On September 26, the Ministry of Health should have given the deputies an evaluation report on the experimentation with medical cannabis.
On this date, we learned that the ministry had in its hands three reports produced externally but preferred to consolidate the “elements recently received” then bring them “to the attention of Parliament within the framework of the debates on the PLFSS 2023” in mid -october.
If the reports made “externally” were done in due time, the ministry in any case preferred to anticipate its communication and conclude directly with an extension of the experiment. However, the various reports support the success of the experiment and the expectation of generalization by the patients included in the experiment, for themselves and for others.
Some statistics from the report
The first report, produced by the company IQVIA, is 163 pages long and studies experimentation in detail: speed, typology, circuit and quantity of prescriptions, age and location of patients treated, satisfaction of doctors and pharmacists, etc.
This report begins by recalling the objectives of the French experimentation with therapeutic cannabis:
- assess the feasibility of the medical cannabis supply circuit at all stages of the care pathway: patient inclusion, cannabis delivery and patient follow-up
- 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 cannabis for medical use” even if it has necessarily been measured.
As of March 31, 2022, a total of 1450 patients have been included in the experiment. 69% of them are still included, ie a total of 1036 patients. 28% of patients have been discharged, and the remaining 3% are about to enter.
Within the 1450 patients included and left the experiment, more than half of them are included for the indication “neuropathic pain refractory to accessible therapies” (51%). The second most frequent indication is “painful spasticity of multiple sclerosis” (15%) followed by the indication “certain drug-resistant forms of epilepsy” (13%). The least represented indication is “painful spasticity from other pathologies of the central nervous system” (4%).
Of the 1450 patients, 414 (28%) left the experiment, including 38% for adverse effects, 37% for ineffective treatment and 15% for death.
Regarding the first results on efficacy, encouraging results have been obtained for certain indications and no worsening has been observed. Significant improvements have been demonstrated in particular for patients with neuropathic pain or for patients with painful spasticity from multiple sclerosis, with an improvement in spasticity and a reduction in the number of spasms.
Results are also positive for the “oncology” and “palliative situations” indications. 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, including 19% showing significant and very significant improvement after 3 months follow-up. The results are more mixed for the indication “painful spasticity of other pathologies of the central nervous system”.
Conclusion of the IQVIA report
The first report concludes with a positive note on the main objective of the experiment:
“The results from the register data and the qualitative information obtained through interviews with the actors in the field made it possible to validate the feasibility of the circuit for the provision of medical cannabis for the majority of the stages”.
The shortcomings are based on the prescription circuit in town, that is to say the prescription by a general practitioner then distribution in pharmacies rather than by a specialist doctor and a pharmacy located within a hospital establishment, which has been very little developed.
“In view of these conclusions, the evaluation carried out here makes it possible to meet the main objective of the experiment, namely that the circuit for making medical cannabis available to French patients is feasible and operational under the conditions defined and put in place. in place in practice. »
Concerning the effectiveness of medical cannabis, which is not the objective of the experiment, the report concludes that the follow-up is too short and a modest number of patients, while recalling that the experiment was not modeled for report efficacy data.
The ANSM did not identify, in a second report on pharmacovigilance, any significant sensitive point in the dispensation of medical cannabis.
What do patients say about the experiment?
1630 patients included in the experiment were questioned by the company ViaVoice and 725 responded. Their feedback was recorded in a third report “Pathways and perception of patients”.
68% of respondents perceived beneficial effects, including 32% who perceived “a lot” of them, in terms of their state of health but also related to their quality of life.
Patients report 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 giving a score of 9 or 10.
In line with the previous results, the respondents questioned during the qualitative phase – 13 telephone interviews – are mainly positioned in favor of the generalization of medical cannabis, whether the treatment has worked for them or not, according to a principle of “recommendation”. “if it can help people who are suffering”.
Those for whom the treatment is seen as effective are all the more in favor of the generalization of medical cannabis, and this in a very clear-cut way, since this treatment has become essential to their daily lives.
In the event of a cessation of experimentation, if patients could no longer have access to medical cannabis treatment, some would consider consuming cannabis illegally.
The feedback finally notes that “medical cannabis constitutes for some patients a treatment which they can no longer do without, for which there is no alternative, with a certain concern vis-à-vis the continuation of experimentation”.
Why does the ministry want to extend?
From these reports made externally, the Ministry of Health draws a final report of 13 pages. Let’s jump to conclusions right away:
- A positive experiment which tends to confirm the feasibility of the cannabis prescription and dispensing circuit for patients (main objective of the experiment)
- Missing data that the National Health Data System (SNDS) could not provide “due to an extremely busy work program on many other ministerial priorities”
- A lack of participation of general practitioners
- A number of enrolled patients less than the 3,000 imagined (editor’s note: which was not an objective to be achieved)
- The absence of work on the definition of a status for the products used during the experimentation and on their terms of coverage in the event of generalization (editor’s note: discussion that started in 2018)
If we wanted to focus on showing the good faith of the Ministry of Health, we would look at the amendment that the presidential majority is presenting to extend the amendment. However, it lacks a commitment from the government to want to legalize medical cannabis on a large scale at the end of the possible postponement.
Several sources, who all wish to remain anonymous, also tell us that the Ministry of Health would not make it a priority to make medical cannabis available to French patients and inform us of various blockages within the General Management. of Health.
Questioned several times, the DGS “come back[t] towards [n]We will soon have an answer”.
The ministry also suddenly forgets to specify that it recently invoked the need to build a French sector and the risk of positions being taken by foreign players on the market who today have a good back in providing medical cannabis free of charge. What would happen if they refused to continue providing free medical cannabis to 3,000 “active file” patients as requested by the ministry?
And finally, why not generalize today and give all the keys to success to current and future French companies wishing to supply cannabis-based medicines to patients?
A question that we had asked Santé Cannabis France, which was also campaigning for an extension of the experiment, and which did not wish to have its answer appear in our columns. However, she told us recently that she had “constantly mobilized[e] alongside patient associations, to ask the French authorities to speed up the definition of the regulatory framework”.
Finally, let us 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, for some, supplying themselves on the black market.
If France were really looking for data on the efficacy (or inefficacy) of medical cannabis to give itself good reasons to legalize medical cannabis, it is likely that it could turn to other countries which already produce or prescribe on a massive scale. medical cannabis: Israel, Canada, Australia, Germany, the Netherlands or 33 states in the United States.