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ehrnst

(32,640 posts)
Fri Apr 20, 2018, 07:24 AM Apr 2018

FDA panel recommends CBD (cannabidiol oil) for pediatric seizure disorders

My dear friend, who I met 25 years ago doing clinic defense, is on this panel.

Your taxpayer dollars are being well spent at the FDA.


Advisors to the Food and Drug Administration have found a generally favorable benefit-risk profile for cannabidiol oil solution in the treatment of two forms of severe pediatric seizure disorders. The drug is under expedited review by the agency.

In a unanimous vote, the 13 members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee found that the benefit-risk profile of cannabidiol is favorable for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in patients 2 years of age and older.

If the FDA supports this recommendation, cannabidiol oral solution would be the first cannabis-based medication approved in the United States.


From the totality of the studies, “We see little evidence that cannabidiol has meaningful abuse potential, even at supratherapeutic doses in adults,” said Katherine Bonson, PhD, a pharmacologist with the FDA’s Controlled Substance Staff, in the Office of the Center Director of the Center for Drug Evaluation and Research (CDER).




https://www.mdedge.com/clinicalneurologynews/article/163796/epilepsy-seizures/fda-panel-recommends-cbd-pediatric-seizure
31 replies = new reply since forum marked as read
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FDA panel recommends CBD (cannabidiol oil) for pediatric seizure disorders (Original Post) ehrnst Apr 2018 OP
There was a very good series on CNN malaise Apr 2018 #1
Her stories of testing the effects of cosmetic hemp oil during the GWB administration ehrnst Apr 2018 #3
Thanks for that malaise Apr 2018 #5
It's a good tool in the tool box. I just want you all to know it works for some not all kids with mucifer Apr 2018 #2
Yep. It should be an option for those that it works for. ehrnst Apr 2018 #4
I've known that since Cha Apr 2018 #6
Here comes Pharma Bro...... getagrip_already Apr 2018 #7
Ganja will soon be legal everywhere malaise Apr 2018 #8
Purity standards often protect the legality of a controversial drug. ehrnst Apr 2018 #9
Yes, purity and standards ARE necessary. progressoid Apr 2018 #11
Hence the very progressive Pure Food and Drug Act ehrnst Apr 2018 #12
Yep. People think big Pharma is bad now. Imagine what they'd be like without restrictions. progressoid Apr 2018 #14
There have been many problems in the supplement industry with truth in labeling ehrnst Apr 2018 #16
If it gets it into the hands of patients who need it, MarvinGardens Apr 2018 #21
Not only that, it's approved for pediatric purposes. haele Apr 2018 #22
I have been trying cbd oil for over a week now for back pain blueinredohio Apr 2018 #10
There have been a few clinical trials of its efficacy in pain relief ehrnst Apr 2018 #13
Depends on the type of pain. haele Apr 2018 #23
Thanks Harley for the information. They also have a cream (salve) form I may try next blueinredohio Apr 2018 #24
This (in body of post) has been a lifesaver for me when dealing with chronic severe pain Lucinda Apr 2018 #26
Have Chronic Migraine Syndrome Heartstrings Apr 2018 #15
Can you have someone pick some up from Canada? ehrnst Apr 2018 #17
I dont think you would want to be caught robbob Apr 2018 #18
True this. I wonder about a Canadian citizen traveling to the US. (nt) ehrnst Apr 2018 #19
If its still a federal crime you could still be busted robbob Apr 2018 #20
Worth a shot..... Heartstrings Apr 2018 #30
I feel for you Heartstrings I suffered with migraines in my younger years blueinredohio Apr 2018 #25
I will check into that... Heartstrings Apr 2018 #29
My sister says blood pressure medication is helping her migraines... Hekate Apr 2018 #27
For some people blood pressure meds do help.... Heartstrings Apr 2018 #28
Message auto-removed Name removed Aug 2018 #31

malaise

(269,054 posts)
1. There was a very good series on CNN
Fri Apr 20, 2018, 07:29 AM
Apr 2018

with Gupta - sanity prevails. Ganja will soon be legal and ganja for medical use has gained significant ground.

Your OP needs to be seen - get thee to the greatest page.

 

ehrnst

(32,640 posts)
3. Her stories of testing the effects of cosmetic hemp oil during the GWB administration
Fri Apr 20, 2018, 07:58 AM
Apr 2018

gave me faith in the FDA.

She presented her findings - that you would need to sit in a bathtub full of hemp oil for three days for it to even register in a blood test were not met with happy faces from the GWB team that wanted to be able to ban it.

She then said, "You know that poppy seed bagel you're eating? That will show up in your bloodwork today. You'd need to ban those before cosmetic hemp oil."

They told her to edit her research to make it more acceptable to them, and she refused. She said, "Here's my research. YOU edit it. I'm a scientist, not a lawyer."





malaise

(269,054 posts)
5. Thanks for that
Fri Apr 20, 2018, 08:01 AM
Apr 2018

"Here's my research. YOU edit it. I'm a scientist, not a lawyer."

Perfect. We need more folks like her.

mucifer

(23,550 posts)
2. It's a good tool in the tool box. I just want you all to know it works for some not all kids with
Fri Apr 20, 2018, 07:46 AM
Apr 2018

seizures. I'm very glad they are doing this.

 

ehrnst

(32,640 posts)
4. Yep. It should be an option for those that it works for.
Fri Apr 20, 2018, 08:00 AM
Apr 2018

And the finding that doesn't have abuse potential even at high doses is very important, and will squelch much of the political ammuntion against it.

Cha

(297,322 posts)
6. I've known that since
Fri Apr 20, 2018, 08:02 AM
Apr 2018

last year. I hope they approve it Federally.

Many states are selling it. I take a smaller measure to help with sleep.

Mahalo, ehrnst

getagrip_already

(14,764 posts)
7. Here comes Pharma Bro......
Fri Apr 20, 2018, 08:26 AM
Apr 2018

While it's great news the FDA is recognizing thew medical benefits of CBD, this is NOT good news.

CBD is simply a plant extract from hemp and cannabis plants. It's very easy to isolate, even in a near pure form, but it is MOST effective when combined with THC. So it's pure form isn't necessarily the best form overall, but it may be for very young children, that's not the issue.

The issue is that once a drug is controlled by the FDA, they quickly move to regulate it's availability and distribution. This will likely lead to having only a few sources available, under pharma giant control.

So an easy to extract plant compound, completely safe even when combined with thc and other plant terpines, becomes highly regulated and priced accordingly. Any doctor who wants to prescribe cbd for these conditions, will have to prescribe this one approved drug source.

While purity and standards to manufacture are great things to have, are they necessary in this case?

Again, it's great the fda is recognizing the benefits of cannabis compounds, but this is where the battle for medical availability will be. Big Pharma will control the market and pricing. Not a good thing.

 

ehrnst

(32,640 posts)
9. Purity standards often protect the legality of a controversial drug.
Fri Apr 20, 2018, 08:37 AM
Apr 2018

Last edited Fri Apr 20, 2018, 09:47 AM - Edit history (1)

In the case of Mifepristone (which is the first part of the regimen in RU486) my friend was also on the panel testing it.

They made strict recommendations as to how it could be used (orally only, not vaginally - which was also a common and effective way to adminster it especially with patients with nausea), and the first dose had to be given by a health provider in an office setting.

While that appears to be restricting the drug and making it less available, it actually was protective of a drug that they knew would be challenged the minute someone had a reaction to it.

If someone who was taking it "off label" had a reaction, the drug itself could be defended against the throngs of anti-choicers, because of the off-use label of it. If the first dose is required to be taken in a doctor's office, there is no way that the claims of anti-choicers that "it could be slipped into a woman's drink without her knowing it" are accurate.

In a scientific setting, they need certain metrics on controls, and the purity of the oil is one of them. Otherwise the data isn't good.

Also, dosage is absolutely important, and impurity - not matter if it's harmful or not - affects dosage.

The job of this panel is to do scientific research, using good scientific methods, so there is no question about the efficacy of a particular substance. They did their job.


FDA Warnings for False CBD Oil Claims

Although CBD oil is widely legal, the U.S. Food and Drug Administration (FDA) are cracking down on placebo products. Back in February of last year, the federal agency distributed warning letters to numerous companies who were actively selling and profiting from products that contained CBD. The reason for the FDA’s action was all down to false claims, with some of the products claiming to cure serious diseases. Not only did this raise concern that customers would refrain from visiting a doctor and taking prescribed medication in favor of the CBD products but also, the FDA discovered that some of the products were completely free from CBD, despite what the scrutinized companies were protesting in their promotional and marketing efforts.


http://www.cannabisfn.com/cbd-oil-legal-u-s-canada/

Better that they answer to the public and not pharma. Public health and safety should always fall under the auspicies of taxpayer funded research.


 

ehrnst

(32,640 posts)
12. Hence the very progressive Pure Food and Drug Act
Fri Apr 20, 2018, 08:58 AM
Apr 2018

Snake oil salesmen will always try to make a buck off people who are suffering, and need to be held accountable by a professional body that answers only to the public.


https://en.wikipedia.org/wiki/Pure_Food_and_Drug_Act

 

ehrnst

(32,640 posts)
16. There have been many problems in the supplement industry with truth in labeling
Fri Apr 20, 2018, 09:28 AM
Apr 2018

and supplements being capsules filled with sand. Until someone investigates for fraud, there is no oversight:

https://www.cbsnews.com/news/herbal-supplements-targeted-by-new-york-attorney-general/

But they are out of the FDA jusrisdiction, unless they make claims that a supplement will treat or cure a condition.

Hence the "This product is not intended to diagnose, treat, cure, or prevent any disease;" or. plural: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease" disclaimer, so they can avoid the FDA inspection and verification requirements for drugs. They are considered food, not drugs.



MarvinGardens

(779 posts)
21. If it gets it into the hands of patients who need it,
Fri Apr 20, 2018, 10:55 AM
Apr 2018

then it's an improvement. Certainly there are problems in the pharmaceutical industry, and yes "they" will control the supply of an approved drug by definition. But it's unlikely to be controlled by a single company since CBD cannot be patented.

haele

(12,660 posts)
22. Not only that, it's approved for pediatric purposes.
Fri Apr 20, 2018, 11:33 AM
Apr 2018

Which implies that at the very least medical use around children can be considered as benign as drinking a glass of wine or taking one's regular medicine around children at dinner - it's not "child endangerment" to have it at home with kids around if stored and used appropriately.

I only agree with you somewhat on Big Pharma.
Luckily, research and studies on unadulterated CBD safety and effectiveness will not be as complex as the research and studies on synthetics and complex biologics - and universities will probably be ready to start much of the groundwork research on the taxpayer dime. From research I was doing for my spouse when he was contemplating medical MJ, there's already been final studies on effective dosages and deployment of CBD for pain done in Europe and with the NIH - two years ago.
I used those studies to figure out how much CBD oil (from a reliable source) I needed to use to make and "dose" his edibles to be effective on a daily and not impact his cognitive and reactive awareness. (He had to go with edibles because I work in a field where drug-testing is always a possibility.)

CBD studies will probably be closer in complexity to studies on salicylic acid. Compounding pharmacies will be able to replicate much of the components at a reasonable cost - especially since politicians like Weld and Boehner are already getting involved in Cannabis products.

So I don't think CBD-based products would end up being outrageously expensive, either from a manufacturer or from a compounding source. It's the specialty synthetics and genetically designed drugs that burden the patient.

Haele

 

ehrnst

(32,640 posts)
13. There have been a few clinical trials of its efficacy in pain relief
Fri Apr 20, 2018, 09:00 AM
Apr 2018

There was a review of studies done a few years ago that concluded that it was effective in some cases.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2503660/

haele

(12,660 posts)
23. Depends on the type of pain.
Fri Apr 20, 2018, 11:49 AM
Apr 2018

Spouse has fibromyalgia and arthritis. CBD oil works for him in a cream form with a few other components that a trusted source created for her mother who has the same issues. He also takes methotrexate and Humira (a bi-weekly injection that costs $2800 a shot if you don't have insurance and a discount plan...) to keep the physical deterioration at bay, so there's several things going on there.
But CBD oil has never worked for his muscle pain, nor for sprains or other strain or tension type pain. A prescription cream called Voltarin and a TENS machine works better for those.

Haele

Lucinda

(31,170 posts)
26. This (in body of post) has been a lifesaver for me when dealing with chronic severe pain
Fri Apr 20, 2018, 07:40 PM
Apr 2018
Nutiva Hempseed Oil

It works amazingly well as a massage oil. I have ZERO working hip joints, and there are times it helps when my pain meds don't even get close. Seriously, I tell everyone to try it. It is amazing. Massage in, get under the covers and let it do it's thing.

CBD is great for things like seizures, and it also works extremely well combined with Kratom for opioid withdrawals, (it helps with the side effects while the Kratom helps the pain) but I have never seen CBD alone touch pain.

Heartstrings

(7,349 posts)
15. Have Chronic Migraine Syndrome
Fri Apr 20, 2018, 09:22 AM
Apr 2018

My neurologist would prescribe any cannabis product, if it were legal in my state. She's a believer! However, instead of cannabis, she's "forced" to administer Botox treatments....30 shots of poison around the hairline and other points, every 3 months, no proven success rate and $3,000. a pop! No thanks....

 

ehrnst

(32,640 posts)
17. Can you have someone pick some up from Canada?
Fri Apr 20, 2018, 09:35 AM
Apr 2018

I would not want to try to verify the purity, or ingredients in regular, unlicensed mail order CBD sources, but the Canadian government inspects any drug that comes into Canada that is intended for dispensing to Canadians, and licenses sources.

FDA Warnings for False CBD Oil Claims
Although CBD oil is widely legal, the U.S. Food and Drug Administration (FDA) are cracking down on placebo products. Back in February of last year, the federal agency distributed warning letters to numerous companies who were actively selling and profiting from products that contained CBD. The reason for the FDA’s action was all down to false claims, with some of the products claiming to cure serious diseases. Not only did this raise concern that customers would refrain from visiting a doctor and taking prescribed medication in favor of the CBD products but also, the FDA discovered that some of the products were completely free from CBD, despite what the scrutinized companies were protesting in their promotional and marketing efforts.


http://www.cannabisfn.com/cbd-oil-legal-u-s-canada/

Here is a list of MMPR registered, licensed sources in Canada:

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-use-marijuana/licensed-producers/authorized-licensed-producers-medical-purposes.html


CBD is medically approved in Canada and it can only be accessed by patients in possession of a valid ACMPR.

Companies that wish to produce and sell the CBD products have to be licensed by Health Canada and patients who wish to buy must have a prescription. Speak to your Doctor about whether medical CBD is right for you. If your Doctor is unable to sign then see https://lift.co/doctors, some will even Skype online.


https://www.cbdoilusers.com/cbd-oil-canada/

I'm not sure if your physician could write a prescription directly to the Canadian pharmacy?



robbob

(3,531 posts)
20. If its still a federal crime you could still be busted
Fri Apr 20, 2018, 10:45 AM
Apr 2018

prescription or not. I was told if one wanted to vacation in Colorado to check out the dispensaries you should NOT say anything at customs or you could be refused entry!

blueinredohio

(6,797 posts)
25. I feel for you Heartstrings I suffered with migraines in my younger years
Fri Apr 20, 2018, 12:26 PM
Apr 2018

It was horrible I must have outgrown them as I rarely get a headache anymore. Both parents suffered with them. To get to my point my niece also has them, she said she called some cbd oil and instantly her headache was gone. Can you order it online?

Heartstrings

(7,349 posts)
29. I will check into that...
Sat Apr 21, 2018, 09:15 AM
Apr 2018

Migraines are very hereditary but unpredictable. Unfortunately, mine were passed down from both sides. My son started getting them at age 8, my daughter has never had one. My 8 year grandson has had 2 episodes.

So glad yours have gone away! And that your niece has found some relief! I will look online and also in the "head" shops in my college city.

Thanks so much!

Hekate

(90,714 posts)
27. My sister says blood pressure medication is helping her migraines...
Sat Apr 21, 2018, 03:46 AM
Apr 2018

That was new info for me; I'm just happy this is helping. (I don't think pot is legal for her in her state.)

Our next door neighbor smokes pot for his migraines, and has for years, long before it was legal here in California -- I'm sorry this is not accessible for you to at least try.

Heartstrings

(7,349 posts)
28. For some people blood pressure meds do help....
Sat Apr 21, 2018, 09:09 AM
Apr 2018

I've been on them, also meds for epilepsy, Alzheimer's, seizures, anxiety, etc. We've tried everything.... currently my neuro has me on just supplements. At least they aren't poison. Barometric pressure is my biggest trigger and I have no control over that.

I take advantage of local sources for the natural relief, if you catch my drift....

The migraines are something I just live with and tell myself it could be so much worse. Still, if this alternative was available, my life could be so much more productive.

Thanks for the info, I'm glad your sister and neighbor have found relief!

Response to ehrnst (Original post)

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