Patients with epilepsy navigate the uncontrolled CBD industry

In 2013, Tonya Taylor committed suicide because her epileptic seizures continued despite taking a long list of medications.

Then a co-patient in the Denver neurologist’s office mentioned something that gave Taylor hope: a CBD oil called Charlottes Webb. The man told her that the oil helps people with uncontrolled epilepsy. However, doctors will only discuss it “out of the record” because CBD was illegal under federal law and he was worried about losing his hospital funds, Taylor said.

The federal government has since legalized CBD, and it has become a multi-billion dollar industry. The FDA has also approved epidiolex, a prescription drug derived from marijuana for three rare seizures.

But not much has changed for people with other types of epilepsy like Taylor who seek advice from their doctors about CBD. Dr. Joseph Sirven, a neurologist who specializes in epilepsy in Florida, says his patients now ask about it. Despite the buzz around it, he and other physicians say they are reluctant to advise patients on over-the-counter CBD because they do not know what is in the bottles.

The FDA rarely controls CBD, so trade groups acknowledge that there are potentially harmful products in the marketplace and that quality varies greatly. They say pending bipartisan federal law will protect those who use CBD. But some consumer advocacy groups say the bills will have the opposite effect.

Caught in the middle, Taylor and other patients are desperate to stop losing consciousness and convulsions, among other symptoms of epilepsy. They must navigate the sometimes obscure CBD market without regulation, doctor’s guidance or the benefit of coverage from health insurers. In short, they are “at the mercy and faith of the farmer,” said Sirven, who practices at the Mayo Clinic in Jacksonville.

Although the CBD industry is a new territory for the FDA, people have used marijuana to treat epilepsy for centuries, according to a report by co-author Sirven in the journal Epilepsy and Behavior.

More than 180 years ago, an Irish doctor gave a child with severe convulsions a drop of hemp tincture. “The baby is now in good health, and he has regained his normal fat and happy appearance,” Dr. William Brooke O’Shaughnessy wrote at the time.

Much of the recent interest in CBD stemmed from the 2013 CNN documentary “Weed,” in which Charlotte Figi, then 5, had hundreds of convulsions per week. With the use of CBD oil, his convulsions suddenly stopped, CNN reported. Since then, hundreds of families, including children like Charlotte, have moved to Colorado, which legalized marijuana in 2012. Then in 2018, the federal government removed flax from the list of controlled substances, which allowed companies to send CBDs across state lines and that meant families were no more. Need to be transferred.

The FDA still prohibits companies from marketing CBD products as dietary supplements and claiming their benefits for conditions such as epilepsy.

The agency “is collecting research, data and other safety and public health inputs to inform our vision and address consumer access in a way that protects public health and maintains impetus for the development of cannabis drugs through established regulatory pathways,” said Dr. Janet Woodcock, then F.D. Says, in 2021, according to a dietary supplement trade group.

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

A recent study of epilepsy and behavior on 11 oils found that three had less CBD than claimed, while four had more. Charlotte has 28% more CBD than ads on the web, the report said. The study further noted that the problems that arise for generic anti-cesarean drugs are “mirror concerns,” which the FDA regulates.

“I’m not against CBD,” said Barry Giddle, a professor of pharmacy and neurology at the University of Wisconsin-Madison who co-authored the study and worked as a consultant to the epidemiologist. “There needs to be supervision so that patients know what they are getting.”

Some states, such as Michigan, have marijuana regulators. For example, Dr. Gregory Berkeley, a neurologist at Henry Ford Hospital in Detroit, thinks that when a person shops at a dispensary in the state, “you have a pretty good idea of ​​what you’re getting.” Berkeley regularly reviews her patients’ CBD products and discusses how many milligrams they take to help control their epilepsy.

But Berkeley said CBD has inherent variability because it comes from a single plant.

“It’s nothing more than saying, ‘I’m going to treat you for a disease with a sweet apple.’ Each apple is a little different, “says Berkeley.” The lack of standardization makes it harder. “

About five years ago, Trina Feringo of Turnersville, New Jersey, asked a pediatric neurologist about giving her teenage son Luke CBD because his prescription drugs caused serious side effects but did not prevent his epilepsy. Doctors “steadily opposed it” due to a lack of FDA oversight, and concerns that it may contain THC, a chemical that produces high levels of cannabis, recalls Ferringo.

Instead, in 2018, the doctor prescribed epidiolex. Luke went from a couple of convulsions per week to a couple per month. Ferringo is satisfied with the results but now often fights with his insurance company because Epidiolex, which has a list price of $ 32,500 per year, is not approved for his son’s epilepsy.

Charlotte’s web usually costs 100 to $ 400 per month, depending on how much someone takes. Unlike epidiolex, insurance never covers it.

Beyond the cost difference, it is not clear whether a high-purity CBD product like Epidiolex is more effective than products like Charlotte’s Web that contain CBD and other plant compounds, which scientists have described as a beneficial “environmental effect.”

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

Patients taking CBD-rich products instead of pure CBD also reported lower daily doses and fewer side effects.

“Each cannabinoid, when tested individually, has a degree of anticonvulsant properties so that if you give a mixture of different cannabinoids, some of their additions will have an effect,” Berkeley said.

A bipartisan law pending in Congress would designate the CBD as a dietary supplement or food. The Senate version will allow the federal government to take “additional enforcement action” against such products.

Jonathan Miller, general counsel at the US Hemp Roundtable, an alliance of hemp companies, said the law would protect consumers and allow CBD manufacturers to sell their products in stores as a dietary supplement.

However, Jensen Jose, counselor at the Center for Science in the Public Interest, said such legislation would actually make consumers less secure. The FDA does not have the ability to review dietary supplements for safety and effectiveness before marketing them and does not regularly analyze their ingredients.

“If a CBD company is doing something suspicious or potentially unsafe at the moment, the FDA can easily remove the product for illegally marketing it as a drug,” Jose said. If the law is passed, he said, the FDA cannot do that.

Instead, Jose said, Congress should provide the FDA with more authority and more funding to appoint inspectors to control CBDs and dietary supplements.

Spokeswoman Courtney Rhodes said the FDA did not comment on the pending laws.

Patients like Taylor, a Colorado woman with epilepsy, are not waiting for the federal government. After the doctor’s visit, he borrowed money from family members to buy a bottle of Charlotte’s Web.

“The effects were night and day,” he said. “I was able to get out of bed.”

He befriended a farmer and spent about 50 50 per month on CBD powder, gummy and oil. She now takes only one prescription medication instead of four for convulsions. He has about one convulsion every month, which means he can’t drive. Her medical providers still don’t seem open to discussing CBD, she said, but it doesn’t bother her very much.

“After living with it for so many years and seeing evidence – that my life has changed 180-degrees – it’s up to me to make a choice whether they’re with it or they’re against it,” she said. “It’s working for me.”

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