Amylea’s Story: The First Baby to Receive Cannabis Oil for Seizures
Today we’ll discuss a history making case. It’s concerning the very first baby to receive cannabis oil in a hospital setting in 2016. This case has several implications that I think are important which we’ll discuss momentarily. It also raises an interesting point regarding CBD oil versus cannabis oil. There exists plenty of confusion both legal and medical regarding the use of CBD oil. In fact, entire states in the USA are wrestling with the legalities of CBD oil as if it were a separate Schedule I drug.
CBD IS NOT THC
You may not be aware of this but CBD oil is very different from whole cannabis extract oils. The whole plant extracts are typically referred to in the cannabis community as either Rick Simpson Oil, hash oil, cannabis oil, essential oil of cannabis or by several other “New Age” sounding names invented by their users for brand recognition and other business reasons.
Regardless of the various monikers they are all essentially the same, differing only in the cannabinoid ratios sourced from different varietals. But that’s RSO or its congeners; and they all contain large amounts of THC by design. On the other hand, CBD oil, which does not contain THC, is already legal – full stop. Anyone can order this product and have it delivered to their door.
It’s vital to know just what exactly the patient is receiving since the ingredients may make the difference between stopping seizures or not or surviving a cancer or dying. It’s even more important to understand that if a patient needs CBD oil only, they can obtain it from dozens of sites that offer Legal CBD oil that has only minute quantities of THC if any. That’s precisely why it is legal.
Yet, there exists in the literature a profound lack of knowledge concerning the legal use of CBD oil. Many people, politicians, law enforcement, lay public are constantly embroiled in discussions or grass roots movements to legalize the use of “CBD oil” in their particular area. Yet, it’s already legal. One need only do a cursory search to reveal this fact.
What this means for the patient is this: if you suffer from a condition, such as a rare seizure disorder requiring the daily use of, for example, Charlotte’s Web, then you may also equally benefit from any CBD oil of the same concentration. Plus, it makes procurement as easy as using a credit card on one of dozens of websites located all over the world. The only real problem I see are the charlatans selling raw hemp oil passed off as CBD oil for example. It is a real problem so be wary.
Returning now to our case study. The Nunez family brought their little girl Amylea, home in December of last year. By every indication their little girl was a picture of perfect health. That is, until she started seizing on day two of her return home. Apparently Amylea has such a strange and novel form of epilepsy that neurologists are having a vexing time trying to give it a name, a diagnostic name. For now, we’ll simply say that it is a rare form of epilepsy which has no cure; and where the current hospital formulary has no specific medication that can arrest her seizures in a consistent and efficacious way.
When they heard the bad news from their doctor they decided to move to Aurora, Colorado so that Amylea could stand a better chance of successful treatment. There, at Children’s Hospital, she was continued on her sub-optimal antiseizure medications as the family scrambled to find an effective cannabis-based prescription. Not only were the traditional antiseizure medications less efficacious but they were exacting a toll on Amylea’s liver.
One should know that conventional medications used for treating chronic seizure disorders often have intolerable side effects ranging from affecting mood and emotions to physical insults such as hepatotoxicity.
At Children’s Hospital they had the option of trying a fairly new cannabinoid product called Charlotte’s Web. This is virtually pure CBD with a small amount of THC in it.
“The [conventional] medication she’s on is hard for her liver, and so we’re trying to do something different that’s not so bad on her body,” Ernie [the father] said, explaining why the couple has decided to use cannabis oil.
When the family heard about the seemingly miraculous effects of the cannabis oil known as Charlotte’s Web, they became hopeful and set out to get it for their daughter.
Charlotte’s Web is a strain of cannabis named after a young girl, Charlotte Figi, whose life it quite literally saved. Charlotte had her first seizure when she was three months old. Over the next few months, she had frequent seizures lasting two to four hours, and she was hospitalized repeatedly.
But her parents found a strain of cannabis that turned their daughter’s suffering completely around. Since then, countless other children have had their lives changed by this amazing plant.
“I sat for a good three weeks fighting with the doctors and trying to talk them into giving me the okay,” Nicole said. “I’ve been working with the case study team and the neurology team here at children’s and I’m hopeful this will work.”
This week, doctors finally agreed to let the cannabis oil into the hospital to treat Amylea.
“For us to get the approval for us to administer it while she in the NICU [neonatal intensive care unit] while she’s a patient…it’s kind of like a miracle,” Nicole said. “Because they were completely against it saying, ‘No you can’t do it, you have to wait until she’s an out-patient.”
Note that even in Colorado, the most liberal state in the US regarding medical cannabis, it was still an uphill struggle getting pot savvy doctors to agree with what they already know to be a win-win situation for all involved. In the end, the family had to procure and administer the drug themselves. Hospital personnel were not allowed to access nor distribute the drug to Amylea for unknown reasons. In spite of the fact that it is completely legal to do so.
After only a couple of doses of this new medication a change was already noted by parents and nurses. Amylea is the first and now the youngest patient to receive cannabis in a hospital setting. This historical development should help to ease the transition for other doctors in Colorado to do the same. From the looks of it, that is by their surprising antagonism to administering cannabis oil to Amylea, it seems warranted.
It’s interesting that these doctors were initially reluctant to use a medication that’s perfectly legal. I find it surprising and a little confusing. However, this is truly an historical event. Think about it. We now have conventional doctors using an “illegal” drug in their own hospital to treat a seizure disorder rather than using their hospital formulary drugs!
SEIZURES DON’T JUST LOOK DANGEROUS, THEY ARE DANGEROUS
As a physician anaesthesiologist I have seen my share of seizures. Generalized tonic-clonic seizures are shocking and dramatic to say the least. Furthermore, you often times feel helpless when witnessing these events in a community setting where medications are not available. Such as one might come upon at a shopping mall or other venue. That underpins a perplexing point: why their neurologist already hamstrung with ineffective drugs, can stand by idly watching a newborn seize uncontrollably knowing that you have a harmless material that will probably stop it cold.
Not only is an uncontrolled seizure a scary event to witness, but it also carries with it the risks of death or permanent brain damage; and it does not take much time to accomplish these dramatic downturns. It would be helpful if I knew why these physicians did not want to use an effective, safe and legal substance immediately.
This also points out the hypocrisy of our current legal system’s response to medical cannabis. Here, we have one state allowing the use of a highly effective drug for which no other compares. In fact, it’s the ONLY drug which works on this baby and hundreds like her who suffer from novel and rare seizure disorders. But should you live in a cannabis unfriendly state—sometimes only a few miles in difference—you cannot and will not have access to Charlotte’s Web.
Should you or your loved ones try to procure and use it, you may find yourself in court hopelessly trying to explain how you could not tolerate watching your child suffer any longer. Generally, this falls on deaf ears. You may face jail time while your child suffers even greater assaults from those that are here to help such as child protective services.
If we can conclude anything so far on the research findings of cannabis, we can say with some confidence that some preparations of cannabis are indeed very, very effective in reducing seizure activity in rare, untreatable seizure disorders. We already know this.
When the same amazing plant that has changed the lives of epileptic children, and treated countless others, is being used in a hospital in one state, while being the cause for kidnapping and imprisonment by police in another state, something must be done.
Those who continue to lock people in cages for possessing this plant would be wise to refuse further orders to do so. If police wish to be on the right side of history, they should not wait for legislation to tell them to stop kidnapping and caging people for a plant, they should simply stop doing it.
How do I know this? Well, we finally have clinical research which supports cannabis oil’s efficacy in treating rare seizure disorders such as Dravet syndrome. For example:
CBD EFFECTIVE IN PREVENTING SEIZURES
A new study was published in 2015 by a team of neurologists at NYU’s Langone Medical Center which clearly demonstrated that one cannabinoid called cannabidiol (CBD) was effective in arresting seizure activity in treatment-resistant epilepsy in children and adults with either Lennox-Gastaut or Dravet syndromes.
This study was headed by principal investigator Dr Orrin Devinsky director of the NYU Langone Comprehensive Epilepsy Center. The ground breaking findings were presented at the American Academy of Neurology’s 67th Annual Meeting in Washington, DC, April 18 to 25, 2015.
Anecdotal reports of cannabidiol’s efficacy for epilepsy have been widely reported in the media, leading some families to move to areas of the country where medical marijuana has been legalized. But until now, the compound has rarely been studied scientifically, notes Dr. Devinsky.
“Seizures that don’t respond to medication or surgical treatments can be devastating for sufferers and their families,” says Dr. Devinsky, a professor in the Departments of Neurology, Neurosurgery, and Psychiatry at NYU Langone. “Trials like ours are crucial to helping families know whether a compound like cannabidiol might provide safe and effective help.”
The study had a decent number of participants totalling 213. The experimental group included ages between 2 and 42 years old with a median age of 11 years old. It took place at 10 U.S. centers that were granted FDA-approved open-label Expanded Access, including NYU Langone. Patients qualifying for the study had to have a treatment-resistant epileptic condition, such as Lennox-Gastaut and Dravet syndromes. Other disorders were not included.
All of the patients were given CBD oil with an unknown initial dose. Over twelve weeks, the dose matured to 25 mg per kilogram per day. So in a 70 kg patient—which is about average for an adult—this comes out to 1,750 mg per day. That’s a fairly large dose considering the average patient using CBD oil for other health reasons might be closer to 50 mg per day or more.
Not everyone who was enrolled in the study stayed in it. Out of 213 patients 137 completed the study. The results were truly impressive and quite unexpected. They found an astonishing decrease in the number of seizures by an average of 54%! To give you an idea of how good this response is let’s compare it to the best statin studies which only showed a decrease in cardiovascular risk by up to 30%.
You might wonder why so many dropped out of the study? We don’t know why the majority dropped out but 6% (twelve patients) dropped out because of the side effects of CBD. Interesting, because CBD has very minimal side effects. However, as stated earlier, this is a huge dose of CBD so side effects become much more prominent at these dosages. Some of the most frequently reported side effects were feeling overly sedated, diarrhoea, fatigue, and decreased appetite. These constitutional symptoms stack up poorly to the profound adverse effects of some anti-seizure medications. Again, I am a little flummoxed by these assertions since those enrolled are veterans of horrific side effects. Often times these patients have to deal with much greater levels of fatigue, sedation and sometimes the opposite such as manic symptoms or profound personality changes, or just simply feeling muddled all the time. There’s more to it.
I know from personal experience that the average patient would be spending about $560 USD per week for this amount of CBD from a commercial supplier. Each of their 30ml bottles contains 1,500mg of CBD. That’s about one bottle per day for an adult. Much less for a child.
That translates into a small fortune for most. This expense is just another bad side effect for those that suffer from these terrible conditions. It also means that hopefully, when this is all worked out, your insurance company will be picking up the bill. I don’t imagine this becoming a reality for another ten years. Consider also that pharmaceutical versions of CBD oil will be ten times the cost of boutique produced, small batch, CBD preparations.
There’s already an enormous, built in patient population just waiting to try a safer and perhaps more reliable medication too.
About 5.1 million people in the United States have been diagnosed with epilepsy, according to the Centers for Disease Control and Prevention. About one-third of them have seizures that cannot be controlled by medication. Severe forms of epilepsy, such as Lennox-Gastaut syndrome and Dravet syndrome, are marked by frequent, treatment-resistant seizures.
Some final words on this study that we need to consider which in time may be remedied with larger, more powerful, and easily reproducible studies.
The biggest drawback to this study was the fact that it was an open-label trial. In an open label trial, all of the participants, both clinicians and patient participants, knew what they were receiving. In other words, the attending physicians, the nurses, the research coordinators and anyone else directly involved in the study, including the patients themselves, know that they are receiving the active drug. Sometimes this means that the study may be biased, that a large percentage of positive responses may in fact be placebo responses. There are other ways to perform clinical trials that are designed to thwart this effect.
The team’s next approach is to get permission to perform a gold-standard trial. This new trial which is intended to reduce the placebo effect, is called a randomized, placebo controlled, double blinded, crossover study. Should the results hold, it will provide the much needed clinical support that cannabis preparations often lack.
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