As Pennsylvania prepares to award its first licenses for the fledgling medical marijuana industry, Lehigh University intends to partner with one of the potential growers in the Lehigh Valley to study the effect of the drug on children with autism.
While some parents of autistic children have preached the benefits of cannabis for years, Lehigh’s Dean of Education Gary Sasso confirmed Monday that the university wants to collect some of the first quantitative data on the controversial drug therapy. Pennsylvania is one of the few states that specifically allows children with autism to be treated with cannabis.
He said the anecdotal evidence is interesting, because marijuana appears to lack the side effects of the psychotropic drugs that are accepted in the treatment of autism. But, he cautioned, the effect of marijuana is largely unknown, underscoring the need for the study.
If it proves to be safe, “does it mitigate some of the major characteristics of autism — social reluctance, language [challenges] and other stereotypical behaviors they sometimes engage in?” he said. “We have that kind of expertise to do that.”
Lehigh has been working with autistic children for years under its Center for Promoting Research to Practice and has organized annual workshops and other symposiums on the topic. Its professors conduct research and work with children at the Centennial School, a Lehigh-governed facility that serves children with autism and behavioral challenges.
Sasso said Lehigh would be working with BioGreen Farms, which is competing for a license to grow marijuana in Williams Township. BioGreen, which includes local developer Lou Pektor, has as a medical director Dr. Sue Sisley, who has agreements with other applicants for studies.
Sisley is a member of the steering committee at Thomas Jefferson University’s Lambert Center for the Study of Medicinal Cannabis and Hemp.
She was part of a research team last year awarded a Drug Enforcement Administration license to study marijuana’s effects on veterans and post-traumatic stress disorder. And she has gained national attention for her criticism of the quality of federally grown cannabis.
Sisley said she is eager to be able to conduct observational studies in Pennsylvania on lab-tested cannabis and autism.
“Moms are certainly using this actively in the black market, and now it’s time to bring everything out and into the open,” she said. “It’s time to let sun shine in.”
Sasso said Lehigh has not yet allocated money for the study and will seek grants if BioGreen is awarded a grower’s license. BioGreen is among 28 growers competing for a license in the Northeast region, which includes the Lehigh Valley. The region is expected to be awarded two grower/producer licenses under phase one of the medical marijuana program. The licenses will be awarded as early as Tuesday.
The use of medical marijuana with autistic children became a national conversation in 2009 after a Diane Sawyer interview with a California mother, Mieko Hester-Perez, who said marijuana brownies helped save her son’s life. Since then, stories have popped up across the country and parents have organized to share their experiences.
Among them is Erica Daniels, a Montgomery County mom. Her son Leo has enough focus to do things other 12-year-olds might find daunting — like assembling a 300-piece puzzle. But he can be sidetracked when anxiety associated with his autism spectrum disorder takes over. She’s tried giving him prescription medication, diet changes, herbs and a hyperbaric oxygen chamber — nothing has made much of an impact.
Until she tried cannabis. The first time he took it, Leo curled up with his mother to watch the entire film, “Where the Wild Things Are,” and was meltdown-free for a month at a time.
“Since he’s been taking cannabis, it relieved that anxiety,” Daniels said.
She’s among the 259 people who obtained a “safe harbor” to have marijuana for medical purposes until Pennsylvania’s industry takes root.
Pennsylvania is among a few of the 29 states with medical marijuana programs that specify autism as a qualifying condition that can be treated by the drug. Delaware allows it be used for autism with self-injurious or aggressive behavior. Doctors in California, Oregon, Massachusetts and Washington, D.C., can recommend marijuana based on the symptoms that make it a debilitating condition.
The Food and Drug Administration has not approved marijuana for medical use.
In fact, the federal government classifies marijuana as a Schedule 1 illegal substance — the same as heroin. The classification means that there is a high potential for abuse and there is no accepted medical value. It’s a higher classification than cocaine.
The American Medical Association in 2009 urged the government to review that classification so there could be more clinical research and the development of cannabinoid-based medicines.
The alternatives for parents like Daniels are not attractive. The Centers for Disease Control and Prevention estimates 1 in 68 children is on the autism spectrum, which can cause outbursts and other symptoms that pose safety risks — such as wandering and attraction to water.
The FDA has approved antipsychotic prescription drugs to help manage irritability associated with some forms of autism, but those drugs come with their own risks.
Marijuana contains a nonpsychoactive component, cannabidiol — CBD — that has shown promise in treating the disorder, but the problem is that it’s mostly anecdotal evidence.
THC is the main mind-altering chemical found in marijuana.
Sisley said oils that are very high in CBD with minimal amounts of THC should not have any psychoactive or intoxicating effects, but studies need to determine that.
Dr. A.J. Marsden, an assistant professor of human services and psychology at Beacon College in Florida, said there is little scientific evidence to suggest it is an effective treatment. Often, she said, the data cited by supporters are from animal-based research that has yet to be generalized to human subjects. The research on humans is a small number of case studies, she said.
“This is not to say that we should give up, but we also must realize that none of the current scientific literature provides sufficient, high-quality evidence to suggest that medical marijuana should be recommended for treatment of ASD at this time,” said Marsden, who is preparing pitches for research in Florida. “We need more research focusing on the effectiveness as well as the potential long-term effects.”
Shaare Zedek Medical Center in Israel has launched the world’s first study on the effect of CBD treatment on autistic children. The study, which concludes next year, includes 120 children with mild to severe autism. Previous research in Israel, where it is easier to study the medicinal use of marijuana, has shown that the drug has helped children with epileptic seizures.