Pubdate: 17 Mar 1997 Source: Chris Clay Author: Robert Randall Note: MAP is archiving each of the affidavits filed in the Chris Clay Constitutional Challenge to preserve these important documents. Bookmark: http://www.mapinc.org/clay.htm (Clay, Chris) ONTARIO COURT OF JUSTICE (GENERAL DIVISION) (Southwest Region) BETWEEN HER MAJESTY THE QUEEN Respondent -and- CHRISTOPHER CLAY Applicant AFFIDAVIT OF ROBERT RANDALL I, ROBERT RANDALL, of the City of Sarasota, in the State of Florida, MAKE OATH AND SAY AS FOLLOW: 1. I received my B.A. degree from the University of South Florida (Tampa) in 1969. I obtained my M.A. degree in Rhetoric and the Oral Interpretation of Literature in 1971. Currently, I am President of the Alliance for Cannabis Therapeutics (ACT), an organization which seeks to make marijuana legally available for legitimate medical uses. Attached hereto as Exhibit "A" is a copy of my curriculum vitae. 2. Attached hereto as Exhibit "B" is a copy of my testimony before the U.S. Drug Enforcement Administration in 1987, which sets out my efforts, at both the state and federal level, to have laws enacted which would make marijuana legally available for legitimate medical uses. 3. I suffer from glaucoma. In 1976, I was successful in raising a defence of "medical necessity" in a legal proceeding regarding my use of marijuana; I secured licit access to marijuana for use in a supervised routine of medical therapy for this condition. By producing reports from my physician which indicated that marijuana had, and continues to have, a critically important contribution to the treatment of my glaucoma (by prolonging my sight), I was able to prove to the Food and Drug Administration (FDA) that access to marijuana was a medical necessity. 4. In 1978, federal agencies terminated my access to marijuana. I sued them. We settled the dispute out of court so that I again had licit access to marijuana. I was the first person in the United States to secure such legal access. As a result of having access to marijuana for therapeutic purposes, I have gained prolonged sight without any apparent medical or physiological injury. 5. In 1980, I co-founded ACT. This is a non-membership organization. We do, however, have an advisory board of approximately 50 people comprised of patients, physicians, medical researchers, FDA approved investigators and elected representatives from a number of states. ACT does not support any non-medical uses for marijuana. 6. In 1982, I received the Galen Award of Rho Pi Phi from the Philadelphia College of Pharmacy "For Superior Achievement in Expanding the Capacity of Health Care Professionals by Introducing New Therapeutic Methods". 7. Over the past 15 years I have given informal talks and formal addresses on marijuana's medical uses before many legal, medical, political, and professional organizations including the American Bar Association, the National Conference of Drug Abuse and the First International Conference for Cannabis Reform (Amsterdam, 1980). 8. I have been qualified as an expert witness on the legal classification and medical utility of marijuana and synthetic THC in the courts of Pennsylvania, North Carolina, Florida, Wisconsin, Alabama, West Virginia, Virginia, Arkansas and Indiana. 9. I have testified regarding marijuana's medical uses before the U.S. House of Representatives as well as many state committees. 10. I have edited six books, the first five of which are on the ACT booklist which is attached hereto as Exhibit "C": Muscle Spasm, Pain & Marijuana Therapy; Cancer Treatment & Marijuana Therapy Manjuana, Medicine & the Law Vol. I and II, Marijuana & AIDS: Pot, Politics & PWAs in America and Marijuana as Medicine: Initial Steps. The first four books are excerpts from the hearings that took place between 1986 and 1988 before the U.S. Drug Enforcement Administration regarding the medical uses of marijuana and its proper legal classification. 11. Muscle Spasm, Pain and Marijuana Therapy provides a comprehensive review of scientific studies, state laws, methods and the results of marijuana use in the treatment of MS, paralysis and pain, spinal cord injuries and arthritis for patients, physicians and other interested parties. The text in the book is taken from testimony in two cases concerning the issue of marijuana's therapeutic utility in the treatment of muscle spasm and chronic pain. 12. Cancer Treatment & Marijuana Therapy contains testimony from several witnesses as well as the results of a recently published survey conducted by Harvard University which indicates that 70% of American oncologists favor prescriptive access to marijuana for reducing nausea, muscle spasm and chronic pain. 13. Marijuana, Medicine & the Law Vol. I and II reviews the testimony of those who are both for and against marijuana's use in medical treatment. Volume I The Direct Testimony includes detailed affidavits from more than fifty-five witnesses, including many of the world's leading medical experts on marijuana's therapeutic uses, patients, scientists, researchers, attorneys and health administrators. Volume II: The Legal Argument includes legal briefs from the Drug Enforcement Administration (DEA) and the petitioning parties as well as selected portions of the oral arguments. The full text of the Chief DEA Administrative Law Judge's ruling, which concluded that marijuana has significant therapeutic benefits, is also included. Attached hereto and marked as Exhibit "D" is a true copy of the decision of Chief DEA Administrative Law Judge Young. 14. Marijuana & AIDS: Pot, Politics & PWAs in America includes: personal stories of four people with AIDS who fought for and won the right to legally use marijuana as treatment for their respective diseases, information on how to legally obtain marijuana from the Food and Drug Administration (FDA), answers to frequently asked questions about the medical use of marijuana, a discussion on marijuana's effect on the immune system, and a comparison between marijuana and Marinol (synthesized delta-9-tetrahydrocannabinol (THC), marijuana's psychoactive ingredient). 15. Marijuana as Medicine: Initial Steps includes a review of medical conditions, including treatment for life-threatening or sense-threatening ailments, for which marijuana is useful. It also makes recommendations for a system of research and approval. Further, it discusses the political undercurrents involved in the debate over the use of marijuana for medical purposes in the U.S., including cases where the defence of medical necessity was advanced. 16. With respect to the issue of whether synthetic THC can be employed for medical treatment in lieu of relying upon the plant substance, the substitution of Marinol for marijuana would be acceptable if it achieved those goals which are the objectives of a synthetic medicine; namely, to increase its bio-availability to the patient's system, to increase the medicine's therapeutic value and to reduce the potential adverse effects caused by the use of the medicine. Marinol does not meet any of these objectives in the context of treating the nausea, vomiting and/or rapid weight loss associated with cancer, chemotherapy and AIDS. 17. In terms of bio-availability to the system, when marijuana is inhaled it effectively reduces nausea and vomiting within 5 to 10 minutes, with many patients reporting instantaneous benefits. Within 45 minutes to an hour of inhalation the desire to eat is stimulated. The oral ingestion of Marinol, by comparison, has very erratic bio-availability properties. The oil-soluble nature of the medicine makes it difficult for the digestive system to access the THC, which means that patients must wait 1 to 4 hours before the nausea and/or vomiting are affected. Consequently, patients may end up regurgitating the synthetic drug before it has time to act as an anti-emetic. Furthermore, it is also less effective in terms of increasing the desire to eat. The same pattern of effectiveness is present where the patient is being treated for spasticity. 18. In terms of the therapeutic utility of the synthetic medicine, numerous studies, including the Chang/National Cancer Institute (1979) study and several state studies from New Mexico, New York, Georgia and Michigan, report a sharp difference between the therapeutic effect of Marinol and marijuana. For example, the New Mexico Department of Health reported to the FDA in 1980 that marijuana significantly reduced nausea in 90% of cancer patients who had failed to respond to more conventional anti-emetic substances. In contrast, Marinol proved to be far less effective, aiding less than 60% of similar patients. In nearly all studies where a comparison was made between Marinol and marijuana, marijuana proved to be far more reliable, predictable and effective. 19. On a personal level, I was tested on marijuana and delta-9-tetrahydrocannabinol (now marketed and distributed as Marinol) during a controlled medical experiment at UCLA's Jules Stein Eye Institute in December 1975. 1n these experiments, I was given 20 to 30 milligram doses of orally ingested delta-9-THC. These proved to have no therapeutic effect in reducing my ocular pressure. Marijuana, however, relaxed my eye pressure by 25% to 50%. As a result, the investigator, Dr. Robert S Hepler, concluded that for me smoking marijuana was clearly superior to the oral ingestion of delta-9-THC. 20. In terms of reducing the adverse effect of taking the medicine, the vast majority of patients who smoke marijuana report that they do not feel negative effects due to the marijuana. In fact, many patients seem to enjoy the minor euphoric effect of smoking marijuana. Similarly, in state sponsored studies of marijuana use, for medical purposes (to offset nausea from cancer chemotherapy etc.), by over 1000 patients, no one ever required hospitalization or other forms of medical treatment as a result of an adverse effect from the marijuana. On the other hand, Marinol appears to have a much greater propensity to produce adverse effects. Many patients are unable or unwilling to withstand delta-9-THC's more pronounced psychoactive effects. In the New Mexico study referred to earlier, patients were allowed to switch from marijuana to Marinol, and vice versa, depending entirely upon their own preference. Many more patients chose to switch to marijuana than to Marinol. 21. In my personal experience, during the UCLA experiment, delta-9-THC produced more powerful anxiety provoking effects than I had ever experienced on marijuana. In the earliest study of marijuana use for medical purposes, Dr. Norman Zinberg from Harvard University administered delta-9-THC to reduce the effects of cancer induced nausea in his patients. While he noted that delta-9-THC seemed to be effective, approximately 25% of his patients left his study in order to use marijuana, which they found to be more effective. 22. Based on the three criteria noted above, marijuana provides relief more reliably, more rapidly and with fewer adverse effects than Marinol. In fact, it should be noted that it is not unusual for a patient on Marinol to return the dosage to the doctor who prescribed because it is either so ineffective or so difficult to cope with its negative effects. As in my own case, many patients find Marinol ineffective while marijuana is repeatedly effective. It should be noted that delta-9-THC contains marijuana's most psychoactive ingredient, but not necessarily its most therapeutic ingredient. Sworn before me at the City of Sarasota in the State of Florida, this 26 day of March, 1997 Robert Randall