Epilepsy Patients Navigate the Murky, Unregulated CBD Industry

In 2013, Tonya Taylor was suicidal because her seizures persisted despite taking a long list of medications.

Then another patient from 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 helps people with uncontrolled epilepsy. However, the doctor would only discuss it “officially” because CBD was illegal under federal law, and he was worried his hospital would lose funding, Taylor said.

The federal government has since legalized CBD, and it has grown into a multi-billion dollar industry. The FDA has also approved a cannabis-derived prescription drug, Epidiolex, for three rare seizure disorders.

But little has changed for people with other forms of epilepsy like Taylor who want advice from their doctor about CBD. Dr. Joseph Sirven, a Florida neurologist who specializes in epilepsy, said all of his patients now ask him about it. Despite the buzz surrounding it, he and other doctors say they are hesitant to counsel patients on over-the-counter CBD because they don’t know what’s in the bottles.

The FDA does little to regulate CBD, so trade groups admit the market includes potentially harmful products and the quality varies widely. They say pending bipartisan federal legislation would protect those who use CBD. But some consumer groups say the bills would have the opposite effect.

Caught in the middle are Taylor and other patients desperate to stop fainting and having seizures, among other symptoms of epilepsy. They must navigate the sometimes murky CBD market without the benefit of regulations, advice from doctors, or coverage from health insurers. In short, they’re “at the mercy and trust of the producer,” said Sirven, who practices at the Mayo Clinic in Jacksonville.

While 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.

Over 180 years ago, an Irish doctor administered drops of hemp tincture to an infant suffering from severe convulsions. “The child now enjoys robust health and has regained his natural plump and happy appearance,” Dr William Brooke O’Shaughnessy wrote at the time.

Much of the recent interest in CBD stems from the 2013 CNN documentary “Weed,” which featured then 5-year-old Charlotte Figi having hundreds of seizures each 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 controlled substances list, allowing companies to to ship CBD across state lines and meant families were no more. need 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 brings together “research, data and other information on safety and public health to inform our approach and to address consumer access in a way that protects public health and maintains incentives for the development of cannabis-based medicines through established regulatory pathways,” Dr. Janet Woodcock, then the FDA’s acting commissioner, said in 2021, according to a dietary supplement trade group.

“The FDA has really done little to protect consumers from an unregulated market it created,” said Megan Olsen, general counsel for the Council for Responsible Nutrition, another dietary supplement trade group.

A recent study in Epilepsy & Behavior of 11 oils found that three contained less CBD than expected, while four contained more. Charlotte’s Web contained 28% more CBD than advertised, according to the report. The study also pointed out that the issues “reflect concerns” raised for generic antiepileptic drugs, which the FDA regulates.

“I’m not anti-CBD,” said Barry Gidal, professor of pharmacy and neurology at the University of Wisconsin-Madison, study co-author and consultant for the maker of Epidiolex. “There needs to be monitoring so patients know what they’re getting.”

Some states, like Michigan, have cannabis regulatory agencies. As such, Dr. Gregory Barkley, a neurologist at Henry Ford Hospital in Detroit, thinks that when a person goes shopping at one of the state’s dispensaries, “you get a pretty good idea of ​​what you obtain”. 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’m going to cure you with a Honeycrisp apple for an illness. Every apple is a little different,” Barkley said. “The lack of standardization makes things difficult.”

About five years ago, Trina Ferringo of Turnersville, New Jersey asked a pediatric neurologist to give CBD to her teenage son, Luke, because his prescription medication was causing serious side effects but not preventing his seizures. of epilepsy. The doctor was “adamantly opposed” to it because of the lack of FDA oversight and concerns it might contain THC, the high-inducing chemical in marijuana, Ferringo recalled.

Instead, in 2018, the doctor prescribed Epidiolex. Luke went from several seizures per week to a few seizures per month. Ferringo is happy with the outcome but now often battles 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.

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 “entourage effect”.

A 2017 review of CBD studies in the journal Frontiers in Neurology, authored by cannabis industry scientists, found that 71% of patients with treatment-resistant epilepsy reported a reduction in seizures after taking CBD-rich products, but among patients taking purified CBD, the share was only 46%.

Patients taking CBD-rich products rather than pure 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 mix of various cannabinoids they will have an additive effect,” Barkley said.

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 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 makers to sell their products in stores as dietary supplements.

However, Jensen Jose, an attorney for the Center for Science in the Public Interest, said such legislation would actually 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 currently doing something questionable or potentially dangerous, the FDA can easily pull the product just because it’s illegally marketed as a drug,” Jose said. If the legislation passes, he said, the FDA could not do that.

Instead, Jose said, Congress should give the FDA more power 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 epileptic woman from Colorado, don’t wait 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,” she said. “I was able to get out of bed.”

She befriended a grower and spends around $50 a month on CBD powder, gummies, and oil. She now only takes one prescription medication for seizures instead of four. She has about one seizure a month, which means she can’t drive. Her medical providers still don’t seem willing to discuss CBD, she said, but she doesn’t mind that much.

“After being on it for so many years and seeing the evidence – the 180 degree turnaround that my life has made – it’s a choice I’m going to make, whether they’re for it or against it,” she said. declared. “It’s okey for me.”

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