History of medical marijuana policy in US

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<ul><li><p>International Journal of Drug Policy 10 (1999) 319328</p><p>History of medical marijuana policy in US</p><p>Kevin B. Zeese 1</p><p>Common Sense for Drug Policy Foundation, 3619 Tallwood Terrace, Falls Church, VA 22041, USA</p><p>www.elsevier.com:locate:drugpo</p><p>1. Introduction</p><p>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</p><p>granted access under the Compassionate In-vestigational New Drug (IND) program of theFood and Drug Administration.</p><p>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.</p><p>2. Litigation</p><p>The BNDD rejected NORMLs initial peti-tion out of hand claiming that rescheduling</p><p> This paper has been peer reviewed.1 Zeese litigated the placement of marijuana in Schedule I of</p><p>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.</p><p>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).</p><p>0955-3959:99:$ - see front matter 1999 Elsevier Science B.V. All rights reserved.</p><p>PII: S0955 -3959 (99 )00031 -6</p></li><li><p>K.B. Zeese : International Journal of Drug Policy 10 (1999) 319328320</p><p>marijuana would violate treaty obligations.3</p><p>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.</p><p>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</p><p>and remanded the petition to the agency foranother review.</p><p>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.</p><p>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</p><p>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.</p><p>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</p><p>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-</p><p>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.</p><p>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.</p><p>10 NORML versus HEW, Civ. Act. No. 79-0898 US DistrictCourt for the District of Columbia.</p><p>11 44 Fed. Reg. 36127 (June 4, 1979).12 44 Fed. Reg. 36123 (June 20, 1979).</p></li><li><p>K.B. Zeese : International Journal of Drug Policy 10 (1999) 319328 321</p><p>with both this order and the prior orders ofthe court.13 The Court went on to reprimandthe DEA, stating:</p><p>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</p><p>3. Legislative developments circa 19781982</p><p>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</p><p>marijuana15 and up to 10 000 medical mari-juana cigarettes had been supplied annuallyby NIDA.16</p><p>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.</p><p>3.1. New Mexico</p><p>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.</p><p>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-</p><p>13 NORML versus DEA, No. 79-1660 (D.C. Cir. Oct. 15,1980).</p><p>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 way for them tolegally make marijuana available was as part of a researchprogram. The federal government would provide the mari-juana for these research programs through the CompassionateIND program which had been created as part of the settlementin Robert Randalls case.</p><p>15 Affidavit of Edward Tocus, In the Matter of MarijuanaRescheduling Petition, Dkt. No. 86-22, July 24, 1987.</p><p>16 Affidavit of Richard Hawks, In the Matter of MarijuanaRescheduling Petition, Dkt. No. 86-22, July 24, 1987.</p></li><li><p>K.B. Zeese : International Journal of Drug Policy 10 (1999) 319328322</p><p>ceived marijuana... reported significant or to-tal relief from nausea and vomiting and hadno major adverse side effects. Only threepatients reported adverse reactions, none ofthese reactions involved marijuana alone.The 1984 report concluded the data accu-mulated over all 5 years of the programsoperation do show that marijuana smokedresulted in a higher percentage of successthan does THC ingested.17</p><p>3.2. Michigan</p><p>The Michigan research, which involved 165patients, compared marijuana to Torecan.Upon admission to the program patientswere randomly assigned to a control group, aconventional anti-emetic Torecan group or amarijuana group. When failure on the initialrandomized drug occurred, patients couldelect to crossover to an alternate therapy.This procedure allowed the Michigan De-partment of Health to evaluate how wellpatients responded to both drugs and allowedpatients to register their preference.</p><p>The Michigan study found that 71.1% ofthe patients who received marijuana reportedno emesis to moderate nausea. Ninety per-cent of the patients receiving marijuanaelected to remain on marijuana and onlyeight of 83 patients randomized to marijuanachose to alter their mode of anti-emetic ther-apy. In contrast, among patients randomizedto Torecan, more than 90% or 22 out of 23patients, elected to discontinue use andswitched to marijuana.18 Very few seriousside effects were traced to marijuana and the</p><p>most common side effect, increased appetitereported by 32.3% of patients, was positive.The most common negative effects weresleepiness, reported by 21 patients and sorethroat, reported by 13 patients.</p><p>3.3. Tennessee</p><p>This study, which involved 27 patients, allof whom had failed on other forms of anti-emetic therapy including oral THC, found anoverall success rate of 90.4% for marijuanainhalation therapy. In comparison it found a66.7% success rate for THC capsules. In theunder 40 age group, the study found a 100%success rate for marijuana inhalation therapy.In sum, the researchers found both mari-juana smoking and THC capsules to be effec-tive anti-emetics We found that the majorreason for smoking failure was smoking in-tolerance; while the major reason for THCcapsule failure was nausea and vomiting sosevere that patient could not retain thecapsule.19</p><p>3.4. New York</p><p>In describing the purpose of the marijuanaresearch program the New York Departmentof Health stated: [t]he program is a large-scale (Phase III) cooperative clinicaltrial20 The central question addressed is</p><p>19 Annual Report: Evaluation of Marijuana and Tetrahy-drocannabinol in the Treatment of Nausea and:or VomitingAssociated with Cancer Therapy Unresponsive to Conven-tional Anti-Emetic Therapy: Efficacy and Toxicity. Board ofPharmacy, State of Tennessee, July 1983.</p><p>20 Phase III is the final stage of the FDA drug approvalprocess. See footnote 25. The New York State Department ofHealth stated that [t]he program is a large-scale (phase III)cooperative clinical trial... see: Evaluation of the Anti-emeticProperties of Inhalation Marijuana in Cancer Patients Receiv-ing Chemotherapy Treatment, New York Department ofHealth, Office of Public Health, Chapter 810, Laws of 1980Article 33-A, Public Health Law, September, 1981, at 3 citedin Randall, R.C. (editor), Marijuana, Medicine and the LawVolume II, Galen Press, 1989, page 47.</p><p>17 The Lynn Pierson Therapeutic Research Program, theBehavioral Health Sciences Division, Health and EnvironmentDepartment, March 1983 and 1984.</p><p>18 Michigan Department of Public Health Marijuana Thera-peutic Research Project, Trial A 198081, Department ofSocial Oncology, Evaluation Unit, Michigan Cancer Founda-tion (March 18, 1982).</p></li><li><p>K.B. Zeese : International Journal of Drug Policy 10 (1999) 319328 323</p><p>[h]ow effective is inhalation marijuana inpreventing nausea and vomiting due tochemotherapy in patients who have failed torespond to previous anti-emetic therapy?</p><p>By 1985, the New York program had ex-tended marijuana therapy to 208 patientsthrough 55 practitioners. They received a totalof 6044 NIDA-supplied marijuana cigarettesduring 514 treatment episodes. Ultimately, 199patients were evaluated. In percentage termsthe results were stunning: North Shore Hospi-tal reported marijuana was effective at reduc-ing emesis 92.9% of the time; ColumbiaMemorial Hospital reported efficacy of 89.7%;Upstate Medical Center, St. Josephs Hospitaland Jamestown General Hospital reportedsignificant benefits among all patients smokingmarijuana.</p><p>The report concludes: Patient evaluationshave indicated that approximately 93% ofmarijuana inhalation treatment episodes arereported to be effective or highly effectivewhen compared to other antiemetics. TheNew York study reports no serious advers...</p></li></ul>