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Re: DarthYoda post# 25411

Tuesday, 08/30/2016 10:31:18 PM

Tuesday, August 30, 2016 10:31:18 PM

Post# of 51845
1- What I meant was that I'm trying to discuss how FDA should be able to regulate it going forward. You keep trying to steer the conversation towards the DEA's stubbornness in keeping it a schedule I controlled substance. That is a separate topic. I'm very aware of the science regarding marijuana. I know that:

a) We are still very early in research phase and it's premature to tout scientific evidence in any pro or con conclusions. Israel has been doing research for decades and they still have a ways to go. There is so much more data that needs to be understood. If a study cites the possible benefits of marijuana, and the research performed is in lab animals, then that study is still in the theoretical stage. That is a very important aspect that one should not overlook in these articles. Ample human testing needs to be performed as proof of concept. Many theoretical treatments fail to achieve their intended purpose. The pharma company that is researching CBD for the treatment for Dravet and LGS does have a study that failed to achieve its intended purpose. Last time I checked, it was in limbo.

Information about the research process:
http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405382.htm

b) Many of the studies are flawed and scientists and medical professionals state they need much more (reliable) data.
The Journal of American Medical Association recently published a study of those clinical studies. They evaluated 28 trials with almost 2500 patients. The evaluation was performed independently by 2 reviewers. Those reviewers found that the quality of the data was moderate and wouldn't have passed FDA review. Now does that mean that cannabis couldn't prove to be effective in similar studies? No. It means that the studies that were evaluated may have been poorly designed to support their findings. Study design is very important in research. Now that things are opened up more, perhaps we will see standardization in clinical studies and more thorough data.

http://www.latimes.com/science/sciencenow/la-sci-sn-medical-marijuana-review-20150623-story.html

Some of the best human data we will have (to date) will come from the clinical trials for Dravet and LGS. Even then, much more data is needed, esp from the THC side of things.

What is encouraging is that DEA is now allowing the testing of marijuana on symptoms of PTSD, after stalling for years. As I've said before, their stance and stubbornness is a separate topic. DEA's stance does still complicate things down the road. We'll see what happens.

2- They ingest cartons knowing the link between cigarettes, heart disease, cancer, etc. People are ingesting marijuana derivatives with the belief that no long term damage will occur. We do not have sufficient clinical studies to prove that theory for all cannabis derivatives. Someone who likes to smoke a joint that has 17% THC may be fine. Someone who likes to dab highly potent oils may not be.

3-Since you wish to stray offtopic: we needed research to be able to tell us that 1 in 1000 men have breast cancer, while 1 in 8 women are at risk of being diagnosed with cancer. How "safe" boobs are depends on your gender as well as other factors.

http://www.cancer.org/cancer/breastcancerinmen/detailedguide/breast-cancer-in-men-key-statistics
http://www.cancer.gov/types/breast/risk-fact-sheet

4-Your straying away from the discussion about the body's ability to absorb vitamins and nutrients and discard the excess now leads us to how things are regulated. Vitamins are known as dietary supplements, not medicine(drug). Dietary supplements are not produced or marketed to prevent, treat, or cure a disease/sickness. Seeing that people have varying diets, they may not receive the recommended amount of nutrients, supplements can be used to increase daily intake. People are just recommended not to take more than the recommended amount. Since medicines (drug) are used to prevent, treat, or cure a disease/sickness, they have more federal requirements.

http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#D
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm050803.htm

My "need" for more (substantial) data comes from my science and engineering background, plus my interest in pharma stocks over the years.

5-What I was saying is that the information that the DEA based its decision on was outdated. I have seen FDA change its position when it was presented with more information on something it regulated (shortwave therapy vs. diathermy). While FDA said that there is no evidence to support medicinal benefits in 2015, they could pivot from that in 2017/2018 with more (substantial) data.

6-It wasn't "fear mongering". You comment about science in your 1st question, well science is evaluating the effects on the human brain. The more balance articles will address the pros as well as cons that scientists are exploring.
https://www.leafly.com/news/health/how-marijuana-affects-the-brain
http://www.livescience.com/51981-does-marijuana-change-the-brain.html
Basically, scientists state that they need more research because much more data is needed to untangle the effects on the human brain at various stages. Some scientist say they are noticing changes, some say they don't. Problem is that they may be looking for different things.

By concentration, I'm talking about potency of THC and CBD compounds in the cannabis derivatives being taken by consumers. The exposure varies on the potency and how the person consumes it. A casual weed smoker may not see the same THC exposure as someone who ingests an edible. Neither may have the same exposure as someone who dabs. As the Leafly article discusses, the biphasic effect means that the right dosage may be provide the optimal experience with marijuana. Too high of a dose is where the issues may arise. The potency of CBD in Charlotte's Web is much greater than that of a standard recreational joint. Those growers have researched and cross-bred plants to achieve the potency found in it. As of right now, the only side effect is dizziness.
https://www.leafly.com/sativa/charlottes-web
I wonder what that CBD potency is. As science gets more involved in the research, the potency could drastically increase. Then those side effects have to be evaluated and scientists would have to determine the lasting effect.

While you assumed that I was not aware of the information that you pointed out, I was 1st introduced to the concepts in Dr. Sanjay Gupta's documentary on medical marijuana back when it first aired back in 2013. As many know, he is one of medical marijuana's more credible advocates (world renowned neurosurgeon) after starting out as an opponent.

He traveled the world researching marijuana and provided a well-balanced evaluated the benefits as well as scientific-related concerns. He addressed the concerns about the developing brains of youth.

My posts are solely my opinion unless presented with (or directed to) factual information. All investors are strongly encouraged by myself to do their own due diligence before making an investment decision.