History of medical marijuana policy in US

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  • International Journal of Drug Policy 10 (1999) 319328

    History of medical marijuana policy in US

    Kevin B. Zeese 1

    Common Sense for Drug Policy Foundation, 3619 Tallwood Terrace, Falls Church, VA 22041, USA

    www.elsevier.com:locate:drugpo

    1. Introduction

    The medical use of marijuana has beensubject to a long, contentious policy debatesince the mid-1970s when Robert Randallbecame the first person to succeed in defendinghimself against marijuana charges using amedical necessity defence.2 He later filed suitseeking access to medical marijuana and in asettlement with the federal government was

    granted access under the Compassionate In-vestigational New Drug (IND) program of theFood and Drug Administration.

    Randalls success highlighted an issue thathad been simmering since 1972 when theNational Organization for the Reform of Mar-ijuana Laws (NORML) filed a petition withthe Bureau of Narcotics and Dangerous Drugs(BNDD), the predecessor to the US DrugEnforcement Administration (DEA), toreschedule marijuana under the ControlledSubstances Act (CSA). When the Act wascreated in 1970 marijuana was placed in Sched-ule I of the CSA, a classification reserved fordrugs with no accepted medical use in treat-ment in the United States. Marijuana remainsa Schedule I drug today. During the nearly30-year history of the CSA, legal, regulatory,research and legislative battlegrounds overmedical marijuana have emerged. Unfortu-nately, the losers thus far have been the sickand dying patients who have been denied bythe federal government legal access to a legit-imate and often highly effective medicine.

    2. Litigation

    The BNDD rejected NORMLs initial peti-tion out of hand claiming that rescheduling

    This paper has been peer reviewed.1 Zeese litigated the placement of marijuana in Schedule I of

    the US Controlled Substances Act with the DEA for manyyears. Initially he got involved in this litigation in 1978 whenhe was at George Washington University Law School inWashington, DC. He went on to become the Chief Counseland Executive Director of the National Organization for theReform of Marijuana Laws which had petitioned the DEA toreschedule marijuana. After he left NORML he started theDrug Policy Foundation with Arnold Trebach. Zeese contin-ued to represent NORML in litigation over medical marijuanauntil the mid-1990s. Throughout his career Zeese has workedwith patients and doctors seeking medical marijuana andadvised patients who had been arrested for their medical use ofmarijuana. Zeese is author of a review of marijuana researchentitled: Research Findings of Medicinal Marijuana Proper-ties (1997) which can be viewed at: www.csdp.org.

    2 US. v Randall, 104 Wash. Daily L. Rep. 2249 (D.C. Super.Ct. 1976). Over the years other patients have succeeded inraising the medical necessity defence as well, see, e.g. Stateversus Diana, 604 P.2d 1312 (Ct. App. Wash. 1979); Jenksversus State, No. 90-2462 (Ct. App. 1st Dist., Fla. Apr. 16,1991); State versus Mussika, No. 88-4395 CFA (17th JudicialCir., Broward County, Dec. 1988).

    0955-3959:99:$ - see front matter 1999 Elsevier Science B.V. All rights reserved.

    PII: S0955 -3959 (99 )00031 -6

  • K.B. Zeese : International Journal of Drug Policy 10 (1999) 319328320

    marijuana would violate treaty obligations.3

    The BNDD held no hearings on this issue,nor did they evaluate the scientific evidence.NORML appealed the decision to the USCourt of Appeals (the CSA requires thatreviews of agency decisions on petitions godirectly to the federal appeals court4). OnJanuary 15, 1975 the court ruled inNORMLs favor, reversing the decision ofthe Agency and remanding the case forfurther consideration, finding thatinternational treaties did not barrescheduling.5 The court used stronglanguage to criticize the agency for failing tohold hearings and ordered the agency toreconsider the petition. Twenty months later,after the Courts first ruling, the DEApublished an order denying the petition in allaspects,6 acknowledging the possibility ofrescheduling marijuana but maintaining theinappropriateness of this measure. Onceagain NORML appealed.

    For a second time the Court of Appealsruled against the agency7 and again the courtwas critical of the DEA.8 This time the courtcriticized the DEA for failing to obtain thescientific and medical evaluation of theNORML petition by the Department ofHealth Education and Welfare (HEW; thepredecessor to the Department of Health andHuman Services (HHS)). The court notedthat the review of the science by HEW wasmandated by the Controlled Substances Act9

    and remanded the petition to the agency foranother review.

    In response to the remand the DEA sentthe NORML petition to HEW forconsideration. HEWs Controlled SubstancesAdvisory Committee recommended thatcomponents of marijuana (cannabinol andcannabidiol) be rescheduled. HEW took nofurther action over the next year despiterepeated requests by NORML. On March 28,1979, NORML filed a complaint in the USDistrict Court alleging that HEW hadunreasonably delayed the action on theNORML petition.10 Shortly after this suitwas filed HEW sent its scientific evaluation toDEA. NORML and HEW entered astipulation dismissing the lawsuit.

    The HEW evaluation concluded thatmarijuana and all its components could beproperly placed in Schedule I or Schedule IIof the Controlled Substances Act butrecommended it be retained in Schedule I.11

    Ten days after receipt of the HEWevaluation, DEA denied the NORMLpetition in all respects.12 Once againNORML appealed. Prior to argument theDEA sought a remand of part of theNORML petition concerning THC. Thefederal government wanted to make THCavailable in an attempt to relieve themounting political pressure in support ofmarijuana.

    For a third time, the Court reversed thedecision of the DEA and remanded the entirecase for reconsideration. The Court was criti-cal of the process of the DEA and orderedHEW to make scientific and medical find-ings on all substances at issue consistent

    3 37 Fed. Reg. 18093 (Sept. 1, 1972).4 21 U.S.C. Sec. 877.5 NORML versus Ingersoll, 497 F.2d 654 (D.C. Cir. 1974).6 40 Fed. Reg. 44164, 44168 (Sept. 25, 1975).7 It is important to note that the general rule in administra-

    tive law is to favor the decision of the agency. He court viewsthe agency as the expert and does not like to substitute itsjudgment for the decision of the expert. Thus, succeeding twicein getting a remand was an unusual occurence.

    8 NORML versus DEA, 559 F.2d 735 (D.C. Cir. 1977).9 21 U.S.C. Sec. 811 (a)(c), 559 F. 2d 74748.

    10 NORML versus HEW, Civ. Act. No. 79-0898 US DistrictCourt for the District of Columbia.

    11 44 Fed. Reg. 36127 (June 4, 1979).12 44 Fed. Reg. 36123 (June 20, 1979).

  • K.B. Zeese : International Journal of Drug Policy 10 (1999) 319328 321

    with both this order and the prior orders ofthe court.13 The Court went on to reprimandthe DEA, stating:

    We regrettably find it necessary to remindrespondents of an agencys obligation onremand not to do anything which is con-trary to either the letter or spirit of themandate continued in the light of the opin-ion of (the) court deciding the case. (cita-tion omitted).13

    3. Legislative developments circa 19781982

    With the litigation with the DEA ongoing,legislative action concerning medical mari-juana quickly emerged at the state level. TheAlliance for Cannabis Therapeutics, led byRobert Randall and his partner AliceOLeary, worked with patients across theUnited States on legislation. Between 1978and 1982, 33 states passed laws to makemarijuana available to their seriously ill citi-zens. These laws were setup as research pro-grams, consistent with federal law14. Once astate passed a law, its state department ofhealth or a similar agency had to apply to thefederal government to acquire marijuanafrom the IND program. This was not an easytask but several states succeeded in meetingthe requirements of the FDA, DEA and theNational Institute on Drug Abuse. By 1984,17 states had active INDs for medical

    marijuana15 and up to 10 000 medical mari-juana cigarettes had been supplied annuallyby NIDA.16

    These state programs allowed hundreds ofpatients each year to get marijuana as well asa wealth of information about its medicaluses. The health departments of six statesCalifornia, Georgia, New Mexico, NewYork, Michigan and Tennesseeconductedstudies focusing on the anti-emetic propertiesof marijuana for cancer patients under re-search protocols approved by the US Foodand Drug Administration. The studies com-pared marijuana to prescription anti-emetics,including synthetic THC or Marinol. In eachstudy, marijuana was found to be an effectiveand safe anti-emetic that for many patients ismore effective than other available drugs.

    3.1. New Mexico

    This study, which involved 250 patients,compared marijuana to THC capsules. Inorder to participate in the research, accordingto the protocol approved by the FDA in1978, patients had to be referred by a physi-cian and have failed on at least three otheranti-emetics. Patients were permitted tochoose marijuana or the THC pill. Both ob-jective (e.g. frequency of vomiting, amount ofvomiting, muscle biofeedback, blood sam-ples) and subjective measures were used todetermine the effectiveness of the drug.

    The study concluded that marijuana wasnot only an effective anti-emetic but also farsuperior to the best available conventionaldrug, Compazine, and clearly superior tosynthetic THC pill. The study found that[m]ore than 90% of the patients who re-

    13 NORML versus DEA, No. 79-1660 (D.C. Cir. Oct. 15,1980).

    14 Initial drafts of bills would have made marijuana legallyavailable as a prescription drug, but the federal governmentsaw these drafts and mounted an aggressive lobbying cam-paign and convinced the states that the only