June 9, 2013 Updated: June 10, 2013 at 1:39 pm
Six-year-old Charlotte Figi, a picture of precious in her "Gatsby"-style bob and blue toenails, stands patiently as her mother reaches up her dress to change her out of her soiled Pull-Ups. - Charlotte never says a word. She hasn't in the past hour, and won't for at least another 30 minutes, when she finally whispers the name of a visitor who is about to leave.
In the Figi household, these are signs of progress: Charlotte saying something. Charlotte eating and drinking. Charlotte standing and walking.
About 18 months ago, in the winter of 2011, Paige and Matt Figi signed a "do not resuscitate" order telling medical personnel to forgo life-saving measures for their daughter and let fate take its course.
They'd done all they could to control the seemingly endless, violent seizures that hit Charlotte 20, 40, 60 times a day. They put her on an extreme diet. They tried at least a dozen medications, many with harmful side effects. Despite some promising starts, nothing worked. And the rescue medications they were giving her to stop the seizures in fact stopped her breathing. CPR brought her back to life more than once.
After years of watching a cruel, incurable genetic disorder called Dravet Syndome rob their daughter of her basic bodily functions and send her into convulsions that caused head injuries and broken teeth, they had reached the end.
"We really thought, this is a horrible existence; she's not going to live much longer." Paige says. "This is not a life for her. This is torture. She is suffering all day. I'm not OK with this. She wasn't even human anymore. She'd lie in my arms drooling, seizing, screaming and crying."
Then, in an act of desperation, or inspiration - or maybe both - Matt called Paige from overseas, where he was working, and suggested a radical approach to Charlotte's treatment.
"We need to try cannabis for Charlotte," he told Paige. "We live in a compassionate state."
Fifteen months later, the little girl with the DNR order is standing in the kitchen of their Black Forest home with her mother getting her Pull-Ups changed, cuddling in the arms of a visitor, playing with toys and strategically pushing the buttons on her "talker," an electronic device that communicates when Charlotte can't.
Her seizures have dropped from 1,200 a month to three, and the ones she has are shorter in duration and less severe. She's off all the other medications with their troubling side effects. And, as one of the youngest medical marijuana patients in Colorado, her dramatic turnaround is starting to draw national attention, with a CNN report on the horizon.
"Charlotte, when I first saw her more than a year ago, she was listless, really lying in her mother's arms. She did not speak, she could not walk," says Dr. Alan Shackelford of Denver, one of the two doctors who recommended medical marijuana for her. "And when I compare that child to the little girl who bounded into my office when I last saw her, and laughed and danced, it was a different human being who was there."
To Paige, there is no other explanation for the stunning reversal in Charlotte's condition than the marijuana.
"That plant is worth everything to me," Paige says.
Dozens of pediatric patients using 'Charlotte's Web' marijuana
"That plant" is a special strain of marijuana, cultivated at a Teller County grow business owned by six brothers who have been featured on the National Geographic Channel show "American Weed." The Stanley brothers breed the marijuana so it's super low in THC, the psychoactive component of pot that gets people high, but full of cannabidiol, or CBD, a component believed to be a key to the medicinal properties of marijuana.
The brothers named their low-THC, high-CBD strain "Charlotte's Web," a tribute to the success of their first pediatric patient.
"In six years, this is the only thing that has given us this type of success with no side effects," Paige says.
Charlotte doesn't smoke her medicine. The Stanley brothers harvest the plant, extract its cannabidoils, then have it lab-tested to confirm its THC and CBD levels. Then they mix the CBD into an olive oil solution, and Paige gives it to Charlotte two times a day, squirting a measured amount under her tongue with a syringe.
Since starting with Charlotte, the Stanleys have added about 40 more pediatric epileptic patients to their list of Charlotte's Web recipients, giving each a tailor-made tincture for just pennies.
"All of them responded well," says Joel Stanley. "Out of nearly 40, only one didn't see such a success that they weren't weaned from pharmaceutical medications, but the others are all off entirely, or are weaning off of them."
Despite Charlotte's turnaround, Paige, the Stanley brothers and Shackelford have one major frustration: No one who lives outside Colorado can get Charlotte's Web because of federal drug laws.
"I have phone calls from desperate parents in Georgia, Indiana, Norway, Sweden, a number of states in the U.S., from parents of children with severe, intractable seizure disorders who have basically run out of options," says Shackelford, who graduated from the University of Heidelburg in Germany and did his post-graduate medical training at Harvard. "They don't know where to turn now. They desperately want to be able to use marijuana to treat their children's seizures. 'How can I get it? Can you mail it?' Of course, all of that is impossible. It's highly illegal. It's frustrating."
'End of the line for medications'
Dravet Syndrome is the most severe form of a rare group of epilepsies tied to a mutation of the SCN1A gene. It typically starts in infancy, with seizures that seem to go on forever. Around age 2, Dravet patients start getting other types of seizures and regressing in their development, losing skills such as walking and talking.
Paige knows all that now, but she and her husband were in the dark when Charlotte - one half of a set of fraternal twins - had her first seizure in 2007 at the age of 3 months. She'd just had a bath, and her dad was changing her diaper.
"She was blue; she was seizing," Paige recalls.
Charlotte was taken to the ER, where she was intubated, but tests revealed nothing. Two weeks later, she had another "status" seizure, a term for one that lasts longer than 30 minutes. It was back to the ER, where doctors wanted to put her on medication. The Figis resisted and tried a few other things, but nothing worked. Every two weeks, always in the late morning, Charlotte would have another status seizure, including one that lasted four hours.
When Charlotte was 6 months old, the Figis put her on prescription medication, but figured it would be a short-term treatment. Doctors said Charlotte would likely grow out of the seizures.
"Everyone thought they were just going to go away, because she was progressing normally. She was a happy, normal kid," says Paige.
But the seizures continued, and the rescue medications used to stifle them also made Charlotte to stop breathing.
Then, at age 2 - right on target - the other types of seizures kicked in. To make matters worse, the Figis realized that while Charlotte's twin, Chase, was tooling along just fine on her developmental path, Charlotte was losing her ability to walk and talk, eat and drink. Paige had to use a syringe to get water into her mouth, and nurse her for sustenance - the only self-feeding Charlotte could still do.
"We started realizing that she wasn't just losing skills because she had a two-hour seizure," Paige recalls. "She had brain damage."
In her research, Paige learned about Dravet, but wasn't sure Charlotte had it. A trip to Chicago with Charlotte to see a specialist confirmed what Paige suspected.
"I think it was probably one of the worst answers, but I was relieved: We know what to work with."
Paige pushed for Charlotte to get the appropriate medications, and insisted on putting her on a strict high-fat, low-carbohydrate diet that required Paige to precisely weigh and measure foods and keep an Excel spreadsheet of data.
"So a meal would be like mayonnaise and oil, and a slice of grape and a hot dog," Paige says.
For awhile, the diet controlled the seizures, and Charlotte was even able to go drug-free for about three months. But there was a cost. The diet put Charlotte's body into an acidic state that caused bone loss and made her osteopenic. She was riddled with respiratory infections, ear infections, bladder infections.
And then, the seizures returned with a vengeance when Charlotte was 5. Adjusting the diet didn't work. The drug she'd been taking didn't work, even when doctors doubled the recommended dose. She was having 1,200 grand mal seizures a month, plus innumerable other types of seizures. Rescue meds were not an option.
"The doctor said, 'we've nearly reached the end of the line for medications," Paige says.
Charlotte was given some last-resort drugs, but those were hard on her liver, and they didn't stop the seizures.
It was about that time that Matt suggested medical marijuana.
Seizure-free with first dose of marijuana
Paige knew little about medical marijuana, and wasn't in the mood to learn more. She was essentially a single parent to Charlotte, Chase and son Max while Matt was overseas, and she was exhausted. She told him she didn't have time to battle the social stigma and line up the two doctors she needed to recommend marijuana for their daughter.
"It was like a mountain I didn't have the time or energy to climb," she says.
She wanted to wait for Matt to come home, but then "things got so scary, I decided it wasn't a choice."
Paige called every dispensary and grower she could find. She called doctors friendly to medical marijuana, but few wanted to take a chance treating a 5-year-old when there is little science behind its use on children. Only 35 of the 108,483 medical marijuana cardholders in Colorado are minors, and just five are under 10 years old.
"People were terrified to treat her," Paige says. "I kept pushing. I called everyone and said, 'Give me five more contacts.' I wouldn't get off the phone until they gave me more. And I eventually found what I was looking for: I found two doctors to sign for her and agree to treat her."
One was Dr. Margaret Gedde, a Stanford-educated doctor with a practice in Colorado Springs. The other was Shackelford.
Shackelford is an advocate of the medical properties of marijuana, and his knowledge of the topic is encyclopedic. Still, he says, he didn't blithely recommend it for Charlotte.
"When you ask, did I have any reluctance: Yes, clearly," he says. "In medicine - and I think this is important to mention - we physicians have to weigh potential benefits against potential risks. But we really don't know a lot about the effects of cannabis on children."
So he looked at Charlotte's case history, talked to her neurologist at Colorado Children's Hospital in Aurora. The prescription medications were apparently doing more harm than good. In doing his usual risk-benefit analysis of recommending any treatment, he fell on the side of marijuana.
"She'd had cardiac arrest, using the medications that had been prescribed for her to interrupt intractable seizures," Shackelford says. "In her case, it seemed worth a try."
Paige found a dispensary that sold a high-CBD, low-THC product. And it was lab-tested to gauge levels of CBC, THC, toxins and pesticides. She liked that.
"Most medical marijuana is not tested," she says.
That day, she bought $800 worth of cannabis, had a friend extract the CBD and mix it in olive oil, then had it retested at the lab.
In February 2012, Charlotte received her first dose of marijuana as the olive oil was placed under her tongue.
"She had seven days seizure-free, on just that first time." Paige says. "I was giving it to her three times a day. I was very scientific and methodical, and very conservative."
The seizures showed up again, and Paige increased the dose. It helped, but the marijuana was expensive. About two months after starting Charlotte on marijuana, she got a call from one of the people she had contacted a few months earlier in her frantic search for help.
"You really need to meet Joel Stanley," the contact told her.
Marijuana growers breed out THC
Coincidentally, the Stanleys had been working on a project to breed the psychoactive component of marijuana - THC - out of the plant to see how effective CBD might be without it. They weren't focusing on pediatric patients, but had read research that showed CBD's promise in treating medical problems that included muscle spasticity and cancer.
"There was a real good reason to be pursuing not just THC, but also CBD," Joel Stanley said, whose business also grows marijuana with higher levels of THC.
Paige contacted him, and liked him immediately.
"He's not a recreational user," she says. "He's very intelligent. He knew all the science behind it. He's the first person I met who knew what I was looking for."
The Stanleys began growing more of the plant, which tests at about 20 percent CBD and 0.5 percent THC - apparently the highest CBD marijuana in the world, Stanley believes.
In April 2012, the Stanleys also started the nonprofit Realm of Caring to promote medical marijuana research and make their products more accessible, especially to people who can't afford it. Now, low-THC, high-CBD marijuana makes up about 75 percent of the Stanleys' crop.
"We're not pharmacists," says Stanley, who graduated from Colorado Springs Christian Schools and started growing medical marijuana as a business venture with five of his brothers. "We don't have medical backgrounds, but we do work with more than 10 doctors on a regular basis for tracking and to understand what is happening. It is legitimate and viable in every way."
Paige began getting Charlotte's medication through the Realm of Caring network the same month it started, and she's become a convert to marijuana's power over Dravet. Charlotte is no longer on prescription medications, and the strain named after her has had no apparent side effects.
"The drugs that ever worked for her, the dose was so high. It was toxic on the liver," Paige says. "You might see some seizure control for some time, but she can't move, or walk or talk. It's amazing to me that this, with no negative side effects, is working."
Federal law means no clinical research
Paige, Stanley and Shackelford would love to see other children afflicted with Dravet or other pediatric epileptic disorders have access to Charlotte's Web.
But federal drug laws make it impossible, so desperate parents have been moving to Colorado - a pioneer state in the use of medical marijuana and where recreational marijuana use is now legal - to establish residency and get treatment for their sick kids.
"We have some people who have uprooted everything they know to move to Colorado, but not everyone can do that," Stanley says. "We get phone calls every day from people who are crying, asking if there is possibly any legal way to get this to them where they're at. They're at the end of their pharmaceutical rope."
Federal law categorizes marijuana as a Schedule I controlled substance, in the same category as heroin, LSD and methaqualone - substances deemed to have no acceptable medical use and a high potential for abuse. This bars any possibility of distributing Charlotte's Web beyond state lines, makes it nearly impossible for it to be tested in the type of large-scale clinical research that brings traditional prescription drugs to market, and even hampers a thorough understanding of how medical marijuana reduces seizures.
"It's kind of sad, but right now, when it comes to clinical trials and FDA-approved studies in the U.S., the government is not in a place where it's going to allow that to happen," Stanley says. "That's very frustrating. We wish we could grow it in the fields like we grow corn, and if we could, we could supply it to everybody who needs it."
So they have to rely on their own testing.
"It's not through an FDA-approved program, but does that make it less legitimate?" Stanley says. "We're doing everything we can scientifically to understand what this is, what it's doing, and every last compound in our medicine."
Catherine Jacobson, a Stanford University researcher and mother of a severely epileptic son, teamed with Brenda Porter on a small study of parents whose children are being treated with Charlotte's Web. According to their unpublished findings, 84 percent of the 19 parents who responded reported a reduction in the frequency of their children's seizures. More objective testing is needed, they conclude, but Jacobson would be willing to try Charlotte's Web now.
"While I think the drug might help my son, I don't have access to it here in California. So he continues to seize uncontrollably," she says in an email. "This is why Charlotte and all the other kids in Colorado are so lucky. No one else has access to that and these children continue to suffer despite there being a possible solution for them."
Life much calmer for the Figis now
Charlotte will always have Dravet, and with little in-depth research behind Charlottes' Web, there's no way to tell whether it will be effective in the long run, or what, if any, issues it may cause.
"That's why we're pushing for studies," Paige says.
But given how Charlotte was doing before, Paige and Matt Figi took the risk, and they're ecstatic with what the plant has done for their child and the other kids who are taking it. And Paige will take on anyone who raises an eyebrow about this unconventional treatment.
"Look, it's just factual what's happening with her," Paige says. "This is a working therapy. She's eating, drinking, sleeping all night - that's unheard of with these kids."
Charlotte's autism-like symptoms, most likely from the prescriptions she took, also have cleared.
"She used to just slam her head against the glass, rip her fingernails off, like there was pain inside of her," Paige says. "Now, she's just calm."
In fact, life is much calmer for the Figis since Charlotte started on her namesake medication. Her twin, Chase, struggled the worst with the upheaval in her home, Paige says.
"They were best friends; Chase lost her sister," Paige says. "When Charlotte was having seizures, they were loud and violent. Chase would come in, give her a kiss and say, 'OK, don't die tonight. Sweet dreams.' This is what is going through this little 5-year-old's head."
Now, Chase is more like a big sister who helps care for Charlotte. Max knows what to do if Charlotte seizes.
"They've had to grow up," Paige says.
As Paige recounts Charlotte's tale, the girl fiddles with her "talker." She gets it to say her name. She touches the screen again, and a song starts playing. It's "Amazing Grace."