[House Hearing, 110 Congress]
[From the U.S. Government Printing Office]
DRUG ENFORCEMENT ADMINISTRATION'S REGULATION OF MEDICINE
SUBCOMMITTEE ON CRIME, TERRORISM,
AND HOMELAND SECURITY
COMMITTEE ON THE JUDICIARY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
JULY 12, 2007
Serial No. 110-111
Printed for the use of the Committee on the Judiciary
Available via the World Wide Web: http://judiciary.house.gov
U.S. GOVERNMENT PRINTING OFFICE
36-607 PDF WASHINGTON DC: 2008
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866)512-1800
DC area (202)512-1800 Fax: (202) 512-2250 Mail Stop SSOP,
Washington, DC 20402-0001
COMMITTEE ON THE JUDICIARY
JOHN CONYERS, Jr., Michigan, Chairman
HOWARD L. BERMAN, California LAMAR SMITH, Texas
RICK BOUCHER, Virginia F. JAMES SENSENBRENNER, Jr.,
JERROLD NADLER, New York Wisconsin
ROBERT C. ``BOBBY'' SCOTT, Virginia HOWARD COBLE, North Carolina
MELVIN L. WATT, North Carolina ELTON GALLEGLY, California
ZOE LOFGREN, California BOB GOODLATTE, Virginia
SHEILA JACKSON LEE, Texas STEVE CHABOT, Ohio
MAXINE WATERS, California DANIEL E. LUNGREN, California
WILLIAM D. DELAHUNT, Massachusetts CHRIS CANNON, Utah
ROBERT WEXLER, Florida RIC KELLER, Florida
LINDA T. SANCHEZ, California DARRELL ISSA, California
STEVE COHEN, Tennessee MIKE PENCE, Indiana
HANK JOHNSON, Georgia J. RANDY FORBES, Virginia
BETTY SUTTON, Ohio STEVE KING, Iowa
LUIS V. GUTIERREZ, Illinois TOM FEENEY, Florida
BRAD SHERMAN, California TRENT FRANKS, Arizona
TAMMY BALDWIN, Wisconsin LOUIE GOHMERT, Texas
ANTHONY D. WEINER, New York JIM JORDAN, Ohio
ADAM B. SCHIFF, California
ARTUR DAVIS, Alabama
DEBBIE WASSERMAN SCHULTZ, Florida
KEITH ELLISON, Minnesota
Perry Apelbaum, Staff Director and Chief Counsel
Joseph Gibson, Minority Chief Counsel
Subcommittee on Crime, Terrorism, and Homeland Security
ROBERT C. ``BOBBY'' SCOTT, Virginia, Chairman
MAXINE WATERS, California J. RANDY FORBES, Virginia
WILLIAM D. DELAHUNT, Massachusetts LOUIE GOHMERT, Texas
JERROLD NADLER, New York F. JAMES SENSENBRENNER, Jr.,
HANK JOHNSON, Georgia Wisconsin
ANTHONY D. WEINER, New York HOWARD COBLE, North Carolina
SHEILA JACKSON LEE, Texas STEVE CHABOT, Ohio
ARTUR DAVIS, Alabama DANIEL E. LUNGREN, California
TAMMY BALDWIN, Wisconsin
Bobby Vassar, Chief Counsel
Michael Volkov, Minority Counsel
C O N T E N T S
JULY 12, 2007
The Honorable Robert C. ``Bobby'' Scott, a Representative in
Congress from the State of Virginia, and Chairman, Subcommittee
on Crime, Terrorism, and Homeland Security..................... 1
The Honorable J. Randy Forbes, a Representative in Congress from
the State of Virginia, and Ranking Member, Subcommittee on
Crime, Terrorism, and Homeland Security........................ 2
Mr. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office
of Diversion Control, U.S. Drug Enforcement Administration,
U.S. Department of Justice, Washington, DC
Oral Testimony................................................. 5
Prepared Statement............................................. 8
Mr. David Murray, Director of Counter-Drug Technology, ONDCP, The
White House, Washington, DC
Oral Testimony................................................. 14
Prepared Statement............................................. 17
Mr. Edward J. Heiden, Ph.D., Heiden Associates, Inc., Washington,
Oral Testimony................................................. 22
Prepared Statement............................................. 23
Ms. Valerie Corral, founder of WAMM, Wo/Men's Alliance for
Medical Marijuana, Davenport, CA
Oral Testimony................................................. 26
Prepared Statement............................................. 28
Ms. Siobhan Reynolds, President, Pain Relief Network, Santa Fe,
Oral Testimony................................................. 32
Prepared Statement............................................. 34
Mr. John Flannery, Attorney, Campbell, Miller, Zimmerman, PC, and
Author of ``Pain in America--and How the Govenment Makes It
Worse!'', Leesburg, VA
Oral Testimony................................................. 39
Prepared Statement............................................. 41
Material Submitted for the Hearing Record........................ 77
DRUG ENFORCEMENT ADMINISTRATION'S REGULATION OF MEDICINE
THURSDAY, JULY 12, 2007
House of Representatives,
Subcommittee on Crime, Terrorism,
and Homeland Security
Committee on the Judiciary,
The Subcommittee met, pursuant to call, at 10:08 a.m., in
Room 2237, Rayburn House Office Building, the Honorable Robert
C. ``Bobby'' Scott (Chairman of the Subcommittee) presiding.
Present: Representatives Scott, Nadler, Forbes, Gohmert,
Staff present: Bobby Vassar, Subcommittee Chief Counsel;
Rachel King, Majority Counsel; Veronica Eligan, Professional
Staff Member; Michael Volkov, Minority Counsel; Caroline Lynch,
Minority Counsel; and Kelsey Whitlock, Minority Staff
Mr. Scott. The Subcommittee will now come to order, and I
am pleased to welcome you today to the hearing before the
Subcommittee on Crime, Terrorism, and Homeland Security on the
Drug Enforcement Administration's regulation of medicine.
The Subcommittee has received numerous complaints about the
Drug Enforcement Administration's regulatory hearings and at
this hearing we will focus on three areas: OxyContin action
plan, Operation Meth Merchant and prosecuting medical marijuana
When it was first introduced, OxyContin abuse became
rampant in such areas as Appalachia and rural New England. DEA
responded by adopting the OxyContin action plan, which involved
prosecuting medical doctors who prescribed high doses of
The DEA claims that this policy was not intended to impact
the availability of legitimate drugs necessary to treat
patients, however, the evidence suggests that the DEA's
decision to prosecute doctors has created a chilling effect
within the medical community, so that some doctors are
unwilling to prescribe pain medication in sufficiently high
doses to treat their patients. The result is that many
Americans live with chronic untreated pain.
The second issue is the DEA's Operation Meth Merchant, a
campaign whose goal is to foreclose the sale of ephedrine in
convenience stores and other small businesses, which the DEA
refers to as gray markets. The DEA bases its policy on the
belief that these businesses are the sources of material that
is used to manufacture methamphetamines.
However, there is evidence that DEA's policy is based on
faulty science and that the DEA may be engaging in racial
targeting. For example, in 2003, the DEA charged 49 store
clerks and owners with selling materials used to make
methamphetamines. Surprisingly, 44 of the 49 defendants were
Indian immigrants who spoke broken English.
The immigrants claimed no knowledge of the illicit drugs,
including the methamphetamines.
Now, finally, the third issue is the DEA's policy of
prosecuting medical marijuana users based on the scientific
conclusion that marijuana has no known medical benefit. The
Federal Government has a monopoly on growing marijuana for
research purposes and this practice has discouraged research
into the efficacy of medical marijuana, so that little progress
has been made toward determining if medical marijuana could
meet the FDA's approval standards.
Recently, a DEA administrative law judge ruled that it was
in the public interest for researchers to be permitted to grow
marijuana, and she recommended that the DEA grant a permit to a
University of Massachusetts professor. The DEA has yet to
decide whether it will follow the advice of the judge, which
could open the area for beneficial medical research.
Lastly, the FDA has continued to federally prosecute people
who use medical marijuana legally in their States, according to
State law. A well-known case is that of Valerie Corral, who
will be testifying before us today.
She and other patients at her hospice were arrested by
armed DEA agents. Even if the law technically gives DEA the
authority to investigate medical marijuana users, it is worth
questioning whether targeting gravely ill people is the best
use of Federal resources.
There has been little or no oversight in the DEA during the
last 12 years. In 1999, the GAO issued a report that was highly
critical of the DEA. The report said that the agency had no
measurable proof that it had reduced illegal drug supply in the
The DEA's use of heavy-handed tactics and its decisions to
investigate and prosecute people for illegal but minor conduct
is perhaps a response to that report.
Regardless, it is important that the agency have the
opportunity to explain its decision-making process and we hope
that this hearing will be the beginning of that dialogue.
And, with that said, it is my pleasure to recognize my
colleague from Virginia, the Ranking Member of the
Subcommittee, the Honorable J. Randy Forbes, who represents
Virginia's fourth congressional district.
Mr. Forbes. Thank you, Mr. Chairman, and I appreciate your
holding this oversight hearing on the Drug Enforcement
Administration. Today's hearing will focus on implementation
and enforcement of the combat methamphetamine act, which was
passed as part of the PATRIOT Act Reauthorization and
Improvement Act; medicinal marijuana; and pain-relief
I understand that additional oversight hearings will be
held so that we can focus on important issues, such as
enforcement of the narcoterrorism and criminal prohibition,
which was passed as part of the PATRIOT Act reauthorization;
illegal drug-trafficking activities along the Southwest border;
and DEA enforcement against major drug-trafficking
organizations and violent international and domestic gangs.
The combat meth act was a bipartisan measure to stem the
growth and spread of meth across our country. From all
accounts, the act has been successful in reducing the number of
home-grown methamphetamine labs in our country.
However, as we have reduced domestic production of meth,
Mexican super-labs have increased and illegal smuggling of meth
has grown. This highlights two important points. Border
security is needed, not only to reduce illegal immigration, but
to protect our country from illegal drug traffickers who
systematically smuggle large quantities of meth in our country.
And new tools and resources are needed to improve enforcement
against Mexican super-labs.
That is not the focus of today's hearings. While domestic
enforcement against the precursor industries is important, I
still think we need to address border security and drug-
On the two other topics of medicinal marijuana and pain-
relief treatment, again, they are important topics, but they
pale in comparison to----
Mr. Scott. The gentleman yields back his time, and I would
respond by saying that I think just all of the hearings that
you have suggested are on the agenda to be planned. One, you
mentioned gangs. We will be having a Juvenile Justice and
Delinquency Prevention Act oversight hearing with the Education
and Labor Subcommittee this afternoon.
Having two Committees on the same day is what we are having
to do to try to get in all the issues.
Mr. Scott. They are working on it now. They are working on
it from the seat of the Chair. We are working on that now.
I will introduce the witnesses.
Without objection, the other opening statements will be
included for the record.
We have a distinguished panel of witnesses before us today,
and I want to apologize because I have another meeting that
came up and I will be leaving and I will be coming back, and I
did read everybody's testimony last night. So when I come back,
I will know what you have said.
The first witness is Joseph T. Rannazzisi. He holds a B.S.
degree in pharmacy from Butler University and J.D. degree from
the Detroit College of Law in Michigan State University, is a
registered pharmacist in the state of Indiana, a member of the
Michigan State Bar Association. He began his career with the
U.S. Drug Enforcement Administration in 1986.
In 2006, he was appointed to the position of Deputy
Assistant Administrator for the Office of Diversion and
Control, where he is responsible for overseeing and
coordinating major diversion investigations, among other
The second witness is Dr. David Murray, who received an
M.A. and Ph.D. from the University of Chicago, subsequently
taught at Connecticut College, Brown University and Brandeis
University before coming to Washington, where he has served as
an adjunct professor in the Graduate School of Public Policy at
He co-authored most recently the book, ``It Ain't
Necessarily So,'' how media remakes the scientific picture of
reality. He has served as special assistant to the director of
the ONDCP, the drug office in the White House, and currently is
the director of Counterdrug Technology Assessment Center.
Next witness is Edward Heiden. He received his Ph.D. in
economics from Washington University in St. Louis, specializing
in industrial organization. He is also a Woodrow Wilson scholar
at Harvard University. He is president of Heiden Associates,
the Washington, DC, economic and product safety consulting
firm, and he has directed studies on health, safety and
environmental regulation and economic issues for numerous
private and government clients. He testified as an expert
witness before a number of courts and administrative and
Prior to becoming a consultant, he held a number of senior
positions in Federal Government, including chief planning
economist at the Federal Trade Commission and the White House
Office of Consumer Affairs.
Next to testify will be Valerie Corral, founder of WAMM,
the Wo/Men's Alliance for Medical Marijuana. For 14 years, WAMM
has provided seriously and terminally ill patients with medical
marijuana at no cost. It is the longest-running medical
marijuana provider in the Nation and for a time had the only
legal garden in the Nation.
It was instrumental in the passage of Proposition 215 and
most recently was involved in the Federal lawsuit Santa Cruz
versus Gonzales. She is appointed by the California State
Attorney General to the medical marijuana task force and served
on the commission for 3 years.
Next will be Siobhan Reynolds, who graduated with a B.A. in
political science from Pitzer College and received her M.A. in
liberal education from St. John's College in Santa Fe, New
Mexico. She has a master's degree in fine arts from Actor's
Studio Program in New York City.
In the mid-1990's, Ms. Reynolds became aware of the lack of
available pain care in the United States, and after marrying
Sean Greenwood, a man with an undiagnosed congenital connective
tissue disorder. She discovered that it was impossible to
secure treatment for her husband.
Following the eventual death of her husband in August of
2006, she organized the Pain Relief Network to redouble its
efforts to help people suffering from chronic pain.
Lastly, John P. Flannery, who holds a bachelor's degree in
physics from Fordham and a bachelor's degree in industrial
engineering from Columbia and a law degree from Columbia and
master's degree in information science from George Washington
graduate business school.
He is a former Federal prosecutor from New York, has held a
number of positions on Capitol Hill. His most recent position
was chief of staff for Congresswoman Zoe Lofgren, a Member of
After leaving Congress, he returned to practice law with
Campbell Miller Zimmerman, where he has represented several
doctors in cases involving prescription of pain medication. He
is the author of the book, ``Pain in America--And How Our
Government Makes It Worse!''
Each of our witnesses' written statements will be made part
of the record in its entirety. I would ask that each witness
summarize his or her testimony in 5 minutes or less.
And to help the witnesses stay within the time, there is a
timing device just in front of us. The light will go from green
to yellow with 1 minute left and, finally, to red when 5
minutes are up.
TESTIMONY OF MR. JOSEPH T. RANNAZZISI, DEPUTY ASSISTANT
ADMINISTRATOR, OFFICE OF DIVERSION CONTROL, U.S. DRUG
ENFORCEMENT ADMINISTRATION, U.S. DEPARTMENT OF JUSTICE,
Mr. Rannazzisi. Thank you and good morning, Chairman Scott,
Ranking Member Forbes and distinguished Members of the House
Subcommittee on Crime, Terrorism, and Homeland Security.
On behalf of Administrator Karen P. Tandy and the men and
the women of the Drug Enforcement Administration, I want to
thank you for the opportunity it discuss and hopefully resolve
some misconceptions about DEA's enforcement of its statutory
I would like to comment at the outset, that the title of
this hearing, ``DEA's Regulation of Medicine,'' is inaccurate.
DEA does not regulate medicine or the practice of medicine.
DEA does investigate violations of the Controlled
Substances Act, regardless of the source of the violation, be
it a Columbian cocaine dealer, a marijuana trafficker or a
doctor who abuses the authority to dispense controlled
substances. DEA's mission statement is more than a cliche
crafted to meet public relations need or strategy directive. It
is the essence of the agency.
The statement begins, ``The mission of DEA is to enforce
the controlled substances laws and regulations of the United
States of America.'' It is with that mission in mind that the
agency conducts its work against methamphetamine manufacturers,
illegal prescription drug suppliers, marijuana distributors and
others who violate the Controlled Substances Act.
In the 1990's and early 21st century, America watched a
home-grown epidemic in the form of methamphetamine spread
across the Nation. Unlike most other illicit drugs,
methamphetamine is easy to make from inexpensive, readily
Accessibility of precursor chemicals caused a boom in the
number of small labs that fed a growing addict population. The
need to control access to these chemicals resulted in the
passage of the Combat Methamphetamine Epidemic Act. This law
complemented similar efforts by States and provided tools for
Federal law enforcement and regulators to monitor precursor
sales at the wholesale and retail levels.
Through these legislative efforts, DEA has seen a 58
percent drop in laboratory sites seized in 2006 over those of
2005. Equally important to this dramatic reduction in lab sites
is the fact that agents and officers can now direct their law
enforcement efforts elsewhere.
Investigations involving methamphetamines labs and their
subsequent clean-ups have traditionally consumed a significant
number of man hours and have caused considerable drain on
The increasing abuse of prescription drugs is one of the
most significant challenges DEA is currently facing. As you
know, one of the Administration's goals is to reduce the abuse
of prescription drugs by 15 percent between 2005 and 2008.
This requires DEA to prevent to the diversion of
pharmaceutical drugs, while ensuring an adequate supply for
legitimate needs. We know that the diversion of pharmaceuticals
occurs from a number of sources, including a small number of
That said, doctors should not hesitate and should continue
to provide their patients with whatever treatment they feel
appropriate, as long as it is for a legitimate purpose and done
in the usual course of medical practice.
Generally speaking, in any given year, DEA arrests less
than 0.01 percent of the 750,000 doctors registered with DEA
for a criminal violation. More often than not, those violations
are egregious in nature and are acts clearly outside the usual
course of accepted medical standards.
Examples of these acts include such things as trading drugs
for sex, self-abuse of drugs and trading prescription drugs for
crack cocaine. Illegal Internet sales, fraudulent prescriptions
and outright theft are other ways that drug dealers are able to
illegally provide prescription drugs to addicts.
No one should underestimate the potential damage that these
substances can do when taken improperly. DEA has recently taken
several steps to assist doctors in understanding the
expectations of the law and aid them in meeting these
While there are always those on the fringe who think the
laws should not apply to them, the steps that DEA has taken
have generally been met with expressions of approval and even
appreciation. Most medical practitioners, particularly those
who specialize in the treatment of pain, are tired of a few bad
physicians giving their entire profession a bad name.
DEA believes that the efforts it has made, including
issuing a policy statement reiterating the requirements of the
Controlled Substances Act and proposing a rule that would allow
doctors to issue multiple schedule two prescriptions for up to
a 90-day supply in a single office visit has significantly
improved the medical community's understanding of what are and
are not the legitimate ways to prescribe controlled substances.
We believe these efforts will assist the medical community
to perform their responsibilities and understand the law.
Similarly, understanding DEA's activities regarding
marijuana can also be traced back to our defined legal
authorities. Like heroin and LSD, marijuana is listed by law as
a schedule one controlled substance.
Approval to conduct research using any schedule one
substance, including cannabis, is a process in which both DEA
and the Food and Drug Administration play a role. The FDA
reviews the merits of the protocol, qualifications and
competency of the applicant, while DEA determines the adequacy
of the necessary security arrangements.
Once these reviews are completed, DEA can issue a
registration. DEA cannot make a judgment as to the legitimacy
of the research, and DEA has never denied registration to a
researcher whose application has been approved by the FDA and
who has had adequate security to prevent diversion of
[The prepared statement of Mr. Rannazzisi follows:]
Prepared Statement of Joseph T. Rannazzisi
Mr. Nadler. [Presiding.] Thank you.
I now recognize Dr. Murray for 5 minutes.
TESTIMONY OF DAVID MURRAY, DIRECTOR OF COUNTER-DRUG TECHNOLOGY,
ONDCP, THE WHITE HOUSE, WASHINGTON, DC
Mr. Murray. Thank you very much, Mr. Chairman, in absentia,
Ranking Member Forbes and distinguished Members of the House
Mr. Nadler. You need to speak up and speak to the
Mr. MurraT1 [continuing]. Indeed--and Judiciary
Subcommittee on Crime, Terrorism, and Homeland Security. Thank
you for the opportunity to appear before you today to discuss
our national efforts to reduce drug use in America and to
discuss Federal drug policy regarding medical marijuana under
State law, or so-called medical marijuana.
I do want to stress that their is good news out there. Let
us not lose track of that, regarding the drug war. Youth use of
all drugs is down by 23 percent over the last 5 years. Youth
use of marijuana is down by 25 percent.
Youth use of specific drugs such as methamphetamine is down
by over 40 percent. Yet, against this backdrop, we face a
stubborn debate that is ongoing for quite a while regarding the
status of claims that marijuana is somehow an acceptable
It is not the medical community, Mr. Chairman, who pushes
this issue. It is not the medical community who identifies a
need out there for a smoked weed to alleviate pain and
suffering. Rather, this is an issue that is pushed
overwhelmingly by legalization advocates for marijuana who fund
initiatives and referenda in various States, trying to push
through what we think is a troubling development.
First of all, let us reiterate, there is no evidence by the
bodies that are charged with making this determination that
marijuana is effective as a medicine for any medical condition
and no evidence of marijuana's safety. That is why it remains
in schedule one, as approved by the FDA and as judged by the
DEA, as a substance without medical utility.
Moreover, there are superior substances already available
in the medical community for treating the diseases for which
marijuana purportedly is efficacious.
Secondly, the charge to medicine is first do no harm. There
is increasing scientific evidence that marijuana actively is
harmful to those for whom it was intended to be a healing
In fact, the evidence of smoked marijuana, a contaminated
product of raw weed with carcinogens in it and the active
ingredients themselves produce effects----
Mr. Nadler. Mr. Murray, do you think it is as harmful as
Mr. Murray. Sir, if you are looking at the issue of an
approved medicine that would be used--excuse me, sir.
Mr. Forbes. Mr. Chairman, a point of order. Mr. Chairman,
can the witness make his statement and then we----
Mr. Nadler. I just wanted to ask him that one question,
because he was saying how harmful it is. I think he is
Mr. Forbes. Can we not take away his time?
Mr. Nadler. I am not going to take away his time. I just
asked to answer that question, and we will give you the time.
Mr. Forbes. Well, just I would like to request regular
order, Mr. Chairman. That is highly irregular.
Mr. Murray. Thank you, sir.
I believe they present different threats in different
communities. There is no effort to say that nicotine should be
treated as a medicine and dispensed for the cure of cancer.
That is because, in its smoked form, it is quite virulent and
Marijuana, however, likewise, is a smoked weed that that is
offered as though it were therapeutic and efficacious, as
though it had healing powers. The active ingredient in
marijuana, increasingly, science has shown, is a risk-producing
substance that is an intoxicant, that produces dependency and
It is an addictive substance that has impact, particularly
on the vulnerable. Those with psychotic predispositions, those
with inclinations toward depression, toward schizophrenia, they
are profoundly affected by this drug and it is risky to them
It should not be treated as though it were benign. It is a
dangerous substance that produces active harm to those for whom
it would be offered.
Moreover, the presence of medical marijuana dispensaries in
communities themselves turns out to be a harmful dimension.
Increasingly, we are learning that these dispensaries are
fronts for, increasingly, drug-dealing crime, that they are
neighborhood nuisances, increasingly associated with high
crime, with noise, with disruption, that communities
increasingly are turning against and troubled by.
We are seeing evidence, moreover, from time to time, that
the medical marijuana movement has not been driven by medicine
but has been driven by politics and by many instances taken
over by criminal elements that are quite dangerous.
We think that, basically, you are going to hear forms of
argument that will anecdote. Tragic tales of suffering, no
matter how genuinely believed in, no matter how emotionally
laden they may be, that is not the way we make public policy
decisions about what is an approved medicine--by tragic tales
or by accounts of suffering.
Rather, it is in a court of medicine and in a court of
science that a drug is approved as being safe and effective and
marijuana has never been able to successfully pass that test.
What we are going to hear will be arguments that somehow we
should get out of the way and let marijuana be offered as
medicine. We think this is a fraud. We think this is a
The medical marijuana movement is at best a mistake, at
worst, a deception, and it has another victim involved here,
the integrity of the drug approval process in America, which is
entrusted to the FDA, has kept America safe with regard to its
We should not bypass that. We should not political
theater--or political pressure groups try to approve medicines,
which in fact damages the integrity of our drug approval
process. If and when marijuana has substances in it that are
shown to be efficacious, therapeutic, it will be done in the
scientific community, and it will not be offered in the form of
a raw, crude, smoked weed.
We know this from the scientific community. We know this
from the medical community. And the people pushing for this are
cynically manipulating tragic tales of suffering in such a way
as to create--and not win in a court of medicine and science.
I will be happy to answer your questions, sir.
[The prepared statement of Mr. Murray follows:]
Prepared Statement of David Murray
Mr. Nadler. I thank the gentleman.
I now recognize Dr. Heiden for 5 minutes.
TESTIMONY OF EDWARD J. HEIDEN, PH.D.,
HEIDEN ASSOCIATES, INC., WASHINGTON, DC
Mr. Heiden. Thank you. I appreciate the opportunity to
appear before this Subcommittee to present my views regarding
various activities of the U.S. Drug Enforcement Administration.
My name is Edward J. Heiden. I am president of Heiden
Associates, an economic consulting firm specializing in health
and safety issues and located in Washington, D.C.
Early this year, my firm and I were retained by the
American Council on Regulatory Compliance, ACRC, an association
that represents suppliers of pseudoephedrine and ephedrine-
based products, such as over-the-counter cough and cold and
asthma relief medications and whose members sell primarily to
convenience stores and other non-mass merchandiser channels.
Our assignment was to help them respond to a DEA draft
report published for comment in the Federal Register that
contained DEA's 2007 national estimate of legitimate medical
need and use for ephedrine and pseudoephedrine and prescription
drug and over-the-counter products.
We were asked to examine two issues, the soundness of the
data and methodology used by FDA to prepare the report and the
estimate and whether the legitimate supply needs of ACRC member
firms for ephedrine-based products to sell had been adequately
taken into account by the DEA draft needs assessment.
ACRC members were seriously concerned that their needs were
not being adequately considered, if at all. A few of them
indicated that they had not been consulted--many of them
indicated they had not been consultant as the needs assessment
was being prepared, and a few indicated, once they saw the
assessment, that it was far less in total for the country as a
whole than just their own sales to convenience stores and other
non-mass merchandising channels.
Let me briefly summarize our work. DEA's assessment relied
on a study by its contractor, IMS Health Government Solutions,
to estimate medical needs for ephedrine and pseudoephedrine,
based on data the company routinely collects on sales to retail
establishments, patients and insurers.
The problem with this data is, and the report of DEA, that
it was very sparse and provided very, very incomplete
documentation as to its methodology, as to how the data was
used. And, like much of the evidence that an interested and
engaged analyst would need and expect to have to determine
exactly how that methodology was applied, elementary materials
such as key data files were not there, were missing. And, in
one important instance, the agency refused to provide us and
ACRC with access to a key set of spreadsheet data.
Likewise, DEA's treatment of how the needs of the
convenience store market channel was treated in its national
estimation process is vague and confusing. Even though
convenience stores are mentioned by DEA as a channel that was
included in the study, there is no way you can tell exactly how
they were included.
In fact, as a starting point of data that we got, we
obtained from DEA a copy of the product code listed by DEA's
contractor for the study, IMS. Reviewed by industry numbers, it
showed that not one of the ACRC member products was included in
the initial DEA product inventory used to develop sales
estimates for the ephedrine and pseudoephedrine needs
So none of the products was considered to be in scope for
purposes of development of that needs assessment and not one of
them, as I said, had been queried by DEA or its consultant as
part of the needs assessment development process.
So we conducted our own study of ACRC needs and sales by
working with industry members to give us such sales on a
confidential basis and then consulting with the board members
to determine what this was. ACRC member firms told us when we
aggregated the data that, collectively, the products they sold
to convenience stores and other channels represented a
tremendously large amount more, seven times more, than the
amount DEA proposed as its preliminary 2007 annual needs
How could something like this happen? How come the DEA
study missed such a large part of the overall market for
ephedrine-based products of convenience stores?
I think there are several possible reasons why DEA might
have missed so much ephedrine-based products sold through non-
mass market merchandising channels. First, many of the
companies involved in making it and marketing it----
Mr. Nadler. The witness's time has expired.
Could you wrap up, please?
Mr. Heiden. Well, as I said, there are several reasons why
this might have happened: technical, economic reasons. But, in
conclusion, I would say that besides not documenting the
procedures and denying access to data that could have indicated
what was happening in this situation, it is quite obvious that
this failure has caused DEA to propose an unrealistically low
preliminary estimate for the amount of ephedrine required for
If this estimate stands as the basis for DEA
decisionmaking, substantial hardships are likely to result, not
only for numerous suppliers in the distribution chain and those
who are employed by them, but also for the many asthmatics and
others in legitimate medical need who rely on convenience
stores and small retailers in locations where other retail
outlets, like mass merchandisers, Targets, et cetera, are
nonexistent or are only open during daytime or early evening
[The prepared statement of Mr. Heiden follows:]
Prepared Statement of Edward J. Heiden
Good morning. My name is Dr. Edward J. Heiden. I am president of
Heiden Associates, Inc., an economic consulting firm specializing in
health and safety issues and located in Washington DC. For the past 26
years, Heiden Associates has been assisting companies and trade
associations in examining the economic impact of government regulation.
A statement of our corporate capabilities and my resume is attached.
Early this year my firm, Heiden Associates, and I were retained by
the American Council on Regulatory Compliance (ACRC)--an association
representing manufacturers, importers, and distributors of
pseudoephedrine and ephedrine-based products such as over-the-counter
cough and cold and asthma relief medications, whose members sell
primarily to convenience stores and other non-mass-merchandiser
channels. Our assignment was to help them respond to a draft report,
prepared by DEA and published for comment in the Federal Register,
containing DEA's 2007 national estimate of legitimate medical need and
use for ephedrine and pseudoephedrine in prescription drug and over-
the-counter (OTC) products.
We were asked to examine two issues: (1) the soundness of the data
and methodology used by DEA to prepare its report and estimate; and (2)
whether the legitimate supply needs of ACRC member firms for ephedrine-
based products to sell had been adequately taken into account by the
DEA draft needs assessment. ACRC members were seriously concerned that
their needs had not been adequately considered, if at all. For
instance, members indicated they had never been consulted as the needs
assessment was being prepared. A few also indicated, after initially
examining the DEA analysis, that the entire estimate of national need
for ephedrine contained in the report was far lower than the supply
need represented just by what they knew to be their own sales to
convenience stores and other non-mass-merchandising channels.
We briefly report below on the results of our work, and the
conclusions and recommendations we have drawn from it.
summary of our work
Analysis of DEA Methodology and Treatment of Ephedrine Needs for
Product Sellers to Convenience Stores and Related Market
DEA's assessment relied on a study by its contractor, IMS Health
Government Solutions (IMS), to estimate medical needs for ephedrine and
pseudoephedrine based on data that the company routinely collects and
offers annually to customers. IMS used several types of data for its
study--sales to retail establishments (including pharmacies), sales by
retail establishments to patients, and medical insurance claims.
However, the DEA report itself provided very sparse and incomplete
documentation as to how this data was used, and lacked much of the
evidence that an interested and engaged professional analyst would need
and expect to have in order to determine exactly how the methodology
was actually applied. Elementary supporting materials, especially the
data files and calculations that would show the key procedures used,
were missing, and in one important instance the agency refused to
provide us with access when we made a request.
Likewise, DEA's treatment of exactly how the needs of the
convenience store market channel was treated in the national estimation
process is vague, confusing, and even contradictory in several
important respects. For example, even though convenience stores are
mentioned by DEA as a market channel included in the study, there is no
way that an analyst can tell how the major data sources used by DEA
actually treat the sales of such stores in their role as suppliers of
ephedrine and pseudo-ephedrine products for sale to the public. Without
any documentation, explanation, or citation to source data, the report
simply states that the convenience store channel had less than 0.1
million grams of legitimate OTC ephedrine-based product purchase needs.
Development of Independent Estimates of Ephedrine Needs for Convenience
Store and Related Market Channels.
Because of this lack of documentation or explanation by DEA of its
estimates, and the strong view by ACRC members that DEA's estimate of
less than 0.1 million grams to convenience stores and other non-mass-
merchandiser channels lacked foundation, Heiden Associates conducted an
independent examination of the need for ephedrine-based products in
these market sectors. As a starting point, we obtained from DEA,
through the ACRC, a copy of the product code listing used by DEA's
contractor for the study, IMS, to develop its estimates. Once we
received this listing, we asked ACRC industry members to review it.
Review by industry members showed that not one of the ACRC member
products was included in the initial DEA product inventory used to
develop sales estimates for the ephedrine and pseudo-ephedrine needs
assessment. This means that none of these products was considered to be
``in scope'' for purposes of development of the DEA needs assessment.
Further, ACRC members indicated that not one of them had been
interviewed or queried by DEA or its consultant as part of the needs
assessment development process.
Consequently, since it was clear that DEA and its consultant IMS
were not adequately capturing the sales of legitimately marketed
ephedrine-based products, we felt it was necessary to work directly
with ACRC staff and member firms on a confidential reporting basis to
develop preliminary estimates of ephedrine-based OTC products to
convenience stores and related channels. Specifically, we asked
individual participating manufacturers, importers, and distributors to
provide 2005 estimates of their total unit sales of ephedrine-based
products for medical use and the channels through which they
distributed these products. We also interviewed ACRC Board members to
obtain their best assessments of the overall size of ephedrine-based
product sales to convenience stores, the sector accounting for the
largest portion of ACRC member industry sales. In addition, we
consulted various extrinsic data sources to develop a profile of the
economic importance of convenience stores and other non-mass-
merchandising distribution channels that appeared not to have been
adequately captured in the DEA consultant's study.
Eight ACRC member firms in all, of varying size and type
(manufacturer, importer, and distributor) responded to our request for
relevant sales data. In all, these eight firms sold more than 1.5
billion doses of 12.5 and 25 mg ephedrine-based products in 2005 to the
public. About 80 percent of these sales were made through ``bricks and
mortar'' outlets such as convenience stores and small independent
grocers, with the remainder reported through mail order and online
channels. Collectively, these products contained approximately 27,880
kilograms of ephedrine, or more than seven times the amount DEA
proposed as its preliminary 2007 annual needs estimate.
In reviewing DEA's own statistical data, it has become clear to me
that these products are not the major source of diversion for the
production of methamphetamine. According to DEA Administrator Tandy's
recent testimony before the Senate Foreign Relations Committee: ``. . .
super labs, which are primarily controlled by Mexican drug trafficking
organizations . . . are supplying the majority of the methamphetamine
consumed in this country.'' The vast bulk of the products found in
small toxic methamphetamine laboratories are name brand pseudoephedrine
cough and cold products, such as Sudafed, purchased in large chain
pharmacies and mass merchandisers. The products distributed by the ACRC
and other small distributors are off brand combination ephedrine asthma
relief products, which are not found in these illicit laboratories as a
precursor to make methamphetamine.
How is it possible that the DEA/IMS study missed such a large
portion of the overall market for ephedrine-based products in its
estimates? It is not as if the convenience store and online/mail-order
market sectors are inconspicuous: according to the most recent source
data available, convenience stores and online/mail order firms sold an
estimated $644 million of non-prescription medicines in 2002, with more
than 38,000 convenience stores selling non-prescription medicines.
There are several possible reasons why DEA might have missed so
much ephedrine-based product sold through non-mass-merchandising
First, many of the companies involved in manufacturing and
marketing ephedrine-based asthma products are also in the business of
producing and distributing dietary and nutritional supplements, sales
of which are tracked under a separate product code than under the code
for non-prescription medicines. It is very possible that retail
establishments might bundle products distributed by ACRC members and
other similar firms under a product code such as vitamins, minerals,
and other dietary supplements, or even general merchandise, that is not
defined as within the scope of the IMS study.
Second, many convenience stores and independent grocers,
particularly smaller ones in center city and rural locations still do
not have the ability to scan individual product purchases. Non-scanning
convenience stores are not likely to have been included in the
databases used for the DEA needs assessment, which rely heavily on
Third, the participants in the DEA needs assessment data base used
to track OTC drug purchases (Homescan) may have under-represented
poorer, lower health status households in urban and rural areas, as is
sometimes the case with national consumer market panels that we have
worked with in past studies. In this connection, it is important to
note that it is convenience stores and small retailers in these less
completely-tracked locations who are most likely to make products
available to asthmatics where other retailers are non-existent or are
open only during daytime and early evening hours. IMS does not have the
ability to accurately capture convenience store data.
The lack of access to data that serve as the foundation of the IMS
study estimates and the sparse, non-transparent, confusing, and in some
cases seemingly contradictory documentation of the procedures used to
derive the annual needs assessment from these data make it difficult to
determine whether the DEA has correctly characterized the volume of
ephedrine requirements for prescription and non-prescription products
sold in chain drug stores, large grocery chains, and mass
merchandisers. However, it is obvious that the IMS study failed to
incorporate any data on ephedrine-based products lawfully marketed by a
substantial and economically significant sector of manufacturers,
importers, distributors, and retailers who market primarily through
convenience stores and online/mail-order channels. This failure has
caused the DEA to propose an unrealistically low preliminary estimate
for the amount of ephedrine required for legitimate needs in 2007.
Should this estimate stand as the basis for DEA decision-making,
substantial hardships are likely to result not only for numerous
suppliers in the distribution chain and those who are employed by them,
but also for the many asthmatics and others in legitimate medical need
who rely on convenience stores and small retailers in locations where
other retail outlets (such as mass merchandisers) are non-existent or
only open during daytime or early evening hours.
We encourage the DEA to revisit this issue and make the data and
analysis that underpin the IMS study estimates available for review
under appropriate restrictions to ensure confidentiality and limit the
use of the data. With access to these materials, we are confident that
we would be able to work with DEA and/or IMS analysts to develop a
fuller and more complete picture of the market needs for ephedrine-
Mr. Nadler. Thank you very much.
I will now recognize Ms. Valerie Corral for 5 minutes.
TESTIMONY OF VALERIE CORRAL, FOUNDER OF WAMM,
WO/MEN'S ALLIANCE FOR MEDICAL MARIJUANA, DAVENPORT, CA
Ms. Corral. Thanks to the Honorable Chair and
distinguished--it is not on. Thank you.
There we go, thanks.
Honorable Chair and distinguished Committee Members, I
thank you for this opportunity to speak before you today. I am
Valerie Corral and I am the co-founder of the Wo/Men's Alliance
for Medical Marijuana, with my husband Mike Corral.
We reside in Santa Cruz, California. We run a medical
marijuana hospice facility and we have done so since 1993.
Following an automobile accident in which I happened to be in
with an airplane, my life changed dramatically.
I became an epileptic and suffered as many as up to five
grand mal seizures a day. In the early 1970's, under the Nixon
administration, some research on medical marijuana was being
done. However, President Nixon's administration blocked that
But, prior to that, my husband had read in a medical
journal that marijuana had been successfully used to treat
laboratory-induced seizures in rats. It was really quite
unbelievable that marijuana might control the seizures that I
was experiencing, when FDA-approved medicines could not. In
fact, I did not believe it, at first.
As time passed, our experience led us to quite a remarkable
healing, if you will. I still experience some difficulty,
neurological problems. However, I don't have seizures.
This also led us to work more broadly in our community.
People who lived in our community contacted us about the
possibility of working with them, and we began this small
outreach program by growing a collective garden of medicine in
which our members or their caregivers participated.
This is quite remarkable--over the 14 years that we have
conducted our operation, 189 of our members have passed. That
gives me, while not the experience of dying, quite a remarkable
experience, that which most people don't have the opportunity
to participate in.
And what we found is that each of our members--and not
everybody that comes to WAMM finds marijuana to be a useful
medicine. However, those that stay with us do.
These 189 people, of which I have been at the bedside of
more than 100, tell us that maijuana works. And while Dr.
Murray has expressed in his testimony that patients say we feel
better, I ask the Committee, isn't that really what every
doctor asks? Do you feel better? Is the medicine working? And
when we say yes, doctors believe us. Why not with this
When I received confirmation that I would be here today
speaking before you, I was at the bedside of a dear friend of
mine of more than 30 years. Little did I know that she would
become a WAMM member.
She lay dying of ovarian cancer. She is the single mother
of a 15-year-old daughter. That child grew up in our
collective, respecting her mother's medicine, understanding the
difference between an abuse and a recreational drug and a very
important, life-altering medicine, pain-relieving medicine.
In a word, I cannot call the members of my community liars.
We have worked diligently since the early 1990's on State law,
on county law and on city law. We work very close with law
enforcement. We are transparent in our work and we offer
medicine at no cost.
We have changed the laws in each governing body, very
slowly, but it has worked. We have convinced people of our
truth by living in this transparent reality.
In 2002, the DEA raided our small collective, arresting
both my husband and myself and this set our members into a
panic, as you might imagine. Yet, while illness is a great
enemy, fear is even greater. And we continued our work, as we
do to this day.
It is not that we wish to break the law, for surely we do
not. We have made every effort to change it.
I ask for a few things here today. One is that I realize
that I can't change America. I know that. But there are simple
things that we can do to relieve human suffering.
When you stand next to a person who is dying, and I suspect
that all of you have had an experience, or will, that it
changes you. You do what you can to relieve that suffering.
We use allopathic medicines, pharmaceuticals, of course.
They are remarkable pain relievers and assist people in
expanding their lives.
But what we ask here today is that you stop the aggressive
antics of the DEA against sick and dying people, because that
is what we are. Stop the raids. Allow research to continue.
Allow the research to continue that the DEA is blocking in the
Craker case, for instance, because only you can do that.
We offer you our testimony and we offer you the truth, and
we ask that you allow us the opportunity to relieve our
suffering, because only can do that.
Mr. Nadler. Time of the witness has expired. You may
Ms. Corral. That is it, and thank you so much.
[The prepared statement of Ms. Corral follows:]
Prepared Statement of Valerie Corral
Mr. Chairman, distinguished members of the committee, I thank you
for inviting me to speak today.
Upon receiving confirmation that I would have the privilege to
appear before you, my elation was tempered only by exhaustion. For
three nights I have had the honor of caring for my beloved friend, a
member of WAMM, the medical marijuana hospice that I co-founded, and
medical marijuana patient who is nearing the end of her struggle with
ovarian cancer. She is the single mother of a 15-year-old daughter, and
today she lays dying at her home in Santa Cruz. As I stood by her
bedside, the impact struck me deeply, and the importance of this
opportunity grew profoundly tangible. It is difficult to deny personal
experience, and having repeatedly witnessed the relief of suffering in
hundreds of my dying friends leaves little room for doubt.
Today, thousands of seriously ill Americans face arrest and
prosecution at the hands of the federal government. Why? Because our
doctors recommend a medicine that is condemned without evidence.
Science does not form the basis of the irrational decision to hold this
medicine hostage. Yet, sick and dying Americans are willing to risk
imprisonment because suffering is a greater enemy than the fear of our
own government. We rely on the medicinal properties unique to marijuana
to help us cope with a variety of debilitating diseases, including
AIDS, cancer, epilepsy and multiple sclerosis. Marijuana provides
otherwise unattainable relief from an array of unbearable symptoms,
such as chronic pain, intractable vomiting and muscle spasticity, as
well as from the side effects of allopathic drugs, pharmaceuticals that
cause addiction, nausea and confusion. This simple medicine allows
seriously ill people to gain a measure of control over symptoms and, in
turn, the ability to affect the circumstances of death.
Despite the testimony of thousands of patients and doctors, coupled
with a tome of scientific research confirming marijuana's medical
value, our government, specifically the Drug Enforcement Administration
(DEA), remains married to subversion in its denial of a state's right
to protect its seriously ill citizens. It is not the purpose of
government to stymie medical science, but to avail itself to the
gathering of knowledge as it seeks to create a compassionate response
to the ills of a nation and its people. Devoid of scientific rationale,
the federal intransigence toward medical marijuana appears to be rooted
in the political calculations of the ``War on Drugs.'' Can our elected
officials ignore an ever-growing patient force that decries the callous
antics of a government which puts politics before people's lives?
On March 23, 1973, at the age of 20, I suffered a severe closed
head trauma in a serious automobile accident, and my life was changed
forever. As a result of the accident, I began to suffer as many as five
gran mal seizures a day. When I began to convulse, my parents would
hold me on the floor while I foamed at the mouth and lost control of my
bladder, urinating all over myself. During the seizures, I had no
conscious control over my body, my mind or my being. Following the
seizures, I typically slept for several hours and would wake up in
tremendous pain with no memory of the seizures.
Doctors prescribed a myriad of anticonvulsants and pain
medications. But the medications did not prevent the seizures and only
minimally reduced my pain. Since phenobarbital and Dylantin offered
little reprieve from the convulsions, my doctors added more
prescription medications to my regimen. They prescribed a crippling
anti-epileptic drug called Mysoline along with Percodan and Diazepam
for pain. I did not fare any better with these medications. Each left
me drunk with side effects and failed to alleviate my seizures. No
medication or treatment offered me any hope.
These anti-convulsant and pain medications also sedated me to the
point that I lived in a near vegetative state. My parents described me
as ``catatonic.'' I felt like I was living under water. I was wholly
dysfunctional. Friends and family had to remind me to eat. I could not
think clearly. I slept fitfully. My doctors changed my medications and
tried different dosages, but the seizures continued to strike with
little warning. The medications affected my vision, disabling my
ability to read. They also affected my joints and connective tissue, my
kidneys and liver, and they depleted my white blood cells, diminishing
my immune system and rendering me vulnerable to viruses. I constantly
battled ordinary colds and flus, which often resulted in
Eventually, I became physically dependent on my medications. I
descended into a deep pharmaceutical darkness that paralyzed me. I
could not work. I discovered that I could not even cross the street by
myself after an incident where I walked into oncoming traffic. On
another occasion, I nearly drowned while taking a bath. I could not
complete the simplest of tasks. Family and friends would not leave me
unattended, because at anytime I could have been overcome by a seizure
and injure myself. I spiraled into the isolation resulting from both
the illness and the only drugs available to treat it. I survived this
way for more than two years.
Meanwhile, my husband and caregiver, Mike Corral, scoured
scientific and medical journals for a sign of some promising new
therapy. His thorough research uncovered information that changed my
life forever. He found an article published in a medical journal in the
early 1970's, discussing marijuana's ability to control laboratory
induced seizures in rats. This revelation, though hard at first for us
to believe, offered a rare glimmer of hope. I yearned for any
alternative to the powerful, debilitating prescription drugs and the
ravages of the seizures and pain that consumed me. I obtained a small
amount of marijuana and found that smoking it diminished my seizure
activity almost immediately. Mike and I carefully figured out how much
and with what frequency I should use medical marijuana to stave off my
symptoms, and I adhered to that religiously. Whenever I felt an aura
(the premonitory sensation that often precedes a seizure), I smoked a
little more. To our amazement, it halted the onset of convulsions.
For the next two-and-a-half years, I slowly decreased the dosages
of my various prescription drugs and finally stopped my anti-
convulsants altogether. The only medication that I continue to rely on
is marijuana. It controls my seizures and restores normalcy to my life.
I can now do virtually everything that I did before my accident. I
still experience neurological problems, but I live seizure-free because
I use medical marijuana.
My personal experience with medical marijuana led me to share what
I had learned with other patients, allowing me to again and again
witness the benefits of medical marijuana firsthand. A particular
patient, Harrold Allen, comes to mind. He was diagnosed with pancreatic
cancer and given a prognosis of six months to live. His illness did not
only devastate his health, it robbed him of his ability to provide for
his family. Financially, he had to rely solely on state disability
funding, which was not enough to pay for his prohibitively costly
medication. Consequently, he lost everything, including his home, his
automobile and family heirlooms. He reached a point where he was taking
42 Dilaudid per day. He substituted medical marijuana for the narcotics
he was taking and within one day he ceased all narcotic use, without
experiencing any withdrawal. His doctor once told me how astonished he
was at the success of medical marijuana in Harrold's case and that he
completely supported this alternative treatment. The miracle is that
Harrold Allen lived six years beyond his prognosis.
It is because of just such experiences that, in the Spring of 1993,
Mike and I co-founded the Wo/Men's Alliance for Medical Marijuana,
WAMM, our hospice care community comprised of patients who rely on
medical marijuana to quell the symptoms of grave illness. WAMM grew to
a membership of 250 patients, mostly terminally ill. In the 14 years
since our inception, 189 WAMM members have died--nearly one per month.
Our collective serves as a critical support group for members and
families who gather at our weekly meetings. Our members are as diverse
as disease itself; still an intimate relationship with illness is the
very thing that unites us. WAMM is committed to working in accordance
with state law and in partnership with our local community and law
Unfortunately, the federal government seems to determined to
sabotage our efforts. Both WAMM and the course of my own life were
irrevocably changed the day the DEA focused its wrath on our small
collective garden in Santa Cruz, California. Their target . . . Mike
Early in the morning on September 5, 2002, Mike and I were awakened
by the sound of approaching vehicles. With no warning, 20 to 30 armed
DEA agents broke into our home with terrifying and overwhelming force.
Yelling, with guns drawn, they commanded us to lie on the floor. They
cuffed us and held guns to our heads. A paraplegic WAMM board member
who sleeps with an assisted breathing device was staying at my home.
She was awakened at gun-point by five agents, handcuffed, and ordered
to stand, which she is physically incapable of doing. Officers brought
me to the other house on the land, leaving my friend behind. Knowing
the severity of her condition, I pleaded with them to remove her
handcuffs and bring her to where we were being detained. Eventually
they did so and I noticed that she was experiencing difficulty in
breathing. She mentioned that she was also experiencing chest pain and
her blood pressure was dangerously high.
The officers proceeded to our collective garden, used to cultivate
medical marijuana, and tore from the ground and seized 160 of WAMM's
marijuana plants and seven plants growing in my personal vegetable
garden. They also seized numerous allotments of marijuana that had been
pre-sorted for correct patient dosages and were kept in assigned
envelopes. Additionally, they took various pieces of property including
personal laptops, and photographs. The confiscation of WAMM's medicine
has had a devastating effect on our ability to serve patients and to
mitigate suffering. In addition, WAMM members have expressed fear that
our government will commit additional acts of reprisal against us
because of our visibility. To date, neither Mike nor myself have been
officially charged with any crimes stemming from the raid. It is worth
noting that at the time of the raid all of WAMM's activities remained
in full accordance with state law.
Following the DEA raid Santa Cruz County Supervisor Mardi Wormhoudt
echoed the sentiments of our community when she said, ``It is not
reassuring to me to know that federal agents, instead of concentrating
on issues of national security, are running around the mountains of
Santa Cruz County disrupting the work of people who provide a valuable
medical resource to the community.''
In fact, both the City and the County of Santa Cruz County have
signed on to our lawsuit against the federal government challenging the
constitutionality of the DEA raid and seeking an injunction against
future raids and arrests. The City of Santa Cruz has further enacted an
ordinance establishing a mechanism for the provision of medical
marijuana to qualified patients as an official government function. The
ordinance becomes effective when federal sanctions are granted.
The situation in Santa Cruz offers a microcosm of the current
tensions between the federal prohibition of medical marijuana and the
will of the American people as expressed through mounting medical
marijuana voter initiatives. Throughout our nation, patients and
doctors, cities and states, are grappling with a means to provide
medical marijuana to those in need. Twelve states have enacted
legislation protecting qualified patients under state law, and more are
destined to follow. But rather than allow the states to serve as
laboratories for the federal system, current federal policy prevents
states from establishing legitimate medical marijuana infrastructures--
no matter how safe or secure such systems may prove. This leaves
patients and state elected officials adrift in a legal morass--
confident that medical marijuana is medicine, but blocked by federal
law from following the recommendations of doctors and the will of
voters. There is a solution to this dilemma provided by a piece of
legislation soon to be considered by the House of Representatives: the
The Hinchey medical marijuana amendment to the Commerce, Justice,
Science Appropriations bill, sponsored by Congressman Maurice Hinchey
(D-NY), would bar the Department of Justice, specifically the DEA from
using funds to interfere with state medical marijuana laws. Under
Hinchey, patients would no longer fear raids, arrests or prosecutions
for using medical marijuana in compliance with state law. The Hinchey
amendment would allow states to chart their own course on medical
marijuana, instituting policies to best protect local patients and
reflect the wishes of local communities.
A second, longer-term federal fix to the medical marijuana impasse
was actually signaled by Supreme Court Justice Stephen Breyer during
oral arguments in Gonzales v. Raich--a Supreme Court case challenging
the federal prohibition on medical marijuana. Justice Breyer suggested
that patients ask the Food and Drug Administration (FDA) to reclassify
marijuana for medical use as ``the obvious way to get what they want,''
adding, ``Medicine by regulation is better than medicine by
referendum.'' Unfortunately, the route suggested by Justice Breyer is
For 40-years the federal government has maintained a monopoly on
the supply of marijuana available for scientific research. Through this
monopoly, the government has prevented any research aimed at taking
marijuana through the established FDA regulatory system by simply
denying marijuana to those attempting to conduct such studies. Efforts
to develop marijuana as a legal, prescription medicine have been
Incredibly, marijuana remains the only Schedule I drug that the DEA
prohibits from being produced by private laboratories for scientific
research. Other controlled substances, including LSD, MDMA (also known
as ``Ecstasy''), heroin and cocaine, are available to researchers from
DEA-licensed private laboratories.
In contrast, the National Institute on Drug Abuse (NIDA)
constitutes scientists' sole source of marijuana in the U.S. This
monopoly exists despite NIDA's inherent conflict of interest due to its
mission to study the harmful effects of drugs of abuse. Further
undermining its position as marijuana gatekeeper, NIDA has been
criticized for its repeated refusal to make marijuana available for
privately funded FDA-approved research seeking to develop smoked or
vaporized marijuana into an FDA-approved prescription medicine.
Researchers also report that marijuana available through NIDA is of
poor quality and variety and is not optimized to meet FDA standards for
prescription drug development.
As the situation currently stands, due to an inability to secure
marijuana to research its development as an FDA-approved prescription
medicine, privately funded scientists in the U.S. are entirely blocked
from conducting such research. Consequently, pharmaceutical companies
are effectively barred from the standard research path that would
enable the FDA to determine whether marijuana should be brought to
market as an approved prescription medicine.
This illogical arrangement is fundamentally responsible for
muddying what would otherwise be a rather clear-cut discussion: If
marijuana is an effective medicine for a variety of debilitating
ailments, then why not simply develop it as a prescription medication
through the accepted pharmaceutical regulatory framework? It is because
this framework, available to all other substances, controlled or
otherwise, is effectively closed to marijuana. The federal government
has created a marijuana exception.
Thankfully, change is in the air. On May 15, DEA Administrative Law
Judge Mary Ellen Bittner officially forwarded to DEA Deputy
Administrator Michele Leonhart her final recommendation in support of
University of Massachusetts-Amherst Professor Lyle Craker's almost six-
year-old petition to cultivate marijuana for use in privately funded
Simply put, Professor Craker is seeking a license from DEA to
cultivate marijuana that would be used by other scientists in privately
funded, FDA-approved studies aimed at developing marijuana as a legal,
On February 12 of this year, following nine days of hearings,
testimony and evidence from both sides, including from researchers who
reported that the government denied their requests for marijuana for
use in FDA-approved research protocols, Judge Bittner concluded that,
``NIDA's system for evaluating requests for marijuana has resulted in
some researchers who hold DEA registrations and requisite approval from
[HHS and FDA] being unable to conduct their research because NIDA has
refused to provide them with marijuana. I therefore find that the
existing supply is not adequate.'' She added, ``Respondent's
registration to cultivate marijuana would be in the public interest.''
Unfortunately, Judge Bittner is not the final arbiter. The Judge's
opinion serves as a recommendation to DEA Deputy Administrator Michele
Leonhart, who will make the final call. It is imperative that Deputy
Administrator Leonhart be made aware of the need to follow the
recommendation of the DEA's own judge and grant Professor Craker's
application. After all, if marijuana is a legitimate medicine, would it
not be logical that it be allowed within the FDA's established
regulatory framework. If it's not, what's the harm in finding out
through legitimate, unobstructed scientific studies?
And has not the federal government already acknowledged marijuana's
medical efficacy? To this day, a federal program established in 1978
provides government grown marijuana to seven patients. This FDA-
administered Investigational New Drug program was closed to new
applicants in 1991 due to a massive influx of applications stemming
from the AIDS crises, which the program was not designed to handle. In
addition, the FDA has approved the cannabinoid drug Marinol. Marinol,
which contains dronabinol, an analog of Delta 9-tetrahydrocannabinol
(THC), is prescribed as an appetite stimulant, primarily for AIDS,
chemotherapy and gastric bypass patients.
The fact is that marijuana is an extremely effective treatment for
many serious ailments. As documented by a recent, rigorous and
unassailable double-blind study conducted by Dr. Donald Abrams at the
University of California at San Francisco that found smoked marijuana
to be extremely effective at relieving the intense pain of a
debilitating condition known as peripheral neuropathy, which often
afflicts AIDS patients as well as those suffering with diabetes or
multiple sclerosis. This study leaves no doubt that marijuana can
safely ease this type of pain, which is often unresponsive to powerful
narcotics like morphine and OxyContin. And of course, the study
necessarily utilized government-supplied marijuana of notoriously poor
quality--as all such research in the U.S. must currently do--and so
likely underestimates marijuana's medical benefit.
As Lester Grinspoon, an emeritus professor of psychiatry at Harvard
Medical School, recently wrote in the Boston Globe, ``Marihuana is
effective at relieving nausea and vomiting, spasticity, appetite loss,
certain types of pain, and other debilitating symptoms. And it is
extraordinarily safe--safer than most medicines prescribed every day.
If marijuana were a new discovery rather than a well-known substance
carrying cultural and political baggage, it would be hailed as a wonder
It is unconscionable for federal agencies to continue to put
politically expedient promotion of reefer madness before irrefutable
medical science and the will and best interest of the American people.
The well-being of thousands of seriously ill Americans backed by the
opinion of the vast majority of their countrymen demands that medical
marijuana be freed from federal interference.
Mr. Nadler. Thank you very much.
We will now recognize----
Ms. Reynolds. Siobhan.
Mr. Nadler. Siobhan.
Ms. Reynolds. It is Siobhan.
Mr. Nadler. Ms. Siobhan Reynolds, for 5 minutes.
TESTIMONY OF SIOBHAN REYNOLDS, PRESIDENT,
PAIN RELIEF NETWORK, SANTA FE, NM
Ms. Reynolds. Thank you, Mr. Chairman, Mr. Ranking Member,
Members of the Committee.
I am not going to go into the really sad story of my
husband's death and everything that we endured leading up to
it. It is in my testimony, and I hope you will read it.
What I am going to go into is how my community perceives
the DEA's behavior over the last 12 years, specifically,
really, though, since 2001, and ask you to intervene and to
stop what we feel is an outrageous crackdown on the medical
treatment of pain.
The DEA contends that they only prosecute 0.01 percent of
registrants. However, that is a misleading figure, because a
very small number of registrants prescribe opioid medicines and
an even smaller number would prescribe in doses that would
relieve serious pain.
So the actually number of doctors who are arrested is far
greater, when you look at the correct denominator, which this
leads me to my next point, which I think is really the most
important point. This is a government agency that plays fast
and loose with the facts, uses incredibly inflammatory
rhetoric, talks about crime and addiction and dependence and
puts them all together and maybe has no cognizance of the fact
that this all ultimately falls on and stigmatizes very, very
sick people. But that is in fact what happens.
So people go to their doctors or they go to their
pharmacists. And the fear that physicians actually have toward
the DEA is expressed as hostility and brutality toward
patients. There are several articles that I could show you in
medical journals, one in particular that I gave to the
Committee, called ``Pitfalls in Pain Management,'' where it is
very openly discussed that physicians who treat pain view their
role as very much prison guards, or captors, of pain patients.
Now, Congressman Forbes, I just wanted to address the
underlying assumption that you expressed, in that you think it
is important to treat pain, but we have to not interfere with
the underlying goals of drug control, or something like that.
I just want to say that I think that that fails to respect
the idea that our country was founded on, which is that each
individual matters and that the individual in this country is
sovereign. And what is happening is that people are being
sacrificed to this goal, which it seems to me to be illusory
I don't know if you can imagine what it is like to have
your husband or your wife or your son or your daughter
sacrificed to an un-winnable goal. But, when you are an
American, at least for me, I thought that my individual
existence and that of my loved ones and my countrymen really
did reign supreme.
And so here I am, bringing you evidence that 10 million
Americans live in out-of-control pain, and that was prior to
the Bush administration crackdown, so we have no idea how bad
it is now. And you have to realize that there are no suicide
statistics kept in the United States for people who commit
suicide as a result of untreated pain.
We see untreated pain pushing the assisted suicide agenda,
we see untreated pain causing enormous costs to the medical
community. We see physicians maybe unwittingly, but taking
advantage of patients who would otherwise choose to treat their
pain instead of, for instance, having extensive surgeries or
So I just want to say that there are tremendous
consequences to the actions that are taking by the Drug
Enforcement Administration and I think that if we are going to
take a responsible view and the country is going to look at
what is genuinely going on here, that you will allow my
community to speak out and to make what is happening known.
And that is that people who are in pain are being set upon
by SWAT teams and we really need your support and we are asking
you to put an end to it as soon as possible. Thank you very
[The prepared statement of Ms. Reynolds follows:]
Prepared Statement of Siobhan Reynolds
Mr. Nadler. Thank you.
And we will now recognize Mr. John Flannery for 5 minutes.
TESTIMONY OF JOHN FLANNERY, ATTORNEY, CAMPBELL, MILLER,
ZIMMERMAN, PC, AND AUTHOR OF ``PAIN IN AMERICA--AND HOW THE
GOVENMENT MAKES IT WORSE!'', LEESBURG, VA
Mr. Flannery. Thank you, Chairman Nadler and Ranking Member
Forbes and the rest of the Committee and those in attendance
today. I want to thank you for giving me an opportunity to
address this critical issue.
I want to commend the Committee and the Congress for
showing oversight of DEA. For too long, the DEA and the
department in which it serves has not been held accountable for
its acts. And I want to commend you for taking a look at these
very difficult issues.
The title of the hearing, which is the regulation of
medicine by DEA is an apt one. Unfortunately, it is an apt one
and DEA has been regulating medicine. For them to come here and
say that they don't know it means that they either are
consciously doing it or recklessly doing it. And I can't
believe they are doing it recklessly, because we see the
quality of people who work at the department. And that means
there is an ideological purpose in regulating medicine. They do
not approve of certain medical practices. And, if that is it,
they should bring it to the Congress and tell us why, with
statistics and explanations, because then it should be a formal
policy rather than the secret one that it is presently.
We had a comment earlier that we are not here to deal with
compassion. Well, I do not understand what a democratic
government does if its policies do not reflect policies that
show compassion and fairness and justice. And the DEA has
become the resident location of a policy that lacks compassion,
has a very harsh effect that is compromising the health of
Americans and has been doing so for years.
We have fewer physicians in this country who dare treat
chronic pain than at any other time in the last 50 years. And
we have a population that is living longer and more susceptible
to pain and more in need of treatment and pain medication than
at any other time, perhaps, in American history.
And, at this point in time, we have to look at the
underlying enforcement structure. Because if the underlying
enforcement structure is not addressing crime and it is
addressing and compromising our health instead, then it has to
be reformed or it has to be replaced, but it cannot be suffered
We have seen in this country, and the DEA doesn't recognize
this, a paradigm shift in our medical treatment. We used to
think of medicine, if you want to compare it to the industrial
age, in terms of mechanical things. But, increasingly, it has
become chemical. It has become digital. It is even more
microscopic, which reflects a much more sophisticated kind of
machinery. But we don't see a reflection of this
acknowledgement of this in our enforcement mechanism.
There are studies from Sloan-Kettering that tell us that 98
percent of people who knock on the door of every physician are
serious pain patients. They are not faking it.
Two percent of those patients may have a problem with
addiction if they are not careful, but they also have pain.
Physicians across this country, by nature and by practice,
trust the people who come to them.
In other words, the physicians can't tell and say in 80
percent of the back pain cases, that the person is faking it,
because there is absolutely no identifiable way, by any imaging
device, to tell that thee patients are or are not in pain.
The government says that we have a standard and we are
enforcing the law. Well, we have to look at the difference
between the words that they say they are enforcing and what
they are actually doing. This is a bait and switch.
The bait is we have a statute that this Congress passed.
Then we have a Supreme Court case in 1975, United States
against Moore, that says what the standard is, that you have to
act outside the course of professional medical practice with
the intent to push drugs, not treat.
Today, the DEA said to us ``outside the course of
standards.'' Even today, the person charged with telling us
what is the law and enforcing it can't state it, because they
enforce it as they stated it here today. They create these
standards on a case-by-case basis. It tells you that they make
The juries in this country get the most complicated
instructions in this case and they are told there is no
standard. We make it up case by case. And how do they do that?
They bring a doctor into the courtroom that they pay, who
travels around the country, and the standard is created on a
case-by-case basis by the DEA doctor.
And take the case that I cited in my testimony. In the case
of Dr. McIver, serving 30 years in prison because of an
incompetent government doctor who says that the standard is an
ever-changing modality. Whatever happened to criminal law?
In the first year of criminal law, we are taught strict
construction, errors are in favor of releasing the guilty. We
have an ever-changing modality and we have a doctor who based
on his testimony--we have a doctor who is ``the expert'' who
says, ``My doctor didn't look at charts,'' when he doesn't look
at charts to give his opinion.
So let us examine what we have to do to look at the
underlying enforcement structure. We have a failure give
constitutional notice of the crime that we are enforcing. That
has got to change.
We seize a person, a business and his property when the
person has been innocent, has been charged, but has not been
convicted of anything. There is a presumption that we should
punish him before we have proven a single thing.
We ambush the defendant at trial with prejudicial hearsay
and experts who say whatever they have to do in each individual
In short, we have a lot to do.
I refer you and commend you to review my prepared
testimony. I thank you for the opportunity to appear here today
and I commend you for scrutinizing, finally, once and for all,
the terrible, unaccountable behavior of the DEA.
[The prepared statement of Mr. Flannery follows:]
Prepared Statement of John P. Flannery, II
Mr. Nadler. Perfect timing. I thank the witnesses for their
testimony. It was perfect timing. The Chairman has returned. I
have to go to a T.V. interview.
I will give the Chairman back his chair to direct the
Mr. Scott. [Presiding.] I want to thank the witnesses and
apologize for my absence. I will recognize myself for 5
I would like to ask, I guess, Dr. Murray, in terms of
policy, what the public policy imperative it is to deny
terminally ill patients the right to both marijuana, if they
believe that it is going to help them, they believe that it
reduces pain, terminally ill patients?
Mr. Murray. Thank you, Mr. Chairman.
The public policy imperative, actually, there are several.
One of the first is the status of marijuana as the most widely
abused medication claim in the United States.
It is a drug that is addictive. It is the leading
prevalence rate drug for abuse and dependency, particularly for
young people, causing more than 60 percent of treatment
admissions for drug dependency.
Marijuana more readily available, marijuana ``legitimized''
as though it were a therapeutic medication, we fear would
become more available and more used by young people who are
already possessed of mistaken notions that somehow it is a
miraculous cure, that it is good for you, that it can be used
for medical conditions. So we think there would be a loss of
Moreover, there is the realization that the scientific and
medical bodies who have looked at this, who are charged with
the responsibility of evaluating medical claims, have said
there are too many risks to the use of the substance, that
patients may be actively harming themselves. Though the intent
there is to feel better, in the process of trying to feel
better, they are not being better treated. They are not getting
The point of a therapeutic medication is to help the
patient heal, not to provide to them a risky, contaminated,
intoxicating substance that transiently gives them the
impression they are getting better, when in fact it is doing
active harm to their lungs, to their minds, to their
susceptibility to depression and psychosis.
It is not the sort of thing that is going to be, in its
raw, smoked form, an approved medication, according to the
bodies charged with making that determination. Much to be lost
and nothing to be gained by putting marijuana into the hands of
people who are actively suffering.
Mr. Scott. Well, if they want it and they are terminally
ill, what scientific studies have you had to show the
effectiveness of marijuana? What scientific studies have you
had? Do you have a list that you can supply to the Committee?
Mr. Murray. Thank you, Mr. Chairman. I think there have
been multiple claims and quite an extensive list of the
purported conditions, medical conditions, that marijuana is
supposed to actively treat.
But when each of these has been investigated in clinical
trials situations, in animal studies, in active medical
investigations, those claims have not been borne out.
Mr. Scott. Could you give us the list of those studies?
Mr. Murray. Yes, sir. The literature is quite replete with
efforts to see whether marijuana is safe and effective, and it
never has been able to satisfy the threshold, the requirement,
that it demonstrates by medical science that it actually is
useful and does do harm. And that has been repeated many, many
Mr. Scott. What is the status of the study that the judge--
I believe it is University of Maryland--Massachusetts. I am
What is the status of that study?
Mr. Murray. Sir, I am not quite sure I follow the question.
If you are referring to the case of an applicant to be a
marijuana provider, that is an active case and we obviously can
make no comment nor weigh in no an active administrative matter
that is being determined properly in the form of government
We have no intervention, nor any commentary, on the
suitability of that application. It is in the hands of others.
It is not a research project, as I understand it, sir.
Mr. Scott. Didn't the judge suggest that the permit should
Mr. Murray. Sir, I think we are constrained from making any
comment on a matter that is actively being considered by the
administrative process of an agency, which I believe this
Mr. Scott. So you don't deny it was 6 years ago.
Mr. Murray. Sir, I think we are constrained at the White
House from making comments or interventions with regard to
actively ongoing cases.
Mr. Scott. Is the court order not public?
Mr. Murray. Sir, I don't wish to offer commentary, because
I think it would be improper for us, and not our role, to step
into an actively considered administrative process where an
agency is doing the correct evaluation of oversight and
determination with regard to this matter.
Sir, I have to defer and say it is not proper for us, I
think, to make commentary on this case that is being actively
considered by other agencies.
Mr. Scott. Mr. Flannery, there is a difference between
criminal activity and malpractice.
Mr. Flannery. There certainly is.
Mr. Scott. And different medical theories about how to
prescribe. Can you say a word about how impossible it is for a
doctor to get in the middle of that?
Mr. Flannery. What has become so impossible is that the
only crime that at doctor should be prosecuted for is pushing
drugs and happening to be a doctor at that time. And the
elements of that crime are that, as a doctor, I know and I
intend to traffic in some drug, and these are controlled
substances. It would mean I would be selling it to you or
writing a prescription for you when you have no need for it, I
know it, there is no question about it.
You haven't fooled me. You have said, ``I am going to give
you $200 if you write a prescription for OxyContin 80-milligram
Now, malpractice, someone comes in and I don't spend enough
time with them. Maybe I don't check all their records. I
believe them, which the studies have shown doctors do believe
their patients. They believe they come there with problems, and
so they do believe them.
And I give them medication and say they get sick. They
don't die, they get nauseas or something. And then I am sued,
because it leads to other things. I, the doctor, am sued. That
would be malpractice.
Mr. Scott. Are these questions better for the DEA or the
board of medicine in the different States to consider?
Mr. Flannery. They are better suited to and historically
and constitutionally suited to have the several States decide
by their boards of medicine. And there have been studies saying
this for years. The medical profession itself has become less
able to articulate and advocate for itself for fear of being
perceived in the current propaganda environment of being ``soft
on drugs'' rather than strong on medicine.
We have discouraged the best voices in America and the most
capable physicians from speaking out on this issue, because
they are terrified that they will be targeted and they will
watch their family and their practice or the patients they can
help with other medicines all be compromised.
Mr. Scott. Mr. Forbes?
Mr. Forbes. Thank you, Mr. Chairman.
First of all, Dr. Murray, let me apologize to you for
having your initial testimony interrupted. That is not normal
order. I am sorry that I was not able to stop that.
I also want to say that when we are talking about
compassion, one of the things that we really--it is really
great to come in here and beat on the desk and yell compassion,
but it is also compassionate when we try to curb teenage
drinking so we stop people from ending up going to funerals. We
had people that were killed by drunken driving, when we stop
the pharm parties that I know you guys have worked on so much.
Because kids are taking drugs that they don't have any idea
what the consequence is about.
We have to go the funerals and look at the parents and they
are telling us, why didn't you do something? Why didn't you try
to stop it? Or when we see suicides that take place because
kids are addicted to drugs or other people are doing it.
So when we talk about compassionate, let us not suggest
that anybody sitting at the table is not compassionate.
Ms. Corral, first of all, I thank you for being here and
for your testimony to everybody. I want to ask you, and I only
have 5 minutes, so I want to be kind of concise, but do you
feel marijuana should be legalized?
Ms. Corral. Medical marijuana should be legalized.
Mr. Forbes. What about ecstasy, the drug, ecstasy?
Ms. Corral. I am here to testify, sir, about medical
Mr. Forbes [continuing]. On that.
Ms. Corral. No, I am just here to speak about medical
Mr. Forbes. I appreciate that.
Ms. Corral. Thank you.
Mr. Forbes. Dr. Murray, let me ask you a question on
Tylenol. Is Tylenol a good drug to relieve pain?
Mr. Murray. Yes, sir. I believe it is widely sold and
Mr. Forbes. If you have an overuse of Tylenol--I am not
talking about on a regular basis but a single or a couple of
overuses of Tylenol, what is the impact?
Mr. Murray. Sir, it is my impression that it is a widely
used and safe drug, taken appropriately, but as with all
effective medicines, inappropriate use can be damaging.
Mr. Forbes. It can damage your liver if you have that.
Mr. Murray. Indeed.
Mr. Forbes. The question I am raising, everybody is talking
about, almost like what should be a controlled substance and
shouldn't be, but doesn't Congress decide whether drugs are
based on a schedule under the Controlled Substance Act? So
isn't it true that Congress is the one who places things on the
Mr. Rannazzisi, you can speak on that, too.
Mr. Rannazzisi. A drug can be scheduled in one of two
manners. Congress could place it on a schedule through
legislation or it could go through the administrative process,
a collaborative effort between FDA, who does a scientific
evaluation, safety and efficacy of the drug, and then DEA
Mr. Forbes. Once it is placed on that list, does DEA have
the discretion to not enforce the drug laws?
Mr. Rannazzisi. No, sir, it doesn't.
Mr. Forbes. So you can't just pick and say that you don't
want to enforce this one, or you do want to enforce this one.
You don't have that discretion, do you?
Mr. Rannazzisi. No, sir, I don't.
Mr. Forbes. If a doctor is over-prescribing pain
medication, even if done for a patient who is suffering, can
the DEA just ignore this?
Mr. Rannazzisi. No, sir. Many of these cases come from
complaints, complaints from law enforcement agencies, other
medical doctors, pharmacists. No, we can't ignore it.
Mr. Forbes. Do you ever have situations where suicides have
taken place, or murders have taken place, as a result of some
doctor over-prescribing medication to some individual that was
Mr. Rannazzisi. We have had cases where there were deaths
related to the prescription medication prescribed by the
Mr. Forbes. And if we had that, wouldn't we be in here
pounding on you and saying, why didn't you try to stop that?
Mr. Rannazzisi. Yes, sir, I believe that is----
Mr. Forbes. Let me ask you, are you familiar with this map
that I believe was put out by Heritage. It is cannabis plants
eradicated in 2006.
Mr. Rannazzisi. It is the national drug intelligence--yes.
Mr. Forbes. Can you explain what this represents to us?
Mr. Rannazzisi. These are the outdoor plants and sites that
were seized in California, by county, in 2006.
Mr. Forbes. And how widespread were they?
Mr. Rannazzisi. Extremely widespread, almost the whole
Mr. Forbes. Is that the same map that is up here now with
this chart up here?
[The material referred to follows:]
Mr. Rannazzisi. Yes, sir.
Mr. Forbes. Is there any concern that you have in some of
these areas, some of those reports that we have looked at that
talk about having armed guards, that they have conducted
counter-surveillance. Are you familiar with any of that on any
of these sites?
Mr. Rannazzisi. Are we talking about the grow sites, the
outdoor grow sites?
Mr. Forbes. Yes.
Mr. Rannazzisi. Yes, absolutely. Currently, in addition to
the grow sites, we are having problems with growing on public
lands and we have just entered into a task force with the Park
Service to address that.
Mr. Forbes. Dr. Murray, can you address that?
Mr. Murray. Yes, thank you, sir.
It is a huge problem in the United States. The domestic
production of marijuana is an enormous danger. Criminal
elements deeply moved in. States of Kentucky, Tennessee,
California and Hawaii predominate, where public lands, national
parks, off limits to people because of dangers of gangs, of
undocumented aliens, cutting down forests to grow marijuana by
the metric ton, spreading through the country.
It is quite a problem, and, moreover, the difficulty is
connected to some of the compassionate care dispensaries,
because some of the marijuana seized in episodes where the DEA
has gotten involved, it was clear that it was not mom-and-pop
locally grown marijuana from an herbal garden. It was criminal
elements that moved into this country to generate indoor,
hydroponically grown, high-potency and/or outdoor grow
marijuana operations that were systematic and made thousands
and thousands of dollars a day to distribute marijuana through
the dispensaries to people for whom it was never intended.
So it is a public threat to have this production going on
in the hinterland. It is moreover a criminal threat to have
them have a readily available outlet. And it is clearly not the
intention or the principle of the well-meaning people who tried
to offer compassionate care for a few.
Mr. Forbes. My time has expired, but if the Chairman would
just allow for an additional question, for either Mr.
Rannazzisi or Dr. Murray, can you tell us about the concept of
pharm parties and how bad they are getting now and you are
problems in trying to deal with Internet pharmacies.
Mr. Rannazzisi. Currently, Internet pharmacies are one of
the fastest-growing pharmaceutical diversion areas. What these
kids are doing, basically, are acquiring drugs from either
their medicine cabinets, their doctors or friends--their
doctors--their relatives or their friends. And they are taking
the drugs and they are coming to these parties where they throw
the drugs into a bowl and then they systematically take the
drugs out and take them.
They really don't know what they are taking. It could be a
benzodiazepine. It could be a narcotic. It could be anything.
And they just take them.
And so they don't know what they are ingesting, and this is
a form of--just a form of adolescent partying now.
Mr. Forbes. It is becoming a widespread concern?
Mr. Rannazzisi. We have had several reports throughout the
Mr. Scott. Thank you, and just one other. We are going to
have a hearing on Internet pharmacy issues coming up.
I would like to ask one other question. I guess, Dr.
Mr. Heiden. Yes.
Mr. Scott. Do we know where ephedrine comes from that makes
methamphetamines, where most of the people get it? And, if you
closed one source, would other sources quickly sprout up?
Mr. Heiden. Yes, I think DEA has even addressed this, that
I think Administrator Tandy in some recent testimony indicated
that methamphetamine production, a major source is the Mexican
super-labs, I guess you call them, in Mexico, controlled by
drug kings are supplying the vast majority of the
methamphetamine that is consumed in this country.
And the vast bulk of the products found in small
methamphetamines are brand pseudoephedrine cough and cold
products, such as Sudafed, and it is not the products
distributed by ACRC members, which are the off-brand
combination ephedrine asthma-relief products.
And it is those products that are being essentially
targeted by the small allocation under the DEA needs assessment
in the draft report that we reviewed and critiqued for ACRC, a
report where there was absolutely no rationale given for the
needs assessment of essentially 100,000 kilograms, essentially,
of product, when the national estimate of the members of what
indeed they sell for legitimate purposes is in the millions of
I am here basically, and I didn't get to say it in my final
remarks, to indicate that DEA just missed a very, very large
portion of the ephedrine that is useful for products that are
relied upon and needed by asthmatics for relief, particularly
in low-income environments and others. And if it allows this
very, very small allocation to go through, based on a study
that completely draws an X through the needs of this ACRC
sector--if it allows that kind of allocation, this whole
sector, it is my understanding, will be wiped out.
But it is not the major source of diversion. As I said, the
major source here, according to DEA itself, is the super-labs
and the small toxic labs, not the members of ACRC or small
categories of suppliers.
Mr. Scott. Do those convenience stores have cost of
compliance with the regulations?
Mr. Heiden. They certainly do have significant costs of
compliance. I have heard nothing in discussing with the members
of ACRC that their sales to convenience stores are anything but
legitimate sales. But I do think the convenience stores have
significant cost of compliance, although I haven't studied that
Mr. Rannazzisi. May I respond, Chairman?
Mr. Scott. Sure.
Mr. Rannazzisi. First of all, the study, the initial needs
assessment, was a proposed assessment. Our contract with IMS is
a two-phase contract. We do the initial assessment by IMS. They
give us the results and we publish them. The whole idea behind
the deliberative process and notice and comment is that it
gives industry an opportunity to respond, and industry can give
their comments and provide data that shows that we can be
And there are times in the past that we were wrong, and we
made the corrections. Right now, we are in the deliberative
process. I could tell you that we are looking at industry
comments and that those numbers will not necessarily stand.
However, for us to do our job, we have to have a starting
point, and that starting point was with our IMS contact. We
appreciate the comments from industry and we take them under
advisement. And a final needs assessment will be out shortly.
As far as the ACRC market, the people that are represented
by ACRC, they are mostly small retail convenience stores and
wholesalers, I believe, that distribute to them. The fact is
that that sector of the market is a large avenue of diversion
to small toxic labs.
Put aside the Mexican methamphetamine labs, which,
incidentally, we didn't say a vast majority comes from Mexico.
A vast majority of the methamphetamine produced by those
organizations is produced in Mexico and the U.S., so we can't
really tie it to either Mexico or the U.S., but we know it is
tied to those organizations.
Well, put that aside for a second. Twenty percent of the
meth on the street, currently, is coming from small labs. We
believe that. And the fact is, is those small labs are
obtaining their chemicals, their pseudoephedrine, or their
ephedrine products, from retail places.
Now, I noticed in Mr. Heiden's testimony, he says the
products distributed by ACRC and other small distributors are
off-brand combination ephedrine asthma relief products which
are not found in illicit labs as precursors to make
methamphetamine. That is incorrect.
In 2006, we had 87 labs with brand names like BDI, Blue
Label, Mini Thins, Bronchis, Mini Ephedrine, Double Action
Ephedrine, Rapid Ephedrine, Fred's Private Label, Ephedrine
Extra, Biotech, AM, BC Powder, Ultra Max Strength. Those are
all off-brand, gray market, crypto-generic products.
So I don't know where his information was coming from and I
would like to talk to him afterwards about it so I could clear
it up with him.
Mr. Murray. Mr. Chairman, may I add one brief commentary as
perspective, please, sir, with regard to methamphetamine
The policy dilemma with regard to combat meth and somewhat
restricting access to pseudoephedrine, ephedrine products and
so forth was a cost-benefit equation. We had to make a balance,
preserving legitimate access to needed medications, and we
thought we did achieve that by making them still available in
supplies that can still be had.
But, at the same time, we had to balance that with the
diversion threat that was a very serious issue. While
methamphetamine flow, already finished product from Mexico,
continues to be a threat, we think we are taking effective
action against that. We think it will be dramatically reduced
in the future, which is a critical point that needs to be
brought into the equation of cost and effect and the balancing
The methamphetamine laboratories that were small, toxic
laboratories, that were fed by diverted pseudoephedrine,
ephedrine products, from retail establishments, was not a small
phenomenon in states in like Missouri and Tennessee, states
like Arizona and Oregon and Oklahoma.
These were extraordinarily threatening circumstances that
both produced meth use and the toxic laboratory residues from
where people had cooked meth that left extraordinarily
dangerous poisons in the atmosphere, on the walls, on the
ground, on the furniture. That has been addressed.
In 2004, there were more than 17,000 such laboratory
incidents reported across the United States. Today, in large
measure due to the effective actions at restricting, not
prohibiting, but narrowing the access to the precursor
chemicals, there are between 6,000 and 7,000 laboratory
That dramatic drop has produced such a powerful beneficial
consequence for these rural communities in particular that face
the methamphetamine threat, including the lives of young, drug-
endangered children, whose parents were exposing them to toxic
environments, that retained that toxicity even after the first
family moves out. Hotel rooms, trailer parks, barns, places
where methamphetamine cooks take place, there is leftover
residues of poison that has respiratory consequences for
children, neurological consequences for children, exposure for
first responders and fire and police, that has been
That was the cost-benefit equation that we had to take into
account of when we made the public policy choice, about not
eliminating these medications, but restricting access in such a
way where we retained the right for legitimate use and yet cut
away the criminal dimension.
I think that has been a powerful success.
Mr. Scott. When all that was going on, did the cost of meth
go up or down?
Mr. Murray. The cost of methamphetamine is measured
somewhat indirectly by a complex system of drug reporting that
the DEA maintains. We have seen both increases and decreases in
the price of methamphetamine nationally over time.
We have also seen increases and decreases in purity, and
the effects of the combat meth act in reducing the laboratory
production has also been felt in reduced access and
availability of methamphetamine itself that we can see in data
such as workplace drug testing, where we have seen a steep
tailing off of the use of methamphetamine of the work force,
and by the survey reports we are getting from young people in
particular, who are turning away from methamphetamine very
Yet the drug importation from Mexico has also been a
countervailing tendency to have purity pushed forward. But we
believe that price and purity has been affected by the success
of taking down the meth labs, that we have gotten success
against the laboratory incidents and the toxic waste issue and
also gotten better purchase on trying to control the use of
It has been a successful and slow, but I think appropriate,
process of curtailing access to these precursor chemicals. They
used to come in from Canada, diverted in bulk form from Canada
and fed super-labs in California, Nevada, Arizona.
We took action in conjunction with the government of Canada
and effectively cut off that route. That is when people turned
to the small toxic lab, pseudoephedrine diversion from the
retail establishment. We took action against that.
Now we have got the third quadrant, the last piece of this
down in Mexico. We are taking effective action in conjunction
with the Mexican government to reduce their importation of
pseudoephedrine and ephedrine products and to help them attack
the methamphetamine laboratory production on their side of the
We are moving against this problem, sir.
Mr. Scott. Thank you, Dr. Murray.
We have been joined by the gentleman from North Carolina,
Mr. Coble. And I understand you did not have questions, or you
do you have questions?
Mr. Coble. Mr. Chairman, my belated arrival was because of
two conflicting hearings and I apologize. And I have no
Mr. Scott. Thank you.
Mr. Forbes. I just have one additional statement to follow
up with yours.
I want to first of all say, based on your testimony, that
the word ``balance'' is always one that we don't like to hear.
A lot of times people don't like to talk about it, but that is
what government is all about.
We are not perfect, but you are going to constantly see
some of these criminals moving from one place to the other.
They are going to come up with new technologies, new ways to do
it. You have to work on it.
Mr. Scott. Thank you.
As the gentleman from Texas is coming in, do any of the
witnesses have any closing comments before I recognize the
gentleman from Texas?
Mr. Flannery. I have one.
Mr. Scott. I will start with Mr. Flannery.
Mr. Flannery. Compassionate seems to me to care when you
have 40 million to 75 million people in America who have
chronic pain, which means that they have pain that has been
living with them for longer than 6 months--it is so bad they
can't sleep at night. When they drive to work, they are falling
asleep, they are irritable.
And, at first, it only bothers them a little bit, and then
they start thinking about, ``should I commit suicide?'' Because
the pain is so great and ``I am so worthless to the people I am
with and that I can't just put up with this pain anymore.''
The Ranking Member appropriately noted that if one takes a
Tylenol for pain, you can only take so much of it before your
gastrointestinal tract is injured, before you literally bleed
and you compromise your organs. And there is an answer to that,
and it is a recent chemical answer, and it is the fact that the
opioids we have in our bodies are not sufficient to take care
of the pain. And it is that oxycodone and other medications can
help us where our bodies fail us.
And I don't think this argument is that dissimilar from the
other issues that are before us today. So if we want to talk
about compassion, and numbers matter, we have to look at the 40
million to 75 million people who are daily living in chronic
pain, many of whom are contemplating suicide because they can't
get medical attention and they can't get medical treatment
because the physicians in this country are not going to risk
going to jail and compromising their own lives and their other
patients by doing so.
Then compassion means, in numbers and for this Nation,
changing how we do our business of law enforcement. It means
changing our structure. It means not hiding behind some
privilege when you are asked a question about a medical study.
It means actually having the medical study and examining it
and then deciding what is the right policy. Thank you.
Mr. Scott. Ms. Reynolds?
Ms. Reynolds. Thank you. Just the thing I was thinking
about as this was going on was that I just don't feel that the
people are really getting their voices heard in this hearing.
I am trying my hardest, and I know that you are, and
several of us are, but I feel that we are being drowned out by
a lot of sort of endless bureaucratic chatter about Mexico and
appropriate procedures and what not. And we are talking about
American citizens being denied medical treatment that they
would afford, that they want, that they need to survive and
take care of their families with.
I mean, it is so serious, and we have been working, my
organization and I, for 5 years to get heard on this issue. And
this is it. This is the culmination of those efforts. Two of us
are here to speak about this.
So much more needs to be done. The platform needs to be so
much bigger. I don't know how to describe it. It is just that
what we need, for you to hear from doctors. You need to hear
from patients. You need to hear about the science, which has
been suppressed by the Drug Enforcement Administration.
Mr. Forbes just demonstrated a real misunderstanding of the
science. Over-prescribing is a misnomer, sir. The doses can go
as high as the sky, if they need to. That is the real anomaly
of this medicine. And so if the medicine is being treated
scientifically, it makes the doctor a target.
That is what I want you to understand, sir.
Mr. Forbes. Mr. Chairman, I am just going to ask that we
have regular order in the Committee.
Mr. Scott. Regular order has been called for.
Mr. Forbes. We have not had it the whole Committee meeting.
Mr. Scott. We will resort to regular order and recognize
the gentleman. I would like to recognize the gentleman----
Mr. Nadler. I just want to know, since I just walked in,
what was the objection to lack of regular order just now? What
was being violated?
Mr. Scott. My recognizing witnesses out of order for
extended periods of time, which was in fact out of order and
the gentleman made a good point. And recognizing the gentleman
from Texas at this point.
Mr. Gohmert. Thank you, Mr. Chairman. I do appreciate that.
I appreciate your being here and I understand the frustration
of not being heard. Actually, there is a majority of my
district that is not represented anywhere here, because the
majority of my district does not want to see marijuana
legalized for anything.
So I understand the frustration you have in feeling that
you are not being heard, but there are also a lot of other
sides to this that have not been heard.
Ms. Reynolds. Sir, I just don't represent marijuana. I just
want you to know that. I am talking about legal medications.
My name is Siobhan Reynolds, I am with the----
Mr. Gohmert [continuing]. Marijuana, right?
Ms. Reynolds. No, nothing to do with marijuana. We are here
about schedule two substances, oxycodone, et cetera, supposedly
legal medications that people can't get hold of.
Mr. Gohmert. I thought you were speaking about marijuana on
that. All right.
Ms. Reynolds. No, thank you, though.
Mr. Gohmert. And I am sorry I had to step out, momentarily.
But I do want to go back very quickly to pseudoephedrine. I was
one of the few that voted against making it so difficult to get
it, because it works to decongest me, as so many Americans.
Pseudoephedrine P.E., in my humble, non-medical opinion, is
absolutely worthless for me. I can't speak for anybody else. It
But, anyway, it is funny, not in a humorous, but ironic,
way, this Administration has been accused of sending jobs to
Mexico, and apparently when we tightened up pseudoephedrine,
that is exactly what we did. The job of making meth went to
Mexico and the people I talk to in law enforcement back in
Texas, having lots of contacts there, as a former judge, they
say, man, it is coming in from Mexico. It is pure, there is
more of it. We don't have the mom-and-pop labs in east Texas,
which was once a real haven for them, because of the trees and
whatnot, the rural areas.
So, anyway, I am not sure--I know we did a lot of good
putting mom-and-pop labs out of operation, but from what law
enforcement is telling me, including--and I won't mention DEA
agents, but some of them are telling me back home, man, it is
coming in faster than ever from Mexico.
Perhaps if we got some border security instead of having
National Guard troops that call in the fact, or radio in the
fact, that there are armed drug smugglers coming in and then
their SOP is to flee the area once they radio that in, maybe we
could get some help there.
But I also want to bring to the DEA's attention, I mean, if
the law is marijuana is illegal and it is, it has been. But I
had a case as a judge where marijuana seeds were an issue. And
we ended up having DEA come from the DEA lab up here back to my
little courtroom in Tyler, TX, and I didn't realize, but,
apparently, if marijuana seeds are sterilized, then they are
not illegal in Texas and most other places. And that is why
they are included in so many birdseeds.
Well, we had a 50-pound bag of marijuana seeds that were
legally bought from a feed seed place in Houston and they kept
using it as an example, as a demonstrative aid in court. And I
kept seeing hands go in and when they would pour the seeds back
in, there were green, leafy substances on their hands, of the
prosecutor, the defense attorney, the witnesses.
And so at the end of the trial, I had it sent out for
analysis and it turned out that 25 percent of that 50-pound bag
would germinate, would produce marijuana plants, legally
So, Ms. Corral, I don't know if you want to take note of
that or not. But, anyway----
Ms. Corral. Well, I can address that, sir.
Mr. Gohmert. You could buy it legally, and not only that,
you buy a 50-pound bag of marijuana seed that is supposedly
sterilized, 25 percent germinate and they had a plastic baggie
full of marijuana as like a Crackerjack prize for buying the
So I provided that all to the FBI. I said, I know you all
are under the same DOJ with Janet Reno, but this really needs
to be looked into.
And it turned out, and we had testimony to this, that the
DEA once in 3 or 4 years went to the single plant in New Jersey
that actually does the sterilization. They said it was a
complete surprise. They had no idea. So it was a really random
Yet they met the ship at the dock, they were able to call
in the people that worked for this company that the DEA was
coming to watch them do the sterilization process. Unlike every
agriculture department, which sticks a rod in and then opens,
turns and gets seeds from every level of this huge vat. So you
see how the DEA agent scooped a handful up.
They took those to the DEA plant. They were put in a petri
dish to see if they would germinate. They were set on top of an
oven, where the temperatures ranged 100 to 200 degrees. And
after they were adequately cooked for 7 days, the report was
they didn't germinate, after we cooked them, which the
Agriculture Department will tell you that is not the way to
I never got a report back on whether we were continuing to
have such thorough investigations in the sterilization of
marijuana. But we are apparently importing, or we were at the
time of this trial in my court, carloads of marijuana seeds
from China that were received at the dock and received that
kind of really explicit study.
So, anyway, I bring that to your attention. I hope it has
been looked into. If it is illegal, we ought to follow the law.
Of course, we have laws on immigration that aren't followed
either, but that is another matter.
Anyway, thank you.
Mr. Scott. The gentleman's time has expired.
The gentleman from New York?
Mr. Nadler. Dr. Murray, marijuana is the only controlled
substance currently for which the Federal Government maintains
a monopoly on the supply for use by scientists conducting
research, even though Federal law requires competition in the
production of research-grade, schedule-one substances, such as
research-grade heroin, LSD, ecstasy and cocaine.
Can you please tell us marijuana, as a comparatively
harmless drug, compared to these other substances, is the only
controlled substance for which the Federal Government maintains
a monopoly on the supply made available to researchers?
In other words, why is it different than heroin, ecstasy,
LSD, et cetera?
Mr. Murray. Thank you, Mr. Congressman.
Mr. Nadler. Quick and short, because I am going to have a
few more questions.
Mr. Murray. All right, sir.
We do not regard marijuana as a relatively benign schedule-
one substance, sir----
Mr. Nadler. Why is it treated differently than these other
Mr. Murray. Sir, I believe that we have international
treaties and obligations that are specific to how we handle
schedule-one controlled substances with regard to a single
government source. And I believe that Mr. Rannazzisi can tell
us even more about how that works.
Mr. Nadler. Mr. Rannazzisi, maybe you will answer my
question and not evade it the way Dr. Murray did.
The question is, why do we handle marijuana differently
than other schedule-one drugs with respect to maintaining a
monopoly of research on it?
Mr. Rannazzisi. Because there is only one supplier, because
that supplier basically handles the need for research. And that
supplier is under a NIDA contract. We look at the NIDA
Mr. Nadler. But why is that different from other drugs.
There is more than one supplier for heroin?
Mr. Rannazzisi. Because heroin poppies are not grown in the
U.S. Cocaine, coca, is not grown in the U.S.
Mr. Nadler. And LSD isn't made in the U.S.
Mr. Rannazzisi. LSD is manufactured for research, yes it
Mr. Nadler. But, again, I don't understand your answer.
What has that got to do with the fact that for LSD, for heroin,
there is not a monopoly for supply for use by scientists
conducting research by the Federal Government, whereas for
marijuana there is? Why?
Mr. Rannazzisi. Well, first of all, the research that is
conducted is approved by NIDA and FDA. NIDA and FDA make a
determination--NIDA makes a determination that that source of
supply for that marijuana fits the needs of those researchers.
We have no dog in that fight, really.
Mr. Nadler. Basically, they refused almost every researcher
Mr. Rannazzisi. I am sorry?
Mr. Nadler. They have refused the supply for basically
every researcher. They have basically cut off medical research
with respect to marijuana.
Mr. Rannazzisi. I don't believe that is the case. If you
look at my testimony----
Mr. Nadler. I won't debate that with you, because it is
clearly the case. Let me go onto the next question.
Mr. Rannazzisi. Well, I mean, would you like me to respond?
Mr. Nadler. I want to get the information I want to get.
Mr. Rannazzisi. So you don't want--okay.
Mr. Nadler. I heard your answer. I am going to go from
Administrative Law Judge Mary Bittner recently recommended
DEA grant a license to the University of Massachusetts
professor Lyle Craker allowing him--and I understand this may
have been referred to--allowing him to grow research-grade
marijuana for use in FDA-approved studies that could evaluate
whether marijuana meets the FDA safety and efficacy standards
for approval of prescription medicine.
This application was submitted to DEA more than 6 years
Mr. Rannazzisi. Rannazzisi.
Mr. Nadler. Rannazzisi.
Mr. Rannazzisi. Yes, sir.
Mr. Nadler. Can you please tell us within what time period
can we expect the DEA will decide whether to accept Judge
Bittner's ruling, before the expiration of the President's
Mr. Rannazzisi. I can't give you a time period about when a
Mr. Nadler. Would you expect it will be--the President has
a year and a half to go. Would you expect a decision whether to
accept an administrative law judge's recommendation would be
made within the next year and a half? Is that reasonable?
Mr. Rannazzisi. Excuse me 1 second, please.
Mr. Scott. I would advise the Committee that we will have
an opportunity to submit questions in writing, and I think this
Mr. Rannazzisi. That would be a question that we would
rather submit in writing. We would like to submit that----
Mr. Nadler. Well, let me ask you a different question.
Mr. Rannazzisi. Yes, sir.
Mr. Nadler. Normally, how long does it take the FDA to
agree or disagree with an administrative law judge's
Mr. Rannazzisi. The FDA would not----
Mr. Nadler. Not the FDA, the DEA.
Mr. Rannazzisi. It just depends on the issue. It is a case-
Mr. Nadler. Well, does it normally take, on average, 6
months, on average 6 years?
Mr. Rannazzisi. I wouldn't have that information handy,
sir. I would have to get back to you on that.
Mr. Nadler. Well, think of any instance where it has taken
more than 5 years. Are there any?
Mr. Rannazzisi. Well, that is erroneous. It has not been 5
years. If I am not mistaken, the decision was handed down
Mr. Nadler. Are there any longer than 2 years?
Mr. Rannazzisi. I don't know that information, sir.
Mr. Nadler. Are there any longer than 1 year?
Mr. Rannazzisi. Sir, again, I will have to get back to you.
I will get back to you, and if you would like, I would----
Mr. Nadler. Okay. I would like a commitment that the
decision will be made within the lifetime of this
Administration. I think that is a minimum that we could ask.
Let me ask you the following question: Does the DEA oppose
or support efforts by scientists to resolve the controversy
over medical marijuana by conducting FDA-approved clinical
trials, yes or no?
Mr. Rannazzisi. Well, the DEA does not oppose any clinical
trials that have been accepted for trial by the FDA and NIDA.
We have never done that.
In fact, in our process, the only thing DEA----
Mr. Nadler. The answer is, no, you do not oppose.
Mr. Rannazzisi. No, we don't oppose any trials.
Mr. Nadler. Thank you, and let me ask you the following----
Mr. Scott. The gentleman's time has expired. We will have
just a few last questions.
Mr. Nadler. A company in England, GW Pharmaceuticals, has
developed a marijuana-derived drug called Sativex that is
already available for patients in Canada, England and Spain. I
understand that GW Pharmaceuticals have now teamed with a major
Japanese pharmaceutical company, Otsuka, to conduct Sativex
trials in the U.S., which the FDA has approved.
Can you please tell the Committee why the Federal
Government is allowing foreign corporations to develop a
monopoly on marijuana-based drugs in this country? Are we
opposed to American economic development?
Mr. Rannazzisi. Sir, I guess you have got to understand
what DEA's role is, here. DEA doesn't approve studies.
All DEA does is issue registrations for controlled
substance handlers and researchers. That is what we do. The
studies are approved at NIDA and HHS, where studies have always
been approved. That is not in our purview.
Mr. Nadler. Thank you.
Mr. Scott. Thank you.
The gentleman's time has expired. I would like to thank the
witnesses for their testimony today.
Ms. Corral. May I just add something quickly?
Mr. Scott. Very quickly.
Ms. Corral. Very quickly. I just wanted to respond to
Congressman Gohmert's assumption about the 50 pounds of
Mr. Gohmert. It wasn't an assumption.
Ms. Corral. I beg your pardon.
Mr. Gohmert. It was some factual testimony.
Ms. Corral. It is factual testimony. And, in fact, those
seeds from sterilized plants, while they were germinate, will
not render full-grown plants that actually sex out male or
female and produce usable marijuana. They actually die after
quite a short time.
I also wanted to mention that there is a great deal of
scientific research. In 1992, the International Cannabinoid
Research Society was founded, and there are numerous
prestigious physicians and researchers throughout the world who
are part of this.
Mr. Scott. I am going to ask you to submit those studies to
Ms. Corral. Yes.
Mr. Scott. Dr. Murray is going to submit the studies he
has, so we will be able to review them all at the same time.
Ms. Corral. Yes, and I would just like to mention that
while the DEA does block research by not approving, throughout
the world, other research, even in the face of these treaties,
continues to provide and substantiate the medical value of
Thank you for your time, and I am sorry to go over.
Mr. Scott. Thank you very much.
And Members may have additional written questions for our
witnesses, which we will forward to you and ask you to answer
as promptly as you can so they will be made a part of the
Without objection, the hearing will remain open for 1 week
for submission of additional materials.
And, without objection, the Committee stands adjourned.
[Whereupon, at 11:44 a.m., the Subcommittee was adjourned.]
A P P E N D I X
Material Submitted for the Hearing Record
Prepared Statement of Martin E. Waugh, D.O.
From the time I was little, I had always dreamed of becoming a
doctor. Though I grew up on a farm, my folks always encouraged me to
pursue my dream, even though that meant not following in my father's
footsteps as a farmer in western Kansas.
I had always pictured myself in the healing profession, sharing the
forgiveness and healing power of Christ to those who were hurting in
body, mind, and spirit.
In 1982, I graduated from Oral Roberts University in Tulsa,
Oklahoma, a body, mind, and spirit university. I met my wife, April,
there, and in May of 1982, we were married. I subsequently attended
Oklahoma State University in Tulsa, where I received my D.O. degree. I
was well on my way to living out my dream as a physician. While living
in Tulsa I entered the Army Reserve, and with that took an oath to
uphold and defend the Constitution of the United States against all
enemies. This was a very proud moment for me, as my father had served
in the Marines in the Korean Conflict.
In the late 80's and early 90's, I was very concerned about the
spread of HIV, and I pursued an opportunity at Yale University after
graduating from medical school. I managed an outpatient clinic whereby
heroin addicts received detoxification on an outpatient basis that I
helped to develop. This population was, of course, at risk for the
spread of AIDS.
After a two year substance abuse fellowship, our clinic's published
success rate won several million dollars of federal grant monies. At
that time, my mentors encouraged me to pursue a specialty in Psychiatry
at Yale. So, I entered and completed the Yale Psychiatry Residency
program in 1995, which added another three years to my postdoctoral
During my time at Yale, I became aware of the use of brain scans
and its application in diagnosing impulses that addicts and other
patients had. Studying brain scans in the university setting was
difficult, mostly due to the fact that we had only one functional brain
scan machine, and many others competed for time on that machine. So,
when the opportunity presented itself in 1996 of joining a
Neuropsychiatric private practice in Northern California with 3,000
brain scans on file with the latest brain scan machine available, I
accepted a position there. I was also able to continue to publish
studies on substance abuse and brain scans.
After a year of working for Dr. Daniel Amen in Fairfield,
California, I opened up my own practice in Davis, California, while
continuing to collaborate with him on using his excellent brain scan
machine for my patients. My practice grew very quickly, mostly from
referrals from other physicians due to my substance abuse fellowship
and Psychiatric training. Many patients who had been problematic to
others were also given to me by the clinic.
My patients were typically people whose diagnoses were lost in the
chasm between Neurology and Psychiatry, proper. This can occur when a
temporal lobe seizure disorder creates a constellation of symptoms that
resemble ADHD, but must be treated primarily with anticonvulsants,
before considering a stimulant for any residual ADHD. Many of them had
tremendously complex medical needs and some of them needed daily
supervision. These were the ones that moved to houses in Davis, CA.
I would typically make rounds early in the morning, sometime
dispensing medications to those who had been unable to manage their
medications on their own. This dramatically cut down the abuse
potential of a medication like Ritalin, and since this was similar to
making house calls in New Haven, CT, as I did throughout my Substance
Abuse Fellowship, and Psychiatric residency, I thought that it was or
should be the standard of care. It certainly was the standard of care
when I was at Yale, so I thought this should be acceptable in Davis,
CA. I did not realize that without the protective arms of Yale around
me, however, this behavior, which was helpful to my patients, became
suspect to the town authorities.
Throughout our married life, my wife and I had always shared extra
rooms in our home with others. Some were patients, some fellow
physicians. Now that we were in California, when the needy presented
themselves for treatment, and we found that they had neither safe
housing nor ability to afford medications, sometimes we would intervene
by offering them a room at the boys house, or even a temporary respite
in our house.
I have been deeply ingrained with the oath I took, the Osteopathic
version of the Hippocratic Oath, which states that we will treat our
patients as friends, and the religious command I had to care for how I
treated the least of these, in matters of hunger or medicine. They had
been put in my path; I could not turn them away.
While at Yale, the treatment and medications were given free to the
patients, paid for by grants. While training at Walter Reed on active
duty in the Army, medications were paid for by the Army. In California,
this was the first time I had ever encountered patients who needed life
saving medicine, who sometimes could not afford to buy it. So, since my
practice was successful, I used up to $5,000 a month to buy medicines
for patients, while we were getting them on State services. In
retrospect, in the town of Davis CA, this was not a wise move.
As I was used to the rigorous, thorough practice of medicine at
Yale, I was shocked to encounter a substandard practice of it in
California. We began to sense that what had been praised and well-
funded on the East Coast, with in-house treatment and outpatient
detoxes, was now scorned, mocked and put under surveillance in
California. The authorities could not accept that I was a Christian
doctor, treating some of my live-in patients for free. They thought
otherwise and after spending quite a bit of time and money
investigating me, they finally resorted to actions below the law. I was
always fully cooperative with any questions they or the State had about
the care I was giving.
Fully mindful of the penalties of perjury to Congress, I shall now
describe what happened on the day that my world turned upside down. I
will only state facts that can be independently verified.
On the morning of May 29, 1999, I was arrested for the unlawful
distribution of a controlled substance.
At 7:15 a.m., our home was raided by a SWAT team. My wife awoke to
five policemen breaking open our bedroom door, guns drawn, screaming at
her to get out of bed and down on the floor. They handcuffed her for
several hours--saying that she was not being arrested but being
``detained'' for questioning. I had already left the house to make my
morning rounds. When my wife asked to see a search warrant, she was
told that one would be forthcoming, (since they didn't have one until
the courts opened at 9 a.m.). The three other people who were staying
with us had their seizure disorder medication taken from them, their
pain medicine (one patient had a few Vicoden for her Fibromyalgia) and
their stimulant medications taken. They also took all of the empty
bottles that my wife had saved in the garage of all of the people we
had bought medication for that she was saving for tax purposes. Most of
these prescriptions were antidepressant or anticonvulsant medications,
not controlled substances.
At the same time across town, my office was being broken into. Many
patients charts were taken, including all of my back copies of
triplicate prescriptions that I was required by State law to save, and
most importantly my computer system that had a custom program to keep
track of all patients' medications, serial numbers of the triplicate
prescriptions, and dates that they were prescribed. When the
prosecutor's office gave me back this computer 1\1/2\ years later, they
said that there was no medical data on it. It had been erased while in
their custody, but since I had a back-up copy of the data on a disk
that they didn't find, I was able to bring the computer back with all
of its lost data.
The worst thing they did that day was to take my triplicate
prescriptions which had just been issued for that month. Even though
the DEA were also present at the time of my arrest, and at my house
raid, they told me and the town police that they had no problem with my
triplicate prescriptions, the town of Davis police force said they did
have a problem with them and were still taking them from me, in direct
violation of State law that mandates a hearing must be conducted before
triplicate prescriptions are confiscated.
So, I now had 100 patients that I had to refer immediately, with no
court hearing and no recourse. These patients were children entering
into summer school, needing their Ritalin, and some were patients with
chronic pain. Thankfully, all the physicians to whom I referred these
100 patients kept them on the same doses as had worked for them in the
All--except for one patient who was on a higher dose of stimulant,
and other doctors initially didn't want to take on his care due to his
complex medical needs. These higher doses of stimulant medications had
literally brought him back from a serious depression in which he had
made a serious attempt at suicide before I took him as a patient.
With his parent's desperate pleas and the fact that I had treated
him for three years, I felt responsible to make sure he had a smooth
transition to another doctor's care. Since I still had legal authority
to issue white prescriptions, I gave him a white prescription and told
him that until we could find another doctor to take him, he could fill
it in Nevada as they had no requirement for a triplicate form for
controlled substances. This action earned me a second arrest, and my
bail was set at $500,000 dollars, clearly an attempt to financially
deplete me. The judge even said that ``we couldn't even hold you for a
day, so money doesn't appear to be a problem.''
In desperation, we hired a San Jose attorney, who told me that he
taught at Stanford. With $25,000 given just for the preliminary
hearing, and $50,000 given to him up front to prepare to fight a trial,
he dragged out my case for 1\1/2\ years, ultimately calling my parents
in Kansas without my permission or knowledge, and told them that he
thought I could get up to 27 years in jail. This prompted them to drive
24 hours straight to Davis, to plead with me to take a no contest plea
to one count of improper distribution of a controlled substance, and to
get out of California. They said they might die and I would not be able
to be with them at that crucial time. They also reminded me that
without my computer records, and the files that had not been given to
my defense lawyer, how could I expect to get a fair trial on my memory
and word of proper diagnoses and treatment of my patients. So, I plead
no contest to a felony count of an unlawful prescription. I did not
want to do this, but my wife and my parents did not want to risk a
trial with a potential outcome of state prison time for the maximum
sentence of 27 years. So, I gave in. In exchange for pleading no
contest to something I did not do, I spent 4 months in county jail and
worst of all, accepted a felony on my record. I was devastated.
When the Osteopathic medical board investigated this, they refused
to accept my backup copies of computer records for all my triplicates
for the past three years, stating that since the police said that they
were not there in my computer at the time of the arrest. They stated
that I must have made these records up from memory. There is no way
that I could remember all the data including serial numbers of three
years of triplicate prescriptions. When I asked them if I could just go
back to the Army, their reply was no, because they did not trust the
Army to properly supervise me. They ultimately revoked my CA license. I
never got past the administrative section of the CA medical board to
the doctors on the board. I felt that if they could just see what had
been done, and hear on a case by case basis the tremendous gains that
patients had made under my care, that they would rule differently.
During my earlier years of training, I had previously been licensed
in New York where I had moonlighted in various ER's. When the State of
New York reviewed my case, they had a three doctor panel. They listened
for hours and reviewed all of my back copies of my recovered records
from the computer, and most notably said that they thought I should be
able to have my license renewed, since I had suffered ``legal
malfeasance,'' in California. Their carefully considered ruling was
overturned by an administrative lawyer from the New York Department of
Health, and it has been stated that until CA says that I can practice
again, they will take no further action, other than to suspend my New
York license. The thought of me going back to CA puts my family into
such fear and depression, that I cannot bring myself to put them
through further trauma.
My hope now resides with my expired license in Connecticut or even
Oklahoma where I have had good records of training. Once I get a state
to license me, I will go straight to the Army, where I served honorably
for 10 years; the Army has already said that they could use me here at
Walter Reed. I would even prefer a tour overseas, so that the returning
wounded could see that I have a combat patch and would relate to me
better. I believe I know something personally about how to rebuild your
life after great trauma. I simply want to discharge the skills that I
have spent so many years getting and desire to be in an institution
where the Constitution of the United States is still revered and
Since there are two cases that highlight the type of patient care
that I gave in Davis, and these folks don't have the honor of having
their voices heard by Congress, I feel that I should briefly describe
Suzanne was a 57 year old woman who was known in Davis as the
town's worst drunk. She had lost her housing years before when she lost
her disability due to her alcoholism. Her case was made more
complicated by a Temporal Lobe Seizure disorder and Fibromyalgia. I
sent her to the town's local ER, when she showed up in my office one
day with early signs of potentially life threatening alcohol withdrawal
seizures. The hospital accepted her referral from me over the phone,
but when they saw it was Suzanne, whom they knew had no way to pay for
her care, they did no treatments other than to give her cab fare, with
instructions to get out of the county. No other treatment facility
would take her, either. So, I took her into my home where she
successfully completed her alcohol detox.
Over the next 6 months, she cleared up all her many public court
cases for public drunkenness, and the court even ordered her as a part
of her probation to continue treatment with me. She was also on a low
dose of opioids for her Fibromyalgia and anticonvulsants for her
seizure disorder. She progressed from barely being able to think
straight, to six months later being able to play the piano again and
recite the Night before Christmas from memory. She was also reconciled
with her daughter. When I asked the police how they could explain her
progress on the day I was arrested, they said that they could not.
Judy was a 37 year old heroin addict from the next town over in
Woodward, CA. I had been treating her daughter for ADHD and when I
asked her grandparents where the mother was, they shook their heads and
said she was a heroin addict and prostitute, and that they could not
even acknowledge her when they saw her on the street. I told them that
we could find her and detox her because I felt that this would go a
long way in helping her daughter with her anger and ADHD. We found her
and since there was no treatment facility that would take her either,
she also moved into our house while she was working on reintegrating
with her parents and daughter. She was on parole and when she was
approached after my arrest, she was given a choice by the police--to
either say that I had been sexually inappropriate with her or had given
her medications for sale. If she chose neither, she faced going back to
prison to serve out her time. She chose the latter and served 11 months
in a CA state prison. She told them and us that she could not lie just
to make it easy for herself.
My office secretary was also a recovering alcoholic whose children
I was treating for ADHD. Court records of her divorce showed that the
police came to her after she sent her children to school with an
afternoon dose of Ritalin in their pocket. They told her that unless
she said that I gave them Ritalin without even properly diagnosing
them, they would file child endangerment charges. Since she was afraid
they would be returned to their father's custody, she agreed to lie.
Her divorce records in Suisun, CA, record these facts about what
choices the police had offered her. This was the charge that I plead no
contest to--since their records had been confiscated, and I had only my
word as proof. I do understand and forgive why she buckled under such
tactics by the Davis police.
While the DEA did not object to my practice, they did nothing to
stop the town police from illegally seizing my triplicates. The fact
that one county over they had one month before employed similar tactics
in the prosecution and arrest of Dr Frank Fisher, from which he was
eventually exonerated, is something that the town police could have
taken a page from the same playbook. I am afraid that the war on drugs
has been turned into a war on doctors and patients.
My seventh great grandfather, John Waugh, came to Virginia to serve
as a Church of England parson in 1660. During that time, he got into
trouble with an English court, controlled by powerful few for such
offenses as taking in pregnant, unwed girls cast out from their homes
from Maryland and performing marriage ceremonies for young couples who
were in love without parental consent. He was even thrown in jail in
When he was elected from Stafford County to the House of Burgesses
in 1699, they denied him his seat, saying that a member of the clergy
could not serve in the House due to having two masters, the King and
the people he would represent. His wife was Elizabeth Madison. His
progeny helped to craft this government of a more perfect union, with a
Constitution and Bill of Rights.
It is a terrible irony that the Bill of Rights has been turned into
a ``Bill of Wishes''--only for those wealthy enough to prosecute when
it is violated. I hope that this House Judiciary Subcommittee on Crime,
Terrorism and Homeland Security, which has oversight supervision of the
DEA, will consider my testimony when thinking about how the tactics
used in the war on drugs in spilling over into local town cops'
attitudes about dealing with doctors with whom they disagree.
I don't seek revenge, because that will cripple me. I don't even
seek justice, because no amount of money could compensate me for the
pain I saw my patients and family put through. I only seek remembrance,
so that this won't continue to happen to others, and that the practice
of medicine be freed from fear of intimidation for treating patients in
good faith. Thank you for your time and attention. I will be happy to
respond to any questions you might have about my testimony.
Prepared Statement of Don Kunz, President, Four Seasons Distributors
My name is Don Kunz, President, Four Seasons Distributors of
My first experience with the DEA was when they came to check our
warehouse and security system in December of l998. The agent that did
our inspection was less versed in the type of pills we carried than we
were. The agent asked some pretty stupid questions just to try to trip
us up. We keep records, I feel, as good as anyone in our business and
the agent just couldn't understand why we did things the way we did.
The agent told us that our documentation on invoices and records at our
warehouse were as good as she had seen. We asked for documentation of
her visit and were told that they did not do that. It sure would be
nice to receive something from the DEA stating what you are doing right
and wrong. It would also be nice to be able to go the DEA for a written
handbook or guidelines pertaining to List 1 Chemicals. They do not put
anything in writing.
Our second experience was when the DEA St. Louis office requested
our sales invoices for Missouri stores that we call on for
pseudoephedrine sales in that state. I told them the only
pseudoephedrine we sold was 8 pills of 25 mg bottles. This did not make
any difference; they still wanted any invoices showing sales of List 1
Chemicals. This was delivered as requested in a timely manner and it
was very difficult to get someone to sign that they had received these
Our third experience was in January 2006. The agents were very
nice; but, again, they were not familiar with the normal terms for
products that all distributors carry. They requested all of our records
for 2004 and 2005 that had any List 1 Chemical sold. This request came
two weeks after a 2-day inspection of our warehouse, vehicles, and
office. The records for those two years comes to approximately 6000
pages and 10 days of work just on this project. After we objected to
releasing our customers' information without some sort of written
request, they changed their mind and requested only 2005 and January1-
5, 2006. Again, I asked for some written documentation of what we were
doing right or wrong; and I was told that they never give any written
We were verbally told that our facilities and records were in the
best shape of anyone they had inspected. They could find nothing wrong
with anything we do.
The problems persist. On Tuesday, May 29, 2007, I received a letter
from the DEA stating that they wish to have a list of our customers
that buy List 1 products. This seems to be a form letter to all
registrants; but our company and its address were used.
First of all, the DEA has this information already from our last
inspection. By the way, the investigators who inspected us said our
records were the best and the cleanest they had seen. The DEA would
also have this information from the self-certification that each store
must go through in order to sell these products.
There is only one conclusion that can be drawn from this letter and
that is to contact and harass and scare our customers into not selling
these products. When we place these products with our customers, we are
very careful to make sure that each one is self-certified and that each
store has a log book (and uses it) and has trained their employees.
Each visit to the stores we talk to the manager or owner about these
products and how they are to be sold.
In the letter, it states ``the DEA will in turn send a notice to
these companies that they are selling regulated products and what their
obligations are under CMEA.'' The next sentence states ``DEA will not
use these lists for any other purpose other than insuring compliance
with the CMEA.'' This is a pure scare tactic to scare our customers. We
have already lost a substantial number of customers due to the
provisions of this new law. This letter will only insure more lost
In the DEA own web site it states that 85% of the illegal meth
comes from Mexico; yet they are still harassing my company and my
My biggest concern is that you don't know if you have done
something wrong until they come knocking on your door. As a legitimate
businessman, I try to always be proactive and take care of any records
or questions before they become a problem. The DEA calls convenience
stores ``gas stations'' or ``gray market''. I think the major petroleum
companies would find this offensive. There isn't an agent anywhere in
the United States that doesn't stop at a convenience store for gas,
cigarettes, coffee, or whatever every day they are working. And they
consider this a ``gray market''!!
I hope the committee takes a hard look at the DEA actions and
intimidation of small businesses and our customers.
Prepared Statement of Buddy Pool, Pool Marketing
My name is Buddy Pool, and I am the owner of Pool Marketing, which
is located in Georgia.
In 1976, Georgia began requiring a State Pharmacy License for any
wholesaler engaging in the sale of pseudoepheedrine products. I applied
for the License. After the state licensing board received my
application, I was instructed by the board to contact the Drugs and
Narcotics Agency to schedule an inspection of my facility. When I made
this request, I was told my company would not be granted a license. The
business has a residential address and the only way to get the license
was for the Licensing Board to grant an exemption. I visited the board
office in Macon and spoke with Ms. Ann Shockley. She advised me to call
Mr. Rick Allan with the Drug and Narcotics Agency. I spoke with Mr.
Allen and he really overreacted even to telling me I could have been
arrested for trespassing for visiting the office. He also stated I
would not be receiving the state license and that he had been in touch
with the DEA and they were in the process of pulling my DEA License. My
DEA License expired on March 31, 2006. I submitted the application to
renew on Feb. 19, 2006. After a few weeks, I began calling the DEA in
Arlington to check on the status of the application. Each time I was
told the application has not been processed yet.
On April 20th I contacted the Atlanta office and was informed by a
lady named Liz, that they had no record of my applying and Liz advised
me to reapply on line and to be sure to get a confirmation no. and run
a copy of the application, which I did. A couple of weeks later I
called Liz back to follow up. She connected me with her supervisor, Mr.
Shortas. The first question Mr. Shortas asked was ``Who are your
I answered that I service Convenience Stores. Mr. Shortas replied
that my DEA License would not be renewed. He said convenience stores
don't need to sell ephedrine products. If a person needs ephedrine
products, he should go to a drug store. He also stated my company would
be investigated and they would make a recommendation to Washington
about my renewal. But the license would not be renewed.