HEARING ON MEDICAL MARIJUANA

[continued from http://www.mapinc.org/drugnews/v04.n554.a02.html ]

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

DUPONT: Thank you Mr. Chairman. It's a privilege and a pleasure to be
here. I am delighted to be able to submit my written testimony and an
article I've written on this topic for more detailed analysis.

I'm going to summarize just a couple of points here. My background in
this field goes back a long way. I was the first director of the
National Institute on Drug Abuse, and was the director from 1973 when
the agency was started until 1978.

And I was also the White House drug czar as the head of Special Action
Office under presidents Nixon and Ford. I served as head of NIDA also
under president Carter.

And I had a period of time when I was appointed by Mr. Nixon where he
said the one thing I couldn't come out and talk about was
decriminalization of marijuana. And I was very interested in heroin in
those days, so that was not a problem.

I had a flirtation with the decriminalization idea from 1975 to '78,
and found myself in and interesting situation under president Carter
when I changed my mind and no longer supported decriminalization and
President Carter did support it.

So with two presidents I was restricted in expression of my views
about marijuana. I bring this up to make the point that I have been
around this issue, including many points of view on it. And I also
want to point out that I enjoy a friendly relationship personally with
many of the people on the opposite side of this argument. And that's
very important to me because I think it's important to respect the
ideas that are presented and the people who are presenting them and to
discuss issues with civility and respect and to contend vigorously in
the marketplace of ideas.

And I am delighted to have this opportunity here. The medical use of
marijuana died, essentially, in the 19th century. And as modern
pharmacology developed, it was totally left for dead. It was
resurrected only in the 1970s as a stalking horse for
decriminalization and legalization of marijuana. And it had a brief
flurry of activity then that led to the publication of a book in 1976
called, "The Therapeutic Potential of Marijuana," edited by two of my
friends, Sidney Cohen and Richard Stillman. And I just want to read
one quote from this book.

I was head of NIDA, commissioned this book. This was 1976 that this
was written. And here is one of the quotes from the book. "Cannabis
itself will never be adopted for medical indication. It contains
dozens of constituents, some of which have undesirable effects.
Delta-9 tetrahydrocannabinol is a possible candidate. But it is more
likely that a synthetic analog tailored to intensify the desired
action and avoid the undesired ones will be preferred."

We haven't gone a long way since then in terms of our understanding of
this. And I point out this was published --it was actually the meeting
was 1975, but it was published in 1976.

Now, marijuana has changed dramatically over that period of time. It
is much more potent now. And it's used much more intensely by much
younger people than it was. In those days, it was primarily used by
- --first used by people in their 20s and their late teens. And that is
not the case now, it's used very early by very young people and often
quite intensely.

Marijuana and the constituents in it is better understood from a
biological point of view than any other chemical in the world. It has
more research done on it. And you heard Dr. Volkow --very proud that
she is the fifth head of NIDA and is doing a wonderful job. And I
support everything that she said today.

It is very well studied. And it may be that some of these chemicals
will produce benefits. And I think she was eloquent in speaking about
that. It is not conceivable that we're going to have smoking as a
delivery system or many chemicals like this in an uncontrolled
situation. That is not medicine. It has not been medicine for more
than 100 years. It's not going to be medicine in the future. This is a
toxic delivery system by definition. It is not scientific.

I was delighted to hear the FDA talk about --Dr. Meyer talk about the
FDA approval procedure and the fact that there is a procedure even for
a botanical. But it would have to meet the standards of safety and
efficacy to be approved. It has not met those. In my opinion it is not
likely to meet those ever in the future.

This idea of medical marijuana is not a harmless idea.

It is a dangerous idea in terms of the public attention because it
legitimizes the use of marijuana. During the period when this idea had
ascendancy, there was an increase in marijuana use in this country
that I think is directly traceable to this issue, in fact.

I think that now in the last two years we have a downturn, and I am
delighted to think about that. And I think part of it has to do with
confronting this issue in a much more direct fashion than has happened
before. And I am delighted to see these developments and proud to be
here today.

Thank you very much.

SOUDER: I thank each of you for your testimony. And I wanted to start
with Dr. Scott and Ms. Jerzak. I am curious, because both of you are
agents of your state government, and I wonder how you factor in FDA
guidelines in general, first, and how you enforce state health law,
and then specifically, how you factor in FDA guidelines on medical
marijuana.

JERZAK: Physicians have to practice the standard of care. In
California, we want good medicine. That's kind of what our aim is, to
protect health care consumers and ensure good medicine.

When we have a case where a concern comes up, we investigate that.
Complaints come from a variety of types and sources. We don't
typically have a case where somebody is asking us to investigate FDA
guidelines being violated because FDA would do those.

So although we are upholding state laws and federal laws as a law
enforcement agency, we have to look at --typically those complaints
would come to us: Is this good medicine? And then we have to look
about it within the standard of care and we would go to medical
experts in the community to say whether that is good medicine...

SOUDER: So you wouldn't take the FDA's position --I mean, they said
today there is no medicinal benefit to marijuana. There's components
inside it --they have been participating in the research. But they
said flat out there is no medicinal benefit to marijuana.

And you don't follow that FDA guideline? Do you follow it on other
issues? Or do you just take the state standard of care, talk to local
people and forget what FDA said? JERZAK: We would be looking at an
individual case and not being proactively setting policy about FDA
rules are being followed. The kind of complaints that we have got have
not been characterized as your question would imply.

JERZAK: And certainly, we would have to look at the kind of question
that would come to us. But the cases that we've looked at, the
complaints that we've looked at involve nine licensees. Some had more
than one complaint. And they were in the context of whether this was
good medicine.

SOUDER: How do you handle other non-FDA approved drugs? If somebody
had --you know, we had years ago, because I'm older --laetrile was an
argument. That do you have kind of random decisions if FDA says
there's no benefit to this drug, but the state doesn't have a ban and
nobody complains about it? And then if somebody does, then you look at
it in the state context?

In other words, the FDA's standard of: This is not an approved drug,
the federal standard this is an illegal drug, don't override state
law?

JERZAK: My best answer would be that laetrile is not legal in
California, so we don't have that issue come up to us. The patients
will go to Mexico for that.

Marijuana is the only drug that we have this apparent disparity in
following the federal law and their policies and state law. In
California, we were urging the physicians to be mindful of the federal
laws, and that we said the state law was not an immunity or a defense
to the federal law. But the voters put this in, and I guess the answer
being that the voters did not want to wait for the science.

In other areas of medicine, various alternative medicine modalities
that the board has been confronted with, various kinds of treatments,
NIH has moved forward to develop more information about that. And
that's been very helpful to consumers and patients, as well as physicians.

SOUDER: So there's a difference between a developing thing where there
is not a stand and an illegal drug that the federal --I mean,
notification was decided a long time ago.

I'd like to hear Dr. Scott on this, too. But quite frankly, this
sounds so much like the civil rights debates where the federal Voting
Rights Act passed, the local states didn't want to give minorities the
right to vote. The local attorney generals and law enforcement people
said: Well, our state law says blacks can't vote, so we're going to
follow state law not federal, and we'll deprive them of the vote. But
there is a federal law here. Furthermore, the health is clear. We just
heard from the national researchers there's not a debate, that they
are looking for ways to provide this.

And my question is, does FDA and NIDA, which are the top experts, when
they say this does not work and it's an illegal drug, do you believe
state law preempts the federal law?

SCOTT: I do not. And our board in Oregon is charged with enforcing
both federal as well as state law. Oregon wrote its law in a very
specific way. It is not a prescriptive drug, marijuana. Physicians do
not prescribe marijuana. You can't go the pharmacy and get marijuana.
You cannot buy it. You cannot sell it, OK.

The law was written that it allows the physician to discuss with the
patient the use of marijuana that may be --may be -- beneficial for
their debilitating condition. And then the law went on to define what
those specific debilitating conditions are.

And the law in Oregon says that this physician will sign a document
that says this patient has this debilitating medical condition and it
qualifies under the law for medical marijuana. But the physician does
not prescribe it. They don't get a prescription for it. His note
indicates that this physician has pain, for example, or nausea, for
example, and then allows state law to do what it does.

And I understand your argument about state and federal law. And I, at
the board level, don't get involved in that conflict except that I
feel that we do follow the federal law, as well as the state law, in
this case the way the law is written in Oregon.

SOUDER: If the patient wants to get marijuana, does it have to be
authorized by a doctor in Oregon?

SCOTT: That is correct.

SOUDER: So doctors do, in fact, have to authorize it.

SCOTT: They sign a --it's written specifically this way. The physician
signs a statement indicating that this patient has one of these
debilitating medical conditions. It's not a prescription. He says that
this patient has pain. That's it; that this patient may benefit from
medical marijuana. But specifically it says, this patient has nausea,
signs it. He doesn't prescribe marijuana.

JERZAK: I would echo what Dr. Scott has said in terms of
California.

We did not look at it as the word prescribing, which would make it a
violation of federal law. We also used the word "recommend," which was
distinctively chosen to separate it out from the federal law. In
California, we said it would be needed to be used for seriously ill
Californians. And we left that definition of seriously ill to our
licensed physicians to be the gatekeepers of describing that category
of patients.

SOUDER: So Dr. Jensen, who showed tremendous sympathy for her patients
believes that ADD was a criteria in two cases to prescribe. Is that
one of the guidelines?

JERZAK: Is that one of the what?

SOUDER: Is that an approved use?

JERZAK: In terms of the seriously ill Californians, I would not be
making that determination about the explanation of that. We would be
relying, if we had a complaint about whether that was the appropriate
care for those patients, what else has been tried? What did she
explain as the risks and benefit ratio? What was the informed consent
of those involved? What other treatment modality? How often they met
in the context of medicine?

SOUDER: I'll come back. Ms. Sanchez?

SANCHEZ: (U. S. Representative Linda T. Sanchez (D-CA)) I thank the
chair. And before I ask questions, I just want to state that the
reason I am here today is because the issue of medical marijuana use
is very important issue to the people in my state. The voters of
California passed a medical marijuana law in 1996. And since that
time, my understanding is that thousands of patients have benefited
from that law.

In fact, a recent field poll demonstrated that 74 percent of
Californians now favor legal protections for patients who use
marijuana to cope with illnesses, compared with 56 percent who
approved the medical marijuana ballot initiative in 1996.

I am particularly concerned that state-approved medical marijuana
patients and providers are being targeted by the DEA. In times like
this when we have such limited federal resources, raiding state
approved medical marijuana patients when neighborhoods are dealing
with an epidemic in the production, for example, of methamphetamine,
does not to me seem to be sound policy.

I'm thankful that this hearing has been called to explore
science-based approached to medical marijuana, not so much the state
federal conflict of laws. And with that in mind, I'm going to go ahead
and jump in to my questions.

Dr. Jensen, is your testimony today that, under a physician's
guidance, the use of marijuana can have beneficial health effects? And
if so, I'm interested in knowing what the cost differential would be
for example, for a child with ADD, if they were to utilize marijuana
versus a prescriptive drug or some other drug?

JENSEN: Well, as I said earlier, I only have a basis of two patients
to discuss this issue with in children. I have talked to some adults
with ADD. But in regards to this particular child who had the anger
management issues, his mother and father at that time --his father was
disabled and they had no health insurance, which is also another problem.

It was costing the mother $120 a month to pay for his Dexedrine, which
is a very sophisticated form of amphetamine and very dangerous. I
don't approve of Dexedrine, in general.

He had Ritalin. He had Adderall. He tried Concerta, which is even more
expensive. I had one of my office staff call all of our local
pharmacies and get a run-down on the average cost for an average
prescription. And it exceeds $100 a month in Ventura County as of this
month; whereas this one particular boy who, by the way is 5-feet-11,
246 pounds even though he's a child, physically and metabolically, he
functions as an adult.

His father grows his medicine for him, and his mother picks leaves out
of the back yard and makes tea for him in the morning before school.

So the cost differential is astronomically different. Now they have
health insurance. Now she can afford to buy other medications for him.

But they don't have any desire to do it because of the side effects
that he was suffering from the other medications. And now he is fully
functional and back in school and getting good grades, whereas before
he was getting Fs and Ds. So the cost differential is just
ridiculously different.

SANCHEZ: Thank you. Dr. DuPont, I have a question for you. I am
interested in knowing about what your thoughts are concerning the
potential use of inhalants, as British firms have proposed, versus the
dangers that are specifically associated with smoking marijuana, and
whether or not you think that inhalant form could be potentially beneficial.

DUPONT: I think it shows promise. And I think it's a very attractive
idea because it doesn't involve smoking. So I think it's good.

My understanding is it's going to be subjected to this FDA approval
process. Should it go through that process, and I think it may very
well successfully go through it, if it does, I would have no
difficulty supporting it. As I have supported the use of controlled
substances approved by the FDA for all kinds of indications, this
would not trouble me in the least.

SANCHEZ: OK, thank you. And then, Mr. Scott, I understand that your
board has investigated and suspended Dr. Phillip Leveque based on some
of his recommendations that he made to patients. And I am interested
in knowing specifically what the recommendations were that led to his
suspension. And how did his recommendations adversely affect his patients?

SCOTT: Part of what I can talk about with Dr. Leveque is public
information. Part of it is not, and there is still some
investigational information.

The public information that's available is that Dr. Leveque originally
was disciplined by the Oregon Board of Medical Examiners approximately
two years ago. And the reason for that discipline was not regarding
the Medical Marijuana Act. It was regarding the Medical Practice Act
of Oregon and his practice as a physician.

At that time, he was signing these physician authorizations for
medical marijuana usage without doing what a physician does. And a
physician sees a patient, does a history, does a physical, comes to a
diagnosis, proposes a treatment plan, prescribes a treatment plan,
which may include medication, and then follows the patient to see the
response to that treatment plan.

Dr. Leveque was not doing that. He was investigated. And he ended up
signing a stipulated order where our board allowed him to continue to
practice, but under a probationary period.

Dr. Leveque was more recently investigated again. And his license was
suspended approximately a month ago because we at the board level
found he was in violation of his original stipulated order two years
ago.

SANCHEZ: Did any of the violations adversely affect the
patients?

SCOTT: That's a matter that I can't answer.

His practice, quite honestly, was not as a primary care provider, but
namely to sign these medical marijuana cards.

So he did not have an ongoing relationship with the patient. He was
not monitoring the patients. And so he was merely signing this
documentation that's required to receive medical marijuana.

I would speculate that his patients, depending upon your opinion and
their availability of medical marijuana is how it would affect their
health. And I can't answer that question for you.

SANCHEZ: Thank you for your testimony.

SOUDER: Why don't you go ahead and finish your questions, and then
I'll conclude.

SANCHEZ: OK, I thank the chair. Mr. Kampia, what credible research has
been done to demonstrate marijuana's therapeutic use?

KAMPIA: Well, in the late '70s and early '80s, there were seven
states, including California and New York, that did statewide research
projects involving marijuana that came from the federal government.
And it involved hundreds of patients in each state.

One of the states actually was Tennessee. Al Gore's sister was using
marijuana for cancer back in, I think, 1981 or '82. And each of these
states concluded their studies in '84 or '85, something like that. And
they all issued reports.

And the reports showed that some patients benefited from Marinol pill.
Some patients benefited from marijuana, but not the pill. And some
patients benefited from neither, which is kind of what we see when we
talk to patients, that some respond to one, some respond to the other,
some don't respond to either.

So those studies were done. And since then there's a whole host of
studies being done in the University of California. There's 10 or 11
studies going right now, I think, which was mentioned earlier today.

And there's been dozens of other studies done by private researchers
here and there in the 1970s and early '80. And those studies were all
summarized by the Institute of Medicine, which released this
comprehensive book in 1999. And it was paid for by the White House
drug czar's office. I think they were looking for some conclusions in
this book that they didn't get.

But we hold the book up now because we like it because it shows that
marijuana actually does have medical value. And furthermore, I should
point out, another glitch here in how we don't follow science around
here is the IOM, in the very beginning of their book, recommended that
until a non-smoked rapid onset cannabinoid drug delivery system
becomes available, we acknowledge that there is no clear alternative
for people suffering from chronic conditions that might be relieved by
smoking marijuana such as pain or AIDS wasting.

And they recommended on the same page that patients be able to get a
24 turnaround if their physician and the patient decide that they need
marijuana, that the federal government should give them the
opportunity to use marijuana within 24 hours.

I have never heard any member of Congress, nor the drug czar, decide
that they were going to jump on that IOM recommendation and make that
happen.

SANCHEZ: Thank you for your testimony. I have no more
questions.

SOUDER: Dr. DuPont, do you have any comment on what he just
said?

DUPONT: Well, the Institute of Medicine report --I think there is some
slippery words going on here. We talk about marijuana --and you, Mr.
Chairman, pointed this out. Much of the talk when you talk about
medical marijuana is dealing with individual chemicals in it and not
with the smoked marijuana.

And the IOM report specifically said with respect to smoked marijuana
that smoking was a bad idea. And let me share this: "In summary, there
are many reasons to worry that people who might choose to use
marijuana as medicine, and especially those who smoke it, the drug
could actually add to their health problems."

So I think that there is very little enthusiasm for smoked marijuana.
And I would try to use that term rather than just marijuana because
marijuana is often talked about as if its the constituent chemicals
like THC or others that are in there.

SOUDER: I thank you for clarifying that because it's something that we
had some debates with the last administration who failed to note in
some of their reports the correct distinctions.

And whether it is Canada, as they move forward and as I've talked to
the legislators who I don't agree with on the general policy, but
agree that they're trying to move ahead without smoked marijuana and
in lower intensity even in the different pills and separate the
components; in the Netherlands where a different government is in the
process of trying to back up, which is now a mess in Amsterdam, they
are attempting to isolate --and don't get this confused with marijuana
- --to say that there are substances in all kinds of things that have
negative impacts on society.

And I appreciate you for clarifying that.

DUPONT: Mr. Chairman, I just point out one thing about what you said
that is very important. And that is that the smoked marijuana is the
only way it's interesting to the advocates in this field. They show no
interest in the development of individual chemicals whatsoever.

And that shows that their purpose is not medical. It's a way of
influencing the country's policies toward marijuana. It's a stalking
horse for legalization of marijuana.

DUPONT: The legitimization of smoking marijuana, you can see that very
clearly, with how little interest they have in individual chemicals or
any delivery system, any delivery system other than smoking. They're
only interested in defending smoking.

SOUDER: Mr. Kampia, you've attempted to defend smoked marijuana again
today, which is far more carcinogenic than tobacco.

It is a major problem. Highway safety adverse effects of illegal drug
use are equal to, or the same scale as, in some cases higher than
associated with alcohol consumption. So this is a national problem
that has not been addressed. And the drug testing technology does let
us do that.

But there is a step here that needs to be taken. And that is to move
away from the question of impairment to the question of whether the
presence of the drug is identified in the driver.

This is the standard that was taken by the U. S. Department of
Transportation in 1988 for commercial drivers. It is essentially a per
se standard. That per se standard should be used for all drivers in
the United States. And the technology is there to do that now.

And I am thrilled, delighted with your interest in this. It is
extremely timely. It is going to make a huge difference of highway
safety and also drug abuse prevention.

So I am a very enthusiastic supporter. But we're going to have to move
to a per se standard, which is what has happened in the workplace.
That's what goes on now with people who do drug testing.

Millions of American workers are drug tested. It's a per se standard.
it is what is done in transportation for commercial drivers. It is the
right standard to apply across the board.

If you are driving a vehicle, you don't have drugs present in your
body.

SOUDER: Thank you. And I think that's the way we have it in Indiana.
And I know there's some form of this in the bill we're voting on in a
little bit here. But I don't know what the final form was and how it
was amended.

Are you familiar at all with the case, when I was a staffer for
Senator Coates, I think Senator Danforth initiated the drug testing
for transportation. There's a case in Oregon that questioned whether
it could be enforced if the person had a medical marijuana
prescription.

DUPONT: My understanding, and there may be something that happened
recently that I'm not familiar with, but my understanding is that the
federal law is preemptive in that, and that is a violation of the standard.

And so even if you have a medical certificate, it's a violation and
you use you license and right to drive. That's my understanding of the
law.

SOUDER: I think it was a local court that challenged that like in the
last...

DUPONT: Well, but that has been the Department of Transportation
standard. And the previous administration took that position. And this
administration takes that position.

There may be something that has happened that I don't know about just
recently, but that has been the position of the Department of
Transportation under both the Clinton administration and the Gore
administration.

SOUDER: Yes. I'm not sure how this is going to move up the court
system because it wasn't a legislative decision, it was a court that
- --I'm very concerned about, because if you could have this medical
waver and then be driving a truck, we have a huge loophole here unless
we very tightly limit which I know that the state boards are trying to
do to get to the abusive excesses of this.

At the same time, unless we radically control this and somehow get
over this idea of states' rights nullifying federal law, we're in deep
trouble in laws like that.

Well, I thank each of you for coming today. If you have any additional
comments you want to put into the record, I appreciate us having a
continuing debate. And I'm sure it won't have ended today.

With that, the subcommittee stands adjourned.