Big Pharma’s Big Problem:
How Whole Plant CBD Is Turning the Tables On Synthetic CBD
Big Pharma’s playbook for drug development and patents is the same as it’s always been.
Large pharmaceutical companies will either invest billions into research and development and ride the seven-year journey from a drug’s discovery, to patent, to its first commercial sale, or they skip the process altogether by acquiring small biotech targets with promising drugs in the pipeline.
But what happens when your tried and true business model suddenly stops working? What happens when you can’t patent isolated natural products that work better than your multibillion dollar synthetic drugs?
In the case of cannabidiol or CBD, that’s what Big Pharma’s trying to figure out.
Whole Plant CBD vs. Synthetic/Pure CBD
Big Pharma is quickly realizing that their cannabis-derived drugs – in synthetic and/or pure form – don’t work as well as whole plant CBD extracts.
Case in point, take a look at the 2014 joint study performed by a group of scientists from Italy, and the U.K. and published in the medical journal Phytomedicine. The researchers tested the effects of whole plant CBD extract (called cannabidiol botanical drug substance or CBD BDS) vs. pure CBD on colorectal cancer cell proliferation and in experimental models of colon cancer in the body.
Although both the CBD extract and pure CBD reduced cell proliferation in tumor cells, the differences between the two were startling. The extract actually showed greater affinity for CB1 and CB2 receptors and was better at reducing lesions and polyps as well as tumor growth in the xenograft model of colon cancer.
In this experiment, the whole plant CBD extract clearly outperformed pure CBD and the results may have some clinical relevance for the future use of cannabis-based medicines in cancer patients.
Although not a CBD product, there’s also the case of dronabinol (sold as Marinol) which is the pure, synthetic form of THC that Unimed Pharmaceuticals Inc. developed in the 1980s. The drug was approved for use as a treatment for anorexia in AIDS patients and to relieve nausea and vomiting in chemotherapy patients.
However, because Marinol is a pure, synthesized product, it lacks the presence of CBD and other important phytocannabinoids as well as terpenoids that offer complementary pharmacological activities that may strengthen and broaden clinical applications and improve the therapeutic index of THC.
Not surprisingly, a 2013 survey published in the Journal of Psychoactive Drugs found that only 1.8% of the 953 participants preferred synthetic dronabinol as their method of intake over inhaled or infused preparations.
As Lester Grinspoon, MD, Professor of Psychiatry at the Harvard Medical School, stated in the 2001 issue of the International Journal of Drug Policy, “If patients were legally allowed to use marijuana, relatively few would choose Marinol.”
Another prime example is Sativex, a cannabis-based oral spray that was developed by GW Pharmaceuticals in London, England and contains CBD as well as THC. Sativex is used to treat multiple sclerosis (MS) and is approved in 16 countries outside the U.S.
But according to the company’s chairman, Dr. Geoffrey Guy, GW Pharmaceuticals ran into some of the same obstacles that Marinol faced when developing Sativex. After more than a decade of experiments, they concluded that a whole plant extract was more effective in reducing the symptoms of MS than a medication made of a single compound.
Of course to really hammer the point home, we can turn to the 2015 study published in Pharmacology & Pharmacy by Israeli scientists Ruth Gallily, Zhannah Yekhtin, and Lumír Ondřej Hanuš titled, “Overcoming the Bell‐Shaped Dose‐Response of Cannabidiol by Using Cannabis Extract Enriched in Cannabidiol.”
In the study, researchers compared the anti-inflammatory and anti-nociceptive effects of a synthetic, purified CBD product to a standardized plant extract derived from the cannabis sativa plant that is highly enriched in CBD, called clone 202. Clone 202 is sold under the brand name Avidekel and is developed by Tikun Olam, the largest supplier of medical cannabis in Israel.
When the synthetic CBD product was tested on mice, either intraperitoneally or orally, a bell‐shaped dose‐response was observed. This means there was basically no beneficial effect at either lower doses or higher doses and that healing was only observed when synthetic CBD was given within a very limited dose range. If this were tested on patients, they would need to find an exact dosage in order to get the full benefits of the drug’s healing effects. Any more or less and the therapeutic impact would decline significantly. This trait of synthetic, purified CBD imposes serious obstacles in planning human and animal studies, which limits its clinical use.
In contrast, the researchers were able to completely eliminate the bell-shaped dose-response of CBD by using a whole plant extract. When tested on mice, clone 202, which is highly enriched in CBD and hardly contains any psychoactive ingredients, provided a clear correlation between the anti‐inflammatory and anti‐nociceptive responses and the dosage. As more clone 202 was administered, it was more effective. This makes the whole plant medicine a much better alternative for clinical uses. The researchers concluded that cannabis clone 202 (Avidekel) extract was superior over purified CBD for the treatment of inflammatory conditions.
The Entourage Effect
The entourage effect for CBD has been supported by numerous reports that show that whole plant CBD oil extracts are more potent or efficacious than pure CBD. Aside from the studies mentioned, researchers have come across similar results in other studies as well.
This boost in effectiveness might be explained by additive or synergistic interactions between CBD and terpenes, phytocannabinoids, and/or non-cannabinoids presented in the extracts.
But more importantly, results from these studies legitimize the use of whole plant medicine as an alternative for treating diseases that have traditionally been treated by using synthetic drugs alone.
As the new generation of phytopharmaceuticals are developed, Big Pharma will need to abandon their old business models and adapt to the new changes in order to compete in the new pharmaceutical landscape.
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