Needless Suffering of Medical Marijuana Patient Embodies Federal-State Conflict: A Prison Extraction

Sunil Kumar Aggarwal at Huffington Post – Associate Member of the New York Academy of Medicine, Senior Resident Physician at Large Academic Medical Center in New York City

When I was in the graduate school portion of the Medical Scientist Training Program at the University of Washington in the Department of Geography, I had an opportunity to work with an intrepid defense attorney by the name of Douglas Hiatt, who brought me face-to-face with major health and human rights cases of persecuted, ill and disabled patients who were caught up in the federal-state conflict on medical marijuana. While the story I share below is from 2005, and was covered by the AP wire, it seems it is only in this age of majority support for ending the federal war on marijuana, when there is still doubt being expressed about the severity of marijuana prohibition enforcement, that people may be able to read and appreciate the full medical details of the following case. I did try to submit the write-up below to medical journals several years ago, but it seems like they were not yet willing to listen. Please lend me your ears and consider the consequences of a federal health policy built on denial of scientific fact of the medical utility of herbal cannabis.

Read the story here

State-sanctioned Knowledge about Cannabis: Willfull Ignorance

Posted: 04/15/2013 2:40 pm

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 notacted 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 theAmerican Medical Association, the American College of Physicians, and theMassachusetts 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.

Taking the Human-Cannabis Relationship Seriously

"Southern Humboldt County California, August, 1978. A volunteer sativa plant out in the meadow. For decades, families and children have lived in multiple contexts which include cannabis culture."  -- Ursi Reynolds.
“Southern Humboldt County California, August, 1978. A volunteer sativa plant out in the meadow. For decades, families and children have lived in multiple contexts which include cannabis culture.” — Ursi Reynolds.

 

‘Tis in our nature: taking the human-cannabis relationship seriously in health science and public policy

  • Department of Rehabilitation Medicine, New York University School of Medicine, New York, NY, USA

To find clearheaded scientific perspective on cannabis use through the prevailing thick smokescreen requires recognizing just what sort of smoke obscures our better understanding. In the United States, in large part, the smokescreen is made up of culture war-charged political rhetoric and obstructionism from those in positions of authority setting up a prejudicial ideological framing for cannabis use. National leaders throughout the twentieth century have taken opportunities afforded by high office or its pursuit to publicly opine on the dangers of cannabis, such as when then-Presidential candidate Ronald Reagan famously stated in 1980 that “leading medical researchers are coming to the conclusion that marijuana, pot, grass, whatever you want to call it, is probably the most dangerous drug in the United States and we haven’t begun to find out all of the ill-effects. But they are permanent ill-effects. The loss of memory, for example Grass (1999).” Not only is such rhetoric overly simplistic, it also obscures and distorts pre-existing facts. In this particular case, Reagan’s statement obscures the fact that the American Medical Association testified in 1937 on record to Congress that, after nearly 100 years of professional experience in Western medical practice with over 2000 prescribable marketed cannabis preparations (Antique Cannabis Museum, 2012), practitioners found that cannabis had an irreplaceable therapeutic role as an aid in theremembering of old and long-forgotten memories in psychotherapy patients (U.S. Congress, 1937). When in office, Reagan’s first drug czar, Carlton Turner, blamed cannabis use for young people’s involvement in “anti-military, anti-nuclear power, anti-big business, anti-authority demonstrations” (Schlosser, 1997), all dissenting positions toward government initiatives. Such clear scapegoating rhetoric has roots in the government’s racialized Reefer Madness campaign of the 1930s which linked cannabis use in Blacks, Latinos, jazz musicians, and juvenile delinquents to racial miscegenation and homicidal mania (Helmer, 1975).

With such a long tradition of distorting rhetoric emanating from leading political authorities and being broadcast widely by the mass media, it is apparent how politicized cannabis use has become and how scientific research and knowledge about its use have been selectively highlighted and skewed to support pre-determined political objectives. These persistent distortions and political evasions are the greatest contributors to the smokescreen that obscures collection and dissemination of accurate evidence on cannabis use. The smokescreen is perpetuated because, as the saying goes, in war, the first casualty is the truth. Maintaining existing controversial policies relegating cannabis to the status of contraband (such as, under US federal law: zero-tolerance for use, a death penalty for trafficking amounts greater than approximately 66 tons, and official denial of currently accepted medical use in treatment) tends to be of a greater priority to governmental bodies than collecting and collating basic evidence regarding its use to inform public policy and health.

What evidence is gathered is often rejected or simply ignored if politically inexpedient. Here are a few examples. On occasion, political leaders are actually caught attempting to make “backroom” deals to ensure that a scientific commission’s findings on cannabis use will have a predetermined outcome intended to marginalize political enemies. Take, for example, what was explicitly caught on tape during Richard Nixon’s presidency. As documented on declassified tape recordings from the White House Oval Office on September 9, 1971, Nixon privately told his appointed Commission chair, former Pennsylvania Governor Raymond Shafer, that it was “terribly important” the Commission, tasked by Congress with helping to determine what level of risk cannabis use should be understood to constitute for the purposes of legal regulation, not come out with a report that was “soft on marijuana.” Strategizing for political expediency over factual review and nuance, Nixon called for obfuscation: “I think there’s a need to come out with a report that is totally, uh, uh, oblivious to some obvious, uh, differences between marijuana and other drugs, other dangerous drugs… ” Nixon further warned Shafer: “Keep your Commission in line (CSDP, 2012).” Despite the Commission’s recommendations to the contrary, cannabis was nevertheless maintained in the most restrictive category under federal law, Schedule I, where it has remained alongside heroin for 42 years, officially deemed to be devoid of medical utility, or safety. After a 14-year-delayed evidentiary hearing on a citizen-led cannabis-rescheduling petition filed in 1972 which lasted for 2 years, a Drug Enforcement Administration (DEA) Administrative Law Judge (ALJ) ruled in 1988 that cannabis should be rescheduled to Schedule II, with painkillers and anesthetics such as morphine and cocaine with currently accepted medical uses, and that to not do so would be “unreasonable, arbitrary, and capricious (SLDP, 2012).” The presidentially-appointed head of DEA rejected his own agency judge’s ruling and, in 1994, a federal court finally denied the petitioners’ appeal. An additional citizen-petition to reschedule cannabis filed in 2002 was rejected by the DEA after 9 years of delay and is presently under appeal (ASA, 2012). In 2007, another DEA ALJ ruled that it would be “in the public interest” to have more than one licensed facility to produce research-grade cannabis, and that a Plant and Soil Sciences Professor petitioner who had applied in 2001 for a production license and been denied be granted one. This DEA judge’s ruling, too, was rejected by the DEA head in 2009 and is presently under appeal (MAPS, 2012). The rejection had the effect of allowing the federal government’s hamstringing of scientific research to continue, with cannabis clinical studies being approved at an unacceptably slow pace, testing substandard-quality material produced under a government-backed private monopoly, and supplied only after potential investigators have waded through tremendous red tape, if supplied at all. Meanwhile, over the same timeframe, private pharmaceutical interests backed by highly-profitable international corporate pharmaceutical distributors have been granted license by the DEA to import and test in large, multicenter clinical trials in the US proprietary whole plant cannabis extracts made in company-owned cannabis production greenhouses licensed by friendlier governments (Aggarwal, 2010).

The persisting Schedule I classification of cannabis that the federal government maintains is itself a smokescreen that is directly discordant with authoritative, independent, medico-scientific evidence-based assessments. Publishing in the open-access scientific literature housed in the U.S. National Institutes of Health’s National Library of Medicine, clinical investigators who oversaw seven separate, government-authorized, gold-standard design clinical trials of the safety and efficacy of smoked and vaporized inhaled cannabis for specific indications conducted at University of California medical centers over a 10 years period from 2002–2012 involving over 300 human subjects reported in an article entitled “Medical Marijuana: Clearing Away the Smoke” that all trials independently showed benefit. The authors concluded that the Schedule I classification of cannabis, based on the evidence collected and reviewed, is “not tenable,” “not accurate,” and one of the main “obstacles to medical progress (Grant et al., 2012).” This position is concordant with the analyses and conclusions in evidence-based positions papers and reports on cannabis medical science from leading national medical academies and specialty societies (National Research Council, 1999American College of Physicians, 2008American Medical Association, 2009).

To begin to clear such a thick and recalcitrant smokescreen of political rhetoric and interference surrounding cannabis use requires that a massive gust of fresh air be let into the room. This will help to spur a fundamental perspectival reorientation that will allow us to breathe freely, return to first principles, and start evidence-gathering from the beginning. An expedient smokescreen clearing approach is a historical and comparative ecological one that focuses on the human-cannabis relationship on a species to species level. We will come back to the theoretical outlines of this approach; for now, consider its results. While Cannabis sativa evolved in the Central Asian-Himalayan region ~36 million years ago (McPartland and Guy, 2004), it has spread to all regions of human habitation due to the long-standing fondness Homo sapiens have had for this semi-domesticated botanical cultivar, evidenced by the undisputed prehistoric archaeological record (Russo et al., 2008) and ancient textual references (Hillig, 2005). Cannabis’s very name belies its longstanding relationship with humanity, as it was pragmatically given the species name “Sativa” in 1542 by German physician-botanist Leonhart Fuchs, meaning “cultivated” or “useful” in Latin (Russo, 2007). It grows easily in numerous climates as a wild and hardy plant whose palmate fan leaf’s geometry is iconic. Uses of Cannabis sativa include production of textiles, building material, canvas, rope, paper, and biofuel using the cellulose and fiber of its stalk; nutritive food, edible oil, and lotions using its oil- and protein-rich seeds; and, most pointedly, herbal medicines, spiritual sacraments, and psychoactive inebriants using its phytocannabinoid-rich resin-producing flowers and leaves which, when ingested after heating, have robust, non-lethal, receptor-based effects via the human endogenous cannabinoid, or endocannabinoid, signaling system. Such effects pharmacologically are properly termed “cannabinergic.” The endocannabinoid system is an essential biological signaling system that appeared 600 million years ago in life (Melamede, 2005) and plays a master-regulatory role in many physiological functions that humans may naturally wish to self-adjust, such as mood, appetite, memory, inflammation, muscle tone, pain perception, and stress management, in addition to other more subtle but equally validated functions such as neuroprotection, bone growth, immunity, tumor regulation, seizure threshold, gastrointestinal motility, and intraocular pressure, to name a few (Di Marzo, 2004Pacher et al., 2006Vettor et al., 2008).

When gathering evidence to address behavioral questions surrounding human consumption and production of potentially psychoactive cannabis preparations, it is absolutely essential that this long, co-evolutionary arc of human history with this cannabinergic plant be appreciated in order to understand underlying human values, and desires that motivate cannabis use and prevent smokescreen prejudices from taking root. The main question is: what sorts of relationships can humans have with cannabis, aside from aberrant, pathological, and addictive ones? And, as a corollary to this question, when cannabis is consumed in contemporary settings, does it necessarily have to be as a scarce consumerist commodity, or do other relational possibilities exist? By addressing such questions, a richer understanding of cannabis use can emerge and lessen the chance that use patterns are improperly understood as pathological or deviant, when they may fact be perfectly normal and healthful. Certainly the caveat that cultural controls and norms regarding cannabis use that play an important public health role may not translate to all social groups must be acknowledged.

A broader understanding of the human-cannabis relationship beyond the dominating twentieth century American and colonial prohibitionist sociolegal frameworks is needed. When there is not a war against cannabis being fought, a less distorted picture of its effects can emerge. The element of psychological distress that cannabis prohibition regimes produce is worth seriously accounting for as it can play a significant role in the conflation of the effect of cannabis on a user with the effect of the criminal or social stigma attached to that use (Aggarwal et al., 2012). A research approach from social science known as political ecology, taken from anthropology and geography, which is able to incorporate into its analysis the total human-plant relationship and the effects of local and global sociopolitical forces, is helpful here (Robbins, 2004). Political ecology is framework used to study human-environment relations that joins cultural ecology with political economy. Cultural ecology studies how cultural groups adapt, adjust, and relate to their natural environments, and political economy studies how political institutions, the political environment, and economic systems influence each other (Mayer, 1996Johnston et al., 2007). A sampling of the results of applying such an approach to demystify the smokescreen was given above.

By applying political ecology to cannabis use and production, we can begin to understand and appreciate traditional ecological knowledge regarding its use and production, extant and extinct cultural practices surrounding cannabis use, and the history of their marginalization. Western delegates first heard officially from other countries who wished not to impose absolute prohibition at United Nations meetings in the early 1960s when the first comprehensive international treaty that would call for strict controls on cannabis was being negotiated. Indeed, while a number of thriving civilizations have found a way to integrate cannabis use into their legally sanctioned cultural fabrics, such alternate sociocultural and political realities were ultimately targeted for suppression.

Substantial evidence has been gathered regarding the efficacious use of cannabis as a medicine to treat specific conditions. Additionally, convincing evidence regarding the use of cannabis as a non-problematic “recreational” psychoactive substance with a low potential for addiction has been collected and become increasingly accepted in the US and abroad. Public policy regimes recognizing such use patterns—medical marijuana and adult marijuana use—have taken root in several US states and internationally. However, two human-cannabis use relationships, oft-neglected in medical and public health literature, but for which substantial evidence exists are cannabis use as a spiritual or religious activity and as an herbal or dietary supplement. These use patterns were presented by international delegates from countries such as India and Pakistan for respectful consideration at the UN but simply ignored and censured (United Nations, 1961Times of India, 2012). I call for more research and documentation on these use patterns globally using the research framework described to fully eradicate the smokescreen and see clearly what exists.

Acknowledgments

Thank you to John Dvorak for his helpful comments on earlier drafts of this article.

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Citation: Aggarwal SK (2013) ‘Tis in our nature: taking the human-cannabis relationship seriously in health science and public policy. Front. Psychiatry 4:6. doi: 10.3389/fpsyt.2013.00006

Received: 30 December 2012; Accepted: 10 February 2013;
Published online: 26 February 2013.

Edited by:

Elizabeth C. Temple, University of Ballarat, Australia

Copyright © 2013 Aggarwal. This is an open-access article distributed under the terms of theCreative Commons Attribution License, which permits use, distribution and reproduction in other forums, provided the original authors and source are credited and subject to any copyright notices concerning any third-party graphics etc.

*Correspondence: aggars03@nyu.edu