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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 they were relieved of the debilitating, exhausting and extremely unpleasant nausea and vomiting previously resulting from their chemotherapy treatment. 10. In about December 1977 the previously underground patient practice of using marijuana to control emesis burst into the public media in New Mexico when a young cancer patient, Lynn Pearson, began publicly to discuss his use of marijuana. Mr. Pearson besought the New Mexico legislature to pass legislation making marijuana available legally to seriously ill patients whom it might help. As a result, professionals in the public health sector in New Mexico more closely examined how marijuana might be made legally available to assist in meeting what now openly appeared to be a widely recognized patient need. 11. In many cases doctors have found that, in addition to suppressing nausea and vomiting, smoking marijuana is a highly successful appetite stimulant. The importance of appetite stimulation in cancer therapy cannot be overstated. Patients receiving chemotherapy often lose tremendous amounts of weight. They endanger their lives because they lose interest in food and in eating. The resulting sharp reduction in weight may well affect their prognosis. Marijuana smoking induces some patients to eat. The benefits are obvious, doctors have found. There is no significant loss of weight. Some patients will gain weight. - 12 -
This allows them to retain strength and makes them better able to fight the cancer. Psychologically, patients who can continue to eat even while receiving chemotherapy maintain a balanced outlook and are better able to cope with their disease and its treatment, doctors have found. 12. Synthetic anti-emetic agents have been in existence and utilized for a number of years. Since about 1980 some new synthetic agents have been developed which appear to be more effective in controlling and reducing chemotherapy-induced nausea and vomiting than were some of those available in the 1970's. But marijuana still is found more effective for this purpose in some people than any of the synthetic agents, even the newer ones. 13. By the late 1970's in the Washington, D.C. area there was a growing recognition among health care professionals and the public that marijuana had therapeutic value in reducing the adverse effects of some chemotherapy treatments. With this increasing public awareness came increasing pressure from patients on doctors for information about marijuana and its therapeutic uses. Many patients moved into forms of unsupervised self-treatment. While such self-treatment often proved very effective, it has certain hazards, ranging from arrest for purchase or use of an illegal drug to possibly serious medical complications from contaminated sources or adulterated materials. Yet, some patients are willing to run these risks to obtain relief from the debilitating nausea and vomiting caused by their chemotherapy treatments. 14. Every oncologist known to one Washington, D.C. practicing internist and board-certified oncologist has had patients who used marijuana with great success to prevent or diminish chemotherapy-induced nausea and vomiting. Chemotherapy patients reporting directly to that Washington doctor that they - 13 -
have smoked marijuana medicinally vomit less and eat better than patients who do not smoke it. By gaining control over their severe nausea and vomiting these patients undergo a change of mood and have a better mental outlook than patients who, using the standard anti-emetic drugs, are unable to gain such control. 15. The vomiting induced by chemotherapeutic drugs may last up to four days following the chemotherapy treatment. The vomiting can be intense, protracted and, in some instances, is unendurable. The nausea which follows such vomiting is also deep and prolonged. Nausea may prevent a patient from taking regular food or even much water for periods of weeks at a time. 16. Nausea and vomiting of this severity degrades the quality of life for these patients, weakening them physically, and destroying the will to fight the cancer. A desire to end the chemotherapy treatment in order to escape the emesis can supersede the will to live. Thus the emesis, itself, can truly be considered a life-threatening consequence of many cancer treatments. Doctors have known such cases to occur. Doctors have known other cases where marijuana smoking has enabled the patient to endure, and thus continue, chemotherapy treatments with the result that the cancer has gone into remission and the patient has returned to a full, active satisfying life. 17. In San Francisco chemotherapy patients were surreptitiously using marijuana to control emesis by the early 1970's. By 1976 virtually every young cancer patient receiving chemotherapy at the University of California in San Francisco was using marijuana to control emesis with great success. The use of marijuana for this purpose had become generally accepted by the patients and increasingly by their physicians as a valid and effective form of treatment. This was particularly true for younger cancer patients, somewhat less common for - 14 -
older ones. By 1979 about 25% to 30% of the patients seen by one San Francisco oncologist were using marijuana to control emesis, about 45 to 50 patients per year. Such percentages and numbers vary from city to city. A doctor in Kansas City who sees about 150 to 200 new cancer patients per year found that over the 15 years 1972 to 1987 about 5% of the patients he saw, or a total of about 75, used marijuana medicinally. 18. By 1987 marijuana no longer generated the intense interest in the world of oncology that it had previously, but it remains a viable tool, commonly employed, in the medical treatment of chemotherapy patients. There has evolved an unwritten but accepted standard of treatment within the community of oncologists in the San Francisco, California area which readily accepts the use of marijuana. 19. As of the Spring of 1987 in the San Francisco area, patients receiving chemotherapy commonly smoked marijuana in hospitals during their treatments. This in-hospital use, which takes place in rooms behind closed doors, does not bother staff, is expected by physicians and welcomed by nurses who, instead of having to run back and forth with containers of vomit, can treat patients whose emesis is better controlled than it would be without marijuana. Medical institutions in the Bay area where use of marijuana obtained on the streets is quite common, although discrete, include the University of California at San Francisco Hospital, the Mount Zion Hospital and the Franklin Hospital. In effect, marijuana is readily accepted throughout the oncologic community in the bay area for its benefits in connection with chemotherapy. The same situation exists in other large metropolitan areas of the United States. 20. About 50% of the patients seen by one San Francisco oncologist - 15 -