--------------- FIDO MESSAGE AREA==> TOPIC: 257 ALTERN. MEDICINE Ref: EBI00024Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [13/28 >>> Part 13 of 28... found a "respectable minority" composed of sixty-five physicians throughout the United States, the Texas court adopted as "the better rule" to apply in its case, that a physician is not guilty of malpractice where the method of treatment used is supported by a respect- able minority of physicians. Ibid. In Chumbler v. McClure, 505 F.2d 489 (6th Cir. 1974) the Federal courts were dealing with a medical malpractice case under their diversity jurisdiction, applying Tennessee law, The Court of Appeals said: . . . The most favorable interpretation that may be placed on the testimony adduced at trial below is that there is a division of opinion in the medical profession regarding the use of Premarin in the Treat- ment of cerebral vascular insufficiency, and that Dr. McClure was alone among neurosurgeons in Nashville in using such therapy. The test for malpractice and for community standards is not to be determined solely by a plebiscite. Where two or more schools of thought exist among competent members of the medical profes- sion concerning proper medical treatment for a given ailment, each of which is supported by responsible - 28 - medical authority, it is not malpractice to be among the minority in a given city who follow: one of the accepted schools. 505 F.2d at 492 (Emphasis added). See, also, Leech v. Bralliar, 275 F.Supp. 897 (D.Ariz., 1967). How do we ascertain whether there exists a school of thought supported by responsible medical authority, and thus "accepted"? We listen to the physicians. The court and jury must have a standard measure which they are to use in measuring the acts of a doctor to determine whether he exercised a reasonable degree of care and skill; they are not permitted to set up and use any arbitrary or artificial standard of measurement that the jury may wish to apply. The proper standard of measurement is to be established by testimony of physicians, for it is a medical question. Hayes v. Brown, 133 S.E. 2d. 102 (Ga., 1963) at 105. As noted above, there is no question but that this record shows a great many physicians, and others, to have "accepted" marijuana as having a medical use in the treatment of cancer patients' emesis. True, all physicians have not "accepted" it. But to require universal, 100% acceptance would be unreasonable. Acceptance by "a respectable minority" of physicians is all that can reasonably be required. The record here establishes conclusively that at least "a respectable minority" of physicians has "accepted" marijuana as having a "medical use in treatment in the United states." That others may not makes no difference. The administrative law judge recommended this same approach for determining whether a drug has an "accepted medical use in treatment" in The Matter Of MDMA Scheduling, Docket No. 84-48. The Administrator, in his first final rule in that proceeding, issued on October 8, 1986 [footnote 8], declined to adopt this approach. He ____________________ 8 51 Fed. Reg. 36552 (1986). - 29 - ruled, instead, that DEA's decision on whether or not a drug or other substance had an accepted medical use in treatment in the United States would be determined simply by ascertaining whether or not "the drug or other substance is lawfully marketed in the United States pursuant to the Federal Food, Drug and Cosmetic Act of 1938 . . . ." [footnote 9] The United States Court of Appeals for the First Circuit held that the Administrator erred in so ruling. [footnote 10] That court vacated the final order of October 8, 1986 and remanded the matter of MDMA's scheduling for further consideration. The court directed that, on remand, the Administrator would not be permitted to treat the absence of interstate marketing approval by FDA as conclusive evidence on the question of accepted medical use under the Act. In his third final rule [footnote 11] of the matter of the scheduling of MDMA the Administrator made a series of findings of fact as to MDMA, the drug there under consideration, with respect to the evidence in that record. On those findings he based his last final rule in the >>> 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: EBI00025Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [14/28 >>> Part 14 of 28... case. [footnote 12] ____________________ 9 Ibid., at 36558. 10 Grinspoon v. Drug Enforcement Administration, 828 F.2d 881 (1st. Cir., 1987). 11 53 Fed. Reg. 5156 (1988). A second final rule had been issued on January 20, 1988. It merely removed MDMA from Schedule I pursuant to the mandate of the Court of Appeals which had voided the first final rule placing it there. Subsequently the third final rule was issued, without any further hearings, again placing MDMA in Schedule I. There was no further appeal. 12 In neither the first nor the third final rule in the MDMA case does the Administrator take any cognizance of the statements to the Congressional committee by predecessor Agency officials that the determination as to "accepted medical use in treatment" is to be made by the medical community and not by any part of the federal government. See page 27, above. It is curious that the administrator makes no effort whatever to show how the BNDD representatives were mistaken or to explain why he now has abandoned their interpretation. They wrote that language into the original bill. - 30 - That third final rule dealing with MDMA is dealing with a synthetic, "simple", "single-action" drug. What might be appropriate criteria for a "simple" drug like MDMA may not be appropriate for a "complex" substance with a number of active components. The criteria applied to MDMA, a synthetic drug, are not appropriate for application to marijuana, which is a natural plant substance. The First Circuit Court of Appeals in the MDMA case told the Administrator that he should not treat the absence of FDA interstate marketing approval as conclusive evidence of lack of currently accepted medical use. The court did not forbid the Administrator from considering the absence of FDA approval as a factor when determining the existence of accepted medical use. Yet on remand, in his third final order, the Administrator adopted by reference 18 of the numbered findings he had made in the first final order. Each of these findings had to do with requirements imposed by FDA for approval of a new drug application (NDA) or of an investigational new drug exemption (IND). These requirements deal with data resulting from controlled studies and scientifically conducted investigations and test. Among those findings incorporated into the third final MDMA order from the first, and relied on by the Administrator, was the determination and recommendation of the FDA that the drug there in question was not "accepted". In relying on the FDA's action the Administrator apparently overlooked the fact that the FDA clearly stated that it was interpreting "accepted medical use" in the Act as being equivalent to receiving FDA approval for lawful marketing under the FDCA. Thus the Administrator accepted as a basis for his MDMA third final rule the FDA recommendation which was based upon a statutory interpretation which the Court - 31 - of Appeals had condemned. The Administrator in that third final rule made a series of further findings. Again, the central concern in these findings was the content of test results and the sufficiency or adequacy of studies and scientific reports. A careful reading of the criteria considered in the MDMA third final order reveals that the Administrator was really considering the question: Should the drug be accepted for medical use?; rather than the question: Has the drug been accepted for medical use? By considering little else but scientific test results and reports the Administrator was making a determination as to whether or not, in his opinion, MDMA ought to be accepted for medical use in treatment. The Agency's arguments in the present case are to the same effect. In a word, they address the wrong question. It is not for this Agency to tell doctors whether they should or should not accept a drug or substance for medical use. The statute directs the Administrator merely to ascertain whether, in fact, doctors have done so. The MDMA third final order mistakenly looks to FDA criteria for guidance in choosing criteria for DEA to apply. Under the Food, Drug and Cosmetic Act the FDA is deciding - properly, under that statute - whether a new drug should be introduced into interstate commerce. Thus it is appropriate for the FDA to rely heavily on test results and scientific inquiry to ascertain whether a drug is effective and whether it is safe. The FDA must look at a drug and pass judgment on its intrinsic qualities. The DEA, on the other hand, is charged by 21 U.S.C. Sec. 812(b)(1)(B) and (2)(B) with ascertaining what it is that other people have done with respect to a drug or substance: "Have they accepted it?;" not "Should they accept it?" >>> 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: EBI00026Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [15/28 >>> Part 15 of 28... - 32 - In the MDMA third final order DEA is actually making the decision that doctors have to make, rather than trying to ascertain the decision which doctors have made. Consciously or not, the Agency is undertaking to tell doctors what they should or should not accept. In so doing the Agency is acting beyond the authority granted in the Act. It is entirely proper for the Administrator to consider the pharmacology of a drug and scientific test results in connection with determining abuse potential. But abuse potential is not in issue in this marijuana proceeding. There is another reason why DEA should not be guided by FDA criteria in ascertaining whether or not marijuana has an accepted medical use in treatment. These criteria are applied by FDA pursuant to Section 505 of the Federal Food, Drug and Cosmetic Act (FDCA), as amended. [footnote 13] When the FDA is making an inquiry pursuant to that legislation it is looking at a synthetically formed new drug. The marijuana plant is anything but a new drug. Uncontroverted evidence in this record indicates that marijuana was being used therapeutically by mankind 2000 years before the Birth of Christ. [footnote 14] Uncontroverted evidence further establishes that in this country today "new drugs" are developed by pharmaceutical companies possessing resources sufficient to bear the enormous expense of testing a new drug, obtaining FDA approval of its efficacy and safety, and marketing it successfully. No company undertakes the investment required unless it has a patent on the drug, so it can recoup its development costs and make a profit. At oral argument Government counsel conceded that "the FDA system is constructed for pharmaceutical companies. I won't ____________________ 13 21 U.S.C. Sec. 355. 14 Alice M. O'Leary, direct, par. 9. - 33 - deny that." [footnote 15] Since the substance being considered in this case is a natural plant rather than a synthetic drug, it is unreasonable to make FDA-type criteria determinative of the issue in this case, particularly so when such criteria are irrelevant to the question posed by the act: does the substance have an accepted medical use in treatment? Finally, the Agency in this proceeding relies in part on the FDA's recommendation that the Administrator retain marijuana in Schedule I. But, as in the MDMA case, that recommendation is based upon FDA's equating "accepted medical use" under the Act with being approved for marketing by FDA under the Food, Drug and Cosmetic Act, the interpretation condemned by the First Circuit in the MDMA case. See Attachment A, p.24, to exhibit G-1 and exhibit G-2. The overwhelming preponderance of the evidence in this record establishes that marijuana has a currently accepted medical use in treatment in the United States for nausea and vomiting resulting from chemotherapy treatments in some cancer patients. To conclude otherwise, on this record, would be unreasonable, arbitrary and capricious. ____________________ 15 Tr. XV-37. - 34 - VI. ACCEPTED MEDICAL USE IN TREATMENT - GLAUCOMA Findings of Fact The preponderance of the evidence establishes the following facts with respect to the accepted medical use of marijuana in the treatment of glaucoma. 1. Glaucoma is a disease of the eye characterized by the excessive accumulation of fluid causing increased intraocular pressure, distorted vision and, ultimately, blindness. In its early stages this pressure can sometimes be relieved by the administration of drugs. When such medical treatment fails adequately to reduce the intraocular pressure (IOP), surgery is generally resorted to. Although useful in many cases, there is a high incidence of failure with some types of surgery. Further, serious complications can occur as a result of invasive surgery. Newer, non-invasive procedures such as laser trabeculoplasty are thought by some to offer much greater efficacy with fewer complications. Unless the IOP is relieved and brought to a satisfactory level by one means or another, the patient will go blind. >>> 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: EBI00027Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [16/28 >>> Part 16 of 28... 2. Two highly qualified and experienced ophthalmologists in the United States have accepted marijuana as having a medical use in treatment for glaucoma. They are John C. Merritt, M.D. and Richard D. North, M.D. Each of them is both a clinician, treating patients, and a researcher. Dr. Merritt is also a professor of ophthalmology. Dr. North has served as a medical officer in ophthalmology for the Department of Health, Education and Welfare and has worked with the Public Health Service and FDA. - 35 - 3. Dr. Merritt's experience with glaucoma patients using marijuana medicinally includes one Robert Randall and, insofar as the evidence here establishes per petitioners' briefs, an unspecified number of other patients, something in excess of 40. 4. Dr. North has treated only one glaucoma patient using marijuana medicinally - the same Robert Randall mentioned immediately above. Dr. North had monitored Mr. Randall's medicinal use of marijuana for nine years as of May 1987 5. Dr. Merritt has accepted marijuana as having an important place in the treatment of "End Stage" glaucoma. "End Stage" glaucoma, essentially, defines a patient who has already lost substantial amounts of vision; available glaucoma control drugs are no longer able adequately to reduce the intraocular pressure (IOP) to prevent further, progressive sight loss; the patient, lacking additional IOP reductions, will go blind. 6. Robert S. Hepler, M.D., is a highly qualified and experienced ophthalmologist. He has done research with respect to the effect of smoking marijuana on glaucoma. In December 1975 he prescribed marijuana for the same Robert Randall mentioned above as a research subject. Dr. Hepler found that large dosages of smoked marijuana effectively reduced Robert Randall's IOP into the safe range over an entire test day. He concluded that the only known alternative to preserve Randall's sight which would avoid the significant risks of surgery is to include marijuana as part of Randall's prescribed medical regimen. He further concluded in 1977 that, if marijuana could have been legally prescribed, he would have prescribed it for Randall as part of Randall's regular glaucoma maintenance program had he been Randall's personal physician. - 36 - Nonetheless, in 1987 Dr. Hepler was of the opinion that marijuana did not have a currently accepted medical use in the United States for the treatment of glaucoma. 7. Four glaucoma patients testified in these proceedings. Each has found marijuana to be of help in controlling IOP. 8. In 1984 the treatment of glaucoma with Cannabis was the subject of an Ophthalmology Grand Rounds at the University of California, San Francisco. A questionnaire was distributed which queried the ophthalmologists on cannabis therapy for glaucoma patients refractory to standard treatment. Many of them have glaucoma patients who have asked about marijuana. Most of the responding ophthalmologists believed that THC capsules or smoked marijuana need to be available for patients who have not benefited significantly from standard treatment. 9. In about 1978 an unspecified number of persons in the public health service sector in New Mexico, including some physicians, accepted marijuana as having medical use in treating glaucoma. 10. A majority of an unspecified number of ophthalmologists known to Arthur Kaufman, M.D., who was formerly in general practice but now is employed as a medical program administrator, accept marijuana as having medical use in treatment of glaucoma. 11. In addition to the physicians identified and referred to in the findings above, the testimony of patients in this record establishes that no more than three or four other physicians consider marijuana to be medically useful in the treatment of glaucoma in the United States. One of those Physicians actually wrote a prescription for marijuana for a patient, which, of course, she was unable to have filled. - 37 - 12. There are test results showing that smoking marijuana has reduced the IOP in some glaucoma patients. There is continuing research underway in the United States as to the therapeutic effect of marijuana on glaucoma. Discussion Petitioners' briefs fail to show that the preponderance of the evidence in the record with respect to marijuana and glaucoma establishes that a respectable minority of physicians accepts marijuana as being useful in the treatment of glaucoma in the United States. This conclusion is not to be taken in any way as criticism of the opinions of the ophthalmologists who testified that they accept marijuana for this purpose. The failure lies with petitioners. In their briefs they do not point out hard, specific evidence in this record sufficient to establish that a respectable minority of physicians has accepted their position. >>> 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: EBI00028Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [17/28 >>> Part 17 of 28... There is a great volume of evidence here, and much discussion in the briefs, about the protracted case of Robert Randall. But when all is said and done, his experience presents but one case. The record contains sworn testimony of three ophthalmologists who have treated Mr. Randall. One of them tells us of a relatively small number of other glaucoma patients whom he has treated with marijuana and whom he knows to have responded favorably. Another of these three doctors has successfully treated only Randall with marijuana. The third testifies, despite his successful experience in treating Randall, that marijuana does not have an accepted use in such treatment. In addition to Robert Randall, Petitioners point to the testimony of three other glaucoma patients. Their case histories are impressive, but they contribute - 38 - little to the carrying of Petitioner's burden of showing that marijuana is accepted for medical treatment of glaucoma by a respectable minority of physicians. See pages 26-29, above. Petitioners have in evidence copies of a number of newspaper clippings reporting statements by persons claiming that marijuana has helped their glaucoma. The administrative law judge is unable to give significant weight to this evidence. Had these persons testified so as to have been subject to cross-examination, a different situation would be presented. But these newspaper reports of extra-judicial statements, neither tested by informed inquiry nor supported by a doctor's opinion, are not entitled to much weight. They are of little, if any, materiality. Beyond the evidence referred to above there is a little other "hard" evidence, pointed out by petitioners, of Physicians accepting marijuana for treatment of glaucoma. Such evidence as that concerning a survey of a group of San Francisco ophthalmologists is ambiguous, at best. The relevant document establishes merely that most of the doctors on the grand round, who responded to an inquiry, believed that the THC capsules or marijuana ought to be available. In sum, the evidence here tending to show that marijuana is accepted for treatment of glaucoma falls far, far short of quantum of evidence tending to show that marijuana is accepted for treatment of emesis in cancer patients. The preponderance of the evidence here, identified by petitioners in their briefs, does not establish that a respectable minority of physicians has accepted marijuana for glaucoma treatment. - 39 - VII. ACCEPTED MEDICAL USE IN TREATMENT - MULTIPLE SCLEROSIS, SPASTICITY AND HYPERPARATHYROIDISM Findings Of Fact The preponderance of the evidence clearly establishes the following facts with respect to marijuana's use in connection with multiple sclerosis, spasticity and hyperparathyroidism. 1. Multiple sclerosis is the major cause of neurological disability among young and middle-aged adults in the United States today. It is a life-long disease. It can be extremely debilitating to some of its victims but it does not shorten the life span of most of them. Its cause is yet to be determined. It attacks the myelin sheath, the coating or insulation surrounding the message-carrying nerve fibers in the brain and spinal cord. Once the myelin sheath is destroyed, it is replaced by plaques of hardened tissue known as sclerosis. During the initial stages of the disease nerve impulses are transmitted with only minor interruptions. As the disease progresses, the plaques may completely obstruct the impulses along certain nerve systems. These obstructions produce malfunctions. The effects are sporadic in most individuals and the effects often occur episodically, triggered either by malfunction of the nerve impulses or by external factors. 2. Over time many patients develop spasticity, the involuntary and abnormal contraction of muscle or muscle fibers. (Spasticity can also result from serious injuries to the spinal cord, not related to multiple sclerosis.) 3. The symptoms of multiple sclerosis vary according to the area of - 40 - the nervous system which is affected and according to the severity of the disease. The symptoms can include one or more of the following: weakness, tingling, numbness, impaired sensation, lack of coordination, disturbances in equilibrium, double vision, loss of vision, involuntary rapid movement of the eyes (nystagmus), slurred speech, tremors, stiffness, spasticity, weakness of limbs, sexual dysfunction, paralysis, and impaired bladder and bowel functions. 4. Each person afflicted by multiple sclerosis is affected >>> 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: EBI00029Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [18/28 >>> Part 18 of 28... differently. In some persons, the symptoms of the disease are barely detectable, even over long periods of time. In these cases, the persons can live their lives as if they did not suffer from the disease. In others, more of the symptoms are present and acute, thereby limiting their physical capabilities. Moreover, others may experience sporadic, but acute, symptoms. 5. At this time, there is no known prevention or cure for multiple sclerosis. Instead, there are only treatments for the symptoms of the disease. There are very few drugs specifically designed to treat spasticity. These drugs often cause very serious side effects. At the present time two drugs are approved by FDA as "safe" and "effective" for the specific indication of spasticity. These drugs are Dantrium and Lioresal baclofen. 6. Unfortunately, neither Dantrium nor Lioresal is a very effective spasm control drug. Their marginal medical utility, high toxicity and potential for serious adverse effects make these drugs difficult to use in spasticity therapy. 7. As a result, many physicians routinely prescribe tranquilizers, muscle relaxants, mood elevators and sedatives such as Valium to patients experiencing spasticity. While these drugs do not directly reduce spasticity - 41 - they may weaken the patient's muscle tone, thus making the spasms less noticeable. Alternatively, they may induce sleep or so tranquilize the patient that normal mental and physical functions are impossible. 8. A healthy, athletic young woman named Valerie Cover was stricken with multiple sclerosis while in her early twenties. She consulted several medical specialists and followed all the customary regimens and prescribed methods for coping with this debilitating disease over a period of several years. None of these proved availing. Two years after first experiencing the symptoms of multiple sclerosis her active, productive life - as an athlete, Navy officer's wife and mother - was effectively over. The Social Security Administration declared her totally disabled. To move about her home she had to sit on a skateboard and push herself around. She spent most of her time in bed or sitting in a wheelchair. 9. An occasional marijuana smoker in her teens, before her marriage, she had not smoked it for five years as of February 1986. Then a neighbor suggested that marijuana just might help Mrs. Cover's multiple sclerosis, having read that it had helped cancer patient's control their emesis. Mrs. Cover acceded to the suggestion. 10. Just before smoking the marijuana cigarette produced by her neighbor, Mrs. Cover had been throwing up and suffering from spasms. Within five minutes of smoking part of the marijuana cigarette she stopped vomiting, no longer felt nauseous and noticed that the intensity of her spasms was significantly reduced. She stood up unaided. 11. Mrs. Cover began smoking marijuana whenever she felt nauseated. When she did so it controlled her vomiting, stopped the nausea and increased her - 42 - appetite. It helped ease and control her spasticity. Her limbs were much easier to control. After three months of smoking marijuana she could walk unassisted, had regained all of her lost weight, her seizures became almost nonexistent. She could again care for her children. She could drive an automobile again. She regained the ability to lead a normal life. 12. Concerned that her use of this illegal substance might jeopardize the career of her Navy officer husband, Mrs. Cover stopped smoking marijuana several times. Each time she did so, after about a month, she had retrogressed to the point that her multiple sclerosis again had her confined to bed and wheelchair or skateboard. As of the Spring of 1987 Mrs. Cover had resumed smoking marijuana regularly on an "as needed" basis. Her multiple sclerosis symptoms are under excellent control. She has obtained a full-time job. She still needs a wheelchair on rare occasions, but generally has full use of her limbs and can walk around with relative ease. 13. Mrs. Cover's doctor has accepted the effectiveness of marijuana in her case. He questioned her closely about her use of it, telling her that it is the most effective drug known in reducing vomiting. Mrs. Cover and her doctor are now in the process of filing an Investigational New Drug (IND) application with FDA so that she can legally obtain the marijuana she needs to lead a reasonably normal life. 14. Martha Hirsch is a young woman in her mid-thirties. She first exhibited symptoms of multiple sclerosis at age 19 and it was diagnosed at that time. Her condition has grown progressively worse. She has been under the care of physicians and hospitalized for treatment. Many drugs have been prescribed for her by her doctors. At one point in 1983 she listed the drugs that had been - 43 - prescribed for her. There were 17 on the list. None of them has given >>> 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: EBI00030Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [19/28 >>> Part 19 of 28... her the relief from her multiple sclerosis symptoms that marijuana has. 15. During the early stages in the development of her illness Ms. Hirsch found that smoking marijuana improved the quality of her life, keeping her spasms under control. Her balance improved. She seldom needed to use her cane for support. Her condition lately has deteriorated. As of May l987 she was experiencing severe, painful spasms. She had an indwelling catheter in her bladder. She had lost her locomotive abilities and was wheelchair bound. She could seldom find marijuana on the illegal market and, when she did, she often could not afford to purchase it. When she did obtain some, however, and smoked it, her entire body seemed to relax, her spasms decreased or disappeared, she slept better and her dizzy spells vanished. The relaxation of her leg muscles after smoking marijuana has been confirmed by her personal care attendant's examination of them. 16. The personal care attendant has told Ms. Hirsch that she, the attendant, treats a number of patients who smoke marijuana for relief of multiple sclerosis symptoms. In about 1980 another patient told Ms. Hirsch that he knew many patients who smoke marijuana to relieve their spasms. Through him she met other patients and found that marijuana was commonly used by many multiple sclerosis patients. Most of these persons had told their doctors about their doing so. None of those doctors advised against the practice and some encouraged it. 17. Among the drugs prescribed by doctors for Ms. Hirsch was ACTH. This failed to give her any therapeutic benefit or to control her spasticity. It did produce a number of adverse effects, including severe nausea and vomiting which, in turn, were partly controlled by rectally administered anti-emetic - 44 - drugs. 18. Another drug prescribed for her was Lioresal, intended to reduce her spasms. It was not very effective in doing. But it did cause Ms. Hirsch to have hallucinations. On two occasions, while using this drug, Ms. Hirsch "saw" a large fire in her bedroom and called for help. There was no fire. She stopped using that drug. Ms. Hirsch has experienced no adverse reactions with marijuana. 19. Ms. Hirsch's doctor has accepted marijuana as beneficial for her. He agreed to write her a prescription for it, if that would help her obtain it. She has asked him if he would file an IND application with the FDA for her. He replied that the paperwork was "overwhelming". He indicated willingness to put the paper work together. 20. When Greg Paufler was in his early twenties, employed by Prudential Insurance Company, he began to experience the first symptoms of multiple sclerosis. His condition worsened as the disease intensified. He had to be hospitalized. He lost the ability to walk, to stand. Diagnosed as having multiple sclerosis, a doctor prescribed ACTH for him, an intensive form of steroid therapy. He lost all control over his limbs and experienced severe, painful spasms. His arms and legs became numb. 21. ACTH had no beneficial effects. The doctor continued to prescribe it many months. ACTH made Paufler ravenously hungry and he began gaining a great deal of weight. ACTH caused fluid retention and Paufler became bloated, rapidly gaining weight. His doctor thought Paufler should continue this steroid therapy, even though it caused the adverse effects mentioned plus the possibility of sudden heart attack or death due to respiratory failure. Increased dosages - 45 - of this FDA-approved drug caused fluid to press against Paufler's lungs making it difficult for him to breathe and causing his legs and feet to become swollen. The steroid therapy caused severe, intense depression marked by abrupt mood shifts. Throughout, the spasms continued and Paufler's limbs remained out of control. The doctor insisted that ACTH was the only therapy likely to be of any help with the multiple sclerosis, despite its adverse effects. Another, oral, steroid was eventually substituted. 22. One day Paufler became semi-catatonic while sitting in his living room at home. He was rushed to the hospital emergency room. He nearly died. Lab reports indicated, among other things, a nearly total lack of potassium in his body. He was given massive injections of potassium in the emergency room and placed on an oral supplement. Paufler resolved to take no more steroids. 23. From time to time, prior to this point, Paufler had smoked marijuana socially with visiting friends, seek some relief from his misery in a temporary "high". He now began smoking marijuana more often. After some weeks he found that he could stand and then walk a bit. His doctor dismissed the idea that marijuana could be helpful with multiple sclerosis, and Paufler, himself, was skeptical at first. He began discontinuing it for a while, then resuming. 24. Paufler found that when he did not smoke marijuana his condition worsened, he suffered more intense spasms more frequently. When he smoked marijuana, his condition would stabilize and then improve; spasms were more controlled and less severe; he felt better; he regained control over his limbs and could walk totally unaided. His vision, often >>> 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: EBI00031Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [20/28 >>> Part 20 of 28... blurred and unfocused, improved. Eventually he began smoking marijuana on a daily basis. He ventured outdoors. He was soon walking half a block. His eyesight returned to normal. - 46 - His central field blindness cleared up. He could focus well enough to read again. One evening he went out with his children and found he could kick a soccer ball again. 25. Paufler has smoked marijuana regularly since 1980. Since that time his multiple sclerosis has been well controlled. His doctor has been astonished at Paufler's recovery. Paufler can now run. He can stand on one foot with his eyes closed. The contrast with his condition, several years ago, seems miraculous. Smoking marijuana when Paufler feels an attack coming on shortens the attack. Paufler's doctor has looked Paufler in the eye and told him to keep doing whatever it is he's doing because it works. Paufler and his doctor are exploring the possibility of obtaining a compassionate IND to provide legal access to marijuana for Paufler. 26. Paufler learned in about 1980 of the success of one Sam Diana, a multiple sclerosis patient, in asserting the defense of "medical necessity" in court when charged with using or possessing marijuana. He learned that doctors, researchers and other multiple sclerosis patients had supported Diana's position in the court proceeding. 27. Irwin Rosenfeld has been diagnosed as having Pseudo Pseudo Hypoparathyroidism. This uncommon disease causes bone spurs to appear and grow all over the body. Over the patient's lifetime hundreds of these spurs can grow, any one of which can become malignant at any time. The resulting cancer would spread quickly and the patient would die. 28. Even without development of a malignancy, the disease causes enormous pain. The spurs press upon adjacent body tissue, nerves and organs. In Rosenfeld's case, he could neither sit still nor lie down, nor could he walk, - 47 - without experiencing pain. Working in his furniture store in Portsmouth, Virginia, Mr. Rosenfeld was on his feet moving furniture all day long. The lifting and walking caused serious problems as muscles and tissues rubbed over the spurs of bone. He tore muscles and hemorrhaged almost daily. 29. Rosenfeld's symptoms first appeared about the age of ten. Various drugs were prescribed for him for pain relief. He was taking extremely powerful narcotics. By the age of 19 his therapy included 300 mg. of Sopor (a powerful sleeping agent) and very high doses of Dilaudid. He was found to be allergic to barbiturates. Taking massive doses of pain control drugs, as prescribed, made it very difficult for Rosenfeld to function normally. If he took enough of them to control the pain, he could barely concentrate on his schoolwork. By the time he reached his early twenties Rosenfeld's monthly drug intake was between 120 to 140 Dilaudid tablets, 30 or more Sopor sleeping pills and dozens of muscle relaxants. 30. At college in Florida Rosenfeld was introduced to marijuana by classmates. He experimented with it recreationally. He never experienced a "high" or "buzz" or "floating sensation" from it. One day he smoked marijuana while playing chess with a friend. It had been very difficult for him to sit for more than five or ten minutes at a time because of tumors in the backs of his legs. Suddenly he realized that, absorbed in his chess game, and smoking marijuana, he had remained sitting for over an hour - with no pain. He experimented further and found that his pain was reduced whenever he smoked marijuana. 31. Rosenfeld told his doctor of his discovery. The doctor opined that it was possible that the marijuana was relieving the pain. Something - 48 - certainly was - there was a drastic decrease in Rosenfeld's need for such drugs as Dilaudid and Demerol and for sleeping pills. The quality of pain relief which followed his smoking of marijuana was superior to any he had experienced before. As his dosages of powerful conventional drugs decreased, Rosenfeld became less withdrawn from the world, more able to interact and function. So he has continued to the present time. 32. After some time Rosenfeld's doctor accepted the fact that the marijuana was therapeutically helpful to Rosenfeld and submitted an IND application to FDA to obtain supplies of it legally for Rosenfeld. The doctor has insisted, however, that he not be publicly identified. After some effort the IND application was granted. Rosenfeld is receiving supplies of marijuana from NIDA. Rosenfeld testified before a committee of the Virginia legislature in about 1979 in support of legislation to make marijuana available for therapeutic purposes in that State. 33. In 1969, at age 19, David Branstetter dove into the shallow end of a swimming pool and broke his neck. He became a quadriplegic, losing control over the movement of his arms and legs. After being hospitalized for 18 months he returned home. Valium was prescribed for him to reduce the severe spasms associated with his condition. He became >>> 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: EBI00032Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [21/28 >>> Part 21 of 28... mildly addicted to Valium. Although it helped mask his spasms, it made Branstetter more withdrawn and less able to take care of himself. He stopped taking Valium for fear of the consequences of long-term addiction. His spasms then became uncontrollable, often becoming so bad they would throw him from his wheelchair. 34. In about 1973 Branstetter began smoking marijuana recreationally. He discovered that his severe spasms stopped whenever he smoked marijuana. - 49 - Unlike Valium, which only masked his symptoms and caused him to feel drunk and out of control, marijuana brought his spasmodic condition under control without impairing his faculties. When he was smoking marijuana regularly he was more active, alert and outgoing. 35. Marijuana controlled his spasms so well that Branstetter could go out with friends and he began to play billiards again. The longer he smoked marijuana the more he was able to use his arms and hands. Marijuana also improved his bladder control and bowel movements. 36. At times the illegal marijuana Branstetter was smoking became very expensive and sometimes was unavailable. During periods when he did not have marijuana his spasms would return, preventing Branstetter from living a "normal" life. He would begin to shake uncontrollably, his body would feel tense, and his muscles would spasm. 37. In 1979 Branstetter was arrested and convicted of possession of marijuana. He was placed on probation for two years. During that period he continued smoking marijuana and truthfully reported this, and the reason for it, to his probation officer whenever asked about it. No action was taken against Branstetter by the court or probation authorities because of his continuing use of marijuana, except once in the wake of his publicly testifying about it before the Missouri legislature. Then, although adverse action was threatened by the judge, nothing was actually done. 38. In 1981 Branstetter and a friend, a paraplegic, participated in a research study testing the therapeutic effects of synthetic THC on spasticity. Placed on the THC Branstetter found that it did help control his spasms but appeared to became less effective with repeated use. Also, unlike marijuana, - 50 - synthetic THC had a powerful mind-altering effect he found annoying. When the study ended the researcher strongly suggested that Branstetter continue smoking marijuana to control his spasms. 39. None of Branstetter's doctors have told him to stop smoking marijuana while several, directly and indirectly, have encouraged him to continue. Branstetter knows of almost 20 other patients, paraplegics, quadriplegics and multiple sclerosis sufferers, who smoke marijuana to control their spasticity. 40. In 1981 a State of Washington Superior Court judge, sitting without a jury, found Samuel D. Diana not guilty of the charge of unlawful possession of marijuana. In so doing the judge upheld Diana's defense of medical necessity. Diana had been a multiple sclerosis patient since at least 1973. He testified that smoking marijuana relieved his symptoms of double vision, tremors, unsteady walk, impaired hearing, tendency to vomit in the mornings and stiffness in the joints of his hands and legs. 41. Among the witnesses was a physician who had examined defendant Diana before and after he had used marijuana. This doctor testified that marijuana had been effective therapeutically for Diana, that other medication had proven ineffective for Diana and that, while marijuana may have some detrimental effects, Diana would receive more benefit than harm from smoking it. The doctor was not aware of any other drug that would be as effective as marijuana for Mr. Diana. Other witnesses included three persons afflicted with multiple sclerosis who testified in detail as to marijuana's beneficial effect on their illness. 42. In acquitting defendant Diana of unlawful possession of marijuana the trial judge found that the three requirements for the defense of medical necessity had been established, namely: defendant's reasonable belief that his - 51 - use of marijuana was necessary to minimize the effects of multiple sclerosis; the benefits derived from its use are greater than the harm sought to be prevented by the controlled substances law; and no drug is as effective as marijuana in minimizing the effects of the disease in the defendant. 43. Denis Petro, M.D., is a neurologist of broad experience, ranging from active practice in neurology to teaching the subject in medical school and employment by FDA as a medical officer reviewing IND's and NDA's. He has also been employed by pharmaceutical companies and has served as a consultant to the State of New York. He is well acquainted with the case histories of three patients who have successfully utilized marijuana to control severe spasticity when other, FDA-approved drugs failed to do so. Dr. Petro knows of other cases of patients who, he >>> 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: EBI00033Date: 07/13/97 From: ALEX VASAUSKAS Time: 08:49am \/To: JANE KELLEY (Read 1 times) Subj: Marijuana as medi [22/28 >>> Part 22 of 28... has determined, have effectively used marijuana to control their spasticity. He has heard reports of additional patients with multiple sclerosis, paraplegia and quadriplegia doing the same. There are reports published in the literature known to Dr. Petro, over the period at least 1970 - 1986, of clinical tests demonstrating that marijuana and THC are effective in controlling or reducing spasticity in patients. 44. Large numbers of paraplegic and quadriplegic patients, particularly in Veterans Hospitals, routinely smoke marijuana to reduce spasticity. While this mode of treatment is illegal, it is generally tolerated, if not openly encouraged, by physicians in charge of such wards who accept this practice as being of benefit to their patients. There are many spinal cord injury patients in Veterans Hospitals. 45. Dr. Petro sought FDA approval to conduct research with spasticity patients using marijuana. FDA refused but, for reasons unknown to him, allowed - 52 - him to make a study using synthetic THC. He and colleagues made such a study. They concluded that synthetic THC effected a significant reduction in spasticity among multiple sclerosis patients, but study participants who had also smoked marijuana reported consistently that marijuana was more effective. 46. Dr. Petro accepts marijuana as having a medical use in the treatment of spasticity in the United States. If it were legally available and he was engaged in an active medical practice again, he would not hesitate to prescribe marijuana, when appropriate, to patients afflicted with uncontrollable spasticity. 47. Dr. Petro presented a paper to a meeting of the American Academy of Neurology. The paper was accepted for presentation. After he presented it Dr. Petro found that many of the neurologists present at this most prestigious meeting were in agreement with his acceptance of marijuana as having a medical use in the treatment of spasticity. 48. Dr. Andrew Weil, a general medicine practitioner in Tucson, Arizona, who also teaches at the University of Arizona College of Medicine, accepts marijuana as having a medical use in the treatment of spasticity. In multiple sclerosis patients the muscles become tense and rigid because their nerve supply is interrupted. Marijuana relieves this spasticity in many patients, he has found. He would prescribe it to selected patients if it were legally available, 49. Dr. Lester B. Collins, III, a neurologist, then treating about 20 multiple sclerosis patients a year, seeing two or three new ones each year, stated in 1983 that he had no doubt that marijuana worked symptomatically for some multiple sclerosis patients. He said that it does not alter the course of - 53 - the disease but it does relieve the symptoms of spasticity. 50. Dr. John P. Morgan, board certified in internal medicine, Professor of Medicine and Director of Pharmacology at CCNY Medical School in New York and Associate Professor of Medicine and Pharmacology at Mt. Sinai School of Medicine, accepts marijuana as having medical use in treatment in the United States. If he were practicing medicine and marijuana were legally available he would prescribe it when indicated to patients with legitimate medical needs. Discussion Based upon the rationale set out in pages 26 to 34, above, the administrative law judge concludes that, within the meaning of the Act, 21 U.S.C. n 812(b)(2)(B), marijuana "has a currently accepted medical use in treatment in the United States" for spasticity resulting from multiple sclerosis and other causes. It would be unreasonable, arbitrary and capricious to find otherwise. The facts set out above, uncontroverted by the Agency, establish beyond question that some doctors in the United States accept marijuana as helpful in such treatment for some patients. The record here shows that they constitute a significant minority of physicians. Nothing more can reasonably be required. That some doctors would have more studies and test results in hand before accepting marijuana's usefulness here is irrelevant. The same is true with respect to the hyperparathyroidism from which Irvin Rosenfeld suffers. His disease is so rare, and so few physicians appear to be familiar with it, that acceptance by one doctor of marijuana as being useful in treating it ought to satisfy the requirement for a significant minority. The Agency points to no evidence of record tending to establish that marijuana is - 54 - not accepted by doctors in connection with this most unusual ailment. Refusal to acknowledge acceptance by a significant minority, in light of the case history detailed in this record, would be unreasonable, arbitrary and capricious. - 55 - >>> Continued to next message... ___ X Blue Wave/DOS v2.30 X --- Maximus 3.01 * Origin: Who's Askin'? (1:17/75)