The Medical Cannabis Advocate’s Handbook

A PATIENT’S HISTORY of MEDICAL CANNABIS

Marijuana, in its natural form, is one of the safest therapeuti- cally 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... It would be unreasonable, arbitrary and capricious for DEA to continue to stand between those sufferers and the benefits of this substance. —Francis L. Young, DEA Chief Administrative Law Judge

Cannabis as Medicine: What the Science Says

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 mar- vel at its rich pharmacopoeia—many of whose chemicals mimic vital molecules in the human body. —The Economist

It can be difficult to locate information about prohibited—even for medical purposes. the safety and therapeutic value of cannabis. The unfortunate result of the federal prohibi- LAGUARDIA REPORT (1944) tion of cannabis is limited clinical research to The Marijuana Tax Act did not end the debate investigate the safety and about whether cannabis, if appropriately con- efficacy of cannabis to con- trolled, could have therapeutic value. In 1939, trol symptoms of serious New York Mayor Fiorello LaGuardia appointed and chronic illness. Many a blue-ribbon panel of renowned physicians, scientists have noted psychiatrists, clinical psychologists, pharmacol- research is "hindered by a ogists, chemists and other scientific and med- complicated federal approval process, limited ical researchers to conduct a review of the availability of research grade marijuana, and assertions that smoking marijuana resulted in the debate over legalization."1 criminal behavior, and a deterioration of phys- However, the documented use of cannabis as ical and mental health. a safe and effective therapeutic botanical Two years before the final report was issued, a dates to 2700 B.C. Between 1840 and 1900, review of the findings was published in the European and American journals of medicine American Journal of Psychiatry which conclud- published more than 100 arti- ed that "prolonged use of [cannabis] does not cles on the therapeutic use of lead to physical, mental or moral degenera- cannabis. In fact, cannabis was tion, nor have we observed any permanent part of the American pharma- deleterious effects from its continued use. copoeia until 1942, and is cur- Quite the contrary, [cannabis] and its deriva- rently available by prescription in Canada and tives and allied synthetics have potentially the Netherlands. valuable therapeutic applications which merit The political interference in the regulation of further investigation." Prepared by the New cannabis as a medicine and subsequently the York Academy of Medicine and issued in 1944, control of medical cannabis research originates the LaGuardia Report echoed these conclu- with the passage of the Marijuana Tax Act in sions, adding that cannabis was not addictive, 1937. Over the objections of the American did not provide a gateway to other drugs of Medical Association,2 the United States enacted abuse, and was not associated with increased the first federal law designed to restrict access criminal behavior or juvenile delinquency. to cannabis, even for medical purposes. Despite decades of repeated reviews by local, THE NATIONAL COMMISSION ON federal and international commissions and MARIHUANA AND DRUG ABUSE (1972) emerging clinical science which confirm the rel- ative safety and efficacy of cannabis as a medi- The Comprehensive Drug Abuse Prevention cine, the use of cannabis is absolutely and Control Act of 1970 included a provision

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27 to study the abuse of cannabis in the United States. President Richard Nixon appointed Pennsylvania Governor Raymond Shafer to chair the National Commission on Marihuana and Drug Abuse. On March 22, 1972, the commission presented its report, Marijuana, A Signal of Misunderstanding, to Congress. The Shafer report, like the LaGuardia report before it, concluded that the risks of using cannabis were minimal and that general use ROBERT RANDALL did not jeopardize health, lead to experimen- Known as the "Father of the Modern Medical tation with other drugs, or cause criminal Cannabis Movement," Robert Randall was the patient activity and specifically recommended the who made legal history when he persuaded a federal decriminalization of marijuana for personal court that his use of cannabis was a matter of medical use. The recommendations provided in the necessity. Commission's report conflicted with many of the provisions provided in the Comprehensive In 1972, at the age of 24, Randall had already lost sight Drug Abuse Prevention and Control Act and in his right eye, when he was diagnosed with a serious the Controlled Substances Act. President form of glaucoma and told that he had at most three to Nixon needed to reject the recommendations five years until he would go blind. His ophthalmolo- and formally declare a "war on drugs". gist tried a variety of medications, but nothing was effective. Surgery was ruled out. INVESTIGATIONAL NEW DRUG Randall soon had to quit his job and ended up on wel- COMPASSIONATE ACCESS (1978) fare. Then he discovered that cannabis helped his In 1975, shortly after discov- vision considerably. He returned to work and began to ering that smoking cannabis grow his own medicine. In 1975 he was arrested, and could relieve symptoms of his in 1976 he stood trial and established a defense of glaucoma, Washington, DC necessity. resident Robert Randall was The charges were dismissed. His attorneys had also arrested for cultivating cannabis in his home. petitioned the Food and Drug Administration to have Citing clinical evidence, Mr. Randall successful- him included in a research program that would give ly used the Common Law Doctrine of him 10 joints a day. As a result, he became the first Necessity to fight the charges. In November person to receive a legal, regular supply of 300 med- 1976, Judge James Washington opined, ical cannabis cigarettes per month provided by the fed- "[w]hile blindness was shown by competent eral government. medical testimony to be the otherwise inevitable result of the defendant's disease, This led to the creation of the Compassionate no adverse effects from the smoking of mari- Investigational New Drug Program (IND Program), juana have been demonstrated. Medical evi- which gave him sustained access to this non-approved dence suggests that the medical prohibition is drug. The Federal IND program was eventually not well-founded." opened to others with medical necessity , but it remained limited to little more than a dozen patients. Mr. Randall petitioned the federal govern- ment to provide him with access to medical Randall spent the rest of his life as an activist, organiz- cannabis in accordance with his medical ing other patients and writing books about medical necessity and shortly thereafter became the cannabis. He kept his vision for the remaining 36 years first American to receive a government-sup- of his life. plied source of cannabis. When Mr. Randall

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28 went public with his victory, the federal gov- in the control of the severe nausea and vomit- ernment retaliated with threats to withdraw ing caused by cancer chemotherapy, and in his access to cannabis. In 1978, Mr. Randall the treatment of asthma."4 filed suit and within days federal agencies More than a decade later, in response to state requested to settle. As a result, the FDA laws that permitted the use of cannabis in established the Investigational New Drug accordance with a recommendation by a (IND) Compassionate Access Program to sup- ply individuals who suffered from severe or licensed physician, the White House Office of chronic illness with a monthly supply of National Drug Control Policy commissioned cannabis, up to nine pounds annually. another report from the IOM to assess the medical and scientific value of cannabis. In In 1992, in response to an overwhelming 1999 the IOM published Marijuana as Medicine: number of applications from people suffering Assessing the Science Base, a comprehensive the effects of AIDS, President H.W. Bush meta-analysis of all existing research concern- closed the program to all new applicants, cit- ing the therapeutic value of cannabis.5 In ing concerns that the program undermined describing the findings of the IOM review, the the "war on drugs." Today, a handful of sur- Congressional Research Service observes that viving IND-participants continue to receive "[f]or the most part, the IOM Report strad- medical cannabis from the U.S. government, dled the fence and provided sound bites for paid for by federal tax dollars. both sides of the medical marijuana debate."6 In 2002, a study of the individuals that have Both IOM reports conclude that there is a used standardized, heat-sterilized, quality- sound medical and scientific basis for using controlled cannabis as part of the federal IND cannabis as treatment for a variety of serious program demonstrated the long-term clinical or chronic medical conditions. They emphasize effectiveness of cannabis in treat- the need for continued research with a focus ing the chronic musculoskeletal on well-designed clinical trials aimed at devel- pain, spasm and nausea, and oping rapid-onset, reliable, and safe delivery spasticity associated with systems. Congress and executive agencies have Multiple Sclerosis. After using largely ignored these findings and have never cannabis supplied by the federal convened a panel to oversee the full imple- government for periods ranging between 11 mentation of recommendations. and 27 years, program participants showed no functionally significant problems in their physiological systems, as determined by MRI THE HOUSE OF LORDS SELECT COMMITTEE scans of the brain, pulmonary function tests, ON SCIENCE & TECHNOLOGY REPORT (1998) chest X-ray, neuropsychological tests, hor- In 1998, the British House of Lords Select mone and immunological assays, electroen- Committee on Science and Technology issued cephalography, P300 testing and neurological a remarkably comprehensive report on 3 clinical examinations. cannabis including testimony from people with serious illness, scientific researchers, and INSTITUTE OF MEDICINE (1982, 1999) physicians. The report recommended immedi- In 1982, the Institute of Medicine (IOM), a ately rescheduling cannabis so that doctors division of the National Academy of Sciences, could prescribe cannabis to their patients and published the report Marijuana and Health. pharmacies could safely distribute cannabis. The IOM noted that "Preliminary studies sug- This recommendation was made in part gest that marijuana and its derivatives or ana- because the committee acknowledged that logues might be useful in the treatment of individuals using cannabis for therapeutic pur- the raised intraocular pressure of glaucoma, poses "are caught in the front line of the war against drug abuse. This makes criminals of

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29 people whose intentions are innocent, it adds made new discoveries that help us better to the burden on enforcement agencies, and understand why and how cannabis works so it brings the law into disrepute. Legalising well for so many people. medical use on prescription, in the way that The therapeutic benefits of cannabis are we recommend, would create a clear separa- derived from the interactions of cannabinoids tion between medical and recreational use, under control of the health care professions."7 and the human body's own endocannabinoid system. The endocannabinoid system (ECS) is The report recommended "that clinical trials a sophisticated group of neuromodulators, of cannabis for the treatment of MS and their receptors, and signaling pathways chronic pain should be mounted as a matter involved in a variety of physiological processes of urgency." Specifically, the committee rec- including the regulation of movement, mood, ommended that research focus on alternative memory, appetite, and pain. modes of administration that "would retain the benefit of rapid absorption offered by Prominent researcher and author Dr. Ethan smoking, without the adverse effects." Russo has one of the most comprehensive descriptions of the ECS16: The analgesic and palliative effects of the cannabis and cannabinioid preparation have been amply reported over the past generation, and have similarly been reviewed at length in previous citations. In essence, the effects result from a combina- tion of receptor and nonreceptor mediated mechanisms. THC and other cannabinoids exert many actions through cannabinoid receptors, G-protein coupled membrane receptors that are extremely densely repre- sented in central, spinal, and peripheral CB1 receptor nociceptive pathways. Endogenous cannabinoids (endocannabinoids) even THE ENDOCANNABINOID SYSTEM (ECS) regulate integrative pain structures such as Humans have used opiate drugs such as mor- the periaqueductal gray matter. The endo- phine and heroin for thousands of years to cannabinoid system also interacts in lessen pain and produce euphoria. In 1973, numerous ways with the endogenous opi- scientists discovered the brain's opiate recep- oid and vanillio systems that that can mod- tor which suggested that opiate drugs work ulate analgesia and with a myriad of other primarily by mimicking natural opiate-like neurotransmitter systems such as the sero- molecules, like endorphins, made and used in tonergic, dopaminergic, glutameatergic, the brain. The discovery of opiate receptors etc, pertinent to pain. Research has shown has revolutionized pain management, includ- that the addition of cannabinoid agonists ing the development of powerful therapeutic to opiates enhances analgesic efficacy drugs like morphine, codeine, and oxycodone. markedly in experimental animals, helps Similarly, humans have used the cannabis diminish the likelihood of the develop- plant for thousands of years to reduce pain, ment of opiate tolerance, and prevents control nausea, stimulate appetite, control opiate withdrawl. The current author has anxiety, and produce feelings of euphoria. In suggested that a clinical endocannabinoid the past 30 years, however, researchers have deficiency may underlie the pathogenesis of migraine, fibromyalgia, idiopathic

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30 bowel syndrome, and numerous other EMERGING CLINICAL DATA: THE painful conditions that defy modern THERAPEUTIC POTENTIAL OF CANNABIS pathophysiological explanation or ade- While research in the United States has been 8 quate treatment. sharply restricted by the federal prohibition Thirty years ago, the endocannabinoid system on cannabis in the past, the last few years was unknown; our understanding of the ECS have seen rapid change. The International began in the mid-1980s when researchers first Cannabinoid Research Society (ICRS) was for- identified the presence of a cannabinoid mally incorporated as a scientific research receptor in the brain and cloned it. Since organization in 1991, and since its incorpora- then, two types of receptors, CB1 and CB2, tion the membership has more than tripled. have been identified and these discoveries The International Association for Cannabis as have dramatically increased our understand- Medicine (IACM) was founded in 2000, pub- ing about how cannabis and related cannabi- lishes a bi-weekly newsletter and holds a bi- noids affect the human body.9-10 annual symposium to highlight emerging clinical research concerning cannabis thera- CB1 receptors are found in the central nerv- peutics. The University of California estab- ous system and in other organs and tissues lished the Center for Medical Cannabis such as the eyes, lungs, kidneys, liver and Research (CMCR) in 2001 to conduct high digestive tract and are particularly well-repre- quality scientific studies sented in the brain. In intended to ascertain the fact, the brain's recep- FEDERATION OF AMERICAN SCIENTISTS general medical safety tors for cannabinoids and efficacy of cannabis "Based on much evidence, from patients far outnumber the opi- products and examine ate receptors, perhaps and doctors alike, on the superior effective- ness and safety of whole cannabis com- alternative forms of by as much as ten to pared to other medications,… the President cannabis administration. one. The relative safety should instruct the NIH and the FDA to In 2010, the CMCR issued make efforts to enroll seriously ill patients of cannabis is reflected a report on the 14 clinical in the fact that cannabi- whose physicians believe that whole cannabis would be helpful to their condi- studies it has conducted, noid receptors are virtu- tions in clinical trials" most of which were FDA- ally absent from those FAS Petition on Medical Marijuana, 1994 approved, double-blind, regions at the base of placebo-controlled clini- the brain that are cal studies that have responsible for such vital functions as breath- demonstrated that cannabis can control pain, ing and blood pressure control. CB2 receptors in some cases better than the available alter- are primarily located in tissues associated with natives.13 immune function such as the spleen, thymus, tonsils, bone marrow, and white blood cells. A 2009 review of controlled clinical studies conducted over a 38-year period, including 33 Research is helping scientists and physicians trials in the U.S., found that "nearly all of the understand the role of the endocannabinoid 33 published controlled clinical trials conduct- system in regulating a variety of bodily func- ed in the United States have shown significant tions. As noted by world-renowned author and measurable benefits in subjects receiving and researcher, Raphael Mechoulam, the dis- the treatment."13 The review's authors note covery of the endocannabinoid system has that the more than 100 different cannabi- generated a great deal of interest in identify- noids in cannabis have the capacity for anal- ing opportunities for the development of a gesia through neuromodulation in ascending wide variety of cannabis-based and other and descending pain pathways, neuroprotec- 11 cannabinoid therapeutic drugs. tion, and anti-inflammatory mechanisms—all of which indicates that cannabis has applica-

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31 tions in managing chronic pain, muscle spas- of clinical studies conducted in several states ticity, cachexia, and other debilitating condi- during the past two decades revealed that, in tons. 768 individuals with cancer, cannabis was a highly effective anti-emetic in chemotherapy.16 To date, more than 15,000 Other studies have concluded that the active modern peer-reviewed scientific components in cannabis produce palliative articles on the chemistry and effects in cancer patients by preventing nau- pharmacology of cannabis and sea, vomiting and pain and by stimulating cannabinoids have been published, as well as appetite. Researchers have also observed that more than 2,000 articles on the body's natural "these compounds have been shown to inhibit endocannabinoids. the growth of tumor cells in culture and ani- Currently, cannabis is most often recommend- mal models by modulating key cell-signaling ed as complementary or adjunct medicine. pathways. Cannabinoids are usually well toler- But there is a substantial consensus among ated, and do not produce the generalized toxic experts in the relevant disciplines, including effects of conventional chemotherapies."17 the American College of Physicians, that cannabis and cannabis-based medicines have COMBATING CHEMOTHERAPY therapeutic properties that could potentially Cannabis is used most often to combat nau- treat a variety of serious and chronic illness. sea induced by chemotherapy agents and What follows is a brief, annotated compila- pain caused by various cancers. More than 30 tion of relevant works representing the human clinical trials have examined the emerging clinical data which support the effects of cannabis or synthetic cannabinoids therapeutic use of cannabis. on nausea,18 not including several U.S. state trials that took place between 1978 and CANNABIS & CANCER People with cancer who must undergo radia- tion and chemotherapy frequently stop treat- ments rather than suffer the nausea, pain, and other unpleasant side effects. Years before any state had authorized the medical use of cannabis, a 1991 Harvard Medical School study revealed that nearly half (44%) of U.S. oncologists were recommending cannabis to their patients as a way of mitigat- ing the side effects of cancer treatments.14 In its 1999 review, the Institute of Medicine concluded that cannabis could be a valid alternative for many people living with can- 1986.19 In reviewing this literature, scientists cer. Specifically, the IOM notes, "In patients have concluded that, ". . . THC [delta-9- already experiencing severe nausea or vomit- tetrahydrocannabinol] is superior to placebo, ing, pills are generally ineffective, because of and equivalent in effectiveness to other wide- the difficulty in swallowing or keeping a pill ly-used anti-emetic drugs, in its capacity to down, and slow onset of the drug effect."15 reduce the nausea and vomiting caused by Since the release of the IOM report, new some chemotherapy regimens in some cancer research has been published which supports patients."20 the use of cannabis to curb the debilitating A 1998 review by the British House of Lords effects of cancer treatment. In 2001, a review Science & Technology Select Committee con-

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32 cluded that "cannabinoids are undoubtedly (apoptosis).41-45 Indeed, research on the com- effective as anti-emetic agents in vomiting plex interactions of endogenous cannabinoids induced by anti-cancer drugs. Some users of and receptors is leading to greater scientific both find cannabis itself more effective."21 understanding of the basic mechanisms by The House of Lords review builds upon data which cancers develop.46 provided in a 1997 inquiry by the British In multiple studies published between 2001 Medical Association that determined cannabis and 2003, cannabinoids inhibited tumor is, in some cases, more effective than growth in laboratory animals.47-50 In another Marinol.22 study, injections of synthetic THC eradicated malignant brain tumors in one-third of treat- CANCER-FIGHTING CANNABINOIDS ed rats, and prolonged life in another third by Recent scientific advances in the study of as long as six weeks.51, 52 And, research on cannabinoid receptors and endocannabinoids pituitary cancers suggest that cannabinoids have produced exciting new leads in the may be the key to regulating human pituitary search for anti-cancer treatments. In the past hormone secretion.53-56 A 2009 review of recent decade, scores of studies, studies that have focused both in vivo and in vitro, on the role of cannabi- have demonstrated that AMERICAN ACADEMY OF FAMILY PHYSICIANS noids and cannabinoid receptors in the treat- various cannabinoids "The American Academy of Family have a significant effect Physicians [supports] the use of marijuana ment of breast cancer fighting cancer cells. To ... under medical supervision and control notes that cannabinoids date, studies have shown for specific medical indications." have been shown in lab- that cannabinoids arrest 1996-1997 AAFP Reference Manual oratory models to be many kinds of cancer effective fighting many growths through promo- types of cancers.57 tion of apoptosis (programmed cell death) Recent research published in 2009 has found that is lost in tumors, and by arresting angio- that the non-psychoactive cannabinoid genesis (increased blood vessel production). cannabidiol (CBD) inhibits the invasion of Unlike conventional chemotherapy treat- both human cervical cancer and human lung ments which work by creating a toxic environ- cancer cells. By manipulating cannabidiol's ment in the body that frequently up-regulation of a tissue inhibitor, researchers compromises overall health, cannabinoids may have revealed the mechanism of CBD's have been shown to selectively target only tumor-fighting effect. A further in vivo study cancer tumor cells. demonstrated "a significant inhibition" of Cannabinoids and Tumor Reduction lung cancer metastasis in mice treated with CBD.58 The mechanism of the anti-cancer The direct anti-tumor and anti-proliferation activity of CBD and other cannabinoids has activity of cannabinoids, specifically CB1 and also been repeatedly demonstrated with CB2 agonists, has now been demonstrated in breast cancers.59-63 dozens of studies across a range of cancer types, including brain (gliomas), breast, liver, Also in 2009, scientists reported on the anti- leukemic, melanoma, phaeochromocytoma, tumor effects of the cannabinoid THC on cervical, pituitary, prostate and bowel.23-40 The cholangiocarcinoma cells, an often-fatal type anti-tumor activity has led in laboratory ani- of cancer that attacks the liver's bile ducts. mals and in-vitro human tissues to regression They found that "THC inhibited cell prolifera- of tumors, reductions in vascularisation (blood tion, migration and invasion, and induced cell supply) and metastases (secondary tumors), as apoptosis." At low levels, THC reduced the well as the direct destruction of cancer cells migration and invasion of cancer cells, while

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33 at high concentrations, THC triggered cell- Similarly, researchers reported in 2010 that death in tumors. In short, THC reduced the the way cannabinoid and cannabinoid-like activity and number of cancer cells. This dose- receptors in brain cells "regulate these cells' dependent action of cannabinoids on tumors differentiation, functions and viability" sug- has also been demonstrated in animal studies. gests cannabinoids and other drugs that tar- Research on cannabinoids and gliomas, a type get cannabinoid receptors can "manage of aggressive brain cancer for which there is neuroinflammation and eradicate malignant 68 no cure, holds promise for future treatments. astrocytomas," a type of glial cancer. These A study that examined both animal and recent studies confirm the findings of multiple human glioblastoma multiforme (GBM) studies that indicated the effectiveness of 69-76 tumors, the most cannabinoids in fighting gliomas. common and Indications of the remarkable potential of aggressive form cannabinoids to fight cancer in humans have of brain cancer, also been seen in three large-scale population describes how studies done recently. The studies were cannabinoids designed to find correlations between smok- controlled ing cannabis and cancers of the lung, throat, glioma growth head and neck. Instead, the researchers dis- by regulating covered that the cancer rates of cannabis the blood vessels smokers were at worst no greater than those that supply the who smoked nothing at all or even better.77 tumors.64 In One study found that 10-20 years of cannabis another study, use significantly reduced the incidence of researchers head, neck and throat cancers.78 Researchers demonstrated suggest that cannabinoids my produce a pro- that the adminis- phylactic effect against cancer development, tration of the as seen in the anti-proliferation effect that non-psychoactive Cannabinoid receptors in the brain has been demonstrated in vitro and in vivo. cannabinoid cannabidiol (CBD) significantly inhibited the growth of subcutaneously implanted U87 CANNABIS & HIV/AIDS AND HEP-C human glioma cells in mice. The authors of Cannabis helps to improve the lives of many the study noted that "... CBD was able to pro- people living with HIV/AIDS; it helps manage duce a significant antitumor activity both in appetite loss, wasting, nausea, vomiting, pain, vitro and in vivo, thus suggesting a possible anxiety, stress, depression and other symp- application of CBD as an antineoplastic toms of both the disease and the anti-retrovi- 65 agent. ral regimes used to treat it. As many as 1 in 4 The targeted effects of cannabinoids on GBM people living with HIV/AIDS use cannabis for were further demonstrated in 2005 by medical purposes.79 researchers who showed that the cannabinoid An international group of nursing researchers THC both selectively inhibited the prolifera- has determined from a longitudinal, multi- tion of malignant cells and induced them to country, multi-site, randomized-control clinical die off, while leaving healthy cells trial that cannabis is frequently used to man- 66 unaffected. While CBD and THC have each age the six common symptoms of HIV/AIDS. been demonstrated to have tumor-fighting The study, published in 2009, found that a sig- properties, research published in 2010 shows nificant percentage of those with HIV/AIDS that CBD enhances the inhibitory effects of find cannabis effective for anxiety, depression, THC on GBM cell proliferation and survival.67 fatigue, diarrhea, nausea, and peripheral neu-

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34 ropathy. Researchers note that "those who did use marijuana rate it as effective as pre- scribed or over the counter medicines for the majority of common symptoms…."80 In addition to symptoms of the disease, cannabis has proven to be effective in control- ling unpleasant effects of the drugs used to treat HIV/AIDS. People living with HIV/AIDS who use cannabis to combat the side-effects of HAART therapy are approximately 3 times "BROWNIE MARY” RATHBUN more likely to remain on their prescribed drug therapies than those who do not use “Brownie Mary,” as Mary Rathbun was affectionately cannabis, according to a 2007 study.81 called, was well known around the city of San Francisco for her courageous work as a volunteer at In the 1970s, a series of human clinical trials San Francisco General Hospital AIDS Ward 86. established cannabis' ability to stimulate food intake and weight gain in healthy volunteers. Mary baked marijuana brownies for "her kids" for In a randomized trial in people living with many years before Proposition 215 made it legal in AIDS, THC significantly improved appetite and California. Three times she was arrested for the crime nausea in comparison with placebo. There of giving free medicine to people with AIDS, but she were also trends towards improved mood and remained committed to her work. The last time she weight gain. Unwanted effects—dry mouth, was arrested was July 21, 1992, while delivering med- drowsiness and anxiety—were generally mild icine to patients in Sonoma County. Before she came or moderate in intensity.82-85 to trial, The City and County of San Francisco pro- claimed a special day in her honor that coincided with After a comprehensive review of the thera- her trial date. The charges were dropped. peutic potential of cannabis, the Institute of Mary also used cannabis herself, to help cope with the Medicine concluded, "For patients such as discomfort of having two artificial knees as a result of those with AIDS or who are undergoing arthritis, which crippled her in her late years. Despite chemotherapy and who suffer simultaneously this, she kept delivering brownies of compassion for as from severe pain, nausea, and appetite loss, long as she could. cannabinoid drugs might offer broad-spec- trum relief not found in any other single “Brownie Mary” died April 10, 1999, having seen medication." medical marijuana legalized in California and several other states. An FDA-approved preliminary safety trial of smoked cannabis was conducted in 2003 at the University of California at San Francisco. The individuals reduce or discontinue their HIV/AIDS therapy because they can neither tol- study concluded that neither synthetic THC nor erate nor diminish the debilitating side effects inhaled cannabis had any significant effect on of the antiretroviral first-line medications. the immune system or viral load. Moreover, the researchers noted that study participants who The effectiveness of cannabis and cannabi- used cannabis gained weight.86 noids in relieving neuropathic pain has been demonstrated in more than three dozen pre- The Clinical Trials: Neuropathic Pain clinical and clinical trials, a 2009 review by More than one-third of people living with researchers at the University of Georgia has HIV/AIDS suffer from excruciating pain in the found. The scientists note that "a large num- nerve endings, many in response to the anti- ber of research articles have demonstrated retroviral therapies that constitute the first line the efficacy of cannabinoids" and conclude of treatment for HIV/AIDS.87 As a result, some that "cannabinoids show promise for treat-

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35 demonstrated that cannabis can reduce neu- ropathy pain and promote weight gain with- out immunological compromise.89 Researchers at the University of California, San Francisco conducted a randomized, place- bo-controlled clinical trial of 50 people who had experienced neuropathy pain for an aver- age of six years. Results showed that smoked cannabis was well-tolerated and effectively BARB & KENNY JENKS relieved chronic neuropathic pain from HIV- Kenny Jenks was a hemophiliac who contracted AIDS associated sensory neuropathy.90 through contaminated blood in 1980 and then unknowingly infected his wife, Barbara. Both became Another double-blind, placebo-controlled, too sick to work, and they lived on disability. Like crossover trial evaluated concentration- many AIDS patients, they discovered cannabis helped response effects of low-, medium-, and high- them eat and gain strength. dose smoked cannabis, concluding that there is a window of modest analgesia for smoked After they were arrested and charged with three cannabis, with lower doses decreasing pain felonies for cultivating cannabis, their lawyer argued and higher doses increasing pain.91 this was a case of medical necessity. Cannabis was the only medicine that lessened the vomiting and nausea A separate clinical trial indicated that low- caused by AIDS and the drugs used to fight the dis- and high-dose cannabis produced similar lev- ease. The Court of Appeals in Tallahassee, Florida els of pain relief, reducing both the intensity ruled in their favor in 1991. and unpleasantness of unbearable nerve pain. Researchers found that cannabis may interact After that lengthy legal struggle, the DEA allowed with opiate-based painkillers to increase their them into the federal Compassionate IND program. At effectiveness, particularly in neuropathic pain, the time, more than 30 people suffering from serious but that using isolated synthetic cannabinoids illnesses had successfully proven their medical neces- such as THC (dronabinol) did not provide the sity and were approved to receive federal cannabis. same degree of efficacy as a whole-plant The Jenks went public with their story, and soon more preparation of cannabis.92 than 300 other AIDS patients had applied to the pro- gram. The sudden surge in applicants prompted the A double-blind, placebo-controlled clinical Bush Administration to shut down the intake program trial on the impact of smoked cannabis on 28 in 1992. Even those who had already been approved people living with HIV who experience neu- were denied access to the medicine, and only the few ropathy pain not adequately controlled by patients who were previously receiving government other pain-relievers, including opiates, found 93 cannabis at that time have been allowed to continue to that cannabis provided pain relief. do so. HEPATITIS-C VIRUS The Jenks' crusade for justice and compassion had been wiped out at the moment of its triumph. The Cannabis may improve the effectiveness of stress of their personal ordeal took a toll on the cou- drug therapy for the hepatitis C virus (HCV), a ple's health. Both Barb and Kenny died soon after the potentially deadly viral infection that affects IND program was closed to new patients. more than 3 million Americans. Treatment for Hepatitis-C virus (HCV) involves months of ment of neuropathic pain."88 therapy with two powerful drugs, interferon and ribavirin, that have severe side effects, A series of double-blind, placebo-controlled including extreme fatigue, nausea, muscle studies of people living with HIV/AIDS have aches, loss of appetite and depression. Due to

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36 these side effects, people often do not finish side-effects with continued use. Drugs such as treatment, which worsens their symptoms aspirin can cause stomach irritation and in and can promote harm to the liver. some cases ulceration. Prolonged use of acet- aminophen can result in liver damage. Researchers from the University of California, Ibuprofen can cause kidney failure. Opiates San Francisco medical school and the are notorious for triggering severe nausea, dis- Organization to Achieve Solutions in orientation and drowsiness, while prolonged Substance-Abuse (OASIS) found that "modest use can increase tolerance and, in some cases, cannabis use may offer symptomatic and viro- result in severe depend- logical benefit to some ence or addiction to the patients undergoing HCV INSTITUTE OF MEDICINE medication. Each of treatment by helping these analgesics can pro- them maintain adher- "Nausea, appetite loss, pain and anxiety . . duce fatal overdose. ence to the challenging all can be mitigated by marijuana.... For 94 patients, such as those with AIDS or under- medication regimen." going chemotherapy, who suffer simultane- The historical use of Other research suggests ously from severe pain, nausea, and cannabis as an analgesic that people combating appetite loss, cannabinoid drugs might is well documented, as is HCV who used cannabis offer broad spectrum relief not found in its remarkable safety any other single medication.” while undergoing combi- record.97, 98 In their nation ribavirin and Marijuana and Medicine: meta-analysis of the interferon treatment Assessing the Science Base, 1999 available data, the were about 3 times more Institute of Medicine likely to complete their acknowledged the wide conventional medical treatment than those use of cannabis for pain, noting that "after participants who did not use cannabis. nausea and vomiting, chronic pain was the condition cited most often to the IOM study While cannabis may have a specific, positive team as a medicinal use for marijuana."99 biomedical effect, it is more likely that it Currently, pain relief is by far the most com- improves appetite and offers psychological mon condition for which physicians recom- benefits such as reduced depression that help mend the use of cannabis. individuals tolerate the treatment's unpleas- ant side effects.95 Many well-designed, double-blind placebo- controlled clinical trials clearly demonstrate CHRONIC PAIN that cannabis can reduce neuropathic pain, as noted above. In advance of these clinical According to the American Academy of Pain, trials involving smoked cannabis, years of nearly 50 million Americans suffer from per- clinical studies confirmed that the active sistent pain. Unfortunately, it is estimated ingredients in cannabis have powerful anal- that four out of every ten people living with gesic effects, sometimes equivalent to moderate-to-severe pain have yet to experi- codeine or morphine.100-104 A review of the ence relief. After reviewing a series of trials body of scientific research concerning the in 1997, the U.S. Society for Neuroscience con- analgesic effects of cannabis concluded that cluded that "substances similar to or derived "[t]here is now unequivocal evidence that from marijuana could benefit the more than cannabinoids are antinociceptive [capable of 97 million Americans who experience some blocking the transmission of pain] in animal form of pain each year."96 models of acute pain."105 Although a wide variety of prescription anal- Research shows that cannabinoids also pro- gesic drugs are available to treat pain—from duce an entourage effect that enhances the aspirin to oxycontin—none of these drugs are effectiveness of opiate painkillers. One animal completely adequate and many cause severe

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37 study found morphine was 15 times more noids show promise for treatment."113 active with the addition of a small dose of Multiple clinical trials have shown that a THC. Codeine was enhanced on the order of dosage-controlled whole-plant extract of mar- 900 fold.106 Human studies have repeatedly ijuana (Sativex) relieves intractable cancer shown that cannabinoids work in concert pain, and does so better than THC alone. A with opiod drugs in relieving neuropathic recent double blind, randomized, placebo- pain. Researchers suggest that direct and indi- controlled trial of 360 cancer patients in 14 rect interactions between opioid and cannabi- countries found that pain scores improved sig- noid receptors not only enhance analgesia nificantly with a cannabis extract. Research-ers but may also reduce the development of tol- report that the combination of natural erance to opiates. The authors of a 2009 study cannabinoids in Sativex "is an efficacious conclude that further research on such inter- adjunctive treatment for cancer-related pain" actions is "critical for for patients who do not understanding how the get relief from opiate receptor systems involved NEW ENGLAND JOURNAL OF MEDICINE painkillers such as oxy- in pain relief are altered "A federal policy that prohibits physicians contin or vicodin. 114 during acute or chronic from alleviating suffering by prescribing pain," as well as design- marijuana to seriously ill patients is mis- Pain from spinal injuries ing better therapies that guided, heavy-handed, and inhumane.... It is may also be treatable also hypocritical to forbid physicians to "directly target the prescribe marijuana while permitting them with cannabis. Several altered neurophysiology to prescribe morphine and meperidine to sets of researchers have of patients experiencing relieve extreme dyspnea and pain…there is recently published find- pain."107 no risk of death from smoking marijuana.... ings on the efficacy of To demand evidence of therapeutic efficacy cannabinoids in treating Decades of research on is equally hypocritical" pain resulting from cannabis' effectiveness in Jerome P. Kassirer, MD, editor spinal cord injuries (SCI). pain management N Engl J Med 336:366-367, 1997 A French team, noting include clinical human that "very few pharma- trials and volumes of cological studies have dealt specifically with anecdotal evidence, as well as new under- neuropathic pain related to SCI," suggests standing of how activation of the cannabi- that for "refractory central pain, cannabinoids noid system in the central nervous system may be proposed on the basis of positive reduces sensitivity to pain.108-112 Some of the results in other central pain conditions (e.g. most encouraging clinical data on the effects multiple sclerosis)."115 Researchers have of cannabinoids on pain involve the treat- demonstrated in an animal model of SCI pain ment of intractable cancer pain and hard-to- that cannabinoids yield more consistent posi- treat neuropathic pain. Somewhere between tive results than conventional analgesics such 25% and 45% of cancer patients experience as opiates, which "decrease in efficacy with neuropathic pain, a type of chronic pain that repeated treatment over time," concluding frequently results from nerve injury and resists that drugs targeting the body's cannabinoid treatment. receptors "hold promise for long-term use in The effectiveness of cannabis and cannabi- alleviating chronic SCI pain."116 noids in relieving neuropathic pain has been Researchers have also determined that neuro- demonstrated in more than three dozen pre- pathic pain may be treatable via bolstering clinical and clinical trials, as noted in a 2009 the body's natural cannabinoids. A study that review. The review notes that "a large num- inhibited the two enzymes that break down ber of research articles have demonstrated the body's natural cannabinoids found that the efficacy of cannabinoids" for treating neu- preserving them "reduces neuropathic pain ropathic pain and concludes that "cannabi-

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38 through distinct receptor mechanisms of action" that "present viable targets" for developing new analgesic drugs.117-118

MULTIPLE SCLEROSIS A survey of people living with Multiple Sclerosis reported that more than 40 percent of respondents used cannabis to relieve symp- toms of the disease. Among them, nearly ED ROSENTHAL three quarters said that cannabis mitigated The then-head of the DEA, Asa Hutchinson, flew in to their spasms, and more than half said it allevi- San Francisco to personally announce the arrest of ated their pain. Similar results were published best-selling author Ed Rosenthal, the man millions of in the Canadian Journal of Neurological readers knew as “Ask Ed”, the grow-your-own advice Sciences where is was observed that 96% of columnist for High Times magazine. Canadians living with MS believe that cannabis is therapeutically useful for treating As Hutchinson announced the arrest during a speech at the disease. Of those who admitted using the Commonwealth Club, the city’s district attorney, cannabis to treat symptoms of MS, the majori- Terence Hallinan, was outside with a bullhorn leading ty cited relief of chronic pain, spasticity, and the protest against the federal raids on Rosenthal, a San depression.119 Fransico dispensary, and the dispensary’s manager. Numerous case studies, surveys and double- Rosenthal had been deputized an officer of the City of blind studies have reported improvement in Oakland for the purpose of growing cannabis for those treated with cannabis and related patients, and everything was done in cooperation with cannabinoids for symptoms including spastici- local law enforcement and city officials, but the jury ty, chronic pain, tremor, sexual dysfunction, was kept in the dark. Under federal law, why he was bowel and bladder dysfunctions, vision dim- growing the plants, or for whom, was considered irrel- ness, dysfunctions of walking and balance evant as evidence. (ataxia), and memory loss.120-124 In fact, As soon as the trial ended, the jurors heard the whole cannabinoids have been shown in animal truth, and within 24 hours nine of them had publicly models to measurably lessen MS symptoms recanted their verdict, igniting another flurry of media and may also slow or halt the progression of stories. They wrote a letter in support of Rosenthal to the disease.125 Researchers have discovered the judge and sat with his family at sentencing. that persons with multiple sclerosis have Though he was facing a mandatory 5 years in federal increased levels of endocannabinoids in their prison and the prosecution was seeking 6-1/2 years, blood, indicating that the endocannabinoid the judge ruled that Rosenthal had reasonably relied on system "may be dynamically modulated city officials who had tried to provide immunity under depending on the subtype of the disease."126 federal law. Rosenthal was sentenced to a single day in jail, with credit for time served. Previous studies of the pharmacology of cannabis have identified effects on motor sys- The defense appealed the conviciton, and prosecutors tems of the central nervous system that have appealed the sentence. The conviction was overturned the potential of affecting tremor and spastici- for juror misconduct, and Rosenthal was retried. The ty. A controlled study of the efficacy of THC U.S. Attorney attempted to pile on 11 additional felony in experimental allergic encephalomyelitis, charges in addition to the original three, but all addi- the animal model of MS, demonstrated signif- tional charges were dismissed as vindictive prosecu- icant amelioration of these two MS symp- tion. Rosenthal was retried in 2007, becoming the first toms. A review of six randomized controlled federal defendant to be tried again after already serv- trials of a cannabis extracts that combines ing his sentence. He was convicted a second time.

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39 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) finds "a trend of reduced spasticity in treated patients" and "evidence that combined THC and CBD extracts may provide therapeutic benefit for MS spasticity symptoms."127 One such dosage-controlled THC-CBD extract, GW Pharmaceuticals' Sativex®, has been shown in numerous clinical trials to ease pain and improve spasm frequency, bladder con- trol, and sleep. Clinical trials of Sativex found that it "demonstrated a statistically significant and clinically relevant improvement in spastic- ity and was well tolerated in MS patients."128 Sativex has been approved in Canada, Spain, CHERYL MILLER New Zealand, and Great Britain for the symp- Cheryl Miller was diagnosed with chronic, progressive tomatic relief of spasticity, neuropathic pain 129 Multiple Sclerosis (MS) in 1971. She tried all the med- or both in adults with Multiple Sclerosis. ications that were prescribed for her, but many had MS patients frequently report cannabis helps such harmful side effects and were so toxic to her liver with bladder control, and a review of studies that she had to stop using them. Eventually she and her on cannabinoid receptors in the bladder notes husband Jim heard that cannabis might help ease some that non-psychoactive cannabinoids are also of her symptoms, and they decided she should give it effective, and psychotropic effects of THC can a try. They were amazed how Cheryl's normally stiff- be mitigated by delivering cannabinoids as-a-board body became relaxed and pliant. directly into the bladder.130 Soon after discovering the helpful properties of Research on the distribution of cannabinoid cannabis, the Millers became tireless activists in sup- receptors in the brain suggests that they may port of the legalization of cannabis for medical use. play a role in movement control. Only recent- Beginning in 1993, after failed attempts to get law- ly have scientists found an animal model for makers' attention to address this matter through lobby- MS, called experimental allergic ing, they found that protesting had more of an impact. encephalomyelitits (EAE), allowing testing for Jim pushed Cheryl’s wheelchair 58 miles across their symptom suppression. Recent pre-clinical state of New Jersey, and the media began to pay atten- reports found that cannabinoids lessened tion. In 1997, even though she had been homebound both tremor and spasticity in mice suffering by her condition for over 10 years, she and her hus- from EAE.131 Moreover, cannabinoids have band participated in that year's Boston-to-Washington demonstrated effects on immune function "Wheelchair Crusade" for medical cannabis. that also have the potential for reducing the As Cheryl's MS progressed, they took their activism to autoimmune attack that is thought to be the the next level, committing public acts of civil disobe- underlying pathogenic process in MS. dience at the Capitol that led to their arrest, though In addition to studying the potential role of charges were dropped. cannabis and its derivatives in the treatment Cheryl Miller died June 7, 2003 from pneumonia and of MS-related symptoms, scientists are explor- other MS-related complications. She was 57 years old. ing the potential of cannabinoids to inhibit As a tribute to Cheryl and her advocacy, her friends neurodegeneration. A 2003 study that the and supporters created the Cheryl Miller Memorial National MS Society called "interesting and Project to continue her legacy. potentially exciting" demonstrated that cannabinoids were able to slow the disease

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40 process in mice by offering neuroprotection movement. Endogenous cannabinoids also against EAE.132 appear to play a role in the manipulation of other transmitter systems within the basal OTHER MOVEMENT DISORDERS ganglia-increasing transmission of certain chemicals, inhibiting the release of others, Muscular spasticity is a common condition, and affecting how still others are absorbed. affecting millions of people in the United Most movement disorders are caused by a States. It afflicts individuals who have suffered dysfunction of the chemical loops in this part strokes, as well as those with multiple sclero- of the brain. Research suggests that an endo- sis, cerebral palsy, paraplegia, quadriplegia, genous cannabinoid tone participates in the and spinal cord injuries. Conventional medical control of movements.151-153 therapy offers little relief for spasticity. Phenobarbital and diazepam (Valium) are Endocannabinoids have paradoxical effects on commonly prescribed, but they rarely provide the mammalian nervous system: Sometimes complete relief, and many patients develop a they block neuronal excitability and other tolerance, become addicted, or complain of times they augment it. As scientists are devel- heavy sedation. These drugs also cause weak- oping a better understanding of the physio- ness, drowsiness and logical role of those other side-effects that natural cannabinoids, or people find intolerable. AMERICAN NURSES ASSOCIATION endocannabinoids, it is becoming clear that The therapeutic use of In 2003 the American Nurses Association these chemicals may be cannabis for treating passed a resolution that supports those health care providers who recommend involved in the patholo- muscle problems and medicinal use, recognizes "the right of gy of several neurologi- movement disorders has patients to have safe access to therapeutic cal diseases. Researchers been known to western marijuana/cannabis," and calls for more are identifying an array medicine for nearly two research and education, as well as a resched- uling of marijuana for medical use. of potential therapeutic centuries. In 1839, Dr. targets within the William B. human nervous system. O'Shaughnessy noted the plant's muscle relax- They have determined that various cannabi- ant and anti-convulsant properties, writing noids found in the cannabis plant interrupt that doctors had "gained an anti-convulsive the synthesis, uptake or metabolism of the remedy of the greatest value."133 endocannabinoids that drive the progression Contemporary animal and human clinical of Huntington's disease, Parkinson's disease, studies reveal that cannabis and its con- and tremor.154 stituent cannabinoids may effectively treat movement disorders affecting older patients, Cannabis also has enormous potential for pro- such as tremors and spasticity, because tecting the brain and central nervous system cannabis has antispasticity, analgesic, from the damage that creates various move- antitremor, and antiataxia actions.134-146 ment disorders. Researchers have found that cannabinoids fight the effects of strokes, as As noted previously, the contemporary under- well as brain trauma, spinal cord injury, and standing of the actions of cannabis was multiple sclerosis. More than 100 research spurred by the discovery of an endogenous articles have been published on how cannabi- cannabinoid system in the human body. This noids act as neuroprotective agents to slow system appears to be intricately involved in the progression of such neurodegenerative normal physiology, specifically in the control diseases as Huntington's, Alzheimer's and par- of movement.147-151 Central cannabinoid recep- ticularly Parkinson's, which affects more than tors are densely located in the basal ganglia, 52% of people over the age of 85.155-158 the area of the brain that regulates body

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41 cannabis and began distributing it of cannabis and provided medicine to terminally ill patients. to approximately 250 members, 85% of whom are terminally ill. Five times over the years they were visited by local law enforcement Then on September 5, 2002, officers. During each visit, they dozens of heavily armed DEA explained her medical cannabis agents stormed the Corral’s home use. The sixth time, they were and held guns to their heads. A arrested. At tiral, Valerie became paraplegic WAMM member who the first to successfully argue a was staying with them at the time VALERIE & MIKE CORRAL medical necessity defense in was handcuffed to her bed and In 1973, Valerie Corral was California. The district attorney abandoned. involved in a freak accident that told the sheriff that he would not Less than two weeks later, the changed her life. A P-51 Mustang, press charges if they were re-arrest- Mayor and City Council of Santa a converted W.W.II fighter plane, ed. The next spring, they planted Cruz joined WAMM to distribute "buzzed" her car. The resulting again; and a few months later they medical cannabis to thirteen accident left her with a head injury were raided and arrested. The com- patients at Santa Cruz City Hall. and a friend badly injured. Valerie's munity rallied around the Corrals, Before 200 members of the media, injury precipitated an epileptic con- and the citizens of Santa Cruz 1,300 people gathered in solidarity. dition with as many as five gran County voted in a measure calling mal seizures a day. for the non-prosecution of medical This crisis prompted the City and Valerie tried using prescription cannabis patients. County of Santa Cruz to join with WAMM in suing the federal gov- drugs to control her seizures, but Along with the other members of ernment over the raids. the side effects were devastating. their collective, the Wo/Men's Remarkabluy, they won a prelimi- But she found she could control the Alliance for Medical Mari-juana nary injunction protecting them seizures using cannabis alone. For (WAMM), Valerie and Mike con- from any future raids or arrests. years, the couple grew their own tinued research on different strains

ARTHRITIS anti-inflammatory properties which could pre- According to the Arthritis Foundation arthritis vent and reduce pain caused by swelling (such 160 is one of the most prevalent chronic health as arthritis). problems and the nation's leading cause of Twenty years ago research suggested that disability among Americans over age 15. A cannabis and its constituents were powerful 2006 report estimated that 46 million immune-modulation and anti-inflammatory Americans—nearly 1 in 5 adults—live with properties indicating it may treat chronic chronic joint pain and arthritis. inflammatory diseases directly.161-164 Since then, The use of cannabis as a treatment for mus- cannabis has proven an effective treatment clo-skeletal pain in western medicine dates to for rheumatoid arthritis, and it is one of the the 1700s.159 New evidence suggests that recognized conditions for which many states cannabis and related therapies can relieve the permit medical use. Specifically, cannabis has a pain associated with arthritis and the other demonstrated ability to improve mobility and rheumatic and degenerative hip, joint and reduce morning stiffness and inflammation, and research suggests that individuals can connective tissue disorders. Not only is reduce their use of potentially harmful Non- cannabis an effective pain reliever, as noted Steroidal Anti-Inflammatory Drugs (NSAIDs) above, it may also enhances the efficacy of when using cannabis as an adjunct therapy.165-166 opiate-based painkillers. In their 1999 meta- analysis of the data available, the IOM specifi- A growing compendium of research suggests cally noted that cannabinoids may also have that safe and effective treatment for arthritis

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42 may be developed from cannabis. One of the become the source of the most effective non-psychoactive components of cannabis, treatments for battling the Central Nervous cannibidol (CBD), has also been shown to System diseases that afflict millions of elderly have numerous medical applications as an Americans.178-181 anti-inflammatory and neuroprotective agent 167- and as a treatment for rheumatoid arthritis. IS CANNABIS SAFE? 170 CBD research also indicates that the Cannabis and its active psychoactive cannabi- cannabinoid suppresses the immune response noid, THC, have an excellent safety profile. in mice and rats that is responsible for a dis- The Drug Awareness Warning Network ease resembling arthritis, protecting them Annual Report, published by the Substance from severe damage to their joints, and Abuse and Mental Health Services markedly improving their condition.171-172 Administration (SAMHSA), contains a statisti- cal compilation of all drug deaths which occur ALZHEIMER'S DISEASE in the United States. According to this report, Alzheimer's disease is a neuro-degenerative there has never been a death recorded from condition for which cannabis and cannabinoid the use of cannabis by natural causes. therapies show promise, both for treating the Pharmacology expert and author Dr. Iverson symptoms and the underlying disease. explains: Agitation is the most common behavioral Laboratory animals (rats, mice, dogs and management problem in people with monkeys) can tolerate does of up to Alzheimer's and affects an estimated 75 per- 1000mg/kg. This would be equivalent to a cent of people with the disease. It may lead 70-kg person swallowing 70g of the to a variety of symptoms ranging from physi- drug—about 5,000 times more than is cal and/or verbal abusive postures, physically required to produce a high. Despite wide- non-aggressive conduct including pacing and spread illicit use of cannabis, there are restlessness, as well as verbally disturbed very few if any instances of people dying behaviors such as screaming and repetitive from an overdose.182 requests for attention. Clinical research DEA Chief Administrative Law Judge, Francis involving THC indicates that the cannabinoid Young, in response to a petition to reschedule reduced the agitation common to Alzheimer's cannabis under federal law concluded in 1988 sufferers. THC is also proven effective in com- that, "In strict medical terms marijuana is far bating anorexia or wasting syndrome, a com- safer than many foods we commonly con- mon problem for people with Alzheimer's sume...Marijuana in its natural form is one of 173-175 disease. the safest therapeutically active substances Alzheimer's disease is widely held to be associ- known to man. By any measure of rational ated with oxidative stress due, in part, to the analysis marijuana can be safely used within 183 membrane action of beta-amyloid peptide the supervised routine of medical care." aggregates. Studies have indicated that one More than a decade later, IOM investigators of the cannabis plant's primary components, considered the physiological risks of using cannabidiol (CBD), exerts a combination of cannabis and concluded that "Marijuana is neuroprotective, anti-oxidative and anti-apop- not a completely benign substance. It is a totic effects by inhibiting the release of the powerful drug with a variety of effects. toxic beta-amyloid peptide.176-177 However, except for the harms associated This new research coupled with the extensive with smoking, the adverse effects of marijua- work done on other neuroprotective qualities na use are within the range of effects tolerat- 184 of cannabis and its components indicates that ed for other medications." cannabis or cannabis-based therapy may Toxicity, Risk of Overdose

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43 Cannabis has a very high lethal dose, estimat- The acute, or short-term, effects of cannabis ed at LD50 (about 1500 lbs smoked in approx- may begin when the drug is first ingested, imately 15 minutes).185 Therefore it is and can last between one and three hours. comparatively difficult to die from an over- Individual response varies, depending upon dose of natural cannabis. Dr. Lester whether cannabis is ingested or inhaled, and Grinspoon, a professor emeritus at Harvard many of the effects will decrease with pro- Medical School and author of several books longed use. Short-term adverse effects from on the medical use of cannabis, had this to using herbal cannabis may include: coughing say in an article in the Journal of the or wheezing if cannabis is inhaled, euphoria, American Medical Association (1995): dry mouth, reddening of the eyes, increased appetite, blurred vision, dizziness, headache, "One of marihuana's greatest advantages delayed reactions, sedation, and anxiety. In as a medicine is its remarkable safety. It most cases, effects are mild and can be con- has little effect on major physiological trolled with careful titration. functions. There is no known case of a lethal overdose; on the basis of animal In rare cases, usually as a result of taking large models, the ratio of lethal to effective doses of cannabis in food or drink, individuals dose is estimated as 40,000 to 1. By com- may experience acute complications such as parison, the ratio is between 3 and 50 to 1 panic attacks, psychosis, or convulsions. for secobarbital and between 4 and 10 to Referred to in medical literature as marijuana 1 for ethanol. Marihuana is also far less psychosis, it can be severe enough to compel addictive and far less subject to abuse admission to an emergency hospital.188 than many drugs now used as muscle Effects of Prolonged Use of Cannabis relaxants, hypnotics, and analgesics. The chief legitimate concern is the effect of Cannabis is a psychoactive drug and legiti- smoking on the lungs. Cannabis smoke mate concerns have been raised about the carries even more tars and other particu- effects of prolonged use. Although cannabis late matter than tobacco smoke. But the remains a tightly controlled substance, even amount smoked is much less, especially in for medical purposes, the FDA has approved medical use, and once marihuana is an synthetic derivatives of cannabis' psychoactive openly recognized medicine, solutions cannabinoid, THC. may be found; ultimately a technology for In considering the consequences of cannabis the inhalation of cannabinoid vapors use, the Institute of Medicine concluded that could be developed."186 these concerns fall into two categories: the Dr. Grinspoon concludes, "the greatest danger effects of chronic smoking of cannabis and in medical use of marihuana is its illegality, the effects of THC. What follows is a brief which imposes much anxiety and expense on review of some of the more serious concerns suffering people, forces them to bargain with often attributed to smoking cannabis and its illicit drug dealers, and exposes them to the psychoactive cannabinoid, THC. threat of criminal prosecution." Hazards of Smoking Cannabis However, cannabis should not be considered a Smoking cannabis raises concerns and harmless substance. Cannabis has a number research has suggested that because cannabis of physiological effects that in limited cases shares many of the same dangerous com- could be hazardous, but most adverse effects pounds found in tobacco that smoking are within the range tolerated for most FDA- cannabis can lead to increased risk of lung approved medications.187 cancer and other chronic respiratory disease. The Acute Effects of Cannabis However, the body of research is controversial because it is not conclusive.

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44 Population studies have found mild lung function changes in heavy cannabis smokers189 and long-term heavy use may present symp- toms of bronchitis, including wheezing, pro- duction of phlegm and chronic cough.190 More study is required to determine any causal relationship between smoked cannabis and the development of respiratory infec- tions, it is therefore recommended that med- ical users of cannabis be cautious of heavy ANGEL MCCLARY RAICH use, especially in concurrence with tobacco On December 16, 2003, Angel McClary Raich smoking. became the first medical marijuana patient to success- While research has historically suggested that fully sue the federal government. Joined by another heavy cannabis smokers are at higher risk of patient, Diane Monson, and the two anonymous care- contracting cancer, new research casts doubt givers who provide Angel the marijuana that sustains on these claims.191 Research on this matter is her life, she sued Attorney General John Ashcroft and often complicated by the fact that many the DEA, seeking an injunction against any future arrests or prosecutions. cannabis smokers are also tobacco smokers and it is often difficult to differentiate the The Ninth Circuit Court of Appeals in San Francisco true cause. Studies at the cellular and molec- ruled that it was unconstitutional to apply the federal ular level have also suggested that smoked ban on marijuana to patients, so long as they use it for cannabis may cause cancer, however, new evi- medical purposes on their doctors' advice, obtain the dence indicates that cannabinoids themselves drug without buying it, get it within their state's bor- may decrease the cancer causing effect of the ders, and comply with state law. The U.S. Supreme carcinogens and particles typically inhaled Court overturned the ruling in a 6-3 decision, with a from smoking cannabis and therefore make scathing dissent defending the rights of patients. cannabis smoke inherently less dangerous Angel has been permanently disabled since September 192 than tobacco smoke. 1995. In late 1997, Angel's doctor recommended In 2006, the results of a five year case-con- cannabis as a possible medication to treat her complex trolled investigation and the largest study of medical conditions. Confined to a wheelchair from its kind unexpectedly concluded that smoking January 1996 to August 1999, Angel regained her cannabis, even regularly and heavily, does not mobility with the help of cannabis. lead to lung cancer or other types of head, Angel also suffers from several conditions that cause neck or throat cancers. Lead investigator Dr. severe, chronic pain, including fibromyalgia, Donald Tashkin of the David Geffen School of endometriosis, scoliosis, uterine fibroid tumors and Medicine, Division of Pulmonary and Critical rotator cuff syndrome. She is battling a brain tumor, Care Medicine, at the University of California- seizures, and life-threatening wasting syndrome Los Angeles, further concluded that cannabis accompanied by near-constant nausea. may contain key components that kill aging These interlocking medical problems have been a cells and keep them from becoming cancer- huge challenge for her doctors. Complicating her ous.193 Dr. Tashkin's findings reaffirm the treatment has been the fact that she has severe chemi- results of prior case-control studies dismissing cal sensitivities and is allergic to almost all of the drugs a causal link between cannabis use and cer- that are modern medicine's defense against most of tain types of lung and upper aerodigestive her illnesses. Even the federal government does not tract (UAT) cancers.194-196 dispute that cannabis is essential to her health, but it No data exists suggesting that orally ingested nonetheless insists she is a criminal who can be arrest- cannabis, like in food or drink, may cause can- ed and imprisoned at will.

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45 Effects on Cognition Cannabis use appears to impair cognition involving short-term memory, performance, attention and concentration among long- term heavy smokers.197 Most studies suggest that chronic users of cannabis suffer varying degrees of cognitive impairment that can sometimes be long lasting. Studies have also shown that these deficits in attention and memory occur more often with heavy MYRON MOWER cannabis use, and that these deficits can Myron Mower was ill in the hospital from extend beyond the period of intoxication.198 complications of his diabetes, when sheriff’s These effects can also be cumulative with deputies searched his home and found 31 longer periods of use, but are to some degree cannabis plants. The sheriff had adopted a reversible after a period post-cessation of use. policy that no patient could grow than three A recent meta-analysis of the long-term plants,so they uprooted all but three. Later effects of cannabis use "failed to demonstrate that day, a deputy questioned Mower in the a substantial, systematic, and detrimental hospital while he was under the influence of effect of cannabis use on neuropsychological morphine. Weeks later, Mower was arrested performance. It was surprising to find such and charged with felony cultivation. few and small effects given that most of the During his trial, the prosecutor even acknowl- potential biases inherent in our analyses actu- edged, "if there is a person in the state of ally increased the likelihood of finding a California for whom Prop. 215 was enacted, it cannabis effect."199 is Myron Mower." But, he urged the jury to Effects on psychomotor performance convict anyway, based solely on the number of plants. An expert testified the garden was The most common types of psychomotor appropriate for Mower’s need, but the jury functions impaired by cannabis use include took only 90 minutes to convict. body sway, hand steadiness, rotary pursuit, Mower appealed. In 2002, the California driving and flying simulation, divided atten- Supreme Court ruled patients should be pro- tion, sustained attention, and the digit-sym- 200 tected from unnecessary prosecution for bol substitution test. The effects are growing and possessing marijuana. The court generally short-lived and do not appear to be ruled that Prop. 215 provides qualified immu- affected over the long-term. Individuals are nity from prosecution, and shifted the burden affected differently by prolonged use of of proof to the prosecution. cannabis: it is still controversial whether or not tolerance to psychomotor effects increas- That landmark decision changed the legal es with chronic use. Research clearly indicates landscape in California, extending patient that cannabis exposure impairs psychomotor protections. performance and people should be warned The charges against Mower were dropped. not to drive or operate dangerous machinery, especially if they feel intoxicated after smok- ing cannabis.201 cer. If smoke inhalation is a concern, cannabis Effects on the immune system can be used with a vaporizer, orally in baked goods and other food product, topically in The effects of cannabis smoking on the oils and lotions, in oral sprays like a tincture, immune system are inconclusive. The IOM or in a suppository. notes that the relationship between cannabis

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46 and the immune system presents interesting CANNABIS-BASED MEDICINES: THE issues, including potential benefit and sus- 'PHARMACEUTICALIZATION' OF CANNABIS pected harm.202 Dr. Lester Grinspoon has defined the "phar- The discovery of the CB-2 receptor, located maceuticalization of cannabis" as the pre- primarily in the various cell types of the scription of isolated individual cannabinoids, synthetic cannabinoids, and cannabinoid immune system has renewed interest in the analogs. In what Dr. Grinspoon describes as interaction of cannabinoids and immune the federal government's desire to introduce function. As a result, several pharmaceutical a cannabis-like pill to replace natural cannabis have expressed interest in developing CB-2- use, the first efforts to "pharmaceuticalize" selective drugs which might have utility as cannabis occurred in 1985 when dronabinol immunosuppressants or in the treatment of (Marinol) was approved by the FDA.209 arthritis, multiple sclerosis and other serious illness thought to be related to immune sys- Dronabinol (Marinol) tem response.203 Dronabinol (Marinol) is a synthetic prepara- tion of THC encapsulated in sesame oil. In 2001, there were some studies that sug- Designed and marketed by Solvay gested people living with AIDS experienced Pharmaceuticals and its subsidiary Unimed, increased mortality and opportunistic bacteri- Marinol was first indicated for treatment of al and fungal infections associated with con- nausea and vomiting associated with cancer 204 taminated cannabis material. However, it is chemotherapy in people who failed to unclear if the increase in infections is a result respond adequately to conventional of suppression of the immune system by antiemetic treatments and later available for cannabis or because the individuals are the treatment of anorexia associated with exposed to more potential pathogens from weight loss for people living with HIV/AIDS. smoking cannabis.205 When first approved for medical use, dronabi- In 2003, concerns that cannabis-induced nol was placed in Schedule II according to the immune suppression may adversely effect Controlled Substances Act where it was tight- people living with HIV/AIDS were addressed in ly controlled. In 1999, in response to a a randomized, placebo-controlled clinical trial rescheduling request by Unimed, it was which concluded that concurrent administra- moved by administrative rule to Schedule III tion of smoked or oral cannabis did not effect to make it more widely available. Currently HIV RNA levels, CD4+ and CD8+ cell counts or Marinol is available in three dosage strengths: protease inhibitor levels over a 21-day treat- 2.5, 5, and 10mg to ensure optimal response by the broadest number of people. Despite ment.206 In another randomized, placebo-con- the well-documented therapeutic value of trolled study the administration of oral THC THC, dronabinol has been met with moderate or smoked cannabis did not significantly alter success. pharmacokinetic properties of the protease inhibitors tested and had no effect on anti- It is widely acknowledged that Marinol's oral retroviral efficacy.207 route of administration hampers its effective- ness because of slow absorption and patients' Although people with weakened immune sys- desire for more control over dosing. In their tem, like those with HIV/AIDS, might be review of Marinol the Institute of Medicine expected to have increased risk, there is no specifically noted that only about 10-20% of evidence that the long-term recreational or an oral dose is absorbed by the human body medical use of cannabis renders users more and onset of action is obtained between two susceptible to bacterial or viral infection.208 and four hours after dosing. 210

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47 Nabilone (Cesamet) and cannabidol (CBD), which is administered as an oral spray absorbed in the patient's Nabilone (Cesamet) is a synthetic derivative of THC with and has slightly modified molecular mouth. structure from dronabinol. Currently available Sativex has been approved for medical use in for medical use in Canada, United Kingdom, Canada for symptomatic relief of neuropathic and Mexico, it was approved by the FDA in pain in Multiple Sclerosis and as adjunctive 1985 for treatment of chemotherapy-induced analgesic treatment in people with advanced nausea and vomiting that has not responded cancer who experience moderate to severe to conventional medication. Although pain during the highest tolerated dose of nabilone was approved more than twenty strong opioid therapy for persistent back- years ago, it began marketing in the United ground pain. GW Pharma is currently under- States as Cesamet in 2006 and used for treat- going late stage clinical development of ment of anorexia and weight loss in people Sativex in Europe and the United States. Upon with HIV/AIDS and as an adjunct therapy for approval in the United States, Sativex will be chronic pain management. marketed by Otsuka Pharmaceuticals. Cannabis-Extract (Sativex) According to Dr. Grinspoon's theory, the "phar- THC is the most familiar cannabinoid, and its maceuticalization" of cannabis will only suc- therapeutic effects have been well estab- ceed if the pharmaceutical derivatives and lished. However, cannabis contains about extracts displace cannabis as medicine. sixty other cannabinoids, like CBD, which not Although a few individuals will prefer dose only offset the psychoactive effect of THC, but consistent pharmaceutical alternatives it seems may contain therapeutic benefits of their unlikely that these drugs will completely own. In fact, research suggests that the ther- replace the use of cannabis especially given its apeutic affect of cannabis might be linked to limited toxicity, easy availability, low cost rela- what researchers call an "entourage effect," tive to pharmaceuticals, ease with which it can the synergistic relationship between multiple be self-titrated, growing access to vaporization cannabinoids which may make them more devices, and its remarkable medical versatility.211 therapeutically beneficial in combination then they are individually. INVESTIGATIVE ROADBLOCKS: THE U.S. Building on this theory, researches affiliated RESEARCH EXPERIENCE with GW Pharmaceuticals (GW Pharma) have In the past three decades there has been an noted that in practice medicines or extracts explosion of international research to investi- derived from the cannabis plant provide gate the therapeutic value of cannabis. greater relief of pain than the equivalent Restrictions on cannabis research in the U.S. amount of synthetic cannabinoid given as a have resulted in very few clinical trials con- single chemical entity like dronabinol. ducted domestically. Meanwhile, research Licensed in the UK, and founded in 1998, GW teams in Great Britain, Spain, Italy, Israel, and Pharma is a pharmaceutical company commit- elsewhere have confirmed—through case ted to developing a portfolio of cannabinoid studies, basic research, pre-clinical and clinical and botanical medicines to meet the needs of investigations—the medical value of cannabis. patients around the world. Equally important, numerous studies have pro- Sativex is GW Pharma's lead cannabinoid vided strong indications of the potential for product, and in 2005 became the world's first more targeted drugs, whole-plant cannabis pharmaceutical prescription medicine derived derivatives and synthetics. The current research from extracts of the cannabis plant. challenge is to conduct human clinical trials Specifically, Sativex is a cannabis extract con- that apply the remarkable range of potential taining equal amounts of dronabinol (THC) applications for cannabis-based treatments

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48 applied to specific medical conditions. That challenge was identified in Marijuana and Medicine, however there has been no additional effort to review or fully implement the IOM's recommendations. Moreover, the unfortunate result of the federal prohibition of cannabis is limited clinical research to inves- tigate the safety and efficacy of cannabis to control symptoms of serious and chronic ill- ness. In the United States research is stalled, and in some cases blocked, by a complicated BRYAN EPIS federal approval process and restricted access Bryan Epis discovered the medical value of marijuana to research grade cannabis for research. when he tried using it to treat the chronic back and neck pain that resulted from fracturing two vertebrae The Failure of a Federal Monopoly in a near-fatal car accident. When California made The only way for cannabis to be evaluated by medical cannabis legal, Epis saw an opportunity to the FDA to determine whether it meets the serve others by starting a medical cannabis collective standards necessary to become a medicine that would be safe, accessible and affordable. under federal law is for privately-funded Chico Medical Marijuana Caregivers had approxi- sponsors to conduct clinical trials. mately 40 patients, all carefully screened, and Epis Despite the fact that federal law clearly personally provided money for five indigent patients requires adequate competition in the manufac- to see physicians. He was in the process of starting ture of Schedule I and II substances, since 1968 another collective in San Jose, California when the the National Institute on Drug Abuse (NIDA) federal government arrested him. has been the sole supplier of cannabis used for Because he had allowed four other physician- legitimate research purposes. DEA helps to pro- approved patients to grow at his house, Epis was tect NIDA's monopoly by refusing to grant charged with, and ultimately convicted of, conspiracy competitive licenses for cannabis production. to manufacture more than 1000 plants. They were NIDA's mission is to support research on the growing far less, but prosecutors convinced the jury he causes, consequences, prevention and treat- had plans to grow more, and Epis received a 10-year ment of drug abuse and drug addiction and federal prison sentence. officials from the Institute have testified that At his trial, the judge refused to allow any mention of it is not NIDA's mission to study medicinal California's medical marijuana law or that the cannabis uses of cannabis or to advocate for such was for medical purposes. The jury was instructed, like 212 research. Consequently, research which all federal juries in states with medical marijuana laws, aims to investigate or prove the therapeutic to disregard any references to the medical circum- value of cannabis is often obstructed or other- stances that slipped into witness testimony,. wise altered to accommodate suggestions by NIDA in order to satisfy the limitations of Afterward, members of the jury said they had no idea their mission. that such a stiff sentence might be imposed, and would have voted differently had they known. Epis is cur- DEA obstructs research by protecting an rently serving the remainder of his sentence. unnecessary federal monopoly on the supply of cannabis available for FDA-approved NIDA has refused to provide the cannabis.213 research. As a result, some medical cannabis researchers (who possess the appropriate For seven years, Professor Lyle Craker, UMass- licenses and requisite approval) have been Amherst, has been struggling to obtain a DEA unable to conduct their research because license for a privately-funded facility to grow

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49 cannabis exclusively for FDA-approved studies cannabis. designed to evaluate cannabis's potential In 1994, Dr. Donald Abrams, a longtime clini- medical value. cal faculty member at the University of In February 2007, after a lengthy hearing that California San Francisco, submitted a pilot included two weeks of testimony from 12 wit- study protocol designed to evaluate high, nesses, U.S. Department of Justice-appointed medium and low potency smoked cannabis or Administrative Law Judge Mary Ellen Bittner dronabinol in stimulating appetite and reduc- issued an 87-page opinion, findings of fact, ing weight loss associated with HIV-related and recommended ruling urging the end of wasting syndrome. Following approval by the the federal monopoly on the supply of FDA, Dr. Abrams submitted an application to cannabis that can be used in FDA-approved NIDA for cannabis to be used in the study. research. In her opinion, Judge Bittner sug- Nine months later, NIDA rejected the applica- gests that "respondent's registration to culti- tion for cannabis, despite the fact the FDA vate marijuana would be in the public had already approved the protocol.215 In June interest" and recommended that DEA grant 1995, NIDA announced a new policy that Professor Lyle Craker the license.214 required all medical cannabis protocols to be Unfortunately, DEA is under no obligation to submitted to the National Institutes of Health accept Judge Bittner's administrative ruling. (NIH) for peer review in the context of a grant When it became apparent that the DEA was application. One year later, Dr. Abrams resub- resisting acting on the ruling, as it did in the mitted a revised protocol to evaluate the safe- case of the 1988 ruling on rescheduling, 45 ty and efficacy of smoked cannabis as an Members of Congress wrote to DEA appetite stimulant for HIV-associated anorexia Administrator Karen Tandy in support of and weight loss, and, in August 1996, NIH Judge Bittner's decision, urging her to rejected the protocol.216 approve the application. The DEA has yet to The research protocol would be submitted a issue a license for the production of research couple more times before, under intense cannabis. Nearly two years have passed since scrutiny, NIDA awarded Dr. Abrams a grant Judge Bittner issued her ruling, and DEA has for his protocol. The results of his two-year yet to provide any response or take any clinical determined that using cannabis did action on the recommendation. not compromise to the immune systems of Arbitrary and Lengthy Delays people living with HIV/AIDS. Despite the fact that it is not NIDA's mission In another example, a DEA-licensed analytical to study the potential therapeutic value of lab, Chemic Labs, was made to wait more cannabis or to advocate for such research, the than two years for a reply to its initial request monopoly on the supply of cannabis available to purchase 10 grams of cannabis for a pri- for research results in arbitrary and lengthy vately sponsored research protocol to investi- delays. Ordinarily, once a protocol has been gate the safety of vaporizers, a non-smoking approved by the FDA, researchers obtain their delivery system which the Institute of research material and proceed with the Medicine report recommended be developed. approved course of study. After two years of delay processing the request, the application was rejected. NIDA In one extraordinary example of interference, has also refused to provide cannabis to two not only did NIDA refuse to accept FDA's other privately sponsored, FDA-approved pro- approved protocol, but the agency took nine tocols that sought to evaluate cannabis for months to provide an initial response and AIDS wasting syndrome (IND #43-542) and made no attempt at discussing the study or another for an investigation of migraines (IND their concerns before denying the request for #58-177).

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50 A Movement in Public Health Despite barriers to research, a growing body of clinical data supports the use of cannabis for medical purposes. While there is still much to learn, the medical value of cannabis is indisputable. As a result, a growing num- ber of public health organizations have endorsed policies the use of cannabis and pro- grams that advance medical and scientific research. PETER MCWILLIAMS In 1994, the Federation of American Scientists recommended that the President instruct the Peter McWilliams was a best-selling writer and pub- National Institutes of Health and the FDA to lisher of numerous self-help and other books. Having reopen investigation protocols to enroll seri- repeatedly pulled his life together after personal hard- ously ill patients who physicians believed that ships, he wrote and published books to help others. cannabis could ease symptoms of a variety of In March 1996, McWilliams was diagnosed with both diseases. The following year, the American AIDS and cancer. Prescribed chemotherapy and radia- Public Health Association passed a resolution tion to fight the cancer and combination drug therapy which encourages vigorous research and for the AIDS, he found that the treatment was almost "urges the Administration and Congress to worse than the disease. Nauseous, unable to eat, and move expeditiously to make cannabis avail- without appetite, McWilliams began to waste away, able as a legal medicine." despite the medications his doctors prescribed . In 1996, the American Academy of Family After some research, McWilliams discovered cannabis Physicians offered their support for medical allowed him to keep down the drugs that were helping cannabis for specific medical conditions so fight his diseases. He made a remarkable recovery and long as use was in accordance with medical was once again his positive, vivacious, productive self. supervision by a licensed professional. And, in 1997, two years prior to the publication of the Then, in 1996, California voters legalized medical Institute of Medicine's report, the New cannabis. McWilliams became an outspoken advo- England Journal of Medicine editorialized the cate, and he commissioned Todd McCormick, an following: activist and patient, to write a book on cultivating dif- ferent strains for different illnesses. McCormick began A federal policy that prohibits physicians his research, but was soon raided by the DEA. from alleviating suffering by prescribing marijuana to seriously ill patients is mis- McWilliams, McCormick, and others were charged guided, heavy-handed, and inhumane...It with conspiracy to cultivate marijuana. Since federal is also hypocritical to forbid physicians to law does not recognize medical cannabis, the judge prescribe marijuana while permitting forced them to stop using medical cannabis as terms of them to prescribe morphine and meperi- their release while they awaited trial. dine to relieve extreme dyspnea and With no legal defense available under federal law and pain...there is no risk of death from smok- facing a mandatory 10-year sentence, McWilliams ing marijuana... pled to a lesser charge that reduced his possible sen- Citing the 1999 Institute of Medicine report tence to a maximum of five years. and studies published since which indicate But while awaiting sentencing he was still unable to that the use of cannabis to alleviate the debil- use the cannabis that had proven effective in control- itating symptoms of cancer chemotherapy ling his nausea where other drugs had not. Peter and wasting, the Lymphoma Foundation of McWilliams died in his home on June 14, 2000 at the America passed a resolution urging Congress age of 50, asphyxiating on his own vomit.

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51 and the President to enact legislation to ment consider "reclassification [of cannabis] reschedule cannabis to allow doctors to pre- into a more appropriate schedule, given the scribe cannabis for their patients in accor- scientific evidence regarding marijuana's safe- dance with need. The Leukemia & ty and efficacy in some clinical conditions." Lymphoma Society also "supports legislation The ACP is the largest medical specialty to remove criminal and civil sanctions for the organization and the second largest physician doctor-advised, medical use of marijuana by group in the United States. Its 124,000 mem- patients with serious physical medical condi- bers are doctors specializing in internal medi- tions" and has encouraged "the federal gov- cine and related subspecialties, including ernment to authorize the Drug Enforcement cardiology, neurology, pulmonary disease, Administration to license privately funded oncology and infectious diseases. The College production facilities that meet all regulatory publishes the Annals of Internal Medicine, the requirements to produce pharmaceutical- most widely-cited medical specialty journal in grade marijuana for use exclusively in federal- the world. ly approved research." Regarding the growing support by public Following the lead of several state nurses health organization, former Surgeon General organizations, the American Nurses Dr. Jocelyn Elders observed that "large med- Association passed a resolution in support of ical associations are by their nature slow and health care providers who recommend the cautious creatures that move only when the use of cannabis and further acknowledged evidence is overwhelming." She continued, that "the right of patients to have safe access "The evidence is indeed overwhelming that, to therapeutic cannabis. The ANA specifically as ACP put it, there is 'a clear discord' called for more research and urged the between what research tells us and what our removal of cannabis from the list of Schedule laws say about medical marijuana."217 I controlled substances. The ACP position is reflected by the numerous Recently, the Assembly of the American professional health organizations which have Psychiatric Association unanimously approved a strongly worded statement championing endorsed the medical use of cannabis. They legal protections for individuals using include the American Medical Association, cannabis in accordance with a physician's rec- American Public Health Association, the ommendation. Representing 40,000 members American Academy of Family Physicians, the and 16 allied organizations (including the American Nurses Association, the National American Academy of Psychiatry and the Law, Association of Boards of Pharmacy, the American Academy of Child and Adolescent California Medical Association, the American Psychiatry, American Association for Social Preventive Medical Association, the American Psychiatry, American Academy of Addiction Society of Addiction Medicine, the Iowa Psychiatry, and the American Association of Board of Pharmacy, and many more. Emergency Psychiatrists) the American The current acceptance of cannabis as medi- Psychiatric Association is the main professional cine in the United States is further evidenced organization for psychiatrists in the United by the thousands of American doctors who States. have recommended its use to their patients, In 2008, the American College of Physicians the tens of thousands of individuals who are (ACP) published a position paper underscor- using it safely and effectively, and millions of ing the therapeutic value of cannabis and American voters and several state legislatures specifically recommends the federal govern- that have approved its legal use as medicine.

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52 THE ROAD TO REFORM

THE STRUGGLE FOR SAFE ACCESS nels seeking to remove cannabis from At the time the Controlled Substances Act Schedule I. The following is a summary of was being drafted in 1970, Assistant Secretary milestones in the movement to secure safe of Health Roger O. Egeberg recommended access to cannabis for therapeutic use. that cannabis temporarily be placed in Schedule I, the most restrictive category of ADMINISTRATIVE APPEALS drugs, pending the findings of the National Petition to Reschedule (1972-1994) Commission on Marihuana and Drug Abuse. Despite the Commission's recommendations The first petition to reschedule cannabis was to permit the medical and personal use of filed by the National Organization for the cannabis, President Nixon enacted the Reform of Marijuana Laws (NORML) in 1972. Comprehensive Drug Abuse Prevention and More than a decade later and following two Control Act.218 years of administrative hearings which includ- ed testimony from more than 60 researchers, Title II of the act, formally known as the doctors, and their patients, the DEA's Chief Controlled Substances Act, places drugs into Administrative Law Judge, Francis L. Young, one of five categories, or schedules. Cannabis ruled in 1988 that "Marijuana, in its natural was restricted to Schedule I, reserved for sub- form, is one of the safest therapeutically stances with no medical value and a high active substances known... It would be unrea- potential for abuse; all use of the substance is sonable, arbitrary and capricious for the DEA strictly prohibited. Examples of other to continue to stand between those sufferers Schedule I drugs include heroin and LSD. and the benefits of this substance..."219 Paradoxically, synthetic forms of THC, the Although Judge Young recommended that most powerful psychoactive chemical compo- cannabis be rescheduled, the DEA rejected nent of cannabis, are classified as Schedule III. the opinion and published their denial in the Schedule III is reserved for drugs that exhibit Federal Register on December 29, 1989.220 In medical value and have a mild potential for 1991, Alliance for Cannabis Therapeutics abuse. Other Schedule III drugs include keta- (ACT), the first non-profit organization dedi- mine, buprenorphine, hydrocodone and cated to reforming the laws which prohibit codeine. medical access to cannabis, petitioned the U.S. Cannabis may be reclassified in one of two District Court of Appeals for the District of ways; by an act of Congress or via administra- Columbia seeing review of the denial.221 tive channels. The Drug Enforcement After further review, DEA issued a final order Administration could remove cannabis from in 1992 underscoring the agency's opinion the list of Schedule I drugs through the rule- that cannabis has no accepted medical use.222 making process in the same way they have In 1994, the D.C. Circuit Court of Appeals handled dronabinol and other substances. denied a second petition to reconsider the However, the Controlled Substances Act also final order, effectively ending any further provides for a rulemaking process by which movement on the petition. the general public could petition the United 2nd Petition to Reschedule (1995-2001) States Attorney General to reclassify cannabis in accordance with the relevant scientific data. The second attempt began in 1995, when Jon Gettman, the former National Director for For 30 years, advocates have exhausted con- NORML, submitted a personal petition gressional, administrative and judicial chan-

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53 requesting that cannabis and all related opments. Notably, the current petition cannabinoids be removed from Schedules I includes a compendium of research contain- and II of the CSA. The petition argued that ing the Institute of Medicine's 1999 report cannabis did not meet the abuse potential and other research published between 1995 required by statute. Jon Gettman, PhD, and 2002. Moreover, the current petition explains, acknowledges the growing number of states permitting the use of cannabis in accordance The first attempt to have marijuana with a physician's recommendation. rescheduled eventually became focused solely on whether marijuana had an DEA formally accepted the petition for filing accepted medical use in the United States. on April 3, 2003, and per the provisions of the Unlike the first proceedings the 1995 CSA referred the petition to HHS in July 2004 rescheduling petition hinges on whether for a full scientific and medical evaluation. marijuana's abuse potential is significant This review is still pending. enough to justify its current Schedule I sta- Data Quality Act Petition (2004-2010) tus. In this respect the 1995 petition goes to the heart of the issue Hollister raised The Data Quality Act (DQA) requires federal before Congress in 1970 -- whether scien- agencies to use reliable science when making tific evidence will support the integrity of regulations and disseminating information. CSA scheduling of heroin, LSD and mari- Specifically, the DQA requires that the infor- juana in the same schedules, and whether mation circulated by federal agencies is fair, marihuana prohibition can be perpetuat- objective, and meets certain quality guide- ed given rapid social change in its use.223 lines. It also permits citizens to challenge gov- ernment information believed to be In April, 2001, pursuant to the results of a inaccurate or based on faulty, unreliable data. review of scientific literature conducted by Business, consumer, environmental and con- the Department of Health and Human servation groups have all used the DQA to Services (HHS) and their own review of rele- pursue changes in federal policy. vant information, DEA denied the petition.224 An appeal of DEA's decision was filed with In 2004, Americans for Safe Access (ASA) filed the District of Columbia circuit of the U.S. a petition with the U.S. Department of Health Court of Appeals, but in May 2002, the Court and Human Services (HHS) to correct misinfor- denied the appeal citing concerns that the mation published in the Federal Register petitioners did not have standing to subject about the accepted medical value of cannabis. DEA's denial of the petition to review by the ASA's petition asserts that the information federal courts because the petitioners were HHS provided in the Federal Register was not injured parties.225 inaccurate and did not consider all the scien- tific evidence available. Current Petition to Reschedule Cannabis (2002-present) In 2005, HHS denied the petition, citing con- cerns that accepting the petition would set The current petition to reschedule cannabis the preconditions for rescheduling cannabis was filed in October 2002 by the Coalition for and the agency was already engaged in a sci- Rescheduling Cannabis (CRC). The CRC is an entific review of the literature in response to association of public-interest groups, individu- the 2002 rescheduling petition. ASA filed an als who use medical cannabis, and advocates appeal, and in response to a letter of intent who support removing cannabis from to sue from ASA, HHS denied the appeal. In Schedule I. 2007, pursuant to provisions of the The CRC petition is almost identical to the Administrative Procedures Act, ASA filed suit 1995 petition, but includes important devel- in the U.S. District Court for the Northern

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54 District of California. On December 29, 2010, of security, as federal raids on medical the Ninth Circuit denied ASA's petition for cannabis dispensaries and cultivation centers rehearing, effectively bringing to a close continue to this day. ASA's six year struggle to force the Federal Victory for Veterans (July, 2010) Government to acknowledge the truth about the accepted medical value of cannabis. Under the rules of the Department of Veterans, veterans can be denied pain med- ADMINISTRATIVE ACTIONS ications if they are found to be using illegal drugs. Until July, 2010, the department had The Creation and Termination of the no written exception for medical marijuana. Compassionate Investigational New Drug On July 22, 2010, veterans who had sought Program (IND): (1978-1992) resolution between federal and state law for Started in 1978 as part of a lawsuit settlement years were finally rewarded. The by the Department of Health and Human Department's current policy now formally Services, the Compassionate IND program allows patients treated at its hospitals and allowed registered patients to receive govern- clinics to use medical cannabis in states where ment supplied medical cannabis from the it is legal. FDA. In response to a flood of applications from HIV/AIDS patients in the 1980s, the CONGRESSIONAL ACTIONS Secretary of Health and Human Services In 1981, U.S. Representatives Stewart under George H.W. Bush closed the program McKinney (R-CT) and Newt Gingrich (R-GA) in 1992. Today, only the six surviving approved co-sponsored the first of a succession of bills patients still receive medical cannabis from to provide for the therapeutic use of cannabis the federal government. in situations involving serious illness and to DOJ Memo (2009) provide adequate supplies of cannabis to indi- viduals who qualify for such use. Specifically, On October 19, 2009, Deputy Attorney the legislation required the Secretary of the General David Ogden issued a memorandum Department of Health and Human Services to to US Attorneys in states that have enacted secure and maintain a supply of cannabis to laws allowing for the medical use of cannabis. meet the medical, research, scientific, and Specifically, the memo discourages the use of export needs of the United States. The bills federal enforcement resources to investigate were referred to committee and no further individuals who are in "clear and unambigu- action was taken on these bills. ous compliance with state law" regarding medical cannabis. The memo also notes that During the next decade, no legislation was the commission of crimes not related to med- introduced in Congress. However, in response ical cannabis should not be ignored. to efforts in the various states to authorize the use of cannabis to treat serious and The memo's tacit recognition that cannabis chronic illness, Congress introduced several has legitimate medical applications and that pieces of legislation designed to undermine allowance should be made for patients whose reformation in the states. physicians have advised them to use it marks Undermining Reform: The 105th Congress a significant policy departure from previous (1998) administrations. Although the memo does not have the force of law, it did appear to In 1996, voters in California and Arizona* ease the conflict between the federal law became the first state to authorize the use of enforcement officials and state-authorized cannabis in accordance with a physician's rec- individuals who use or provide cannabis for ommendation. In 1998, Oregon, Alaska, and therapeutic use. However, it was a false sense Washington State enacted similar laws. The

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55 adoption of these laws fascinated national Representatives Maurice Hinchey (D-NY) and media prompting Congressional action. In Dana Rohrabacher (D-CA) introduced the first fact, the first pieces of legislation introduced in a succession of bipartisan amendments to during the 105th Congress sought to penalize the Commerce, Justice, State appropriations individuals participating in state reforms.226 bill to prohibit the Department of Justice from using appropriated funds to interfere During the fall of 1998, the U.S. House of with the implementation of medical cannabis Representatives debated and passed a resolu- laws in the states that have authorized such tion expressing the sense of Congress that use. The amendment has been offered a "marijuana is a dangerous and addictive drug handful of times, with marginal gains. and should not be legalized for medicinal use."227 No action was taken by the U.S. Senate, Fighting for Truth in Trials but the language was incorporated into the The unfortunate result of the U.S. Supreme FY1999 omnibus appropriations legislation.228 Court's decision in Gonzales v. Raich is that A separate amendment to the same legisla- federal defendants who are authorized to tion instructed that the District of Columbia use, possess and cultivate cannabis in accor- could not spend appropriations money to dance with state law are prohibited from pre- administer a ballot initiative authorizing the senting evidence in federal court related to use of cannabis for medical purposes. The their therapeutic use of cannabis or their amendment was successfully challenged, and compliance with local and state laws. 69% of voters in the nation's capital approved Consequently, most individuals indicted on the measure. However, Congress has effective- federal counts plead to lesser charges. In fact, ly used the appropriations process to bar the since the Raich decision, at least two-dozen implementation of the D.C. ballot initiative. individuals have been convicted and sen- tenced to several years in prison, despite not Ending the Raids: The Hinchey-Rohrabacher breaking any local or state laws.229 Amendment (2003-2007) In 2005, U.S. Representative Within weeks of the terror- Sam Farr (D-CA) introduced ist attacks on September 11, The Steve McWilliams Truth 2001, dozens of federal in Trials Act (H.R. 4272) to drug enforcement agents amend the Controlled raided and closed the West Substances Act both to pro- Hollywood-based Los vide an affirmative defense Angeles Cannabis Resource Center (LACRC), a for the medical use of cannabis in accordance non-profit dispensing collective that provided with the laws of the various states and to cannabis to approximately 1,000 people living limit the authority of federal agents to seize with AIDS, cancer, and other terminal illnesses. cannabis authorized for use under state law. Despite the fact that the LACRC was legal The bill originated in the 108th Congress and under state law and operated with the full sup- was reintroduced in the 111th Congress and port of local elected officials and law-enforce- every year since then through 2010. It was ment officers, federal agents seized cannabis named in honor of a Californian who took his plants, business documents, bank accounts, and own life while awaiting sentencing for feder- about 3,000 confidential medical records. Since al cannabis distribution charges. During his the raid, the Drug Enforcement Administration trial, jurors were not informed that he was has continued to conduct paramilitary-style providing medical cannabis to individuals with raids across the state of California. seriously illness as part of a small collective in In 2003, in an effort designed to put scarce San Diego. law enforcement resources to better use, U.S. The "Truth in Trials" Act enables individuals

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56 facing federal prosecution for marijuana- authorized under state law from obtaining, related offenses to provide evidence during possessing, transporting within their state, or trial that the activities they were engaged in manufacturing cannabis on behalf of an were performed in compliance with their authorized patient, or (4) an entity authorized state's duly-enacted medical marijuana laws. under local or state law to distribute medical The "Truth in Trials" Act is not about the mer- cannabis from obtaining, possessing, or dis- its of medical cannabis. Instead, the bill would tributing cannabis to qualified individuals. restore fundamental fairness in federal trials Similar versions of this bill (also known as the concerning the use or provision of marijuana States' Rights to Medical Marijuana Act) have solely for medical purposes and in accordance been introduced in every Congress since the with state law. 105th in 1997, but have not yet seen action Protecting States' Rights: The Medical beyond the committee referral process. Marijuana Patient Protection Act During the 110th Congress, U.S. LANDMARK FEDERAL CASES Representative Barney Frank (D-MA) and sev- In the past decade, a dozen states have enact- eral co-sponsors introduced ed laws that afford legal protections on indi- the "Medical Marijuana viduals who use medical cannabis and the Patient Protection Act of people who provide care to them. However 2008" (H.R. 5842). This legisla- the federal government has never directly tion makes necessary changes challenged the legitimacy of these laws in to federal law to provide for court. While the state laws differ from federal the medical use of cannabis in law and stand contrary to the claim that accordance with the laws of the various cannabis has "no accepted medical value", states. Specifically, H.R. 5842 would have these laws do not directly or positively "con- reclassified cannabis from a Schedule I drug to flict" with federal law so as to trigger a a Schedule II drug, which would acknowledge Supremacy Clause challenge. Federal case law the medical value of cannabis and create a maintains that individual federal agencies regulatory framework for the FDA to begin a remain free to enforce federal marijuana drug approval process for cannabis. The laws, even in jurisdictions that have enacted "Medical Marijuana Patient Protection Act" medical cannabis laws. would have also prohibited federal agencies Conant v. McCaffrey from interfering with the implementation of state-authorized medical cannabis programs. (2000): In the wake of state laws authorizing the use of In addition, the Medical Marijuana Patient cannabis in accordance with a Protection Act would provide protection from recommendation from a physi- provisions of the federal Controlled cian, federal officials threat- Substances Act (CSA) and the Food, Drug, and ened to revoke the prescribing Cosmetic Act (FDCA) for those qualified to use privileges of any physician who or obtain cannabis in states that have author- provided a recommendation to their patients ized the use of medical cannabis. In particu- for medical use. In response, a group of doc- lar, the act prevents the CSA and FDCA from tors led by AIDS specialist Dr. Marcus Conant prohibiting or restricting: (1) a physician from filed suit in federal court contending that prescribing or recommending cannabis for such a policy violates guarantees under the medical use, (2) an individual from obtaining, First Amendment to freedom of speech. The possessing, transporting within their state, government was enjoined by the U.S. District manufacturing, or using cannabis in accor- Court in San Francisco from penalizing physi- dance with their state law, (3) an individual cians who recommend the medical use of

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57 cannabis. The ruling states that physicians obtain cannabis. There have been no such have a First Amendment right to make rec- criminal or administrative proceedings against ommendations, but may not aid or abet doctors to date.232 patients in actually obtaining cannabis.230 U.S. v. Ed Rosenthal U.S. v. Oakland Cannabis Buyers Cooperative (2006): A jury in San Francisco (OCBC) federal court found Oakland (2001): In an opinion rendered on May 14, resident Ed Rosenthal guilty of 2001, the U.S. Supreme Court dealt a blow to cultivating cannabis, conspira- medical cannabis advocates by declaring that cy to cultivate, and maintain- a person in federal court may not argue that ing a place where drugs are distribution of cannabis to those with a rec- manufactured. Members of ommendation is a medical necessity. As a the jury were not permitted to result, a federal district court in California hear evidence regarding Mr. issued a permanent injunction against the Rosenthal's deputization by Oakland Cannabis Buyers Cooperative, pro- the city of Oakland to grow hibiting it from distributing medical cannabis medical cannabis in accordance with state to authorized persons. While the Court was law. Rosenthal was deemed guilty and sen- adamant that federal law still criminalizes the tenced to one-day, time served. After the trial, use and distribution of medical cannabis, the jurors publicly recanted their "guilty" verdict opinion left open several questions, such as after learning facts that were omitted at trial. constitutional limitations on federal authority, Mr. Rosenthal appealed to the Ninth Circuit, which will be litigated in the OCBC's pending which reversed his conviction in April 2006, 233 appeal in the Ninth Circuit.231 citing jury misconduct. Conant v.Walters (2007): Unhappy with the one-day, time- served sentence and subsequent reversal, the (2002): On appeal, the Ninth Circuit Court of Department of Justice re-indicted Mr. Appeals held that the federal authorities Rosenthal, this time adding new (and frivo- could not punish, or threaten to punish, a lous) charges for money laundering and tax doctor merely for telling a patient that his or evasion. Because the prosecutor admitted her use of cannabis for medical use is appro- that these new charges were added in priate. However, because it remains illegal for response to Rosenthal's statements against a doctor to "aid and abet" a patient to obtain the government, the additional charges were cannabis or conspire with him or her to do so, dismissed by the court as a form of vindictive the court drew the line between protected prosecution. Mr. Rosenthal was, again, con- First Amendment speech and prohibited con- victed of cultivating cannabis and, again, was duct as follows: A physician may discuss the given a sentence of one-day, time-served.234 pros and cons of medical cannabis with his or her patient, and issue a written or oral recom- Alberto Gonzales v. Angel Raich mendation to use cannabis within a bona fide (2006): After federal drug enforcement doctor-patient relationship without fear of agents seized and destroyed medical cannabis legal reprisal. This is so regardless of whether plants belonging to authorized patients and s/he anticipates that the patient will, in turn, providers in California, filed a lawsuit and use this recommendation to obtain cannabis sought a preliminary injunction barring the in violation of federal law. On the other hand, Department of Justice from further interfer- the physician may not actually prescribe or ence. The suit argued that application of the dispense cannabis to a patient, or recommend Controlled Substances Act in cases where it with the specific intent that the patient will medical cannabis was being cultivated and use the recommendation like a prescription to

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58 consumed for no Amendment does not bar enforcement of the remuneration entirely CSA. within and in accor- Despite the unfavorable outcome, the court dance with state law underscores the accepted medical value of exceeded Congress's cannabis and specifically indicated that there authority under the could a fundamental liberty interest to use Commerce Clause. In cannabis for medical purposes deserving pro- December 2003, the tection. The Court notes, "We agree with Ninth Circuit Court of Raich that medical and conventional wisdom Appeals held that so that recognizes the use of marijuana for med- long as the medical cannabis-related activities occur entirely within a state, the Controlled ical purposes is gaining traction in the law as Substances Act shall not apply.235 well. But that legal recognition has not yet reached the point where a conclusion can be The case reached the Supreme Court after drawn that the right to use medical marijua- Attorney General John Ashcroft appealed the na is 'fundamental' and 'implicit in the con- December 2003 federal Ninth Circuit Court of cept of ordered liberty." The court concluded, Appeals decision. On June 6, 2005, the U.S. "For now, federal law is blind to the wisdom Supreme Court ruled that federal law of a future day when the right to use medical enforcement officials may prosecute individu- marijuana to alleviate excruciating pain may als who use medical cannabis, even if they cul- be deemed fundamental. Although that day tivated their own cannabis and even if they has not yet dawned, considering that during reside in a state where such activity is protect- the last ten years eleven states have legalized ed under state law. The decision does not the use of medical marijuana, that day may invalidate the laws of California or any other be upon us sooner than expected."237 state that authorizes the use of cannabis in accordance with a physician's recommenda- In re: Grand Jury Subpoena for THCF Medical tion nor does it suggest that federal officials Clinic Records are required to prosecute those authorized by (2007): The United States District Court for the state law to use or obtain medical cannabis. Eastern District of Washington quashed a sub- Decisions about prosecution are still left to poena directed to the State of Oregon to the discretion of U.S. Attorneys. The Court reveal information about 17 individuals indicated that Congress and the Food and enrolled in the state medical cannabis pro- Drug Administration should work to resolve gram. The court found that the subpoena 236 this issue. issued by a federal court to prove criminal vio- McClary-Raich v. Gonzales lations against a medical cannabis clinic was unreasonable, since the government did not (2007): In 2007, the Ninth Circuit Court of have strong need for the information and the Appeals resolved the remaining issues raised state would be violating its own laws regard- in Raich. In McClary-Raich v. Gonzales, the ing confidentiality to reveal the information Ninth Circuit held that McClary-Raich: (1) sought, which, in addition, would deter peo- could not obtain a preliminary injunction to ple from participating the state's medical bar enforcement of the Controlled Substances cannabis program. Balancing these interests, Act (CSA) based on common law medical the court concluded that the subpoena necessity, although she appeared to satisfy should be quashed.238 the factual predicate for such claim; (2) appli- cation of the CSA to medical cannabis cultiva- tors and users did not violate substantive due STATES WITH MEDICAL CANNABIS LAWS process guarantees; and (3) the Tenth After exhausting attempts to remove cannabis from Schedule I of the Controlled

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59 Substances Act in a series of petitions, frus- Marijuana Program (MMP), pursuant to trated patients and advocates turned to the Senate Bill 420. This bill was adopted by the states for protection. Since 1996, fourteen state legislature in with the following pur- states and the District of Columbia have pose: "(1) Clarify the scope of the application adopted laws which authorize the use of of the act and facilitate the prompt identifica- cannabis as recommended by a licensed physi- tion of qualified patients and their designated cian without legal sanction: Alaska, Arizona, primary caregivers in order to avoid unneces- California, Colorado, Hawaii, Maine, sary arrest and prosecution of these individu- Montana, Nevada, New Jersey, New Mexico, als and provide needed guidance to law Oregon, Rhode Island, Vermont, and enforcement officers. (2) Promote uniform Washington. and consistent application of the act among the counties within the state. (3) Enhance the Considerable disparities exist among the state access of patients and caregivers to medical laws regarding the specific medical conditions marijuana through collective, cooperative cul- for which physicians may provide a recom- tivation projects." mendation. California's medical cannabis laws leave treatment decisions to the trained The MMP included provisions requiring the professional judgment of physicians, but California Department of Health to establish many states limit the legal use of medical and maintain a voluntary registry program cannabis to narrow lists of conditions, exclud- whereby qualified individuals could acquire a ing serious and chronic illness for which state-wide identification card verifying that research has shown cannabis to be helpful. the cardholders are enrolled in the state pro- gram and authorized to use, possess, cultivate The vast majority of arrests and prosecution and transport cannabis. of cannabis offenses occur at the state and local level. If nothing else, state medical Oregon (1998) cannabis laws offer individuals authorized to Ballot Measure 67, The Oregon use medical cannabis specific protection from Medical Marijuana Program Act, arrest and criminal prosecution in their state. was approved by 55% of voters. It removes Some also provide civil protections for those the state's criminal penalties for use, posses- who use medical cannabis so these individuals sion, and cultivation of cannabis by individu- do not lose their parental rights, their proper- als whose physicians have advised that the use ty or housing, their jobs or health insurance of cannabis "may mitigate the symptoms of benefits. A few states establish mechanisms effects" of debilitating medical conditions. for individuals to obtain medical cannabis The measure also created and mandatory reg- from licensed distributors. All of these laws istry program and permitted licensed individu- operate in conflict with the federal law and als to cultivate up to seven plants in leave patients and their providers vulnerable accordance with medical need. Later, the state to federal enforcement raids, arrest, and pros- legislature increased the limit to 24 plants per ecution by U.S. attorneys. patient. California (1996) Alaska (1998) Proposition 215, also known as The Ballot Measure 8 was approved by Compassionate Use Act, was 58% of voters in Alaska. The meas- approved by 56% of voters. It exempts quali- ure removed criminal penalties for individuals fied individuals and their caregivers from who suffer from a debilitating medical condi- criminal liability under state law for the culti- tion for which approved medicines have vation, possession and use of cannabis failed and possess a recommendation for a In 2004, California enacted the Medical physician to use cannabis. In 1999, the state

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60 legislature passed Senate Bill 94 which created gram is housed in the state's Department of a mandatory state registry system and Public Safety, one of the few states where law removed legal protections for those who enforcement is responsible for administering refuse to register with the state health the medical cannabis program. department, or who possess greater amounts Colorado (2000) of cannabis than authorized by state law. Amendment 20 to the state consti- Washington (1998) tution was approved by 54% of the Initiative 692 was approved by 59% voters. As adopted, the law authorizes indi- of voters. The law permits individu- viduals diagnosed by a physician as having a als with terminal illnesses and persons with spe- debilitating condition to use cannabis in cific chronic diseases to use and possess accordance with a recommendation from a cannabis once they've received appropriate physician. The Board of Health has estab- documentation from their physician. The law lished a mandatory registry program whereby further protects their physicians and primary individuals and a caregiver may possess two caregivers against criminal prosecution and/or usable ounces of cannabis and up to six penalizing administrative actions by the state of plants. Colorado's law was amended in June Washington. The law only gives an affirmative of 2010 to provide a regulatory framework defense at trial, not a protection from arrest. for dispensaries, including giving local com- munities the ability to ban or place controls Maine (1999) on the operation, location and ownership of The Maine Medical Marijuana Act the dispensaries. of 1998 was enacted to protect Nevada (2000) individuals who find therapeutic and pallia- tive benefits from using cannabis from civil or Question 9 amended the state con- criminal penalties when their doctors advise stitution and was approved by 65% that such use may provide a medical benefit of voters. The law removes state-level criminal to them and when other reasonable restric- penalties against those who have obtained a tions are met regarding that use. In 2009, the "written documentation" from their physician law was amended to increase the number of affirming that the use of cannabis may allevi- conditions covered under this law. The ate his or her condition. The law establishes a amendment also instructed the Department confidential state registry that issues identifi- of Health and Human Services to establish a cation cards to qualified patients. registry identification program for patients Vermont (2004) and caregivers. Vermont became the second state Hawaii (2000) to pass a medical cannabis law by This was the first state in which the the legislative process. The law was enacted in legislature debated and adopted a 2004 without the Governor's signature. In law later signed by the governor which accordance with the law, individuals qualified authorized the use of medical cannabis. to use cannabis are authorized to cultivate up Specifically, the legislation removes state-level to nine cannabis plants in a locked room and criminal penalties for medical cannabis use, to possess two ounces of dried cannabis under possession, and cultivation of up to seven the supervision of the Department of Public plants. A physician must certify that the Safety, which maintains a patient registry. patient has a debilitating condition for which Montana (2004) "the potential benefits of the medical use of cannabis would likely outweigh the health Ballot initiative 148 was approved risks." Hawaii's mandatory state registry pro- by 62% of voters. The law permits

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61 qualified individuals to use cannabis under Michigan (2008) medical supervision. Eligible medical condi- After numerous Michigan cities, tions include cancer, glaucoma, HIV/AIDS, including Detroit and Ann Arbor, wasting syndrome, seizures, and severe or had passed medical cannabis measures, the chronic pain. A doctor must certify that the state’s voters in 2008 passed the "Michigan patient has a debilitating medical condition Medical Marihuana Act" by 63% of the vote. and that the benefits of using cannabis Patients may qualify for protections with a would likely outweigh the risks. The patient doctor’s recommendation for a number of may grow up to six plants and possess one debilitating conditions. Patients may possess ounce of dried cannabis. The state public up to 2.5 ounces of usable marijuana and may health department maintains a mandatory cultivate up to twelve marijuana plants in an registry system. enclosed, locked area. Rhode Island (2006) New Jersey (2010) In a gubernatorial veto override, The New Jersey Compassionate Use the Rhode Island state legislature Medical Marijuana Act, was signed enacted The "Edward O. Hawkins and into law by outgoing Governor John Corzine Thomas C. Slater Medical Marijuana Act" in on January 18, 2010. The purpose of the law 2006. Rhode Island's law allows individuals to is to protect "patients who use marijuana to possess up to 12 plants or 2-1/2 ounces to alleviate suffering from debilitating medical treat cancer, HIV/AIDS, and other chronic ail- conditions, as well as their physicians, primary ments. The law included a sunset provision caregivers, and those who are authorized to and was set to expire on July 1, 2007, but the produce marijuana for medical purposes" law was made permanent in 2007. In 2009, from "arrest, prosecution, property forfeiture, the law was amended by substituting The and criminal and other penalties."The New Edward O. Hawkins and Thomas C. Slater Jersey Department of Health and Senior Medical Marijuana Act for the original bill. Services released draft rules outlining the reg- Though the Governor vetoed this bill, both istration and application process in October of the Senate and House overrode this veto and 2010. Finding these rules to be too restrictive, the new law was adopted. the New Jersey State Legislature ultimately New Mexico (2007) sent them back to Governor Christie, ordering him to rewrite the proposed regulations. The Lynn and Erin Compassionate Use Medical Marijuana Act was Washington, DC (1998 & 2010) adopted by the state legislature, and enact- In 1998, voters in Washington, DC ed by Governor Bill Richardson in 2007. The approved a ballot measure to law requires the state's Department of authorize the use of medical cannabis in Health to set rules governing the distribution accordance with a physician's recommenda- of medical cannabis to state-authorized tion. During the 105th Congress, an amend- patients. Unlike other state programs, the ment to the Consolidated and Emergency legislation directed the establishment of Supplemental Appropriations Act, 1999, state-licensed "cannabis production facili- instructed that the District of Columbia could ties." In 2008, after abandoning a plan to not spend appropriations money to adminis- have state officials cultivate cannabis for dis- ter a ballot initiative. The amendment was tribution to program participants, the New successfully challenged, and 69% of voters in Mexico Department of Health has proposed the nation's capital approved the measure. licensing private growers and non-profit dis- The "Legalization of Marijuana for Medical tributors. Treatment Amendment Act of 2010" was approved 13-0 by the Council of the District of

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62 Columbia on May 4, 2010 and signed by the Ehrlich, the first Republican governor to sign a Mayor on May 21, 2010, becoming effective bill relaxing penalties for medicinal use of on July 27, 2010. After being signed by the cannabis, signed the measure despite pressure Mayor, the law underwent a 30-day from the Bush administration to veto it. Congressional review period. Congress did not act to stop the law, so it became effective Connecticut (2007) when the review period ended. In 2007, after five legislative committees and Arizona (2010) the full Connecticut House and Senate passed H.B. 6715, Gov. M. Jodi Rell (R) vetoed the leg- Ballot proposition 203, The Arizona islation which would have permitted seriously Medical Marijuana Act, was ill individuals to use medical cannabis with approved by 50.13% of voters in November their doctor's recommendation. Although of 2010. It allows registered qualifying more than 60% of Connecticut's legislators patients to obtain cannabis from a registered voted in favor of the bill, two-thirds of each non-profit dispensary, and to possess and use medical cannabis to treat the condition. chamber is necessary to override a veto, a Registration is mandatory. Unlike other state veto-override vote never occurred. laws, Arizona's law specifies that a registered Other state laws patient's use of medical cannabis is to be con- sidered equivalent to the use of any other Between 1978 and 1997, 35 states and the medication under the direction of a physician District of Columbia passed legislation and does not disqualify a patient from med- acknowledging the potential medical value of ical care, including organ transplants. cannabis. These states include: Alabama, Arizona, Arkansas, California, Colorado, The law also states that employers may not Connecticut, Florida, Georgia, Illinois, Iowa, discriminate against registered patients unless Louisiana, Massachusetts, Maine, Minnesota, that employer would lose money or licensing Missouri, Montana, Nevada, New Hampshire, under federal law. Employers may not penal- New Jersey, New Mexico, New York, North ize registered patients solely for testing posi- tive for cannabis in drug tests, although the Carolina, Ohio, Oklahoma, Oregon, Rhode law does not authorize patients to use, pos- Island, South Carolina, Tennessee, Texas, sess, or be impaired by cannabis on the prem- Vermont, Virginia, Washington, West Virginia, ises or during the hours of employment. and Wisconsin. Except for the District of Columbia and the SPECIAL CASES AND OTHER STATE LAWS fourteen states that explicitly grant protection Maryland (2003) from arrest, most of these state laws do not currently protect medical cannabis users from In 2003, Maryland enacted the state prosecution. Some of these laws permit Darrell Putnam Compassionate Use individuals to acquire and use cannabis Act. The bill applies to defendants through therapeutic research programs, how- possessing less than one ounce of cannabis ever, none of these programs has been opera- and who can prove that their cannabis-relat- ed activities were in pursuit of a medical tional since 1985. Other state laws allow necessity and with a doctor's recommenda- doctors to prescribe cannabis or allow people tion. Under Maryland's law, individuals are to possess cannabis if it has been obtained protected from a criminal record and possible through a prescription, but the federal imprisonment. The maximum penalty for pos- Controlled Substances Act prevents these laws session of cannabis by a patient with a valid frombeing implemented. A few states have doctor's recommendation is $100. Governor placed cannabis in a controlled drug schedule that recognizes its medical value.

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63 THE CROSSFIRE OF STATE & FEDERAL LAW To the extent that the vast majority of arrests Despite hundreds of peer-reviewed scientific for cannabis-related activity occur at the state research studies, including dozens of double- and local level, these state laws offer substan- blind, placebo-controlled clinical trials, all of tial protection. However, while these laws which demonstrate cannabis can effectively shield authorized persons from arrest and treat symptoms of HIV/AIDS, muscle spasticity, prosecution, many individuals who use and severe neuropathic and chronic pain, cannabis to relieve symptoms of serious or among other conditions, the federal chronic illness continue to suffer pervasive dis- Department of Health and Human Services crimination in employment, child custody, continues to maintain the position that housing, public accommodation, education, cannabis "has no currently accepted medical and medical care. Moreover, the conflict use in treatment in the United States." between state and federal laws leaves some individuals - usually those providing a safe The federal government's dogmatic approach point of access or engaged in the cultivation to marijuana is dangerous and causes unnec- of medical cannabis - vulnerable to federal essary suffering by deterring individuals who prosecution and lengthy prison sentences. suffer from serious and chronic illness from And the majority of Americans do not enjoy obtaining and using cannabis, a remedy that any legal protection if their doctors recom- could provide needed relief and significantly mend cannabis for treatment. improve quality of life. Worse still, it allows the Department of Justice and the Drug Enforcement Administration to conduct a campaign of intimidation against individuals authorized in the various states to use or pro- vide medical cannabis in accordance with state law. For more than 30 years, advocates have used the appropriate administrative channels to petition the United States to remove cannabis from the list of Schedule I drugs, those with no medical use. After exhaustive hearings, the DEA's Chief Administrative Law Judge ruled in 1988 that cannabis should be made The Community-Based Solution to Access: available for medical use. But despite over- Medical Cannabis Dispensing Centers whelming evidence of the therapeutic efficacy So long as research supports the therapeutic of cannabis, federal law continues to prohibit value of cannabis and physicians recommend its use for medical purposes. it to control symptoms of serious and chronic As a consequence of this longstanding federal illness, patients will seek safe and consistent intransigence, advocates sought legal protec- access to quality cannabis. Many individuals tions within the various states. Since the suffering from a serious or chronic illness may founding of the nation, state and local gov- not have the time or resources to cultivate ernments have long been "laboratories of their own cannabis, or might not know people democracy," particularly in cases when federal willing and able to act as a caregiver and grow obstruction was borne of political cowardice cannabis on their behalf. As a result, individu- or ignorance. More than one-third of the U.S. als are forced to break the law and risk unnec- essary and potentially harmful entanglements population currently lives in a state that has with illicit dealers and law enforcement offi- authorized the use of medical cannabis, and cers in order to gain access to cannabis. more states consider similar laws each year.

For more information, see www.AmericansForSafeAccess.org or contact the ASA office at 1-888-929-4367 or 510-251-1856.

64 Medical cannabis dispensing centers have dize access to other natural or complimentary emerged as a sensible, community-based health care services that would otherwise be response designed to provide a safe place for unavailable to their clients. Whether dispens- qualified individuals to access a consistent ing centers are regulated by the state or supply of medical cannabis. These points of (someday) the federal government, local poli- access represent an effort in various states to cymakers still have an important role to play fully implement state law. Moreover, the to the extent any proper regulation will importance of these facilities is underscored require zoning, permitting, policing, fees, and by the reluctance of the federal government other issues which will remain the prerogative to address the issue of medical cannabis in a of local governments. meaningful way. Since the U.S. Supreme Court issued the deci- While most of these facilities operate like sion in Gonzales v. Raich, which did not invali- wellness facilities, medical cannabis dispensing date state medical cannabis laws, and upheld centers exist specifically to provide qualified Kha v. Garden Grove, which clarified the individuals exclusive and reliable access to responsibility of the states to uphold state cannabis, much as a pharmacy exists to pro- and local laws even when they are in conflict vide prescribed medication. Moreover, the with federal law, many local and state gov- regulations that permit and control dispens- ernments have been working overtime to ing centers ensure local governance and over- implement their state laws to curb abuse and sight of the cultivation and distribution of to set up the appropriate systems to carefully medical cannabis in accordance with state regulate and control the distribution of med- law. By requiring compliance with compre- ical cannabis to authorized individuals in their hensive regulatory ordinances, local officials communities. Community-based medical mari- can monitor the operation of medical juana access centers are beginning to take cannabis dispensing centers to be certain that root in locations outside of California. proper verification procedures are followed, Oregon, Washington, Colorado, New Mexico, to assure that the place and hours of opera- Maine, Michigan, Montana, Rhode Island, and tion are consistent with community needs, the District of Columbia are just a few of the and to minimize diversion of medical cannabis jurisdictions seeking to appropriately control to the illicit market. and regulate the production and distribution of medical cannabis. In California, Colorado, and a few other states, locally regulated patient-collectives The Federal Response: Interrupt Access, have been widely successful. In most cases, Intimidate Providers, Undermine Authority these collectives pool the resources of quali- Despite the affirmative implementation fied members to cooperatively cultivate med- efforts in 15 states and the District of ical cannabis and distribute it to other Columbia, the Department of Justice and the members who may not be able to provide it Drug Enforcement Administration have cho- for themselves. For these individuals, particu- sen to use their discretion to undermine the larly those most in need, dispensing centers effective implementation and authority of provide more than reliable access; they also state law, instead of working to bridge the offer alternative forms of cannabis extracts gap between legitimate state laws and out- and experienced guidance on dosage and dated federal laws. In 1999, federal agencies efficacy for different cannabis varieties. Many initiated a series of paramilitary style enforce- even have social services and support net- ment raids on individuals and collectives works that assist those who would otherwise authorized to use or provide medical cannabis be isolated by their conditions. in accordance with California state law that In many cases, these dispensing centers subsi- continues today.

For more information, see www.AmericansForSafeAccess.org or contact the ASA office at 1-888-929-4367 or 510-251-1856.

65 Following the Supreme Court's decision in Attorney delivered an ultimatum: evict the Raich, federal agencies intensified their collectives within 45 days or face federal asset enforcement tactics. Between 2007 and 2008, forfeiture, prosecution, and DEA raids at the national advocates recorded an unprecedent- facilities. ed number of enforcement raids against indi- Another tactic employed by the federal gov- viduals authorized to use or dispense medical ernment is designed to interrupt safe access cannabis in accordance with their state law, by preventing collective operators from and currently, the Department of Justice is depositing their funds into bank accounts. seeking to prosecute more than 100 of these Forcing collectives to carry large sums of cash individuals even though they were adhering on hand makes them an attractive risk for to state law. These campaigns to circumvent criminal activity which risks the safety of state law happened despite inquiries from patients and providers affiliated with these members of the U.S. House Judiciary establishments. To remedy the situation, ASA Committee and requests from local policy- is engaging congressional allies. makers to halt raids in deference to local reg- ulators. In May 2010, 15 Members of Congress, includ- ing members from both the Banking and Federal enforcement activity against individu- Judiciary committees, sent a letter to Treasury als qualified to use or possess medical Secretary Timothy Geithner urging him to cannabis has not been restricted to California. issue "written guidance for financial institu- In Washington, federal law enforcement tions," which would commit the Treasury agents in 2007 raided the offices of a medical Department to not targeting those institu- cannabis advocacy group that was supplying tions whose account holders are in compli- hundreds of authorized individuals with ance with state medical marijuana laws. This starter plants. In New Mexico a few months dialogue with Treasury and Congress is ongo- later, the DEA threatened state officials with ing, and if history is any indication, is not like- federal prosecution if they proceeded to ly to be resolved until the federal government implement a state-mandated medical ends the conflict between state and federal cannabis distribution program. In Oregon medical marijuana laws. that same year, a federal grand jury subpoe- naed the medical records of 17 qualified indi- The latest federal interference tactic utilizes viduals enrolled in the Oregon Medical an antiquated tax code (IRS provision 280E) to Marijuana Program. A federal court later prohibit medical marijuana dispensing centers denied the subpoena of patient records, but from taking standard business deductions and as of March 2011, federal authorities are credits. Several medical cannabis centers have attempting to subpoena the confidential been targeted under the guise of federal tax records of seven patients enrolled in audits. These "audits" appear to target cen- Michigan's medical cannabis program, despite ters serving the greatest percentage of the a provision of state law that makes it a crime population. to release such information. For the patients who rely on access to the med- In 2008, the Department of Justice began to icine these centers provide, enforcement of this levy threats against property owners who tax provision could result in a number of conse- leased property to medical cannabis dispens- quences. First, collectives will significantly raise ing collectives. On June 30, the U.S. Attorney the cost of medicine and services in order to for the Central District of California and compensate for the loss of standard business Special Assistant U.S. Attorney, Asset deductions and credits. Second, it's possible Forfeiture Section, sent letters to multiple that some collectives may simply stop filing property owners requesting that they attend federal tax returns, which may jeopardize the a meeting in August at which the U.S. integrity of the centers and put patients in

For more information, see www.AmericansForSafeAccess.org or contact the ASA office at 1-888-929-4367 or 510-251-1856.

66 harm's way. And finally, in the worst case, ing with a serious or chronic illness to use and medical cannabis dispensing centers will simply obtain cannabis as recommended by a physi- shut their doors, forcing what are otherwise cian. However, these state laws differ from well regulated facilities underground. the federal law and leave patients and their providers vulnerable to federal raids, arrest, Despite these tactics, the movement for safe and prosecution. Since 2006, many state and access continues to thrive across the country. local governments have been working over- Heightened federal enforcement efforts and time to fully implement their state laws in prosecutions have had a negligible impact on order to curb abuse and create the appropri- the distribution of medical cannabis in Cali- ate systems to carefully regulate and control fornia and other states. In fact, more jurisdic- the distribution of medical cannabis to tions, not fewer, are seeking to create the authorized individuals in their communities. regulations necessary to control safe produc- tion and distribution of marijuana for med- Effective implementation of state medical ical purposes. cannabis laws is stymied by federal interfer- ence. The U.S. Department of Justice, togeth- The Obama Administration recently issued er with the Drug Enforcement Administration, written guidelines to U.S. Attorneys discour- has conducted scores of enforcement raids aging the prosecution of patients and and employed intimidation tactics designed providers who are in compliance with existing to undermine the implementation of state state laws. These guidelines are an important and local law. The importance of state laws, step in the right direction and a welcome and and the protection they provide, is under- significant departure from the policies of pre- scored by the reluctance of the federal policy- vious Administrations. Of course, much more makers to address the issue of medical needs to be done to ensure that all patients cannabis in a meaningful way. Until Congress who might benefit from medical cannabis and the Administration create a comprehen- have access to it. sive national medical cannabis strategy, indi- The Advocates Solution: vidual states should not be obstructed from ASA's Federal Policy Agenda responding to the public health needs of their citizens. ASA's National Office opened in April 2006 to 2. Permit an affirmative defense and bring the patients' voice to Washington, D.C., establish federal legal protection for to end the arrests and prosecutions of individuals authorized by state or local patients using medical cannabis therapeutics, law to use or provide cannabis for to end the ban on research, and to create an therapeutic use. access plan for the entire nation. ASA works on Capitol Hill and within the Administration Currently, the Department of Justice has pros- to improve the federal government's under- ecuted more than 100 licensed medical standing of the therapeutic uses of cannabis cannabis patients and providers. and the immediate and long-term needs of Unfortunately, federal defendants are forbid- our members. ASA's advocacy in DC is based den from presenting evidence at trial that on the following Federal Policy Agenda. their marijuana-related activities were for When implemented, these policies will finally therapeutic purposes and in compliance with free state and local governments to adopt state law, limiting their ability to present a effective, compassionate access models. defense in federal court. Congress and the Administration should amend the Controlled 1. End Federal Raids, Intimidation, and Substances Act to provide an affirmative Interference with State Law. defense in federal court and establish legal Fifteen states and the District of Columbia protections for individuals who use or provide have passed laws authorizing individuals liv- cannabis for therapeutic use in accordance

For more information, see www.AmericansForSafeAccess.org or contact the ASA office at 1-888-929-4367 or 510-251-1856.

67 with state and local law. instead should create incentives to conduct 3. Encourage advanced clinical research trials research in accordance with the Institute of that meet accepted scientific standards. Medicine's recommendations. 4. Create a national medical cannabis Federal law clearly requires adequate compe- strategy that includes a safe and legal tition in the manufacture of Schedule I and II access plan. substances, but since 1968 the National Institute on Drug Abuse (NIDA) has main- A scientific consensus supports the therapeu- tained a monopoly on the supply of cannabis tic use of cannabis to control symptoms of used for legitimate research purposes. The serious and chronic illness. In the past decade, Drug Enforcement Administration helps to clinical research has clearly demonstrated that protect NIDA's monopoly by refusing to grant the use of cannabis and its constituents can competitive licenses for the production of safely and effectively treat symptoms of seri- research-grade cannabis. In 2007, U.S. ous and chronic illness like nausea and vomit- Department of Justice-appointed ing, loss of appetite, pain and spasticity. Administrative Law Judge Mary Ellen Bittner The science and policy regarding the medical issued an Opinion and Recommended Ruling use of cannabis should not be obscured or which concluded that granting competitive hindered by the debate surrounding the licenses would be "in the public interest." legalization of marijuana for general use. However, the Administration has taken no Scientific consensus coupled with state leader- action, and the Administrative ship has provided a solid foundation for fed- Recommendation remains pending. eral policymakers to create a comprehensive Congress and the Administration should work plan to support long-term solutions for safe to remove the political and bureaucratic and legal access to cannabis for therapeutic obstacles that inhibit clinical research and use and research.

MODEL LEGISLATION For model state legislation on medical cannabis and a model local ordinance for regulating medical cannabis dispensing centers, see the Appendix.

For more information, see www.AmericansForSafeAccess.org or contact the ASA office at 1-888-929-4367 or 510-251-1856.

68 The Medical Cannabis Advocates’ Handbook

APPENDIX

The CMA has always recognized and acknowledged the unique requirements of those individuals suf- fering from a terminal illness or chronic disease for which conventional therapies have not been effec- tive and for whom marijuana for medicinal purpos- es may provide relief." —-Canadian Medical Association

SCIENTIFIC & LEGAL REFERENCES

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