As an emergency room doctor, Kyle Kingsley felt frustration at seeing the drug-addicted patients return to his ER over and over, trying to find a doctor who would prescribe them more opioid painkillers.
Those pain pills cause twice as many deaths in Minnesota as street heroin, even though both are made from same plant, the poppy. Now Kingsley is hoping to use a different plant — cannabis — to divert pain patients from opioids to marijuana drugs. But the ambitious plan will require approval from one of the toughest bureaucracies on the planet: The U.S. Food and Drug Administration.
"This is a real alternative," said Kingsley, whose Minneapolis company Vireo Health LLC is one of two in Minnesota with a license to cultivate medical marijuana and convert it to oils and pills. "Anytime you are talking about potential FDA-track medicines, it takes years for this to happen. But in parallel to our current production of medications in Minnesota and New York, we're going to pursue these FDA endeavors."
The effort is separate from last week's announcement that the Minnesota Health Department is adding intractable pain to the list of reasons why patients can be prescribed medical marijuana next year.
Rather, Vireo's long-term goal is to figure out how to make non-smokeable marijuana drugs with clinically reliable potency and solubility that can be tested in controlled studies at academic medical centers. The study data would support an application for FDA approval, which would make Vireo's patented cannabis drug legal in all 50 states, according to Kingsley and some attorneys.
"I think if it is FDA approved, they would have to consider it lawfully available in all jurisdictions," said Minneapolis FDA regulatory attorney Mark DuVal, who is not representing Vireo. "It's a function of the Interstate Commerce clause to the Constitution."
However, marijuana is classified as a Schedule 1 drug, meaning that it is highly addictive and has no accepted medical use. Either Congress, the FDA, or the Obama administration would have to take a step like moving it down to Schedule 2, which includes addictive drugs that do have medical uses.
The data to show clinical safety have been elusive in part because the potency and soluability of the active chemicals in marijuana vary widely. Vireo chemists believe the key to making stable (and patentable) marijuana drugs lay in a chemical compound called Captisol.