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Staking Claim to Medical Cannabis Research

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Because the federal government (FDA and NIDA in particular) continues to claim that medical cannabis has no proven clinical benefit, marijuana is burdened with a Schedule 1 restriction, thereby limiting opportunities for research to prove the efficacy and safety of cannabis for the treatment of medical conditions. Clinical research on cannabis has also been limited by the lack of patent protection for most cannabis strains. Formulation science enables IP for alternative extracts and cannabinoid combinations to offer differential treatment effects specific to a disease or condition. With clinical trials demonstrating the efficacy of medical cannabis for the treatment of a disease indication, as per FDA standards, the company that manufactures the product can make label (package insert) claims to overcome the federal challenge.

How can we expand opportunities for clinical research in the medical cannabis space?

Cannabis
Clinical Research
Package Inserts
Richard Purcell
25 months ago

7 answers

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CNN report (https://www.cnn.com/2018/04/19/health/fda-committee-marijuana-drug-epilepsy-bn/index.html):

"A US Food and Drug Administration advisory committee on April 18, 2018 unanimously recommended approval of an epilepsy drug that would be the first plant-derived cannabidiol medicine for prescription use in the United States.

The FDA will vote in June whether to approve the drug, Epidiolex, an oral solution, for the treatment of severe forms of epilepsy in a small group of patients. The FDA has approved synthetic versions of some cannabinoid chemicals found in the marijuana plant for other purposes, including cancer pain relief.

Cannabidiol, also called CBD, is one of more than 80 active cannabinoid chemicals, yet unlike tetrahydrocannabinol, or THC, it does not produce a high.

The committee's recommendation was delivered after reviewing data from the drug's maker, GW Pharmaceuticals PLC, a UK-based biopharmaceutical company."

I am not sure if this CBD product will get the FDA approval, but the experience from the drug's maker is highly valuable for medical cannabis clinical research and development.

Weihong Lai, MD, PhD, MMCi
25 months ago
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I'm sorry, this is not an area of expertise for me.

Richard Bohannon
25 months ago
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I am conducting the pilot study on medical cannabis and brain electrical activity (QEEG-brain mapping) before and after medical cannabis administration (CBD and/or THC) in medically approved conditions in the state of Florida (epilepsy, Parkinson disease, chronic pain, Cancer, Multiple Sclerosis, PTSD/anxiety). So far the results are very promising however we would like to get an external funding to accelerate this study. Once more evidence of beneficial effects is available the change from schedule one to another will be possible. I would be glad to explore any collaboration/funding on this project.

J. Lucas Koberda, MD,PhD,
25 months ago
Dear Lucas in your cohort do you include teenagers? - Amelie 25 months ago
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some countries like Swizerland have cannabis intake legal. The clinical trials can be performed in such countries.

Hussam Abu-Farsakh
25 months ago
It would be also possible in Neederland. - Amelie 25 months ago
Trials must be strictly supervised. - Dr. David E. 18 months ago
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Candy is Dandy
Liquor is Quicker
POT is NOT!
By Ogden Nash
 
I have only seen serious side effects not yet documented in the literature. Side effects of unprovoked aggression, anxiety , insomnia, depression, osteoporosis, hypogonadism, and thyrotoxicosis, etc.

Crimes committed like assaults they were unaware of. All patients were young 16-30 age groups . The psyche groups don’t have a clue.

Treatment with melatonin, HRT, vitamin D and support worked wonders .

Please share your thoughts?

Dr. David E. M
17 months ago
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MARIJUANA?

I think the terminology should be corrected.

Marijuana contains THC as its active ingredient and that is the one that affects certain conditions. It is available in multiple forms, some in conjunction with CBD.

Using the word marijuana has some negative connotations which some still find offensive.

Any thoughts?


Dr. David E. M
17 months ago
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Canada has recently made it legal.

This may help a bit https://www.thegrowthop.com/cannabis-health/whats-going-on-with-marijuana-research-in-canada

Hitesh Mathpal
17 months ago
Great news = patients should feel free to go to Canada. - Dr. David E. 17 months ago

Have some input?