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For my own reference, what studies support conditions being "positively treated with very low concentrations of cannabinoids"?
As far as I know FDA has only labeled cannibidiol as a drug. It is the focus of the major studies. The discussion is not all cannabinoids. If a cannabinoid is marketed as a dietary supplement by a company before it was authorized as a drug for clinical studies, then it may be exempt per FDA warning letters last year.
I will concede that you are right about the chemical process.
I don't see the intentional cross-breeding of plants to enhance certain cannabinoids as "natural". As science furthers in this area, I can see more human tampering with the chemical properties.
You want FDA to regulate like tobacco? Interesting because they can set limits on the amount of nicotine.
It isn't what the FDA determined for themselves. FDA doesn't acto alone in making decisions. They also have advisory boards of independent specialists to help determine a ruling. Only thing they have determined is that they want more information before moving forward with regulation. Perhaps the opiod epidemic is precisely why they are being sensitive to this topic.
Your avoidance of what was addressed by the Leafly article, as well as the specialists in the Weed video concerning the effects on developing brains, proves that you are willing to accept some scientific research that favor your beliefs, but will disregard concerns in other research and dismiss it as "fear mongering".
The end of the fiscal year is 6/30. Their 10-K is due at the end of September.
Again that's great. I'm glad Google is working for you. I'm sure many things in nature have cannabinoids just like the breast milk you keep bringing up. What I have been referencing over the past few days involves the specially manufactured cannabidiol for the specific purpose of being used as medicine as well as the much higher potent THC strains or marijuana derivatives.
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.
I'll only address a handful of things here b/c it is getting late.
First, not sure why you posted links to the reasons why marijuana is illegal. We are not talking about the legality of marijuana from a broad POV, we are talking about how to regulate it.
Second, from research, we know that the human body absorbs around .1 mg of nicotine for every 1.2 mg of nicotine found in a cigarette.
http://www.med-health.net/How-Many-Milligrams-Of-Nicotine-In-A-Cigarette.html
That is close to what it was several decades ago (1-1.5 mg per 10-14 mg).
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2953858/
FDA setting a threshold limits the amount of exposure per pack. Typically cigarettes contain between 8-20mg of nicotine. Some may contain a little more than 20mg, but the average is closer to 12 mg. We'll see if they change that limit with their new power. Again, the difference between nicotine, alcohol, and THC/CBD is the medicinal benefit.
Third, the disconnect in this debate is that you are giving CBD levels from the lower end of the spectrum via breast milk. The medicinal grade CBD levels that are currently being tested are further down the spectrum. We will have a clearer picture on efficacy levels when more clinical tests are performed on thousands of more patients and threshold levels can be established.
Fourth, we don't know how different people would treat excess amount of the chemical substances. Daily dose of vitamins and nutrients are good for you, but an excess can actually have both short term and long term negative effects (ie. kidney stones, hardening of arteries, etc). That is where clinical studies come into play.
Fifth, FDA created its report for the DEA last year. They basically said there is no approved use of marijuana for medicinal purposes. That is true. Since then, we have more data from the Dravet and LGS clinical trials from this year. By next year, their attitude may change if that company receives approval for the treatment of Dravet Syndrome.
Sixth, kids are being exposed to high levels of THC to treat ailments due to life threatening diseases such as cancer, so we will have to find out the effects of higher concentrations on developing bodies.
Are you saying that the CBD concentration levels found in breast milk are the same as those found in the formula for Charlotte's Web to treat seizures? As it was pointed out in the Dr. Sanjay Gupta documentary, those levels were very high and specially grown in Colorado. People from around the country (at the time) had to fly to Colorado for that particular strain.
My point is that just because the body produces a chemical, doesn't mean the manufacturing of the same chemical for commercial public use shouldn't be regulated. As I said in a previous post, you can grow your own food. The issue is when you grow food and try to distribute it to others. I gave 3 specific examples where regulation benefits consumers. As I said before, it's not an efficient system.
One issue we do have is that we don't know what the long term effects of high concentrations of the various chemical compounds in marijuana have on a developing body. We also don't know how they interact with other chemical compounds.
FDA does provide some regulation in the cigarette industry. Recently, their power over the tobacco industry was expanded. Their main requirement is for the industry not to exceed certain nicotine levels.
I said a positive decision that would at least open up research on marijuana since they had said they didn't want to limit research. I thought the furthest they would go would be rescheduling to II or III (slim chance at the latter). I also said that descheduling wasn't going to happen, so forget about it. They didn't go as far as I hoped, but they did open up an avenue for more research by taking away the monopoly.
A study suggests that the human body may produce small amounts of morphine. Should the FDA not regulate that either?
http://news.nationalgeographic.com/news/2010/04/100426-natural-morphine-drugs-humans-mice/
I've addressed what you've said in previous posts. I'm talking about tighter regulation at higher levels of CBD and THC (ie medicinal grade). Lower levels would be regulated the same as the food industry.
Actually I said it would come sometime in the 3rd or 4th quarter. Seeing that people were still anxious that a memo gave soft deadline of the end of the 1st half of the year.
Yep, just like I was wrong about July 5th.
Alcohol isn't being specially produced to treat various forms of diseases, such as epilepsy.
*FDA oversees production plants.
Was in a hurry and that line was redundant.
FDA oversees the production facilities of production plants.
Again the difference and where it's apples and oranges with alcohol is b/c of the medical benefits of marijuana. FDA does regulate medicine for the treatment/cures of diseases.
I'll go more in depth as to how regulations can work, and try to stay ontopic (meaning I can't give the specific company names). I'm not saying it's a perfectly efficient system, but it is a preventative one.
There is one particular drug company (who is sort of the laughing stock of the biopharm investing world) that tries to grab attention anytime a new disease causes panic. They did it with Zika, Ebola, etc. They claim that their drug may be able to treat those diseases. Problem is that they don't have proof, which is what FDA wants in order for that company to market and sell their drug for those conditions in the US. If there weren't tight regulations, they could advertise those claims and sell it to the panic-induced, unsuspecting public for whatever they decide to charge. It should be noted that even if a drug is approved for one particular treatment, it cannot be marketed for another. That violates FDA policy.
Second example is more specific to the hemp/marijuana industry. Recently FDA gave warning letters to a handful of companies that were promoting CBD products and touting the medical benefits. The two problems with that were:
a) the medical benefits cited have not been proven yet on humans,
b) several of those companies had less that the advertised amount of CBD.
The amounts of CBD those products had was the bigger issue. Efficacy for the treatment of diseases may depend on the levels of CBD in the product. If you saw the documentary on Charlotte's Web, the parents tried to use certain concentrations of CBD near where they lived. They were not as effective as the much higher concentrations found in the products from a particular Colorado grower. What happens is that some companies will try to piggyback off of that finding to promote their product, knowing that the levels of CBD aren't the same - hence limiting the effectiveness. FDA's approach is that if you are going to make the claim that your CBD product formula can effectively treat a disease or condition, you need to prove it.
Third, FDA would oversee the production of marijuana products for standard commercial use. One such issue that arose recently was the use of certain pesticides in the production process. Keep in mind that not everyone is going to grow their own weed. People can grow their own food now, but prefer to buy it from somewhere b/c it is easier.
https://www.leafly.com/news/headlines/pesticides-101-questions-and-answers-for-cannabis-patients-and-co
http://agr.wa.gov/pestfert/pesticides/pesticideuseonmarijuana.aspx
The crux of the pro-marijuana argument is the medicinal benefits of the plant. What many proponents are essentially saying is that they want access to a form of medicine, but they don't want that medicine to be regulated by the governing body that was created to regulate medicine. You aren't going to be able have your cake and eat it too.
The "my way is the only way" approach is why we have a deadlocked government on so many different issues, not only marijuana. There needs to be compromise between differing ideologies.
Believe it or not, the government regulates the production of food as is to a certain degree. If food is being distributed commercially, then it regulates how it is manufactured and distributed. You can grow your own corn, but if you grow your own corn and distribute it, then there are guidelines. They perform inspections of the manufacturing plants. The government would prohibit the use of certain toxins and allow a set amount of contaminants. It seems that people hate regulation, until an unregulated product affects them negatively.
The difference being is that we aren't looking to use alcohol for medicinal purposes. That is where your comparison is apples and oranges. Any limits would be supported by clinical tests, not ignorance. I'm not talking about 15-25% THC either since that appears to be the area where there haven't been reported issues (from what I have seen so far). Those are levels were people seem to be managing things OK. It would be at much higher thresholds. Hopefully we see a spike in clinical tests now that restrictions have loosened a little.
To assume that all consumers would just smoke less at higher THC levels is ignorance. That may be the case for many who are responsible and know their limits, but that wouldn't be the case for those who do not.
What I think should happen is that people (or businesses) should be able to freely grow marijuana (or cultivate its extracts) up to certain THC and CBD levels. FDA would only monitor the manufacturing process as they do with the food and supplement industry (to ensure there are limited harmful contaminants). Once you go past those certain THC and CBD levels, then the marijuana is considered to be medicinal grade and would require much more oversight by FDA.
I'll also add (since I was in a bit of hurry with the last response) that there is concern about exposure to high THC levels to developing brains. That is part of the reason why using marijuana is recommended for adults. That topic was covered a bit in Dr. Sanjay Gupta's (neurosurgeon) 1st report on weed on CNN, when he formally pivoted from his early feelings on marijuana and expressed being in favor of its medical benefits.
Studies do need to be performed on those who continually expose themselves to high THC levels as adults too, since it is a psychoactive chemical compound.
Even marijuana proponents will tell you there are risks associated with higher concentrations of THC, and they warn you to be careful. THC is a psychoactive compound. It is said that you can't overdose on THC, but high levels that your body hasn't (or can't) adjust to can impair your coordination and reactionary skills and even make you have bad "trips" where people have panic attacks. That's why people are warned to stay at home if they are going to ingest something containing higher levels of THC. That is the concern with the higher concentration of THC found in oils and edibles, esp when there is a delayed reaction to the high concentration of THC.
If the US is going to have a serious conversation about legalizing marijuana, opponents have to begin to recognize the benefits, and the proponents can't neglect the risks and brush them off.
Not sure I completely agree. At lower concentrations of (certain) CBD and THC, it appears to be relatively safe. At much higher concentrations of (certain) CBD and THC, we aren't fully aware of both the short term and long term effects.
She was pandering. This is the election season. That's what mostly everyone seeking an office in DC is doing. I'll believe her (or any politician) when it actually happens.
Here is part of the problem with that article:
During the campaign season, you should take the words of politicians (that does include Trump) with a grain of salt. They are pandering to gain as many votes as they can. If they get elected, and when reality of DC smacks them in the face, then they eventually will back away from some (if not many) of those promises.
I think he is referring to 2011/2012 when Whelan neglected to update retail shareholders.
I forget when the NSE letters were seen by some on this board. We all saw the 1/31/12 warning letter shortly after it was posted on the FDA website.
Could be good or bad. Not sure why they are habitually late.
I assume it's to avoid issues with the DTC.
GRNH is not required to file with the SEC, so any late filings would not result in action from them at any time. SEC is mainly worried about registering shares/transactions or adequate/false/misleading information from Pink Sheet companies. False or misleading should not be confused with forward-looking. Only thing that comes from late filings in the Pink Sheet world is a change in the status from OTC Markets. That can be (easily) fixed. Late filings just don't do shareholders any favors.
Speaking of 100% wrong, I wonder what the Santa Monica Observer's inbox looks like right about now.
Why not take it off the list? Basic answer is politics and red tape BOTH domestically AND internationally. US is tied to international drug treaties they helped create and enforce decades ago. Ignoring those treaties creates a slippery slope with other countries and international treaties. Domestically, still some resistance all around.
They are loosening up the CBD aspect of cannabis b/c there is sufficient data (not to be confused with no data) in the eyes of the DEA and FDA to support a degree of safety and efficacy for the treatment of diseases.
As sufficient data is gathered for the other chemical compounds within cannabis to support safety and efficacy for the treatment of various diseases, then I suspect things will be loosened up more in the coming years.
The FDA and DEA want more data than is presently available through clinical testing.
Smaller companies are also engines for discovery. That is why big pharma may partner with smaller companies at times. I know of one in particular that has bought up these smaller companies b/c of an impressive portfolio. Before the pumpers on this site misconstrue what I had just mentioned, I'm not saying that this will be the case for TRTC. I'm just giving a vague example without straying too far offtopic. There are several companies that are at various stages of CBD clinical testing. The one that is talked about the most these days is the furthest along.
I've never heard of a limit on R/S's on the pink sheets.
As long as Ken follows the basic guidelines that publicly-traded companies have to follow, SEC isn't going to do anything.
I doubt that. That approval would be in the 2nd half of 2017 or later if FDA is not satisfied with the contents of the New Drug Application. That company still has to finalize that Phase III clinical data, meet with the FDA, and then submit the application. I do believe the DEA is using that clinical data as a part of the evaluation process.
DEA said they are close to a decision. If they weren't close, they would give a more vague answer to how far along they are. The fact that they actually gave a soft deadline in a memo suggests that they are close. I think DEA will announce something in a matter of weeks or months.
Here's a 2014 Brookings Institution discussion forum on the international hurdles the US faces as its attitude towards marijuana changes.
*1hr 50 mins*
49:27 - Additional comments on international hurdles
1:01:45 - Audience Q&A
(warning: very dry discussion)
Some FYI, to avoid plagiarism grief by websites and their authors, you should make it a habit to cite the source in the posts where you directly quote paragraphs. Easiest method is to post the link.
These countries move slow, so to have all of these countries to amend these treaties may take years.
I'm not saying descheduling could never happen, but it highly unlikely to happen in the near future as many hope. Both the DEA and FDA said they would like sufficient data on the different chemical compounds within the cannabis plant in order to make certain determinations. That is why I believe the DEA will open up some (possibly complicated) avenues for clinical research soon, but they probably won't make a decision (in the near term) that will make every cannabis proponent happy. As I said before, I think they will respect the states' rights and won't get involved unless individual(s) decide to go against the rules set by each state or even other countries. Canada did seize a shipment of medical marijuana oil from the US recently b/c marijuana isn't legal there yet. If the DEA wasn't going to do anything to change its stance even one bit, then we would've heard from them by now.
De-scheduling is highly unlikely to happen. Part of the reason is b/c marijuana is tied to international treaties that require countries to limit or prohibit possession/use/trade/distribution of drugs outside of medical or scientific purposes. Technically, the US may be in violation of such treaties now since it allows recreational use in some states - depending on who you ask.
http://www.vox.com/cards/war-on-drugs-marijuana-cocaine-heroin-meth/war-on-drugs-international-treaties
FDA does put out press announcements with certain approvals.
There is a stay of proceedings (temporary suspension)and they were supposed to have a Case Management Hearing last Friday with the judge. Unfortunately, the Fulton County clerk of courts doesn't provide a lot of details online. I kind of wish it had remained in the federal court.
Investigations/actions can take months or years depending on the amount of digging they have to do. If they go after a company, they want to build a strong case. I've seen them take action 1 or 2 years after the alleged misconduct occurred b/c they tracked down every transaction by the companies plus 3rd parties over a period of years.
It doesn't matter if it is an SEC-reporting company, or a pink sheet stock either. If the SEC believes a company violated federal law, the SEC will act.