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Two years on Project Twenty21 helps almost 2,000 patients access medical cannabis

David Horn, the project’s development lead, reflects on its progress so far.

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Project Twenty21
Almost 2,000 patients are now enrolled on Project Twenty21

Project Twenty21 has helped almost 2,000 patients access medical cannabis treatment. Two years on from its launch, the project’s development lead, David Horn, reflects on its progress so far.

Project Twenty21 (T21) was in conception long before the expression Covid-19 was even coined. Launched by Drug Science, the UK’s charity for drug reform, its initial aim was to enrol 20,000 medical cannabis patients by the end of 2021, in a bid to build Europe’s largest real-world evidence base for the safety and efficacy of medical cannabis.

But when the groundbreaking project became officially operational in August 2020 the world was well into the depths of the pandemic. The data collection, which had been anticipated to take place through face-to-face consultations and follow-up interviews between patients and their doctors – inside bricks and mortar clinics – was suddenly forced entirely online.

“At one stage with the emergence of Covid, we wondered whether we would have to shelve the entire effort,” admits Twenty21 project’s development lead, David Horn.

“The impact of Covid has been very interesting; we were subject to lockdowns, which necessitated a redesign of internal processes within T21.”

Twenty21 launch

Since the first patients were enrolled, there are now almost 2,000 participants, a number that is growing every month. It’s not quite the ambitious 20,000 target Drug Science was aiming for, but it’s nonetheless significant in terms of the data it is collecting on cannabis.

“20,000 patients was always a stretch target,” says David.

“We’re certainly nearer 10 per cent of that certainly than was our initial intention, but let’s not lose sight of the fact that 2,000 patients is by far and away from an order of magnitude greater than most studies and certainly significantly bigger than any other study that’s been done in cannabis.”

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Dramatic first findings

The first findings from the observational study, which were published earlier this year, have indicated that medical cannabis is having a dramatic improvement in their quality of life.

David Horn, ProjectTwenty21 development lead.

By 13 March 2021, a total of 75 individuals had completed both an initial and three-month follow-up appointment. Results showed a 51 per cent increase in patients’ self-reported health and ability to lead a more normal life, as well as significant improvements in managing debilitating secondary conditions such as anxiety, insomnia and depression.

Almost two thirds (63 per cent) of patients in the study had previously turned to illegal cannabis use in an attempt to treat their conditions, but have been able to avoid criminality thanks to a legal prescription.

“Our first publication has shown very strongly that patients consider cannabis to be very effective in treating their symptoms, based upon the reported levels of symptom abatement as calculated on validated data scales,” David explains.

“Suffice to say that as the numbers in the study grow and the reviews come back, we are increasingly able to make publications around what is effective in what diagnosis and to what extent.”

Twenty21 growth

Through its monthly newsletter, T21 now publishes regular data updates to give followers deeper insights into what it is learning. In August it revealed that 86 per cent of patients reported an improvement in anxiety or depression after three months of treatment – better than is typically seen with commonly prescribed antidepressants. A third of patients also report disrupted sleep or insomnia as a secondary condition.

In September it was reported that the majority of patients enrolled on the project are male (around two thirds) while the number of female patients increases steadily with age. Among those aged 18-25, only 29 per cent identify as female, while the over 75s group is made up of mainly women (64 per cent).

The data also contradicts a popular belief that young people using cannabis tend to be healthy, recreational users, as findings indicate that everyone seeking cannabis starts out with poor health, regardless of their age.

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Project Twenty21

Reducing costs

As well as gathering conclusive data, through subsidising the costs of private prescriptions, T21 has allowed thousands of people to benefit from cannabis-based medicines who likely wouldn’t have been able to access the treatment otherwise.

Indications currently prescribed for include multiple sclerosis (MS), PTSD, Tourettes, substance abuse disorder (SUD) and in recent weeks it added ADHD to its list of prescribed conditions.

But by far the most common diagnoses are chronic pain (59 per cent, according to the latest data) and anxiety (almost 30 per cent).

“Both of those diagnoses significantly impact the economic activity of the patient,” says David.

“The cost of cannabis care is highly significant in relation to the numbers of people who can entertain it.”

Driving down the costs of medical cannabis is another key objective of Twenty21 and it’s one it has been successful in.

Covid has had a hand in this too. The use of telemedicine has not only meant that patients who may not have been able to travel to clinics, due to either financial or health limitations, have had the opportunity to access treatment, but it’s also reduced overall clinical costs.

As David explains: “Covid-19 drove all the clinics onto a virtual platform with only online consultations. This has the effect of driving down the amount of clinical time and the consequent cost to the patient and has resulted in clinic charges being massively reduced since the launch of T21.

“Something that we are particularly proud of is the design and establishment of £5 per gram for flower as an industry price-point that is now well established, and is relatively affordable by economically challenged patients.”

He added: “There is no doubt that the manipulation of the cost of cannabis and the cost of the clinic time that supports the prescription of cannabis has been driven down and has enabled a larger cohort of patients to access cannabis care.”

Project Twenty21

Boosting numbers

In the last six months, the project welcomed three new clinics on board and hopes to have more to announce soon. It has also ramped up its awareness, with a presence at major sector events such as Product Earth this August and Beyond the Green, the COP26 hemp fringe event in November.

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The fact that the data is being collected electronically has also presented the opportunity for expansion overseas, including Germany and Australia, where negotiations are ongoing with stakeholders to launch their own versions of Twenty21.

“We are now aspiring to expand T21 offshore and through this fashion, we hope to accelerate to our goal of enrolling 20,000 patients,” David says.

“We have a particular interest in what we call ‘cannabis naive’ patients, in other words, they are new patients to cannabis, because that provides possibly the greatest insights into the response to cannabis and how that might decay or otherwise with time.

“We are interested in that information whilst it is still available in Europe, as complete deregulation has not yet occurred. Having said that, we are also potentially interested in creating a worldwide cannabis registry.”

Its overarching goal, of course, is to see cannabis-based products available to patients through the NHS. Three years since the change in legislation in November 2018, and with only three prescriptions thought to have been issued through the NHS, it seems like this is still some way off. But David is confident that soon the evidence will be impossible to ignore.

“The fact that it is only available privately underlines the fact that cannabis is still out of UK culture, and still framed as extra-mainstream,” he says.

“One of the prime objectives of Drug Science by publication is to push back against this, and our aim is to play into commissioning decisions to permit cannabis to be prescribed on the NHS.

“This will take some time to come, but the bigger that our database becomes the more irresistible our call will be.”

Twenty21 is always on the lookout for new clinics and clinicians to join the project as prescribers. If you’re interested, please email prescribers@drugscience.org.uk to arrange a chat with the team.

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US Congresswoman speaks out about how cannabis helped her depression

Nancy Mace spoke out about using cannabis to help her depression after experiencing a traumatic event as a teenager

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Image credit: Nancy Mace/Instagram

A Republican congresswoman who has proposed a federal bill to legalise cannabis has spoken out about her experience using cannabis to combat depression.

Nancy Mace, a republican politician from South Carolina appeared on Fox Business’s ‘Kennedy’ show to talk about the bill which would legalise cannabis but would also focus on veteran access.

It also includes expungement for non-violent cannabis crimes and imposes a revenue tax that would support reinvestment into communities hurt by the war on drugs.

Bill: A banner for always pure organics

The bill titled the States Reform Act would federally legalise and tax cannabis has been proposed ahead of competing Democrat proposed bills. While the bill was originally proposed in July, Mace shared her story after officially filing the State Reform Act in November.

At the end of the discussion, host, Lisa “Kennedy” Montgomery asked the congresswoman if she smoked cannabis.

Nancy replied: “When I was 16, I was raped. I was given prescription medication that made the feelings I had of depression worsen, and I stopped taking those prescription drugs and I turned to cannabis for a brief period of time in my life.”

She added that she believed her experience with cannabis made her more sympathetic to veterans who may use cannabis for conditions such as post-traumatic stress disorder (PTSD).

Bill protection for veterans

The congresswoman explained that the new bill is “particularity protective of veterans, ensuring they are protected, not discriminated against and that the US Department of Veteran Affairs can utilise cannabis for their PTSD.”

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She added: “When I talk to vets and I see that pain, it hurts because I felt that pain before in my life. Veteran suicide, we see every single day.”

One other provision in the bill is that cannabis would be under the Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau (TTB) instead of the Food and Drug Administration (FDA). The FDA would have some involvement similar to its current control over the alcohol industry.

Bill history

Mace has already won an exception for rape and incest victims in a fatal fetal heartbeat bill. She mentioned her history when it came to proposing that bill in 2019.

She said: “I’ve had family that have overdosed from hardcore opiates and prescription drugs. And I’ve mentioned part of this in 2019, at the time I got the exception for rape and incest in the fetal-heartbeat bill I told my story about being raped when I was 16, but I’ve never said this part publicly before: I was prescribed antidepressants afterwards, and it made my feelings a lot worse. And so I started using cannabis for a brief moment, for a time in my life. It helped me. It cut down on my anxiety and helped me get through some dark periods.”

 

Fibromyalgia: A banner advert for cannabis health news

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First patient set to receive cannabis products on Ireland’s MCAP programme

CannEpil is the first drug available through the programme but has yet to be prescribed

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Ireland HSE offer medical cannabis
CannEpil was announced as the first drug to be made available through the programme

Earlier this year, the Irish Health Service Executive (HSE) has announced that the first cannabis-based products will be available through the Medical Cannabis Access Programme from mid-October.

Despite an update from the Irish health service (HSE) and Health Products Regulatory Authority (HPRA) that CannEpil would be prescribed by the middle of October, the first prescription has been delayed.

People before Profit TD for Dublin Mid-West Gino Kenny tweeted that the first prescription should be available from next week.

The HSE has yet to confirm that the products will be available from next week but says they would not be aware until the consultant neurologist has issued claims at the end of the month.

In a statement to Cannabis Health News, a press officer at the HSE stated: “The HSE has registered three patients under the MCAP in recent days. We would not be aware whether the consultant neurologist has proceeded with prescribing for an individual until claims were submitted from pharmacies at the end of the month.”

He also raised the issue in the Dáil earlier this month to Taoiseach, Michael Martin.

“Many families would have been very joyous during the summer when the medical cannabis access programme was to commence. But sadly, in a PQ response today, not one patient has been given access thus far. That is a huge disappointment to those families that this treatment could make life-changing benefits,” he said.

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“So what do you say to families that feel let down by the program and now they have to look at other treatments and probably getting no treatment at all?” He asked.

Michael Martin replied that a lot of patients have been facilitated by the original ‘imported license’ but he was unsure as to why patients had not availed of the MCAP. He promised to follow up with the Minister for Health, Stephen Donnelly of Fianna Fáil.

Gino announced changes to the Cannabis Regulation and Control bill that he is due to submit. It will now take place next year with a focus on production and consumption for personal use.

HSE committee meeting

In a joint committee meeting held in September, CannEpil was announced as the first drug to be made available through the program from mid-October.

Ireland’s Health minister Stephen Donnelly announced funding for the Medical Cannabis Access Programme (MCAP) in January, almost two years since the legislation was signed off in June 2019.

The programme will offer access to cannabis-based medicines to people living with one of three qualifying conditions. These include intractable nausea and vomiting associated with chemotherapy, severe treatment-resistant epilepsy and spasticity associated with multiple sclerosis (MS) where patients have failed to respond to authorised treatments.

The meeting saw officials from the Department of Health and the Health Products Regulatory Authority (HPRA) outline the current state of the MCAP programme and the Ministerial License system.

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The suppliers of two products, CannEpil and Tilray are said to have confirmed their prices to the HSE, but Tilray has yet to announce its availability date.  Two more cannabis-based products have been added to the schedule but suppliers are not thought to have current plans to supply the Irish market.

Morris O’Connor, the assistant national director of primary care reimbursement, announced that two additional products were expected to be added to the schedule in the coming weeks and that the programme may be extended for longer than the initial five year pilot period.

He stated: “There are currently four cannabis products on the schedule and two more to be added to schedule one of the regulations in the coming weeks. I understand that one of the products in the schedule namely CannEpil is expected to be available in October, subsequent to the introduction of the necessary legislation.”

According to Lorraine Nolan the chief executive of HPRA, since the MCAP regulations came into force in June 2019, 34 applications have been made for cannabis-based products.

Of these four cannabis oils have been placed in schedule one of the regulations, and two dry herb products have completed the final HPRA review and are awaiting a ministerial decision. Five are currently under active review.

Nolan commented: “The first cannabis-based products are expected to be made available to Irish patients through MCAP in October 2021. Once these are accessed by Irish patients, the HPRA will receive any reports of suspected adverse events and review them for any signals of concern regarding the safety of the product.

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“The HPRA will also have a role in investigating any quality issues that may arise and coordinate any action that might be subsequently required.”

Doctors are asked to register patients who may benefit from this treatment to the HSE including the condition they are being prescribed for.

The HPRA will be monitoring patients for adverse effects over the coming weeks once the medication is available.

The MCAP programme has been criticised by patients who are still waiting for access to products despite the introduction of the scheme in 2019 under then Minister for Health, Simon Harris.

O’Conner also highlighted that 192 ministerial licenses have already been issued for 67 individuals who access medication from the Netherlands.

In July a direct funding scheme was announced to remove the need for patients to pay for these prescriptions up front and then apply for reimbursement from the Government.

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Irish politicians receive cannabis in mail to mark National Legalise Cannabis day

The letters outlined the reasons why legalising cannabis in Ireland needs to be a top priority for government officials.

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Irish: A banner advert for National Legalise cannabis day

Two hundred Irish TDs received a letter outlining the reasons for cannabis legalisation and a roll-up in the post sparking an investigation

The cannabis was sent by An Póst by leading cannabis activists to mark National Legalise Cannabis Day in Ireland. The cannabis was accompanied by a letter outlining ten reasons why cannabis should be legalised and made accessible. Cannabis activists including Cannabis Activist Alliance, ReLeaf CBD Café, and Martin Condon from the podcast Martin’s World shared images of the letters online before sending them to ministers.

Two hundred letters containing cannabis roll-ups and edibles were sent to ministers including the President of Ireland, Michael D Higgins. A further forty were sent to members of the media and senators. Mary Lou McDonald of Sinn Fein was even sent a tricolour roll-up.

In a statement online, those involved encouraged other cannabis consumers and activists to get involved in the action.

“To mark the 20th anniversary of this event the Martins World Podcast, The Cannabis Activist Alliance and the ReLeaf Cafe have teamed up to recreate this event. Cannabis containing joints will again be posted to every TD and Senator in Ireland. With the joint, we will include a letter about the campaign and 10 reasons why Cannabis prohibition should be ended (there are thousands to choose from). We encourage anyone who wants to get involved to do so. It will only cost you the price of a stamp and envelope.”

Some of the benefits listed in the letters included the creation of jobs, open access for patients and researchers, the end to the discrimination faced by patients and also the protection of minors with the introduction of regulation.

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Irish cannabis market

While the letter highlighted the reasons why cannabis should be legalised in Ireland, it also gave a stern warning about the dangers of buying cannabis from an unregulated market.

“As this product was sourced from an unregulated market, you as a consumer have very little protection. There is no guarantee that this joint contains any cannabis. If it does contain cannabis you as a consumer have no idea as to the potency of the cannabis. This makes dosing incredibly difficult and could put you at risk.”

The action has sparked an investigation by Irish authorities after scanners at the ministerial buildings failed to recognise the substance. It was reported that nearly all of the Green party received a letter along with members of Fianna Fáil and Fine Gael.

Irish ministers response

Most of the ministers have not confirmed if they have or have not received the letters. However, Cathal Crowe, a Fianna Fáil TD for Clare posted a photo of the letter on Twitter confirming he had received one.

Irish Green party councillor, Oliver Moran also received a letter and tweeted his response. “Many thanks for including me in this action—and for the prudent warning that potency and content are unknown when drugs are purchased from an underground market.”

November 5 was declared  National Legalise Cannabis Day by Independent TD, Luke Ming Flanagan back in 2001. The letters campaign was created to mark the 20th anniversary of this.

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Ireland’s cannabis reform

The campaign comes amidst criticism that the Medical Cannabis Access Programme is still not functioning despite reassurances that Cannephil would be available from mid-October.

People before Profit TD for Dublin Mid-West, Gino Kenny raised the issue in the Dáil to Taoiseach, Michael Martin.

“Many families would have been very joyous during the summer when the medical cannabis access programme was to commence. But sadly, in a PQ response today, not one patient has been given access thus far. That is a huge disappointment to those families that this treatment could make life-changing benefits,” he said.

He added: “So what do you say to families that feel let down by the program and now they have to look at other treatments and probably getting no treatment at all?”

Michael Martin replied by saying that a lot of patients have been facilitated by the original ‘imported license’ but was unsure as to why patients had not availed of the MCAP. He promised to follow up with the Minister for Health which is currently Stephen Donnelly of Fianna Fáil.

Gino also announced changes to the Cannabis Regulation and Control bill that he is due to submit. It will now take place next year with a focus on production and consumption for personal use.

Image credit : Martin’sWorld

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