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“Mother fears son could die as Brexit stops medical cannabis supply”

Hannah Deacon, mother of nine-year-old epilepsy patient Alfie Dingley, sounded the alarm in the British press on 6 January. She says Alfie’s life is at risk after being told that Brexit stops medicinal cannabis supply for English patients.

Alfie suffers from a severe form of epilepsy, with 150 seizures a day being no exception. The condition is considered “life threatening” and Alfie does not respond to available regular medication. A few years ago it appeared that cannabis oil, according to pharmaceutical quality requirements and on the basis of standardized medicinal cannabis produced by the Transvaal Pharmacy in The Hague, was the solution.

Brezit threatens Alfie

After petitioning, in which Deacon received support from more than 40 families with children who have the same condition, British doctors were given permission in 2017 to prescribe the Dutch oil and the children had access to their “life-saving” medicine. Initially by travelling to The Netherlands and picking up the medicines themselves, later with the help of a courier service.

There was great shock when the parents received a letter from the British Ministry of Health on December 17, in which it became clear that – in line with Brexit – they will have to look for an alternative medicine as of January 1, 2021. But according to Deacon, there is currently no alternative and her son’s life – and that of the other children – is in danger. “I am facing the fact that my son might go into refractory epiletic seizures again which can kill people”, she told the British press. “If Alfie is forced to take another product, his life is in danger.”

Empty-handed

Hannah Deacon’s alarm bell has also been heard in the Netherlands. The AD, one of the largest daily newspapers, asked pharmacist Paul Lebbink of the Transvaal Pharmacy for an initial response. Lebbink and colleagues are not allowed to honor doctors’ prescriptions from the United Kingdom due to Brexit and are currently left empty-handed. “We have developed a relationship with these patients and now have to abandon them.”
Lebbink indicates that the Transvaal Pharmacy will do everything possible to make sure that English patients can obtain their medicine in the future. At the same time, the Dutch Ministry of Health, Welfare and Sport has announced that the Dutch government wants to prevent as many problems as possible as a result of Brexit, “certainly for vulnerable people” and also if it concerns residents of the United Kingdom. “The Netherlands has indicated which steps the United Kingdom can take to solve the problem in practical terms and is in discussion with the British government about this. For this group it is important that a solution is found as soon as possible”, the AD quotes.

Update January 12

On December 9, 2020, Sage Journals published Ending the pain of children with severe epilepsy? An audit of the impact of medical cannabis in 10 patients, in which RR Zafar, AK Schlag and DJ Nutt report a case of series of 10 individuals using CBMP’s in the UK to treat their conditions. This retrospective study suggests that a combination of CBD and THC based products are effective in reducing seizure frequency in a range of epileptic conditions.
See link below.

On january 6, the Dutch Member of Parliament Carla Dik-Faber (ChristenUnie) has sent questions to the Minister for Medical Care on the consequences of Brexit for the supply of Dutch medicines to the United Kingdom. These questions explicitly refer to the situation of the more than 40 British children who are dependent on cannabis oil from the Netherlands. She also questions the solution provided by the UK Department of Health, namely alternatives to cannabis-based medicines that are accessible to British patients, but which are not a solution for Alfie Dingley and the other children. Almost at the same time, the Dutch ministry answered press questions, in which it was again indicated that in close consultation with the English government, a solution is being sought for the supply of products based on medicinal cannabis in both the short and long term.

On Saturday, January 8, The Times also posts an interview with Hannah Deacon. She outlines the seriousness of the condition Alfie suffers from and elaborates on the proposal by the English authorities (DHSC) to use similar alternatives to Dutch cannabis oil available in England, with different cannabinoid profiles. According to Deacon, this is ‘evidence of the DHSC’s “gross misunderstanding of botanical products.”

“Each product is made with a different plant, with different cannabinoid profiles. So it’s not like swapping a generic paracetamol for another one. You can’t just switch and hope for the best.”

Farewell to 2020… And then suddenly everything was a bit different

This year the world has become a little different, both in general and for cannabis as a medicine in particular. I don’t need to say more about the first, as we know the Corona (Covid-19) implications all too well. But for cannabis as a medicine, there has been a small landslide in 2020. A majority in our world is now convinced that cannabis really has medicinal qualities. Or at least the way is open to investigating it further thanks to a positive decision by the UN Commission on Narcotic Drugs (CND) on the last December 2nd.

I have to disappoint anyone who thinks that cannabis has become freely accessible now. According to the UN, cannabis still remains a ‘dangerous’ substance with rather worse than good properties for healthy people. But it is clear that those good properties do exist for people with certain, sometimes really nasty conditions. It offers mankind a route to a whole new class of medicines with natural cannabinoids as active ingredient(s).

Farewell to 2020… And then suddenly everything was a bit different
Tjalling Erkelens

This means that an important barrier in research into the efficacy of cannabis has been removed and, in particular, in the training of doctors, pharmacists and other medical care providers.

For 2021, I hope that we can continue on the right path: On the level of cannabis research, improving accessibility to cannabis medicine for patients in more countries and with regulatory harmonisation. But especially also with education. The next topic on the cannabis agenda should be structural education on cannabis as a medicine for our new generation of doctors and pharmacists.

In particular, concerning the cannabis receptor system (endocannabinoid system) in our human body and the clinical results (and successes) that have been achieved so far. The time is now right as we have finally formally stated that cannabis has medical value.

Despite everything, I wish you all happy holidays and a beautiful 2021.

Tjalling Erkelens

CEO/Founder

Genetic research: Production of THC and CBD really unique for cannabis plant

Scientists are increasingly learning more about the genetic composition of the cannabis plant. All genes have now been mapped so that researchers can study them in-depth.

Dutch plant expert Robin van Velzen has discovered that the genes responsible for making THC, CBD and CBC originated in the cannabis plant. They do not occur, as has been suggested, in the genetically related hop plant. “The question of whether plants that are closely related to the cannabis plant can also make cannabinoids, such as THC and CBD, is virtually ruled out,” said the researcher from Wageningen University, who also works as a scientist for Bedrocan.

Cannabinoid oxidocyclase gene family

Van Velzen, together with fellow researcher Eric Schranz, has analysed available gene sequences from cannabis plants from the Genbank, a worldwide gene database. This genetic research focused on the very last step of biosynthesis. That is the moment when enzymes are controlled to produce cannabinoids, the active substances in the cannabis plant.

Cannabis initially produces CBG (cannabigerol) and then converts it into either THC, CBD or CBC. Van Velzen: “We know which enzymes are responsible for this conversion and which genes are involved. But we didn’t know when these genes originated.” In the research, this gene family is called the cannabinoid oxidocyclase gene family.

In addition, Van Velzen makes a recommendation for the classification of this gene group: “Many genes within this family are still relatively unknown and did not yet have unambiguous names. I compared all gene sequences that are known so far, and then made an unambiguous classification. That improves communication between scientists.”

The results of the research have now been made public in a so-called preprint with the title Origin and evolution of the cannabinoid oxidocyclase gene family. Fellow researchers can now comment on the findings before the result is published in a scientific journal.

cannabinoid oxidocyclase gene family

Comprehensive phylogenetic classification of all currently known sequences, including three main clades and seven subclades (top right corner) that is intended to aid unequivocal referencing and identification of cannabinoid oxidocyclase genes.

Ireland announces permanent delivery service for medicinal cannabis

Patients in Ireland who are prescribed medical cannabis will no longer need to travel to the Netherlands to collect medication, according to Health Minister Stephen Donnelly. A new permanent delivery service – providing medicinal cannabis for Irish patients – will be established, after a temporary delivery service was created in April due to the travel difficulties created by the Covid-19 pandemic.

Delivery of medicinal cannabis to Irish patients to be made permanent

“Many patients and their families have shared stories with both me and officials in my Department about how this initiative has made a huge improvement to their lives”, Donnelly says.

Medicinal Cannabis for Irish patients

“They spoke about the stress of having to travel regularly and the associated health risks with that, as well as their concerns that they would run out of their medication”, says Donnelly. “I am so pleased that these problems will now be a thing of the past for them. There will no longer be a need for them to travel abroad in order to collect their prescribed cannabis products. Instead, they can focus on their health and wellbeing. The welfare of patients and their families comes first and I am happy to reassure them that they will no longer have to personally source their prescriptions.”

See also:

Availability
Bedrocan currently produces medicinal cannabis for patients (under the care of a physician), pharmaceutical companies and researchers from around the world. Availability per country is listed  here

Commission on Narcotic Drugs transfers cannabis to schedule 1

According to some, Wednesday, December 2 will go down in the history books as a historic day. At least, for those involved in medicinal cannabis. Why? Because the United Nations, more specifically the Commission on Narcotic Drugs (CND), has decided to transfer cannabis from ‘Schedule 4’ to ‘Schedule 1’ of the Single Convention. Bedrocan’s Director of Government Affairs Ole Heil responds to question what this change means for Bedrocan. Is this indeed a historical moment?

Commission on Narcotic Drugs transfers cannabis to schedule 1 transfers cannabis to schedule 1
Ole Heil

What is Schedule 4 of the Single Convention about?

‘In 1961 the countries affiliated to the UN signed a treaty in which they make agreements on to deal with drugs. This is popularly called the Single Treaty. However, not all agreements apply to all drugs. There are four categories of drugs, and each category has its own rules. The substances on Schedule 4 have the strictest regime. They are considered to be dangerous and with no positive aspects. Countries are, therefore, prohibited from doing anything with these substances. In fact, it is an unfortunate numbering. Schedule 4 is the toughest category, but Schedule 1 is the second toughest category. The lightest criteria apply to Schedules 2 and 3.’

Has the Commission on Narcotic Drugs now removed cannabis from this strict list 4?

‘That’s right. The World Health Organization already recommended in 2018 to remove cannabis from that toughest list (Schedule 4). This is because the WHO says that there are indeed positive sides to cannabis. The CND voted on this recommendation, and the majority was in favour.’

Can cannabis now be traded freely?

‘No, definitely not. Cannabis is still on Schedule 1 of the convention, the second toughest category. So very strict rules still apply, and cannabis products cannot be traded freely. However, cannabis is no longer seen as “completely bad and absolutely prohibited.” The substances on Schedule 1 are still prohibited substances, but they are recognized as having medicinal value. Research and product development is therefore allowed if a country so wishes.’

So what changes for Bedrocan?

‘Not to spoil the fun, but nothing really changes. It is primarily a symbolic statement. All kinds of legislative changes are needed to have a real impact. Starting with the treaty itself, as it still states that countries must set up an agency which buys the entire harvest if they want to do something with cannabis. If we really want something to change, that article will also have to change.

The symbolism will definitely have much positive influence in the longer term. The Netherlands, for example, is now conducting research into the system surrounding medicinal cannabis and how we want to proceed with it. The outcome of that process will probably look different now with this decision than it would without this decision. For countries that do not yet make medicinal cannabis available to patients, this may be a boost to do something with it.

In short, this decision has no effect on day-to-day business. In the very long term, it can indeed have a positive impact on laws and regulations in the Netherlands and other countries. But as long as they have not yet been changed, nothing will happen in practice.’

If you want to know more, read the MJBizDaily article about this topic. Or read the articles Bedrocan has published about this matter: Will the UN point of view on cannabis be modified or not? and ‘WHO recommendations are likely to change international law’.

Bedrocan supports unique research into pain that is difficult to treat

The Danish Center for Clinical Research will conduct research into the treatment of chronic pain patients who have been prescribed the products Bedrocan® and Bediol®. Bedrocan supports the research financially, together with Nordic Cannabis Research, a research arm of CannGros – distributor of Bedrocan products in Denmark. The researchers will analyse retrospective data from 415 Danish patients treated at the Danish pain clinic Clinic Horsted.

Bedrocan support research into pain

Research into pain: real-patient data

According to Dr. Mikael Kowal, research coordinator at Bedrocan, this is a unique retrospective study: “It is not often that researchers have access to very solid real-patient data on difficult-to-treat chronic pain patients which are using Bedrocan products.”

The aim of the study is to assess the efficacy and tolerability of medicinal cannabis in patients with chronic pain who do not respond adequately to conventional medications.

Among other things, it is examined whether the current conventional pain medication, like opioids, and associated side-effects were reduced after the start of adjunctive medicinal cannabis.

Knowledge about the efficacy and tolerability of cannabinoids, the active substances in cannabis, for medicinal treatment is limited so far. The researchers hope to identify potential indicators of evidence that cannabis can be used as an adjunctive therapy with the aim of reducing pain significantly and, as a result, improving the patients’ quality of life.

The analysis of the retrospective data will focus on patients who were prescribed the medicinal cannabis products Bediol (THC 6.3% | CBD 8%) and Bedrocan (THC 22% | CBD <1.0%) during their outpatient treatment. This involves patients with refractory neuropathic pain, spasticity due to multiple sclerosis or spinal cord injury. Refractory pain means pain that does not respond adequately to conventional therapy.

The research results are expected in mid-2021.

1.9 million euros for research into neuropathic pain

The Dutch government is supporting research into the use of medicinal cannabis in the treatment of neuropathic pain with € 1.9 million. The grant has been awarded to a joint project of the Centre for Human Drug Research (CHDR), a Dutch independent institute that specializes in clinical drug research, and the Leiden University Medical Center (LUMC). Neurologist Geert Jan Groeneveld (CSO / CMO at CHDR and professor of Clinical Neuropharmacology at the LUMC) and Albert Dahan (professor of Anesthesiology at the LUMC) will conduct the research.

The research intends to lead to a specific recommendation of an optimal delta-9-tetrahydrocannabinol (THC) –  cannabidiol (CBD) dosage for the treatment of neuropathic pain in a particular subgroup of patients. In addition, it contributes to evidence for the effectiveness of medicinal cannabis. Bedrocan’s raw materials will be used for the production of the research material.

Geert Jan Groeneveld

Innovative

The research does not look at the entire plant, but purely at the pharmacological effect of THC and CBD. Groeneveld: “We want to approach this research exactly as a drug developer would. As a clinical pharmacologist, you extract the proven pharmacological components from a plant and do research with it. That is also innovative in this research”.

The researchers will very accurately measure the pharmacodynamics and pharmacokinetics of THC and CBD, the effects of both substances on pain and brain function and how the substances behave in the human body.

“We are going to isolate the THC and CBD from Bedrocan cannabis and administer them in tablet form in different proportions. We will then look at the influence of CBD on the effects of THC , and investigate which THC-CBD combination is best for the treatment of neuropathic pain”, said Groeneveld.  The Dutch company Echo Pharmaceuticals from Leiden will produce the tablets for the research.

Healthy subjects

The study consists of two parts. In the first part, healthy subjects will be administered the tablets with different THC and CBD ratios. The first part of the research will show whether the adverse effects of THC, such as getting high or feeling anxious, can be reduced by administering CBD simultaneously. According to Groeneveld, the scientific literature has so far provided conflicting results about this: “To be honest, I do not expect much from CBD alone as a treatment for neuropathic pain. From a pharmacological point of view, it is likely that THC affects pain, but this is less the case for CBD. CBD could have an effect on inflammation, but there is no reason  to use CBD as a treatment for inflammatory pain. We already have Ibuprofen for that. It will only become interesting if the adverse effects of THC, such as feelings of anxiety, can be alleviated by administering CBD at the same time. “

Search for the ideal ratio between THC and CBD

THC (9-tetrahydrocannabinol) and CBD (cannabidiol) are the two most studied active ingredients of the cannabis plant. THC is known for its analgesic effect, but it also causes psychoactive side effects. CBD could lead to pain-relieving effects through other mechanisms. It is believed that CBD may also influence the psychotropic effects of THC by modulating THC binding to the CB1 receptor. However, it is still unclear what the ideal ratio of THC to CBD would be to take advantage of the CB1 modulating effects of CBD while preserving the positive effects of THC on pain. In addition, it is still unclear whether the analgesic effects that some patients experience as a result of CBD use are due to a pharmacological action of CBD, or simply because CBD prevents the metabolism of concomitantly used pain killers. The latter will also be investigated in these studies.

Patients with neuropathic pain conditions

The effects on pain in patients will not be investigated until the second part of the study, after the results of the first study are known. This will provide information on which THC:CBD ratio works best. The second part of the study will take place among a diverse group of 200 patients with different neuropathic pain conditions. Groeneveld: “We are going to phenotype this group very well in advance. This means that we want to know exactly how the neuropathic pain manifests itself specifically in this group. Do patients have demonstrable nerve damage, do they have a personality disorder, are they depressed, or do they have sleep disorders? All these are variables that we are going to map.”

Subsequently, the participants in a crossover study will receive placebo for five weeks, and after a wash-out period, they will receive five weeks of cannabinoid treatment or vice versa. Pain will be measured in each treatment period. Groeneveld: “In patients with clear pain relief, we want to further investigate whether there is a correlation between their variables, such as sleeping problems, anxiety or peripheral nerve damage, and the response to treatment with THC.”

The first part of the study will start in the spring of 2021, and Groeneveld expects the first results in the summer. The second part of the study with the pain patients will start in the autumn and will last at least two years.

Carola Pérez: ‘All European patients deserve the same treatment’

For patient Carola Pérez, it is contradictory. She as a Spanish citizen has no access to medicinal cannabis, while a German, Italian or Dutch patient does. “All European citizens deserve the same treatment, and we all deserve to be treated equally.”

Recently, Pérez, founder of the Dosemociones patient organisation, made a plea for European harmonisation during the digital conference Towards a European Approach on Medicinal Cannabis. “How is it possible that an Italian fibromyalgia patient can get the treatment that I can’t have as a Spanish citizen?”

She spoke with other patient organisations at an online meeting of European parliamentarians, organisations and policymakers from the European Commission, organised by Medicinal Cannabis Europe. “The European Union has to take control. All European citizens have the same rights and the same obligations, and we all need the same support”, she stated.

Carola Pérez

Carola Pérez

Carola Pérez has suffered from severe pains since she was eleven after breaking her coxes bone while skating. After more than ten back surgeries, she still has to spend fifteen hours a day laid down on her belly every day.

Among other things, she is the founder of the Spanish patient association Dosemociones, where she advises and supports other patients who want to use cannabis for medicinal purposes.

As president of the Spanish Medicinal Cannabis Observatory and in her work as patient council coordinator for the International Association for Cannabinoid Medicines (IACM) she is committed to the regulation of therapeutic cannabis in Spain and abroad.

Home grower

Carola is a home grower because she has no access to medicinal cannabis products in her country. According to her, the black market and social clubs do not always offer a reliable alternative. But caring for her plants worries her. Every two years, she undergoes an operation that prevents her from taking care of her plants for a long time: “Patients shouldn’t have to make their own medicines. We are entitled to safe and reliable products, just as any standard medication.”

Legal framework

European rules should be equalised today rather than tomorrow. But unfortunately, it is not that simple. Medicinal cannabis and its derivatives have not been officially registered as medicines yet. They are made available in some countries under special access schemes. Maja Léon Grzymkowska is a policymaker at the European Commission department dealing with food safety and public health (DG SANTE). “I understand the difficulties for patients. But unfortunately, the basic principle is that any medicine must first be authorised to be placed on the EU market. The legal framework requires product developers  to submit an application for marketing authorisation. With reliable and complete data to support quality, safety and efficacy.”

In addition, according to Grzymkowska, the term medicinal cannabis is not well defined from a regulatory point of view. During the digital conference, she stated: “It is a category of products and not specific enough for pharma legislation. The first step would be to agree on a common definition. Based on this terminology we can gather data to support marketing authorisation claims.” Grzymkowska also sees opportunities, namely, to better tailor research projects to the needs of the patient.

European Parliament

One of the members of the European Parliament, who is committed to improving EU regulation is Frédérique Ries. She also spoke during the webinar: “More MEPS really want to move this forward. It is terrible for us as policymakers to hear that patients do not have access. Of course, they deserve the same rights. We need a single European approach on medicinal cannabis, and that starts with a unique definition of the correct terminology. It is not well defined yet, and it must be. Patients’ rights should be equal throughout Europe, and they should be able to take their treatment with them when they travel.”

Our endocannabinoid system explained

Like in the case of the opioid system reacting to opioids (morphine, codeine), humans have a distinct receptor system for cannabinoids. The endocannabinoid system contains cannabinoid receptors and influences the activity of many other body systems. The phytocannabinoids of the cannabis plant work in a similar way to our naturally produced endocannabinoids.

Cannabinoid receptors

The human brain and other organs contain naturally occurring cannabinoid (CB) receptors and the chemicals that bind to them. This is called the human endocannabinoid system (ECS). The system’s role is to maintain our body’s ability to function normally by influencing the functioning of other systems. It plays a critical role in our nervous system, and regulates multiple physiological processes. This includes the adjustment of our response to pain, appetite, digestion, sleep, mood, inflammation, and memory.

The endocannabinoid system also influences seizure thresholds (i.e. in epilepsy), coordination, and other processes such as the immune system, heart function, sensory integration (touch, balance, sense of space), fertility, bone physiology, the central stress response system (the HPAA), neural development, and eye pressure.

Cannabinoid receptors

Endocannabinoids

Humans produce their own cannabinoids, the endocannabinoids. These endocannabinoids act on, or stimulate, the cannabinoid receptors. These compounds act in a similar way to phytocannabinoids which also bind to the receptors. The plant cannabinoids are called phytocannabinoids. They are the unique constituents of the cannabis plant. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the main constituents. There are other cannabinoids, but currently far less is known about them.

For example, the CB1 receptor is located in a number of regions of the brain which control various physical and behavioural functions. As a result, cannabinoids influence sensory and motor responsiveness (movement), heart rate, emotional reactions, appetite and nausea/vomiting, sensitivity to pain, learning and memory, and high-level decision making. As our knowledge of the human endocannabinoid system develops so will our understanding of how the phytocannabinoids, THC, CBD and other cannabinoids work. This understanding will lead to better medicines.

Endocannabinoidsystem (EDS)

GPCRs

Cannabinoid receptors are G-protein-coupled receptors (GPCRs). GPCRs are found on the surface of our cells. These receptors are said to ‘act like an inbox for messages, talking with cells and therefore our body’. GPCRs have a great number of functions in the human body. As a result, many medicines, including medicinal cannabis, work on GPCRs. Humans produce endocannabinoids which interact with the GPCRs CB1 and CB2. We know the most about the endocannabinoids anandamide (AEA) and 2-arachidonoylglycerol (2-AG).

The problem with CBD oil

The quality of CBD oil, and other CBD products, on the global market varies drastically. From pharmaceutical quality, prescription medicines, to those which are of dubious quality, and in some cases outright dangerous.

There has been a lot of interest, and indeed, investment in cannabidiol (CBD). This is partly because, unlike THC, it is not intoxicating. [1] [2] It has also been re-scheduled in a number of countries, permitting use as a prescription medicine. [3] [4] In the background of regulatory change, CBD has been showcased globally as a wonder drug – almost a panacea.

The rise in use of CBD oils, or any other product containing CBD, reflects a sharp rise in self-medication. The trend is underscored by the population risk of taking high doses of a medicine we still know very little about. [5]

Medicinal cannabis oil

The rise of CBD oils

‘Charlottes Choice’ ignited a storm – the online video and story went viral. ‘CBD oral dosing reduced a young child’s epileptic seizures brought on by Dravet syndrome.’ [6] [7] [8] Media coverage increased CBD oil demand, [9] while political power plays promoted accessibility. [10]

While anecdotal reports sparked interest cannabinoid treatments, the lack of clinical evidence did not support safety or efficacy. Subsequently, GW Pharmaceuticals published solid research supporting the use of CBD in treatment resistant epilepsy (i.e. Dravet syndrome and Lennox-Gastaut Syndrome). Epidiolex™ then received FDA approval. [11]

In the background, rapidly moving away from the epilepsy focus, CBD was gaining momentum in other conditions. With the great promise of its therapeutic potential, combined with the lack of regulatory oversight, a huge, worldwide market for (unregulated) CBD products has emerged. [12]

Unregulated, or poorly regulated products are a problem for consumers and patients alike. The cannabinoid composition may not be correctly disclosed, nor checked by a certified control laboratory. Products may contain no CBD at all, while others may contain high doses of THC. [13] Such dubious products may also include residual manufacturing solvents, and contaminants such as microbes, pesticides, heavy metals or mycotoxins.[14] Besides posing a health threat to consumers, the lack of product consistency makes it difficult to evaluate the therapeutic effects. [15]

The demand for CBD is expected to markedly increase if CBD becomes available for use as wellness products (e.g. lotions, balms, oral drops), and, or is incorporated into consumer products (i.e. beverages and other food stuffs). This trend may be partly driven by the might of the alcohol industry, with the likes of Constellation Brands (an alcohol company) and Canopy Growth Corporation (a Canadian recreational/medicinal cannabis producer) weighing into the market. [16]

Can CBD be harmful?

There seems to be a global concensus that CBD is safe, without harm. Perhaps this is driven by that it is not intoxicating, alongside its relative success certain specific cases.

The FDA are deliberating this very issue “there are many unanswered questions about the science, safety, and quality of products containing CBD”. [17] As such, if CBD is shown to be a risky substance, causing harm such as toxicity to the liver, the entire industry that has invested so heavily in it will fall under heavy scrutiny. Many companies could fail.

CBD is a medicine, so always consult a doctor

Given CBD affects the endocannabinoid system, it can also disrupt that system. There are also many unknowns about CBD, especially about the long term use and in high daily doses. [18] [19]

Some side-effects from CBD might include fatigue, diarrhoea, decreased appetite, and weight loss. [20] [21] Furthermore, CBD is typically an adjunct treatment (taken with other medicines) and is metabolised by the liver cytochrome P450 enzymes (CYP450). When taken together with other medicines metabolised by the CYP450 system, there is the potential for drug-drug interactions. [22] Finally, dose adjustment is recommended in patients with moderate to severe hepatic impairment, to reduce burdening the metabolic process. [23]

Widespread ‘self-medication’ poses risks beyond poor quality products. Consumers or patients should be encouraged to ask about or inform health professionals before trying CBD. Health professionals should suggest using only reliable, safe and standardised products, preferably of pharmaceutical quality. Typically, this would mean accessing products from a pharmacy.

A reputable CBD oil, or any CBD product, will have a Certificate of Analysis (CoA) to confirm the label claimed CBD content (milligrams per millilitre (mg/mL)), and that it is free of contaminants. A CoA is produced by an external, independent contracted laboratory. Ask for this. [24] A quality product is also likely to have online reviews, which can be compared with the CoA.

Quality is the question for the CBD oil market

CBD products can be purchased online, are distributed through informal cannels, or from the drug store. In Europe and the USA, many are sold as a food supplements, with most not having been approved by the European Food Safety Authority (EFSA) or Food and Drug Administration (FDA).

Quality control and standardisation is very important. The use of sub-standard materials and methods to produce CBD medicine, for example, risks batch-to-batch variation and the potential for medicine contamination (i.e. toxicity) [25] [26] [27] [28] [29]. Good quality products are produced by pharmaceutical companies, or a compounding pharmacy. The manufacturing process assures consistent strength, purity and the monitoring of the manufacturing operations. Unregulated producers cannot assure consumers and patients this level quality.

In sum, there is a dire need to confirm the clinical value of CBD, as well as to properly regulate its quality and distribution as a potential medicinal product.

References

[1] Kowal, M., Hazekamp, A., Colzato, L., van Steenbergen, H., Hommel, B.. (2013). Modulation of cognitive and emotional processing by cannabidiol: the role of the anterior cingulate cortex. Frontiers in Human Neuroscience. 7

[2] Mechoulam, R., Parker, L., Gallily, R. (2002). Cannabidiol: An Overview of Some Pharmacological Aspects. The Journal of Clinical Pharmacology. 42(S1):11S-19S

[3] For example, New Zealand currently permits CBD as a prescription medicine, while Australia is currently considering low dose CBD as Pharmacy Only Medicines.

[4] Despite its widespread use, CBD remains a controlled drug. The UN Single Convention 1961 lists cannabis and preparations in Schedule I (extracts and tinctures) and IV (cannabis and resin). Given CBD is derived from cannabis, it is a controlled drug.

[5] WHO (2018). Cannabidiol critical review report. WHO Expert Committee on Drug dependence. Geneva; June 2018. . Retrieved online 28 October 2020

[6] Marijuana stops child’s severe seizures. Retrieved online 28 October 2020

[7] Charlotte’s Web CBD products: 2020 review. Retrieved online 28 October 2020

[8] Charlotte’s Web. Retrieved online 28 October 2020

[9] Example. Epilepsy patients flock to Colorado after medical pot gives them hope. Retrieved online 28 October 2020

[10] Example. Medicinal cannabis: Victorian families hopeful as state grows crop to treat children with severe epilepsy. Retrieved online 28 October 2020

[11] FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy.U.S. Food and Drug Administration. Retrieved online 28 October 2020

[12] Dance, a. (2019).  As CBD skyrockets in popularity, scientists scramble to understand how it’s metabolized. Nature magazine on November 14, 2019. Retrieved online 28 October 2020

[13] Hazekamp, A. (2018). The trouble with CBD oil. Med Cannabis Cannabinoids;1:65–72

[14] Romano, L & Hazekamp A. (2013). Cannabis Oil: chemical evaluation of an upcoming cannabis-based medicine. Cannabinoids;1(1):1-11

[15] Freeman, T., et al. (2019). Medicinal use of cannabis based products and cannabinoids. BMJ 2019;365:l1141

[16] What Constellation Brands’ massive investment in Canopy Growth Corp. means for both companies. Retrieved online 28 October 2020.

[17] FDA consumer updates. What you need to know (and what we’re working to find out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. Retrieved online 28 October 2020

[18] Ibid.

[19] Huestis, M., et al. (2019). Cannabidiol adverse effects and toxicity. Curr Neuropharmacol. 2019 Oct; 17(10): 974–989

[20] Epidiolex. Highlights of prescribing information. Retrieved online 28 October 2020

[21] Iffland, K., & Grotenhermen, F. (2019). An update on safety and side effects of cannabidiol: A review of clinical data and relevant animal studies. Cannabis Cannabinoid Res. 2017; 2(1): 139–154.

[22] Lucus, C., et al. (2018). The pharmacokinetics and the pharmacodynamics of cannabinoids. Br J Clin Pharmacol (2018) 84 2477–2482 2477

[23] Ibid

[24] See this reference for advice. Chesak, J., (2019). Reading a CBD label: How to find a quality product. Retrieved online 28 October 2020

[25] Hazekamp, A. An evaluation of the quality of medicinal grade cannabis in the Netherlands. Cannabinoids 2006;1(1):1-9

Compared to pharmaceutical cannabis, non-pharmaceutical cannabis has been found to contain less cannabinoids, is contaminated with bacteria and fungi, and often will contain the pesticides, fungicides or heavy metals.

[26] Bettiol et al. (2019). Galenic preparations of therapeutic Cannabis sativa differ in cannabinoids concentration: A quantitative analysis of variability and possible clinical implications. Front. Pharmacol., 17 January 2019 |

[27] Calvi, L., et al. (2018). Comprehensive quality evaluation of medical Cannabis sativa L. inflorescence and macerated oils based on HS-SPME coupled to GC-MS and LC-HRMS (q-exactive orbitrap®) approach. J Pharm Biomed Anal. 2018 Feb 20;150:208-219

[28] Hazekamp, A. (2018). The trouble with CBD oil. Med Cannabis Cannabinoids;1:65–72

[29] Romano, L & Hazekamp A. (2013). Cannabis Oil: chemical evaluation of an upcoming cannabis-based medicine. Cannabinoids;1(1):1-11

Study finds: Medicinal cannabis oil can reduce migraine attacks

Medicinal cannabis oil, based on the raw materials Bediol and Bedica, may have a positive effect on the severity and frequency of migraine attacks. This is evident from a cross-sectional retrospective study, in which patients completed a questionnaire about their experiences with the use of cannabis oil. The patients were approached by the Transvaal Pharmacy in The Hague. According to the researchers, medicinal cannabis oil could serve as a possible alternative for migraine attacks from a pharmacological point of view.

Strongest decline

Bediol oil was the most prescribed in the participating patients and showed the strongest decrease in the number of migraine attacks per month and their severity. Bedica oil also showed a significant decrease in the number and severity of the migraine attacks. Bedrocan cannabis oil does not appear to have an effect on the frequency and severity of the migraine attacks.

Medicinal cannabis oil is administered sublingually drop by drop. Medicinal cannabis flos, the dried version, is used in evaporated and edible forms, among others.

Migraine & Menopause

The average age of the consulted patients was 54 years old. Of these, about 80% were women, and most women were around the menopause age. According to the researchers, this may have played a role in the positive results with women. Studies show that most women who suffer from migraines see improvement after menopause. However, other studies suggest that migraines seem to worsen in women after menopause. According to the researchers, it is therefore not possible to affirm with certainty that menopause had a positive effect on the results with women.

Side effects

Furthermore, the questionnaire asked about five direct side effects, namely: nausea, drowsiness, nervousness, nightmares and memory loss. With the use of medicinal cannabis oil, nausea and drowsiness were mainly reported as side effects.

However, there were more patients with a decrease in nausea than with an increase. According to the researchers, this can be considered a therapeutic effect rather than a side effect. This decrease was mainly due to the use of Bedica oil. As a result of this study, Bedica oil could be recommended for patients who suffer from nausea during a migraine attack.

To confirm this study’s findings and to include medicinal cannabis oil in current migraine treatment guidelines, the researchers argue that randomized, controlled clinical trials with a larger study population are desirable.

Cannabis studies with Bedrocan products

Over the years, Bedrocan cannabis has been used in many scientific studies. Initially, research focused on a better understanding of the pharmacology of cannabis and its components. However, many cannabis studies involving human subjects also investigated the psychopharmacological effects of Bedrocan products. While more recent research has aimed at exploring the clinical applications of cannabis in patients.

When possible, Bedrocan supports independent research, and we are open for collaboration with academic and medical institutions, such as the LUMC.

We believe that supporting scientific research contributes to our mission to bridge the gap between patients’ needs and the regulatory demands of modern medicine.

Please check the updated list for an overview of published researches with the use of Bedrocan cannabis.

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