Bedrocan present at Cannabinoid 2019 Conference

From November 31 to November 2, Berlin is the setting for the Cannabinoid 2019 conference. The conference, organized by the International Association for Cannabinoid Medicines (IACM) aims – just like the IACM itself – to advance the knowledge on cannabis, cannabinoids, the endocannabinoid system and their therapeutic potential.

The biennial conferences – this will be the tenth edition – have grown substantially throughout the years and the IACM is privileged to continuously have world-class scientists and clinicians among their speakers and attendees. But the conference welcomes patients and industry members as well.

‘Throw away your bias, your preconceptions and try’

In Italy, access to cannabis-based medicines is complicated because of the ‘excess of bureaucracy’, according to Dr Marco Bertolotto, an Italian pain specialist. Dr Bertolotto is an experienced prescriber of cannabis-based medicines, having already treated more than 2500 patients. While other Italian doctors do not even consider prescribing. Dr Bertolotto points out: “Every step is complex and insidious. A serious error can be punishable by law. Every step has a trap inside.” Limited prescribing means few patients access medicines they could benefit from. “It is a recurrent story. Patients suffer from the disease and from the lack of therapy.”

Cannabis Business Italy

This week Bedrocan will be present at the Cannabis Business conference, held on October 16th and 17th 2019 in Rome. Bedrocan’s CEO Tjalling Erkelens will talk about standardisation, harmonisation and education. At the same conference Dr Marco Bertolotto will also talk about his experience with medical cannabis.

Dr Bertolotto runs a regional pain clinic and palliative care centre ASL2 in Liguria, Italy. At the end of 2018 he launched a personal website with information about the use of cannabinoids as a medicine. Due to a special Bedrocan cannabis Masterclass in December 2015 in the Netherlands, Dr Bertolotto and a small group of Italian medical experts were trained in depth on the use of medicinal cannabis according to Bedrocan standards. He now considers himself an expert and an Italian pioneer in the field. “My experience started five years ago, at the start of the Italian medical cannabis programme. I found out that there was a group of patients that were suffering and had tried so many drugs, without efficacy. They were looking for an alternative and an expert doctor who could help them.”

Despite the maze of rules, Bertolotto’s motto to doctors starting out prescribing is ‘not to be afraid. Throw away your bias, your preconceptions and try. Choose the dosage by starting low, and continue going slow. Follow the patient day by day.” Bertolotto also provides advice with regards to which administration form to use. “It depends of the patient and the disease. I normally prefer to use oil, because the titration with drops is easy, but I also prescribe cannabis dried flower by vaporization.” As Western medicine is entirely based on scientific evidence that requires randomised, double-blind studies there is unfortunately still not enough evidence. Bertolotto about this issue: “This is a big problem as doctors are therefore reluctant to prescribe. Evidence based medicine is not adapted to studying cannabis-based medicine. We need a different approach. My personal approach, that I will present later this week at the Italian Cannabis Business conference, is called Personalised Medicine. We collect and analyse a lot of data until we have an algorithm to help doctors.”

Bedrocan present at first CECF Conference in Poland

On 22 and 23 October, Warsaw will see the first Central European Cannabis Forum Conference in Poland. Bedrocan will be presenting the company and the latest news on its clinical research. We spoke to the man behind this first time event, Andrew de Roy, to find out why he decided to organise this event in Poland and the goals he wants to achieve.

Andrew de Roy has been a risk consultant and corporate investigation specialist. He has built over the past twelve years Bearstone Global, a risk consultancy with offices in Poland, Berlin and opening in London. Over this time they have increasingly been working in the space of medical cannabis as the industry has developed at such great speed over the past few years.

‘The industry is not only fast moving but obviously also controversial, as the industry goes from Black to White, most visibly in North America, but also in greater frequency in Europe. As the industry has developed, Poland is one of the more interesting countries in Europe in terms of progressive laws and numbers of registered patients. The industry requires the development of a more organised ecosystem and the ability to speak with one voice on issues which are key for the whole industry in general,’ De Roy explains.

‘Patients are the most important here’

He organises the event in order to educate, network and help the industry to speak with one voice in Poland, and to help regional integration within the industry. De Roy: ‘I am convinced that Poland has huge potential to develop businesses, as well as be a leader in an industry which still has such a significant room for innovation and development. We hope that the conference will result in a Memorandum of Understanding for a Polish Medical Cannabis Association. We hope that a more collaborative approach will assist everyone within the ecosystem, from cultivators to companies, and of course right through to the patients, who are the most important here.’

‘Future is promising, but process is difficult’

Looking at the future, De Roy sees huge potential in Poland, but it is not easy: ‘The election on October the 13th will likely show a lot! We have just had four new products registered in Poland raising the overall number to five, and there is a significant pipeline of products in line. There are rumors that all registrations have been halted, but this has not been verified officially, and there is much confusion about this. What is certain is that at present the process is cumbersome and difficult. We also have issues in terms of access for patients and cost, which is very much in line with many others in Europe.’

Vaping vs vaporization

There has been a lot of talk in the media about the risks of vaping. This article discusses the differences between vaping and the administering cannabis flos by vaporization.

Not all vaporizers are the same

Many of us have heard of vaporizers, and instantly we think of ‘e-cigarettes’ or ‘vape-pens’. However, these are not the only types of devices available. Vaporizers (as medical devices) for the administration of cannabis flos [1] are in fact quite different from ‘vape-pens’ or ‘e-cigarettes’.

The vaporizer vapour does not contain nicotine, or carrier agents such as liquid propylene glycol, glycerol, or vitamins and synthetic flavours. [i] [ii] [iii] The large, socially intrusive vapour clouds of ‘e-cigarettes’ do not apply for the medicinal use of cannabis flos by vaporization.

Vaporization devices do not include liquids, rather dry cannabis is heated by precise temperature control, efficiently releasing active ingredients without toxic by-products.

Vaporization devices offer patients an effective, safe, and easy to use delivery system for cannabis flos. [iv] [v] The inhaled vapour contains THC, CBD, and terpenes [2] in consistent, measurable quantities. The use of a high quality vaporizer device avoids the respiratory disadvantages of smoking, [vi] and of the inhalation of compounds from liquid vape-pens.

An efficient administration route

The most efficient administration route of medicinal cannabis is by inhalation. Indeed, administration by inhalation is a rapid way to induce measurable serum levels of cannabinoids. [vii]

A vaporizing medical device, compared to smoking or vaping, [3] dramatically lowers concentrations of toxic compounds such as carbon monoxide, ammonia and polyaromatic carbohydrates (PACs). Compared to smoking, higher therapeutic levels of THC and consistent, reproducible THC extraction and delivery is possible. [viii] [ix]

Vaping Controversy

In the United States the vaping phenomenon hit the headlines this year after the American Centre for Disease Control and Prevention (CDC) reported at least eighteen fatalities and more than 1,000 people with serious lung complaints after vaping. Although almost all of these concerned the use of so-called e-cigarettes and vape pens for recreational use, the use of a vaporizer to administer medicinal cannabis is now being questioned.

The vapour is quickly absorbed by the lungs, permitting patients to effectively titrate to optimise their dose based upon symptom severity, tolerability and avoidance of side-effects. The rapid onset of effects of inhaled cannabinoid use allows easier titration of dose, while standardised cannabis products enable patients to administer an exact dose. [vi] [x][xi][xii]

Patient perspectives and providing therapeutic options

Prescribers, pharmacists and patients should be aware of this differences between ‘vaping cannabinoids’ and ‘vaporising cannabis flos’.

The importance of vaporization is underlined in patient use surveys. The majority of survey respondents report higher satisfaction (approval) scores with the inhalation route. In general, whole plant, herbal cannabis-based medicines received higher scores than other products containing isolated cannabinoids. [viii][xiv]

Patients seek a reliable, affordable and portable vaporizer for administering cannabis flos. Presently there is research dedicated to advancing administration technology. Some examples of major developments in vaporizer devices, using standardised cannabis flos, include the Volcano® and Mighty Medic vaporizer (Storz & Bickel) [xv] [xvi] [xvii], and the Syqe® Inhaler [xviii] [xiv].  All devices have relied on Bedrocan standardised cannabis flos for their quality testing and clinical trials.

Vaporizer medical devices, delivering standardised doses, underline quality assurance, safety, and efficacy. With these administration technical advancements, smoking of cannabis flos can soon be a thing of the past. Backed by proper scientific studies, cannabis flos will become an acceptable therapeutic among patients, prescribers, and regulatory authorities. [xx]

Future thinking – critical policy decisions

It should be recognised that vape-pens for inhalation of cannabinoids often are not subjected to any technical or clinical testing. While, by comparison, a number of the devices for administering cannabis flos by vaporisation have robust supporting clinical and technical studies.

With regard to administration, future policy must be clear and obvious. For example, in the Netherlands, Germany, Australia and New Zealand, smoking cannabis flos is actively discouraged and/or not permitted, respectively. While the clinical guidelines support cannabis flos for inhalation administered by vaporization.

While there are similarities between the administration methods – vaping vs vaporisation – a blanket ban on inhalation or on vaporizer devices for administering cannabis flos would be nonsensical. This would have implications for administration options and prescriber-patient choice. It would also impact on their valid use in hospitals and hospices, rest-homes, and home settings.

[1] Fully-standardised, pharmaceutical-quality cannabis flos is the whole, dried flowers of the cannabis plant which is genetically and chemically standardised according to pharmaceutical standards with a defined cannabinoid and terpene composition. Also, it is free of contaminants such as microbial contaminants (molds, fungi, and bacteria) pesticides (residues), aflatoxins, impurities and heavy metals.

[2] Terpenes are a major component of Cannabis sativa. Responsible for the plant’s aroma, terpenes may also act synergistically with the cannabinoids. x

[3] When administering pharmaceutical quality cannabis flos.

References

[i] Douglas, H., Hall, W., Gartner, C. (2015). E-cigarettes and the law in Australia. Australian Family Physician. 44 (6): 415-418.

[ii] Jensen, P., Luo, W., Pankow, J., Strongin, R., Peyton, D. Hidden formaldehyde in e-cigarette aerosols. New England Journal of Medicine. 372 (4): 392-393.

[iii] Editorial and Review (2019). E-Cigarettes and Vaping-Related Disease. New England Journal of Medicine. Online: https://www.nejm.org/vaping

[iv] Eisenberg, E., Ogintz, M., Almog, S. (2014). The pharmacokinetics, efficacy, safety, and ease of use of a novel portable metered-dose cannabis inhaler in patients with chronic neuropathic pain: A Phase 1a study. Journal of Pain & Palliative Care Pharmacotherapy. 28:216–225.

[v] Hazekamp, A., Ruhaak, R., Zuurman, L., van Gerven, J., Verpoorte, R. (2006). Evaluation of a vaporizing device (Volcano) for the pulmonary administration of tetrahydrocannabinol. Journal of Pharmaceutical Sciences. 95(6):1308-17.

[vi] Pomaahcova, B., Van der Kooy, F., Verpoorte, R. (2009). Cannabis smoke condensate III: the cannabinoid content of vaporised Cannabis sativa. Inhalation Toxicology. 21(13): 1108-12.

[vii] Grotenhermen, F. (2003). Pharmacokinetics and pharmacodynamics of cannabinoids. Clinical Pharmacokinetics. 42: 327-360. Also, Grotenhermen, F. (2004). Clinical pharmacodynamics of cannabinoids. Journal of Cannabis Therapeutics. 4(1): 29-78.

[viii] Abrams, D., Vizoso, H., Shade, S., et al. (2007) Vaporization as a smokeless cannabis delivery system: a pilot study. Clinical Pharmacology and Therapeutics. 82 (5): 572 – 8.

[ix] Gieringer, D., Laurent, J., Goodrich. (2004). Cannabis Vaporizer Combines Efficient Delivery of THC with Effective Suppression of Pyrolytic Compounds. Journal of Cannabis Therapeutics. 4(1)

[x] Hazekamp and Heerdink (2013). The prevalence and incidence of medicinal cannabis on prescription in The Netherlands. The European Journal of Clinical Pharmacology.

[xi] Van de Donk, T., Niesters, M., Kowal, M., Olofsen, E., Dahan, A., Van Velzen, M. (2019). An experimental randomized study on the analgesic effects of pharmaceutical-grade cannabis in chronic pain patients with fibromyalgia. Pain; 160: 860–869.

[xii] Russo, E. (2011). Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects. British Journal of Pharmacology. 163: 1344–1364.

[xiii] Hazekamp, A., Ware, M., Muller-Vahl, K., Abrams, D., Grotenhermen, F. (2013). The medicinal use of cannabis and cannabinoids: An international cross-sectional survey on administration forms. Journal of Psychoactive Drugs. 45 (3), 199–210.

[xiv] de Hoop, B., Hazekamp, A., Kopsky, D., Wijnkoop, L. (2016). Experiences and motives of medicinal cannabis patients: A cross-sectional questionnaire. Radboud Universiteit Nijengen, the Netherlands. (Unpublished work)

[xv] The Volcano® Medic vaporizer medical device is listed on the Medical Devices Active Licences Listing (Health Canada), licence No.: 82405.

[xvi] Hazekamp, A., Ruhaak, R., Zuurman, L., van Gerven, J., Verpoorte, R. (2006). Evaluation of a vaporizing device (Volcano) for the pulmonary administration of tetrahydrocannabinol. Journal of Pharmaceutical Sciences. 95(6):1308-17.

[xvii] Pomahacova, B., Van der Kooy, F., Verpoorte, R. (2009). Cannabis smoke condensate III: the cannabinoid content of vaporised Cannabis sativa. Inhalation Toxicology. 21(13):1108-12.

[xviii] Eisenberg, E., Ogintz, M., Almog, S. (2014). The pharmacokinetics, efficacy, safety, and ease of use of a novel portable metered-dose cannabis inhaler in patients with chronic neuropathic pain: A Phase 1a study. Journal of Pain & Palliative Care Pharmacotherapy. 28:216–225.

[xix]  Vulfsons S, Ognitz M, Bar-Sela G, Raz-Pasteur A, Eisenberg E (2019). Cannabis treatment in hospitalized patients using the SYQE inhaler: Results of a pilot open-label study. Palliative and Supportive Care, 1–6.

[xx] Van de Donk, T., Niesters, M., Kowal, M., Olofsen, E., Dahan, A., Van Velzen, M. (2019). An experimental randomized study on the analgesic effects of pharmaceutical-grade cannabis in chronic pain patients with fibromyalgia. Pain; 160: 860–869.

Bedrocan at CPhI Worldwide 2019 in Frankfurt

Bedrocan will be present at the world’s largest pharmaceutical exhibition, CPhI Worldwide. At the fair we will present ourselves as the first GMP supplier of plant-based full-spectrum cannabis APIs. CPhI gathers over 45,000 pharma professionals from around the globe with more than 2,500 international exhibitors. It is the place for Bedrocan to network and meet pharmaceutical companies that are interested in cannabis as an active pharmaceutical ingredient. (API).

Global trend

A global trend has arisen: Prescribers are becoming more familiar with cannabis-based medicines and prescribing them. The increasing demand for pharmaceutical quality cannabis-based medicines has resulted in greater need for reliable and consistent APIs.

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In their quest for a reliable source of API, pharmaceutical companies are increasingly finding their way to Bedrocan.

This is unsurprising given Bedrocan is the only fully GMP-certified producer of standardised medicinal cannabis in the world. Founder and CEO Tjalling Erkelens talks about standardised pharmaceutical quality medicinal cannabis.

Can you define standardised medicinal cannabis?
“It refers to cannabis products that are consistent in terms of its active ingredients – the cannabinoids tetrahydrocannabinol (THC) and cannabidiol (CBD), but also the terpenes which are the aromatic compounds. Bedrocan produces five different varieties of medicinal cannabis. They are produced in accordance with pharmaceutical quality requirements, because our production sites comply with the requirements imposed by GMP – from cultivation to packaging. Each variety shows a constant composition of cannabinoids and terpenes; batch-to-batch, year after year. That’s what we call standardised medicinal cannabis. We have been doing this for over two and a half decades now. And we’re only getting better.”

Why standardisation?
“To us standardisation is a core concept. It is the essence of our mission and vision that were defined years ago but that are still relevant today. The patient is at the heart of all this. Prescribers, pharmacies and patients expect a safe product that works. They expect a product that complies with all the pharmaceutical production requirements, and that starts with high quality starting materials. The pharmaceutical industry needs an API that is consistent in its composition to develop and manufacture novel cannabis-based medicines.”

Tjalling Erkelens

How do you achieve pharmaceutical standardisation with cannabis?
“Over the past 25 years we have developed and refined a unique method that has taken cannabis to the level of a pharmaceutical API. It starts with stable plant genetics, followed by a series of processes that are fully standardised and controlled. Our cannabis is produced under climate-controlled conditions, with minimised external influences. Furthermore, Bedrocan was the first medicinal cannabis producer to be compliant with the European Medicines Agency’s GMP standards, covering the whole production process.”

How does the pharmaceutical industry benefit from this?
“Bedrocan is the world’s first GMP producer of standardised, full-flower medicinal cannabis. Consequently, our API offers seamless GMP finished product manufacturing. We offer both blended and genetically distinct herbal preparations suitable to develop novel, cannabis-based medicines.”

The importance of standardisation

Unlike other medication, cannabis does not have a fixed chemical/molecular composition. A cannabis plant contains hundreds of different substances and each individual plant is different in terms of its composition. THC and CBD are the best-known substances, but there are dozens to hundreds of other known and unknown substances in the plant that may have an effect. No two cannabis plants are the same. Even if the levels of THC and CBD are the same, the substances around them can produce a different effect for the patient; this known as the ‘entourage effect’. There have been various studies of this entourage effect. Ultimately, the complete ‘fingerprint’ of the plant determines its effect.

Four crucial reasons why medicinal cannabis should be standardised

In the Netherlands, there are now five medicinal cannabis varieties available. Each variety has a unique, fully standardised genetic composition that is and remains the same each time, for every batch, year in, year out, because of the unique production process. The result is that the CBD and THC levels are always the same, but the other substances are also always present in the same ratio. The reproducible chemical profile enables doctors to monitor the dose and the effect on the disorder in the same way as for other certified medication. Furthermore, it makes these varieties suitable for carrying out scientific medical research.

1. PATIENTS

Constant availability of a standardised product is extremely important to the patient

Just like ‘normal’ medication, all patients are ‘set’ on a certain variety. Sometimes it can take a long time to get patients on the right variety with exactly the right dose on the basis of the existing five varieties. The same applies to the use of cannabis oil. Changing the dose or administering medication with a different genetic composition can have adverse consequences for individual patients. In some cases medicinal cannabis oil is used for children and adults with serious epilepsy. The Dutch Epilepsy Fund and doctors recommend changing brands as little as possible for epilepsy medication, because somebody can end up with a seizure after changing medication.

2. DOCTORS

Constant availability of a standardised product is extremely important to the doctor

Quite rightly, doctors want to know exactly what they give to their patients and what its effects are. It takes a lot of time and effort for doctors to become used to prescribing cannabis. The reproducible chemical profile of standardised medicinal cannabis enables doctors to monitor the dose and the effectiveness in the same way as for other certified medication. As this medicinal cannabis is also produced in accordance with pharmaceutical standards (GMP), quality and safety are guaranteed as much as possible. As doctors have prescribed the same products from the Office of Medicinal Cannabis for years, they know what it does and they feel comfortable with it. The same applies to the pharmacists who ultimately hand over the product.

3. RESEARCHERS

Constant availability of a standardised product is extremely important to researchers and clinical research

For the first time, there is now larger scale serious clinical research into the effect of medicinal cannabis. In December 2018, the first results were published of a placebo-controlled, comparative study of 3 of the 5 varieties available in the Netherlands, carried out by the University Medical Centre Leiden. Different doctors, pharmacists, and study groups are now preparing further clinical research. They prefer to work with standardised medicinal cannabis that has a guaranteed quality, safety and availability.

In order to obtain permission for medical scientific research with humans, you need a detailed statement of the product that is studied. At the end of the study, the outcomes only say something about the specific plant, and its unique genetic composition, that was used in the study. Clinical research that is carried out with the existing Bediol variety, can only be carried out with that plant. Changing variety in the meantime is not possible from a substantive point of view, it is legally impossible, and certainly not desirable. If there were to be a change to a plant with only comparable THC and CBD levels, permission for the research would have to be applied for again. THC and CBD may well be comparable, but the chemical and genetic composition of the plant and the presence of other substances changes. So therefore, in essence the product used for the research changes too. It means the outcomes that were gathered up to that point are no longer usable, because they do not apply to this new, different plant.

4. MEDICINE DEVELOPERS

Constant availability of a standardised product is extremely important to developers of medication and medical devices

At the moment, medicinal cannabis only applies as a medical raw material, i.e. an API or Active Pharmaceutical Ingredient. Various companies around the world are working on developing medication or medical devices on the basis of this active pharmaceutical ingredient. One example is an extremely advanced inhaler, which was developed by using standardised products from the Netherlands from the beginning. This inhaler is so advanced that it detects even the slightest change in the form and composition of the product to be administered. For the device to work correctly, the same percentage of THC and CBD and exactly the same genetic and chemical composition of the product are important. Any change in plant will produce high modification costs and months, if not years, of delay in its further development.

Scientific research with standardised products; an overview

The importance of standardising the complete chemical composition of the plant is supported by various scientific studies. Below is a list of a number of studies into other substances in the cannabis plant and the entourage effect they cause:

  1. From Cultivar to Chemovar II—A Metabolomics Approach to Cannabis Classification

The study considered the ‘cultural’ designation of cannabis varieties, how to distinguish them in terms of effect and how they can be separated chemically and scientifically. The chemical difference is expressed in THC and CDB values, but also in other cannabinoids and terpenoids. This means that clinical research and anecdotal evidence could be used to study the various therapeutic effects of cannabis and/or certain varieties of cannabis could be prescribed to patients on the basis of the complete chemical profile.

More information>

  1. Taming THC: Potential Cannabis Synergy and Phytocannabinoid-Terpenoid Entourage Effects

This study introduces the ‘entourage effect’, which assumes interaction between cannabinoids and terpenes. This interaction may lead to positive effects regarding treatment of pain, inflammation, depression, anxiety, addiction, epilepsy, cancer, fungal and bacterial infections. Unique therapeutic properties are ascribed to terpenes, the odour and flavour substances in cannabis.

More information>

  1. Terpenes and Derivatives as a New Perspective for Pain Treatment: A Patent Review

This study deals with the role of terpenes in pain relief and is particularly focused on the role those terpenes could play in developing new analgesics.

More information>

  1. Synergy Between Cannabidiol, Cannabidiolic Acid, and Δ⁹-Tetrahydrocannabinol in the Regulation of Emesis in the Suncus Murinus (House Musk Shrew)

This study demonstrated that a combination of THC, CBD, and CBDA (cannabidiolic acid) produced better control of vomiting and fewer side effects. This combination was administered to shrews. These effects are also expected to occur in humans.

More information>

  1. Beyond Cannabis: Plants and The Endocannabinoid System

Not just the substances in cannabis have an effect on the endocannabidoid system. This article deals with a number of other plants that could produce similar effects. It also deals more in-depth with the ‘entourage effect’.

More information>

  1. Cannabis Pharmacology: The Usual Suspects and a Few Promising Leads

This article aims to answer the question as to the synergy between cannabinoids and terpenes in the therapeutic treatment of pain, psychiatric complaints, cancer and various other disorders. It also considers the therapeutic effects of substances in cannabis roots, leaves and seeds.

More information>

  1. Cannabis Constituent Synergy in a Mouse Neuropathic Pain Model

This animal study demonstrated that CBD strengthens the pain-killing power of THC during the treatment of neuropathic pain. The results suggest that a combined low dose of THC and CBD is the best option for dealing with neuropathic pain.

More information>

  1. Single and Combined Effects of Δ⁹-Tetrahydrocannabinol and Cannabidiol in a Mouse Model of Chemotherapy-Induced Neuropathic Pain

This study in mice demonstrated that really small doses of CBD or THC – administered separately – do not have an effect on reducing neuropathic pain caused by chemotherapy. However, when THC and CBD are administered in combination, these two substances have a synergetic effect and can be effective in dealing with pain.

More information>

  1. Appraising the “Entourage Effect”: Antitumor Action of a Pure Cannabinoid Versus a Botanical Drug Preparation in Preclinical Models of Breast Cancer

This animal study demonstrated that a full extract of cannabis has a better effect on treating tumours (breast cancer) than pure THC.

More information>

  1. The Case for the Entourage Effect and Conventional Breeding of Clinical Cannabis: No “Strain,” No Gain

This article proposes to stop categorising cannabis varieties by strains and to categorise them by chemical properties (‘chemovars’) instead. Furthermore, according to this article it is assumed that the combination of substances has a better therapeutic effect than the active substances alone – the ‘entourage effect’.

More information>

  1. An Experimental Randomized Study on the Analgesic Effects of Pharmaceutical-Grade Cannabis in Chronic Pain Patients With Fibromyalgia

This clinical study demonstrated that administering a combination of THC and CBD demonstrated a synergetic effect in patients, whereby the CBD increased the amount of THC in the bloodstream.

More information>

THC level in blood increases in combination with CBD

CBD can have a strengthening effect on the THC level in the blood. This was observed in data from a clinical study with fibromyalgia patients. A poster presentation about this matter gathered a large and engaged group of researchers and regulators at the ICRS congress last June. The ICRS congress is a leading scientific conference where international scientists present their findings in the field of cannabinoid research.

ICRS Poster

Previous research has shown that administering THC together with CBD can help reducing the undesirable side effects of THC, especially those related to increased anxiety. However, recent clinical and psychopharmacological research shows that co-administration of THC and CBD can lead to additional, unexpected effects.

Specifically, a recently published clinical study conducted at the Leiden University Medical Center, with the support of Bedrocan, compared the blood levels of THC in chronic pain patients after the administration of three cannabis chemovars (varieties): Bedrocan® (THC 22% | CBD <1.0%), Bediol® (THC 6.3% | CBD 8%), and Bedrolite® (THC <1.0% | CBD 9%).

Bedrocan’s research coordinator Mikael Kowal presented the results at the ICRS congress and there was great interest in his analyses. “The findings from our clinical study regarding the complex interactions between THC and CBD in the body are novel and were surprising to many.”

Knowledge

“Apparently, the effect of CBD increasing THC concentrations in the blood was discovered by one researcher in the early days of creating the formulation of Sativex. However, at that time this finding was difficult to explain, due to lack of sufficient knowledge on the workings of CBD. Currently, we seem to be the first to have this data published and similar results are being found in animal research.”

Mikael Kowal PhD

In the case of Bediol, the mixed THC/CBD cannabis chemovar, the blood levels of THC were about 50% higher than expected from the administered THC dose. Moreover, a similar effect was observed in a psychopharmacological study conducted with healthy cannabis users at the University of Sydney, in which higher THC levels were found in the blood of subjects who received cannabis containing equal amounts of THC and CBD, than in the case of cannabis containing an equal dose of THC, but without CBD.

The exact mechanism by which this effect occurs is still not clear. Possible explanations include an increased absorption of THC in the lungs or the inhibition of THC metabolism, both induced by CBD, or the conversion of CBD into THC. In any case, knowledge of these pharmacokinetic THC-CBD interactions can help physicians and patients in establishing a proper therapeutic dose of cannabis to treat their symptoms. Further research is needed to confirm this, however it is possible that lower doses of THC are required when co-administering it with CBD, in order to achieve symptom control of a particular disease.

Three misconceptions about medicinal cannabis

What are we talking about when we talk about medicinal cannabis?

The term ‘medicinal cannabis’ leads often to faulty assumptions and misconceptions. That’s why we think it’s important to make clear what medicinal cannabis actually is. In a series of short articles we present the most common misconceptions about medicinal cannabis, in order to speak the same language in discussions, news articles and so on.

All cannabis is suitable for medicinal use

There is a great difference between ‘medicinal cannabis’ and ‘cannabis for medicinal use’. That difference is all about the manner in which and the purpose for which the cannabis is produced. Medicinal cannabis is intended solely for patients and the production process is fully attuned to that purpose.

Production takes place in a fully standardised manner, in a pharmaceutical environment, and is subject to those stringent quality and safety standards. The production processes are designed so that the cannabis is genetically consistent, the proportion of active ingredients is consistent, and there is minimum risk of contamination (microorganisms, heavy metals, and no pesticides). The cannabis quality is tested by an independent laboratory. This way quality is guaranteed. Both the patient and doctor clearly know what is being prescribed.

Industrial hemp is medicinal too

Hemp belongs to the family of Cannabis sativa L. It contains cannabinoids and is sometimes used for ‘recreational’ or ‘medicinal’ purposes, although it is never produced under pharmaceutical conditions. When referring to hemp, this typically concerns ‘industrial hemp’; a sturdy agricultural crop with long, strong fibres.

It differs genetically from the medicinal cannabis species. Mainly used in clothing, paper, (animal) feed, and automobile industries, industrial hemp contains negligible or zero levels of THC (the psychoactive component of cannabis). This is why it may be legally grown in many countries under more relaxed regulations. Industrial hemp does however contain CBD. As a result it is sometimes also used for the production of CBD rich oils which are not for medical use.

Medicinal cannabis is expensive

The production of medicinal cannabis requires considerable investment. The production process must continuously comply with the applicable quality and safety requirements of medicines. Nonetheless, in the Netherlands – a programme designed to provide patients with acceptably priced pharmaceutical quality medicines was initiated in 2003 – it has proven possible to gradually reduce the price.

Indeed, the price for one gram of medicinal cannabis has remained below the average price for recreational cannabis in the Netherlands for some time. This was made possible due to industrial efficiencies, scalable production process, and – in more recent years – income from exports.

In 2018, the Minister for Public Health, Welfare and Sport – who is ultimately responsible for the Dutch medicinal cannabis programme – further reduced the price per gram. A patient today pays € 5.80 (net) at the pharmacy.

Dr Timna Naftali: ‘IBD patients feel a lot better after being treated with cannabis’

Dr. Timna Naftali, Gastroenterologist at the University of Tel Aviv, was the first person to research the effect of medicinal cannabis on inflammatory bowel disease (IBD). While she received great criticism, one patient always inspired her not to give up. Scientific evidence is crucial for Naftali, and she is therefore devoted to the cause. She is determined to supply proof that medicinal cannabis works for IBD sufferers.

Ten years ago, a young patient walked into Dr Naftali’s surgery for her initial consultation. She had not been back for a check-up for a year. Naftali was surprised to see her again and wondered why she had never made a follow-up appointment.

“She had something to confess,” says Naftali. “The patient explained she had been using cannabis for the last year. All pain had disappeared, and had therefore felt no need to come back. In the meantime the patient had married, was trying to get pregnant, and had therefore stopped using cannabis. Her situation had once again deteriorated.”

The positive effect of cannabis on this young woman triggered many questions for Naftali. Would it not be fantastic to help more patients suffering from Crohn’s disease and colitis ulcerosa?

Dr Timna Naftali
Dr Timna Naftali

Lecture

In the end, it was a lecture by Dr. Yehuda Baruch, former head of the Israeli medicinal cannabis programme that was the deciding factor to look for answers. “To my amazement, he informed me that medicinal cannabis could be prescribed for patients in Israel suffering from Crohn’s disease. I was surprised that as a doctor, I was unaware of this.”

With total dedication, Naftali searched for clinical studies that supported the policy of the Israeli government. Finally, she concluded there was nothing to be found. “Nothing at all. Not a scrap of scientific evidence.” In the end, it was Naftali herself who took up the challenge to produce the much-needed scientific evidence. But where to start the research?

Dispensaries

Israel has special cannabis dispensaries where patients with a government permit may source their medicinal cannabis. “I approached a local cannabis producer and supplier and they put me in contact with thirty Crohn’s disease patients. Their experience with medicinal cannabis was impressive.

Patients required less (typical prescription) medication, suffered less pain, retained a healthy weight. Some patient no longer needed hospitalisation. Their quality of life had visibly improved because of their medical use of cannabis.”

That research was published in the Israel Medical Association Journal (2011) and promptly received criticism. The small retrospective observational study asked patients about their experience. It did not include patients who experienced little or no improvement. However, the positive consequences made Naftali more convinced of the necessity of continuing her research. She was determined to undertake a randomised, double-blind study. “A proper study”, as she herself refers to it, complete with a placebo, so that patients would not know what they were taking.

The research took around two years and the results were nothing less than spectacular. “Nearly half of the patients (45%) felt completely healthy after using medicinal cannabis. As if their disease had disappeared. In the placebo group on the other hand, a mere 10% experienced a complete remission. Once again, Naftali research was criticised within her professional field. Apparently, the study was not objective enough and there was insufficient clarity on the effect in the bowel after the use of cannabis. A justifiable observation, Naftali believes with hindsight: “We all know that cannabis can give a sense of euphoria. Was that why these patients felt better or was it the condition of their digestive tract and an actual solution for the disease?” She had also deployed an unhealthy method of application, namely smoking. A new study therefore proved to be essential. The latest study used a different administration method (cannabis oil for oral use). Patients received endoscopic intestinal examinations before and after the use of medicinal cannabis, in order to detect any improvement in inflammation levels.

Latest study

The results, published in October 2018 at the annual United European Gastroenterology congress, received positive reactions. Naftali herself was not satisfied. “Although patients felt much better after consuming the cannabis, no improvement was visible in the digestive tracts during the endoscopy. What does that mean? Either cannabis has no influence or there was not enough time between administration and the intestinal examination. It was only an eight-week period after all. Perhaps an interval of three months would have been more useful.”

Naftali also encountered another problem: “There are many types of cannabis, and as a researcher you have no idea which will work best. I still genuinely wonder what type of cannabis to administer, for how long and in what form.” In other words, her work is not finished yet.

Naftali is in the early stages of a new study designed to show the effects of purely synthetic CBD. CBD is known to have few side effects and is therefore considered safe. “It could serve as a supplement to further medication. But we first need to know whether it actually works.”

Crohn’s disease and Ulcerative Colitis

Crohn’s disease is a chronic inflammatory disease of the bowel. Like Ulcerative Colitis, it is therefore generally referred to as inflammatory bowel disease (IBD). In Ulcerative Colitis, there is usually chronic, recurrent inflammation of the large intestine. In most Crohn’s disease patients, there is inflammation of the small intestine, large intestine and/or rectum. Although there may also be inflammation in the rest of the digestive tract.

Naftali would appreciate being able to cooperate with researchers outside of Israel. Although the Meir Medical Centre in the Israeli city of Kefar Sava, where Naftali works, treats a thousand IBD patients, she believes this population to be too limited. The main obstacle to international cooperation however is that all researchers must be able to use the same cannabis. “The product I use here in Israel is not the same as that available in the Netherlands. We would therefore need to export the product, which has not exactly proved simple so far.”

By now, the patient who revisited Dr. Naftali ten years ago, has married and moved away to a different region of Israel. Naftali no longer has contact with her, but it is thanks to this patient that she remains convinced of the usefulness of medicinal cannabis for a majority of patients.

If you are interested in further research by Dr Timna Naftali, check out PubMed.

Podcast organiser Cannabis Economy launches first digital workshop

Bedrocan’s CEO Tjalling Erkelens has been featured on the Cannabis Economy podcast a significant number of times over the past few years. For the first time, Cannabis Economy’s Digital Workshop will take place on July 30th and 31st, bringing together leaders in policy, science and business. American events moderator Seth Adler is the driving force behind these podcasts. We discussed his background and the reasoning behind the podcast.

Who are you?

I’m a host, moderator, producer and unlicensed anthropologist. I’ve spent over 20 years producing international events, podcasts, video, and the written word. I am responsible for bringing “The greatest show on earth Ringling Bros and Barnum & Bailey”, the former American traveling circus, to town. I have also produced music showcases at the historic – now closed – New York City music club CBGB. I’m currently focused on the societally significant industries of legal cannabis and artificial intelligence through the production and hosting of Cannabis Economy and the AI & Intelligent Automation Network.

Seth Adler

I procured a network of leaders in the space, including Catherine Sandvos of the Netherlands’ Office of Medicinal Cannabis’, and began running events. A six month gap between events is too long, and so I launched the Cannabis Economy podcast. The podcast has now reached the 850K downloads milestone and over 400 episodes have aired.

Cannabis Economy Digital Workshop
Date: July 30 & 31
Location: Online
Cost: It is free

What is the digital workshop about?

The Digital Workshop brings global leaders from across the cannabis space together on one platform. Experts include elected officials, regulators, scientists, business leaders, advocates and activists discussing cannabis as a medicine, wellness and economic opportunity.

Why do you organise it? And why digital?

While the global cannabis economy has experienced dynamic growth, 2019 is specifically a year of sea-change with the World Health Organization setting guidelines, Israel exporting, EU members taking action, Asia-Pacific diving in, the first full year of legal cannabis in Canada and actual federal legislation receiving votes in the United States.

With a huge variety of cannabis events specialising in global policy, science and business, the Cannabis Economy Digital Workshop supplements this extensive calendar and provides parties the opportunity to learn from leading experts without blocking up schedules.

What do you want to achieve?

The goal of the Cannabis Economy Digital Workshop is to connect best-in-class thought-leadership and information-sharing in order to identify standard sensible regulations, safe patient access and industry advancement within the cannabis space.

How, where and when can people join?

While the content is designed for leaders in business, policy and science, attendance is free thanks to our sponsor’s support. Please register at the Cannabis Economy website.

Bedrocan presents at Cannabis Europa

Cannabis Europa has grown to become the foremost arena to share knowledge and shape the future of medicinal cannabis in Europe. The 2019 event hosts more than eighty expert speakers – ranging from politicians, policy-makers, scientists,  health care professionals, patients and industry. Bedrocan will be there.

Tjalling Erkelens, founder and CEO of Bedrocan, has been invited to speak about business leadership and global business development. It is indeed an interesting subject. Working within highly fragmented regulatory environments and often immature markets, the challenges facing industry leaders are numerous.

 

Cannabis Europa
Date: 24 & 25 June 2019
Location: Southbank Centre
London, United Kingdom

Programme Highlights

Monday 24 June – 15.30 – 16.30

Strong and Stable | Business Leadership
Nicholas Vita – Columbia Care
Tjalling Erkelens – Bedrocan
Nick Davis – Memery Crystal
Sabah Meddings – Sunday Times (Chair)

Tuesday 25 June – 10:00 – 11:00

Seizing the Initiative | Political Opportunity
Dr Ricardo Baptista Leite MP – Assembly of the Republic of Portugal
Delano Seiveright – Cannabis Licensing Authority Jamaica
Dr Marco van de Velde – Office for Medicinal Cannabis of the Netherlands
Andrea Paine – Aurora (Chair)

New research into use of opiates and medicinal cannabis

Can medicinal cannabis reduce the use of opiates? In order to answer that question, Leiden University Medical Centre (LUMC) is starting a study into the use of medicinal cannabis as an opiate-saving product among chronic pain patients. The product Bediol®, which contains both the cannabinoids THC and CBD, is used for this purpose. The study is carried out by the Anaesthesiology Department and is partly supported by Bedrocan, the world’s most experienced producer of legal medicinal cannabis.

The principal investigator, Prof. Albert Dahan, previously did research into the effect of medicinal cannabis in the treatment of chronic pain caused by fibromyalgia. An article about this was published in the journal PAIN at the end of 2018. Results of that research were positive and Dahan will now start a follow-up study. The main purpose of the study is to assess whether comedication with Bediol (6.3% THC and 8% CBD) will reduce the side effects of opioids among chronic pain patients.

Opiates are painkillers based on the natural substance opium. Examples of opiates are morphine, oxycodone and fentanyl. Prof Dahan said “Long-term use of these painkillers is addictive and causes unpleasant side effects like drowsiness, nausea and constipation. We believe that you can reduce the amount of oxycodone prescribed if you give people the option to use medicinal cannabis.”

The research team is currently working on the study’s preparatory phase. It is expected that the first patients will participate this year. From then on the study will take about two years to complete.

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