Bedrocan joins discussions at World Economic Forum

The World Economic Forum in Davos starts today and for the first time (medicinal) cannabis is part of the discussions being held there. Our founder and CEO Tjalling Erkelens will join these discussions for the rest of this week. His message will focus on the company’s core values: separation of markets (medical vs recreational) and global harmonisation of laws and regulations in order ease patient access and allow for easier transfer of products around the world.

Cannabis Conclave
This Thursday Tjalling Erkelens will also attend the Cannabis Conclave in Davos to discuss the global cannabis movement with other cannabis leaders and investors.

Fibromyalgia study proves effectiveness of Bedrocan’s products

Pharmaceutical-grade cannabis with THC relieves pain in fibromyalgia

A recent study shows that Bedrocan’s standardised pharmaceutical-grade cannabis with a high tetrahydrocannabinol (THC) content is effective in treating pain in fibromyalgia. However, cannabis with only cannabidiol (CBD) did not show relief at all. The study was conducted by the Dutch Leiden University Medical Centre (LUMC) in cooperation with Bedrocan International BV, world’s most experienced producer of legal medicinal cannabis. Principal Investigator, Professor Albert Dahan, head of the Anaesthesia & Pain Research Unit of the Department of Anaesthesiology at the LUMC, believes this is the first real scientific proof that at least two of Bedrocan’s products are effective for fibromyalgia.

Reimbursement

It is the first time a randomised, placebo-controlled four-way cross-over study is conducted into the therapeutic effects of inhaling Bedrocan’s medicinal cannabis products. Tjalling Erkelens, founder and CEO of Bedrocan is especially delighted for patients: “The outcome is very important for patients who suffer from fibromyalgia. Now we have the serious clinical evidence that medical doctors are asking for when prescribing our products and that health insurance companies want to have, to legitimise reimbursement.”

Now we have the serious clinical evidence that medical doctors are asking for”

Tjalling Erkelens, CEO Bedrocan

What is fibromyalgia?

Fibromyalgia is a disorder characterised by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues.

A total of twenty patients participated in the study. They were treated at four distinct moments. Administration of three different cannabis products (Bedrocan®, Bediol®, Bedrolite®) and placebo (cannabis without the main active substances THC and CBD) was done by means of a vaporizer.

All subjects were exposed to externally inflicted pain by applying increasing pressure. With the Bedrocan and Bediol products, patients experienced significantly less pressure pain compared to the placebo. Furthermore, many respondents noted they experienced relief in their spontaneous pain after using Bediol.

Furthermore, the Principal Investigator, Professor Dahan, reached the following conclusion about THC: “Fibromyalgia patients experience pressure pain on muscles and tendons especially. Because only Bediol and Bedrocan show good results and the CBD product Bedrolite not at all, it means that especially THC is effective in this specific condition.”

Investigators conducted a series of measurements and tests before and after the cannabis was administered in order to systematize the variables. In one test, a weight was placed on the muscle between the thumb and forefinger. Dahan: “Healthy people can handle ten kilograms. For a fibromyalgia patient, one kilogram is already painful. But after administering Bedrocan products with THC, we saw that the same patient could suddenly bear ten kilos.”

Both Bedrocan and the Principal Investigator believe that investigation is now required to determine whether the same results on pain relief can be reproduced in a long-term study with fibromyalgia patients. “The next study takes place with patients at home. I want to investigate whether THC can be used as an opiate-saving drug. Many people use, and abuse opiates, such as oxycodone. We think that you do not have to prescribe much oxycodone if you also allow patients to use THC,” said Professor Dahan.

Bedrocan® Bediol® Bedrolite®

THC 22%

CBD <1.0%

THC 6.3%

CBD 8%

THC <1.0%

CBD 9%

Overview of used products and their THC and CBD levels

New Zealand 10 years on – Increasing access to cannabis-based medicines

A decade ago, under the previous Labour Government, New Zealand introduced policy to permit eligible patients to access cannabis-based medicines. This was accompanied by clinical guidance for a range of indications, reviewed by New Zealand’s medicines regulator, Medsafe, and specialists in palliative care, general practice, oncology and pain. At that time, Sativex™ was considered most appropriate, as it was high quality and offered standardised dosing. However, cost was a big barrier to patient access.

Ten years on, under a new Labour Government, New Zealand is intent on making great strides to increase access. The emphasis is terminally ill patients and seriously ill patients needing palliative relief where the focus of treatment is on improving quality of life. Like before, a medicines framework will remain in place. This means access to pharmaceutical-quality medicines, via a doctor’s prescription and pharmacy dispensing.

This is the most progressive legislation on medicinal cannabis that has ever passed through the Parliament”

Hon. David Clark, Minister of Health

The Misuse of Drugs (Medicinal Cannabis) Amendment Bill will require new regulations, licensing rules and quality standards. Now being drafted, these will establish the foundation of a regulated market. The legislation will also permit products to be manufactured in New Zealand for the global marketplace.

The groundswell support for the Bill, in Parliament and across society, was focussed on increasing access for those in need. That includes making medicines more affordable.

Like in other jurisdictions, the wider access to pharmaceutical-quality medicines requires a well-considered health professional education curriculum. A robust pharmacovigilance programme to enhance the safety of these medicines is also vital.

The Bill passed its third reading in Parliament and now requires Royal Assent to become part of New Zealand legislation. Regulations, licensing rules and quality standards will be concluded in 2019.

France is taking steps towards medicinal cannabis

Scientific Committee gives green light to medicinal cannabis

Like most other European countries, France is considering a programme for medicinal cannabis, to ensure patients have legal access to a product that can improve their quality of life. On Thursday the 13th of December, the temporary scientific Committee CSST submitted its advice and findings to the ANSM, the French National Agency for Medicines and Health Products Safety. The preliminary conclusion is that ‘It would be “appropriate to authorise the use of therapeutic cannabis […] in certain clinical situations and in cases where [existing] therapies provide insufficient relief or are not well tolerated”.

CSST

According to the French media, that means the temporary Committee gives the ‘green light’ for medicinal cannabis in France, even though this Comité Scientifique Spécialisé Temporaire (CSST) – which started under the Chairmanship of the psychiatrist Dr Nicolas Authier on the 10th of September 2018 – does impose some prerequisites. Next, the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) will take a decision about the Committee’s advice. This decision is expected shortly.

Important steps

The Belgian pharmacist and adviser Igna Huyghe has been closely tracking the process in France and she believes that important steps have been taken over the past few months. Certainly since June this year. “It has been a long time coming, but now there is real movement and it is clear that signals about the potential of medicinal cannabis are taken seriously at the highest level. Over a short period of time, the CSST Committee interviewed a large number of stakeholders in France and beyond and appears to be following the lead of many other European countries. Although the Committee quite rightfully acknowledges that large amounts of scientific research are required, it also recognises that cannabis provision for medicinal purposes meets a major need.”

Igna Huyghe (1960) is a pharmacist and co-initiator of the Cannabis Patient Care organisation. Together with nurse Emelie Vanhoenacker, she provides information about medicinal cannabis to patients and healthcare professionals in Belgium and France.

French patients

France has an estimated 300,000 to 1 million patients that could benefit from medicinal cannabis. The country has permitted use of two products based on cannabinoids, but one is only prescribed to patients with neuropathic pain in extremely specific conditions (Marinol®), whilst the other (Sativex®) is still not available in pharmacies due to discussions about the price.

It is a well-known fact that a large number of French patients has discovered cannabis as medication, but need to enter the illegal circuit and are not guaranteed a consistent or safe product. There is an urgent need to regulate cannabis for medicinal use in France, and the Minister for Public Health Agnès Buzyn has said that she will not exclude cannabis as a legal medicinal product for patients.

Medicinal cannabis

As in many other countries, the concept of ‘medicinal cannabis’ leaves plenty of room for discussion. “The problem is that the concept of ‘medicinal cannabis’ is not clear to many people, including patients, healthcare professionals or politicians”, concludes Ms Huyghe. “There is a demand for a standardised full-spectrum product that is produced in accordance with pharmaceutical standards, i.e. that is GMP compliant. A product that is of consistent quality, guaranteed safe as much as possible, affordable and still available in the future. A product that is tested carefully and ends up with patients through the healthcare systems – doctors and pharmacists – and where there are options to monitor the patients and consequently the product. Such a standardised product is also the only basis for scientific research.”

Round table in Paris

Ms Huyghe, who provides information about medicinal cannabis to patients in Belgium and France was in Paris on the 5th of December, when the temporary CSST Committee shared the first findings of its study with the public during a round table. “On that day we actually heard the recommendations from the report”, she said. “They want to make medicinal cannabis available for chronic pain, certain types of epilepsy, palliative care, supportive care in oncology and for multiple sclerosis. Smoking cannabis is not an option, but the Committee sees possibilities for vaporizing or oral administration.”
The Committee also recommends that patients are monitored to ensure that the effectiveness and any side effects of medicinal cannabis are charted. There will be special attention for the assessment of the benefits of treatment and any risk of addiction. The Committee also aims to promote scientific and other research. When the ANSM adopts the Committee’s recommendations, the second phase of the research starts. That will determine the most appropriate administration method, how the distribution of medicinal cannabis can be organised and whether there can be any reimbursement. The final advice from the temporary Committee is expected in September 2019 and it would seem logical that the French programme for medicinal cannabis will not start before 2020.

Agricultural country

Aside from the discussion about the contribution that medicinal cannabis makes to public health, France also has a discussion about the economic impulse promised by the cultivation of medicinal cannabis. Traditionally, France is an agricultural country and in some départements and régions farmers are struggling to keep their heads above water. It is not surprising that the agricultural sector is considering the opportunities provided by medicinal cannabis with interest and espoir (hope). Hemp is grown in many parts of France and the country is already able to deal with cultivating controlled substances; France harvests more than 100 tonnes of opium poppies, which accounts for 21% of total global production, per year. Ms Huyghe continued “It is logical that the French wish to study how they can control the production of medicinal cannabis themselves, but for patients we hope that the economic interests will not undermine the medicinal importance. I have the distinct impression that they are well aware of this in France.”

History is made: from flos to cannabis oil

The Dutch Transvaal Apotheek is a pharmacy with a history. The library contains books from 1889 and according to the website one of the clients has been coming here for more than seventy years. Under the leadership of Paul Lebbink and Arwin Ramcharan, in 2015 they made medicinal cannabis oil available in the Netherlands for the first time.

With this, the pharmacy from The Hague made headlines both in the Netherlands and abroad, much to the surprise of the Transvaal Apotheek staff. “The impact was larger than expected”, Arwin Ramcharan, chemist and QA at Transvaal Apotheek, remembers.

OMC

Since 2003 Dutch patients have access to medicinal cannabis flos. The cannabis programme is run by the Office for Medicinal Cannabis (OMC) on behalf of the Dutch government. Ramcharan about this time: “As pharmaceutical chemist we were already well acquainted with the dried product and many of the users. But once we had refined the production process and the oil was released onto the market, the demand proved to be much greater than expected.” The pharmacy currently serves patients throughout the Netherlands and sometimes even abroad. The oil, which is available in five different varieties, is used for a multitude of conditions, with pain, epilepsy, glaucoma, migraines, nausea, infections, restlessness and insomnia, spasms and decreased appetite being the most common.

Cystic fibrosis

The Dutch pharmacist made history again in 2017. The Transvaal Apotheek started to fight big pharma with their own cost-effective alternative to exorbitantly priced medication for cystic fibrosis.

Patients in the Netherlands can only get the oil on doctor’s prescription. They can obtain it at the counter or have it delivered to their home by ‘medical post’. The number of patients who come to The Hague from neighbouring countries to take home oil is gradually increasing. They need a doctor’s prescription and – of course – permission to bring the cannabis oil home. Ramcharan: “We mainly see patients who have tried all other types of medication and who have become more or less therapy resistant. They have heard of medicinal cannabis, but they also want a product with known contents and a traceable origin. And they often appreciate receiving guidance from their physician and the chemist. The price of the oil is sometimes the subject of a debate, but most patients understand that the production requires investing in equipment and knowledge and that this is a labour-intensive and strictly-controlled pharmaceutical production process.”

Magistral preparations

Cannabis oil is a commonly used form among patients who administer their medication themselves because it is easy to dose. Transvaal Apotheek is one of the last Dutch pharmacies that still make magistral preparations so it came as no surprise that Ramcharan and his colleagues were asked to produce cannabis oil. “The request for oil came from the BMC and was initially aimed at young patients”, Ramcharan says. “In approximately nine months time we, in collaboration with (then still) pharamcist-in-training Svenja Laarhuis and researcher Arno Hazekamp, created a standardised process for the preparation of oil with mainly CBD, based on the then new Bedrolite® brand. After a large number of trial runs and tests we were able to start supplying oil to our patients in 2015. We were lucky to have good active pharmaceutical ingredient.” Bedrocan products are being used for the production of the oils. Ramcharan: “The medicinal cannabis available through pharmacies in the Netherlands is standardised and extensively tested on contents and the absence of contamination. It is also produced in compliance with GMP which prevents unnecessary discussions. And… our oil is also extensively tested. Because if you supply a medicinal product while being unsure about its quality and safety, you are on the wrong track, to put it mildly. The responsibility is simply too great.”

Other pharmacies

Transvaal Apotheek is no longer the only pharmacist in the Netherlands that is allowed to produce cannabis oil. Three other chemists also received permission and have started production and deliveries in the last few years. Two of these received guidance from Ramcharan and his colleagues. “These pharmacies thought it was unnecessary to re-invent the wheel and wanted to start production of medicinal cannabis oil as quickly as possible, while also assuring top quality”, Ramcharan says, who thinks a standardised way of working is important. “We think it is important to work in a standardised way and to use the same ingredients. This way you produce the exact same product every time, which means you can make statements about the effects and possible side effects in the long run.”

In the meantime the pharmacists exchange information and thus collect clinically relevant information. Ramcharan says: “Especially in the case of medicinal cannabis, everyone is waiting for clinically relevant information. Collaborating with other dispensers can also reveal information about the application of medicinal cannabis for other conditions. We therefore have collected information about migraine patients.”

According to Ramcharan, more patients can be followed by the collaboration: “In collaboration with a specialist, our chemist is currently monitoring a group of approximately 20 epilepsy patients. We are seeing, for example, positive effects from the administration of CBD. But we can now also provide information about possible side effects. As soon as we are able to broaden and deepen the scope of this type of research, we will gain access to incredibly valuable data. Not just for patients and professional care providers, but also for researchers.”

Is medicinal cannabis on the rise in Australia?

Medicinal use of cannabis has been legal in Australia since 2016. There are currently an estimated one thousand patients who have been granted permission. That is a very small number in a population of 24 million. Indeed,  it is assumed that one hundred thousand patients still obtain their medicine from illegal sources. How is that possible? We talked about this with Professor Iain McGregor, Academic Director of the Lambert Initiative for Cannabinoid Therapeutics, an Australian research institute within the University of Sydney.

Since its establishment in 2015, McGregor and his team have been researching the effects of medicinal cannabis, among other things. This year they published the results of two surveys from both physicians and patients. This was the first time both target groups were surveyed about the medicinal use of cannabis. And it showed hidden populations.

High price

According to McGregor, the high price of medicinal cannabis is a major reason why Australian patients still depend on the black market: “Most of the people are extremely poor because they live on social welfare or pensions. People cannot afford pharmaceutical products that are on offer in the federal scheme. It would cost 60,000 Australian dollars a year to treat an epileptic child with 1,000 milligrams of CBD a day.”

Medicinal cannabis is not covered by health insurance or government pharmaceutical subsidies in Australia. Therefore, McGregor is not surprised that patients are looking for cheaper alternatives. “Our research even shows that a quarter of the patients sometimes don’t pay anything at all for their cannabis. They get it for free or grow it themselves.”

Professor Iain McGregor

The same research shows that Australian patients do not want it to be this way. “The same as with other medications, patients want a standardised product of pharmaceutical quality that is available at the chemist. This wish does not comply with the current programme”, says McGregor.

General Practitioners

The Australian GP is not to blame. The majority of GPs think that medicinal cannabis should be available on prescription. The Lambert Initiative surveyed 640 General Practitioners (family physicians) last year and the results astounded even researcher McGregor: “We knew pain doctors and specialists are very negative about medicinal cannabis. But the majority of the GPs, the family doctors, are in fact in favour of medicinal cannabis. This was quite surprising.”

GPs also say they support the use of cannabis for conditions such as chronic pain, epilepsy (intractable epilepsy) and palliative care, but less for depression or anxiety disorders. According to McGregor, the problem with the Australian system is that GPs are not allowed to prescribe medicinal cannabis, although they would like to. This task is reserved for specialist physicians (neurologists, oncologists and palliative care physicians) only. McGregor: “In Australia it is very difficult to get access to specialised medical care, let alone to find a specialist who is interested in cannabis-based medication.”

Research inspired by the Lambert family

Despite the medicinal cannabis programme, parents in Australia are still treating their children who suffer from epilepsy with cannabis products of unknown composition. This often includes severely sick children for whom regular medication barely works or does not work at all.

This is a big concern for the Lambert Initiative because the organisation is closely involved with families with children who suffer from epilepsy. The establishment of the research institute was made possible by a large donation from the prosperous Lambert family. Their grandchild Katelyn suffers from Dravet Syndrome, a rare and severe form of epilepsy affecting young children. Her family fought for years to legalise medicinal cannabis in Australia after discovering that cannabis oil reduced their daughter’s epileptic seizures. Katelyn is currently being treated successfully with approved medicinal cannabis oil. But at one time Katelyn’s father was standing in front of a judge himself because he grew cannabis illegally to treat his daughter.

Katelyn and Barry Lambert

The Lambert Initiative was curious to know if more Australian families were breaking the law to treat their children. In the end they found 65 families who were willing to participate in a study. Most of the parents are using cannabis oil obtained through the illegal circuit. They think they are administering CBD oil to their child. CBD is an active ingredient in cannabis. However, analysis showed that a considerable number of samples also contained THC. Iain McGregor, Academic Director of the Lambert Initiative, was very surprised: “Families were surprised as well. There are a whole lot of families that think that CBD has a fantastic effect. But we found out that there was no or low doses of CBD in their oils, but quite a lot of THC.”

The study was not designed in such way to provide any definitive conclusions on how effective these cannabis extracts are for childhood epilepsy. McGregor: “However, the study does throw a spotlight on the world of families who are resorting to the use of illicit cannabis products to treat their child’s epilepsy when conventional treatments have failed.”

Therapeutic Goods Administration

Over the past two years the Australian drug agency the Therapeutic Goods Administration (TGA) has approved 1,442 applications. The number of patients who actually use cannabis is lower than the number of applications because some physicians submit multiple applications for the same patient. McGregor and his team estimate there are about one thousand patients who actually make use of the programme legally. But he thinks there could be many more: “Our opinion is that people that are suffering should have the benefit of medicinal cannabis if it is going to have a favourable effect. It is very simple: if the doctor wants to prescribe it and the patient wants it then the politicians and regulations should probably get out of the way.”

Another obstacle is the complex application procedure for the Australian medicinal cannabis programme. The physician must first submit an application to the Federal Department of Health. This application must clearly show that alternative treatments are not effective and that an extensive literary study has been carried out.

Paperwork

Until recently the same application also had to be sent to the Department of Health in the state where the patient lives. McGregor: “The paperwork was just terrible. There were also a lot of refusals because both the state health and federal departments were really looking for evidence that cannabis products were better than existing medication.”

The procedure has been adapted so physicians only have to fill out one online form and most applications are now assessed within 48 hours. Still McGregor is not satisfied and advocates for expanding the number of permitted conditions: “Patients are using cannabis for quite different conditions to the ones that you can get an approval for from the government. Most of the conditions are not acknowledged by the Therapeutic Goods Administration. For example, fifty percent of the patients are using cannabis for controlling their back pain and back pain is not on the TGA list. There is no evidence or clinical study that shows back pain is a condition that cannabis treats. But people are doing it anyway.”

Medicinal cannabis chewing gum in clinical phase

Nicotine gum is probably the most well-known medicinal application. But chewing gum containing medicinal cannabis is something new. So new that the first batch has not even been made yet. AXIM Biotechnologies developed the product and is waiting to start the first clinical trials in the Netherlands, Israel and Canada.

Earlier this month they uncorked the champagne bottles at both the American head office in New York and in the Netherlands. The company that is listed on the American stock market (AXIM U.S.: OTC) received a GMP certificate from the Dutch government to produce samples for clinical trials. This test medication may now be used worldwide as a research resource. This is a huge milestone for the company that has been trying to bring medicinal cannabis gum onto the market since 2007.

MedChew Rx

MedChew Rx, a type of gum produced by AXIM looks very promising. It contains 5 milligrams of CBD – a non-psychoactive component of cannabis – and 5 milligrams of THC – a psychoactive cannabinoid. The cannabis for this chewing gum is supplied by Bedrocan. The medication was developed to treat pain and spasms in Multiple Sclerosis (MS) patients. The Dutch VU University Medical Center in Amsterdam will carry out the clinical trials.

Motion sickness, pain, quitting smoking, dental decay and middle ear infections are all well-known or lesser-known medical conditions for which medicinal chewing gum is available. AXIM consciously chose chewing gum as a method of administration.

Lekhram Changoer

According to Lekhram Changoer, Chief Technology Officer, it is a socially accepted and user-friendly method. Much more so than smoking or inhaling cannabis. And does it work? Changoer: “Chewing has a considerable effect. Chewing activates your brain. Scientists at the Vrije Universiteit in Amsterdam have proven that the medication has a greater effect when chewed, especially for pain.”

More clinical trials

AXIM Biotechnologies will be carrying out more clinical research next year. QPS, a medication research company based in Groningen (Netherlands), will conduct a study on chewing gum with synthetic dronabinol (THC). This gum should, among other things, prevent nausea and vomiting (chemotherapy) or stimulate the appetite (anorexia, AIDS). The University of British Columbia in Canada will carry out clinical trials for treating drug-related psychoses with cannabis chewing gum. A double-blind, randomised, phase 2 study with 30 RLS patients will start in Israel next year.

Restless Leg Syndrome

AXIM Biotechnologies developed a chewing gum containing CBD to help patients suffering from Restless Leg Syndrome (RLS). RLS patients suffer from muscle spasms in their lower legs, knees and sometimes arms during the night. This leads to sleep disorders and the condition is also often accompanied by excruciating pain. The gum contains 1,000 milligrams of CBD and gabapentin, an anticonvulsant.

Just like a pill

According to Changoer, physicians have responded positively to this administration method: “It is not entirely new. They are already familiar with nicotine gum. Physicians don’t want their patients to smoke cannabis because it is unhealthy. Some physicians are also weary of inhaling. Not all patients can or want to use a vaporizer. Chewing gum is easy to take with you, just like a pill.”

The goal is to have the gum officially registered as medication. This way a physician can prescribe it and determine the dose. But clinical trials must first show that the product works.

Changoer: ”Preliminary studies paint a positive picture of the implementation of CBD and THC. Research will provide us with more insight into dosage. The approach is that the patient will calmly chew on one piece of gum for about twenty minutes. The absorption of the active chemicals will then take place via the mucous membranes in the cheek.” Changoer expects it will take at least another three years before the chewing gum will be available on the market.

‘Without doctors and pharmacists cannabis is not medication’

Friday the 20th of April 2018 was a momentous day in Israel – a number of pharmacies are now permitted to issue medicinal cannabis to patients. This also marked the start of a pilot programme, charting the course to a regulated and properly documented system for issuing medicinal cannabis in Israel once and for all. For Yuval Landschaft, head of the Israeli Medical Cannabis Unit (MCA), this is a dream come true. “We wanted a system where the entire chain – from research and cultivation to diagnosis and distribution – is carefully regulated. We call that the medicalisation of cannabis. That system is now in place.”

Since 2013, Yuval Landschaft has been on top of Israel’s cannabis programme. The programme intends to provide medicinal cannabis for patients in Israel, but over time it will also deal with the export of medicinal cannabis abroad. Compliant with quality and safety requirements, the starting point was ‘medicalisation’; the use of cannabis for medicinal purposes based on scientific knowledge. Landschaft recollects that “all the available knowledge of medicinal cannabis in Israel was brought together and was used to develop this programme. It makes medicalisation something quite different from decriminalisation or legalisation, because our programme is focused on patients.”

Photo courtesy of Yuval Landschaft

The Green Book

The Israeli programme – recorded as ‘The Green Book’ – covers medicalisation, the standardisation of cannabis products, the training of doctors and pharmacists and the organisation of agro-technical and medical research and development. That provides for a clear chain – from product development to the patient. It goes without saying that growers are selected carefully and that requirements are imposed on the distribution side (prescribers, pharmacists). The National Center for Cannabis, part of the Ministry of Agriculture and the Ministry of Health, maintains tight control.

Whilst in Israel the medicinal use of cannabis has been permitted for some time, a controlled programme for ‘medicalisation’ proved difficult to get off the ground. Setting up the MCA paved the way for a programme for medicinal cannabis. Yuval Landschaft was appointed to lead the unit. “There was a system where growers worked in a ‘traditional’ way and played a role in the distribution and information provision to patients”, remembers Landschaft. “But you can’t call that a medicinal programme, because it didn’t involve any healthcare professionals. In other countries, including the Netherlands, they were much further ahead. We obtained comprehensive information from the Dutch government and were impressed by the achievements; a clear programme focused on medicinal use and pharmaceutically responsible products. That was exactly what we had in mind.”

How it works

Israeli patients need a medical cannabis license, based on a specialist’s recommendation. This health care professional needs to be specialised in treating the condition for which the cannabis is recommended. This recommendation is examined by the MCA, based on relevant criteria and indications. Upon receiving the approval for a medical cannabis permit for the patient, the permit will be issued and transferred to the supplier. The supplier will contact the patient to coordinate instructions and supply to him or her.

Cannacopia

The MCA – which has representatives from the Ministries of Agriculture, Health, Justice and National Security – summarised the chain for production and distribution into five chapters, which Yuval Landschaft refers to, in jest, as the ‘Cannacopia’ or ‘the Torah of cannabis’. “We have a clinical approach that is focused on collecting and distributing scientific knowledge, identifying indications, designing a treatment protocol, defining products and their potential, administration and risk of abuse and addiction. Furthermore the entire chain – from cultivation to distribution – is covered by quality protocols based on the familiar and recognised good practices at agricultural, clinical, delivery, manufacturing and security level. We are aiming high, but it is the only way to properly regulate the availability of medicinal cannabis for patients.”

Landschaft believes that Israel has now joined a small group of countries where the production and distribution of medicinal cannabis is organised by the book. “In Israel we have paved the way to a thorough system. The patient is always the starting point and the only route is that of safe, standardised products, prescribed and issued by healthcare professionals. They have the medical knowledge required to determine a diagnosis, to prescribe medication and to support patients. Without doctors and pharmacists cannabis is not medication.”

This inhaler will increase the acceptance of cannabis as medicine

It took him seven years and tens of millions of dollars to transform a raw plant into a mainstream medical drug. Perry Davidson is the creator of the Syqe Inhaler – a new technology that allows doctors and patients to precisely dose pharmaceutical quality ‘cannabis flos’ by inhalation. After all these years of hard work, according to Davidson ‘it is still something worthwhile waking up each morning for’.

Is that still the case?

‘Yes. What’s really driving everyone at Syqe is the realisation that what we achieved with cannabis can and should be replicated with other medicinal plants. Plants that pharma has shied away from for so many years. A technology that from one end takes a raw plant, and from the other end produces a pharmaceutical grade product, will have a profound impact on health.’

You founded Syqe Medical seven years ago and you are running the business. How does a usual business day look like?

‘A usual business day in a medical start-up is relentless. Add to that the fact that the Syqe Inhaler is the first product of its kind, designed for an industry which is still in its infancy. This forces us to innovate in practically every frontier, be it technological, clinical, regulatory or legislative. Therefore a usual business day in Syqe is an interaction between the multiple dedicated teams – biology, chemistry, mechanics, electronics, software, design, product, engineering, operations, clinical, pharmacology, QA/RA, legal and of course the standard teams of HR, finance, business development, marketing and IP.’

What inspired you to start this company?

‘What drove me to start Syqe was sheer frustration. In 2006, I co-founded the first cannabis company in Israel and while I was the CEO I interacted with nearly 2,000 patients and of course the medical community at large. I experienced first-hand the hardships of introducing a plant into a western health system and offering patients a predictable and safe treatment. I did not accept the fact that cannabis had such a significant therapeutic role, but not a single pharmaceutical company was able to transform it into an acceptable and efficacious mainstream drug.’

Perry Davidson

What makes the Syqe Inhaler different from all other ‘vaporizers’ on the market?

‘For the cannabis industry, Syqe is the first and only metered dose cannabis inhaler meeting pharmaceutical standards, a strong emphasis on meeting pharmaceutical level drug delivery precision.

For the pharmaceutical industry, Syqe is the first and only drug delivery platform able to administer whole plants within pharmaceutical standards, and also the first that allows changing dose levels in real time – the first Selective Dose Inhaler.’

Syqe Inhaler

How did you manage to put the whole cannabis plant into a small cartridge that’s is not larger than a biscuit?

‘Syqe’s selective-dose inhaler consists of a cartridge that holds 75 VaporChipsTM. Each chip is loaded with an exact amount of fully-standardised whole-plant cannabis, ground in a unique process that preserves the medicinal properties of the plant in their entirety. Real-time thermal and airflow controls enable the inhalation of precise amounts of naturally-occurring molecules directly from the cannabis plant.’

Clinical trials

Since 2014 Syqe has completed three clinical trials. The first trial was already published – a pharmacokinetic study that demonstrated the technology indeed meets pharmaceutical standards for drug delivery via inhalation. Subsequent trials focused on safety and efficacy for dosing in microgram levels. Outcomes were very positive, and Syqe expects to publish the rest of the clinical data soon. The inhaler has been in use in a hospital setting since 2015, and is expected to be available to patients in Israel later this year, distributed by Teva Pharmaceuticals. But Syqe also has prepared its infrastructures for the international markets, as they has set their sights on Europe, Canada and the United States.

You are using Bedrocan’s standardised raw plant material for the micro dosed cartridges. Why have you chosen for Bedrocan as a supplier?

‘Quite simply Bedrocan was able to provide us with pharmaceutical-grade GMP starting material. The standardisation levels Bedrocan has achieved is unparalleled, allowing us to guarantee the pharmaceutical precision levels which are so needed for this industry.’

Do you think this device can contribute to a better acceptance of cannabis as a medicine? 

‘Any technology that takes the cannabis plant as a whole and transforms it into a pharmaceutical product will immediately increase the acceptance of cannabis as medicine.’

New brochure provides more information about medicinal cannabis

Bedrocan recently funded the publication of a booklet explaining the effects of medicinal cannabis in clear language.

This booklet covers key information on the cannabis plant, cannabinoids, the biological pathway for their action, and the quality requirements of modern medicines. It also takes a forward step to consider the perspectives of experienced health professionals, and insights from patients.

The booklet is intended as an introductory text to the therapeutic use of cannabis. For now it is an English publication intended for the health sector, policymakers, and patient groups.

The booklets official release was at the International Cannabinoid Research Society 2018 conference; this coincided with its New Zealand release, by the author, at Medsafe, the Ministry of Health.

See link to download a copy.

‘Avoid using sativa/indica terminology’

There is perhaps no debate in the world of cannabis more contentious than that of species. The genus Cannabis sativa L. is the only official species, but the cannabis industry is using other terms as indica and hybrid to promote their varieties. Associate Professor Sean Myles from the Canadian Dalhousie University recommends avoiding the use of these terms as a recent study has demonstrated that current labelling of varieties as sativa and indica does not reflect any meaningful genetic identity.

Myles, who supervised the study on the genetic differences between the two cannabis types and their hybrids, will present his results on the International Cannabinoid Research Society (ICRS) conference in Leiden, Netherlands, from 1 – 4 July 2018. In the run-up to the conference, Bedrocan asked him a few questions.

Do you consider the results as ground-breaking?
‘No, I don’t. Any professional in breeding or genetics with even peripheral knowledge of the cannabis industry would have bet that the ‘sativa’ and ‘indica’ labelling in the current cannabis market was unlikely to reflect genetic reality. It just took some data to demonstrate the degree to which this is the case, which we have done and continue to do.’

How did you come up to study cannabis?
‘Our laboratory developed an interest in cannabis because we do similar research in genetic ancestry deconvolution in other species, like grapes and apples. It made a lot of sense to extend our expertise to cannabis since it is an economically valuable agricultural species, little was known about its genetic structure, and there was widespread use of a dichotomy (i.e. ‘sativa’ vs. ‘indica’) that was believed to reflect ancestry. For the study together with Bedrocan, we benefited from their expertise in chemical profiling and paired it with our expertise in genomics and bioinformatics. The result has been fruitful in terms of insights into the question of variety identity.’

Sean Myles
Sean Myles

What are the reactions to your research results so far?
‘Overall, the public has taken a strong interest in our results, which suggest that the manner in which the labels ‘sativa’ and ‘indica’ are currently being used do not reflect meaningful genetic identities. Many of those in the cannabis industry, both medical and recreational, have also headed our advice to avoid using these terms until there is a consensus about what they mean. In the end, I believe our results have contributed to a shift whereby varieties are being increasingly described by their measurable chemical content rather than by their purported ancestry.’

Cannabis reclassified

Cannabis labelled sativa and indica may not come from distinct ancestries, according to a study performed by the Canadian Dalhousie University in cooperation with Bedrocan on the genetic differences between the two types and their hybrids. In this study 149 Dutch cannabis samples were analysed, correlating the genotype and chemotype to their reported ancestries. Indica- and Sativa-labelled samples were not as distinct as sub species would be assumed to be, but the genetic differences between them do correlate to their terpene profile (resin fragrance), which could explain the variation between them.

What were the responses from companies that sell cannabis?
‘There are those in the recreational cannabis market who are unlikely to abandon the terms ‘sativa’ and ‘indica’ because they are useful terms for marketing their products. This is especially the case for companies selling seeds online. Their discontent is acknowledged, but the evidence speaks for itself and I’m hopeful that, in the end, labelling of cannabis products will be based on empirical data rather than marketing tricks.’

Some people claim to be able to smell the difference between an indica or sativa type. What would you like to say to them?
‘Our results do in fact suggest that the labelling of strains as ‘sativa’ vs. ‘indica’ may have more to do with their aromas than their genetic ancestry. Thus, in this case, these people may in fact be partially correct – they can associate a smell with a label. However, this still does not mean that the labels are capturing meaningful genetic information.’

What Bedrocan does

Bedrocan takes the advice into account and will reconsider how the differences can be classified better in the future.

What would be your recommendation to medicinal cannabis producers? Whether or not to make the distinction?
‘Our recommendation is to avoid the use of ‘indica’ and ‘sativa’ as it’s likely to create confusion in the marketplace.  So far, there is no evidence to support this dichotomy as a useful tool for describing ancestry or chemical composition.  We advise producers to describe the content of their product empirically with regards to cannabinoid and terpenoid content.’

‘WHO recommendations are likely to change international law’

Cannabis has been on the worldwide list of banned substances since 1961 and according to the World Health Organization (WHO) has hardly any medical value. This view could very well be coming to an end. Last week the ECDD, a special WHO drug committee, met for the first time to discuss exclusively the pros and cons of cannabis for health. Various parties from the field – doctors, patients and experts – were invited to the hearing to give their advice to the committee.

At the ECDD meeting the International Association for Cannabinoid Medicines (IACM) showed a video message with the intention of giving doctors and patients more opportunities to prescribe medicinal cannabis. According to IACM director Franjo Grotenhermen, it is a good sign that his organisation was allowed to speak. The positions of the selected speakers say a lot about the possible outcome of the meeting. Grotenhermen: “For the first time in history speakers had the opportunity to say the current situation is no longer justified. The committee will probably use these statements in their own recommendations. Otherwise they would have invited parties which are more focused on the dangers of cannabis use.”

Michael Krawitz of the FAAAT, an international think-tank on drug addiction, calls the meeting of historical importance. Krawitz, an expert in the field of international drug policy for over twenty years, was in Geneva at the fortieth meeting of the ECDD to submit an advisory report. “It was a great meeting. Their recommendations are likely to change international law,” is the high expectation of Krawitz. “It is the very first time the medicinal use of cannabis is on the ECDD’s agenda. In 1961, cannabis ended up as a prohibited drug in the UN treaty without ever being officially reviewed by experts. A genuine formal scientific evaluation of cannabis as a medicine has never been done. That is now being put right.”

ECDD

The Expert Committee on Drug Dependence (ECDD) is a WHO committee and is composed of independent experts in the field of drugs and medicines. The committee is convened by the WHO about once a year to assess the impact of psychoactive substances on public health and to make recommendations to the international community. This year the fortieth meeting was completely dominated by cannabis. This being the first time after the foundation of the WHO in 1948.

The Dutch Harm Hids was one of the individual speakers. “The meeting was very well set up. You would expect everyone to be against cannabis, but that was certainly not the case.“ Hids has a son with Crohn’s disease, a chronic inflammation of the intestine.

UN treaties

The Commission on Narcotic Drugs is a UN body that determines which drugs fall under international control. The committee comes to these decisions based on recommendations from the World Health Organization (WHO).

There are three major UN treaties that regulate drugs around the world:

  • The Single Convention on Narcotic Drugs (1961)
  • The Convention on Psychotropic Substances (1971)
  • Illegal trafficking in narcotic drugs and psychotropic substances (1988)

The 1961 treaty states that cannabis and cannabis preparations are out of date and there is no reason for their medical use. That treaty is what the proponents of medicinal cannabis use would like to see adapted.

His son has successfully used CBD capsules and THC oil for years, which locally counteracts inflammation. Hids: “He is given a maximum of 12 mg of THC per day. He does not get high and can just go to school and study.”

During the meeting of the World Health Organization, it became clear that the committee is struggling with recreational cannabis use. In order not to blur the market, according to Hids, the medicinal cannabis industry must remain far away from recreational use. “As long as the product remains smokable, then you know for certain that people will also use it for recreational purposes. You prevent abuse by transforming cannabis to forms that are totally uninspiring for recreational use. That was my message to the committee.”

The final report and recommendations from the meeting will be available on the ECDD website by the end of July 2018.  After approval from the WHO the recommendations will then be put to a vote with the 53 member states of the Commission on Narcotic Drugs. This body must eventually reach agreement on whether the current UN treaties may be amended.

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