Pubdate: Tue, 03 Jun 2014
Source: Buffalo News (NY)
Copyright: 2014 The Buffalo News
Contact: http://drugsense.org/url/GXIzebQL
Website: http://www.buffalonews.com/
Details: http://www.mapinc.org/media/61
Author: Tom Precious, News Albany Bureau Chief
Page: D1
Bookmark: http://www.mapinc.org/find?323 (GW Pharmaceuticals)

CUOMO OKS TRIAL OF MEDICAL MARIJUANA

Kids With Seizures to Receive Oil-Based Form of the Drug

ALBANY  The Cuomo administration has signed a deal with a British
pharmaceutical company to conduct a medical marijuana clinical trial
in New York State involving children who suffer from rare forms of
epilepsy.

The letter of intent between the state and GW Pharmaceuticals, signed
May 31 and obtained Monday by The Buffalo News, envisions the drug
being made available in an oil-or spray-based form to eligible
children across the state who do not respond to traditional drug
therapies and can suffer from hundreds of seizures in a day.

The agreement will be announced today by Gov. Andrew M.
Cuomo.

The clinical trial calls for GW Pharmaceuticals to collaborate with
state Health Department scientists and provide its drug, Epidiolex, as
part of a study to determine if the medical marijuana drug is as
effective as some advocates claim in treating the seizures.

Like an oil-based marijuana product parents have flocked to in
Colorado to obtain for their children, Epidiolex is not smoked and
contains no THC, which is the compound that gets marijuana users high.

Advocates of medical marijuana, though, say the governor's plan does
not go far enough, will take too long to get approved and that he
should be backing legislative efforts to make the drug legally
available to people who have specific medical conditions.

The governor's plan would be the second part of his proposal to permit
medical marijuana in a limited fashion. He previously said his Health
Department would begin implementing a 1980 New York law that would
permit medical marijuana to be dispensed in 20 hospitals statewide to
patients, most of them adults, suffering from certain conditions, such
as cancer.

The clinical trial with GW Pharmaceuticals still needs approval from
the U.S. Food and Drug Administration. State officials said Monday
that they were unsure how long the process might take but that work
has already begun on an application that would include such
information as the research protocols, conditions to be treated and
hospitals and principal investigators involved in the project.

The letter of intent states that New York seeks "a source of
cannabidiol that has been standardized and tested" in ways that are in
"accordance with accepted scientific and regulatory standards."
Advocates pushing for medical marijuana's legalization, though, say
there are volumes of research on the effectiveness of the drug
treating a variety of health conditions.

The decision by Cuomo to move ahead with a clinical trial comes as the
Legislature is trying to move on a measure called the Compassionate
Care Act, which would make marijuana eligible to be dispensed by
private companies both in oil-based forms to people under age 21 and
able to be smoked for adults with certain conditions and under a
doctor's care.

That measure, which has been approved for years by the Assembly, is
seen as having its greatest chance of passage this year in the Senate,
with its chief sponsor, Sen. Diane Savino, a Staten Island Democrat,
saying she has 40 sponsors in the Senate, which now has 61 members.

But Albany is suddenly a more confusing place than usual with the
announcement by Cuomo over the weekend that he wants to flip control
of the Senate to the Democratic column in the fall elections. He made
the pledge in order to get the backing of the small, left-leaning
Working Families Party line on the November ballot in his reelection
bid. Lobbyists on an assortment of issues, including medical
marijuana, Monday were left puzzled with the sudden political turmoil
at the Capitol.

Cuomo has been slow to the medical marijuana issue, dismissing a push
for its passage during his first three years in office. This year,
though, he backed the effort, although on a more limited basis than
advocates want, and Monday's revelation of a clinical trial for
children with rare seizure disorders represents the next step in
Cuomo's game plan to have the matter be run by his administration and
not dictated by the Legislature.

But advocates questioned the newest effort by the governor and
wondered if he isn't trying to scuttle any hopes of the Compassionate
Care Act's passage this session, which is set to end June 19. The
legislation received another Republican co-sponsor Monday, with Sen.
George Maziarz of Newfane signing onto it a week after Sen. Mark
Grisanti, a Buffalo Republican, went from supporter to official
co-sponsor of the bill.

"We've always said it's fine to move ahead with research. Our concern
is the extent to which the governor is framing this as a solution for
patients in New York, which it is not. This is not going to provide
medical marijuana to patients in New York," said Gabriel Sayegh, state
director of the Drug Policy Alliance, which has been advocating a
medical marijuana law for years in New York.

He noted that a New York University study for children with seizures
is limited to a couple dozen patients. "You have thousands of people
in this state, people with MS, people with cancer, people with HIV or
intractable pain, who could benefit from the use of medical marijuana,
and they won't be able to benefit from that use under the governor's
plan," he said.

Precisely where in the state the clinical trial medical marijuana for
children would be available is uncertain. Nor is it clear how many
children might participate.

The Buffalo News over the last year has interviewed parents of
children who suffer from severe seizures, sometimes 1,000 or more in a
day. One of those parents, Wendy Conte of Orchard Park, was back again
at the Capitol on Monday lobbying for the Legislature to go beyond
what has been put into motion so far by Cuomo. Conte, whose child
suffers from seizures, recently obtained a Colorado's driver's license
and is setting up official residency there so she can obtain an
oil-based marijuana treatment for her child.
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