Jacob Redmond
Well-Known Member
For the first time, the FDA is teaming up with leading facilities, like Texas Children's Hospital, to find out if a new drug, made from a component in marijuana, will help the tough symptoms of epilepsy. In fact, Texas Children's is the only facility in Texas that is participating. It has the highest number of enrollees of any institute. Five or their patients are involved in a double-blind study using a liquid form called Epidiolex.
FOX 26 News spoke with the Director of the epilepsy program at Texas Children's, Dr. Angus Wilfong, who is one of the only people who has access to Epidiolex. This is not the type of marijuana the medical world has used before.
"The component from the marijuana plant is THC or Tetrohydrocannabidnol. It's what people use marijuana for to get high, and it has abuse potential, and it is against federal law to use THC. The product we're using in our research studies is called CBD or Cannabadiol. It's made by a pharmaceutical company, and it's regulated by the FDA to be purified, so when we give our patients the liquid form of Epidiolex, it has 100 mg per ml, we know that each ml of that product - has exactly 100 mg of CBD in it and doesn't have other contaminants in it," says Dr. Wilfong.
Researchers are conducting this clinical trial to find out if he can help patients, like six year old Izaiah Ruiz, who has a rare form of epilepsy called Dravet Syndrome. Patients with this type of epilepsy often endure hundreds of seizures each day, and they suffer from every type of seizure.
"It's very terrifying, because you don't know if that's going to be the last seizure or the last one that's going to take his life," explains Izaiah's grandmother, Lori Robinson.
Epilepsy is more prevalent than you may imagine.
"It's unbelievably common! One in 10 people will have a seizure in their life - 100 people will develop epilepsy. The lifetime risk of developing epilepsy for an individual is 1 in 26," exclaims Dr. Wilfong. He goes on to tell us that it is more prevalent than Multiple Sclerosis, Muscular Dystrophy, and Parkinson's Disease combined, yet it is more under-funded than any of those conditions. Dr. Wilfong explains that there are four different types of treatments for epilepsy, ranging from medication (thirty different ones) to surgery. He says some patient's families complain that side effects from medications are worse than the seizures. That's why many doctors and patients believe there is a drastic need for new treatments.
The hope of an effective treatment is a big deal for Izaiah's family. Lori and her husband are his grandparents and main caretakers. They're frustrated that they've received negative feedback from strangers (not their family and friends) about the prospect of this new drug, but she refuses to let it discourage them.
"People I don't know ask why I want to get him high. My response is - well first of all, I'm not going to get him high - you're thinking of the marijuana plant, and you're stigmatizing the plant. I don't care if it's a plant! I don't care what they call it, I am not getting my boy high," she exclaims.
The Robinsons were thinking about selling their home in the Houston, Texas area and moving to Colorado, after word that a child with epilepsy there was doing better after using medical marijuana. That involves a little girl named Charlotte, and the CBD oil they're using has been named Charlotte's Web.
"What we're using is different from Charlotte's Web, which is not a pharmaceutical grade product. That is a semi-purified form of plants that are grown and thought to be higher in CBD and lower in THC, but Charlotte's Web is not regulated by the FDA, it is not a pharmaceutical grade product, which what we're using is," explains Dr. Wilfong.
When Izaiah's doctor at Texas Children's told the Robinson's about their Compassion Investigation, that is safely monitored by the FDA, they jumped at the chance. The Robinsons will never know if Izaiah received a placebo or the "real deal", but they do know they've seen a shocking difference in him, so they believe he's been taking the actual drug. Since it's a double-blind study, their doctor doesn't even know if he has been taking the drug or a placebo. Lori feels strongly it's going to help her grandson. She literally protects him day and night, volunteering at his school and sleeping by his side, ready to jump into action during a medical crisis.
"We immediately lay him on the floor, we get the oxygen immediately because when you're having a "tonic clonic", everything in your body shuts down," she explains. They go through that several times every day. She hopes Epidiolex will stop it. So far, Dr. Wilfong says it's too early to say, but it's at least promising. "They all seemed to tolerate it well - no unusual or strange side effects. No one had dizziness, sleepiness, or vomiting. There weren't any worrisome changes on blood tests or those sorts of things," says Dr. Wilfong.
Lori says Izaiah's seizures were reduced to half the amount, during the study. She saw positive changes in his development as well. Her loving grandson is mentally more like a two year old, than a six year old.
"He has so much trapped in that little head that I know wants to come out," says Lori. The seizures make Izaiah "lose his words", and Lori hopes that will stop soon, since CBD is bringing them the first hope they've had in years. This first stage of the clinical trial is determining the correct dosage. Lori expects to get the "open label" of the drug prescribed for Izaiah in March.
News Moderator: Jacob Redmond 420 MAGAZINE ®
Full Article: Marijuana component providing new hope for Houston-area epilepsy - FOX 26 News | MyFoxHouston
Author: Melissa Wilson
Contact: Contact KRIV FOX 26 - FOX 26 News | MyFoxHouston
Photo Credit: None Found
Website: Home - FOX 26 News | MyFoxHouston
FOX 26 News spoke with the Director of the epilepsy program at Texas Children's, Dr. Angus Wilfong, who is one of the only people who has access to Epidiolex. This is not the type of marijuana the medical world has used before.
"The component from the marijuana plant is THC or Tetrohydrocannabidnol. It's what people use marijuana for to get high, and it has abuse potential, and it is against federal law to use THC. The product we're using in our research studies is called CBD or Cannabadiol. It's made by a pharmaceutical company, and it's regulated by the FDA to be purified, so when we give our patients the liquid form of Epidiolex, it has 100 mg per ml, we know that each ml of that product - has exactly 100 mg of CBD in it and doesn't have other contaminants in it," says Dr. Wilfong.
Researchers are conducting this clinical trial to find out if he can help patients, like six year old Izaiah Ruiz, who has a rare form of epilepsy called Dravet Syndrome. Patients with this type of epilepsy often endure hundreds of seizures each day, and they suffer from every type of seizure.
"It's very terrifying, because you don't know if that's going to be the last seizure or the last one that's going to take his life," explains Izaiah's grandmother, Lori Robinson.
Epilepsy is more prevalent than you may imagine.
"It's unbelievably common! One in 10 people will have a seizure in their life - 100 people will develop epilepsy. The lifetime risk of developing epilepsy for an individual is 1 in 26," exclaims Dr. Wilfong. He goes on to tell us that it is more prevalent than Multiple Sclerosis, Muscular Dystrophy, and Parkinson's Disease combined, yet it is more under-funded than any of those conditions. Dr. Wilfong explains that there are four different types of treatments for epilepsy, ranging from medication (thirty different ones) to surgery. He says some patient's families complain that side effects from medications are worse than the seizures. That's why many doctors and patients believe there is a drastic need for new treatments.
The hope of an effective treatment is a big deal for Izaiah's family. Lori and her husband are his grandparents and main caretakers. They're frustrated that they've received negative feedback from strangers (not their family and friends) about the prospect of this new drug, but she refuses to let it discourage them.
"People I don't know ask why I want to get him high. My response is - well first of all, I'm not going to get him high - you're thinking of the marijuana plant, and you're stigmatizing the plant. I don't care if it's a plant! I don't care what they call it, I am not getting my boy high," she exclaims.
The Robinsons were thinking about selling their home in the Houston, Texas area and moving to Colorado, after word that a child with epilepsy there was doing better after using medical marijuana. That involves a little girl named Charlotte, and the CBD oil they're using has been named Charlotte's Web.
"What we're using is different from Charlotte's Web, which is not a pharmaceutical grade product. That is a semi-purified form of plants that are grown and thought to be higher in CBD and lower in THC, but Charlotte's Web is not regulated by the FDA, it is not a pharmaceutical grade product, which what we're using is," explains Dr. Wilfong.
When Izaiah's doctor at Texas Children's told the Robinson's about their Compassion Investigation, that is safely monitored by the FDA, they jumped at the chance. The Robinsons will never know if Izaiah received a placebo or the "real deal", but they do know they've seen a shocking difference in him, so they believe he's been taking the actual drug. Since it's a double-blind study, their doctor doesn't even know if he has been taking the drug or a placebo. Lori feels strongly it's going to help her grandson. She literally protects him day and night, volunteering at his school and sleeping by his side, ready to jump into action during a medical crisis.
"We immediately lay him on the floor, we get the oxygen immediately because when you're having a "tonic clonic", everything in your body shuts down," she explains. They go through that several times every day. She hopes Epidiolex will stop it. So far, Dr. Wilfong says it's too early to say, but it's at least promising. "They all seemed to tolerate it well - no unusual or strange side effects. No one had dizziness, sleepiness, or vomiting. There weren't any worrisome changes on blood tests or those sorts of things," says Dr. Wilfong.
Lori says Izaiah's seizures were reduced to half the amount, during the study. She saw positive changes in his development as well. Her loving grandson is mentally more like a two year old, than a six year old.
"He has so much trapped in that little head that I know wants to come out," says Lori. The seizures make Izaiah "lose his words", and Lori hopes that will stop soon, since CBD is bringing them the first hope they've had in years. This first stage of the clinical trial is determining the correct dosage. Lori expects to get the "open label" of the drug prescribed for Izaiah in March.
News Moderator: Jacob Redmond 420 MAGAZINE ®
Full Article: Marijuana component providing new hope for Houston-area epilepsy - FOX 26 News | MyFoxHouston
Author: Melissa Wilson
Contact: Contact KRIV FOX 26 - FOX 26 News | MyFoxHouston
Photo Credit: None Found
Website: Home - FOX 26 News | MyFoxHouston
