[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]





     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
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                     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:]

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    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:]

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    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:]

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    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:]

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    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:]

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    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:]

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    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:]

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    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:]

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    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 
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