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Renger Witkamp: “Cannabis is constantly making fun of us”

Biologist and pharmacologist Renger Witkamp is a professor of Nutritional Biology at Wageningen University & Research (WUR). Since 2005, he has also been professionally interested in the (im)possibilities of cannabis as a medicine. He has been involved in research into the medicinal effect of cannabis for over twenty years and also chairs the Institute for Medicinal Cannabis (IMC) in the Netherlands since spring 2021. As he notes, “the development and sharing of scientific knowledge about cannabis is a priority.”

Renger Witkamp constantly balances his work at the intersection of food and pharmaceuticals. He once described his field as ‘the field of science concerned with studying the effects of biologically active substances in food, with the aim of achieving a health-promoting or curative effect.’ According to Witkamp, ​​the key to a good and healthy life is a ‘healthy lifestyle’ and it is now generally known that nutrition plays a crucial role in this. But sometimes adjustments are necessary and pharmacology can offer a solution. And Witkamp and his team look further than just regular medication, because the department also focuses on herbs with a proven or alleged medicinal effect. Cannabis is one of them.

No panacea

Witkamp’s interest in the medicinal use of cannabis does not come out of the blue. “I was trained as a pharmacist, I studied biology, and I have always been interested in medicinal herbs. Precisely because the medicinal use of some herbs has been known worldwide for centuries, but often no scientific explanation has yet been found. Cannabis is definitely one of the most interesting plants, especially when you look back in history. The plant has been used for medicinal purposes for centuries and since the late last century, when the endocannabinoid system (“ECS”) was discovered, interest has been rekindled – and rightly so. But cannabis is certainly not a panacea and we still need a lot of scientific evidence to make well-founded statements about how it works.

Bedrocan webinar

The problem is that cannabis – with all its different substances – is not an easy ‘product’ to research scientifically. The plant is constantly making fun of us. Cannabis is full of all kinds of substances, of which we only know a small part of what they do. And if we want to conduct research, which condition should we choose? In addition, we are not yet sure which formulation, which dosage form, and which dosage is best. In short, there is still a lot of scientific work to be done.”

Research

Witkamp has certainly contributed to scientific research. Since 2005, when he worked at TNO Pharma, he was involved in the analysis of THC in preparations and research into cannabinoids as a painkiller and appetite-stimulating or – inversely –inhibiting substance. “We already knew that there are cannabinoids (phytocannabinoids) in the plant, but now we also knew that similar substances (endocannabinoids) exist in the human body. Incidentally, also in many other organisms; we even found them in worms…

Like other researchers, we want to know how these phytocannabinoids affect the ECS. I remember that around 2006 all eyes were on the function of CB1 receptors in the body, which are involved in, amongst other things, the regulation of appetite and the development of diabetes. Many researchers – including Big Pharma – went in search of a suitable new CB1 blocker in cannabis, because that would mean a breakthrough in the search for the ‘new generation of drugs’. The idea behind such a synthetic blocker of the CB1 receptor was that it seemed to not only inhibit appetite, but such drugs also seemed to work in other ways against diabetes and its associated complications (collectively referred to as ‘metabolic syndrome’).

Ultimately, this was not successful, because such substances turned out to have serious side effects, precisely because the ECS is so complex and plays a role in so many processes in the body. Interestingly, the cannabis plant also contains a CB1 blocker, in amounts depending on the variety, which may seem more interesting in this regard. This is THCV. Big Pharma subsequently dropped out, but the indications that the ECS offers in the field of appetite and pain and other disorders are still there. Meanwhile, research in the field of phytocannabinoids in many different disorders continues, so that has not stopped. We are also continuing research at WUR, as we recently started in collaboration with the National MS Fund. Together with them, and a number of other parties, we will investigate what CBD can do for MS patients with sleeping problems. But we also see interesting research programs in, for example, Leiden (chronic pain, replacement of supplemental opioids) and Groningen (liver cancer).”

Dutch program

Renger Witkamp also witnessed first-hand the introduction of the Dutch medicinal cannabis programme, which, from 2003, has provided patients with medical prescription cannabis that has been standardised and produced to pharmaceutical grade. “That was an important step, which has also been taken in several other countries. Especially because strict demands were placed on the product from the start. In addition, the way in which patients can obtain it is well regulated. The route via prescriber and pharmacy is the most appropriate for patients, because both the doctor and pharmacist are watching, while the quality of the medicinal cannabis is guaranteed. This brings me to another important point of attention, and that is pharmacovigilance. It is extremely important that any side effects are documented, because we now know that cannabis is not necessarily harmless. For top fit people that may not matter that much, but for people with a reduced resistance – patients, that is – vigilance is required. In addition, priority will have to be given to smart formulations of cannabis-based medicines and, as mentioned, we must continue with scientific research.”

The right route

In the past plus twenty years, Witkamp has seen the world of medicinal cannabis constantly change, but in 2021 he can draw up a balance. “Cannabis is still loaded. Governments are cautious, and so are prescribers. There is still a lot of activism and often the dividing line between medicinal and recreational use is razor thin. All kinds of things are said about the plant, without there being any evidence for it. That’s fine, because traditionally a lot of knowledge comes from the ‘recreational’ angle. But sometimes things are said that could be dangerous for patients, because cannabis, as I said, is not necessarily harmless. I want patients to choose the right route; that they do not start ‘doing’ themselves, but get information and help in the right place; with their doctor, specialist, and pharmacist. But I also want to focus on prescribers because we know that knowledge about medicinal cannabis is sometimes lacking and patients are referred to the coffee shop.”

Share knowledge

With that in mind, Witkamp said ‘yes’ earlier this year when he was asked to become chairman of the IMC, a Dutch foundation that combines all scientific, medical, and production technical knowledge and experience in the field of medicinal cannabis. The foundation, which officially started on 1 March, consists of various organisations, including pharmacists, scientific institutions, universities, and manufacturers. And all affiliated organizations have a common DNA, according to Witkamp: “We are all legally active with medicinal cannabis. All participating organizations have an exemption to work with or conduct research on medicinal cannabis. In addition, we put the patient and the prescriber at the center of all our activities. Combining and expanding the knowledge about medicinal cannabis, and good scientifically based information and discussion about it are matters that are close to my heart and that is exactly what we want to do with the IMC.”

Renger Witkamp

Renger Witkamp (1959) studied Biology and Pharmacy at Utrecht University. After his pharmacy exam and PhD, he continued his work at Utrecht University as an associate professor of pharmacology. In 1996 he transferred to TNO Pharma, where he held various scientific and managerial positions. In 2006, he was appointed professor at WUR, where he currently leads the Nutritional Biology group. This group mainly focuses on the role of nutrition, whether or not in combination with other lifestyle factors and medicines, in aging and (recovery after) chronic diseases.

Since 2005, he has also been involved in research in the field of cannabis and the functioning of the ECS. In addition to his role in education and research, and as chairman of the IMC, he is also active at the Nutrition Lives Foundation, where he is involved in the application of lifestyle intervention as therapy. He is also a board member of the Alliantie Voeding in de Zorg and of the European Nutrition Leadership Platform.
Renger Witkamp was the first guest at Bedrocan Series (see picture). You can view the half hour webinar here.

source: Instituut Medicinale Cannabis

Social Visual Bedrocan Series Renger Witkamp 300x251

Bedrocan at the Australian United in Compassion Medicinal Cannabis Symposium

The Australian United in Compassion symposium is a highly publicised medicinal cannabis conference attended by industry, health professionals, government regulators and patient advocacy groups. Bedrocan will host a booth and present at the Symposium from Friday 29 to Sunday 31 October 2021.

United in Compassion Symposium

The United in Compassion (UIC) began five years ago as a patient-led movement that actually managed to change the law in Australia. Where are we now?

The Australian federal law changed in 2016, permitting the prescribing of pharmaceutical-quality medicinal cannabis. Quickly, State legislators – Australian states set their own laws – quickly followed suit.

Currently, most medicinal cannabis products in Australia are unregistered, meaning prescriptions require a rapid online application (i.e. 24–48 hours) under a Special Access Scheme (SAS) and medicines must be dispensed by a pharmacy.  In 2017, around 450 patients accessed medicinal cannabis. That number soared toward 70,000 prescribing approvals by the end of 2020.

Prescribing occurred among more than 1,400 doctors, with most prescribing in General Practice (Family Medicine). The prescriptions are mainly for chronic non-cancer pain, anxiety, cancer-related symptoms, epilepsy and other neurological disorders.

Dried cannabis flower and whole extracts

The UIC’s primary mission is advocating for ‘patient access to full-spectrum herbal medicinal cannabis extracts and dried herb cannabis’. There are currently 100 different cannabis products available on prescription. Most are full-spectrum oral preparations (oils) containing THC or CBD, or the dried cannabis flower. Currently, around 30% of SAS applications are for herbal products for pulmonary administion (inhalation).

The full range of Bedrocan are available on prescription to Australian patients. Novachem, the distributor, faces fierce competition, despite that other companies cannot guarantee pharmaceutical-quality products on an ongoing basis.

Bedrocan Australia attends UIC

This year Bedrocan will host an information booth at the United in Compassion Medicinal Cannabis Symposium. Bedrocan’s booth is a viewing window to our newest services for health professionals, regulators, industry, and patient advocacy groups. At the booth, delegates can:

  • Take a 3D interactive tour of our first-in-class cultivation facilities (Oculus 3D googles),
  • Learn more about our Australian health professional guidance, and the education resources we support.
  • Gain access to our regular, enlightening articles on diverse topics on cannabis-based medicines.

Bedrocan will also present at the symposium on the topic ‘GACP, GMP and Quality in cultivation’. This presentation will discuss Bedrocan’s draft ‘White Paper’ on standards for the cultivation of pharmaceutical-quality medicinal cannabis. Bedrocan’s Good Medicinal Cannabis Cultivation Practices (GMCCP) standards align with current global thinking on clearly separating pharmaceutical from recreational.

Cost to patients and education for health professionals

The UIC continues the push for affordable medicines as cost to patients remains the biggest issue in Australia. Like many countries, there is no pharmaceutical subsidy for cannabis products, meaning patients pay out-of-pocket for all of their medication.

Another hurdle is education. Prescribers are the gate keepers. The recent and rapid introduction of cannabis-based medicines to modern practice means there is still a lot to understand and discover. Australian prescribers and pharmacists are concerned about the correct dosing regimens for the condition being treated, the quality of the medicines themselves, and accountability for treatment-related decisions.

According to Bedrocan, high quality, easy to access, free education is therefore required. Bedrocan is supporting the production of a Clinical Primer text which provides health professionals valuable insights to the rational use of cannabis-based medicines. This compliments the 2018 text A primer to medicinal cannabis, an other free text written for health professionals, regualtors, and policy makers. See download button below.

Matthijs Bossong: “THC conducts psychotic-like symptoms in healthy people”

Matthijs Bossong is a neuroscientist at the University Medical Center Utrecht, where he conducts scientific research into the effect of cannabinoids (especially THC and CBD) on the human brain. Bossong has been involved in such research for sixteen years, first upon completing his PhD in Utrecht, where he investigated the endocannabinoid system’s role in psychiatric disorders in the human brain. That research focused mainly on the influence of THC in the development of psychosis-like symptoms. Later, Bossong conducted research on CBD and how this cannabinoid works in people at high risk of developing psychosis at the Institute of Psychiatry (King’s College) in London. Bossong subsequently deepened this research at the Department of Psychiatry of the University Medical Center Utrecht with a study into the effect of CBD in patients with a psychotic disorder.

Matthijs Bossong kicks off the second edition of Bedrocan Series with a brief explanation of the endocannabinoid system (ECS). Simply put, the functioning of our brain depends on communication between neurons (nerve cells), and that communication takes place via neurotransmitters. Well-known neurotransmitters include dopamine, glutamate, and gamma-aminobutyric acid (GABA), all of which affect feelings of tension, fear, and anxiety. But cannabinoids are also neurotransmitters. We only knew since the end of the last century that they are not only found in cannabis (phytocannabinoids), for example, but also in the human body (endocannabinoids). It is, therefore, logical to assume that the administration of phytocannabinoids influences communication in the human body. And thus also the brain and how our body is controlled.

Bossong can already share a clear conclusion with more than fifty participants during the webinar. “THC contributes to psychosis-like symptoms in healthy people,” he says. This conclusion follows from research in which a group of healthy people vaporized THC and were subsequently examined using an MRI scanner while performing a number of assignments. “We saw increased activity in certain parts of the brain when THC was administered in these tasks,” Bossong says. “This involved those parts of the brain where you can also see increased activity in psychosis. Everything indicates that THC causes those parts of the brain of healthy people to work harder than normal to carry out certain tasks.” Bossong compares that to a car that suddenly needs more fuel to cover the same distance.

Bedrocan Series Matthijs Bossongg

In later research, Bossong focused on the effect of CBD. The central question was whether CBD could normalize psychosis or psychosis-like symptoms. In London, it was investigated how people at increased risk of psychosis (but who have not yet been diagnosed) respond to CBD. It became clear that symptoms of psychosis (anxiety, depression) were reduced by using CBD. The study among 31 patients with psychosis that was subsequently conducted in Utrecht seems to confirm this. It also raises questions on whether CBD, like THC, is a psychoactive substance. “That quickly raises a semantic discussion about ‘psychoactive’, but the fact is that CBD also affects certain parts of the brain, at least in people with a psychiatric background. In healthy people, you see that THC has an ‘intoxicating’ effect,” says Bossong.

THC is a risk factor in the development of psychosis, even when using medicinal cannabis, Bossong says when asked. “You can compare that to the role that smoking or eating hamburgers have in developing cardiovascular problems.” So be careful.

Like many of his colleagues, Matthijs Bossong emphasizes the importance of (more) scientific research. In the coming years, he will be involved in a large, multi-year international study into the effect of CBD among approximately 750 patients, partly people with psychosis and partly people with an increased risk of psychosis. The research, led by King’s College, should provide even more insight into how the endocannabinoid system works and how cannabinoids affect the function of our brain.

Well-known Belgian travel program ‘Reizen Waes’ visiting Bedrocan

If you are going to the Netherlands from Belgium for a travel program and are allowed to visit several special places, where would you go? The editors of the well-known television program ‘Reizen Waes’ asked themselves the same question and ended up at…Bedrocan.

The Belgian actor/presenter Tom Waes (known from the Netflix series Undercover, Kamp Waes and Reizen Waes) recently got a look behind the scenes of our Dutch facility in Emmeloord. CEO Tjalling Erkelens gave him and his crew a tour. We have to wait a little longer for the final result; the broadcasts are planned this year in October (Netherlands) and November (Belgium).

Tom Waes van het bekende reisprogramma bezoekt Bedrocan

Medicinal cannabis or medical marijuana?

The way of referring to cannabis for medicinal use varies across the globe. Is it better to use the word medical or medicinal for cannabis? And what about medical marijuana? Bedrocan has a clear preference for what the correct term is, i.e. which is suitable and which is not. We are quite outspoken about that. In this article, we explain why.

Medical or medicinal

Let’s start with the terms medical or medicinal cannabis. Both are used, but are these two terms interchangeable? Is there a difference in meaning? At Bedrocan, we think so.

We avoid using the term medical next to cannabis. Medical is more applicable to a location or a practice such as a hospital or a dispensary. Its use is also better suited when referred to a condition, problem or treatment.

On the other hand, medicinal is defined, according to the Merriam Webster dictionary, as “tending or used to cure disease or relieve pain.” Unfortunately, cannabis cannot cure any disease, but it can definitely relieve pain and help treat several other medical conditions.

Medicinal cannabis or medical marijuana
Medicinal cannabis or medical marijuana

Bedrocan’s glossary

Medicinal cannabis, n: cannabis, or a product derived from cannabis, that is intended for medicinal use. Also, likely is: (i) prescribed by a trained medical professional; (ii) for a known medical condition or a set of conditions where it has proven to be an effective treatment; (iii) for which there is research demonstrating its efficacy as a treatment and/or where other treatments have been ineffective.

What about the term medical marijuana or weed?

Medical marijuana or marihuana is also being used to refer to medicinal use. In some countries, patients are forced to turn to products meant for the adult recreational market, often from the same outlet or delivered by post. Whereas in the Netherlands and in many other countries where Bedrocan is available, patients can access pharmaceutical-grade medicinal cannabis, not marijuana, through their pharmacy on prescription.

We avoid the term medical marijuana or weed as much as we can because it is linked to recreational use. Bedrocan believes in the strict separation between medicinal cannabis and cannabis for recreational use. We are committed to providing a pharmaceutical product that is only available on prescription for patients who benefit from it. We are entirely focused on this assignment. Besides that, the word cannabis is directly linked to the plant name: Cannabis sativa L. So why look for another term when one is already available. A nice side effect is that this scientific name fits a science driven company like us perfectly.

Cannabis, marijuana or weed?

Cannabis goes by many names. Marijuana, gañjā and hemp being the most well-known. Other less salubrious names include weed, pot or smoke.

Hemp is associated with the fibre-type cannabis plant, low in THC. Marijuana is most used in the Americas, while gañjā and derivations of the word are used in India and South-East Asia. Another well-known word is hash or hashish – a THC-rich resin extracted from the cannabis plant.

Regardless of all these terms and their differentiation by type (Indica, Sativa, Ruderalis), the term is now commonly accepted as simply Cannabis sativa L., or just cannabis. However, when produced pharmaceutically and used for medicinal purposes, the term medicinal cannabis is most appropriate.

Science is shaping how we talk about medicinal cannabis

Today, science shapes how we think and talk about medicinal cannabis. Along with like-minded companies, science is at the heart of Bedrocan. Our research programme focuses on advanced cultivation techniques and the development of unique, standardised cannabis strains for use by patients and the pharmaceutical industry. Other companies are taking steps toward registering cannabis-based medicines and medical devices (e.g. Epidiolex, Syqe). While, at a global level, the United Nations International Narcotics Control Board (INCB) is currently preparing a guideline of good practices. Driven by scientific evaluation, this global regulatory framework aims to achieve greater uniformity in good practices around cultivation, manufacture, distribution and global trade of cannabis for medicinal and scientific use.

All these actions are helping shape the future – including how we talk about cannabis for medicinal use and a broader acceptance of its use in more countries around the world.

Bedrocan starts a series of informative webinars

Bedrocan offers doctors, researchers and scientists an online platform to share their information and findings on medicinal cannabis with a wider audience. In a series of informative webinars of half an hour each, moderator Ole Heil from Bedrocan talks to all kinds of experts. Recent studies, experiences of doctors and patients and the effects of medicinal cannabis are discussed under the title “Bedrocan Series”.

Cannabis as medicine; the scientific approach

Bedrocan webinar

Bedrocan Series starts with Renger Witkamp, ​​Professor of Nutritional Biology at Wageningen University & Research, Netherlands, and chairman of the Institute Medicinal Cannabis Netherlands. He will talk about scientific research and the need for a Dutch Institute Medicinal Cannabis.

The informative webinar has already taken place.

Cannabis as medicine; the effects on our brain

Bedrocan Series Matthijs Bossongg

The second speaker in the Bedrocan Series is Matthijs Bossong, neuroscientist at Utrecht University Medical Center, Netherlands. Bossong will dive deeper into our endocannabinoid system and explain the effect on the function of the brain and psychiatric conditions.

This informative webinar takes place on Thursday, July 8 at 12.30 pm (CET).

More information about the Bedrocan Series, the guest speakers and the registration process can be found on the Bedrocan Series webpage.

Bedrocan proud partner of Institute Medicinal Cannabis

Reliable information about medicinal cannabis and it effects is not always easy to find. For that reason, Dutch pharmacists, doctors, companies and researchers have joined forces and set up a new partnership: the Institute Medicinal Cannabis Netherlands (IMC). Bedrocan is one of the proud partners of this new institute. The IMC aims to improve the provision of information about medicinal cannabis to patients and prescribers and strengthen collaboration in scientific research. Professor Dr. Renger Witkamp, professor of Nutrition and Pharmacology at Wageningen University, is the chairman of the IMC. Ole Heil, director Communications & Government Affairs at Bedrocan, is treasurer.

Thousands of patients

In the Netherlands, medicinal cannabis has been available to patients on a doctor’s prescription through pharmacies since 2003. Currently, about 10,000 people, with various conditions, make use of it every year. It is used, among other things, as a painkiller and as a symptom reliever in certain forms of epilepsy, MS and palliative care. Nevertheless, it appears to be difficult to find good and reliable information about the use and application of medicinal cannabis.

Bedrocan proud partner of the Institute Medicinal Cannabis

Renger Witkamp: “Unfortunately, we see a lot of incorrect information about medicinal cannabis. Many patients who may benefit from the product end up unnecessarily in the coffee shop or with illegal providers. Or worse, some doctors even actively refer their patients to this. The IMC aims to change this through good information. The IMC promotes that the treatment of patients who may benefit from medicinal cannabis takes place under the medical supervision of a doctor and pharmacist.”

Coordination of research

In recent years, more and more research has been conducted into the effect and application of medicinal cannabis. This is also the case in the Netherlands. Researchers are working on this at almost every university in our country. Because the research area is still in its infancy, there is still little collaboration and coordination. The IMC provides a platform to bring researchers together and join forces where possible.

Dr. Monique van Velzen, research manager of the Anesthesiology department of the Leiden University Medical Center (LUMC), is a board member of the IMC, in charge of research: “I notice that there is a great need for collaboration in the field of medicinal cannabis scientific research. Many studies, sometimes even within the same institution, overlap. And it is also difficult for researchers to find out what is and what is not allowed when it comes to cannabis, with many delays as a result. That is a shame, and we will soon change that with the IMC. By connecting researchers, we can learn from each other and streamline, coordinate and structure research.”

Substantive experts

The IMC is a foundation to which various partners and substantive experts have joined. In addition to a number of companies from the medicinal cannabis chain in the Netherlands, including pharmacies, these are doctors and researchers from the LUMC, UMC Utrecht, University Medical Center Groningen and Wageningen University & Research.

More information and contact details are available on the IMC website.

Tjalling Erkelens and MEP Alex Agius Saliba @Prohibition Partners Live

During the upcoming Prohibition Partners Live event, Bedrocan’s CEO Tjalling Erkelens will talk about the current state of the European medicinal cannabis market. He will discuss this topic with Maltese MEP Alex Agius Saliba, who recently launched the Medicinal Cannabis Alliance within the European Parliament. The session will be led by Alfredo Pascual, Vice President of Investment Analysis at FastForward and former International Analyst for MJBizDaily. During their discussion, they will touch upon the harmonisation of EU regulations, patient access and some of the latest developments in the European medicinal cannabis market.

More information on the program, tickets and speakers can be found at Prohibition Partners Live website.

The session with Tjalling Erkelens and Alex Agius Saliba will be aired on Wednesday 19th May at 2.30 pm UK time.

The whole event will last from Tuesday 18 – Thursday 20th May.

Tjalling Erkelens and MEP Alex Agius Saliba @Prohibition Partners Live

UMCG starts scientific research into cannabis oil and liver-cancer

The University Medical Center Groningen (UMCG) will start this year, 2021, a study on the effect of cannabis oil on liver-cancer patients who have exhausted all the avenues of treatment. The purpose of the pilot study, which will have 20 participants, is to see whether cannabis oil can reduce liver-cancer tumours. This is unique, as this type of study has not been carried out before. “It is pioneering in many ways”, said surgeon and lead researcher Maarten Nijkamp.

In three years from now, Nijkamp and his colleague Frederik Hoogwater, oncologist Derk Jan de Groot and gastroenterologist Frans van der Heide would like to be able to say whether medicinal cannabis oil has an impact on the growth, or rather the regression, of liver-cancer tumours. In this study twenty patients will be enrolled who all have come to the end of their standard treatment but still have a good liver function. The latter is important, because a functioning liver will ‘process’ cannabis oil on the basis of natural processes. As soon as the correct dose of cannabis oil has been determined and administration has started, a liver scan will be performed for every participant after three, six and nine months. Blood samples will also be taken to study the liver function and to check the presence of tumour markers. No later than in 2024 – or as much sooner as possible – the research team aims to present a clear conclusion.

UMCG starts scientific research into cannabis oil and liver-cancer

Anecdotal evidence

The idea for this clinical trial came up more than three years ago, when an UMCG patient with advanced liver cancer showed remarkable results upon using cannabis oil. The tumours in his liver started to disappear gradually after he started taking cannabis oil and now – five years following the diagnosis – he has been given the ‘all clear’. When comparable results were seen in a second patient, Nijkamp and his colleagues started to become excited. “We would have been equally excited if the patients had used fish oil”, tempers Nijkamp.

“However, cannabis and cannabis products are unusual. You only need to go on the internet to find a fair amount of anecdotal evidence for cannabinoids as a weapon in the fight against cancer. However, it is incidental and you do not know in how many patients the use of cannabinoid-based products did not have the desired effects. Then there is laboratory research that demonstrates that cannabis can have an inhibiting effect on the growth of liver-cancer cells. However, if you pour hot water or chlorine on cancer cells in a laboratory, you will see a comparable effect. In other words, you cannot state that cannabinoid-based medicines are able to cure cancer – in this case liver cancer – because there is no scientific proof. That requires a clinical trial with real patients. These two patients gave the topic ‘cannabis oil and liver cancer’ ‘meaning’ for my colleagues and me, because we are scientists as well as specialists. From a scientific point of view, we felt compelled to start up a trial. At the same time, we knew that it would be pioneering in many respects.”

Review

The set-up up of the trial presented a number of practical issues for Nijkamp and his team. First of all, the trial topic had to be approved and reviewed by various bodies, including the Medical Research Ethics Committee. Nijkamp: “Cannabis oil is not a registered drug and there are many unknowns. The wildest stories do the rounds, and we certainly did not want to fuel any fires with this trial. The review committee made sure that our trial complies with all the requirements imposed on such scientific research. At the same time, we needed answers to a number of questions. Such as: What are the substances that make cannabis effective? In what ratio are they required in the oil? Which dose is most suitable? Both patients used cannabis oil that contained THC and CBD, so that was our starting point.”

Good foundations

Then the team had to look for a manufacturer and supplier of the oil. “It is not difficult to obtain cannabis oil, but medicinal cannabis oil is a different story. For a trial like this one, the bar has been raised as high as possible”, said Nijkamp. “It goes without saying that the review bodies do the same. You need to have solid foundations: you need to procure material from a party with the right certificates for the production of your trial material. That is part of the requirements imposed on such a trial. You need to be sure that the trial material has a consistent composition, because otherwise you cannot make any statements about the results of the study. We knew that since a few years the Transvaal Pharmacy specialised in the responsible production of medicinal cannabis oil. They prepare that on the basis of standardised medicinal cannabis that is produced by Bedrocan under a contract with the Ministry of Health. The oil of Transvaal Apotheek is of a consistent quality and is tested by an independent laboratory. We knew that Transvaal Apotheek was working on obtaining certificates for the production of trial materials. That requires a significant amount of prior testing and review, and we had to wait for that to be completed. Then it was a case of selecting the right cannabis oil for the trial.”

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Transvamix®

For this pilot study, a medicinal cannabis oil that was already part of the range of Transvaal Apotheek has been chosen. Nijkamp: “We used the composition of the oils that were used by both patients as the starting point. That was oil with a relative high THC content. Transvaal Apotheek makes the oil on the basis of the standardised plant varieties Bedrocan® and Bedrolite®; it contains 10 percent THC and 5 percent CBD and is known as ‘Transvamix®’. We will use that oil as the material for the clinical trial.”

Dosage

The dosage was another point of attention, because in that sense cannabis oil is not comparable to regular medication. According to Nijkamp it may well be a reason why there have been very few clinical trials with cannabis or cannabis oil thus far. “Again, we were pioneering. With regular medication – like painkillers for example – there is a set dose; you know what the medication will do at a certain dose”, says Nijkamp. “Cannabis or cannabis oil is another story. Every patient responds differently to the product and the amount of oil that is required to be effective, may differ from patient to patient. That makes a trial much more complicated. For every patient we will raise the dose on a daily basis until there are side effects. Then we go down to the dose without side effects. In theory that would give you the highest possible dose without side effects.”

Pilot study

As far as we know, the UMCG is the first research institute in the world to carry out a study of cannabis oil for liver cancer. “In this form anyway”, said Nijkamp. “There are various laboratory studies into the effect of cannabis on tumours. We know about studies about cannabis oil for brain tumours, but as far as we know there has been no follow up. It goes without saying that cannabis is also used by cancer patients for a positive effect on the quality of life during treatment. So, this is a real pilot study. The study will only tell something about the effect of cannabis on patients with liver cancer who still have a functional liver. As soon as we know that it works in one patient, we will have taken one step forward and we can start thinking seriously about further research. Patients with liver cancer and liver damage, for example and other types of cancer. We might be able to observe that cannabinoids – in this ratio and for these patients – make a positive contribution to the quality of life. On that basis, cannabis-based products could play a set role in oncology in the future.
The outcome could also be that there is no response in any of the twenty people. Then, to that point, we have done what was required from a medical-scientific point of view, but would still be faced with a mystery in terms of why both patients were cured.”

UMCG studies cannabis oil for liver cancer patients with no further treatment options

The University Medical Centre Groningen (UMCG), Netherlands, is to study the effect of cannabis oil on liver cancer patients who have exhausted all other treatment options. The aim of the study is to see whether cannabis oil acts as an anti-cancer agent that will shrink the liver tumours.

This article is based on an UMCG press release.

The study was started after two separate reports that patients with advanced liver cancer had seen  their tumours shrink after using cannabis oil. Now, two and five years  after their diagnoses, the tumours have completely dissapeared and the patients are cured. Although laboratory research shows that cannabis can curb the growth of liver cancer cells, a possible anti-cancer effect of cannabis oil  in patients cannot be explained as no scientific research has been carried out.

UMCG studies cannabis oil for liver cancer patients
Cannabis oil as made by the Transvaal pharmacy

Cannabis oil

The cannabis oil being used is produced by the Transvaal Apotheek, a specialist pharmacy with the certificates needed to produce drugs for research purposes. The oil is produced according to a fixed recipe with precise amounts of THC and CBD, two of the important substances contained in cannabis.

The pharmacy only uses medicinal cannabis produced by Bedrocan. The Ministry of Health, Welfare and Sport has commissioned Bedrocan to standardize and grow the plant pharmaceutically in order to guarantee a consistent composition of the cannabis oil.

Research design

The first step in this study is to determine the correct dose for each patient. Patients will be given the maximum dose of cannabis oil that can be given without causing side-effects. Blood tests will be carried out and images made of the livers of those taking part after three, six and nine months to see whether the liver tumours are responding. The blood will be tested for the presence of tumour markers and to check the liver function of the participants.

Patients with liver cancer who have exhausted all treatment options

This study is being carried out with the help of patients with advanced liver cancer, for whom best supportive care is the only remaining option. As cannabis oil is broken down by the liver, all participants must have a good liver function. Patients with severe liver cirrhosis (liver damage caused by the formation of scar tissue) will not be considered for the study unless the cirrhosis is not affecting their liver function. Patients willing to join the study can be referred to the UMCG by their specialist. A total of 20 patients can take part. The study will last approximately three years.

Switching cannabidiol is not recommended

The Dutch Medicines Evaluation Board (MEB) has added cannabidiol to a list of medicines for which switching is not recommended. This is in the interest of the patient because it concerns medicines of which incorrect intake leads to serious problems. Cannabidiol is used by patients with epilepsy.

The MEB list has been drawn up on behalf of the Dutch Ministry of Health, Welfare & Sport. In the Netherlands, cannabidiol, compounded by a pharmacist, can be prescribed according to the Epilepsy guideline from June 2020 in children (from 2 to 18 years old) with a treatment-resistant Dravet syndrome or in patients (from 2 years old) with a treatment-resistant syndrome Lennox Gastaut.

In the Netherlands, and several other countries, oil made from the pharmaceutical CBD-containing cannabis product Bedrolite is prescribed to these patients.

Brexit threatens Alfie
Alfie Dingley

Alfie Dingley

Patients in the Netherlands can obtain this oil from pharmacies on prescription from the doctor. Around the turn of the year, unrest arose in England because this product would no longer be available to English patients due to Brexit. The dire situation of several patients, including nine-year-old Alfie Dingley, hit the press in England and the Netherlands. The Dutch and English governments have now found a temporary solution.

Response of Health Minister

The Dutch Health Minister, Van Ark, endorses the MEB list. “After all, patients should not run any unnecessary health risks as a result of switching drugs,” the ministry said in response.

Bedrocan’s response

Bedrocan is pleased with this decision by the MEB and the minister. The Dutch cannabis producer produces various cannabis products that are processed as medicinal cannabis oil on behalf of the Dutch Ministry of Health. CEO Tjalling Erkelens: “The decision is in line with what we have seen and emphasized in practice for years; namely that our products cannot simply be exchanged by another product with a comparable amount of CBD. Medical cannabis is simply more complex than just CBD or THC. See, for example, the situation in England at the beginning of this year. Many epilepsy patients were in danger of getting into acute problems because they could no longer access cannabis oil from the Netherlands due to Brexit. Hopefully, the inclusion of cannabidiol on this list will eventually lead to European regulations that guarantee availability for the patient.”

Study: Medicinal cannabis can ease seizures in childhood epilepsy

The outcome of a retrospective study suggests a combination of CBD and THC-based products are effective in reducing seizure frequency in a range of epileptic conditions.

The study Ending the pain of children with severe epilepsy? An audit of the impact of medical cannabis on 10 patients shows that cannabis-based medicinal products (CBMPs) can offer patients significant relief from intractable epilepsy. According to the researchers, all ten patients used combined CBD and THC-based products (Bedrolite and Bedica), and the result was ‘statistically significant’. Of the ten patients enrolled in the study, 97% experienced a reduction in monthly seizure frequency after treatment with CBMPs.

The paper came out just before the British newspapers headlined about the struggle of English epileptic patients to get cannabis oil from the Netherlands after Brexit.

Despite the positive outcome of this study, authors Rayyan Zafar, Anne Katrin Schlag and professor David Nutt do not ignore the high costs and difficulties of accessing the treatments in the UK. “We highlight the inefficacy of the healthcare system in supporting these patients who bare great personal and financial burdens. We encourage specialist physicians and relevant bodies to permit easier access to these medications by those patients to whom efficacy has been shown.”

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