Clayton youngster might benefit from law allowing study of medicinal hemp as epilepsy treatment

swheeler@newsobserver.comJuly 7, 2014 

  • Cannabidiol and medical marijuana

    Medicinal cannabis and related cannabinoid compounds as reviewed in the June issue of Epilepsia and in the 1999 report by the Institute of Medicine:

    Cannabinoid biology: Cannabidiol, or CBD, is one type of cannabinoid compound found in marijuana and other sources. CBD’s therapeutic potential comes from the role these compounds play in brain signaling. Brain neurons transmit signals to control body function. Chemical proteins like cannabinoids temporarily bond to neurons and affect the transmission of brain signals. The cannabinoids produced naturally in humans likely have a role in pain modulation, movement control, cognition and memory and are called the endocannabinoid system. During epileptic seizures, brain signals overwhelm signal pathways. CBD works by diminishing signals to normal levels.

    CBD safety: CBD side effects include drowsiness and dizziness. In general, marijuana side effects are all within the range of those accepted for other medications. Humans tolerate a wide CBD dosage range. Limited safety data exist for long-term use in humans, although the drug has been monitored over many patient-years in other countries following approval.

    Misconceptions: There is no convincing evidence that the medical use of marijuana or related compounds will lead to increased public use of marijuana, researchers say. No conclusive evidence exists that medicinal marijuana or CBD is linked to substance abuse.

A law that lets doctors use oil from hemp plants to treat drug-resistant epilepsy makes the new treatment available only to a small number of patients who take part in pilot studies, not to a broader patient base as many families had hoped.

Before Gov. McCrory signed the bill into law last Thursday, some patients were already calling doctors, hoping to sign up for the hemp-oil treatment, only to learn they might not be eligible.

“People need to know what the bill is not,” said Dr. Mohamad Mikati, an epileptologist and chief of child neurology at Duke University. “The only way you can access it (hemp oil) is through a study.”

The hemp oil bill cleared the General Assembly with overwhelming support – only one “no” vote in the House.

“This law will help ease the suffering endured by children (for) whom no other treatments are effective against their seizures,” McCrory said in an earlier statement.

The law authorizes neurologists to conduct pilot studies to evaluate the medicinal use of cannabidiol, or CBD, extracted from hemp, for patients with intractable epilepsy.

Rep. Pat McElraft, a Carteret County Republican who sponsored the measure, told a Senate committee recently that its main purpose was to allow families who have gone to Colorado to procure the hemp extract to come back to North Carolina and legally continue the treatment.

But patients who possess medicinal hemp oil without being enrolled in a pilot study will still be in violation of state drug laws, said Barbara Riley, a staff attorney in the Research Division, who was involved in writing the bill.

“This is a feel-good measure that may only affect a handful of people,” said Rep. Kelly Alexander Jr., a Democrat from Mecklenburg County who has sponsored another cannabis-related bill.

Duke University and Wake Forest Baptist Medical Center are in the planning phase to conduct a small clinical trial for Epidiolex, GW Pharmaceutical’s CBD plant extract, only on patients with specific intractable forms of epilepsy. The trials are in conjunction with an international study of 100 patients. Doctors say the clinical trials will include only patients fitting specific criteria, and each trial will include no more than 10 patients.

Wait could be fatal

Such studies could help lead the way eventually to action by the Food and Drug Administration approving a pharmaceutical CBD. But patients and their families say FDA approval could take years – a wait that could prove fatal because of the high risk of unexplained sudden death in epilepsy.

“My daughter could have one to two severe seizures today. One of those could be her last,” said Stephen Carlin of Clayton, whose daughter Zora has a severe form of epilepsy called Dravet syndrome.

The use of CBD is legal in Colorado under state law, and the oil is produced there by a nonprofit organization, The Realm of Caring. Each potential patient must get on a waiting list, establish Colorado residency and get a doctor to sign the “red card” application.

Hemp and marijuana are different varieties of cannabis, but medicinal CBD should not be confused with medical marijuana. The cultivated cannabis strain producing the CBD extract contains less than 1 percent of the psychoactive component tetrahydrocannabinol, or THC, and eliminates its effect.

Decades of strict marijuana prohibition have created barriers to medical research of cannabis and the development of drug therapies. Medical groups including the American Public Health Association support doctor-supervised access to medical marijuana and underscore the need for research and clinical trials of medicinal cannabis and its associated cannabinoid compounds.

Many people have turned to CBD because of its strong therapeutic potential and reports that it significantly reduces seizures. The first report coming out of the Epidiolex clinical trials is encouraging, said Dr. Edward Maa, who heads the Comprehensive Epilepsy Program at Denver Health and Hospitals.

“Patients had not seen any side effects,” Maa said.

CBD has been shown to be beneficial in both animal studies and clinical trials, and it exhibits relatively low health risk to patients, according to a June 2014 review published in the journal Epilepsia.

A patient named Charlotte Figi was the inspiration for the CBD treatment now called Charlotte’s Web, which is produced by The Realm Care. Charlotte saw a 90 percent reduction in her seizure frequency and regained her ability to walk and talk with CBD administration, Maa said.

“This could give my daughter the chance to at least try something that we know works,” said Carlin, the Clayton father. “This could change our lives.”

Medical experts have called for a systematic investigation of CBD’s efficacy and safety through rigorously controlled experiments.

“The testimonies are compelling to perform studies on this drug. What is needed is to conduct a controlled study to know its effectiveness or ineffectiveness,” said Mikati, the Duke epileptologist.

Many FDA-approved anti-epileptic drugs have serious side effects.

Zora, the Clayton youngster, suffered heavy sedation – sleeping for three days straight – from drug therapy that included Valium, Trileptol and Topamax. Topamax side effects include blindness, brittle bones, thoughts of suicide and nervousness. In response to her treatment, Zora became aggressive and attempted to tear the skin away from her legs and face, her father said.

CBD side effects include fatigue and dizziness, Maa said.

Legalizing medical marijuana

The hemp oil bill was named “Hope 4 Haley and Friends” because of concern about Haley Ward, a young patient with intractable epilepsy. Children with intractable epilepsy can have up to 50 seizures per day and have a high risk of sudden unexplained death. These children often do not respond to other anti-epileptic drug treatments, leaving patients and families in desperate need for new drug therapies.

Twenty-two states and the District of Columbia have laws legalizing the medicinal use of marijuana. Medical organizations that have supported doctor-supervised access to medical marijuana include the American Nurses Association, the American Public Health Association, the Lymphoma Foundation of American, the National Association for Public Health Policy, the Epilepsy Foundation and many others.

Rep. Alexander, the Mecklenburg Democrat, has sponsored legislation to authorize a statewide referendum on authorizing medical marijuana as treatment for cancer, AIDS, multiple sclerosis and other debilitating conditions.

“We need to have a full, open discussion of the medical efficacy of medicinal cannabis,” Alexander said.

Wheeler: 919-829-8994

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