People Working to Legalize Medical Marijuana (11/29/2005)
Lyle E.
Craker, Ph.D.
Lyle Craker
is a professor of Plant and Soil Sciences at the University
of Massachusetts, Amherst. Since 1967 when Professor Craker
earned his Doctorate degree in Agronomy & Plant Genetics
from the University of Minnesota, his research has centered
on crop physiology, principally on the physiology of medicinal
and aromatic plants.
Professor Craker has written
more than 100 articles on a range of topics from the effects
of heavy metals in soil on plant growth to the development
of essential oils in everyday herbs like rosemary and sage.
In addition to his teaching and research responsibilities
at the University, Professor Craker is currently editor of The
Journal of Herbs, Spices and Medicinal Plants and Chairman
of the Medicinal and Aromatic Plant Section of the International
Society for Horticultural Science. Professor Craker's research
interest in medical marijuana developed from his work with
other medicinal plants. Professor Craker is currently appealing the U.S. Drug Enforcement
Administration's (DEA's) denial of his application to grow
marijuana at the University of Massachusetts for medical research.
Professor Craker's battle to break the federal government's
monopoly on medical marijuana available for research began
in 2001 when a non-profit organization seeking to develop
marijuana into a prescription medicine approached him about
growing research-grade marijuana of the quality needed to
meet FDA approval. At that time, he applied to the DEA for
a permit to grow medical marijuana, a controlled substance,
for use in medical research. The DEA took no action on the
application for almost three years until a federal court ordered
DEA to respond to the application. In December 2004, the DEA
finally denied Professor Craker's application to grow medical
marijuana for medical research.
The American Civil Liberties Union represents Professor Craker
in the appeal before the DEA's Administrative Law Judge. The
Judge could recommend that the DEA approve the application
on the basis that doing so would benefit the general public's
interest.
Statement
of Lyle Craker, Ph.D., respondent in DEA
administrative law judge hearing
Since being approached
by MAPS with an interest in funding the growth of quality
plant material with balanced, consistent constituent
levels for use in testing the possible health benefits
of medical marijuana, I have considered this case important
to me as a scientist. In this role, I have viewed marijuana
the same as any other medicinal botanical in which possible
health benefits are unknown or unproven. That is, the
plant and plant extracts should be investigated by qualified
medical professionals to determine whether the plant
material has any potential for treating human afflictions,
separating the anecdotal from the tested.
From the beginning, I have recognized
that this plant is somewhat different from other medicinal
plants, long suppressed because of misuse as a recreational
drug. Yet, I also recognized that with proper security
any misuse of plant material grown for medical trials
could be prevented. Indeed, the danger from growing
this plant seems no more hazardous than other illicit
drugs to which the government limits access through
appropriate security arrangements.
As a faculty member at a great
public, land-grant University, I have the responsibility
of serving the people by participating in scientific
studies that supply evidence through experimental trials.
In this effort, I have spent the last 20 years as an
agronomist investigating the growth and development
of various medicinal and aromatic plants and providing
leadership in the study of these plant materials at
the local, national, and international level. These
investigations, I trust, have been helpful to a number
of medicinal and aromatic plant growers and ultimately
to the people interested in using these products for
health purposes.
Overall, the proposed research
effort with medical marijuana involves several people
with different specialties and different roles. My job
would be to produce a selection of plant material that
could be used in clinical trials trials established
so that medical doctors can determine if use of this
plant material could improve patient health or provide
symptom relief. If we do not seek the answer to this
question, I believe that we all lose, our fear of scientific
investigation blinding us to patients' continued suffering. |
Allen
Hopper
Allen Hopper is a senior staff attorney at the American
Civil Liberties Union's Drug Law Reform Project. He represents
Professor Lyle Craker in his appeal of the U.S. Drug Enforcement
Administration's denial of his application to grow research-grade
marijuana for use in studies that aim to develop it into
a legal, prescription medicine.
 Immediately
prior to joining the ACLU, Mr. Hopper was a post-conviction
death penalty defense attorney with the California Appellate
Project (CAP) in San Francisco.
CAP was established by the California Supreme Court and the
State Bar to act as liaison to the Court, overseeing and providing
case assistance to the lawyers appointed by the Court to represent
death row defendants in their state and federal post-conviction
proceedings.
At the ACLU, Mr. Hopper focuses on marijuana policy-related
litigation. He wrote a legal analysis of the continued validity
of state medical marijuana laws in the aftermath of the U.S.
Supreme Court's recent decision in Gonzales v. Raich and
has been quoted extensively in the national news media on
the topic. Mr. Hopper wrote letters to the attorneys general
and head officials in four states demanding that they reinstate
medical marijuana laws that were improperly suspended after
the Raich decision in June 2005. All states complied.
In addition to litigating cases, Mr. Hopper works with ACLU
staff to conceptualize public education campaigns that aim
to shift our nation's punitive drug policies away from over-incarceration
and towards a public health approach.
Mr. Hopper earned his J.D. from the University
of California, Davis, School of Law in 1992. While
in law school, he worked with a Washington D.C. public interest
law firm engaged in litigation seeking to expose the relationship
between the war on drugs and American foreign policy in
Central and South America. Mr. Hopper worked in the Immigration
Law Clinic at the U.C. Davis School of Law and did anti-apartheid
impact litigation with the Legal Resources Centre in Durban,
South Africa. After graduating from law school and
before joining CAP, he worked in private practice focusing
on criminal defense, prisoners' rights and police misconduct
litigation.
Statement
of Allen Hopper, Attorney with the ACLU Drug
Law Reform Project
The American Civil Liberties Union welcomes the opportunity
to represent Professor Craker. We believe that scientists
and doctors should be free to pursue the truth about
all drugs and to conduct legitimate research without
government obstruction or censorship rooted in the politics
of the drug war. We believe that the public has a right
to know the truth about the drugs and medicines they
consume. And we believe that sick people have a right
to safely access the medicines their doctors say they
need to save their lives or alleviate pain; they should
not have to buy these drugs off the street. Patients
throughout America are already benefiting from medical
marijuana, but further research is needed to develop
a safe, affordable, predictable and reasonably attainable
treatment.
The U.S. Supreme Court recently held in Gonzales
v. Raich that the federal government maintains
authority under the commerce clause of the Constitution
to enforce federal marijuana laws, even in states
that have made the medical use of marijuana legal.
During the Raich oral arguments, however,
Justice Breyer signaled the way forward, telling one
of Angel Raich's attorneys that his clients should
ask the Food and Drug Administration to reclassify
marijuana as appropriate for medical use. Justice
Breyer noted, medicine by regulation is better than
medicine by referendum.
We'd like to take Justice
Breyer up on his suggestion on behalf of the nearly
80 percent of Americans who support medical marijuana.
Unfortunately, the federal government has set up a
classic Catch-22: They say we need more research to
establish the safety and efficacy of marijuana as
a medicine, yet at the same time obstruct that very
research. One of the primary ways the federal government
has kept medical marijuana research from moving forward
is through the monopoly the National Institute of
Drug Abuse (NIDA) has on marijuana that can legally
be used for research. No other controlled substance including LSD, MDMA (ecstasy), heroin, and
cocaine is subject to this absurd NIDA monopoly. All
other controlled substances can be procured by scientists
from any number of DEA-licensed laboratories once their
research protocol has been approved by the FDA. Yet
with marijuana, even after the FDA approves a research
protocol and grants permission for a study to go forward,
NIDA maintains virtually sole discretion over the provision
of material required for research. And NIDA has refused,
time and again, to provide marijuana for legitimate,
FDA-approved research, bowing, instead, to the politics
of the government's war on drugs.
Under the current regulatory
scheme, the only realistic way that scientists will
be able to conduct the research necessary to evaluate
marijuana's safety and efficacy as a medicine is to
develop an alternative source to NIDA. That is what
Professor Craker seeks to do, barred only by the DEA's
refusal to grant him a license a
license the DEA is legally obligated to issue if so
doing would be in the public interest. We intend to
prove through the testimony of scientists, doctors and
patients that it is, without question, in the public
interest to grant Professor Craker's application.
The government
is afraid of the truth: Marijuana may be a safe and
effective medicine. The government is forsaking science
and putting politics before the public good. We hope
that Professor Craker's legal challenge will expose
and begin to redress this reprehensible situation.
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Rick Doblin,
Ph.D.
Rick Doblin is the founder and director of the non-profit
research and educational organization, the Multidisciplinary
Association for Psychedelic Studies (MAPS). One of the primary
missions of MAPS is to sponsor scientific research designed
to develop marijuana into a Food and Drug Administration-
-approved prescription medicine and to educate the public
honestly about the risks and benefits of this drug.
 MAPS holds the only Orphan Drug designation granted by
the FDA for the medical use of marijuana, specifically for
AIDS Wasting Syndrome. The Orphan Drug program was created
by Congress to facilitate development of drugs for rare diseases diseases
affecting less than 200,000 people in a year. Drugs for such
rare diseases are not considered sufficiently profitable for
pharmaceutical companies, and their research has therefore
been minimal, leaving such drugs as orphans. Orphan Drug
designation provides a package of incentives for research
and development, including seven years of patent protection
(exclusive right to market) should convincing data about the
drug's safety and efficacy ever be submitted to the FDA, and
the drug subsequently approved. Marinol, the oral pill containing
the active ingredient in marijuana, THC, was approved for
AIDS Wasting under the Orphan Drug program.
MAPS is the sponsor of a research project
at a Drug Enforcement Administration -licensed laboratory
into the safety and efficacy of the marijuana vaporizer,
an alternative non-smoking delivery system for medical cannabis.
This laboratory applied over two years ago to purchase 10
grams of marijuana for research from the National Institute
on Drug Abuse (NIDA) currently,
the sole supplier of marijuana for medical research. Because
NIDA and relevant federal agencies have failed to review the
simple research protocol to date, this study has been effectively
blocked. NIDA has also refused to supply marijuana to two
other FDA-approved human studies sponsored by MAPS, preventing
them from taking place. The government's monopoly on marijuana
fundamentally obstructs MAPS' effort to develop marijuana
into an FDA-approved prescription medicine. Furthermore, NIDA's
marijuana, even if made available to MAPS-sponsored researchers,
is not necessarily of sufficient quality to meet FDA approval
standards.
Beginning in 2000, MAPS has sponsored University
of Massachusetts Professor Lyle Craker's efforts to establish
a marijuana growing facility to produce marijuana of the quality
required to legitimately pursue FDA approval. Rick Doblin
is presenting testimony before a DEA Administrative Law Judge
that approval of Professor Craker's application to grow research-grade
marijuana would benefit the public interest by allowing critical,
privately funded, MAPS-sponsored research into the potential
medicinal effects of marijuana.
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