Sitting on cushions in the corner of a brightly decorated room in Jerusalem’s Shaare Zedek Medical Centre, 11-year-old Eitan anxiously watched the sliding door leading to the hallway outside. Each time someone entered the room, he rushed past the hanging mobiles and flowers painted on the walls to make sure the door was shut securely.
Eitan was at the hospital with his parents to receive extracts of cannabis that researchers hope will help treat his severe autism. The project, which will test the effects of cannabinoids on 120 autistic children and young adults, is the first of its kind worldwide, said Dr. Adi Aran, the director of the hospital’s neuropediatric unit. The study is made possible by Israel’s progressive approach to research on cannabis and has generated interest in the scientific community and among families of children with autism.
“Our waiting lists are full. Many, many families want to participate and they come from all over Israel,” Aran said. “They hope and they heard from their friends and other families that it might help.”
Autism is a neurodevelopmental disorder whose symptoms include impaired communication and social skills, and compulsive and repetitive behaviours. The disease usually appears in infancy or early childhood, and can be debilitating. Eitan, for instance, cannot speak at all. The causes of the disease are poorly understood and there is no known cure. It affects roughly one percent of the population in Israel and worldwide, Aran said.
Most autistic children are currently treated with antipsychotic medications, which are not always effective and can have harmful side effects. Eitan’s father, Aviv, said that Eitan became obese after previous medications caused him to eat compulsively. Some medications aggravate him and cause him to throw tantrums, Aviv said.
The impetus for the current study was prior research on epilepsy and a smaller trial in which Aran administered cannabis extracts to around 70 young people with autism, which saw some positive results. The extracts were found to be safe and effective for the treatment of epilepsy, which also afflicts around 20 per cent of autistic children. Researchers studying the effects of cannabis extracts on epilepsy realised that the compounds helped participants deal with some symptoms of autism as well.
The Health Ministry has taken a progressive, scientific approach to medical uses for cannabis, though, opening the door for further research, said Dr. Tamir Gedo, CEO of Breath of Life Pharma, the company producing the cannabis extracts used in the study.
“The Ministry of Health in Israel has channelled a lot of energy here in order to examine all the evidence based medicine, and is willing to take that approach. Other ministries of health around the world are hesitant,” Gedo said.
Israel also has a critical mass of scientists and clinicians familiar with and open to medical uses for cannabis, a strong biotech industry and researchers in leading medical institutes and universities who support the work.
The participants will receive one of the two mixtures, or a placebo, for 12 weeks, then go through a four-week washout period, then take the second mixture or a placebo for another 12 weeks. The placebo will contain only flavoured olive oil. Participants are aged 5 to 29 and suffer from moderate to severe autism. Some engage in self-harming behaviours and about 40 per cent do not respond well to existing medication. They will be evaluated before beginning the study, after the first treatment period, after the first washout period, and after the second treatment period. Caregivers and teachers will also report on the subjects’ behaviour. It is a double-blind study, meaning neither the participants nor the researchers will know which mixtures the participants are taking during the study. So far, 13 participants have started treatment.
The researchers hope to eventually determine which compounds, and at which ratios, are most effective, and who will benefit most from the treatment.Friday, March 17, 2017