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96–746 PDF 2005

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

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

KATHERINE HARRIS, Florida

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

——— ———

———

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

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

DOUG OSE, California

JO ANN DAVIS, Virginia

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

ELIJAH E. CUMMINGS, Maryland

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

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

(III)

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

(1)

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 socalled 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.

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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

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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.

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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

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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 CoVerDate 11-MAY-2000 15:03 Jan 15, 2005 Jkt 000000 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 D:\DOCS\96746.TXT HGOVREF1 PsN: HGOVREF1
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lumbia 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.

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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.

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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 recepVerDate 11-MAY-2000 15:03 Jan 15, 2005 Jkt 000000 PO 00000 Frm 00017 Fmt 6633 Sfmt 6633 D:\DOCS\96746.TXT HGOVREF1 PsN: HGOVREF1
14

tor, 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.

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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

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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 SchedVerDate 11-MAY-2000 15:03 Jan 15, 2005 Jkt 000000 PO 00000 Frm 00051 Fmt 6633 Sfmt 6633 D:\DOCS\96746.TXT HGOVREF1 PsN: HGOVREF1
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ule 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 addicVerDate 11-MAY-2000 15:03 Jan 15, 2005 Jkt 000000 PO 00000 Frm 00052 Fmt 6633 Sfmt 6633 D:\DOCS\96746.TXT HGOVREF1 PsN: HGOVREF1
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tion 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

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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

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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

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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

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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.

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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.

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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

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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

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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

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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

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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.

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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

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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 seVerDate 11-MAY-2000 15:03 Jan 15, 2005 Jkt 000000 PO 00000 Frm 00104 Fmt 6633 Sfmt 6633 D:\DOCS\96746.TXT HGOVREF1 PsN: HGOVREF1
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riously 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 StateFederal 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.

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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.

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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.

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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

105

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.

106

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.

107

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.

108

Mr. SOUDER. This case in Oregon questioned whether it could be

enforced if the person had a medical marijuana prescription.

Dr. DUPONT. My understanding, and there may be something

that happened recently that I’m not familiar with, but my understanding is that the Federal law is preemptive. So called medical

marijuana is a violation of this standard. So even if you have a

medical certificate, it’s a violation and you lose your license and

right to drive. That’s my understanding of the law.

Mr. SOUDER. I think it was a local court that challenged it.

Dr. DUPONT. But that has been the Department of Transportation standard. The previous administration took that position,

and this administration takes that position. There may be something that’s happened that I don’t know about just recently. But

that has been the position of the Department of Transportation

under both the Clinton administration and the Bush administration.

Mr. SOUDER. I’m not sure how this is going to move up the court

system, because it wasn’t a legislative decision. It was a court decision I’m very concerned about. Because if you can have this medical waiver and be driving a truck, we have a huge loophole here

unless we very tightly limit it, which I know is what the State

boards are trying to do, to address the abusive excesses of this. At

the same time, unless we radically control this, and somehow get

over this idea of State’s rights nullifying Federal law, we’re in deep

trouble in laws like that.

I thank each of you for coming today. If you have any additional

comments, you can put them into the record. I appreciate our having a continuing debate, and I’m sure it won’t have ended today.

With that, the subcommittee stands adjourned.

[Whereupon, at 4:40 p.m., the subcommittee was adjourned, to

reconvene at the call of the Chair.]

[Additional information submitted for the hearing record follows:]

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