Bill 2238 passed by the House and Senate, is on the Governor’s desk. It is not known if he intends to sign it or veto it. The bill gives the Missouri Department of Agriculture the job of growing marijuana plants, hiring someone from the Colorado, a “Charlotte’s Web” type group to extract raw CBD, and dispense it in a manner to be regulated by the Missouri Department of Health.
A state budget has not been approved for this method. Members of Show Me Cannabis and NORML have given their support. It is not supported by the FDA or the DEA.
This bill is not in the best interest of the children and their parents who are desperate to find a cure. Parents become unwitting allies of the marijuana supporters and their media promoters. One can’t blame worried parents for wanting to find relief for their children immediately, but there is good reason to hold off until the clinical trials are completed. The American Society of Addiction Medicine is clear: stick with medicines that are approved by the process of identification and distribution of medicines.
Why is Missouri following the proposals of Show Me Cannabis and NORML by using the Departrment of Agriculture to grow marijuana plants to manufacture hemp oil rather than working with a legitimate pharmaceutical company? This is not the only option and definitely not the best.
The best option would be a direct working relationship with GW Pharmaceuticals that supplies a purified CBD product. Epidiolex is being tested in FDA trials for children with severe epileptic seizures. A medical pharmacy supplies doctors for their patients. Patients participate in a double blind study to determine effectiveness. This is FDA approved and covered by family insurance. It is much faster than the Missouri route as it can be set up and running in five to seven months and no more than one year. This program is no cost to the state.
The Georgia Legislative Bill for Research is working with the FDA approved Epidiolex, October 2013, for seven expanded-access programs giving families whose children suffer severe seizures from rare forms of epilepsy access to this investigational new drug. This has been accomplished through state legislation. The children are not being placed in experimental groups or control groups, but will take the drug continuously while clinical trials are underway. The purpose of these expanded access programs is two-fold:
1. To treat severely ill children who do not respond to standard medications with a drug that has met FDA requirements for safety in preclinical research while clinical trials take place, and
2. To gather preliminary information for phased trials that will determine whether Epidiolex can reduce epileptic seizures more effectively than standard medications.
Similar expanded-access applications from more physicians await FDA approval. Each may enroll 25 children, or possibly more. As a result, hundreds of children will likely have access to such programs throughout the U.S. soon. Epidiolex is purified CBD that contains no THC which can cause seizures. When the FDA approves Epidiolex, doctors will be able to prescribe a fourth medicine derived from marijuana.
The New York State Department of Health is also involved in a clinical trial of Epidiolex. The trial is designed to be conducted at New York-based hospitals, universities and medical colleges, and 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 with the NYU’s Langone Medical Center where 60 children are already authorized by the FDA to receive Epidiolex.
Marijuana use by children and adolescents has been proven to impair learning, judgment and memory and can cause lasting harm to the brain. The pharmaceutical researchers want to give the patient the benefit of the CBD without the harm. Medicine is developed in laboratories and not grown by the Department of Agriculture or in one’s own back yard. Think again, Missouri.
Roby Little is the director of Lees Summit CARES and a Lees Summit resident.