Pubdate: Sun, 16 Aug 2015
Source: Chicago Tribune (IL)
Copyright: 2015 Chicago Tribune Company
Author: Robert McCoppin


Hank Kovach's experience mirrors the recent success stories of other 
children with drug-resistant epilepsy.

Wracked by frequent, daily seizures that delayed his brain 
development, the 7-year-old Chicago boy was unable to speak, learn 
much or even sleep without waking up in tears after an hour or two. 
Conventional drugs didn't help much.

But after he began using a marijuana extract last year, his parents 
said, they were astounded when Hank went six months without a 
seizure. He began uttering sounds, learning numbers and colors, and, 
for the first time, sleeping through the night.

"This has been life-changing for our family," said his mother, Megan 
Turner. "We can actually see Hank be a happy little boy again."

Hank's story differs, though, from similar tales of patients treated 
through state medical pot programs; Hank was part of a clinical trial 
authorized by the federal government and conducted by a respected 
medical institution, Lurie Children's Hospital of Chicago.

Lurie is taking part in what is believed to be the first clinical 
trial in the U.S. of cannabidiol, an oil extracted from pot that 
contains none of the THC that gets users high. Though further study 
is needed, preliminary results showed it cut seizures in half for patients.

With Illinois on the verge of making medical marijuana available to 
those who suffer from any of about 40 medical conditions, including 
epilepsy, doctors, patients and legislators are closely watching the 
results of Lurie's trial.

For years, advocates and critics of medical pot have agreed that much 
more study needs to be done on its effects. Federal law, which 
classifies marijuana as being as dangerous as heroin, has made it 
difficult to conduct research. Now, the U.S. Food and Drug 
Administration is considering fast-track approval for the cannabidiol 
Epidiolex, and Lurie is part of a nationwide trial of its effectiveness.

Even as about half the states now allow medical pot, controversy over 
its efficacy remains. A recent review analyzed dozens of scientific 
studies on the effectiveness of medical marijuana. The report found 
that while some studies showed pot to be effective for treating 
maladies such as chronic pain and muscle spasticity, the results of 
other studies pointing to pot's effectiveness were overstated.

To address such concerns, the current phase of the Lurie trial is 
using the gold standard of medical research: a randomized, 
double-blind, placebo-controlled study. That means that neither 
doctors nor patients know who is getting the drug and who is getting 
an impostor oil with no medical effect.

Hank was among 25 patients who began receiving Epidiolex, distributed 
by dropper, at Lurie last summer in the first phase of the trial to 
test the drug's safety. Though reports of side effects were minimal, 
6 percent of participants nationwide dropped out because of side 
effects including drowsiness.

The current phase of the study, conducted at hospitals across the 
country, involves up to about 500 children and adults with rare and 
catastrophic forms of epilepsy. London-based GW Pharmaceuticals, 
which makes the drug, plans to get the final results by early next 
year and apply to the FDA for the drug's use by prescription in mid-2016.

Dr. Linda Laux, who leads the study at Lurie, reported that patients 
had better concentration, sleep and behavior, and some became more 
verbal and showed better coordination.

"The (preliminary) study was very promising," she said. "It was 
enough to go forward with medical trials for FDA approval."

GW Pharmaceuticals already sells Sativex - a 50-50 mix of cannabidiol 
and THC, used to treat spasticity in people with multiple sclerosis - 
in 27 countries, but that's also not yet approved in the U.S.

Epidiolex is much more reliable than the cannabis found in many state 
medical pot programs because it is going through the FDA-approval 
process and because each dose is standardized so patients know what 
they're getting, GW spokesman Stephen Schultz said.

A study published in June in the Journal of the American Medical 
Association found discrepancies between what edible marijuana product 
labels stated and the actual content. Lab tests of marijuana products 
from dispensaries in California and Washington found that only 17 
percent were accurately labeled for THC and cannabidiol.

"There are so many question marks around the use of dispensary 
products that the ultimate solution we believe is an FDA-approved 
pharmaceutical medicine," Schultz said. "So you know what you take 
today is the same medicine you'll take a year from now, with full 
dosing instructions you can count on."

Parents of patients in the Lurie study who spoke to the Tribune 
support the state medical marijuana program, though they won't have 
to participate because they may keep receiving the raspberry-flavored 
Epidiolex syrup through the hospital.

One of those patients is Katie Dysart, a 12-year-old girl from out of 
state who suffered severely debilitating seizures known as Doose syndrome.

Shortly after Katie started taking a teaspoon of Epidiolex twice 
daily, there was a dramatic reduction in her seizures, from several a 
week to one every couple of months, said her mother, Elizabeth 
Dysart. Katie made big strides in reading and vocabulary, and 
personal interactions.

"We can't believe it. The doctors can't believe it," Dysart said. 
"Everybody's just amazed at this child that has emerged. ... Now we 
have hope she eventually will be the person she was created to be."
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