Tag Archives: National Families in Action

You can get Epidiolex in a month if your definition of a month is 210 days to years.

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.

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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

 

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The hearing on HB 885 and a diet decision

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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.