Pubdate: Tue, 25 Feb 2014
Source: Chicago Tribune (IL)
Copyright: 2014 Chicago Tribune Company
Authors: Robert Mccoppin and Duaa Eldeib


They Tout Effective Epilepsy Treatment; Some Experts Wary

Nicole Gross was so desperate to find relief for her son's 
near-constant, debilitating seizures that she moved him from 
Naperville to Colorado so he could receive medical marijuana.

Weeks after Chase Gross, 8, started taking a marijuana oil extract 
through a dropper, his mother said she saw a dramatic decrease in the 
number of daily seizures he had, allowing him to make developmental 
leaps such as dressing himself and learning new sign language words, 
since his condition has left him unable to speak.

Gross became so convinced of pot's effectiveness in treating her 
son's severe epilepsy that she joined a growing number of parents and 
advocates lobbying Illinois to change its rules - not only to add 
epilepsy to the list of qualifying conditions but to make medical 
marijuana available to children, as Colorado and several other states do.

The drug's positive effects on Chase, his mother said, were "shocking."

Public opinion has been shifting in favor of medical marijuana: 
Twenty states have legalized it, and the vast majority allow children 
access to it.

But its use, particularly among juveniles, remains controversial.

Marijuana is illegal under federal law, where it is classified as a 
dangerous substance with no medical value.

While proponents cite largely anecdotal evidence as they lobby to 
expand the use of medicinal pot for a growing number of conditions, 
many physicians warn that there's not nearly enough research to 
demonstrate marijuana's effectiveness for treating sick adults - let 
alone children.

Dr. Kent Kelley, chief of pediatric neurology at North Shore 
University Health System's Evanston's hospital, treats several 
children who suffer from seizures and whose parents have asked him 
about marijuana as a last-resort option.

He said he advises them to wait and to seek out clinical trials for 
their children.

"It's a hard thing to ask parents. On the other hand, it may not be 
as good as we think, so we want data to know how effective it is and 
what the risks are," Kelley said.

He added that he would support the proposed change in the Illinois 
law but hopes more clinical research would take place first.

The American Academy of Pediatrics notes that while research on pot's 
potential therapeutic benefits is scarce, the drug's harmful effects 
on memory, motivation, judgment and motor control are well-known.

Dr. Sharon Levy, director of the Adolescent Substance Abuse Program 
at Boston Children's Hospital, said using state laws to sidestep 
federal medical regulations is bad public policy.

She noted that marijuana abuse remains common among her patients and 
that use during adolescence is associated with drops in IQ and 
increased rates of schizophrenia and other psychiatric disorders.

While there may be rare special cases that warrant exceptions to the 
rule, Levy said, drugs derived from the marijuana plant, called 
cannabinoids, should go through the same rigorous testing and 
approval process as every other drug to show that they work safely.

Otherwise, she said, children may be taking something that ends up 
doing more harm than good, particularly for conditions more common 
than extreme forms of epilepsy.

"Failing to develop cannabinoids as medication is a disservice to the 
kids who may benefit from them," she said.

"The answer is better regulation, not less of it."

Marijuana advocates counter that federal regulation has stood in the 
way of the very research that is needed.

The Drug Enforcement Administration classifies marijuana in the same 
category as it does heroin, as a Schedule I controlled substance with 
no accepted medical use and high potential for abuse.

Yet of the 38,000 people who died from drug overdoses in the U.S. in 
2010, according to the Centers for Disease Control and Prevention, 60 
percent were related to prescription drugs, while reported deaths 
from marijuana are extremely rare.

Advocates argue that children with debilitating, sometimes fatal 
diseases don't have time to wait for the years it typically takes the 
Food and Drug Administration to approve a new medication.

Many parents say they've already spent years giving their children 
prescription drugs that don't work or have horrible side effects and 
that they deserve access to other treatment options.

Before their struggle to help their son, Nicole and Randy Gross said 
they were the last people to support marijuana use.

Their feelings began to shift when they heard that other children 
with severe epilepsy were finding relief through marijuana.

Chase is thought to have myoclonic-astatic epilepsy, also called 
Doose syndrome, and his parents say that before he started ingesting 
marijuana, he would have hundreds of short seizures each day.

The oily extract they administer their son is low in THC - the 
psychoactive component of marijuana that causes smokers to get 
"stoned" - and high in CBD, or cannabidiol, which has shown promising 
results in animal studies.

That strain of marijuana is known as Charlotte's Web, named after 
5-year-old Charlotte Figi, who gained national attention last year 
when CNN reported that the drug had drastically reduced her severe seizures.

Though Charlotte previously could not walk, talk or feed herself, she 
is now doing all those things and riding a bike, according to her 
physician, Dr. Alan Shackelford, who also helped approve Chase for 
medical marijuana use.

But even advocates like Shackelford, who estimates he has seen about 
30 children being treated successfully with medical marijuana, agree 
that the drug needs clinical trials to establish proper and 
standardized content and dosing. However, he said, time is of the essence.

About 200 kids are registered in Colorado to receive medical 
marijuana, according to the Colorado Department of Public Health and 

Children need approval from two doctors, not just one as for adults.

Dr. Larry Wolk, the department's director and chief medical officer, 
said it appears that most of the children approved to use medical pot 
have epilepsy, and the majority come from out of state.

Yet children make up only a small fraction of medical marijuana 
patients, he said.

Wolk worries that the spotlight on children brings medical 
expectations that research has yet to support.

"It's possible that your child may not respond," Wolk said.

"And it's also possible that even if your child does respond, you 
might be trading treating the seizure for creating a different kind 
of problem."

Despite calls for broader legalization, FDA officials say not so 
fast. Spokeswoman Sandy Walsh said in an email that manufacturers and 
researchers must show new drugs to be safe and effective before 
they're marketed in the U.S.

Any efforts to bypass that process "would not serve the interests of 
public health because they might expose patients to unsafe and 
ineffective drug products," she wrote.

The FDA has approved two synthetic drugs to treat nausea, Marinol and 
Cesamet, which contain active ingredients found in marijuana, but 
neither was studied for children.

The National Organization for the Reform of Marijuana Laws reports 
that few patients like Marinol because of its high price, delayed 
onset and heightened psychoactivity.

In clinical trials, Cesamet was found safe and effective but also 
prompted adverse reactions such as moderate drowsiness, vertigo or 
euphoria, according to the National Institutes of Health.

Last year the FDA gave approval for five studies of 25 pediatric 
patients with severe epilepsy, each being treated with Epidiolex, a 
raspberry-lime syrup that has CBD but no THC. One of those clinical 
trials will be conducted at Lurie Children's Hospital in Chicago.

Lurie officials issued a statement saying that "the findings will 
then guide us on the best treatments available for children with epilepsy."

The maker of Epidiolex, GW Pharmaceuticals in London, also makes 
Sativex, a THC/CBD mix that has been approved for legal use in 25 
countries, generally for spasticity in multiple sclerosis patients. 
The company plans to seek FDA approval for both drugs.

Illinois, Delaware and Connecticut are the only states whose medical 
marijuana laws do not cover children, said Karen O'Keefe, the 
Marijuana Policy Project's director of state policies.

She said it is becoming much less controversial to include children 
and noted that the states that allow it often establish additional 

"I think any sentiment among a minority of otherwise supportive 
legislators that minors should be excluded has changed," O'Keefe said 
in an email.

"There are hundreds of parents who are desperate to quell their 
children's seizures, which can result in sudden death and can prevent 
them from walking, talking, and using the toilet."

Other groups also have started weighing in to support the medical 
uses of marijuana.

On Thursday, the nonprofit Epilepsy Foundation called for changing 
state laws to allow children to receive the drug for seizures.

It also called on the DEA to ease its classification of marijuana to 
promote its use in research, a move the agency has resisted.

The foundation estimates that 1 million people with epilepsy do not 
respond to conventional treatment and stated that "an end to seizures 
should not be determined by one's ZIP code."

In Illinois, state Sen. Iris Martinez is sponsoring a bill to add 
myoclonic-astatic epilepsy as a qualifying condition for medical 
marijuana and to add children as potential recipients for that condition alone.

She plans to have a committee hearing on the matter in March in hopes 
of passage this spring.

That would be the first change to the Illinois medical marijuana law, 
which took effect this year but is not expected to be fully 
implemented until next year.

Until the FDA takes action, Martinez said, "if this is going to bring 
some form of relief, we really need to look at this."

Randy Gross, Chase's father, said that after trying 10 pharmaceutical 
medications with little relief and sometimes serious side effects, 
Chase deserves the opportunity to use a drug that his parents assert 
is helping him.

"Every day lost is one that we can't get back to teach him the most 
basic of life skills," Randy Gross said. "We're at the end of our 
rope medically."

Margaret Storey, whose 10-year-old daughter Josie has Aicardi 
syndrome, a rare and debilitating seizure disorder, is hoping the 
bill passes. The Evanston mother said she's aware of the potential 
risks but said they've tried numerous medications and even implanted 
a nerve stimulation device to treat Josie's seizures. Nothing has 
worked, she said.

"From our point of view, (medical marijuana) just doesn't look that 
scary after what we've been through," said Storey, whose daughter is 
a patient of Kelley's at North Shore Evanston Hospital.

Storey and her husband, Jonathan Heller, have contemplated moving to 
Colorado or California to get treatment for Josie. They said they 
talked about everything it would entail - leaving their home and 
jobs, Josie's school, doctors, therapists, their entire support 
system - and said they're going to wait before making that decision.

"What I would love is for Illinois to change the law," Storey said, 
"and we wouldn't have to go anywhere."
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MAP posted-by: Jay Bergstrom