Bedrocan’s medicinal cannabis production not affected by COVID-19 crisis

In an online video interview with Marijuana Business Daily, CEO Tjalling Erkelens explains that the measures to curb the spread of the coronavirus do not yet affect Bedrocan’s production of medicinal cannabis. You cannot keep patients waiting for medication, which is why the company has taken all the necessary measures to ensure that production – which serves many patients in Europe – goes according to plan. “We can produce for the next few months undisrupted”, says Erkelens.

According to Erkelens, the coronavirus outbreak once again underlines the importance of scientifically based knowledge and, thus, also scientific research. “These uncertain times will hopefully teach us that money is way less important than people’s health. We have to lean on science as our guide in staying healthy.”

Coronavirus update from Bedrocan

We are in a strange and uncertain time. In just a few weeks, the coronavirus has changed our lives completely. Health has become everyone’s primary concern.

At this moment, Bedrocan´s production and supply chain are not affected. As standard, we maintain several months of supply for our critical stocks. Also, in case of a crisis, we can continue to function as normal with minimal personnel. That is the advantage of working within a highly controlled environment where little human action is required.

Bedrocan did, of course, implement several measures in line with the recommendations of the Dutch authorities. For instance, all our office personnel is working from home and all travels, company visits and external meetings have been cancelled.

From a sales perspective, we are not affected. All orders from our sole client (the Office of Medicinal cannabis, part of the Dutch Ministry of Health) are executed as usual and delivered at the agreed times for now.

At Bedrocan, we hope that during these days everyone can find their way, no matter how difficult the situation is. Ultimately, it is all about our health and that binds us all.

Fibromyalgia and medicinal cannabis. An update.

Bedrocan is always glad to explain to scientifically educated public the (im)possibilities of medicinal cannabis for certain disorders. Dr. Mikael Kowal, clinical trial coordinator at Bedrocan International, was a guest at the annual conference of the Norwegian organization Norsk Smetteforening in the Rikshospitalet in Oslo, where healthcare professionals and scientists met to discuss the latest scientific developments in pain management. Kowal gave a concise presentation about the study conducted by the Leiden University Medical Center (LUMC) into the effects of medicinal cannabis in fibromyalgia patients. This research, previously published in the scientific journal Pain, is regarded as the first randomised, placebo-controlled, crossover study on the therapeutic effects of inhaling different types of standardised medicinal cannabis in fibromyalgia patients.

The research showed that THC-containing medicinal cannabis reduced the sensation of pressure pain in patients. The results of this study are hopeful, says Kowal. “It appears that at least two THC-containing varieties – which are now prescribed to patients in different countries – may bring pain relief. Especially the variety containing a standardised mixture of THC and CBD seems most promising in this regard. The outcome is important for fibromyalgia patients. It can help with further acceptance of medicinal cannabis by healthcare professionals, so that there is less discussion about prescribing it.”

Updates

Medicinal cannabis and opiates

Dr. Kowal’s presentation naturally raised questions. The most important one: can medicinal cannabis play a role in reducing opiate use? As is well known, opiates such as oxycodone are increasingly being prescribed and there is now widespread abuse worldwide, resulting in a real opiate crisis in various countries. “The researchers at the LUMC also immediately thought of the problems that opiate use can cause,” says Kowal. “Principal Investigator Prof. Albert Dahan and his team have not only demonstrated that cannabis containing THC may be effective in fibromyalgia, but are also in the process of preparing a follow-up study to see if medicinal cannabis can reduce the use of opiates. The research team suspects that you do not have to prescribe much oxycodone if you also allow patients to use a standardised mixture of THC and CBD .”

Will the UN point of view on cannabis be modified or not?

Will it come to a vote in March or not? To date it is unclear whether the Commission on Narcotic Drugs (CND) will adopt the six recommendations from the World Health Organization (WHO) regarding the reclassification of cannabis. The European Commission advises EU Member States to reject one of the recommendations and to postpone the vote on other two recommendations. Does this mean the loss of an historic moment, where cannabis is ascribed medicinal value by the highest health organisation for the first time in history?

The Dutch expert on UN Drugs Conventions, Martin Jelsma, associated with the Transnational Institute, doesn’t think so. “In case one or several WHO recommendations are not adopted, countries may continue with medicinal cannabis. That happens anyway.” In addition, member states should not question the scientific opinion of the Expert Committee on Drug Dependence (ECDD), the advisory body of the WHO. “The WHO’s recognition and scientific substantiation of medicinal applications remain in force, even if the recommendations are not adopted.“

Updates
  1. Extracts and tinctures are removed from Schedule I of the 1961 Convention.
  2. THC (dronabinol) is added to Schedule I of the 1961 Convention under the category Cannabis & Resin. Subsequently, THC is removed from Schedule II of the 1971 Convention.
  3. THC isomers are added to Schedule I of the 1961 Convention under the category Cannabis & Resin. Subsequently, THC isomer is removed from the 1971 Convention.
  4. Pure CBD and CBD preparations with maximum 0.2% THC are not included in the international conventions on controlling drugs
  5. If they comply with certain criteria, pharmaceutical preparations that contain delta-9-THC should be added to Schedule III of the Convention of 1961, recognising the unlikelihood of abuse and for which a number of exemptions apply.
  6. Cannabis and cannabis resin are removed from Schedule IV, the category reserved for the most dangerous substances, in the 1961 Convention.

Back in 2018, the WHO issued an historic recommendation to reclassify cannabis at international level. In doing so, the WHO gave a clear signal that cannabis has therapeutic value. The final link in this process of change, where 53 countries may vote on the recommendations, was postponed last year. Now the official vote by the UN body that determines which drugs come under international control, is planned for the first week of March.

One of the recommendations is the removal of cannabis from list IV, intended for dangerous drugs without relevant medicinal usages. According to Mr Jelsma, this recommendation is not at all as “ground-breaking” as is supposed. “The WHO still sees cannabis as a public health hazard. That is why the WHO recommends removing it from Schedule IV only and not from Schedule I, the same list for cannabis, opium, heroin and cocaine. Even if the WHO recommendations are adopted cannabis is still on the same list as heroin and cocaine and all criminal treaty provisions remain in force for cannabis. So the WHO does not in any way follow the distinction between “hard” and “soft” drugs such as in the Netherlands and explicitly confirms with this package of recommendations that cannabis should be kept as strictly controlled as cocaine.”

Lack of clarity

Mr Jelsma, who keeps a close eye on the change process of the UN Drugs Conventions, said there are many critical questions regarding the consequences of the new classification. “There is still lack of clarity about the annual reporting obligations. Each year, every member state should report the use and trade in all types of drugs, including medicinal cannabis, to the INCB (International Narcotics Control Board, ed). The recommendation to transfer the substance THC from the 1971 Convention to the 1961 Convention doesn’t make that process any easier.”

Administrative problems

Another important WHO recommendation is to remove products with cannabidiol (CBD) and less than 0.2 percent THC from the Schedule completely. Mr Jelsma fears that the control on cannabis will actually become more stringent and that this will generate administrative problems. He said “Not everyone is aware of this. Indirectly, transferring THC to the 1961 Convention means that even the plant material that contains THC will have to be controlled in the same way. The Convention does not distinguish between the content and the materials they were extracted from. It means that more will have to be controlled, including leaves and stems. The recommendation was supposed to be an improvement, but if you scrutinize it, it actually deteriorates the situation.” Countries with a major hemp industry, don’t need that at all. Hemp is cultivated for its low THC content and high CBD concentrations. With the extremely low threshold criterion of 0.2%, many hemp products and derivatives are likely to fall under the stricter control regime. “I believe that this is one of the possible consequences that was overlooked by the ECDD. This was never the intention”, according to Mr Jelsma.

Majority

Fate is in the hands of 53 countries with voting rights. If they proceed to a vote in March, the question remains as to how those 53 countries will vote. This will depend strongly on whether a country has a medicinal-cannabis programme or not. A total of 24 of the 53 countries have legislation on this issue or have plans to issue legislation. That is just not enough to achieve the necessary 50% majority required for an amendment to the 1961 treaty. The further complicating factor is that an amendment to the 1971 treaty requires a majority of at least two thirds. Although the EU*, including the United Kingdom, represents nearly a quarter of the total number of countries with voting rights, a majority is not guaranteed. Mr Jelsma is concerned, as there is a significant chance that EU countries will vote as one block and the voting advice of the European Commission has quite a few flaws. “The vote will be extremely important, because some WHO recommendations can worsen the current situation.”

UN Conventions

The CND, the Commission on Narcotic Drugs, is a UN body that determines which drugs come under international control. The CND regularly amends the schedules of substances that are included in the drugs conventions on the basis of recommendations from the World Health Organization (WHO), which in turn is advised by its Expert Committee on Drug Dependence (ECDD).

There are three important UN Conventions that control drugs throughout the world:

In the current 1961 treaty, cannabis and cannabis preparations are in Schedule IV. The drugs in this Schedule are a partial selection of the drugs in Schedule I that are considered the most dangerous and have the least medicinal value. Heroin is therefore placed on both lists.

In recent years, the WHO has started up a quiet but powerful change process behind the scenes. The process started in 2016 with the scientific assessment of cannabis by ECDD as its highlight.

Office of Medicinal Cannabis

Internationally it was agreed that countries undertake to protect their citizens against cannabis abuse, production is only permitted for medical or research purposes and marketing only by a cannabis agency managed by the government. In the Netherlands that is organised through the Office of Medicinal Cannabis.

*) As of 1 January 2020, the following 13 EU Member States have a voting right on the CND: Belgium, Germany, France, Hungary, Italy, Croatia, the Netherlands, Austria, Poland, Spain, the Czech Republic, Sweden and the United Kingdom.

Important dates

  • CND intersessional in Vienna on Monday 17 February where the basic decision must be made about the vote in March
  • Horizontal Working Party on Drugs (HDG) in Brussels on Wednesday 19 February, where the EU must determine the joint position
  • The final vote of the CND from Monday 2 to Friday 6 March 2020 in Vienna

Battle for better access in Poland remains essential

The battle for access to lawful medicinal cannabis is often a long struggle by an individual patient. In Poland, it is the battle of mother Dorota Gudaniec for her son Max, now ten years old. The personal fight to have medicinal cannabis oil prescribed for her seriously ill child contributed to an amendment of the law in Poland. Medicinal cannabis is now permitted and in Poland they are now more positive about the use of medicinal cannabis. Yet, according to Dorota, the battle is far from over.

“In Poland there are still a lot of things that need to improve. It is a constant battle. Although it has been possible to change the law in Poland, doctors still have little knowledge of cannabis treatment. There is a lack of education, and doctors are often steeped in stereotypes. There is also a lack of proper cannabis treatment. If a patient is lucky enough to find a competent doctor, access is extremely limited. At the moment, there is one preparation available at a very high price. Patients continue to hit the black market and this is a terribly sad and worrying situation.”

Which changes would you like to see in Poland?

“I would like different and affordable cannabis preparations with different CBD to THC ratios to be available in Poland. I would like medical staff to be trained properly, so that doctors are not afraid to administer such a therapy. I would like improved regulation of the CBD market, because right now it is an El Dorado for less ethical entrepreneurs. We already have reports of Chinese synthetic CBD flooding the market. This is a dangerous situation, especially for patients.”

You believe that education is the key to true success. Only reliable information, derived from reliable sources, based on facts. Is that a difficult battle in Poland?

“I believe that reliable and confirmed knowledge is the only way of overcoming stereotypes, prejudices and phobias of every kind. However, patients’ experience should also be recognized as knowledge. Science is all about facts, but humans are complex beings and many aspects of human experience escape the annals of scientific research.”

The story of Max

Dorota’s son Max was born with Down’s Syndrome. When he was a baby of just eight months old, he was also diagnosed with West Syndrome, a serious type of epilepsy that manifests itself in the first year of life. Max’ development halted completely. From a curious and cheerful baby he transformed into a living, emotionless doll. His life was nothing but a series of seizures. From a few dozen to, at its worst, a few hundred a day.

The epileptic condition of her son changed into a form without treatment, Lennox-Gastaut Syndrome. At the age of five, Max’ situation deteriorated to such an extent that the young toddler ended up in intensive care where he was kept in an induced coma. Doctors thought there was a real chance he would not survive. Not one treatment brought solace.

That was the time his mother Dorota could not sit and watch in suffering any longer and started her trawl of the internet. “I felt powerless and desperate. I literally held Max with one hand and searched the internet with the other. My child was dying.” On the internet she found information about how medicinal cannabis had saved the life of an American girl that struggled with a similar syndrome. “I showed the article to the doctors but they ignored me and went as far as to forbid me to even think about cannabis.“

Photo: Magdalena López Pawłowicz

However, Dorota was undeterred and started up a difficult procedure to have cannabis oil prescribed for her son. With official permission from the Polish Ministry of Public Health and a doctor’s prescription, she managed to get cannabis oil from the Netherlands. She administered this to her son without the knowledge of doctors or relatives. “At that time, Dr Bachański was the only doctor who knew about administering cannabis. Other doctors either knew nothing or warned me of long-term effects, drug addiction or criminal liability.“

After just two weeks, Max showed noticeable signs of recovery and after nine weeks Max had recovered from all the complications caused by his illness. It is not known why the boy survived, but it is assumed that this was largely down to administering cannabis oil. “A few doctors who have seen Max’ progress now think more positively about the use of cannabis as a therapy and have become our allies and even collaborators.”

Today, ten-year old Max is a happy boy who learns new skills day by day. “He is a healthy, cheerful and slowly developing boy. He sits on his own, stands on his own feet and is learning how to walk. He is slowly regaining his life but still needs intensive rehabilitation.”

You started the Max Hemp Therapeutic Center. What does this institute do?

“The Max Hemp Therapeutic Center is a facility that was founded because of the need to give patients real help based on reliable facts, understanding and respect for human dignity. The center is also a kind of manifesto against the objectification of patients who are forced into soulless systems as a result of their illness. Our doctors and consultants look at each person as a whole, with dignity and mindfulness. Each visit to our center is an act of human-to-human relationships. A visit can take anything up to 2-3 hours depending on the patient’s situation and needs. We have created a friendly place for people in suffering. We provide them with many different types of support on the road to health. We care about the body’s needs, about well-being and emotions. We do not give out illusions but we’re not allergic to hope either.”

Where do you think Poland will be in five years time? 

“I have faith in the wisdom of Poles. I believe that in five years time, the legal, social, scientific and business situation will be better regulated. Poland will conduct its own scientific research, it will be normal for cannabis to be used in Polish hospitals, and Polish growers will make a real contribution to developing new varieties dedicated to patients around the world. We will definitely grow cannabis on Polish soil.”

Do you have a message for parents who are engaged in the same battle?

“Don’t be afraid of cannabis. Don’t be afraid to fight for the lives of your children. Don’t let any system in the world prohibit a basic human right – the right to save health and life in all kinds of ways.”

What dose should I give my patients?

What dose should I give my patients? The most difficult thing for a doctor is to determine the dosage for medicinal cannabis. Leading Maltese doctor advocating for a better understanding of the medicinal properties of cannabis, Dr Andrew Agius, knows how. In his pain clinic on Malta he treats patients with challenging chronic pain conditions, like fibromyalgia, who have tried many different types of medications and have not found relief from their symptoms.

What are the key benefits of cannabinoids as a therapeutic product?

“It provides very effective relief from pain symptoms with very little side effects compared to the other available medications. Most side effects are positive unlike most other medications. This could include less anxiety, better sleep, better mood and better control of chronic conditions such as diabetes, asthma and eczema.”

Which form of administration do you advise?

“I advise vaporizing the dried flower that is available in pharmacies as this provides legal, quick, safe and effective relief of symptoms. They can also combine it with a safe CBD oil product which has been recommended from a trusted supplier, taken as sublingual drops.”

Most doctors are not trained in the use of medicinal cannabis. How did you familiarise yourself?

“I learnt by reading a lot from the internet. I enrolled into online educational courses and went overseas to conferences and educational meetings. When I felt confident enough, I prescribed and recommended various types of medicines to my patients and through the feedback they provided, I learnt more and more on how various cannabinoids effect different patients and relieve various symptoms. This kind of patient feedback helped me improve on various treatment strategies to obtain better results.”

Western medicine is entirely based on scientific evidence that requires randomized, double-blind placebo-controlled studies. Unfortunately, there is still not enough evidence. And that’s why doctors are reluctant to prescribe. What would be your comment on that?

“I fully agree that there are not enough randomized, double-blind studies to provide the same evidence that backs the use of other types of medication. However, cannabis has been used over 5,000 years and we know that it is extremely safe and it has shown to be very effective in many different types of medical conditions, especially conditions where conventional medication was not effective. From my experience over the last two to three years, I have very strong observational evidence that medical cannabis is very effective for most of my patients, especially patients suffering from disabling chronic pain conditions such as fibromyalgia which are very difficult to manage by using available registered medicines.”

Do you have any advice for doctors starting out prescribing?

“Since it is very safe to use and it is now legally available, if you have a patient that has tried medications to relieve chronic pain or other disabling symptoms with minimal effect, start by prescribing a low dose to these patients and see how grateful they will be that you have made a significant improvement in their quality of life.”

Medicinal cannabis on Malta

In Malta, every registered doctor can prescribe medical cannabis. If a patient suffers from a chronic illness and has tried at least one medication which hasn’t been effective, they are eligible to try medical cannabis. The doctor makes an application to the Superintendent of Public Health requesting her permission for the patient to use the medicine. If the patient has never attended an opiate detoxification program in the past, the application is approved for thirty days. Following this thirty-day trial, the patient needs to go back to their doctor who prepares a medical report and another application which is then approved for six months. The patient needs to be reviewed every six months and each time a new approval is granted by the Superintendent of Public Health. There are four medicinal cannabis products available on Malta, this includes Bedrocan® (THC 22% | CBD <1.0%)  and Bediol® (THC 6.3% | CBD 8%).

Your pain clinic is an integrative medical centre for the holistic management of persistent pain. What do you mean by that?

“Persistent pain is chronic pain for more than three months which greatly effects patients’ quality of life. Holistic management means integrating a biopsychosocial approach to managing such patients and supporting them in all areas of their life not just by providing medication. We give advice on lifestyle changes, improving sleep routines, increasing physical activity, adjusting the diet and reducing stress through mindfulness meditation and yoga and also psychotherapy when indicated.”

, Updates

What makes your approach special?

“We adopt a very conservative approach and start by prescribing physical activity, a healthy diet and mindfulness-based stress reduction before considering medication or more invasive measures. When prescribing drugs, we opt for the safest, most natural alternatives that promote natural healing and effective relief from symptoms with minimal side effects.”

A fully standardised product, but with different prices. How come?

Since 2006, medicinal cannabis produced by Bedrocan for the Dutch Office of Medicinal Cannabis has become available to patients in various countries. Bedrocan is the only company in the world that has the proven capability of producing standardised cannabis flos (whole, dried flower) – containing consistent levels of cannabinoids, every time. Products used by patients in Australia or Italy are identical to the products used by patients in The Netherlands or Germany. Once difference is the price of the products in different countries. In The Netherlands, patients pay € 5.80 per gram (excluding prescription fee) in the pharmacy, while in some other countries prices can go up to € 25 or more. We often get questions why these prices differ so much. In this article, we explain why.

How come patients in other countries pay more than € 5.80?

Here it gets difficult. The Dutch OMC sells all products for the same price to anyone. However, the rules and regulations in other countries differ a lot, resulting in very different prices in each country. The price difference (from  € 5.80 per gram) for which the product is sold in another country is caused by the cost of transportation and import fees, permits and licensing fees, taxes and additional regulatory steps in the chain. German pharmacies, for instance, are obliged by German law to increase the price of their raw (cannabis) material by 100% in order to be allowed to deliver a final product to patients. This is just one of many examples showing Bedrocan and the OMC have no control over the final price of the product in other countries.

, Updates

How does Bedrocan feel about the huge price difference between the original production cost and the amount patients have to pay?

We do not like it. It is our mission to produce affordable, constantly available, high quality, safe and standardised medicinal cannabis for patient use. In The Netherlands, we have succeeded in this mission. It is now our goal to improve patient affordability worldwide. We feel that it is not fair to patients that such high prices are set in other countries. With the harmonisation of international rules and regulations, we hope prices will become more equal and, most importantly, more affordable for patients.

And what about the oil?  

Bedrocan does not produce or sell cannabis oil. Nor does the OMC. Medicinal cannabis oil extracted from Bedrocan’s standardised products is currently only available in the Netherlands and Germany and is extracted by third parties for patient’s use only. The companies extracting and producing an oil dose from, like compounding pharmacies, decide the final price to patients. Bedrocan therefore has no control over the prices of oils based on our products, currently.

Bedrocan recognised for setting the industry standard

Bedrocan won the Regional Game Changer Award at MJBizCon 2019, a cannabis conference held in Las Vegas. The award recognises Bedrocan as a regional game changer in Europe, the Middle East, Asia and Oceania. The MJBizDaily Award was presented at a major cannabis conference in the US, organised by American cannabis magazine Marijuana Business Daily.

The awards were awarded during a gala on Thursday December 12 in Las Vegas, USA.

Italian pharmacist provides doctors with cannabis advice

The Italian pharmacist Dr Marco Ternelli received so many requests from doctors and patients about how to prescribe medicinal cannabis that he decided to put all the information together. Prescribing in Italy is not an easy matter. Doctors have little knowledge, do not know how to dose cannabis, and there are complicated forms a doctor should fill in to prescribe.

By now his clients come from all over Italy, albeit mainly from north and central Italy. For over three years, he saw 10,000 to 15,000 prescriptions for medicinal cannabis (oils, capsules, suppositories, eye drops and creams) pass through his hands for the most wide ranging conditions. He incorporated all those data in a comprehensive brochure (only available in Italian). It contains an overview of all the cannabis prescriptions he has handled over the years. ”It is a sort of personal statistics I decided to share. Reporting the strains prescribed by Italian doctors and what conditions they prescribe them for.”

Besides doctors, other pharmacists and patients benefit from the information in his blog. Dr Ternelli continuedPharmacies and pharmacists understand how a prescription for medicinal cannabis has to be completed by doctors to be accepted and for them to be permitted to proceed with the compounding preparation. In other words, what pharmacists need to check to consider the prescription as valid.”

New edition of booklet on medicinal cannabis

Our brochure ‘A primer to medicinal cannabis’ has been revised by adding the latest research in the area of medicinal cannabis. Ideal for healthcare providers, policy makers and patients who would like to have more insight into the medical and scientific aspects.

Looking for fibromyalgia patients for a new LUMC cannabis study

The Leiden University Medical Center (LUMC) is looking for fibromyalgia patients who wish to participate in a new study into the effects of medicinal cannabis on the medication oxycodon. Patients may register through a special website of the Anaesthesiology Department. Lead researcher Professor Albert Dahan aims to demonstrate that medicinal cannabis in combination with the opiate product oxycodon may have added value in pain relief.

Bediol

The study will use the cannabis product Bediol®, which contains cannabinoids THC (6.3%) and CBD (8% CBD). There will be three study groups – one group is only given oxycodon, a painkiller based on opium; the second Bediol in combination with oxycodon; and the third group just Bediol.  The research is carried out by the Anaesthesiology Department and is partly financed by Bedrocan.

The main purpose of the study is to assess whether co-medication with Bediol reduces the side effects of oxycodon in patients with chronic pain. The study will run for several years. According to the Professor it will be a complex study, because the patients may determine the dose they take. “We will give a maximum, but within that limit patients may determine what they use.” Furthermore, the study takes place in patients’ homes. They will be given a vaporiser that can be used to take the cannabis. “This set-up will definitely succeed, because our researcher will be in continuous contact with the patients.”

“Even in a country like America, where a form of cannabis is legalised in most States, pain specialists do not know how to prescribe or dose medicinal cannabis. I know I cannot make any recommendations on the basis of this experimental study, but I can set them on their way.”

If you are interested in participating in the LUMC study, you can register with the online form on the Dutch website Samen tegen Pijn.

1.9 million Euro available for pain research

The Dutch Ministry of Health, Welfare and Sport (VWS) has made 1.9 million Euro available for research into the effectiveness of medicinal cannabis for neuropathic pain. The Ministry instructed ZonMw, a Dutch stimulus fund for healthcare, to look for suitable research. The subsidy will be awarded to one Dutch research organisation, knowledge institute or other type of organisation.

A maximum of 1.9 million Euro is available for the entire project over a maximum period of four years.

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