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7KH(WKLFVRI0HGLFDO0DULMXDQD*RYHUQPHQW5HVWULFWLRQVYV0HGLFDO1HFHVVLW\ $XWKRUV3HWHU$&ODUN 6RXUFH-RXUQDORI3XEOLF+HDOWK3ROLF\9RO1RSS 3XEOLVKHGE\Palgrave Macmillan Journals 6WDEOH85/http://www.jstor.org/stable/3343473 . $FFHVVHG Your use of the JSTOR archive indicates your acceptance of JSTOR's Terms and Conditions of Use, available at . http://www.jstor.org/page/info/about/policies/terms.jsp. JSTOR's Terms and Conditions of Use provides, in part, that unless you have obtained prior permission, you may not download an entire issue of a journal or multiple copies of articles, and you may use content in the JSTOR archive only for your personal, non-commercial use. Please contact the publisher regarding any further use of this work. Publisher contact information may be obtained at . http://www.jstor.org/action/showPublisher?publisherCode=pal. . Each copy of any part of a JSTOR transmission must contain the same copyright notice that appears on the screen or printed page of such transmission. JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range of content in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new forms of scholarship. For more information about JSTOR, please contact [email protected]. Palgrave Macmillan Journals is collaborating with JSTOR to digitize, preserve and extend access to Journal of Public Health Policy. http://www.jstor.org The Ethicsof MedicalMarijuana: GovernmentRestrictionsvs. MedicalNecessity PETER A. CLARK e I HERE is a healthy debate raging in the medical community about the increasing popularity of alternative medicine (also termed unconventional, com- plementary, or integrative) in the United States (i). It is estimated that 40% of the public is using someform of alternative medicine, which reflects the ,51eD and values in our culture today (z). The major critichanging needs cism of these alternative therapies is that they have not been scientifically tested; therefore, their safety and efficacy has been called into question. One such alternative therapy that is gaining prominence is the medical use of marijuana for treating pain, nausea, and vomiting associated with chemotherapy, and severe weight loss associated with AIDS. Medical marijuana can be both a treatment in itself, and it can be used to help patients withstand the effects of accepted treatments that can possibly lead to a cure or amelioration of their condition (3). As a result of its effectiveness, seven states -California, Alaska, Arizona, Colorado, Nevada, Oregon, and Washington have approved initiatives to make marijuana legal for medical purposes. The stumbling block has been the Federal government, which has threatened to prosecute any physician who prescri'besmarijuana. The Federal government's basis for threatening prosecution is that marijuanais listed as a Schedule I drug under the I970 Uniform Controlled Substance Act. Possession of a Schedule I drug is illegal and such drugs can only be utilized for research purposes. Attempts to reassign marijuana to a Schedule II drug have been rejected by the Drug Enforcement Administration (DEA) on the basis that "there - 3 40 CLARK * THE ETHICS OF MEDICAL MARIJUANA 41 was no scientificevidence showing that marijuanawas better than otherapproveddrugsfor any specificmedicalcondition"(4). The Federal government'sobjectionto the medicaluse of marijuanais based on a nationalpolicy of zero-tolerancetowardillicit drugs.The objection to legalizingmarijuanafor medical purposesis based on three suppositions.First, the Clinton Administrationbelieves that marijuanais an illegaldrugwhich remainsunprovenin termsof safetyor efficacy.Second,theycontendthatmarijuanais a "gatewaydrug"that leads to more serious drug use. Third, legalizatonof marijuanafor medicalpurposeswill send the wrong messageto the public, and in particularto our children,namely that marijuanais acceptablefor recreationaluse andevenbeneficial.Basically,the governmentbelieves its argumentis groundedin logic. The argumentgoes this way: marijuanais an illegaldrug;no one shouldeveruse illegaldrugs;therefore, no one should ever use marijuanafor any reason (S). The government'spolicy againstthe legalizationof medicalmarijuanahas been challengedby medicalresearchers,physicians,and patientsbased on its reportedeffectivenessas a therapyand becausethey believe the government'sargumentis groundedin bad logic. On March17, I999, the mostcomprehensive analysisto dateof the medicalliteratureabout marijuanawas issuedby a WhiteHousecommissionedcommitteeof ii independentscientistsappointedby the Instituteof Medicine.The reportconcludedthat "the benefitsof smokingmarijuanawere limitedby the toxic effectsof the smoke,but nonethelessrecommendedthat the drug be given underclose supervision to patientswho do not respond to other therapies"(6). The reportalso statedthat "therewas no evidencethat givingthe drugto sick people would increaseillicit drug use in the generalpopulation. Nor is marijuanaa 'gateway drug' that prompts patients to use harder drugs like cocaine and heroin" (7). This government-sponsored study found solid scientificdata that indicates the potential therapeuticvalue of marijuanain controlling some forms of pain, alleviatingnausea and vomiting, treatingwasting due to AIDS, and combatingmusclespasmsassociatedwith multiplesclerosis(MS)(8). Neither does it increasedrug usage or lead to harderdrugs. Why, then, is the Federalgovernmentprohibitingthis effectivedrug from being prescribedby physiciansfor patients sufferingfrom specific treatment side-effects?The ethical dilemma at the center of this debatefocuseson whetherthe Federalban on the use of medicalmar- 42 JOURNAL OF PUBLIC HEALTH POLICY * VOL. 2-1, NO. I ijuanaviolates the physician-patientrelationship.Patientshave the rightto expectfromtheirphysiciansfull disclosureand discussionof all availabletreatmentoptions.Denyinga patientknowledgeof and accessto a therapythat relievespain and suffering,especiallywhen the patienthas a terminaldisease,violatesthe basicduty of a physician. Physiciansfind themselvesat the center of this controversy, searchingfor a compromisebetweenmedicalnecessityand governmentrestrictions. The purposeof this article,therefore,is threefold:first,to examine the scientificdataregardingthe medicaluse of marijuana;second,to give an ethicalanalysisof the argumentsfor and againstthe medical use of marijuana;third,to determineif the ClintonAdministration shouldmove to have marijuanareclassifiedas a ScheduleII drug so that physicianscan legallyprescribeit to patientsas an alternative medicaltherapywhichwill relievepain and suffering. MEDICAL USES OF MARIJUANA Marijuanacomes from the leaves and floweringtops of the hemp plant, Cannabissativa, which grows in most regionsof the world. The marijuanaplant contains over 460 known compounds,6o of which are cannabinoids,compoundsuniqueto cannabis.The chief psychoactivecompoundof marijuanais delta-g-tetrahydrocannabinol (THC) (9). Clinical findings have documented marijuana's efficacyin treatingpain, neurologicaland movementdisorders,nausea of patientsundergoingchemotherapyfor cancer,loss of appetite and weight (cachexia)relatedto AIDS,and glaucoma(io). The negativeeffectsof marijuanaincluderapidheartbeat,some loss of coordination,and impairedimmediatememory.In addition,the drugcan adverselyaffectone'scriticalskills,includingthoseskillsnecessaryto operatevehicles safely, such as judgmentof distanceand reaction time (i i). Froma clinicalstandpoint,the positiveeffectswould seem to greatly outweigh the negative effects in controlled situations. However,despitereportedpositivemedicaleffects,the DEAhas marijuanaclassifiedas an illegalScheduleI drugwhichhas "nocurrently acceptedmedical use." The DEA refuses to reschedulemarijuana withoutan officialdeterminationof safetyandefficacyfromthe Food and Drug Administration(FDA).TheFDA requirescontrolled,double-blindedclinicaltrials for reschedulingto occur.One reason for the lack of clinicaltrialsis a roadblockwhich faces all herbalmedi- CLARK * THE ETHICS OF MEDICAL MARIJUANA 43 cines:the lack of a patentableproduct.The othermajorreasonis that the governmenthas always requiredthat such clinical studies be fundedfrom scarcegrantmoneycontrolledby the National Institutes of Health (iz). Both restrictionshave discouragedresearchersfrom studyingthe medicalbenefitsof marijuana. Two forms of marijuanahave been used for medicalpurposes:a syntheticform, dronabinol (Marinol?), which is taken orally, and smoked marijuana.Both forms contain the psychoactiveingredient THC. Marinol?, manufacturedby UnimedPharmaceuticals,Inc., is a ScheduleII prescriptiondrug, approvedby the FDA in i985 for treatmentof nausea and vomiting of cancerchemotherapypatients who have not respondedto the conventionalantiemetictherapy.In i992, the FDA also approvedit for use in loss of appetiteand weight loss relatedto AIDS (13). There are three majorconcernswith prescriptionMarinol?. First, some patients have complainedthat the effects of the pill were too strongat first,then wore off quickly(14). Second, Marinol? is very expensive, costing about $500 for one hundred io-mg capsules. Third, it can be difficult for nauseous patients to consume. Some patients fail to keep the pill down long enoughfor it to be effective(I 5). It has beenarguedthat smokedmarijuana,on the other hand, is substantiallymore effective.The THC in aerosolform in the inhaledsmoke is absorbedwithin secondsand is deliveredto the brainrapidlyand efficiently,as would be expected of a highly lipid-solubledrug. Maximum blood concentrationsare reachedaboutthe time smokingis finishedandthen rapidlydissipate. Psychopharmacologiceffects peak at 30 to 6o minutes. The clear advantageof smokedmarijuanais the rapidonset and dissipationof effects,becausethe patientis able to self-titratethe dose. In addition, the plant contains many other compounds (including about 6o cannabinoids) that may produce some additional benefits (i6). Oncologistswere among the first medicalprofessionalsto advocate for the medicaluse of smokedmarijuana.Reactingto a DEA suggestion that only a "fringegroup"of oncologistsacceptedmarijuanaas an antiemeticagent, a randomsurveyof the membersof the Ameri- can Societyof Oncologywas conductedin I990. Morethan IOOO oncologistsrespondedto the survey;44% reportedthat they had recommendedmarijuanato at least one patient.Smokedmarijuanawas believedto be more effectivethan oral dronabinol(Marinol?) by the respondents.Of those who believedthey had sufficientinformation 44 JOURNAL OF PUBLIC HEALTH POLICY * VOL. 2I, NO. I to compare the two drugs directly,44% believed marijuanawas more effective and I 3 % that Marinol? was more effective (I 7). In addition, the cost of marijuana is considerably cheaper. "The cost of producing cannabis is about a dollar an ounce, and medical distribution would add at most a few more dollars. There are about 6o marijuana cigarettes in an ounce, and the average dose is one cigarette or less" (I8). On a cost-effectiveness analysis, smoked marijuana is more effective and less costly that Marinol?. Despite the medical benefits of smoked marijuana, there are also a number of medical risks associated with this drug. First, it is difficult to determine the effective dosage of smoked marijuana,since the concentration of the active ingredient, THC, varies according to the particular plant and how it is grown. Second, nonconclusive studies have shown that THC both suppresses macrophages and human T-lymphocytes and enhances macrophage secretion of interleukin-i (i9). These are critical components of the immune system and could seriously jeopardize AIDS patients who used marijuana. Other studies emphasize the potential for toxic compounds in marijuana smoke, which include harmful cannibinoids, gases, and other particulates. Studies have shown that marijuana tar contains 50% more phenols than does tobacco tar (zo). Finally, marijuana can also be contaminated by microorganisms and fungi, which can cause possible infections by pathogenic organisms. There have been reported cases of marijuanasmokers contracting pulmonary fungal infections. In addition, adulterants such as pesticides and fertilizerscan compromise the purity of the marijuana (zi). To combat these risks, various methods, such as filtering marijuana in water pipes and vaporizing the marijuana, have been shown to remove certain toxins and to deliver a higher cannabinoid-to-tar ratio than do cigarettes or pipes. In addition, sterilizing the marijuanaby dry heat (300 degrees F) kills spores and fungi (zz). These risks can be minimized further if the supply of marijuana is grown under government-regulated conditions rather than by illicit sources. Scientificresearchon the medical effects of marijuanahas been limited due to the stipulation that all studies must be funded by the National Institutes of Health. Since I978 the Federalgovernment has provided zo patients with medical marijuana under a compassionate investigational new drug program. The Institute of Drug Abuse pays the University of Mississippi to grow a consistent, reliable source of CLARK * THE ETHICS OF MEDICAL MARIJUANA 45 research-gradecannabis.This is an unadulteratedand standardized form of marijuanawithout contaminantsor pesticides.A North Carolina manufacturerreceives$6z,ooo a yearfrom the Federalgovernment to roll the marijuanacigarettesand ship them FederalExpress, in sealed tins of 300 each, to the patients'doctors and pharmacists. Eachparticipantwas givena letterfromthe FDA authorizingthemto use this illegal substancethat can bringa Federalprisonterm of five years. In I99I, the Federal government terminated this program, which was the only legalway to obtainaccessto marijuana.This program was terminated, in the government's opinion, because too many people becameawareof it andwere askingfor accessto medicalmarijuana supplies. Twelve individualswere receivingmarijuanacigawhen the programwas rettesin I99I and theywere "grandfathered" terminated.Since that time, four individualshave died from AIDS, and the remainingeightcontinueto receivetheirsupplyof marijuana cigarettes (23). The government'shope is that this program will quicklydisappearthroughattrition.To allow some to have accessto medicalmarijuanawhile others are deniedseemsa graveinjusticeto many and placesthe Federalgovernmentin a precarioussituation. In February1997, the National Institutesof Health releasedits reporton the resultsof an expertpanelthat was convenedto investigate the therapeuticpotential of marijuanaand to identify future research avenues that would be most productive. The panel of expertsidentifiedfive areaswhere therewas at least a suggestionof therapeuticvalue of marijuanaand for which furtherstudywas indicated. The five areas were: (i) stimulates appetite and alleviates cachexia, (z) controls nausea and vomiting associatedwith cancer chemotherapy,(3) decreasesintraocularpressurefor those suffering from glaucoma,(4) analgesia,and (S) neurologicand movementdisorders are relieved.The group also concluded that more extensive studies were needed to fully evaluatethe potential of marijuanaas supportivecare for cancerpatients.Suggestedareasof study were a smoke-freedelivery system of marijuana'sactive ingredientTHC, effects of marijuanaon the lungs and immunesystem, and the dangerous byproductsof smokedmarijuana(24). On March I7, I999, a panelof I I independentexpertsat the Institute of Medicine released the most comprehensiveanalysis of the medicaluses of marijuanato date. This two-yearstudy was ordered and financedby the White House Office of National Drug Control 46 JOURNAL OF PUBLIC HEALTH POLICY * VOL. 2I, NO. I Policy.The reportcautionedthat the benefitsof smokingmarijuana were limitedbecausethe smoke in itself is so toxic. Yet at the same time, the panelof expertsrecommendedthat marijuanabe given,on a short-termbasis underclose supervision,to patientswho did not respondto other therapies.The panel believedthat becauseof the toxicity of the smoke, the true benefitsof marijuanawould only be realized when alternative methods like capsules, patches and bronchialinhalerswere developedto deliver more active components,calledcannabinoids,withoutthe harmfuleffectsof the smoke. The researchersrecommendedthat the governmentshouldtake the lead in developingmoreeffectivecannabinoiddrugs.However,realizing this would take yearsto develop,the panel recommendedthat peoplewho did not respondto othertherapybe permittedto smoke the marijuanain the interim.In additionto these recommendations, reportalso containedsome new findingsabout the effects of marijuanaon variousmedicalconditions.In additionto the usefulnessof medicalmarijuanain treatingpain, nausea,and weight loss associated with AIDS, the report concludedthat despite popular belief, marijuanawas not useful in treating glaucoma. Marijuanadoes reduce some eye pressureassociatedwith glaucoma;however,the effectswere short-term,and did not outweighthe long-termhazards of using the drug. In addition,the study found therewas little evidencethat marijuanahad any effecton movementdisorderssuch as Parkinson'sdisease of Huntington'sdisease, but it was effectivein combating the muscle spasms associatedwith multiple schlerosis (25). As a resultof thismedicalresearch,sevenstateshaveapprovedballot initiativesmakingmarijuanalegal for medicalpurposes(z6). In the NovemberI996 elections,ArizonavoterspassedPropositionzoo by a vote of 65% to 35 % and CalifornianspassedPropositionzi 5 by a vote of 56% to 44%. Theseendorsementsof the medicinaluse of marijuanaforcedthe Federalgovernmentto respondpublicly.The Arizonameasuremandatedthat the prescribingphysicianmustdocument that scientificresearchexists which supportsthe use of a ScheduleI substancefor this purpose,must receivewrittenconsent from the patient, and must obtain the writtenopinion of a second physicianthat the prescriptionis appropriate.The majorconcernof the Arizonapropositionwas that it allowed physiciansto prescribe any ScheduleI drug.To rectifythis, the Arizonalegislaturein April CLARK * THE ETHICS OF MEDICAL MARIJUANA 47 I997 amended the law to apply only to FDA-approved drugs (27). The California measure, entitled the Compassionate Use Act of I996, amended the Health and Safety Code "to allow a patient or primary caregiver (person who has consistently assumed responsibility for the housing, health, or safety of the patient) to grow or possess marijuana for medical use when the drug is recommended by a physician who has determined that the patient's health would benefit from its use in the treatment of cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis, migraine, or any other illness for which marijuana provides relief. The physician's recommendation may be oral or written. No prescription or other record keeping is required" (z8). The problem is that physicians are fearful of writing prescriptions because the Federal government has threatened to prosecute them. Attorney General Janet Reno announced that physicians who complied with the California law would be new targets of Federal law enforcement, and threatened physicians with loss of their registrations with the DEA and with exclusion from participation in Medicare and Medicaid (29). In April 1997, Judge Fern Smith of the U.S. District Court granted a preliminary injunction prohibiting the DEA from carrying out its threats against California physicians and encouraged the litigants to try to work out a reasonable settlement. The settlement allowed physicians to discuss the option of medical marijuana as part of the First Amendment protection of physicianpatient communication, but physicians could not assist in obtaining the illegal substance for the patient (30). In addition, the Federal government has moved to shut down the Cannabis Buyer's Clubs in California that were providing and distributing the standardized marijuana grown without any contaminants or pesticides to individuals with a medical need for the drug. Because marijuana remains a Schedule I drug, there is no regulated pharmacy system for marijuana; thus there is no control on its purity or strength. The result is that those suffering from AIDS, cancer, MS, etc., are being forced either to seek out black-market marijuana which contains various contaminants or to rely on other medications that have proven to be ineffective. This is one of the major arguments for seeking a change in classification of marijuana to a Schedule II drug so that it could be prescribed and obtained through controlled and regulated channels. The fear of the Federal government is that reclassifying marijuana to a Schedule II drug will open the door to the slippery slope that could lead to the 48 JOURNAL OF PUBLIC HEALTH POLICY * VOL. 2I, NO. I legalizationof marijuanaandsendthe wrongmessageto ourchildren about drugs.This fear,while havingno scientificbasis,is real to the people who feel it. But from an ethical point of view, is not the demonstratedreliefthat medicalmarijuanacan provideto those sufferingfromvariousillnessesthe greatergood? ETHICAL ANALYSIS Society,in general,has alwaysrecognizedthat in our complexworld thereis the possibilitythat we may be facedwith a situationthat has two consequences-one good and the other evil. The time-honored ethicalprinciplethat has beenappliedto thesesituationsis calledthe principleof double effect. As the name itself implies, the human action has two distincteffects. One effect is the intendedgood; the other is the unintendedevil. As an ethical principle,it was never intendedto be an inflexiblerule or a mathematicalformula, but ratherit is to be usedas an efficientguideto prudentmoraljudgment in solving difficultmoral dilemmas(3 i). The principleof double effect specifiesfour conditionswhich must be fulfilledfor an action with both a good and an evil effectto be ethicallyjustified: i) The action, consideredby itself and independentlyof its effects,mustnot be morallyevil.Theobjectof the actionmust be good or indifferent. z) The evil effectmust not be the meansof producingthe good effect. 3) The evil effectis sincerelynot intended,but merelytolerated. 4) There must be a proportionatereason for performingthe action,in spiteof the evil consequences.(3z) The principleof doubleeffectis applicableto the issue of whether it is ethicalfor a physicianto prescribemarijuanafor medicalreasons becauseit has two effects, one good and the other evil. The good effect is that smokedmarijuanais more effectivethan conventional therapiesin helpingpatientswithstandthe effectsof accepted,traditionaltreatmentswhichcan bringabouta cureor the ameliorationof their condition. The evil effect is that marijuanasmoke has toxic effectsand as a ScheduleI illegaldrugit has beenarguedit couldlead to more seriousdrug abuse and send a wrong messagethat illegal drug use is safe and even condoned.To determineif it is ethicalfor physiciansto prescribemedicalmarijuanafor patientsas a medical CLARK * THE ETHICS OF MEDICAL MARIJUANA 49 therapy,this issue will be examinedin light of the four conditionsof the principleof double effect. The firstconditionallows for the medicaluse of marijuanabecause the object of the action, in and of itself, is good. The moral object is the precisegood that is freelywilled in this action.The moralgood of this action is to help treatpain, nausea,severeweight loss associated with AIDS, and to combat muscle spasms associatedwith multiple sclerosis,that cannot be treatedadequatelyby traditionalmedicines. The immediategoal is not to endorse,encourageor promote illegal drug use. Rather,the directgoal is to relievepatientsof their unnecessary pain and suffering (33). The second condition permits the medical use of marijuanabecause the good effect of relievingpain and sufferingis not producedby means of the evil effect. The two effectshappensimultaneously.The thirdconditionis met becausethe direct intention of medical marijuanais to give patients suffering fromlife-threateningillnessesrelieffromthe effectsof acceptedtreatments that could cure their medical condition. Recent studies have shown that medical marijuanais more effectivein controllingpain and nausea from chemotherapytreatments, and in boosting the appetitesof AIDSpatientsso as to combat wasting, than any of the traditionalFDA-approvedmedications.To denya physicianthe right to discuss,recommend,andprescribemarijuanato patientsis a direct violation of the physician-patientrelationship.To make an informed decisionabout their treatment,patientshave the rightto expect full disclosureand discussionof all availabletreatmentoptionsfromtheir physicians.Failureto do this violates the patient'sright of informed consent (3 4). The hypothesizedforeseenbut unintendedconsequencesof legalizing medicalmarijuanaare twofold. First,the smoke from marijuana is highlytoxic and can cause lung damage.The intentionof smoked marijuanais not to cause more health problemsbut to remedythe effects of existing treatments.Second,some membersof the Clinton Administrationbelievethat legalizingmedicalmarijuanamay lead to usage of harderdrugs,and may be seen as condoningand encouraging recreationaldrug use. Nevertheless,this has not been proven to be true. The March I7, I999 report by the Instituteof Medicine found no evidencethat the medicaluse of marijuanawould increase illicit use in the generalpopulation,nor was it a "gatewaydrug"that would lead to the use of harderdrugs like cocaine or heroin (35). 50 JOURNAL OF PUBLIC HEALTH POLICY * VOL. 2I, NO. I According to bioethicist William Stempsey, M.D., the government's belief that "the availability of drugs on the street is a function of the availability of prescription drugs is wrong. Morphine and other narcotics are available at present only by prescription, and there is no widespread abuse of these drugs"(36). In addition, a I994 survey in the New YorkTimes found that I7% of current marijuanausers said they had tried cocaine, and only o.z% of those who had not used marijuana had tried cocaine. Ethicist George Annas points out that there are two ways to interpretthis study. One way is to conclude that those who smoke marijuana are 85 times as likely as others to try cocaine; another way is that 83% of pot smokers, or five out of six, never try cocaine (37). If GeneralBarryMcCaffrey,the Director of the Office of National Drug Control Policy, is worried that the legalization of medical marijuana will send the wrong message to our children about drugs, then Boston Globe columnist Ellen Goodman asks a good question: "What is the infamous signal being sent to [children] . . . if you hurry up and get cancer,you, too, can get high?" (38). Will some people view the legalization of medical marijuana as the condoning and encouraging of marijuanafor recreationaldrug use? The answer is "yes." But this is not the direct intention of legalizing medical marijuana. The direct intention is to relieve pain and sufferingthat cannot be relieved by presently approved medications.This misinterpretation of the legalization of medical marijuanacan be correctedthrough public education. Finally,the argumentfor the ethical justificationof marijuana for medical use by the principle of double effect focuses on whether there is a proportionately grave reason for allowing the foreseen but unintended possible consequences. Proportionate reason is the linchpin that holds this complex moral principle together. Proportionate reason refers to a specific value and its relation to all elements (including premoral evils) in the action (39). The specific value in legalizing medical marijuana is to relieve pain and suffering associated with treatment for life-threateningillnesses. The premoral evil (33), which can come about by trying to achieve this value, is the foreseen but unintended possibility of the potential harmful effects of the smoke and the possibility that some may view this as condoning and even encouraging illegal drug use. The ethical question is: does the value of relieving pain and suffering outweigh the premoral evil of the potential harmful effects of the smoke and the possibility of scandal? To determine if a proper relationship exists between the CLARK * THE ETHICS OF MEDICAL MARIJUANA 51 specific value and the other elements of the act, ethicist Richard McCormickproposesthree criteriafor the establishmentof proportionate reason: The means used will not cause more harmthan necessaryto achievethe value. z) No less harmfulway exists to protectthe value. 3) The meansusedto achievethe valuewill not undermineit. (40) i) The applicationof McCormick'scriteriato the legalizationof medical marijuanasupportsthe argumentthat there is a proportionate reasonfor allowingphysiciansto prescribemarijuana.First,the most comprehensivescientificanalysisto date by the Instituteof Medicine cautioned that the benefits of smoking marijuana were limited becausethe smokeitselfis toxic, but recommendedthat it be givenon a short-termbasis, under close supervision,to patientswho do not respondto other therapies.The possible damageto an individual's lungsis a legitimatehealthconcern;however,the patientswho would benefitfrom the smokedmarijuanaare sufferingfrom cancer,AIDS, MS, etc. Many of these conditions are terminaland the treatments they are undergoingalso have toxic effects-chemotherapy, radiation, the AIDScocktail,etc. The point is that the benefitof the treatments outweighsthe burdens.The focus should be on encouraging the Federalgovernmentto direct its researchresourcestoward the developmentof alternativemethodsof deliveringcannabinoidsin the form of patches,capsulesand bronchialinhalers.In this way the toxicity could be eliminated. The Institute of Medicine study also reportedthat there was no evidencethat prescribingmedical marijuana would increaseillicit drug use or that it is a "gatewaydrug" that promptspatientsto use harderdrugslike cocaineor heroin.Second, at present,there does not seem to be an alternativemedication that is as effectiveas smokedmarijuana.Thousandsof patientswho have smoked marijuanaillegallyfor medicalpurposeshave attested to its effectiveness.Those patientswho were and are involvedin the government-sponsoredcompassionatecare program also attest to smokedmarijuana'seffectiveness.In addition,scientificstudieshave shown that Marinol? is less effective, more difficultfor nauseous patients to consume, and more expensive than smoked marijuana. There are also other approvedantiemeticdrugs or combinationsof these drugswhich have been shown to be effectivein relievingpain 52 JOURNAL OF PUBLIC HEALTH POLICY * VOL. 2I, NO. I and suffering in some cancer patients (4I). However, for others these medicationshave provenineffective.To date, the only therapythat relieves their nausea and vomiting is smoking marijuana.Third, smoking marijuanafor medical reasons does not underminethe value,which is the reliefof pain and suffering.Many of the patients who would use medicalmarijuanaaresufferingfromterminalconditions and are undergoingtherapiesthat have serious side-effects. Sincethis seemsto be the only therapyto date that relievesthe pain and sufferingof thesepatients,one can argueconvincinglythat it is a concernthat legalizmedicalnecessity.The ClintonAdministration's ing medicalmarijuanacould lead to the possibilityof the slippery slope in regardsto druguse is a real fear.But, this has not occurred with otherprescriptionpsychoactivedrugs(e.g., morphine,codeine, cocaine,etc.) andthereis no evidenceit would occurwith marijuana. Therefore,it is ethicallyjustifiedunderthe principleof doubleeffect for the Federalgovernmentto legalizemarijuanafor patientswho do not respondto traditionaltherapies.Seriouslyill patientshave the rightto effectivetherapies.To deny them accessto such therapiesis to denythemthe dignityand respectall personsdeserve.The greater good is promotedin spiteof the potentialevil consequences. CONCLUSION After reviewingthe pertinentscientificdata it is clear that there is morethan sufficientevidenceto warrantthe ClintonAdministration to authorizethe DEAto reclassifymarijuanaas a ScheduleII drugso that it can be used for medicalpurposes.As a ScheduleII drug,the governmentwill be able to properlyregulatethe use of marijuanaso thatpharmacies,in conjunctionwith physicians,can providepatients with unadulteratedand standardizedforms of marijuana.Unless marijuanais regulatedby the propermedical and pharmaceutical authorities,thereis the possibilitythat those seekingrelieffrompain and sufferingwill be forced to resort to black-marketmarijuana, which could lead to legal prosecution and could jeopardize their health and safety. The philosophy guiding this position is one of harm reduction.With the appropriatelegal and medicalcontrolsa proper strategycould be formulatedto identifyand reducehealthhazards facing those individualswho use smoked marijuana(42). To deny physiciansthe right to prescribeto their patients a therapy that relationrelievespainandsufferingis to violatethe physician-patient CLARK * THE ETHICS OF MEDICAL MARIJUANA 53 ship. Patientshave the right to expect full disclosureof all possible treatment options from their physicians, so that they can make informedmedical decisions regardingtheir health. Physicianshave the medicalresponsibilityto provideadequaterelief from both pain and sufferingin orderto give their patientsan acceptablequalityof life. Failureto offer an availabletherapythat has provento be effective would violate the basic ethical principle of nonmaleficence, which prohibitsthe inflictionof harm,injury,or death, and is related to the maximprimum non nocere ("aboveall, or first,do no harm"), which is widely used to describethe duties of physicians.To allow a patientto sufferneedlessly,when this sufferingcan be relieved,is to do direct harm to the patient. Scientificdata has shown that the benefitsof medical marijuanafar outweigh the burdens.However, there is a need for continuedresearchboth in regardsto maximizing marijuana'stherapeuticeffectsand minimizingits adverseeffects. The Clinton Administrationmade a significantstep in the right directionwhenit announcedon May zi, I999, that it wouldease restrictionson medical marijuanaresearchby selling governmentgrown marijuanato researchersand allowing them to secure their own researchfunding.In the past, only a handfulof researcherswere investigatingthe benefitsof marijuanabecausethey had to show not only that theirresearchwas of high quality,but also that it was more important than competing applications for National Institutes of Health funding.Now, accordingto ChuckBlanchard,chief counsel for the WhiteHouse Officeof National DrugControlPolicy,"aslong as you are willing to show that it is high-qualityresearchand also provideyourown funding,you can haveaccessto medicalmarijuana" (43). This new developmentwill not only lead to furtherassessment of the effectivenessof medicalmarijuanaand developmentof purified forms of cannabinoids,but could lead to the developmentof new deliverysystemsthat would allow patientsto benefitfrom the active ingredientsof marijuanawithout sufferingthe toxic side-effects. The Federalgovernment'sannouncementthat it was easingrestrictions for studieson medicalmarijuanawill have long-termbeneficial effects.However,it will do little to help those sufferingat the present time. The regulationsissuedsaid, "thegovernmentdid not intendto approvesingle-patientrequestsfor marijuana,becausethey did not producescientificinformation"(44). GeneralMcCaffrey,afterreviewing the reportissuedby the Instituteof Medicinethat his agencyhad 54 JOURNAL OF PUBLIC HEALTH POLICY * VOL. 2I, NO. I commissioned,stated that the analysiswas a superbpiece of work underadvisement.But and that he would take the recommendations he also went on to say that "therewas enormousconfusionin law enforcementabout how to handle this issue and we've got people with mischievousagendasat work" (45). This confusioncould be eliminatedand safeguardsput in placewith the reclassifyingof marijuanato a ScheduleII drug. To legalizemedicalmarijuanawill go policy of zero tolerancetoward againstthe ClintonAdministration's illicit drugs,but the benefitsit will providefor those sufferingfrom devastatingdiseaseswould surelyoutweighthe possibleburdens. The quality of life of those sufferingfrom cancer,AIDSwasting syndrome,multiplesclerosis,etc. should concernall of us, but particularlythe Federalgovernmentand the medicalprofession.Recent studieshaveshownthat one reasonpublicopinionhas becomemore suicideis becausemedicalprofessionals tolerantof physician-assisted have not adequatelymanagedthe pain and sufferingof those with terminalillnesses.Medicalmarijuanahas beenprovento be another valuabletherapyin the war againstterminalillnesses;however,until the Federalgovernmentrecognizesthis as a reality,many terminal patients will continue to suffer needlessly.The result will be an suicideis the increasein the public'smindsetthat physician-assisted only option for those who want to die with dignityand respect.The fight againstdrug abuseis importantbecausemany lives are lost to drug addiction.But the fight againstthe effects of devastatingdiseases impactsa substantiallylargernumberof Americans.Medical marijuanamay be justthe weaponphysiciansneedto meetthe challenge of those people'spain and suffering.It appearsthe Clinton Administrationhas placedpoliticsand appearancesaheadof science andhealthcareconcerns(46). Theappearanceof scandalandthe fear of beingaccusedby a RepublicanCongressof beingweak on drugs must not stand in the way of provenscientificevidence.The quality of human lives hangs in the balance.If the dignity and respectof everyperson'slife is a priorityfor this Administration,then it is time to standup for thosewho arethe mostvulnerable.Thismeansreclassifying medicalmarijuanaas a ScheduleII drug, becausefor some patientsit is trulya medicalnecessity. CLARK * THE ETHICS OF MEDICAL MARIJUANA 55 **Postscript: On SeptemberI3, I999, the United States Court of Appealsfor the Ninth CircuitorderedJudge CharlesBreyerof FederalDistrictCourtto reviewa I998 decisionthat closedthe Oakland Cannabis Buyers Cooperative for violating antidrug laws. The Appeals Court said that JudgeBreyerhad not given enough considerationto the possibilitythat marijuanawas an indispensabletreatment for people served by the club-including patients with AIDS and cancer-and thus potentiallyprotectedas a "medicalnecessity." The AppealsCourtdid not vacatethe injunctionagainstthe Oakland club, but it did suggest that Judge Breyeramend the injunctionto allow marijuanaclubs to resumeservicefor patientswho can prove that cannabisis a medicalnecessity(47). NOTES AND REFERENCES i. Alternativemedical therapiesare functionallydefinedas interventions neithertaughtwidely in U.S. medicalschools nor generallyavailablein U.S. hospitals. For a more detailed analysis, see David M. Eisenberg, Roger B. Davis, SusanL. Ettneret al. "TrendsIn AlternativeMedicine Use In The United States, I990-I997," Journal of the American Medical Association z8o (November II, I998): I569. z. The reasons for this popularity are a rise in prevalence of chronic disease, an increase in public access to worldwide health information, reduced tolerance for paternalism, an increased sense of entitlement to a quality of life, declining faith that scientific breakthroughs will have relevance for the personal treatment of disease, and an increased interest in spiritualism. For a more detailed analysis, see Wayne B. Jonas, M.D. "Alternative Medicine-Learning From The Past, Examining The Present, Advancing To The Future," Journal of the American Medical Association z8o (November ii, I998): i6i6. See also, P. Starr. The Social Transformation of American Medicine. San Francisco, CA: Harper Collins Publishers, i98z: 5I4; A. Furnham and J. Foley. "The Attitudes, Behaviors, And Beliefs Of Patients Of Conventional vs. Complementary (Alternative) Medicine," Journal of Clinical Psychology so (I994): 458-69; and J. A. Astin, "Why Patients Use Alternative Medicine: Results Of A National Study," Journal of the American Medical Association 279 (I998): I548-53. 3. George J. Annas, "Reefer Madness-The Federal Response To California's Medical-Marijuana Law," The New England Journal of Medicine 337 (August 7, I997): 439. 56 JOURNAL OF PUBLIC HEALTH POLICY * VOL. Z2I, NO. I 4. Ibid., 438. The following findings must be made to place a drug on Schedule I: "(A) The drug . . . has a high potential for abuse; (B) The drug ... has no currentlyaccepted medical use in treatment in the United States;and (C) there is a lack of accepted safety for use of the drug under medical supervision." Part A for a Schedule II drug is identical; the other requirements are "(B) The drug . . . has currently accepted medical use in the United States ... and (C) Abuse of the drug ... may lead to severe psychological and physical dependence." Ibid. 5. William E. Stempsey, M.D. "The Battle For Medical Marijuana In The War On Drugs," America 23 (April i i, i998): I4. 6. Sheryl Gay Stolberg, "For A Very Few Patients, U.S. Provides Free Marijuana," The New YorkTimes, I9 March 1999, A-Io. 7. Sheryl Gay Stolberg. "Government Study On Marijuana Sees Medical Benefits," The New YorkTimes, i 8 March I 999: A- i. See also, Janet E. Joy, Stanley J. Watson, Jr., and John A. Benson. Marijuana And Medicine: Assessing The Science Base (Washington, D.C.: Institute of Medicine, March I999): 99. 8.Joy et al., 3. 9. Lester Grinspoon, M.D., and James B. Bakalar.Marijuana, The Forbidden Medicine. New Haven, CT: Yale University Press, I993: I-2. io. There has been considerable research done in understanding how cannabinoids exert their cellular effects. "Two kinds of cannabinoid receptors have been identified: CB-i and CB-z. CB-i receptors are present widely in the brain. An endogenous ligand for this receptor system is the arachidonic acid derivative, anandamide, and there is some evidence that the cannabinoid-receptor system is part of the natural pain control system distinct from the endogenous opioid system. Small clinical studies indicate that THC has some analgesic activity in patients with cancer pain, but there is a narrow therapeutic window between doses that produce useful analgesia and those that produce unacceptable central nervous system effects. Defining the naturally occurringcannabinoid-receptor system is good reason to pursue researchinto selective analogues that may enhance therapeutic effects and minimize adverse effects." See Jane B. Marmor, M.D. "Medical Marijuana," WesternJournal of Medicine i68 (I998): 542. See also, W. A. Devane, L. Hanus, A. Breuer,et al. "Isolation And Structure Of A Brain Constituent That Binds To The Cannabinoid Receptor," Science 258 (I992): I946-49. i i. United States Department of Health and Human Services, "Investigating Possible Medical Uses Of Marijuana," March 25, I999: I-2. I2. John M. McPartland and Patty Pruitt, "Medical Marijuana And Its Use By The Immunocompromised," Alternative Therapies 3 (May I997): 39. It should be noted that the DEA has rejected proposed protocols CLARK * THE ETHICS OF MEDICAL MARIJUANA 57 accepted by the FDA. "The clinical trial devised by D. I. Abrams et al., has been approved by the FDA (as well as the California Research Advisory Panel, the institutional review board of the University of California, and the scientific advisory board of the San Francisco Community Consortium). Unfortunately, the protocol was rejected by the DEA and the National Institute of Drug Abuse. Political disingenuity involved in this rejection has frustrated members of Congress" (Ibid., 39-40). Five years later, Dr. Abrams of the University of California at San Francisco finally obtained approval and a $978,000 National Institutes of Health grant. "Even then, Dr. Abrams said he had to mask his true research interest. Although he wanted to examine the effects of marijuana on the weight loss associated with AIDS, he pitched the study as one that would look at potentially toxic interactions between marijuana and standard AIDS medications. 'We designed a study that would appeal to the group of people funding the grant."' Sheryl Gay Stolberg. "Restrictions Ease For Studies On Marijuana As Medicine," New York Times, zz May I999: A-I I. I 3. United States Department of Health and Human Services, z. I4. Stolberg. "Restrictions Ease For Studies On Marijuana As Medicine": A- II. I 5. Peter Gwynne. "Medical Marijuana Debate Moving Towards Closure," The Scientist 7 (March I8, I997): I. i6. Marmor: 54I. See also, I. B. Adams, and B. R. Martin. "Cannabis: Pharmacology And Toxicology In Animals And Humans," Addiction 9I (I996): I585-I6I4. Annas: 438. See also, R. E. Doblin and M. A. Kleiman, "Marijuana As Antiemetic Medicine: A Survey Of Oncologists' Experiences And Attitudes," Journal of Clinical Oncology 9 (i 99 i): I 3 I4-I9. I8. Grinspoon and Bakalar: I50. I9. For a more detailed analysis, see, G. S. Rachelfsky and G. Opedz, "Normal Lymphocyte Function In The Presence Of Delta-g-THC," Clinical Pharmacology Therapy (I977): 44-46; G. A. Cabral and K. FisherStenger, "Inhibition Of Macrophage Inducible Protein Expression By Delta-g-THC," Life Science 54 (I994): I83 I-44; and W. Zhu, C. Newton, Y. Daaka, et al. "Delta-g-tetrahydrocannabinol Enhances The Secretion On Interleukin i From Edotoxin Stimulated Macrophages," Journal of Pharmacological Experimental Therapy 270 (I994): 17. I334-39. zo. McPartland: 4I. zi. Ibid., 4I-42. 22. Ibid., 42-43. 23. Stolberg. "For A Very Few Patients, U.S. Provides Free Marijuana":A-iO. 58 JOURNAL OF PUBLIC HEALTH POLICY * VOL. Z2I, NO. I National Institute on Drug Abuse, Report to the Director. Bethesda, MD: National Institutes of Health, Workshop on the Medical Utility of Marijuana, I997. 25. Stolberg. "Government Study Of Marijuana Sees Medical Benefits":Ai, A-i9. z6. It should be noted that in November I998, the District of Columbia had a ballot referendumwhich contained a proposal to legalize medical marijuana, but Congress intervened and prevented the vote from being counted. Stolberg. "Government Study Of Marijuana Sees Medical Benefits":A-i9. 27. Nancy T. Lantis. "California,Arizona Laws Permit Medical Use of Marijuana," AmericanJournal of Health System Pharmacy 54 (January 1 5, 24. I997): Iz6. z8. Ibid. z9. Attorney General Reno stated, "Federallaw still applies ... U.S. attorneys in both states will continue to review cases for prosecution and DEA officials will review cases as they have to determine whether to revoke the registration of any physician who recommends or prescribes so-called Schedule I controlled substances. We will not turn a blind eye toward our responsibility to enforce federal law and to preserve the integrity of medical and scientific process to determine if drugs have medical value before allowing them to be used," Annas: 436-37. 30. Ibid., 347. 3 I. Joseph Mangan, S.J. "An Historical Analysis Of The Principle Of Double Effect," Theological Studies io (March, 1949): 41. 3 2. Gerald Kelly, S.J. Medico-Moral Problems. St. Louis, MO.: The Catholic Health Association of the United States and Canada, 1958: 13-14. 33. It should be noted that some might argue that smoking marijuana by itself, independently of its effects, is morally evil. This implies that certain actions in themselves are intrinsically evil and to do them is always morally wrong. However, when one enters the realm of a "moral" action, one is speaking of an action qualified by intention and circumstances. So unqualified actions can only be called "premoral actions." For a more detailed analysis, see Richard M. Gula. Reason Informed By Faith: Foundations Of Catholic Morality. New York: Paulist Press, Premoral evil refers to the lack of perfection in anything I989: 270-7I. whatsoever. As pertaining to human actions, it is that aspect that we experience as regrettable, harmful, or detrimental to the full actualization of the well-being of persons and of their social relationships. For a more detailed description, see Louis Janssens. "Ontic Evil And Moral Evil," in Readings In Moral Theology, No. I: Moral Norms And CLARK * THE ETHICS OF MEDICAL MARIJUANA 59 Catholic Tradition, ed. C. F Curran and R. A. McCormick. Ramsey, N.J.: Paulist Press, I979: 6o. 34. Annas: 437. 3 5. Stolberg: "Government Study Of Marijuana Sees Medical Benefits":A-i. 36. Stempsey: i6. 37. Annas: 438. See also, Christopher Wren. "Phantom Numbers Haunt The War On Drugs," New York Times, zo April I997: E-4. 38. Annas: 438. 39. James J. Walter. "Proportionate Reason And Its Three Levels Of Inquiry: Structuring The Ongoing Debate," Louvain Studies io (Spring, I984): 32. 40. McCormick's criteria for proportionate reason first appeared in Richard McCormick. Ambiguity In Moral Choice. Milwaukee, WI: Marquette University Press, I973. He later reworked the criteria in response to criticism. His revised criteria can be found in Doing Evil To Achieve Good, eds. Richard McCormick and Paul Ramsey. Chicago, IL: Loyola University Press, I978. 4I. Examples include drugs called serotonin antagonists which include ondansetron (Zofran) and granisetron (Kytril), used alone or combined with dexamethasone (a steroid hormone); metoclopramide (Reglan) combined with diphenhydramine and dexamethasone; high doses of methylprednisolone (a steroid hormone) combined with droperidol (Inapsine); and prochlorperazine (Compazine). National Institute on Drug Abuse: z. 42. McPartland & Pruitt: 44. 43. Stolberg: "Restrictions Ease For Studies On Marijuana As Medicine": A-i I. 44. Ibid. 45. Stolberg: "Government Study Of Marijuana Sees Medical Benefits": AI9. 46. Ethan Nadelmann, director of the Lindesmith Center, which backed initiatives in California and Arizona to make marijuana legal for medical use, believes the easing of government restrictions on the study of medical marijuana has exposed the government's intentions over the past zo years. He states, "It's an implicit acknowledgment that the Government has blocked research into medical marijuana for explicitly political reasons for the last two decades." Ibid. 47. Reuters. "Court Ruling A Boost For Marijuana Clubs." New York Times, I4 September I999: A-i9. 6o JOURNAL OF PUBLIC HEALTH POLICY * VOL. 2 I, NO. I ABSTRACT Marijuana is listed by the Drug Enforcement Agency (DEA) as an illegal Schedule I drug which has no currently accepted medical use. However, on March I7, I999, ii independentscientistsappointedby the Instituteof Medicine reported that medical marijuanawas effective in controlling some forms of pain, alleviating nausea and vomiting due to chemotherapy, treating wasting due to AIDS, and combating muscle spasms associated with multiple sclerosis. There was also no evidence that using marijuana would increase illicit drug use or that it was a "gateway" drug. Despite this evidence the DEA refuses to reclassify marijuana as a Schedule II drug, which would allow physicians to prescribe unadulterated and standardized forms of marijuana. After reviewing the pertinent scientific data and applying the principle of double effect, there is a proportionate reason for allowing physicians to prescribe marijuana. Seriously ill patients have the right to effective therapies. To deny patients access to such a therapy is to deny them dignity and respect as persons.