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Feds limit research on marijuana for medical use

Storm Shadow

Well-known member
Veteran
http://www.usatoday.com/story/news/2015/08/18/feds-limit-research-marijuana-medical-use/31547557/

Feds limit research on marijuana for medical use

Research on marijuana’s potential for medicinal use has been hampered for years by federal restrictions, even though nearly half of the states and the District of Columbia have legalized medical marijuana in some form.
An analysis by News21 shows that $1.1 billion of the $1.4 billion that the National Institutes of Health spent on marijuana research from 2008 to 2014 went to study abuse and addiction. Only $297 million was spent on its effects on the brain and potential medical benefits for those suffering from conditions like chronic pain. News21 is a Carnegie-Knight national student reporting project based at Arizona State University’s Walter Cronkite School of Journalism.
“We don't have new things to treat for pain,” Dr. Todd Vanderah, chief of pharmacology at the University of Arizona, said. “We're still dealing with narcotics that have been around for thousands of years, and it's led to this issue of people abusing drugs, and the rise of heroin.”
Some parents with children suffering from seizures want to try using medical marijuana to treat their children more effectively than currrent medicine has been able to. But the Food and Drug Administration has not approved any marijuana-based medicines for seizures.
“We know it will help our children or potentially give them a better quality of life,” said Heather Shuker, the mother of a child with Dravet syndrome, a form of epilepsy. “We’re being denied that because they (federal agencies and doctors) don't know the long-term side effects of medical cannabis.”

Amphetamines and similar stimulants, typically prescribed as Adderall or Ritalin, are used to treat attention deficit disorder despite their potential to be addictive. “I was diagnosed with ADD when I was a kid. They gave me Ritalin and that was just a really bad thing,” said Jason Mac Adam, a medical marijuana patient in Hawaii. “I ended up becoming a meth addict. … I’ve used medical marijuana to help me get away from my meth addiction, as a medication to get me away from my anxiety.”

Yet researchers like Vanderah have faced challenges getting federal approval and funding to study marijuana’s potential medical uses for these and many other conditions. “The progress is a little limited because research is done based off of grants that have been harder and harder to get,” Vanderah said.
Although medical and even recreational marijuana use has been increasingly legalized by states, the federal government still classifies marijuana as a Schedule 1 drug — along with heroin and ecstasy — defining it as having potential for abuse and no medical benefits.
The approval process for doing any kind of research on marijuana is lengthy and difficult, with the FDA, Drug Enforcement Agency and National Institute on Drug Abuse all playing a role in allowing an approved researcher access to federal funding and federally-provided marijuana.
“It took me three years from the time I got funding to the time I could enroll my first subject,” Dr. Mark Wallace, a researcher studying pain treatments at the University of California-San Diego, said. “Once we got approval it wasn’t that hard to do, as far as getting the marijuana.”
Fewer than 1,000 NIH-supported research projects studied marijuana for purposes other than abuse or addiction in the last seven years. University-backed researchers and a few larger companies have been able to use their own funding, rather than grants from the NIH, and their own advanced laboratories to study marijuana and cannabinoids — the chemicals found within it — as potential treatments for conditions such as seizures and breast cancer pain.
“I think in the near future we’re going to see (research) get easier and easier to do,” Wallace said. “I don’t see how the federal government is going to continue to put so many restrictions on it.”
SPENDING DISPARITY
News21 analyzed federally funded drug research projects from 2008 to 2014 using the NIH’s publicly available database. The $1.1 billion the agency spent to study marijuana abuse and addiction was $200 million more than what the organization spent on research into crystal meth, a highly addictive stimulant that the DEA has called an epidemic.
While NIH spent $297 million on grants for non-abuse research of marijuana, it provided two to four times as much for similar research of opiates and benzodiazepines, including drugs such as Xanax, according to the News21 analysis. Opiates are the narcotics that Vanderah said can cause prescription drug dependency or even heroin abuse.
The research on marijuana abuse and addiction was largely, but not exclusively, funded by the National Institute on Drug Abuse, a branch of NIH. The research covered subjects including how parents can prevent substance abuse and studies of cannabis-use disorder, which the American Psychiatric Association calls a problematic pattern of marijuana use.
More federal money was spent researching potential marijuana abuse than on abuse of amphetamine and ketamine (an anesthetic sometimes used as a club drug), despite those drugs' histories of recreational use.

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Responding to questions about research spending, Mahmoud ElSohly, the director of NIDA’s marijuana program, said that the agency’s job is to fund abuse and addiction research, and that other NIH branches should be funding other kinds of research.
“It’s not that NIDA would take it upon itself to investigate the medical aspects of cannabis,” ElSohly said. “It's not the charge of NIDA. It's the charge of other institutes within the NIH to investigate the use of cannabis.”
But the other parts of the NIH have not funded much marijuana research. A National Institute of Neurological Disorders and Stroke spokesperson said that most NIH grants were based on what peer reviewers thought was the most promising science.
The National Institute of Mental Health, for example, has spent just $48 million on medical-marijuana research despite states approving it to treat post-traumatic stress disorder. Yet the NIMH gave grants totaling $91 million for ketamine research — largely to treat depression — and almost $120 million for amphetamine research, to treat attention disorders.
635750532970044611-RESEARCH-MARIJUANA-News21002.jpg
Researchers at the University of Arizona found that the growth of breast cancer cells in a dish slowed when treated with cannabinoids. (Photo: ALEXA ARD, News21)


Similarly, despite several states’ approval of marijuana and cannabinoids to treat epileptic seizures, the National Institute of Neurological Disorders and Stroke spent just $38 million through 2014 researching the potential effects of marijuana, compared with almost $100 million spent on opiate research, largely to treat different kinds of pain. Researchers said that number is expected to increase this year as more work is done on cannabidiol — a major chemical in marijuana that doesn’t have psychoactive effects — and seizures.
POT CONSIDERED SCHEDULE 1 DRUG

In 1970, Congress passed the Controlled Substances Act, which created one piece of federal law classifying all drugs. The law organized drugs into schedules based on their potential for abuse, status in international treaties and medical benefits.
Marijuana was temporarily designated as Schedule 1, but President Richard Nixon created a commission to do a review of the drug to determine if it should keep the most restrictive scheduling. The commission’s findings from research projects and public polls made up almost 4,000 pages of reports and technical papers published in four volumes in 1972. It concluded that marijuana should not be criminalized, and suggested rescheduling the drug. But Nixon decided otherwise.
One hundred sixty substances have been removed, added or transferred from one schedule to another since the Controlled Substances Act went into effect.
Investigators working with Schedule 1 drugs need an additional level of clearance from the DEA, also created during the Nixon administration to enforce the laws of the Controlled Substances Act and to regulate the use of controlled substances. Wallace, the doctor at UC-San Diego, cited five separate state and federal groups that sent him requests before he received approval for his research on how different doses of marijuana might be used to treat pain.
If marijuana were to be reclassified as a Schedule 2 drug, which would mean it has a federally accepted medical use, researchers would no longer need clearance from the DEA to work with it.

“The Schedule 1 designation makes it challenging,” Wallace said. “I think if they move it to Schedule 2, it’s going to get a lot easier to research.”

That change is easier said than done, according to Matthew Barden, a DEA spokesman. “A lot of people in the marijuana debate say to just put it under a different schedule. But in order to do that, the FDA would have to change everything.” Barden said. “So we, the DEA, can’t just put something in Schedule 2. That would be a violation of how things are scheduled.”

Rescheduling can be done by congressional or administrative action. A few bills have been proposed in Congress, but they’ve all died in committee.
The administrative route involves more steps and more agencies. To get the ball rolling, a petition must be filed by an interested outside party or by the secretary of Health and Human Services. The attorney general reviews the petition, then sends it back to HHS to request scientific and medical evaluation by the FDA.
Findings and recommendations from HHS are reported to the attorney general, who then makes the decision whether to proceed, often in consultation with the DEA. The DEA and FDA have the power to deny the petition if there is not sufficient scientific and medical evidence. If the attorney general can go forward, the White House then decides if the rule could have economic effects or raises important policy issues.
APPLYING TO RESEARCH
Even when researchers are cleared to do federally funded marijuana research, they must obtain their marijuana from a farm at the University of Mississippi operated under the authority of NIDA. The farm is nestled in the eastern portion of the 640-acre Ole Miss campus, a short distance from the stadium where the Rebels play football.

The heavily secured farm is surrounded by fences, guard towers and vaults. The sprawling 12-acre, marijuana farm, with its growing room, is the only federally sanctioned marijuana grow in the country.
“The National Institute on Drug Abuse is the only agency that is allowed under the federal law ... to actually be in charge of the manufacturing and distribution of cannabis for any purpose,” ElSohly said. “We at the University of Mississippi, we're acting as the agent for the government to carry out that function.”
Before researchers can obtain marijuana and start their studies, they need three things: an approved investigational new drug application from the FDA, a letter of approval from NIDA and a Schedule 1 clearance from the DEA.
DEA approval is needed for possessing and transporting the marijuana and researchers must prove they have a secure facility to store and keep track of the marijuana. Once they have both FDA and DEA approval, researchers can contact NIDA to obtain their marijuana.
Outside of the University of Mississippi’s contract with NIDA, ElSohly said he and the other researchers at Ole Miss also are conducting marijuana research of their own. Even though federally approved marijuana is right outside their door, they have to go through the same application process as everyone else.
With a new $68.8 million contract, however, NIDA plans to help marijuana researchers by producing and growing products at the Mississippi farm that more closely mimic what dispensaries are selling to medical marijuana users.
635750532883932059-ESEARCH-MARIJUANA-News21011.jpg
In addition to its 12-acre outdoor field, the University of Mississippi has an indoor grow room at its School of Pharmacy. (Photo: University of Mississippi)




“The products were quite limited, as far as what we could get from them (before),” Wallace said. “Now, the NIH is coming out with a lot of different products for research, as far as oils, extracts and different strains that have different levels of THC (the psychoactive cannabinoid in marijuana) versus CBD.”
NIDA’s marijuana grow at Mississippi is producing more varieties of marijuana that should be similar to medical marijuana in the states that have approved it, ElSohly said. It’s also growing 30 times more marijuana than it did under its last contract with NIDA, two signs that researchers and NIH branches are requesting much more marijuana for medical studies.

LIMITS OF CURRENT RESEARCH
Limited grant availability to fund those requests means that researchers need the backing and funding of a major university — as Vanderah has with Arizona or Wallace has with UC-San Diego — or business investors. Britain-based GW Pharmaceuticals has turned investor funding into marijuana research advances in the United States. Its British base allows GW to work with marijuana grown in its greenhouse in the United Kingdom.
“We’ve got a full pipeline of products that are in the clinics, that have gotten through the preclinical steps,” said Steve Schultz, GW’s vice president of investor relations. “We’re looking at cannabinoids in a very large number of different therapeutic areas.”
Among those products are Sativex, a full-plant marijuana extract with both THC and CBD, and Epidiolex, a purely CBD extract. While Sativex is approved for multiple sclerosis patients in 27 countries, it is not approved in the United States. Epidiolex is still in clinical studies.
GW extracts the marijuana’s cannabinoids in the company’s greenhouses in Britain, so only the finished Sativex or Epidiolex products enter the U.S. It still needs DEA licensing to bring marijuana-based products into the country, but it has total control over the quality of marijuana.
“I think having a significant amount of variability in these medical marijuana products is a problem for research,” Schultz said. “It doesn’t result in research that has the required level of integrity because the product itself that you’re testing tends to be different every time you test it.”
Any differences from one cultivation to another have the biggest impact on whole-plant marijuana, Schultz said, which is why the company works only with extracts. Very little information about the quality and properties of federally provided marijuana was given to U.S. researchers in the past.
While marijuana-based medicine is still in its early stages, Vanderah emphasized that it’s no different than the development process for other medications.

“I think that we are today where we were with narcotics 30 or 50 years ago,” Vanderah said. “I hope that we can advance the cannabinoid field much quicker with all that research we've done for the last 100 years on narcotics.”

FUTURE OF RESEARCH
Congress could play a major role in speeding up the marijuana research process. Legislators have crafted bills that would recategorize marijuana to Schedule 2 — which would ease some steps of the research approval process — and create federal marijuana grows beyond the one in Mississippi.
HHS removed the mandatory public health services review from the marijuana research approval process to reduce the number of approval steps for marijuana research.
635750532897036143-ESEARCH-MARIJUANA-News21010.jpg
The National Institute of Drug Abuse contracts with the University of Mississippi to grow marijuana. But researchers at Ole Miss have to go through the same application process as everyone else to receive approval for marijuana research. (Photo: University of Mississippi)


Parents campaigning for a form of CBD to treat their children’s seizures already have made strides in attracting public attention to marijuana research. Vanderah said that research and treatments with CBD should pave the way for future research because it proves that marijuana-based medicine can really work.

“If you have your own child that's having 100 seizures per day and then they take some of this and it stops, you’ll look at it very differently,” Vanderah said. “They look at it as a medication, instead of how we always think of something like marijuana.”

Wallace, Vanderah and Schultz predicted future development in areas like multiple sclerosis, dementia, Lou Gehrig’s disease and neonatal hypoxic-ischemic encephalopathy , a condition that cuts the flow of oxygen in infants. To treat such a wide variety of conditions, researchers are going to have to look at marijuana in many different forms — not just the extracts that companies like GW work with, Wallace said.
“I think what we’re going to find is a wide range of patient preferences, so we can’t think that we can just do away with the leaf and just extract it,” Wallace said. “It needs to be available in a wide range of products.”
 

HempKat

Just A Simple Old Dirt Farmer
Veteran
Yep, unfortunately the people who decide grants are controlled by the same people that keep it as a schedule one drug. Which is totally hypocritical when you consider that the Federal Government has been filling prescriptions of marijuana for it's medical benefits to a handful of people, since the 70's. How can the Federal government fairly say it has no medical value while simultaneously giving it out to some as medicine to treat medical conditions?

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

Big-Narstie

Member
Yep, unfortunately they people who decide grants are controlled by the same people that keep it as a schedule one drug. Which is totally hypocritical when you consider that the Federal Government has been filling prescriptions of marijuana for it's medical benefits to a handful of people, since the 70's. How can the Federal government fairly say it has no medical value while simultaneously giving it out to some a medicine to treat medical conditions?

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


The same happens in the UK in making the medication Sativex with something like 5000% profit.
It's uber hypocritical and just shows they make this shit up to benefit no one but their pocket and we as dumb public educated sheeple have bow n eat shit no matter what they say is right/wrong.
 

aridbud

automeister
ICMag Donor
Veteran
Unfortunately, most studies focus on marijuana abuse and addiction (money maker for rehab stints?), not potential medical benefits. There are studies, but largely done with no corporate (Big Pharma) backing.

It's a threat or competition if regaling the medical benefits of cannabis and the Merck giants are not reaping any profit.....yet. Marinol was first introduced in 1985...and more brands (Sativex and the like) are in the periphery.

The tide is turning...more studies, more worldwide acceptance. It's just not by leaps and bounds as most pharmaceutical R&D, FDA approved Rx currently evolving.
 

stoned-trout

if it smells like fish
Veteran
gw pharm will have their product on the market soon bet on it.. the thing is everyone is not accepting that thc also has medicinal uses...I don't want hemp I require thc too....yeehaw
 

aridbud

automeister
ICMag Donor
Veteran
Wonder if Dixie Elixirs or Scripts will transcend as bonafide pharmaceuticals.
 
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stoned-trout

if it smells like fish
Veteran
the cbd will get a lot of research once gw deal is done as they have to or the fda wont let them claim it does anything...yeehaw.... but I need thc too cbd is for children and epileptics lol only kidding but thc seems to be getting put aside and buried...their bringing back ditchweed
 

mean mr.mustard

I Pass Satellites
Veteran
In the 80's they moved it from Schedule 1 to Schedule 2, got their patents on Dronabinol and Marinol, then switched it back to Schedule 1.

I wouldn't be surprised if the same underhanded pocket lining is at hand all over again.

Ask GW.

They'll lie.

You have wool on you.

They know it.
 

aridbud

automeister
ICMag Donor
Veteran
In the 80's they moved it from Schedule 1 to Schedule 2, got their patents on Dronabinol and Marinol, then switched it back to Schedule 1.

I wouldn't be surprised if the same underhanded pocket lining is at hand all over again.

Ask GW.

They'll lie.

You have wool on you.

They know it.

Shell game.
 

St. Phatty

Active member
Many of us do not recognize the US gov. as having jurisdiction in this matter.


The primary feedstocks for American pharmacists for the first 150+ years of the nation's history ... from 1776 to 1930's ...
Cannabis
Opiates
Derivatives of Cocaine

All with a 1000+ year usage history.

I will venture a guess ... the illegality of these substances has a relation to the advent of Big Pharma.

Plus maybe TPTB wanted to have a club to beat the General Public over the head with, i.e. a reason for cops to pull them over.

Big Pharma and American (allopathic) medicine have failed to show that their Pseudo-Drug-War policies have anything to do with the HEALTH of Americans.

The "Drug War" obviously reinforces the Monopoly of Big Pharma and American Medicine.


They should find a new scam.
 

angelgoob

Member
“I think having a significant amount of variability in these medical marijuana products is a problem for research,” Schultz said. “It doesn’t result in research that has the required level of integrity because the product itself that you’re testing tends to be different every time you test it

CLones. C'mon now.



What about cigarettes and alcohol. High risk for addiction and causes cancer.

Tax cannabis for being a "drug that gets you high" and be done with it. Add a little morality tax or something. Something that says "cannabis is uneeded in society but is fun."


The state lottery doesn't have a problem taking people's money either, but I don't see the state outlawing it. I wonder why. Oh wait..I don't.
 

mean mr.mustard

I Pass Satellites
Veteran
Cannabis is more needed in society now than ever!!!

Why would you give them a "morality tax" when it doesn't harm anybody and benefits beyond the individual??

What are we going to start paying taxes on it for?

To admit that some lie is true?

I find this dubiously misguiding.
 

HempKat

Just A Simple Old Dirt Farmer
Veteran
the cbd will get a lot of research once gw deal is done as they have to or the fda wont let them claim it does anything...yeehaw.... but I need thc too cbd is for children and epileptics lol only kidding but thc seems to be getting put aside and buried...their bringing back ditchweed

See this is where their unyielding view of Cannabis fails them. It never should have been about one cannabinoid over another. What makes a strain work medically is it's cannabinoid profile. The blend of different cannabinoids and there are many of them, all play a role in creating the effect, even THC. I think what's gotten CBD such notice was that it had some exciting benefits for kids suffering seizures and while yes there is a high concentration of CBD in such strains there are still at least 85 cannabinoids in marijuana and they all play a role in the end result.
 

HempKat

Just A Simple Old Dirt Farmer
Veteran
Many of us do not recognize the US gov. as having jurisdiction in this matter.


The primary feedstocks for American pharmacists for the first 150+ years of the nation's history ... from 1776 to 1930's ...
Cannabis
Opiates
Derivatives of Cocaine

All with a 1000+ year usage history.

I will venture a guess ... the illegality of these substances has a relation to the advent of Big Pharma.

Plus maybe TPTB wanted to have a club to beat the General Public over the head with, i.e. a reason for cops to pull them over.

Big Pharma and American (allopathic) medicine have failed to show that their Pseudo-Drug-War policies have anything to do with the HEALTH of Americans.

The "Drug War" obviously reinforces the Monopoly of Big Pharma and American Medicine.


They should find a new scam.

The main things that worked against cannabis that made it illegal nearly a century ago were two things, a way to vilify blacks and immigrants from south of the boarder. The other thing was really more to do with the versatility of hemp which offer superior options for markets controlled by Andrew Mellon, Randolph Hearst, and the Du Pont family.
 

HempKat

Just A Simple Old Dirt Farmer
Veteran
Cannabis is more needed in society now than ever!!!

Why would you give them a "morality tax" when it doesn't harm anybody and benefits beyond the individual??

What are we going to start paying taxes on it for?

To admit that some lie is true?

I find this dubiously misguiding.

The only way it's gotten legalized so far is thru the promise of significant tax revenue to be obtained. To label it as immoral and place a "sin" tax on it is how politicians justify themselves to the voters against it while at the same time appeasing the pro marijuana side by legalizing it.

The problem is they're too greedy in the states that have legalized it, between the Feds and The state, businesses selling marijuana are paying as much as 75-80% of their profits in taxes and even still they're raking in money hand over fist which is why they put up with it and so they accept the high tax as part of doing business. This is also why they charge their customers so much they're passing on that part of "doing business" to the consumer like usual.
 

angelgoob

Member
Cannabis is more needed in society now than ever!!!

Why would you give them a "morality tax" when it doesn't harm anybody and benefits beyond the individual??

What are we going to start paying taxes on it for?

To admit that some lie is true?

I find this dubiously misguiding.

I just meant from their standpoint they would determine that it's another drug just like alcohol and isn't needed.


I guess what I am shooting for would be luxury tax. Like Tea. It's not producing food or shelter, or producing a building.

I was also just playing devil's advocate and making the terms agreeable on their end so they can legalize it and I guess that's not right. I recognize cannabis is a healing herb and would benefit society, but this is not how they look at it from their end.
 
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Sam_Skunkman

"RESIN BREEDER"
Moderator
Veteran
Who moved it from schedule 1 to schedule 2? And then switched it back to schedule 1? What date was that? Dronabinol/Marinol is schedule 3 has been a while, see 75 Fed. Reg. 67054 (Nov. 1, 2010) (Listing of Approved Drug Products Containing Dronabinol as Schedule III).
It was earlier moved to schedule 2 from 1:
On May 13, 1986, the Drug Enforcement Administration (DEA) issued a Final Rule and Statement of Policy authorizing the "Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules From Schedule I to Schedule II" (DEA 51 FR 17476-78).



In the 80's they moved it from Schedule 1 to Schedule 2, got their patents on Dronabinol and Marinol, then switched it back to Schedule 1.

I wouldn't be surprised if the same underhanded pocket lining is at hand all over again.

Ask GW.

They'll lie.

You have wool on you.

They know it.

Your "facts" are not facts they are just you rambling on and on.... This post and others...
-SamS
 

HempKat

Just A Simple Old Dirt Farmer
Veteran
Who moved it from schedule 1 to schedule 2? And then switched it back to schedule 1? What date was that? Dronabinol/Marinol is schedule 3 has been a while, see 75 Fed. Reg. 67054 (Nov. 1, 2010) (Listing of Approved Drug Products Containing Dronabinol as Schedule III).
It was earlier moved to schedule 2 from 1:
On May 13, 1986, the Drug Enforcement Administration (DEA) issued a Final Rule and Statement of Policy authorizing the "Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules From Schedule I to Schedule II" (DEA 51 FR 17476-78).





Your "facts" are not facts they are just you rambling on and on.... This post and others...
-SamS

I think he meant cannabis was moved from schedule 1 to 2, so the pharmaceuticals could secure their patents for the synthetics Dronabinol/Marinol, after which Cannabis was then moved back to schedule 1. That being said this is the first time I've heard that claim so I'm uncertain how "factual" it is.
 

mean mr.mustard

I Pass Satellites
Veteran
Who moved it from schedule 1 to schedule 2? And then switched it back to schedule 1? What date was that? Dronabinol/Marinol is schedule 3 has been a while, see 75 Fed. Reg. 67054 (Nov. 1, 2010) (Listing of Approved Drug Products Containing Dronabinol as Schedule III).
It was earlier moved to schedule 2 from 1:
On May 13, 1986, the Drug Enforcement Administration (DEA) issued a Final Rule and Statement of Policy authorizing the "Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules From Schedule I to Schedule II" (DEA 51 FR 17476-78).


Perhaps the only entity who could???


Who did research in the classic sense?

Don't think I don't tell the truth.

Don't think those who would profit from lies would differ in opinion either.

I really wonder if the same gold pocketed individuals who moved the classification to profit from a synthetic would let the synthetic classify anywhere over CSA II...

Why wouldn't they? Probably because THC isn't really worth shit without the rest of the gifts that came with it... In the ORIGINAL form...

But we all protect our interests ;)

Why is Sativex extracted rather than being synthesized?
 

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