After a 40-year battle over the placement of marijuana in Schedule I,
the U.S. Court of Appeals, DC Circuit, ruled in January on the most
recent petition to reschedule marijuana in the case of AMERICANS FOR
SAFE ACCESS (ASA) v. DRUG ENFORCEMENT ADMINISTRATION (DEA). The court ruled that the DEA had not
acted arbitrarily and capriciously when it denied ASA’s petition filed 9
years earlier to remove marijuana from Schedule I. Schedule I drugs
have "no currently accepted medical use in treatment in the United
States" and "a lack of accepted safety for use under medical
supervision" — a classification that holds marijuana more dangerous
than cocaine, morphine, or methamphetamine, all listed in Schedule II
with accepted medical uses. The court ruled that the research needed to
move marijuana out of Schedule I does not exist. We respectfully beg to
differ.
The DEA’s argument, stated in a 2006 report
from the US Department of Health and Human Services (HHS), is that
there are no "adequate and well-controlled studies" proving marijuana’s
efficacy. Though they noted a number of U.S.-based small-to-medium
sized randomized, double-blind, placebo-controlled studies of inhaled
marijuana for severe pain, spasticity, and wasting syndromes, all
showing valid medical benefits, they felt these were not big enough.
What DEA wants to see are akin to Phase III clinical trials — large
studies, involving hundreds of subjects, comparing marijuana to placebo
in a double-blind, randomized fashion for a specific indication —
exactly what the Food and Drug Administration (FDA) wants when
evaluating interstate drug marketing applications. Here’s the rub: those
kinds of studies have been done and are published
in the peer-reviewed scientific literature and yet neither the DEA, nor
the HHS, nor the Court took notice. Large, multicenter, randomized,
double-blind, placebo-controlled studies involving hundreds of patients
in America and abroad that are in some cases a year in duration have
been published in U.S. National Library of Medicine indexed journals
showing that marijuana, orally administered in extract form, can treat intractable pain in cancer and improve mobility and symptom control
in multiple sclerosis. What is arbitrary and capricious is federal
agencies have chosen to ignore these studies because they have been done
mainly in the private pharmaceutical drug development sector where
marijuana-infused products are produced, tested, and sometimes
strategically renamed. This hide and seek game has resulted in rigorous
research having little to no bearing on public scientific understanding
of the medical use of marijuana.
In the case of GW Pharma Ltd
(GWP) of Wiltshire, England, it is a mouth spray directly extracted
with liquid carbon dioxide from the flowers of two strains of marijuana
plants grown in UK-licensed company greenhouses from a worldwide marijuana seed collection that resided in the Netherlands until the late 1990s. In the case of the non-profit Institute of Clinical Research
(IKR) of Berlin, Germany, it is a capsulated alcohol extract made from
marijuana flowers grown in Switzerland and extracted in Germany.
Marijuana extracts have been produced for millennia for consumption, and
the public has an overriding interest and right to know that these
marijuana studies exist and that their results should logically have
bearing on how we as a society understand, utilize, value, and
ultimately classify marijuana.
So why do the feds not include marijuana resin extract studies when
weighing marijuana’s evidence base? Sometimes it is as simple as a name
game. Congress’s definition of marijuana — unchanged since 1937 — has
always included any compound, extract, or manufactured mixture containing a detectable amount of marijuana resin.
If marijuana resin has been extracted and dissolved into a solvent or
otherwise concentrated, that new substance is still called marijuana,
hash, or hash oil, and this form of marijuana often carries stricter
penalties, such as the life sentence penalty
recently adopted by Oklahoma in 2011 for first-offense hash production.
Millions have been punished under this full definition of marijuana
via their possession or distribution of marijuana-infused edibles such
as brownies or hash oil. Marijuana medicines made by GWP and IKR are
concentrated forms of the marijuana plant with marijuana resin as a
base. GWP’s lead product, imported for U.S. trials under DEA license,
was named "nabiximols"
(Sativex
