Recreational Marijuana and CBD: Public Attitudes, Science, and the Law

Recreational Marijuana and CBD: Public Attitudes, Science, and the Law


MICHELLE WILLIAMS: Welcome
to the forum, live-streamed worldwide from the
Leadership Studio at the Harvard T.H. Chan
School of Public Health. I’m Dean Michelle Williams. The forum is a collaboration
between the Harvard Chan School and independent news media. Each program features
a panel of experts addressing some of today’s most
pressing public health issues. The forum is one way
the school advances the frontiers of
public health and makes scientific insights accessible
to policymakers and the public. I hope you find this program
engaging and informative. Thank you for joining us. [MUSIC PLAYING] PAUL DEMKO: Hi, my
name is Paul Demko. I am the cannabis
editor at Politico. Thank you so much
for joining us. Thanks for everyone in the room
for braving the elements today. We have a wonderful
panel today to talk about CBD and marijuana. I’m going to introduce
everyone very quickly here. We have to my
right, Bob Blendon, who’s a professor
of Health Policy and Political Analysis at
the Harvard T.H. Chan School of Public Health and the
Harvard Kennedy School. We have Staci Gruber who is
the director of the Marijuana Investigations for
Neuroscientific Discovery program at McLean Hospital
and associate professor of psychiatry at
Harvard Medical School. We have Andrew Freedman,
co-founder and partner at Freedman & Koski
Consulting Firm and former director of
the marijuana coordination for the state of Colorado. And finally joining
us remotely, we have David Grelotti,
medical director of the Center for
Medicinal Cannabis Research at the University
of California San Diego School of Medicine. This event is being presented
jointly with Politico. We are streaming live on
the website of the forum, as well as Politico. And we will be doing a Q&A
at the end of the program. So if you do have questions
that you want to email, the email address is
[email protected] Again, that’s
[email protected] So to set the table a little
bit about marijuana and CBD, I think it’s fair
to say where we’re living in some very
interesting times in terms of a rapidly changing policy
landscape around the country. We now have 33 states that
have legal either medicinal or recreational markets,
and it’s literally changing every day. I mean, right here
in Massachusetts, you can walk down the street,
I think about a mile from here, and visit a dispensary
and purchase marijuana. Just on Sunday, we saw the
first recreational or adult-use sales in Michigan begin. So this is really
an interesting time. And on the CBD side,
we had in 2018, Congress passed a farm
bill that legalized hemp. And what we’ve seen
in the last year is just this massive growth in
CBD, hemp-derived CBD products in lotions, in tinctures,
in foods, in beverages that is just exploding
in popularity. And people are taking it
for everything from insomnia to treating cancer. And at the same time, you
have the Food and Drug Administration really
struggling and wrestling with how to regulate all
these new products that people are taking. So that’s just fascinating. Just last week, the FDA sent out
15 warning letters to companies for making medical
claims that you know that they shouldn’t
be making, I guess, is the easy way to put it. So it’s really interesting time. And to give us a
little more background, we’re going to watch a clip from
the Mayo Clinic News Network about CBD. BRENT BAUER: CBD comes
from cannabis sativa, which is the plant from
which we get marijuana, which has THC, which is the
effect that gets people high. JASON HOWLAND: CBD is being
touted to help treat nausea, anxiety, cancer, arthritis,
and even Alzheimer’s. Does it work? BRENT BAUER: We know
in animal studies and some test tube
studies, seems to be pretty good for
anti-inflammatory. It may have some anti
pain, and it certainly has some effect on mood. JASON HOWLAND:
Patients, such as those being treated with cancer,
should talk with their care team before using CBD. BRENT BAUER: It can
interfere with the metabolism of some chemotherapy agents. JASON HOWLAND:
Doctor Brent Bauer says there needs to be
more research on CBD. Early indicators show it’s
safe, but many questions remain. BRENT BAUER: If it’s
strong enough to help you, it’s strong enough to hurt you. JASON HOWLAND: Doctor
Bauer tells his patients to do their homework and be sure
to talk with their health care provider. BRENT BAUER: I’m very
optimistic that there will be something beneficial there. I don’t think it’s
going to be magic. JASON HOWLAND: For the
Mayo Clinic News Network, I’m Jason Howland. PAUL DEMKO: Terrific. And we’ll start with Bob here. Bob, you did a poll, I
believe, in October– ROBERT BLENDON: We did a poll. PAUL DEMKO: –in conjunction
with Politico and Harvard T.H. Chan School of Public Health. Walk us through some of the
interesting and surprising findings from asking folks about
CBD and recreational marijuana. ROBERT BLENDON: So
quickly, how did we get here for this session,
because there’s actually been very broad
changes in the beliefs and values of the average
general public around marijuana and it’s legalization
for recreational purposes and how CBD is seen. And you can see CBD
as something that’s a pharmaceutical
project at the FDA, or you could see it like
dietary supplements, which the FDA itself takes
treatment for every week, because it’s relatively
unregulated for that. So we asked just
simple questions. And what you’re going
to see is change. And then some of the
results are really going to have people
taken back a second. So let’s just look. The first slide is
we asked people today on a harmfulness scale, what
is harmful if people use it? So to no surprise, tobacco
cigarettes are at the top. But for a number
of people who’ve been emailing me
every single minute, you wouldn’t think that
electronic cigarettes where the second biggest threat. And would you
absolutely think about, since we filled jails in
America for years for people selling marijuana for
recreational purposes, that it’s seen as less
harmful than alcohol. So next slide. It’s always been like this? No. There’s been an incredible
cultural change. And politics is my field,
and let me tell you what that number says. If I put it on a referendum,
it’s going to win. That’s simply what it says. For that, and if the state next
to me got it by referendum, they’re going to
people in my state who are going to try to get
the legislature to do it. So this is quite
a profound– we’re talking about 20 years
here from “of course not.” And the federal
law hasn’t changed, and people are just
drifting themselves along. Next slide. So we were able to
separate out people who reported that marijuana
was legal in their state for recreational
purposes, and asked them a very complex question. You need notes for this. Is it a good thing
or a bad thing? And it turns out that
most people living in a state that did
this regardless of all the stories about
driving and this and that and everything else,
think that the legalization actually worked out. So that sort of sets the tone
for a debate that’s going on and an oddity where
this is highly illegal at the federal
level and the culture is changing through
the state level. So let me just switch
quickly to CBD. And quickly, for anybody
watching, one half of Americans doesn’t know what the three
words, three letters mean. So let’s agree to that. However, those that do have
somewhat strong feelings. Next slide. So what we have is the
people familiar with the term and people who
actually use it, which is a small sub share
of the population. And so, essentially,
the first question is should the FDA
regulate CBD for safety before it’s put out there like
other pharmaceutical projects. And you could see it’s, among
the people familiar, just over half. However, if I’m a user
of this product today, the answer is no,
keep the FDA out. And for the record,
that’s pretty close to what you find for
dietary supplements today. So on our panels,
everybody wants to regulate dietary supplements. For the person at
the Topeka Turnpike, they have a different
answer for that. And so, should they be able
to buy it if it’s not safe? For the general person– no. For the person who
actually is a user, for a public health
school– sort of striking– you’ve just told them it’s
not safe, and they say, I still should be able to buy
it if I want to use it for that. So the next has to do
with effectiveness. And so, just so we
have a balance here, schools of public
health generally believe that things
should only be available if they’re effective. That that’s our bias for this. So right out of
the box, should it be available even if it’s
shown not to be effective? The bottom line is, yes. Yes, by the public in general. Yes, overwhelmingly
by people who use it. And this is exactly
the same findings that were reported 15 years
ago in dietary supplements. When people said we don’t
know what’s in them, these are risky,
and everything else, there was some
support for safety to take things off the market
that really threaten people’s health, but there was let me
judge myself whether or not this works. And this is totally
different than the other side I called a
pharmaceutical product, and we do not put it out there
unless the clinical trials are very powerful. So this is the environment. None of this, we have
no national referendum. None of this requires
something nationally, but it does change the
culture of what goes on here. PAUL DEMKO: Terrific. Thank you, Bob. Staci, you’ve been studying the
long-term effects of marijuana, particularly on the brain and
cognition for a long time. What does that research
tell us and where is there’s still more work
to be done in this area? STACI GRUBER: So, I think
it’s a great question. And it’s important to remember
that despite the proliferation of things like CBD-based
products, et cetera, nearly all of what we know about
the impact of marijuana comes from studies of
recreational consumers, despite the fact that
legalized medical cannabis has been around since
1996 in this country. And what studies of recreational
cannabis consumers or marijuana consumers typically show
us is that these folks have alterations on things like
cognitive performance, measures of brain
structure and function. Earlier onset of
marijuana use is typically associated with more pronounced
alterations, likely due to the fact that the
brain is particularly vulnerable during adolescence,
not just to marijuana, but to lots of things–
alcohol, illness, injury. Another concern is rising
potency of marijuana products. We all know that products
have changed over the last two decades. THC, the primary intoxicating
constituent of the plant has gone up precipitously
in these products, in terms of the
potency, if you will. And novel concentrate products–
things like dabs, shatter wax– we’ve all heard these terms– start life at about 35% THC
and go north of 90% THC, raising concern for some of
our more vulnerable consumers, like our adolescents. But it’s important to remember
that marijuana use is not the same when you’re talking
about recreational or medical patients. It’s just not the same. The goal of use is
wholly different. So our recreational consumers
versus our medical patients– recreational consumers are using
to change their current state of being, to get high. Our medical patients,
on the other hand, are looking to
alleviate symptoms. Because of this difference,
the products that they choose are often very different. Our recreational
consumers are looking for products high in THC. That’s why we have these
concentrated products across the marketplace. Our medical patients are often
looking for products with THC in them, but they’re often
choosing products high in cannabidiol. And for the 50% who don’t know
what the three letters mean, cannabidiol is a primary
non-intoxicating constituent of the plant. There are hundreds
of other compounds and turpenes and flavonoids
and other things. But it is important to
remember the differences between these two groups. It’s also important
to remember that we need more data regarding
the impact of the benefit and the risks associated
with medical marijuana use, despite the fact that we’ve
had legalization since ’96, we have no longitudinal data. I started something called
the Mind Program in 2014 to help address some of
those gaps in the literature. And what I can tell you is data
from our first longitudinal studies of medical marijuana
patients are in stark contrast to what we’ve seen in the
recreational consumer, specifically relative
to a baseline where they don’t have
any, quote, marijuana or cannabis on board. After three, six, 12,
18, and now 24 months, what we’re seeing are
improvements on measures of cognitive performance. We’re seeing improvements in
clinical state, normalization of brain structure and
function, and interestingly, a rather precipitous
reduction in the use of conventional medications,
specifically opioids– critically important. But in addition to these
longitudinal observational studies, of which
we have many, we are also conducting the
very first clinical trials of plant-derived high
CBD, very low, but not no, THC sublingual solutions. We started with anxiety
as our first indication. These studies are
underway and actually may provide some of the data
that we so desperately need. They’re open-label to
double-blind, which basically means open-label– everybody
gets the drug, double-blind– some people get the drugs,
some people get placebo. This is the way we will
be able to determine if, in fact, there’s
anything to it. But these studies are
not so easy to begin. Current regulations
actually limit our ability to study actual products that
patients and consumers are taking. I can’t do those studies,
contrary to popular belief. We’re still rather limited. And we do need investigations
to clarify the impact of things like product source. We talked about
hemp for a second. What’s the difference
between things that are hemp derived versus
cannabis-sativa derived? Are there differences? What about extraction methods? How do those things change? What about the entourage effect? The synergistic action of
cannabinoids, terpenoids, flavonoids, all the things
inherent in the plant that may actually yield a more
efficacious benefit than single extracted compound-based
products or an isolated CBD-based product at
significantly lower doses– sort of the full spectrum
versus single compound question. It’s important, also,
just to remember that one size doesn’t fit all
when it comes to marijuana. It’s not all good or
all bad for any person. And we need continued research
on medical and recreational cannabis use in order to
maximize therapeutic potential and mitigate risk and harm. PAUL DEMKO: Excellent. Thank you, Staci. David– CBD– what do we know
about the medical uses of CBD, and what are some of the studies
that are out there right now, and what don’t we know? DAVID GRELOTTI: Well,
thank you for inviting me to join you guys, and I’m
sorry I couldn’t be there in person. I think with
respect to CBD, it’s actually important to recognize
that the United States Food and Drug Administration, which
is the regulatory agency that is dedicated to assuring that
our medicines meet quality and safety standards and have
a demonstrated medical benefit, they actually just approved
the first CBD-based medication for severe and rare
forms of epilepsy. And that was based really
on a parental report of CBD-enriched [AUDIO OUT]
helping their [AUDIO OUT] epilepsy. So the Center for
Medicinal Cannabis Research has actually been
around for 20 years. Actually, it started
in California after California
became the first state to legalize medical marijuana. And the state wanted
to actually look to see if there was any
real benefit of cannabis or marijuana for the conditions
people were using it. And we looked to patients,
at first, to see well, how are you using it? How can we then apply some
rigorous scientific methods to seeing if what they’re doing
actually makes medical sense. And so we had some of the first
clinical trials of cannabis for pain and for spasticity
in multiple sclerosis. We used a placebo to assure
that the findings that we had were related to
something to cannabis– cannabis, in this
case, with THC. There’s different
concentrations of THC. And there were really
three take-home messages from the first eight
studies that we did. First off, in all
the studies cannabis actually showed to be effective. It reduced pain and it
reduced spasticity in multiple [AUDIO OUT]. And the side-effect profile
was actually very consistent with some of the
other medications that were traditional using
for these conditions. The third thing is– and
this one actually was only– there were two studies. The lower the THC
concentration, we found that the
cannabis was still very helpful for,
in this case, pain, but didn’t have a lot of the
intoxicating side effects that we sometimes
worry about when we’re thinking about applying
cannabis as a medicine. That’s very different
than CBD, which doesn’t have any [AUDIO OUT]. But in all, we’re
really still trying to figure out how all the
various ways which CBD and THC can be helpful. We’re still [AUDIO OUT] the
patient accounts for that. We’re also looking
at some of the ways that we know CBD
and THC interact with different parts of the
body, receptors in the body, or cell types, and how
that might actually relate to different conditions
that we are treating. So we have CBD trials under way. They’re looking at
CBD for low back pain, for tremor, and for
neuropathic pain. We have seven funded
studies that we’re trying to get off
the ground as well, and they look at a number of
other different conditions, like psychiatric conditions,
like anxiety, psychosis, eating disorder, sleep,
neurological conditions like migraine and pain,
neurodevelopmental conditions, like [AUDIO OUT]
problems in autism, and then inflammatory
conditions like arthritis. CBD is a fascinating molecule. It has a lot of different
potential activity out there. And so there’s a lot of hype
around what it might do. Some of that may turn
out to be very real. It’s the things– those are
the things that we’re trying to pursue to make
sure that CBD is– really does find a place
in our armamentarium of medical therapeutics. So we need the controlled
studies for CBD. We need to try CBD, as
Dr. Gruber was saying, with other derivatives
of cannabis as well to see if it’s
a combination of things that works best. We also want to look at the
different ways of administering it. So is inhalation
better than taking it orally or [AUDIO OUT]? I mean, heck, there are people
even trying suppositories out there. So at the end of the
day, I’m a physician, and I want to make
sure that CBD fits within the whole kind
of treatment portfolio that we have for conditions. So it’s one of
the things that we could do to actually
treat a patient and relieve suffering
or cure illness. CBD is not unsafe, but
it’s not without risks. So we need to have– it has
to be placed into context to make sure that the
risk and benefits are appropriate for the condition. And the CMCR is really
looking at all– is really focusing
on clinical trials, and then also
trying to put things into a broader perspective. The liberalization of
cannabis use legislation is a global phenomena. I personally have
talked about cannabis in Ukraine, Canada, and Mexico. We’ve been discussing
this in Asia as well. There is an
epidemiological issues that we need to focus on. We need to look at some of the
potential impact of cannabis on driving. Those are things that
we are also doing. We want to look at
some of the mechanisms as well, so the science
behind these cannabinoids. And so, all this hopefully
will help us inform the public, inform doctors and patients,
and really get [AUDIO OUT] our way of doing medicine. PAUL DEMKO: Thanks, David. And finally, we’ll go to Andrew. We’re going to talk a little
bit about the policy landscape. We’ve got this
situation where we have this incredible
disconnect between state law and federal law where marijuana
is illegal under federal law, and yet, we have 33 states that
have some form of legalization. I guess, what– how is the
policy situation serving patients and consumers,
and what could be done to improve that situation? ANDREW FREEDMAN:
So it’s, I think, one of the most extraordinary
political phenomenon of this generation, that
where we are with cannabis is certainly the most striking
form of direct democracy and political
populism that we’ve seen in American democracy
in the modern age. And so, part of what I do
for a living is essentially figure out how to undo some
of the complications of that, such that public
health can actually be the framework with
which we look at cannabis. I think the problem
came in from the fact that, as David pointed out,
public sentiment has been shifting for a long
time on cannabis and the federal
government has not. And there was a build up
of political support that essentially just bubbled
over into state referendums, which essentially just asked
us to defy federal government. And it really was a rejection
of institutions, because even– it was in the face
of doctors, police, everybody telling them please
don’t vote yes on legalization and overwhelming still
populist support, in a time where
things are actually– it’s hard to get 50 plus one and
it was getting 60%-65% approval rating. But there’s some complications
that come from that. I think it’s both
extraordinary and and, frankly, heartening that there’s
that sort of path forward still in
American politics. But it has created
a movement that is going to be
really hard to now fit a public framework–
a public health framework to, for a couple of reasons. First of all, at the
state and local level, and probably overall on the
federal level at the end, people are going
to be– politicians are going to be unlikely to
promote any policy that reduces access to patients, but
even to recreational users at this point,
because it’s been such a powerful grasstops campaign. They’re hearing directly
from constituents that anything you
do that then reduces the access that we
currently have is antithetical to our movement. And so we are going to
ask you not to do that. And frankly, when you
go to these states, you see they have power
over both the Democrats and the Republicans to really
stop any legislation that might do that. And that comes at a time of
heightened consumer confusion over what all of this can do
and a time of heightened snake oil in the retail space with
essentially no enforcement of our traditional institutions
because they’ve all been rejected in this space. And so, how to figure out
how to both educate consumers up and get the correct
institutions back in the game enforcing a
regulatory system that ensures not just efficacy but also
safety of the products, is going to be an extremely
difficult challenge in this policy space, but
one that ultimately probably will fall on public
health specialists. For the most part, looking
at federal law going forward, and even state
law going forward, there has to be an acceptance,
I think, on some level that most of this stuff is now
innocent until proven guilty. Claims are innocent
until proven guilty. Specific forms of
the product are innocent until proven guilty,
which again runs against most of the way we’ve seen consumer
protection in this world, where most of the time we are highly
skeptical of a new product. It has to pass a lot
of rigor before we allow it to go to consumers. That simply is not going to
be the way with cannabis. And so, how do we
get back to a place where policy is led by
science in this place? And the answer is
we’re going to have to become really creative here,
both at the public health level and at the policy level. PAUL DEMKO: Terrific. As you mentioned, there
is a lot of enthusiasm around recreational marijuana. I mentioned Michigan had
its first sales on Sunday. I think there were three
dispensaries, initially, that opened in Ann Arbor,
and you had people lined up around the block. And I think we’ve seen that
repeated in state after state when they’ve allowed sales. And we’re going to take
a look at a clip here of the first legal sale at the
New England treatment access dispensary in
Northampton, and you’ll see that the mayor here
was the first in line to show his support for
this new realm of commerce. So let’s take a look. DAVID NARKEWICZ:
Obviously, historic that Northampton is
playing an important role in making history, in terms
of the adult legalization of cannabis. And I’m proud to have
been the first person to make the purchase. I think it sends a symbolic
message that an elected official is giving some
credibility to this industry that for years has been– that marijuana, cannabis
has been stigmatized. And so now, we’re bringing
it out of the shadows. We’re making it legal,
regulated, safe, and available for adults to be able
to purchase and consume responsibly. SPEAKER 1: Customers coming in. Let’s go. [CHEERING] PAUL DEMKO: Well, I
think that shows well some of the enthusiasm there. What about, Bob, you
mentioned the polling data. I think the poll that you
conducted showed 62% support for legalization nationwide. I think a lot of other polling
data has shown similar results. And yet, we haven’t really
seen any action by Congress to address this disconnect
between state and federal law. I guess, what do you think
about the kind of lack of action by Congress there, given
where public perception is? ROBERT BLENDON: So it turns
out this is not the only issue. Guess what? People want pharmaceutical
prices regulated. It’s the 70% level. No bill has come out. So there is a paralysis
in institutions. That has struck the
American public, and it’s going to have
electoral implications. People just can’t figure for it. Also, there’s something called
unwarranted medical billing. There’s nobody in Topeka
Turnpike who says, I want an unwarranted
medical bill. Congress has done nothing. They cannot come together on
Monday and by Wednesday have done this. So we’re going to have a
situation where you’re just going to have states,
one after the other. And then legislators are
going to have a problem when the adjoining state
has it and everybody’s driving in the Massachusetts
and you’re in New Hampshire. But we have a paralysis and
it’s affecting the public views about how government
functions, because the Congress can’t take things that
are 75% and pass anything. So we have a real
institutional problem for this, and it’s not a
voting issue where you’re voting everybody out. But it’s an issue
where people have just paralyzed the process. You need x number of votes
to get out of a committee, and they can’t deliver. But this is a broader
problem for this country that the elected representatives
can’t take a popular issue and move on it. And this is just one of them. PAUL DEMKO: Yeah,
I mean since then, we had a vote on banking
legislation in September. Basically, this
legislation would say banks can do business
with cannabis companies without fear of
federal punishment, and it passed 321 to 103– overwhelming support– almost
half of Republicans backing it. But we haven’t seen any
action in the Senate. So it’s kind of
meaningless at this point. Andrew, what about from the
regulatory landscape, how does the continuing federal
prohibition affect the ability to have substantive meaningful
regulations to protect the public and to
provide consumers what they’re looking for. ANDREW FREEDMAN:
Well, I think states are having to grow new muscles
that they haven’t had before. Testing labs is a
good example of that. Never before have
states been asked to do so much quality control. And I think doing an
OK job at it, actually, I think it’s probably
part of the weaker systems in every state. But pesticides,
testing, banking– there’s a whole bunch
of things that really the federal government
has been always in charge of that
the states are having a really difficult time getting
their hands around and figuring out. So it’s really round
pegs, square holes, and a lot of really silly
ways of getting things done. But I think, for a lot of
people, and this polling shows, they still prefer it over the
status quo of prohibition. I think, quickly to Bob’s
point about why we’re not seeing any federal
action, I think it’s absolutely this is a much
bigger institutional issue. But also to your
initial point, there’s a difference between support
versus voter salience. This is not one of
their top 10 issues, no matter how you put it. And then you mix on top of
that, this takes all the oxygen in the room when you go for it. For some reason, and
you see this in Canada, even though it’s
nobody’s top issue, it certainly gets to the top
of the papers every time. And so, when we do
this, we’re going to have to have a
national conversation. When that national
conversation fits into a whole bunch of problems
that we’re having right now, I have no idea. PAUL DEMKO: I want to
bring Dr. Grelotti in here. I think you might have
used the term snake oil, or somebody did anyway. But we have– patients
are using these products, whether it’s CBD or
marijuana, millions of people are using these products. But I don’t think there’s been
a lot of physician education in terms of helping doctors
help their patients figure out how to use these products. What are the challenges
there, and maybe Dr. Gruber you can jump in on this too, but
what are some of the challenges there, and what do we need
to do to address that? DAVID GRELOTTI: Well,
so you’re right, there is a parallel
health system out there. It’s occurring at the
level of the dispensary. People are going and
they’re getting information about treating conditions from
what are called bud tenders. And many people, when I– they’ve actually done research. And people who are bud
tenders [AUDIO OUT] actually understand
the cannabis science in guiding their recommendations
for cannabis to patients. I think, from our end,
when I’m in the community, talking with patients, a lot
of people are coming up to me. And they say, you know, we
want to go to UC San Diego and talk to a doctor
about cannabis and get some recommendations
about cannabis from physicians. We need to do a better
job educating physicians. It’s not really currently part
of medical school curriculum. People often– physicians are
often learning about cannabis through continuing medical
education courses that will feature cannabis. That is a good start. We’ve been working with our
medical board of California. And there’s a federation
of medical boards that give clinicians
guidelines about how can they approach recommending
cannabis to patients when it’s appropriate. We obviously need to
improve the science. And we need to give
physicians greater tools. These tools include, like
medicines they may actually be able to prescribe,
but also education about what the science tells
us, what it doesn’t tell us, how we can inform
patients about [AUDIO OUT] involving cannabis and
cannabinoid-based medicines. PAUL DEMKO: OK. Terrific. Staci, what about– you
mentioned the high THC products that are
out there, sometimes upwards of you know 30%
THC, and that potency is rising across the country. What challenges are there
in researching the products that people are actually
using in the market place and understanding what the
potential health ramifications of those are there? STACI GRUBER: That’s
a great question. And because of our
current guidelines and our current
regulatory status, we don’t have
access to assessing the impact of these high
concentrated– highly concentrated products. For example, whether you’re
a recreational consumer or a medical patient,
it doesn’t matter. We can’t study those. And typically, if
you’re going to do a study, a clinical trial
with human subjects, you have two choices. You can have your products
sourced by the National Institutes on Drug Abuse. And they have expanded
their drug supply program exponentially in the
last almost a decade. But there are limitations
to those products. They primarily exist in
only flower-based product. They have two extracts. And there’s no such
thing as shatter wax, dabs, nothing like that. There’s no turnkey, sublingual
solutions that are available. So products that patients
typically avail themselves of, we wouldn’t have access to in
a turnkey fashion through NIDA. Now that hemp is outside
of the Controlled Substance Act, that gives us a
little bit more latitude. But understanding the impact
of high-potency products, whether it’s in our more
vulnerable consumers, our adolescents and kids
for recreational purposes, or even our medical patients,
most of our medical patients try to concentrate once
and say, yep, not for me– too much, way too much. So it’s important to be able to
give them actual information. And as Dave was
mentioning, there’s so little that most
practitioners actually know these days. Most patients come in far more
informed than any health care provider. And it’s really,
really important to change that narrative. Everybody needs to
be on the same page. It’s our job to
actually give them the best information
they can have to guide their own treatment,
and so we can actually help make these things slightly
less harmful where we can. High-potency products in
our more vulnerable folks whose brains are, quote,
still under construction, may very well yield a
very, very different effect than those who are
over the age of 60, 70. We’re not so vulnerable
at that time. Actually, we’re going
on the other side. Our brain is no
longer developing. We’re going the other way. So we need to be
mindful of both sides. Well, it’s the fastest growing
consumer group of cannabis and cannabinoid-based products
are those over the age of 50, by definition now,
are older adults. So we actually have– I know– we actually have
to be very mindful of this, because as we age, we
have reduced metabolism, we have interactions
with the cytochrome P450 system in the liver involving
all sorts of other issues, since as we get older, we
tend to take more medicines. So it’s very, very important
that we have the ability to actually assess products
folks are really taking. I think there have
been some initiatives, but nothing’s actually
come to fruition just yet. PAUL DEMKO: And what about CBD? Do we know– are there
concerns about the level– the dosing levels
that people are taking and our lack of knowledge
about what’s in these products? STACI GRUBER: I mean,
I think Dave mentioned, when we think about Epidiolex,
which sits on its own in schedule five– schedule five– it’s a single
extracted CBD-based product, which means it’s
99.3% percent pure. There’s no terpenoids
or other cannabinoids featured in that product. When we talk about
single-extracted compounds and the doses that individuals
are yielding, quote, benefit from, for example,
pediatric-onset intractable seizure disorders,
the range of the dose is actually significantly
higher than what we call full spectrum, sort
of plant-derived full spectrum products, where you have other
cannabinoids, terpenoids, the essential oils that give
cannabis its scent and flavor profile, but also have their
own biobehavioral effects. The dose ranges for
efficacy apparently are significantly lower. Do we have a ton of
empirically sound data on that? No. Do we need it? Absolutely. And that’s probably
going to differ from non-plant derived
products, these sort of synthetic CBD-based products. So you have a huge range. People will buy a
product that’s one ounce and it has 10 to 15 or
20 milligrams of CBD, but it’s full spectrum. That may be just as
efficacious or more than something that’s
150 or 200 CBD isolate. So we need these studies. PAUL DEMKO: I want to pivot
a little bit to vaping and the public health
crisis that we’ve been seeing around that, and
some of the questions about what’s actually causing
these lung illnesses. We’ve had, I think,
the most recent numbers are somewhere around
2,300 confirmed lung illnesses and 47 deaths– I think I’m getting that right– that the CDC has confirmed. They’ve tied it to vitamin
E acetate as a culprit, but the CDC has also
said there could be other compounds in here that
are causing illnesses as well. I guess I wonder about
public perception, Bob. How does– do you think
that has the potential to affect what you’re seeing
in this data in terms of people being supportive of
marijuana legalization? ROBERT BLENDON: So this is
absolutely critical here. The public is much
more interested in a safety violation than it
is in efficaciousness here. So just since July, the
very harmfulness of vaping and my problem of
being in public health, it’s not clear that
vaping for my colleagues is that much worse than
legalized marijuana for recreational purposes, but
it’s now 40 points difference. The minute people
heard about the cases, they wanted action on safety. They were not asking questions
about whether or not smokers give it up or whatever it
is, safety really plays out. So when there is
a safety concern, there is dramatically
more support for public intervention. It has no impact on the
legalization of marijuana, because until we can just share
this, to the people I survey, THC is a misspelling of the. They have no idea. It had a little THC. They do understand vitamin e. I mean, they have no idea
what the combination is. But the important
point to take away is when something
is unsafe, there’s support for government
intervention. We’ll get back to this later. And that gets activity. And so the ability to respond
when there’s an outbreak and set parameters around that,
there is a real both state health department and the
FDA have a real opening. Nobody is dragging
Governor Baker through the streets for some
pretty tough stands on vaping. But it only occurred after
there was a safety issue. If he did that
three months before, they would not understand why
he was taking that action. So safety changes
the public mood. But they want action
on the safety, not on the generic issue– we’ll
have no vaping or no marijuana, but it’s on that particular
incident they want action. PAUL DEMKO: And Andrew, I
think most of the evidence with vaping points to
THC Vapes, Varana Vapes, and particularly from the black
market or the illicit market. And yet, if you look at
the policy discussion in Washington, it’s
whether we should ban flavored e-cigarettes. I guess, how does the federal
prohibition on marijuana that exists, even though
millions of people are using it, affect
our ability to have an effective public policy
response to this public health issue? ANDREW FREEDMAN: Yeah. It is– I think we are probably
wasting a crisis right now. In that, I mean, all
public health crisis these are unfortunate. We are– this is an
extremely unfortunate crisis to have happened to vaping,
because as far as I can tell, the best thing that we
should be talking about is quality control
and quality assurance. And that means ramping
up a regulatory system. Instead, it’s become
a divisive issue about the nature of vaping
and the nature of marijuana on the public
policy debate side, even though, again,
I agree with Bob, that is not how it’s being
viewed on the population side. There is a lot of
people who have been waiting for
vaping crisis in order to have a few vaping debates. And so, those are
the debates they’re deciding to have,
regardless of what the actual good public policy
would be going forward. I wish that we were at a
place where we said great, this is just proof that
we need quality assurance. We need quality control. And then we need to
separately address the issue of is vaping overall
a benefit to public health or is it an actual crisis that
leads to more tobacco use down the road or whatever
the much bigger picture of what vaping does to society. But we’ve just
completely confused them. PAUL DEMKO: Yeah. Yes, it’s fascinating
the disconnect there. What about– the FDA, the
Food and Drug Administration, has really been
actively wrestling with what to do about this
proliferation of CBD products. And you’ve seen them
take some action around particularly
companies that have made medical claims that
aren’t backed up by evidence. Just last week, I
think I mentioned before, they sent out 15
warning letters to companies. And they also sort of
reiterated that they don’t think CBD is a harmless substance. I guess I want to start with
the public perception here, so I’ll go to you, Bob. Is there an appetite for FDA
to take aggressive action to regulate this
burgeoning space? ROBERT BLENDON: So again,
I always have to apologize, because the answer doesn’t
fit a school of public health. There’s the public interest in,
not efficacy, but in safety. And this is really important. And it’s the exact
reversal of what we do with prescription drugs. We don’t care if it’s
safe or they don’t work. Here, there is a
real role for the FDA to be able to
intervene post market, is what they like to call
it, if anything shows up and pull it off the market. Secondly, to be testing various
things about whether or not they’re dangerous. But you get into a public
problem if you say, mom and dad think they think
better as a result of this, and the FDA couldn’t show
it so you can’t have it. That’s different than, mom
and dad went in a coma, and you pull it off the market. So there’s a real opening. Recall, most Americans–
half don’t know what it is. Most aren’t using it. For them to really have a
floor in the safety issue, including pulling things off
very quickly, which oddly they have in food. So if your lettuce is in
trouble, they can pull it off. If you’re CBD is in trouble,
no, it’s sitting there. So to me, it’s the
safety that they– which is reverse of
what we normally do. They really want to
have it and the ability didn’t move very quickly
to protect people, and they will find that. There is public
supports not allowing people to go on television
and say that your cancer will be cured with one of these. So there is– keep that off
the air if you can’t prove it. But the safety is really
where you have to be, and we tend to do it in reverse. If it’s efficacious,
we then later find out it may not be safe. But the ability to
respond quickly– and just one other point
we’ll get back to is– and it’s the problem with
politics versus public health. Public health has a lot of
very legitimate concerns about dietary supplements,
but in my world of politics, they lost that battle. You are not taking dietary
supplements off those counters. And so, I’m afraid
with CBD, if you don’t have at least
the footwork on safety, you could be in
a situation where we can’t take action because it
is so part of people’s lives. But now there is– CBD– very few
people are using it. It’s just something
that’s out there. You could set up
a safety framework and it would be acceptable PAUL DEMKO: I want to
drill down on the safety issue a little bit. Maybe David, if
you could jump in. I mean, how– what concerns
are there about CBD and safety, and how concerned should
we be about it, given that everybody is taking it? DAVID GRELOTTI: That’s
a good question. You know, it’s
interesting, it’s still murky for researchers
about what approach we can take to
actually study this, because the law is
in flux, and we’re trying to keep up with Whole
Foods and other marketplaces that are selling it
on their shelves. I think the
vaping-associated lung injury that we
were talking about is a good example of this. When those reports
were coming out, researchers like ourselves
who work at institutions that receive federal
funding may have put all that federal
funding in jeopardy if we actually tried
to study these, what were illegal products. So we felt somewhat
handcuffed in our ability to actually respond
to the vaping crisis, even though kids were dying. Now, fortunately the
government and the CDC actually did a lot of
the work to get that– to identify vitamin e acetate–
at least one of the problems associated with those
vaping injuries. But in general, CBD does
have some safety concerns. For one thing, it can
irritate your liver. We don’t really understand that. It may have to do
with other medications that they’re taking at the time. But that’s something
that when you’re going– if you were in our
clinical trials, for example, we monitor. We monitor your
liver function tests. Now, people in the
community maybe giving– using very low doses
of CBD and things that may not irritate your liver. And so the concerns
may be very much less. But as Staci was
saying, we really don’t have a lot of
information about what– how– if CBD is helpful,
and these very low doses that seem to be more
common in the community. One thing that we
do know is that CBD, regardless of where you get
it, costs a lot of money. So we need to do
this work, because– just to save people from making
choices about their money that may actually not
really benefit them at all. PAUL DEMKO: What about– you want to jump in, Andrew? ANDREW FREEDMAN: I
would just point out, that I think, one of the things
that’s missing the most in here is that the FDA actually
has no path forward for CBD to be legal in any way. And so, one of the most
effective mechanisms for enforcement is
just that the industry wants to remain on the
right side of the law. But what we’ve
essentially just said is there’s no way to remain
on the right side of the law. So you have places
like Curaleaf that says well, let’s just make
outrageous statements still, because we’re already illegal,
so we can be extra illegal. And so, even though the
efficacy part of the debate is not what’s important
to the populace, it is very important
that FDA figures out how to set guidelines for
CBD as soon as possible, because once they do,
industry will follow that. MICHELLE WILLIAMS: Yeah. There seems to be a
big divide in industry from what I’ve seen, in terms
of how aggressive they want FDA to be, to police this industry. And you’re seeing
a lot of companies that are begging FDA to
take action because they’re concerned that some of the
bad players in this space are going to cause reputational
harm to everyone, to folks that are doing things right,
that are testing, that are using
legitimate products. So it’ll be interesting
to see where they finally come down here. I think we mentioned earlier
that one of the fastest growing areas of use is
among older adults, whether we’re talking
about CBD or marijuana. Are there particular
concerns, Dr. Gruber, that we should have about
people who are 65 plus who are using these products? STACI GRUBER: Sure. And again, it’s the fastest
growing group in the country. And I think, unfortunately,
as we age, biology is cruel. We don’t typically
get better with regard to cognitive performance. So the question is will cannabis
or marijuana-based products or cannabinoid-based
products impact that even more negatively? So do people get worse? Which is why we have these
longitudinal studies where we look at folks taking
real-world products. And actually, it looks
like they get better, because perhaps their
symptoms are alleviated. Perhaps it’s because
they’re beyond the period of neurodevelopmental
vulnerability. There’s some preclinical
data suggesting that a little bit of
exogenous or outside cannabinoid exposure to the
aging endocannabinoid system, the system we all have inherent
to each of us, actually results in a benefit. But in terms of the risks,
we have reduced metabolism. So it takes longer for
us to clear things. This is especially important
when we think of modes of use, not just smoking or vaping
or sublingual solutions or thankfully,
suppositories, but things like edibles, which are
incredibly popular in our older population. They take a little bit. They take a little more, and
the rise time or the time to get an effect is
significantly longer than you might expect
as we get older. And the duration of effect
is significantly longer. That could be a problem. So duration of effect– time to clear it, and
of course then, we have the involvement with the
liver, the cytochrome P450 system, unfortunately,
whether it’s THC or CBD, both
impact these enzymes. So we have to be mindful
about inadvertently increasing or decreasing the efficacy of
other things, quote, on board. So these are all
things to keep in mind. It doesn’t mean
they can’t use it. But it means we
really have to be mindful about the ways in
which people are using it. And mode of use, as
well as product choice is going to be very,
very important here. PAUL DEMKO: And I should
say, that was a question that was sent in by Lisa. And I’m going to try one more
here before we need to wrap up. And we have a question
here from Judy. It says, can you address
the concerns about marijuana being a gateway drug? And I’ll tee this up a little
bit, in that Joe Biden recently used this phrase in
talking about marijuana and got a lot of blowback,
and I think eventually sort of walked that back. But that’s been a perception and
a talking point in federal drug policy for decades. And I’ll throw this– I’m not sure who
to toss this to. So, but maybe, Dr.
Gruber, it sounds like. Should we be
concerned that this is going to lead to other
more problematic drug use? STACI GRUBER: So I think
it’s a great question, and it’s one that’s been
posed for many, many decades, as most people know. Is marijuana a gateway to
health or a gateway to hell? This is what I typically get– which is it? And I think the answer is
coming clearer for most people. When we think about the height
of cannabis or marijuana use in this country, we didn’t see
exponentially increased rates of other substance use. We just didn’t. The fact that other drugs
become more frequently used by individuals who, quote, start
off using cannabis very often comes down to other factors,
like the individuals you’re spending time with, your
social group, your peer group. All of those things
make a difference. From a neurobiologic
perspective, the reward circuitry
in your brain responds to cannabis, to
sugar, to all sorts of things. So it’s not as if
cannabis will necessarily change the ways in which those
receptors respond and say, ah, now I’m hungry for this,
now I’m hungry for that. It’s a reinforcing system and
so you have to be mindful. But I don’t think there’s much
evidence in terms of, quote, the gateway phenomenon in human
subjects studies at this point. PAUL DEMKO: We’ve got one
more question coming in, and I think we can
do it quickly, maybe, and this is from Dana. How does marijuana
and CBD interact with mental health issues? Do we know if their use can
amplify existing problems, such as bipolar disorder? STACI GRUBER: So we’ve actually
done–and David may want to weigh in– we’ve actually
done some studies of folks with– our first studies
were in patients with bipolar disorder,
who did and did not use cannabis or marijuana. So it’s the second most commonly
use substance in patients with bipolar disorder. Why? Because some folks
experience mood regulation. I had patients
say, you know, when I feel like I’m spinning out
of control, I take two hits. I feel calm. Other folks said, when I feel
really down or depressed, I take a few hits. I feel better. We did an EMA study,
so folks actually rated their mood before
and after using cannabis throughout the day. And as it turns out, for
at least a subset of folks using cannabis, they actually
did experience a mood stabilization. Does that mean all patients with
bipolar disorder should go out and just use any cannabis? Probably not. And one of the reasons that we
started the Mind Program was to try to figure out the ways
in which we could harness therapeutic potential
and mitigate risk by figuring out which
constituents were more helpful. As it turns out,
some of the folks that we deal with chronic
anxiety or bipolar disorder, do very well on a combination
very low THC, high CBD. But whether that remains
true over time, we’ll see. PAUL DEMKO: We do
have to wrap up here. I want to send it to you, David,
for kind of a final thought, either teeing off on
that or anything else you’d like to kind
of sum up here. DAVID GRELOTTI: Well,
I’m a psychiatrist, and I think when
patients come in, and they tell me that they’re
having a lot of problems, and they’re using
a lot of marijuana, I might say, well, maybe,
that’s not really helping. And then for other
conditions, we actually think there might be
a benefit out there. We just don’t know a lot. We’re– you know, for 3,000
years, cannabis was a medicine. It was used for a variety
of different conditions. And it was really,
like, 100 years ago that it was taken off, largely
for political reasons that– taken out of our
pharmacopia for medicine. We’re now putting it back in. Those were our dark
ages, and we’re kind of emerging into
this Renaissance. [AUDIO OUT] that for
all the questions that we have pondered
today, science is this candle in the dark. We need to kind of really
reinforce the science so we can have a better
understanding of cannabis and its constituents,
so we can make the most educated decisions
about how to use them. We know that there is
some benefit out there. We’ve demonstrated that already. And we just need to then put
it in context, just like we would do any other medicine. And then, the recreational
side, I’ll defer to others, but it’s also an
important consideration that we need to bring to count. PAUL DEMKO: Andrew,
a final takeaway you want to leave us with today? ANDREW FREEDMAN: Yeah, when I
was the director of marijuana coordination for
the governor, one of the things I often had
to say to our public health specialists is for a while,
some things need to just be good enough for government. I think there is
a paralysis that is going around marijuana
that until we know everything, we should govern nothing,
and that’s just not going to work here. So I hope that the
public health specialists start to come through
with frameworks, both for recreational
and for medicinal, that we can use in the
interim between when the science actually
does catch up here. PAUL DEMKO: Staci,
final thoughts you want to leave us with? STACI GRUBER: I couldn’t
echo the sentiments any more strongly. It’s like rock and
roll in the old days. It’s here to stay. It’s not going anywhere. Patients and consumers
are using it. And to wait until we have
all of the information is just not logical or feasible. And our patients and
our consumers deserve– they deserve this data. And so, what we need
to do is whatever we have to do to get the
science to be in an empirically sound place where we say we
know this, we don’t know this. But along the way,
we have to make choices that make good sense. PAUL DEMKO: Bob, you
get the final word here. ROBERT BLENDON: So
on the CBD side, there’s a need that the
FDA recognizes exists. And then secondly, it has
to deal with safety first. And it’s not going to go away. When the Senate Majority
leader leads the bill through that has
hemp, many of you may have thought he was
interested in having rope sold in the United States,
but that really wasn’t it. This isn’t going back. But all across stores
in the United States, signs are out there– CBD. It’s not going back. And so the question
is whether or not there is an established
role that if it’s dangerous, we can pull it off the market. And as long as the
FDA doesn’t recognize it exists, it just
going to grow. You’re not going to seize
the military in the CVS and take the counters off. I’m sorry. I lived through this
with dietary supplements. You didn’t show
me Ginseng worked. You try to take
it off the market. So we really need to
have safety protection and then the [INAUDIBLE]. But the safety thing has
to be there by the FDA. So if somebody gets hurt,
we pull it off the market, because that doesn’t exist now. PAUL DEMKO: That’s terrific. I think we’ll leave it there. Thanks to our panelists. I do want to plug that we’re
going to have– that Harvard’s going to be hosting another of
these events next Wednesday, I believe this is
December 11th at noon. It should be very interesting– Curbing Gun Violence–
Strategies– ROBERT BLENDON: Another
controversial issue. PAUL DEMKO:
Strategies for Change. So I hope everybody can
tune in for that next week. And thanks for joining us today. [APPLAUSE] [MUSIC PLAYING]

Leave a Reply

Your email address will not be published. Required fields are marked *