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In 2013, says Tonya Taylor, she committed suicide because her epileptic seizures continued to come even though she was taking a long list of medications.
Then a patient in the office of a Denver neurologist 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. The doctor, however, would only discuss it “off the record” because cannabidiol was illegal under federal law and worried his hospital would lose funds, Taylor said.
Since then, the federal government has legalized the CBD and become a multimillion-dollar industry. The Food and Drug Administration has also approved a prescription drug derived from cannabis, Epidiolex, for three rare seizure disorders.
But it hasn’t changed much for people with other forms of epilepsy like Taylor who want their doctors ’advice on CBD. Joseph Sirven, a Florida neurologist who specializes in epilepsy, said all his patients now ask. Despite the buzz around, he and other doctors said they are reluctant to advise patients on over-the-counter CBD because they don’t know what’s in the bottles.
The FDA has recently regulated 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.
In the middle are Taylor and other patients desperate to stop losing consciousness and have seizures, among other symptoms of epilepsy. They have to navigate the sometimes murky CBD market without the benefit of regulations, physician guidance, or health insurance coverage. In short, they are “at the mercy and trust of the producer,” said Sirven, who practices at the Mayo Clinic in Jacksonville, Florida.
Although the CBD industry is new territory for the FDA, people have been using cannabis to treat epilepsy for centuries, according to a report written jointly by Sirven in Epilepsy & Behavior magazine.
More than 180 years ago, Irish doctor William Brooke O’Shaughnessy administered drops of a hemp tincture to a baby suffering from severe seizures. “The child is now enjoying robust health and has regained his natural, happy appearance,” O’Shaughnessy wrote at the time.
Much of the recent interest in the CBD comes from CNN’s 2013 documentary “Weed,” which featured then-5-year-old Charlotte Figi, who had hundreds of seizures each week. With the use of CBD oil, his seizures stopped abruptly, CNN reported. After that, hundreds of families with children like Charlotte emigrated to Colorado, which had legalized marijuana in 2012. Then, in 2018, the federal government removed hemp from the list of controlled substances, allowing companies send CBD through state lines and made families no longer. necessary to move.
The FDA still bans companies from marketing CBD products as dietary supplements and making claims about their benefits for conditions like epilepsy.
The agency is collecting “research, data and other public health and safety contributions 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, “said Janet Woodcock, then director of the FDA. the acting commissioner said in 2021, according to a commercial group of dietary supplements.
“The FDA has done very little to protect consumers from an unregulated market they have created,” said Megan Olsen, general counsel for the Council for Responsible Nutrition, another commercial group of dietary supplements.
A recent study in Epilepsy & Behavior on 11 oils found that three contained less CBD than claimed and four more. Charlotte’s website contained 28 percent more CBD than advertised, according to the report. The study also noted that the “mirror concerns” issues raised for generic seizure medications, which the FDA regulates.
“I’m not anti-CBD,” said Barry Gidal, a professor of pharmacy and neurology at the University of Wisconsin in Madison, who co-wrote the study and worked as a consultant for manufacturer Epidiolex. “There is oversight so patients know what they are 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 at one of the state’s dispensaries, “you have a pretty good idea of what you’ll get.” Barkley regularly reviews his patients ’CBD products and discusses how many milligrams they take to help control their epilepsy.
But Barkley said CBD has inherent variability because it comes from a plant.
“It’s no different than saying,‘ I’ll treat you to a Honeycrisp apple for a disease. ’Every apple is a little different,” Barkley said. “The lack of standardization makes it difficult.”
About five years ago, Trina Ferringo of Turnersville, NJ, asked a pediatric neurologist about giving CBD to her teenage son, Luke, because her prescription drugs caused serious side effects but did not prevent her epileptic seizures. The doctor “strongly opposed” it because of the lack of FDA oversight and concern that it might contain THC, the marijuana-producing chemical that causes a high, Ferringo recalled.
Instead, in 2018, the doctor prescribed Epidiolex. Luke went from having several seizures each week to a couple a month. Ferringo is pleased with the outcome, but now often struggles with his insurance company because Epidiolex, which has a list price of $ 32,500 a year, is not approved for his son’s form of epilepsy.
Charlotte’s website usually costs between $ 100 and $ 400 a month, depending on how much someone takes. Unlike Epidiolex, insurance never covers it.
Beyond the cost difference, it’s unclear whether a highly purified CBD product like Epidiolex is more effective than products such as Charlotte’s Web that contain CBD and other plant compounds, creating what scientists describe as a beneficial “environment 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 taking CBD-rich products instead of purified CBD also reported taking lower daily doses and experiencing fewer side effects.
“When tested individually each cannabinoid has a certain degree of anticonvulsant properties, so if you give a mixture of several cannabinoids, they will have some additive effect,” Barkley said.
Bipartisan congressional legislation would designate CBD as a dietary supplement or food. The Senate version would allow the federal government to “take additional enforcement action” against these products.
Jonathan Miller, general counsel for the U.S. 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.
But Jensen Jose, regulatory adviser at the Center for Science in the Public Interest, said such 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 because it is being marketed illegally as a drug,” Jose said. If the legislation is passed, he said, the FDA could not do so.
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 the pending legislation, spokeswoman Courtney Rhodes said.
Patients like Taylor are not waiting for the federal government. After the doctor’s visit, he borrowed money from family members and bought a bottle from 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 powder, jelly beans and CBD oil. Now he only takes one prescription drug 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 made, it’s a choice I will make if they are there with or against it,” he said. “It’s working for me”.
This article was produced by Kaiser Health News, a program of the Kaiser Family Foundation, a gifted nonprofit organization that provides information on health issues in the nation.
