We’ve been waiting months for confirmation that Connor can take part in a compassionate use trial for Epidiolex. His doctor was on board, but had to submit paperwork and jump hurdles due to the absurd schedule 1 classification by the DEA. Epidiolex is a marijuana-derived pharmaceutical. It contains CBD, and no THC. As we are still fighting for medical cannabis legislation here in Georgia, Chris and I desperately wanted this legal opportunity for Connor.
I actually cried when I got the confirmation. I had no idea how much of a weight this was on my shoulders until that moment because I hardly ever cry anymore. People who have known me for a long time might think, yeah right. I used to be Queen Crybaby, crying over the stupidest little things all the time. But now, on the rare occasions I do cry, it is still over something stupid — like the death of a favorite character on Walking Dead (and unlike some people who like to spoil things instantaneously on Facebook, I STILL won’t name names here for those who are playing catch up on Netflix–oops, veered off on a pet peeve tangent. Suffice to say, the instant someone croaks, you don’t need to flippin’ post it). But I never cry over important things that I probably should. Sometimes it kind of weirds me out and I wonder if something is wrong with me. At any rate, I knew tears were a sign of how important this is to me. As you can see, I may not be able to display emotion when it comes to Connor and TSC, but I’ll sob and punch you in the face over The Walking Dead.
Epidiolex trials are exceptionally difficult to get into, and I don’t know how we got so lucky. I know so many who have tried and haven’t been accepted. This also doesn’t change the need for legislation. Epidiolex is one formulation. It is not the same thing that kids like Charlotte Figi or Haleigh Cox are using out in Colorado. They are on whole plant strains of high-CBD, low-THC oils called Charlotte’s Web and Haleigh’s Hope. Some kids are benefitting from THCa. Others are supplementing with THC when the ratios in the oils don’t hit the spot for seizure control. And it will still be years before Epidiolex is available to the general public. What I’m saying is, Epidiolex isn’t one size fits all. But we hope it will fit Connor.
We aren’t sure on the start date yet. Before he can receive his first dose, he’s required to have a screening appointment. Being the holidays, the next available appointment isn’t until Jan. 6. I was rather dismayed by that as you must keep track of the seizures for a month after that appointment, and that meant he can’t start the med until February. But he happens to have a follow up appointment on the calendar already in early December. The study coordinator is looking into whether that slot will allow enough time for the screening. That would put him on the med by early January. Fingers crossed it’s sooner rather than later.
My heart is going a mile a minute and I am trying not to go into a rage. The one thing that made it okay that HB 885 didn’t pass in its final form last session was that by then it had been stripped to an immunity bill. Not a lot of good when you can’t obtain it in your state. But Realm of Caring has decided not to move forward to with their plans to ship Charlotte’s Web UNLESS the state has already passed AT LEAST an immunity bill due to the closer scrutiny they have endured since rolling out this plan. GEORGIA FAMILIES THAT THOUGHT THEY WERE GOING TO BE ABLE TO GET IT SHIPPED AS EARLY AS NEXT MONTH NOW CAN’T. This is thanks to the despicable actions of SENATOR RENEE UNTERMAN of Buford (who is on the current medical cannabis committee and typically appears to be asleep in meetings–IF she bothers to stay for the whole thing) and LT. GOV. CASEY CAGLE who thought it would be cute to smirk at the grieving families as the session closed without it being allowed to go to a vote at his discretion. Please share the word of what they have done. Georgia families now have to wait for the next session to get a law that will allow them to receive it, when every state around us already can.
“This change will not impact availability for those of you who live in states with clearly defined statutes that allow individuals to possess CBD or low THC, regardless of the specific means by which these products are acquired. For everyone else: we will be seeking clarification from the appropriate agencies in all 50 states in order to determine the legal accessibility and risks of possession of CBD products. To be clear, as soon as we have confirmation from your state authorities that you will be exempt from prosecution, we will ship to you.”
Connor had a 48-hour VEEG a few weeks ago. It was awesome. Instead of waiting weeks and weeks to get into CHOA, we were given the option to use a company that comes to your house and hooks everything up. No hospital! God, it was beautiful. We had received the basic results, but recently had an appointment to discuss it more in depth with his neuro. I’ve been confused in documenting his seizures recently because they often have elements of his typical complex-partials, as well as his tonic-clonics. The EEG confirmed that his CPS (which are in one area of the brain), then generalize to the rest of the brain resulting in clonic seizures. He has a couple hot spots and it seems like every EEG seems to indicates a tradeoff in which is doing the dirty work. This time they all started in the right frontal lobe in the spot where he had surgery when he was four months old. Greeeeaaat.
This is not to say the surgery was not done well or wasn’t successful. It made a huge difference in reducing his seizure activity. That removed tuber was the reason Connor spent 37 days in NICU at birth. But sometimes the area left that surrounded the tuber can still trigger activity. This means a second surgery to remove more of that area is an option. But the doctor already knew we weren’t interested in exploring that route, not before we try medical cannabis. Connor is currently being considered for a compassionate use trial of Epidiolex, the GW pharmaceutical using extracted CBD.
We’ve been somewhat quiet about that because we already got disappointed once. Despite Rep. Sharon Cooper and Sue Rusche of National Families in Action swearing up and down during the last Georgia legislative session that we could all get into the clinical trials WITHIN A MONTH! JUST ASK YOUR DOCTOR! it was confirmed quickly what the families already knew. That’s. Bull. Shit.
Many families never had a shot at the trials being conducted by GW. They are focusing on Dravet and LGS. Plus, there is a lot of exclusionary criteria, such as having additional diagnoses. Many tried. Many were told no. One of those children, whose mom was assured she could get it, has since tragically passed away due to a seizure. He didn’t qualify.
Connor only has a shot because there happens to be a compassionate use trial here that isn’t limited to those two diagnoses. But it is very small, very expensive for the doctor and very complicated for a doctor to take part in due to the schedule 1 status of cannabis. So, sure, you can ask your doctor to look into this, but don’t hold your breath. However, the first time we thought we could be included, we found out Connor was excluded by GW because of his age. His doctor has since submitted paperwork to expand the age requirement and we are holding our breath for it to be approved. Sooooo, a month? Let’s see, the legislative session ended in March, so it has been at least seven since we were all told a month. And Connor is damn lucky he even has a shot at taking a part in such a small trial. Cross your fingers for him and us. Everyone else can just move to a legal state, break the law or wait the years it will take for Epidiolex to hit the market (and then hope that formulation is the one that will actually help).
Realm of Caring is also about to start shipping Charlotte’s Web, the the high CBD oil, made famous by CNN’s Weed with Sanjay Gupta. So the CBD options are slowly and fantastically coming our way, but should Connor be one of the cases that requires a different ratio of THC, we will either need to move to a legal state or hope Georgia can pass legislation in 2015 that will let us get what we need. The comfort level with CBD has skyrocketed nationwide, but THC is still demonized despite the fact that it is needed to treat many medical conditions. For now, we are hopeful that Connor will be one of the patients that responds well to CBD without the need for tweaking the ratio. It also remains to be seen how shipping the oil will play out due to the legal gray areas, especially for people in states with no legislation on the books. Certain politicians and people with authority think we should all settle for their word that they won’t prosecute us here. But tell that to Angela Brown in Minnesota who was recently arrested for giving her son CBD oil.
We’ll just be gnawing our fingernails, waiting to hear about the trial. Connor’s been having more seizures at night. His Emfit monitor was malfunctioning the other night (we were advised to adjust some settings which seems to be doing the trick), and now that I’m used to having a monitor that will alert us to convulsive seizures, I couldn’t sleep knowing it wasn’t on. I tried to sleep with Connor in the guest bed, but moving him woke him up and for the next hour and 15 minutes he appeared to be on speed. We played several rounds of “Got Your Nose” Scarface style –him grabbing mine, not the other way around. The bed and my head also made for equally sufficient trampolines. I finally gave up and had to put him back in the crib where he entertained himself for at least another hour. Life with epilepsy, ya’ll.
If you are interested in putting yourself on the wait list for Charlotte’s Web, go here.
In the months since Georgia’s 2014 legislative session ended without passing proposed medical cannabis legislation (due to political games, not lack of support), the community of medical refugees in Colorado has grown.
Notice anything funny about the south? Sing with me! One of these things is not like the others… Admittedly, the laws in the bordering states are of varying efficacy. South Carolina, for example, is only an immunity law that protects you if you are caught with high CBD strains, but does nothing to help patients obtain it. Florida, on the other hand, is allowing for the growing and selling of high CBD strains next year. If Amendment 2 passes in November, Florida will be able to enact an even more comprehensive program that will benefit more people and conditions.
So now meet some of the Georgia families that are waiting to return to their homes, families, doctors, therapists and friends.
The Cox family
The Georgia bill HB 885 was also named Haleigh’s Hope in honor of this little girl who turns five this month. Shortly before this year’s legislative session ended, Janea and Haleigh packed up and moved to Colorado because Haleigh, who has Lennox-Gastaut syndrome, was suffering life-threatening seizures that caused her to stop breathing. Her dad, Brian, was unable to go with them because of his job and now they have to live apart.
As I scrolled through the Hope for Haleigh page I was struck again by the change in her. Janea takes and posts a lot of pictures and I could see the improvement, but in looking for before pictures, I was struck by how difficult it was to find photos of her looking at the camera or smiling. Now we see quite a few of those. Sitting in a swing by herself wasn’t possible a few months ago. She also said her first word in Colorado — Mama. Haleigh is not seizure free and still has some rough days, but she has also had some seizure free days. That simply didn’t happen before she started on Haleigh’s Hope provided by the Hope Foundation. Janea has said that she felt like she was finally meeting her child these last few months. Haleigh has even been able to wean off one of her seizure medications. But living apart from Dad is emotionally taxing and they hope that 2015 will bring legislation that will allow them to be a family again.
The Oliver family
Tripp had his first seizure on April 9, 2009 and was diagnosed with Dravet syndrome. He has tried more than a dozen medications since then and in April of this year, he and his mom moved to Colorado where he started THCa through Realm of Caring. It was hard to leave Dad and his team of therapists who have spent years working with Tripp in speech, occupational, feeding and physical therapy, but since then he has had two separate three-week streaks in which he had no convulsive seizures. Mom describes him as brighter and happier with improving speech capabilities. You can follow his journey at Tripp’s Trip.
The Klepinger family
The Klepingers left for Colorado late last year. They still own their Georgia home with the hopes they can return to it and their extended family and support network. Hunter is still doing well on Charlotte’s Web. I shared Hunter’s successes previously in this post. Since then, Aaron and Dawn have a welcomed a third child, lovingly nicknamed their Colorado Tumbleweed.
Aaron invites any legislators with doubts to come to Colorado and meet the kids. “Seeing is believing,” he says.
“My Caden has had thirteen completely seizure-free days! Understand that was never a possibility before! He no longer seizes during the daytime at all, only at night,” Kim Clark posted in May of this year. “There was no hope before this, nothing. Caden’s life was seizing somewhere between ten up to into the hundreds times a day. There was no life. Coupled with the side effects from medications, my boy was miserable. Now we are so blessed that he is 10 years old and we are trying to learn how HE CAN LIVE!”
But Caden’s healing has come at a price. The Clarks are also a split family. Kim is in Colorado with the kids and Dad Chris has had to stay behind in Georgia for work. They share the same reality as the other families living hundreds of miles apart. Dad can come visit them, but they can’t go home to see him because they can’t legally travel with the oil. Recently, Kim and Chris traded places for a short period so she could make a trip home.
The Sumlin family
Sheryl and her daughter Trinity arrived in Colorado earlier this summer.
It’s early to gauge the response of Trinity’s seizures to Haleigh’s Hope since mom opted to titrate up to the usual starting dose, an incoming tooth is causing seizures and Trinity is requiring supplemental oxygen as she adjusts to the altitude. However, Mom is seeing beacons of hope in small things like wiggling her toes, calmness, awareness, making sounds and sleeping better.
But leaving her support network has been extremely tough. “It is harder than I thought it would be,” Sheryl says. “Although it’s beautiful here, it is not home. My daughter’s school and that whole network has been a huge part of our lives for the last 5-6 years. Also, friends who knew us since forever. I think it’s unfair that we have to move so far to have an opportunity to try this medicine.”
Sheryl is out there without nursing help or a car. Prior to flying out she donated her vehicle to another family in need. A fundraiser was set up by a third party to help her with expenses, but she never received any of the donations that were made on her behalf. She is grateful to the Journey of Hope foundation, a non-profit started by Rep. Allen Peake, for coming through and helping her financially with the move.
Corey worked tirelessly during the 2014 legislative session to persuade Georgia legislators how badly we need access to cannabis. She was devastated when it didn’t pass, and by May, her daughter’s seizures were getting out of control. She had a tough decision to make.
In June, with help from Journey of Hope, they packed up the car and drove across the country leaving behind Corey’s job, her husband and Victoria’s siblings.
Since starting on Haleigh’s Hope, Corey tells me Victoria has had an 80 percent reduction in seizures. From several a day to this:
The incredible eye contact and improved communication Victoria is showing now helps alleviate the pain of leaving their home, but Corey still worries.
“It’s great, but at what cost,” she told me. “How will this affect my children, who I left behind, in the long run? Will they resent Victoria because I had to leave them behind? How is not having a mom around affecting them?”
She also feels guilty about the families that simply don’t have the means or circumstances to move across the country. “The absolute worst part about having this medicine is seeing kids back home that need it. It’s hard to celebrate the success when kids are going into the hospital because of seizures.”
I’ve posted before about Hunter, an eight-year-old boy from Georgia, whose family relocated to Colorado several months ago to try and treat his severe epilepsy with cannabis oil. Previously 12 FDA-approved meds, the ketogenic diet and a surgically-implanted VNS had failed to make him seizure free. He was not a candidate for brain surgery. Some of his meds made him sleep constantly or scream. Here is an update.
This non-psychoactive oil has made an incredible difference in Hunter’s quality of life. According to Mom, “His bad seizures (myclonic clusters) would happen almost daily before and last 5-10 minutes. NOW, he is averaging one a week and they are under 2-3 minutes. In the month of February he has had 4 so far. This is HUGE! His quick seizures used to last upwards of 30 seconds and happen 10-20 times a day. After a month or so we were still seeing them every day and several times a day but they were literally seconds and half the time we couldn’t tell if he was actually having a seizure. Now, after 3 months, we are hardly seeing ANY!”
But in fairness, we must address the side effects of this medication. Sure, it might help kids with terrible seizure disorders that are damaging their brains and ability to function and learn, but surely there are SIDE EFFECTS? Well, you’re right. There are. Here are the side effects Hunter is experiencing.
1. Increased eye contact and the ability to maintain eye contact.
2. He no longer needs Miralax and daily suppositories to go to the bathroom.
3. He is relaxed. His fists no longer remain in a clenched position with his nails digging into his palm, making his hands bleed.
4. After eight years of only being able to sleep on his back, he can now roll to his side and sleep in a new position.
5. He now rides the school bus since Mom no longer worries about him having a bad seizure on the bus.
6. There have been no calls from the school for EMS.
But I guess a few side effects are the price a parent must pay for giving their child quality of life. That and leaving your entire life behind in another state.
Update 3/10/14: The Klepingers were on CNN today. Check it out here.
I guess blogging really can be therapeutic. After I posted Friday about our trip to Birmingham regarding the ketogenic diet, I just didn’t feel right. I had a tightness in my chest that I hadn’t experienced in a long time. Anxiety? I couldn’t stop obsessing over our appointment with the neurologist and how she just wasn’t on the same page at all. I guess it’s true what people say about going with your gut. I looked back over my correspondence with CHOA. I had never cancelled our March appointment just in case. Connor is already responding so well to the tweaks in his diet that aren’t even the full-blown MAD or ketogenic diet. I went upstairs to find Chris and said, “you know…we still have the CHOA appointment, and the nutritionist said she could help me start MAD at home…” And within seconds it was confirmed that neither of us were comfortable moving forward in Alabama with that neurologist. So I emailed the nutritionist that we would be sticking with CHOA and I am waiting to here from her.
Yesterday I attended the first committee hearing on HB 885. I don’t know what I expected, but it wasn’t what I got. It started late as the morning session had gone long. Some members came in late to the hearing as they were at other meetings that overlapped. Paige Figi — Charlotte’s mom featured in the Sanjay Gupta special — flew in with Joel Stanley from Realm of Caring to testify about what they are doing in Colorado and the success they are having. They are in the process of getting FDA-approval and they are doing studies, but it is a time consuming process and children with severe seizure disorders don’t have time to wait. They explained that they are a heavily regulated industry. They also said they now have a waiting list of over 2,000 people nationally and internationally, hoping they will be allowed access.
Dr. Mike Green then testified and shared that the Medical Association of Georgia supports the bill. Dr. Smith testified about his experiences having a child with a seizure disorder (Doose syndrome) and the awful side effects that can come with seizure medications. He and Dr. Green also shared about the Epidiolex drug trials that are going on. Epidiolex is manufactured by GWPharma using CBD as the active ingredient. Dr. Smith tried to get his child into one of the studies, but they were full. Dr. Flamini also testified. He is the neurologist to many of the kids whose parents are fighting for this. He is actually the mysterious neurologist I frequently refer to in this blog. He is very supportive of CBD studies and is applying for Investigational New Drug status (IND) so that he can work with Epidiolex in his office. It is a very lengthy, difficult process to work with a schedule 1 substance, but even if he is approved he is very limited in how many people can use it. Though he was testifying in support of HB885, he is actually excluded by the bill because he has a private practice. It would only be available via research hospitals.
I also want to point out that Epidiolex is in trial phase and not yet FDA approved. It has been granted orphan status, which speeds things up, but we’re still talking years. May I remind you that vigabatrin was not FDA -approved in the U.S. until 30 years after the first trials. Ahem.
Several parents shared their heartbreaking stories. Janea Cox shared about Haleigh, pleading with the committee not to let her daughter die. Aaron Klepinger shared about the amazing success their son Hunter is having in Colorado and how badly the family wants to come home. One dose stopped him from clenching his fists so tightly that his hands would bleed. Jonathan Jiles shared about his son Kason’s battle with Ohtahara syndrome. Sgt. Chris Clark, a 26-year veteran of the police department shared about his family and how his wife and child are in Colorado for treatment while he remains behind to provide income and insurance. He also shared that his son had a brain surgery that caused a stroke. I wished they could have had more time, but were all rushed because of time constraints and the impending bad weather.
Then came the oppositional speakers with lengthy presentations. Sue Rusche from National Families in Action opened with a YouTube video she took of an advertisement for Indispensary in Colorado. Dispensaries are where you can buy marijuana products. It took me a while to ascertain her point, but it seemed to be, hey, look at all these recreational marijuana products. These are available in the same place as where some of these Colorado parents are obtaining their child’s medication. It was a long, slow video with lots of silent footage of recreational products. Personally, I was shocked it was allowed to play out in full considering the rush for time and that testifying parents had to talk quickly. It was also quickly pointed out by Rep. Kaiser that it was irrelevant. Georgia is not Colorado. This is not what we are doing here. That is simply a place in Colorado where medicine may be picked up, but we wouldn’t have that here. We are interested in a non-psychoactive oil that can’t get you high only ONLY; recreational is not on the table. We want an oil form, not buds. Rusche was clearly not supportive of products such as Charlotte’s Web which has saved many lives in Colorado. She pushed the Epidiolex trials repeatedly and insisted it was not hard to get, that any doctor can apply for IND status and have it in 30 days. This was after Dr. Flamini already testified that it was a difficult process. The doctors behind her were also shaking their head as she spoke. But no matter what was asked, she insisted that Epidiolex, courtesy of GW pharmaceuticals was the only suitable option. She was so insistent that one of the reps eventually questioned whether her organization received money from GW. A representative then asked her if Epidiolex is so easy to get, why aren’t these parents doing that? “I wish they would!” was her response. And at this time, I ask you to recall above where I mentioned that one of the testifying doctors tried to get it for his kid and couldn’t. At that point, Rep. Peake asked her, ‘Would you tell Aaron Klepinger to stop giving Hunter Charlotte’s Web and get in line for Epidiolex?” She said no.
Some doctors from CHOA spoke. While they have reservations, they are very interested in possibilities of CBD oil. Then Rick Allen of the Georgia Drug and Narcotics Agency spoke of the challenges of getting it here due to it’s classification as a schedule 1 substance — no doubt a major hurdle. He said that where we stand, something like Charlotte’s Web cannot be brought into the state legally. University of Mississippi is the only place permitted by law to supply as part of research projects.
Then came, what was for me, some of the most disturbing testimony. Karen Tinker gave lengthy testimony as a mother of a son with epilepsy. I was confused at first. Why was she at the end rather than with the other parents? Why have I never seen her or heard her name before? As it turned out, she wasn’t testifying for the bill. She was testifying against it. She started out with a similar story. Many meds failed her son and he recently received the VNS implant, which she acknowledged comes with it’s own dangers, and wasn’t guaranteed to solve the problem. She talked about her methods of evaluating treatment options for her son, and said that she had chosen not to use Onfi because of potential side effects (a med that I felt we had to try for Connor). But she stated that CBD oil did not have the research to back it. That we needed wait to several years to see what studies would say. She likened the passing of the bill to opening Pandora’s Box and said she worried that all the positive headlines about marijuana would lead her teenage son to try recreational pot. After the fact, I saw her Linked In profile. It turns out she owns a company that provides mobile drug testing of employees to companies. She doesn’t seem to differentiate between medicinal and recreational.
It was heartbreaking that a parent of a child with seizures would do this to other parents. Especially after Janea Cox had cried and shared that Haleigh has stopped breathing 56 times in the last month.
I respect the right of every parent to choose the course of action for their child. Not every parent is comfortable with medical cannabis at this point and I respect some would not opt to use it. Just as Tinker chose not to use Onfi, we did choose to use it. I do not respect someone that tells others they shouldn’t do something that could save their child’s life. I am so lucky that Connor’s situation is not as dire as the situation of the testifying parents. It’s cruel to try and stand in the way of something that could save their lives.
After that, a couple doctors testified that had been recruited by Rusche. I’ll be honest. I didn’t hear much of what they had to say because I was still in shock over Tinker’s testimony. At that point the hearing had hit three hours and it was an hour and a half past when it was supposed to end. The remainder of speakers were asked to return to the next hearing.
I’m not sharing all my thoughts at this time on the hearing in the blog. If interested, I can talk more one-on-one. I will provide more detail at a later date. All I can say is that yesterday was an eye-opening experience.
Living in Atlanta, loving travel and watching my son kick tuberous sclerosis complex's butt.