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OfflineNikon Addict
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3 Medicines Containing Synthetic THC Just Received FDA Approval
    #25206610 - 05/16/18 01:09 AM (2 months, 30 days ago)

It's a short article but it questions the relationship that exists between the FDA and Pharmaceutical companies while the DEA continues to enforce strict restrictions on a plant...


3 Medicines Containing Synthetic THC Just Received FDA Approval


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OfflineKonyap
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Nikon Addict]
    #25206662 - 05/16/18 02:02 AM (2 months, 30 days ago)

http://www.pbs.org/newshour/updates/scientists-say-governments-pot-farm-moldy-samples-no-guidelines/


Sue Sisley, a primary care physician in Scottsdale, Arizona, recalls the moment she picked up the carefully wrapped package fresh from the delivery truck. Nearly two years after Sisley and her colleagues were awarded a grant to study marijuana as a treatment for 76 military veterans suffering from chronic post-traumatic stress disorder, her shipment of the drug was finally in hand.

But minutes later, as she opened the packets to weigh the drug – as required by the federal Drug Enforcement Administration – her enthusiasm turned to dismay. It didn’t look like marijuana. Most of it looked like green talcum powder.

“It didn’t resemble cannabis. It didn’t smell like cannabis,” Sisley says. What’s more, laboratory testing found that some of the samples were contaminated with mold, while others didn’t match the chemical potency Sisley had requested for the study.

There’s only one source of marijuana for clinical research in the United States. And “they weren’t able to produce what we were asking for,” Sisley says.

It’s unclear whether mold, lead or discrepancies in potency has been a problem in prior cannabis studies, because until now, it appears that no one looked.
In January — four months and three rounds of testing after that first delivery — Sisley and researchers working with the Multidisciplinary Association for Psychedelic Studies (MAPS) were finally able to enroll their first subjects. But the delay and the reasons behind it have raised questions about the reliability of the facility responsible for supplying marijuana to every clinical study in the country.

The marijuana came from a 12-acre farm at the University of Mississippi, run by the National Institute on Drug Abuse (NIDA). Since 1968, it has been the only facility licensed by the DEA to produce the plant for clinical research. While eight states and the District of Columbia have legalized marijuana — and all but a handful allow at least some medical cannabis — growing the plant in large quantities remains forbidden under federal law. For all practical purposes, that means that any medical study that wants to use marijuana on human subjects must go through the University of Mississippi.

Rick Doblin, MAPS’ director, says this recent episode “shows that NIDA is completely inadequate as a source of marijuana for drug development research.”

“They’re in no way capable of assuming the rights and responsibilities for handling a drug that we’re hoping to be approved by the FDA as prescription medicine,” he says.

The demand for the facility’s product has surged in the past year, mirroring interest from medical researchers. Through mid-October 2016, the agency says it had fulfilled 39 requests for marijuana, from 10 different researchers. That’s a jump from the 23 requests it filled in 2015, the most recent numbers available, according to an April letter from the DEA to Sen. Elizabeth Warren (D-Mass).

It’s unclear whether mold, lead or discrepancies in potency has been a problem in prior cannabis studies, because until now, it appears that no one looked.

NIDA says this is the first time researchers have expressed concern about mold or potency testing. Neither the agency nor the University of Mississippi tests samples for mold before they’re shipped.

Sisley says researchers have taken too much for granted. “There’s no telling how many subjects in past studies were exposed,” she says.

The uncertainty highlights a broader challenge in the growing field of cannabis research: there’s little consensus on what testing is appropriate or on what findings constitute a hazard.
The uncertainty highlights a broader challenge in the growing field of cannabis research: there’s little consensus on what testing is appropriate or on what findings constitute a hazard. Scientists and officials say they would love to have more guidance.

“Our biggest concern is patient safety,” says Mike Van Dyke, chief of toxicology with the Colorado Department of Public Health and Environment, which is funding the MAPS-sponsored study on PTSD. “The lack of a federal regulatory structure makes it a huge challenge. We don’t have all the information we’d like to have.”


A researcher in Dr. Sue Sisley’s lab prepares to weigh a sample of marijuana received from the federal facility responsible for growing marijuana for clinical research. Photo courtesy of MAPS.
A researcher in Dr. Sue Sisley’s lab prepares to weigh a sample of marijuana received from the federal facility responsible for growing marijuana for clinical research. Photo courtesy of MAPS.

As part of the original study protocol, the marijuana that Sisley received was tested at an independent laboratory in Colorado, which found a high level of total yeast and mold (TYM) in several samples. The tests also found that the potency of some samples didn’t match what study organizers had ordered, or what it says on the certificate of analysis from the federal supplier.

One sample, billed as having a 13 percent level of THC — the main psychoactive compound in marijuana — had just 8 percent when tested at the independent facility in Colorado. Other samples were off by lesser amounts. Subsequent testing at the University of Illinois-Chicago confirmed the presence of total yeast and mold.

The Chicago tests also found all four samples contained trace amounts of lead, though well below the levels generally considered to be hazardous, at least for adults.

Amsterdam cafe owner Michael Veling explains pot potency to PBS NewsHour by comparing it to liquor.

On the state level, testing requirements for recreational and medical marijuana vary widely. Most states require some testing for heavy metals such as lead, but not for pesticide residue. Yeast and mold testing is required in most states where cannabis is sold legally. The failure rate – frequently defined as a total mold and yeast count higher than 10,000 “colony-forming units” per gram (CFU/g) — is not officially tracked in Colorado. But state records show that approximately 7 percent of samples tested last year did not pass “microbial” standards, a category that includes bacterial contamination as well as TYM. Colorado only requires microbial testing for marijuana sold on the recreational market, not for medicinal use.

The Chicago tests found total yeast and mold (TYM) counts in Sisley and team’s samples ranging from 23,000 to 64,000 CFU/g.

NIDA says it suspects the mold problem was introduced on the receiving end, when the Colorado lab accidentally left samples in a refrigerator for two days, instead of keeping them frozen at -10 to -25 degrees Celsius, as called for by handling instructions.

But Rebecca Matthews, who oversees clinical trials for MAPS, says the elevated TYM counts were found in samples that never left the freezer before testing. In the samples that were inadvertently defrosted, TYM counts were even higher, as much as 110,000 CFU/g.

Nevertheless, Sisley and the team ultimately concluded after months of research that it was safe to proceed with the study. They began in January. In an internal memo that outlines their reasons for moving forward, they wrote that there’s no agreement on whether tests for TYM should be required, and no guidance from NIDA or the FDA.

One reason for that is a high TYM count does not always constitute a health risk, says Kevin McKernan, an entrepreneur and geneticist who is looking to improve the quality of testing in the realm of cannabis research. Certain types of fungus, notably a group of species known as aspergillus, can cause a variety of health problems when smoked, especially in people with compromised immune systems. But, many other mold varieties are considered harmless, McKernan says. Testing found the samples in question were not a harmful variety.

Immunocompromised patients were already excluded from Sisley’s MAPS-sponsored study.

NIDA says its own tests show THC levels closer to what was expected – in the 10 to 12 percent range, instead of the 8 percent that MAPS found. It says it’s reviewing MAPS’ results and protocols to try to understand the discrepancy. NIDA also says it tested for heavy metals before shipping the material, and found nothing above acceptable levels.

Tighter control, broader playing field

Dr. Sue Sisley points to marijuana samples she received as part of a study that’s testing whether marijuana can have a positive effect on veterans with PTSD. Photo courtesy of MAPS.

NIDA is also taking some steps to tighten oversight. In January, it announced a grant to McKernan’s two Massachusetts-based companies, Medicinal Genomics and Courtagen, to develop a DNA-based test that would identify specific types of harmful mold and bacteria in marijuana.

Beyond quality control issues, some critics say the Mississippi farm doesn’t provide researchers with enough options. For example, the potency of marijuana in NIDA’s collection tops out at 13 percent THC. That’s less than half the level in the most potent strains sold in states where the drug is legal and regularly tested.

That means “if you’re trying to do a study where you imitate what patients do in the real world, you can’t,” Sisley says.

“If you’re trying to do a study where you imitate what patients do in the real world, you can’t.” – Dr. Sue Sisley
Van Dyke echoes her concern. “It’s an important issue. The products in Colorado are different from the products produced by NIDA, and there’s untapped demand to study those products that people are really using.”

In an email to NewsHour, the agency says it’s growing new material that will likely contain higher THC levels. NIDA officials insist they’re keeping up with demand, and in 2014, increased its production and diversified the strains of marijuana it grows.

Another criticism stems from NIDA’s practice of achieving higher THC concentrations by mixing different strains together, rather than growing new plants.

In its April 2016 letter, the agency told Warren the Mississippi facility has “approximately 185” batches of cannabis, at varying concentrations of THC and CBD. Different varieties, the letter says, “may be blended to achieve specific cannabinoid concentrations of interest to researchers.”

Critics, including Sisley, say that mixing strains is a lost opportunity. Every cannabis plant contains several hundred unique compounds, which some believe may significantly alter the drug’s effects. If different plants are mixed together, scientists have a harder time tracking those effects.

Many scientists were heartened this summer when the Drug Enforcement Agency (DEA) announced that it would license additional bulk growers, ending NIDA’s monopoly.

According to the DEA, 16 organizations have submitted the paperwork to launch the application process, which comes with a $3,047 fee. None of those applications have been approved, however, and the agency says there is no set timeline to take action.

The delays in Sisley’s study are energizing those who say the federal government needs to speed things up.

Frustrated by her experience, Sisley is hoping to take a more hands-on approach. One of the DEA applicants is the Scottsdale Research Institute (SRI), where she is the principal investigator. SRI has submitted a proposal to grow cannabis from tissue culture rather than seedlings, a more sterile method of producing the plant.

She doesn’t mince words about the setback.

“We waited 20 months to get going, and then we got this sub-optimal study drug,” she says. “The longer we allow this monopoly to continue, the more efficacy [of the] research will continue to be thwarted.”


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OfflineFractal420
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Konyap]
    #25206873 - 05/16/18 05:32 AM (2 months, 29 days ago)

Well yeah heres a pic of some NIDA weed



No wonder it keeps testing "no medical benefit". Theres prolly like 2% thc in there tops


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OfflineCoolwhip GA
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Fractal420]
    #25206975 - 05/16/18 08:03 AM (2 months, 29 days ago)

The plants on the farm, at least from a birds point of view, don't look terrible. But are they actually weeding out the males and ensuring no pollenation occurs? Even if the answer is yes, there seems to be a HUGE problem with how they harvest/dry the marijuana, from what I can tell they are harvesting the entire fucking plant and grinding it up whole.

Why are they not harvesting just the flowers and sending them out intact? I know their excuse is because they are blending different plants together to meet the needs of the researcher, perhaps so, but they are clearly adding more to the mix than just buds, that shit is full of stems and leaves.

If they've got 185 different strains surely they can find one that comes close to what the scientists are asking for, and with 12 acres to work with you are telling me they can't come up with a phenotype which meets their request? If the researchers needs are that specific then they need to be working with extracts.


Edited by Coolwhip GA (05/16/18 08:05 AM)


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OfflineButterWeasels
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Coolwhip GA]
    #25207008 - 05/16/18 08:28 AM (2 months, 29 days ago)

Why can't they just get their Marijuana from a green state? Living in Nevada we have quite the array of medicinal plants here.

I don't see the point of having synthetic THC as a medicine, seems like the same type of chemical in spice just legal. Even pure THC isn't really medicinal, it's recreational. They should be using Cannabidiol or something very similar to it. That would be effective though, wouldn't want to actually cure something or their profits might go down. Humans just don't look at the bigger picture of more happiness and well-being for all as a positive. They only see things in their narrow world view, benefits for one but consequences and repercussions for all.

Makes me think the people who follow religion just do it to put on a happy facade, if they really had faith they'd help their fellow man (I know I'm way off subject here but whatever).


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OfflineFractal420
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: ButterWeasels]
    #25207228 - 05/16/18 10:41 AM (2 months, 29 days ago)

Quote:

Why can't they just get their Marijuana from a green state? Living in Nevada we have quite the array of medicinal plants here




Federal law vs state law. Actual Research needs federal, and they classify as schedule 1. So, its all crap weed. They cant use "illegal" california medical marijuana for research,

So this is why most research on cannabis happens in Israel.

Tikunolam.com


--------------------
Dreaming of That face again.
It's bright and blue and shimmering.
Grinning wide
And comforting me with it's three warm and wild eyes.

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Invisiblebadchad
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Nikon Addict] * 1
    #25207377 - 05/16/18 11:42 AM (2 months, 29 days ago)

There are many other aspects of the drug approval process to consider as well. A single example is drug consistency and purity. Approved drugs need to be pure, stable, and consistent. The advil you buy in NY is identical to the advil you get in CA.

There are thousands of different strains of MJ, and even within a single strain, its exceptionally difficult to produce an agricultural product with the same consistency as a synthetic drug. This is one (of many) reasons MJ is unlikely to be legalized via a medicinal/drug approval route.


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...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.

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OfflineMorel Guy
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: badchad]
    #25207669 - 05/16/18 01:33 PM (2 months, 29 days ago)

No wonder the US Government says weed has no medical benefit


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OfflineCoolwhip GA
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: badchad]
    #25207745 - 05/16/18 02:00 PM (2 months, 29 days ago)

Quote:

badchad said:There are thousands of different strains of MJ, and even within a single strain, its exceptionally difficult to produce an agricultural product with the same consistency as a synthetic drug. This is one (of many) reasons MJ is unlikely to be legalized via a medicinal/drug approval route.




Once you've found a phenotype which suits your needs you can just clone said plant to get a fairly consistent product. I mean it may not pass muster as a FDA approved drug given their bioequivalency requirements, but for research purposes(not drug trials) I would think it would do.

But if trying to actually create a product with mass distribution in mind, they can just use extracts with the required levels of each compound, no different than what they were requesting from the NIDA in the first place. You could even imitate a certain strain/phenotype by finding plant material which produces all the desired effects, then analyzing its makeup, identifying the most abundant/important cannabinoids and what ratio they are found in, then producing an extract which mirrors that.

But really this is moot, as you only need a consistent product for research purposes, as cannabis SHOULD be sold as a dietary supplement just like any other herb and does not require FDA approval.


Edited by Coolwhip GA (05/16/18 02:02 PM)


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Offlinetrvptamine
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Coolwhip GA]
    #25209195 - 05/17/18 01:05 AM (2 months, 29 days ago)

Quote:

Synthetic THC has a similar chemical structure to natural THC. It binds to the brain’s CB1 receptors as well but since it’s much more potent, patients routinely complain of side-effects up to and including the conditions listed above.




LMAO! its hilarious how little people understand about basic chemistry. THC is THC.  Are they saying its more potent because its a pure drug rather than a plant? obviously! I think its really dumb that they are synthesizing thc to make these drugs rather than extracting it, but why do people have to spew fallacies when they are fighting for a just cause?


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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: ButterWeasels]
    #25209199 - 05/17/18 01:10 AM (2 months, 29 days ago)

Quote:

ButterWeasels said:
I don't see the point of having synthetic THC as a medicine, seems like the same type of chemical in spice just legal. .



I have to disagree. Synthetic THC is the same thing as THC from cannabis. THC is THC. Any other chemical wouldn't be THC. Meaning synthetic THC is not the same thing as the synthetic RC cannabinoids used in "Spice".


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Invisiblepablokabute
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Fractal420]
    #25209622 - 05/17/18 09:16 AM (2 months, 28 days ago)

Quote:

Fractal420 said:
Well yeah heres a pic of some NIDA weed



No wonder it keeps testing "no medical benefit". Theres prolly like 2% thc in there tops





isnt that industrial hemp or maybe just some stray feral hemp? hahahaha fuckin govt fucks with us and its so disgusting


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OfflineFractal420
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: pablokabute]
    #25209629 - 05/17/18 09:23 AM (2 months, 28 days ago)

^no its actual federal research "marijuana" from NIDA, used for all research within the US that is federal Lol

Now keep in mind theres mold too lol.

They really Are fucking with that whole industry. What a laugh

I bet if you smoke that shit youll feel alot worse than you did before


--------------------
Dreaming of That face again.
It's bright and blue and shimmering.
Grinning wide
And comforting me with it's three warm and wild eyes.

Prying open MY third eye



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OfflineFractalMind
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Fractal420]
    #25209659 - 05/17/18 09:44 AM (2 months, 28 days ago)

Goddamn lets kick off civil war 2 amirite? Fuck this nation

Brain dead baby boomer alzheimers kikes. Fuck the usa and fuck the pharma industry. I hope Israel gets nuked


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Edited by FractalMind (05/17/18 09:47 AM)


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Invisiblepablokabute
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Fractal420]
    #25209708 - 05/17/18 10:27 AM (2 months, 28 days ago)

Quote:

Fractal420 said:
^no its actual federal research "marijuana" from NIDA, used for all research within the US that is federal Lol

Now keep in mind theres mold too lol.

They really Are fucking with that whole industry. What a laugh

I bet if you smoke that shit youll feel alot worse than you did before





nuthin a good coconut oil pull could not do to remedy those 'hay' weed. just make sure you saturate with lots of plant matter for some fire edibles xD

they do those fuckups to stall some more time, makin sure to squeeze out the last remaining profits from pHARMa fucken druugz.

geez. why cant all the world govt just let anyone who wishes to grow weed just grow their own fuckin weed. ganga are becoming more and more expensive and overrated each passing day.. good lord! its just a fuckin vegetable.


--------------------

Fermented Mushrooms!!
--- https://www.shroomery.org/forums/showflat.php/Number/23378638/fpart/1/vc/1

'The second seal: “All CONTAMINATED things and events are unsatisfactory.”'



"I envy you. You North Americans are very lucky. You are fighting the most important fight of all - you live in THE HEART OF THE BEAST."

--Anonymous Guerilla, or is he..


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Invisiblepablokabute
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: pablokabute]
    #25209729 - 05/17/18 10:34 AM (2 months, 28 days ago)

some purists say, by synthesizing or isolating certain cannabinoids, you lose the entourage or synergistic effect that one gets from the actual buds

not to mention, the quarks or molecular spins of the medicinal cannabinoid compounds could not be easily replicated just by synthesizing... I wonder whats the real deal about this issue..


--------------------

Fermented Mushrooms!!
--- https://www.shroomery.org/forums/showflat.php/Number/23378638/fpart/1/vc/1

'The second seal: “All CONTAMINATED things and events are unsatisfactory.”'



"I envy you. You North Americans are very lucky. You are fighting the most important fight of all - you live in THE HEART OF THE BEAST."

--Anonymous Guerilla, or is he..


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OfflineFractal420
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: pablokabute]
    #25209905 - 05/17/18 11:59 AM (2 months, 28 days ago)

Quote:

some purists say, by synthesizing or isolating certain cannabinoids, you lose the entourage or synergistic effect that one gets from the actual buds





Absolutely. Even extracts arent quite "the same" as smoking some good herb, while it may be stonger in terms of thc

113 known cannabinoids. Even just BHO, they only test thc cbd cbn etc


--------------------
Dreaming of That face again.
It's bright and blue and shimmering.
Grinning wide
And comforting me with it's three warm and wild eyes.

Prying open MY third eye



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Offlinedwnlw2slw
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Fractal420]
    #25210140 - 05/17/18 01:50 PM (2 months, 28 days ago)

"...aren't quite the same as smoking some good herb." Yes, thank you. Also, this is pretty dissimilar but maybe a good comparison: I read an article comparing smoothies, which are blended produce, to eating the whole fruit or vegetable. The point was that since we've been doing the latter for aeons, our digestive systems have "formed" to benefit from digesting the unblended fibers.
I'm definitely aware that blending and extracting are way different.
Somebody already mentioned that the point of this is that they are just stalling so they can milk that last bit of profits out of big pharma. This seems like the most likely explanation.


--------------------
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OfflineCoolwhip GA
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Fractal420]
    #25210173 - 05/17/18 02:04 PM (2 months, 28 days ago)

Quote:

Fractal420 said:
113 known cannabinoids. Even just BHO, they only test thc cbd cbn etc




And I am sure dozens of them have medicinal value, but probably not while in the marijuana plant. The levels are so low that they are irrelevant when talking about the medicinal properties of marijuana, you can fairly easily look at EC50 and the levels found in the flowers to determine which ones are actually having an effect. Although it would still be worthwhile to explore the pharmacological properties of each.

Also, when I say extract I mean whole marijuana extract, not isolated THC or CBD, so it would still have all those other alcohols and phenols present. But more specifically, unless there is some compound whose EC50 shows it would be relevant despite being found in minute levels, pick the top 6 or at least the 6 which you suspect of being relative to any treatment protocol discovered and create a tincture which contains the correct ratio of each.


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OfflineCaddilac
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Re: 3 Medicines Containing Synthetic THC Just Received FDA Approval [Re: Coolwhip GA]
    #25226683 - 05/25/18 12:43 AM (2 months, 21 days ago)

For a  sake it must be done, I'd there are 3 types to open the 1 clock, then the stage is set in foreground for policies and recreation to free use behind and whence that they can freely capture you for hanenous crime. Or rather it gives anyone the naivete to be cool and be like damn that's good shit I hope our attitudes can change for the better together.


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