Pubdate: Mon, 18 Apr 2016
Source: Denver Post (CO)
Copyright: 2016 The Associated Press
Contact:  http://www.denverpost.com/
Details: http://www.mapinc.org/media/122
Author: Julie Carr Smith, The Associated Press

EPILEPSY DRUG STARTS DEBATE

Pot Activists Worry Cannabis Extract May Undercut Political Movement

Columbus, Ohio (AP) - An experimental epilepsy drug made from 
cannabis plants grown in England is complicating the medical 
marijuana debate in hospitals and statehouses.

Epidiolex is a nearly pure extract of cannabidiol, or CBD, with 
little of the tetrahydrocannabinol, or THC, that gets traditional pot 
users high. CBD products are the current rage in medicinal pot 
products, and activists fear that if the maker of Epidiolex manages 
to get FDA approval, it could undercut the political momentum of the 
medical marijuana movement.

Anup Patel, a pediatric neurologist who oversees Epidiolex's clinical 
trials at Nationwide Children's Hospital in Columbus, insists the 
drug contains the optimal known marijuana compound for treating 
seizures. He cited a study that found children can be hurt by using 
the whole plant.

Patel laments that children with epilepsy are being used - including 
during an unsuccessful Ohio ballot campaign last year - to push for 
medical marijuana legalization.

"People are mixing terms, mixing ideas," he said. "I'm not sure if 
that's just because of confusion, lack of knowledge or on purpose."

Karmen Hanson, the expert on marijuana policy for the nonpartisan 
National Conference of State Legislatures, said the two sides are at odds.

"The argument for traditional (wholeplant) medical marijuana is that 
people know what works for them - whether they're going to make their 
own concentrates or vape or combust, use flowered products, oils, you 
name it - so they want to protect their ability to do that," she 
said. "The other camp wants to see the head-tohead science, to give 
it more scientific validity, to elevate the products that are 
produced in terms of reliability and consistency."

Patel is in Camp 2. He personally lobbied to get U.S. patients access 
to Epidiolex, which he said is effective, consistent and doesn't get 
users high.

About two years ago, Patel persuaded London-based GW Pharmaceuticals 
to give him enough of the medicine for a single patient, and his 
hospital's study was born. Last month, the company released positive 
results of late-stage testing. It plans to take Epidiolex to the U.S. 
Food and Drug Administration later this year.

The FDA has not yet found any botanical form of marijuana to be safe 
or effective to treat any disease or condition, spokesman Michael 
Felberbaum said. If approved, Epidiolex would be the first. Two 
synthetic cannabinoids - Marinol and Cesamet - are available.

FDA approval would allow any doctor to prescribe Epidiolex to any 
patient, and it would be covered by insurance. No law or ballot issue 
would be required.

Many medical marijuana activists fear Epidiolex approval will mark 
the beginning of Big Pharma's takeover of the marijuana plant, 
undercutting patients' ability to treat themselves as they see fit.

"We are not concerned with the pill (actually oil) form of a natural 
plant," said Wendy Johnson, who represents the Cannabis Safety 
Association in Ohio. "In fact, it is looked upon very unfavorably and 
as a stumbling block on our way to whole plant."

Twenty-three states now have medical marijuana and cannabis programs 
- - but 17 others have chosen only to permit use of "low THC, high 
cannabidiol" products, mostly cannabis oils or hemp extracts.
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MAP posted-by: Jay Bergstrom