Cannabidiol is a non-psychoactive cannabis compound touted for its medicinal promise–but marijuana- and hemp-derived extracts rich in CBD and low in intoxicating THC are facing a future yet to be determined.
The Cannabist’s special report “CBD, TBD” explores the issues with CBD — federal-state conflicts, national drug policy, pioneering research efforts and the paths toward the compound’s full legalization. This is the first installment in an ongoing series.
Seizures are a constant in Nancy Pasiecznik’s life.
In a typical month, they come by the dozen. In some months, they have come on the order of 100.
Attempts to control the uncontrollable have been practically futile and, in some instances, nearly fatal for Pasiecznik, 59, who lives in a state-run facility in western New York.
At one point, roughly five years back, the dosages on her medications were ratcheted up too high, hurtling her into a life-threatening, prolonged seizure.
A different course of treatment had to be charted.
Last October, her neurologist recommended that Nancy receive a daily half-milliliter dose of Charlotte’s Web, a whole plant hemp extract oil formulated and developed by Colorado-based CW Hemp. The oil is rich in cannabidiol (CBD), a non-psychoactive cannabis compound that has been highly touted for its potential medicinal benefits and attracted national attention for its claimed ability to reduce seizures for some patients.
“(Nancy) has been tried on multiple antiseizure medications without significant lasting improvement in her seizure control and/or with intolerable side effects,” Dr. Kenneth R. Murray, of the Dent Neurologic Institute in Buffalo, N.Y., wrote to the state of New York in a letter provided to The Cannabist. “I feel it is imperative that she be afforded an opportunity for stabilization of her seizure disorder.”
But in the eyes of the federal government, CBD not only remains unproven, it’s also an illicit cannabis derivative, creating a legal and ethical conundrum for doctors, patients and their families — even in states like New York that allow medical marijuana.
To date, Nancy has yet to receive the recommended medicine.
Another treatment option from Colorado
Nancy has relied on a network of state and family support since age 18.
Her developmental disabilities and epilepsy require her to be under constant care, and she resides at a state-run group home in Orchard Park under the purview of New York’s Office for People With Developmental Disabilities.
Special Report: CBD, TBD
Part I – Forbidden medicine: Caught between a doctor’s CBD advice and federal laws
Part II – How advocates are inspiring congressional action on CBD legalization
Part III – With DEA digging in its heels on “marijuana extracts,” legality of CBD oil on trial in federal courts
Part IV – CBD research is going to the dogs in quest to legitimize pet products
Part V – CBD on the international stage: WHO committee delving into science, control status of cannabis compound
Part VI – Race for CBD medication breakthrough: Is pharma firm’s boon the hemp industry’s doom?
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Intellectually, Nancy functions at about a 10-year-old level. She loves eating pizza, going on walks with her brother and legal guardian, Paul Pasiecznik, 74, and hearing tales about other people’s dogs.
For more than eight months, Paul has waged a battle on behalf of his sister so that she could follow her doctor’s orders.
The conversation about adding Charlotte’s Web to Nancy’s treatment plan began last fall when Murray, who sought out cutting-edge therapies in areas such as epilepsy, told Paul that he saw potential in an emerging area of cannabis compounds, specifically CBD.
Murray explained to Paul how Epidiolex, a possible breakthrough CBD drug developed by U.K.-based GW Pharmaceuticals, was making its way through clinical trials. Dr. Orrin Devinsky, the principal investigator of the Epidiolex study, recently presented positive findings from late-stage trials about the drug’s potential in treating seizures associated with certain types of epilepsy.
Knowing it could take years for Epidiolex to make it to market, Nancy’s doctor presented another treatment option: Charlotte’s Web, the brand name for a whole plant hemp CBD extract grown and processed in Colorado by CW Hemp.
Since it legalized medical marijuana in 2000 and adult-use marijuana in 2012, Colorado has developed into a hub for anecdotal evidence about CBD’s ability to treat symptoms of seizure disorders and other ailments. Charlotte’s Web gained national media attention for its seemingly otherworldly ability to reduce seizures in a local girl named Charlotte Figi.
Scores of medical marijuana refugees have flocked to the state and proclaimed success of CBD oil as an alternative care option. News reports about Figi and many other patients buoyed CW Hemp, formerly known as CW Botanicals, to national prominence.
After learning about Charlotte’s Web from Nancy’s doctor, Paul began furiously researching CBD — querying New York state officials, lawmakers and lawyers; scouring the internet for information; and cold-calling The Cannabist’s Colorado offices in a quest to learn what could and could not be done for his sister while she was in the care of her group home.
A tangled web of regulatory and legal uncertainty
In the letter penned to state officials recommending Charlotte’s Web for Nancy, Murray referred to it as a dietary supplement “classified as hemp and thus legal to ship to all 50 states.” But Paul soon learned that others didn’t view CBD extracts in that same light.
The federal government considers CBD oil and other cannabis-derived extracts to be Schedule I substances — the strictest of the classifications in the U.S. Controlled Substances Act.
New York legalized medical marijuana in 2014, but the state’s program is among the most prohibitive in the nation. Dispensaries are sparse — fewer than 20 are scattered throughout the state — and the law prohibits the smoking of cannabis and a select few medical conditions qualify for the program.
Murray could not be reached for comment. His letter to New York state officials was among several letters of correspondence provided by Paul to The Cannabist.
As New York navigated the choppy waters of medical marijuana legalization, the Dent Neurologic Institute in which Murray practices has positioned itself as a resource for potential medical marijuana patients and the broader medical community, said Dr. Laszlo L. Mechtler, Dent medical director and chief of neuro-oncology at the Roswell Park Cancer Institute.
Mechtler formed the Dent Cannabis Clinic, which serves 1,000 patients and has another 1,000 on the waiting list. His wider aim is to have Dent land a Schedule I research license to conduct prospective clinical studies involving medical marijuana.
Without studies, he and his colleagues have to rely on their clinical experience and the results that they’re seeing in patients — much like a physician would do 200 years ago, he said.
In trying to learn how to help his sister receive CBD oil while in the care of the state-run group home, Paul butted up against a bureaucratic system that itself was trying to understand and unravel a tangled web of regulatory and legal uncertainty.
Paul’s initial correspondence with the clinical director for New York’s Community Services for the Developmentally Disabled, the office that oversees Nancy’s group home, left him optimistic.
While the office sought clarification from the state about what was permissable, officials made suggestions for helping Nancy get Charlotte’s Web in the interim. Among the solutions floated was that Paul could transport Nancy, who is a registered medical marijuana patient, to his personal residence where he could administer the recommended medication himself.
Before a temporary treatment plan could be developed, the state came back with its clarification:
Under New York state law, the act of nurses administering, supervising or tracking any marijuana product — even CBD oil low in the psychoactive compound THC — would constitute the committal of a crime and, thus, personal misconduct, state officials wrote in a Jan. 31, 2017, letter to Paul.
Although Paul and his lawyer balked at the Schedule I classification, claiming the hemp-derived extract was legal under protections offered by the 2014 U.S. Farm Bill, the state stood firm.
The letter didn’t just put the kibosh on the possibility of integrating Charlotte’s Web with Nancy’s medical treatment — it also chilled Paul’s plans to transport her to his home so that he could personally administer the oil to Nancy.
Earl Cohan, director of clinical services for New York’s Community Services for the Developmentally Disabled, could not be reached for comment.
‘Absolutely no relief’
Paul doesn’t want to have to look over his shoulder to administer a potential medicine that he thinks could help his sister.
If a nurse were to see him deliver the oil to Nancy, Paul wondered if they would call the police and have him arrested. Worse yet, it could threaten Nancy’s medical benefits with the state, he said.
“Here is a doctor prescribing it to a patient, and the state is the inhibiting factor,” he said. “There is absolutely no relief from the state-provided oversight.”
The New York State Department of Health provided the following statement:
New York State’s Medical Marijuana Program regulates the manufacture, sale and use of medical marijuana in New York State. Approved medical marijuana products sold by organizations registered with the State’s Medical Marijuana Program (ROs) often contain CBD. However, products purchased outside of the ROs that claim to be “CBD oil” or “hemp-derived plant extracts” are outside the purview of the State’s Medical Marijuana Program and may be of unknown content and quality.
Department of Health officials did not respond to follow-up questions about the policies of state-run special and developmental needs facilities.
Separately, officials with New York’s Office for People With Developmental Disabilities did not provide a response to The Cannabist’s multiple emails and calls seeking an interview and information about the office’s policy toward medical marijuana and CBD oil.
Paul considered trekking across New York to purchase another brand of CBD extract, but the percentages of cannabidiol did not align with that of Charlotte’s Web, he said. He also didn’t know whether the extracts at a dispensary 20 minutes away in Buffalo or 200 miles away in Binghamton matched up to the ingredients, formulation, testing, safety and potency Nancy’s neurologist referenced to him about Charlotte’s Web.
“I trust the experts for recommendations,” Paul said. “Plus, there are some good stories coming out of Colorado.
In the absence of federal legalization of medical cannabis and its related products, it’s up to the states to advance research and provide access, said Mechtler, the head of the Dent Cannabis Clinic.
And if the state or a facility is a hindrance, that could be grounds for a challenge, he added.
“Especially in a state where it’s legal, I would find myself an attorney and fight them,” he said.
Paul said he considered legal action on behalf of his sister, “if it didn’t cost me a car or two.”
He said he just wants the opportunity to see if this doctor-recommended supplement could help his sister.
“Will it work for Nancy? I don’t know,” he said. “Without a doubt, I would want to try it (for her).”