Medical Cannabis trials are taking place around the globe as the effort to comercialize coincides with the push to legalize. France’s case is somewhat special though as the criticisms by the Academy of Pharmacy on the latest plan for Medical Cannabis trials are taking place around the globe as the effort to comercialize coincides with the push to legalize. France’s case is somewhat special though as the criticisms by the Academy of Pharmacy on the latest plan for wide scale medical therapeutics testing of cannabis reveal. But why are the French pharmacists upset, and what exactly sets this trial apart from previous ones.
The Academy of Pharmacy has expressed its reservations about an upcoming experiment with therapeutic cannabis in France.
The National Academy of Pharmacy announced this Tuesday, November 24, its “greatest reservations” about the next round of testing of therapeutic cannabis. Expressing worries about an apparent “lack of scientific rigor”.
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A cannabis therapeutics trial under french pharmacy scrutiny
The latest research phase, which is to serve as a full-scale clinical trial to evaluate the usefulness and effectiveness of the medical use of cannabis, is to begin no later than March 31 of 2021. It is set to run for a period of two years and will involve approximately 3,000 patients in France.
The cannabis products used in the various testing categories (in the form of oils, capsules or dried flowers) are considered to be drugs by many, including french legal and legislative authorities. This clinical trial however “introduces an overriding procedure for obtaining marketing authorization that unjustifiably contravenes regulatory, safety and ethical requirements,” or at least, so the academy deplores.
Whats wrong with the french test of cannabis therapeutics?
If “certain pharmaceutical specialties based on tetrahydrocannabinol (THC) and/or cannabidiol (CBD), or even cannabinoids, may be of medical interest in specific therapeutic indications”, the academy of pharmacy spokesperson continued, they must be validated “by randomized clinical trials” that “take into account the medical service rendered”. Notably, it is argued that any cannabis therapeutics tests aught to be evaluated and validated by the High Authority for Health (HAS).
The institution also pointed out that the use of the whole plant and not “pure products” can “in no case guarantee the quality and safety required for a drug” because the raw plant contains unspecified amounts of various other compounds and substances (over 200). Furthermore, the ratios and quantities of these other molecules and macromolecules are determined by innumerable variables (such as growth conditions, cultivation techniques and storage) meaning that their presence cannot be adequately controlled to allow for scientific results.
What is the Academy of Pharmacy asking for?
Unsurprisingly they would prefer if the trial did not take place outside the strict pharmaceutical control for therapeutics composed exclusively of a laboratory made and tested cannabis extracts. Their worries are thus in alignment with their own relevance and expertise in French society. However, some of their objections do seem genuinely motivated by concern for the patients and test subjects.
If the trial is to proceed despite their protestations about the quality and nature of the products involved, The Academy of Pharmacy in France recommends the involvement of regional drug and addiction watchdogs and centers. Their roles would be “both in the collection of information and in the precise evaluation of possible risks” during the follow-up with the 3,000 patients in the trial.
In many ways it all comes down to who the participants in the therapeutics trial are:
The call for applications launched by ANSM to provide the products used in the trial free of charge, closed yesterday at Tuesday at 4:30 pm. We might not know the companies involved for some time yet of course, but we do have more information on who the patients will be.
Somewhere between 500 and 750 patients will be able to participate for each of the five selected indications for cannabis therapeutics use. This means over 2500 individuals at least, with conditions ranging from certain forms of epilepsy or neuropathic pains to those suffering the side effects of chemotherapy, palliative care or multiple sclerosis.
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First published in Ouest France, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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