Why FDA Approving A Marijuana Epilepsy Drug Is Game Over For Cannabis Prohibition
How can the USA government argue that cannabis has no medical value, when they just approved a cannabis-based drug with evident medical value?
Cannabis-based epilepsy medicines under the name Epidiolex, manufactured by GW Pharmaceuticals, are now pending approval from the Food and Drug Administration. The drug may be available in the United States by the second half of this year.
GW Pharmaceuticals announced on Wednesday that clinical studies of the new drug came back with promising results. The study looked at 171 patients with Lennox-Gastaut syndrome who were categorized into placebo and treatment groups. The participants, aged 2 to 55, were suffering from seizures and current drugs they were taking weren’t working for them. They were taking 6 anti-seizure treatments but they were still experiencing an average of 74 drop seizures a month, a type of seizure that involves the entire body.
The results of the study, which took place over the course of 14 weeks, showed that 44% of patients who took Epidiolex showed dramatic decreases in seizures. On the other hand, only 22% of the patients in the placebo group experienced any benefits. The patients taking Epidiolex also saw a 50% or greater reduction in drop seizures. According to Elizabeth Thiele, who heads the pediatric epilepsy department at the Massachusetts General Hospital and a professor of neurology at the Harvard Medical School, the results were different on each patient. Thiele is the lead author of the study. “For some, it does not do a whole lot. But for the people it does work in, it is priceless,” she says. “One child who comes to mind had multiple seizures a day. She had been on every medication possible,” Thiele says. The said patient tried Epidiolex and hasn’t had a seizure in almost 4 years. “She is now talking about college options. She would have never had that conversation before. It has been life-changing.”
Epidiolex is made from pure cannabidiol (CBD), which has gained traction over the last few years because of its prowess in treating many chronic disorders especially conditions that conventional pharmaceutical medications have had little success in treating. One CBD product in particular, a CBD strain called Charlotte’s Web, was used to treat a child named Charlotte. Her mother, Paige Figi, began writing about this unique strain, resulting in the move of many families to Colorado state just to get their hands on the medicine. However, Charlotte’s Web remains controversial since no one has taken the responsibility of regulating the product, sales, and dosing. Charlotte’s Web in oil form was produced by a pair of brothers in Colorado, who run a small cannabis grow business.
While in essence, Charlotte’s Web and Epidiolex are the same product because they are both CBD-based extracts, Epidiolex is intended to be prescribed by doctors while the whole-plant medicine still isn’t. The FDA has also approved 2 versions of tetrahydrocannabidiol (THC), the compound in cannabis that gets you high, although these products are synthetic. If Epidiolex is approved, it would be the first plant-based cannabis drug ever to be approved by the FDA for epilepsy.
“As a pharmaceutical product, it is the subject of rigorous and intense manufacturing controls. Patients have the reassurance that the product is what we say it is and what they think it is,” says GW CEO Justin Gover, who refused to comment on pricing although says that they are already in talks with medical providers with the possibility of including it in coverage plans. Even though Epidiolex is still pending FDA approval, around 1,500 people are already using it under the FDA’s “compassionate use” program, which allows patients to use the drug on a limited time basis prior to approval.
As of now, we still don’t know if Epidiolex will have negative interactions when combined with clobazam, another widely-used anti-seizure drug. GW Pharmaceuticals’ study also still doesn’t prove that the drug will work permanently.
The FDA has until June 27, 2018 to decide if they will approve Epidiolex based on data from clinical trials. Even if it gets approved, Epidiolex could come out to be costly, but a report from the New York Times revealed that the expected costs could reach as much as $30,000-$60,000 annually.
Regardlesss, Thiele remains optimistic. “Hopefully, it will be approved,” she says. “Patients want it.”