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.”
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.
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.”
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.”
Calls for psilocybin access rights for UK cluster headache sufferers
Letter to Home Office ministers calls for the rescheduling of psilocybin.
Backed by three top psychiatrists, 161 cluster headache sufferers in the UK have written an open letter to Home Office ministers Savid Javid and Kit Malthouse calling for politicians to reschedule psilocybin.
Cluster headache sufferers from ClusterBusters UK have said breaking the law pales in comparison to getting rid of the pain they live with. The organisation is the national branch of the global ClusterBusters organisation based in the US which works to improve the lives of cluster headache suffers.
In the open letter to Secretary of State for Health and Social Care, Savid Javid, and Minister of State for Crime and Policing, Kit Malthouse, the 161 UK citizens call for the substance to be rescheduled from its Schedule 1 status in order to fight for symptom relief.
Cluster headaches are rare and debilitating neurological condition known as suicide headaches for their excruciating pain – currently untreatable with existing treatments. The condition affects 1 in 1000 people in the UK.
Psilocybin has shown promise in treating the condition and the citizens highlight it can also address the mental health impacts that stem from it.
The letter, which was written by ClusterBusters’ Vice President, Ainslie Course, states: “Sadly, there are very few medications which offer any relief whatsoever, and those that do are short-lasting at best but many, many people living with Cluster Headache have been successful in treating our condition with sub-hallucinogenic doses of psilocybin.
“Not only is this a way to treat the physical symptoms of our condition, but this medicine can also treat the associated mental ill health, that is the depression, anxiety and post-traumatic stress related to knowing the excruciating pain will inevitably return.
“Psilocybin is helping hundreds of thousands of people to live a predominantly pain-free life with encouragingly long periods of remission. This medicine has saved my life and the lives of many others.”
Three top psychiatrists – President of the British Association for Psychopharmacology, Professor Allan Young, Wellcome Centre for Human Neuroimaging, Professor Karl Friston and Regius Professor of Psychiatry, Head of the Department of Psychological Medicine, King’s College, London, Professor Simon Weseley – have also written in support of the suggestion.
They emphasise that psilocybin research can garner insights about the human brain: “When administered as a pharmacological challenge, changes in brain activity can be brought to light that inform our understanding of functional brain architectures and processing, advancing human knowledge and translational applications.”
Due to its classification as a Schedule 1 substance, psilocybin research is off-limits to numerous UK higher education institutions and businesses, they say, as many of these institutions “do not have the economic and temporal resources to secure the necessary licences.”
The psychiatrists also highlight that psilocybin can be used as an adjunct psychotherapeutic agent to treat conditions such as anorexia nervosa, obesity, post-traumatic stress disorder and addictions to substances such as alcohol, cocaine and tobacco.
The two letters are part of the Conservative Drug Policy Reform Group’s (CDPRG) Psilocybin Access Rights campaign. Founder of the CDPRG, MP Crispin Blunt, held a meeting with Prime Minster Boris Johnson in May 2021 in which Johnson agreed the rescheduling of psilocybin into Schedule 2. However, there have been Home Office delays relating to a misinterpretation of existing legislation.
Blunt raised the question of rescheduling psilocybin in Parliament later in October, to which Johnson stated he would consider the Advisory Council on the Misuse of Drugs’ (ACMD) advice on reducing barriers to research with controlled drugs, and would “get back to him as soon as possible”.
In their letter, the psychiatrists state: “The Government has confirmed that there has been no recent review of the evidence for psilocybin’s current scheduling,” calling for Chief Medical Officer Chris Whitty to review the evidence that support rescheduling the substance.
“Having assessed the evidence and history of this legislation ourselves, we understand that there is not and has never been an evidential basis for psilocybin’s current scheduling, based as it is on the UN Single Convention on Psychotropic Substances 1971. This is strange given the emerging evidence of psilocybin’s therapeutic potential and clear neuroscience research utility.”
Why Italy blocked the campaign on psychotropic substance cultivation
Legalizziamo! campaign coordinator Marco Perduca shares his thoughts on why Italy’s court has blocked the referendum.
Last week Italy’s Constitutional Court blocked the country’s campaign calling for the decriminalisation of psychotropic substance cultivation.
The motivation for not allowing the referendum to proceed is not yet clear and the campaign has been accused of being misleading, says campaign coordinator Marco Perduca.
Despite handing in 630,000 verified signatures calling for a referendum, Italy’s Constitutional Court stated that the campaign will not trigger a referendum. The Legalizziamo! campaign group has said the decision is a win for the mafia and “the failure of a court that cannot guarantee Italians a constitutional right”.
The campaign aimed to modify the wording of “cultivation” in the Consolidated Law on the Discipline of Narcotic Drugs and Psychotropic Substances in Presidential Decree 309/1990. The court, however, stated that the campaign would force the country to violate its obligations to the UN regarding the prevention of drug trafficking.
Marco Perduca is co-founder and international co-ordinator Associazione Luca Coscioni and founder of Science for Democracy, the international platform promoted by the Luca Coscioni Association. He has been the coordinator for the Legalizziamo! campaign since 2015.
In a comment to Psychedelic Health, Marco Perduca, said: “The motivation of the decision of the Constitutional Court against the admissibility of our referendum has not been published yet so we can only respond to the words of Giuliano Amato the President of the Court uttered in his press conference on 16 February.
“We were accused of having submitted a referendum that was poorly drafted, with a misleading title and that the whole proposal was not in line with Italy’s obligation stemming from the ratification of the three UN Conventions.
“Mr Amato made reference to the website address on which we collected the signatures knowing quite well that that was the name of the political campaign to collect signatures but not the actual title of the question, which was decided in conjunction with the Cassation Court.
“Italy’s drugs law is very complicated to interpret but once you know your way through that legislative maze you know where it is heading: to punish conducts from cultivation to production, from transportation to export and import of illicit plants and substances.
“Our referendum was deleting penalties only for one of those actions, cultivation, keeping all the other conducts in place – hence only growing for personal use would have been decriminalised, as massive cultivation would have remained illicit. Furthermore, one doesn’t need to be a botanist to know that one grows plants and not substance, one thing is cultivating coca bush, another producing cocaine, one thing is growing poppy seeds, another refining heroin. We do not cultivate wine but grapes.
“Mr Amato made that confusion and “forgot” to mention that prohibition to grow cannabis indeed appears in a paragraph of one of the articles we deleted as well as in the previous one – the 1990 law was toughened in 2006 but changed again in 2014 and sometimes it is difficult to keep track of all the changes, also for jurists – so, the accusation of having poorly drafted the referendum is a judgement that is up in the air as the law says otherwise.
“Until we won’t have the motivations of the decision we can only speculate on the rationale behind it and respond to a brief, if not superficial, summary of the President of the Constitutional Court shared in a very unconventional manner on behalf of the 15 judges that took that decision.”
Speaking to Psychedelic Health, Perduca previously highlighted that the campaign also aimed to allow people to use cultivation for scientific research targeting specific physical conditions or pathologies. Perduca said that Italy is lagging behind other countries in psychotropic substance research.
“We only have one centre at the University of Rome that is starting to study psilocybin for therapeutic purposes. We also grow cannabis for medical reasons, but nobody’s studying it,” said Perduca.
Perduca is also now involved in a campaign for the Right to Science – an enshrined right in the International Covenant on Economic, Social and Cultural Rights. This entered into force in 1976 and covers freedom of research, freedom of knowledge, including open access, as well as free and open data.
Whilst more studies are demonstrating the efficacy of psychotropic substances, such as psilocybin, for treating mental health conditions, prohibition of cultivating such substances hinders scientific research in Italy that could contribute to this new fountain of knowledge.
To address what the country lacks in the field of psychedelic research, Associazione Luca Coscioni recently published a collection of presentations and international symposia – The Dose Makes the Poison. The collection features psychedelic pioneers such as Amanda Feilding, Rick Doblin, Ben Sessa, Carl Hart and Raphael Mechoulam.
The campaigners have stated they will not stop the fight to push through the referendum.
Italian campaign on psychotropic substances has signatures verified
Co-founder and international co-ordinator at Associazione Luca Coscioni shares his thoughts on the outlook for the campaign.
Signatures for an Italian campaign calling for the decriminalisation of psychotropic substance cultivation have now been verified by officials.
In 2021, the campaign gathered the half a million signatures needed to trigger a referendum in less than a week. All of those signatures needed to be verified as Italian citizens in order to progress.
With the signatures now verified, one more step remains until a referendum can be called in the spring.
The campaign has focused on cannabis but pertains to the cultivation of all psychotropic substances, such as mushrooms and peyote.
It has been spearheaded by Forum Droghe, Meglio Legale, Antigone, Luca Coscioni Associations, Società della Reagione, and is supported by parties Volt Italia, Possible, Italian + Europa, and the Communist Refoundation.
Speaking to Psychedelic Health, Marco Perduca, co-founder and international co-ordinator at Associazione Luca Coscioni, which supports freedom of scientific research, commented: “I think this confirms the good idea we had in August, which was that there’s so much popularity concerning the need to amend the drug laws – in particular concerning cannabis – that the moment in which a lot of people would have been allowed to do something very quickly to support the referendum, they would have done it.
“We collected the necessary 500,000 signatures in less than a week and the remaining 30,000 signatures in the additional 10 days. According to the law, it’s not only necessary to submit signatures, you have to document that those who signed are certified registered voters in Italy.
“This is why it took two and a half months to count. This is the first step.”
The campaign aims to modify the wording of “cultivation” in the Consolidated Law on the Discipline of Narcotic Drugs and Psychotropic Substances in Presidential Decree 309/1990.
“The second step is that a title is offered for the referendum – which, according to our reading, was a little too strict on the words that we were eliminating,” said Perduca.
“So, we found a compromise solution in which, despite the fact that the word “cannabis” will not appear in the text nor in the title, at least the conduct of cultivation, sharing and personal use are represented in the title.
“The law is very complicated to amend. You cannot just take away a plant or a substance from the schedule. You have also to find other parts of the law that should be eliminated because what is penalised is the action of the plant, per se.
“So, according to our reading not only of the law but also of the jurisprudence of previous decisions of the Constitutional Court that have blocked similar referenda proposals in 1997 – we decided to go this way. But at least it is clear that it’s a referendum about cultivation and the personnel use and sharing of so-called “soft drugs”.”
Perduca highlighted that the campaign is now working on a document that will be presented by two lawyers before the Constitutional Court on February 15 together with seven other referenda.
“This document will touch upon issues such as the international implications of the deletion of the parts of the law and the constitutional requirements of Article 75 that prohibits the submission of referendum on issues – changes to the constitution, changes in the fiscal system, but also changes in laws that have enacted international treaties.
“And there could be a doubt here that we are in fact, working to do that. We are not because we are just eliminating some words, so we are not un-ratifying a document.
“The law we are working on has never been considered an implementing instrument of the 1988 Convention on Drugs. And the third part is the penal part because of course, taking away criminal sentences, we have to give satisfying arguments that the law after the elimination of the words of the referendum is an immediately applicable law.”
The Constitutional Court has until 10 March 2022 to make its decision public.
Perduca highlights that Italy is currently in a critical political situation, as, due to a new agreement that on 24 January 2021, the Parliament must elect the new president of the Republic.
“If the current head of government is going to be elected president of the Republic, there is going either going to be a reshuffling in government or – and this will pose a huge problem for the referendum – if they won’t sign an agreement there is going to be early elections.
“The referendum will push to 2023 because our law doesn’t allow us to have political elections and referenda at the same time.”
If early elections do not happen – Perduca says the campaign will request a vote on the referendum to take place on the same day of administered municipal elections at the beginning of June.
“The major obstacle now will be to reach the quorum which is 50 per cent of the population plus one vote. We are talking about 27 to 28 million people beyond the age of 18 to turn out and vote.
“The other important political element to take into consideration is that there’s going to be eight referenda before the Constitutional Court on 15 February.
“As well as this campaign, there will be one on euthanasia which is also co-promoted by the Luca Coscioni Associations, which collected twice as many signatures as this one. So, legalisation of euthanasia is a hugely popular theme, but the other six have been promoted by the parties belonging to the center-right coalition, who are all opposing the other two referendums. So, if there is this synergy between those that will ask their voters to go and vote yes for their six and at the same time vote no to the other two.
“We are counting on people to show up because we know both euthanasia and cannabis are so hugely popular. There’s absolutely no discussion that we’re going to win if there’s going to be a quorum.
“There is some hope that the turnout will be significant. If the Constitutional Court will say no to either, all six or to some of the most politically charged of the six referendums concerning the reform of the administration of justice in Italy, things will turn out in a different way.
“We are ready to fight our battle.”
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