--------------- FIDO MESSAGE AREA==> TOPIC: 257 ALTERN. MEDICINE Ref: EBI00014Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [03/28 >>> Part 3 of 28... 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. Sec. 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 NORML v. DEA, et al., No. 79.1660, United States Court of Appeals for the District of Columbia Circuit, unpublished order filed October 16, 1980.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: >>> Continued to next message... ___ X Blue Wave/DOS v2.30 X --- Maximus 3.01 * Origin: Who's Askin'? (1:17/75) --------------- FIDO MESSAGE AREA==> TOPIC: 257 ALTERN. MEDICINE Ref: EBI00015Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [04/28 >>> Part 4 of 28... 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, considered 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. Sec. 1316.65(a)(1). III. ISSUES >>> Continued to next message... ___ X Blue Wave/DOS v2.30 X --- Maximus 3.01 * Origin: Who's Askin'? (1:17/75) --------------- FIDO MESSAGE AREA==> TOPIC: 257 ALTERN. MEDICINE Ref: EBI00016Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [05/28 >>> Part 5 of 28... 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. Sec. 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 >>> Continued to next message... ___ X Blue Wave/DOS v2.30 X --- Maximus 3.01 * Origin: Who's Askin'? (1:17/75) --------------- FIDO MESSAGE AREA==> TOPIC: 257 ALTERN. MEDICINE Ref: EBI00017Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [06/28 >>> Part 6 of 28... 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 - >>> Continued to next message... ___ X Blue Wave/DOS v2.30 X --- Maximus 3.01 * Origin: Who's Askin'? (1:17/75) --------------- FIDO MESSAGE AREA==> TOPIC: 257 ALTERN. MEDICINE Ref: EBI00018Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [07/28 >>> Part 7 of 28... 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 >>> Continued to next message... ___ X Blue Wave/DOS v2.30 X --- Maximus 3.01 * Origin: Who's Askin'? (1:17/75) --------------- FIDO MESSAGE AREA==> TOPIC: 257 ALTERN. MEDICINE Ref: EBI00019Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [08/28 >>> Part 8 of 28... 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 - during the year l987 were smoking marijuana medicinally. This is about 90 to 95 individuals. This number is higher than during the previous ten years due to the nature of this physician's practice which includes patients from the "tenderloin" area of San Francisco, many of whom are suffering from AIDS-related lymphosarcoma. These patients smoke marijuana to control their nausea and vomiting, not to "get high." They self- titrate, i.e., smoke the marijuana only as long as needed to overcome the nausea, to prevent vomiting. 21. The State of New Mexico set up a program in 1978 to make marijuana available to cancer patients pursuant to an act of the State legislature. The legislature had accepted marijuana as having medical use in treatment. It overwhelmingly passed this legislation so as to make marijuana available for use in therapy, not just for research. Marijuana and synthetic THC were given to patients, administered under medical supervision, to control or reduce emesis. The marijuana was in the form of cigarettes obtained from the Federal government. The program operated from 1979 until 1986, when funding for it was terminated by the State. During those seven years about 250 cancer patients in New Mexico received either marijuana cigarettes or THC. Twenty or 25 physicians in New Mexico sought and obtained marijuana cigarettes or THC for their cancer patients during that period. All of the oncologists in New Mexico accepted marijuana as effective for some of their patients. At least ten hospitals involved in this program in New Mexico, in which cancer patients smoked their marijuana cigarettes. The hospitals accepted this medicinal marijuana smoking by patients. Voluminous reports filed by the participating physicians make it clear that marijuana is a highly effective anti-emetic substance. It was found in the New Mexico program to be far superior to the best available conventional - 16 - anti-emetic drug, compazine, and clearly superior to synthetic THC pills. More than 90% of the patients who received marijuana within the New Mexico program reported significant or total relief from nausea and vomiting. Before the program began cancer patients were surreptitiously smoking marijuana in New Mexico to lessen or control their emesis resulting from chemotherapy treatments. They reported to physicians that it was successful for this purpose. Physicians were aware that this was going on. 22. In 1978 the Louisiana legislature became one of the first- State legislatures in the nation to recognize the efficacy of marijuana in controlling emesis by enacting legislation intended to make marijuana available by prescription for therapeutic use by chemotherapy patients. This enactment shows that there was widespread acceptance in Louisiana of the therapeutic value of marijuana. After a State Marijuana Prescription Review Board was established, pursuant to that legislation, it became apparent that, because of Federal restrictions, marijuana could be obtained legally only for use in cumbersome, formal research programs. Eventually a research program was entered into by the State, utilizing synthetic THC, but without much enthusiasm, since most professionals who had wanted to use marijuana clinically, to treat patients, had neither the time, resources nor inclination to get involved in this limited, formal study. The original purpose of the Louisiana legislation was frustrated by the Federal authorities. Some patients, who had hoped to obtain marijuana for medical use legally after enactment of the State legislation, went outside the law and obtained it illicitly. Some physicians in Louisiana accept marijuana as having a distinct medical value in the treatment of the nausea and vomiting associated with certain types of chemotherapy treatments. - 17 - 23. In 1980 the State of Georgia enacted legislation authorizing a therapeutic research program for the evaluation of marijuana as a medically recognized therapeutic substance. Its enactment was supported by letters from a number of Georgia oncologist and other Georgia physician, including the Chief of oncology at Grady Hospital and staff oncologist at Emory University Medical Clinic. Sponsors of the legislation originally intended the enactment of a law making marijuana available for clinical, therapeutic use by patients. The bill was referred to as the "Marijuana-as-Medicine" bill. The final legislation was crafted, however, of necessity, merely to set up a research program in order to obtain marijuana from the one legitimate source available - >>> Continued to next message... ___ X Blue Wave/DOS v2.30 X --- Maximus 3.01 * Origin: Who's Askin'? (1:17/75) --------------- FIDO MESSAGE AREA==> TOPIC: 257 ALTERN. MEDICINE Ref: EBI00020Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [09/28 >>> Part 9 of 28... the Federal Government, which would not make the substance available for any other purpose other than conducting a research program. The act was passed by an overwhelming majority in the lower house of the legislature and unanimously in the Senate. In January 1983 an evaluation of the program, which by then had 44 evaluable marijuana smoking patient- participants, accepted marijuana smoking as being an effective anti- emetic agent. 24. In Boston, Massachusetts in 1977 a nurse in a hospital suggested to a chemotherapy patient, suffering greatly from the therapy and at the point of refusing further treatment, that smoking marijuana might help relieve his nausea and vomiting. The patient's doctor, when asked about it later, stated that many of his younger patients were smoking marijuana. Those who did so seemed to have less trouble with nausea and vomiting. The patient in question obtained some marijuana and smoked it, in the hospital, immediately before his next chemotherapy treatment. Doctors, nurses, and orderlies coming into the room as he finished smoking realized what the patient had been doing. None of them - 18 - made any comment. The marijuana was completely successful with this patient, who accepted it as effective in controlling his nausea and vomiting. Instead of being sick for weeks following chemotherapy, and having trouble going to work, as had been the case, the patient was ready to return to work 48 hours after that chemotherapy treatment. The patient thereafter always smoked marijuana, in the hospital, before chemotherapy. The doctors were aware of it, openly approved of it and encouraged him to continue. The patient resumed eating regular meals and regained lost eight, his mood improved markedly, he became more active and outgoing and began doing things together with his wife that he had not done since beginning chemotherapy. 25. During the remaining two years of this patient's life, before his cancer ended it, he came to know other cancer patients who were smoking marijuana to relieve the adverse effects of their chemotherapy. Most of these patients had learned about using marijuana medically from their doctors who, having accepted its effectiveness, subtly encouraged them to use it. 26. A Boston psychiatrist and professor, who travels about the country, has found a minor conspiracy to break the law among oncologists and nurses in every oncology center he has visited to let patients smoke marijuana before and during cancer chemotherapy. He has talked with dozens of these health care oncologists who encourage their patients to do this and who regard this as an accepted medical usage of marijuana. He has known nurses who have obtained marijuana for patients unable to obtain it for themselves. 27. A cancer patient residing in Beaverton, Michigan smoked marijuana medicinally in the nearby hospital where he was undergoing chemotherapy from early 1979 until he died of his cancer in October of that year. He smoked it in - 19 - his hospital room after his parents made arrangements with the hospital for him to do so. Smoking marijuana controlled his post-chemotherapy nausea and vomiting, enabled him to eat regular-meals again with his family, and he became outgoing and talkative. His parents accepted his marijuana smoking as effective and helpful. Two clergymen, among others, brought marijuana to this patient's home. Many people at the hospital supported the patient's marijuana therapy, none doubted its helpfulness or discouraged it. This patient was asked for help by other patients. He taught some who lived nearby how to form the marijuana cigarettes and properly inhale the smoke to obtain relief from nausea and vomiting. When an article about this patient's smoking marijuana appeared in a local newspaper, he and his family heard from many other cancer patients who were doing the same. Most of them made an effort to inform their doctors. Most Physicians who knew their patients smoked marijuana medicinally approved, accepting marijuana's therapeutic helpfulness in reducing nausea and vomiting. 28. In October 1979 the Michigan legislature enacted legislation whose underlying purpose was to make marijuana available therapeutically for cancer patients and others. The State Senate passed the bill 29-5, the House of Representatives 100-0. In March 1982 the Michigan legislature passed a resolution asking the Federal Congress to try to alter Federal policies which prevent physicians from prescribing marijuana for legitimate medical applications and prohibit its use in medical treatments. 29. In Denver, Colorado a teenage cancer patient has been smoking marijuana to control nausea and vomiting since 1986. He has done this in his hospital room both before and after chemotherapy. His doctor and hospital staff know he does this. The doctor has stated that he would prescribe marijuana for - 20 - >>> Continued to next message... ___ X Blue Wave/DOS v2.30 X --- Maximus 3.01 * Origin: Who's Askin'? (1:17/75) --------------- FIDO MESSAGE AREA==> TOPIC: 257 ALTERN. MEDICINE Ref: EBI00021Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [10/28 >>> Part 10 of 28... this patient if it were legal to do so. Other patients in the Denver area smoke marijuana for the same purpose. This patient's doctor, and nurses with whom he comes in contact, understand that cancer patients smoke marijuana to reduce or control emesis. They accept it. 30. In late 1980 a three year old boy was brought by his parents to a hospital in Spokane, Washington. The child was diagnosed as having cancer. Surgery was performed. Chemotherapy was begun. The child became extremely nauseated and vomited for days after each chemotherapy treatment. He could not eat regularly. He lost strength. He lost weight. His body's ability to ward off common infections, other life-threatening infections, significantly decreased. Chemotherapy's after-effects caused the child great suffering. They caused his watching parents great suffering. Several standard, available anti-emetic agents were tried by the child's doctors. None of them succeeded in controlling his nausea or vomiting. Learning of the existence of research studies with THC or marijuana the parents asked the child's doctor to arrange for their son to be the subject of such a study so that he might have access to marijuana. The doctor refused, citing the volume of paperwork and record-keeping detail required in such programs and his lack of administrative personnel to handle it. 31. The child's mother read an article about marijuana smoking helping chemotherapy patients. She obtained some marijuana from friends. She baked cookies for her child with marijuana in them. She made tea for him with marijuana in it. When the child ate these cookies or drank this tea in connection with his chemotherapy, he did not vomit. His strength returned. He regained lost weight. His spirits revived. The parents told the doctors and nurses at the hospital of their giving marijuana to their child. None objected. - 21 - They all accepted smoking marijuana as effective in controlling chemotherapy induced nausea and vomiting. They were interested to see the results of the cookies. 32. Soon this child was riding a tricycle in the hallways of the Spokane hospital shortly after his chemotherapy treatments while other children there were still vomiting into pans, tied to intravenous bottles in an attempt to re-hydrate them, to replace the liquids they were vomiting up. Parents of some of the other patients asked the parents of this "lively" child how he seemed to tolerate his chemotherapy so well. They told of the marijuana use. Of those parents who began giving marijuana to their children, none ever reported back encountering any adverse side effects. In the vast majority of these cases, the other parents reported significant reduction in their children's vomiting and appetite stimulation as the result of marijuana. The staff, doctors and nurses at the hospital knew of this passing on of information about marijuana to other parents. They approved. They never told the first parents to hide their son's medicinal use of marijuana. They accepted the effectiveness of the cookies and the tea containing marijuana. 33. The first child's cancer went into remission. Then it returned and spread. Emotionally drained, the parents moved the family back to San Diego, California to be near their own parents. Their son was admitted to a hospital in San Diego. The parents informed the doctors, nurses and social workers there of their son's therapeutic use of marijuana. No one objected. The child's doctor in San Diego strongly supported the parent's giving marijuana to him. Here in California, as in Spokane, other parents noticed the striking difference between their children after chemotherapy and the first child. - 22 - Other parents asked the parents of the first child about it, were told of the use of marijuana, tried it with their children, and saw dramatic improvement. They accepted its effectiveness. In the words of the mother of the first child: ". . . When your kid is riding a tricycle while his other hospital buddies are hooked up to IV needles, their heads hung over vomiting buckets, you don't need a federal agency to tell you marijuana is effective. The evidence is in front of you, so stark it cannot be ignored." [footnote 6] 34. There is at least one hospital in Tucson, Arizona where medicinal use of marijuana by chemotherapy patients is encouraged by the nursing staff and some physicians. 35. In addition to the physicians mentioned in the Findings above, mostly oncologists and other practitioners, the following doctors and health care professionals, representing several different areas of expertise, accept marijuana as medically useful in controlling or reducing emesis and testified to that effect in these proceedings: a. George Goldstein, Ph.D., psychologist, Secretary of Health for the State of New Mexico from 1978 to 1983 and chief administrator in the implementation of the New Mexico program utilizing >>> Continued to next message... ___ X Blue Wave/DOS v2.30 X --- Maximus 3.01 * Origin: Who's Askin'? (1:17/75) --------------- FIDO MESSAGE AREA==> TOPIC: 257 ALTERN. MEDICINE Ref: EBI00022Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [11/28 >>> Part 11 of 28... marijuana; b. Dr. Daniel Danzak, psychiatrist and former head of the New Mexico program utilizing marijuana; c. Dr. Tod Mikuriya, psychiatrist and editor of Marijuana: Medical Papers, a book presenting an historical perspective of marijuana's medical use; d. Dr. Norman Zinberg, general psychiatrist and Professor of Psychiatry at Harvard Medical School since 1951; ____________________ 6 Affidavit of Janet Andrews, ACT rebuttal witness, par. 98. - 23 - e. Dr. John Morgan, psychopharmacologist, Board-certified in Internal Medicine, full Professor and Director of Pharmacology at the City University of New York; f. Dr. Phillip Jobe, neuropsychopharmacologist with a practice in Illinois and former Professor of Pharmacology and Psychiatry at the Louisiana State University School of Medicine in Shreveport, Louisiana, from 1974 to 1984; g. Dr. Arthur Kaufman, formerly a general practitioner in Maryland, currently Vice-President of a private medical consulting group involved in the evaluation of the quality of care of all the U.S. military hospitals throughout the world, who has had extensive experience in drug abuse treatment and rehabilitation programs; h. Dr. J. Thomas Ungerleider, a full Professor of Psychiatry at the University of California in Los Angeles with extensive experience in research on the medical use of drugs; i. Dr. Andrew Weil, ethnopharmacologist, Associate Director of Social Perspectives in Medicine at the College of Medicine at the University of Arizona, with extensive research on medicinal plants; and j. Dr. Lester Grinspoon, a practicing psychiatrist and Associate Professor at Harvard Medical School. 36. Certain law enforcement authorities have been outspoken in their acceptance of marijuana as an antiemetic agent. Robert T. Stephan, Attorney General of the State of Kansas, and himself a former cancer patient, said of chemotherapy in his affidavit in this record: "The treatment becomes a terror." His cancer is now in remission. He came to know a number of health care professionals whose medical judgment he respected. They had accepted marijuana - 24 - as having medical use in treatment. He was elected Vice President of the National Association of Attorneys General (NAAG) in 1983. He was instrumental in the adoption by that body in June 1983 of a resolution acknowledging the efficacy of marijuana for cancer and glaucoma patients. The resolution expressed the support of NAAG for legislation then pending in the Congress to make marijuana available on prescription to cancer and glaucoma patients. The resolution was adopted by an overwhelming margin. NAAG's President, the Attorney General of Montana, issued a statement that marijuana does have accepted medical uses and is improperly classified at present. The Chairman of NAAG's Criminal Law and Law Enforcement Committee, the Attorney General of Pennsylvania, issued a statement emphasizing that the proposed rescheduling of marijuana would in no way affect or impede existing efforts by law enforcement authorities to crack down on illegal drug trafficking. 37. At least one court has accepted marijuana as having medical use in treatment for chemotherapy patients. On January 23, 1978 the Superior Court of Imperial County, California issued orders authorizing a cancer patient to possess and use marijuana for therapeutic purposes under the direction of a physician. Another order authorized and directed the Sheriff of the county to release marijuana from supplies on hand and deliver it to that patient in such form as to be usable in the form of cigarettes. 38. During the period 1978-1980 polls were taken to ascertain the degree of public acceptance of marijuana as effective in treating cancer and glaucoma patients. A poll in Nebraska brought slightly over 1,000 responses - 83% favored making marijuana available by prescription, 12% were opposed, 5% were undecided. A poll in Pennsylvania elicited 1,008 responses - 83.1% favored availability by prescription, 12.2% were opposed, 4.7% were undecided. These - 25 - >>> Continued to next message... ___ X Blue Wave/DOS v2.30 X --- Maximus 3.01 * Origin: Who's Askin'? (1:17/75) --------------- FIDO MESSAGE AREA==> TOPIC: 257 ALTERN. MEDICINE Ref: EBI00023Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [12/28 >>> Part 12 of 28... two surveys were conducted by professional polling companies. The Detroit Free Press conducted a telephone poll in which 85.4% of those responding favored access to marijuana by prescription. In the State of Washington the State Medical Association conducted a poll in which 80% of the doctors belonging to the Association favored controlled availability of marijuana for medical purposes. Discussion From the foregoing uncontroverted facts it is clear beyond any question that many people find marijuana to have, in the words of the Act, an "accepted medical use in treatment in the United States" in effecting relief for cancer patients. Oncologists, physicians treating cancer patients, accept this. Other medical practitioners and researchers accept this. Medical faculty professors accept it. Nurses performing hands-on patient care accept it. Patients accept it. As counsel for CCA perceptively pointed out at oral argument, acceptance by the patient is of vital importance. Doctors accept a therapeutic agent or process only if it "works" for the patient. If the patient does not accept, the doctor cannot administer the treatment. The patient's informed consent is vital. The doctor ascertains the patient's acceptance by observing and listening to the patient. Acceptance by the doctor depends on what he sees in the patient and hears from the patient. Unquestionably, patients in large numbers have accepted marijuana as useful in treating their emesis. They have found that it "works". Doctors, evaluating their patients, can have no basis more sound than that for their own acceptance. Of relevance, also, is the acceptance of marijuana by state attorneys- - 26 - general, officials whose primary concern is law enforcement. A large number of them have no fear that placing marijuana in Schedule II, thus making it available for legitimate therapy, will in any way impede existing efforts of law enforcement authorities to crack down on illegal drug trafficking. The Act does not specify by whom a drug or substance must be "accepted [for] medical use in treatment" in order to meet the Act's "accepted" requirement for placement in Schedule II. Department of Justice witnesses told the Congress during hearings in 1970 preceding passage of the Act that "the medical Profession" would make this determination, that the matter would be "determined by the medical community." The Deputy Chief Counsel of BNDD, whose office had written the bill with this language in it, told the House subcommittee that "this basic determination . . . is not made by any part of the federal government. It is made by the medical community as to whether or not the drug has medical use or doesn't". [footnote 7] No one would seriously contend that these Justice Department witnesses meant that the entire medical community would have to be in agreement on the usefulness of a drug or substance. Seldom, if ever, do all lawyers agree on a point of law. Seldom, if ever, do all doctors agree on a medical question. How many are required here? A majority of 51%? It would be unrealistic to attempt a plebiscite of all doctors in the country on such a question every time it arises, to obtain a majority vote. In determining whether a medical procedure utilized by a doctor is actionable as malpractice the courts have adopted the rule what it is acceptable ____________________ 7 Drug Abuse Control Amendments - 1970: Hearings on H.R. 11701 and H.R. 13743 Before the Subcommittee on Public Health and Welfare of the House Committee on Interstate and Foreign Commerce, 91st Congress, 2d Sess. 678, 696, 718 (1970) (Statement of John E. Ingersoll, Director, BNDD). - 27 - for a doctor to employ a method of treatment supported by a respectable minority of physicians. In Hood v. Phillips, 537 S.W. 2d 291 (1976) the Texas Court of Civil Appeals was dealing with a claim of medical malpractice resulting from a surgical procedure claimed to have been unnecessary. The court quoted from an Arizona court decision holding that a method of treatment, as espoused and used by . . . a respectable minority of physicians in the United States, cannot be said to be an inappropriate method of treat- ment or to be malpractice as a matter of law even though it has not been accepted as a proper method of treatment by the medical profession generally. Ibid. at 294. Noting that the Federal District court in the Arizona case >>> Continued to next message... ___ X Blue Wave/DOS v2.30 X --- Maximus 3.01 * Origin: Who's Askin'? (1:17/75)