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LLOYD JESSEN: We will try
to
accommodate that. We had announced five to ten
minutes, and so we'll try to accommodate that.
GEOFF GREENWOOD: For members
of the
media and also for the reporter, could you ask the
speakers to spell their names?
UNIDENTIFIED FEMALE:
Could you speak
closer to the mic? I'm hearing impaired. I didn't
get half what you said. Thank you.
LLOYD JESSEN: Okay.
Our next public
hearing will be held from 10 a.m. to 7 p.m. on
Wednesday, September 2 in Reunion Hall at the Music
Man Square in Mason City, Iowa.
We will now begin with our first
speaker who is Dr. Joe McSherry.
JOE McSHERRY: Honorable Chair
Vernon
Benjamin and members of the board, present and
absent, and Director Jessen, thank you for the
opportunity to address this group.
I am Joe McSherry, M-c-S-h-e-r-r-y. I
didn't copy my CV to you, but I was born in
Washington, D.C. in 1943, graduated in physics from
Harvard in 1965 with an M.D. and a Ph.D. from
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Baylor College of Medicine in 1971.
Did lots of doctoring and research
things, but most importantly for this group, in
2002, I participated in a study committee that was
created by the legislature -- and cleverly, they
did not include any legislators -- to consider the
problem of medical marijuana because the
legislature didn't know what to do about it.
And the committee was relatively
balanced. We had a person from the AG's office and
a person from the state's attorney's,
representative of the police chief's organization,
and a judge as well as two doctors appointed by the
medical society -- I was one of them -- and
patients and some patient advocate groups.
And we took testimony and heard lots
of stuff from the people who wrote the Institute of
Medicine report which I'm going to recommend to you
at least several times from 1999, but it is a great
way to get up to a base line.
There were 13 conclusions of this
committee, I would say, and two of them were agreed
to by everyone. The law-enforcement people
couldn't get around our recommendations regarding
how to circumvent the federal law. There seemed to
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be some sort of inconsistency from their point of
view, but they did agree that marijuana is a
medicine and that it's misclassified as a
Schedule I drug at the federal level because it has
accepted value, and Marinol is an example, which is
a Schedule III drug, both here and at the federal
level. It's not exceptionally prone to abuse and
not remarkably toxic.
The meat of why I'm here, though, is
why would you approve marijuana given that you have
Marinol already? The usual concern of people is
Marinol is a combination sesame oil and THC, and
there are two reasons why it's not a useful
medicine for the most part.
One is it only has THC in it, and GW
Pharmaceuticals that makes an oral mucosal medicine
called Sativex did a great deal of research, and
just straight THC is not the right way to provide
the benefits of cannabis. There are many -- there
are 60, 70 cannabinoids in cannabis. Most of them
are not psychoactive. THC is very psychoactive and
really limits the use of Marinol or for anything
for any of those benefits from cannabis.
Cannabidiol, on the other hand, is not
psychoactive, actually counteracts a lot of the
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effects of THC, and is a part of the Sativex
medication. And there are -- there is research in
recent years on various other cannabinoids which
also have medical value without remarkable
toxicity.
So the absence of -- or only using the
most toxic element in the marijuana is one reason
Marinol is not a perfect drug. It's only useful
for those who take the medicine orally and take THC
only.
The other significant factor is that
it's taken orally, and when you inhale a drug, you
get almost instant blood levels, and that's
important for a lot of the people who use
marijuana; for instance, for pain. And there's a
little graphic which I've given to the group here,
but basically when you treat pain, you treat a base
line level of pain, and you usually use opiates and
long-acting substances for that.
But people also have break-through
pain which is characterized as something that lasts
30 minutes to an hour. And if you try to treat
that with things like Percodan and it comes on
suddenly and you can't anticipate it, the Percodan
kicks in after the pain has already gone away, and
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you get the side effects of the Percodan.
The pharmaceutical industry has tried
to treat this with Fentanyl fizzies and lollipops,
little things that go in through their mouth. It
still takes 20 minutes to get any kind of relief.
If they develop -- and I thiink they're working on
an inhalational form of Fentanyl that's going to be
almost as fast as heroin with all of the side
effects and risks of abuse of very rapid onset
drugs which are highly addictive.
Marijuana goes in very rapidly, but in
terms of its addictive potential, it's not the same
order of magnitude.
And another case where this is
similarly important, to people with nausea. And
again, when you hear patients testify, you'll hear
that when they're sick and throwing up, they can't
take medicine at that particular point, and on the
other hand, you can inhale cannabis and get the THC
value, which has been well studied. It works as a
5-HT3 blocker as well as working in the central
nervous system with cannabinoid receptors which
reduce the nausea component.
The 5-HT3 blockers is what the
pharmaceutical industry uses to control vomiting.
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Being able to inhale that is a great advantage for
people who take drugs which makes them very ill or
have other responsibilities.
On the third page, also have
included for you some graphs, and these are in
the -- I left Mr. Jessen with the -- the references
that I brought for this, but when you take THC
orally, only 6 percent of it gets into the blood.
And how much gets into the blood is highly
unpredictable.
The top graph on that page shows a
large rise. It's a solid line. That's an inactive
metabolite of THC. The dashed line is an active
metabolite, and the dotted line down there barely
getting off ground zero on the left-hand side of
blood levels on the bottom is time.
The THC very rarely gets absorbed,
which is why in studies people often find that
patients who are complaining of toxicity don't have
measurable levels in their blood. If you're going
to take it at bedtime and you're going to sleep
through any intoxication you get, it's a
potentially very useful way of delivering the
medicine.
If you look at the next graph down,
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though, when you inhale it, the THC level is the
dotted line that goes way up on the blood level
side and comes down again within a half an hour.
The solid black line again is the metabolites,
which are inactive, and the dashed line, there's
not very much of that, but that's the active
metabolite.
So when you inhale it, it goes in.
It's redistributed in the body so that the effects
of the cannabis or the THC, I should say, last for
a couple of hours. But the -- the ability to get
it in very quickly is very important to people with
nausea, break-through pain, and things like that.
On the next page I have another -
these are graphs swiped out of those articles of a
study of when doctors give medicine, we like to
give 325 milligrams of aspirin or something we know
what we're doing. We know it's the right dose. It
should take care of people.
And when you inhale things, you don't
really know how much goes in or how much stays
unless you do a lot of complicated measurements,
and so it happens that tobacco was found 40 years
ago. People who smoked smoked to get a level of
nicotine, so if you want to sell more cigarettes,
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you sell low tar and nicotine cigarettes because
then you sell more cigarettes. If you wanted to
cut down on smoking, you'd give everybody Camels.
The similar situation exists with
smoking cannabis. No matter what you buy on the
street, illegal market, from the pharmacy, or
wherever else, you'll inhale to get an effect. And
so this is a study that was done with NIDA-approved
THC cigarettes of three different strengths, one
1.7 percent THC, which is kind of like modified
grope (phonetical), 3.4 percent THC cigarette,
which is probably standard Mexican-grade stuff, and
I don't know what they call these things nowadays,
but the 6.8 percent stuff is probably like Acapulco
gold.
In the left-hand column, the vertical
axis is carbon monoxide. And the -- there is also
the open squares. The closed squares is the smoked
variety. They cut each of these cigarettes in
half, and one day they didn't smoke the cigarette,
and the other day they did through a vaporization
system, which is a much preferable system.
But the lowest doses, they get a lot
of carbon monoxide basically from smoking, and they
still get quite a bit of the 3.4 percent dose and
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considerably less at 6.8 percent THC content.
So the fact that the pot you get today
if you're lucky is not the pot your grandfather got
or father got actually is the wrong way of putting
it because the stronger the cannabis, the less
you'll smoke, the less you'll get the polycyclic
hydrocarbons, the less you'll get the carbon
monoxide.
On the right-hand column is the
subjective levels these people achieved with a
vertical line being their visual analog scale of
how intoxicated or high or whatever they were, and
it's apparent that they all, no matter which kind
of cigarette you get, you go up to about a 70 on
that scale rating.
Again, I don't recommend smoking. I
don't recommend smoking over vaporization
particularly, and this was done with a vaporizer
that was made by a German medical equipment
manufacturer, and I see their name all the time in
the operating room where I work a lot because they
make the monitors in that room.
But I would also briefly address the
downside risks. And for the patients, there are
none. Basically, I've included in there a couple
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of review articles on cancer in the last year or so
that go through all the different ways that the
cannabinoids actually cause cancer cells to die,
and neighboring healthy cells are unaffected.
I could -- I could -- they would
probably be a lot higher if I brought all the
articles that have accumulated since 2002 when I
started paying attention to these things.
And for people with neurogenative
diseases, again, this is another area that's
growing rapidly in terms of research that's
available in humans. There's lots of rat research,
and again, I would say the Institute of Medicine
report, terrific way to find out where animal
research is at, where human research was at in
1999, and there has been a lot of progress. But
that's -- the base line there is not to be ignored.
And they were the people who
recommended or told us that there were medical uses
back then in 2002. And the only downside was
smoking.
MS patients, people with inflammatory
disease, it's a terrific anti-inflammatory. It
works directly on the immune system through the
cannabinoid-2 receptor and turns down inflammation
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without impairing the cell's response to bacteria,
and so it doesn't promote infection. It doesn't,
of course, cause all the body changes that steroids
do when you have multiple sclerosis and is -- you
know, for diseases like Crohn's disease treats the
symptoms because it reduces bowel spasms no matter
what they're caused by, and it also treats
inflammation, which is the underlying cause of the
disease.
One of the things that everybody who's
concerned about this brings up at this point, so
what is the message we're going to send to the kids
if you legalize or say it's okay for medicine? And
I have put in a couple of studies which study
states and neighboring states before and after it's
permitted as a medicine in those states that it has
been permitted, and in both of those studies, there
is no increase in the use among kids. In fact,
there's generally a decrease.
I also tried to address your questions
more specifically, and I don't know how I'm doing
on time? Have I got another minute or two?
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first thing is its actual relative or potential for
abuse, and I have a little trouble understanding
exactly what abuse is in your definition, and I'm
sure you have a good one. I looked up things like
violence and self-harm, which are two things which
you might worry about. Certainly patients who are
taking it are not prone to violence. It's not
associated with increased violence. And it's also
not associated with increased injuries.
There are other aspects of abuse which
I'm sure you're interested in, and again, that's --
don't have to do everything.
The pharmacological effects are much
too long to talk about at this point. They are in
some of the articles that I've given you, and if
you'd like, I'd certainly be delighted to send
more.
The current status of the scientific
knowledge, again, I would suggest that the board
really needs its own copy of the IOM report. I
would be glad to have brought it, but the
government charges money for it even though we paid
for it when it was done, and it's a book. It's got
five chapters, deals with patients, deals with
animal research, deals with social consequences,
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and deals with the health values and then finally
concludes that probably the pharmaceutical industry
won't ever make it.
In the history and current pattern of
abuse of marijuana, I suggest the Shafer report
because it was another government-funded report
which is wildly underread and dealt with the abuse
part, and it didn't agree with Dr. -- President
Nixon's view at the time, and it was discarded.
But it brings you up to date in 1972. Abuse hasn't
changed that much. Large number of people still
use it and such.
The risk to public health, again, I
don't think it affects kids. I'm not sure what the
other risks would be. The potential for it to
produce psychic or physiologic dependence, I did
snap out one table from the Institute of Medicine
report, and that's the table that's included there.
It goes -- shows tobacco is used by about
76 percent of the population; alcohol, 92 percent
and so on in the left column.
In the right column, of those who have
ever used these drugs, it shows what percentage
became dependent. And again, with tobacco, about a
third of the people who use it become dependent;
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with alcohol and cocaine, about a sixth; heroin,
about a quarter; and with anxiolytics and
marijuana, less than 10 percent.
So in terms of its risk of abuse, it's
lower than a lot of the drugs that you have to
schedule here.
I also put in an article on the
withdrawal syndromes. I have lots -- there are
other articles that have been on the withdrawal
syndromes. Essentially, it's about four days of
being more irritable. It's the same as tobacco in
many regards. Being more irritable, maybe trouble
with sleep. In the case of marijuana, they also
lose some weight when they stop taking it.
On whether it's an immediate precursor
of a substance or other controlled substance
schedule, I was a little puzzled by that because
think of a precursor as something that's chemically
transformed into something else, and marijuana, of
course, is a plant, so I looked up your definition.
I included that. Wasn't very helpful.
In your Schedule I, I pointed out what
you have there, which is anything that has to do
with THC is bad. Schedule II, I was somewhat
puzzled in that it says "unless specifically
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accepted or listed in another schedule, it's" -- I
have to get my other glasses on, but -- where are
they? I don't get them on. But at some point in
that, it does allow that the Board of Pharmacy can
actually put things on Schedule II that are
marijuana, marijuana when used for medicinal
purposes pursuant to the rules of the board. Is
that your board?
JOE McSHERRY: Anyway, I would just
in
terms of whether you have to get an act of Congress
or whatever to do this, the state legislature, I
wasn't sure.
And so I don't find any of the other
drugs -- and I will say on Schedule I there are
things I've never heard of and have no idea what
they are, but I don't think there are any
derivatives other than what you've listed in these
other schedules, and I'd be delighted to address
any questions.
LLOYD JESSEN: Thank you. Thank
you,
Dr. McSherry. I do have a few questions. The
Institute of Medicine study you refer to, is that
the one dated 1999?
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JOE McSHERRY: Excellent, excellent.
It's good reading. Gets you to sleep at night.
LLOYD JESSEN: In your opinion,
do you
think we have current scientific evidence that
supports the medical use of marijuana?
LLOYD JESSEN: And in your opinion,
do
you feel the benefits outweigh the risks?
JOE McSHERRY: Yes. But that's
based
on the things that we've talked about here.
LLOYD JESSEN: Correct. Okay.
Thank
you very much, Dr. McSherry, for your time.
LLOYD JESSEN: We'll now proceed
with
our first -- our second speaker, and she's identified, I think, with Speaker No.
1.
I'd also like to ask if anyone has a
cell phone, if they could please turn it to
vibrate, that would help with the noise level.
Thank you.
LINDA LEE O'NEEL: Sorry about the
phone. My name is Linda Lee O'Neel. I'm from
Creston, Iowa. My last name is spelled O'N-e-e-l