By / November 30, 2021

Therapeutic cannabis: in Clermont-Ferrand, the first results of French experiment

“Finally! For Mounir, aged 47, his treatment with medical cannabis is a real relief. He is one of the first to have joined the experiment launched last April at the Clermont-Ferrand University Hospital. He had previously been followed by Nicolas Authier, a psychiatrist at the Clermont-Ferrand University Hospital, for an addiction to morphine-based drugs prescribed to relieve his pain. Following his withdrawal, he was able to join the experiment conducted in Clermont-Ferrand. He says: “I had a stroke 21 years ago. I have neuropathic pain following this hemorrhagic stroke. It was a relief to join the experiment”.

His story, like many of those from the world of cannabis, CBD and hemp, are changing medical, agricultural, and economic sectors across the globe. Stay in touch with all the latest hemp news by downloading our companion Hemp.IM app, and discover more about this groundbreaking therapeutic cannabis experiment.

Promising French Cannabis Study Opens Doors for Therapeutic Cannabis Treatment

And the results are already in: “The first results are quite satisfactory. I still need to fine-tune it because I am not yet totally relieved of pain. There is still some pain, but it’s nothing like what I felt before. Cannabis acts as an analgesic. It calms my neuropathic pains. They manifest themselves as headaches. My whole left hemisphere is very sore, like spikes, stabbing. Thanks to cannabis, these pains fade away. You get relief in the hours that follow.”

Mounir had been hoping to join the experiment for several years: “It was a relief to join the experiment. The experimental aspect didn’t scare me. I’m a biologist by training, so it’s perhaps easier for me to understand than for others. I had already tried therapeutic cannabis when traveling abroad. I had noticed that it worked very well. I had made a request to Dr Authier more than two years ago.”

Therapeutic Cannabis in Oils to Swallow

He takes his medical cannabis like any other treatment: “I take medical cannabis in oil form. You take it from a pipette and swallow the given amount. I take the treatment twice a day, morning and evening. At first we started with 100% CBD. Then we switched to 50-50, increasing the doses of THC. We experimented and are still experimenting to find the right dosage.”

He takes his treatment from the hospital pharmacy because everything is highly regulated. The forty-year-old adds: “The people around me reacted well, except for my mother. She makes the connection between medical and recreational cannabis. I would like to see the medical use of cannabis fully legalized.”

Medical Cannabis in France a Tightly Regulated Experiment

Nicolas Authier is a psychiatrist at the Clermont-Ferrand University Hospital and president of the scientific committee on medical cannabis. He is Mounir’s referring doctor. He has been piloting the experimentation conducted at the university hospital since March 2021: “A public policy experiment has been set up throughout France. It consists of testing and evaluating access, for certain patients whose suffering is poorly relieved by conventional treatments, to cannabis-based products.”

This is cannabis presented in the form of products manufactured according to pharmacy standards, mainly oils, which are prescribed by doctors and dispensed by pharmacists. “This experimentation does not primarily aim to test the efficacy, even if we will do so, but rather to evaluate the best conditions of access to these products in the perspective of the legalization of medical cannabis” concluded the psychiatrist.

For what Cases can Therapeutic Cannabis now be Prescribed

For the time being, the ANSM (National Agency for the Safety of Medicines and Health Products) has retained five therapeutic indications for this experiment.

  • certain forms of severe and drug-resistant epilepsy
  • certain intractable symptoms in oncology
  • neuropathic pain refractory to accessible therapies
  • palliative situations
  • painful spasticity in central nervous system pathologies.

Several patients are registered in this program. Prof. Authier explains: “This involves palliative care as well as pain, neurology and oncology. I don’t have the exact number of patients. For pain, which is what I deal with, we must have about twenty patients at the moment, knowing that we will continue to include some, notably for multiple sclerosis.”

First results of the French Therapeutic Cannabis Test in Clermont-Ferrand are in:

The results are in, and not just for Mounir, the first results of medical cannabis are here: “We have patients for whom other medicines have not helped. They were refractory to the usual treatment prescribed. Medical cannabis has brought relief.” The relief provided ranges from mild to moderate to severe relief. “It depends on the patient and it is difficult to draw conclusions. In the international scientific literature, it is said that it is not a miracle, but in some patients, it brings an improvement in their quality of life, whereas they had a chronic suffering.”

There are also patients for whom it does nothing, however. Some have left the experiment in Clermont-Ferrand as elsewhere. There are patients who have more undesirable effects than therapeutic ones and who have also left the experiment. The treatment is adapted to several pathologies: “The first use worldwide is for chronic pain. The one for which there is the most scientific evidence is neuropathic pain. This is pain associated with a dysfunction of the nerves, because they have been damaged. For example, there are cases of herniated discs with the sciatic nerve pinched between two vertebrae. There may also be a cancer treatment that is neurotoxic, with sequential pain. These are unbearable pains for which we have the highest level of evidence. Then there is epilepsy and multiple sclerosis. When three or four anti-epileptic treatments have been tried for drug-resistant forms, a product containing cannabidiol can be combined and this can improve the patient’s condition by reducing the number of attacks or their intensity. For multiple sclerosis there is some evidence. In this disease, there are abnormal muscle contractions and some cannabis products can help relieve the patient.”

Therapeutic Cannabis: The case of cancer patients

Treatment can also be proposed for cancer patients, but within a very specific framework: “Patients who are being followed in oncology for cancer can be treated, but not during their chemotherapy treatment. It has been decided that outside of a palliative situation, the use of cannabis products should be avoided because there is a doubt about the interaction between cannabis and chemotherapy drugs. There is no question of increasing the toxicity of chemotherapy or making it ineffective. Cannabis does not treat cancer itself. Obviously.”

Progress in Uncharted Cannabis Territory

This program is an experiment. Patients and doctors are still groping their way forward, as Prof. Authier explains: “Medical cannabis is a panel of products whose composition varies. We start with a plant, cannabis, and from different varieties of this plant, we can extract oils from the flower that have different compositions. This is a set of cannabis-based medicines with different compositions. Some medicines are specific for treating epilepsy, and these are medicines that are very rich in cannabidiol (CBD). We have medicines that are mixed with cannabidiol and THC, the famous molecule that makes you high in cannabis when you take too much. This mixture of the two is of interest for multiple sclerosis and to treat certain muscle pains. We have forms rich in THC and poor in cannabidiol, we make our mixtures and we can compose to adapt as much as possible to the patient and his suffering. “

This is still an experimental medicine because there are few certainties. For some patients it works and that they are relieved. “We don’t yet have a good command of this medicine to say that a particular composition is needed for a particular product. The doctor and the patient will work together for several weeks to find the right mix of THC and CBD molecules.”

Two forms of Therapeutic Cannabis are Currently being Administered in the Experiment

Medical cannabis is administered in two forms: “These oils are administered orally, swallowed by mouth. It can exist in other forms, such as tablets, capsules, sprays. For the moment in France we have access to oils to be swallowed. There are pipettes and you take a certain number of milliliters of THC or CBD. This allows everyone to take it, including people with swallowing problems.”

There is another form, dried flowers. These are well-calibrated flowers that are used as a complement, if necessary, to the oils. The oils are a basic treatment that is taken morning and evening for chronic suffering. “If the oil treatment is not sufficient and the pain is exacerbated, we can suggest to certain patients that they take flowers which they will vaporise. They are put in a special device, a vaporiser, which avoids burning. This allows the active substances to be released into the vapour, especially THC and CBD. This vapor is inhaled. It is not dangerous and it allows a very fast effect”.

The delivery of medical cannabis is very controlled: “The treatment is prescribed at the very beginning by a hospital doctor. Afterwards, it can be handed over to a general practitioner or neurologist. The patient picks up his prescription either at the hospital pharmacy or in a town pharmacy. The only condition is that doctors and pharmacists must have undergone compulsory training, which is offered in e-learning by the medicines agency.”

Major differences with recreational cannabis

Professor Nicolas Authier highlights the differences between medical and recreational cannabis: “We know exactly the composition of the product we are going to administer to the patient, whereas in the case of non-medical cannabis, this is not the case. Usually, when you go to buy weed on the corner or resin, you don’t know exactly what you are consuming. With medical cannabis, the doctor knows what he is prescribing.”

The difference also lies in the purpose of use. The aim is not to have a festive or recreational effect but the relief of one or more symptoms. This is a therapeutic effect. Recreational or party cannabis seeks a high, euphoric effect that often requires the consumption of larger quantities. It is associated with a higher risk of developing dependence or adverse effects. It is smoked most often, which carries its own dangers. It is not the same at all. The purpose and methods of use change, as does the framework.

France has a Complicated Legal Framework for Therapeutic Cannabis Experiments

The psychiatrist recalls the legal contours of experimentation: “Cannabis use is not authorized and it is done in the context of an experiment. All use of cannabis is illegal in France, except for use in experimentation. Science is slow to show the effectiveness of medical cannabis. There are also authorities who are cautious because cannabis has the image of a drug. There are patients in France who use it for self-treatment.”

The legalization of medical cannabis must be well supervised. For certain patients for whom conventional medicine cannot relieve them “as long as we can offer them products that are well characterized from a qualitative point of view, where things are monitored, it is no more dangerous than prescribing certain opioids like oxycodone. There may be side effects but if you are careful, there is no great danger in implementing medical cannabis. The real challenge is to determine which patient profiles are most likely to have a therapeutic response. I am in favor of legalizing medical cannabis.”

Experiment uses Cannabis Produced Outside France, For now

The next step will be the evaluation of this experiment at the end of 2022. The end of the experiment is planned for March 2023. We can imagine that access to these products will then be legalized, with a framework that will have been adapted. Nicolas Authier concludes: “Cannabis is not produced in France because it is currently not authorized. So everything must be imported.”

There is a draft decree in the coming weeks that should authorize the production of cannabis for medical use in France, with a scientific committee that will meet at the level of the drug agency. It will determine in the next six months the modalities of this culture and its transformation. For the moment, cannabis comes from other countries, such as Canada, Israel and Australia. Authorization to cultivate these varieties does not exist in France. In medical cannabis, THC is needed. Hemp, which does not contain THC, is authorized in France.

France’s Agricultural Sector is Chomping at the Cannabis Bit

Jean-Baptiste Moreau is a farmer and LREM deputy for the Creuse. He was the rapporteur of the National Assembly’s committee on cannabis. Aware of the stakes involved in legalizing therapeutic cannabis, he says that an entire agricultural sector is waiting: “We are in the starting blocks. Today, experimentation has begun. It is done with imported products because there is no French sector. We need to rewrite a 1990 decree that will allow the exploitation of cannabis flowers to extract CBD and THC substances for medical experimentation. This decree is currently being rewritten. But I don’t really agree with the way it will be rewritten.”

Currently the law will allow a therapeutic sector to be set up, but it prevents the setting up of a wellness sector, based around CBD. Economically, a purely therapeutic sector for experimentation represents only small volumes. It’s complicated to set up a complete chain for such small volumes. He continues: “We have farmers who are ready to produce, or who are already producing, on the fringes of legality. This was the will of the President of the Republic because he had said at a press conference in Reunion that he wanted production to be set up in Reunion and in Creuse, to generalize the experiment. The experiment is currently being conducted on five diseases, but it will be extended to other diseases by the end of the year.”

Cannabis Represents Costly Investments for French Farmers

But the deputy has reservations: “The problem is that if we are satisfied with therapeutic cannabis, these opportunities will be very small. It requires quite expensive installations, such as greenhouses, because there must be no cross-pollination. The economic opportunities will be small if we are satisfied with medical cannabis. You have to add wellness, to make CBD-based oils and ointments, and that can be grown in the field.” This is a real economic opportunity, with CBD not considered a drug by the WHO or the EU but a food supplement.

Jean-Baptiste Moreau explains: “The decree is being rewritten. I have seen the first draft and it is not satisfactory. We have to rewrite this decree because the European Court of Justice has said that French legislation on cannabis does not comply with European law. At European level, we have the right to use the flower as long as it contains less than 0.3% THC. But today France prohibits the exploitation of the flower. The government has taken this on. The only problem is that it wants to rewrite the decree as a minimum, i.e. only for therapeutic experimentation, except that this prevents the creation of a French industry. A farmer is not going to invest three million euros to build a greenhouse just for therapeutic purposes, it is not viable in the long term.”

Legalizing Therapeutic Cannabis… in an Election Year?

He underlines why the government is cautious: “There is pressure from the Ministry of the Interior, which thinks that if we rewrite this decree in a too flexible way, we are promoting cannabis. This is totally contrary to science because the WHO has downgraded CBD, it is no longer a drug. But we are in a kind of security ideology that is completely disconnected from reality.”

However, the deputy reminds us that there are opportunities to be seized: “Departments in Brittany and the Lot are waiting. This could allow for diversification, especially in our areas. It is not a very water-intensive plant, it does not need much fertilizer. From a purely agronomic point of view, it is interesting because it covers a lot of ground and reduces the need for herbicides, it suffocates all weeds. For our Massif Central areas, this plant can be an interesting diversification. The decree must be rewritten before the end of the year.”

(Featured image by Drew Taylor via Unsplash)

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