ALBANY, N.Y. — The New York affiliate of Project SAM (Smart Approaches to Marijuana) and a nonpartisan alliance of lawmakers, scientists and other concerned citizens coordinated by Dr. Jeffrey Reynolds of the Long Island Council on Alcoholism and Drug Dependence (LICADD) and chaired nationally by former U.S. Rep. Patrick J. Kennedy, applaud today the State of New York’s efforts to help children with severe epilepsy receive promising, new medication based on the non-intoxicating component of the cannabis plant.
The State of New York and GW Pharmaceuticals today announced a memorandum of understanding that is a smart and compassionate way to deliver responsibly developed medication to those who need it. The State of New York and GW Pharmaceuticals have agreed to work together to study GW’s investigational cannabidiol (CBD) product Epidiolex® for the treatment of children with medication-resistant epilepsies.
SAM does not receive any funding from GW Pharmaceuticals or the State of New York.
The New York State Department of Health (DOH) will take the lead in developing the clinical trial for submission to the U.S. Food and Drug Administration. GW Pharmaceuticals will provide consultative advice and commit personnel and other resources to the partnership, including a supply of Epidiolex®, their CBD product. Designed to be conducted at New York-based hospitals, universities and medical colleges, the clinical trial will address a critical healthcare priority while expanding the scientific community’s understanding of potential treatments for children with medication-resistant epilepsies.
The collaboration with the State of New York builds on the foundation established by our relationship with New York University’s Langone Medical Center where 60 children are already authorized by the FDA to receive Epidiolex
“It is heartening to see New York State spearhead potentially life-saving research into marijuana-based medications while avoiding the temptation to call smoked marijuana “medicine” and repeating the mistakes made in other states,” remarked Dr. Jeffrey Reynolds, the coordinator of SAM New York. “This approach gives desperate families real options, rather than false hope and safeguards public health.”
There is pre-clinical evidence that CBD, a non-intoxicating component of marijuana, can be helpful in children with intractable epilepsy. Earlier in the year, SAM urged the FDA to speed up medication development related to CBD. In the meantime, products claiming to be “high-CBD” have been found to also have significant levels of THC. There is strong evidence that THC can be damaging to very young brains and in some cases may act as a pro-convulsant. Additionally, medicines claimed to be CBD-rich, found on the internet or through “medical marijuana dispensaries” have no assurances of quality and safety from independent scientific bodies like the FDA.
“We continue to urge FDA, working with DEA, to speed up the development of CBD so that every family can go into a pharmacy and purchase an affordable, reliable dose of medication,” said SAM National Chair Patrick Kennedy. “For now, New York has found a novel approach that will likely save lives – without legalizing smoked marijuana. This is a model for all states to follow.”
[box type=”shadow”]Project SAM, has four main goals:
• To inform public policy with the science of today’s marijuana.
• To prevent the establishment of “Big Marijuana” — and a 21st-Century tobacco industry that would market marijuana to children.
• To promote research of marijuana’s medical properties and produce, non-smoked, non-psychoactive pharmacy-attainable medications.
• To have an adult conversation about reducing the unintended consequences of current marijuana policies, such as lifelong stigma due to arrest.[/box]
About Project SAM
Project SAM is a nonpartisan alliance of lawmakers, scientists and other concerned citizens who want to move beyond simplistic discussions of “incarceration versus legalization” when discussing marijuana use and instead focus on practical changes in marijuana policy that neither demonizes users nor legalizes the drug. Project SAM has affiliates in twenty-five states, including Georgia, New York, California, Colorado, Vermont, Hawaii, Massachusetts, Missouri and other jurisdictions.