Pubdate: Wed, 20 Apr 2016
Source: Chicago Tribune (IL)
Copyright: 2016 Associated Press
Contact:  http://www.chicagotribune.com/
Details: http://www.mapinc.org/media/82
Author: Julie Carr Smyth

DRUG STIRS UP MEDICAL POT ACTIVISTS

They Fear Epilepsy Medication, Whose Maker Seeks FDA OK, Could Blunt 
Their Movement

COLUMBUS, Ohio - 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 approval by the U.S. Food and Drug Administration, it could 
undercut the political momentum of the medical pot movement.

Anup Patel, a pediatric neurologist who oversees Epidiolex 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, an expert on marijuana policy at the nonpartisan 
National Conference of State Legislatures, said the two sides are at odds.

"The argument for traditional (whole-plant) 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-to-head science, to give 
it more scientific validity, to elevate the products that are 
produced in terms of reliability and consistency."

Patel is in the latter camp. 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 Londonbased 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 FDA 
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, where medical marijuana legislation was 
introduced last week. "In fact, it is looked upon very unfavorably 
and as a stumbling block on our way to whole plant."

Twenty-three states now have comprehensive medical marijuana and 
cannabis programs - but 17 others have chosen only to permit use of 
"low THC, high cannabidiol" products, mostly mom and pop cannabis 
oils or hemp extracts.

Since marijuana can't be legally grown in those 17 states, the 
narrower bills aren't much more than legal protections for people who 
are able to access the products, Hanson said. A lowTHC, high-CBD 
strain of medical marijuana called Charlotte's web is grown in 
Colorado, for example, where marijuana is legal.

"They're worried about political pushback. That's it in the end," 
said John Hudak, a senior fellow at the Brookings Institution who 
studies marijuana law. "They're worried about an ad being run against them."

Tara Cordle, of Wheelersburg, Ohio, has a 10year-old son, Waylon, who 
has a severe form of epilepsy and is part of Epidiolex trials at 
Nationwide Children's Hospital.

She said she also wants Waylon to have access to the whole marijuana 
plant, even if it has risks. Cordle said it's difficult as a parent 
not to hope for a miracle cure - like the widely circulated story of 
6-year-old Charlotte Figi seeing her seizures drop from 300 a week to 
three, giving her name to Charlotte's web.

She said Waylon daily takes 47 pills, which make him sweat, give him 
diarrhea, put him at risk of kidney stones and promote early onset 
osteoporosis.

"I'm not afraid of doing a trial and error," she said, "because every 
seizure medication ... is a trial and error."
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