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The FDA supports a cannabis drug, but it's still too hard to study pot



For the first time, the US Food and Drug Administration has recommended the approval of a cannabis-derived drug. It is an important step in acknowledging that the plant has a valid medical benefit, but this does little without loosening the research restrictions that keep scientists from finding out the other health effects of cannabis.

The drug in question is Epidiolex, used to treat severe forms of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome. Epidiolex includes cannabidiol (CBD), a chemical derived from the cannabis plant, but is not psychoactive. Researchers have applauded the move and it looks likely that the drug will soon be officially approved. "This is a very good development, and it basically underlines that some of the cannabinoids have medicinal properties," Dr. Igor Grant, director of the Center for Medical Cannabis Research at the University of California San Diego, The New York Times .

Yet, the recommendation for approval is "a single compound that leaves the plant and is approved for two very specific forms of epilepsy," says Daniel Friedman, associate professor of neurology at NYU Langone Epilepsy Center. has authored a study investigating Epidiolex for the treatment of Dravet's syndrome. "What that means for other conditions or other cannabinoids, we do not know yet."

It is certainly possible that CBD could be very helpful in the treatment of other forms of epilepsy or other disorders. But in order to know and develop drugs that help people, the Drug Control Authority must relax the restrictions on cannabis research. At present, cannabis is illegal at the federal level and according to DEA, a Level I drug, along with heroin, LSD and cocaine – meaning it has "no currently accepted medical use and high abuse potential". "

As a result, Friedman's team had to go through a complicated bureaucratic process to conduct their study on Epidiolex, including a special license from the DEA and special equipment, and" this whole infrastructure makes it impossible, under other conditions, to allow human studies The same limitations mean that since 2013, fewer than 20 randomized controlled trials (the gold standard for scientific research) have tested the benefits of marijuana, according to the American Medical Association On the other hand, a lack of FDA and DEA approval has barely precluded an industry of beauty and wellness companies from taking over the plant.

Use of CBD in everything, from mascara to bath although most of these products have no legitimacy. Epidiolex is derived from a genetically-cloned cannabis strain that has been bred to produce CBD and then carefully milled, Friedman said. It is unlikely that the same can be said about products like Kush Mascara, Vertly Lip Balm or even weed lubricant.

The CBD wellness industry suffers from the same hype and lack of regulation as the supplement industry (a lack of regulation that leads to "dietary supplements" including dangerous simulants.) Last year, the FDA tested CBD wellness products and many did not contain the amount they claimed.

The FDA's positive recommendation is a good step towards legitimating CBD and cannabis for medicine. "As a clinician, I do not care if a drug comes from a plant or is made in a lab – I am glad to see that there is another option for these patients," says Friedman. Hopefully, it will be another impetus for the DEA to rethink the drug and stop the research. At the same time, the FDA must regulate this side of CBD products more closely, because although the genuine version of CBD could help heal, the $ 24 cannabis oil mascara will barely be the remedy for what's plaguing us.


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