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MEDICAL CANNABIS
PUBLISHED (Peer Review) STUDIES
The following is someone dated, being put together in 1996 shortly after the passage of California’s “Prop. 215”, also known as the Compassionate Use Act.” However it is still of use as it lists various Medical Cannabis (Medical Marihuana) studies. Note that many of them were published in various peer review journals.
For those interested in the subject, the following web-site contains a listing of over 200 peer-reviewed published studies demonstrating marihuana’s efficacy for various medical uses: http://www.cannabis-med.org/index.php?tpl=page&id=39&lng=en
Should the website ever go down, feel free to contact the museum for a copy, it can be emailed to you.
As per : -- http://www.csdp.org/kz/mmj2.htm#note12
[NOTE SOME TRANSCRIBER ERRORS (On our part) from one website to the other are possible]
As can see from this compilation there has been a tidal wave of published research demonstrating marijuana's medical usefulness. Indeed, it is stated in the research studies conducted by various states under FDA protocol that the research being conducted was in the final phase of approval by the FDA.(12) When the federal government stopped research on the medical use of marijuana in 1992 the drug had nearly completed the requirements for new drug approval.
Drug Czar Barry McCaffrey's assertion in his Scripps-Howard News Service column that No clinical evidence demonstrates that smoked marijuana is good medicine" is inconsistent with the facts. Whether this is an intentional deception, as part of the federal government's stated public relations offensive against medical marijuana, or whether it is based on ignorance does not matter. The reality is General McCaffrey's statements are not consistent with the facts.
The research reprinted in this compilation includes randomized, double-blind, placebo controlled studies, research using a variety of objective and subjective measurements and a range of research protocols. Doctors have a sound basis on which to recommend marijuana for use by their patients. Indeed, physicians are well aware of the medical value of marijuana. One study, a scientific survey of oncologists found that almost one half (48 percent) of the cancer specialists responding would prescribe marijuana to some of their patients if it were legal. In fact, over 44 percent reported having recommended the illegal use of marijuana for the control of nausea and vomiting. (13)
This publication addresses research that has been published in three areas: cancer, glaucoma and muscle spasticity. All of the materials herein were published after 1970. The materials enclosed are either published in peer review journals, government publications or are reports submitted to the federal government by state agencies. (14)
A. Published Research Studies
There have been several studies which have been published which focus on the medical value of smoked marijuana and cancer therapy. These include:
Vinciguerra et al., Inhalation Marijuana as an Antiemetic for Cancer Chemotherapy," The New York State Journal of Medicine, pgs., 525-527, October 1988 involved 56 patients who had no improvement with standard antiemetics. When treated with marijuana 78 percent demonstrated a positive response. No serious negative side effects were seen.The cancer research is relevant to marijuana as a useful therapy for AIDS patients. The same symptoms are needed to be controlled among AIDS patients: appetite, nausea and vomiting. There have been recent reports of AIDS and marijuana in the literature.(15) A study with THC found relief of nausea and significant weight gain in 70 percent of patients. However, one- fifth of the patients did not like the psychoactive effective of synthetic THC, (16) indicating marijuana is likely to be preferred by AIDS patients. This is consistent with a survey of people with AIDS conducted by a researcher in Hawaii in 1996. The survey found that 98.4 percent of AIDS patients were aware of the medical value of marijuana and 36.9 percent had used it as a antiemetic. Of those that had used is 80 percent preferred it over prescription drugs including synthetic THC.(17) A study being conducted in Australia of HIV patients found that those who use marijuana had a better quality of life. In particular, those that were HIV positive for over ten years found marijuana to be critical. One patient told the researcher that he considered marijuana to his savior." (18)
Chang et al., Delta-9-Tetrahydrocannabinol as an Antiemetic in Cancer Patients Receiving High Dose Methotrexate," Annals of Internal Medicine, Volume 91, Number 6, pg. 819-824, December 1979 is a randomized, double-blind, placebo controlled trial of THC and smoked marijuana which found a 72 percent reduction in nausea and vomiting. The research found that smoked THC (marijuana) was more reliable than oral THC.
Foltin, R.W., Brady, J.V. and Fischman, M.W. 1986. Behavioral analysis of marijuana effects on food intake in humans. Pharmacology, Biochemistry and Behavior. 25: 577-582 and Foltin, R.W. et al., 1988 Effects of Smoked Marijuana on Food Intake and Body Weight of Humans Living in a Residential Laboratory," Appetite 11:1-14;
Greenberg, et al. 1976 Effects of Marijuana use on Body Weight and Caloric Intake in Humans," Psychopharmacology 49: 79-84. All demonstrate that marijuana increases appetite and food intake.
Doblin et al., Marijuana as Antiemetic Medicine: A Survey of Oncologists' Experiences and Attitudes," Journal of Clinical Oncology, Vol. 9, No. 7, July 1991. A random survey of clinical oncologists found that 44 percent of respondents report recommending the (illegal) use of marijuana for the control of emesis and 48 percent would prescribe marijuana to some patients if it were legal.
Sallan, S.E., Zinberg, N.E. and Frei, D., Antiemetic Effect of Delta-9-tetrahydrocannabinol in Patients Receiving Cancer Chemotherapy," New England Journal of Medicine, 293(16): 795-797 (1975). The researchers conducting this study of THC noticed that some patients were dropping out of the research and choosing to use marijuana from the street instead. They followed up on these patients. In their conclusion they reported on the marijuana patients and stated that natural .....marijuana was more successful than synthetic THC for some patients.
Regarding glaucoma, there have been published studies which consistently show that marijuana is effective in lowering intraocular eye pressure.(19) Heightened intraocular eye pressure is the cause of glaucoma. Thus published evidence indicates marijuana preserves the vision of people with glaucoma.
Finally, regarding the control of muscle spasm there is published literature demonstrating marijuana to be effective in controlling convulsions.(20) The control of muscle spasm is important to patients with multiple sclerosis, epilepsy, spinal cord injury, paraplegia and quadriplegia.
B. State Health Department Studies
In addition to the published research there have been a series of six studies conducted by state health departments under research protocols approved by the U.S. Food and Drug Administration.The focus of these studies, conducted by six state health agencies was the use of marijuana as an anti-emetic for cancer patients. The studies, conducted in California, Georgia, New Mexico, New York, Michigan and Tennessee, compared marijuana to antiemetics available by prescription, including the synthetic THC pill, Marinol. Marijuana was found to be an effective and safe antiemetic in each of the studies and more effective than other drugs for many patients.
New Mexico:
This study involved 250 patients.The study compared marijuana to THC capsules. The research protocol was approved by the FDA in 1978. In order to participate in the research the patient had to be referred by a physician and had to have failed on at least three other antiemetics. Patients were permitted to choose marijuana or the THC pill. Both objective (e.g., frequency of vomiting, amount of vomiting, muscle biofeedback, blood samples and patient observation) and subjective measures were made to determine the effectiveness of the drug.
The study concluded that marijuana was not only an effective antiemetic but also far superior to the best available conventional drug, Compazine, and clearly superior to synthetic THC pill." The study found that [m]ore than ninety percent of the patients who received marijuana reported significant or total relief from nausea and vomiting." The study found no major adverse side effects. Only three patients reported adverse reactions, none of these reactions involved marijuana alone. The 1984 report concluded the data accumulated over all five years of the program's operation do show that marijuana smoked resulted in a higher percentage of success than does THC ingested."(21)
Michigan:
The Michigan research compared marijuana to Torecan. It involved 165 patients. Upon admission to the program patients were randomized into control groups with some randomized on the conventional antiemetic Torecan and the remainder randomized to marijuana. When failure on the initial randomized drug occurred, patients could elect to crossover to the alternate therapy. This procedure allowed the Michigan Department of Health to evaluate how well patients responded to both drugs and allowed patients to register their preference.
The Michigan study reported 71.1 percent of the patients who received marijuana reported no emesis to moderate nausea. Ninety percent of the patients receiving marijuana elected to remain on marijuana. Only 8 of 83 patients randomized to marijuana chose to alter their mode of antiemetic therapy. This was almost the inverse of patients randomized to Torecan, there more than 90 percent — 22 out of 23 patients — elected to discontinue use of Torecan and switched to marijuana.(22) Very few serious side effects were found related to marijuana use. The most common side effect was increased appetite — reported by 32.3 percent of patients — this was a positive effect. The most common negative effects were sleepiness, reported by 21 patients and sore throat, reported by 13 patients.
Tennessee:
This study involved an evaluation of 27 patients. The patients had all failed on other forms of antiemetic therapy including oral THC. The study found an overall success rate of 90.4 percent for marijuana inhalation therapy. In comparison it found a 66.7 percent success rate for THC capsules. In the under 40 age group, the study found a 100 percent success rate for marijuana inhalation therapy.
The report concludes:
We found both marijuana smoking and THC capsules to be effective anti-emetics. We found an approximate 23 percent higher success rate among those patients administered THC capsules. We found no significant differences in success rates by age group. We found that the major reason for smoking failure was smoking intolerance; while the major reason for THC capsule failure was nausea and vomiting so severe that patient could not retain the capsule.(23)
New York:
In describing the purpose of the marijuana research program the New York Department of Health stated: [t]he program is a large-scale (Phase III) cooperative clinical trial . . . ."(24) The central question addressed is [h]ow effective is inhalation marijuana in preventing nausea and vomiting due to chemotherapy in patients . . . who have failed to respond to previous antiemetic therapy?"
By 1985, the New York program had extended marijuana therapy to 208 patients through 55 practitioners. Of that, 199 patients were evaluated. These patients had received a total of 6,044 NIDA-supplied marijuana cigarettes which were provided to patients during 514 treatment episodes.
In percentage terms the results were stunning:
The report concludes: Patient evaluations have indicated that approximately ninety-three (93) percent of marijuana inhalation treatment episodes are reported to be effective' or highly effective' when compared to other antiemetics." The New York study reports no serious adverse side effects. No patient receiving marijuana required hospitalization or any other form of medical intervention. See, Evaluation of the Antiemetic Properties of Inhalation Marijuana in Cancer Patients Receiving Chemotherapy Treatment," New York Department of Health, Office of Public Health (Annual Reports).(25)
Georgia:
The Georgia program evaluated 119 patients. It compared THC to standardized smoking of marijuana and with patient-controlled smoking. To enter the program a patient had to have failed on other antiemetics. Patients were randomized to either patient-controlled smoking of marijuana, standardized smoking of marijuana or THC pills.
The report found that both THC and marijuana were effective in providing antiemetic relief for patients who were previously unresponsive to antiemetics. The rate of success was 73.1 percent. Patient controlled smoking of marijuana was successful in 72.2 percent, standardized smoking was successful in 65.4 percent and THC was effective in 76 percent of the cases. In comparing the reasons for failure between marijuana and THC the report found:
The primary reasons for failure of THC capsules were due to either adverse reaction (6 out of 18) or failure to improve nausea and vomiting (9 out of 18). The primary reason for failure of smoking marijuana were due to smoking intolerance (6 out of 14) or failure to improve the nausea and vomiting (3 out of 14).(26)
California:
California conducted a series of studies from 1981 through 1989. Annual reports were submitted to the FDA, state legislature and Governor. Each year approximately 90 to 100 patients received marijuana. The California research was described as a Phase III trial."(27)
The study protocol preferred THC pills by making it much easier for patients to enter that portion of the study. Patients who received marijuana had to be over 15 years of age (the THC pill patients had to be over 5 years of age); had to be marijuana experienced, use the drug on an in-patient basis (patients could only use marijuana in the hospital and not take the medicine home) and had to be receiving rarely used and severe forms of chemotherapy. Thus, the design of the study did not favor marijuana.
Even with this built in bias against marijuana, the study consistently found marijuana to be an effective antiemetic. In 1981 the California Research Advisory Panel reported: Over 74 percent of the cancer patients treated in the program have reported that marijuana is more effective in relieving their nausea and vomiting than any other drug they have tried." In 1982, a 78.9 percent effectiveness rate was found for smoked marijuana. By 1983 the report was conclusory in its findings, stating:
The California Program also has met its research objectives. Marijuana has been shown to be effective for many cancer chemotherapy patients, safe dosage levels have been established and a dosage regimen which minimizes undesirable side effects has been devised and tested.
The California Research Advisory Panel continued to review data on marijuana until 1989 with similar results.(28)
C. Studies of Marijuana Constituents
In addition to research on smoked marijuana there has been a host of research on constituents of marijuana. This research is relevant in measuring the effectiveness of marijuana.
The drug for which there has been the most research is the THC pill. This pill contains pure delta-9- tetrahydrocannabinol in sesame seed oil. This substance is now scheduled in Schedule II of the Controlled Substances Act. When the drug was rescheduled the Food and Drug Administration acknowledged: The effects of pure THC are essentially similar to those of cannabis containing THC in equivalent amounts." Thus, the federal government has acknowledged that THC, which is available as a medicine, adequately emulates the effectiveness to marijuana. In fact, the research described above shows that marijuana is in fact a more effective medicine than the THC pill.
The research which compares marijuana to the THC pill found that patients preferred marijuana to THC and that marijuana was more effective at treating symptoms. State studies in Michigan and New Mexico found that most patients who tried THC chose to use marijuana instead. The most common reasons for this choice was because THC was more psychoactive, erratic and unpredictable. Patients found they had more control and a quicker response with smoked marijuana than with oral THC. Patients found it difficult to swallow the pill when they were nauseous. Patients were also able to limit their use of marijuana to only the amount needed when it was smoked. For many cancer and AIDS patients this can involve smoking a very small quantity of the drug. With the THC pill the patient must ingest the whole pill and therefore cannot control the dose.
The Chang study published in The Annals of Internal Medicine found that marijuana was more consistent than the oral THC pill. As they note this was consistent with the observations of Sallan and his colleagues in their study published in The New England Journal of Medicine, Alfred Chang et al. stated: Sallan and his co-workers considered inadequate drug absorption as a possible contributing factor to the lack of antiemetic response seen in some patients. We concur, since THC plasma concentrations appeared to be causally related to an antiemetic response in our study. To avoid this problem, we switched patients to the inhalation route of drug administration when vomiting occurred. Inhaled marijuana results in the same psychological effects as orally administered THC. In our patient populations, smoked THC was more reliable than oral THC in achieving therapeutic blood concentrations. A final reason why marijuana cigarettes are superior to the THC pill is because it is not only delta-9-THC which provides positive medical effects. The bibliography includes research involving other components of marijuana, including various cannabinoids and delta-8-THC. This research indicates that it is not only delta- 9-THC which has beneficial medical effects but other components of marijuana. Smoking marijuana provides the patient with the benefits of the combination of marijuana's active ingredients as opposed to the effects of only THC.
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IV. State Laws Provide an Avenue to Resolve The Medical Marijuana Problem
There is strong scientific evidence that marijuana is a safe and effective medicine. The voters in California and Arizona have recognized this at the ballot box. It is time for the federal government to help resolve this problem rather than threaten doctors with sanctions for providing medical advice to their patients and denying seriously ill patients access to a much needed medicine.
The California and Arizona initiatives, as well as state laws in two dozen states, provide an opportunity to resolve the medical marijuana problem. Research on the safety and effectiveness of marijuana is in its final phase. All that is needed is late-Phase III research. These are broad-based research studies which result in large numbers of patients receiving marijuana.
The federal government, in its policy announcement of December 30, stated that it wanted to ensure the integrity of the drug approval process. Part of their plan to do so includes reviewing the research and seeking to fill gaps in research with new research.
Combining the Food and Drug Administration's need for late-Phase III research before they approve marijuana as a medicine, with the decision of voters in California and Arizona to make marijuana medically available, will satisfy two needs. It can make marijuana available to large numbers of people under a research umbrella. (In the early 1980s nearly 1,000 patients a year were using marijuana medically under federally approved research programs. In fact, one year California requested one million medical marijuana cigarettes from the FDA.) In addition, it could finally resolve the medical marijuana problem and make marijuana available as a medicine by prescription.
The Food and Drug Administration should contact the health departments of Arizona, California and other states which have expressed interest in medical marijuana and ask them to participate in the final Phase III studies needed to complete the new drug application process. Getting results from this research should take less than one year. If they are consistent with previous research it should result in marijuana becoming a prescription drug under Schedule II of the Controlled Substances Act. Such a process will restore the integrity of the medical scientific process of drug approval which has been undermined by the use of medical marijuana as a political tool by those favoring expanded drug war policies.
By taking a constructive approach, rather than a confrontational one, the federal government avoids conflict with state law, does not intrude on the doctor-patient relationship and ensures that, in the end, marijuana is only made available as a prescription medicine to the seriously ill. Arizona and California have presented an opportunity to resolve an issue that is long overdue for resolution.
Bibliography
Overviews of Marijuana's Safety and Effectiveness
Beaconsfield, D., Ginsburg, J., and Rainsbury, R. (1973). Therapeutic potential of marihuana. New Eng. J. Medicine 289, 1315.
Therapeutic Aspects. 1974. Marijuana and Health, Fourth Annual Report to the U.S. Congress, Nat'l Institute on Drug Abuse, 134-143.
Therapeutic Aspects. 1975. Marijuana and Health, Fifth Annual Report to the U.S. Congress, Nat'l Institute on Drug Abuse, 117-132.
Bhargave, H. (1978). Potential therapeutic application of naturally occurring and synthetic cannabinoids. Gen. Pharmac., 9, 195-213.
Ungerleider, J. (1979). Marijuana as a good medicine: Its uses against disease. Lecture delivered to UCLA Center for the Health Sciences, August 21, 1979.
Zinberg, N. (1979). On cannabis and health. J. Psychedelic Drugs, 11, 135-144.
AMA Council on Scientific Affairs. (1980). Marihuana reexamined: Pulmonary risks and therapeutic potentials. Conn. Medicine, 44, 521-523. Cohen, S. (1980). Therapeutic aspects. Nat'l Inst. Drug Abuse. Res. Mono. Ser., No. 31, 199-216.
Council on Scientific Affairs. (1981). Marijuana: Its health hazards and therapeutic potentials. JAMA, 246, 1823-1827.
DuQuesne, J. (1981). Cannabis and the Rule of Law. Lancet, Sept. 12, 1981, 581.
Rose, M. (1981). Cannabis and the rule of law. Lancet, July 18, 1981.
Therapeutic potential and medical uses of marijuana. (1982). In Marijuana and Health, Inst. of Medicine, 139-155.
Schurr, A. (1985). Marijuana: Much ado about THC. Comp. Biochem. Physiol., 80 C, 1-7.
Ungerleider, J. and Andrysiak, T. (1985). Therapeutic issues of marijuana and THC., Int'l J. Addictions, 20, 691-699.
Grinspoon, L. and Bakalar, J., (1995). Marihuana as Medicine, A Plea for Reconsideration, JAMA, 273: 1875-1876.
Medical Marijuana and Nausea, Vomiting and Appetite
Hollister, L (1970) Hunger and appetite after single doses of marihuana, alcohol and dextroamphetamine. Clin. Pharmacol. and Therapeutics, 12, 44-49.
Sallan, S.E., Zinberg, N.E., Ferei, E., III, (1975), Antiemetic effect of delta-9- tetrahydrocannabinol in patients receiving cancer chemotherapy. N. Eng. J.Med., 293, 795-797.
Greenberg, I., Kuehnle, J., Mendelson,J.H. and Bernstein, J.G. 1976. Effects of marihuana use on body weight and caloric intake in human. Journal of Psychopharmacology (Berlin) 49: 79-84.
Harris, L. (1976). Analgesic and antitumor potential of the cannabinoids. In Therapeutic Potential of Marijuana. (Cohen and Stillman, eds., 299-309.
Harris, L. Munson, A. and Carchman, R. (1976). Antitumor properties of cannabinoids. In The Pharmacology of Marihuana (Braude and Szara, eds.), 749-762.
Chang, A. et al. (1979). Delta-9-tetrahydrocannabinol as an antiemetic in cancer patients receiving high- dose methotrexate. Annals of Internal Medicine, 91, 819-824.
Sallan, S.E., Cronin, C. Zelen, M., Zinberg, N.E. (1980). Antiemetics in patients receiving chemotherapy for cancer. A randomized comparison of delta-9-tetrahydrocannabinol and prochlorperazine. N. Engl. J. Med., 302: 135-8.
California State Reports, Therapeutic Cannabis Program, Annual Report to the Governor and Legislature, California Research Advisory Panel (1980-1986).
Bateman, D.C., Rawlins, M. (1982). Therapeutic potential of cannabinoids. Br. Med. J., 284, 1211-1212.
Cannabinoids for nausea, (1981). Lancet, Jan. 31, 1981, 255-256.
Frytek, S., Moertel, C.G., (1981), Management of nausea and vomiting in the cancer patient, JAMA, 245, 394-396.
Neidhart, J., Gagen, M., Wilson, H. and Young, D. (1981). Comparative trial of the antiemetic effects of THC and haloperidol. J. Clin. Pharmacol., 21, 385-425.
Michigan Department of Public Health Marijuana Therapeutic Research Project, Trial A 1980-81," Department of Social Oncology, Evaluation Unit, Michigan Cancer Foundation (March 18, 1982).
Ungerleider, J., Andrysiak, T., Fairbanks, L., Goodnight, J., Sama, G. and Jamison, K. (1982). Cancer chemotherapy and marijuana.
Ungerleider, J., Andrysiak, T., Fairbanks, L., Goodnight, J., Sama, G. and Jamison, K. (1982). Cannabis and cancer chemotherapy: A comparison of oral delta-9-THC and prochlorperazine. Cancer, 50, 636-645.
Sensky, T., Baldwin, A., and Pettingale, K. (1983). Cannabinoids as antiemetics. Br. Med. J. ,286, 802.
Kutner, Michael H., Evaluation of the Use of Both Marijuana and THC in Cancer Patients for the Relief of Nausea and Vomiting Associated with Cancer Chemotherapy After Failure of Conventional Anti-Emetic Therapy: Efficacy and Toxicity" as prepared for the Composite State Board of Medical Examiners, Georgia Department of Health, by physicians and researchers at Emory University, Atlanta, (January 20, 1983).
Annual Report: Evaluation of Marijuana and Tetrahydrocannabinol in the Treatment of Nausea and/or Vomiting Associated with Cancer Therapy Unresponsive to Conventional Anti-Emetic Therapy: Efficacy and Toxicity," Board of Pharmacy, State of Tennessee, July 1983.
"The Lynn Pierson Therapeutic Research Program," the Behavioral Health Sciences Division, Health and Environment Department, March 1983 and 1984.
Foltin, R.W., Brady, J.V. and Fischman, M.W. 1986. Behavioral analysis of marijuana effects on food intake in humans. Pharmacology, Biochemistry and Behavior. 25: 577-582.
Foltin, R.W. et al., 1988 Effects of Smoked Marijuana on Food Intake and Body Weight of Humans Living in a Residential Laboratory," Appetite 11:1-14
Vinciguerra, V., Moore, T., Brennab, E., Inhalation marijuana as an antiemetic for cancer chemotherapy, (Oct. 1988) N.Y. State J. Medicine, 525-527.
T.F. Plasse, R.W. Gorter, S.H. Krasnow, et al., 1991. Recent clinical experience with dronabinol. Pharmacology, Bichemistry and Behavior 40: 695-700.
Doblin, R., Kleiman, M., Marijuana as antiemetic medicine: A survey of oncologists experiences and attitudes, (1991), J. Clin. Oncology, 9:7, 1314-1319.
Abrams, D. 1995, Marijuana, the AIDS Wasting Syndrome, and the U.S. Government (Response to Letter) New England Journal of Medicine, Vol. 333 (10): 670-671.
Grinspoon, L, J, and Doblin, R. 1995. Marijuana, the AIDS Wasting Syndrome, and the U.S. Government (Letter to ed.) New England Journal of Medicine, Vol. 333(10): 670-671.
Wesner, B. 1996. The Medical Marijuana Issue Among PWAs: Reports of Therapeutic Use and Attitudes Toward Legal Reform. Drug Research Unit, Social Science Research Institute, University of Hawaii at Manoa.
Medical Marijuana and Glaucoma
Hepler, R. and Frank, I., (1971). Marijuana smoking and intraocular pressure. JAMA, 217, 1932.
Hepler, R., Frank, I. and Ungerleider, J. (1972). Pupillary constriction after marijuana smoking. Am. J. Ophthalmol., 74, 1185-1190.
Shapiro, D. (1974). The ocular manifestations of the cannabinoids. Opthalmologica, 168, 366-369.
Hepler, R. and Petrus, R. (1976). Experiences with administration of marijuana to glaucoma. In The Therapeutic Potential of Marijuana. (Cohen and Stillman, eds.), 63-75.
Perez-Reyes, M., Wagner, D., Wall, M. and Davis, K. (1976). Intravenous administration of cannabinoids and intraocular pressure. In The Pharmacology of Marihuana (Braude and Szara, eds.), 829-832.
Goldberg, I., Kass, M. and Becker, B. (1978-1979). Marijuana as a treatment for glaucoma. Sightsaving Review, Winter issue, 147-154.
Crawford, W., and Merritt, J. (1979). Effects of tetrahydrocannabinol on arterial and intraocular hypertension. Int'l J. Clin. Pharmacol. and Biopharm. 17, 191-196.
Merritt, J., Crawford, W., Alexander, P., Anduze, A. and Gelbart, S. (1980). Effect of marihuana on intraocular and blood pressure in glaucoma.Ophthalmology, 87, 222-228.
Merritt, J., McKinnon, S., Armstrong, J., Hatem, G. and Reid, L. (1980). Oral delta-9-tetrahydrocannabinol in heterogenous glaucomas. Annals of Ophthalmology, 12, No. 8.
Zimmerman, T. (1980). Efficacy in glaucoma treatment -- the potential of marijuana. Annals of Ophthalmology, 449-450.
Green, L., (1984) Marijuana effects on intraocular pressure, Applied, Pharmacology in the Medical Treatment of Glaucomas, (S.M. Drance, ed.), 507-526.
Merritt, J., et al. (1981). Effects of topical delta-9-tetrahydrocannabinol on intraocular pressure in dogs. Glaucoma, Jan./Feb., 13-16.
Merritt, J., Perry, D., Russell, D. and Jones, B. (1981). Topical delta-9-tetrahydrocannabinol and aqueous dynamics in glaucoma. J. Clin. Pharmacol., 21, 467S-471S.
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[1] - Proposition 215 in California creates a defense to criminal charges if a doctor recommends medical use of marijuana to a patient . Proposition 200 in Arizona, among other things, allows a doctor to prescribe any Schedule I drug if it is supported by another doctor and the medical literature.
[2] - Statement Released by Barry R. McCaffrey, Director of the Office of National Drug Control Policy, The Administration's Response to the Passage of California Proposition 215 and Arizona Proposition 200, December 30, 1996, page 2.
[3] - Ibid.
[4] - Golden, Tim, "U.S. Government to Prosecute Doctors Who Prescribe Marijuana," The New York Times, December 23, 1996.
[5] - Statement Released by Barry R. McCaffrey, Director of the Office of National Drug Control Policy, The Administration's Response to the Passage of California Proposition 215 and Arizona Proposition 200, December 30, 1996, pg. 6.
[6] - Drug Czar McCaffrey has consistently claimed there is no research showing smoked marijuana works. On CNN on December 30 at 1:04 EST, he was asked whether there is any evidence that marijuana is an effective medicine. McCaffrey responded that there was none: No, none at all. There are hundreds of studies that indicate that it isn't." This claim is so preposterous that the drug czar's employees will not even support it. On January 2, a spokesperson for McCaffrey's office denied her boss had ever made such a claim. On CNN's Burden of Proof," Pat Seitz said: He has not said there is no research. He has not said there is no research."
[7] - Therapeutic Aspects. 1975. Marijuana and Health, Fifth Annual Report to the U.S. Congress, Nat'l Institute on Drug Abuse, 118-119.
[8] - Therapeutic Aspects. 1975. Marijuana and Health, Fifth Annual Report to the U.S. Congress, Nat'l Institute on Drug Abuse, 117; Grinspoon, Lester and Bakalar, James, Marihuana as Medicine," The Journal of the American Medical Association, vol. 273, No. 23 1875-1876.
[9] - Therapeutic Aspects. 1974. Marijuana and Health, Fourth Annual Report to the U.S. Congress, Nat'l Institute on Drug Abuse, 134 citing: O'Shaughnessey, W.B. On the preparation of the Indian hemp or gunjah. Translations of Medicine, Physiology and Sociology, Bengal: 1838-1840, pp. 71-102; 1842, pp. 421-461 and Moreau de Tours, K. Psychotic depression with stupor: tendency toward dementia: treatment with an extract of cannabis indica. Lancette Hospital Gazette, 30: 391 (1857).
[10] - Therapeutic Aspects. 1975. Marijuana and Health, Fifth Annual Report to the U.S. Congress, Nat'l Institute on Drug Abuse, 117.
[11] - Mechoulam, S., Lander, N., Dikstein, S., Carlini, E.A., and Blumenthal, M. (1976). On the Therapeutic Possibilities of Some Cannabinoids. In The Therapeutic Potential of Marihuana (Cohen and Stillman eds.), 36.
[12] - co, 1981 at 5. The New York State Department of Health stated that [t]he program is a large-scale (phase III) cooperative clinical trial. . ." see: Evaluation of the Antiemetic Properties of Inhalation Marijuana in Cancer Patients Receiving Chemotherapy Treatment," New York Department of Health, Office of Public Health, Chapter 810, Laws of 1980 Article 33-A, Public Health Law, September, 1981, at 3 cited in Randall, R.C. (editor), Marijuana, Medicine and the Law Volume II, Galen Press, 1989, page 47. For further discussion see note 23.
[13] - Doblin, R., Kleiman, M., Marijuana as antiemetic medicine: A survey of oncologists' experiences and attitudes, (1991), J. Clin. Oncology, 9:7, 1314-1319.
[14] - Almost all of the materials published in this compilation were part of the record of proceedings challenging the scheduling of marijuana under the Controlled Substances Act before the U.S. Drug Enforcement Administration. In the Matter of Marijuana Rescheduling Petition, No. 86-22 (U.S. Department of Justice, Drug Enforcement Administration, Sept. 6, 1988). Most of the materials were compiled by the Alliance for Cannabis Therapeutics led by Robert Randall and Alice O'Leary. Also included in this compilation are materials contained in the evidence submitted by the U.S. Drug Enforcement Administration. Finally, some of the materials included were published after that litigation was completed.
[15] - Abrams, D. 1995, Marijuana, the AIDS Wasting Syndrome, and the U.S. Government (Response to Letter) In New England Journal of Medicine, Vol. 333 (10): 670-671; Grinspoon, L, J, and Doblin, R. 1995. Marijuana, the AIDS Wasting Syndrome, and the U.S. Government (Letter to ed.) In New England Journal of Medicine, Vol. 333(10): 670-671.
[16] - T.F. Plasse, R.W. Gorter, S.H. Krasnow, et al., 1991. Recent clinical experience with dronabinol. Pharmacology, Bichemistry and Behavior 40: 695-700.
[17] - Wesner, B. 1996. The Medical Marijuana Issue Among PWAs: Reports of Therapeutic Use and Attitudes Toward Legal Reform . Drug Research Unit, Social Science Research Institute, University of Hawaii at Manoa.
[18] - Dope Use Improves Lives of Patients: Research," The Canberra Times, January 15, 1997.
[19] - Hepler, R. and Frank, I., (1971). Marijuana smoking and intraocular pressure. JAMA, 217, 1932; Hepler, R., Frank, I. and Ungerleider, J. (1972). Pupillary constriction after marijuana smoking. Am. J. Ophthalmol., 74, 1185-1190; Hepler, R. and Petrus, R. (1976). Experiences with administration of marijuana to glaucoma. In The Therapeutic Potential of Marijuana. (Cohen and Stillman, eds.), 63-75; Goldberg, I., Kass, M. and Becker, B. (1978-1979). Marijuana as a treatment for glaucoma. Sightsaving Review, Winter issue, 147-154; Merritt, J., Crawford, W., Alexander, P., Anduze, A. and Gelbart, S. (1980). Effect of marihuana on intraocular and blood pressure in glaucoma. Ophthalmology, 87, 222-228; Zimmerman, T. (1980). Efficacy in glaucoma treatment -- the potential of marijuana. Annals of Ophthalmology, 449-450.
[20] - Carlini, E., Leite, J., Tannhauser, M. and Berardi, A. (1973). Cannabidiol and cannabis sativa extract protect mice and rats against convulsive agents. J. Pharm. Pharmac., 25, 664-665; Dunn, M. and Davis, R., (1974). The perceived effects of marijuana on spinal cord injured males, Paraplegia, 12, 175; Consroe, P., Wood, G., and Buchsbaum, H. (1975). Anticonvulsant nature of marijuana smoking. JAMA, 234, 306-307; Feeney, D.M., Marihuana and epilepsy: paradoxical anticonvulsant and convulsant effects, Marijuana Biological Effects: Analysis, Metabolism, Cellular Responses, Reproduction and the Brain, (Nahas, GG., Paxton, M., Bruade, J.C., Hardillier, and Harvey, D.J. eds.) Pergamon Press, Oxford, England, 643-657; Petro, D., (1980), Marihuana as a therapeutic agent for muscle spasm of spasticity, Psychosomatics, 21: 81, 85.; Cannabis, (1986) Therapeutic Claims in Multiple Sclerosis, Int'l Federation of Multiple Sclerosis Societies, 226.
[21] - The Lynn Pierson Therapeutic Research Program," the Behavioral Health Sciences Division, Health and Environment Department, March 1983 and 1984.
[22] - Michigan Department of Public Health Marijuana Therapeutic Research Project, Trial A 1980-81," Department of Social Oncology, Evaluation Unit, Michigan Cancer Foundation (March 18, 1982).
[23] - Annual Report: Evaluation of Marijuana and Tetrahydrocannabinol in the Treatment of Nausea and/or Vomiting Associated with Cancer Therapy Unresponsive to Conventional Anti-Emetic Therapy: Efficacy and Toxicity," Board of Pharmacy, State of Tennessee, July 1983.
[24] - See note 12 and note 23.
[25] - The results of this study were published at: Vinciguerra et al., Inhalation Marijuana as an Antiemetic for Cancer Chemotherapy," The New York State Journal of Medicine, pgs., 525-527, October 1988.
[26] - Kutner, Michael H., Evaluation of the Use of Both Marijuana and THC in Cancer Patients for the Relief of Nausea and Vomiting Associated with Cancer Chemotherapy After Failure of Conventional Anti-Emetic Therapy: Efficacy and Toxicity" as prepared for the Composite State Board of Medical Examiners, Georgia Department of Health, by physicians and researchers at Emory University, Atlanta, (January 20, 1983).
[27] - See footnote 12. In describing Phase III research, the final phase before market approval, the California Research Advisory Panel stated:
Among the safeguards for developing an investigational new drug is a step-wise testing process: the drug is tested in animals before humans, in normal volunteers before patients, and in small groups of people before large groups. Preclinical refers to non-human experiments, e.g., toxicity and pharmacology experiments in animals. Phase I is conducted in small numbers of normal human volunteers to determine dosage levels and other pharmacologic parameter. Phase II clinical trials typically involve small numbers of patients and comparisons to other treatment. Phase III is confirm effectiveness and to assess adverse effects in a large and diverse patient population. Phase IV is used to describe post-marketing reporting on drug safety and effectiveness. Eleventh Annual Report for 1980 to the Governor and Legislature, CRAP, San Francisco, 1981 at 5.
[28] - Annual Report of the California Research Advisory Panel submitted to the Governor and Legislature from 1981 (Twelfth Annual Report) to 1989 (Twentieth Annual Report).
[29] - 47 Fed. Reg. 10082, column 3. The FDA also noted: The risks to the public health from illicit use of THC are likely to be similar to marihuana." 47 Fed. Reg. 10083, column 2.
[30] - Chang et al., Delta-9-Tetrahydrocannabinol as an Antiemetic in Cancer Patients Receiving High Dose Methotrexate," Annals of Internal Medicine, Volume 91, Number 6, pg. 823, December 1979.
[31] - Statement Released by Barry R. McCaffrey, Director of the Office of National Drug Control Policy, The Administration's Response to the Passage of California Proposition 215 and Arizona Proposition 200, December 30, 1996, page 4 where it states:
HHS to ensure the protection of the public health will: (a) examine all medical and scientific evidence relevant to the perceived medical usefulness of marijuana; (b) identify gaps in knowledge and research regarding the health effects of marijuana; (c) determine whether further research or scientific evaluation could answer these questions; and (d) determine how that research could be designed and conducted to yield scientifically useful results.
Once again, ALL of the above studies are (at this point) a bit dated. |
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