Updated by Alyson Martin
Some children in New South Wales, Australia, will soon have access to GW Pharmaceuticals’ high-CBD Epidiolex as part of clinical trials in the country set to begin in March.
Certain types of severe epilepsy can be very difficult to control; and while pharmaceuticals can at times reduce the number of seizures, children may experience other debilitating side effects. More than a dozen states in America have chosen to allow these patients to have limited access to cannabis oil high in cannabidiol (CBD), the cannabinoid believed to offer relief to patients with seizures. Some of these programs do not specify the source of the CBD oil, while others establish formal clinical trials with GW’s Epidiolex.
“These families are desperate,” said Pru Goward, the Minister for Medical Research, according to Australian Broadcasting Company. “When children fit dozens, hundreds of times a day, they often develop brain damage,” Goward continued. “They certainly have a very interrupted life, they can’t read or write, they find it difficult to go to school.”
Below published on November 23 under the same headline.
Michelle Whitelaw is now discovering who her son is for the first time. For years, Jai had been a nonverbal child. At four, he uttered his first words, learned to play the piano and even wrote his own music, Whitelaw said. But in the years that followed, Jai’s quality of life took a turn for the worse. At six years old, doctors diagnosed him with several neurological disorders, including Pseudo Lennox syndrome, Continual Spike Wave syndrome and Landau Kleffner syndrome, all three of which are severe forms of epilepsy that often cause abnormal seizures. Shortly after being diagnosed, Jai experienced his first epileptic fit that would soon intensify and grow in number, causing him to lose what he had learned, said Whitelaw.
“He couldn’t breathe. He couldn’t pick up a pen. He was an empty shell,” she said.
At one point, 11-year-old Jai had hundreds of seizures a day. The Whitelaws tried to combat his seizures with various prescription drugs, including Epilim and Zarontin, but nothing had worked. To make matters worse, many of the drugs rendered Jai unresponsive and caused irreversible damage, including a burned esophagus and hair loss, said Whitelaw.
“There wasn’t much left of him other than a heartbeat,” she said. “I felt like I wanted to die.”
Feeling desperate yet determined to save her son’s life, Whitelaw researched ways to obtain cannabis. An increasing number of parents across the world have done the same in recent years, as anecdotes emerge about the plant’s potential. A cannabis-based pharmaceutical, Epidiolex, is undergoing clinical trials in the U.S. for use in patients with epilepsy, and some states have allowed use of cannabis extracts, high in a non-psychoactive compound called cannabidiol, for this purpose.
Australia is the latest country in which there are efforts to legalize the use of medicinal cannabis products. Movement at the federal level began in earnest last month, when Health Minister Sussan Ley announced her support for the cultivation of medicinal cannabis for scientific research and for patients suffering from debilitating illnesses, including multiple sclerosis, rare forms of pediatric epilepsy, and chemotherapy-induced nausea. Growing cannabis for recreational use will remain illegal.
A strong majority of Australians are in favor of passing legislation to allow for medicinal use of cannabis, according to a Roy Morgan Research poll. Ninety-one percent of Australians who were surveyed expressed support. (The survey question didn’t differentiate between whole plant cannabis versus pharmaceutical products derived from cannabis.)
This past June, two Australian philanthropists, Joy and Barry Lambert, gave an internationally unprecedented donation of $33.7 million to the University of Sydney for medicinal cannabis research. (The Lamberts have a granddaughter who suffers from pediatric epilepsy.)
Proposals at the national and state levels have left details undefined, but to pass legislation, federal and state parliaments will need to amend three laws: the Therapeutic Goods Act (federal), the Drugs, Poisons & Controlled Substances Act (state) and the Commonwealth Narcotic Drugs Act (federal), all of which ban the production of illicit drugs, including marijuana. Furthermore, any legislation passed must also comply with the Single Convention on Narcotics Drugs of 1961, a global treaty that prohibits the manufacturing of illicit drugs for non-medical or scientific purposes.
The federal plan, should it move forward, would be threefold: One, parliament would make the aforementioned amendments to allow for the cultivation of whole plant cannabis, which would then be used to manufacture cannabis-based products for clinical research and medicinal purposes. Two, the government would create a national licensing scheme so that cannabis growers nationwide could comply with federal guidelines and ensure that products are pure and safe to use. Three, cannabis pharmaceuticals would be regulated by the Therapeutic Goods Administration, Australia’s version of the U.S. Food and Drug Administration.
Some states are also forging ahead with plans to make medicinal cannabis accessible to patients. As of now, three Australian states–New South Wales, Queensland and Victoria—are planning clinical trials of cannabis-based products to explore their medical benefits and develop pharmaceuticals, but only Victoria is on the path to legalize access to medical cannabis-derived products for select groups of people with severe illnesses.
Victoria’s movement is largely due to a medical cannabis report published by the Victorian Law Reform Commission in August.
The report outlines recommendations to legalize access to medicinal marijuana in Victoria. Private licensed entities would cultivate cannabis to produce cannabis oil and alcohol-based tinctures. No smokable cannabis products will be available due to health concerns. Those who suffer from multiple sclerosis, pediatric epilepsy, chemotherapy-induced nausea, and HIV/AIDS will have access to the medicine, said Dr. Ian Freckelton Q.C., a barrister who also served as a special commissioner for the Victorian Law Reform Commision. Patients with PTSD, lupus and arthritis could also benefit from such treatment, he added, but there wasn’t sufficient evidentiary-based research to include these illnesses.
Although the Commission reviewed scientific research and heard testimonies about the benefits of cannabis from users, Freckelton said he hoped that people understood that cannabis was not a panacea.
“We don’t want people to believe that medicinal cannabis is a magic bullet, because it’s not,” he said.
Forty-two recommendations listed in the report will be implemented by Victoria’s parliament next month, said Freckelton. Before the cannabis products go on the market, the Therapeutic Goods Administration will test for efficacy and safety, as they would with any prescribed drug. Once approved by the TGA, pharmacies will dispense the cannabis-based products. Children suffering from rare forms of epilepsy will be the first group to have access to the medicinal cannabis products, which should be available in January 2017.
Although Whitelaw’s son would most likely be eligible for the medicinal cannabis products as well as the clinical trials, Whitelaw says neither she nor her son could wait for clinical trials or for the government to amend its laws.
And she hasn’t.
In December 2014, Whitelaw, a Queensland resident, said she procured cannabis oils from an illegal source. Within hours of taking his first dose, Jai made eye contact, something he hadn’t been able to do for some time, she said.
Since taking the cannabis oil, Jai’s quality of life has improved. His daily seizures dropped from hundreds a day to four this year, in just under a year of treatment.
“We thought he’d die before we’d see a seizure-free day,” said Whitelaw. “He was a legally drugged-up kid. Now Jai loves to go to school. He’s got his first academic report card,” she added.
Legalizing access to medicinal marijuana-based products in Victoria may be an impetus for the rest of the nation. However, Victoria’s legislative efforts won’t apply to Australians living outside of the state.
Tasmania has yet to see movement toward legalizing medicinal cannabis. However, that hasn’t stopped Tasmanian resident Lyn Cleaver from growing and giving her 24-year-old son, Jeremy, cannabis.
When he was six years old, Jeremy suffered a brain injury that caused uncontrollable seizures. Like Whitelaw’s son Jai, Jeremy exhausted all prescription drugs available to him. Often times, the prescription drugs’ side effects were worse than the seizures themselves, said Cleaver. After 10 years of experimenting with various pharmaceuticals and seeing no results, the only drug left to try was cannabis, she said.
“I was terrified. It took four weeks before Jeremy tried it,” said Cleaver.
Even though Jeremy is not seizure-free, he experiences fewer epileptic fits. Cleaver still grows and distills her own medicinal cannabis, though the fear of getting arrested hasn’t left her.
“It’s pretty stressful to live outside the law,” she said. “The government needs to act swiftly to help end the suffering.”
As government officials work on passing legislation, including Queensland Parliament Member Steve Dickson, who recently sponsored a petition that would give people with medical conditions access to whole plant cannabis treatments, the demand for medicinal cannabis products continues to increase.
Every week, someone asks about medicinal cannabis or how to participate in clinical trials, said Carol Ireland, chief executive officer of Epilepsy Action Australia, a non-profit organization that offers various services to families of patients with severe epileptic disorders.
Ireland said she was aware that many Australians, including Whitelaw and Cleaver, were breaking the law, but she also understood that they had exhausted all options for their children.
“We don’t say to people ‘break the law,’” said Ireland. “We know that people are desperate to treat their children. They’re not criminals, they are desperate.”