Adequate and Well-Controlled Studies Proving Medical Efficacy of Cannabis Exist but Are Ignored by Marijuana Schedulers
April 14, 2013
Sunil Kumar Aggarwal and Amanda Reiman, Huffington Post
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 courtpdf&sa=D&sntz=1&usg=AFQjCNG5ePTNALLdgZY8_IcsbaKSMhR1-g'>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®) and not marijuana by the United States Adopted Names Council, a body composed of organized medicine and pharmacy with FDA backing. In IKR's case, the company chose the name Cannador® for their marijuana extract seemingly without any regulatory oversight.
Cannabis, marijuana's proper name, is a commonwealth medicinal plant belonging to no government or private entity. Licensed producers of marijuana extracts in the private sector have a rare and coveted wide latitude of scientific freedom to explore and discover, in a rigorous way, many of the medicinal benefits inherent to cannabis. Does the government have the right to ignore rigorous peer-reviewed published evidence about marijuana's medical utility accumulated in the pharmaceutical sector which enjoys privileged access to marijuana for research and development? Does private industry have the right to demand, as GWP once did, that marijuana not be rescheduled based in part on their collected data, which they recently achieved in the UK, presumably to protect company market share and pricing by avoiding competition from future marijuana producers who would be empowered by a rational reclassification of marijuana in federal law? Cannabis should not be cordoned off for the sake of private patents, monopolies, or FDA drug marketing applications.
In the U.S., federal agencies have set-up onerous roadblocks that limit researchers' abilities to access marijuana -- the very impetus for private marijuana research to get started overseas, licensed by friendlier governments. A DEA judge actually ruled that the U.S. marijuana supply monopoly was not in the public interest in 2007, but this decision has been ignored. Many major medical societies want marijuana rescheduled or are urging a scheduling review be undertaken, including the American Medical Association, the American College of Physicians, and the Massachusetts Medical Society, publishers of the New England Journal of Medicine. In fact, there has been ongoing resistance to marijuana's placement in Schedule I ever since Congress first attempted it in 1970. When drafting the law, Congress sought input from Dr. Roger Egeberg, Assistant Secretary of Health at HHS and former personal physician to General MacArthur. He testified that "our recommendation is that marihuana be retained within schedule I at least until the completion of certain studies now underway to resolve the issue", referring to the comprehensive "National Commission on Marihuana and Drug Abuse" study being undertaken at that time. His recommendations were echoed in a Congressional Committee report which stated "the recommendations of this Commission" would be "of aid" in determining "the appropriate location of marihuana within the schedules of the bill." When the Commission reported in 1972 that the public threat of marijuana had been greatly exaggerated and recommended that its classification be lowered so that it was no longer on par with heroin, no one took responsibility and marijuana was left in Schedule I. Immediately afterwards, citizens filed the first of several petitions to reschedule marijuana. After 16 years, the first petition was favorably viewed by a DEA judge who concluded after an extensive, two-year evidentiary hearing, that "marijuana, in its natural form, is one of the safest therapeutically active substances known to man. By any measure of rational analysis marijuana can be safely used within a supervised routine of medical care." He ruled that marijuana be rescheduled to Schedule II, with painkillers and anesthetics, and that to not do so would be "unreasonable, arbitrary, and capricious." His decision was overruled by the politically appointed DEA head who said that data were inadequate.
Forty years later, the ASA v. DEA case, now on appeal, is the latest major legal challenge to marijuana's schedule I status, and new rescheduling bills have been filed in Congress. We cannot let the federal government play fast-and-loose with science on marijuana research any longer--cannabis in all forms must be down-scheduled and de-scheduled. The public health justice imperative to stop curtailment of scientific inquiry and free medical professionals to explore alternative treatments like marijuana with patients is paramount. There are too many lives at stake, not to mention scientific integrity and a burgeoning field of medical discovery requiring much freer access to the marijuana plant.
Sunil Aggarwal, M.D., Ph.D. and Amanda Reiman, Ph.D., M.S.W.
Dr. Aggarwal is a board member of Americans for Safe Access Foundation and a resident physician at a large academic medical center in New York City. Dr. Reiman is a California policy manager for the Drug Policy Alliance and a Lecturer in the School of Social Welfare at the University of California, Berkeley.
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