Jacob Redmond
Well-Known Member
More than half of the Utah children with epilepsy who are trying an experimental marijuana extract are having significantly fewer seizures, a University of Utah pediatrics expert told lawmakers Wednesday.
The U., working with Primary Children's Hospital, is one of 11 sites approved by the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) to test Epidiolex – a purified form of cannabidiol, or CBD. CBD comes from marijuana plants, but it is not the chemical that gives users a high.
The Utah Legislature earlier gave the go-ahead for the trial. It also created a registry so that families of the estimated 1,500 children with intractable epilepsy in Utah can legally import hemp extracts. As of June, 84 cards had been issued by the Department of Health. No other patients can qualify for the cards.
Ed Clark, head of pediatrics at the U., was testifying at the most in-depth legislative hearing yet on medical marijuana. He was joined by three adults suffering from various ailments that could be eased by cannabis, as well as the father of a 4-year-old girl with Dravet syndrome, a particularly serious form of epilepsy. The girl has had fewer seizures since she began using a hemp extract shipped in from Colorado, he said.
The Health and Human Services Interim Committee also got a preview of how contentious the issue will be as it considers a bill being drafted for next session by Sen. Mark Madsen, R-Saratoga Springs, which would allow broader use of medical marijuana in Utah. Sen. Evan Vickers, R-Cedar City, co-chairman of the committee, announced Wednesday that he and Rep. Brad Daw, R-Orem, also plan a more modest proposal for an expansion.
Kevin Sabet of the national organization Smart Approaches to Marijuana gave a lengthy presentation urging Utah to back away from medical marijuana and instead wait for Congress to pass a compassionate-use law.
Connor Boyack of Utah's Libertas Institute, a proponent of medical marijuana, accused Sabet of smearing medical marijuana proponents and spreading "inaccurate propaganda."
That prompted Sabet to say he'd never been so disrespected. He also suggested the committee consider that major medical associations also urge caution.
Clark, from the U., noted that researchers are still crunching the data from the research underway at the U. and Primary Children's Hospital. That will take another six months.
"It is an encouraging study and it is the first step in a very long process," Clark said.
Whether – and when – the FDA will approve Epidiolex is unknown, he said.
The U. has spent $100,000 so far, and would like to expand it "tenfold" from the 25 patients now in the study. The university would need more money to do so, he said.
The first study involves giving 25 children daily doses of Epidiolex, with the parents reporting their responses for 12 weeks.
While more than half have had fewer seizures, some children have had minor side effects, such as sleeping problems or diarrhea, Clark said. At another study site, however, a child suffered liver failure, he said. "This is not a perfectly safe pharmaceutical," he said.
Among the Utah children, one did not have a single seizure during the 12 weeks of treatment, Clark said.
The U. also has begun a double-blind study involving the use of Epidiolex in three children with Dravet syndrome, and it plans a double-blind study for eight children with Lennox-Gastaut, another form of epilepsy. In a double-blind study, neither the patient nor the medical provider know which patient is getting the tested drug and which is getting a placebo.
Epidiolex is made by GW Pharmaceuticals, based in London.
The DEA had to sign off on the research project, and it has already audited the U. to ensure compliance with provisions of its agreement, Clark said.
News Moderator: Jacob Redmond 420 MAGAZINE ®
Full Article: Utah medical marijuana study 'encouraging' for children with epilepsy | The Salt Lake Tribune
Author: Kristen Moulton
Contact: Staff - The Salt Lake Tribune: Utah News, Sports and Weather
Photo Credit: AP Photo/Rick Bowmer
Website: Utah Local News - Salt Lake City News, Sports, Entertainment, Business - The Salt Lake Tribune
The U., working with Primary Children's Hospital, is one of 11 sites approved by the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) to test Epidiolex – a purified form of cannabidiol, or CBD. CBD comes from marijuana plants, but it is not the chemical that gives users a high.
The Utah Legislature earlier gave the go-ahead for the trial. It also created a registry so that families of the estimated 1,500 children with intractable epilepsy in Utah can legally import hemp extracts. As of June, 84 cards had been issued by the Department of Health. No other patients can qualify for the cards.
Ed Clark, head of pediatrics at the U., was testifying at the most in-depth legislative hearing yet on medical marijuana. He was joined by three adults suffering from various ailments that could be eased by cannabis, as well as the father of a 4-year-old girl with Dravet syndrome, a particularly serious form of epilepsy. The girl has had fewer seizures since she began using a hemp extract shipped in from Colorado, he said.
The Health and Human Services Interim Committee also got a preview of how contentious the issue will be as it considers a bill being drafted for next session by Sen. Mark Madsen, R-Saratoga Springs, which would allow broader use of medical marijuana in Utah. Sen. Evan Vickers, R-Cedar City, co-chairman of the committee, announced Wednesday that he and Rep. Brad Daw, R-Orem, also plan a more modest proposal for an expansion.
Kevin Sabet of the national organization Smart Approaches to Marijuana gave a lengthy presentation urging Utah to back away from medical marijuana and instead wait for Congress to pass a compassionate-use law.
Connor Boyack of Utah's Libertas Institute, a proponent of medical marijuana, accused Sabet of smearing medical marijuana proponents and spreading "inaccurate propaganda."
That prompted Sabet to say he'd never been so disrespected. He also suggested the committee consider that major medical associations also urge caution.
Clark, from the U., noted that researchers are still crunching the data from the research underway at the U. and Primary Children's Hospital. That will take another six months.
"It is an encouraging study and it is the first step in a very long process," Clark said.
Whether – and when – the FDA will approve Epidiolex is unknown, he said.
The U. has spent $100,000 so far, and would like to expand it "tenfold" from the 25 patients now in the study. The university would need more money to do so, he said.
The first study involves giving 25 children daily doses of Epidiolex, with the parents reporting their responses for 12 weeks.
While more than half have had fewer seizures, some children have had minor side effects, such as sleeping problems or diarrhea, Clark said. At another study site, however, a child suffered liver failure, he said. "This is not a perfectly safe pharmaceutical," he said.
Among the Utah children, one did not have a single seizure during the 12 weeks of treatment, Clark said.
The U. also has begun a double-blind study involving the use of Epidiolex in three children with Dravet syndrome, and it plans a double-blind study for eight children with Lennox-Gastaut, another form of epilepsy. In a double-blind study, neither the patient nor the medical provider know which patient is getting the tested drug and which is getting a placebo.
Epidiolex is made by GW Pharmaceuticals, based in London.
The DEA had to sign off on the research project, and it has already audited the U. to ensure compliance with provisions of its agreement, Clark said.
News Moderator: Jacob Redmond 420 MAGAZINE ®
Full Article: Utah medical marijuana study 'encouraging' for children with epilepsy | The Salt Lake Tribune
Author: Kristen Moulton
Contact: Staff - The Salt Lake Tribune: Utah News, Sports and Weather
Photo Credit: AP Photo/Rick Bowmer
Website: Utah Local News - Salt Lake City News, Sports, Entertainment, Business - The Salt Lake Tribune
