Why You Shouldn’t Compare the FDA Approval Process for Cannabis and COVID Vaccines
by Chane Leigh
by Kat Helgeson
The global COVID-19 pandemic has changed the way we think about almost everything, and that includes cannabis. Users of cannabis have explored the question of whether their cannabis use might increase their chances of contracting the virus. Many users are experimenting with the use of cannabis as an alternative or companion to pharmaceutical drugs to alleviate the depression and anxiety that comes along with living through these times, and others are finding new ways to enjoy cannabis while still adhering to social distancing regulations. But, as cannabis is an extremely versatile substance that has already shown itself to be useful in dealing with a wide variety of medical conditions, from chronic pain to insomnia to cancer, it’s worth questioning whether there is anything cannabis can do for those who have already contracted COVID-19. And that’s exactly what FSD Pharma, a Philadelphia based company, has set out to discover.
The pharmaceutical being studied for its effects against COVID-19 is not a new one. Known as ultra micronized palmitoylethanolamide, or micro PEA for short, it’s made using a synthetic cannabinoid. In the 60s and 70s, micro PEA was used in Czechoslovakia as a treatment for influenza and the common cold. During that time, clinical trials showed that the drug was safe to use and as effective as a prophylactic and at countering respiratory infections.
Currently, micro PEA is available as a prescription medication in both Italy and Spain. FSD Pharma acquired the rights to the drug from Epitech Group, an Italian pharmaceutical company that holds a patent on it. After purchasing the drug, FSD Pharma rebranded it as FSD-201. They gained permission from the Food and Drug Administration to submit an application to begin a clinical trial that would explore a new usage for the drug—combating the effects of COVID-19.
FSD-201 is not an anti-viral drug. It has no hope of being used as a vaccine, and neither will it be able to cure people of COVID-19 if they are already infected. But it might be able to reduce the severity of the infection and enable people to better cope with it.
Severe cases of COVID-19 are characterized by extreme inflammatory reactions in the body. In many cases, these reactions lead to a cytokine storm, an event in which the body starts to attack its own cells. This happens when a powerful immune system response is triggered, which can happen when the body is fending off a severe disease such as COVID-19. The immune system produces high levels of proteins known as cytokines, which begin to attack native cells and tissues. This response is believed to have been responsible for many COVID-19 deaths.
But FSD Pharma theorizes that FSD-201 will be able to help mitigate that immune system response, and that is what they hope to demonstrate in their clinical trials. If FSD-201 proves itself to be effective at suppressing cytokine storms in COVID-19 patients, we may find that the virus becomes significantly less deadly.
The drug is currently in phase one of a study in Australia to see what kind of effect it might be able to have. When that study is concluded, FSD Pharma will seek approval to begin a trial here in the United States.
Perhaps it is fate, in a way, that cannabis legalization is spreading throughout the United States at the same point in history as we are faced with one of the greatest public health crises we’ve ever seen. Cannabis has tremendous potential as a medical substance, and though it doesn’t have the power to cure COVID-19 or to innoculate us against us, it might just be able to give us the strength we need to survive.
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