oakland have filed a ballot that seeks to legalise safe and legal access to psychedelics for therapeutic uses. 

The Psychedelic Wellness & Healing Initiative would enable the sale, possession and use of psychedelics for therapeutic purposes if passed. Psychedelics that would be allowed under the ballot include Psilocybin, MDMA, DMT, and Mescaline.

If passed, the initiative would give doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of problems, including obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), depression, anxiety, addiction, suicidality and traumatic brain injury (TBI), among others.

See also  Australia reschedules psilocybin and MDMA

Additionally, it would create a statewide framework for regulating the possession, use, cultivation and production of substances for medical and therapeutic use.

The initiative has been introduced by proponent and founder of the Oakland-based Church of Ambrosia, Dave Hodges, to the California Attorney General’s office for the 2024 ballot, and will need 546,651 valid signatures to qualify.

See also  CDPRG discusses the UK's Reschedule Psilocybin campaign

The filing follows California Governor Gavin Newsom’s recent veto of Senate Bill 58, the bill that sought to decriminalise the use of certain psychedelic drugs. 

Hodges emphasised that SB58 would have been a step forward, but that it had major flaws concerning its lack of provisions to ensure access, public safety and quality control. That veto, Hodges said, compelled him to move quickly on the initiative filing.

When the California Attorney General certifies the initiative for circulation, backers will have about four and a half months to gather the required signatures for ballot placement. 

Signature collecting will begin in early December.

Continue Reading

Trending