Approval of marijuana-derived drug may backfire

Tuesday, June 19, 2018

Some people swear by cannabidiol, a compound derived from marijuana that doesn’t get users high, but can help control seizures.

A British company should have a decision by the end of the month on whether its version will be approved by the U.S. Food and Drug Administration.

So what’s the problem?

Marijuana and derivatives are still categorized as a Schedule I drug, with “no currently accepted medical use, and a high potential for abuse.”

If GW Pharmaceuticals’ Epidiolex is approved, it will be able to be legally used to treat children with Dravet and Lennox-Gastaut syndromes, both rare forms of epilepsy.

The company’s U.S. branch, Greenwich biosciences, has been quietly lobbying states like Nebraska and South Dakota, which have no medical marijuana laws, to change their legal definition of marijuana.

The problem is that parents who have found seizure relief through other forms of cannabidiol worry they will find them no longer available once an FDA approved and doctor prescribed form is available.

A panel of FDA advisers in April unanimously recommended the agency approve Epidiolex for the treatment of severe seizures in children with epilepsy, conditions that are otherwise difficult to treat.

GW Pharmaceuticals says it never intended the changes to affect other marijuana products, but while the FDA has approved synthetic versions of another cannabis ingredients for medical use, it has never approved marijuana or hemp for medical use.

And, some parents find it is necessary to experiment with the right combination of CBD and THC — the component that gives marijuana users the high — to bring difficult seizure cases under control.

Marijuana will probably always carry the stigma of being seen as a gateway to harder drugs, but its actual benefits must be explored in a completely impartial manner to determine what legitimate medical value it has for particular maladies.

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