Epidiolex - The next step for medical Cannabis

in #science2 years ago

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By micripper on pixabay.com


Cannabis. It’s a topic discussed again and again, especially on the internet. Even I have made a post about it 7 months ago, summarizing how cannabis influences our endocannabinoid system. As usual, there are those who strongly support it and those who are strongly against it and, as usual, I think the answer is somewhere in a grey area. It’s not a wonder cure for everything, but it’s also not useless. @suesa

This week, a news article popped up on my feed, which was talking about Epidiolex, apparently, the first marijuana plant-based drug approved by the FDA1.
After seeing this, I did a quick google search to see if there are posts covering this on Steemit and, if yes, how informative they are. Sadly, the top results were just rephrased (or copied) news articles, which is why I decided to give you a slightly more extensive piece on it.



1. The Company2



GW Pharmaceuticals, that’s the name of the company which developed the new drug. It was founded in 1998 and focuses on using cannabis to develop new medications. Knowing that it’s not surprising that they’re the ones pushing everything forward. Funny enough, the fact that it has been founded in 1998 kind of speaks against the often used claim that “all medical research about cannabis is being suppressed by big pharma”, as there was more than enough time to shut this company down in the last 20 years …

Instead, we now have Epidiolex.



2. Cannabidiol (CBD) Oil/Epidiolex



CBD oil is nothing new, as it’s just cannabis concentrate in oil, which makes it easy to ingest (I doubt you can smoke that much), and can be more or less harmful.3. How dangerous it can be highly depends on where it came from. Did you make it yourself? Did your friend, the chemist make it for you? Or was it aunt Mary, who has no idea what’s the difference between olive oil and tea tree oil? Hint: One of them is edible, the other shouldn’t even be used on your skin without mixing it with something else first. And if ingested, it's toxic.

By BelindaNash on pixabay.com

There are many people who have been using CBD, sometimes even for years. Parents giving it to their sick children, because nothing else seems to be working. And yes, therapeutic effects for health problems like epilepsy, Parkinson’s disease, and schizophrenia have been shown to be affected by CBD. But that should always be taken with a grain of salt3.

When does self-medication with alternative medicine become a problem? When you think it’s the only thing you need to cure your disease and refuse proper treatment, as it’s sadly too often the case with cancer.

With some cancers, it might help3. Others just grow faster4. Do you know how yours will react? Are you willing to take the risk? If yes, please only use yourself as a test subject, not anyone in your care.

Generally, CBD oil is supposed to be safe and well tolerated, even free of tetrahydrocannabinol (THC). But again, this depends on where you got it from, who produced it. In the worst case, you get a product contaminated with a lot of things you really don’t want inside your body3.

Now, Epidiolex is CBD purified directly from the plant (not synthetically produced) by a pharmaceutical company, which has to meet specific production standards. It does not have any THC left in it5 and while approval from the European Medicines Agency is still pending6, the FDA has approved it on the 25th June 2018 to be used for treatment of Lennox-Gastaut syndrome (LGS) and Dravet syndrome1.

These two diseases aren’t the only ones the drug is intended for: Tuberous sclerosis (non-cancerous tumors caused by a genetic condition7) and intractable epilepsy (which is characterized by seizures that can’t be controlled with currently available medication8) are presently being looked at as additional targets9.



3. Lennox-Gastaut Syndrome (LGS) and Dravet syndrome



LGS, I’ve never heard of it before looking into this but was horrified by its results. It’s a form of epilepsy that starts during childhood, and the seizures are so frequent that the children suffering from them usually end up having mental disabilities10.

How severe this disease is becomes clear when you look at those who participated in the studies: On average, they had tried six antiepileptic drugs11. Six!

By frolicsomepl on pixabay.com

Dravet syndrome isn’t any better, as it’s also an epileptic disease which usually shows itself during the first year of life12.

For both diseases, there were, in total, three phase 3 clinical trials with a total of 516 patients13.

Of course, there were adverse side effects. I can’t think of a single drug, not even a single food that hasn’t some kind of adverse effects on people. That’s how nature is, nothing works in one way without influencing something else too. What were these side effects? Mostly sleepiness, lethargy, elevated liver enzymes, decreased appetite, diarrhea, weakness, infections13, vomiting, and fever11.

That might not sound too pleasant but were apparently not so common or dangerous that the drug was rejected for medical use.14.



4. The take-home Message



So many people have been pushing to legalize various applications for cannabis, and now this drug has been approved. Has the time for cannabis finally come?

I’m skeptical. In many countries, it’s still recognized as an illegal drug, which can hinder research and the permission to use it in clinical trials. Additionally, it’s still not the wonder cure for everything (remember, the cancer that actually grows faster because of it?), even though many people wish it to be.

I do indeed hope that we will be able to find all possible uses for this plant and, in the process, cure (or at least ease) diseases that can’t be treated yet. Let’s see what the future will bring.


Sources:


1Greenwich Biosciences Announces FDA Approval of EPIDIOLEX® (cannabidiol) Oral Solution – the First Plant-derived Cannabinoid Prescription Medicine

2GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences Announce Publication in The New England Journal of Medicine of a Phase 3 Study of Epidiolex® (cannabidiol oral solution) in Lennox-Gastaut Syndrome

3The Trouble with CBD Oil

4CB2 cannabinoid receptor activation promotes colon cancer progression via AKT/GSK3β signaling pathway

5In the Pipeline-Epilepsy: Cannabidiol Oil Reduces Drop Seizures in Lennox-Gastaut Syndrome

6 GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences Announce Publication in The New England Journal of Medicine of a Phase 3 Study of Epidiolex® (cannabidiol oral solution) in Lennox-Gastaut Syndrome (Yes, I notice that I have this source twice. But I only realized after finishing everything, and editing the source numbers might have created more of a mess than just accepting I have the same source for two numbers.)

7Tuberous sclerosis

8Intracable Epilepsy

9Cannabinoid-Based Drugs Seek New High, Part I

10Lennox-Gastaut syndrome

11In the Pipeline-Epilepsy: Cannabidiol Oil Reduces Drop Seizures in Lennox-Gastaut Syndrome

12Dravet Syndrome

13FDA Approves Oral Cannabidiol for Dravet and Lennox-Gastaut Syndromes

14Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome


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@suesa, I'm curious to know if you see the trend toward legalising recreational marijuana causing problems for for medical cannabis research in the future.

Right now, there is a lot of "hype" about medical marijuana. I'm a person who doesn't believe in bull-shitting, regardless of the potential upside. If I went around saying things I don't believe just because I think it'd be convenient if people believed them, you might hear things like this:

  • I have spoken directly with what the religions of the world generally refer to as God, and It said everyone's cool, so y'all can stop worrying about killing each other now.
  • I have undeniable proof that every single leader of the so-called "free world" is a lizard person; naturally, this means we should all rise up together and abolish government through peaceful collective action.
  • I have insider information that STEEM will trade at $687 by the end of 2020 and if it doesn't, I will eat my antennae on national television.

What I'm getting at is that the medicinal significance of cannabis, while definitely credible in certain situations (and we should keep looking for them!), is way overblown, and I think it's that way because people are looking for a reason-- any reason-- to legalise it. It's an agenda I support, but it is an agenda nonetheless.

I think a lot of the funding and outreach and hype and other societal "support" for these medical research initiatives is going to dry up once everyone can smoke weed whenever they want. The motive just won't be there anymore (and not just because everyone is stoned, either).

This isn't to say that I think weed should not be legal. I'm sure you know me better than that at this point :)

I agree, it's actually something I considered adding to the post and then didn't. While there are certainly people who push for it because of the medical possibilities, the majority likely just wants to smoke.

This could even have other consequences: interactions with other medication is likely. And if everyone is smoking, the actual pharmaceuticals might be much less effective for those people.

I don't really care what drugs people take, as long as others don't feel the consequences (I hate smoking with a burning passion), but yes, the support for medical cannabis is likely not happening because of the healing potential.

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I'll have to beg to differ here... from this article itself it states

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5356589/

To asses our hypothesis in an in vivo model, subcutaneous tumors were generated in nude mice with HT29 cells. Tumor-bearing animals were treated daily with the vehicle, 1 mg/kg JWH-133 or 5 mg/kg JWH-133 for 14 days. Tumor volume was calculated every day, and at the end of the experiment tumors were dissected. As shown in Figure ​Figure6A,6A, tumors increased their growth rate significantly in response to 1 mg/kg of JWH-133 with respect to the vehicle-treated group; whereas a 5 mg/kg of JWH-133 produced the opposite effect, a reduction in tumor growth rate (although significant effect is only observed at day 14).

And, contrary to what they state, we can see a clear deviation in tumor volume in the in vivo study from day 8, not day 14. Sure, they might say the word significant only on the 14th day, but there is already a change from the vehicle well before that from the chart they provided.

The study cites no conflicts, but I am wondering what the criteria to declare a conflict are. So for example, we see Esther Martínez-Martínez cited in this paper:

https://www.ncbi.nlm.nih.gov/pubmed/24910342

whose key results state this

CBD reduced breast cancer metastasis in advanced stages of the disease as the direct result of down-regulating the transcriptional regulator Id1. However, this was associated with moderate increases in survival. We therefore screened for analogues that could co-target cannabinoid anti-tumour pathways (CBD- and THC-associated) and discovered the compound O-1663. This analogue inhibited Id1, produced a marked stimulation of ROS, up-regulated autophagy and induced apoptosis. Of all the compounds tested, it was the most potent at inhibiting breast cancer cell proliferation and invasion in culture and metastasis in vivo.

And to me, it makes the most sense to see the subtle ways in which researchers present their arguments from a somewhat guarded standpoint, as there is no money to be made in declaring CBD as an anti-cancer agent, but perhaps there is money to be made in patenting compound O-1663.

I would take any such studies with a grain of salt, especially when they are writing things that appear to contradict the data they themselves are presenting in order to present a more streamlined narrative.

Personally I am biased as well, so it was a relief to see the 5 mg/kg approach did reduce tumor volume.

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Of course, everything should be taken with a grain of salt and not just accepted at face value. Still, there are so many different cancers, and if people just take random cannabis products to "cure" it, the results aren't necessarily predictable.

I'm all for exploring what possible benefits cannabis has, especially on cancer. But people have to stop randomly using things, believing it'll cure them, just because "big pharma" isn't the one producing it.

Unethical, but it would be convenient for science if everything people ever ingested or were exposed to was tracked so we could unravel the links faster.

And I would definitely have to say that anyone just eating brownies to fight latestage cancer is trying really hard to select themselves out of the gene pool.

Not just eating brownies, smoking joints and drinking oil too :P

What's that you say? Smoking brownies, drinking joints and eating oil cures cancer?

420 SMOKE WEED EVERYDAY

Just kiddin'! I hope that rationale attitude towards marijuana will be someday resolved. I see many misconceptions and wishful thinking on both skeptics and advocate for this plant

Smoking weed is seriously illegal in my country. Good to always see the article for and against the use of cannabis, a plant as controversial as they come. I'd love to get it legalised though, that way the drug traffickers may look for another plant to peddle :)

This topic will always be controversial especially in Africa. I am not sure which strain is locally available (though I have been told by people from the US, SA, and Ethiopia that Kenyan weed is wack) but I know I have felt extremely guilty for smoking in my house while my son sleeps. Having that in mind plus now getting to know that what those children ingest is even higher makes me sad.

I have watched their stories on a very interesting (weed documentary) series called Weediquette so this helps in understanding some things further. It's good to have you back Queen of Science :)

I'd generally recommend against smoking anything, mostly because you shouldn't inhale smoke.

It's good to be back :)

What is the best to get high on weed then? :(

Lol.

According to my plant physiology professor, you should put it into brownies or similar.

Thank you :)

An oil with a high smoking temp, grapeseed oil for example if you can afford it.

Just saying that healthier oils like that would be better than putting it in, say, butter.

So much ado about Cannabis when there are even more deadly plants out there in the wild with no law guiding their usage. ANyway, taking Cannabis is officially legal in some parts of Canada (if not all), perhaps with regulation.

So glad to see the FDA is finally starting to get on board here! It is not a cure all for everything, your right there, but let's use what it can help with to our advantage instead of just adding to the opioid epidemic!

I agree on that view. Neither to condemn it nor to praise it but to look at the individual. It needs good doctors and people who treat their patients with care. I find that the relationship between doctor and patient is of great importance, too and if my doctor knows me he also can tell whether medical cannabis could be an alternative for my personal case.

I highly dislike this "either, or" attitudes and it's mainly used by media broad casts who need viewer quotes.

Time is, I'd say, nowadays the most precious currency when it comes to dialogues between the one who offers a treatment and the one who needs it.

I am glad to see CBD becoming more standardized and accepted. I hope THC follows suite as well; some of the synthetic alternatives are really terrible.

An extensive write up indeed!

It is a widely accepted belief here in my country that there are plant materials that has some level of therapeutic value against many if not all diseases.
Cannabis is one, over here bitter leaf is another.


However, I have always been of the opinion that nature as the answer to virtually all disease conditions. I believe phytochemicals has this high therapeutic potential but, real time care should be taken to study possible side effects just like you mentioned "I can’t think of a single drug, not even a single food that hasn’t some kind of adverse effects on people. That’s how nature is, nothing works in one way without influencing something else too. "

There are yet some plants out there, of great medical benefits not discovered yet.
Left to me, I want cannabis legalized at least for research purposes. Lets unlock nature's provided answers.

It's also important to keep in mind that, just because something has therapeutic potential doesn't mean the chemicals are in a concentration that's helpful - and not useless or even toxic.

That's something many people forget: Nature doesn't willingly give us something. Most phytochemicals are intended to protect the plant against being eaten.

It's also important to keep in mind that, just because something has therapeutic potential doesn't mean the chemicals are in a concentration that's helpful - and not useless or even toxic.
Oh yes, I agree with this. However, for most of these plant chemicals, I believe the concentrations made available in doses (standardized preparation) shouldn't be too toxic for human use.
Most phytochemicals are intended to protect the plant against being eaten.
Please, can you help me understand why you used "most"? Because I am sensing some high level botanical knowledge in that statement.

Well, I only have basic botanical knowledge, as my degree focuses more on human - and molecular biology. But phytochemicals are generally produced to help the plant thrive, be it to avoid being eaten (most uses) or kill other plants nearby (that's not too rare either).

One thing somewhat related to this topic - I have a small bottle of hemp oil in my fridge. I know it shouldn't contain THC, but can it contain something else, like CBD? This is confusing.

It's not specifically CBD oil, but just hemp seed oil. Should be super healthy, really green and tastes weird.

As I don't know where you got it from, I can't answer this. But I think it should be fine.

A very good point.

I'm not sure if I could get a reply from the producer, as they might want to avoid any stigma that it contains "scary cannabis stuff", especially when Finns are extremely intolerant against anything related to cannabis.

At least they're stating that the oil doesn't contain THC which gets you high.

Then I think it should generally be okay. As usual, licensed companies are safer than random, creepy men in dark alleys.

Last year I saw a kid who suffered from Lennox-Gastaut Syndrome,, it was a really unpleasant experience...Anyway, I read some researchs about using TCH as a treatement for depression any thoughts??

Dangerous, in my opinion. When you already suffer from something that fucks up your brain chemistry, I wouldn't take a drug that has an unpredictable effect. THC could make everything just worse, just as likely as it could help.

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Awesome article and great information. Thanks for sharing. Congratulations on the effort.

Did you even read it? Congratulations on the effort of spamming too :D

What made you think that I haven't read it? I'm from India and I have a family friend and relative with cancer. We even tried to procure it from Afghanistan and Australia but we failed. In India it is illegal. Please don't decide before you are not sure about something.

Many apologies. But... Maybe you should also rectify how you comment because it sounded like a spam. The one above to me seems more appropriate than the first one. Anyway, apologies.

Tezmel is correct, a comment like this, that has no obvious connection to the post, looks a lot like spam. Usually, I would have flagged it.

Ok, if you think so. I'll concentrate more on what I'm commenting. Regards.

Check out my article about the new law in Luxembourg where cannabis has also been legalized for medical use.

Not even a word about my post? Just advertisement of yours? How rude.

GW Pharmaceuticals is a British biopharmaceutical company

GW Pharmaceuticals was founded in 1998 and is listed on the NASDAQ Global Market (GWPH). The company has operations in both the US and the UK.

Source

There was a time that I found it to be the best relief for my chronically itchy skin. It would stop me from scratching in my sleep, which is something that alcohol made far worse.

The THC and CBD in the cannabis plant are not an addictive substance, and as I know they aren't harmful, so it is safe. CBD can help a patient with epilepsy, now what about taking CBD oil to help cancer patient? Does it help or that's just a myth? If not helping with the cure at least can it help with the side effects of a patient taking chemotherapy sessions?

Declaring a hallucinogenic substance "safe" is a bit dangerous. The cancer thing depends on the patient, the cancer, the treatment, the specific CBD oil,...

I can't give you a definitive answer to that.

Marijuana is classified as a toxic substance by the ancient texts on Ayurvedic herbs, but it has been used in healing preparations after purification. It is mentioned in many of the ancient texts on Ayurveda like the Charaka Samhita, Sushruta Samhita, and Shargandhara Samhita. Marijuana is described as a toxic substance by Sushruta and the description of the toxicity of marijuana is elaborated upon by many of the Rasa Shastras (the texts on medicinal preparations made from Metals, Minerals and Toxic plants). We must understand that in most formulas traditionally calling for marijuana in Ayurveda, that the marijuana is now usually omitted due to issues with legality. The use of marijuana in mainstream Ayurvedic practice today is virtually non-existent.

Earlier I posted these pages from my 1936 US Pharmacopoeia, which is the governments official listing and standards for medicines approved for physicians to prescribe. https://steemit.com/life/@qiyi/official-1936-usp-lists-cannabis-as-approved-prescribed-medicine

...which is why I decided to give you a slightly more extensive piece on it.

I like this. It shows good intention on your part. Thanks a lot.

@sciencetech

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