[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
MIXED SIGNALS: THE ADMINISTRATION'S POLICY
ON MARIJUANA, PART FOUR--THE HEALTH EFFECTS
AND SCIENCE
=======================================================================
HEARING
before the
SUBCOMMITTEE ON GOVERNMENT OPERATIONS
of the
COMMITTEE ON OVERSIGHT
AND GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
JUNE 20, 2014
__________
Serial No. 113-132
__________
Printed for the use of the Committee on Oversight and Government Reform
Available via the World Wide Web: http://www.fdsys.gov
http://www.house.gov/reform
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89-729 WASHINGTON : 2014
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COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM
DARRELL E. ISSA, California, Chairman
JOHN L. MICA, Florida ELIJAH E. CUMMINGS, Maryland,
MICHAEL R. TURNER, Ohio Ranking Minority Member
JOHN J. DUNCAN, JR., Tennessee CAROLYN B. MALONEY, New York
PATRICK T. McHENRY, North Carolina ELEANOR HOLMES NORTON, District of
JIM JORDAN, Ohio Columbia
JASON CHAFFETZ, Utah JOHN F. TIERNEY, Massachusetts
TIM WALBERG, Michigan WM. LACY CLAY, Missouri
JAMES LANKFORD, Oklahoma STEPHEN F. LYNCH, Massachusetts
JUSTIN AMASH, Michigan JIM COOPER, Tennessee
PAUL A. GOSAR, Arizona GERALD E. CONNOLLY, Virginia
PATRICK MEEHAN, Pennsylvania JACKIE SPEIER, California
SCOTT DesJARLAIS, Tennessee MATTHEW A. CARTWRIGHT,
TREY GOWDY, South Carolina Pennsylvania
BLAKE FARENTHOLD, Texas TAMMY DUCKWORTH, Illinois
DOC HASTINGS, Washington ROBIN L. KELLY, Illinois
CYNTHIA M. LUMMIS, Wyoming DANNY K. DAVIS, Illinois
ROB WOODALL, Georgia PETER WELCH, Vermont
THOMAS MASSIE, Kentucky TONY CARDENAS, California
DOUG COLLINS, Georgia STEVEN A. HORSFORD, Nevada
MARK MEADOWS, North Carolina MICHELLE LUJAN GRISHAM, New Mexico
KERRY L. BENTIVOLIO, Michigan Vacancy
RON DeSANTIS, Florida
Lawrence J. Brady, Staff Director
John D. Cuaderes, Deputy Staff Director
Stephen Castor, General Counsel
Linda A. Good, Chief Clerk
David Rapallo, Minority Staff Director
Subcommittee on Government Operations
JOHN L. MICA, Florida, Chairman
TIM WALBERG, Michigan GERALD E. CONNOLLY, Virginia
MICHAEL R. TURNER, Ohio Ranking Minority Member
JUSTIN AMASH, Michigan JIM COOPER, Tennessee
THOMAS MASSIE, Kentucky MARK POCAN, Wisconsin
MARK MEADOWS, North Carolina
C O N T E N T S
----------
Page
Hearing held on June 20, 2014.................................... 1
WITNESSES
Nora Volkow, M.D., Director, National Institute on Drug Abuse
Oral Statement............................................... 12
Written Statement............................................ 15
Doug Throckmorton, M.D., Deputy Director for Regulatory Programs,
Center for Drug Evaluation and Research, Food and Drug
Administration, U.S. Department of Health and Human Services
Oral Statement............................................... 30
Written Statement............................................ 32
Carl Hart, Ph.D., Associate Professor of Psychology, Co-Director,
Institute for Research in African American Studies, Columbia
University
Oral Statement............................................... 46
Written Statement............................................ 48
APPENDIX
NE Journal of Medicine Article, ``Adverse Health Effects of
Marijuana Use,'' submitted by Rep. Mica........................ 74
Article from CNN by Dr. Sanjay Gupta, ``Why I Changed my Mind on
Weed,'' submitted by Rep. Connolly............................. 83
Letters and testimonies from families on medical marijuana
benefits, submitted by Rep. Connolly........................... 87
Statement of Mr. Connolly constituent Ms. Elizabeth Collins,
submitted by Rep. Connolly..................................... 143
Congressional letter to HHS Secretary Burwell, submitted by Rep.
Connolly....................................................... 146
Quesstions for the record from Rep. Blumenauer and Rep. Fleming
to Dr. Nora D. Volkow, submitted by Rep. Mica.................. 150
Answers to questions for the record from Dr. Throckmorton from
Rep. Fleming and Rep. Blumenauer, submitted by Rep. Mica....... 158
MIXED SIGNALS: THE ADMINISTRATION'S POLICY ON MARIJUANA, PART FOUR--THE
HEALTH EFFECTS AND SCIENCE
----------
Friday, June 20, 2014
House of Representatives,
Subcommittee on Government Operations,
Committee on Oversight and Government Reform,
Washington, D.C.
The subcommittee met, pursuant to call, at 9:09 a.m., in
Room 2154, Rayburn House Office Building, Hon. John Mica
[chairman of the subcommittee] presiding.
Present: Representatives Mica, Turner, Woodall and
Connolly.
Also present: Representatives Fleming, Cohen, and
Blumenauer.
Staff Present: Melissa Beaumont, Assistant Clerk; Will L.
Boyington, Deputy Press Secretary; Molly Boyl, Deputy General
Counsel and Parliamentarian; John Cuaderes, Deputy Staff
Director; Emily Martin, Counsel; Katy Rother, Counsel; Laura L.
Rush, Deputy Chief Clerk; Andrew Shult, Deputy Digital
Director; Jaron Bourke, Minority Director of Administration;
Courtney Cochran, Minority Press Secretary; Devon Hill,
Minority Research Assistant; and Cecelia Thomas, Minority
Counsel.
Mr. Mica. Good morning, and I'd like to welcome everyone to
the Subcommittee on Government Operations hearing this morning.
And the title of today's hearing is ``Mixed Signals: The
Administration's Policy on Marijuana.'' And this is actually
the fourth hearing that we have conducted on the issue of again
changes in policies between State, Federal, and local
government on marijuana. And today we're going to focus on the
health effects and science.
We have done several other hearings. One focused, I think
the most recently, on the District's change--and we have a
unique relationship, the Congress does, with the District of
Columbia--on the legalization and decriminalization issue,
change in their law. We did two other hearings, one with the
office of ONDCP, and some of it was prompted, too, by the
President and the administration's statements that we have
heard over the past few months.
Then I think the other hearing that we did was looking at
changes in State laws. This subcommittee deals with Federal
issues and laws sometimes that end up in conflict. That's one
of our responsibilities in the subcommittee, is sorting out the
differences between the different levels of jurisdiction and
the Federal Government.
As I said, this is our fourth hearing. I will announce,
too, in mid-July, and we'll settle on a date with the minority,
we're going to do a fifth hearing. And that one will look at, I
call it trains, planes, automobiles, and marijuana. There are a
number of issues in conflict relating to transportation safety
that we do want to examine carefully, where we're headed there,
as far as the Federal laws conflict and, again, some of the
changes in State statutes relating to marijuana use.
The order of business will be, I'll start with an opening
statement. Then I will yield to other members. And today we
have one panel of witnesses. We welcome them. We will introduce
them shortly. And after we hear from those witnesses we'll go
to a series of questions. We may be joined by other Members of
Congress. We're starting off a little early this morning. Some
of whom I heard will be with us, and we'll give them the
opportunity to participate through a unanimous consent
agreement.
So with that we'll begin the hearing, and let me just state
again, we have heard different testimony about, again, conflict
between State and Federal law, changes in the law, and some
societal changes in attitude toward the legalization question.
Part of the hearing is prompted by what we have learned about
the state of chaos that exists now between some of the
administration's actions and their policy.
The focus today is going to really look at the science of
the issue, but we also are concerned about sort of the jumbled
messaging about marijuana's effect on public health and also
the science involved in classifying marijuana as a Schedule 1
drug. That issue has come up several times during these past
hearings.
This was all initiated by the President's own statements,
and I think some of that contributed and has contributed to
some of the confusion. I've got the President's statement in
January. President Obama gave an interview about marijuana,
describing marijuana as a bad habit and not very different from
cigarettes. And he also added in a statement, again, don't take
any additional words or add any words to what he said, but he
said, I don't think it's more dangerous than alcohol. Part of
what we'll hear today is, again, sorting out the science of
marijuana and its use and its effect as a health and safety
issue.
However, in our first hearing we heard from the Deputy
Director of the Office of National Drug Control Policy, and his
testimony, as you may recall, differed from that of the
President. He first of all told the committee and testified
that marijuana's potency has tripled over the past 30 years.
And actually this is a very good article, and I'm going to
probably ask that we put this as part of the record. Without
objection.
And it just came out June 4. It is the New England Journal
of Medicine, and it's entitled ``The Adverse Effects of
Marijuana Use.'' But this report, the scientific report differs
with what the President has said. And actually if you look at
this chart, you can see--and that's also published from this
scientific journal--that, in fact, that potency has tripled
over the past 30 years. So, in fact, what was testified by
ONDCP, in fact, is true, that you have so much more potent
marijuana on the streets and in the marketplace today.
They also testified to us that long-term marijuana use when
begun during adolescence is associated with an average 8-point
lower IQ in later life. And, again, the New England Journal of
Medicine cites again some of the impact on the brain and its
impact, particularly on adolescents, in that regard. I was
quite taken aback when I heard the Deputy Director of ONDCP
testify to us about its effects, again more potent, and it does
have some serious implications on the mental capacity of our
youth.
The other thing, I don't know if we had it on that chart or
not, is the increased use--have we got that chart? I know it's
in this report, but it does show marijuana. Put that chart up
again.
[Chart]
Mr. Mica. The lower part of it shows marijuana, you've seen
some pretty dramatic increases in the youth from 2008 to 2007;
also, unfortunately, cocaine, and also heroin. So we have
higher use of drugs and also higher incidence of abuse problems
cited in this report.
The National Institute--well, first of all, let me also
take one other statistic before I finish my opening statement,
from this report. This report indicates that 2.7 million
Americans are dependent on marijuana and that we have
approximately 9 percent of the users who become addicted to
marijuana, again from the report. Everybody seems to be chiming
in. Today on the way in one of my staffers said that Pope
Francis had also actually today issued a statement. And here is
a copy of that. He told the delegates attending a Rome drug
enforcement conference that even limited steps to legalize
recreational drugs are not only highly questionable from a
legislative standpoint, but they fail to produce the desired
effects. And he went on to say it's only a veiled means of
surrendering to the phenomenon; let me state in the clearest
possible terms, the problem of drug use is not solved with
drugs.
So we have got a lot of folks weighing in on their opinion.
And, again, the purpose of this hearing is to look at the
science of the use of marijuana. The National Institute on Drug
Abuse is tasked with studying drug abuse and addiction and
other health effects. We are going to hear from representatives
there today. NIDA has found that marijuana use has negative
effects on the brain, particularly, again as also mentioned in
this journal study, the developing brains of our adolescents.
Research shows that adults that smoked marijuana during
adolescence have impairment in key brain regions associated
with alertness, self-consciousness, awareness, memory, and
learning.
The Food and Drug Administration, which assists the council
on establishing drug scheduling--and again the question has
come up that marijuana continues to be listed as a Schedule 1
drug--but the FDA has found that marijuana has no accepted
medical use, again, their findings and reports. We'll hear more
about that hopefully today.
Regardless, some 20 States--and again driving in today--no,
I think that was shaving. Driving I heard the Pope. Shaving I
heard that I think New York, maybe today, the 23rd State to
legalize marijuana for medical use. And in addition we have
Colorado and Washington States have legalized marijuana for
recreational use. You may recall we brought in the U.S.
Attorney from Colorado to look at the issues and conflict
between State and Federal law and enforcement and prosecution.
These States' actions did not change the fact that marijuana
still remains illegal under Federal law.
Officials from the Office of National Drug Control Policy,
the Drug Enforcement Agency, and the National Institute on Drug
Abuse insist that marijuana remains a health risk and should
not be made legal. However, officials from the Department of
Justice issued guidance that explicitly declines to enforce
Federal marijuana laws in States that have legalized marijuana
for recreational use and have even issued guidance allowing
federally regulated banks about dealing in dollars and money
obtained through, unfortunately, illegal marijuana businesses
that have sprung up.
The President, Federal law enforcement, DEA, U.S.
Attorneys, Food and Drug Administration, National Institute on
Drug Abuse, we have heard a whole host of differing messages.
Last year DEA Administrator Michele Leonhart affirmed that
mixed messaging can be harmful by stating the mixed messages
being sent to America's teens and our young people about
harmfulness and legality of using record high potency marijuana
are sometimes obscuring kids' awareness of the effects that the
use of marijuana would have on them. I think America owes it to
its children, its young people, to give them the best possible
start to life, also a responsible message from all of the
various jurisdictions, responsible legal jurisdictions, so they
and society aren't hindered in the future.
Today we'll hear from two distinguished government
witnesses, and then we also have a third witness who joins us
from Columbia University. I look forward to a discussion about
how mixed messaging from the administration affects drug abuse
prevention and treatment. I will also discuss the process of
classifying drugs as a Schedule 1 narcotic. Today I hope we can
separate fact from fictions.
Mr. Connolly, I've met with my staff yesterday, and we were
talking about what this hearing would be about, and I told them
this is going to be like the old television series, law
enforcement series, you had Jack Webb, you're old enough to
remember, who said, he'd go in and say, all I want is the
facts, just the facts, ma'am. And the startling thing was----
Mr. Connolly. I'm really not old enough. I just remember
hearing about it.
Mr. Mica. I'll give you that, Mr. Connolly. But my point is
that none of the staff had heard that phrase or had heard of
Jack Webb and that series. ``Dragnet,'' I guess, was the name
of the series. But that's really our purpose here is all we
want are the facts, and that's what we are going to deal with
hopefully in this and future sessions.
So with that, Mr. Connolly, you're recognized.
Mr. Connolly. Thank you, Mr. Chairman, and thank you for
holding this fourth in a series of hearings to examine today
the scientific perspective on scheduling marijuana under the
Controlled Substances Act. I must say, in this examination
what's going to be revealed is that we have some of the most
restrictive guidelines in terms of research all skewed toward
outcomes that talk about the harmful effects of marijuana,
almost none of which talk about the beneficial effects
potentially, the positive health effects of marijuana, because
we don't allow the research.
And we have one agency that severely restricts for
researchers access to marijuana in a way that is almost unique
to marijuana. In fact, we don't do that with other controlled
substances. But we're going to examine that today.
I think the title of this hearing shouldn't be about this
administration. It really is almost 40 years of U.S. drug
policy with respect to marijuana through Republican and
Democratic administrations.
Today as you indicated, Mr. Chairman, 22 States and the
District of Columbia have actually departed from Federal policy
and now have laws on the books that allow for some medical use
of marijuana. Since 1970, the Federal Government has classified
marijuana alongside heroin, LSD, and Ecstasy as a Schedule 1
drug for which there is, ``no currently accepted medical use
and a high potential for abuse''--that's interesting, that's
quite an interesting message to the 22 States and the District
of Columbia who have respectfully decided otherwise--in
addition to constituting one of, ``the most dangerous drugs of
all the drug schedules with potentially severe psychological
and physical dependence.'' That's an astounding statement, and
it will be very interesting whether that holds up in terms of
science.
I'm neither a doctor nor a scientist--neither is the Pope,
I might add--but I surely am not alone in raising my eyebrows
over a classification system that would not only group
marijuana among heroin, LSD, and Ecstasy in terms of danger for
abuse, but would rank cocaine, Oxycontin, and methamphetamines
as less dangerous, with less potential for abuse than
marijuana. Is that science?
In recent years, there's been a growing acceptance of the
potential benefits of medicinal marijuana. Last year Dr. Sanjay
Gupta, a staff neurosurgeon at Emory Clinic and CNN's chief
medical corespondent, penned an op-ed in support of medical
marijuana. And I would ask that his full statement be entered
into the record.
Mr. Mica. Without objection.
Mr. Connolly. I thank the chair. In which he stated, quote,
``We have been terribly and systematically misled for nearly 70
years in this country, and I apologize for my own role in it.''
He noted, ``While investigating, I realized something else
quite important. Medical marijuana is not new, and the medical
community has been writing about it for a long time. There
were, in fact, hundreds of journal articles, mostly documenting
the benefits. Most of those papers, however, were written
between the years of 1840 and 1930.'' And in part it's because
we created a system limiting research to skew the outcome so
that we downplayed the positive benefits and highlighted the
harmful effects.
Meanwhile, on April 28, 2014, my Republican colleague and
fellow Virginian, Morgan Griffith, hardly a liberal Democrat,
introduced H.R. 4498, the Legitimate Use of Medicinal Marijuana
Act, which would reclassify marijuana as a Schedule 2 drug.
Currently practitioners that are registered with DEA and have
HHS approval may only obtain marijuana for approved research
through one single entity, the National Institute on Drug
Abuse, NIDA. NIDA acts as the single official source through
which researchers may obtain marijuana for research purposes,
and it's estimated that more than 90 percent of the marijuana
research NIDA approves is to only examine the harmful effects
of cannabis. That skews research.
Regrettably, the more I learn about the process, the more I
feel we may be trapped in a Catch-22--another reference to an
older era, Mr. Chairman--that would make Joseph Heller proud.
As one nonprofit organization noted, ``DEA and NIDA have
successfully created a Catch-22 for patients, doctors, and
scientists by denying that marijuana is a medicine because it
is not FDA approved, while simultaneously, of course,
obstructing the very research that might be required for FDA
approval.''
Indeed, in a 2007 ruling that found allowing private
production of cannabis for research purposes was in the public
interest, a DEA administrative law judge stated, and I quote,
``NIDA's system for evaluating requests for marijuana research
has resulted in some researchers who hold DEA registrations and
the requisite approval from the Department of Health and Human
Services being unable to conduct their research because NIDA
has refused to provide them with marijuana.'' Again, skewing
research. If this is about science, then let the scientists and
the researchers have at it, and let's see what they come up
with. But if in advance you prevent them from having the very
means to do that research, well, how can any of us be surprised
at the outcome?
Thus as it stands today, on the one hand we have the
Federal Government that for more than four decades--not just
this administration, Mr. Chairman--running has insisted on
placing marijuana under the most restrictive drug schedule
possible, impeding scientific research into the drug's
potential benefits. And that's one of the reasons I guess 22
States and the District of Columbia, and maybe a 23rd State,
have rebelled against this heavyhanded Federal approach.
On the other hand, we have very compelling anecdotal
evidence and some emergent science that indicates cannabis may
well have medicinal properties that can benefit individuals
with certain conditions, such as individuals experiencing
severe epileptic seizures or veterans suffering post-traumatic
stress syndrome. And in the middle stand policymakers such as
myself who would love nothing more than to carefully examine
and review the evidence, but find ourselves facing an
astonishingly barren research environment by design.
It is time for our Nation to approach the debate over
marijuana policy with more honesty and less hyperbole and more
science. It's a disservice to public discourse when
policymakers refuse to grapple with challenging and complex
issues in an objective and open manner. We can't ignore the
growing evidence of families whose lives have been positively
impacted by medicinal marijuana.
For example, one of my constituents in northern Virginia,
Ms.Beth Collins, has watched her daughter suffer for years with
severe epilepsy. This horrible disease has caused Ms. Collins'
teenage daughter, Jennifer, to experience multiple seizures, at
times more than 300 seizures in a single day. For years the
Collins family tried everything, they tried multiple medication
regimes, all of which wrought painful side effects to their
daughter and none of which were efficacious in treating her
systems.
Today Jennifer's seizures have dramatically dissipated by
85 to 90 percent. That's the good news. The bad news is that
Jennifer was forced to leave Fairfax County and move to
Colorado Springs because the treatment that has proven quite
effective, a daily dose of medicinal marijuana oil from a
syringe, not smoking joints, cannot be legally purchased in the
Commonwealth of Virginia.
Our Nation can't continue to ignore compelling stories like
that of the Collins family and so many others. In fact, Mr.
Chairman, I would also ask unanimous consent, I have a series
of letters and pieces of testimony from families attesting to
the beneficial effects of medicinal marijuana for their medical
conditions.
Mr. Mica. Without objection, it will be part of the record.
Mr. Connolly. I thank the chair, and I'm almost done.
I recognize that anecdote must be reinforced with rigorous
scientific data. That's why I believe we should act swiftly to
reclassify marijuana in order to allow for legitimate medicinal
uses and research and enable rigorous scientific research that
will provide a better understanding of how marijuana may be
used if proper.
I have long believed that the Federal Government governs
best when it truly listens and learns from our States, which
have been for decades called the laboratories of democracy.
They want their local governments to have the opportunity to
innovate and experiment with regulatory and enforcement
frameworks governing medicinal marijuana research and use, and
I believe it is in our national interest to let those ongoing
laboratories of democracy proceed, and to proceed within a
rational Federal framework, one which I do not believe exists
today. Thank you, Mr. Chairman.
Mr. Mica. Thank you for your opening statement.
And Mr. Turner has left. We have three members, and Mr.
Connolly moves that----
Mr. Connolly. Mr. Chairman, I do.
Mr. Mica. --and ask unanimous consent that our colleague
from Oregon, Mr. Blumenauer, our colleague from Tennessee, Mr.
Cohen, and our colleague from Louisiana, Dr. Fleming, be
allowed to participate in today's hearing.
Mr. Connolly. I so move, Mr. Chairman.
Mr. Mica. Without objection, so ordered.
Mr. Connolly. And, Mr. Chairman, just one other thing, a
unanimous consent request. Very compelling testimony, and I
commend it to you and my colleagues, from my constituent Beth
Collins on their story, and I'd ask that that be entered fully
into the record.
Mr. Mica. Without objection, so ordered.
Mr. Connolly. I thank the chair.
Mr. Mica. Now, let's see. We heard from Mr. Connolly.
Mr. Fleming.
Mr. Fleming. Thank you, Mr. Chairman. And I want to thank
the panel for allowing me to be here today and welcome the
panel.
Yes, the medicinalization, the decriminalization, and the
legalization of marijuana has been sweeping the Nation. But
it's been happening as a result of myths, mythology about
marijuana. And I just want to touch on those from the book from
Kevin Sabet, a Ph.D. And an expert on the subject.
Myth number one, marijuana is harmless and nonaddictive.
That's simply not true. It's a complete myth. The most common
diagnosis today for young people into drug and alcohol centers
is for marijuana addiction. It does have a recognized
withdrawal syndrome.
Myth number two, countless people are behind bars simply
for smoking marijuana. Not true. Yes, there are a lot of people
behind bars who smoked marijuana, but that's not why they're
behind bars. They're either behind bars for dealing or involved
in violence or theft or some other crime.
The legality of alcohol and tobacco strengthens the case
for legal marijuana. Terrible myth. If we have problems with
tobacco and alcohol, why do we want to add a third problematic
substance of addiction and create even more problems in our
society? It makes no sense whatsoever.
Also a myth, legal marijuana will solve the government's
budgetary problems. The outcomes in terms of health problems,
the outcomes in terms of government dependency when people
can't get or maintain a job will cost governments a huge amount
of money. We'll see our welfare roles, our Medicaid roles, and
other things will skyrocket.
Another myth, a common myth, Portugal and Holland provide
successful models of legalization. First of all, smoking pot
there is not legal. It's decriminalized, not legal, and in
recent years they have begun to turn back the time, turn back
the clock on the steps of liberalization of that use.
Prevention, intervention, and treatment are doomed to fail.
Not true at all. Wherever we see that there is prevention,
wherever we see that there is intervention, we see lower use.
And, in fact, we talked yesterday in the Addiction Caucus where
there is liberalization of thought, where there is less threat
to use, we see the use go up and all the other problems that go
with it, addiction, drug driving, accidents, deaths from
accidents, et cetera.
Now, let's talk about medicinal use. And Mr. Connolly
suggests that we just haven't been studying that. Well, I beg
to disagree, because my university that I graduated from, the
University of Mississippi, both undergraduate and as a
physician, this has been studied there in their Pharmacology
Department for forty years. The reason why you're not hearing
about all the great things that come from marijuana is they're
not finding good things coming from marijuana. The only thing
they can find is the harm.
Now, there is a discussion about seizures. I have raked
across the literature on this. I can't find any authority on
this, whether it's rare seize disorders or common ones, where
marijuana is used as a treatment, where it's a recognized use.
Now, you might say, well, yeah, but it's a Schedule 1 drug.
Well, actually no. There is a Schedule 3 drug called Marinol,
which is actually an oral form of marijuana, and it is used and
it can be used at the same equivalency of, say, Lortab or
Oxycontin or a drug like that that's used in more common,
everyday medical use.
So you see, it's been there and can be used, and there is a
discussion about, well, maybe the oil that doesn't include THC
can be used for seizure disorders. Well, sure, that's an
extract, and I'm sure we would be able to make that a safely
used drug. But no one's been able to prove that the use of
marijuana oil has any real benefit. Yeah, we here the anecdotal
stories, but that's how the myths come out, is someone tells a
story and they tell someone else, and before you know, it's
been blown completely out of proportion.
And then lastly, something of which I've studied for years
and wrote a book on in 2007, is the fact that we know the
earlier in life that the human brain is exposed to addicting
substances, again, realizing that the human brain does not
mature until age 25 to 30. That's right; half this room have
immature brains today. And as a result----
Mr. Connolly. Would my colleague want to tell us which
half?
Mr. Fleming. Don't get me started, sir.
But if you look at the fact that the average age of first
use of alcohol, tobacco, and marijuana is 10 years old, then
you find that the pathway, the building of the reward system
towards addiction begins very early in life. And so when you
diagnose someone with an addiction at age 25 or 30, they've
been in that process for a decade.
And so as we legalize, decriminalize, or otherwise
medicinalize marijuana, that means more and more marijuana will
be available to young people, and they will use it. And we're
already finding this, looking at California and Colorado,
places where this process has been going on.
So I would say to my colleagues today that I look forward
to hearing from our panel, but as we study marijuana, all we
find is bad news, more heart disease, more lung disease, higher
rates of schizophrenic, and many other problems, all apart from
addiction, which, of course, is a problem.
And I'll end with this. The other myth is that not only is
marijuana non addictive, but it's not a gateway drug. And I'll
tell you what a drug addict told me. He said, Doctor, every
addicting substance is a gateway drug, and marijuana is no
exception to that. Thank you and I yield back.
Mr. Mica. I thank the gentleman.
Mr. Mica. And let me see seniority.
Mr. Blumenaur, thank you for joining us, you're recognized.
Mr. Blumenauer. Thank you very much, Mr. Chairman. Chairman
Mica, I appreciate your on going efforts to sort of peel back
the level of the onion with the these hearings, your courtesy
in permitting us to join in, to follow the information. And
it's certainly timely, and you've highlighted some areas of
contradiction, and in this area I think today's hearing is one
that hopefully we can all agree there needs to be some
progress.
I appreciate Dr. Fleming not talking about which half of
the brain are immature. I just think it may not always deal
with chronology or early substance abuse, but I appreciate the
benefit of the doubt.
I also appreciate, I think he used the phrase three times
in his opening statement that no one has been able to prove,
and then had a clause after that. And I think that's exactly
the case, and that is why this is such an important hearing.
It's because when we have a million people in the United States
who are currently using medical marijuana legally under the
laws of the 22--it looks like it's going to be 23 states now,
in the State of New York and the District of Columbia, and then
there are other states that are dealing with variations on
this--it's inexcusable that we don't have better information.
I'm embarrassed for this administration and previous
administrations for not having a robust, effective program to
be able to deal with the facts. I'm embarrassed when I'm at
OHSU dealing with neuroscientists and physicians who are
talking about patients that they have, similar to what Mr.
Connolly was talking about, who are having very positive
results, and it is harder for those scientists and doctors to
get marijuana to research than it is for parents to self-
medicate the kids and really not knowing what they're being
given. And part of that is the fault of the Federal Government
and stupid policies.
I would note for the record, Mr. Chairman, and ask
respectfully that I could enter into the committee's record a
letter dated June 17, a bipartisan letter signed by 30 Members
of Congress to Secretary Burwell urging that there be changes
in the research protocol.
Mr. Mica. Without objection, so ordered.
Mr. Blumenauer. Thank you, Mr. Chairman.
It points outs in the letter that only with marijuana and
no other Schedule 1 substance is there an additional Public
Health Service review for non-NIH-funded protocols established
in May 21, 1999, in the guidance for procedures for provision
of marijuana for medical research. We have got examples as well
of people who are jumping through procedural hoops, people who
are approved for research, and we have got this little narrow
spigot that does not work.
I'm embarrassed. I'm embarrassed for you having to be here
to defend a broken system. I'm embarrassed that we, after years
and years and years, and as the States are moving ahead of us,
the Federal Government is not an effective partner to be able
to have the information.
Now, Dr. Fleming and I have modestly different views about
what a sustainable marijuana policy should be, but we are
absolutely in accord that we shouldn't be guessing, that we
should have facts, we should have effective research, it should
work for the American people.
And I, Mr. Chairman, appreciate the courtesy of being able
to join. I will be monitoring this. I'm bouncing back and forth
between a Ways and Means hearing. I'm going to be here as much
as I can. But I really think this is critically important. I
appreciate you doing it and you and the ranking member allowing
us to participate.
Mr. Mica. Thank you, Mr. Blumenauer.
Let me recognize the gentleman from Tennessee, Mr. Cohen.
Mr. Cohen. Thank you, Mr. Chair. And again, I appreciate
your having the hearing and your allowing those that are not on
the committee but have an interest in the subject to
participate.
First, I want to compliment Dr. Hart for maintaining his
demeanor during some of the statements that have been made,
rather amazing ability to withhold. My colleague from Louisiana
talks about marijuana and says there's been nothing found
beneficial. Of course, we know that's not true because the
people with epileptic seizures, the mothers who have found that
part of that is the cannabinoids, or whatever it is, it
definitely helps their children. There's no question about
that. And States are falling over themselves now, even
Tennessee, to study that in Mississippi because kids are having
their seizures reduced, which shows that the whole idea of it
being Schedule 1 and having no accepted medical benefit is
wrong because these kids are benefiting from it.
Montel Williams is pretty strong on beneficial treatment,
and a lot of people with cancer find it to help with nausea. I,
for one, think that we should expand our horizons and all
opportunities we can to people who have cancer and other life-
threatening diseases to ease their pain and their anguish, to
alleviate their hunger desires for which they may have been
limited because of the illness and to give them some type of
ability to smile. That would be a nice thing to do.
Mr. Fleming talks a lot about medical marijuana, but
doesn't bring up anything about the effects of arrests. Dr.
Hart talks about that a lot. You have to balance everything in
society and how it affects people. And, yeah, maybe 9 percent,
I don't know what the figures that Dr. Volkow mentioned or Dr.
Throckmorton, I think it was Dr. Volkow, is that 9 percent may
become addicted at some point, et cetera. Well, a great number
more than that get arrested and get a scarlet ``M'' fastened to
their chest for life, which means they don't get a job maybe or
a college scholarship or an opportunity to live in public
housing and other things.
And you have to weigh, no question there are some bad
effects of marijuana, but there are some even more harmful
effects in taking people's liberty. And you take judgment,
informed judgment, and you take depriving people of their
liberty and putting them in jail. And there are people in jail
for possession. There are lots of people in jail for
possession. Even for a short time it's not good. But some of
them for a short time. Some of them longer because they don't
have money to get bailed out, and they don't have access to
attorneys that can get them out. So that's just not accurate.
We talk about 40 years of this policy. Nixon started the
war on drugs, and we know that Nixon did it for politics and
that Ehrlichman talked to him about it, or Haldeman, I get the
two of them confused, the twin devils of that administration.
They were not the twin devils, there were lots of devils in
that administration, but they were the two poster children for
harmful conduct and dirty tricks that were illegal, brought
down a President. But they admitted that scheduling as Schedule
1 was for the purpose of politics, and it was a great thing and
it had to do with race.
And it really goes back to the 1930s, and while President
Roosevelt probably wasn't too aware of it, Harry Anslinger came
around, and it was the Hispanics. And Mr. Fleming talked about
these myths that get out there, and all of a sudden these myths
are out there about medical benefits, and then they become kind
of like Goebbels' lie--I can't say that, excuse me, pardon me--
kind of like repeating lies over and over again and they become
accepted. You know, that's what ``Reefer Madness'' was, and
those lies got perpetrated.
So the bottom line is what Mr. Blumenauer talked about is
so true. We need research. We need study. We need study for the
States. We need studies for the children. And there's no
question children shouldn't be doing, smoking marijuana. That's
not what this should be about. They shouldn't be doing alcohol,
tobacco, marijuana, having sex, none of that. It's true some of
that happens, but it shouldn't happen, and nobody is suggesting
it.
But for adults in a society that prides itself on life,
liberty, and the pursuit of happiness, if you make it illegal
that's liberty, and some people think it's the pursuit of
happiness. Whether that's true happiness or not, whether you
find it in a bottle of Jack Daniels or whether you find it in a
nice pinot noir or Budweiser or whatever, that's each person's
choice in a free society. So I think the study is so important.
Anyway, thank you, Mr. Chairman. I appreciate you, and I
hope when you're shaving next you'll hear about the 24th State.
Mr. Mica. Well, thank you, Mr. Cohen, for joining us again.
And I think there are no other opening statements, so what
we'll do now is turn to our three witnesses. Again welcome
them. Before I do that, let me say that members may have 7 days
to submit opening statements for the record. And without
objection, we'll include that.
Let me again welcome our three witnesses. And I don't think
you all have testified before our panel before. Our method of
operation, so to speak, is to allow you about 5 minutes. We
only have three witnesses and one panel, so we'll be a little
bit generous there. But we ask you, if you have additional
lengthy information or data you'd like to be made part of the
record, just to request through the chair and we'd accommodate
you.
Let me introduce our witnesses, and then I'll swear you in.
We have first Dr. Nora Volkow, and the doctor is Director of
the National Institute of Drug Abuse. Dr. Doug Throckmorton,
and he is the Deputy Director for Regulatory Programs for the
Food and Drug Administration. And then we have Dr. Carl Hart.
He's an associate professor of psychology at Columbia
University. So those are our three witnesses in this panel.
This is an investigation and oversight subcommittee of
Congress, so just stand please, and I'll swear you in.
Raise your right hand. Do you solemnly swear or affirm that
the testimony you are about to give before this subcommittee of
Congress is the whole truth and nothing but the truth?
And all of the witnesses, the record will reflect, answered
in the affirmative. And I welcome each of you, and I will
recognize you for your testimony. First we'll have our Director
of the National Institute of Drug Abuse, Dr. Volkow.
Welcome, and you're recognized.
WITNESS STATEMENTS
STATEMENT OF NORA VOLKOW
Dr. Volkow. Good morning. I very much appreciate the
opportunity to come to speak with you, and I also very much
appreciate your comments, addressing and clearly identifying a
subject that is complex and that has evidently polarized very
much our perspective. I like the concept of saying where the
facts is, and I'm going to try to actually identify where
things are, the information is factual, and where the
information is currently not fully available or unclear.
Marijuana is used because it activates the endogenous
cannabinoid signaling systems in reward areas, and the
endogenous cannabinoid system actually is not just in reward
areas, but it is involved in multiple functions of the brain
and multiple functions of our body. And that's why there has
been so much interest in terms of the potential of manipulating
the endogenous cannabinoid system for a variety of medical
conditions, and that's, I think, at the essence of the debate.
The issue with taking marijuana which activates the system
is that it inhibits the individual's endogenous cannabinoid
systems, so as a result of that the person may be actually in a
state of deprivation when the drug is no longer available. And
that is an issue that needs to be addressed as one considers
the effects of repeated administration of marijuana.
Marijuana is the most common used elicit drug in our
country, and its use is particularly high among adolescents.
And this has been increasing over the past years. More high
school seniors now smoke marijuana than smoke cigarettes, and
we have one of the highest rates of regular use of marijuana
that we've had since we've been actually evaluating it; 6.5
percent of 12th graders report regular use of marijuana. So
that's almost daily use, which is the one that's most likely to
be associated with adverse effects.
This increased use of marijuana we know reflects a
decreased perception that marijuana is risky, which then
increases the prevalence of its use certainly among teenagers.
But this belief is really not backed up by evidence that has
evolved over the past 10, 15 years when these changes in
perception actually over the past 10 years have dramatically
shifted. In fact, there is significant evidence that marijuana
can have a deleterious effects.
Now, not everybody will get the deleterious effects. It's
like not everybody that smokes cigarettes will get cancer. And
yet we don't question it. But we do use that logic in order to
actually address the so-called safety of marijuana.
So what is it, how harmful it is, and where is the
harmfulness coming from? Well, in addressing marijuana we have
to differentiate between acute and chronic effects, repeated
effects. Acute effects relate to intoxication. And where is the
facts? We know that marijuana impairs motor coordination,
perception of time, and we do know that marijuana contributes
significantly to car accidents, including fatal ones. And that
is basically no question. I mean, the facts are there. There is
also evidence that marijuana from studies, if you are
intoxicated with marijuana, the risk of being in a car accident
is basically double. And if you combine it with alcohol, the
risk increases over a dose of each drug alone.
Now, acute intoxication of marijuana is also associated
with psychotic episodes, overall most of them short lasting;
and we are starting to see reports in the medical literature of
medical complications we did not know about, like
cerebrovascular and cardiovascular pathology evidently
associated with a higher content THC.
So what about the long-term effects of marijuana? Factual,
marijuana produces addiction, and as mentioned before, not
everybody becomes addicted. Nine percent will become addicted,
of those that get exposed; 16 percent if it started when they
were teenagers; and 50 percent, they use it regularly.
The discussion of is marijuana gateway drug, very well
placed. Marijuana usually precedes the use of other drugs, but
this does not negate that the other drugs can actually also act
as gateway drugs. Clinical studies in animals indicates that
exposure early on actually changes the sensitivity of the
reward centers of the brain. Also, animal studies show that
exposure to marijuana early on impairs with the connections
among neurons, the connections that form in order for neurons
to communicate with each other are disturbed by the use of
marijuana very early on, cannabinoids.
On human subjects there is evidence that those that were
exposed very early on to marijuana have disrupted connectivity
in areas of the brain involved with memory and interceptive
awareness. There is also evidence from many studies independent
that individuals that smoke marijuana regularly during
adolescence actually are much more likely to drop out of school
and have much lower educational achievement. The mechanisms
underlying these associations, however, are not completely
understood and could be multifactorial.
Now, because of all of these, and even though there are
many, many, many studies that have emerged, many of them have
been criticized for one of the factors--they may have not had
sufficient sample sizes; they were not controlling for
premorbid performance prior to use of marijuana; they actually
did not follow individuals long enough or they did not have the
sensitivity.
So it is clear in my brain right now as we look forward
that we need to actually ask an organization that develops
evidence. We need to conduct a properly evaluated study to
assess the consequences of marijuana exposure in teenagers,
because regardless of what happens with regulations, they are
the ones that are more likely to be vulnerable to the adverse
effects.
I would like to conclude by the fact that as we look at
discussions of where we are and where we are not, the greatest
number of cases associated with mortality, morbidity, and
economic cost to our society from drugs, by far, by far, are
the legal drugs, alcohol and tobacco, much more than all of the
other drugs even multiplied. And it's not because alcohol and
tobacco, nicotine are more dangerous. Certainly no one will
question methamphetamine or cocaine. It is because their legal
status makes them more available, and actually perception of
risk is much lower.
And I think we have to keep this in mind as we go into
these discussions, and whatever the solutions come around, we
have to look towards what we have seen in the past of
consequences of some of these policies to try to minimize the
risk of policies. We all want to do the right thing, and how we
look at the data is slightly different. And I think that that
is the value of getting together and also very importantly the
partnerships among the different agencies.
Thanks very much for having me here, and I will be happy to
answer any questions.
Mr. Mica. Thank you.
[Prepared statement of Dr. Volkow follows:]
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Mr. Mica. And we'll hold them until we have heard from the
other witness. I'll recognize next the Deputy Director for
Regulatory Programs of Food and Drug Administration, Dr. Doug
Throckmorton.
STATEMENT OF DOUG THROCKMORTON
Dr. Throckmorton. Mr. Chairman, Ranking Member Connolly,
members of the subcommittee, thank you for this opportunity to
discuss the role that the FDA plays in regulating marijuana in
the United States. In addition to important work overseeing the
approval of prescription drugs and use of drugs derived from
marijuana and its constituents, FDA understands the importance
of supporting efficient and scientific assessment of marijuana
in connection with drug development.
Marijuana contains compounds with potential to provide
important new treatments for important diseases, and rigorous
studies are needed to assess their potential, and where
appropriate, deliver new drugs for use by Americans. FDA
continues to believe that the drug approval process established
by Congress represents the best way to ensure that safe and
effective new medicines from marijuana are available as soon as
possible for the largest numbers of patients.
First, FDA is the agency that is responsible for the
assessment and regulation of new drugs in the United States.
The Food, Drug, and Cosmetic Act requires that drugs be shown
to be safe and effective for their intended uses before being
marketed. In addition, drugs must be shown to be manufactured
consistently, lot to lot, with high quality. Because many
factors influence the makeup of plant materials, such as
temperature, time of year, and location, this essential part of
drug development presents special challenges when the drug is
derived from a botanical source such as marijuana.
As a part of our work to regulate prescription drugs, FDA
also provides scientific recommendations to the Drug
Enforcement Administration, or DEA, on drugs and other products
that have the potential to be abused, so-called controlled
substances, including marijuana. While DEA is the lead Federal
agency responsible for regulating controlled substances and
enforcing the Controlled Substances Act, FDA, working with
NIDA, provides scientific recommendations about the appropriate
controls for those substances.
To make these recommendations, FDA is responsible for
preparing what's called an eight-factor analysis, which is a
document that is used to assess how likely a drug is to be
abused. At the request of DEA, in 2001 and again in 2006, FDA
conducted a review of the available data for marijuana and
recommended that marijuana remain in Schedule 1, the most
restrictive schedule, both because of its high potential for
abuse and because there was not sufficient evidence that
marijuana had an accepted medical use in treatment in the
United States.
Next let me turn to the FDA work to support the efficient
development of drugs from marijuana. As a part of our mission
to promote availability of safe and effective medical products
for all Americans in all therapeutic areas, FDA is actively
streamlining regulatory processes at various steps along the
path from drug discovery to delivery to a patient. We
understand that this is an important part of our mission.
We have developed and successfully used a number of
flexible and innovative approaches intended to expedite drug
development. These approaches are being applied to developing
drugs derived from marijuana. For example, FDA granted fast-
track designation to Sativex, composed primarily of two
cannabinoids, being studied for the treatment of pain in
patients with advanced cancer. More recently, in June of this
year FDA granted fast-track designation to the investigational
cannabidiol product Epidiolex, being developed for the
treatment of childhood epilepsy.
As a part of this work to encourage efficient drug
development, FDA recognizes that many patients are urgently
waiting for new potentially beneficial drugs, and we are
committed to supporting timely patient access to them. FDA's
expanded access mechanisms are designed to facilitate the
availability of investigational drug products to patients while
those drugs are being studied for approval.
These mechanisms are also being used in the area of
marijuana drug development. For example, GW Pharmaceuticals has
announced that they have established 21 expanded access INDs
for Epidiolex to treat patients with epilepsy syndromes, and to
date over 300 patients have received Epidiolex through those
programs.
In support of scientific research into marijuana and its
constituents, FDA also works with researchers who are
developing new drugs from marijuana. Recently several States
have announced their intentions to study it for therapeutic
purposes, and the FDA is providing ongoing assistance to
support their efforts. I have had the opportunity to speak with
many of those researchers from those States myself. For
example, Georgia and New York have recently announced their
intention to develop clinical trials using Epidiolex to help
treat patients diagnosed with epilepsy.
Finally, the FDA is working with other Federal agencies on
marijuana. In addition to the work I mentioned earlier on drug
scheduling with NIDA and DEA, our scientific staffs work
closely together to understand the effects of marijuana. FDA
also participates in regular meetings with the Office of
National Drug Control Policy and other Federal agencies
discussing marijuana.
To close my remarks then, there is considerable public
interest in developing new therapies from marijuana. FDA
understands this and will support the continuing development of
specific new drugs that are safe, effective, and manufactured
to a high quality. Drug development grounded in rigorous
scientific research is essential to determining the appropriate
uses of marijuana and its constituents in the treatment of
human disease. We are committed to making this process as
efficient as possible and looking for ways to speed the
availability of new drugs from marijuana for the American
public.
Thank you for your interest in this important topic. I'd be
happy to answer any questions that I can.
Mr. Mica. Thank you. And we will get back to you with
questions.
[Prepared statement of Dr. Throckmorton follows:]
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Mr. Mica. I want to now recognize the Associate Professor
of Psychology at Columbia University, Dr. Carl Hart.
Welcome. And you are recognized.
STATEMENT OF CARL HART, PH.D.
Mr. Hart. Chairman Mica, Ranking Member Connally, and
distinguished members of the subcommittee, it is a privilege
and honor to offer my expertise in your quest to more
comprehensively understand the impact of marijuana on the
individual as well as our society.
As you all pointed out, I am a tenured professor at
Columbia University in the Departments of Psychology and
Psychiatry. I also serve as a research scientist in the
division on substance abuse at the New York State Psychiatric
Institute.
I am also a member of the National Advisory Council on Drug
Abuse, and I am on the board of directors for the College of
Problems of Drug Dependence and, also, for Drug Policy
Alliance.
As you all may know, I am a trained
neuropsychopharmacologist who has spent the past 16 years
studying the neurophysiological, psychological, and behavioral
effects of marijuana.
As part of my research, I have given thousands of doses of
marijuana to people and I have carefully studied the immediate
and delayed effects on the drug on them. My findings are
published in some of the most prestigious scientific journals.
I have coauthored a popular college-level textbook that
focuses on drugs in society. My most recent book, ``High
Price,'' is aimed at educating the general public about drugs
and preventing drug-related tragedies.
But I want to be clear here today that my remarks will
focus primarily on the effects of marijuana on adults, since we
all agree that recreational use of marijuana as well as other
drugs by children should be discouraged.
So, to be clear, marijuana is a psychoactive drug. That
means that it alters the functioning of brain cells and
influences our thinking, mood and behavior. It can have both
positive as well as negative effects. This is true of all
psychoactive drugs, including alcohol and tobacco.
A major potential negative consequence of marijuana use is
addiction. As has been pointed out correctly, marijuana--about
9 percent of the people who use marijuana will become addicted.
By comparison, however, about 15 percent of the people who use
alcohol will become addicted and a third of the people who
smoke tobacco will become addicted.
The point is, yes, marijuana is addictive. However, when
you compare it to our legally available drugs, its addictive
potential is lower.
Another concern related to marijuana is disruption of
cognitive functioning. As is the case with alcohol, during
marijuana intoxication, some cognitive operations, such as
response time, may be temporarily slowed, but the intoxicated
individual is able to respond to environmental stimuli in
appropriate manners.
Marijuana intoxication typically lasts no more than 2 to 4
hours, depending upon the individual's level of experience with
the drug. It is important to understand that, even during
periods of intoxication, the user is able to carry out his or
her usual behavioral repertoire. That means engaging in
appropriate social behaviors, including responding to
emergencies.
After the intoxicating effects of marijuana have
dissipated, there are no detectable physiological or behavioral
effects of the drug in recreational and casual users. This is
similar to what is observed following alcohol intoxication.
In fact, many of the people who I have studied who
participate in our research studies where we actually give the
drug, they are responsible members of their community. They are
graduate students. They are actors. They are schoolteachers.
They are waitresses, waiters, professors, lawyers, among other
professions.
One of the least discussed effects of our current approach
to marijuana deals with arrest rates. It was briefly mentioned
here today.
Each year there are more than 700,000 marijuana arrests,
which account for half of all the drug arrests in the country.
By the way, the overwhelming majority of people who are
arrested for marijuana, 80 percent or so, are arrested for
simple drug possession.
But what is worse is that, at the State level, black people
are 2 to 7 times more likely to be arrested for marijuana than
their white counterparts.
And at the Federal level, Hispanics represent two-thirds of
all the people arrested for marijuana violation, despite the
fact that blacks, Hispanics and whites use the drug at similar
rates.
The scientific community has virtually ignored this
shameful marijuana-related effect. The National Institute on
Drug Abuse could help remedy this situation by requesting
research applications that explicitly focuses on race, for
example, trying to understand the long-term consequences of
marijuana arrests on black and Hispanic people, especially as
they relate to disrupting one's life trajectory.
So as we move forward here to develop a more rational
approach to marijuana in our society, it is my most sincere
hope that we not only focus on the potential negative effects
of the drug, but we also include some of the beneficial effects
of the drug and, most importantly, the consequences of our
current policies on certain communities of color.
Thank you, guys.
Mr. Mica. Thank you.
[Prepared statement of Dr. Hart follows:]
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Mr. Mica. And I thank all three of our witnesses for their
testimony.
And we will start with some questions.
First of all, I will start with our Director of the
National Institute on Drug Abuse and ask the question:
President Obama had said that smoking marijuana is not very
different from smoking cigarettes, and he also said that
marijuana is less dangerous than alcohol--or intimated that. I
think we had up on the screen his exact comments.
How would you respond, Doctor?
Dr. Volkow. Well, we all use our own experience to actually
get conclusions. And, as I mentioned, for cigarette smoking,
not everybody that smokes cigarettes is going to get lung
cancer. And so, in their experience, this is not a harmful
drug.
And there are very significance differences, we know,
variability, probably determined by genetic factors that make
some people more vulnerable and others more resilient.
To the comment of whether marijuana is more or less harmful
than alcohol and tobacco--and, again, I do agree with my
colleague, Dr. Hart--there is always positive and negatives.
I think one of the issues in those comparisons, which I
don't like, to start with, is that you are comparing the
percentage of people that become addicted to marijuana when
they get exposed to it, which is 9 percent, versus, say, 15
percent for alcohol, which is much higher.
But alcohol is legal and marijuana is illegal, and the
legal status affects the norms and the willingness of people to
get exposed to it.
So in order to really compare the likely--the relative
potency of one drug versus the other vis--vis how humans end up
consuming it, you have to have similar social conditions for
both of them.
And so, in animal models, nicotine is not very addictive.
It is very hard to make animals addicted to nicotine.
But it is a very widely available drug. It is dispersed to
groups through an administration that leads to very high
concentration, which is smoking, just like marijuana.
And, also, finally, the other aspect that we need to
consider, which was brought by Mr.--Dr. Fleming, is that the
marijuana that he may have smoked is likely to have had, we
know, probably very low content of 9-THC opposed to the
marijuana that we currently have now.
And we do know that the higher the content of 9-THC, the
higher the likelihood that you will develop adverse effects and
much more likely to become addicted to it.
So I think that all of these factors----
Mr. Mica. You also testified that marijuana becomes--is
responsible for being a gateway drug.
Dr. Volkow. Well, epidemiological data has shown that most
individuals that smoke cocaine or take heroin started with
marijuana, but they also show that they started with alcohol
and nicotine.
So there is--this could be just a social phenomena of which
is the drug that is the most readily available or a
pharmacological effect of the drug that, when you take it when
you are an adolescent brain, when your brain is developing very
rapidly, influences, primes, your brain in such a way that then
you become more vulnerable to other drugs, which would then
explain why, for example, individuals that get exposed to
marijuana before age 17 are not only at greater risk of
becoming addicted to marijuana, but they are also at greater
risk of becoming addicted to other drugs of abuse, even when
you control for genetic backgrounds and environmental
backgrounds.
So there is evidence to suggest that there may be a priming
effect that could account for this concept of a gateway drug.
Mr. Mica. I am not a scientist. But we have had testimony
now. And I guess some of these reviews also indicate that there
is--particularly when used by adolescents, that there is a
diminution in the level of intelligence.
Do you--is there evidence to that?
Dr. Volkow. This study was actually--the one that you are
referring to was a study done in New Zealand in 1,050
individuals that were monitored periodically from age 13 until
age 32. So they were evaluating the cognitive performance
actually before they took marijuana.
And what they found, that those that consistently took
marijuana during adolescence have overall lower--8 points lower
I.Q. When they were consistently taking it.
Mr. Mica. Okay.
Dr. Volkow. So that is a strong study. But like anything
else in science, you need to replicate. But it is evidence we
cannot ignore because it actually does address many of the
criticisms that have been done by prior studies.
Mr. Mica. Okay. Now, Dr. Throckmorton, you don't set
marijuana as a Schedule I narcotic, but you do participate in
the process which you described, and I guess you recommend to
DEA and DOJ.
And you are not prepared to make any other recommendation
but to keep it in Schedule I?
Dr. Throckmorton. So in 2001 and, again, in 2006----
Mr. Mica. Right. 2001, 2006, you did the last studies.
But right now the question around the country is: This is
classified as a Schedule I drug. We had DEA in. We didn't have
DOJ. We had a U.S. attorney. But the DEA was adamantly opposed
to taking it, I think, out of a Schedule I classification.
What is your position? Has it changed from the 200---you
said 2001 they studied it, 2006 they studied it. Where are we
now?
Dr. Throckmorton. So if I could say, there are two reasons
why the FDA conducts an 8-factor analysis, why we look at the
scheduling of a product. And I think it might worthwhile just
making sure that we understand both of those because they both
relate to, potentially, marijuana.
The first is if we have a drug submitted to us for
approval. So a new drug and--for an indication comes to us,
including a drug that comes from marijuana. We would be
required to conduct an analysis.
Mr. Mica. And you also testified that you are looking at
several of--I don't know if--I am not a scientist--at
derivatives or--one was Epidiolex----
Dr. Throckmorton. ``Epidiolex.''
Mr. Mica. ``Epidiolex.''
-- that you are looking at that and, again, several others
I think you indicated. And that is the first time I have heard
testimony about, again, the direction you are taking on medical
marijuana.
But, again, as--and that is part of your responsibility. I
mean, I don't know how soon it is going to be before we see
``FDA approved'' stamp on--well, maybe you can talk about that.
But the process, too, of the Schedule I is part of what has
been at issue here. We have DEA. We have the Department of
Justice. We have--just in the District of Columbia we have 26
Federal law enforcement agencies enforcing Federal law. And it
is still an illegal narcotic in the highest classification.
Are you about to change that?
Dr. Throckmorton. I wouldn't be able to comment about
potential changing of our recommendation. First, my
recommendation would go through layers above me.
Mr. Mica. How would we get--can we get the----
Dr. Throckmorton. That was what I wanted to--that was why I
wanted to talk a little about the two pathways. So----
Mr. Mica. Well, one is--I mean, you do have some studies
that you are conducting about the medical benefits of some
derivatives and you are on the path.
But the--again, the major question is the Schedule I
classification. And you are not prepared to say there is going
to be any change?
Dr. Throckmorton. What I am prepared to say is that, under
two possible scenarios, we would have to conduct another 8-
factor analysis on marijuana or its constituents.
And either of those scenarios----
Mr. Mica. Do you plan to do a factor analysis? The last one
was done in 2006. Right?
Dr. Throckmorton. The last one requested for us by the DEA.
So there are--the--there are--the two ways are, one, a drug
company submits a drug for application to us and we conduct an
8-factor----
Mr. Mica. That is not what we are talking about.
Dr. Throckmorton. And the second one--I understand that is
the center of your interest--is the one where the DEA requests
that we conduct an additional 8-factor analysis. They have
done--2001, 2006, did those at those points. Recommended that
it remain in Schedule I.
It is public knowledge that the DEA has received additional
citizens petitions asking them to look again at the medical
evidence surrounding the safety and effectiveness----
Mr. Mica. But that would bounce back to you.
Dr. Throckmorton. And that has been sent to us, and we are
in the process of conducting that 8-factor analysis. We have
not yet come to a conclusion there.
Mr. Mica. So you are conducting an 8-factor analysis, an
update?
Dr. Throckmorton. Yes.
Mr. Mica. When do you expect that would be done?
Dr. Throckmorton. I wouldn't be able to comment, partly
because it is a recommendation first. So we make a
recommendation to Health and Human Services after we consult
with the National Institute on Drug Abuse. And then that
recommendation goes to the DEA. Things out of my control.
Mr. Mica. Are you able to tell us, Dr. Volkow, your
recommendation at this point?
Dr. Volkow. Well, I have to see----
Mr. Mica. I am moving forward.
Dr. Volkow. I have to see exactly what the data is and then
definitely will act swiftly with that information.
Mr. Mica. So you're going to rely on the first data that's
produced by the 8-factor analysis and then you would respond to
that? That's the order?
Dr. Volkow. Correct.
Mr. Mica. Okay. Dr. Hart, did you want to respond to
anything?
Mr. Hart. Yeah. It seems to me that we need to clarify some
of the--there's been some misinformation stated.
There was a comment made about the average age of people
who smoke marijuana now--begin smoking marijuana is, like, 10.
That's just not true. It's about 17 or 18.
And, also, as we think--move forward and think about the
increasing amount of marijuana potency, it certainly has
increased. But the question becomes: What does that mean?
When you think about potency and you think about people
smoking marijuana, one of the advantages of smoking a drug
compared to some other route of administration is that, when
you smoke a drug, you can quickly detect the potency or the
strength of the psychoactive effects. So that means you will
decrease the amount you intake.
It's like drinking a stiff drink versus drinking a beer.
You don't drink the two the same way. So this issue of potency
has been overstated.
Second point. When we think about gateway drug, as has been
talked about here, it is true that the majority of the people
who go on to use heroin and cocaine may have used marijuana
first.
That's true. That's a fact. But it is also a fact that the
majority of the people who smoke marijuana don't go on to
cocaine or heroin.
And if we are calling marijuana a gateway drug, we have to
think about this fact: The last three occupants of the White
House all smoked marijuana.
If we use this logic about gateway, we could very well say
that marijuana is a gateway drug to the White House. It just
doesn't make sense.
Finally----
Mr. Mica. Okay.
Mr. Hart. Finally, when we think about I.Q.--the study that
has shown the decrease in I.Q. Points, it's important to note
that the group that has shown the decrease in I.Q. Points--
there were 20 people in that group.
And when you look at the I.Q. Range that they have
decreased to, they remained within the normal range. They are
normal. And so it's important for people to understand what the
science actually says.
Mr. Mica. Thank you. And we'll yield now to Mr. Connally.
Mr. Connolly. Thank you.
And I do want to remind Dr. Hart that one of those three
Presidents never inhaled.
Mr. Mica. That's what he said.
Mr. Connolly. Dr. Throckmorton, I think the chairman and I
were both struck by your testimony because, if we understood
your testimony, you were acknowledging that, in fact, there
were positive medicinal benefits in terms of medicinal
treatment with a derivative of marijuana for epileptic
seizures. Was that correct?
Dr. Throckmorton. No. What I was saying was that there are
people who are very enthusiastic about the potential for
cannabidiol and THC and some of its derivatives to treat a
number of important medical conditions. My job, given that
potential, is to make sure that that development happens as
quickly as possible.
Mr. Connolly. Okay. But your testimony does not dismiss
that possibility?
Dr. Throckmorton. Absolutely not. I look forward to seeing
the full data.
Mr. Connolly. Okay. And I don't want to put words in your
mouth because both the chairman and I thought we heard you
acknowledge that at least there is some preliminary data beyond
the placebo effect with respect to the treatment for epileptic
seizures.
Dr. Throckmorton. I really wouldn't be able to comment. I'm
sorry.
Mr. Connolly. You think the science is too early?
Dr. Throckmorton. It's important science to get right and--
--
Mr. Connolly. But, conversely, neither are you testifying
that it is, in fact, only a placebo effect?
Dr. Throckmorton. We have approved drugs from plants. And
this plant has several compounds in it that people have
identified as very promising.
Our job is to take those developments----
Mr. Connolly. I think that is really important because my
colleague, Dr. Fleming, seemed to suggest it could only have a
placebo effect and, in fact, the science doesn't tell us that
necessarily.
The science may very well lead us to the fact that there is
an empirical, efficacious, medical effect that can benefit
people like my constituent, Jennifer Collins, who suffers 300
seizures a day. It would come as news to her family that the
effect is only a placebo effect.
Mr. Fleming. Would the gentleman yield?
Mr. Connolly. And let me just say that family had to move
their daughter to another State. She's separated from her
friends at school. She's separated from her family for medical
reasons, not to get a high, not for recreational use, but
because her body is tormented 300 times a day with epileptic
seizures.
And we owe it to her and the other families in this country
that may suffer from similar medical conditions. So put aside
the politics, put aside the bias scientifically that has
prevented us from genuinely researching this topic to see
whether, in fact, there can be an efficacious effect.
Mr. Fleming. Would the gentleman yield?
Mr. Connolly. I would briefly yield to my colleague.
Mr. Fleming. Yeah. I never suggested that there was a
placebo effect at all. All I said was that we have no proven
benefit to seizures or otherwise and that to simply go out and
mass-produce this, allow the population as a whole to use it,
when, in fact, it is in research and we are trying to find
answers on this makes no sense at all.
Mr. Connolly. Reclaiming my time. And I thank my colleague.
And, by the way, I'd be delighted to have my colleague meet
my constituent so that he could hear their story directly.
Mr. Fleming. I would be happy to as well. But it's still an
anecdotal----
Mr. Connolly. Okay. But I would also just point out my
friend has just created a straw man. No one has talked about
mass production and letting everyone use it anyway they want.
That's not the topic of this hearing nor----
Mr. Fleming. That is medicinal marijuana, sir.
Mr. Connolly. Well, actually, talk to the 22 States that--
--
Mr. Fleming. There are more marijuana----
Mr. Connolly. Excuse me. This is my time.
But I would just suggest to my colleague you can talk to
the 22 States who have decided otherwise. And if Louisiana
doesn't want to do it, that's its choice.
But there are 22 States and the District of Columbia that
have decided otherwise because they feel they have been held
back at the Federal level.
Now, Dr. Volkow----
Dr. Volkow. Yes.
Mr. Connolly. --your testimony seems to completely
disregard lots of other data. You referred to marijuana, as Dr.
Hart said, as a gateway drug.
Is there any evidence that marijuana is uniquely so, any
more or less than other controlled substances?
Dr. Volkow. I think that in my testimony I explicitly
stated that we have no evidence that marijuana, as a gateway
drug, is different from alcohol and tobacco and that tobacco,
in fact----
Mr. Connolly. But isn't it even misleading to call it a
gateway drug?
I mean, if you've got an addictive personality, you started
with something. It might be prescription drugs. It might be
alcohol. It might be tobacco.
I mean, there's no evidence that marijuana stands out among
those other substances if you've got an addictive personality
and you're going to go on to an addiction, is there?
Dr. Volkow. No. Absolutely. And if you have an addictive
personality, it may just be what's more available as a young
person that will just start to take it first.
Mr. Connolly. I guess I'm suggesting to you, however, given
the data--for example, you only cited the addiction rate for
marijuana. You didn't mention in contrast to what.
So 9 percent of the people who start out with marijuana
become addicted. But you didn't mention that 33 percent of
people who start out with tobacco become addicted and, as Dr.
Hart pointed out, 15 percent with alcohol.
What is it if you started out with cocaine? What's the
addiction rate of that?
Dr. Volkow. Cocaine is probably, like, 20, 25 percent.
Mr. Connolly. Okay. So in all of these case so far, they
are much higher than marijuana.
Dr. Volkow. Cocaine, methamphetamine, heroin are much
higher than marijuana. But you need to--when you are making
these comparisons, you have to compare with an illegal and
legal because the social changes make the perception different
and make it much more available.
Mr. Connolly. I understand.
But for you to only cite the addiction rate with marijuana
seems to me to be cherry-picking statistics for a purpose.
Dr. Volkow. I only have 5 minutes, and I apologize for not
saying it, because I always present all of the data. But I had
5 minutes.
Mr. Connolly. All right. Dr. Hart had the same 5 minutes
and managed to somehow put it in context.
Let me ask you about NIDA. Right now NIDA has a monopoly on
the production of marijuana to be used for FDA-approved
research for medical purposes, and that's been the case since
1974. Is that correct?
Dr. Volkow. That is my understanding.
Mr. Connolly. That's your understanding.
Dr. Volkow. Yes.
Mr. Connolly. Your title is director?
Dr. Volkow. Yes. That's my understanding. It's a use of
words.
Mr. Connolly. All right. Is there any other Schedule I drug
used for research purposes that's available only for--only from
one government source like yours?
Dr. Volkow. You were correct. And I don't think there is.
Mr. Connolly. So, again, unique to marijuana, you have
exclusive control for research purposes, unlike any other
substance?
Dr. Volkow. Correct. In the United States, yes.
Mr. Connolly. What's the rationale for that? Is there any
rationale for that?
Dr. Volkow. I guess that one of the rationales--the reasons
why this is described to be the case is that you want to be
able to have control over the material that you are providing
for research.
Mr. Connolly. Why wouldn't that be true about cocaine?
Dr. Volkow. Cocaine has different mechanisms for--I mean,
it is a drug that is regulated differently vis--vis where we
get it for researchers. The production of marijuana is based on
plants.
Mr. Connolly. Well, all right. DEA has licensed privately
funded manufacturers, privately funded manufacturers, to
produce methamphetamines, LSD, MDMA, heroin, cocaine and a host
of other controlled substances for research purposes. Is that
not correct?
Dr. Volkow. They are for research purposes. Yes. And most
of those go to--for clinical studies, laboratory animals.
Mr. Connolly. Right now HHS guidelines prohibit the use of
NIDA-produced marijuana for use in research designed to develop
marijuana into an FDA-approved prescription medicine. Is that
correct?
Dr. Volkow. Not to my understanding. To--my understanding
is we can--we are--we provide the marijuana for clinical
research that has been approved by the committee of the DEA,
the FDA, and by----
Mr. Connolly. There's no restriction that says but you
can't use it for research that's aimed at producing an FDA-
approved prescription medicine. Is that correct?
Dr. Volkow. Well, there the wording--I don't want to be
imprecise because, when you say the FDA-approved medications,
since it is a Schedule I, I don't want to say something that is
incorrect.
We can fund research that can provide the evidence that
then can be brought into the FDA to bring up an argument about
why this should be considered as a medical application. That's
what we do. And there's no--and we will----
Mr. Connolly. Dr. Throckmorton----
I'm sorry, but I have a limited time. I appreciate your
answer.
Dr. Throckmorton, is that correct?
Dr. Throckmorton. Could you just ask briefly again. I'm
sorry.
Mr. Connolly. Yes.
The HHS guidelines prohibit the use of NIDA-produced
marijuana--and it has a monopoly on it--for use in research
that could be designed--or is designed to develop marijuana
into an FDA-approved prescription medicine.
Dr. Throckmorton. No. I don't believe that's true. I
believe, in fact, we do see applications that make use of the
NIDA marijuana.
Mr. Connolly. I would ask you both to get back to the
committee for the record.
Dr. Throckmorton. Absolutely.
Mr. Connolly. Because that would be at variance with our
understanding, but that's good to know.
Human studies on Schedule I drugs have to be approved by
the FDA. Is that not correct?
Dr. Throckmorton. That's correct.
Mr. Connolly. But studies involving marijuana, additional
approval also has to be sought from NIDA and HHS. Is that not
correct?
Dr. Volkow. Scientifically, they have to be approved by a
committee on NIDA.
Mr. Connolly. Is that true about heroin, cocaine and
methamphetamines? Do they have to go through that triple-tier
approval process for research as well----
Dr. Volkow. No. The----
Mr. Connolly. --on human studies?
Dr. Volkow. The approval for those human studies--most of
it comes from review committees at the NIH. And if the DEA
approves of giving them the drug, then it's a--it's a different
procedure.
Mr. Connolly. But don't we--yes. It's a different process
and it's less cumbersome.
What is it about marijuana?
You know, I asked the deputy director of the DEA at one of
our previous hearings, ``Name a single death in America due to
an overdose from marijuana.'' He couldn't do it. Prescription
drugs, legal, every 19 minutes. We could--we could cite other
substances as well.
Now, that's not to say, therefore, we shouldn't be
concerned about marijuana, but it does raise the question of
whether our behavior has been appropriate with respect to
marijuana.
The restrictions on research, the extraordinary
incarceration--prosecution and incarceration rates, look at
what we've unleashed. We've created a subclass of criminal
behavior in America that seems out of proportion to the fact
that, as Dr. Hart says, 80 percent are for small, you know,
possession.
Now, ideally, they wouldn't have it at all. But we have
really skewed the system and we've created all kinds of special
barriers with respect to marijuana as if it were the uber alles
of all drug abuse when, in fact, it is not.
And we've impeded the abilityto have legitimate research
that could benefit human health, and it just doesn't--it's very
hard for me to frankly understand why we continue to insist
it's a class 1 substance.
I yield back, Mr. Chairman.
Mr. Mica. Thank you.
And, Mr. Turner, gentleman from Ohio.
Mr. Turner. Thank you, Mr. Chairman.
I appreciate the passion that Mr. Connally has, but I'm
going to return the hearing back to members asking questions
and the panel testifying.
Thank you for having this hearing.
Mr. Connolly. I hope that's what we have all the time.
Mr. Turner. It should be our goal.
So public health encompasses a wide range of
considerations. And I'm certainly pleased that we have the
National Institute on Drug Abuse and the Food and Drug
Administration representatives today.
As it stands, what role does the FDA play in providing
consumer protections for individuals who use recreational drugs
in the United States?
Dr. Throckmorton, for example, does the FDA mandate that
the products sold in Colorado or Washington State bear warning
labels? What about statements as to the potency or strength of
the product? Is there information provided to the user at all?
What information does the FDA currently have relating to
the strength of various marijuana strains? And how is that
information provided to consumers? And should State governments
have it? And how does the FDA work with States to make certain
that they have that information?
Dr. Throckmorton?
Dr. Throckmorton. I hope I got all four of those down. I'll
try to respond to them----
Mr. Turner. It's very simple.
What do you know? And how does it get to a user?
Dr. Throckmorton. So as far our role in terms of the
State's activities going on in Colorado, they are very limited.
We do communicate with the Public Health Department there
because they are doing important work to understand the impact
of marijuana, the impact of the State laws there and things and
the access of marijuana in Colorado.
With regards to labeling, we have--we have no role in terms
of labeling of the products that are approved under State law
in Colorado, including things like strength, purity, any
assurances like that. I think that's an important feature of
approved drug development that differs from some of the things
that are going on in Colorado.
And then, finally, you asked about our interactions with
Colorado. As I said, we work with the Public Health Department
there because it's important for us to understand where
marijuana is going, the kinds of experiences they're having----
Mr. Turner. Dr. Throckmorton, I just want to go back to
that.
You just said nothing to do with labeling. Interestingly
enough, food can be harmless or not harmless, and you're very
active in its labeling.
But here this clearly is a drug and you're not active at
all in any of the information sharing or with respect to the
issues of labeling.
Dr. Throckmorton. No. To be clear, the products in Colorado
are not approved drugs. They've not come before the Agency. We
haven't reviewed them for safety effects or security----
Mr. Turner. And so there's a process that's been skipped so
that there's no interaction----
Dr. Throckmorton. Those are the things that my Agency
oversees. Those are the things we're trying to encourage to the
fullest extent possible.
Mr. Turner. But if I went to go buy a bottle of ketchup--I
mean, that labeling is an issue that's been under the FDA, but,
yet, we have this as a product and it has not.
Dr. Volkow, in the absence of warning labels or a statement
of some kind as to the potency or strength of the marijuana an
individual is using, it seems that some very basic consumer
protections are absent here.
For example, marijuana can be directly linked to impaired
driving. Even Dr. Hart would indicate from his own research
that it would have that.
But, again, back to no labeling, no warning, with regard to
this serious safety concern, are you aware of any existing
methodology that might enable a law enforcement officer with
probable cause to assess whether a driver is operating a
vehicle under the influence of marijuana? How do they determine
that?
Dr. Volkow. Well, it's much harder--with marijuana, it's
particularly difficult because you actually have--marijuana and
its constituents can be in your body for a long period of time,
up to 1 week or sometimes even 2 weeks, but that does not mean
that you are impaired.
So whereas with alcohol you can measure a certain level and
you know that that is associated with the impaired functioning,
with marijuana, it is much more complex.
So there's research going on to try to get biomarkers that
will allow us to know that someone has smoked marijuana, but
that someone is within the range that is dangerous.
Mr. Turner. And, obviously, with alcohol use, as we
understand, it would be the Breathalyzer that can be applied.
But law enforcement in this area is left without any real
specific tools that make it very difficult to apply what is the
law and what clearly, even in Dr. Hart's research, shows an
effect on the impairment of driving and operating a vehicle.
Mr. Chairman, I yield back.
Mr. Mica. Thank you.
Mr. Cohen.
Mr. Connolly. Mr. Cohen, would you yield?
Mr. Cohen. Yes.
Mr. Connolly. Just want to observe that last comment
sounded like a comment, not a question to the panel. Thank you.
Mr. Cohen. Mr. Turner, as a denizen of 400 Mass, would you
like to respond?
We share the same condo unit. Thank you.
Dr. Volkow, one thing I can't grasp real well is, when Dr.
Hart pointed out that the studies say 9 percent of people who
smoke marijuana get addicted and 15 percent of people who do
alcohol get addicted, you've talked about legal and illegal as
if, if it was--marijuana was legal, more people would smoke,
which is true.
How does that affect a ratio of 9 percent when it's not
about the people, it's about the drug and its interaction with
people?
Is there not a large enough class of people that made up
the 9 percent to be an accurate gauge of those that would
become addicted?
Are you suggesting that those who have not smoked because
it's illegal are more likely to get addicted and will run the
level from 9 percent up to 15 percent?
Dr. Volkow. Two factors. Actually, many people don't smoke
because--marijuana because it is illegal. So the moment that
it's legalized, they do adapt to social norms and that
modulates their behavior.
But, more importantly, I think that what determines the
extent to which a person gets exposed to a drug and becomes
addicted is not that you get exposed once, but the likelihood
that you will be exposed repeatedly.
So by having a drug that is legal, particularly in
adolescence, they are actually much more likely to get exposed
to it repeatedly, that is, that drug is elicit.
So the more that you get exposed to it, the greater the
likelihood that you could become addicted. And that's why, as I
say, if you are going to compare it, you have to compare it in
the similar----
Mr. Cohen. I understand what you're saying. I just simply--
I don't agree.
And I think Dr. Hart--Dr. Hart, how would you respond to
that?
Mr. Hart. I don't know how to respond.
I agree with your point in terms of we--as has been pointed
out accurately, marijuana is the most frequently smoked illicit
drug. We have about 18 million current users in the country.
I think those numbers are sufficient to determine what the
addictive potential will be. But, you know, it's an empirical
question. But I think that there is--it is sufficient.
Mr. Cohen. Thank you, Doctor.
You talked, Dr. Volkow, about--you said--and I guess there
are car accidents involved in marijuana. But you said
marijuana, car accidents, and particularly fatal accidents, and
that those are facts.
What are the facts? What are the facts you're relying upon?
Dr. Volkow. Well, this is data from the Department of
Transportation. And, in fact----
Mr. Cohen. And what's that data say?
Dr. Volkow. That data says that, unequivocally, the use of
marijuana is associated with doubling your risk for getting
into a car accident. And the data----
Mr. Cohen. Doubling your risk of getting in car accident as
distinguished from not smoking marijuana?
Dr. Volkow. From not being intoxicated when you are driving
the car.
Mr. Cohen. Right.
But how does it relate to alcohol?
Dr. Volkow. Alcohol is much greater risk.
Mr. Cohen. Right.
And let me submit--because these are kind of somewhat red
herrings.
Nobody in the world, I don't think--nobody I know in
Congress or anywhere I know in the world that's dealing with
this is suggesting that adolescents should be doing--smoking
marijuana or that anybody should be driving a car while under
the influence.
And the whole problem may be solved by Uber Cars. You just
pick up and you get more people. That may take care of the
problem. But nobody is suggesting that that should happen.
Dr. Throckmorton, I think you said that y'all are doing
some study on possibly looking at Schedule I and marijuana?
Dr. Throckmorton. There's--we've been requested to conduct
another 8-factor analysis, and that requires that we look at
eight sets of data that Congress laid out.
They said, ``Look at these factors and then make a
recommendation to the DEA about what the appropriate schedule
is.'' And so we are working through those factors.
Mr. Cohen. Right.
Is there no question, even without studying, to know that
cocaine is a more likely addictive substance than marijuana and
that heroin is, too?
Dr. Throckmorton. Scheduling isn't just about comparative
risk, though. The other aspect about scheduling and the reason
why cocaine has features that allow it to be at a different
schedule is that it has ascribed benefits.
So there are approved uses for cocaine as a topical
anesthetic and things like that. With those approved uses comes
accepted medical use in the United States.
And that's--that's the thing that's fundamentally missing
at present from the--you know, our current conclusions
regarding marijuana is that absence of accepted medical use.
Typically, the best way to demonstrate accepted medical use
has been through a drug approval. So with an approval comes
accepted medical use.
And that's why I started out saying that that's another
pathway to think about as far as rescheduling of marijuana,
looking at other avenues to encourage better science, fully
understand its benefits and risks and, as a part of that,
reconsider the scheduling.
Mr. Cohen. Thank you.
Mr. Chairman, I want to thank you once again for this
hearing. I think that both Dr. Volkow and Dr. Throckmorton have
done a splendid job.
I do think, to some extent, they have remained, which is
understandable because of their position in the government,
within the silos in which they are authorized. And so they've
talked about marijuana and health and marijuana and addiction
and marijuana and these areas.
But Dr. Hart has taken a holistic approach. He's not siloed
by his government job and his superiors. And it is a holistic
approach we need to take in this case.
And to judge it as against the merits of incarcerating
hundreds of thousands of people and putting millions of people
in a secondary class for the rest of their lives because of
what might have been an adolescent or young or mature choice or
mistake, however you want to look at it, should they be
punished? Is the punishment relative to the action merited?
And so I thank Dr. Hart for his holistic approach.
And I know y'all would probably take the same ones if you
didn't have the straightjacket of government jobs.
Thank you.
Mr. Mica. Thank you.
And now we'll turn to Dr. Fleming. You're recognized.
Mr. Fleming. Thank you, Mr. Chairman.
Dr. Hart, you're obviously a very strong advocate for the
decriminalization, even legalization, of marijuana. Would that
be correct?
Mr. Hart. I'm an advocate for justice and science.
Mr. Fleming. Well, that's--again, it's a ``yes'' or ``no.''
Are you an advocate for legalization of marijuana?
Mr. Hart. No. I'm not an advocate. I wrote a book----
Mr. Fleming. Are you an advocate for decriminalizing?
Mr. Hart. Wait. Wait. If you're going to ask me questions--
--
Mr. Fleming. It's a ``yes'' or ``no'' question, sir.
Mr. Hart. If you ask me a question, I'm going to answer it.
Mr. Fleming. It's a ``yes'' or ``no.''
Are you----
Mr. Hart. I am an advocate for decriminalization. Yes, I
am. And I wrote that in my book.
Mr. Fleming. But not legalization?
Mr. Hart. No.
Mr. Fleming. Okay. Now----
Mr. Hart. But I am not against legalization. I am for what
makes sense for the society as a whole.
Mr. Fleming. Okay. But, again, along the way, we have to
make a decision ``yes'' or ``no.''
So you're saying that you are in favor of decriminalization
and you're not against the legalization. Is that a correct
characterization?
Mr. Hart. That is correct.
Mr. Fleming. Okay. Now, you make a strong argument taking
the data, turning it on its side and doing a lot of things with
it.
But I would suggest to you a lot of it is inaccurate and
out of date. For instance, you say the beginning use age of
marijuana is 17. That may have been true 20 years ago when it
wasn't being legalized or medicinalized.
But what we're finding out today is, like alcohol and
tobacco, the average starting age is in the range of 9 to 12.
That is the average starting range.
In places where marijuana is widely available through
decriminalization and through legalization, medicinalization,
we are seeing that age close in on tobacco and alcohol.
In fact, just the other day, they reported 4-year-olds
ingesting marijuana through the goodies, the baked goods and so
forth and even fourth-graders dealing marijuana.
So, you see, what Dr. Volkow is suggesting is quite true.
And that is, as the threats go away, as it becomes legalized or
decriminalized and the stigma is removed, the usage rates go up
and so do the addiction rates.
So, again, that explains the 9 versus 15 percent. If you
put marijuana at the same status as alcohol and tobacco, you're
going to see similar, if not greater, rates.
But the thing that I think is unforgivable in your
statement----
Mr. Hart. Can I respond to that?
Mr. Fleming. No, sir.
The thing that I find unforgivable in your statement is
that you said that--let me see if I get this correct--marijuana
only remains in a person's system for a few hours.
Mr. Hart. No. No. No. You misunderstood.
I have to--you cannot--you cannot----
Mr. Fleming. No, sir.
Mr. Hart. You cannot----
Mr. Fleming. No, sir. I have the----
Mr. Hart. That's wrong. I did not say that. I did not say
that.
Mr. Fleming. All right. Specifically, how long does
marijuana stay in the system?
Mr. Hart. Marijuana can stay in your system for as long as
30 days, depending upon the level of the users.
Mr. Fleming. That is correct.
You suggested----
Mr. Hart. Of course it's correct. I do these studies.
Mr. Fleming. But you suggested otherwise. You suggested
otherwise.
And we also heard from testimony yesterday in the addiction
caucus that not only does it remain in the body, but it remains
active longer than alcohol.
So to suggest that marijuana is less active and for a
shorter period of time than alcohol is simply incorrect. Do you
concede that?
Mr. Hart. I don't know what you heard.
Mr. Fleming. All right. But I'm asking you specifically.
Which stays in the body longer? Alcohol or marijuana?
Mr. Hart. Marijuana, of course.
Mr. Fleming. Okay. Very good. We got that.
All right. Now, Dr. Volkow, you said something I thought
was very interesting and something I very agree with, and it's
the theme in my book in 2007.
You said that marijuana and other drugs, anything
addicting, has a priming effect in the brain. The human brain,
particularly the immature brain, is still open to all sorts of
stimuli that may occur, whether it's cannabinoid receptors,
dopamine receptors, norepinephrine, whatever the receptors are.
And so would you elaborate on this priming effect and the
fact that younger--the younger people are who use addicting
substances, the more likely they are to have problems down the
road.
And, again, that's in a context of decriminalization and
legalization. Because we all know that, if it's illegal, it's
less likely to be in the home, available to kids through their
parents, but if it's legal, it is more likely to be there.
So would you please comment on that.
Dr. Volkow. Yeah. What we know--and this is true--but
certainly for alcohol, nicotine and marijuana, is the earlier
initiation, the greater the likelihood of addiction.
And this is, in part, from the fact that these drugs
stimulate endogenous signaling systems that during those
developmental stages are specifically involved in creating the
architecture of the brain, and it changes very dramatically in
the transition from childhood into adulthood.
So cannabinoids specifically, for example, will determine
how a particular neuron will connect with another one. And so,
if you saturate and bombard with marijuana, what you're going
to be doing is having a state of hyperstimulation followed by
an inhibition.
So that, in turn, disrupts this very, very perfectly
orchestrated process, which is why--one of the reasons why
there is concern about cannabinoids.
Similarly with nicotine you also have this role. So it's
not something that's unique to marijuana, but it is clear both
nicotine and marijuana can be interfering with a normal process
of brain development.
Mr. Fleming. So not only do we have epidemiological data
that suggests that a forerunner to heroin and crack cocaine use
or methamphetamine is marijuana, but, also, if you look at
the--the pump-priming effect of drugs even as common as
nicotine, that we see that there's really a scientific pathway,
there's a brain pathway in development that certainly explains
that likelihood?
Dr. Volkow. Yeah. And it's exactly why we are particularly
focused on understanding what are the consequences of exposure
to the adolescent brain of these drugs in their individual
trajectories.
And I completely agree. Nobody's here saying we are
expecting--we're approving the use of these drugs in
adolescents.
Unfortunately, when we make decisions that are targeted to
adults, we are changing also the attitudes of the adolescents
and we are influencing.
So we need to be cognizant of that, and we need to actually
obtain the information that can lead us to prevention efforts,
whatever finally the regulations or policy are.
Mr. Fleming. Right.
And, Dr. Throckmorton, you talk about the fact we actually
are working on extracts and even fast-tracking extracts
particularly for seizure disorders.
And was there other uses as well?
Dr. Throckmorton. There's also fast-track designation
that's been given to another product called Sativex being
developed for cancer pain.
Mr. Fleming. For cancer pain.
So what we're really doing is what we typically do for
other drugs and, as we find some potential benefit, we begin to
try to focus and extract and purify a drug to do that.
So, again, that begs the question. My colleague before
suggested that, well--because I said, well, look, we have the--
we have the mass use now of medicinal marijuana. We have more
marijuana dispensaries in California and Denver than we do
Starbucks.
So aren't we putting the cart before the horse? Why are we
widely distributing this to millions of Americans as a
treatment when we haven't done the research and extracted and
purified and really gone to the very target treatment that
we're really trying to achieve?
What is your response to that?
Dr. Throckmorton. As I said in my opening statement, drug
development is the best way to assure safe, effective, high-
quality medicines are available for the U.S. public as quickly
as possible. I think that's got--I think that's everyone's goal
in this room.
Mr. Fleming. Would that be consistent with I, as a
physician treating patient with penicillin, giving them a
purified product by mouth or by injection rather than giving
them, say, moss or mold?
Dr. Throckmorton. I don't think I want to comment about the
other paths.
Mr. Fleming. Yes.
Dr. Throckmorton. My job at the FDA is to make sure that
the drug development pathway works and is being applied
efficiently.
Mr. Fleming. Right. I appreciate that. And I want you to
continue to do that. That's really the safe pathway to go down.
Also, something we really haven't talked about--and, Dr.
Volkow, I'll come back to you--is recent studies are rolling
out that are telling us very terrifying things about even
casual use of marijuana.
For instance, you alluded to structural changes of the
brain. We're seeing that, even in moderate users or even--
casual, I think, is the term they use--twice-a-day smokers,
huge changes in the structure of the brain, a tremendous spike
now in disease of the heart and the lungs in users.
Would you elaborate on some of this data.
Dr. Volkow. Well, in the data of brain imaging studies,
which actually is the one that I've personally been involved
with and I can look at it critically, I think that the--the
studies that show evidence of harm are studies that relate to
the regular use of marijuana, heavy use of marijuana.
There was a recent study on adolescents that were not very
frequent users, once a month or twice a month, and they
reported changes. But, in science, one needs to replicate.
So I see it's valuable. It's the first one to document that
perhaps not-so-frequent use could create harm. But I would be
caution--cautious until we get a replication study.
With respect to the other area that has generated a lot of
interest is schizophrenia because, if you give high enough
doses of THC, you are going to make someone psychotic. Most of
those episodes are short-lasting. But there is a group that
goes into chronic psychosis that then results as the diagnosis
of schizophrenia.
So there's been a lot of interest to determine can
marijuana produce schizophrenia. And what the data seems to
suggest is it triggers an episode. It may advance it in someone
that has the vulnerability. And that is associated also with a
higher content THC.
So while Dr. Hart says correctly a lot of people say you
can model it, the data actually seems to show otherwise. We're
seeing higher content of plasma, content of 9-THC, over all of
these years.
Mr. Fleming. The stronger the drug gets----
Dr. Volkow. The higher the plasma content----
Mr. Fleming. --the higher the----
Dr. Volkow. --the 9-THC, the higher the consequences.
Mr. Fleming. Yeah. There's no science to suggest that, just
because marijuana--the THC level is higher, that people are
using it less to compensate. That simply isn't the case.
Before I yield back, Mr. Chairman, I just wanted to say, in
terms of what Dr. Hart says, even if you take what Dr. Hart
says at face value, which I think a lot of what he said is
incorrect and the wrong direction, he still makes a very
compelling case to keep this as a Schedule I drug. It is a
dangerous drug.
And I yield back.
Mr. Mica. Thank the gentleman.
Let me yield for wrap-up Mr. Connolly.
Mr. Connolly. Yes. You know, I respect my colleague from
Louisiana. I don't think he makes any such case.
In fact, I think this whole hearing and the other hearings
we've had, certainly for this member of Congress, who started
out not wanting to touch marijuana, leave it where it is--I've
been forced to study this.
I've been forced to look at it. I've been forced to look at
the science of it when I didn't want to, really. I had plenty
of other things I was worried about.
And I am--I don't believe that we--that the testimony we've
heard today in any way reinforces how dangerous this drug is
and it needs to be a Substance I drug. Quite the opposite.
I think it raises profound questions about the policy of
the United States in the last 30 or 40 years with respect to
marijuana as a gross overreaction.
The fact that cocaine is Substance II and marijuana is
Substance I tells you a lot about how skewed the United States'
policy--Federal policy is with respect to this drug.
And I again suggest that's one of the reasons why 22, maybe
23, States are going in a different direction. And there's
danger to that because being out of sync with the Federal
Government creates some problems.
My friend is still here. And he's a doctor. And I know he
has a good heart and wants to hear patient stories.
I hope he will indulge me if I just share for the record
with him and with the panel the testimony of my constituent,
Beth Collins, about her daughter's experience in Colorado under
treatment with a derivative of marijuana, Jennifer.
Jennifer's medication administered as an oil under her
tongue is called THCA, an inactive form of THC. So it has no
psychoactive effect. However, it is scheduled the same as
heroin precisely because it's a Schedule I drug.
Marinol, a synthetic form of THC, is Schedule III. Marinol
is used to help control pain and nausea for cancer patients,
but it does not help with seizures.
We're currently seeing a significant decrease in Jennifer's
seizers. Her neurologist here in Colorado, who is very
supportive, feels that in the next few months she may be ready
to start weaning from the heavy pharmaceuticals that are
causing her physical, cognitive, and emotional damage, that is
to say, the non-marijuana-derivative pharmaceuticals.
I'm witnessing a great deal of success with other epilepsy
cases using various Cannabis extracts here in Colorado.
Of the approximately 200 pediatric patients using Cannabis
oil from the Realm of Caring--trademark--in Colorado, 78
percent show a reduction in seizures. 78 percent.
Of that 78 percent, 25 percent have had a greater than 90
percent reduction in seizures or are seizure-free. Most of
these patients have exhibited a significant increase in
cognition.
Now, here's where--the Federal regulation problem because
it's a Substance I abuse and because we so skew against
marijuana in our so-called research.
Rescheduling marijuana to a Schedule III drug would enable
Jennifer to leave the State of Colorado for visits home to her
friends and family back in Virginia. It would also allow
doctors to begin studies of the efficacy of marijuana in
pediatric epilepsy.
While Jennifer's neurologist here is supportive, he's
unable to provide us with the advice on dosing and compile his
findings and observations into usable research as this is
against Federal law.
I and other parents are nervous about making these
decisions with very little input from our children's doctors.
We'd really like the guidance of our physicians because this is
a serious medical concern with serious ramifications. Current
Federal law prohibits us from receiving such guidance.
Mr. Fleming. Would the gentleman yield?
Mr. Connolly. Of course.
Mr. Fleming. Because I'd like to agree, to an extent, to
what you say. You know, a little over a century ago medicine
moved to the direction of modern science.
You know, we want to research these things. And just as Dr.
Throckmorton has said, these things that hold promise should be
studied.
And in the case of this little girl, if we want to use
rigorous scientific evaluation, enter her into a study--I have
a grandson, by the way, who has cystic fibrosis.
And I would love for him to get some of the experimental
drugs, but he doesn't qualify at this point. So we hope that he
will qualify or a new drug will come out. But what I don't want
to do is to see us throw medication at children.
And so that's why I say, to me, it conflates the reality by
saying that we should have medicinal pharmacies all across the
Nation where millions of people get a drug that is really being
used for recreational use.
We really need to be honest with that. To conflate that
with a specific situation where a child may benefit from a
nonactive THC product, we all agree. I just, as a physician,
ask that we go through the rigor of research.
Mr. Connolly. But I--you know, I very much appreciate your
comment, and I agree with you. I don't have any agenda here.
I'm not one who is in favor, necessarily, of recreational use
or just legalizing it everywhere, not at all.
But I have been, as I said, because of these hearings,
actually forced to re-examine what I thought I knew about
marijuana.
And I agree with my friend that we should have rigorous
empirical studies to convince ourselves that it is--can be used
in limited circumstances or broad circumstances, whatever it
may be.
But I hope my colleague has heard through this hearing that
marijuana, though--if we--we both agree that rigorous
scientific research ought to occur here, it should occur in an
unbiased fashion.
Marijuana is not treated like any other substance. In fact,
cocaine is more liberally treated for research purposes than is
marijuana. And it is clear marijuana is not more dangerous.
Mr. Fleming. As a point of order, I think that crack
cocaine is still a Schedule I drug. Correct? There's a
medicinal form of cocaine that is classified differently. The
same would be true of Marinol, which is a Schedule III. It's
the same thing.
Mr. Connolly. My point wasn't that it's not a Class I. It
is that the research allowed on cocaine has a lower standard.
NIDA is the--marijuana is the only drug that NIDA has an
exclusive research control over. In the case of cocaine, it's
actually easier to do research. And if you and I both agree
that we want rigorous research, I think we have to re-examine
the control of NIDA.
Mr. Fleming. I agree with my colleague.
Mr. Connolly. Okay. That was the point I was making.
Mr. Fleming. I think we should allow as much research on
marijuana as we would cocaine.
Mr. Connolly. I thank my friend.
Dr. Volkow. And, if I may answer, because--just to clarify,
I mean, definitely--I mean, we do a lot of research as it
relates to cannabinoids.
And we speak about marijuana, but marijuana is a series of
chemicals, many cannabinoids. So what we are interested in is
extracting the active ingredients.
So, for example, for the cases of this very intractable
epilepsy in children, Dravet's, the compound--the cannabinoid
compound that appears to be responsible is cannabidiol.
Cannabidiol content of the marijuana you get out there is
decreasing and decreasing, and it's not rewarding, it doesn't
produce a high.
Mr. Connolly. Dr. Volkow, my chairman has been very
generous with me on this. So I'm going to just make one point.
Okay. But the mission of your agency is drug abuse.
Dr. Volkow. Correct.
Mr. Connolly. It's not medical research into the possible
efficacy of derivatives from otherwise dangerous or semi-
dangerous drugs.
And given the fact that you have a monopoly over the
control of marijuana for research purposes in the Federal
family, one could--a reasonable inference could be drawn that
you are less than motivated, as an agency, to assist us in that
rigorous medical research Dr. Fleming and I were just talking
about.
I'm not calling into question the legitimacy of your
mission. I am saying, however, that your mission is not the
same as that of those wishing to pursue medical research as to
the beneficial effects. Your own testimony never even mentioned
beneficial effects or even the potentiality of it.
Dr. Volkow. And you're absolutely right. We're the
Institute of Drug Abuse. And you're absolutely right. We have
the farm that has to provide with the marijuana for research
purposes, and that was something that was determined many years
ago. And I think that--I mean, you are bringing it up as an
issue, I think.
Mr. Connolly. I thank you.
And I thank my colleague, Dr. Fleming.
Thank you, Mr. Chairman.
Mr. Mica. Thank you, both.
Let me just conclude with a couple of things.
First of all, I take away from this--I've heard for the
first time that FDA is actually going to--is in the process of
conducting another 8-factor analysis.
Is that correct, Dr. Throckmorton?
Dr. Throckmorton. That's correct.
Mr. Mica. Okay. So we heard that they are--they did it in
2001. They said ``no.'' They did it in 2006. And that is a
scientific evaluation.
And then you consult with NIDA. And I'll give--and we heard
again the director say that they would look at your findings
and make a recommendation.
So as far as the Schedule I, that analysis is underway.
Correct, everyone?
Dr. Throckmorton. That's correct.
Mr. Mica. Okay. And you have enough funds and research
capability of conducting that in a thorough manner?
Dr. Throckmorton. Yes.
Mr. Mica. Okay. And the second thing is across the country
there's been a wave of votes and legislative actions to take us
into using marijuana or some of its derivatives--I'm not going
to be technically accurate here--for medical beneficial
purposes.
You don't study that, right, at NIDA?
Dr. Volkow. We study it as it pertains to two conditions,
can we use some of these derivatives for the treatment of drug
addiction and when we use them for the treatment of pain.
Mr. Mica. Okay. Okay. Well, then--okay. Then, you do some
review of its capability.
We also heard--I heard for the first time that FDA has
several drugs that contain either a derivative or some form of
marijuana for medical purposes and that's under consideration
for the FDA stamp of approval, for lack of a better term. Is
that correct?
Dr. Throckmorton. We talked about two drugs that are----
Mr. Mica. Yes. Two.
Dr. Throckmorton. Yes.
Mr. Mica. Okay. So there--and you have enough funds. You
have that research going on. You couldn't tell us when the 8-
factor analysis would be complete.
If we could--we could ask them a question and then if you
want to respond, if you have some estimate or guesstimate you
could provide for the record, a timeline.
And then--you don't. Well, we're going to ask you the
question anyway. And then I'll subpoena your butt back here.
Mr. Connolly. Yeah. Maybe you should.
Mr. Mica. But, seriously, what we're trying to find out--
because people say, ``Well, what's going on with the Schedule
I?'' And this has big implications.
I mean, we've had law enforcement people, we've had
prosecutorial folks, we have the head of the DEA, we've got
ONDCP, a whole bunch of people going in different directions on
this.
So, again, we'll hear at some time on both the rescheduling
and then we'll hear on the efficacy or the acceptance of using
some of these substances that contain marijuana for medical
purposes.
So that's where we are in that regard. I think that's been
helpful for me. And, again, I have not heard some of this
before.
Both of you have enough resources? Because then people say,
``Well, they're not able to study. They're not able to
conduct.''
Is there a shortage in anything you're doing, Dr.
Throckmorton?
Dr. Throckmorton. Both of these are important parts of our
mission.
Mr. Mica. Are you okay, Dr. Volkow? You can always use more
money?
Dr. Volkow. I'm smiling. I'm just smiling. I mean, the
amount of resources allows us to expedite----
Mr. Mica. Do you need more resources? Tell us.
Dr. Volkow. Faster. You can always do things much faster if
you have more resources.
Mr. Mica. Okay. Well, I think that's something I'd ask the
staff to look at. Because, again, you want good review, good
studies, and people have to have the adequate resources to
conduct that responsibly.
Mr. Connolly. Mr. Chairman, I mean, you've got a Republican
chairman asking if you have enough money in your budgets. Run
all the way to the bank with that question.
Mr. Mica. Well, again, I feel a little bit like Solomon.
I'm trying to get the answers. Many questions have been raised.
And we have an important oversight responsibility. Societal
impressions about this are changing, and attitudes are
changing.
Now, one of the things that--and I thought--Dr. Fleming
brought up something we didn't talk about. But FDA has a
responsibility over consumer safety.
And we now have products on the market, some being
dispensed with alleged medical benefits, not controlled by you.
Right?
Dr. Throckmorton. Depending on what they're claiming, they
could fall under our jurisdiction.
Mr. Mica. I find very little today that you can eat or
consume or buy off the shelf for medical remedies that has no
labeling, no disclosure. So I think that we've got to look at
that particular aspect, too, and see where we're headed there.
You do have a couple of drugs, as you said, that you're looking
at specifically. But the lack of consumer information.
The other thing, too, is going down this path of
legalization, kids are very impressionable. Everybody, Dr.
Hart, Dr. Throckmorton, Dr. Volkow, all of our panelists,
everyone starts out we don't want this in the hands of
adolescents. But the statistical data that we have is you're
seeing more and more use of this narcotic by young people. Lack
of information, but again more promotion as far as its
acceptability. And then it's hitting our most vulnerable, young
people.
And there are consequences. We'll get into some of them.
We're going to look at differences in law and enforcement. We
don't have tests that can tell us how stoned people are or how
incapacitated they are that are uniform or acceptable, and then
we have the residual aspect that Dr. Hart, Dr. Fleming got
into.
The other thing, too, is now this is being touted. I talked
about driving, shaving, and then watching TV today, I see the
ad with a candidate in Maryland who is going to balance the
budget, pay for education, just by taxing marijuana. So there
are a whole host of implications of what is happening. If you
try to get a job and you use marijuana or you have it in your
system, or join the military, there is a whole other set of
subpenalties that we currently have. So, again, we raise
questions.
And now, Mr. Connolly, we have the return of one of our
subcommittee members who has not had an opportunity to
participate. The gentleman from Georgia, Mr. Woodall, has asked
for time, so I'll yield to him. Thought I was going to close,
but that didn't work out.
Mr. Woodall. I appreciate the chair's indulgence. I
appreciate the ranking member as well.
I had to rush back, Mr. Chairman, because had things been
going wrong and we dragged the FDA in here today, we'd be the
first one to talk about all the delays, all the paperwork, all
the folks who could have been helped if only FDA had been done
things differently. But I come from the great State of Georgia,
and when you talk to the regulators down in Georgia, when you
talk to folks trying to make a difference in people's lives in
Georgia, in fact, I talked to them before this hearing and they
said, I don't know who you're going to have testify, but have
you have Dr. Throckmorton testify I want you to know he's been
the most helpful Federal Government person that we have worked
with in our tenure. And he is all about making a difference,
wants to do it safely, wants to do it wisely, but if it's worth
doing, wants to do it rapidly.
And it means a lot with all the frustration and mistrust
that oftentimes government rightly deserves, when we have an
opportunity to brag on folks who are doing everything they can
to restore that trust, everything they can to fulfill the
mission of their agency, I want to be a part of saying thank
you for that. Generally, when we find those folks, they get
promoted out of that job on to do something where they are not
nearly as effective as they used to be. So I don't wish those
promotions upon you, Dr. Throckmorton. I want to tell you that
candidly.
And with that, Mr. Chairman, I'm grateful for your
indulgence, and I encourage you all to watch the partnership
that we have, GW Pharmaceutical, Regents University, Georgia,
New York. It's going to be something worth paying attention to.
Mr. Mica. I'm sort of in shock. I don't think we have ever
had--well, first of all, Mr. Woodall, the gentleman from
Georgia, is a tiger on anyone from the Federal bureaucracy, so
that holds me in awe with his statement of you. Then, I've been
on the committee longer than anyone in Congress, and I don't
think I've ever heard such a compliment before this committee
of someone who works in an agency or a bureaucrat, no offense.
So it's a rare occasion. I may need medical treatment.
Mr. Connolly. So two record-shattering events have
occurred, Mr. Throckmorton, here. One is a Republican chairman
has said, do you have enough money, do you need more? And
secondly, a Georgian Republican is praising a Federal official.
I'm telling you, run to the bank.
Mr. Mica. Well, again, we end on sort of a light and
positive note, which is good. But, again, this series of
hearings is to review some important questions. Our
subcommittee in particular has jurisdiction over State-Federal
relations and conflicts and laws. And I think, again, we'll be
having another hearing in July.
And I thank each of our witnesses. I thank the members
who've participated. There being no further business before the
Government Operations Subcommittee, this hearing is adjourned.
[Whereupon, at 11:23 a.m., the subcommittee was adjourned.]
APPENDIX
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Material Submitted for the Hearing Record
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