For the first time, the US Food and Drug Administration. UU Has recommended the approval of a drug derived from cannabis. It is an important step to recognize that the plant has a valid medical use, but it will mean little without losing the research restrictions that prevent scientists from discovering the other effects of cannabis on health.
The drug in question is Epidiolex, used to treat severe forms of epilepsy called Dravet's syndrome and Lennox-Gastaut syndrome. Epidiolex includes cannabidiol (CBD), a chemical that comes from the cannabis plant, but that is not psychoactive. Researchers have applauded the measure, and it seems likely that the drug will be officially approved soon. "This is a very good development, and basically underlines that there are medicinal properties for some of the cannabinoids," said Dr. Igor Grant, director of the Medicinal Cannabis Research Center at the University of California at San Diego The New York Times .
Still, the recommendation for approval is for "a single compound that comes from the plant and is approved for two very specific forms of epilepsy," says Daniel Friedman, associate professor of neurology at NYU Langone & # 39; s Comprehensive Epilepsy Center that co-authored a study investigating Epidiolex to treat Dravet syndrome. "What that means for other conditions or other cannabinoids, we do not know yet."
It is certainly possible that CBD may be useful in the treatment of other forms of epilepsy or other conditions altogether. But to know and develop medicines that will help people, the Drug Enforcement Agency needs to relax the restrictions on cannabis research. At this time, cannabis is illegal at the federal level and, according to the DEA, it is a Schedule I drug along with heroin, LSD and cocaine, meaning that it is considered "not to have a currently accepted medical use and a high potential for abuse. " "
As a result, Friedman's team had to undergo a complicated bureaucratic process to carry out their study of Epidiolex, which included having a special license from the DEA and special teams, and" all that infrastructure makes it prohibitive. perform studies in other conditions by people who want to do it, but do not have the resources. "These same restrictions mean that as of 2013, less than 20 randomized controlled trials (the gold standard for scientific research) have proven the benefits of marijuana, according to the American Medical Association To do more good, we should make it easier for researchers to study the plant and potentially bring new useful drugs to the market.
On the other hand, lack of FDA approval and DEA has barely prevented an industry of beauty and wellness companies from using CBD in everything from masks to bath bombs, despite that most of these products lack legitimacy. Epidiólex is derived from a cannabis strain genetically cloned to produce CBD and then carefully refined, according to Friedman. It is unlikely that the same can be said for products such as Kush Mascara, the Vertly lip balm or even the herb lubricant.
The CBD wellness industry is experiencing the same exaggeration and lack of regulation as the supplement industry (a lack of regulation leading to "dietary supplements" that include dangerous simulants.) Last year, the FDA tested CBD wellness products, and many did not contain the amount they had claimed.
The positive recommendation of the FDA is a good step forward in the legitimization of CBD and cannabis for medicine. "As a doctor, I am indifferent to whether a drug is obtained from a plant or manufactured in a laboratory, I am happy to see that there is another option for these patients," says Friedman. Hopefully, it's another push for the DEA to reprogram the medication and stop the paralyzing investigation. At the same time, the FDA needs to more closely regulate this secondary industry of CBD products, because even though the actual version of CBD could help it heal, the $ 24 mask of cannabis oil will hardly be the cure for what it afflicts us