After several months of delays and wading through federal bureaucracy, the University of Alabama at Birmingham has finally been approved to begin its CBD oil study under “Carly’s Law,” which was passed unanimously by the Alabama Legislature last year.
“It’s taken us a whole year to get to this point,” said Dr. David Standaert, Chairman of UAB’s Department of Neurology. “It’s been very difficult with this because of all of the federal restrictions.”
That sentiment isn’t lost on Dustin Chandler, father of the bill’s namesake, Carly.
“It’s been a long, hard process and it took a lot of patience,” Chandler said. “It taught me that the people have a voice and that voice is even more powerful when it comes from our children.”
Carly has applied to be involved in the program, though Chandler has not received any word on her application or when applicants will be notified of their inclusion or exclusion.
Chandler is optimistic that the CBD oil will provide his daughter with relief from her seizures, as well as it make it possible for her to get off of the various medications she is currently taking.
UAB is slated to begin two different programs, one for adult patients and another for pediatric patients, to test effectiveness of CBD oil to treat severe, intractable seizures.
UAB plans to enroll 50 patients into each of the studies, patients who will be chosen by a panel of neurologists who will decide who gets in and who does not.
Alabama’s study will be the largest in the country, according to Standaert.
Because the oil, which is derived from the cannabis plant, can not be manufactured in Alabama, UAB has partnered with GW Pharmaceuticals (GWP) to have the oil manufactured.
“We have many drugs that come from plants,” Standaert said. “The only thing unusual here is the social stigma surrounding marijuana. Opium would be easier to work with.”
GWP is providing a limited amount of the oil to UAB at no charge, which will translate to those involved in the clinical trials.”
Standeart noted that should the study be a success, GWP has said they it will “work with” UAB on providing more of the product, though Standaert added they may contract another company
Further, GWP is planning to orchestrate a third study to be conducted at UAB, one that will be a double-blind study with a placebo.
All patients enrolled in the two UAB studies will receive CBD oil, according to a press release from UAB.
Standaert noted that the trials will likely begin in “a few weeks,” as the university awaits the delivery of the oil and enrolls as many patients as possible.
Though getting signed up for the program requires a multitude of paperwork and medical examinations, more than 20 people have already applied to be involved.
“We’re getting pretty close,” Chandler said. “This is going to be a process you have to go through to get this medication.”
For Amy Young, whose daughter Leni suffers from intractable complex epilepsy and a rare form of cerebral palsy, the recent approval has been a blessing.
“We are excited and hoping that Leni gets in,” Young said. “If it works for her it could significantly increase her quality of life and, possibly, her life expectancy.”
Young is currently in the process of gathering all of the necessary paperwork and documentation to have Leni involved in the study, but details are scarce on what the panel’s qualifications will be for inclusion in the study.
“It’s been time consuming, at a few times a little stressful, but the most important part has really been just making sure we follow the study submission instructions completely,” Young said of the multitude of tests and exams that Leni has had to undergo. “We are very lucky to have doctors and their staff who are supportive.”
Though Leni has been doing well over the past few months, Young believes her daughter will greatly benefit from CBD oil.
“She’s doing great,” Young said of her daughter. “She struggles with her seizures, but overall she’s a very happy little girl.”
The study will center on patients who have been unable to see improvement from their current medications, according to Standaert.
In Leni’s case, her current medications have lessened her seizures but have caused detrimental side-effects which cause lethargy and vomiting, as well as cause her teeth to decay and rot.
“It’s not possible to think of every scenario in advance,” Standaert said when asked about the inclusion of patient’s whose current drugs cause damaging side-effects. “We just want to help people.”
Standaert is confident that the studies will be successful and hopes that the Food and Drug Administration (FDA) will eventually approve the drug so it can be dispensed at pharmacies.
“This process is something I never will forget, from the time spent in a small office writing out this bill to now,” Chandler said. “I wouldn’t trade meeting all of those families and these kids for anything in the world. It’s been a long experience, but it’s been good. I only wish we could have gotten it done sooner.”
Anyone interested in more information on UAB’s cannabidiol study should visit http://www.uab.edu/cbd.
Crossposted from Piece of Mind.
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