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Kentuckian Rita Wooton of Hyden has tearfully shared the story of son Eli's frequent seizures – and the promise of marijuana oil to treat it – with dozens of people, ranging from doctors to journalists to legislators. Earlier this year, her story helped persuade the Kentucky General Assembly to unanimously – and somewhat speedily – pass a bill approving the first medicinal use of marijuana in Kentucky. But now doctors and researchers are saying it could take years to begin trials treating epileptic children such as Eli with marijuana oil.
"We're really, really heartbroken," Wooton said. "It's just really sad that everyone put that much time and effort and energy into it and now it's going absolutely nowhere. For people like us and Eli, who have intractable epilepsy, seizures that are nearly impossible to even control or get a handle on, our hope is gone." Some of issues stalling the trials are the availability of marijuana oil, the possible need for approval from the Food and Drug Administration and the cost of studiesthat preliminary estimates say could be $10,000 per participant.
Still, doctors hoping to conduct the trials are optimistic. "I am extremely excited about it," University of Louisville Dr. Karen Skjei, who specializes in pediatric epilepsy, said, citing anecdotal reports of the medicine reducing seizures where traditional medications, diets and surgery can't. Supporters say the oil, administered under the tongue, can provide relief to children who have severe cases of epilepsy. The oil contains low amounts of THC, the perception-altering ingredient in marijuana.
"I suspect that it probably won't live up 100 percent to the hype," Skjei said, but for some, " it could be a life changing experience. ... (F)or these kids who have no other options, we have to remain optimistic." Senate Bill 124, sponsored by Louisville Republican Julie Denton, allows trials of marijuana oil at the Universities of Louisville and Kentucky medical schools or through FDA trials. Winning legislative approval for the bill is "just the initial part of the puzzle," said U of L Dr. Christopher Shafer, who specializes in adult epilepsy.
Shafer and Skjei said there will be no problem finding participants for the trial they are working to develop at U of L. Shafer said three of the five patients he saw in one day last week wanted to try the medication. "Dr Skjei and I want this for our patients, probably, almost as badly as the patients want it themselves," Shafer said. "And it's really discouraging for us to be not be able to tell them that we have it available. ... It's going to take some time."
A UK spokesman expressed the same concerns. "While there is certainly interest in this initiative, there are significant issues that remain to be addressed," spokesman Jay Blanton said. "Additional research, the securing of funding and support, as well as support from the appropriate regulatory body, all would be required before a trial could be conducted. That process could likely take months, if not years."
Though the universities discussed collaborating, they've decided to conduct separate trials because more than enough patients are available and there's fear that coordination between the two would slow the study, the U of L doctors said. "I think in the interest of our patients, we've decided to just keep it local and try and push it through as quickly as we can," Skjei said.
On 'front lines'
Details of the U of L trial are still being determined, but researchers say they'd like to use an equal sampling of adults and children. It would involve several phases, including one where doctors would give half of the patients the oil and the other half a placebo before switching. The final phase of the study would be another year where all the patients get the oil.
Candidates could include children who are seizing dozens of times daily, have tried 10-plus medications and whose surgery didn't work or who weren't candidates for surgery, Skjei said. The new state law doesn't specify age limits on patients but testimony before the legislature focused almost exclusively on young children because severe seizures in children are so much worse than in adults, Skjei said. Children "can be so incredibly debilitated by their seizures. ... and sometimes these kids don't even make it into adulthood. ... We are seeing the sickest of the sickest on the pediatric front lines that the possibility of something to help these children is just incredible," she said. That doesn't mean the drug wouldn't have value in adults, Shafer said. Limited data from the 1970s says it would. "I don't see any reason why it couldn't," he said.
Restrictions, cost
Currently, marijuana oil isn't being manufactured in Kentucky, and there are numerous hurdles to consider when shipping it across state lines. Discussions are ongoing with pharmaceutical companies and others – including a meeting next week with West Coast businessmen – about possibly setting up a Kentucky dispensary, Skjei said.
"As of right now, there's really nowhere to get it," she said. Currently, there is an FDA-approved trial for use of the oil in GW Pharmaceuticals' Epidiolex, but only for two types of epilepsy, Dravet and Lennox-Gastaut syndromes. Skjei fears that would be too limiting. "I have so many kids who are refractory and I would just feel horrible if I could only give it out to some kids based on their genetic syndrome and not others," she said. The researchers are unsure of whether any hemp grown in Kentucky – which is supposed to be going in the ground this year in pilot projects – could provide oil for patients.
Then there's the issue of the FDA itself.
Skjei said she and Shafer hope the FDA would accept existing data related to multiple sclerosis and other disorders regarding the safety of marijuana oil that would clear the way for the advanced trials U of L is considering. Skjei said trials could be done without the FDA approval, but doctors would have to have the oil. Lastly, there's the cost, which Skjei said is dependent on the study's structure, timing of phases and number of subjects. If the study had 60 patients, Skjei said, "then that's an awful lot of money right there." Shafer said he hears patients wanting to try marijuana oil – some of whom he says are willing to take out a second mortgage to get it over the Internet – in any study.
"I feel their desperation," Shafer said, adding he wishes U of L could start prescribing it tomorrow. "Everybody who asks me about it, I'm keeping a list and I have a long list already." Skjei said, "I still have patients that are talking about moving to Colorado," where marijuana is legal, "because they understand it's going to be awhile before this is up and running," For now, the Wootons are trying other potentialremedies, such as lavender oil on Eli's temples, forehead and neck, and controlling his diet in an effort to limit seizures. She's considered going to Colorado, but doesn't believe there will be any oil available there until after this year's fall harvest.
"And people like us just don't have the extra money to travel to do that," Wooton said, adding that there's still the risk of transporting the medication across state lines. "It's heartbreaking as a mommy to see my son suffer with seizures when we were hoping – all we needed was a little bit of oil a few times a day to make him healthy and better and function better and have a normal life – whatever normal's supposed to be."
News Moderator - The General @ 420 MAGAZINE ®
Source: Courier-journal.com
Author: Gregory A. Hall, and Gregory A. Hall
Contact: Contact | Louisville Courier Journal
Website: Marijuana oil trials in Kentucky could be years away
"We're really, really heartbroken," Wooton said. "It's just really sad that everyone put that much time and effort and energy into it and now it's going absolutely nowhere. For people like us and Eli, who have intractable epilepsy, seizures that are nearly impossible to even control or get a handle on, our hope is gone." Some of issues stalling the trials are the availability of marijuana oil, the possible need for approval from the Food and Drug Administration and the cost of studiesthat preliminary estimates say could be $10,000 per participant.
Still, doctors hoping to conduct the trials are optimistic. "I am extremely excited about it," University of Louisville Dr. Karen Skjei, who specializes in pediatric epilepsy, said, citing anecdotal reports of the medicine reducing seizures where traditional medications, diets and surgery can't. Supporters say the oil, administered under the tongue, can provide relief to children who have severe cases of epilepsy. The oil contains low amounts of THC, the perception-altering ingredient in marijuana.
"I suspect that it probably won't live up 100 percent to the hype," Skjei said, but for some, " it could be a life changing experience. ... (F)or these kids who have no other options, we have to remain optimistic." Senate Bill 124, sponsored by Louisville Republican Julie Denton, allows trials of marijuana oil at the Universities of Louisville and Kentucky medical schools or through FDA trials. Winning legislative approval for the bill is "just the initial part of the puzzle," said U of L Dr. Christopher Shafer, who specializes in adult epilepsy.
Shafer and Skjei said there will be no problem finding participants for the trial they are working to develop at U of L. Shafer said three of the five patients he saw in one day last week wanted to try the medication. "Dr Skjei and I want this for our patients, probably, almost as badly as the patients want it themselves," Shafer said. "And it's really discouraging for us to be not be able to tell them that we have it available. ... It's going to take some time."
A UK spokesman expressed the same concerns. "While there is certainly interest in this initiative, there are significant issues that remain to be addressed," spokesman Jay Blanton said. "Additional research, the securing of funding and support, as well as support from the appropriate regulatory body, all would be required before a trial could be conducted. That process could likely take months, if not years."
Though the universities discussed collaborating, they've decided to conduct separate trials because more than enough patients are available and there's fear that coordination between the two would slow the study, the U of L doctors said. "I think in the interest of our patients, we've decided to just keep it local and try and push it through as quickly as we can," Skjei said.
On 'front lines'
Details of the U of L trial are still being determined, but researchers say they'd like to use an equal sampling of adults and children. It would involve several phases, including one where doctors would give half of the patients the oil and the other half a placebo before switching. The final phase of the study would be another year where all the patients get the oil.
Candidates could include children who are seizing dozens of times daily, have tried 10-plus medications and whose surgery didn't work or who weren't candidates for surgery, Skjei said. The new state law doesn't specify age limits on patients but testimony before the legislature focused almost exclusively on young children because severe seizures in children are so much worse than in adults, Skjei said. Children "can be so incredibly debilitated by their seizures. ... and sometimes these kids don't even make it into adulthood. ... We are seeing the sickest of the sickest on the pediatric front lines that the possibility of something to help these children is just incredible," she said. That doesn't mean the drug wouldn't have value in adults, Shafer said. Limited data from the 1970s says it would. "I don't see any reason why it couldn't," he said.
Restrictions, cost
Currently, marijuana oil isn't being manufactured in Kentucky, and there are numerous hurdles to consider when shipping it across state lines. Discussions are ongoing with pharmaceutical companies and others – including a meeting next week with West Coast businessmen – about possibly setting up a Kentucky dispensary, Skjei said.
"As of right now, there's really nowhere to get it," she said. Currently, there is an FDA-approved trial for use of the oil in GW Pharmaceuticals' Epidiolex, but only for two types of epilepsy, Dravet and Lennox-Gastaut syndromes. Skjei fears that would be too limiting. "I have so many kids who are refractory and I would just feel horrible if I could only give it out to some kids based on their genetic syndrome and not others," she said. The researchers are unsure of whether any hemp grown in Kentucky – which is supposed to be going in the ground this year in pilot projects – could provide oil for patients.
Then there's the issue of the FDA itself.
Skjei said she and Shafer hope the FDA would accept existing data related to multiple sclerosis and other disorders regarding the safety of marijuana oil that would clear the way for the advanced trials U of L is considering. Skjei said trials could be done without the FDA approval, but doctors would have to have the oil. Lastly, there's the cost, which Skjei said is dependent on the study's structure, timing of phases and number of subjects. If the study had 60 patients, Skjei said, "then that's an awful lot of money right there." Shafer said he hears patients wanting to try marijuana oil – some of whom he says are willing to take out a second mortgage to get it over the Internet – in any study.
"I feel their desperation," Shafer said, adding he wishes U of L could start prescribing it tomorrow. "Everybody who asks me about it, I'm keeping a list and I have a long list already." Skjei said, "I still have patients that are talking about moving to Colorado," where marijuana is legal, "because they understand it's going to be awhile before this is up and running," For now, the Wootons are trying other potentialremedies, such as lavender oil on Eli's temples, forehead and neck, and controlling his diet in an effort to limit seizures. She's considered going to Colorado, but doesn't believe there will be any oil available there until after this year's fall harvest.
"And people like us just don't have the extra money to travel to do that," Wooton said, adding that there's still the risk of transporting the medication across state lines. "It's heartbreaking as a mommy to see my son suffer with seizures when we were hoping – all we needed was a little bit of oil a few times a day to make him healthy and better and function better and have a normal life – whatever normal's supposed to be."
News Moderator - The General @ 420 MAGAZINE ®
Source: Courier-journal.com
Author: Gregory A. Hall, and Gregory A. Hall
Contact: Contact | Louisville Courier Journal
Website: Marijuana oil trials in Kentucky could be years away
