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Cuomo signs deal to conduct clinical trial of medical marijuana

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 re-election 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.

In a statement issued today, Conte said she is “tired of working with politicians who claim they want to help our kids and then propose unworkable solutions.”

“My child almost died last night, and every time she has a seizure, it could be her last. We don’t need a limited research program that will only help the lucky few who can get in enrolled. Epidiolex may not even work for every kid who has a seizure disorder. We want options. And we want a workable system that creates access for all patients needs – not just my daughter but all those living with epilepsy, cancer, MS, HIV/AIDS, and other serious illnesses. If Governor Cuomo wants to help Anna, he would support the Compassionate Care Act,” she said.