The Tiny Little Mother MInd™ and the FDA and Epidiolex

Today, the FDA announced its approval of GW Pharmaceuticals' Epidiolex, a cannabis-based medicine for epilepsy. As I've written countless times here on this blog, I do not begrudge those who want to try this concoction a fair chance to try it. If it works, fantastic. If it doesn't, you know where to go and what to do. What is that? You will probably need to jiggle around your CBD and add THC or one or more of the other cannabinoids. You will embark on a twisty path to healing. I believe this with all of my heart, but it's not a religion. It's fact and science and experience-based.

The reason the tiny little mother mind™ is writing this update is because of the following announcement by the FDA that accompanied their approval:

FDA is deeply concerned about the proliferation of unapproved CBD drug products marketed using unproven medical claims to diagnose, cure, mitigate, treat or prevent serious conditions and we’ll continue to take action against such products.

Cue the revolution. That's right. If the FDA or Big Pharma takes away our freedom to make, use, buy or otherwise give our cannabis medicine to our children or ourselves, there will be a revolution.

Epidiolex will cost between $2,000-$6,000 a month. If you have any experience with manufacturers and insurance companies and how drugs are priced, go figure that shit out. Contemplate that. Read my post from a few weeks ago where I discuss the difference between Epidiolex and the cannabis meds that many of us currently use.

My tiny little mother mind™has said it before over the five years that I and my compadres have been doing this, that there's a swimming pool here and plenty of lanes. Initially, we told the docs and anyone who would listen that they should get on the train because it was leaving the station. We were mocked and humiliated -- literally -- but we didn't give a flying foo and proceeded to save each other's children. We were told that we couldn't discuss cannabis medicine with our neurologists. We were reported to Child's Protective Services. We were obstructed over and over. That did not stop us.

Now, I'm telling you that Big Pharma should use their lane and not infringe on ours or take over the entire pool. 

I mean it.













*This has been a Public Service Announcement

Cannabis and Pediatric Neurology: A Modern Day Fairy Tale with a Villain

Sophie and Me
La Jolla, CA 1999

Sophie was about four years old in that picture. I was 35, and it was the turn of the century and the millennium.

Once upon a time.

I sure wish that I could have had access to CBD oil back then.

I might have avoided nearly twenty years of frustration in controlling Sophie's seizures. She might have never become addicted to the benzo. We might not have had to try fifteen more drugs (she'd already been on eight in this picture). We might have avoided the second trial of the ketogenic diet which reduced Sophie to a pacing tiger in a cage waiting for her slice of strawberry embedded in a stick of butter, her stool impacted and no seizure relief, myself a fucked-up wreck of a woman. We might have avoided a broken leg, a broken nose, a broken hand, a split-open forehead and back of head, more than twenty stitches, permanent teeth knocked out, and a host of side effects: screaming, rigidity, sleeplessness, catatonia, anorexia, stomach pain, headache, fevers, rashes, hives, irritability, ataxia, dizziness, muscle weakness, blurry vision and cognitive decline.

Tonight I learned that another family has been threatened by a pediatric neurologist at UCLA. I'm not going to use his name, but I've written about him on this blog. I've also written quite recently about my own encounter with a bully -- Sophie's adult neurologist and her superiors who refused to discuss medical cannabis with us, even after we had been doing so for nearly five years. The irony of the recent scandal going on in the USC medical school is not lost on me. Look it up if you want to hear some serious shit.

But I digress.

This UCLA pediatric neurologist's  "area of expertise" is infantile spasms, the disorder that Sophie was diagnosed with in 1995. I will remind you that the treatment protocol for infantile spasms is nearly identical to the one we used twenty-two years ago with the exception of a "new" drug that is not new. It was approved by the FDA years after we used it. We tried it back in the last century at the urging of our very cutting edge neurologist because Sophie had already failed eight or so drugs in various combinations. She was nine months old. We got it from England, and we gave it to Sophie along with two other drugs. It didn't work and caused what I thought was psychotic behavior in a baby. Screaming for most of the day and night. It had not been tested, you see, on babies, and who knew whether that particular cocktail of drugs was causing more harm?

This drug Vigabatrin went off the market for a time because it can, in rare instances, cause serious irreversible vision damage. When your doctor prescribes it for your child's infantile spasms or seizures, you have to sign a waiver that you know about this risk. The other standard treatment for infantile spasms is ACTH, a high dosage steroid, administered by intramuscular injection. I believe brain surgery as a treatment has advanced somewhat, but -- it's brain surgery, and you have to be a candidate for it. You have to have a focus area to mess with in the operating room. Sophie did not have a focus.

90% of babies diagnosed with infantile spasms will have moderate to severe cognitive disability and refractory seizures. This number has not improved in decades despite "advancements."

This pediatric neurologist at UCLA is one of the several neurologists in the city, in the country, who are involved in GW Pharmaceuticals' studies of cannabis medicine and their cannabis product Epidiolex.

This pediatric neurologist openly tells his patients about CBD oil and tells those of us in the "veterans" community that he supports its use, but then he threatens families with Child Protective Services.

He is a Janus-like figure, or perhaps that is too kind.

He is two-faced.

We can only surmise that he and others like him want people to stop using what Big Pharma calls "artisanal oils" and start using Epidiolex. We can only surmise that they are  -- let's say -- "on the dole" with GW Pharmaceuticals.

Follow the money, as they say. Except that these are not crumbs laid to remember your way to safety.

I will say that he is a bully. I will say that there a lot of bullies in the neurology world -- both pediatric and adult. I understand that there is a lot of fear. There is liability, lawyers, corporate policy. Medicine As Business.

I will say that we do not trust these neurologists.

I will say that there are pediatric and adult neurologists who are not bullies and who are willing to work with parent experts in a manner that is family-centered. I encourage you to leave your pediatric neurologist or adult neurologist if you are being bullied. I encourage you to advocate for full and open communication with your physicians and demand that they do the same. If they can't work with you, and you are using cannabis medicine, then they should tell you so directly and give you the choice to leave and find another neurologist. I realize that this might be impossible, so do what you need to do. You are in charge.

I don't know if there's a happy ending to this story, or if there's an ending at all. It seems, sometimes, as if we are always beginning.








Feel free to share this post with anyone that might find it helpful. I'm sorry that it pertains primarily to legal states and particularly California, but as long as we have docs averse to communication, we're going to see similar crap going down all over the country as the laws are eased.



Here are your rights and some resources:

Where to Find Pediatric Cannabis Support
Is Medical Marijuana Legal for Children in California
Patients' Guide to Medical Marijuana Law in California

Cannabis Oil Questions Answered

What do you think about the recently released study that GW Pharmaceuticals with 11 other epilepsy centers published yesterday about Epidiolex and Dravet Syndrome?


Enough people have highlighted and sent my way the "big" news that cannabis medicine helps children with Dravet syndrome, a particularly devastating type epilepsy. Dravet is what little Charlotte Figi has -- the Charlotte of the eponymous Charlotte's Web oil. You can look it up and find a lot of links, and evidently the story appeared on many television networks last night as well as in Canada.

Here's the link.

Yup.

Good news.

Raised eyebrows.

I'm not going to be doing any jumping up or down or anything, and it's hard not to yawn. It's even harder not to feel irritated, given all the goings on I've been privy to of late regarding The Powers That Be and cannabis medicine. It appears, to my tiny little mother mind™that the pharmaceutical company is looking to ram their drug through the FDA. But, hey, if their CBD drug helps some kid before that kid is subject to multiple drugs and other shit, then hallelujah.   

Hallelujah, too, for the families that can't afford the products out there already and for those who don't have access to cannabis because of the clusterfuck that is our government.

The train left the station years ago with many of us on board, and instead of grabbing our hands, most physicians and researchers chose to get on at a later stop. That's all right, I guess, unless they claim the whole thing for themselves.

My friend Chris said it best:

I know it's a step but it sure feels like an impossibly small step designed to benefit big pharma, which controls our country. It's jamming one piece of the plant into the western medicine paradigm, discounting those for whom massive doses of cbd don't help and actually harm and ignoring the medicinal value of the rest of it. I'm not holding my breath for a system that wants to control the product to allow for the individuation of mmj for each patient, which relies on individual observation and anecdotal evidence. That's not what the medical industrial complex does.

 Dr. Bonni Goldstein and two other doctors have also published a research paper that I find quite interesting, perhaps more interesting than the pharmaceutical company's one, because it references the extraordinarily wide dosage ranges of cannabis, as well as the fact that epilepsy patients might generally do better with access to a wider range of artisanal products rather than the single molecule compounds that pharmaceutical companies are developing.

Here's the link.

The Tiny Little Mother Mind™ Reports

First of all, I'm going to ask you to view the following video, if you can.


https://www.facebook.com/DavidGeffenSchoolofMedicineUCLA/videos/1277904508994589/ 

If you can't see it, let me tell you what it's about.

Dr. Shaun Hussain, a pediatric epilepsy specialist at UCLA School of Medicine is a leading expert in the hard to control epilepsy syndromes category. That would include children who suffer from refractory seizures -- the seizures that medication does not help. Sophie was diagnosed with infantile spasms, one of the catastrophic epilepsies, when she was less than three months old. Dr. Hussain was probably in high school when I began injecting Sophie's thighs and arms with high-dosage intravenous steroids and then her first benzodiazepine which was, in the dark days of the waning twentieth century (1995), not approved for use in the United States. The drug was called nitrazepam, and it was given to me in a process called "compassionate protocol," a phrase that I can only throw my head back and laugh a long and bitter laugh over, today. 

Today. April 27th, 2017.

Today, when children are diagnosed with infantile spasms, they are still treated with much the same protocol, even though that protocol is not effective. Yes, new drugs have been developed and approved, imaging is more powerful and surgical intervention is more prevalent and sophisticated, but treatment is still not entirely effective, and a diagnosis of infantile spasms remains one of the most devastating pediatric epilepsies. Not a week goes by that I don't read about, receive an email from, a telephone call or a referral from someone whose child had infantile spasms, has infantile spasms or another epilepsy syndrome and who is struggling with constant seizures despite multiple drugs, often in combinations of three and four -- drugs with hideous side effects.

As most of you readers here know, over the next nineteen years after her diagnosis, Sophie was given twenty more drugs in various combinations, many of which were not approved for use in the United States, were only newly approved and little studied or not approved for use in children. I can honestly say that at a certain point, these drugs were prescribed in a way that I can only compare to a primitive crap shoot -- that the series of neurologists who prescribed them would often compare the situation to throwing darts, and that one or two of them openly admitted that they just didn't know how the drugs worked, why they didn't work and what to do, really, about Sophie. Sophie is not alone in this experience. Children like her are legion. When she was nineteen years old, I learned about The Realm of Caring* and the Stanley Brothers and put Sophie's name on a waiting list to try their high CBD oil. We began to give her cannabis oil called Charlotte's Web in late 2013, and her seizures stopped for the first time in her life for a period of weeks. In the nearly four years since, we have weaned her completely from one drug and are slowly weaning her from the benzodiazepine clobazam (Onfi) that she's been on for nine years, a drug so vicious that we might never be able to get her off of it, such is her dependency and the damage it's wrought on her brain. While she is not seizure-free, and there have been periods of great struggle, we achieve long periods of seizure freedom through careful tinkering with dosages and strains, the addition of THC and careful monitoring. Her quality of life -- and our family's -- is vastly better.

But this isn't about me.

The video. 

Dr. Shaun Hussain is leading the cannabidiol studies at UCLA and thus has ties to two pharmaceutical companies, namely GW Pharmaceuticals and Insys. Feel free to read up about both companies and what they're doing. The title of this Washington Post report should give you a taste: A Pharma Company that spent $500,000 trying to keep pot illegal just got DEA approval for synthetic marijuana.

In the video, Dr. Hussain makes some startling and very disingenuous remarks about cannabis medicine, including the horrendous last case history. It is literally rife with inaccuracies and bombast -- stuff that I won't deign to go over.  I participated in a panel "discussion" (quotes are because there was no discussion as the Powers That Be literally shut down we uppity folks with the tiny little mother minds™) with Dr. Hussain several years ago at a Brain Summit put on by the Epilepsy Foundation of Greater Los Angeles. The panel "discussion" was about cannabis medicine, and I spoke from a parent perspective. I wrote about it here as it was the proverbial straw that broke this camel's back as far as my trust and respect for the neurology world in general and the party line about cannabis in particular. It was insulting, demeaning and patronizing, and it continued even afterward in a series of emails with Dr. Hussain. 

 Toward the end of his presentation on the video, he advises the doctors in the audience that it would behoove them to report those parents who are using cannabis medicine with their children to Children's Protective Services. 

That might be the second straw that drives the broken-backed camel into the sand.

Here's my comment to the post and video on Facebook:

This video will probably be taken down, but before it is, take a look and a listen. These are the people -- DOCTORS -- with whom we must work as we navigate the medical cannabis world. Here's my comment, in case, it's taken down as well:

After parenting a daughter with a severe and uncontrolled seizure disorder for over two decades, I can't say I'm surprised, but I am appalled at the outright disingenuousness of Dr. Hussain's presentation here. The pretension, the condescension and outright ignorance don't enrage me as much as they confirm what I've learned as well about the neurology profession in general but specifically this subject. The laughter in the audience confirms, to me, that those in attendance, including the presenter, are nothing more than shills for the pharmaceutical industry. To speak of and warn doctors of their duties as "mandated reporters" is unethical and profoundly disturbing. I know for a fact that these same doctors are actively nodding their heads as parents navigate the cannabis world. You HAVE violated your Hippocratic Oath, quite effectively and systematically, over and over. I imagine this video wasn't intended for public viewing and that it will be removed, but there are many of us out here who will have seen it, transcribed it or will have heard of it. It doesn't surprise us, but it will further disintegrate the relationship between doctor and patient and foster increased mistrust toward those who are supposed to be serving us. Yours is a profession that will prescribe a powerful benzodiazepine to an infant, or any number of powerful drugs not studied in children yet remain obdurate about a treatment and a medicine for which there is reams of data and information. Shame on you.




*Realm of Caring is a non-profit foundation. The Stanley Brothers make Charlotte's Web. There are several other manufacturers of cannabis oil  using different strains of marijuana. Dr. Hussain, while joking about the good-looking brothers, neglects to differentiate between the two.

House of Cards: A Whole Plant Manifesto

How do you follow up a post about the death of four children whom you actually know? Shouldn't there be a period of silence, of mourning?











Today, The New York Times published an article titled Marijuana-Based Drug Found to Reduce Epileptic Seizures. You see, the big guns at GW Pharmaceutical had been conducting studies, and these studies are confirming what we already know. Yeah, I think there need to be studies. I've got one going in my house and have been diligently studying for three years and seventeen years before that. One of the residual effects of dealing with all of this shit for so long is that I don't have even a fingernail's worth of trust in the system. And at risk of sounding like one of those crazy conspiracy people, I suspect all the big pharmaceutical companies are working their asses off to keep marijuana from being de-scheduled so that they can control the whole pie. Sorry about all the banalities, the pies and the fingernails, the houses of cards, but using trite language can be as effective and judicious as a good curse word.

I have learned that it's essential we talk about whole plant medicine. So, if you send me that article, I'm going to say, thanks, I saw it but I don't give a damn what GW Pharmaceuticals is doing. What I'm going to think is fu*k GW Pharmaceuticals and the horse it rode in on. Then I'm going to laugh my ass off over the big 'ole CDC announcing today that they are no longer recommending opiates for pain control.

Doctors Told to Avoid Prescribing Opiates for Chronic Pain

Meanwhile, I've had to halt the weaning process of the opiate that Sophie's been on for over eight years so I can give her a break from the agony.




What I do give a damn about is this story that I wrote for marijuana.com -- not my story, of course, but the story of brave and dogged people like Lindsay Rose Sledge.

A Passionate Mother's Reluctant Path to Lobbying.

Fight the Power*

That's Sophie, and when her mind is clear and the seizures at bay, she can stare right into your soul. New readers should know that despite 22 medications and treatments, Sophie found no relief from tens of thousands of seizures over the first nineteen years of her life. When she began using Charlotte's Web in late 2013, her seizures lessened dramatically and that gaze became ever more penetrating and knowing. We're one of those families you've been hearing about, a family decimated by two decades of uncontrolled seizures, vicious side effects from powerful FDA and non-FDA approved antiepileptic drugs and then a radical reduction when cannbis oil is introduced.

Sophie is not alone. There are thousands of children like her, but they do not have access to CBD.

As her voice, I'm going to talk a little here about what's going on in Washington regarding CBD and hemp. There is a meeting on Wednesday, June 24th to determine the fate of CBD. This is the meeting of Senate members called the Caucus on International Narcotics Control. The Senate Caucus on International Narcotics Control was created to monitor and encourage against drug abuse and narcotics trafficking and to monitor and promote international compliance with narcotics control treaties. 

As you can imagine, that's one scary and powerful group of senators.

How would something so benign as CBD end up in their caucus? Here's a metaphor: We're all in a giant swimming pool, swimming in our carefully marked lanes. The Stanley Brothers are just one swimmer in that pool, along with countless other people growing and making hemp products. There's lots of room. Pharmaceutical companies, namely GW Pharmaceuticals, a British behemoth, has a lane, too. They've working on Epidiolex. That's fine. They should have a lane. The really extraordinary swimmers, the lane where all the action is, though, is not this giant pharmaceutical company. The lane that literally came out of nowhere is our lane, and it's made up of hundreds of families whose lives have been changed by CBD -- whether it's Charlotte's Web or any number of strains of high CBD/low THC products. Keep that image in your head.

Here are some facts:

1. CBD and Hemp should be regulated as dietary supplements due to the very low toxicity (LD:50 (lethal dose rating) of 1:40,000 compared to aspirin at 1:20). These products already fill our store shelves in all 50 states with known amounts of THC (less than 0.3%) and unknown quantities of CBD. 
2. There has already been research to establish that 1500 mg of CBD daily was well tolerated in humans.
3. 17 states have passed cannabis legislation since February 2014. That's 16 months. All but three of those are high CBD/low THC legislation. This is an example of the extreme need of this underserved population.

Who do you think is the strongest opponent of this process?

The strongest opponent of this process has been pharmaceutical companies, namely GW Pharmaceutical Company who stands to lose a large part of the market if CBD becomes a dietary supplement. In some states like Alabama and Florida, GW Pharmaceuticals is actually using state funds to pay for their expensive trials.

You do not need legislation to do a clinical trial. This could very well be a serious misappropriation of state and health department funds. Do you want your state paying the tab for a gazillion dollar company?

Here are some more facts:

1. GW Pharmaceuticals partnered with Bayer HealthCare, a subsidiary of Bayer AG. Bayer was on the original ALEC committee that introduced the original medical marijuana legislation back in the mid-noughties.
2. ALEC is the American Legislative Exchange Council, and is just one of the ways that Big Pharma lobbyists write and influence laws in their favor. 

Hmmmmmmm. 

Apparently, GW Pharmaceuticals is fine with cannabis legislation and efforts that would help them to line their pockets, but it's a stretch of the old imagination to imagine them wanting families to get access now to keep their loved one alive, especially if it cuts into their lane. 

We're talking about room for everyone, here, a lane for all swimmers. GW Pharmaceuticals wants the whole damn pool.

At risk of sounding like a conspiracy theorist, let me tell you something.

1. Parents' stories are being discredited. Just think of the disparaging remarks about placebo effects that Dr. Amy Brooks Kayal made on the Dateline special. We are, evidently, a bunch of crazy parents who can't properly count seizures and evidently have voodoo powers to regulate EEGS (that's sarcastic, of course).
2. Doctors who are supportive of CBD are discredited and frowned upon. There's a party line that is being pushed.
3. They're using propaganda to destroy the quality of the product, throwing around the term "artisanal" with the implication that we need the pharma model (despite the fact that we've been safely using cannabis for 1000s of years without that broken model)
4. They're attacking the safety of the product and of the compound in general.
5. In pushing for more research, they used unknowing and inexperienced families with promises of enrolling their children in the trials to push their agenda.
6. In pushing for more research, they're pushing the dosage of the product so high in trials that it creates negative events (so far, diarrhea). It seems to me that they need to prove that this can't exist as a dietary supplement.

Expect them to run their public relations and marketing campaigns (the pharmaceutical advertising budget is in the tens of billions) next on the basis of how wonderful their companies are, and insurance companies will follow suit, covering this "orphan drug" that will reap them untold profits.

In the proverbial nutshell, it looks like Big Pharma wants the whole shebang. It wants CBD to be a pharmaceutical. It's some scary shit.

As people who have been hurt again and again by a broken pharmaceutical system, we will not allow this to happen. You can't allow this to happen. If you think you don't care about CBD, that it's a limited component and that CBD legislation is destructive, think again. I hate to say it, but mark my words: these people will come after THC next. Can these powers be more powerful than the people? They are proving to be so.

We are Sophie's and countless other kids' voices, and we're swimming in a very big pool. We might very well get kicked out this week. Please help us fight for access. This is not about THC. That's another very worthy fight. This is about access to cannabis. It's about fighting the power. It's about doing the right thing. It's about being able to look back into your child's eyes and have them look right into your own soul.

Coalition for Access Now



*This post was co-authored by Heather Jackson, Executive Director, Realm of Caring Foundation