Pubdate: Wed, 20 Jun 2018
Source: Orlando Sentinel (FL)
Copyright: 2018 Orlando Sentinel
Authors: Kathleen Foody and P. Solomon Banda


A British pharmaceutical company is getting closer to a decision on
whether the U.S government will approve the first prescription drug
derived from the marijuana plant, but parents who for years have used
cannabis to treat severe forms of epilepsy in their children are
feeling more cautious than celebratory.

The U.S. Food and Drug Administration is expected to decide by the end
of the month whether to approve GW Pharmaceuticals' Epidiolex. It's a
purified form of cannabidiol -- a component of cannabis that doesn't
get users high -- to treat Dravet and Lennox-Gastaut syndromes in
kids. Both forms of epilepsy are rare.

Cannabidiol's effect on a variety of health conditions is frequently
touted, but there is still little evidence to back up advocates'
personal experiences. The U.S. Drug Enforcement Administration has
long categorized cannabis as a Schedule I drug, a category with "no
currently accepted medical use and a high potential for abuse." That
strictly limits research on potential medical uses for cannabis or the
chemicals in it, including cannabidiol, or CBD.

But for years, parents desperate to find anything to help their
children have turned to the marijuana-based products made legal by a
growing number of states.

Meagan Patrick is among the parents using CBD to treat symptoms in
their children. She moved from Maine to Colorado in 2014 so she could
legally get CBD for her now-5-year-old daughter, Addelyn, who was born
with a brain malformation that causes seizures.

"My child was dying, and we needed to do something," Patrick said.

As for the potential approval of a pharmaceutical based on CBD, she
said fear is her first reaction.

"I want to make sure that her right to continue using what works for
her is protected, first and foremost. That's my job as her mom,"
Patrick said.

Advocates like Patrick became particularly concerned when GW
Pharmaceuticals' U.S. commercial business, Greenwich Biosciences,
began quietly lobbying to change states' legal definition of
marijuana, beginning in 2017 with proposals in Nebraska and South Dakota.

Some worried the company's attempt to ensure its product could be
legally prescribed and sold by pharmacies would have a side effect:
curtailing medical marijuana programs already operating in more than
two dozen states.

The proposals generally sought to remove CBD from states' legal
definition of marijuana, allowing it to be prescribed by doctors and
supplied by pharmacies. But the change only applies to products that
have FDA approval.

Neither Nebraska nor South Dakota allows medical use of marijuana, and
activists accused the company of trying to shut down future access to
products containing cannabidiol but lacking FDA approval.

GW Pharmaceuticals never intended for the changes to affect other
marijuana products, but they are necessary to allow Epidiolex to be
sold in pharmacies if approved, spokesman Stephen Schultz said.

He would not discuss other places where the company will seek changes
to state law. The Associated Press confirmed that lobbyists
representing Greenwich Biosciences backed legislation in California
and Colorado this year.

"As a company, we understand there's a significant business building
up," Schultz said. "All we want to do is make sure our product is

Industry lobbyists in those states said they take company officials at
their word, but they still insisted on protective language ensuring
that recreational or medical marijuana, cannabidiol, hemp and other
products derived from cannabis plants won't be affected by the changes
sought by GW Pharmaceuticals.

A marijuana extract significantly reduced seizures in severely
epileptic children, according to a landmark study conducted in part at
Lurie Children's Hospital of Chicago.

Supporters said the results greatly improve the chances for the drug,
called Epidiolex, to win eventual approval by federal...

Patrick Goggin, an attorney who focuses on industrial hemp issues in
California, said the company would run into trouble if it tried to
"lock up access" to marijuana-derived products beyond FDA-approved

"People need to have options and choices," he said. "That's the battle

Legal experts say the changes are logical. Some states' laws
specifically prohibit any product derived from the marijuana plant
from being sold in pharmacies. The FDA has approved synthetic versions
of another cannabis ingredient for medical purposes but has never
approved marijuana or hemp for any medical use.

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. It's
not clear why CBD reduces seizures in some patients, but the panel
based its recommendation on three studies showing significant
reduction in children with two forms of epilepsy.

A closely watched medicine made from the marijuana plant reduces
seizures in children with severe forms of epilepsy and warrants
approval in the United States, health officials said Tuesday.

Denver-based attorney Christian Sederberg, who worked on the GW
Pharmaceuticals-backed legislation in Colorado on behalf of the
marijuana industry, said all forms of marijuana can exist together.

"The future of the industry is showing itself here," Sederberg said.
"There's going to be the pharmaceutical lane, the nutraceutical
(food-as-medicine) lane, the adult-use lane. This shows how that's all
coming together."

Alex and Jenny Inman said they won't switch to Epidiolex if it becomes
available, though their son Lukas has Lennox-Gastaut syndrome.

Alex, an information technology professional, and Jenny, a preschool
teacher, said it took some at-home experimentation to find the right
combination of doctor-prescribed medication, CBD and THC -- the
component that gives marijuana users a high -- that seemed to help
Lukas with his seizures.

"What makes me a little bit nervous about this is that there's sort of
a psyche amongst patients that, 'Here's this pill, and this pill will
solve things,' right? It works differently for different people," Alex
Inman said.

The Inmans moved from Maryland to Colorado in 2015 after doctors
recommended a second brain surgery for Lukas' seizures. The couple and
other parents and advocates for CBD said children respond differently
to a variety of strains.

The Realm of Caring Foundation, an organization co-founded by Paige
Figi, whose daughter Charlotte's name is attached to the CBD oil
Charlotte's Web, said it maintains a registry of about 46,000 people
worldwide who use CBD.

For Heather Jackson, who said her son Zaki, now 15, benefited from CBD
and who co-founded the foundation, Epidiolex's approval means insurers
will begin paying for treatment with a cannabis-derived product.

"That might be a nice option for some families who, you know, really
want to receive a prescription who are going to only listen to the
person in the white coat," Jackson said.
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