Pubdate: Sun, 15 Dec 2013
Source: Denver Post (CO)
Copyright: 2013 The Denver Post Corp
Author: Michael Booth


A Cannabis Product Is Proving to Be Both for Families Battling 
Debilitating Seizures

Desperate parents are flocking to Colorado in search of pot-derived 
medical treatments they consider a last resort, yet many researchers 
are alarmed by parallels to past miracle-cure manias later proved false.

Accelerating legalization sentiment across the nation could open 
doors to legitimate medical research, testing marijuana products 
blocked for decades by federal law.

But the movement also opens the way for bad medicine, researchers 
said, through treatments at best giving hope to the hysterical and at 
worst delivering damaging side effects.

Is legalization a scientist's dream or a doctor's nightmare?

Longtime researchers are struck by the openness of current parents to 
marijuana derivative treatments, Devinsky said.

"There's a comfort level" among those who have used or been around 
marijuana for a generation, he said.

By contrast, Devinsky said, "There's a group of medical leaders that 
are appalled by what's going on."

Colorado's status as "ground zero" for new, unauthorized research 
went national in recent months with news coverage of a few hundred 
children with untreatable seizures taking cannabidiol made by a 
Colorado Springs dispensary.

Doctors agree with parents such as Paige Figi that their children 
were suffering crippling, life-threatening seizures by the dozens, a 
regressive condition proved untreatable by current medicine. Paige 
and Matt Figi heard of cannabidiol's proven ability to bind with key 
brain receptors and tried it on daughter Charlotte.

The refined and dosage-tested oil has low THC and therefore no 
psychoactive effects. In Web videos, on national TV and in local 
interviews, Paige Figi describes how 7-year-old Charlotte has gone 
from suffering 1,200 seizures a month and a devastating regression 
from walking and eating, to resuming happy childhood moments on a 
park playground in north Colorado Springs.

"I literally couldn't watch another minute of her suffering," Paige 
Figi said of the moment two years ago when they first tried the oil. 
Now she is among volunteer parent advocates pushing for medical 
marijuana legalization in New York and other states as part of an 
effort to broaden the experiments.

Figi acknowledges and agrees with doctor precautions about unproven 
medicines, and says she always calls for rigorous testing. Yet she 
quickly adds a doctor's standard is different from the judgment of a 
parent whose child is dying a slow and violent death.

On a recent sunny afternoon in Fox Run Regional Park, Charlotte sat 
on a sled and ate grapes while her fraternal twin sister and her 
brother played nearby. The back of the car had grocery bags with eggs 
and paper towels from an errand along the way.

Two years ago, Paige said, the family's run to the store would have 
ended with Charlotte seizing on the ground amid broken eggs and 
terrified store managers dialing an ambulance.

"I do believe in a (Food and Drug Administration) clinical trial 
model," Figi said. "I just didn't have time to wait for that."

Remarkable progress

Interest in cannabidiol increased last week with the release of a 
scientific study abstract by Maa and Colorado Springs physician Dr. 
Margaret Gedde, who advises many of the epilepsy patients using it in Colorado.

Gedde and Maa's research showed parents of a handful of 
traumatic-seizure children reporting remarkable improvement on 
cannabidiol, or CBD. Eight of 11 families had "sharp reduction 
patterns in intractable seizures," Gedde said in an interview.

Maa is taking the results to a Colorado medical research review board 
to gauge the plausibility and the interest in supporting safety and 
clinical trials in the state.

The waiting list grows daily for hard-to-produce CBD, now called 
Charlotte's Web, produced by a legal dispensary run by the Stanley 
family in Colorado Springs. Parents who move here to get it can't 
return to their home states, as the substance is illegal across most 
state borders.

The FDA has approved only a couple of marijuana derivatives for 
prescription drug use, including tablets for treating nausea and lack 
of appetite in cancer patients and those with other wasting diseases. 
Proponents of marijuana medications, with the support of some 
mainstream lab research, say promising applications for derivatives 
include immune disorders, inflammation and psychotic mental illnesses.

But researchers warn that without loosened federal restrictions and 
then years of sanctioned clinical trials, there are few ways to prove 
those claims. Studies also need to isolate which of many compounds 
produced by marijuana plants are the key ingredients to medical treatment.

In the scientific and medical worlds, a parent and a doctor claiming 
to observe success is vastly different from the high standards of a 
clinical trial. In such stringent, FDA-controlled tests, neither the 
patients nor their treating doctors know who is given CBD, for 
example, and who is given a placebo.

"Observational data is regarded as fairly low quality in the 
hierarchy of things," said Dr. J. Michael Bostwick, a Mayo Clinic 
psychiatrist who has written a survey of research into medical 
marijuana claims titled "Blurred Boundaries."

Major placebo effect

Clinical researchers are wary of the heightened placebo effect in 
treatments involving children, when reports of progress depend on the 
view of parents - and even their family physicians - desperate for hope.

Justin and Annie Koozer uprooted their family from Tennessee to 
pursue cannabidiol in Colorado for their 2-year-old daughter, Piper. 
Yet Justin Koozer, too, worries about trying to see too much progress 
in Piper's intense seizures since she started taking the oil in late October.

Piper suffers from Aicardi syndrome, missing a crucial bundle of 
fibers attaching the brain hemispheres. After trying every other 
recommended drug with little impact, the most Koozer will say about 
CBD is that Piper has improvements that are "unquantifiable." She's 
having seizures, but fewer of them; she sleeps through many nights, a 
huge change.

"She can tolerate exercising and playing with toys much longer," Koozer said.

Still, he knows the risk of the placebo effect in experimental treatments.

"You've pulled up stakes and moved out here, and people around you 
are saying it's working, and you want to be part of that," he said. 
"We have to be careful of that."

Those urging caution on cannabidiol note the evocative reputations of 
past frenzy-driven treatments such as "laetrile" and "Lorenzo's oil." 
Both allegedly miraculous treatments caught the American fancy, in 
part from their "natural" components, only to have their 
effectiveness and safety dismantled by clinical research.

Gedde said she comes from a pharmacological research background 
herself and is committed to pushing derivatives toward clinical trials.

The FDA, she said, has approved many medications that proved safe and 
effective, before scientists knew exactly what mechanism made them effective.

"People like to believe we know everything about approved drugs, but 
that's just not the case," she said.

Licensing special strain

Gedde, Maa and other doctors worry that dispensaries less careful 
than the Stanley brothers' Indispensary and Realm of Caring are 
promoting marijuana products with widely varied dosages of CBD. The 
Stanleys have theirs tested to calibrated milligrams in labs, Maa said.

Joel Stanley said publicity over Charlotte's Web adds to their 
waitinglists for the oil every day. They get requests from marijuana 
adventurers who want to try the oil for nonmedical reasons, Stanley 
said, but they restrict their limited supply to seizure patients.

The next step is licensing their special strain of high-CBD marijuana 
varieties to responsible growers in other states and countries, he said.

The Stanleys say they produce the oil at a loss, which they are 
willing to absorb. Joel Stanley sounds more exhausted by keeping up 
with production than worries over hyped medical claims.

"We're very objective. We're not a bunch of potheads. We're not 
making claims," he said. "We're simply sharing what we're seeing."


What's approved

Marijuana derivatives approved by the Food and Drug Administration 
for prescription drug use, including tablets for treating nausea and 
lack of appetite in cancer patients and other wasting diseases.

What may show promise

Proponents of marijuana medications, citing some mainstream lab 
research, say there are applications for derivatives with immune 
disorders, inflammation and psychotic mental illnesses.
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