New York to hold clinical trials for ganja

Tuesday, June 03, 2014

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NEW YORK, USA — NEW York state is partnering with a British company to hold clinical trials for marijuana-based medication for children who have seizures that are resistant to their medicine.

An agreement was signed Sunday between Governor Andrew Cuomo's administration and GW Pharmaceuticals. The state Health Department and the company will develop the framework for a clinical trial for a marijuana-based drug for people under the age of 18.

It will involve Epidiolex, an investigational medication that uses cannabidiol, a marijuana extract that doesn't get users high. It could help children with rare forms of epilepsy such as Dravet and Lennox-Gastaut syndromes.

"Young New Yorkers battling these diseases deserve treatments that work for them, and by investigating the merits of cannabidiol we are pushing the boundaries of modern medicine and working to fundamentally improve the quality of life for those children," Cuomo said yesterday.

Dravet syndrome is a rare genetic disorder typically untreatable by anti-epileptic drugs. It can be fatal. Lennox-Gastaut syndrome, another rare form of childhood-onset epilepsy, is characterised by different types of seizures multiple times a day and cognitive dysfunction. To be eligible for the trial, the children would have to show signs that their current medication is not working.

In Colorado, the Charlotte's Web strain of marijuana, which is high in cannabidiol content, has received international attention for its effect on children with severe seizures. It also is low in the chemical responsible for most of marijuana's psychological effects. The Realm of Caring, a nonprofit organisation that produces the strain, currently has 206 people on its waiting list in the United States and separate waiting lists worldwide.

The Health Department is working on the framework for the protocol, which needs to be approved by the Food and Drug Administration before it is enacted. State officials expect FDA approval relatively quickly.

But advocates for legalising medical marijuana criticised Cuomo's drug trial, saying it draws attention from a proposal making its way through the Republican-led Senate that would legalize medical marijuana, and that FDA approval could take a while.

"It certainly seems like it's a distraction from what needs to be done and that it's an inappropriate distraction," said Karen O'Keefe, director of state policies at the Marijuana Policy Project, which is airing commercials in New York in favour of the bill before the Senate.

The bill would allow patients with one of 20 serious illnesses to use the drug. The bill would bar anyone under the age of 21 from smoking marijuana but would allow the drug to be administered through a vaporiser, oil or something edible.

The announcement of the agreement with GW Pharmaceuticals comes as medical marijuana legislation is being pushed into the forefront of New York state politics.

In January, Cuomo, a Democrat, proposed a pilot programme to allow 20 hospitals statewide to administer medical marijuana to seriously ill patients under the Health Department's guidelines.

And the Legislature is considering two medical marijuana bills. The Compassionate Care Act and another measure would prohibit smoking the drug in its entirety, but legalise medical marijuana use in vaporiser, oil or edible form for seriously ill patients.




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