Pubdate: Sun, 09 Jun 2013
Source: Gazette, The (Colorado Springs, CO)
Copyright: 2013 The Gazette
Author: Barb Cotter


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.

Charlotte breathing.

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 Heidleburg 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."
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