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self index.cfm
site_filepath /www/sites/mfapp/templates/main/
 
Alan Trachtenberg, Md  
     
     
                                                        DEA Judge Francis Young - Part 1                               

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
                               

                               

                               


                               

                               

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Title:                                                
DEA Judge Francis Young's ruling that Marijuana Must be reclassified
                                               
Author:                                                
DEA Judge Francis Young                                               
Date:                                                
Nov. 6, 1988
                                               
Summary:                                                
Landmark September 1988 order, fought and ignored by DEA chiefs
                                               
Download:                                                
Not yet available - check back [get adobe acrobat (PDF) reader]
                                               
Html:                                                
Part 1 | Part 2 | Part 3 | Part 4
                               
                               
UNITED STATES DEPARTMENT OF JUSTICE                       Drug Enforcement Administration _______________________________________                                        )   In The Matter Of                     )                                        )              Docket No. 86-22      MARIJUANA RESCHEDULING PETITION   ) _______________________________________)                 OPINION AND RECOMMENDED RULING, FINDINGS OF                   FACT, CONCLUSIONS OF LAW AND DECISION OF                        Administrative LAW JUDGE. FRANCIS L. YOUNG, Administrative Law Judge DATED: SEP 6  1988 
                               
                                                               
                   UNITED STATES DEPARTMENT OF JUSTICE                       Drug Enforcement Administration _______________________________________                                        )   In The Matter Of                     )                                        )              Docket No. 86-22      MARIJUANA RESCHEDULING PETITION   ) _______________________________________)                  OPINION AND RECOMMENDED RULING, FINDINGS OF                    FACT, CONCLUSIONS OF LAW AND DECISION OF                         ADMINISTRATIVE LAW JUDGE. FRANCIS L. YOUNG, Administrative Law Judge APPEARANCES:  KEVIN B. ZEESE, Esq.  ARNOLD S. TREBACH, Esq.   for National Organization For The Reform of   Marijuana Laws  FRANK B. STILWELL, III, Esq.   for Alliance for Cannabis Therapeutics  DAVID C. BECK, Esq.   for Cannabis Corporation of America  CARL ERIC OLSEN, Pro Se  CHARLOTTE J. MAPES, Esq.  MADELEINE R. SHIRLEY, Esq.   for the Government  KARL BERNSTEIN   for National Federation of Parents for Drug-Free Youth  VIRGINIA PELTIER, Esq.   for the International Association of Chiefs of Police DATED: SEP 6 1988 
                               
                                                               
                                 CONTENTS                I.     INTRODUCTION                            1                II.    RECOMMENDED RULING                      7                III.   ISSUES                                  7                IV.    STATUTORY REQUIREMENTS FOR SCHEDULING   8                V.     ACCEPTED MEDICAL USE IN TREATMENT                        - CHEMOTHERAPY                         10                          Findings of Fact                     10                          Discussion                           26                VI.    ACCEPTED MEDICAL USE IN TREATMENT                        - GLAUCOMA                             35                          Findings of Fact                     35                          Discussion                           38                VII.   ACCEPTED MEDICAL USE IN TREATMENT                        - MULTIPLE SCLEROSIS, SPASTICITY &                          HYPERPARATHYROIDISM                  40                          Findings of Fact                     40                          Discussion                           54                VIII.  ACCEPTED SAFETY FOR USE UNDER MEDICAL                        SUPERVISION                            56                          Findings of Fact                     56                          Discussion                           65                IX.    CONCLUSIONS AND RECOMMENDED DECISION    67                       CERTIFICATION OF SERVICE                69                                    - i - 
                               
                               
                   UNITED STATES DEPARTMENT OF JUSTICE                       Drug Enforcement Administration _______________________________________                                        )   In The Matter Of                     )                                        )              Docket No. 86-22      MARIJUANA RESCHEDULING PETITION   ) _______________________________________)                  OPINION AND RECOMMENDED RULING, FINDINGS OF                    FACT, CONCLUSIONS OF LAW AND DECISION OF                         ADMINISTRATIVE LAW JUDGE.                                      1.                                 INTRODUCTION      This is a rulemaking pursuant to the Administrative Procedure Act, 5 U.S.C. ¤ 551, et seq., to determine whether the marijuana plant (Cannabis sativa L) considered as a whole may lawfully be transferred from Schedule  I to Schedule II of the schedules established by the Controlled  Substances Act (the Act), 21 U.S.C. ¤ 801, et seq.  None of the parties  is seeking to "legalize" marijuana generally or for recreational  purposes.  Placement in Schedule II would mean, essentially, that  physicians in the United States would not violate Federal law by  prescribing marijuana for their patients for legitimate therapeutic  purposes.  It is contrary to Federal law for physicians to do this as  long as marijuana remains in Schedule I.  This proceeding had its origins  on May 18, 1972 when the National Organization for the Reform of  Marijuana Laws (NORML) and two other groups submitted a petition to the  Bureau of Narcotics and Dangerous Drugs (BNDD) [footnote 1], predecessor ______________________ 1    The powers and authority granted by the Act to the Attorney General      were delegated to the Director of BNDD and subsequently to the      Administrator of DEA.  28 C.F.R. ¤ 0.100, et seq. 
                               
                               
agency to the Drug Enforcement Administration (DEA or the Agency), asking that marijuana be removed from Schedule I and freed of all controls entirely, or be transferred from Schedule I to Schedule V where it would  be subject to only minimal controls.  The Act by its terms had placed marijuana in Schedule I thereby declaring, as a matter of law that it had no legitimate use in therapy in the United States and subjecting the substance to the strictest level of controls.  The Act had been in effect for just over one year when NORML submitted its 1972 petition.      On September 1, 1972 the Director of BNDD announced his refusal to accept the petition for filing, stating that he was not authorized to institute proceedings for the action requested because of the provisions  of the Single Convention on Narcotic Drugs, 1961.  NORML appealed this  action to the United States Court of Appeals for the District of Columbia  Circuit.  The court held that the Director had erred in rejecting the  petition without "a reflective consideration and analysis," observing  that the Director's refusal "was not the kind of agency action that  promoted the kind of interchange and refinement of views that is the  lifeblood of a sound administrative process."  NORML v. Ingersoll, 162  U.S. App. D.C. 67, 497 F.2d 654, 659 (1974).  The court remanded the  matter in January 1974 for further proceedings not inconsistent with its  opinion, "to be denominated a consideration on the merits."  Id.      A three-day hearing was held at DEA [footnote 2] by Administrative  Law Judge Lewis Parker in January 1975.  The judge found in NORML's favor  on several issues but the Acting Administrator of DEA entered a final  order denying NORML's petition "in all respects."  NORML again petitioned  the court for review.  Finding fault _________________ 2    DEA became the successor agency to BNDD in a reorganization carried      out pursuant to Reorganization Plan No. 2 of 1973, eff. July 1,      1973.  38 Fed Reg. 15932 (1973).                                   - 2 - 
                               
                               
with DEA's final order the court again remanded for further proceedings  not inconsistent with its opinion.  NORML v. DEA, 182 U.S. App. D.C. 114,  559 F.2d 735 (1977).  The Court directed the then-Acting Administrator of  DEA to refer NORML's petition to the Secretary of the Department of  Health, Education and Welfare (HEW) for findings and, thereafter, to  comply with the rulemaking procedures outlined in the Act at 21 U.S.C. ¤  811 (a) and (b).      On remand the Administrator of DEA referred NORML's petition to HEW for scientific and medical evaluation.  On June 4, 1979 the Secretary of HEW advised the Administrator of the results of the HEW evaluation and recommended that marijuana remain in Schedule I.  Without holding any further hearing the Administrator of DEA proceeded to issue a final order ten days later denying NORML's petition and declining to initiate proceedings to transfer marijuana from Schedule I.  44 Fed. Reg. 36123 (1979).  NORML went back to the Court of Appeals.      When the case was called for oral argument there was discussion of  the then-present status of the matter.  DEA had moved for a partial  remand.  The court found that "reconsideration of all the issues in this  case would be appropriate" and again remanded it to DEA, observing: "We  regrettably find it necessary to remind respondents [DEA and HEW] of an  agency's obligation on remand not to 'do anything which is contrary to  either the letter or spirit of the mandate construed in the light of the  opinion of [the] court deciding the case.'"  (Citations omitted.)  NORML  v. DEA, et al., No. 79.1660, United States Court of Appeals for the  District of Columbia Circuit, unpublished order filed October 16, 1980.   DEA was directed to refer all the substances at issue to the Department  of Health and Human Services (HHS), successor agency to HEW, for scien-                                   - 3 - 
                               
                               
tific and medical findings and recommendations on scheduling.  DEA did so and HHS has responded.  In a letter dated April 1, 1986 the then-Acting Deputy Administrator of DEA requested this administrative law judge to commence hearing procedures as to the proposed rescheduling of marijuana and its components.      After the Judge conferred with counsel for NORML and DEA, a notice  was published in the Federal Register on June 24, 1986 announcing that  hearings would be held on NORML's petition for the rescheduling of  marijuana and its components commencing on August 21, 1986 and giving any  interested person who desired to participate the opportunity to do so.   51 Fed. Reg. 22946 (1986).      Of the three original petitioning organizations in 1972 only NORML  is a party to the present proceeding.  In addition the following entities responded to the Federal Register notice and have become parties, participating to varying degrees:  the Alliance for Cannabis Therapeutics (ACT), Cannabis Corporation of America (CCA) and Carl Eric Olsen, all seeking transfer of marijuana to Schedule II; the Agency, National Federation of Parents for Drug free Youth (NFP) and the International Association of Chiefs of Police (IACP), all contending that marijuana should remain in Schedule I.      Preliminary prehearing sessions were held on August 21 and December  5, 1986 and on February 20, 1987. [footnote 3]  During the preliminary  stages, on January 20, 1987, NORML filed an amended petition for  rescheduling.  This new petition abandoned NORML's previous requests for  the complete descheduling of marijuana or rescheduling to Schedule V.  It  asks only that marijuana be placed in Schedule II.      At a prehearing conference on February 20, 1987 this amended  petition was _______________ 3    Transcripts of these three preliminary prehearing sessions are      included in the record.                                   - 4 - 
                               
                               
discuss. [footnote 4]  All Parties present stipulated, for the purpose of this proceeding, that marijuana has a high potential for abuse and that abuse of the marijuana plant may lead to severe psychological or physical dependence.  They then agreed that the principal issue in this proceeding would be stated thus:           Whether the marijuana plant, considered as a whole, [footnote           5] may ________________ 4    The transcript of this prehearing conference and of the subsequent      hearing session comprise 15 volumes numbered as follows:           Vol. I     -  Prehearing Conference, October 16, 1987           Vol. II    -  Cross Examination, November 19, 1987           Vol. III   -  Cross Examination, December 8, 1987           Vol. IV    -  Cross Examination, December 9, 1987           Vol. V     -  Cross Examination, January 5, 1988           Vol. VI    -  Cross Examination, January 6, 1988           Vol. VII   -  Cross Examination, January 7, 1988           Vol. VIII  -  Cross Examination, January 26, 1988           Vol. IX    -  Cross Examination, January 27, 1988           Vol. X     -  Cross Examination, January 28, 1988           Vol. XI    -  Cross Examination, January 29, 1988           Vol. XII   -  Cross Examination, February 2, 1988           Vol. XIII  -  Cross Examination, February 4, 1988           Vol. XIV   -  Cross Examination, February 5, 1988           Vol. XV    -  Oral Argument, June 10, 1988 Pages of the transcript are cited herein by volume and page, e.g. "Tr. V- 96"; "G-" identifies an Agency exhibit. 5    Throughout this opinion the term marijuana" refers to "the marijuana      plant, consider as a whole".                                   - 5 - 
                               
                               
          lawfully be transferred from Schedule I to Schedule II of the           schedules established by the Controlled Substances Act.      Two subsidiary issues were agreed on, as follows:           1.  Whether the marijuana plant has a currently accepted               medical use in treatment in the United States, or a               currently accepted medical use with severe restrictions.           2.  Whether there is a lack of accepted safety for use of               the marijuana plant under medical supervision. As stated above, the parties favoring transfer from Schedule I to Schedule II are NORML, ACT, CCA and Carl Eric Olsen.  Those favoring retaining marijuana in Schedule I are the Agency, NFP and IACP.      During the Spring and Summer of 1987 the parties identified their witnesses and put the direct examination testimony of each witness in writing in affidavit form.  Copies of these affidavits were exchanged. Similarly, the parties assembled their proposed exhibits and exchanged copies.  Opportunity was provided for each party to submit objections to the direct examination testimony and exhibits proffered by the others.   The objections submitted were considered by the administrative law judge  and ruled on.  The testimony and exhibits not excluded were admitted into  the record.  Thereafter hearing sessions were held at which witnesses  were subjected to cross-examination.  These sessions were held in New  Orleans, Louisiana on November 18 and 19, 1987; in San Francisco,  California on December 8 and 9, 1987; and in Washington, D.C. on January  5 through 8 and 26 through 29, and on February 2, 4 and 5, 1988.  The  parties have submitted proposed findings and conclusions and briefs.   Oral arguments were heard by the judge on June 10, 1988 in Washington.                                   - 6 - 
                               
                               
                                   II.                             RECOMMENDED RULING      It is recommended that the proposed findings and conclusions  submitted by the parties to the administrative law judge be rejected by  the Administrator except to the extent they are included in those  hereinafter set forth; for the reason that they are irrelevant or unduly  repetitious or not supported by a preponderance of the evidence.  21  C.F.R. ¤ 1316.65(a)(1).                                    III.                                   ISSUES      As noted above, the agreed issues are as follows:           Principle issue:           Whether the marijuana plant, considered as a whole, may           lawfully be transferred from Schedule I to Schedule II of           the schedules established by the Controlled Substances Act.           Subsidiary issues:           1.  Whether the marijuana plant has a currently accepted               medical use in treatment in the United States, or a               currently accepted medical use with severe restrictions.           2.  Whether there is a lack of accepted safety for use of               the marijuana plant under medical supervision.                                   - 7 - 
                               
                               
                                   IV.                   STATUTORY REQUIREMENTS FOR SCHEDULING      The Act provides (21 U.S.C. ¤ 812(b)) that a drug or other substance may not be placed in any schedule unless certain specified findings are made with respect to it.  The findings required for Schedule I and  Schedule II are as follows:           Schedule I. -             (A)  The drug or other substance has a high potential           for abuse.             (B)  The drug or other substance has no currently accepted           medical use in treatment in the United States.             (C)  There is a lack of accepted safety for use of the           drug or other substance under medical supervision.           Schedule II. -             (A)  The drug or other substance has a high potential for           abuse.             (B)  The drug or other substance has a currently accepted           medical use in treatment in the United States or a currently           accepted medical use with severe restrictions.             (C)  Abuse of the drug or other substances [sic] may lead to           severe psychological or physical dependence.      As noted above the parties have stipulated, for the purpose of this proceeding, that marijuana has a high potential for abuse and that abuse  of it may lead to severe psychological or physical dependence.  Thus the dispute between the two sides in this proceeding is narrowed to whether  or not marijuana has a currently accepted medical use in treatment in the United States, and whether or not there is a lack of accepted safety for use of marijuana under medical supervision.      The issues as framed here contemplate marijuana's being placed only  in                                   - 8 - 
                               
                               
Schedule I or Schedule II.  The criteria for placement in any of the  other three schedules established by the Act are irrelevant to this  proceeding.                                   - 9 - 
                               
                               
                                    V.                     ACCEPTED MEDICAL USE IN TREATMENT                               - CHEMOTHERAPY      With respect to whether or not marijuana has a "currently accepted medical use in treatment in the United States" for chemotherapy patients, the record shows the following facts to be uncontroverted. Findings Of Fact           1.  One of the most serious problems experienced by cancer patients undergoing chemotherapy for their cancer is severe nausea and vomiting caused by their reaction to the toxic (poisonous) chemicals administered to them in the course of this treatment.  This nausea and vomiting at times becomes life threatening.  The therapy itself creates a tremendous strain on the body.  Some patients cannot tolerate the severe nausea and vomiting and discontinue treatment.  Beginning in the 1970's there was considerable doctor-to-doctor communication in the United  States concerning patients known by their doctors to be surreptitiously  using marijuana with notable success to overcome or lessen their nausea  and vomiting.           2.  Young patients generally achieve better control over nausea and vomiting from smoking marijuana than do older patients, particularly when the older patient has not been provided with detailed information on how to smoke marijuana.           3.  Marijuana cigarettes in many cases are superior to  synthetic THC capsules in reducing chemotherapy-induced nausea and  vomiting.  Marijuana                                   - 10 - 
                               
                               
cigarettes have an important, clear advantage over synthetic THC capsules in that the natural marijuana is inhaled and generally takes effect more quickly than the synthetic capsule which is ingested and must be  processed through the digestive system before it takes effect.           4.  Attempting to orally administer the synthetic THC capsule  to a vomiting patient presents obvious problems - it is vomited right  back up before it can have any effect.           5.  Many physicians, some engaged in medical practice and some teaching in medical schools, have accepted smoking marijuana as effective in controlling or reducing the severe nausea and vomiting (emesis) experienced by some cancer patients undergoing chemotherapy for cancer.           6.  Such physicians include board-certified internists, oncologists and psychiatrists.  (Oncology is the treatment of cancer through the use of highly toxic chemicals, or chemotherapy.)           7.  Doctors who have come to accept the usefulness of marijuana in controlling or reducing emesis resulting from chemotherapy have dose  so as the result of reading reports of studies and anecdotal reports in  their professional literature, and as the result of observing patients  and listening to reports directly from patients.           8.  Some cancer patients who have acknowledged to doctors that they smoke marijuana for emesis control have indicated in their  discussions that, although they may have first smoked marijuana  recreationally, they accidentally found that doing so helped reduce the  emesis resulting from their chemotherapy.  They consistently indicated  that they felt better and got symptomatic relief from the intense nausea  and vomiting caused by the chemotherapy.  These patients                                    - 11 - 
                               
                               
were no longer simply getting high, but were engaged in medically  treating their illness, albeit with an illegal substance.  Other  chemotherapy patients began smoking marijuana to control their emesis  only after hearing reports that the practice had proven helpful to  others.  Such patients had not smoked marijuana recreationally.           9.  This successful use of marijuana has given many cancer chemotherapy patients a much more positive outlook on their overall treatment, once