Marijuana clinical trials on Texas children net positive results
A marijuana extract experimental drug has been dubbed a success after testing in a number of Texas hospitals.
GW Pharmaceuticals is currently conducting clinical trials with Epidiolex, an orally administered CBD oil medicine used to treat epilepsy. The medicine does not contain THC, a component of the cannabis plant that gets a consumer high.
Texas Children’s in Houston participated in the FDA-approved clinical trial, giving some patients the oil at different doses while administering others a placebo.
The trials are focusing on Dravet Syndrome, which can cause anywhere from a dozen to hundreds of seizures each day. It affects about one in 30,000 births.
Results from three other trials are expected later this year, including those being conducted at Cook Children’s in Fort Worth where 10 patients are being treated for Lennox-Gastaut Syndrome, a severe form of epilepsy which involves up to 150 seizures a day, some of them very violent.
GW said on Monday the 120-patient trial showed patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39 percent compared with a reduction on placebo of 13 percent.
GW Pharmaceuticals saw its value drastically after the announcement, with shares up 125 percent. The company was founded in 1998 with the aim of capitalizing on the medical benefits of cannabis, while purifying the active ingredients so as to avoid psychoactive effects. It currently has a license to grow cannabis plants for its medicines in southern England.
“This shows that cannabinoids can produce compelling and clinical important data and represent a highly promising new class of medications, hopefully in a range of conditions,” Chief Executive Justin Gover told Reuters.
With data of positive results, Gover said GW would now request a meeting with the U.S. Food and Drug Administration (FDA) to discuss its plans to seek regulatory approval for treating this particular form of epilepsy.
There are currently no FDA-approved therapies for Dravet syndrome.
Marijuana is a Schedule 1 drug, like heroin and LSD, meaning that it has no acceptable medical uses. This has not stopped states from striking out on their own to establish and regulate their own medical cannabis industries, however none of them have the blessings of the FDA.
Dean Bortell, the father of Alexis Bortell, a 10-year-old girl who moved from Texas to Colorado to receive cannabis oil treatments for her epilepsy, applauded the research but urged caution.
The organization which raises awareness about Alexis’ and other seizure patient’s stories, Team Alexis, issued a statement concerning the clinical trials.
At Team Alexis we support research on all cannabinoids found in the cannabis plant. The most recent study on GW’s Epidiolex is a step in the right direction but as with any product research people need to take a close look at the goals of the study. If the goal of research is to provide knowledge to providers and patients while protecting their right to choose then we support it. The problem arises when companies claim to be doing research on cannabis and in reality they are doing research on a single cannabinoid in hopes their strain or product can ‘corner’ the market. Science is vital and we support patient-centric research 100% but we will NEVER support any research that aims to take choice away from patients or hands the cannabis plant to a corporate entity. In the case of cannabis, because of its fairly unique safety profile, we stand by our position that research is necessary, a doctor’s discretion on ratios and dosages is vital, but above all, the patient’s right to grow their own medicine and have access to labs for testing must be safe guarded from corporate oppression.
We hope research continues but we strongly urge people to look at the research, its origin, and above all its impact on their freedom before they praise every study and company behind them.
Since moving to Colorado, Alexis has now made it over a year without experiencing any seizures. She originally had up to dozens a day, and the Bortells credit a dosage of both CBD and THC together with helping manage Alexis’ epilepsy.
El Paso resident Colt DeMorris, who heads up a local non-profit chapter of the National Organization for the Reform of Marijuana Laws, was happy to see positive results, but worries that medicines such as this will set the stage for ultimately harming other current medical cannabis patients due to federal scheduling issues.
“This is a prime example of why we need to de-schedule rather than reschedule. Rescheduling cannabis is going to put it right into the hands of the pharmaceutical companies and that is not what patients need. Once it is in the hands of the pharmaceutical companies as a Schedule II, you can kiss patients rights to access good by,” he says. “Everything will be determined by a doctor and I am almost positive patients will not be able to have home grow. Can patients acquire their Schedule II two medications on their own now? No, and it will be no different if this happens.”
Across the country in states both where medical cannabis is legal and illegal, patients have seen very positive results in seizure reductions and management.
In recent years many families have had to uproot from their homes and lives in Texas and move to states where medical cannabis is legal, with many patients being children. A number of parents pleaded with state law makers during the 2015 legislative session for a whole plant medical cannabis program, and often their children were experiencing severe seizures.
A medical cannabis bill was introduced, however the health committee chair blocked a vote on the measure.
The legislature next convenes in 2017.
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