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Bedrocan opens its own cannabis Clinical Research Unit

Bedrocan, which for years has only supported external researchers financially, has opened its own Clinical Research Unit to conduct research into the effects of the cannabis products it produces on behalf of the Dutch government. Dutch cannabis researcher Matthijs Bossong will lead the Clinical Research Unit in Utrecht, Netherlands.

The Clinical Research Unit has long been a wish of Bedrocan’s Chief Scientific Officer Mikael Kowal: “Much research is being done worldwide with these products, but then other scientists decide what is being investigated. Now, we take the lead by conducting our own research.”

The first study has already been approved by a Medical Ethics Committee. Mikael: “We will take a closer look at two products: Bedrocan® and Bediol®. The study will determine the risk factors of cannabis use and hopefully serve as a guide to patients on how to use these products safely, i.e. in a way that does not cause anxiety or psychotic symptoms.”

Clinical Research Unit with Matthijs Bossong & Mikael Kowal
Matthijs Bossong & Mikael Kowal

Chronic pain

The future plan is to put together a cohesive clinical research program that addresses relevant scientific issues, such as chronic neuropathic pain. Matthijs Bossong: “There is scientific evidence that medicinal cannabis can help with certain conditions, including chronic pain. However, the problem with clinical research with cannabis is that there are large differences between studies. For example, the administration route, dosage and cannabis composition may vary, which makes the results difficult to interpret. We will conduct research with the standardised products Bedrocan produces, which will hopefully contribute to the willingness of doctors to prescribe medicinal cannabis.”

Clinical Research Unit

CEO Jaap Erkelens is very pleased with the opening of Bedrocan’s research unit: “Bedrocan can now conduct targeted research into the effects of the cannabis products it produces on behalf of the Dutch government. That is the only way to obtain official recognition of the safety and efficacy of these products by regulatory authorities worldwide. This is a goal the company has always strived to achieve, and now it is one step closer with the opening of the Clinical Research Unit.”

Bedrocan is an EU GMP-certified producer of pharmaceutical-grade medicinal cannabis. The high-quality products are used as pharmaceutical raw materials and active pharmaceutical ingredients (APIs). Bedrocan operates multiple indoor cultivation facilities and an R&D facility in the Netherlands. Soon, a brand new production facility will open in Denmark.

Canadian patients struggle to access consistent cannabis treatment

Since Canada legalised the recreational use of cannabis in 2017, a lot has changed for patients who use medicinal cannabis. While access was expected to be facilitated, patients are actually struggling to get products with consistent quality and content. Here, patients, a doctor, and a patient organisation talk about how they see the current medicinal cannabis system in Canada.

Canadian patients struggle 1
Canadian patient Patricia McGill

Mother of six and grandmother of four, Patricia McGill has been using medicinal cannabis for twenty years. She has been a therapeutic riding instructor in both Quebec and Nova Scotia. In 2003, she suffered an injury which generated a Reflex Sympathetic Dystrophy condition, known for causing chronic pain. She was prescribed other drugs but experienced negative side effects, so her doctor prescribed medicinal cannabis.

Before and after legislation

As a patient from before the legalisation of recreational use in Canada, Patricia sees the differences before and after the legalisation in 2017: “The access to cannabis has been increased, but not in a positive way. The places where you get the cannabis have no qualified personnel, and the quality of the products have significantly decreased once companies started to produce for both recreational and medical markets.”

Patricia also experiences problems with availability: “Sometimes the product I was using is no longer available the next time I go pick it up.” According to her, patients also face the challenge of a shortage of qualified general practitioners in Canada: “The doctor that used to treat me has now retired. My new doctor does not want to prescribe cannabis because he has no knowledge about it. Now, I have to go to a doctor from a specialised company who will give me a prescription based on my condition and history. Prescribing medicinal cannabis should be taught in all medical schools.”

One Canadian doctor who prescribes medicinal cannabis is Dr Andrew Cooper. He is an anaesthesiologist with thirty years of experience in general practice, anaesthesiology, and critical care medicine. He prescribes medicinal cannabis in his clinic in Caledon, Ontario, and believes the priority should be keeping patients away from the illegal market: “Unfortunately, the illegal cannabis industry is winning the price war with the legal cannabis industry. The legal cannabis industry must comply with very stringent standards for security, storage, and quality control, along with all the associated costs. I would like to see the standards relaxed so they can enter into competition with and defeat the illegal industry.”

Dr Andrew Cooper
Dr Andrew Cooper

Recreational and medicinal use

Unlike Patricia, Dr Cooper believes that cannabis for recreational and medicinal use are both suitable for patient use. “Products sold in retail stores are identically analysed and labelled as medical products. They have the necessary labelling of chemovar and milligram (mg) content. I differentiate between non-medical legal and non-medical illegal. If patients source their products from illegal sources, I express concern about quality or adulteration, and I encourage them to source from the legal streams.” However, he believes it would be better to have a traditional pharmacy model for medicinal cannabis in Canada: “A traditional pharmacy model incorporates fewer steps than the current system and would be much more efficient.”

Robert Featherby
Canadian patient Robert Featherby

Patient Robert Featherby, 50, has chosen a different route: home cultivation.
Robert lives in Victoria, British Columbia. In his early twenties, he had a serious ankle injury. After an unsuccessful surgery to repair it, he was left with chronic pain. Doctors prescribed him different medications, but he got all sorts of negative side effects. Robert then decided to “self-medicate” with cannabis meant for recreational use, which also did not generate positive results.

CBD flowers

After many years, his doctor finally prescribed medicinal cannabis to help him cope with the pain: “I discovered the benefits of CBD flowers and oils. Initially, my doctor set me up with a Canadian company that had a very inconsistent supply of CBD products, and the quality of the flowers was questionable. When I spoke to my doctor about the issues of supply and quality, he recommended products from Bedrocan. This is when everything really improved for me. Nothing helped with the pain like the flower that contains higher CBD and little THC. It literally changed my life.”

When Canada legalised recreational use, Robert started cultivating cannabis for his treatment because he did not trust the quality of other products: “At the point that recreational cannabis was legalised in Canada, there were still very few CBD options, and none of them were good quality. This is when I decided to start growing my own cannabis. I am growing mostly CBD plants and have discovered a few that work well.”

While Robert consciously chose to grow cannabis at home, other Canadian patients rely on their doctors. According to Max Monahan-Ellison, Board Chair of patient organisation Medical Cannabis Canada (MCC),  patients in Canada struggle to find support from healthcare professionals (HCPs): “I can say that support from HCPs is minimal. That comes down to a lack of investment in evidence-based training in Canada, and the government’s own healthcare data provided for HCPs is little and out of date.” The patient organisation strives to ensure patients can access medicinal cannabis treatment safely, equitably and with the support of healthcare professionals.

Changing the cannabis legislation

The Canadian government has recently started a review of the cannabis act. Max: “The Cannabis Act is structured to prevent misuse instead of encouraging safe and accessible use with a medical authorisation.” MCC is currently completely focused on the review for the maintenance of a robust medical framework and released a 5,000+ collaborative patient study identifying barriers in the framework, cited by Health Canada’s expert panel: “People who use cannabis as a treatment should be accessing it with the support of a healthcare professional and with needed coverage to ensure affordability, but the system pushes them away. This is our chance to really make a difference, and that is why we have invested all of our energy to push for real patient-driven changes in this review.”

Bedrocan products in Canada

Bedrocan-branded products used to be available in Canada. However, after the legalisation of recreational use and the decision of the licensee Canopy Growth to enter the recreational market, Bedrocan decided to sell its shares and leave the Canadian market. An arbitration also prohibited Bedrocan from returning to Canada until 2019. Bedrocan has always had the ambition to return to the Canadian market and hopes the cannabis legislation in Canada changes in a way that medical and recreational use are clearly separated, and patients are given access to pharmaceutical-quality products with proper healthcare guidance.

Study: Long-term use of medicinal cannabis improves quality of life

The majority of patients say their quality of life has improved since using medicinal cannabis. The Netherlands pharmacovigilance centre Lareb and the Office of Medicinal Cannabis (OMC) have studied Dutch patients’ experience with medicinal cannabis and published the results in the December 2023 issue of Dutch Pharmaceutical Weekly magazine (PW). The article concludes that patients who use medicinal cannabis for more than six months see an improvement in their quality of life. However, some side effects are also mentioned, such as dizziness, drowsiness, dry mouth, headache and increased appetite. A negative side note is that ‘many users find the costs a barrier, as medicinal cannabis is not eligible for reimbursement in the Netherlands.’

Quality of life

The researchers write in the PW: “The majority of participants (87%) agree that their quality of life has improved since using medicinal cannabis. This is especially true for patients who use it for more than six months (93%). Of the patients who used it for less than six months, a smaller proportion believe that their quality of life has improved (62%) and 33% are neutral about this. The most frequently mentioned explanation for an improvement in quality of life is that the symptoms are under control, sleep is improved and the number of symptoms is reduced.”

Medicinal cannabis

Medicinal cannabis is an unregistered medicine that can only be prescribed by a doctor. Indications for which cannabis is used include chronic neuropathic pain, palliative treatment of HIV/AIDS and cancer, epilepsy, chemotherapy-related nausea and vomiting, and treatment-resistant glaucoma. However, the Dutch Association of General Practitioners (NHG) does not recommend the use of medicinal cannabis because there is still too little scientific evidence about its effect. In the coming years, Bedrocan will conduct its own research into the effects of medicinal cannabis.

SyqeAir Inhaler approved by the Therapeutic Goods Administration (TGA)

The high-tech, metered-dose SyqeAir Inhaler, which contains Bedrocan® material, has been officially approved by the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods (ARTG). Bedrocan is thrilled with Syqe’s historic achievement.

CEO Jaap Erkelens: “Syqe has reached an incredible milestone. The TGA’s approval sets a positive example in the global regulatory environment for medicinal cannabis. Bedrocan has always advocated for the proper registration of medicinal cannabis products through official regulatory pathways. Syqe’s achievement needs to be celebrated by everyone who strives for medicinal cannabis to be seen and regulated as a pharmaceutical product.”

SyqeAir is the first metered-dose cannabis inhaler to obtain the ARTG register. The device has been available on prescription in Australia since January this year.

Pharmaceutical-grade device

The Israeli MedTech company has spent eight years developing the device with a strong focus on meeting pharmaceutical standards and dosage precision. The advanced technology developed by Syqe allows the inhaler to deliver metered and consistent doses of THC along with all other cannabinoids and terpenes found in full-spectrum cannabis. The inhaler includes a pre-loaded cartridge containing 60 uniform doses of pharmaceutical-grade, standardised Bedrocan® product.

SyqeyAir 2023

Research-based

There are several real-world evidence publications related to the device. It has also been used in a number of clinical trials. Among other things, the studies demonstrated that with medicinal cannabis administration using the SyqeAir Inhaler, patients experienced a reduction in pain intensity and improved sleep and quality of life, with little adverse effects compared to other routes of administration.

Irradiation does not affect medicinal cannabis

Gamma-irradiation does not cause significant changes in the composition of medicinal cannabis. A recent study has shown that the most important therapeutically active components THC and CBD are not affected by the radiation. Herbal cannabis products, often used by vulnerable patients, are treated by gamma-irradiation to free them from contamination with potentially harmful microbes. Patients have occasionally expressed their concerns about the effects of irradiation treatment on medicinal cannabis. Some have claimed a change of taste or effect, while others worry about changes in the chemical composition or the quality of their medicine.

Irradiation treatment

The study evaluated the effects of irradiation treatment on four different cannabis varieties covering different chemical compositions. Samples were chemically analysed before and after standard gamma-irradiation treatment. In addition, water content and microscopic appearance of the cannabis flowers was evaluated.  The effect of gamma-irradiation was limited to a slight reduction of some terpenes present in the cannabis, but keeping the terpene profile qualitatively the same. No effects on THC or CBD content was observed.

Recommended method of decontamination

Based on the study results gamma-irradiation of herbal cannabis remains the recommended method of decontamination, at least until other more generally accepted methods become available.

How is Bedrocan’s cannabis irradiated?

For twenty years now, medicinal cannabis, which Bedrocan produces in the Netherlands on behalf of the Office of Medicinal Cannabis (OMC), is also irradiated. This process is also called sterilisation. The article How is Bedrocan’s cannabis irradiated? offers an insight into how the irradiation process works.

How is Bedrocan’s cannabis irradiated?

All Bedrocan’s cannabis products manufactured in the Netherlands are gamma-irradiated by an external company. This has been contracted by the Dutch government. We have written before about how gamma radiation does not change the medicinal cannabis’ composition and how irradiation is necessary to ensure a sterile product for patient use. However, this is the first time we offer an insight into how the irradiation process works.

Gamma radiation, so-called ionising radiation, is the same type of radiation used in X-rays. Gamma rays are deadly to microorganisms, including fungi, viruses and bacteria. Gamma radiation, generated by Cobalt-60 isotopes, is also very harmful to humans. That is why an irradiation company must have a special room, a type of bunker with walls of 2.5 to 3 meters thick concrete, where the products are irradiated. Employees and visitors are not allowed to enter it.

Cannabis Flos Lr 42

In the Netherlands, mainly medical and hospital equipment is irradiated with gamma rays, such as heart valves, baby bottles, knee prostheses, and contraceptive implants. For twenty years now, medicinal cannabis, which Bedrocan produces in the Netherlands on behalf of the Office of Medicinal Cannabis (OMC), is also irradiated. Sterilisation, as the process is euphemistically called, is done 24 hours a day, seven days a week, and is fully automated. All kinds of medical products go into the bunker inside a box through a conveyor belt. Cannabis is treated in the bunker for about 1 to 1.5 hours.

In addition to medical equipment and medicinal cannabis, food is also irradiated in some countries. This is done to reduce microorganisms in food and extend shelf life. The EU tracks which foodstuffs are irradiated annually in the European Union. According to the latest figures from 2019, the three most commonly irradiated products are frog legs (65.1%), poultry (20.6%) and dried aromatic herbs, spices and vegetable seasoning (14.0%). In the EU, the irradiation of foodstuffs is limited and must certainly not replace hygienic conditions. Irradiated food or ingredients must be labelled as such.

However, in America and Asia, food irradiation is more common. This mainly concerns meat and fruit. According to the US Food and Drug Administration (FDA), irradiation does not affect nutritional quality or change the taste, texture or appearance of food.

Nuclear cannabis

Still, patients are concerned. This is mainly due to the lack of clarity on how cannabis is irradiated. While most European countries have clear regulations, American cannabis growers, for example, have unclear rules. Cannabis that has failed a contamination test can be subsequently irradiated so it can still be sold, according to an article by MJBiz Daily. “Generally because of bad microbial growth due to poor sanitation in the grow and processing stages – growers will have to nuke it.”

Cannabis medicinal

“Nuke” suggests that irradiation is associated with nuclear contamination or radioactive danger. But is that so? Is nuclear energy released? The answer is clear: Gamma irradiation has nothing to do with radioactive contamination. Some people have negative associations with the word ‘radiation’, but the gamma irradiation process is entirely safe. The process kills microorganisms and cleans the products. Products sterilised in this way are entirely free of radiation after treatment. In fact, these products are safer after the irradiation process and also have a longer shelf life.

Why to irradiate?

As a natural product, cannabis cannot be 100% free of microorganisms, even when grown in a strict-controlled environment. Non-irradiated cannabis may contain traces of microbes or fungal spores. These can be harmful to health. For example, some Aspergillus fungi, present all around us, can cause severe illnesses. Patients with reduced resistance are particularly more vulnerable. Therefore, governments that make medicinal cannabis available require some form of sterilisation.

The effects of gamma-irradiation for decontamination of medicinal cannabis

The blue glow of cobalt

Cobalt is a crucial part of batteries in, for example, a smartphone. This mineral is mainly mined in African cobalt mines. In only a limited number of locations in the world, cobalt is converted into Cobalt-60, the isotope that generates the final gamma rays. The largest reactor is in Canada. Cobalt-60 is supplied in granular form in long metal rods. An irradiation company has hundreds of such rods in use. When the irradiation installation is out of operation, these rods are submerged in water, giving off the well-known cobalt blue colour. Water, like the thick walls, blocks the radiation. The bunker is built like a labyrinth so the radiation cannot leak.

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