ARTICLES

Medical Marijuana: The Conflict Between ScientificEvidence and Political Ideology. Part One of Two

Peter J. Cohen

ABSTRACT. Whether medical marijuana (Cannabis sativa used to treat a wide variety ofpathologic states) should be accorded the status of a legitimate pharmaceutical agent has longbeen a contentious issue. Is it a truly effective drug that is arbitrarily stigmatized by many andcriminalized by the federal government? Or is it without any medical utility, its advocates hidingbehind a screen of misplaced (or deliberately misleading) compassion for the ill? Should Congressrepeal its declaration that smoked marijuana is without current medical benefit"? Should cannabisbe approved for medical use by a vote of the people as already has been done in 13 states? Orshould medical marijuana be scientifically evaluated for safety and efficacy as any other newinvestigational drug? How do the competingand sometimes antagonisticroles of science,politics and prejudice affect societys attempts to answer this question?

This article examines the legal, political, policy, and ethical problems raised by the recognitionof medical marijuana by over one-fourth of our states although its use remains illegal under federallaw. Although draconian punishment can be imposed for the recreational" use of marijuana, I willnot address the contentious question of whether to legalize or decriminalize the use of marijuanasolely for its psychotropic effects, a fascinating and important area of law and policy that is outsidethe scope of this paper. Instead, the specific focus of this article will be on the conflict between thedevelopment of policies based on evidence obtained through the use of scientific methods and thosegrounded on ideological and political considerations that have repeatedly entered the longstandingdebate regarding the legal status of medical marijuana. I will address a basic question: Shouldthe approval of medical marijuana be governed by the same statute that applies to all other drugsor pharmaceutical agents, the Food, Drug, and Cosmetic Act (FD&C Act), after the appropriate

Peter J. Cohen, MD, JD, is Adjunct Professor of Law at the Georgetown University Law Center. He is Chairof the Physicians Health Program of the District of Columbia Medical Society and former Vice Chair of theInstitutional Review Board of the Intramural Research Program of the National Institute on Drug Abuse. Formerly,he was Professor of Anesthesiology at the University of Pennsylvania Medical Center and Professor and Chairmanof Anesthesiology at the Universities of Colorado and Michigan Medical Centers.

Address correspondence to Dr. Peter Cohen, 10703 Clermont Avenue, P.O. Box 569, Garrett Park, MD 20896(E-mail: ccohenp@aol.com).

This article is adapted from a presentation by Dr. Cohen at an interdisciplinary symposium entitled Drugs:Addiction, Therapy and Crime held at the University of Utah, March 1324, 2008. This paper is being publishedconcurrently in the Utah Law Review and is published herein with permission of the Utah Law Review.

Editors Note: This paper is published in two sections, the first of which containing Parts I through III appearsherein and the second of which containing Parts IV through VII will appear in Volume 23, Issue 2 of this Journal.

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Journal of Pain & Palliative Care Pharmacotherapy, Vol. 23(1), 2009Available online at http://informaworld.com/JPPCP

doi: 10.1080/15360280902727973

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P. J. Cohen 5

regulatory agency, the Food and Drug Administration (FDA), has evaluated its safety and efficacy?If not, should medical marijuana be exempted from scientific review and, instead, be evaluated bythe Congress, state legislatures, or popular vote? I will argue that advocacy is a poor substitute fordispassionate analysis, and that popular votes should not be allowed to trump scientific evidencein deciding whether or not marijuana is an appropriate pharmaceutical agent to use in modernmedical practice.

KEYWORDS. Cannabis, law, marijuana, nausea, medical, pain, policy

PART I: INTRODUCTIONMEDICALMARIJUANA: FORBIDDEN FRUIT OR

BOON FOR HUMANITY?

Two plantsCannabis sativa (marijuana)and Papaver somniferum (the opium poppy1)which have been cultivated for millennia, have aremarkable ability to alleviate physical and men-tal pain. Yet both may also cause harm. Opioidshave significant addiction liability, and even asmall dose causes measurable respiratory de-pression, whereas larger doses are capable ofproducing respiratory arrest and death.1,2 Evenso, their undisputed capability to relieve pain3

is thought to far outweigh these risks. Conse-quently, opium and its derivatives are a legalmainstay in todays medical practice. In con-trast, although marijuana4 is far less addictingthan the opioids5 and there is no documentedevidence of death resulting from its use, evenin large doses,6 it is illegal under federal law7

to cultivate or distribute marijuana in order totreat patients or for a sick individual to use it onthe advice of a physician. Indeed, in some juris-dictions, even a physicians recommendation8

to patients that marijuana might alleviate theirsymptoms has been sanctioned.9 Nonetheless,at this point in time medical marijuana had beenlegalized by 13 states, either by legislation or di-rect statewide popular vote in referenda or ballotinitiatives.10 The federal government, however,has asserted that the Controlled Substances Act(CSA)11 preempts such actions by the individ-ual states, a claim that has been upheld by theSupreme Court.12

In this article, I will examine the legal, polit-ical, policy, and ethical problems raised by therecognition of medical marijuana by almost onequarter of our states in the face of federal oppo-sition. I will use the term medical marijuanato refer to any form of Cannabis sativa used(usually by smoking13) to treat a wide variety ofpathologic states and diseases. Although draco-

nian punishment can be imposed for the recre-ational use of marijuana,14 I will not addressthe contentious question of whether to legalizeor decriminalize the use of marijuana solely forits psychotropic effects, a fascinating and im-portant area of law and policy that is outside thescope of this paper.15 Instead, the specific focusof this article will be on the conflict betweenthe development of policies based on evidenceobtained through the use of scientific methods16

and those grounded on ideological and politicalconsiderations that have repeatedly entered thelongstanding debate regarding the legal status ofmedical marijuana.17 I will address a basic ques-tion: Should the approval of medical marijuanabe governed by the same statute that appliesto all other drugs or pharmaceutical agents, theFood, Drug, and Cosmetic Act (FD&C Act),18

after the appropriate regulatory agency, the Foodand Drug Administration (FDA), has evaluatedits safety and efficacy?19 If not, should medicalmarijuana be exempted from scientific reviewand, instead, be evaluated by the Congress, statelegislatures, or popular vote? I will argue thatadvocacy is a poor substitute for dispassionateanalysis, and that popular votes should not beallowed to trump scientific evidence in decid-ing whether or not marijuana is an appropriatepharmaceutical agent to use in modern medicalpractice.

Part II will examine the authority of the Food,Drug, and Cosmetic Act and the Controlled Sub-stances Act, focusing on their application to theapproval of medical marijuana. I will proposethat because those advocating for medical mar-ijuana are proposing its use as a drug, it shouldevaluated as a drug according to the statutoryrequirements of the Food, Drug, and CosmeticAct.

Part III will address the known risks ofmedical marijuana as documented in the peer-reviewed scientific literature. When possible, Iwill distinguish between the adverse effects of

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6 JOURNAL OF PAIN & PALLIATIVE CARE PHARMACOTHERAPY

recreational and medical use of marijuana be-cause its pathology may not be identical in bothsettings.

Part IV will summarize the known benefits ofmedical marijuana as demonstrated in the peer-reviewed scientific literature.

Part V will examine the battle between inves-tigators who have attempted to obtain scientifi-cally valid data to use as a basis for formulatingpublic policy and those who, apparently for ide-ological and political reasons, have erected bar-riers to such studies. I will propose that both dis-approval by the Congress and approval by statereferenda are equally inappropriate because eachbypasses the normal FDA regulatory and evalu-ation procedure.

Part VI will examine the potential impact oftwo approved medications that contain at leastone active ingredient of marijuana and analyzewhy their legitimate use does not moot the ques-tion of whether medical marijuana should alsobe accepted.

Part VII will conclude that activists on bothsides are responsible for the current state of af-fairs and that scientific evidence devoid of po-litical considerations should be allowed to guidefuture decisions regarding the status of Cannabis