It Shouldn’t Be This Hard For Scientists To Study Weed

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 when “some” pharmaceutical 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.