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  • A couple hours outside London, thousands of cannabis plants are growing in this enormous

  • glasshouse.

  • Scientists here are testing different strains, processing raw plant matter, and converting

  • it into potent medicinal extracts.

  • But this isn't your typical grow house, it's a pharmaceutical research operation

  • in the U.K. — which as it turns out, is the world's largest supplier of medical

  • grade cannabis Here, they've developed Epidiolex, a new

  • medicine containing cannabidiol, a compound derived from cannabis, that's shown potential

  • to treat severe forms of epilepsy.

  • It's the first of its kind to be approved by the US Food and Drug Administration, and

  • is available to patients in the United States at special pharmacies.

  • But, cannabis is still a Schedule I drug in the US, meaning it has no medicinal value.

  • If doctors here want to study it further, they have to walk through a complicated patchwork

  • of regulations.

  • And if they make it through the hurdles, once the medicine arrives, it has to be stored

  • in a roughly 750lb vault that's bolted to the floor and secured with a lock.

  • But outside a doctor's office, weed seems more accessible than ever.

  • As it's gotten easier for the average person to go buy cannabis at a dispensary, it's gotten

  • even harder for scientists to be able to study it.

  • Cannabis is a controversial and complex plant, with over 100 unique chemicals called cannabinoids.

  • There's very little that we really understand about a lot of these chemicals.

  • We understand the effects of two of them, somewhat.

  • Delta 9 THC which is the chemical that produces the classic cannabis intoxication.

  • THC in relatively high doses can cause euphoria, hunger, anti nausea properties, anti-pain

  • properties.

  • Cannabidiol is very different.

  • It doesn't produce any intoxication whatsoever yet it has anti inflammatory effects.

  • It is scientifically interesting because there is a receptor in the brain called the cannabinoid

  • receptor that binds to these chemicals and produces a whole range of effects.

  • And this network of receptors are found throughout the brain and body.

  • So it's really a new frontier in many ways to understand its role in brain development

  • and regulating mood and food intake and cognition.

  • It's a complicated plant and just labeling it a medicine as is isn't sufficient.

  • Society has jumped ahead and is just moving on treating it like it's a medicine in lieu

  • of this data.

  • Everybody's taking CBD and ointments and massages and oils and added to their coffee.

  • We don't know anything about if it's absorbed by these routes of administration.

  • I have no idea if it actually gets into your bloodstream at any level that would be meaningful.

  • So it's critically important that we were able to conduct these studies so we can say

  • what it works for at what concentration, which cannabinoids, and what it doesn't work for.

  • And right now we're severely hampered in our ability to conduct these studies.

  • And that goes back to weed's status as a Schedule I drug, a classification that puts

  • it in the same line as heroin, with no recognized medicinal value in the eyes of the U.S. federal

  • government.

  • Meanwhile, states have moved forward to legalize cannabis and patients with severe diseases

  • are turning to their doctors for answers.

  • I get patients coming into my clinic asking me all the time, "What do you think of this?"

  • and "My friend tried it for this and it worked, and my other friend tried it for that," and

  • it seems to have these magical properties where it seems to work for almost everything.

  • And physicians and researchers are stuck.

  • On the one side, we don't have adequate studies that establish the safety and efficacy of

  • these drugs, but we don't have studies that negate it, either.

  • The National Academy of Science released a major report that found conclusive evidence that cannabis

  • can treat chronic pain, multiple sclerosis, and improve nausea symptoms during chemotherapy.

  • There's moderate and limited evidence for other diseases in the 10,000 abstracts they considered.

  • Still there's a lot scientists don't know about weed.

  • But that's not stopping patients from taking matters into their own hands.

  • Patients really didn't need our permission or our approval to go after these therapies.

  • And given the desperation that parents face when they have a child with infantile spasms

  • or other similar disorders, it's understandable that they would be looking outside the box.

  • There were a few patients who responded to cannabidiol extracts and we didn't have a

  • better explanation for why and that's what really got us curious.

  • Self-medicating with cannabis may be able to solve some medical issues, but unknowingly

  • they could be causing others.

  • So doctors responded to their patients by launching their own investigations.

  • The first step that we started upon was to systematically survey parents and we asked

  • people to bravely describe what they were doing even though it was illegal.

  • And that's pretty low quality research when you ask clinical scientists out there.

  • We wanted to go after formal clinical trials, but that's where it got tricky.

  • All three experts we spoke to are at different stages of their trials, but the hoops they

  • have to jump through are mostly the same.

  • The first step is to go to the FDA.

  • Describe your study.

  • Explain all the risks and benefits.

  • It's quite a process.

  • There really wasn't a lot of literature.

  • At the end of the day, we did have to make some reasonable guesses to design the study.

  • And once you get approval from the FDA.

  • The next step is going to the DEA.

  • So there is a federal DEA and then each state has its own narcotics control regulatory agency.

  • In order to be granted a Schedule 1 license, the DEA wants to make sure that you are taking appropriate

  • precautions to protect and safeguard drugs.

  • And it seems strange that we need to lock it in a vault, while the same patients that we are

  • trying to recruit into our studies have the opportunity to get a nearly identical

  • product in a dispensary one mile from our hospital.

  • And this entire process could take years.

  • And I'll be frank, I'm not sure if my funding is going to last before all these regulatory

  • agencies approve the study so it's enormously frustrating.

  • We tried to work our way through the red tape and pretty much gave up.

  • It wasn't until there was a little bit more pharmaceutical development, and that folks

  • with deeper pockets and more resources were willing to partner with me to run clinical trials.

  • That seems to be the trend here.

  • Because the red tape is so thick, pharmaceutical companies can jump in to partner with doctors

  • on cannabis clinical trials.

  • They know how to work the system and have the resources to develop cannabis therapies

  • in the UK and Canada.

  • It gets more complicated for the public whensomepharmaceutical companies fight weed

  • legalization, and then receive approval to

  • develop synthetic cannabis.

  • Because another hurdle, can be the weed itself.

  • With the current DEA regulations, the only way federal researchers can study cannabis

  • is to study it from one source and that's a farm in Mississippi that the National Institute

  • of Drug Abuse regulates.

  • The problem is that there's a huge variety of products that are available online, in

  • dispensaries, which have had favorable responses associated with them.

  • There are not reports of kids responding beautifully to NIDA farm products.

  • If you compare the potency between what doctors receive from NIDA versus what a recreational

  • user can get at a dispensary, the difference is pretty striking.

  • And this constant approach where we ignore the specific product which has been associated

  • with plausible response, and we substitute it either with a pure pharmaceutical product,

  • or a NIDA farm product doesn't make sense.

  • We should really study what seems to be working.

  • But I also understand the other side of this argument, that we want to use the best standardized products.

  • And when you depend on those products which are available in dispensaries they are

  • known and notorious for not being adequately consistent.

  • For any kind of clinical trial, doctors need to control the variables.

  • It's not to say that what may be purchased through a dispensary is necessarily less pure.

  • We don't know if it has the exact percentages that are listed on the label or what the purity

  • is and whether it's been run through screenings for pesticides or things like heavy metals.

  • The farm can't keep up with all the federal researchers so if

  • the DEA allowed other sources of cannabis that are well vetted.

  • That's an important next step.

  • Recently hemp was made legal and that is very exciting for us because hemp could be a source

  • for cannabidiol because right now as researchers we don't have a good source.

  • There's a huge interest in the medical field to better understand efficacies, side effects,

  • tolerability, what sort of best ways to deliver it.

  • The chief mission at this point is to have rational, scientifically-based, medically-based

  • regulation of research.

  • And that really requires action from Congress.

  • Epidiolex, is now Schedule 5, meaning the DEA says that it has accepted medical use

  • and limited abuse potential.

  • So it's hard for me to understand how the DEA can say that one product is Schedule 1,

  • and one product is Schedule 5.

  • And that is the chief quandary, I think.

  • I don't know how we can reconcile that without simply changing the designation of all marijuana products.

  • We have to recognize that marijuana in general does have therapeutic potential, and that

  • at the very least it should be scheduled as a Schedule 2 drug, meaning it's a drug that

  • has some acceptable use but still has potential for abuse.

  • That would be scientifically rational.

  • We have a tough challenge before us.

  • We need to balance our desire to do things that are most scientifically rigorous with

  • the need to make real forward progress with these diseases that are so severe and for

  • which the need for new therapies is so desperate.

A couple hours outside London, thousands of cannabis plants are growing in this enormous

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科学者が雑草を研究するのは難しいことではない (It Shouldn't Be This Hard For Scientists To Study Weed)

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    林宜悉 に公開 2021 年 01 月 14 日
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