Parents Lobby for 'Miracle Drug’ That Comes From Pot

Extracted from marijuana, it seems to offer relief for kids with seizures

Photo: Julysa Sosa - San Antonio Express-News

Photo: Julysa Sosa - San Antonio Express-News

Melissa Fletcher Stoeltje, San Antonio Express-News - When the seizure begins, Conrad Tullis’ frail body cramps up in a painful contraction.

The 12-year-old who suffered a severe brain injury a decade ago endures spasms that can last five minutes or more, his head craning hard to the right. Sometimes he whimpers during the convulsions, which can strike 10 to 15 times a day.

Afterward, the seventh-grader is exhausted, unable to interact with the world in even the minimal way he’s learned since falling into his grandfather’s swimming pool when he was 2.

A host of traditional seizure medications haven’t helped Conrad — indeed, they’ve likely hurt the boy, with their cascading roster of debilitating side effects.

Now, mother Liz Tullis hopes that two bipartisan bills before the Texas Legislature will become law so Conrad and other children with uncontrollable epilepsy might have access to a substance some have deemed a miracle drug — cannabidiol oil, or CBD oil.

A compound extracted from the marijuana plant, the oil is legal in more than a dozen states; a number of others are weighing legislation to make it so. Proponents, which include a growing cadre of parents of kids with intractable epilepsy, emphasize that CBD oil, which is administered orally and not smoked, is “noneuphoric” because it’s very low in THC, the psychoactive component of pot.

“This is not about getting children high,” said Tullis, who is among a small battalion of Texas parents and epilepsy advocates lobbying for passage of the Texas Compassionate Use Act. “It’s about relieving them of these devastating seizures, which can be life-threatening.”

Now, possession of any amount of CBD oil in Texas is illegal, causing great frustration among parents who decry what they believe is a fundamental injustice: They’re barred from giving a possibly life-altering medicine to their suffering children simply because they live in the wrong state.

A number of families in Texas, including some from San Antonio, have moved to states where CBD oil already is legal, becoming so-called “medical refugees” so they can provide the treatment to their kids.

As far as scientific proof that CBD oil works, the jury still is out. Since marijuana is classified by the federal government as a dangerous, addictive drug, on par with heroin, no rigorous studies have been completed to date — the kind that pass muster with the Food and Drug Administration — that show CBD oil is safe and effective in treating intractable epilepsy or seizures that are not controlled by standard drugs.

A trickle of early studies have shown mixed results, including one small study done at a Colorado hospital.

It examined parental reports and other data on how well CBD oil and other forms of medical marijuana worked in children and adolescents with intractable epilepsy, finding about one-third experienced a greater than 50 percent reduction in seizures — a significant benefit. But some children weren’t helped at all by the drug, and a few experienced adverse effects, such as an increase in seizures.

A double-blind, placebo-controlled study — the “gold standard” of research — by GW Pharmaceuticals, a British drug company, is under way at several sites in the U.S. Early trials of its CBD oil Epidiolex have shown that in nearly 40 percent of children, their seizures declined by more than half — again, an optimistic finding. A second drug company is studying a synthetic form of the oil as well.

While the oil is being researched in other parts of the world, the majority of CBD therapuetic use has occurred in the U.S. It’s thought that molecules in the oil attach to certain receptors in the brain, in doing so quieting an excess of electrical and chemical signals, such as those seen in epilepsy.

Until the scientific data comes in, the anecdotal reports of parents are filling the void, a growing body of personal testimony, told in the media and statehouses, that contends CBD oil has radically improved the lives of their children.

Reports of positive results are one reason some pediatric neurologists and epileptologists, as well as groups like the Epilepsy Foundation of Texas, are agitating for the bills to pass.

“We need another tool in the toolbox,” said Sindi Rosales, CEO of Epilepsy Foundation Central & South Texas. “We don’t expect CBD oil to cure intractable epilepsy or to help everyone. But for families living with the horror and anxiety of seizure disorder, this is a chance for hope. CBD oil provides hope.”

The twin bills, both authored by Republicans and supported by lawmakers across the aisle, await hearings in Senate and House subcommittees. Advocates point out they are narrowly written — both would closely regulate the cultivation and dispensing of CBD oil in Texas, which would only be available at a particular, low-THC dose and only to patients with uncontrolled epilepsy.

 

The bills are far more restrictive than those that legalized medical marijuana in 23 states, broad laws that in general green-light the marketing of “whole plant” products to a wide range of patients, such as those with cancer, multiple sclerosis, HIV and other illnesses.

The Texas bills would allow for the implementation of “compassionate use” of CBD oil by 2018, a move that would effectively bypass FDA drug trials, which can take as long as a decade to vet and approve a drug. Rep. Stephanie Klick, R-Fort Worth, lead author of the bill in the House, said that date might be moved up even further.

“These are families that have run out of options,” said Klick, who is a nurse. “Other states have legalized CBD oil with promising results. We want Texans with intractable epilepsy to have that option.”

Klick said she expects a hearing date to be set in the House this month; the Legislature winds up its work by June 1. Time is of the essence, she stressed.

“Two children have died of seizures in Texas during this session,” she said.

The bills face opposition, and not just from conservative lawmakers who fear a yes vote might cast them as champions of weed, antagonizing their base. The Texas Medical Association has come out against legalizing CBD oil, stating more testing needs to be done before making it available to families.

Medical marijuana advocates criticize the narrowness of the proposed laws, saying they leave out too many people who would benefit and shut the door to broader uses of the entire plant.

Even some parents of children with intractable seizures are against it, arguing their kids need higher levels of THC to make their convulsions stop, a dose ratio the Texas law wouldn’t allow.

Stories full of pain

Perhaps the most compelling argument in favor of the compassionate use law can be found in the stories of San Antonio families who desperately want it to pass.

An estimated 149,000 people in Texas — about one-third of all epilepsy sufferers — find no relief in the spectrum of existing drugs, many of which carry serious, even potentially fatal side effects.

The group includes 6-year-old Emily Ammann, who began having seizures as an infant. Her parents took her from clinic to clinic, trying to find the right diagnosis.

At the direction of her doctors, they dosed Emily with a range of heavy drugs, from drastically sedating phenobarbital to a steroid, which set the 6-month-old on a nine-week jag of continuous crying, sleep coming only in rare, 45-minute intervals.

“The drug wiped out her entire immune system, so we could never leave the house,” mother Victoria Ammann said.

Doctors finally determined Emily had a form of epilepsy that causes a near-constant electrical chaos in her brain. None of the drugs has helped, Victoria said, including an implanted Vagus Nerve Stimulator that seeks to interrupt the storms inside her skull.

A beautiful little girl in a wheelchair, she has glossy brown sausage curls and pink-painted fingernails. She neither can speak nor move purposefully. Her bladder must be regularly emptied by a catheter; her bowel must be evacuated as well.

Something as innocuous as saliva pooling in Emily’s mouth can trigger a seizure, said Victoria, who believes CBD oil may hold out the only hope of her daughter having anything close to a normal life.

“Each time you try a new medication, you pray it will fix your child,” she said. “We want the opportunity to try (CBD oil) with Emily. I think if people were only educated about this, they would be on board, too.”

About a year ago, Victoria saw a CNN show about Charlotte Figi, a little girl in Colorado with Dravet Syndrome, a rare and severe form of epilepsy. Her mother, Paige Figi, now a leading CBD oil activist, famously pioneered a therapeutic brand of hemp oil, which now is marketed and sold under the name Charlotte’s Web.

The 2013 CNN special by Dr. Sanjay Gupta extolled the benefits of medical marijuana, told through the story of Charlotte, who went from catatonic to walking and talking. Viewed by hundreds of thousands of people since its debut, the show was a galvanizing moment that put CBD oil on the map.

In San Antonio, Leslie Moccia is hoping the oil will help her 25-year-old son Zachariah, who like Charlotte also has Dravet Syndrome.

To that end, she and her son have personally visited lawmakers in their offices in Austin, as have other parents who belong to CAFE Texas (Compassionate Access for Epilepsy.)

Before he was diagnosed with Dravet, Zachariah endured many medications that didn’t work, said Moccia, including unnecessary brain surgery.

Once, when he was a boy, he experienced a nine-hour seizure. To stop it, doctors had to put him into a medically induced coma.

“Even small changes in Zach’s body temperature can trigger a seizure,” said Moccia, looking fondly at her son, a smiling young man who loves to bowl but struggles with interpersonal communication. He flaps his hands when he talks and cannot maintain eye contact. He speaks in the third person.

Moccia must keep a supply of powerful seizure “rescue drugs” on hand, including one that’s used in lethal injections, she said. Over time, the seizures have damaged her son’s developing brain, she said, equating convulsions to repetitive concussions.

“He’s at high risk of sudden unexpected death from epilepsy,” she said. “Every morning, I don’t know if he’s going to be alive. I shouldn’t have to go to another state to get him this drug.”

Taking drastic steps

One San Antonio parent actually moved his family to Colorado to do just that.

Fahad Afeef’s son Ibrahim, now 10, began having seizures when he was 5. He was diagnosed with Batten Disease, a fatal genetic disorder that causes seizures and the slow loss of sight and motor skills. His son was put on 14 different medications — most turned him into a “zombie,” his dad said — and was hospitalized multiple times.

After hearing about CBD oil, Afeef relocated his family to Colorado Springs in 2013.

“It was a no-brainer,” said the father, who owned a convenience store in San Antonio but now works for a Colorado home-health agency. “It was hard to uproot the whole family, but the doctors back home said there was nothing else they could do for us. So we downsized and took a drastic step.”

Afeef said his son’s seizures are under such good control — his medicine costs $250 a month — that he has been weaned off all the other drugs he was taking.

“It’s been a huge, positive impact on him,” he said. “He can go four, six months with no seizures. He’s still nonverbal, but he’s more alert. I think if we had had the opportunity to start him on the oil earlier, he may have retained more of his skills. But this has been a blessing. I feel for all the families in Texas who can’t just pack their bags and go.”

Tullis, Conrad’s mother, said moving her son to Colorado or another state where CBD oil is legal would mean uprooting him from family and his supportive squadron of doctors and therapists, years in the making.

“This is about the potential to help my son without hurting him, and seizures hurt him,” she said. “That I would have to leave my home state to do that just doesn’t make sense.”

Tullis said she pays more than $30,000 a year for therapies and nonseizure medication for her son, expenses that are not covered by insurance — costs that might go down if her son’s convulsions were better controlled.

One study found that patients with uncontrolled epilepsy spent more than $10,000 a year in direct medical expenses. The same study found intractable seizures cost the U.S. as a whole upwards of $12.5 billion annually.

'Too narrow’ bill?

Dr. Linda Leary, a pediatric neurologist and epileptologist in San Antonio, said that while parental reports about the efficacy of CBD oil are persuasive, “they can be biased.”

“There’s a lack of data,” said Leary, clinical associate professor in the department of neurology and pediatrics at the University of Texas Health Science Center. “We don’t know how well CBD oil works yet and which type of epilepsy it works best for. So we need more information. But among my patient population, 20 to 30 percent don’t respond well to the standard drugs.”

An observational trial — less rigorous than placebo-controlled studies — that found one-third of children with Dravet Syndrome were seizure-free after using CBD oil for three months was “compelling,” she said

“But we need some mechanism in place for standardizing the oil and making sure it’s safe, especially when using it on children,” she said.

A botanical derived from plants, CBD oil would have to be calibrated from different batches to conform to the strict, low-THC ratio the Texas law would mandate.

It’s that very ratio that has made Dean Bortell an opponent of the Texas Compassionate Use Act.

His daughter Alexis, now 9, began having seizures at age 7, convulsing wildly and foaming at the mouth. The various medications doctors gave her actually made her condition worse, he said.

After seeing Gupta’s documentary, Bortell moved his family from the Dallas area to Colorado, becoming “medical refugees,” he said.

Bortell said his daughter’s epilepsy now is well-controlled on CBD oil — $150 for a 40-day supply — but one of her doses contains more THC than would be allowed under the proposed Texas law. To get the right ratio, he must add pure THC oil to the CBD oil.

“If I got caught with that in Texas, I’d go to prison,” he said. “I’ve talked to tons of parents here in Colorado, and for many of them, the ratios in the Texas bills wouldn’t help their children because they require more THC. For no other medication does the law dictate dosing levels.”

Bortell said the idea that CBD oil has to be noneuphoric to become legal is ironic in the extreme: Many of the drugs routinely given to children with seizure disorder, such as Valium and other benzodiazepines, are highly intoxicating and strongly addictive as well. Indeed, “benzos” figure largely in the prescription drug abuse epidemic in America.

Further, he said, worry over the side effects of cannabis-derived oil — so far, studies show sleepiness is the main one — is absurd, given the potentially disastrous side effects of accepted drugs, many of which are given to children even though they are not FDA-approved for such use.

Bortell also doesn’t like the fact that children have to show they are not helped by existing drugs before they can try CBD oil.

“For some children, brain surgery might help,” he said. “Will kids have to get brain surgery before they can try the oil?”

Dr. M. Scott Perry, a pediatric epileptologist at Cook Children’s Hospital in Fort Worth, one of the sites of the Epidiolex trial, said children who are “good candidates” for such surgery would be wise to pursue that option over the oil.

“Why? Because the use of epilepsy surgery, the outcome, and the risks are well researched and known, while the efficacy and risks of CBD oil are not,” he said.

Once CBD oil has been adequately researched, it too can be an option to consider, along with the array of medications and special diets, he said.

“For now, patients that are poor surgical candidates and patients that have failed all reasonable, well-investigated medical treatments would be candidates for CBD oil.”

He also said that, while some children may need more THC to control their seizures, the bills as they are written represent “the best way to start.”

“The goal is for this one to get passed,” he said. “Instead of saying, 'Let’s tinker with every dose,’ we need to make it as uniform as possible. There’s so little science at this point to substantiate (the proper dose), it’s best to err on the side of being safe.”

Laws that allow for wide-ranging medical marijuana use “get us no closer to understanding if CBD works, as it simply adds too many variables and lack of standardization,” he added.

The Texas bills also require that only doctors who specialize in epilepsy can dispense the oil, and they must register with the government before doing so.

Advocates for the broader medical marijuana bills that also have been introduced this session say the CBD bills are woefully insufficient.

“These bills are not so much to help people as to appease some people who are particularly loud in Austin,” said Shaun McAlister, executive director of the Dallas-Fort Worth chapter of NORML, National Organization for the Reform of Marijuana Laws.

Only a small number of people with epilepsy are going to benefit, he said, and the bills allow no “wiggle room” for parents to change the dose ratio if need be. And what about all those cancer patients who need pot-based help? The people with post-traumatic stress disorder? With gastrointestinal illness?

McAlister sees the narrow CBD oil law as blowing the other, better marijuana bills out of the water.

“We’ve been waiting 20 years for a medical marijuana bill in Texas, and this is just a wedge issue to divide a very united movement,” he said.

These arguments do little to daunt the determination of Tullis and the other parents in favor of the bills, who plan to bring their children to public hearings in the subcommittees — when, and if, hearing dates finally are set.

They believe the presence of their damaged children before the dais will provide indisputable evidence that this law must pass — and pass now.

Meanwhile, Paige Figi, whose fight to help her daughter Charlotte stop seizing got the whole CBD ball rolling, recently submitted a proposed piece of federal legislation in Washington that would reclassify marijuana to a less-restrictive status, a move that would free up funding for more scientific research, she said.

Co-written with a congressman from Pennsylvania, the bill has the backing of the American Academy of Pediatrics.

The time for CBD oil, which has absolutely no street value, has come, Figi said. (One brand even has the humorous name “Hippie’s Disappointment.”) There’s no way for it to be diverted for nefarious purposes or abused by those seeking a buzz.

“This is not a blue-state, red-state issue,” she said. “This is not a liberal or a conservative issue. This is about educating people. This is about helping children.”

mstoeltje@express-news.net

Twitter: @mstoeltje