The Florida Department of Health has announced a grant that will allow researchers at the University of Florida to study the safety and efficacy of using cannabidiol as a therapy for treating childhood epilepsy. The grant was made in accordance with Florida’s Compassionate Medical Cannabis Act and dedicates $1 million to cannabidiol (CBD) research at the university.
The decision to fund the research achieved support following a thorough inspection of peer-reviewed science previously generated in the research community. Dr. John Armstrong, Florida’s Surgeon General and Secretary of Health, said of the grant:
“This funding helps Florida’s families dealing with severe childhood epilepsy to have access to an investigational cannabidiol medication as researchers work to answer important questions about the effect of this medication.”
In accordance with Florida law, researchers and patients who elect to participate in cannabidiol studies will be required to gain FDA approval and adhere to the FDA’s Expanded Access program protocols which govern the use of investigational new drugs. The University of Florida’s research is intended to examine the effects of cannabidiol in children whose epilepsy has not responded to a majority of the current FDA-approved drug therapies for the disease. Cannabidiol will be used in conjunction with conventional therapies for controlling epilepsy, a disorder that affects the daily quality of life for children and their parents and may be fatal in some instances.
Florida State Senator Rob Bradley and State Representative Matt Gaetz released separate statements praising the Florida Department of Health’s decision to fund cannabidiol research. Gaetz said of the grant:
“I’m grateful for the Florida Department of Health’s continued efforts to ensure children with intractable epilepsy have access to a safe, effective product.”
The “Medical Cannabidiol Act,” signed by Iowa Gov. Terry Branstad in May of last year, took effect on July 1, 2014. This limited medical marijuana legislation protects patients suffering from only one form of epilepsy and their caregivers from facing prosecution for possessing the form of medical marijuana known as cannabidiol (CBD) oil.
As of January 2015, the Iowa Department of Public Health has not issued a single medical marijuana identification card. This means that zero patients have been helped from the enactment of this restrictive law.
Under the Medical Cannabidiol Act, only patients suffering from intractable epilepsy are permitted to use only the non-psychoactive cannabinoid known as CBD, in the form of oil. This medicine must contain less than 3 percent of the psychoactive cannabinoid THC. Not only does this legislation seriously restrict who can use cannabis therapy, it also does not allow for the CBD oil to be produced or manufactured in the state. This means that even if a patient is able to qualify for the Iowa medical marijuana program, he or she would be forced to obtain their medicine on the black market.
One of the parents of a boy with intractable epilepsy, who advocated for this law, Maria La France explained her fear of using CBD oil to the quad city times,
“It’s just too dangerous. It’s too scary to break the law, too difficult to lose sleep at night. I frankly spend enough time worrying if my child is going to live another week. I have experimented … I don’t want to say anything that’ll get me arrested or in jail. I don’t want a lynch mob. Who would take care of him if I got arrested.”
La France did obtain a medical marijuana card for her son in Colorado last year, but she let it expire out of fear of prosecution. Even if she kept the Colorado medical marijuana card up to date, she would be committing a crime punishable by years in jail every time she carried the medicine across state lines.
Essentially, the Medical Cannabidiol Act of Iowa is a completely pointless piece of legislation that benefits no one. Senator Joe Bolkom of Iowa City realized this and plans to introduce a bill to develop the medical marijuana program a bit further when the Iowa legislature reconvenes. Bolkom reported that he wants to allow patients suffering from more medical conditions to be eligible, and pointed out, “The medicine has to be produced within the state.”
For the sake of those suffering from many different debilitating medical conditions in the state of Iowa, hopefully the state legislature will take a good look at the weakness of the Medical Cannabidiol Act, and make the necessary amendments for it to be an effective law.
Back in November, Fox News 13 of Memphis, TN reported on a 3-year-old child that had exhausted her options in search of a treatment for her debilitating seizures. That is, except for one medicine that her family couldn’t get access to due to state and federal laws that block access to the medicine.
By age 3 Chloe had suffered from more than 75,000 seizures, affecting the development of muscles, coordination, and cognition. Suffering from around 100 seizures per day, doctors tried everything in the book to heal young Chloe, including multiple surgeries at Le Bonheur Children’s Hospital and 20 different types of medication. In November her family reported that she was taking 5 medications 3 times a day including medications like Methadone. One of the medications forced Chloe’s parents to sign a waiver due to a severe risk of blindness as a side effect.
Back in January Chloe’s grandmother, Gail Grauer, went in front of state legislators to ask for access to the non-psychoactive form of cannabis oil. Legislators soon passed a bill allowing clinical research from Vanderbilt University in conjunction with Tennessee Tech to grow and distribute the medicine to sick children in need. However, Federal regulations blocked this course of action putting Chloe and her family in a life-threatening bind.
In November, Chloe’s mother, Elizabeth Peden said, “You want to do anything, you would do anything, you would literally do anything to save the life of your child.” Her father Shea added, “One day we will be able to try it and we will be able to get those smiles and those little laughs that a lot of people to take for granted.” Tragically, that day never came for Chloe.
On December 10, Fox News Memphis reported that Chloe Grauer died waiting for the treatment she so desperately needed. Sadly, many parents around the country could be facing this life-threatening scenario with their hands tied by the Federal government. In the United States alone, around 3 million individuals suffer from epilepsy.
At the Federal level traction is picking up, but children who are dying for a cure can’t wait for the slow and politicized legislative process to creep along. In July, Pennsylvania Representative Scott Perry introduced a bill that would allow legalize the non-psychoactive CBD oil at the national level. The bill, H.R.5226 – Charlotte’s Web Medical Hemp Act of 2014 has just begun to gain traction in Congress and will likely be subject to a vote in early 2015. So far there are a total of 38 cosponsors on the bill.
If you would like to take action you can find your district’s Representative here. Write your Congressional leaders and urge them to jump on board with the bill before another child’s life is shamelessly lost due to an inhumane and undignified Federal law.
via: Fox News 13
As the final days of November wind down, we wanted to make note of this month as National Epilepsy Awareness Month in the United States. Epilepsy affects around 3 million people in the United States alone, with around 65 million suffering from epilepsy worldwide. Every year, around 200,000 individuals are diagnosed with epilepsy. That’s more than multiple sclerosis, cerebral palsy, muscular dystrophy and Parkinson’s combined.
In recognition of this month, we’ve put together some of the top headlines from this month in epilepsy. From mothers in Chile uniting for access to CBD oil to farmers in Oregon donating precious medicine to sick children, efforts to treat epilepsy with CBD are rapidly expanding. Here’s what this month brought in epilepsy awareness:
Three moms in Florida got together in an effort to advocate for the right and option to utilize cannabis in the care of their critically ill children. The moms were traveling out of state to get the medicine that they need for their sick children and were heavily involved in the effort to legalize medical marijuana in Florida. Though Amendment 2 did not not pass in Florida, the CannaMoms still have access to the life saving CBD oil and will push even harder for medical marijuana in 2016.
Clinical Testing For Cannabis Oil
Three different cities in the United States will soon begin testing cannabis oil in the treatment of Dravet Syndrome, a rare form of epilepsy. Texas Children’s hospital will be among the first to test the cannabis compound Epidiolex. The drug is a purified CBD oil with no psychoactive effects and will be tested on children between 4 and 10 years old who are afflicted by Dravet’s Syndrome. Georgia and Illinois will be hosting future studies.
A worldwide movement? Perhaps. Similar to the CannaMoms of Florida, this group of Chilean Mother’s just put together a group of over 100 moms in order to exchange information about the use of CBD oil in the treatment of epilepsy. Though cultivation of cannabis remains illegal in Chile, these mothers found this treatment to be exponentially more effective than others at 1/8th of the cost.
An Oregon-based grow-op called TJ’s Organic Garden is treating Oregon children free of charge. Pictured above is 8-year-old Forrest Smelser who is one of the organization’s patients. Forrest was suffering from epileptic seizures up to every 15 minutes before he began using the CBD oil. After receiving the cannabis-based CBD pills, Forrest has now gone over 9 weeks without a seizure. TJ’s owner Jim Murphy vows to give out the medicine for free and has enough to supply around 500 patients.
As epilepsy awareness month draws to an end, let’s take time to celebrate the victories in the treatment of epilepsy and remember that there are millions still suffering. More research is on the way, and you can do your part by spreading this valuable information or donating to The Epilepsy Foundation here.
Photo Credit: Enduring Epilepsy
The first FDA-authorized clinical trial for a cannabis therapy medication, Epidiolex, is recruiting children with Dravet Syndrome, a severe form of epilepsy, to test the efficacy of the new drug. Epidiolex is a purified cannabis extract containing only the cannabinoid, Cannabibiol (CBD). It does not contain any amount of the psychoactive cannabinoid, Tetrahydrocannabinol (THC).
The trials, funded by Epidiolex producer, GW Pharmaceuticals, are being hosted by three different children’s hospitals in the United States. The first location is in Texas, center two is in Georgia, and the third is in Illinois. Each location is currently seeking to enroll ten participants between the ages of four and ten years old, for a total of thirty participants nationwide. In each set of ten participants, eight will be treated with Epidiolex, and two participants will be given a placebo instead. This phase of the trial will last for a total of twenty-one days. Out of thirty participants, twenty-four will be treated with one of three different dosage amounts of the CBD medication. The purpose of this phase of the study is to determine the ideal dosage for children suffering from Dravet Syndrome. This phase is anticipated to conclude before the end of the year.
Phase II of this clinical trial will be used to determine the safety and efficacy of long term use, once the appropriate dosage has been determined in Phase I. The second phase will increase participation from thirty to eighty children, and increase duration from three weeks to three months.
Texas Children’s Hospital was selected to be the trial location center in Texas, and Dr. Angus Wilfong, neurologist at the hospital, is the first physician in Texas certified to administer the medication, Epidiolex, to pediatric patients. Dr. Wilfong told KHOU11,
“As one of the largest epilepsy centers in the country, our focus has always been to find new and innovative ways to treat and cure children with various forms of epilepsy. Initial trials of Epidiolex have shown promising signals of efficacy in children with treatment- resistant epilepsy, and we are pleased to have the opportunity to partner with GW Pharmaceuticals in the first worldwide trial for this group of patients with such a catastrophic form of epilepsy.”
One of the patients, enrolled in the trial last week to be treated at Texas Children’s Hospital is six year old, Izaiah Ruiz, pictured below with his grandmother, Lori Fountain. Izaiah has a confirmed case of Dravet Syndrome, and suffers from daily seizures as a result. These daily seizures have caused Izaiah to develop at a much slower pace than other children who do not suffer from epilepsy. Developmentally, Izaiah is only about two years old. His grandmother, Lori, is also hopeful that this CBD medication may improve Izaiah’s quality of life.
She told KHOU11 that she is does not care what other people think about Izaiah’s participation in the study because she would try anything to give him the chance to live the life that most children are able to live, and grow to have a better quality of life as a teenager and eventually a man.
photo credit: Celebstoner, Houston Chronicle