Of late, there has been an ongoing reassessment of cannabis and the use of natural cannabinoids for medical purposes. The mainstream perception - which initially formed in the 1970s, labelling cannabis as being harmful to health and a drug of abuse - was upended in November 2017 when, the 39th World Health Organization Expert Committee on Drug Dependence declared one of its main components, the non-psychotropic cannabidiol, safe to use.
Possible applications abound, from stimulating the appetite to treat weight loss caused by anorexia and AIDS, to the benefits observed in cancer-related treatment - like reductions in nausea and weakness - and synergistic action in the treatment of diseases of the central nervous system, such as Dravet syndrome.
Clearly, the market has responded favourably to this change; manufacturing multiplied, as did discussions on the topic, on and offline. This movement reflects a widespread, across-the-board interest in cannabis that easily and firmly takes root in the popular imagination, amplifying this trend exponentially.
However, this renewed excitement over the therapeutic properties of cannabis by stakeholders goes hand in hand with a lack of scientific understanding of the product and its processing methods.
Despite being equipped with efficient methods of preparation, the businesses that have launched in recent years often lack a solid background and expertise in the processes involved, from cultivation to extraction and manufacturing.
The result is the marketing of products that differ from one another in terms of raw materials used, methods of preparing extracts and the percentage of cannabinoid content. These significantly different features also make it impossible to assess clinically, which is the only way to obtain a solid panel of usable data that can be compared, with the aim of creating valid treatment pathways.
This chaotic state of overproduction has been met with a cautious response from the scientific community, which has recognised that only a few of the many proposed trials are actually under way. This clearly ties back to the lack of regulation that considers the production process.
If there are to be more studies in medical literature, standardised treatment options must be available. indeed, the use of a standardised extract would make it possible to produce a real, unequivocal efficacy profile for a particular extract with a drug clinical trial.
The best way to maintain uniformity is having a monograph of pharmacopoeia. It is not only a Linnea's wish, but also that of the entire community, starting from the manufacturer to the final customer. Even if the end consumer is not aware of all these procedures subconsciously, they need - and want - to have standardisation for a functioning product. In the meantime, it is crucial that standardised extracts are used, and that good agricultural and collection practice (GACP) as well as GMP are followed as the only guidelines. Specifically, the plants must come from certified growers and harvests; and the entire growing process, harvest and drying must adhere to GACP, while the production process and quality control must observe GMP.
The required phases for marketing a drug are an initial safety test (phase I) and a subsequent efficacy analysis (phases II and III) alongside assessments based on good clinical practice.
Obtaining a GMP manufacturing licence - which authorises production for pharmaceutical purposes - is extremely complex and there are very few companies that have actually obtained it for cannabis.
Why is this the case? Simply put, standardisation that follows the regulation processes for the production of drugs calls for a great deal of experience, a designed structure, and various levels of competency in manufacturing, quality, analysis and research.
These measures might be excessive for nonpharmacological products, like the food supplements or cosmetics industries - although the trend is moving towards also using pharma-grade products in these areas of manufacturing - because the final quality is far superior. Linnea advocates for the use of standardised products that follow a pharmaceutical-quality process for cannabis extracts.
A standardised product guarantees the precise amount of active ingredient contained, and its expected and relative efficacy, as well as the absence of prohibited or harmful substances. Numerous FDA recalls were announced along these lines, as noted in JAMA research. Another study, from UC Davis in California, observed cases where contaminated lots caused serious side effects.
Ultimately, in a scenario where cannabis and cannabinoid products are relatively new but are encountering high, generalised market demand, Linnea believes the quality of a standardised product is going to be crucial for the development of more coherent trials from the scientific community on the clinical applications of the cannabis extract and the cannabinoid active ingredient.
With the aim of widespread application of specific standardisation criteria, Linnea and Crystal Hemp promote excellence in setting new standards for this area.
Engaged for more than 35 years in the extraction of herbs and medicinal plants, Linnea systematically applies pharmaceutical standards to the production of botanical and plant-derived extracts, setting itself apart in terms of transparency and quality.
At Crystal Hemp, organic cultivations strictly produced under GACP are the bedrock of the ongoing perfection of the therapeutic applications of cannabinoids.
A shared passion for quality, and a vision of the need to apply scientific criteria and pharmaceutical research to the processes of plant extraction, led the two companies to establish the Therahemp project.
Therahemp is the scientific answer to the chaotic state of management within the cannabis and cannabinoid market. Both businesses want to ensure standardised and safe products.
They want cannabis to be therapeutic, and perceived as such by the medical community and the public at large, so this completely natural plant falls within the array of possible medicines considered for various clinical cases.
The goal is to provide people with a totally safe and healthful therapeutic product.
References available upon request.