Why you should care
Because alleviating previously untreatable conditions will improve the lives of millions of patients.
Update: On June 25, 2018, the FDA approved the cannabidiol-based Epidiolex, the first drug derived from marijuana to earn FDA approval.
It’s a prognosis patients never want to hear: “No successful treatment regimens have been devised.”
That’s the American Migraine Foundation’s summary of an ailment known as New Daily Persistent Headache (NDPH). Since Jonathan Zaid was diagnosed with the rare condition in 2007 at age 14, he’s been prescribed more than 40 different drugs in a futile attempt to alleviate migraines so debilitating that he couldn’t concentrate or fall asleep at night. Then, in 2014, his physician shifted tactics and prescribed a surprising new medication that almost immediately improved Zaid’s quality of life — medical marijuana.
The righteous bush has been used medicinally for millennia, and in recent years an estimated 1.5 million Canadians and Americans have turned to it for relief from a variety of ailments. There’s a big catch: No one knows which of the 100+ compounds called cannabinoids produced by the plant provide relief for which condition. For many doctors and patients, including Zaid, finding the right compound or cocktail of compounds can mean a frustrating and time-consuming game of guess-and-check. That uncertainty also means that many doctors are reluctant to prescribe medical marijuana, even to those like Zaid, who are otherwise out of options. But recent breakthroughs in the field of synthetic marijuana — test-tube versions of the naturally occurring compounds — may soon eliminate the guesswork and revolutionize how medicinal marijuana is understood and prescribed.
The goal is not to formulate to get people high; the goal is to formulate to get people better.
Rob Hunt, President, Teewinot Life Sciences
First, let’s clarify a few key points. Synthetic medical cannabinoids are not to be confused with highly toxic synthetic marijuana that’s sold under names like Spice and K2 and is responsible for widespread overdosing and health complications. Another key distinction: “The goal is not to formulate to get people high; the goal is to formulate to get people better,” explains Rob Hunt, president of Teewinot Life Sciences, an organization that uses biosynthesis to produce its artificial cannabinoids.
Hunt and his team believe they can develop cannabinoid-based medications to treat a wide variety of ailments, from epilepsy and glaucoma to inflammation and pain management. “What we’re able to do is produce all 111 different cannabinoids in kilogram quantities,” Hunt tells OZY, “and then we can tweak formulas until we find what works best for any indication out there that’s shown to have benefit from the use of cannabis.” According to Hunt, the potential is huge. By testing different combinations of the compounds, researchers can better understand why cannabis is effective in treating certain ailments and which cannabinoids provide those beneficial effects. The ultimate goal is to produce medications without the long, wasteful and costly process of growing and processing marijuana plants.
Hunt points to one drug in development that could prove pivotal. The U.K. company GW Pharmaceuticals developed Sativex, the first cannabis derivative to gain market approval in any country, in 2010. The oral spray, which is used to treat spasms and other symptoms of multiple sclerosis, has since been approved in 16 countries and has received regulatory approval in an additional 12 countries — but not in the United States. GW’s latest product, Epidiolex, contains pharmaceutical cannabidiol designed to treat various types of pediatric epilepsy. The FDA recently completed Phase 3 clinical trials that showed promising results. Should Epidiolex get the thumbs-up from the FDA, it would force the DEA to downgrade marijuana from a Schedule 1 drug to a Schedule 3 or 4 so that it could be prescribed to patients in the U.S. “It’s right at the edge of being approved, and if it does get approved, you’re going to see an absolute gold rush of pharma companies trying to enter the cannabinoid-based drug market,” Hunt predicts. Biotech companies already are the recipients of more than half of the $400 million that investors poured into the pot industry in 2015, according to Viridian Capital Advisor, a cannabis advisory firm.
The regulatory hurdles may be higher than Hunt expects. Seth Yakatan, the CEO of Kalytera Therapeutics, which is developing cannabinoid-based medicines for treatment of osteoporosis and bone fractures, among other conditions, notes that just because one pharmaceutical product gets approved doesn’t necessarily mean others will follow. “I think you might have a bunch of people running to the door,” he says, “but I’m not sure you’ll get a bunch of people that will get through the exit to market, just because of the way the FDA works.”
Meanwhile, Zaid, now 23, is enjoying his hard-won freedom from the killer migraines that used to plague his life. He attends undergraduate classes at the University of Waterloo, in southern Ontario, and has founded an advocacy group called Canadians for Fair Access to Medical Marijuana. While he still experiences near daily headaches, he says medical cannabis has helped “shorten both the frequency and impact of the very painful migraines,” allowing him to do something that would not have been possible without medicinal marijuana: lead a normal life.