FDA Approves UAB Medical Marijuana Study
December 11, 2014/in News, Treatments /by Nicole Watkins
Comments by Dr. J. COLOMBERA (in red)
The US Food and Drug Administration (FDA) has given the University of Alabama at Birmingham (UAB) the green light to study the use of a marijuana derivative to treat seizures.
On Wednesday, UAB received an approval letter from the agency, allowing for studies that would focus on the health effects of cannabidiol, or CBD. The FDA authorized two studies evaluating CBD for seizures, one of which will be conducted in children and the other in adults. The approval from the federal agent was welcoming news for families who had pushed to make CBD oil legally available in the state.
According to Bob Shepard, a UAB spokesman, the letter did ask for some modifications to the protocols employed. However, Shepard said that the changes are minor, and mostly in some of the language and information provided to patients (Patients need a clear explanation of what happens).
In April, the Alabama Legislature approved $1 million for the study, as well as a bill called “Carly’s Law,” protecting those who participate in the program from criminal prosecution (Incredible…young children as criminals???).The law was named after Carly Chandler, a three-year old with a rare genetic disorder that causes her to have up to 200 seizures a day. Carly’s father and police officer Dustin Chandler spoke to incoming state representatives on Tuesday at House Speaker Mike Hubbard’s invitation, telling them that he believed their efforts were giving parents around the state hope. (I wonder if a minister’s daughter would be in the same case… her father wouldn’t respect law procedure at all…would he?)
UAB officials must now go before the UAB Institutional Review Board in January, and the university must also get permission from the US Drug Enforcement Administration. (What a waste of time… but better later than never).