Monday, August 24, 2009

MCSC Nomenclature Report

Executive Summary

            The naming of cannabis medicines is an important factor in creating a professional and positive perception of the industry. There are many areas which need to be standardized in order for us to grow collectively and represent our goals and ideals in a clear and accurate manner. The goal of this report is to study the many resources available and choose the best nomenclature for the current environment in California as well as the other medical cannabis states which are evolving and growing. We are embarking upon a new era of governance that we hope will be more accepting and honest in in regard to cannabis therapies. To best explain the standards and practices of the cannabis medicines industry it is necessary to set proper terminology for reference purposes.

            This study is expansive, reaching the far corners of the globe, and includes the long history of cannabis medicines and the current state of affairs in the global environment. An internal survey of people directly involved with the medical cannabis movement is also included. This survey is a good measure of what are seen as acceptable terms in the medical cannabis community, based on the short history of the industry’s growth in America. This report also examines the many practices of international entities and governing bodies, including Health Canada, The European Commission, The Netherlands’ Office of Medicinal Cannabis, the World Health Organization, and the International Conference on Cannabis. It also examines terms used in America by the Food and Drug Administration, the U.S. Pharmacopoeia, The State of California, and some other valuable resources.

            None of the models we studied has a complete set of universal terms that would easily transfer to the situation we face. By compiling and choosing relevant information from many sources we can begin to make informed and well-thought recommendations on which to base our structure. This report will detail the findings from these organizations and entities, and make a set of nomenclature recommendations to narrow down and hopefully reach consensus in order to continue moving forward.

            This purpose of this report is to create a framework which the many patients and providers of cannabis medicines can look to as a resource to help structure their efforts in a consistent and professional manner. In order to be recognized as a legitimate force in the health care industry it is necessary to operate in a cohesive manner. That effort begins with the way we reference cannabis medicines, the methods of production, the methods of distribution, and the methods of use. This survey is meant to be a definitive guide and the results will not necessarily represent the final recommendations of the Nomenclature Committee, nor the MCSC. Nonetheless by creating such standards the industry can begin to open the hearts and minds of medical professionals, regulatory authorities, and society as a whole to be more accepting of cannabis therapeutics and the practices associated with them.

Introduction

            The Nomenclature Committee has four basic tasks to better define the cannabis medicines industry. The first is defining proper classification names for the many different types of cannabis medicines, including raw plant material, extracts, and other common derivatives of cannabis. This task also includes terms of reference for producers and providers of these medicines. The second task is developing a standardized naming guideline for cannabis medicines. It is important to find a more professional manner to identify the many types of cannabis and to move away from some unprofessional and comical practices in current use. The third and fourth tasks involve developing labeling and packaging practices to clearly convey this information to the end-user, the patient. The many findings in this report will touch on what is currently done in other areas of cannabis therapies, what has been done historically, and what could be applied to the current state of affairs in medical cannabis states.

What the Community Thinks (Survey)

            We conducted a survey on nomenclature, reaching out to patients, providers and activists on many online forums and lists. This feedback produced some very interesting findings and provides a great deal of insight into some areas of consensus, as well as some areas of confusion. The survey touched on naming concepts for different medicine types, ideas for clarifying strain names and labeling matters, and thoughts on packaging requirements.

            The community consensus was that the term “Whole Plant Medicine” most accurately described Cannabis in a broad way to include the entire Cannabis plant. The term “plant material” was the second choice. Some other good ideas submitted were whole cannabis plant, medicinal plant, and simply Cannabis. This term is important, as it is the basis for the entire industry. All cannabis medicines are derived from the “whole plant” experience.

            Two terms for describing the “fruit,” more commonly referred to as “buds,” of the Cannabis plant garnered fairly equal support: “flowers” and “buds” ran neck-and-neck in the polling with “flowering clusters” running about 10 percent behind them. Some other good ideas submitted were flowering tops, primary material, female flowering tops, and blossoms. These products are the predominant form of cannabis medicine used by far. Defining a responsible term for them is of paramount importance to our efforts to change the perception of medicinal cannabis.

It is also important to define the term used for a person who produces these medicines, such as patient cultivator or medicinal plant producer.

            When describing the by-product or “trim” of the plants, that is often used in extraction and processing of other medicines the terms “trim” or “trimmings” were the overwhelming choices of those surveyed. “Secondary Material” and “Leaf” were the next nearest, though far behind trim. Other good ideas submitted were “foliage,” and “byproduct.”  This term is also important, as it is a primary ingredient in most medicines derived from cannabis.

            The stems of the plant are not widely used, but are sometimes referred to and used in some preparations. The simple term “stems” received an overwhelming 80% of the choices. Some interesting ideas submitted were “cellulose fiber,” “stem byproducts,” and “woody material.”

            There was an interesting result regarding hashish. When describing the term in general manners the majority of folks believe “concentrate” is the best term, but when asked to describe the different types of hash, such as water and gas processed products, the consensus was that “extraction” was the best choice. Some other terms for hash were “resins,” “concentrated material,” and “concentrated trichomes.”  Hashish is a product which needs to be defined clearly, as it is often the subject of scrutiny by governing bodies. The community can dispel myths of irresponsibility, and open people up to viewing extractions as efficient medicine for patients, by creating a standardized and professional term for this type of medicine.

            Cannabis foods are often misrepresented by the media, by enforcement agencies, and others outside the community. The truth is that ingestible products are one of the safest forms of cannabis medicines as there are no carcinogens being burned and no hot gases to otherwise disrupt lung tissue. The effects are also different from normal inhalation methods of ingestion, that can be beneficial to many patients. The term “food-based medicine” for this product was the favorite choice of those surveyed, with the term “edible” about 6 percent behind. Some other good terms suggested were “nutritional medicines,” “food supplements,” and “medibles.”  Defining these medical food products is essential to their survival in the regulatory process. Alameda County has banned “edibles” at county-regulated facilities. This term “edibles” is one which our community has already adopted and which is being used by some governing authorities. By changing the term to “food-based medicines,” we may change the perception of these products and more clearly define their benefits. There are many medicinal foods available worldwide; it is an emerging industry that we in the cannabis community should follow closely.

            The term “kief” was a clear choice amongst participants for describing what is commonly known as “kief,” the loose resin glands shaken from plant products and ordinarily refined in a screening filter. “Resin Glands” was a distant second. Some other ideas proposed were “dry sift,” “loose resin gland concentrate,” and “dry hash.”  The alternative spelling of “kif” was also suggested. This product is often overlooked by regulators and lumped in with hash products by enforcement agents, but kief can be a very powerful and effective medicine and ingredient in other medicinal products. The way in which this product is named and classified is essential to it being recognized as a legitimate form of cannabis medicine.

Tinctures are often overlooked, as they make up a small portion of the market. Yet cannabis tinctures and elixirs, which were popular at the turn of the century according to the US Pharmacopoeia, are still effective methods today. It is interesting to speculate whether they should be considered an “edible” product or a “concentrated” product. Tinctures are a staple in alternative and herbal medicine supplies and can be made with a number of bases, including alcohol and glycerin. The term “tincture” is a common clinical term for these products, so it is no surprise that this was chosen by an overwhelming majority of participants. These methods of ingestion are essential for many patients, as it allows them to add cannabis essence to beverages or food, and otherwise medicate in an easy-to-consume way. This is extremely important to patients that are working through chemotherapy and wasting as the medicine can be consumed in a mostly unobtrusive manner, and it can take effect rapidly.

            An aspect of nomenclature which is a source of controversy in the cannabis medicine industry is the naming of strain types. Lack of guidelines or regulations has left the door open to individual interpretation. Rolling Stone and other media have in the past exploited some of the more comical or unusual names in order to sensationalize journalistic pieces on the industry. This can create a negative perception of the industry. Some in the public may be offended or skeptical that terms like “Pussy Kush” or “Catpiss” would be used to describe medication. The survey posed the question: “When naming individual cannabis strains what methods could be used to create a system that is more professional in nature and acceptable to societal standards?”  The choices varied from a “coded system” detailing characteristics such as plant fractions and genetics; an “abbreviated system” that would simplify common names into recognizable abbreviations; an “appearance-based system” that would classify medicine into sight and smell based names; or a “simple guideline system” disallowing unethical, pandering, or “humorous” names. The majority of the people surveyed believed that a detailed coded system would be the best option. Not far behind in the voting was the choice to create simple guidelines which allow collectives to name medicine within a clear set of boundaries. Other positive suggestions were to develop gene mapping and DNA ability for strains, using the best scientific and common names available, and naming the medicines based upon actual measured percentages of indica and sativa genetics. This issue is extremely important as it is at the core of the perception of our industry. It is difficult to be taken seriously by medical professionals and regulators when some cannabis medicine names sound childish and comical. Finding a method by which providers can clearly define their medicine type without having to use unprofessional terms will be an important step in creating a more positive perception of the industry.

            Dealing with proper labeling requirements for the many different types of cannabis medicines is also a major part of regulating this industry. Deciding what labeling information is necessary for cannabis medicines will also help to better inform patients and will give providers a framework for providing necessary information to patients. Respondents were surveyed regarding labeling of raw flowers, extractions, food-based medicines, and topical productions.

            The majority believed that type of medicine, production method, manufacturing date, packaging date, and potency were extremely important components that should be on the label for raw flowers. Surprisingly, not many believe that drug facts panels, prominent warnings, list of potential contaminants, or growth term were of much relevance. Other suggestions included net weight, recommendations for day or nighttime use, and curing period.

            The labeling recommendations for extracts were similar to those for raw flowers, not surprising as they are both commonly used in similar manners. People saw a need for labeling to indicate medicine type, production method, manufacturing dates, and strength. Only about half of respondents believed that prominent warnings, possible contaminants, and packaging date were of importance. Drug facts were only deemed necessary by about one third of those surveyed. Also deemed important were suggested use, ingredients, and net weight.

            Food-based medicines seem to get a more rigid response, as most categories listed were chosen by at least two-thirds of participants. One could speculate that there is a perception that the danger is greater with food-based medicines than with other forms of cannabis medicine. Type of medicine used, expiration dating, medical vehicle, ingredients, and dosage were all overwhelmingly chosen as necessary information for edible labels. Most people also saw nutritional values, allergens, usage, storage instructions, and warnings as important. Drug facts was the only category that most participants saw as unnecessary. This could suggest that respondents were unsure of what “Drug Facts” panels are and what purpose they serve. Other suggestions were to declare if it was made with bud or leaf, if it is organic or non-organic, and net weight.

            Topical medicines were also seen as requiring more label information. Type of medicine used, expiration dating, base product, ingredients, usage instructions, storage needs, and dosages were all chosen by the majority of those surveyed as needed information on a label. Warnings, packaging date, and allergens were also deemed important, by a smaller percentage of the group yet still a majority. Drug facts was the only item not receiving a majority vote. Notably, some respondents did not believe in the use of cannabis topical medicines.

            What is on the label of cannabis medicines is extremely important. It is often the only information a patient will have about that particular medication. It also protects the provider by clearly defining the medicine and its suggested uses. In terms of patient safety there may be no better way to convey information than through the packaging of the actual medicines used. Deciding on necessary labeling information for each kind of cannabis medicine enables the industry to develop clearer protocols for providing these medicines.

            The final question concerned packaging of cannabis medicines. The four choices made available were full tamper-resistant packaging, tamper-evident methods, packaging promoting freshness but not required to seal, or no packaging regulations at all. Tamper evident packaging, such as paper or sticker seals that could be seen if broken received the most votes (44%). Full tamper-resistant regulations, and packaging which promotes freshness but does not seal, both received an equal number of votes (30% each). Only 18% supported having no regularion of packaging.

Packaging of cannabis is important for a number of reasons: assurance of freshness, protection from contamination, and discouraging unintended use of the medicine. Packaging cannabis medicines in a manner consistent with societal expectations of medicinal packaging could make those who currently oppose cannabis therapies more open to their use, as well as creating an environment of patient safety and satisfaction.

            This survey was conducted with over one hundred and fifty activists and medical cannabis stakeholders. While a relatively small sample, the results provide a good measure of the community’s perception of the current state of affairs and where they would like to see the movement progress. The community will be implementing these standards, so finding out what this sample sees as optimal choices regarding the many nomenclature issues surrounding medical cannabis will help the community to make more clear and informed decisions.

What Terms Do Other Agencies and Organizations Use?

            Vast amounts of material from agencies and organizations which have established terms of reference for cannabis and other herbal medicines have been researched and analyzed in order to come up with language which is relevant to our industry. The following are findings from these organizational practices and ideas:

European Union/European Commission

            The European Union does not officially regulate cannabis medicine in any manner. Most countries in Europe have yet to allow the use of cannabis medicines. The EU has an extensive program regulating use of herbal medicines which could serve as a model for this project in creating standards for production, storage, processing, documentation, and quality control in the cannabis industry. There are also terms which may be adopted and adapted to the medical cannabis industry.

            Plants used in the creation of herbal medications are referred to as “Medicinal Crude Plants” In their whole-plant state This term acknowledges the plant as medicinal though it is in a crude, raw form and can thus be further refined for medicinal purposes. EU documents refer to some preparations as “extracts” or “extractions,” and “tinctures.” They refer to “concentration stages” in requirements for documenting the processing of medicinal crude plants into products such as “liquids, creams, and ointments.” The EU requires that producers clearly identify whether the “whole plant” or only part of the plant was used in the refinement process. “Starting material” is a term repeatedly used in the EU’s documentation process in relation to “finished products.” The term used for finished products is “vegetable drug preparations.”

            There are references to cannabis on EU websites, but not in relation to any regulatory processes. They seem to be very in line with terminology used by the World Health Organization, and many related materials from the EU overlap with terms used by the WHO. They refer to the botanical name of the plant, Cannabis sativa, and refer to its preparations as “teas, hash, or resin.” These terms could be adopted and adapted as appropriate nomenclature by the more advanced organizations in regulating herbal medicines. Furthermore, these sound EU policies can serve as a blueprint of global expectations for regulating the methods and processes by which herbal preparations are created.

Netherlands: Office of Medicinal Cannabis

            The Netherlands may have the most advanced program for actual regulation of medicinal cannabis. Its program is inclusive, as only three companies make medicinal-grade cannabis for patient consumption. The Netherlands is widely known for its tolerance of cannabis in a more social (i.e. non-medical) environment yet the production methods used in creating cannabis medicines are taken very seriously.

            The producer of “Bedrocan” details their production methods, highlighting the extremely sterile and environmentally-friendly regulations they have for producing cannabis. They explain that hygiene is their number one method for avoiding plant contamination. Thorough, daily inspection of garden areas and use of only cleaning solvents which leave no residue are important elements in their production process. They go into great detail about the importance of not afflicting the environment during production, highlighting their use of energy-efficient lighting and climate control, recycling rock wool to make roads, and methods by which they dispose of wastewater. These ideas provide great models for possibly reducing the environmental impact of producing cannabis medicines.

            The terminology used by the Netherlands is of major interest as they represent the most advanced system currently available. They use the simple term “Cannabis” when referring to the plant in whole form. They describe the medicinal product of cannabis as “dried flowers of the female cannabis plant.”  There is an ongoing debate as to whether cannabis is a “magisterial preparation,” which is prescribed and covered by national insurances, or if it is a “standardized preparation,” much like over-the-counter medications here in the US, that would not be covered by insurances. At present, national insurance providers in the Netherlands cover most cannabis medicines.

            The Office of Cannabis Medicines prohibits any claim that any cannabis medicines are organic, thus resulting in the use of the term “bio” by producers. The Office also also the term “cannabis resin” for extracted preparations commonly known as hashish. They have two recommended “methods of administration”: “oral” and “inhalation.”  They even have a recipe for making a cannabis-based tea, in which they recommend adding milk to the tea if storing it to bind the medicinal properties of the cannabis.

            They use the term “dried inflorescences” for flowers in their labeling process and refer to “absorption rates” in their instructions for use. Their labeling requirements for cannabis medicines are extremely detailed and give the patient a great deal of information about their medicine. The labels detail the “appearance, identity, microscopy, fineness, absence of pesticides, foreign material, and mold and aerobic bacteria contents.”  They clearly specify the results of “thin layer chromatography,” defining the levels or lack of many elements including lead, mercury, cadmium, dronabinol, cannabinol, and other related substances. They even detail the moisture content and expected loss on drying. Their “assay” section goes into detail about the many active ingredients and they use the term “fingerprint” in discussing the monographic similarities of the medicine.

             The program in the Netherlands may be more advanced than is practical for California in the introductory stages of labeling cannabis medicines as appropriate testing is not yet available on a large scale, yet it is important to envision the future and begin looking more deeply into these processes. “Specifications” are given with each 5-gram allotment of medical cannabis to ensure that patients are well informed about the properties of their medicine. There are many areas of information, such as appearance and microscopy, which could immediately be applied in California’s current environment and be given to the patient with their medicine in order to address some of the safety concerns and labeling practices of cannabis medicines.

            A clearer understanding of what is expected of medical cannabis companies which are currently regulated in the Netherlands can help provide a window into what may be expected of producers of cannabis medicines here at home. Replicating portions of this detailed program where feasible may help provide assurances into the safety of cannabis medicines and create better understanding among medical professionals, regulators, and concerned citizens who use the lack of safety regulation in the manufacturing process to excuse their lack of support of cannabis therapies.

International Association of Plant Taxonomy and Small and Cronquist

            The International Association of Plant Taxonomy in association with the Royal Gardens in the United Kingdom declared that this subject had virtually lain dormant since the 1970s. They submitted as the most common reference a study done by Small and Cronquist in 1976, “A practical and natural taxonomy for Cannabis.” This is a highly debated study, as Small and Cronquist claim that there is one “single, highly variable species” of cannabis, Cannabis sativa. They claim that the many seemingly different “types” or “strains” of cannabis are the results of genetic selection that have evolved due to “morphological and geographical conditions, chemical induced features, features of cytology and breeding behavior as essential specific criteria, and phenotypic data.” 

            They claim that there are three common “species” of cannabis, being C. sativa, C. indica, and C. ruderalis. They refer to three types of “cannabis drugs” in their work. They refer to “marihuana, hashish, and hashish oil” as common forms of these drugs. They repeatedly refer to cannabis as being “wild or domesticated,” and refer to “taxonomic delimitation” as the reason for the many different types of Cannabis sativa. There are many short writings in opposition to Small and Cronquist’s research and conclusions, but as Cannabis is largely a prohibited drug little work has been done in this area. It is significant that this study was done shortly after the Controlled Substance Act was enacted in the US. Also, the Psychotropic Substances Act of 1978 which amended the CSA to conform to United Nations treaties stifled the research on this subject. As a result, Small and Cronquist’s outdated and subjective material is the most in-depth “bona fide” study of the species of Cannabis sativa.

International Conference On Cannabis

            The International Conference on Cannabis issued a detailed report on their findings which included some very useful terms. They referred to “whole plant preparations” as being more beneficial than “isolated substances” such as dronabinol or CBN alone. They repeatedly refer to “raw material” and refer to the “dosage form” as a very important aspect to cannabis therapy. The ICC briefly touches on the different “cannabis preparations and products,” including “hashish.” Potency levels range from “very strong, to strong, to moderate, and mild.” Their preferred term for cannabis flowers is “sinsemilla blossoms,” and they acknowledge the many “variations” of the cannabis plant. These terms are used by some of the leading researchers in the field of cannabis studies and carry scientific weight. These terms are quite useful when looking at the industry through the scope of researchers and medical professionals.

Health Canada

            Health Canada is the government agency regulating the developing medical cannabis industry in Canada. This government agency is currently revising its policies and recently changed its distribution practices. When Canada’s program began, HC contracted with one company to grow its cannabis. They had less than stellar results and have since revamped their system to allow independent producers to apply for a “License to Produce” which can even be done in an “ordinary place of residence.”  They use the term “marihuana” in most of their documentation, often referring to the botanical name Cannabis sativa L. “Indica” in their descriptions. Common terms are “dried and milled marihuana or cannabis plants.”

            Their strain allocation is referred to in a very scientific sounding “hybridization of MS-17/338 and MS/17/596” which is most likely a code of some sort, but at the time of this writing has yet to be confirmed by a representative of Health Canada. They send “seeds” of this strain to those with a valid license to produce. The plants’ appearance is described in their patient information literature as “dense, conical, resin laden flowering heads.”

            Health Canada allows use of cannabis for patients with symptom categories of 1, 2, and 3. Symptom Category 1 refers to the most serious afflictions, Symptom Category 2 refers to less serious conditions requiring more than one professional recommendation, and Symptom Category 3 are the least serious afflictions requiring multiple opinions and sworn affidavits that all other options have been exhausted. They refer to cannabis in terms of “conventional treatment” for some symptoms and serving a “medical purpose” for other afflictions.

            In dealing with cultivation Health Canada refers to “production areas or sites” and requires the producer to clarify if the product is grown “indoors, outdoors, or partly indoors/outdoors.” They require that the producer define the “form” in which the medicine is produced and the suggested “route of administration” for patients. A patient is required to apply for an “Authorization to Possess.” Those holding a license to produce are subject to searches by regulators and law enforcement at any time to ensure compliance with the program’s standards and regulations. They also have an intricate method of deciding how much medicine can be produced by calculating a patients “daily required dosage” in grams in conjunction with the “growth cycle of a marihuana plant from seedling to harvest” to determine the maximum number of plants a producer may grow at any given time.

            The “specification sheet” which accompanies cannabis medicines delivered to patients is extremely detailed, much like those in the Netherlands program. The sheet includes categories for “strain (selected line), description (mature flowering heads), thc level, and moisture content.”  They provide a detailed leaflet to patients which includes “storage instruction, more detailed plant description, cannabinoid levels, chemical profile, physical identity, pesticides (if any), foreign materials present, chemical identity, potency levels, metals and heavy metals (if any), microbiological purity, aflatoxins, and general information.”  For seed shipments, the germination process is defined as well. These details may be impractical in the current medical cannabis environment in America, but can serve as a possible roadmap for the future. Learning to adhere to as many of these practices as possible will provide the patient with more information for their well-being and will address concerns of those interested in the safe production and handling of cannabis medicines.

World Health Organization (WHO)

            The World Health Organization is a leader in the advancement of herbal medicines and recognizing the need to regulate these types of therapies. Many of their terms are similar to those used in the European Commission section so more general terms for herbal medicines need not be repeated here, yet they do have some important, definitive terms regarding cannabis.

            For the most part the WHO refers to marijuana simply as “cannabis.” They refer to THC as being the “major psychoactive constituent” in cannabis. They use the term “crude plant material” to refer to cannabis in its raw form. Their references to cannabis preparations include “hashish, cannabis oil (hashish oil), and concentrate of cannabinoids.” They refer to methods of “solvent extraction of crude plant material in the making of resin.” The WHO clearly states that its contention that lower prices of cannabis lead to more abuse, yet they do recognize that “therapeutic uses of cannabinoids are being demonstrated by controlled studies, including treatment of asthma and glaucoma, as an antidepressant, appetite stimulant, anticonvulsant and anti-spasmodic, research in this area should continue.”

            The World Health Organization is a highly respected global agency which has done a great deal of work confronting the challenges faced in the declaration of all herbal treatments as medicines, working to develop sound practices and standards for their production and uses. The model they set forth is extremely detailed and will most likely become the international standard for producing herbal medicines, as society grows to accept these natural forms of medicine, cannabis included. It would be beneficial to begin adopt, adapt, and implement certain of their practices in the standards and guideline being developed here in California.

FDA Definitions for Controlled Substances

            The US Food and Drug Administration draws its terms for cannabis from the Controlled Substances act. They refer to “marihuana” as “all parts of Cannabis sativa L., whether growing or not.”  The act refers to “seeds,” and “resin extracted from any part of such plant.”  It defines for legal purposes “every compound, manufacture, salt, derivative, mixture, or preparation of such plant” in order to fully encompass the meaning of cannabis and the many methods of its use. They use the term “agent” in describing a “manufacturer, distributor, or dispenser” of controlled substances of any kind. The terms defined for methods of using controlled substances are “injection, inhalation, ingestion, or any other means by which a substance can be taken.” They define the term “manufacture” as the “production, preparation, propagation, compounding, or processing by extraction from substances of natural origin.” These are legal terms used for all medicines and drugs, and are associated with the use and manufacturing of controlled substances. The terms are very relevant because they are used by the US Food and Drug Administration, which could ultimately be the agency responsible for classifying, scheduling, and regulating the medical cannabis industry in the US.

U.S. Pharmacopoeia Verified Program for Dietary Supplements

            The U.S. Pharmacopoeia Verified Program directly addresses the need to better regulate the herbal products industry. They claim that products carrying their verified logo have been thoroughly tested and adhere to high levels of “integrity, purity, dissolution, and safe manufacturing.” The USP recognizes “botanical extracts” as a valid form of therapy and all supplements must adhere to their “rigorous program requirements.” They guarantee that products they verify are “consistent in quality from batch to batch,” and that they have conformed to an “accepted manufacturing process.” Herbal products are tested for “acceptable levels of contamination” and are tested to verify the “certificate of analysis claims” for each product. Recognized product types are “caplets, hard gelatin capsules, liquids, powders, soft gelatin capsules, tablets, and teas.” Their labels must contain a minimum of “product name, official name: finished product, item code numbers, bulk product code numbers, and product specifications in detail.” This organization’s focus on voluntarily verifying and certifying these lightly regulated herbal products does not entirely transfer to the system of cannabis medicines, but their principles and methodology are extremely relevant to the self-regulatory model which the cannabis industry may have to implement.

State of California

            The State of California has terms associated with medical cannabis from the Compassionate Use Act (Prop. 215) and State Bill 420. Some useful terms are “qualified patient and primary caregiver” in defining who may lawfully possess cannabis medicines. The “serious medical conditions” for which cannabis is allowed to be used in California are “AIDS, Anorexia, Arthritis, Cachexia, Cancer, Chronic Pain, Glaucoma, Migraine, Muscle Spasms (MS), Seizures (Epilepsy), Nausea, Chronic or Persistent Medical Symptoms.” California medical cannabis laws refer to “dried marijuana and dried mature flowers of female plants.” They use the term “smoke or otherwise consume” in referring to ingestion methods. The terms “cultivate or distribute” are used to refer to methods of providing cannabis. The former California Attorney General Bill Lockyer referred to “concentrated cannabis or hashish,” in his opinion that concentrates be treated in the same manner as raw cannabis. These terms are important, as they are the definitions currently being used to describe cannabis therapies in the legal process in California. Learning to use these terms or adjust them where necessary is helpful in addressing an audience of could be regulators in the future.

Conclusion

            No clear “correct” nomenclature and standards have yet been set for the emerging medical cannabis industry. We have the opportunity to make informed decisions and recommendations in order to create better understanding among the community. Standards are necessary for a number of reasons. Providing clarity to patients ensures a safer environment in which to access cannabis therapies. A clear message in our collective communications will encourage regulators to adopt our terminologies and base their decisions on information that is reasonable and accurate in nature. Creating a perception of professionalism and having a more consistent attention to detail will help to open the hearts and minds of medical professionals, hesitant patients, and opposing agencies which are merely misinformed about cannabis medicines and their history of safe use.

            The terms recommended by the MCSC can help provide appropriate structure to the broader community as the industry promulgates standards. Ideally all dispensing collectives, patients, and providers of medicine would adopt such standards, thus providing clarity and unity for the industry. Official recommendations will be vetted thoroughly by the community and will represent the ideals and principles toward which we want collectively to move. Mastering the language associated with the industry and its many stakeholders is vital for providing a clear framework on which to build. Cannabis is the medicine of the future. We must begin to clarify our expectations for the many people involved in the medical cannabis continuum, from plant to patient. It is hoped that as the industry moves forward this report will spark a dialogue about the nomenclature issues facing the community.

Saturday, August 22, 2009

History of Medical Cannabis

Cannabis was a part of the American pharmacopoeia until 1942 and is currently available by prescription in the Netherlands, Canada, Spain, and Italy in its whole plant form.

In 1937, the U.S. passed the first federal law against cannabis, despite the objections of the American Medical Association (AMA). Dr. William C. Woodward, testifying on behalf of the AMA, told Congress that, "The American Medical Association knows of no evidence that marijuana is a dangerous drug" and warned that a prohibition "loses sight of the fact that future investigation may show that there are substantial medical uses for Cannabis."

Ironically, the U.S. federal government currently grows and provides cannabis for a small number of patients. In 1976 the federal government created the Investigational New Drug (IND) compassionate access research program to allow patients to receive up to nine pounds of cannabis from the government each year. Today, five surviving patients still receive medical cannabis from the federal government, paid for by federal tax dollars.

In 1988, the DEA's Chief Administrative Law Judge, Francis L. Young, ruled after extensive hearings that, "Marijuana, in its natural form, is one of the safest therapeutically active substances known... It would be unreasonable, arbitrary and capricious for the DEA to continue to stand between those sufferers and the benefits of this substance..." Yet the DEA refused to implement this ruling based on a procedural technicality and resists rescheduling to this day.

In 1989, the FDA was flooded with new applications from people with HIV/AIDS. In June 1991, the Public Health Service announced that the program would be suspended because it undermined federal prohibition. Despite this successful medical program and centuries of documented safe use, cannabis is still classified in America as a Schedule I substance “indicating a high potential for abuse and no accepted medical value. Healthcare advocates have tried to resolve this contradiction through legal and administrative channels to no avail.

In 1996, patients and advocates turned to the state level for access, passing voter initiatives in California and Arizona that allowed for legal use of cannabis with a doctor's recommendation. These victories were followed by the passage of similar initiatives in Alaska, Colorado, Maine, Montana, Nevada, Oregon, Washington, and Washington D.C. The legislatures of Hawaii, Maryland, New Mexico Rhode Island, and Vermont have also acted on behalf of their citizens, and every legislative session sees more bills introduced at the state level across the country.

In 1997, The Office of National Drug Control Policy commissioned the Institute of Medicine (IOM) to conduct a comprehensive study of the medical efficacy of cannabis therapeutics. The IOM concluded that cannabis is a safe and effective medicine, patients should have access, and the government should expand avenues for research and drug development. The federal government has completely ignored its findings and refused to act on its recommendations.

Despite the federal barriers to research, hundreds of peer-reviewed studies have been published worldwide since the IOM report. While there is still much to learn, the medical potential is indisputable for a variety of symptoms and conditions.

In 1997, the federal government began a campaign to arrest and prosecute medical cannabis patients and their providers. These raids resulted in two Supreme Court Cases, OCBC and Gonzales v. Raich. In each of these cases the Justices found that the federal law and state law can exist in conflict and that the federal government could continue their campaign against medical cannabis patients if they so choose. However, the Justices questioned "the wisdom' of going after patients and their providers and called on Congress to change the current laws to allow for medical use.

Since the U.S. Supreme Court decision in Gonzales v. Raich, on June 6, 2005, the federal government has intensified its war against patients across the state of California. These raids have resulted in more than two-dozen patients and providers being needlessly prosecuted by the federal government.

Unfortunately, these defendants will not be permitted to mention during trial that their use of cannabis was for legitimate purposes and in accordance with state law. These raids alone are estimated to have cost taxpayers over $10,000,000.

Patients who could and do benefit from cannabis therapeutics face a variety of challenges at both the federal and state levels. Patients have been made to needlessly suffer because they have been denied access or, worse, because they have been imprisoned for using a medicine their doctors recommended.

Medical cannabis patients and current Executive Director Steph Sherer founded Americans for Safe Access (ASA) in 2002 in response to federal raids on patients in California. Ever since then, ASA has been instrumental in shaping the political and legal landscape of medical cannabis. Our successful lobbying, media, and legal campaigns led to positive court precedents, new sentencing standards, more compassionate legislative and administrative polices and procedures, as well as new legislation.

ASA protects the rights of cannabis patients. We are working to change federal policy to meet the immediate needs of patients as well as create long-term strategies for safe access and programs that encourage research.

Our goals are to:

  • Establish Federal Legal Protections for Medical Cannabis Patients and their Providers
  • Implement the Institute of Medicine recommendations, provided in its 1999 report,Marijuana and Medicine.
  • Create a National, Comprehensive and Safe Access Plan

Friday, August 21, 2009

Medical Cannabis Endorsements

Safe access to cannabis for patients and research has been endorsed by a growing number of professional healthcare organizations, including the American Public Health Association, the American Nurses Association, and most recently, the Medical Student Section of the American Medical Association.

Medical Marijuana Endorsements and Statements of Support

The following is a representative sample of the large number of government panels, medical organizations, health charities and individuals of note who have publicly stated their support for medical access to marijuana and/or their opposition to criminal penalties for medical marijuana users.

" Nausea, appetite loss, pain and anxiety are all afflictions of wasting, and all can be mitigated by marijuana." 
- Institute of Medicine, "Marijuana and Medicine: Assessing the Science Base," 1999

" [T]here will likely always be a subpopulation of patients who do not respond well to other medications ... The critical issue is not whether marijuana or cannabinoid drugs might be superior to the new drugs, but whether some group of patients might obtain added or better relief from marijuana or cannabinoid drugs ... Although some medications are more effective than marijuana for these problems, they are not equally effective in all patients." 
- Institute of Medicine, "Marijuana and Medicine: Assessing the Science Base," 1999

" ACP urges review of marijuana status as a Schedule I controlled substance and reclassification into a more appropriate schedule, given the scientific evidence regarding marijuana's safety and efficacy in some clinical conditions ... Given marijuana's proven efficacy at treating certain symptoms and its relatively low toxicity, reclassification would reduce barriers to research and increase availability of cannabinoid drugs to patients who have failed to respond to other treatments."

" ACP strongly urges protection from criminal or civil penalties for patients who use medical marijuana as permitted under state laws." 
-American College of Physicians (representing 124,000 members, ACP is the largest specialty and second largest medical society in the U.S.), January 2008

" [T]he Leukemia & Lymphoma Society supports legislation to remove criminal and civil sanctions for the doctor-advised, medical use of marijuana by patients with serious physical medical conditions ... [the] Leukemia & Lymphoma Society strongly urge that in a state where patients are permitted to use marijuana medicinally for serious and/or chronic illnesses and a patient's physician has recommended its use in accordance with that state's law and that state's medical practice standards, the patient should not be subject to federal criminal penalties for such medical use." 
- Leukemia & Lymphoma Society, July 2007

" The American Academy of Addiction Psychiatry endorses the Institute of Medicine (IOM) report supporting the therapeutic value of cannabinoid drugs for pain relief, control of nausea and vomiting and appetite stimulations for debilitating conditions such as AIDS. We are in favor of compassion for the ill and the availability of marijuana for medical purposes based on current evidence." 
- American Academy of Addiction Psychiatry, "Medical Use of Marijuana," June 2002, www.aaap.org/policies/marijuana.html

" [The AAFP accepts the use of medical marijuana] under medical supervision and control for specific medical indications." 
- American Academy of Family Physicians, 1989, reaffirmed in 2001

" When appropriately prescribed and monitored, marijuana/cannabis can provide immeasurable benefits for the health and well-being of our patients." 
- American Academy of HIV Medicine, 2003

" Therefore be it resolved that the American Nurses Association will: ... Support the right of patients to have safe access to therapeutic marijuana/cannabis under appropriate prescriber supervision." 
- American Nurses Association, resolution, 2003

" Approved medical uses for marijuana or [THC] for treatment of glaucoma, illnesses associated with wasting such as AIDS, the emesis associated with chemotherapy, or other uses ... should be administered only under the supervision of a knowledgeable physician." 
- American Society of Addiction Medicine, April 16, 1997

" The CMA has always recognized and acknowledged the unique requirements of those individuals suffering from a terminal illness or chronic disease for which conventional therapies have not been effective and for whom marijuana for medicinal purposes may provide relief." 
- Canadian Medical Association, January 2006, www.cma.ca/index.cfm/ci_id/3396/la_id/1.htm

" Present evidence indicates that [cannabinoids] are remarkably safe drugs, with a sideeffects profile superior to many drugs used for the same indications." 
- British Medical Association, November 1997

" For a significant number of patients, clinical experience and research confirm that marijuana serves as the only effective medicine for relieving pain, suppressing nausea or stimulating appetite. Numerous studies by blue-ribbon government panels and federally funded, peer-reviewed scientific studies have consistently found that marijuana is effective for treating certain debilitating symptoms." 
- American Pain Foundation, American Medical Women's Association, Lymphoma Foundation of America, American Nurses Association, California Nurses Association, AIDS Action Council, National Women's Health Network, Doctors of the World-USA, Gay Men's Health Crisis, Amici Curiae in Support of Petitioner, Ross v. Ragingwire, 2006 WL 3244938 (August 7, 2006 Appellate Brief)

" [M]arijuana has an extremely wide acute margin of safety for use under medical supervision and cannot cause lethal reactions ... [G]reater harm is caused by the legal consequences of its prohibition than possible risks of medicinal use." 
- American Public Health Association, Resolution #9513, "Access to Therapeutic Marijuana/Cannabis," 1995

" [T]he use of marijuana may be appropriate when prescribed by a licensed physician solely for use in alleviating pain and nausea in patients who have been diagnosed as chronically ill with life threatening disease, when all other treatments have failed." 
- The Medical Society of the State of New York, May 3, 2004

" [T]here is sufficient evidence for us to support any physician-patient relationship that believes the use of marijuana will be beneficial to the patient." 
- Rhode Island Medical Society, 2004

" [The] CMA continue to support the ability of physicians to discuss and make recommendations concerning the potential benefits or harm to the patient of smoked herbal cannabis consistent with state and federal law and oppose criminal prosecution of patients who possess or use smoked herbal cannabis for medical reasons upon the recommendation of a physician." 
- California Medical Association, October 30, 2006

" [I]t cannot seriously be contested that there exists a small but significant class of individuals who suffer from painful chronic, degenerative, and terminal conditions, for whom marijuana provides uniquely effective relief." 
- HIV Medicine Association of the Infectious Diseases Society of America, American Medical Students Association, Lymphoma Foundation of America, Dr. Barbara Roberts, and Irvin Rosenfeld, Amicus Curiae brief filed in the U.S. Supreme Court (in the case of Gonzales v. Raich), October 2004

" We think people who use cannabis to relieve the pain of arthritis should be able to do so." 
- Arthritis Research Campaign, October 23, 2001

" Whitman-Walker Clinic supports the valid use of marijuana, under a physician's supervision, to help alleviate AIDS wasting syndrome and nausea associated with treatment regimes." 
- Whitman-Walker Clinic, April 1998

" [F]or cancer patients with advanced cancers who want to improve the quality of their life, a risk versus benefit analysis [of smoked medical marijuana] weighs heavily on the benefit side." 
- Cancer Monthly, May 2006

" In states where patients are permitted to use marijuana medicinally for serious and/or chronic illnesses and a patient's physician has recommended its use in accordance with that state's law and that state's medical practice standards, the patient should not be subject to federal criminal penalties for such medical use." 
- HIV Medicine Association, October 30, 2006

" The American Medical Student Association strongly urges the United States government ... to reschedule marijuana to Schedule II of the Controlled Substance Act, and ... end the medical prohibition against marijuana." 
- American Medical Students Association, March 1993

" [We] recommend that the APA support the AMA recommendation, 'The AMA believes that effective patient care requires the free and unfettered exchange of information on treatment and alternatives and that discussion of these alternatives between physicians and patients should not subject either party to criminal sanctions.'" 
- Assembly of the American Psychiatric Association, November 3, 2007 (Note: This language has not been yet been adopted as official policy of the APA)

" [We] support protection for patients and physicians participating in state approved medical marijuana programs." 
- Assembly of the American Psychiatric Association, November 3, 2007 (Note: This language has not been yet been adopted as official policy of the APA)

" [The LFA] urges Congress and the President to enact legislation to reschedule marijuana to allow doctors to prescribe smokable marijuana to patients in need ... [and] urges the U.S. Public Health Service to allow limited access to medicinal marijuana by promptly reopening the Investigational New Drug compassionate access program to new applicants." 
- Lymphoma Foundation of America, January 20, 1997

" [We] support the right of physicians to recommend marijuana for limited medical purposes, consistent with prevailing state laws. [We] recommend that patients be protected when in possession of and/or using legal quantities of marijuana under physician supervision in state-sanctioned medical marijuana programs. [We] recommend to the federal government that it revise its current policies that subject patients to the threat of federal arrest and prosecution even though they are under physician supervision and in possession of legal quantities of medical marijuana under state-sanctioned programs." 
-Marijuana: Medical Use Action Paper endorsed by various members of the American Psychiatric Association in leadership positions, including seven past presidents, two trustees, and the APA Lifers, November 2007

" [A] federal policy that prohibits physicians from alleviating suffering by prescribing marijuana for seriously ill patients is misguided, heavy-handed, and inhumane." 
- Dr. Jerome Kassirer, "Federal Foolishness and Marijuana," editorial, New England Journal of Medicine, January 30, 1997

" [T]he American Association for Social Psychiatry supports full legal status for states to implement their own doctor-advised, medical marijuana programs for patients with serious physical medical conditions ... [T]he American Association for Social Psychiatry strongly urge that in a state where patients are permitted to use marijuana medicinally for serious and/or chronic illnesses and a patient's physician has recommended its use in accordance with that state's law and that state's medical practice standards, the patient should not be subject to federal criminal penalties for such medical use." 
- American Association for Social Psychiatry, May 20, 2007

"[We] support pharmacy participation in the legal distribution of medical marijuana." 
- California Pharmacists Association, May 26, 1997

" The evidence is overwhelming that marijuana can relieve certain types of pain, nausea, vomiting and other symptoms caused by illnesses like multiple sclerosis, cancer and AIDS - or by the harsh drugs sometimes used to treat them. And it can do so with remarkable safety. Indeed, marijuana is less toxic than many of the drugs that physicians prescribe every day." 
- former U.S. Surgeon General Joycelyn Elders, M.D., "Myths About Medical Marijuana," Providence Journal, March 26, 2004

" We must make sure that the casualties of the war on drugs are not suffering patients who legitimately deserve relief." 
- Scott Fishman, president of the American Academy of Pain Medicine, February 2006

" It [medical marijuana] should be an option for patients who have it recommended by knowledgeable physicians." 
- Dr. Jesse L. Steinfeld, former U.S. Surgeon General, July 2003

" Marijuana, in its natural form, is one of the safest therapeutically active substances known ... The evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. It would be unreasonable, arbitrary and capricious for [the] DEA to continue to stand between those sufferers and the benefits of this substance." 
- Francis L. Young, DEA Chief Administrative Law Judge, 1988

" I consider the most important recommendation made by the IOM (Institute of Medicine) panel [to be] that physicians be able to prescribe marijuana to individual patients with debilitating or terminal conditions ... I believe such compassionate use is justified." 
- Andrew Weil, M.D., July 1999

" Cannabinoids and THC also have strong pain-killing powers, which is one reason medical marijuana should be readily available to people with cancer and other debilitating diseases." 
- Dean Edell, M.D., March 2, 2000

" I'm an oncologist as well as an AIDS doctor, and I don't think that a drug that creates euphoria in patients with terminal diseases is having an adverse effect." 
- Donald Abrams, M.D. 2005

" Cannabis will one day be seen as a wonder drug, as was penicillin in the 1940s. Like penicillin, herbal marijuana is remarkably nontoxic, has a wide range of therapeutic applications and would be quite inexpensive if it were legal." 
- Dr. Lester Grinspoon, professor of psychiatry at Harvard Medical School, Los Angeles Times, May 5, 2006

" Not everybody needs marijuana for medical illness. But for those who really do, it's very helpful. As more and more states are taking medical marijuana – New Mexico just did it the other day – eventually it will just be overwhelming. And it will happen. But I'm shocked that it's taken this long." 
- Dr. Thomas Ungerleider, Professor Emeritus of psychiatry at UCLA and member of President Nixon's National Commission on Marijuana and Drug Abuse, "3rd Degree," LA City Beat, March 29, 2007

" Overall, by comparison with other drugs used mainly for 'recreational' purposes, cannabis could be rated to be a relatively safe drug ... In contrast, cannabis might have beneficial effects in some medical indications ... It seems likely that medicinal cannabis will re-enter the pharmacopeia." 
- Dr. Leslie Iversen, pharmacologist at Oxford University and member of the British government's Advisory Council on the Misuse of Drugs, "Long-term effects of exposure to cannabis," Current Opinion in Pharmacology, 2005

" Cannabinoids, the active components of cannabis sativa and their derivatives ... exert palliative effects in patients with cancer and inhibit tumour growth in laboratory animals."
- Dr. Manuel Guzman, associate professor of biochemistry and molecular biology at Complutense University, Madrid, Spain, "Cannabinoids: Potential Anti-Cancer Agents," Nature Reviews - Cancer, October 2003

" 54% of oncologists favor the controlled medical availability of marijuana, and 44% have advised at least one of their cancer patients to obtain marijuana illegally." 
- Doblin/Kleiman (Harvard University) scientifically valid, random survey of oncologists, Journal of Clinical Oncology, 1990

" I have spent my entire career in search of more effective treatments for this awful disease [amyotrophic lateral sclerosis (ALS, aka Lou Gehrig's disease)]. We have now found that the cannabinoids, the active ingredients in medical marijuana, work remarkably well in controlling the clinical symptoms of ALS. Even more exciting is that we are now discovering that the cannabinoids actually protect nerve cells and may prolong the life of patients with ALS." 
- Gregory Carter, M.D., clinical professor of Rehabilitation Medicine, University of Washington School of Medicine, and co-director, Muscular Dystrophy Association (MDA)/Amyotrophic Lateral Sclerosis (ALS) Center (testimony submitted to Illinois Senate Public Health Committee, March 2007)

" There is no problem, basically, with marijuana as a medicine ... Marijuana is no different than morphine, no different than codeine, no different than Aspirin." 
- Health Canada's Jeremy Mercer, "'We Will Approve Marijuana Prescriptions: Marijuana 'No Different than Aspirin,' Health Canada official says," Ottawa Citizen, December 19, 1997

" [R]esearch has shown that cannabis can be of medicinal use. ... This is an area where public health must prevail." 
- Belgian Ministry of Health, Willem Scholten, "Statement of the Health Ministry," IACM Conference, Brussels, September 4, 2003

" Despite the positive appraisal of the therapeutic potential of cannabinoids ..., they have not been widely used ... Part of the reason for this is that research on the therapeutic use of these compounds has become a casualty of the debate in the United States about the legal status of cannabis ... As a community we do not allow this type of thinking to deny the use of opiates for analgesia. Nor should it be used to deny access to any therapeutic uses of cannabinoid derivatives that may be revealed by pharmacological research." 
- Australian National Task Force on Cannabis, Wayne Hall, Nadia Solowij, and Jim Lemon, "The health and psychological consequences of cannabis use," National Drug Strategy Monograph Series No. 25, 1994, www.health.gov.au/internet/wcms/publishing.nsf/Content/health-pubs-drug-cannab2-home.htm

" People can debate marijuana's potential for abuse, but it is increasingly clear that cannabis has definite medicinal benefits. Studies and abundant anecdotal evidence demonstrate that marijuana can stimulate the appetites of people with AIDS and cancer, reduce nausea in chemotherapy patients, and help people with such debilitating conditions as multiple sclerosis, diabetes and glaucoma." 
- Wesley J. Smith, senior fellow at the Discovery Institute, San Francisco Chronicle, December 2, 2007

" So let`s get this straight: I am against the legalization of marijuana ... However, there are cases when marijuana makes sense, like in medicine. There are a host of serious diseases when smoking pot is the best and sometimes the only relief for pain and suffering. There are plenty of people who abuse all sorts of prescription drugs, but law-abiding citizens can still have access if they need them. So, when I read about the Drug Enforcement Agency, the DEA, raiding ten medical marijuana clinics in California last week, totally legal businesses. I have to agree with the critics that call this case, and the DEA, bullies." 
- Glenn Beck, August 3, 2007

"[We] recommend ... allow[ing] [marijuana] prescription where medically appropriate." 
- National Association for Public Health Policy, November 15, 1998

" The National Nurses Society on Addictions urges the federal government to remove marijuana from the Schedule I category immediately, and make it available for physicians to prescribe. NNSA urges the American Nurses Association and other health care professional organizations to support patient access to this medicine." 
- National Nurses Society on Addictions, May 1, 1995

" Marijuana has proven to be effective in the treatment of people with HIV/AIDS, multiple sclerosis, cancer, and those suffering from severe pain or nausea ... The legalization of medical marijuana would be a step forward for the health of all New Yorkers." 
- New York State Association of County Health Officials, resolution, 2003

" The SFMS takes a support[ive] position on the California Medical Marijuana Initiative [legalizing medical marijuana]." 
- San Francisco Medical Society, August 1996

" [The American Bar Association] recognizes that persons who suffer from serious illnesses for which marijuana has a medically recognized therapeutic value have a right to be treated with marijuana under the supervision of a physician." 
- American Bar Association, May 4, 1998

" If Cannabis were unknown, and bio-prospectors were suddenly to find it in some remote mountain crevice, its discovery would no doubt be hailed as a medical breakthrough. Scientists would praise its potential for treating everything from pain to cancer, and marvel at its rich pharmacopoeia - many of whose chemicals mimic vital molecules in the human body." 
- "Reefer Madness, Marijuana Is Medically Useful Whether Politicians Like It or Not," The Economist, April 29, 2006

Great Info from the Good Folks at Americans For Safe Access

 "As the number of patients in the state of California who rely upon medical cannabis for their treatment continues to grow, it is increasingly imperative that cities and counties address the issue of dispensaries in our respective communities. In the city of Oakland we recognized this need and adopted an ordinance which balances patients' need for safe access to treatment while reassuring the community that these dispensaries are run right. A tangential benefit of the dispensaries has been that they have helped to stimulate economic development in the areas where they are located." 
—Desley Brooks, Oakland City Councilmember

 
ABOUT THIS REPORT
Land-use decisions are now part of the implementation of California's medical marijuana, or cannabis, laws. As a result, medical cannabis dispensing collectives (dispensaries) are the subject of considerable debate by planning and other local officials. Dispensaries have been operating openly in many communities since the passage of Proposition 215 in 1996. As a compassionate, community-based response to the problems patients face in trying to access cannabis, dispensaries are currently used by more than half of all patients in the state and are essential to those most seriously ill or injured. Since 2003, when the legislature further implemented state law by expressly addressing the issue of patient collectives and compensation for cannabis, more dispensaries have opened and more communities have been faced with questions about business permits and land use options.

In an attempt to clarify the issues involved, Americans for Safe Access  has conducted a survey of local officials in addition to continuously tracking regulatory activity throughout the state. (safeaccessnow.org/regulations.) The report that follows outlines some of the underlying questions and provides an overview of the experiences of cities and counties around the state. In many parts of California, dispensaries have operated responsibly and provided essential services to the most needy without local intervention, but city and county officials are also considering how to arrive at the most effective regulations for their community, ones that respect the rights of patients for safe and legal access within the context of the larger community.


ABOUT AMERICANS FOR SAFE ACCESS
Americans for Safe Access (ASA) is the largest national member-based organization of patients, medical professionals, scientists and concerned citizens promoting safe and legal access to cannabis for therapeutic uses and research. ASA works in partnership with state, local and national legislators to overcome barriers and create policies that improve access to cannabis for patients and researchers. We have more than 30,000 active members with chapters and affiliates in more than 40 states.


THE NATIONAL POLITICAL LANDSCAPE
A substantial majority of Americans support safe and legal access to medical cannabis. Public opinion polls in every part of the country show majority support cutting across political and demographic lines. Among them, a Time/CNN poll in 2002 showed 80% national support; a survey of AARP members in 2004 showed 72% of older Americans support legal access, with those in the western states polling 82% in favor.

This broad popular consensus, combined with an intransigent federal government which refuses to acknowledge medical uses for cannabis, has meant that Americans have turned to state-based solutions. The laws voters and legislators have passed are intended to mitigate the effects of the federal government's prohibition on medical cannabis by allowing qualified patients to use it without state or local interference. Beginning with California in 1996, voters passed initiatives in eight states plus the District of Columbia — Alaska,  Colorado, Maine, Montana, Nevada, Oregon, and Washington.  State legislatures followed suit, with elected officials in Hawaii, Maryland, Rhode Island, and Vermont taking action to protect patients from criminal penalty, and the California legislature amending its voter initiative in 2003.

Momentum for these state-level provisions for compassionate use and safe access has continued to build as more research on the therapeutic uses of cannabis is published. And the public advocacy of well-known cannabis patients such as the Emmy-winning talkshow host Montel Williams has also increased public awareness and created political pressure for compassionate state and local solutions.

Twice in the past decade the U.S. Supreme Court has taken up the question. In the most recent case, Gonzales v. Raich, a split court upheld the ability of federal officials to prosecute patients if they so choose, but did not overturn state laws. In the wake of that decision, the attorneys general of California, Hawaii, Oregon, and Colorado all issued legal opinions or statements reaffirming their state's medical cannabis laws. The duty of state and local law enforcement is to the enforcement and implementation of state, not federal, law.


HISTORY OF MEDICAL CANNABIS IN CALIFORNIA

Local officials and voters in California have recognized the needs of medical cannabis patients in their communities and have taken action, even before voters made it legal in 1996.  In 1991, 80% of San Francisco voters supported Proposition P, a ballot initiative which recommended a non-enforcement policy  for the medical use, cultivation and distribution of marijuana. In 1992, citing both the interests of their constituency and the endorsement of therapeutic use by the California Medical Association, the San Francisco Board of Supervisors adopted a resolution urging the mayor and district attorney to accept letters from recommending physicians (Resolution No. 141-98). In 1993, the Sonoma Board of Supervisors approved a resolution mirroring a Senate Joint Resolution passed earlier that year, noting that a UN committee had called for cannabis to be made available by prescription and calling on "Federal and State representatives  to support returning [cannabis] preparations to the list of available medicines which can be prescribed by licensed physicians" (Resolution No. 93-1547).

Since 1996 when 56% of California voters approved the Compassionate Use Act (CUA), public support for safe and legal access to medical cannabis has only increased. A statewide Field poll in 2004 found that "three in four voters (74%) favors implementation of the law. Voter support for the implementation of Prop. 215 cuts across all partisan, ideological and age subgroups of the state." (field.com/fieldpollonline/subscribers/Rls2105.pdf)

Even before the release of that Field poll, state legislators recognized that there is both strong support among voters for implementing the safe and legal access promised by the Compassionate Use Act (CUA) and little direction as to how local officials should proceed. This led to the drafting and passage of Senate Bill 420 in 2003, which amended the CUA to spell out more clearly the obligations of local officials for implementation.


WHAT IS A CANNABIS DISPENSARY?
The majority of medical marijuana (cannabis) patients cannot cultivate their medicine for themselves or find a caregiver to grow it for them. Most of California's estimated 200,000 patients obtain their medicine from a Medical Cannabis Dispensing Collective (MCDC), often referred to as a "dispensary." Dispensaries are typically storefront facilities that provide medical cannabis and other services to patients in need. There are more than 200 dispensaries operating in California as of August 2006. Dispensaries operate with a closed membership that allow only patients and caregivers to obtain cannabis and only after membership is approved (upon verification of patient documentation). Many dispensaries offer on-site consumption, providing a safe and comfortable place where patients can medicate. An increasing number of dispensaries offer additional services for their patient membership, including such services as: massage, acupuncture, legal trainings, free meals, or counseling. Research on the social benefits for patients is discussed in the last section of this report.


RATIONALE FOR CANNABIS DISPENSARIES
While the Compassionate Use Act does not explicitly discuss medical cannabis dispensaries, it calls for the federal and state governments to "implement a plan to provide for the safe and affordable distribution of marijuana to all patients in medical need of marijuana." (Health & Safety Code § 11362.5)  This portion of the law has been the basis for the development of compassionate, community-based systems of access for patients in various parts of California. In some cases, that has meant the creation of patient-run growing collectives that allow those with cultivation expertise to help other patients obtain medicine. In most cases, particularly in urban settings, that has meant the establishment of medical cannabis dispensing collectives, or dispensaries. These dispensaries are typically organized and run by groups of patients and their caregivers in a collective model of patient-directed health care that is becoming a model for the delivery of other health services.


MEDICAL CANNABIS DISPENSARIES ARE LEGAL UNDER STATE LAW

In an effort to clarify the voter initiative of 1996 and aid in its implementation across the state, the California legislature enacted Senate Bill 420 in 2004, which expressly states that qualified patients and primary caregivers may collectively or cooperatively cultivate cannabis for medical purposes (Cal. Health & Safety Code section 11362.775). This provision has been interpreted by the courts to mean that dispensing collectives, where patients may buy their medicine, are legal entities under state law. California's Third District Court of Appeal affirmed the legality of collectives and cooperatives in 2005 in the case of People v. Urziceanu, which held that SB 420, which the court called the Medical Marijuana Program Act (MMPA), provides collectives and cooperatives a defense to marijuana distribution charges. Drawing from the Compassionate Use Act's directive to implement a plan for the safe and affordable distribution of medical marijuana, the court found that the MMPA and its legalization of collectives and cooperatives represented the state government's initial response to this mandate. By expressly providing for reimbursement for marijuana and services in connection with collectives and cooperatives, the Legislature has abrogated earlier cases, such as Trippett, Peron, and Young, and established a new defense for those who form and operate collectives and cooperatives to dispense marijuana. (See People v. Urziceanu (2005) 132 Cal.App.4th 747, 33 Cal.Rptr.2d 859, 881.)

This new case law parallels  the interpretation of SB 420 provided to the League of Cities last year by Berkeley Assistant City Attorney Matthew J. Orebic, in his presentation "Medical Marijuana: The conflict between California and federal law and its effect on local law enforcement and ordinances." As he states in that report: 

In the 2004 legislation, Section 11362.775 … expressly allow[s] medical marijuana to be cultivated collectively by qualified patients and primary caregivers, and by necessary implication, distributed among the collective's members… Under the collective model, qualified patients who are unwilling or unable to cultivate marijuana on their own can still have access to marijuana by joining together with other qualified patients to form a collective. 

Orebic also notes that the law allows for those involved to "receive reimbursement for services rendered in supplying the patient with medical marijuana."


WHY PATIENTS NEED CONVENIENT DISPENSARIES
While some patients with long-term illnesses or injuries have the time, space, and skill to cultivate their own cannabis, the majority in the state, particularly those in urban settings, do not have the ability to provide for themselves. For those patients, dispensaries are the only option for safe and legal access. This is all the more true for those individuals who are suffering from a sudden, acute injury or illness.

Many of the most serious and debilitating injuries and illnesses require immediate relief. A cancer patient, for instance, who has just begun chemotherapy will typically need immediate access for help with nausea, which is why a Harvard study found that 45% of oncologists were already recommending cannabis to their patients, even before it had been made legal in any state. It is unreasonable to exclude those patients most in need simply because they are incapable of gardening or cannot wait months for relief.


WHAT COMMUNITIES ARE DOING TO HELP PATIENTS

Many communities in California have recognized the essential service that dispensaries provide and have either tacitly allowed their creation or, more recently, created ordinances or regulations for their operation. Dispensary regulation is one way in which the city can exert local control over the policy issue and ensure the needs of patients and the community at large are being met. As of August 2006, twenty-six cities and seven counties have enacted regulations, and many more are considering doing so soon. See appendix D.)  

Officials recognize their duty to implement state laws, even in instances when they may not have previously supported medical cannabis legislation.  Duke Martin, mayor pro tem of Ridgecrest said during a city council hearing on their local dispensary ordinance, "it's something that's the law, and I will uphold the law." 


"Because they are under strict city regulation, there is less likelihood of theft or violence and less opposition from angry neighbors. It is no longer a controversial issue in our city." 
—Mike Rotkin, Santa Cruz City Councilmember


This understanding of civic obligation was echoed at the Ridgecrest hearing by Councilmember Ron Carter, who said, "I want to make sure everything is legitimate and above board. It's legal. It's not something we can stop, but we can have an ordinance of regulations."

Similarly, Whittier Planning Commissioner R.D. McDonnell spoke publicly of the benefits of dispensary regulations at a city government hearing. "It provides us with reasonable protections," he said. "But at the same time provides the opportunity for the legitimate operations."

Whittier officials discussed the possibility of an outright ban on dispensary operations, but Greg Nordback said, "It was the opinion of our city attorney that you can't ban them; it's against the law. You have to come up with an area they can be in." Whittier passed its dispensary ordinance in December 2005.

Placerville Police Chief George Nielson commented that, "The issue of medical marijuana continues to be somewhat controversial in our community, as I suspect and hear it remains in other California communities. The issue of 'safe access' is important to some and not to others. There was some objection to the dispensary ordinance, but I would say it was a vocal minority on the issue."

Benefits of Dispensaries to the Patient Community

DISPENSARIES PROVIDE MANY BENEFITS TO THE SICK AND SUFFERING 

Safe and legal access to cannabis is the reason dispensaries have been created by patients and caregivers around the state. For many people, dispensaries remove significant barriers to their ability to obtain cannabis. Patients in urban areas with no space to cultivate cannabis, those without the requisite gardening skills to grow their own, and, most critically, those who face the sudden onset of a serious illness or who have suffered a catastrophic illness — all tend to rely on dispensaries as a compassionate, community-based solution that is an alternative to potentially dangerous illicit market transactions. 

Many elected officials around the state recognize the importance of dispensaries for their constituents. As Nathan Miley, former Oakland City councilmember and now Alameda County supervisor said in a letter to his colleagues, "When designing regulations, it is crucial to remember that at its core this is a healthcare issue, requiring the involvement and leadership of local departments of public health. A pro-active healthcare-based approach can effectively address problems before they arise, and communities can design methods for safe, legal access to medical marijuana while keeping the patients' needs foremost." 

Likewise, Abbe Land, mayor of West Hollywood says safe access is "very important" and long-time councilmember John Duran agreed, adding, "We have a very high number of HIV-positive residents in our area. Some of them require medical marijuana to offset the medications they take for HIV." Jane Bender, mayor of Santa Rosa, says, "There are legitimate patients in our community, and I'm glad they have a safe means of obtaining their medicine." 

Oakland's city administrator for ordinances, said safe access to cannabis is "very important" for the community. "In the finding the council made to justify the ordinance, they say 'have safe and affordable access'." 

And Mike Rotkin, the longtime Santa Cruz elected official, said that this is also an important matter for his city's citizens: "The council considers it a high priority and has taken considerable heat to speak out and act on the issue." 

It was a similar decision of social conscience that lead to Placerville's city council putting a regulatory ordinance in place. Councilmember Marian Washburn told her colleagues that "as you get older, you know people with diseases who suffer terribly, so that is probably what I get down to after considering all the other components." 

While dispensaries provide a unique way for patients to obtain the cannabis their doctors have recommended, they typically offer far more that is of benefit to the health and welfare of those suffering both chronic and acute medical problems. 

Dispensaries are often called "clubs" in part because many of them offer far more than a clinical setting for obtaining cannabis. Recognizing the isolation that many seriously ill and injured people experience, many dispensary operators chose to offer a wider array of social services, including everything from a place to congregate and socialize to help with finding housing and meals. The social support patients receive in these settings has far-reaching benefits that is also influencing the development of other patient-based care models. 

RESEARCH SUPPORTS THE DISPENSARY MODEL 
A 2006 study by Amanda Reiman, Ph.D. of the School of Social Welfare at the University of California, Berkeley examined the experience of 130 patients spread among seven different dispensaries in the San Francisco Bay Area. Dr. Reiman's study cataloged the patients' demographic information, health status, consumer satisfaction, and use of services, while also considering the dispensaries' environment, staff, and services offered. The study found that "medical cannabis patients have created a system of dispensing medical cannabis that also includes services such as counseling, entertainment and support groups, all important components of coping with chronic illness." She also found that levels of satisfaction with the care received at dispensaries ranked significantly higher than those reported for health care nationally. 

Patients who use the dispensaries studied uniformly reported being well satisfied with the services they received, giving an 80% satisfaction rating.  The most important factors for patients in choosing a medical cannabis dispensary were: feeling comfortable and secure, familiarity with the dispensary, and having a rapport with the staff. In their comments, patients tended to note the helpfulness and kindness of staff and the support found in the presence of other patients. 

Patients in Dr. Reiman's study frequently cited their relationships with staff as a positive factor. Comments from six different dispensaries include: 

"I love this spot because of the love they give, always! They treat everyone like a family loved one!" 
"This particular establishment is very friendly for the most part and very convenient for me." 
"The staff and patients are like family to me!" 
"The staff are warm and respectful." 
"The staff at this facility are always cordial and very friendly. I enjoy coming." 
"This is the friendliest dispensary that I have ever been to and the staff is always warm and open.  That's why I keep coming to this place. The selection is always wide." 


MANY DISPENSARIES PROVIDE KEY SOCIAL SERVICES 
Dispensaries offer many cannabis-related services that patients cannot otherwise obtain. Among them is an array of cannabis varieties, some of which are more useful for certain afflictions than others, and staff awareness of what types of cannabis other patients report to be helpful. In other words, one variety of cannabis may be effective for pain control while another may be better for combating nausea. Dispensaries allow for the pooling of information about these differences and the opportunity to access the type of cannabis likely to be most beneficial. 


"There are legitimate patients in our community, and I'm glad they have a safe means of obtaining their medicine." 
—Jane Bender, Santa Rosa


Other cannabis-related services include the availability of cannabis products in other forms than the smokeable ones. While most patients prefer to have the ability to modulate dosing that smoking easily allows, for others, the effects of edible cannabis products are preferable. Dispensaries typically offer edible products such as brownies or cookies for those purposes. Many dispensaries also offer classes on how to grow your own cannabis, classes on legal matters, trainings for health-care advocacy, and other seminars. 

Beyond providing safe and legal access to cannabis, the dispensaries studied also offer important social services to patients, including counseling, help with housing and meals, hospice and other care referrals, and, in one case, even doggie daycare for members who have doctor appointments or work commitments. Among the broader services the study found in dispensaries are support groups, including groups for women, veterans, and men; creativity and art groups, including groups for writers, quilters, crochet, and crafts; and entertainment options, including bingo, open mike nights, poetry readings, internet access, libraries, and puzzles. Clothing drives and neighborhood parties are among the activities that patients can also participate in through their dispensary. 

Social services such as counseling and support groups were reported to be the most commonly and regularly used service, with two-thirds of patients reporting that they use social services at dispensaries 1-2 times per week.  Also, life services, such as free food and housing help, were used at least once or twice a week by 22% of those surveyed. 


"Local government has a responsibility to the medical needs of its people, even when it's not a politically easy choice to make. We have found it possible to build regulations that address the concerns of neighbors, local businesses law enforcement and the general public, while not compromising the needs of the patients themselves. We've found that by working with all interested parities in advance of adopting an ordinance while keeping the patients' needs foremost, problems that may seem inevitable never arise." 
—Nancy Nadel, Oakland 


Dispensaries offer chronically ill patients even more than safe and legal access to cannabis and an array of social services. The study found that dispensaries also provided other social benefits for the chronically ill, an important part of the bigger picture: 

[T]he multiple services provided by the social model are only part of the culture of social club facility.  Another component of this model … is the possible benefit that social support has for one diagnosed with a chronic and/or terminal physical or psychological illness.  Beyond the support that medical cannabis patients receive from services is the support received from fellow patients, some of whom are experiencing the same or similar physical/psychological symptoms…. It is possible that the mental health benefits from the social support of fellow patients is an important part of the healing process, separate from the medicinal value of the cannabis itself. 

Several researchers and physicians who have studied the issue of the patient experience with dispensaries have concluded that there are other important positive effects stemming from a dispensary model that includes a component of social support groups. 

Dr. Reiman notes that, "support groups may have the ability to address issues besides the illness itself that might contribute to long-term physical and emotional health outcomes, such as the prevalence of depression among the chronically ill." 

For those who suffer the most serious illness, such as HIV/AIDS and terminal cancer, these groups of like-minded people with similar conditions can also help patients through the grieving process. Other research into the patient experience has found that many patients have lost or are losing friends and partners to terminal illness.  These patients report finding solace with other patients who are also grieving or facing end-of-life decisions. A medical study published in 1998 concluded that the patient-to-patient contact associated with the social club model was the best therapeutic setting for ill people. 

CONCLUSION 
Dispensaries are proving to be an asset to the communities they serve, as well as the larger community within which they operate. 

ASA's survey of local officials and monitoring of regulatory activity throughout the State of California has shown that, once working regulatory ordinances are in place, dispensaries are typically viewed favorably by public officials, neighbors, businesses, and the community at large, and that regulatory ordinances can and do improve an area, both socially and economically. 

Dispensaries - now expressly legal under California state law - are helping revitalize neighborhoods by reducing crime and bringing new customers to surrounding businesses. They improve public safety by increasing the security presence in neighborhoods, reducing illicit market marijuana sales, and ensuring that any criminal activity gets reported to the appropriate law enforcement authorities. 

More importantly, dispensaries benefit the community by providing safe access for those who have the greatest difficulty getting the medicine their doctors recommend: the most seriously ill and injured. Many dispensaries also offer essential services to patients, such as help with food and housing. 

Medical and public health studies have also shown that the social-club model of most dispensaries is of significant benefit to the overall health of patients. The result is that cannabis patients rate their satisfaction with dispensaries as far greater than the customer-satisfaction ratings given to health care agencies in general. 

Public officials across the state, in both urban and rural communities where dispensary regulatory ordinances have been adopted, have been outspoken in praise of what. Their comments are consistent on and favorable to the regulatory schemes they enacted and the benefits to the patients and others living in their communities. 

As a compassionate, community-based response to the medical needs of more than 150,000 sick and suffering Californians, dispensaries are working.