In 2013, Tonya Taylor committed suicide because her epileptic seizures persisted despite taking a long list of medications.
Then a patient at a Denver neurologist’s office mentioned something that gave Taylor hope: a CBD oil called Charlotte’s Web. The person told him that the oil helped people with uncontrolled epilepsy. However, the doctor would only discuss it “off the record” because CBD was illegal under federal law and he was concerned his hospital would lose funding, Taylor said.
Since then, the federal government has legalized cannabidiol (CBD) and it has become a multi-billion dollar industry. The FDA has also approved a cannabis-derived prescription drug, Epidiolex, for three rare seizure disorders.
But not much has changed for people with other forms of epilepsy like Taylor who want advice from their doctors about CBD. Joseph Sirven, a neurologist in Florida who specializes in epilepsy, said all his patients now ask that. Despite the buzz around it, he and other doctors say they’re reluctant to advise patients about over-the-counter CBD because they don’t know what’s in the bottles.
The US Food and Drug Administration does little to regulate CBD, so trade groups admit that the market includes potentially harmful products and that quality varies widely. They say pending bipartisan federal legislation would protect those who use CBD. But some consumer advocacy groups say the bills would have the opposite effect.
Caught in the middle are Taylor and other patients desperate to stop losing consciousness and having seizures, among other symptoms of epilepsy. They must navigate the sometimes murky CBD market without the benefit of regulations, guidance from doctors, or coverage from health insurers. In short, they are “at the mercy and trust of the grower,” said Sirven, who practices at the Mayo Clinic in Jacksonville.
Cannabidiol, epilepsy and the FDA
CBD is not regulated in the same way as a typical drug. Anna Efetova/Moment/Getty Images
Although the CBD industry is new territory for the FDA, people have used cannabis to treat epilepsy for centuries, according to a report co-authored by Sirven in the journal Epilepsy & Behavior.
More than 180 years ago, an Irish doctor administered drops of a hemp tincture to a baby suffering from severe convulsions. “The child is now in robust health and has recovered his natural and happy appearance,” William Brooke O’Shaughnessy wrote at the time.
Much of the recent interest in CBD stemmed from the 2013 CNN documentary Weed, which featured then-5-year-old Charlotte Figi, who was having hundreds of seizures every week. With the use of CBD oil, her seizures suddenly stopped, CNN reported. After that, hundreds of families with children like Charlotte migrated to Colorado, which legalized marijuana in 2012. Then, in 2018, the federal government removed hemp from the list of controlled substances, allowing companies send CBD across state lines and made families no longer necessary. to move
The FDA still prohibits companies from marketing CBD products as dietary supplements and making claims about their benefits for conditions such as epilepsy.
The agency is collecting “research, data, and other public health and safety input to inform our approach and address consumer access in a way that protects public health and maintains incentives for cannabis drug development through of established regulatory pathways,” then Dr. Janet Woodcock. the FDA’s acting commissioner said in 2021, according to a dietary supplement trade group.
“The FDA has done very little to protect consumers from an unregulated market they’ve created,” said Megan Olsen, general counsel of the Council for Responsible Nutrition, a separate dietary supplement trade group.
cloudy water
A recent study in Epilepsy & Behavior of 11 oils found that three contained less CBD than claimed, while four contained more. Charlotte’s Web contained 28 percent more CBD than advertised, according to the report. The study also noted that the issues “mirror concerns” raised for generic anti-seizure drugs, which the FDA regulates.
“I’m not anti-CBD,” said Barry Gidal, a professor of pharmacy and neurology at the University of Wisconsin-Madison. He co-authored the study and worked as a consultant for the manufacturer Epidiolex.
“There needs to be oversight so patients know what they’re getting.”
Some states, such as Michigan, have cannabis regulatory agencies. So Gregory Barkley, a neurologist at Henry Ford Hospital in Detroit, thinks that when a person buys from one of the state’s dispensaries, “you have a pretty good idea of what you’re going to get.”
Barkley regularly reviews his patients’ CBD products and discusses how many milligrams they’re taking to help control their epilepsy.
But Barkley said CBD has inherent variability because it comes from one plant.
“It’s no different than saying, ‘I’ll treat you to a Honeycrisp apple for an ailment.’ Every apple is a little different,” Barkley said. “The lack of standardization makes it difficult.”
The patient’s problem
About five years ago, Trina Ferringo of Turnersville, New Jersey, asked a pediatric neurologist about giving CBD to her teenage son, Luke, because his prescription drugs were causing severe side effects but not preventing his epileptic seizures. The doctor was “vehemently opposed” to it because of the FDA’s lack of oversight and concerns that it might contain THC, the chemical in marijuana that produces a high, Ferringo recalled.
Instead, in 2018, the doctor prescribed Epidiolex. Luke went from having several seizures every week to a couple a month. Ferringo is pleased with the result, but now often fights with her insurance company because Epidiolex, which has a list price of $32,500 a year, is not approved for her son’s form of epilepsy.
Charlotte’s Web typically costs between $100 and $400 per month, depending on how much someone takes. Unlike Epidiolex, insurance never covers it.
“The effects were night and day.”
Beyond the cost difference, it’s unclear whether a highly purified CBD product like Epidiolex is more effective than products like Charlotte’s Web that contain CBD and other plant compounds, creating what scientists describe as a beneficial “environmental effect.”
A 2017 review of CBD studies in the journal Frontiers in Neurology, written by cannabis industry scientists, found that 71 percent of patients with treatment-resistant epilepsy reported a reduction in seizures after taking the products rich in CBD, but among patients taking purified CBD. , the share was only 46 percent.
Patients who took CBD-rich products instead of purified CBD also reported taking lower daily doses and experiencing fewer side effects.
“Each cannabinoid, when tested individually, has some degree of anticonvulsant properties, so if you give a mixture of several cannabinoids, they will have some additive effect,” Barkley said.
Future regulation
Bipartisan legislation pending in Congress would designate CBD as a dietary supplement or food. The Senate version would allow the federal government to “take additional enforcement actions” against these products.
Jonathan Miller, general counsel of the US Hemp Roundtable, a coalition of hemp companies, said the legislation would protect consumers and allow CBD manufacturers to sell their products in stores as dietary supplements.
However, Jensen Jose, an adviser to the Center for Science in the Public Interest, said this legislation would make consumers less safe. The FDA does not have the authority to review the safety and effectiveness of dietary supplements before they are marketed and does not routinely analyze their ingredients.
“If a CBD company is doing something questionable or potentially unsafe right now, the FDA can easily remove the product simply for being illegally marketed as a medicine,” Jose said. If the legislation passes, he said, the FDA would not be able to do that.
Instead, Jose said, Congress should provide the FDA with more authority to regulate CBD and dietary supplements and more funding to hire inspectors.
The FDA does not comment on pending legislation, spokeswoman Courtney Rhodes said.
Patients like Taylor, the Colorado woman with epilepsy, aren’t waiting for the federal government. After the doctor’s visit, she borrowed money from family members and bought a bottle of Charlotte’s Web.
“The effects were night and day,” he said. “I was able to get out of bed.”
She befriended a grower and spends about $50 a month on CBD powder, gummies and oil. He now only takes one prescription medication for seizures instead of four. He has about one seizure a month, which means he can’t drive. Her medical providers still don’t seem open to talking about CBD, she said, but that doesn’t bother her much.
“After being there for so many years and seeing the evidence, the 180-degree turn my life took, it’s a choice I’m going to make whether they’re with it or against it,” he said. “It’s working for me.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and surveys, KHN is one of the three main operational programs of KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization that provides information on health issues to the nation.
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