Pubdate: Sun, 26 Jan 2014
Source: Boston Globe (MA)
Copyright: 2014 Globe Newspaper Company
Contact: http://services.bostonglobe.com/news/opeds/letter.aspx?id=6340
Website: http://bostonglobe.com/
Details: http://www.mapinc.org/media/52
Author: Kay Lazar

CHILDREN WITH EPILEPSY WAITING FOR MEDICAL MARIJUANA

Could Be an Answer for Affliction, but It's Not Here Yet

Seventeen medications during the past four years have failed to quell 
the haywire electrical signals in Haley Osborn's brain that send her 
young body into convulsions dozens of times a day.

The 7-year-old climbs into bed at night with her service dog, Sofie, 
a border collie mix trained to push an alarm with her nose when the 
seizures start, summoning Haley's parents. The dog then gently lays 
her body over Haley to protect her from hurting herself.

Now Jill and Arthur Osborn of Georgetown would dearly love to have 
their daughter try marijuana, after hearing that it helped children 
in Colorado with severe, unrelenting seizures. But more than a year 
after voters approved legalizing marijuana for medical use in 
Massachusetts, Haley and hundreds of other children with severe 
epilepsy are still waiting to get the drug.

Dispensaries authorized to sell marijuana are not expected to open 
until this summer at the earliest; the state is expected to award the 
first 35 licenses this week, but it will take months more for the 
chosen companies to grow their products and negotiate with local 
authorities for building and other permits. Even then, there is no 
guarantee the stores will stock the strain of marijuana believed to 
help prevent seizures, and federal law prohibits families from having 
the drug shipped to their homes from other states where it is legally 
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"We are desperate to help our daughter, and running into obstacles at 
every turn," said Jill Osborn. In the interim, Haley wears a padded 
helmet to protect her head during seizures, and attends school only 
part-time, with a nurse at her side.

In November, when Haley was hospitalized for an uncontrollable 
seizure, and physicians considered putting her into a 
medically-induced coma for the second time in her short life, the 
Osborns thought about packing up and moving to Colorado to get 
marijuana specially grown for people with epilepsy.

"We don't think we should have to uproot our medically fragile child 
and our whole support team to go there," Jill Osborn said. "We 
shouldn't be limited because of geography."

Marijuana is promoted as a treatment for a long list of ailments, 
though few rigorous studies have been done to show it works. For 
children with epilepsy, however, the evidence of marijuana's benefits 
is slowly accumulating. A handful of small studies have suggested 
that one primary ingredient of marijuana, cannabidiol, or CBD, might 
reduce the frequency of seizures, and a study starting soon at 
MassGeneral Hospital for Children and four other hospitals nationally 
will test CBD on young patients who have seizures that are not 
controlled by traditional drugs.

Unlike THC, the ingredient that causes marijuana's high," CBD is 
nonpsychoactive, and it has captured widespread attention amid 
anecdotal reports that it has helped tame seizures in children in 
Colorado and California.

Many of the medications available for children with epilepsy have 
severe side effects that can impair their development, memory, 
behavior, and mood, so parents have become desperate to get marijuana 
for their children.

"Haley has tried every medicine on the market, as well as steroids, 
as well as a modified [anti-epilepsy] diet. She is kind of out of 
options," said Dr. Ronald Thibert, a pediatric epilepsy specialist at 
Mass. General who treats Haley.

"For kids like her," Thibert said, "even if we don't know all the 
effects of CBD, the other alternatives are not great."

Mass. General treats more than 2,000 children with epilepsy who have 
seizures that are resistant to medications, but federal regulators 
have authorized the CBD study to enroll only 25 children at each 
site. The Osborns are hopeful that Haley will be among the chosen few.

The one-year study is primarily testing whether a drug called 
Epidiolex, manufactured by a British company that extracts the CBD 
from marijuana, is safe for use in children and whether it has side effects.

A secondary goal will be to measure whether Epidiolex eases 
intractable seizures. About one-third of patients with epilepsy are 
not able to control their seizures with drugs or surgery, according 
to the National Institutes of Health. As many as 8,500 Massachusetts 
children are estimated to have such uncontrollable seizures.

For the many children who will not be selected for the study, another 
challenge will be getting physicians to sign a form certifying them 
to legally purchase marijuana for medical use. State law requires one 
physician certification for adults, and two for children.

Haley's mother has secured one signature from her daughter's longtime 
pediatrician, but the Mass. General specialists who treat Haley have 
hesitated, in part because their hospital has not yet developed a 
policy on the issue, said Dr. Elizabeth Thiele, director of Mass. 
General's pediatric epilepsy program.

"The problem in signing the forms is, we won't necessarily know what 
our patients will be getting," she said, noting that there is 
"significant variability" among medical marijuana preparations.

Massachusetts' medical marijuana rules are considered more stringent 
than many other states', requiring dispensaries to have an 
independent lab test their products for contaminants such as 
pesticides and mold, and for potency, but there is no mandate that 
store personnel have the expertise to match a patient's specific 
illness with the strain of marijuana most likely to be of benefit.

When dispensary doors finally open, it is not clear how many will 
sell marijuana rich in CBD. Andrew DeAngelo, director of operations 
at Harborside Health Center, a large California marijuana dispensary 
that carries CBD-rich products, said he is unlikely to initially grow 
such strains in Massachusetts if he wins one of the coveted 
dispensary licenses. He hopes to open in Suffolk County.

"I have to start a production facility in Massachusetts, and it has 
to be able to pay for itself," DeAngelo said. "So I have to grow 
things I know I will be able to sell, and most people who come into a 
dispensary are looking for THC, not CBD.

He said cancer patients, for instance, typically benefit from strains 
with higher concentrations of THC.

But at least one dispensary applicant said he is committed to growing 
marijuana that might help Haley and other children with seizures.

"We are not worried about the small, added cost to growing strains 
that are not in high demand," said Brandon Tarricone, chief executive 
of Medicinal Evolution, which intends to open in Essex County, if 
granted a license.

Tarricone has been consulting with Haley's mother, who has been 
researching CBD strains in other states as she awaits word on whether 
Haley has been chosen for the Mass. General study.

"I am not the kind of person who is going to sit back and wait for 
this to happen for us," Jill Osborn said. "I am a mom, and that 
trumps everything."
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