HEARING ON MEDICAL MARIJUANA

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House Committee on Government Reform: Subcommittee on Criminal Justice,
Drug Policy and Human Resources Holds a Hearing on Marijuana Medicine

VOLKOW: Yes and this, of course, is a difficult proposition because
particularly, I think, in the case of opiates, drugs that you are
referring, because we are faced now that the number two illegal drug
in this country are prescription compounds.

The number two are opiates, are an algasics after marijuana --and that
also includes kids and elderly people. And these are drugs that are
being prescribed by physicians that have very good therapeutic
applications, but somehow are being diverted and abused and leading to
addiction and high levels of toxicity.

So the number one issue, I think, is extremely important we know from
research that one of the best strategies to combat drug addiction is
prevention. And one of the best ways of addressing prevention is
education. So in order to educate people, you have to have the
information. So that is one of the aspects that is very, very relevant.

In the case of marijuana, there have been extensive studies conducted
to determine the effects of toxicity of marijuana. And there are many
studies that have shown that they have been adverse, but there have
also been other studies that have shown it's not adverse. And so this
has led to controversy.

As new technologies become available and studies become more rigorous,
we're starting to get extremely interesting information documenting,
in fact, that marijuana is not benign. And there is clear evidence to
suggest that.

So our responsibility, the way that I view it, is to generate that
knowledge such that that data will speak for itself. And it doesn't
become, "I think this is a benign drug." It is the data that is going
to state it.

And I mentioned two studies. I think they are quite impressive on what
they are telling us. There's one showing identical twins; the one that
started taking marijuana before age 17 had significantly higher
problems with drug abuse and addition. These are identical twins, same
genetics. And another study shows that the chronic use of marijuana,
and it wasn't whether it was not remembering or memorizing, led to
significantly poorer performance in life as assessed by how much money
you make, as assessed by years of education, as assessed by how happy
you are.

So to summarize, is the way that we do this is to prevention and the
way that we do it is via education: education of lay public, education
of policy-makers, education of officials. So it's education across the
different levels of society.

SOUDER: How would you, both Dr. Volkow and Dr. Meyer, if in balancing
- --OK, you might get some good from doing something, but there are also
risks --if smoking tobacco, cigarettes, turned out to reduce obesity,
would either of you recommend smoking tobacco to reduce obesity? Why
would that even be a discussion matter in marijuana? Or how do you
balance the countervailing forces? Because tobacco harms an
individual, shortens their life, but doesn't have an impact on other
people. You don't, for example, wreck a car and kill somebody while
you're high on tobacco. So the argument that it shortens somebody's
life actually has less impact on other people's life unless we find
more data on second-hand smoke, which we're rapidly developing. That's
another question.

But I'm curious even why things like obesity and other things would
come up unless it could be isolated from the dangerous addiction and
whether in fact if cigarette smoking was shown to reduce obesity, as
many people think it does, whether you'd approve it on those grounds.

VOLKOW: I am certain, I think that that's one of those answers that
that is very simple. No, you would not approve smoking for things like
obesity because to start with, the risk associated with smoking would
be much worse than those associated with obesity, number one.

Number two, there are many alternatives even if, in fact, it was shown
- --it hasn't been shown --that nicotine is an effective treatment for
obesity, which it is not, but even if it were, for matter of argument,
there are ways of delivering nicotine that, number one, do not have
the adverse consequences of smoking a cigarette.

So why would you want to promote a delivery system that you know is
harmful when you can actually deliver the same pharmacological agent
in a safe way that also minimizes its addictive potential?

VOLKOW: One of the things we've learned through the past 10 years in
science is that the effects of a drug are very much modified by the
way that you take it. So when you take a drug smoking for drugs of
abuse (ph), that's the group of administration that assures you the
higher likelihood of abuse and addictiveness. It has to do with the
rapidity at which it gets to the brain and the concentration it reaches.

So when you are smoking marijuana, the effects are going to be very
different than when you take it orally. The same thing with nicotine.
When you smoke nicotine, the effects are very different from a patch.
And that really dramatically modifies the addictive liability. So even
with marijuana, changing the route of administration has a significant
effect.

But with marijuana, a step further is, as we are recommending, there
are multiple elements to marijuana. So you can now dissect them and
optimize a compound that will have the properties you want without the
other effects. That's why we have science. So that's why we're
investing in institutes like the NIDA in order to be able to develop
compounds that are safer and can help people. I think from my
standpoint I would state that the safety and risk, as opposed to the
efficacy, is wholly dependent upon what situation you're talking
about. And I agree with the comments that Dr. Volkow made about
smoking and weight loss.

So there may be, and I'm not saying there are, but there may be
circumstances where a smoked drug such as marijuana in very limited
circumstances could be found to be overall safe and effective for
something in a patient where perhaps they are quite terminal for instance.

But I agree very much, and have said in my oral testimony, that I
think while smoked marijuana may be an expedient way to begin research
looking for effects, that it's my belief that any approval, just as
Marinol was approved, it's an oral dosage form, any approval down the
road from this kind of research will likely be some other dosage form
than smoked marijuana.

SOUDER: So for example, if nicotine, a component of tobacco, I'm not
arguing it is, but if nicotine had a side benefit such as --who knows
if you break out cigarettes and its components inside tobacco
cigarette, maybe we'd find certain things that have certain usages.
But let's say nicotine did and you took it in pill form, do you think
it would justify to then refer to cigarettes that are smoked as
medical cigarettes?

This is part of the political problem we're having here is you're
saying there can be side things in the chemicals in marijuana and then
people get away --if it's taken in pill form. But then people refer to
it as medical marijuana. Whereas we have other things that we take the
chemicals and components out that we would never let advocates say
that it's medical cigarettes because you could get something out of
it, or medical heroin because you can get something out of it.

And why isn't that false marketing and false labelling? And why aren't
you speaking out against it more aggressively in the public arena that
this is not medical? It's a component inside it, just as there are
components inside of all kinds of things that are terribly unhealthy.
And then we come up with other names for them, but we don't call the
primary, if it's dangerous, medical. That's the kind of baffling thing
here which suggests a much broader agenda than a health agenda.

MEYER: Again, I think from the FDA perspective, we have within the
last few years gone ahead and again said that we felt that marijuana
is an appropriate schedule one controlled substance, that it has no
known medical benefit at this point and that it does have that high
abuse potential.

So I think between that and the fact that we, you know, we're clearly
on record saying otherwise saying that it is not approved for any
medical use, I think that's where we stand.

SOUDER: So there is no medical marijuana from the FDA's perspective?
There are components within it that can be used in Marinol or other
alternatives. We were having a discussion a little bit earlier about
what are --Marinol is one alternative. What are other alternatives to
marijuana to treat some conditions?

VOLKOW: The conditions that have been brought forward in terms of
research, apart from the issue of nausea and vomiting for cancer and
increasing appetite of individuals that have (inaudible), that is they
are not hungry like with HIV or cancer, there are other indications
that are actually being investigated, particularly from California,
and that is pain, neuropathic pain, pain that comes from the
peripheral nerves. And marijuana appears to be effective in those grounds.

One of the things that's interesting is that research has found that
there are two cannabinoid receptors. One is in the brain, and the
other ones are in the outside. And it's these, the cannabinoid
receptors outside the body that are responsible for this pain-killing.
So pharmaceutical companies now developing these compounds that don't
go into the brain, so they are not going to be addictive, that
actually have very, very promising analgesic effects with none of the
untoward effects of the drug.

Because if you actually even look at the patients that are getting
marijuana, or even Marinol, they complain of sedation. And that's not
desirable for a lot of people. So if you can treat pain without having
the person sleepy all day long very effectively with no psychoactive
effects, so this doesn't change your mental state, believe me, you'll
have a much more powerful medication. So that's for the pain.

The other one that is being promoted is glaucoma, high pressure of the
eye. And there the stories are controversial because while effectively
cannabinoids decrease the pressure in the eye, they also decrease
blood pressure.

And so there's concern that that ultimately may not be beneficial to
protect the eye. So the effects there of cannabinoids are not so good.
But in terms of the ones that are just for marijuana --nausea and
vomiting --they are several compounds that are now available. Kiketsia
and the one --Marinol --appears to be useful in patients. And the one
on analgesia is absolutely fascinating.

Now, there's the other area of research of developing drugs that
antagonize the systems that are activated by marijuana, and those are
ones that are being targeted for obesity, those are ones that are
being targeted for smoking and for alcoholism.

MEYER: And from the FDA perspective, I would say that for the majority
of the indications that Dr. Volkow just spoke to, there are many
pharmaceuticals approved. And, in fact, Marinol is not particularly
widespread in its use because there are alternatives. It's proved both
as anti-nausea for chemotherapy patients and for kiketsia or for
weight loss in the setting of AIDS. And there are a variety of drugs
and other modalities that seem to be preferable for many patients.

That said, I think that there certainly are patients who do not seem
to respond even to the best of our pharmaceutical (inaudible), and I
can understand where patients would want to see further research. But
I think until we have research that shows that any cannabinoid or
marijuana itself is safe and effective for these indications, as an
agency, we really can't say anything other than that we know these
other drugs that are approved for these purposes work.

SOUDER: Let me see if I can summarize this. I'm not known for being
kind of neutral on this issue. I'm very outspoken on the narcotics
issue. So I don't want to misstate this.

But there are literally millions of people across America who have the
impression that the federal government doesn't care or is responding
as to how to address people with AIDS or cancer who are in terrible
pain, and we're so obsessed with the drug war on the United States, we
don't care about that. We're more concerned theoretically with locking
people up because we have this obsession with marijuana than we are
the concern.

Let me see if I understood your positions correctly --and I'm going to
try to say it precisely because you were both pretty precise --that
you do not believe that marijuana is medical. But there are components
and chemicals in marijuana that you are actively researching in both
agencies and there are products that have been developed from those
chemicals that are helping treat the parts of different illnesses that
some people have used the arguments for marijuana to treat, and that
the Marinol, even as I understood it earlier --that we always heard
did not help in nausea cases in many cases --has been improved and
that while it may not treat all cases, you're continuing to try to
make it more effective.

And in the minds of both your agencies, marijuana itself is not
medical, but it does have components that you will continue to
research, you've continued to have breakthroughs and will continue to
improve the health of the United States.

Is that a fair statement? Is there anything I misspoke there or
overstated?

MEYER: I think just from the agency's standpoint, I would say that we
do not have the evidence to say that it has a legitimate, safe and
effective use --marijuana has a legitimate, safe and effective use.

SOUDER: Components within it can be used in other products when not
smoked?

MEYER: Well, certainly one component is approved, Marinol, which is
the Delta-9 THC. But, I guess, from my standpoint then, if there was
to be a medical use for marijuana or any of these other components
apart from Delta-9 THC, we feel that there would be much more research
needed to both explore the efficacy and to document the safety.

SOUDER: And it wouldn't be marijuana?

MEYER: Pardon?

SOUDER: And it wouldn't be marijuana? It would be some component
inside the marijuana.

MEYER: Well, again, I think there are inherent toxicities to smoking
anything. My best guess as a physician is that it would likely be a
dosage form other than marijuana or a route of administration other
than smoking, certainly.

SOUDER: But it wouldn't, probably even if it was in dosage form, have
all 200 --did you say there were 200 chemicals? 400. Four hundred
chemicals probably wouldn't be in it because you'd be isolating what
you're treating. Is that correct, Dr. Volkow?

VOLKOW: Yes. Ideally, of course, you want to get as pure a medication
as you can to minimize side effects. In certain instances,
combinations appear to be better than just a single one, but there are
very rare indications where that has been shown. The only
statement...

SOUDER: May I ask to clarify that statement? In other words, you could
take a component of marijuana and maybe find another one somewhere
else that wasn't even in marijuana to combine with something that you
find inside marijuana to make a more effective pill.

VOLKOW: Correct. And there are naturally occurring compounds that, for
example, in the case of the amphetamines, which we used to treat
children with ADHD. There are actually two really components to it,
and it has been shown that both of them exert slightly different effects.

So that's one of the elements. But correct. And the main component
that it is believed to add in marijuana is the Delta-9
tetrahydrocannabinol, THC. But there is evidence that others are also
having effects, but much less so.

Having said that, I do think that there's an element that is relevant
in terms of research on marijuana and potential medical applications
that help us on certain instances to identify areas where we say
marijuana, for example, has this analgesic effect. Then we do the
research and say what are the mechanisms by which marijuana lead to
that analgesic effect, and then try to identify what the mechanisms
are so then we can target compounds that go directly to it.

But that's a different perspective. That was the research that led to
it. But we used it in order to get better intervention.

SOUDER: Dr. Meyer?

MEYER: I just felt I needed to be clear on this issue. FDA does not
have an inherent bias against botanical products. If botanical
products are developed correctly and shown to be safe and effective
even though they contain a variety of substances, many of which may be
known, some of which may be unknown, but if those are properly
approved and shown to be safe and effective, we would approve of a
botanical product.

SOUDER: Do you have any smoked product that you've
approved?

MEYER: I don't believe so. No.

SOUDER: Anything else that you want to add before we conclude the
panel? Thank you all for coming. We appreciate your testimony.

MEYER: You're welcome.

SOUDER: The next panel could come forward and remain standing? The
next panel is Dr. James Scott, board member of the Oregon Board of
Medical Examiners; Ms. Joan Jerzak, chief of enforcement, Medical
Board Of California; Dr. Claudia Jensen, Ventura, California; Mr.
Robert Kampia, executive director of the Marijuana Policy Project; Dr.
Robert DuPont, Institute For Behavior And Health of Rockville, Maryland.

I'm going to need to have you each stand. Do you swear of affirm that
the testimony you give today is the truth, the whole truth and nothing
but the truth, so help you God?

Let the record show that each of the witnesses responded in the
affirmative. And we'll start with Dr. Scott.

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