<DOC>
[108th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:96746.wais]
MARIJUANA AND MEDICINE: THE NEED FOR A SCIENCE-BASED APPROACH
=======================================================================
HEARING
before the
SUBCOMMITTEE ON CRIMINAL JUSTICE,
DRUG POLICY AND HUMAN RESOURCES
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
APRIL 1, 2004
__________
Serial No. 108-226
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
96-746 WASHINGTON : 2004
____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512ÿ091800
Fax: (202) 512ÿ092250 Mail: Stop SSOP, Washington, DC 20402ÿ090001
COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania WM. LACY CLAY, Missouri
CHRIS CANNON, Utah DIANE E. WATSON, California
ADAM H. PUTNAM, Florida STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia CHRIS VAN HOLLEN, Maryland
JOHN J. DUNCAN, Jr., Tennessee LINDA T. SANCHEZ, California
NATHAN DEAL, Georgia C.A. ``DUTCH'' RUPPERSBERGER,
CANDICE S. MILLER, Michigan Maryland
TIM MURPHY, Pennsylvania ELEANOR HOLMES NORTON, District of
MICHAEL R. TURNER, Ohio Columbia
JOHN R. CARTER, Texas JIM COOPER, Tennessee
MARSHA BLACKBURN, Tennessee ------ ------
PATRICK J. TIBERI, Ohio ------
KATHERINE HARRIS, Florida BERNARD SANDERS, Vermont
(Independent)
Melissa Wojciak, Staff Director
David Marin, Deputy Staff Director/Communications Director
Rob Borden, Parliamentarian
Teresa Austin, Chief Clerk
Phil Barnett, Minority Chief of Staff/Chief Counsel
Subcommittee on Criminal Justice, Drug Policy and Human Resources
MARK E. SOUDER, Indiana, Chairman
NATHAN DEAL, Georgia ELIJAH E. CUMMINGS, Maryland
JOHN M. McHUGH, New York DANNY K. DAVIS, Illinois
JOHN L. MICA, Florida WM. LACY CLAY, Missouri
DOUG OSE, California LINDA T. SANCHEZ, California
JO ANN DAVIS, Virginia C.A. ``DUTCH'' RUPPERSBERGER,
JOHN R. CARTER, Texas Maryland
MARSHA BLACKBURN, Tennessee ELEANOR HOLMES NORTON, District of
PATRICK J. TIBERI, Ohio Columbia
------ ------
Ex Officio
TOM DAVIS, Virginia HENRY A. WAXMAN, California
J. Marc Wheat, Staff Director
Nicolas Coleman, Professional Staff Member and Counsel
Nicole Garrett, Clerk
Tony Haywood, Minority Counsel
C O N T E N T S
----------
Page
Hearing held on April 1, 2004.................................... 1
Statement of:
Scott, James D., M.D., member and past chair, Oregon Board of
Medical Examiners; Joan Jerzak, chief of enforcement,
Medical Board of California; Claudia Jensen, M.D., Ventura,
CA; Rob Kampia, executive director, Marijuana Policy
Project; and Robert L. DuPont, M.D., president, Institute
for Behavior and Health.................................... 54
Volkow, Nora D., M.D., Director, National Institute on Drug
Abuse, National Institutes of Health, U.S. Department of
Health and Human Services; Robert J. Meyer, M.D., Director,
Office of Drug Evaluation II, Center for Drug Evaluation
and Research, Food and Drug Administration, U.S. Department
of Health and Human Services; and Patricia Good, Chief,
Liaison and Policy Section, Office of Diversion Control,
Drug Enforcement Administration............................ 13
Letters, statements, etc., submitted for the record by:
DuPont, Robert L., M.D., president, Institute for Behavior
and Health, prepared statement of.......................... 92
Good, Patricia, Chief, Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement Administration,
prepared statement of...................................... 44
Jensen, Claudia, M.D., Ventura, CA, prepared statement of.... 63
Kampia, Rob, executive director, Marijuana Policy Project,
prepared statement of...................................... 76
Meyer, Robert J., M.D., Director, Office of Drug Evaluation
II, Center for Drug Evaluation and Research, Food and Drug
Administration, U.S. Department of Health and Human
Services, prepared statement of............................ 26
Scott, James D., M.D., member and past chair, Oregon Board of
Medical Examiners, prepared statement of................... 56
Souder, Hon. Mark E., a Representative in Congress from the
State of Indiana, prepared statement of.................... 5
Volkow, Nora D., M.D., Director, National Institute on Drug
Abuse, National Institutes of Health, U.S. Department of
Health and Human Services, prepared statement of........... 15
MARIJUANA AND MEDICINE: THE NEED FOR A SCIENCE-BASED APPROACH
----------
THURSDAY, APRIL 1, 2004
House of Representatives,
Subcommittee on Criminal Justice, Drug Policy and
Human Resources,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 2:30 p.m., in
room 2154, Rayburn Office Building, Hon. Mark Souder (chairman
of the subcommittee) presiding.
Present: Representatives Souder, Cummings, Carter, Sanchez,
and Norton.
Staff present: J. Marc Wheat, staff director and chief
counsel; Nicholas Coleman, professional staff member and
counsel; Roland Foster, professional staff member; Nicole
Garrett, clerk; Tony Haywood, minority counsel; Cecelia Morton,
minority office manager; and Ricky Choi, minority intern.
Mr. Souder. The subcommittee will now come to order.
Good afternoon, and thank you all for coming. This hearing
will address the highly controversial topic, the use of
marijuana for so-called medical purposes.
In recent years, a large and well-funded pro-drug movement
has succeeded in convincing many Americans that marijuana is a
true medicine to be used in treating a wide variety of
illnesses. Unable to change the Federal laws, however, these
pro-drug activists turned to the State referendum process and
succeeded in passing a number of medical marijuana initiatives.
This has set up a direct conflict between Federal and State
law, and put into sharp focus the competing scientific claims
about the value of marijuana and its components as medicine.
Marijuana was once used as a folk remedy in many primitive
cultures. And even in the 19th century, it was frequently used
by some American doctors, much as alcohol, cocaine and heroin
were once also used by doctors. By the 20th century, however,
its use by legitimate medical practitioners had dwindled, while
its illegitimate use as a recreational use had risen.
The drug was finally banned as a medicine in the 1930's.
Beginning in the 1970's, however, individuals began reporting
anecdotal evidence that marijuana might have medically
beneficial uses, most notably in suppressing the nausea
associated with cancer chemotherapy. Today, the evidence is
still essentially anecdotal, but many people take it as a fact
that marijuana is a proven medicine. One of the main purposes
of this hearing is to examine that claim.
At present, the evidence in favor of marijuana's utility as
a medicine remains anecdotal and unproven. An Institute of
Medicine study published in 1999 reviewed the available
evidence and concluded that at best, marijuana might be used as
a last resort for those suffering from extreme conditions. This
report is repeatedly cited by the pro-marijuana movement as
proof that marijuana is safe for medical use. In fact, the
report stressed that smoking marijuana is not a safe medical
delivery device and exposes patients to a significant number of
harmful substances.
In contrast to its supposed medical benefits, the negative
health effects of marijuana are well known and have been proven
in scientific studies. Among other things, the drug is
addictive, impairs brain function and when smoked greatly,
increases the risk of lung cancer. The respiratory problems
associated with smoking any substance makes the use of
marijuana cigarettes as medicine highly problematic. Indeed, no
modern medicine is smoked.
It is quite possible, however, that some components of
marijuana may have legitimate medical uses. Indeed, the
Institute of Medicine report so often erroneously cited as
support for smoked marijuana actually stated that, ``If there
is any future for marijuana as a medicine, it lies in its
isolated components, the cannabinoids, and their synthetic
derivatives.'' Interestingly, the Federal Government has
already approved a marijuana derivative called Marinol, but
rarely do the pro-marijuana advocates mention this. The Federal
Government has also approved further studies of the potential
use of marijuana or marijuana derivatives as medicine.
However, in the United Kingdom a pharmaceutical company has
applied for a license to market an inhalant form of marijuana
called Sativex. Thus, the real debate is not over whether
marijuana could be used as medicine, the debate is over the
most scientifically safe and effective way the components of
marijuana may be used as medicine. The responsibility for
ensuring that any drug, whether derived from marijuana or not,
is safe and effective has been entrusted to the U.S. Food and
Drug Administration [FDA].
Under Federal law, the FDA must review, test and approve
each medicine and determine what conditions or diseases may be
used to treat and at what dosage level. The FDA continues to
monitor each drug, making sure that it is manufactured and
marketed properly and that unforeseen side effects do not
jeopardize the public health. State laws purporting to legalize
marijuana for medicinal purposes bypass these important
safeguards.
California and Oregon have adopted the most wide reaching
such laws. They allow anyone to use, possess and even grow his
own marijuana provided he obtains the written recommendation of
a doctor. Few if any restrictions are placed on what conditions
marijuana may be used to treat, virtually no restrictions are
placed on the content, potency or purity of such medical
marijuana.
The laws adopted in California, Oregon and other States are
extremely open-ended. California law even allows marijuana to
be used for migraine headaches. This has led to a number of
uses of marijuana as medicine that I believe to be highly
questionable. For example, one of our witnesses, Dr. Phillip
Leveque, has personally written recommendations for over 4,000
people to use marijuana. Another of our witnesses, Dr. Claudia
Jensen, has recommended that teenagers use marijuana for the
treatment of psychiatric conditions like attention deficit
disorder [ADD]. Only a small percentage of medical marijuana
users in California and Oregon have actually used the drug to
treat the conditions for which it was publicly promoted,
namely, the nausea associated with chemotherapy and AIDS-
wasting syndrome.
In Oregon, statistics kept by the State medical marijuana
program indicate that well over half the registered patients
use the drug simply for pain, while less than half of them use
it for nausea, glaucoma or conditions related to cancer or
multiple sclerosis. In San Mateo, CA, a study of AIDS patients
showed that only 28 percent of the patients who used marijuana
did so even to relieve pain. Over half used it to relieve
anxiety or depression, and a third used it for recreational
purposes.
This raises one of the key questions we must address today.
If we are going to treat marijuana as a medicine, will we
subject it to the same health and safety regulations that apply
to other medicines? We do not allow patients to grow their own
opium poppies to make painkillers like morphine, oxycontin or
even heroin with just a doctor's recommendation. We do not
allow people to manufacture their own psychiatric drugs like
Prozac or Xanax to treat headaches.
Why then should we authorize people to grow their own
marijuana when the potential for abuse is high and there is
little or no scientific evidence that it can actually treat all
the illnesses and conditions? Why should we abandon the
regulatory process that ensures that drugs are manufactured at
the right potency level and contaminant free? Why should we
stop the oversight that makes sure drugs are being administered
in the right dosage and in the safest manner? Our witnesses
today will try to answer those and other key questions from a
wide variety of perspectives.
We welcome back Dr. Nora Volkow, Director of the National
Institute on Drug Abuse [NIDA], at the National Institutes of
Health, the Federal agency with the greatest expertise on the
health effects of marijuana and other drugs. Representing the
key Federal agency with responsibility for regulating medical
drugs, we also welcome back Dr. Robert Meyer, Director of FDA's
Office of Drug Evaluation II, Center for Drug Evaluation and
Research. Here to discuss the process of applying for a Federal
license to grow marijuana for research purposes, we are joined
by Ms. Patricia Good, Chief of the Liaison and Policy Section
at the DEA's Office of Diversion Control.
We are also pleased to welcome two representatives of State
medical boards that have been forced to attempt to regulate the
use of marijuana by doctors, Dr. James D. Scott, a member of
the Oregon Board of Medical Examiners, and Ms. Joan Jerzak,
chief of enforcement for the Medical Board of California.
We are also joined by two advocates of the use of marijuana
as medicine, Dr. Jensen and Mr. Robert Kampia, of the Marijuana
Policy Project. I am grateful in particular to Dr. Jensen for
her willingness to come and testify about her controversial
medical practices, and I hope, anticipate a frank and open
discussion with her.
Dr. Leveque apparently will not be able to be here,
although he did not inform the committee, so if he shows up we
will include him in the second panel.
Finally, we are pleased to welcome Dr. Robert DuPont of the
Institute for Behavior and Health, Inc., an expert on marijuana
and drug abuse and former head of NIDA.
We thank everyone for taking the time to join us today and
I look forward to all of your testimony.
[The prepared statement of Hon. Mark E. Souder follows:]
[GRAPHIC] [TIFF OMITTED] T6746.001
[GRAPHIC] [TIFF OMITTED] T6746.002
[GRAPHIC] [TIFF OMITTED] T6746.003
[GRAPHIC] [TIFF OMITTED] T6746.004
Mr. Souder. Mr. Cummings.
Mr. Cummings. Thank you very much, Mr. Chairman.
The possession and sale of marijuana has been illegal under
Federal law since 1937 when Congress passed the Marijuana Tax
Act. Prior to that time, however, Americans could legally
purchase at least 27 medicines containing marijuana, many of
them manufactured by reputable pharmaceutical firms that remain
in existence today.
In 1970, Congress passed the Controlled Substance Act,
classifying all illegal and prescription drugs according to
five schedules. Marijuana was and remains classified as a
Schedule I substance, meaning that it has a high potential for
abuse, has no currently accepted medical use and treatment in
the United States, and cannot be used in an acceptably safe
manner under medical supervision. Possession and sale of
Schedule I substances are generally prohibited and punishable
by Federal criminal statutes. Clinical trials involving
Schedule I and other controlled substances are permitted,
subject to the approval of the Food and Drug Administration.
The Controlled Substances Act allows for the
reclassification of substances on the basis of new evidence of
their safety and efficacy. Along with other Federal law
enforcement agencies, the Drug Enforcement Administration
enforces Federal anti-drug laws and the DEA also is responsible
for approving applications by research institutions to
cultivate marijuana in bulk for research purposes.
Changes in the law have not altered the perception or
belief of many Americans who continue to believe that marijuana
has medical or medicinal benefits and that it should be legally
available for the treatment of various conditions and ailments.
Beginning in the 1990's, numerous States, California and Oregon
prominent among them, passed legislation or ballot initiatives
legalizing medical marijuana, resulting in a conflict in those
States between State law and the Controlled Substances Act.
In 2001, the Supreme Court ruled that California's Medical
Marijuana Law, Proposition 215, did not create a valid defense
to a Federal prosecution for marijuana possession on the basis
of medical necessity. Still, Proposition 215 remains on the
books and medical marijuana remains legal as a matter of State
law.
Federal law enforcement agencies have asserted their
authority to enforce the Federal prohibition by conducting
raids on medical marijuana distribution centers and private
homes in medical marijuana States. Further complicating the
matter, a 2003 ruling by the Supreme Court affirmed the right
of physicians under the first amendment to recommend marijuana
for their patients free of Government censorship. A few
physicians have earned notoriety for prescribing marijuana for
a wide range of ailments ranging from pain and wasting
associated with cancer and HIV-AIDS to depression and attention
deficit disorder.
Meanwhile, research has confirmed the efficacy of the
synthetic marijuana drug, Marinol, which is classified separate
from natural marijuana on Schedule III, rather, on the
Controlled Substances Act. As of 1999, the bulk of the
scientific literature as evaluated by the Institute of Medicine
in a prominent study appears not to support the use of smoked
marijuana as a medicine, except in a small number of unusual
cases. The IOM recommended, however, that additional scientific
research should be undertaken to determine the potential
benefits of marijuana and marijuana-derived drugs.
Our witnesses represent a wide range of perspectives and
will attempt to help the subcommittee to sift through the
competing claims regarding the efficacy or potential efficacy
of marijuana and marijuana-derived medicines, as well as the
harms that accompany marijuana use and the public health
implications of State medical marijuana laws. Hopefully they
will shed new light on the current state of research within and
beyond the United States, including recent developments in the
United Kingdom, where a drug company has submitted an
application to market an inhalant form of marijuana to treat a
variety of symptoms and conditions.
I look forward to the hearing today and I yield back. Thank
you, Mr. Chairman.
Mr. Souder. Mr. Carter, do you have any opening comments?
Ms. Norton.
Ms. Norton. Thank you, Mr. Chairman.
I'm not going to be able to stay to hear the testimony, but
I did want to come and say I appreciate your having this
hearing and the range of witnesses that you have invited to
testify. Because it is the absence of Federal leadership that I
think is why many States move ahead on their own to try to at
least make medicinal marijuana available. Of course,
occasionally there are prosecutions, but not a great many,
because the Federal authority obviously understands where they
are most needed when it comes to the prosecution of our drug
laws.
I would think, though, that the fact that we have 8 to 10
States moving ahead to legalize medical marijuana would have
caused far more vigorous Federal research and leadership than
we have seen thus far. This city was one of the several cities
that had simply moved forward on its own, not because the
council or the legislative body for the District of Columbia
decided that medicinal marijuana was something that the people
of the District of Columbia should have, but because the people
of the District of Columbia voted to allow medical marijuana in
this city in Initiative 59. That of course, that provision of
course, was remanded by the Congress of the United States, as
it has not been able to do in any of the States, which have
proposed similar laws, and shouldn't be able to do to a local
law here.
In any case, the point of Initiative 59 should be
understood. There was no elected official that put it on the
ballot, there was no official body that put it on the ballot.
An AIDS victim collected the signatures and put the matter on
the ballot. That AIDS victim has since died. Essentially what
he was seeking was the use, the legal use of medical marijuana
to alleviate some of his own AIDS symptoms.
I must say that there were some organizations and
individuals seeking legalization of marijuana for its own sake
that morphed into the District all of a sudden, but it should
be said that this proposition emanated from a patient, and was
approved by the residents of the District of Columbia and had
nothing to do with the legalization of marijuana itself. The
people of the District of Columbia have been very clear that
they want the two to be distinguished.
My own sense is that young people should lay off the entire
set of controlled substances, whether they are very harmful or
terribly harmful, from marijuana to heroin, or for that matter,
and by the way, heroin has become increasingly popular with
young middle class students. And for that matter they should
lay off alcohol, which is perhaps the drug of choice for young
people in college today. So you don't find me saying any of
these things are good for you, or because you're young and
foolish, go right ahead.
When it comes to medical marijuana, we are about a serious
matter and one that frankly, I think our Government could have
found the answer one way or the other to long before now. But
the greatest objection I have is not about this medical
controversy. Most people with AIDS today are not going to seek
medical marijuana. This is not a raging controversy in the
country.
Do you know what is a raging controversy in the country? It
is putting young people in jail for smoking pot. Wherever you
stand on these matters, it doesn't seem to me that we ought to
ruin a kid's life by giving him a record for smoking pot, and
to the credit of most of the States of the United States, they
understand that. There are very few such arrests made,
nevertheless, as it stands, it is on the books that way, and
you can get yourself a prosecutor who will in fact enforce it
that way, particularly if you don't happen to be an empowered
part of this society, which brings me to the next point.
The Congress of the United States has gone so far as to say
you can't get educational grants if you've been put in jail
for--sorry, if you have a record of any kind for smoking pot.
Do you know who that falls on? Middle class white kids don't
very often have records for smoking pot. But if you live in
drug infested parts of the inner city where you're surrounded
by drugs from the moment you hit the streets as a kid, it is
probably the case that you will smoke something before you go
to college.
The notion of denying Pell Grants and denying therefore a
college education to kids who happen to live in a drug culture,
no matter how drug free they are today, is the real crime to
me. While this is an important hearing, because it's way past
time for the Federal Government to in fact straighten out this
matter, the state-of-the-art research could have been done by
now, so that we lay this matter to rest, there are far more
serious matters affecting controlled substances that deserve
our attention.
Thank you.
Mr. Souder. Thank you.
A couple of things for the record. I think it needs to be
said that the Ninth Circuit ruled and the Supreme Court didn't
review, which is a little different than the Supreme Court
making the decision. We're not going to debate the preemption
law today, because the Supreme Court has already ruled on
preemption. In fact, we fought a civil war over preemption.
States do not have the right to pass laws contrary to Federal
law any more than the States have referendums to pass and
support slavery. We fought a war and said, Federal law
prevails. You don't have the right of nullification. Now, how
we enforce those is another question.
One other thing on the record. As the author of an
amendment, I did not, Congress did not pass a law that said if
you had a drug conviction you couldn't get a Pell Grant or a
loan. Congress passed a law that said if you have a Pell Grant
you will lose it. The Clinton administration interpreted it and
the Bush administration falsely continued that interpretation,
which we are about to repeal in the Higher Ed Act.
Also before we start, I want to take a point of personal
privilege, because today is the last day for a long time member
of my staff, Nicole Garrett. She came to us highly recommended
from the California Department of Justice, Bureau of Narcotic
Enforcement, where she had worked on California's growing
problem of clandestine meth labs.
I hired her as a junior staffer the first week of June
2002, and promoted her to clerk of the Subcommittee on Criminal
Justice, Drug Policy and Human Resources on July 28th of that
year. Since then she has been ably and efficiently handling the
logistics and follow-through that has been required for 36
congressional hearings in Washington and across America. She
has also made invaluable contributions to our policy work on
extradition and other criminal justice issues, and as our
subcommittee's primary public relations staffer, was always
both pleasant and effective.
Her work on this subcommittee, the California Department of
Justice, Bureau of Narcotics Enforcement, the San Jose Police
Department and her volunteer work with the concerns of police
survivors does great honor to the memory of her father,
Sergeant George Garrett, who was head of the Redwood City
Police Department's narcotics detail. He was killed in the line
of duty on May 8, 1981.
Nicole, I have been impressed by your dedication to making
this country a better place and wanted to say so on the record.
I wish you and your family all the best as you return to
California, and we will miss you very much.
[Applause.]
Mr. Souder. Now I would like to ask unanimous consent that
all Members have 5 legislative days to submit written
statements and questions for the hearing record, and that any
answers to written questions provided by the witnesses also be
included in the record. Without objection, it is so ordered.
I also ask unanimous consent that all exhibits, documents
and other materials referred to by Members and witnesses may be
included in the hearing record, and that all Members be
permitted to revise and extend their remarks. Without
objection, it is so ordered.
Our first panel, if you'll stand and raise your right
hands, I'll administer the oath.
[Witnesses sworn.]
Mr. Souder. Let the record show that each of the witnesses
has answered in the affirmative.
I want to welcome Dr. Volkow back, and you are recognized
for 5 minutes.
STATEMENTS OF NORA D. VOLKOW, M.D., DIRECTOR, NATIONAL
INSTITUTE ON DRUG ABUSE, NATIONAL INSTITUTES OF HEALTH, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES; ROBERT J. MEYER, M.D.,
DIRECTOR, OFFICE OF DRUG EVALUATION II, CENTER FOR DRUG
EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND PATRICIA GOOD,
CHIEF, LIAISON AND POLICY SECTION, OFFICE OF DIVERSION CONTROL,
DRUG ENFORCEMENT ADMINISTRATION
Dr. Volkow. Good afternoon, Chairman Souder and members of
the subcommittee. I am pleased to be here with my colleagues,
Dr. Robert Meyer from FDA and Patricia Good from DEA.
I would like to focus my comments today on the tremendous
progress that the National Institute on Drug Abuse has made in
the past 16 years to inform us about marijuana and its health
consequences. Fact No. 1, marijuana has been and continues to
be the No. 1 illegal drug in this country. Fact No. 2,
marijuana is not a benign drug. It has many adverse health and
social consequences, including the often overlooked fact that
marijuana can lead to addiction.
Of the 21 million people who reported using marijuana in
2001, more than 2 million met the diagnostic criteria for
marijuana addiction. More people are addicted to marijuana than
to heroin, cocaine and all the other illicit drugs put
together. It is also bringing more people to our emergency
rooms. There has been a 164 percent increase in emergency room
visits involving marijuana since 1995.
Moreover, a recent study found that early exposure to
marijuana increased the likelihood of a life filled with drug
and addiction problems. Another study found that those who have
engaged in a lifetime of heavy marijuana use report an overall
dissatisfaction with their mental and physical health, as well
as their life achievements. These data provide a glimpse of the
impact this drug has on our society.
Marijuana disrupts memory, attention, judgment and other
cognitive functions. It can impair motor coordination, time
perception and balance, and its likely to contribute
significantly to motor vehicle accidents. Basically, marijuana
can affect almost every organ and system in the body, including
the immune system, the heart and the lungs. Because marijuana
is typically rolled into a cigarette, or joint, and smoked, it
has many carcinogenic chemicals. It can also increase the
likelihood of some cancers.
Marijuana itself is not just a single drug. It consists of
dry leaves from the hemp plant, cannabis sativa, and it
contains more than 400 chemicals. Delta-9-tetrahydrocannabinol
[THC] is the primary ingredient in marijuana that causes the
intoxicating effects, or high.
While researchers were investigating why marijuana is
abused and how it affects the brain, they discovered a new
neural transmitter system. They found the brain has specific
sites where marijuana binds, called cannabinoid receptors. Many
of these receptors are found in the brain areas related to
pleasure, motivation, memory and movement coordination.
Recently, a second type of cannabinoid receptor was discovered,
and this cannabinoid receptor, which is outside the brain, is
involved in immune function and in pain perception.
The discovery of these endogenous cannabinoid systems is
now allowing scientists and pharmaceutical companies to develop
some very useful medications, not just for drug abuse, but for
a wide variety of medical conditions, including chronic pain,
obesity, smoking and alcoholism, among others.
In addition to pursuing promising new compounds, the
Department of Health and Human Services has also responded to
the recommendations made by the NIH and the Institute of
Medicine reports. Both reports concluded that further research
into the potential medical uses of marijuana is justified. NIH
has been open to receiving research proposals on this topic,
and those that are deemed meritorious by the peer review
process are considered for funding.
One current NIH study is looking at the effects of oral THC
and smoked marijuana on appetite, weight gain and other
behavioral and performance measures in HIV infected patients.
To maximize research opportunities, HHS created a mechanism to
provide research grade marijuana on a reimbursable basis to
non-federally funded researchers. Currently, there are 17
protocols from a California State funded research center that
have been approved. The protocols are for a range of medical
conditions, including pain, spasticity, nausea and HIV
infection. These represent a substantial increase in
scientifically valid research studies involving marijuana.
This research, coupled with the recent discovery of the
cannabinoid system and the tremendous science advances that
have followed are leading us to a wealth of new opportunities
for the development of useful non-addictive cannabinoid based
medications for a variety of health conditions. To conclude,
the scientific evidence is clear, marijuana is an addictive
substance that has adverse health and behavioral consequences.
It is also true that the cannabinoid system through which
marijuana asserts its effects offers a wide range of potential
therapeutic applications. However, cannabinoid medications are
being developed that optimize the therapeutic properties and
minimize adverse effects.
Thank you, and I will be happy to respond to any questions
you may have.
[The prepared statement of Dr. Volkow follows:]
[GRAPHIC] [TIFF OMITTED] T6746.005
[GRAPHIC] [TIFF OMITTED] T6746.006
[GRAPHIC] [TIFF OMITTED] T6746.007
[GRAPHIC] [TIFF OMITTED] T6746.008
[GRAPHIC] [TIFF OMITTED] T6746.009
[GRAPHIC] [TIFF OMITTED] T6746.010
[GRAPHIC] [TIFF OMITTED] T6746.011
[GRAPHIC] [TIFF OMITTED] T6746.012
[GRAPHIC] [TIFF OMITTED] T6746.013
Mr. Souder. Thank you very much.
Dr. Meyer, thank you for coming to our subcommittee again,
and please go ahead with your testimony.
Dr. Meyer. Good afternoon, Mr. Chairman and members of the
subcommittee. I'm Dr. Robert Meyer, Director of the Office of
Drug Evaluation II at FDA's Center for Drug Evaluation and
Research.
I'm pleased to be here today with my colleagues from NIDA
and DEA. FDA appreciates the opportunity to discuss the need
for a science based approach to evaluating the merits of
marijuana for medical purposes. Marijuana, botanical marijuana
is not an approved drug.
Let me first speak about the drug approval process. FDA's
primary mission for over 90 years has been to promote and
protect the public health under the authority of the Federal
Food, Drug and Cosmetic Act and the Public Health Service Act.
The FD&C Act requires that new drugs be shown to be safe and
effective before being marketed in this country. A new drug may
not be distributed in interstate commerce until a sponsor,
usually a drug manufacturer, has submitted and FDA has approved
a new drug application or a biologic license application for
that product.
For approval, an NDA or BLA must contain substantial
scientific evidence that demonstrates the safety and
effectiveness of the drug for its intended use. The first step
a sponsor usually must take to obtain approval for a new drug
is to test the drug in animals for toxicity. The sponsor
submits these data, along with proposed studies, the
qualifications of its investigators and assurances of informed
consent and protection of the rights and safety of the human
subject to the FDA in the form of an investigational new drug
application [IND]. FDA reviews the IND for assurance that the
proposed studies, generally referred to as clinical trials, do
not place human subjects at unreasonable risk of harm. FDA also
verifies that there are adequate assurances of informed consent
in human subject protection.
At that point, the first of three phases of studies in
humans can begin. Phase I studies primarily focus on the safety
of the drug in humans. Phase II studies are clinical studies
involving a limited number of subjects to explore the
effectiveness of the drug for a particular indication over a
range of doses and to determine short term common side effects.
The next step is to conduct phase III studies involving up to
several thousands subjects. These studies firmly establish
efficacy for a particular indication, and also provide further
safety data.
Once the phase III trials are completed, the sponsor may
submit the results of all the relevant testing to the FDA in
the form of an NDA. FDA's reviewers review the application to
determine if the sponsor's data in fact show the drug is both
safe and effective. The drug's manufacturing processes are also
evaluated to make sure the drug can be produced consistently
with high quality.
Results of controlled clinical trials, which form the core
of an NDA or BLA are the basis for evidence based medicine.
These trials allow physicians and patients to use therapies
with a clear understanding of their benefits and risks, and in
some cases, form the basis for strong public health
recommendations.
Let me now turn to the topic of marijuana. I want to
repeat, botanical marijuana is not approved for any indication
in the United States. Pursuant to the Food, Drug and Cosmetic
Act, FDA is responsible for the approval and marketing of drugs
for medical use, including controlled substances. DEA is the
lead Federal agency responsible for regulating controlled
substances and enforcing the Controlled Substance Act [CSA].
The CSA separates controlled substances into five schedules,
depending upon their approved medical use and abuse potential.
Schedule I controlled substances, such as marijuana, are
those deemed not to have any legitimate medical use, as well as
a high potential for abuse. The primary responsibility for
enforcement of CSA again resides with the DEA. The criminal
penalties related to Schedule I controlled substances are far
greater under the CSA than those available under the Food, Drug
and Cosmetic Act for the distribution of an unapproved drug.
FDA regulates marijuana when it is being investigated for
use in the diagnosis, cure, mitigation, treatment or prevention
of disease in man or animals. Much of that research is focused
currently on smoked marijuana. However, due to the inherent
toxicities of smoking, it is likely that any future approvals
would not be of smoked botanical marijuana. Indeed, the
Institute of Medicine has recommended that clinical trials be
conducted with the goal of developing safe delivery systems.
To date, FDA has approved two drugs, Marinol and Cesamet,
for therapeutic use in the United States, both of which contain
active ingredients related to those present in botanical
marijuana. As approved drugs, these products have been through
FDA's rigorous approval process and have been determined to be
safe and effective.
In conclusion, when a drug treatment goes through the FDA
drug approval process, solid clinical data are obtained and
scientifically based assessment of the risks and benefits of
the investigational drug is made. Upon FDA approval for
marketing, patients who need the medication could have
confidence that the approved medication will be both safe and
effective. Without this rigorous scientific evaluation,
benefits and safety remain uncertain.
However, FDA will continue to be receptive to sound,
scientifically based research into medical uses of botanical
marijuana and its derivative cannabinoids.
I would like to thank the subcommittee again for this
opportunity to testify on this important issue, and I would be
happy to take any questions the members of the subcommittee may
have. Thank you.
[The prepared statement of Dr. Meyer follows:]
[GRAPHIC] [TIFF OMITTED] T6746.014
[GRAPHIC] [TIFF OMITTED] T6746.015
[GRAPHIC] [TIFF OMITTED] T6746.016
[GRAPHIC] [TIFF OMITTED] T6746.017
[GRAPHIC] [TIFF OMITTED] T6746.018
[GRAPHIC] [TIFF OMITTED] T6746.019
[GRAPHIC] [TIFF OMITTED] T6746.020
[GRAPHIC] [TIFF OMITTED] T6746.021
[GRAPHIC] [TIFF OMITTED] T6746.022
[GRAPHIC] [TIFF OMITTED] T6746.023
[GRAPHIC] [TIFF OMITTED] T6746.024
[GRAPHIC] [TIFF OMITTED] T6746.025
[GRAPHIC] [TIFF OMITTED] T6746.026
[GRAPHIC] [TIFF OMITTED] T6746.027
[GRAPHIC] [TIFF OMITTED] T6746.028
[GRAPHIC] [TIFF OMITTED] T6746.029
Mr. Souder. Thank you very much. Ms. Good.
Ms. Good. Chairman Souder, Congressman Cummings and
distinguished members of the panel, I appreciate your
invitation to testify today regarding the process that would
need to be gone through for someone to obtain a DEA
registration under the Controlled Substances Act [CSA], to grow
marijuana for scientific research. While I cannot discuss any
specific pending applications or discuss hypothetical
situations, I'm pleased to explain the general process.
In the United States, anyone who wishes to cultivate
marijuana to supply scientific requirements would have to
obtain a bulk manufacturer registration from the Drug
Enforcement Administration. The statutory basis for considering
applicants is contained in Title 21, U.S. Code Section 823(a),
and these considerations are applied to anyone who wishes to
apply to manufacture a substance in Schedules I or II of the
Controlled Substance Act.
The Attorney General, and subsequently the DEA, is
empowered to register those whose applications are consistent
with the public interest and are in compliance with various
U.S. treaty obligations. The statute sets out six factors that
DEA shall consider when determining whether or not to grant an
application, and considering whether it's in the public
interest. First is DEA's ability to maintain effective controls
against diversion of the substance in question to make sure it
does not get into other than legitimate medical scientific
research or industrial channels. This is done by limiting the
number of bulk manufacturers to that number necessary to
produce an adequate and uninterrupted supply of marijuana or
any other substance under adequately competitive conditions for
legitimate medical, scientific and research purposes.
We must also consider the applicant's compliance with State
and local law, the applicant's ability to promote technical
advances in the art of manufacturing controlled substances and
in the development of new substances. DEA must also consider
any conviction record that the applicant may have under State
or Federal law related to the manufacture, distribution or
dispensing of controlled substances. We must also consider the
applicant's past experience in the manufacture of controlled
substances and the existence of effective controls by that
applicant to prevent diversion. And finally, DEA must consider
any other factor which is relevant to and consistent with the
public interest.
In order to determine whether a proposed applicant would be
consistent with U.S. treaty obligations as the law requires, we
must consider the requirements of the Single Convention on
Narcotic Drugs of 1961 and the Convention on Psychotropic
Substances of 1971. Among the basic principles of these
treaties is that the cultivation of marijuana should be limited
to the number of producers who can provide an adequate supply
to meet the country's legitimate medical, scientific and
research needs. Congress has expressly incorporated this
principle into the CSA.
The DEA regulations provide more detailed information on
the process of obtaining registration to bulk manufacture bulk
marijuana. This is contained in chapter 21 of the Code of
Federal Regulations, Section 1301.33. Briefly, an applicant
wishing to cultivate marijuana for scientific studies or to
bulk manufacture any class of a Schedule I drug, for that
matter, is required to submit a DEA Form 225, an application
for registration, along with the appropriate fee.
Upon receipt of that application, assuming it is completed
in its entirety, DEA publishes a notice of application in the
Federal Register. This notice identifies the applicant as well
as the controlled substances they are wishing to apply to
handle. And a copy of that notice is provided to every other
bulk manufacturer who handles that same class of drug. By
regulation, all those other manufacturers have 60 days to file
written comments or objections to the proposed registration of
this new applicant by filing notice with the DEA administrator.
At the same time, DEA conducts an investigation of the
applicant to determine the information necessary to satisfy the
six public interest factors I described previously. DEA takes
into consideration any comments or objections filed on behalf
of the other registered manufacturers in that same class of
drug, as well as information gathered during the investigation
in making its decision on whether or not the applicant in
question would be consistent with the public interest.
In general, if no comments or objections are filed and the
results of the investigation conclude that the registration is
consistent with the public interest and that all U.S.
obligations under international treaties have not been
contravened, then the applicant will be approved and a notice
of registration will be published in the Federal Register.
If DEA seeks to deny registration, it must serve the
applicant with an order to show cause, which provides that
applicant with an opportunity for a hearing in accordance with
the Administrative Procedures Act. Any applicant whose
application is denied is then entitled to seek review of that
decision through the U.S. Court of Appeals.
In conclusion, DEA will carefully consider any application
for registration as a bulk manufacturer of marijuana consistent
with the relevant statutory criteria. Mr. Chairman, thank you
for the opportunity to testify today, and I will be happy to
answer any questions.
[The prepared statement of Ms. Good follows:]
[GRAPHIC] [TIFF OMITTED] T6746.030
[GRAPHIC] [TIFF OMITTED] T6746.031
[GRAPHIC] [TIFF OMITTED] T6746.032
Mr. Souder. Thank you very much.
Dr. Meyer, I wanted to ask you a few questions. If the
pharmaceutical companies wish to bring a new or even existing
medical product to market and chose to bypass the FDA approval
process by using valid initiatives or State legislative
approval, would FDA take any action? If so, what would it be?
For example, if a company tried to pass a State referendum
allowing oxycontin to be recommended by a doctor for any
condition whatsoever, what action would FDA take?
Dr. Meyer. Actually, Mr. Chairman, I'm having a little
trouble hearing you, but I believe I did hear the question.
I don't think I can speculate on what the FDA action would
be. I'm more of a scientific-medical expert than I am a legal
expert. So I'd hate to speculate on that.
Mr. Souder. Let me ask you this question, then. Would you
think it's fairly safe to say that the FDA would not approve of
pharmaceutical companies avoiding the Federal FDA guidelines
through State referendums to introduce new drugs?
Dr. Meyer. I think you could certainly point to instances
where the FDA has acted in such circumstances.
Mr. Souder. Would that not call into some degree the whole
question of having an FDA and a scientific process that you
described so thoroughly? What would be the point of having you
and others do all this research if it can just be done by
referendum?
Dr. Meyer. Right. Again, I don't want to talk about
speculation here, but I think FDA certainly strongly feels that
the FD&C Act and our actions under that are protective of
public health and the right way to develop drugs.
Mr. Souder. One of our concerns is that this whole so-
called medicinal marijuana movement has implied that marijuana
is medicinal, and as Dr. Volkow has pointed out, there are 200
ingredients marijuana, just like heroin and cocaine and other
narcotics that are dangerous, with sub-ingredients that can be
used and harnessed in certain ways to help with certain
conditions, but that FDA has been virtually absent in the
debate over the medical value of marijuana use.
The reason FDA was established and is funded by Congress is
to make sure that such confusion in fact does not exist. Will
the FDA now consider issuing warning letters to all States,
localities and sellers of marijuana, explaining that botanical
marijuana has not been approved by the FDA for medical use and
cannot be advertised as such, as you would do in other things?
In fact, it was just announced in the Washington Post you're
investigating walnuts.
The question is, why hasn't this been more aggressively
handled by FDA, and will it consider imposing appropriate
penalties on those that continue to illegally promote this
dangerous drug as medicine? We're not even talking about, at
this point, the clinics. We're talking about those who
advertise it as medicine without FDA approval. It is, if
nothing else, false advertising.
Dr. Meyer. Let me answer that in two ways, Mr. Chairman.
First, within the last couple of years, the FDA has given a
consultation to the DEA on the status of marijuana as far as
where it should be scheduled. We agreed that it should remain
on Schedule I under the Controlled Substance Act and should
therefore be controlled. It should be enforced as a Schedule I
product, meaning it has no known medical use and has
substantial possibility for abuse.
The second thing is, I believe part of your question was
directed to the FDA in written form recently. I believe that
preparation for answering is underway, and I will defer to that
written answer for that.
Mr. Souder. I understand that when we bring a researcher
in, you're not necessarily making the political policy level
decisions. But it has been a frustrating process because we
read that the FDA is cracking down on other things. By the way,
I feel compelled to make this comment. We had one of our most
appalling hearings in Florida on oxycontin just recently, with
the sweeping number of deaths there in Florida.
We have a similar problem in Indiana. No. 1, it just
exploded through a bunch of bank robberies, a bunch of kids,
the abuse of a legal drug. As I understood Ms. Good's comment,
one of the first criteria is, can this be controlled and
managed. What we learned at that hearing is the No. 1 cause of
narcotics deaths in the United States are from legal, approved
drugs that were supposed to be in this category of things that
we were managing. It's going to be pretty hard to convince a
lot of us that in fact, there can be a management process for
controlled drugs.
I'll go a second round here. Let me yield to Ms. Sanchez
next.
Ms. Sanchez. I thank the chairman. At this time, I actually
have no questions for the first panel.
Mr. Souder. OK, so I'm going to go on. I wanted to move to
Dr. Volkow, what do you think, you went through the research,
you isolated pretty clearly what we're trying to find out in
the subcomponents of marijuana, where we might find some things
to help some people. This, however, has been seized upon by
some to try to falsely imply that marijuana itself is safe.
What do you think are the best ways we can try to balance
this very difficult problem that we're having with oxycontin,
with heroin, with other types of derivatives, the opioids, if
we find some medical things that can be treated through very
controlled usage that then give the impression that the
narcotic itself is somehow safe? How can we more aggressively
show through the Federal Government health divisions that
marijuana is actually very dangerous? You've outlined a whole
series of things, not only including gateway, but impacts on
individuals and addiction and other things.
Dr. Volkow. Yes, and this of course is a difficult
proposition, particularly I think in the case of opiates, the
drugs you are referring to, because we are faced now with the
No. 2 illegal drugs in this country are prescription compounds.
These are opiates, analgesics, after marijuana. And that
includes kids and elderly people.
And these are drugs that are being prescribed by physicians
that have very good therapeutic applications but somehow are
being diverted and abused and leading to addiction and high
levels of toxicity. So the No. 1 issue I think is extremely
important, we know from research that one of the best
strategies to combat drug addiction is prevention. And one of
the best ways of addressing prevention is education.
So in order to educate people, you have to have
information. That's one of the aspects that is very, very
relevant. In the case of marijuana, there have been extensive
studies conducted to determine the effects of toxicity of
marijuana. There are many studies that have shown that it is
adverse, but there are also other studies that have shown it's
not adverse. This has led to controversy.
As new technologies become available and studies become
more rigorous, we're starting to get extremely interesting
information documenting in fact that marijuana is not benign.
There is clear evidence to suggest that. So our responsibility,
the way that I view it, is to generate that knowledge such that
the data will speak for itself. It doesn't become, I think this
is a benign drug. It is the data that are going to state.
And I mentioned two studies, because I think they are quite
impressive in what they are telling us, the one showing
identical twins, the ones that started taking marijuana before
age 17, had significantly higher problems with drug abuse and
addiction. These were identical twins, with the same genetics.
And another study showing that chronic use of marijuana, and it
wasn't whether you are not remembering or memorizing, led to
significantly poorer performance in life as assessed by how
much money you make, as assessed by years of education, as
assessed by how happy you are.
So to summarize, the way we do this is through prevention.
The way that we do it is via education: education of lay
public, education of policymakers, education of physicians.
It's education across the different levels of society.
Mr. Souder. How would you, both Dr. Volkow and Dr. Meyer,
if in balancing the good and the risks, if smoking tobacco,
cigarettes, turned out to reduce obesity, would either of you
recommend smoking tobacco to reduce obesity?
Why would that even be a discussion matter in marijuana, or
how do you balance the countervailing forces? Because tobacco
harms an individual, shortens their life, but doesn't have an
impact on other people. You don't, for example, wreck a car and
kill somebody while you're high on tobacco. So the argument
that it shortens somebody's life actually has less impact on
other people's life, unless we find more data on second hand
smoke, which we're rapidly developing. That's another question.
But I'm curious even why things like obesity and other
things would come up, unless it would be isolated from the
dangerous addiction, and whether in fact if cigarette smoking
was shown to reduce obesity, as many people think it does,
whether you would approve it on those grounds.
Dr. Volkow. I think that's one of those answers that's very
simple. No, you would not approve smoking for things like
obesity, because to start with, the risk associated with
smoking would be much worse than those associated with obesity,
No. 1.
No. 2, there are many alternatives, even if in fact it was
shown, and it hasn't been shown that nicotine is an effective
treatment for obesity. But even if it were, for matter of
argument, there are ways of delivering nicotine that do not
have the adverse consequences of smoking a cigarette. So why
would you want to promote a delivery system that you know is
harmful, when you can actually deliver the same pharmacological
agent in a safe way that also minimizes its addictive
potential?
Because one of the things that we've learned through the
past few years in science is that the effects of a drug are
very much modified by the way that you take it. So when you
take a drug smoking, that's the route of administration that
assures you the higher likelihood of abuse and addictiveness.
It has to do with the rapidity with which it gets to the brain
and the concentration it reaches.
So when you are smoking marijuana, the effects are going to
be very different than when you take it orally. The same thing
with nicotine, when you smoke nicotine, the effects are very
different than that from a patch. And that dramatically
modifies the addictive liability. So even with marijuana,
changing the route of administration has a significant effect.
But with marijuana, a step further is, as we are
recommending, there are multiple elements to marijuana. So you
can now dissect them and optimize a compound that will have the
properties you want without the other untoward effects. That's
why we have science. And that's why we're investing in
institutes like NIDA, in order to be able to develop compounds
that are safer and can help people.
Dr. Meyer. I think from my standpoint, I would state that
the safety and risk, as opposed to the efficacy, is wholly
dependent on what situation you're talking about. I agree with
the comments that Dr. Volkow made about smoking and weight
loss. So there may be, and I'm not saying there are, but there
may be circumstances where a smoked drug such as marijuana in
very limited circumstances could be found to be overall safe
and effective for something in a patient where perhaps they are
quite terminal, for instance.
But I agree very much, and said in my oral testimony, that
I think while smoked marijuana may be an expedient way to begin
research looking for effects that it's my belief that any
approval, just as Marinol was approved, it's an oral dosage
form, any approval down the road from this kind of research
will likely be some other dosage form than smoked marijuana.
Mr. Souder. So for example, if nicotine, a component of
tobacco, I'm not arguing that it is, but if nicotine had a side
benefit such as, who knows, if you break out cigarettes and the
components inside a tobacco cigarette, maybe we'd find certain
things that have certain usages. But let's say nicotine did and
you took it in pill form. Do you think it would be justified to
then refer to cigarettes that are smoked as medical cigarettes?
This is part of the political problem we're having here.
You're saying there can be side things in the chemicals in
marijuana, if it's taken in pill form. But then people refer to
it as medical marijuana, whereas we have other things that if
we take the chemicals and components out, we would never let
advocates say that it's medical cigarettes because you could
get something out of it, or medical heroin because you can get
something out of it. And why isn't that false marketing and
false labeling, and why aren't you speaking out against it more
aggressively in the public arena that this is not medical? It
is a component inside it, just as there are components inside
all kinds of things that are terribly unhealthy. Then we come
up with other names for them, but we don't call the primary
drug, when it's dangerous, medical.
That's the baffling thing here, which suggests a much
broader agenda than a health agenda.
Dr. Meyer. Again, I think from the FDA perspective, we have
within the last few years gone ahead and again said that we
felt that marijuana is an appropriate Schedule I controlled
substance, that it has no known medical benefit at this point,
and that it does have that high abuse potential. So I think
between that and the fact that we're clearly on record today
and otherwise saying that it is not approved for any medical
use.
Mr. Souder. So there is no medical marijuana from the FDA's
perspective? There are components within it that can be used in
Marinol or other alternatives.
We were having a discussion a little bit earlier about what
are other alternatives to marijuana to treat some conditions?
Marinol is one alternative.
Dr. Volkow. There are conditions that have been brought
forward in terms of research, apart from the issue of nausea
and vomiting from cancer, and increasing appetite of people
that have cachexia, that is they are not hungry, like with HIV
or cancer. There are other indications that are actually being
investigated, particularly funded through California. And that
is pain that comes from the peripheral nerves. And marijuana
appears to be effective on those grounds.
One of the things that's interesting is that research has
found that there are two cannabinoid receptors, one is in the
brain and the other one is on the outside. And it is the
cannabinoid receptors outside the brain that are responsible
for this pain killing. So the pharmaceuticals are now
developing these compounds that don't go into the brain, so
they are not going to be addictive, that actually have very,
very promising analgesic effects, with none of the untoward
effects of the drug. Because if you actually even look at the
patients that are getting marijuana or even Marinol, they
complain of sedation. That's not desirable for a lot of people.
So if you can treat pain without having the person sleepy
all day long, very effectively, with no psychoactive effects,
if this doesn't change your mental state, believe me, you'll
have a much more powerful medication. So that's for the pain.
The other one that is being promoted is glaucoma, high
pressure of the eye. There the stories are controversial,
because while cannabinoids effectively decrease the pressure in
the eye, they also decrease blood pressure, so there is concern
that ultimately may not be beneficial to protect the eye. So
the effects there of cannabinoids are not so good, but in terms
of the ones that are used for marijuana, nausea and vomiting,
there are several compounds that are now available. Cachexia,
and that's the one that Marinol appears to be useful in
patients, and the one analgesia, which is absolutely
fascinating.
Now, there's one other area of research of developing drugs
that antagonize the systems that are activated by marijuana.
Those are the ones that are being targeted for obesity, those
are the ones that are begin targeted for smoking and for
alcoholism.
Dr. Meyer. And from the FDA perspective, I would say that
for the majority of the indications that Dr. Volkow just spoke
to, there are many pharmaceuticals approved. In fact, Marinol
is not particularly widespread in its use, because there are
alternatives. It's approved both as anti-nausea for
chemotherapy patients and for cachexia or for weight loss in
the setting of AIDS. And there are a variety of drugs in other
modalities that seem to be preferable for many patients.
That said, I think that there certainly are patients who do
not seem to respond even to the best of our pharmaceutical
armamentarium. And I can understand where patients would want
to see further research. But I think until we have research
that shows that any cannabinoid or marijuana itself is safe and
effective for these indications, as an agency we really can't
say anything other than that we know these other drugs that are
approved for these purposes work.
Mr. Souder. Did you have any questions?
Ms. Sanchez. No, thank you.
Mr. Souder. Let me see if I can summarize this. I'm not
known for being neutral on this issue, I'm very outspoken on
the narcotics issue, so I don't want to misstate this. But
there are literally millions of people across America who have
the impression that the Federal Government doesn't care or
respond to people with AIDS or cancer who are in terrible pain;
that we're so obsessed with the drug war in the United States,
we don't care about that, we're more concerned theoretically
with locking people up because we have this obsession with
marijuana.
Let me see if I understand your positions correctly. And
I'm going to try to say it precisely, because you were both
pretty precise. You do not believe that marijuana is medical,
but there are components and chemicals in marijuana that you
are actively researching in both agencies. There are products
that have been developed from those chemicals that are helping
treat the parts of different illnesses that some people have
used the arguments for marijuana to treat.
And that Marinol, even as I understood it earlier, that we
always heard did not help in nausea cases, has been improved,
and that while it may not treat all cases, you are continuing
to try to make it more effective. And that in the minds of both
your agencies, marijuana itself is not medical, but it does
have components that you will continue to research. You have
continued to have breakthroughs and we are continuing to
improve the health of the United States. Is that a fair
statement? Is there anything I misspoke or overstated?
Dr. Meyer. I think just from the agency standpoint, I would
say that we do not have the evidence to say that marijuana has
a legitimate, safe and effective use.
Mr. Souder. Components within it can be used in other
products when not smoked.
Dr. Meyer. Well, certainly one component is approved,
Marinol, which is the delta-9-THC. But I guess from my
standpoint then, if there was to be a medical use for marijuana
or any of these other components, apart from delta-9-THC, we
feel there would be much more research needed to both explore
the efficacy and to document the safety.
Mr. Souder. And it wouldn't be marijuana.
Dr. Meyer. Pardon?
Mr. Souder. It wouldn't be marijuana. It would be some
component inside the marijuana.
Dr. Meyer. Well, again, I think there are inherent
toxicities to smoking anything, and, my best guess as a
physician is that it would likely be a dosage form other than
marijuana or a route of administration other than smoking,
certainly.
Mr. Souder. But it probably, even if it was in dosage form,
have all 200 chemicals. Did you say there were 200 chemicals?
Dr. Volkow. 400.
Mr. Souder. 400; 400 chemicals probably wouldn't be in it,
because you would be isolating what you're treating, is that
correct, Dr. Volkow?
Dr. Volkow. Yes. Ideally of course you want to get as pure
a medication as you can to minimize side effects. Under certain
instances, combinations appear to be better than just a single
one. But there are very rare indications where that has been
shown.
Mr. Souder. May I ask you to clarify that statement? In
other words, you could take a component of marijuana and maybe
find another one somewhere else that wasn't even in marijuana
to combine with something that you found inside marijuana to
make a more effective pill?
Dr. Volkow. Correct. And there are naturally occurring
compounds that, for example, in the case of the amphetamines,
which we use to treat children with ADHD. They're are actually
two components to it, and it has been shown that both of them
exert slightly different effects. So that's one of the
elements. But correct. And the main component that is believed
to act in marijuana is the delta-9-THC. But there is evidence
that others are having effects, but much less so.
Having said that, I do think there's an element that is
relevant in terms of research on marijuana and potential
medical applications. It has helped us in certain instances to
identify areas where we say, marijuana, for example, has these
analgesic effects. Then we do the research and say, what are
the mechanisms by which marijuana led to that analgesia, and
then try to identify what the mechanisms are, and target
compounds that go directly to it. But that's a different
perspective. That was the research that led to it. But we use
it in order to get better interventions.
Mr. Souder. Dr. Meyer.
Dr. Meyer. I just felt I needed to be clear on this issue.
FDA does not have an inherent bias against botanical products.
If botanical products are developed correctly and shown to be
safe and effective, even though they contain a variety of
substances, many of which may be known, some of which may be
unknown, but if those are properly approved and shown to be
safe and effective, we would approve a botanical product.
Mr. Souder. Do you have any smoked product that you have
approved?
Dr. Meyer. I don't believe so, no.
Mr. Souder. Anything else you want to add before we
conclude the panel?
Thank you all for coming. We appreciate your testimony.
If the next panel will come forward, and remain standing.
The next panel is Dr. James Scott, board member of the Oregon
Board of Medical Examiners; Ms. Joan Jerzak, chief of
enforcement, Medical Board of California; Dr. Claudia Jensen,
Ventura, CA; Mr. Robert Kampia, executive director of the
Marijuana Policy Project; Dr. Robert DuPont, Institute for
Behavior and Health, of Rockville, MD.
I will need to have you each stand and raise your right
hands.
[Witnesses sworn.]
Mr. Souder. Let the record show that each of the witnesses
responded in the affirmative, and we'll start with Dr. Scott.
STATEMENTS OF JAMES D. SCOTT, M.D., MEMBER AND PAST CHAIR,
OREGON BOARD OF MEDICAL EXAMINERS; JOAN JERZAK, CHIEF OF
ENFORCEMENT, MEDICAL BOARD OF CALIFORNIA; CLAUDIA JENSEN, M.D.,
VENTURA, CA; ROB KAMPIA, EXECUTIVE DIRECTOR, MARIJUANA POLICY
PROJECT; AND ROBERT L. DUPONT, M.D., PRESIDENT, INSTITUTE FOR
BEHAVIOR AND HEALTH
Dr. Scott. Mr. Chairman and members of the committee, I
thank you for the opportunity to be here today.
My name is Dr. James D. Scott, I'm an otolaryngologist,
which is more easily known as an ear-nose-throat physician. I
have practiced medicine in Roseburg, OR since 1971.
I am a member of the Oregon Board of Medical Examiners and
past Chair. The Oregon Board of Medical Examiners was created
by the State legislature in 1889 to regulate the practice of
medicine. The Board's mission is to protect the health, safety
and welfare of the Oregon citizens by regulating the practice
of medicine in a manner that promotes quality care.
The Board is governed by and enforces the Oregon Medical
Practices Act, and Oregon related administrative rules. The
Board conducts investigations, imposes disciplinary actions and
supports rehabilitation, education and research to further its
legislative mandate to protect the citizens of Oregon.
In 1998, Oregon voters adopted the Oregon Medical Marijuana
Act. This act creates an exception to State criminal laws by
permitting certain individuals to possess, produce and use
small amounts of marijuana which may mitigate a disabling
medical condition. The Oregon Health Services Division was
assigned the rulemaking authority necessary for the
implementation and administration of this act.
To qualify for protection provided by the law, the patient
must apply for or have a registry identification card. To
obtain this card, the patient is required to have written
documentation from the attending physician that the patient has
a qualifying disabling medical condition. Attending physician
means a physician licensed under the Oregon Medical Practice
Act, who has the responsibility, the primary responsibility for
the care and treatment of a person diagnosed with a disabling
medical condition.
The Board of Medical Examiners is responsible for verifying
that physicians are licensed to practice in Oregon with no
restrictions that would legally prevent them from signing an
attending physician statement regarding medical marijuana. The
Oregon medical marijuana program requests such verification
from the BME licensing and investigative staff.
No one representing the Oregon Board of Medical Examiners
is prepared to give any testimony regarding any scientific or
medicinal value of marijuana or any sociopolitical issues
regarding marijuana. These issues are beyond our jurisdiction.
Our Board's role is to ensure that marijuana is recommended for
medicinal use through the same practice of medicine as any
other controlled substance. In Oregon, physicians are required
to verify patients' identities, review previous patient medical
records, collect current histories, perform thorough, in-person
physical examinations, reach diagnosis and recommend treatment
plans. We also recommend discussion with patients regarding the
benefits and risks of such treatment plans.
Physicians are required to have complete, accurate patient
records. Our Board has disciplined an Oregon physician who
signed attending physician statements for the use of medical
marijuana without following the aforementioned procedures. The
Board makes no distinction between medical marijuana and any
other controlled substance. Physicians have been and will
continue to be investigated and disciplined for inappropriate
prescribing of all controlled substances regardless of the
nature of the drugs in question.
The Oregon Board of Medical Examiners has made no policy
statement formally or informally on the use of marijuana for
medical purposes. The State's voters and the legislature
approved medical use of marijuana without the approval of the
U.S. Food and Drug Administration, which has stringent
requirements for scientific testing, approval, manufacture and
dispensing of legal drugs. The people of Oregon have determined
through the process of law that using marijuana for medicinal
purposes is part of the standard of care for the State's
doctors. The Board of Medical Examiners is responsible for
seeing that all standards of care under Oregon law are strictly
and fairly enforced.
Thank you very much. I'd be happy to answer questions.
[The prepared statement of Dr. Scott follows:]
[GRAPHIC] [TIFF OMITTED] T6746.033
[GRAPHIC] [TIFF OMITTED] T6746.034
[GRAPHIC] [TIFF OMITTED] T6746.035
Mr. Souder. Thank you for your testimony. We'll now move to
Ms. Jerzak.
Ms. Jerzak. Chairman Souder and members of the
subcommittee, my name is Joan Jerzak, I'm the chief of
enforcement for the Medical Board of California, which is a
sworn law enforcement position.
Our enforcement program currently employs 90 investigators
and supervisors statewide. The Board is legislatively mandated
to protect the health care of consumers through the proper
licensing and regulations of physicians and surgeons and
through the vigorous, objective enforcement of the Medical
Practice Act. The Board licenses and regulates more than
115,000 physicians.
Thank you for the opportunity to speak to you regarding the
use of medicinal marijuana as a treatment modality from
California's perspective. Although the subcommittee is looking
at science based medicine and studies on medicinal marijuana,
I've been asked to comment on how California physicians deal
with medicinal marijuana and its health related impact on
patients from the perspective of a regulatory agency.
The Compassionate Use Act of 1996 was passed by California
voters through the initiative process and became law in
November 1996. The main thrust of the act was to allow
seriously ill Californians to obtain and use marijuana for
medicinal purposes where such use is deemed appropriate and has
been recognized by a physician. The act provides that marijuana
may be used by patients for a wide variety of medical
conditions, and envisions that the physician will serve as a
gatekeeper to ensure that users are indeed patients whose
health would benefit from the use of marijuana.
Since 1996, the Board has investigated a small number of
physicians who have had complaints filed against them
questioning their recommendation for medicinal marijuana. To
put this into perspective, the Board receives approximately
12,000 complaints each year. After completion of the triage
process, approximately 2,000 complaints are assigned to an
investigator. Complaints are received from a wide variety of
sources and impact all facets of the practice of medicine. They
include quality of medical care, sexual misconduct, substance
abuse, unlicensed practice, physical or mental impairment, and
an assortment of other issues, including improper prescribing
or handling of controlled substances.
Of the physicians the Board has investigated for medicinal
marijuana related issues, four cases were closed, one case
remains in the investigative stage, and the other four cases
resulted in charges being filed. In those four cases where
charges were filed, the medical experts were not critical that
marijuana was recommended but rather they were critical of the
overall care and treatment provided by the physicians and that
there was not a good faith prior exam or medical indication,
the records were inadequate, or there was failure to obtain
proper informed consent. The Board does not pursue disciplinary
action against physicians merely for recommending medicinal
marijuana.
Physicians in California have expressed concern as to what
their role is with regard to medicinal marijuana and the
Board's view of physicians who are involved in issuing
recommendations. The Board has taken a proactive approach to
educating physicians on the required protocol prior to
recommending the medicinal use of marijuana.
After the act passed, the Board published an informational
article in its January 1997 newsletter clarifying the role of
the physician under the law. The Board was clear in its
expectations that any physician who recommends the use of
marijuana by a patient should have arrived at that decision in
accordance with generally accepted medical standards, which
include a history and physical examination, development of a
treatment plan, provision of informed consent, periodic review
of the treatment and proper recordkeeping. In July 2003, the
Board published another article discussing a physician's choice
to use medicinal marijuana as a treatment for patients, and the
legality of that choice at the State versus the Federal level.
The immunity provision in the California Act does not
extend to violations of Federal statute, and for that reason,
physicians recommending marijuana know that they may be
vulnerable to action by the Federal Government. As you know,
the traditional medical model flows from the presentation of
ideas that lead to new, emerging medicine. These typically
include studies with positive trial outcomes and physicians are
introduced to these new methods through educational settings
and through ongoing review of medical journals.
In contrast, alternative medical modalities, such as
medicinal marijuana, are typically consumer driven, whereby the
consumers find out about a particular modality or treatment and
they ask their practitioner about it. Physicians must ensure
the recommendation is in fact appropriate for a particular
patient and that their recommendation for marijuana has been
arrived at in a manner which is consistent with the standards
of practice for physicians in all other contexts.
To date, no court cases have overturned California's
Compassionate Use Act, and in October 2003 the U.S. Ninth
Circuit Court of Appeals produced a ruling that first amendment
freedom of speech allowed physicians to legally discuss
medicinal marijuana with their patients, and this decision was
upheld by the U.S. Supreme Court.
Again, thank you for allowing me, on behalf of the State of
California, to share this information with you.
Mr. Souder. By the way, once again, it was declined to be
reviewed by the Supreme Court, which is different. It was not
overturned, which is different than being upheld.
Ms. Jerzak. I'm sorry.
Mr. Souder. Dr. Jensen.
Dr. Jensen. Hi. Good afternoon, Congressman Souder and
members of the committee. I'm very grateful to be here today.
I wanted to just tell you what I've learned about Cannabis
indica and Cannabis sativa, which is also known as medical
marijuana. I'm a 49 year old mother of two teenage daughters.
I've been a pediatrician for 23 years. I trained at University
of Arkansas and I did my residency training at U.C. Irvine
Medical Center. I have worked 12 years as a managed care
physician, staff model HMO doctor and since 1996, in private
practice. I also currently work in a small community based
clinic servicing primarily Spanish speaking patient population.
I was not an advocate of using medical marijuana; however,
I was forced into taking responsibility for caring for some
patients a few years ago because of the suffering that I saw.
They were patients with no money and were unable to seek the
aid of some other physicians because they had transportation
difficulties. So I called the Medical Board and I asked for
some guidance on how to do this, and found that there really
weren't systems set up to help physicians yet.
But I elected to go ahead and try and help these people
anyway. And since then, I have found that this is one of the
most fascinating and challenging fields of medicine that I have
ever been involved in. I have learned so much and I have seen
so much that I felt compelled to come and talk to you about it
today, and I greatly appreciate your asking me to come.
In specific, you asked me about treating children with
attention deficit hyperactivity disorder. To make it clear, I
have only two patients in my practice that have used cannabis
for that problem as children. Both of their parents came to me
and asked me to help their kids. Both of those children had
very, very serious functional problems in school. One of them
was also a social deviant to some level. He was unable to stay
in a normal classroom and he had very serious anger management
issues. Not quite on the level of Columbine, but he had trouble
at home and at school in maintaining his behavior.
He had been tried on all of the usual drugs that we use to
treat for ADD, which basically are the amphetamines. I find it
very concerning that we treat adolescents, who have authority
issue problems, with drugs that cause them to have mood swings
and irritability and loss of appetite, which affects their
nutritional status, reduces their ability to sleep properly and
are well known to cause seizures, can trigger mental illness,
etc., albeit small numbers of people are affected negatively by
the amphetamines, but there are some.
There are other drugs to use for ADD, but they are off
label. They have not been studied in children, for example,
Welbutrin, and then some of the anti-depressants. It says very
clearly in the PDR nothing about treating children with ADD
with those drugs, and yet physicians over the years do that. In
this country, we spent over $1 billion annually on giving kids
drugs for ADD.
Now, in doing research for this presentation, I discovered
that Americans have spent billions of dollars on medical
marijuana. You stated in your papers that in 1999, Americans
spent $10.6 billion buying marijuana. My feeling is that money
should be diverted out of the black market, it should not be
funneled into criminal sources, it should be diverted into
health care management systems, teach physicians, give the
regulatory boards the tools that they need to be able to do it
properly, have the money funneled into public health systems
and use cannabis as a medication under the guidance of
physicians rather than the free for all that it is now.
It is clearly not regulated, the American people are not
obeying the Federal Government, and I really feel that with
what you're doing today, perhaps we can rectify this. I am here
to answer any questions that you have that I could, which might
facilitate that process.
[The prepared statement of Dr. Jensen follows:]
[GRAPHIC] [TIFF OMITTED] T6746.036
[GRAPHIC] [TIFF OMITTED] T6746.037
[GRAPHIC] [TIFF OMITTED] T6746.038
[GRAPHIC] [TIFF OMITTED] T6746.039
[GRAPHIC] [TIFF OMITTED] T6746.040
[GRAPHIC] [TIFF OMITTED] T6746.041
[GRAPHIC] [TIFF OMITTED] T6746.042
[GRAPHIC] [TIFF OMITTED] T6746.043
[GRAPHIC] [TIFF OMITTED] T6746.044
[GRAPHIC] [TIFF OMITTED] T6746.045
[GRAPHIC] [TIFF OMITTED] T6746.046
Mr. Souder. Thanks, and as I said at the beginning, your
full statement will be in the record as well.
Dr. Jensen. Thank you.
Mr. Souder. Mr. Kampia, good to see you again.
Mr. Kampia. Thank you, Mr. Chairman, and thank you in
particular to Congresswoman Sanchez, who has been such a strong
supporter of the medical marijuana patients who are suffering
in California.
I'm Rob Kampia, I'm executive director of the Marijuana
Policy Project, which is the largest marijuana policy reform
organization in the United States. There has been ample
research that shows that marijuana is both safe and effective.
It's safer than most prescription medicines, it's safer than
aspirin, and it's certainly medically efficacious. Patients
with MS, AIDS, cancer, chronic pain, have all benefited from
marijuana, and the Institute of Medicine, of course, reviewed
all that 5 years ago now for the Congress and for the drug
czar.
That said, I will admit that there are insufficient studies
to prove to the FDA that marijuana should be approved as a
prescription medicine. There are political reasons for this.
One is that the Department of Health and Human Services issued
guidelines which makes it more difficult to research marijuana
than to research any other drug on the planet. It's more
difficult to research marijuana than ecstasy, LSD, or any newly
developed pharmaceutical. So that has a chilling effect on
research.
In addition, the DEA has been obstructionist again.
Currently, the University of Massachusetts is trying to get DEA
permission to grow privately grown, privately funded marijuana
up in Massachusetts for the purpose of studying it. After 3
years of waiting, the DEA still has not given them an answer.
So consequently, because there is no private source of
marijuana in this country, no private sector industry is
actually going to go and try to spend money, because you can't
get a privately produced drug approved by the FDA if you can't
get hold of the drug.
So there's a big political problem, and because of this, it
could be years, if ever, before the FDA would approve marijuana
as a prescription medicine.
Now, this hearing purports to be about science, and yet I
find that hard to believe. This Congress in general and the
chairman in particular are not exactly bound by science in
their statements. To give you some examples, Chairman Souder
here criticized the State medical marijuana laws today as if
it's some new discovery. Yet a couple years ago he asked GAO to
do a comprehensive study of what's going on in the medical
marijuana States. I just read this last night again, and I say
this study came down on our side. You must not have liked it,
perhaps you didn't read it.
But most of the laws are working just fine, most of the
patients are not abusing, the vast majority of the doctors are
not abusing. In fact, GAO said that only 1 to 3 percent of the
physicians were recommending medical marijuana in these States,
and those who are recommending, 82 percent of these physicians
made only one or two recommendations. So the vast majority are
the people who are actually abiding by the program correctly,
but yet in your scientific inquiry you invited Dr. Leveque, who
is literally the only physician in Oregon to have written an
inordinate number of recommendations. It seems highly biased.
Two, you wonder what impact medical marijuana has on these
patients, given that it hasn't gone through the FDA, but yet
you didn't invite any patients to speak today. You could have
invited Richard Brookheiser, senior editor of the National
Review, who could have told you about his medical marijuana
use. You could have invited Lyn Nofsinger from the Reagan
administration, who would have told you about his daughter's
use. The Federal Government is currently mailing marijuana
regularly to seven patients across the country, and yet those
seven patients who are currently legally using the Federal
Government's marijuana, they were not invited to testify.
Yet another example is on the House floor a year ago. You
said, Mr. Chairman, ``It does not help sick people. There are
no generally recognized health benefits to smoking marijuana.''
It is generally recognized. The American Nurses Association,
the American Public Health Association, the American Academy of
Family Physicians and dozens and dozens and dozens of other
organizations recognize marijuana's medical value. This
information is in the written testimony I've provided. So what
you said on the House floor was false.
Also on the House floor you said that you met with
officials from the Netherlands and they said, supposedly, that
they rejected the use of smoked marijuana for so-called medical
purposes. I don't believe you. Holland is currently allowing
physicians to prescribe marijuana and patients are currently
picking it up at pharmacies. It hardly seems to me that the
Dutch oppose medical marijuana.
Unfortunately, this is not a scientific issue, but a
political issue. Therefore, because of the obstruction of
science, we are moving forward politically. We are going to
keep passing State bills and State initiatives until a majority
of the States cry out to the Federal Government to fix the
Federal problem.
In closing, I want to quote the DEA's own administrative
law judge in 1988. He said, ``Marijuana in its natural form is
one of the safest therapeutically active substances known. The
provisions of the Controlled Substances Act permit and require
the transfer of marijuana from Schedule I to Schedule II. It
would be unreasonable, arbitrary and capricious for DEA to
continue to stand between those sufferers and the benefits of
this substance.''
I agree with the DEA and, Mr. Souder, to the extent that
you are not helping research go forward and to the extent that
you continue to oppose our legislative efforts, your position
on medical marijuana is in fact, as the DEA said, unreasonable,
arbitrary and capricious. Thank you.
[The prepared statement of Mr. Kampia follows:]
[GRAPHIC] [TIFF OMITTED] T6746.047
[GRAPHIC] [TIFF OMITTED] T6746.048
[GRAPHIC] [TIFF OMITTED] T6746.049
[GRAPHIC] [TIFF OMITTED] T6746.050
[GRAPHIC] [TIFF OMITTED] T6746.051
[GRAPHIC] [TIFF OMITTED] T6746.052
[GRAPHIC] [TIFF OMITTED] T6746.053
[GRAPHIC] [TIFF OMITTED] T6746.054
[GRAPHIC] [TIFF OMITTED] T6746.255
[GRAPHIC] [TIFF OMITTED] T6746.256
[GRAPHIC] [TIFF OMITTED] T6746.257
[GRAPHIC] [TIFF OMITTED] T6746.258
[GRAPHIC] [TIFF OMITTED] T6746.259
[GRAPHIC] [TIFF OMITTED] T6746.260
Mr. Souder. I appreciate that you are at least consistently
wrong.
Dr. DuPont.
Dr. DuPont. Mr. Chairman, it's a privilege and a pleasure
to be here. I am delighted to be able to submit my written
testimony and an article I've written on this topic for a more
detailed analysis. I'm going to summarize just a couple of
points here.
My background in this field goes back a long way. I was the
first Director of the National Institute on Drug Abuse [NIDA]
and was the Director from 1973, when the agency was started,
until 1978. I was also the White House drug czar, head of
Special Action Office for Drug Abuse Prevention [SAODAP], under
Presidents Nixon and Ford. I served as head of NIDA also under
President Carter. I had a period of time when I was appointed
by Mr. Nixon where he said the one thing I couldn't come out
and talk about was decriminalization of marijuana, since I was
experiencing heroin in those days, so that was not a problem.
I had a flirtation with the decriminalization idea from
1975 to 1978, and found myself in an interesting situation
under President Carter when I changed my mind and no longer
supported decriminalization. President Carter did support it.
So with two Presidents I was restricted in the expression of my
views about marijuana.
I bring this up to make the point that I have been around
this issue, including many points of view on it. I also want to
point out that I enjoy a friendly relationship personally with
many of the people on the opposite side of this argument.
That's very important to me, because I think it's important to
respect the ideas that are presented and the people who are
presenting them, to discuss issues with civility and respect
and to contend vigorously in the marketplace of ideas. I'm
delighted to have this opportunity here.
The medical use of marijuana essentially died in the 19th
century. As modern pharmacology developed, it was left for
dead. It was resurrected only in the 1970's, as a stocking
horse for the decriminalization and legalization of marijuana.
It had a brief flurry of activity then that led to the
publication of the book in 1976 called The Therapeutic
Potential of Marijuana, edited by two of my friends, Sidney
Cohen and Richard Stillman.
I want to read one quote from this book. I was the head of
NIDA that commissioned this book. This was in 1976 that this
was written, and here is one of the quotes from the book.
``Cannabis itself will never be adopted for medical indication.
It contains dozens of constituents, some of which have
undesirable effects. Delta-9-tetrahydrocannabinol is a possible
candidate, but it is more likely that a synthetic analog,
tailored to intensify the desired action and to avoid the
undesired ones, will be preferred.''
We haven't gone a long way since then in terms of our
understanding of this issue. And I point out that this was
published, the meeting on medical marijuana was 1975, but it
was published in 1976. Now, marijuana has changed dramatically
over that period of time. It is much more potent now, and is
used much more intensely by much younger people than it was. In
those days, it was primarily used by people in their 20's and
late teens. That is not the case now. It is used very early by
very young people and often quiet intensely.
Marijuana and the constituents in it are better understood
from a biological point of view than any other chemical in the
world. It has had more research done on it. You heard Dr.
Volkow, I'm very proud that she is the fifth head of NIDA and
she is doing a wonderful job. I support everything that she
said today. Marijuana has been very well studied. It may be
that some of these chemicals will produce medicinal benefits,
and I think she was eloquent in speaking about that.
It is not conceivable that we're going to have smoking as a
drug delivery system, or use many chemicals like this in an
uncontrolled situation. That is not medicine. It has not been
medicine for more than 100 years. It's not going to be medicine
in the future. Smoking is a toxic delivery system by
definition. It is not scientific.
I was delighted to hear the FDA representative, Dr. Meyer,
talk about the FDA approval procedure and the fact that there
is a procedure even for a botanical. A marijuana chemical would
have to meet the standards of safety and efficacy to be
approved. Smoked marijuana has not met those, and in my
opinion, it is not likely to meet those standards in the
future.
The idea of medical marijuana is not a harmless idea. It is
a dangerous idea in terms of the public attention, because it
legitimizes the use of marijuana. During the period when this
idea had ascendancy, there was an increase in marijuana use in
this country that I think is directly traceable to this issue,
in fact. I think that now, in the last 2 years, we have had a
downturn, and I'm delighted to think about that. I think part
of it has to do with confronting this issue in a much more
direct fashion than has happened before, and I am delighted to
see these developments and proud to be here today.
Thank you very much.
[The prepared statement of Dr. DuPont follows:]
[GRAPHIC] [TIFF OMITTED] T6746.055
[GRAPHIC] [TIFF OMITTED] T6746.056
[GRAPHIC] [TIFF OMITTED] T6746.057
[GRAPHIC] [TIFF OMITTED] T6746.058
[GRAPHIC] [TIFF OMITTED] T6746.059
[GRAPHIC] [TIFF OMITTED] T6746.060
[GRAPHIC] [TIFF OMITTED] T6746.061
Mr. Souder. I thank each of you for your testimony, and I
wanted to start with Dr. Scott and Ms. Jerzak. I'm curious,
because both of you are agents of your State government. I
wonder how you factor in FDA guidelines in general, first, and
how you enforce State health law, and then specifically how you
factor in FDA guidelines on medical marijuana.
Ms. Jerzak. Physicians have to practice the standard of
care. In California, we want good medicine. That's kind of what
our aim is, to protect health care consumers and ensure good
medicine.
When we have a case where a concern comes up, we
investigate that. Complaints come from a variety of types and
sources. We don't typically have a case where somebody's asking
us to investigate FDA guidelines being violated, because FDA
would do those.
So although we're upholding State laws and Federal laws as
a law enforcement agency, we have to look at, typically those
complaints that come to us. Is this good medicine? And then we
have to look at it within the standard of care, and we would go
to medical experts in the community to say whether that is good
medicine.
Mr. Souder. So you wouldn't take the FDA's position? They
said today there is no medicinal benefit to marijuana. There
are components inside it, they have been participating in the
research, but they said flat out, there is no medicinal benefit
to marijuana. And you don't follow that FDA guideline? Do you
follow it on other issues? Or do you just take the State
standard of care, talk to local people and forget what FDA
said?
Ms. Jerzak. We would be looking at an individual case, and
not be proactively setting policy about whether FDA rules are
being followed. The kinds of complaints we have have not been
characterized as your question would imply, and certainly we
have to look at the kind of question that would come to us.
But the cases that we've looked at, the complaints that
we've looked at, involve nine licensees. Some had more than one
complaint. And they were in the context of whether this was
good medicine.
Mr. Souder. How do you handle other non-FDA approved drugs?
Years ago, because I'm older, Laetrile was an argument. Do you
have kind of random decisions? If the FDA says there's no
benefit to this drug, but the State doesn't have a ban and
nobody complains about it, and then if somebody does, do you
look at it in the State context? In other words, the FDA
standard is that this is not an approved drug. The Federal
standard that this is an illegal drug, doesn't overwrite State
law.
Ms. Jerzak. My best answer would be that Laetrile is not
legal in California, so we don't have that issue come up to us.
The patients will go to Mexico for that.
Marijuana is the only drug that we have this apparent
disparity in following the Federal law and their policies and
State law. In California, we were urging the physicians to be
mindful of the Federal laws, and that we said the State law was
not an immunity or a defense to the Federal law. But the voters
put this in, and I guess the answer being that the voters did
not want to wait for the science.
In other areas of medicine, various alternative medicine
modalities that the Board has been confronted with, various
kinds of treatments, NIH has moved forward to develop more
information about that, and that's been very helpful to
consumers and patients as well as physicians.
Mr. Souder. But there's a difference between a developing
thing where there's not a stand, and an illegal drug.
Nullification was decided a long time ago. I'd like to hear Dr.
Scott on this, too. But quite frankly, this sounds so much like
the civil rights debates where the Federal Voting Rights Act
passed. The States didn't want to give minorities the right to
vote. The local attorneys general and law enforcement people
said, well, our State law says Blacks can't vote, so we're
going to follow State law, not Federal law, and we'll deprive
them of the vote.
But there's a Federal law here. Furthermore, the health is
clear. We just heard from the national researchers. There is
not a debate that they are looking for ways to provide this. My
question is, does FDA and NIDA, which are the top experts, when
they say, this does not work, and it's an illegal drug, do you
believe State law preempts the Federal law?
Dr. Scott. I do not. And our Board in Oregon is charged
with enforcing both Federal as well as State law. Oregon wrote
its law in a very specific way. It is not a prescriptive drug,
marijuana. Physicians do not prescribe marijuana. You can't go
to the pharmacy and get marijuana. You cannot buy it and you
cannot sell it.
The law was written that it allows the physician to discuss
with the patient the use of marijuana that may be beneficial
for their debilitating condition. Then the law went on to
define what those specific debilitating conditions are. And the
law in Oregon says that the physician will sign a document that
says, ``this patient has this debilitating medical condition
and it qualifies under the law for medical marijuana.'' But the
physician does not prescribe it, they don't get a prescription
for it. His note indicates that this patient has pain, for
example, or has nausea, and then allows State law to do what it
does.
I understand your argument about State and Federal law. And
I at the Board level don't get involved in that conflict,
except that I feel that we do follow the Federal law as well as
the State law in this case, the way the law is written in
Oregon.
Mr. Souder. If a patient wants to get marijuana, does it
have to be authorized by a doctor?
Dr. Scott. That is correct.
Mr. Souder. So doctors do in fact have to authorize it?
Dr. Scott. It's written specifically this way. The
physician signs the statement indicating that this patient has
one of these debilitating medical conditions. It's not a
prescription. He says that this patient has pain. That's it.
That this patient may benefit from medical marijuana. But
specifically it says, this patient has nausea, signs it. He
doesn't prescribe marijuana.
Ms. Jerzak. I would echo what Dr. Scott has said in terms
of California. We did not look at it as the word prescribing,
which would make it a violation of Federal law. We also used
the word recommend, which was distinctively chosen to separate
it out from the Federal law. In California, we said it would be
needed to be used for seriously ill Californians, and we left
that definition of seriously ill to our licensed physicians to
be the gatekeepers of describing that category of patients.
Mr. Souder. So Dr. Jensen, who showed tremendous sympathy
for her patients, believes that ADD was a criteria in two cases
to prescribe. Is that one of the guidelines?
Ms. Jerzak. Is that one of the what?
Mr. Souder. Is that an approved use?
Ms. Jerzak. In terms of the seriously ill Californians, I
would not be making that determination about the explanation of
that. We would be relying, if we had that complaint, about
whether that was the appropriate care for those patients. What
else had been tried? What did she explain as the risks and
benefit ratio? What was the informed consent of those involved?
What other treatment modalities? How often they met in the
context of medicine?
Ms. Sanchez.
Ms. Sanchez. I thank the Chair. Before I ask questions, I
just want to state that the reason I'm here today is because
the issue of medical marijuana use is a very important issue to
the people in my State. The voters in California passed a
medical marijuana law in 1996, and since that time, my
understanding is that thousands of patients have benefited from
that law.
In fact, a recent field poll demonstrated that 74 percent
of Californians now favor legal protections for patients who
use marijuana to cope with illnesses, compared with 56 percent
who approved the medical marijuana ballot initiative in 1996.
I'm particularly concerned that State approved medical
marijuana patients and providers are being targeted by the DEA.
In times like this, when we have such limited Federal
resources, rating State approved medical marijuana patients
when neighborhoods are dealing with an epidemic in the
production, for example, of methamphetamine, does not, to me,
seem to be sound policy.
I'm thankful that this hearing has been called to explore
science based approaches to medical marijuana, not so much the
State-Federal conflict of laws. And with that in mind, I'm
going to go ahead and jump into my questioning.
Dr. Jensen, I just wanted to be very clear. Is your
testimony today that under physician guidance, the use of
marijuana can have beneficial health effects? And if so, I'm
interested in knowing what the cost differential would be, for
example, for a child with ADD if they were to utilize marijuana
versus a prescriptive drug form in some other drug?
Dr. Jensen. As I said earlier, I only have a basis of two
patients to discuss this issue in children. I have talked to
some adults with ADD, but in regards to this particular child
who had the anger management issues, his mother and father at
that time, his father was disabled and they had no health
insurance, which is also another problem. It was costing the
mother $120 a month to pay for his Dexadrine, which is a very
sophisticated form of amphetamine, and very dangerous. I don't
approve of Dexadrine in general. He had Ritalin, he had
Adderal, he tried Concerta, which is even more expensive. I had
one of my office staff call all of our local pharmacies and get
a run-down on the average cost for an average prescription, and
it exceeds $100 a month in Ventura County, as of this month.
This one particular boy, who by the way is 5 feet 11, 246
pounds, so even though he's a child, physically and
metabolically he functions as an adult. His father grows his
medicine for him and his mother picks leaves out of the back
yard and makes tea for him in the morning before school. So the
cost differential is astronomically different.
Now they have health insurance. Now she can afford to buy
the other medications for him, but they don't have any desire
to do it because of the side effects that he was suffering from
the other medications. Now he's fully functional and back in
school and getting good grades, whereas before he was getting
Fs and Ds. So the cost differential is just ridiculously
different.
Ms. Sanchez. Thank you.
Dr. DuPont, I have a question for you. I'm interested in
knowing what your thoughts are concerning the potential use of
inhalants as British firms have proposed, versus the dangers
that are specifically associated with smoking marijuana, and
whether or not you think that inhalant form could be
potentially beneficial?
Dr. DuPont. I think this product shows promise. And I think
it's a very attractive idea. Because it doesn't involve
smoking. So I think it's good. My understanding is that it's
going to be subjected to this FDA approval process. Should
sativex go through that process, and I think it may very well
successfully go through that, if it does, I would have no
difficulty supporting it, as I have supported the use of
controlled substances approved by the FDA for all kinds of
indications. This would not trouble me in the least.
Ms. Sanchez. OK, thank you. And then Mr. Scott, I
understand that your Board has investigated and suspended Dr.
Phillip Leveque based on some of his recommendations that he
made to patients. And I'm interested in knowing specifically
what the recommendations were that led to his suspension, and
how did his recommendations adversely affect his patients?
Dr. Scott. Part of what I can talk about with Dr. Leveque
is public information. Part of it is not, and there is still
some investigational information.
The public information that is available is that Dr.
Leveque was originally disciplined by the Oregon Board of
Medical Examiners approximately 2 years ago. The reason for
that discipline was not regarding the Medical Marijuana Act, it
was regarding the Medical Practice Act of Oregon and his
practice as a physician.
At that time, he was signing these physician authorizations
for medical marijuana usage without doing what a physician
does. And a physician sees a patient, does a history, does a
physical, comes to a diagnosis, proposes a treatment plan,
prescribes the treatment plan, which may include medication,
and then follows the patient to see the response to that
treatment plan.
Dr. Leveque was not doing that. He was investigated and he
ended up signing a stipulated order where our Board allowed him
to continue to practice, but under a probationary period. Dr.
Leveque was more recently investigated again and his license
was suspended approximately a month ago because we at the Board
level found he was in violation of his original stipulated
order 2 years ago.
Ms. Sanchez. Did either of the violations adversely affect
the patients?
Dr. Scott. That's a matter that I can't answer. His
practice, quite honestly, was not as a primary care provider,
but mainly to sign these medical marijuana cards. So he did not
have an ongoing relationship with the patient. He was not
monitoring the patients. So he was merely signing this
documentation that's required to receive medical marijuana.
I would speculate that his patients, depending upon your
opinion and their availability of medical marijuana is how it
would affect their health. And I can't answer that question for
you.
Ms. Sanchez. Thank you for your testimony.
Mr. Kampia, what credible research has been done to
demonstrate marijuana's therapeutic use?
Mr. Kampia. Well, in the late 1970's and early 1980's,
there were seven States, including California and New York,
that did statewide research projects involving marijuana that
came from the Federal Government. It involved hundreds of
patients in each State. One of the States actually was
Tennessee. Al Gore's sister was using marijuana for cancer back
in, I think, 1981 or 1982.
And each of these States concluded their studies in 1984 or
1985, something like that. They all issued reports, and the
reports showed that some patients benefited from the Marinol
pill, some patients benefited from the marijuana but not the
pill and some patients benefited from neither, which kind of is
what we see when we talk to patients. Some respond to one, some
respond to the other, some don't respond to either. So those
studies were done and since then, there's a whole host of
studies being done in the University of California; 10 or 11
studies going right now, I think, which was mentioned earlier
today.
And there have been dozens of other studies done by private
researchers here and there in the 1970's and early 1980's.
Those studies were all summarized by the Institute of Medicine
which released this comprehensive book in 1999. It was paid for
by the White House drug czar's office. I think they were
looking for some conclusions in this book that they didn't get.
But we hold the book up now, because we like it, because it
shows that marijuana actually does have medical value.
Furthermore, I should point out, another glitch here in how
we don't follow science around here is the IOM. In the very
beginning of their book, they recommended that until a non-
smoked, rapid onset cannabinoid drug delivery system becomes
available, we acknowledge that there is no clear alternative
for people suffering from chronic conditions that might be
relieved by smoking marijuana, such as pain or AIDS wasting.
And they recommended on the same page that patients be able to
get a 24-hour turnaround if their physician and the patient
decided that they need marijuana. The Federal Government should
give them the opportunity to use marijuana within 24 hours.
I have never heard any Member of Congress nor the drug czar
decide if they were going to jump on that IOM recommendation
and make that happen.
Ms. Sanchez. Thank you for your testimony. I have no more
questions.
Mr. Souder. Dr. DuPont, do you have any comment on what he
just said?
Dr. DuPont. Well, about the Institute of Medicine report, I
think there are some slippery words going on here. We talk
about marijuana, and you, Mr. Chairman, pointed this out, much
of the talk when we talk about medical marijuana is dealing
with individual chemicals in it and not with the smoked
marijuana. The IOM report specifically said with respect to
smoked marijuana that smoking was a bad idea. Let me say this,
in summary, there are many reasons to worry that people who
might choose to use marijuana as medicine, especially those who
smoke it, the drug could actually add to their health problems.
So I think that there is very little enthusiasm for smoked
marijuana. And I would try to use that term, rather than just
marijuana. Because marijuana is often talked about as if it's
the constituent chemicals, like THC or others, that are in
there.
Mr. Souder. Thank you for clarifying that. It's something
that we had some debates about in the last administration, who
failed to note in some of their reports the correct
distinctions. In Canada, as they move forward, and as I've
talked to the legislators, who I don't agree with, on the
general policy, but agree that they are trying to move ahead
without smoked marijuana and in lower intensity, even in the
different pills that separate the components. In the
Netherlands, the government is in the process of trying to back
up, which is now a mess in Amsterdam. They are attempting to
isolate chemicals. Don't get this confused with marijuana.
There are substances in all kinds of things that have negative
impacts on society. And I appreciate your clarifying that.
Dr. DuPont. Mr. Chairman, I would just point out one thing
about what you said that is very important. And that is that
smoked marijuana is the only way it is interesting to the
advocates in this field. They show no interest in the
development of individual chemicals whatsoever.
That shows that their purpose is not medical, it is to
influence the country's policies toward marijuana. Medical
marijuana is a stocking horse for legalization of marijuana,
the legitimization of smoking marijuana. You can see that very
clearly with how little interest they have in individual
chemicals or any alternate delivery system other than marijuana
smoking. They're only interested in defending smoking.
Mr. Souder. Mr. Kampia, you attempted to defend smoked
marijuana again today, which is far more carcinogenic than
tobacco.
Mr. Kampia. That's wrong.
Mr. Souder. You said it in your testimony. But my question
is, and then you can make your comments, because I want to give
you your day in court here, so to speak. Why isn't your push to
separate out and have your primary effort where we can actually
find more agreement, and that is separating these 400 chemicals
in tablet form to try and help people? Why are you mostly
focused on smoked marijuana?
Mr. Kampia. Right. Well, Dr. DuPont was wrong on two
points, and this is answering your question. One is, the IOM
specifically recommended smoking marijuana. The word smoking
marijuana is right amongst the words that I just read. So it's
not just me and MPP. It's the IOM that recommended that. Not as
a long term solution, but as a short term solution, while we're
studying marijuana in a way that could eventually be developed
into additional pills or a vaporizer or what have you.
Dr. DuPont. For a few patients, yes.
Dr. Jensen. Congressman Souder----
Mr. Kampia. That's the second part to my answer, which is
that not all of our work actually has to deal with smoked
marijuana. The work that I referenced about the University of
Massachusetts trying to get DEA permission to start growing a
legal supply of marijuana so that they can do some research to
get it approved by the FDA, that need not be smoked marijuana.
In fact, my organization gave a grant recently to some
researchers to look into whether a vaporizer could be used
instead of smoking marijuana. As far as we're concerned, we
want the best possible medicine out there for the patients,
whether it's a vaporizer, whether it's smoked marijuana or
whether it's a new pill or what have you.
The bottom line I think what differentiates the Marijuana
Policy Project from, say, you, Mr. Chairman, is that in the
meantime we all have the same vision for the end goal. In the
meantime, what do you do with the patients who are currently
smoking or eating marijuana? Your position seems to be, put
them in prison. Our position is, let them do it while the
research goes on and do not arrest them.
Dr. Jensen. Congressman Souder, first of all, I wanted to
leave this with you, if I might. This is a book from Dr. Mitch
Earleywine. He is a clinical professor at University of
Southern California. He offered it to you. It's got some of the
latest science on cannabinoids. As a physician, I actually
think that I can address this issue. There are so many
different routes of administration and it's been very difficult
for me to figure out how to advise patients. They all come to
me smoking. I recommend to all of them how to quit smoking.
And as a matter of fact, I have a very effective tobacco
cessation program. Because I will not give them a note if they
don't make a contract with me to quit smoking cigarettes. And I
give them a period of time and I give them help on how to do
that.
Basically when you inhale marijuana, preferably through a
vaporizer, but traditionally what most people do is they inhale
it either through a cigarette, which includes papers, or
through a water pipe, which changes the constituents of it.
Now, I'm not an expert on this. What I've learned I've learned
from patients, unfortunately, because I have not been able to
go to a learned body of my peers to educate me. I have learned
this from my experience with my patients. But when smoking the
joint itself with the paper on it appears to help the
asthmatics more than if they use it from a water pipe, it is
interesting. When they inhale it from a water pipe, the
asthmatics seem to actually get worse, which makes no sense.
But functionally, that's what happens.
Now, they do have vaporizers available, but there are such
a wide variety of vaporizers, the cheapest you can get is $100.
I bought one as a demonstration tool to show patients how to
use them. It broke the first week. It had never been used, but
it was just mechanically so defective it broke. The best
vaporizer on the market runs around $600 or $700.
Mr. Souder. Can I ask you a question? I hear your concern
for the individual patients. But what's really hard for me to
sort out in listening to this in your testimony is that you
referred in your testimony that marijuana had been used as folk
medicine for many years, and you're relying a lot on whether
people saying a rolled joint or a water pipe is most effective.
You're a doctor.
Dr. Jensen. I want the science.
Mr. Souder. But the FDA was clear. You just don't agree
with it.
Dr. Jensen. No, the FDA unfortunately failed to attend to
the fact that marijuana does have medicinal use.
Mr. Souder. No, they didn't. That's not what----
Dr. Jensen. He said so himself, that in chronic pain,
glaucoma, there is proven evidence that it affects those
conditions. By definition, it has medicinal value. It should
not be Schedule I.
Mr. Souder. By definition, there are 400 components.
Dr. Jensen. Right, but the point is, why do you want to
take and analyze out and define each component into a little
pill that could be sold from some pharmaceutical company when
somebody can grow it themself? I think they need guidance. I as
a physician need guidance. But it doesn't make any sense to me
to try and market it. It grows right up out of the Earth.
Mr. Souder. You're a physician. You're supposed to follow
good health practices, and you're also supposed to follow the
law.
Dr. Jensen. Congressman Souder, I am desperate for guidance
from my peers. They are unwilling to give it to us. In the
absence of----
Mr. Souder. They have given it to you.
Dr. Jensen. In the absence of reading it in an FDA report,
I have to rely on people who are doing work in the field. And
I've conducted my own studies.
Mr. Souder. What you mean is, you disagree with the experts
who have done it, and you would rather rely on people whose
judgment you like better, is that it?
Dr. Jensen. My patients, Congressman Souder, I am a patient
advocate. And even if one patient benefits from this drug, then
it should never, ever be Schedule I. Because Schedule I means
no medicinal uses. And even if one patient is helped, we should
help them.
Mr. Souder. Your heart is in the right place, but you are
incredibly ill-advised as a doctor to depend on your patients'
wisdom rather than science.
Dr. Scott, I wanted to ask a question. In Oregon, one of
the things that has occurred, and I'm not sure whether you have
any knowledge of this, but it's a complicating variable, and
I'm just asking if you have any knowledge. Apparently a drug
testing law, as it relates to the transportation department,
has ruled and overturned for people who are practicing
medicinal marijuana and they can't test them. Do you know
anything about that?
Dr. Scott. I'm not aware of that, sir. I can't testify to
that. I don't have any knowledge.
Mr. Souder. OK, I didn't know whether that's come up.
Dr. DuPont, I wanted to ask you a final question here. In
the transportation bill today, a number of us have worked to
see that the Federal law starts to reflect what we've done in
alcohol, and that is that we have a testing process for people
who are high and that abuse marijuana and are driving and
endangering other drivers. It's more complicated, because while
excess alcohol has an immediate devastating impact on impairing
a driver, it also doesn't stay in the system as long, which is
why it doesn't have the same cumulative negative effect.
My question, and I don't know the answer to this, because I
haven't asked this question before, do you sense that we're
going to be able to devise a test that is able to measure how
impaired a person is from the marijuana? What I don't
understand is, if the marijuana stays in your system for a long
period of time, I presume that the level of impairment drops,
but if you smoke another joint a couple days in, you're getting
the most recent overlapping with the previous in impairment.
The second part of that is, will we have a reasonable, reliable
test to see how impaired the person is, unlike alcohol, where
we can give them a breathalyzer or whatever? Because they're
not going to do a hair follicle test.
Dr. DuPont. Mr. Chairman, I mentioned that I am the
president of the Institute for Behavior and Health. Drugged
driving is one of our two top priorities to bring to bear
testing and law enforcement in the drug driving field, as we
have in the last two decades with drunk driving. It is a major
problem. In highway safety the adverse effects of illegal drug
use are equal to or on the same scale as, and in some cases
higher, than those associated with alcohol consumption. So
drugged driving is a national problem that has not been
addressed. The modern drug testing technology does let us do
that.
But there is a step that needs to be taken, and that is to
move away from the question of impairment to the question of
whether the presence of the drug is identified in the driver.
This is the standard that was taken by the U.S. Department of
Transportation in 1988 for commercial drivers. It is
essentially a per se standard. That per se standard should be
used for all drivers in the United States. The technology is
there to do that now.
I am thrilled, delighted with your interest in this. It is
extremely timely, and it is going to make a huge difference in
highway safety and also drug abuse prevention. So I am a very
enthusiastic supporter, but we're going to have to move to a
per se standard, which is what has happened in the work place.
That's what goes on now with people who do drug testing.
Millions of American workers are drug tested using this
standard. It's a per se standard. It is what is done in
transportation for commercial drivers. It is the right standard
to apply across the board. If you are driving a vehicle, you
don't have drugs present in your body.
Mr. Souder. Thank you. I think that's the way we have it in
Indiana. I know there is some form of this in the bill we're
voting on in a little bit here. But I don't know what the final
form was and how it was amended.
Are you familiar at all with the case, when I was a staffer
for Senator Coates, I think Senator Danforth initiated the drug
testing for transportation.
Dr. DuPont. Yes.
Mr. Souder. This case in Oregon questioned whether it could
be enforced if the person had a medical marijuana prescription.
Dr. DuPont. My understanding, and there may be something
that happened recently that I'm not familiar with, but my
understanding is that the Federal law is preemptive. So called
medical marijuana is a violation of this standard. So even if
you have a medical certificate, it's a violation and you lose
your license and right to drive. That's my understanding of the
law.
Mr. Souder. I think it was a local court that challenged
it.
Dr. DuPont. But that has been the Department of
Transportation standard. The previous administration took that
position, and this administration takes that position. There
may be something that's happened that I don't know about just
recently. But that has been the position of the Department of
Transportation under both the Clinton administration and the
Bush administration.
Mr. Souder. I'm not sure how this is going to move up the
court system, because it wasn't a legislative decision. It was
a court decision I'm very concerned about. Because if you can
have this medical waiver and be driving a truck, we have a huge
loophole here unless we very tightly limit it, which I know is
what the State boards are trying to do, to address the abusive
excesses of this. At the same time, unless we radically control
this, and somehow get over this idea of State's rights
nullifying Federal law, we're in deep trouble in laws like
that.
I thank each of you for coming today. If you have any
additional comments, you can put them into the record. I
appreciate our having a continuing debate, and I'm sure it
won't have ended today.
With that, the subcommittee stands adjourned.
[Whereupon, at 4:40 p.m., the subcommittee was adjourned,
to reconvene at the call of the Chair.]
[Additional information submitted for the hearing record
follows:]
[GRAPHIC] [TIFF OMITTED] T6746.062
[GRAPHIC] [TIFF OMITTED] T6746.063
[GRAPHIC] [TIFF OMITTED] T6746.064
[GRAPHIC] [TIFF OMITTED] T6746.065
[GRAPHIC] [TIFF OMITTED] T6746.066
[GRAPHIC] [TIFF OMITTED] T6746.067
[GRAPHIC] [TIFF OMITTED] T6746.068
[GRAPHIC] [TIFF OMITTED] T6746.069
[GRAPHIC] [TIFF OMITTED] T6746.070
[GRAPHIC] [TIFF OMITTED] T6746.071
[GRAPHIC] [TIFF OMITTED] T6746.072
[GRAPHIC] [TIFF OMITTED] T6746.073
[GRAPHIC] [TIFF OMITTED] T6746.074
[GRAPHIC] [TIFF OMITTED] T6746.075
[GRAPHIC] [TIFF OMITTED] T6746.076
[GRAPHIC] [TIFF OMITTED] T6746.077
[GRAPHIC] [TIFF OMITTED] T6746.078
[GRAPHIC] [TIFF OMITTED] T6746.079
[GRAPHIC] [TIFF OMITTED] T6746.080
[GRAPHIC] [TIFF OMITTED] T6746.081
[GRAPHIC] [TIFF OMITTED] T6746.082
[GRAPHIC] [TIFF OMITTED] T6746.083
[GRAPHIC] [TIFF OMITTED] T6746.084
[GRAPHIC] [TIFF OMITTED] T6746.085
[GRAPHIC] [TIFF OMITTED] T6746.086
[GRAPHIC] [TIFF OMITTED] T6746.087
[GRAPHIC] [TIFF OMITTED] T6746.088
[GRAPHIC] [TIFF OMITTED] T6746.089
[GRAPHIC] [TIFF OMITTED] T6746.090
[GRAPHIC] [TIFF OMITTED] T6746.091
[GRAPHIC] [TIFF OMITTED] T6746.092
[GRAPHIC] [TIFF OMITTED] T6746.093
[GRAPHIC] [TIFF OMITTED] T6746.094
[GRAPHIC] [TIFF OMITTED] T6746.095
[GRAPHIC] [TIFF OMITTED] T6746.096
[GRAPHIC] [TIFF OMITTED] T6746.097
[GRAPHIC] [TIFF OMITTED] T6746.098
[GRAPHIC] [TIFF OMITTED] T6746.099
[GRAPHIC] [TIFF OMITTED] T6746.100
[GRAPHIC] [TIFF OMITTED] T6746.101
[GRAPHIC] [TIFF OMITTED] T6746.102
[GRAPHIC] [TIFF OMITTED] T6746.103
[GRAPHIC] [TIFF OMITTED] T6746.104
[GRAPHIC] [TIFF OMITTED] T6746.105
[GRAPHIC] [TIFF OMITTED] T6746.106
[GRAPHIC] [TIFF OMITTED] T6746.107
[GRAPHIC] [TIFF OMITTED] T6746.108
[GRAPHIC] [TIFF OMITTED] T6746.109
[GRAPHIC] [TIFF OMITTED] T6746.110
[GRAPHIC] [TIFF OMITTED] T6746.111
[GRAPHIC] [TIFF OMITTED] T6746.112
[GRAPHIC] [TIFF OMITTED] T6746.113
[GRAPHIC] [TIFF OMITTED] T6746.114
[GRAPHIC] [TIFF OMITTED] T6746.115
[GRAPHIC] [TIFF OMITTED] T6746.116
[GRAPHIC] [TIFF OMITTED] T6746.117
[GRAPHIC] [TIFF OMITTED] T6746.118
[GRAPHIC] [TIFF OMITTED] T6746.119
[GRAPHIC] [TIFF OMITTED] T6746.120
[GRAPHIC] [TIFF OMITTED] T6746.121
[GRAPHIC] [TIFF OMITTED] T6746.122
[GRAPHIC] [TIFF OMITTED] T6746.123
[GRAPHIC] [TIFF OMITTED] T6746.124
[GRAPHIC] [TIFF OMITTED] T6746.125
[GRAPHIC] [TIFF OMITTED] T6746.126
[GRAPHIC] [TIFF OMITTED] T6746.127
[GRAPHIC] [TIFF OMITTED] T6746.128
[GRAPHIC] [TIFF OMITTED] T6746.129
[GRAPHIC] [TIFF OMITTED] T6746.130
[GRAPHIC] [TIFF OMITTED] T6746.131
[GRAPHIC] [TIFF OMITTED] T6746.132
[GRAPHIC] [TIFF OMITTED] T6746.133
[GRAPHIC] [TIFF OMITTED] T6746.134
[GRAPHIC] [TIFF OMITTED] T6746.135
[GRAPHIC] [TIFF OMITTED] T6746.136
[GRAPHIC] [TIFF OMITTED] T6746.137
[GRAPHIC] [TIFF OMITTED] T6746.138
[GRAPHIC] [TIFF OMITTED] T6746.139
[GRAPHIC] [TIFF OMITTED] T6746.140
[GRAPHIC] [TIFF OMITTED] T6746.141
[GRAPHIC] [TIFF OMITTED] T6746.142
[GRAPHIC] [TIFF OMITTED] T6746.143
[GRAPHIC] [TIFF OMITTED] T6746.144
[GRAPHIC] [TIFF OMITTED] T6746.145
[GRAPHIC] [TIFF OMITTED] T6746.146
[GRAPHIC] [TIFF OMITTED] T6746.147
[GRAPHIC] [TIFF OMITTED] T6746.148
[GRAPHIC] [TIFF OMITTED] T6746.149
[GRAPHIC] [TIFF OMITTED] T6746.150
[GRAPHIC] [TIFF OMITTED] T6746.151
[GRAPHIC] [TIFF OMITTED] T6746.152
[GRAPHIC] [TIFF OMITTED] T6746.153
[GRAPHIC] [TIFF OMITTED] T6746.154
[GRAPHIC] [TIFF OMITTED] T6746.155
[GRAPHIC] [TIFF OMITTED] T6746.156
[GRAPHIC] [TIFF OMITTED] T6746.157
[GRAPHIC] [TIFF OMITTED] T6746.158
[GRAPHIC] [TIFF OMITTED] T6746.159
[GRAPHIC] [TIFF OMITTED] T6746.160
[GRAPHIC] [TIFF OMITTED] T6746.161
[GRAPHIC] [TIFF OMITTED] T6746.162
[GRAPHIC] [TIFF OMITTED] T6746.163
[GRAPHIC] [TIFF OMITTED] T6746.164
[GRAPHIC] [TIFF OMITTED] T6746.165
[GRAPHIC] [TIFF OMITTED] T6746.166
[GRAPHIC] [TIFF OMITTED] T6746.167
[GRAPHIC] [TIFF OMITTED] T6746.168
[GRAPHIC] [TIFF OMITTED] T6746.169
[GRAPHIC] [TIFF OMITTED] T6746.170
[GRAPHIC] [TIFF OMITTED] T6746.171
[GRAPHIC] [TIFF OMITTED] T6746.172
[GRAPHIC] [TIFF OMITTED] T6746.173
[GRAPHIC] [TIFF OMITTED] T6746.174
[GRAPHIC] [TIFF OMITTED] T6746.175
[GRAPHIC] [TIFF OMITTED] T6746.176
[GRAPHIC] [TIFF OMITTED] T6746.177
[GRAPHIC] [TIFF OMITTED] T6746.178
[GRAPHIC] [TIFF OMITTED] T6746.179
[GRAPHIC] [TIFF OMITTED] T6746.180
[GRAPHIC] [TIFF OMITTED] T6746.181
[GRAPHIC] [TIFF OMITTED] T6746.182
[GRAPHIC] [TIFF OMITTED] T6746.183
[GRAPHIC] [TIFF OMITTED] T6746.184
[GRAPHIC] [TIFF OMITTED] T6746.185
[GRAPHIC] [TIFF OMITTED] T6746.186
[GRAPHIC] [TIFF OMITTED] T6746.187
[GRAPHIC] [TIFF OMITTED] T6746.188
[GRAPHIC] [TIFF OMITTED] T6746.189
[GRAPHIC] [TIFF OMITTED] T6746.190
[GRAPHIC] [TIFF OMITTED] T6746.191
[GRAPHIC] [TIFF OMITTED] T6746.192
[GRAPHIC] [TIFF OMITTED] T6746.193
[GRAPHIC] [TIFF OMITTED] T6746.194
[GRAPHIC] [TIFF OMITTED] T6746.195
[GRAPHIC] [TIFF OMITTED] T6746.196
[GRAPHIC] [TIFF OMITTED] T6746.197
[GRAPHIC] [TIFF OMITTED] T6746.198
[GRAPHIC] [TIFF OMITTED] T6746.199
[GRAPHIC] [TIFF OMITTED] T6746.200
[GRAPHIC] [TIFF OMITTED] T6746.201
[GRAPHIC] [TIFF OMITTED] T6746.202
[GRAPHIC] [TIFF OMITTED] T6746.203
[GRAPHIC] [TIFF OMITTED] T6746.204
[GRAPHIC] [TIFF OMITTED] T6746.205
[GRAPHIC] [TIFF OMITTED] T6746.206
[GRAPHIC] [TIFF OMITTED] T6746.207
[GRAPHIC] [TIFF OMITTED] T6746.208
[GRAPHIC] [TIFF OMITTED] T6746.209
[GRAPHIC] [TIFF OMITTED] T6746.210
[GRAPHIC] [TIFF OMITTED] T6746.211
[GRAPHIC] [TIFF OMITTED] T6746.212
[GRAPHIC] [TIFF OMITTED] T6746.213
[GRAPHIC] [TIFF OMITTED] T6746.214
[GRAPHIC] [TIFF OMITTED] T6746.215
[GRAPHIC] [TIFF OMITTED] T6746.216
[GRAPHIC] [TIFF OMITTED] T6746.217
[GRAPHIC] [TIFF OMITTED] T6746.218
[GRAPHIC] [TIFF OMITTED] T6746.219
[GRAPHIC] [TIFF OMITTED] T6746.220
[GRAPHIC] [TIFF OMITTED] T6746.221
[GRAPHIC] [TIFF OMITTED] T6746.222
[GRAPHIC] [TIFF OMITTED] T6746.223
[GRAPHIC] [TIFF OMITTED] T6746.224
[GRAPHIC] [TIFF OMITTED] T6746.225
[GRAPHIC] [TIFF OMITTED] T6746.226
[GRAPHIC] [TIFF OMITTED] T6746.227
[GRAPHIC] [TIFF OMITTED] T6746.228
[GRAPHIC] [TIFF OMITTED] T6746.229
[GRAPHIC] [TIFF OMITTED] T6746.230
[GRAPHIC] [TIFF OMITTED] T6746.231
[GRAPHIC] [TIFF OMITTED] T6746.232
[GRAPHIC] [TIFF OMITTED] T6746.233
[GRAPHIC] [TIFF OMITTED] T6746.234
[GRAPHIC] [TIFF OMITTED] T6746.235
[GRAPHIC] [TIFF OMITTED] T6746.236
[GRAPHIC] [TIFF OMITTED] T6746.237
[GRAPHIC] [TIFF OMITTED] T6746.238
[GRAPHIC] [TIFF OMITTED] T6746.239
[GRAPHIC] [TIFF OMITTED] T6746.240
[GRAPHIC] [TIFF OMITTED] T6746.241
[GRAPHIC] [TIFF OMITTED] T6746.242
[GRAPHIC] [TIFF OMITTED] T6746.243
[GRAPHIC] [TIFF OMITTED] T6746.244
[GRAPHIC] [TIFF OMITTED] T6746.245
[GRAPHIC] [TIFF OMITTED] T6746.246
[GRAPHIC] [TIFF OMITTED] T6746.247
[GRAPHIC] [TIFF OMITTED] T6746.248
[GRAPHIC] [TIFF OMITTED] T6746.249
[GRAPHIC] [TIFF OMITTED] T6746.250
[GRAPHIC] [TIFF OMITTED] T6746.251
[GRAPHIC] [TIFF OMITTED] T6746.252
[GRAPHIC] [TIFF OMITTED] T6746.253
[GRAPHIC] [TIFF OMITTED] T6746.254
[GRAPHIC] [TIFF OMITTED] T6746.261
[GRAPHIC] [TIFF OMITTED] T6746.262
[GRAPHIC] [TIFF OMITTED] T6746.263
[GRAPHIC] [TIFF OMITTED] T6746.264
[GRAPHIC] [TIFF OMITTED] T6746.265
[GRAPHIC] [TIFF OMITTED] T6746.266
[GRAPHIC] [TIFF OMITTED] T6746.267
[GRAPHIC] [TIFF OMITTED] T6746.268
[GRAPHIC] [TIFF OMITTED] T6746.269
[GRAPHIC] [TIFF OMITTED] T6746.270
[GRAPHIC] [TIFF OMITTED] T6746.271
[GRAPHIC] [TIFF OMITTED] T6746.272
[GRAPHIC] [TIFF OMITTED] T6746.273
[GRAPHIC] [TIFF OMITTED] T6746.274
[GRAPHIC] [TIFF OMITTED] T6746.275
[GRAPHIC] [TIFF OMITTED] T6746.276
[GRAPHIC] [TIFF OMITTED] T6746.277
[GRAPHIC] [TIFF OMITTED] T6746.278
[GRAPHIC] [TIFF OMITTED] T6746.279
[GRAPHIC] [TIFF OMITTED] T6746.280
[GRAPHIC] [TIFF OMITTED] T6746.281
[GRAPHIC] [TIFF OMITTED] T6746.282
[GRAPHIC] [TIFF OMITTED] T6746.283
[GRAPHIC] [TIFF OMITTED] T6746.284
[GRAPHIC] [TIFF OMITTED] T6746.285
[GRAPHIC] [TIFF OMITTED] T6746.286
[GRAPHIC] [TIFF OMITTED] T6746.287
[GRAPHIC] [TIFF OMITTED] T6746.288
[GRAPHIC] [TIFF OMITTED] T6746.289
[GRAPHIC] [TIFF OMITTED] T6746.290
[GRAPHIC] [TIFF OMITTED] T6746.291
[GRAPHIC] [TIFF OMITTED] T6746.292
[GRAPHIC] [TIFF OMITTED] T6746.293
[GRAPHIC] [TIFF OMITTED] T6746.294
[GRAPHIC] [TIFF OMITTED] T6746.295
[GRAPHIC] [TIFF OMITTED] T6746.296
[GRAPHIC] [TIFF OMITTED] T6746.297
[GRAPHIC] [TIFF OMITTED] T6746.298
[GRAPHIC] [TIFF OMITTED] T6746.299
[GRAPHIC] [TIFF OMITTED] T6746.300
[GRAPHIC] [TIFF OMITTED] T6746.301
[GRAPHIC] [TIFF OMITTED] T6746.302
[GRAPHIC] [TIFF OMITTED] T6746.303
[GRAPHIC] [TIFF OMITTED] T6746.304
[GRAPHIC] [TIFF OMITTED] T6746.305
[GRAPHIC] [TIFF OMITTED] T6746.306
[GRAPHIC] [TIFF OMITTED] T6746.307
[GRAPHIC] [TIFF OMITTED] T6746.308
[GRAPHIC] [TIFF OMITTED] T6746.309
[GRAPHIC] [TIFF OMITTED] T6746.310
[GRAPHIC] [TIFF OMITTED] T6746.311
<all>