Some fear changes to state laws as U.S. weighs marijuana medicine
COLORADO SPRINGS, Colo. — Some American parents who for years have used cannabis to treat severe forms of epilepsy in their children are feeling more cautious than celebratory as U.S. regulators near a decision on whether to approve the first drug derived from the marijuana plant.
The U.S. Food and Drug Administration is expected to issue a decision by the end of the month on the drug Epidiolex, made by GW Pharmaceuticals. It’s a purified form of cannabidiol — a component of cannabis that doesn’t get users high — to treat Dravet and Lennox-Gastaut syndromes in kids. Both forms of epilepsy are rare.
Cannabidiol’s effect on a variety of health conditions is frequently touted, but there still is little evidence to back up advocates’ personal experiences. The U.S. Drug Enforcement Administration has long categorized cannabis as a Schedule I drug, a category with “no currently accepted medical use and a high potential for abuse.” That strictly limits research on potential medical uses for cannabis or the chemicals in it, including cannabidiol, or CBD.
But for years, parents desperate to find anything to help their children have turned to the marijuana-based products made legal by a growing number of states.
Meagan Patrick is among the parents using CBD to treat symptoms in their children. She moved from Maine to Colorado in 2014, so she could legally get CBD for her now-5-year-old daughter, Addelyn, who was born with a brain malformation that causes seizures.
“My child was dying, and we needed to do something,” Patrick said.
As for the potential approval of a pharmaceutical based on CBD, she said fear is her first reaction.
“I want to make sure that her right to continue using what works for her is protected, first and foremost. That’s my job as her mom,” Patrick said.
Advocates such as Patrick became particularly concerned when GW Pharmaceuticals’ U.S. commercial business, Greenwich Biosciences, began quietly lobbying to change states’ legal definition of marijuana, beginning in 2017 with proposals in Nebraska and South Dakota.
Some worried the company’s attempt to ensure its product could be legally prescribed and sold by pharmacies would have a side effect: curtailing medical marijuana programs already operating in more than two dozen states.
The proposals generally sought to remove CBD from states’ legal definition of marijuana, allowing it to be prescribed by doctors and supplied by pharmacies. But the change only applies to products that have FDA approval.
Neither Nebraska nor South Dakota allows medical use of marijuana, and activists accused the company of trying to shut down future access to products containing cannabidiol but lacking FDA approval.
Britain-based GW Pharmaceuticals never intended for the changes to affect other marijuana products, but they are necessary to allow Epidiolex to be sold in pharmacies if approved, spokesman Stephen Schultz said.
He would not discuss other places where the company will seek changes to state law. The Associated Press confirmed that lobbyists representing Greenwich Biosciences backed legislation in California and Colorado this year. “As a company, we understand there’s a significant business building up,” Schultz said. “All we want to do is make sure our product is accessible.”
Industry lobbyists in those states said they take company officials at their word, but they still insisted on protective language ensuring that recreational or medical marijuana, cannabidiol, hemp and other products derived from cannabis plants won’t be affected by the changes sought by GW Pharmaceuticals.
Patrick Goggin, an attorney who focuses on industrial hemp issues in California, said the company would run into trouble if it tried to “lock up access” to marijuana-derived products beyond FDA-approved drugs.
“People need to have options and choices,” he said. “That’s the battle here.”