[House Hearing, 110 Congress]
[From the U.S. Government Printing Office]



 
      DRUG ENFORCEMENT ADMINISTRATION'S REGULATION OF MEDICINE

=======================================================================



                                HEARING

                               BEFORE THE

                   SUBCOMMITTEE ON CRIME, TERRORISM,
                         AND HOMELAND SECURITY

                                 OF THE

                       COMMITTEE ON THE JUDICIARY
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               ----------                              

                             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 



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                       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

                                                                   Page

                           OPENING STATEMENTS

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

                               WITNESSES

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, 
  DC
  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, 
  NM
  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

                                APPENDIX

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,
                                                    Washington, DC.

    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, 
and Coble.
    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 
Assistant.
    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 
patients.
    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 
painkillers.
    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 
country.
    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 
medication.
    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-
enforcement priorities.
    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.
    [Audio difficulties.]
    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 
duties.
    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 
Georgetown University.
    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 
regulatory agencies.
    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 
this Committee.
    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.
    Administrator Rannazzisi?

    TESTIMONY OF MR. JOSEPH T. RANNAZZISI, DEPUTY ASSISTANT 
     ADMINISTRATOR, OFFICE OF DIVERSION CONTROL, U.S. DRUG 
    ENFORCEMENT ADMINISTRATION, U.S. DEPARTMENT OF JUSTICE, 
                         WASHINGTON, DC

    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 
obligations.
    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 
obtainable chemicals.
    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 
governmental resources.
    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 
unscrupulous doctors.
    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 
requirements.
    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 
controlled substances----
    [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 
Judiciary----
    Mr. Nadler. You need to speak up and speak to the 
microphone.
    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 
medicine.
    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 
device.
    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 
nicotine?
    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 
correct----
    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 
quite troubling.
    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 
withdrawal.
    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 
actively.
    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 
misrepresentation.
    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 
medicines.
    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 
assessment.
    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 
assessment.
    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 
legitimate needs.
    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 
hours.
    [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 
        Channels.
    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 
channels.
    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 
scanned data.
    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.
                               conclusion
    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-
based products.

    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 
research.
    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 
medicine?
    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.
    Thank you.
    Mr. Nadler. Time of the witness has expired. You may 
conclude.
    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 
hospitalization.
    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 
enforcement agencies.
    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 
and me.
    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 
Hinchey amendment.
    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 
currently closed.
    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 
effectively hamstrung.
    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 
FDA-approved studies.
    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, 
prescription medicine.
    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 
drug.''
    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 
and un-winnable.
    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 
what not.
    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 
much.
    [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 
any longer.
    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 
it up.
    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 
case.
    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 
questioning.
    Mr. Scott. [Presiding.] I want to thank the witnesses and 
apologize for my absence. I will recognize myself for 5 
minutes.
    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 
deterrent effect.
    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 
better.
    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 
times over.
    Mr. Scott. What is the status of the study that the judge--
I believe it is University of Maryland--Massachusetts. I am 
sorry.
    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 
now.
    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 
be awarded?
    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 
matter is.
    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 
tablets.''
    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 
marijuana.
    Mr. Forbes [continuing]. On that.
    Ms. Corral. No, I am just here to speak about medical 
marijuana.
    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 
offered.
    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 
schedule one?
    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 
scheduling recommendation.
    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 
taking it?
    Mr. Rannazzisi. We have had cases where there were deaths 
related to the prescription medication prescribed by the 
physician, yes.
    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 
State.
    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 
country, yes.
    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. 
Heiden----
    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 
products.
    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 
issue.
    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 
wrong.
    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.
    Thank you.
    Mr. Murray. Mr. Chairman, may I add one brief commentary as 
perspective, please, sir, with regard to methamphetamine 
issues?
    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 
here.
    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 
incidents reported.
    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 
dramatically reduced.
    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 
strikingly.
    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 
methamphetamine.
    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 
border.
    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 
questions.
    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 
is anecdotal.
    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 
bought.
    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 
50-pound bag.
    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 
survey.
    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 
germinate.
    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 
harmful drugs?
    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 
contract----
    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 
is.
    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 
for marijuana.
    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 
there.
    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 
ago. Mister----
    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 
term?
    Mr. Rannazzisi. I can't give you a time period about when a 
ruling is----
    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 
might be----
    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 
recommendation?
    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-
by-case basis.
    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 
months ago.
    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 
marijuana seeds.
    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 
the Committee.
    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 
marijuana.
    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 
record.
    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

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               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 
studies.
    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 
past.
    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 
followed.
    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 
their stories:
    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 
Jamestown.
    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 
Belleville, Illinois.
    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 
records.
    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 
inspection report.
    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 
customers.
    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 
customers.
    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.
    Thank you.

                                

            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 
customers?''
    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.