France’s health ministry was originally meant to submit a report on the progress of its medical cannabis study on September 26. Instead, despite having several independent reports in its hands, it decided to delay the submission of its report until it had consolidated “recently received elements.” Simultaneously, it also extended the study, despite the overwhelmingly positive independent reports.
On September 26, the Ministry of Health should have submitted an evaluation report on the country’s medical cannabis study to the deputies.
Instead, on that date, we learned that the ministry had three external reports in its hands, but preferred to consolidate the “recently received elements” and then bring them “to the knowledge of the Parliament in the context of the debates on the PLFSS 2023″ in mid-October.”
Although the “external” reports arrived in due time, the ministry preferred to anticipate communication and immediately concluded that it should extend the study. However, the independent reports support the study’s success and the expectations of patients participating in the study.
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Some Statistics From the Report
The first report, produced by health tech company IQVIA, is 163 pages long and reports on the study in detail: speed, typology, circuit and quantity of prescriptions, age and location of patients treated, and satisfaction of doctors and pharmacists…
This report begins by recalling the objectives of the French medical cannabis study:
- To evaluate the feasibility of the medical cannabis delivery circuit on all the steps of the care pathway: patient inclusion, cannabis delivery, and patient follow-up.
- To collect the first data on the effectiveness of the use of cannabis in a medical setting.
This report insists on this last point: “It is important to remember that this study is not an evaluation of the effectiveness of medical cannabis,” even if it was necessarily measured.
As of March 31, 2022, 1450 patients joined the study. 69% of them are still participating, leaving a total of 1036 patients. 28% of patients have exited, and the remaining 3% are in the process of entering.
More than half of the 1450 patients who participated in the trial report the indication “neuropathic pain refractory to accessible therapies” (51%). The second most common indication is “painful spasticity in multiple sclerosis” (15%), followed by “certain forms of drug-resistant epilepsy” (13%). The least represented indication is “painful spasticity of other central nervous system pathologies” (4%).
Of the 1450 patients, 414 (28%) were withdrawn from the trial, of which 38% were for adverse events, 37% for treatment ineffectiveness, and 15% due to death.
Report Is Overwhelmingly Positive
Concerning the first results on efficacy, certain indications returned encouraging results, and no worsening was observed. In particular, significant improvements have been demonstrated for patients with neuropathic pain or for patients with painful spasticity in multiple sclerosis, with an improvement in spasticity and a decrease in the number of spasms.
Results are also positive for the indications “oncology” and “palliative situations.” For example, for patients included and discharged in the “oncology” indication, the results indicate a perceived improvement (slight, significant, and very significant) for 52% of patients, with 19% showing significant and very significant improvement after three months of follow-up. The results are more mixed for the “painful spasticity of other central nervous system pathologies” indication.
Conclusion of the IQVIA Report
The first report concludes with a positive note on the main objective of the experimentation.
“The results from the registry data and the qualitative information obtained through interviews with field actors validated the feasibility of the medical cannabis provision circuit for the majority of the stages.”
The gaps are based on the prescription circuit in town, i.e. prescription by a general practitioner and then distributed in a pharmacy rather than by a specialist doctor and a pharmacy located within a hospital establishment, which has remained under-developed.
“Because of these conclusions, the evaluation carried out here makes it possible to meet the main objective of the experimentation, namely that the circuit for making medical cannabis available to French patients is feasible and operational under the conditions defined and implemented in practice.”
Regarding the effectiveness of medical cannabis, which is not the objective of the experimentation, the report concludes that the follow-up was too short and the number of patients modest, while recalling that the study was not modeled to bring up effectiveness data.
In a second report on pharmacovigilance, the ANSM did not identify any notable sensitivities to the dispensing of medical cannabis.
What Do the Patients Say about the Study?
The 1630 patients in the study were offered the chance to respond to an inquiry by the company ViaVoice, and 725 responded. Their responses were recorded in a third report, “Pathways and perception of patients.”
68% of respondents perceived beneficial effects, including 32% who perceived “a lot” in terms of their state of health and their quality of life.
Patients report a clear satisfaction with their medical care since their inclusion in the experiment. An average score of 8.2 out of 10, and 51% of respondents scored 9 or 10.
In line with the previous results, the majority of the respondents interviewed during the qualitative phase – 13 telephone interviews – were in favor of the generalization of medical cannabis, whether the treatment had worked for them or not, according to a “recommendation” principle: “if it can help people who are suffering”.
Those for whom the treatment is seen as effective are all the more in favour of the generalization of medical cannabis, which is very clear since this treatment has become essential to their daily life.
In the hypothesis of an end to the experimentation, if patients could no longer have access to medical cannabis treatment, some would consider using cannabis illegally.
The feedbacks finally note that “medical cannabis constitutes for some patients a treatment they can no longer do without, for which there is no alternative, with a certain anxiety regarding the continuation of the experimentation.”
Why Does the Ministry Want to Extend?
The Ministry of Health has produced a final report of 13 pages from these external reports. Let’s jump straight to the conclusions:
- The study was positive and tends to confirm the feasibility of cannabis prescription and the available delivery circuits for patients (the main objective of the study).
- There is missing data that the National Health Data System (SNDS) could not provide “due to a hectic work schedule on many other ministerial priorities.”
- There was a lack of participation by general practitioners.
- The number of patients enrolled was lower than the 3,000 imagined.
- There is an absence of work on the definition of status for the products used during the experimentation and on their modalities of assumption of responsibility in case of generalization.
If one wanted to focus on showing the good faith of the Ministry of Health, one would look at the amendment that the presidential majority presented to extend the study. Missing from it, however, is a commitment from the government to legalize medical cannabis on a large scale after the eventual delay.
Several sources, all of whom wish to remain anonymous, tell us that the Ministry of Health would not make it a priority to make medical cannabis available to French patients and report various blockages within the Directorate General of Health.
Questioned several times, the DGS “will come back to us soon with an answer.”
The ministry also suddenly forgot to specify that it recently invoked the need to build a French sector and the risk of foreign players taking up positions on the market, who today are willing to provide free medical cannabis. What would happen if they refused to continue to provide free medical cannabis to 3000 patients “in active file” as requested by the ministry?
And finally, why not generalize today and give all the keys of success to the current and future French companies willing to provide cannabis-based medicines to patients?
This is a question we asked Santé Cannabis France, which also militated for an extension of the experiment, and which did not wish to publish its answer in our columns. However, it recently told us that it had “constantly mobilized alongside patients’ associations to ask the French authorities to accelerate the definition of the regulatory framework.
Let’s finally understand that the Ministry of Health wants to give time to time, even if it means leaving sick people in a therapeutic impasse without a solution or buying on the black market.
Suppose France was genuinely looking for data on the effectiveness (or ineffectiveness) of medical cannabis to give itself good reasons to legalize it. In that case, it could likely turn to other countries that already produce or prescribe medical cannabis on a massive scale: Israel, Canada, Australia, Germany, the Netherlands, or 33 states in the United States.
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