A PATIENT’S HISTORY of MEDICAL CANNABISamerican-safe-access.s3.amazonaws.com ›...

A PATIENT’S HISTORY of MEDICAL CANNABIS

The Medical Cannabis Advocate’s Handbook

Marijuana, in its natural form, is one of the safest therapeuti-cally active substances known... The evidence in this recordclearly shows that marijuana has been accepted as capable ofrelieving the distress of great numbers of very ill people... Itwould be unreasonable, arbitrary and capricious for DEA tocontinue to stand between those sufferers and the benefitsof this substance.

—Francis L. Young, DEA Chief Administrative Law Judge

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

It can be difficult to locate information aboutthe safety and therapeutic value of cannabis.The unfortunate result of the federal prohibi-tion of cannabis is limited clinical research to

investigate the safety andefficacy of cannabis to con-trol symptoms of seriousand chronic illness. Manyscientists have notedresearch is "hindered by a

complicated federal approval process, limitedavailability of research grade marijuana, andthe debate over legalization."1

However, the documented use of cannabis asa safe and effective therapeutic botanicaldates to 2700 B.C. Between 1840 and 1900,European and American journals of medicinepublished more than 100 arti-cles on the therapeutic use ofcannabis. In fact, cannabis waspart of the American pharma-copoeia until 1942, and is cur-rently available by prescription in Canada andthe Netherlands.

The political interference in the regulation ofcannabis as a medicine and subsequently thecontrol of medical cannabis research originateswith the passage of the Marijuana Tax Act in1937. Over the objections of the AmericanMedical Association,2 the United States enactedthe first federal law designed to restrict accessto cannabis, even for medical purposes.Despite decades of repeated reviews by local,federal and international commissions andemerging clinical science which confirm the rel-ative safety and efficacy of cannabis as a medi-cine, the use of cannabis is absolutely

prohibited—even for medical purposes.

LAGUARDIA REPORT (1944)

The Marijuana Tax Act did not end the debateabout whether cannabis, if appropriately con-trolled, could have therapeutic value. In 1939,New York Mayor Fiorello LaGuardia appointeda blue-ribbon panel of renowned physicians,psychiatrists, clinical psychologists, pharmacol-ogists, chemists and other scientific and med-ical researchers to conduct a review of theassertions that smoking marijuana resulted incriminal behavior, and a deterioration of phys-ical and mental health.

Two years before the final report was issued, areview of the findings was published in theAmerican Journal of Psychiatry which conclud-ed that "prolonged use of [cannabis] does notlead to physical, mental or moral degenera-tion, nor have we observed any permanentdeleterious effects from its continued use.Quite the contrary, [cannabis] and its deriva-tives and allied synthetics have potentiallyvaluable therapeutic applications which meritfurther investigation." Prepared by the NewYork Academy of Medicine and issued in 1944,the LaGuardia Report echoed these conclu-sions, adding that cannabis was not addictive,did not provide a gateway to other drugs ofabuse, and was not associated with increasedcriminal behavior or juvenile delinquency.

THE NATIONAL COMMISSION ONMARIHUANA AND DRUG ABUSE (1972)

The Comprehensive Drug Abuse Preventionand Control Act of 1970 included a provision

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Cannabis as Medicine:What the Science Says

If Cannabis were unknown, and bio-prospectors were suddenly tofind it in some remote mountain crevice, its discovery would nodoubt be hailed as a medical breakthrough. Scientists would praiseits potential for treating everything from pain to cancer, and mar-vel at its rich pharmacopoeia—many of whose chemicals mimicvital molecules in the human body.

—The Economist


to study the abuse of cannabis in the UnitedStates. President Richard Nixon appointedPennsylvania Governor Raymond Shafer tochair the National Commission on Marihuanaand Drug Abuse. On March 22, 1972, thecommission presented its report, Marijuana, ASignal of Misunderstanding, to Congress.

The Shafer report, like the LaGuardia reportbefore it, concluded that the risks of usingcannabis were minimal and that general usedid not jeopardize health, lead to experimen-tation with other drugs, or cause criminalactivity and specifically recommended thedecriminalization of marijuana for personaluse. The recommendations provided in theCommission's report conflicted with many ofthe provisions provided in the ComprehensiveDrug Abuse Prevention and Control Act andthe Controlled Substances Act. PresidentNixon needed to reject the recommendationsand formally declare a "war on drugs".

INVESTIGATIONAL NEW DRUGCOMPASSIONATE ACCESS (1978)

In 1975, shortly after discov-ering that smoking cannabiscould relieve symptoms of hisglaucoma, Washington, DCresident Robert Randall was

arrested for cultivating cannabis in his home.Citing clinical evidence, Mr. Randall successful-ly used the Common Law Doctrine ofNecessity to fight the charges. In November1976, Judge James Washington opined,"[w]hile blindness was shown by competentmedical testimony to be the otherwiseinevitable result of the defendant's disease,no adverse effects from the smoking of mari-juana have been demonstrated. Medical evi-dence suggests that the medical prohibition isnot well-founded."

Mr. Randall petitioned the federal govern-ment to provide him with access to medicalcannabis in accordance with his medicalnecessity and shortly thereafter became thefirst American to receive a government-sup-plied source of cannabis. When Mr. Randall

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ROBERT RANDALLKnown as the "Father of the Modern Medical

Cannabis Movement," Robert Randall was the patient

who made legal history when he persuaded a federal

court that his use of cannabis was a matter of medical

necessity.

In 1972, at the age of 24, Randall had already lost sight

in his right eye, when he was diagnosed with a serious

form of glaucoma and told that he had at most three to

five years until he would go blind. His ophthalmolo-

gist tried a variety of medications, but nothing was

effective. Surgery was ruled out.

Randall soon had to quit his job and ended up on wel-

fare. Then he discovered that cannabis helped his

vision considerably. He returned to work and began to

grow his own medicine. In 1975 he was arrested, and

in 1976 he stood trial and established a defense of

necessity.

The charges were dismissed. His attorneys had also

petitioned the Food and Drug Administration to have

him included in a research program that would give

him 10 joints a day. As a result, he became the first

person to receive a legal, regular supply of 300 med-

ical cannabis cigarettes per month provided by the fed-

eral government.

This led to the creation of the Compassionate

Investigational New Drug Program (IND Program),

which gave him sustained access to this non-approved

drug. The Federal IND program was eventually

opened to others with medical necessity , but it

remained limited to little more than a dozen patients.

Randall spent the rest of his life as an activist, organiz-

ing other patients and writing books about medical

cannabis. He kept his vision for the remaining 36 years

of his life.


went public with his victory, the federal gov-ernment retaliated with threats to withdrawhis access to cannabis. In 1978, Mr. Randallfiled suit and within days federal agenciesrequested to settle. As a result, the FDAestablished the Investigational New Drug(IND) Compassionate Access Program to sup-ply individuals who suffered from severe orchronic illness with a monthly supply ofcannabis, up to nine pounds annually.

In 1992, in response to an overwhelmingnumber of applications from people sufferingthe effects of AIDS, President H.W. Bushclosed the program to all new applicants, cit-ing concerns that the program underminedthe "war on drugs." Today, a handful of sur-viving IND-participants continue to receivemedical cannabis from the U.S. government,paid for by federal tax dollars.

In 2002, a study of the individuals that haveused standardized, heat-sterilized, quality-controlled cannabis as part of the federal INDprogram demonstrated the long-term clinical

effectiveness of cannabis in treat-ing the chronic musculoskeletalpain, spasm and nausea, andspasticity associated withMultiple Sclerosis. After usingcannabis supplied by the federal

government for periods ranging between 11and 27 years, program participants showedno functionally significant problems in theirphysiological systems, as determined by MRIscans of the brain, pulmonary function tests,chest X-ray, neuropsychological tests, hor-mone and immunological assays, electroen-cephalography, P300 testing and neurologicalclinical examinations.3

INSTITUTE OF MEDICINE (1982, 1999)

In 1982, the Institute of Medicine (IOM), adivision of the National Academy of Sciences,published the report Marijuana and Health.The IOM noted that "Preliminary studies sug-gest that marijuana and its derivatives or ana-logues might be useful in the treatment ofthe raised intraocular pressure of glaucoma,

in the control of the severe nausea and vomit-ing caused by cancer chemotherapy, and inthe treatment of asthma."4

More than a decade later, in response to statelaws that permitted the use of cannabis inaccordance with a recommendation by alicensed physician, the White House Office ofNational Drug Control Policy commissionedanother report from the IOM to assess themedical and scientific value of cannabis. In1999 the IOM published Marijuana as Medicine:Assessing the Science Base, a comprehensivemeta-analysis of all existing research concern-ing the therapeutic value of cannabis.5 Indescribing the findings of the IOM review, theCongressional Research Service observes that"[f]or the most part, the IOM Report strad-dled the fence and provided sound bites forboth sides of the medical marijuana debate."6

Both IOM reports conclude that there is asound medical and scientific basis for usingcannabis as treatment for a variety of seriousor chronic medical conditions. They emphasizethe need for continued research with a focuson well-designed clinical trials aimed at devel-oping rapid-onset, reliable, and safe deliverysystems. Congress and executive agencies havelargely ignored these findings and have neverconvened a panel to oversee the full imple-mentation of recommendations.

THE HOUSE OF LORDS SELECT COMMITTEEON SCIENCE & TECHNOLOGY REPORT (1998)

In 1998, the British House of Lords SelectCommittee on Science and Technology issueda remarkably comprehensive report oncannabis including testimony from peoplewith serious illness, scientific researchers, andphysicians. The report recommended immedi-ately rescheduling cannabis so that doctorscould prescribe cannabis to their patients andpharmacies could safely distribute cannabis.This recommendation was made in partbecause the committee acknowledged thatindividuals using cannabis for therapeutic pur-poses "are caught in the front line of the waragainst drug abuse. This makes criminals of

29


people whose intentions are innocent, it addsto the burden on enforcement agencies, andit brings the law into disrepute. Legalisingmedical use on prescription, in the way thatwe recommend, would create a clear separa-tion between medical and recreational use,under control of the health care professions."7

The report recommended "that clinical trialsof cannabis for the treatment of MS andchronic pain should be mounted as a matterof urgency." Specifically, the committee rec-ommended that research focus on alternativemodes of administration that "would retainthe benefit of rapid absorption offered bysmoking, without the adverse effects."

THE ENDOCANNABINOID SYSTEM (ECS)

Humans have used opiate drugs such as mor-phine and heroin for thousands of years tolessen pain and produce euphoria. In 1973,scientists discovered the brain's opiate recep-tor which suggested that opiate drugs workprimarily by mimicking natural opiate-likemolecules, like endorphins, made and used inthe brain. The discovery of opiate receptorshas revolutionized pain management, includ-ing the development of powerful therapeuticdrugs like morphine, codeine, and oxycodone.

Similarly, humans have used the cannabisplant for thousands of years to reduce pain,control nausea, stimulate appetite, controlanxiety, and produce feelings of euphoria. Inthe past 30 years, however, researchers have

made new discoveries that help us betterunderstand why and how cannabis works sowell for so many people.

The therapeutic benefits of cannabis arederived from the interactions of cannabinoidsand the human body's own endocannabinoidsystem. The endocannabinoid system (ECS) isa sophisticated group of neuromodulators,their receptors, and signaling pathwaysinvolved in a variety of physiological processesincluding the regulation of movement, mood,memory, appetite, and pain.

Prominent researcher and author Dr. EthanRusso has one of the most comprehensivedescriptions of the ECS16:

The analgesic and palliative effects of thecannabis and cannabinioid preparationhave been amply reported over the pastgeneration, and have similarly beenreviewed at length in previous citations. Inessence, the effects result from a combina-tion of receptor and nonreceptor mediatedmechanisms. THC and other cannabinoidsexert many actions through cannabinoidreceptors, G-protein coupled membranereceptors that are extremely densely repre-sented in central, spinal, and peripheralnociceptive pathways. Endogenouscannabinoids (endocannabinoids) evenregulate integrative pain structures such asthe periaqueductal gray matter. The endo-cannabinoid system also interacts innumerous ways with the endogenous opi-oid and vanillio systems that that can mod-ulate analgesia and with a myriad of otherneurotransmitter systems such as the sero-tonergic, dopaminergic, glutameatergic,etc, pertinent to pain. Research has shownthat the addition of cannabinoid agoniststo opiates enhances analgesic efficacymarkedly in experimental animals, helpsdiminish the likelihood of the develop-ment of opiate tolerance, and preventsopiate withdrawl. The current author hassuggested that a clinical endocannabinoiddeficiency may underlie the pathogenesisof migraine, fibromyalgia, idiopathic

30

CB1 receptor


bowel syndrome, and numerous otherpainful conditions that defy modernpathophysiological explanation or ade-quate treatment.8

Thirty years ago, the endocannabinoid systemwas unknown; our understanding of the ECSbegan in the mid-1980s when researchers firstidentified the presence of a cannabinoidreceptor in the brain and cloned it. Sincethen, two types of receptors, CB1 and CB2,have been identified and these discoverieshave dramatically increased our understand-ing about how cannabis and related cannabi-noids affect the human body.9-10

CB1 receptors are found in the central nerv-ous system and in other organs and tissuessuch as the eyes, lungs, kidneys, liver anddigestive tract and are particularly well-repre-sented in the brain. Infact, the brain's recep-tors for cannabinoidsfar outnumber the opi-ate receptors, perhapsby as much as ten toone. The relative safetyof cannabis is reflectedin the fact that cannabi-noid receptors are virtu-ally absent from thoseregions at the base ofthe brain that areresponsible for such vital functions as breath-ing and blood pressure control. CB2 receptorsare primarily located in tissues associated withimmune function such as the spleen, thymus,tonsils, bone marrow, and white blood cells.

Research is helping scientists and physiciansunderstand the role of the endocannabinoidsystem in regulating a variety of bodily func-tions. As noted by world-renowned authorand researcher, Raphael Mechoulam, the dis-covery of the endocannabinoid system hasgenerated a great deal of interest in identify-ing opportunities for the development of awide variety of cannabis-based and othercannabinoid therapeutic drugs.11

EMERGING CLINICAL DATA: THETHERAPEUTIC POTENTIAL OF CANNABIS

While research in the United States has beensharply restricted by the federal prohibitionon cannabis in the past, the last few yearshave seen rapid change. The InternationalCannabinoid Research Society (ICRS) was for-mally incorporated as a scientific researchorganization in 1991, and since its incorpora-tion the membership has more than tripled.The International Association for Cannabis asMedicine (IACM) was founded in 2000, pub-lishes a bi-weekly newsletter and holds a bi-annual symposium to highlight emergingclinical research concerning cannabis thera-peutics. The University of California estab-lished the Center for Medical CannabisResearch (CMCR) in 2001 to conduct high

quality scientific studiesintended to ascertain thegeneral medical safetyand efficacy of cannabisproducts and examinealternative forms ofcannabis administration.In 2010, the CMCR issueda report on the 14 clinicalstudies it has conducted,most of which were FDA-approved, double-blind,placebo-controlled clini-cal studies that have

demonstrated that cannabis can control pain,in some cases better than the available alter-natives.13

A 2009 review of controlled clinical studiesconducted over a 38-year period, including 33trials in the U.S., found that "nearly all of the33 published controlled clinical trials conduct-ed in the United States have shown significantand measurable benefits in subjects receivingthe treatment."13 The review's authors notethat the more than 100 different cannabi-noids in cannabis have the capacity for anal-gesia through neuromodulation in ascendingand descending pain pathways, neuroprotec-tion, and anti-inflammatory mechanisms—allof which indicates that cannabis has applica-

31

FEDERATION OF AMERICAN SCIENTISTS

"Based on much evidence, from patientsand doctors alike, on the superior effective-ness and safety of whole cannabis com-pared to other medications,… the Presidentshould instruct the NIH and the FDA tomake efforts to enroll seriously ill patientswhose physicians believe that wholecannabis would be helpful to their condi-tions in clinical trials"

FAS Petition on Medical Marijuana, 1994


tions in managing chronic pain, muscle spas-ticity, cachexia, and other debilitating condi-

tons.

To date, more than 15,000modern peer-reviewed scientificarticles on the chemistry andpharmacology of cannabis and

cannabinoids have been published, as well asmore than 2,000 articles on the body's naturalendocannabinoids.

Currently, cannabis is most often recommend-ed as complementary or adjunct medicine.But there is a substantial consensus amongexperts in the relevant disciplines, includingthe American College of Physicians, thatcannabis and cannabis-based medicines havetherapeutic properties that could potentiallytreat a variety of serious and chronic illness.What follows is a brief, annotated compila-tion of relevant works representing theemerging clinical data which support thetherapeutic use of cannabis.

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. Yearsbefore any state had authorized the medicaluse of cannabis, a 1991 Harvard MedicalSchool study revealed that nearly half (44%)of U.S. oncologists were recommendingcannabis to their patients as a way of mitigat-ing the side effects of cancer treatments.14

In its 1999 review, the Institute of Medicineconcluded that cannabis could be a validalternative for many people living with can-cer. Specifically, the IOM notes, "In patientsalready experiencing severe nausea or vomit-ing, pills are generally ineffective, because ofthe difficulty in swallowing or keeping a pilldown, and slow onset of the drug effect."15

Since the release of the IOM report, newresearch has been published which supportsthe use of cannabis to curb the debilitatingeffects of cancer treatment. In 2001, a review

of clinical studies conducted in several statesduring the past two decades revealed that, in768 individuals with cancer, cannabis was ahighly effective anti-emetic in chemotherapy.16

Other studies have concluded that the activecomponents in cannabis produce palliativeeffects in cancer patients by preventing nau-sea, vomiting and pain and by stimulatingappetite. Researchers have also observed that"these compounds have been shown to inhibitthe growth of tumor cells in culture and ani-mal models by modulating key cell-signalingpathways. Cannabinoids are usually well toler-ated, and do not produce the generalized toxiceffects of conventional chemotherapies."17

COMBATING CHEMOTHERAPY

Cannabis is used most often to combat nau-sea induced by chemotherapy agents andpain caused by various cancers. More than 30human clinical trials have examined theeffects of cannabis or synthetic cannabinoidson nausea,18 not including several U.S. statetrials that took place between 1978 and

1986.19 In reviewing this literature, scientistshave concluded that, ". . . THC [delta-9-tetrahydrocannabinol] is superior to placebo,and equivalent in effectiveness to other wide-ly-used anti-emetic drugs, in its capacity toreduce the nausea and vomiting caused bysome chemotherapy regimens in some cancerpatients."20

A 1998 review by the British House of LordsScience & Technology Select Committee con-

32


cluded that "cannabinoids are undoubtedlyeffective as anti-emetic agents in vomitinginduced by anti-cancer drugs. Some users ofboth find cannabis itself more effective."21

The House of Lords review builds upon dataprovided in a 1997 inquiry by the BritishMedical Association that determined cannabisis, in some cases, more effective thanMarinol.22

CANCER-FIGHTING CANNABINOIDS

Recent scientific advances in the study ofcannabinoid receptors and endocannabinoidshave produced exciting new leads in thesearch for anti-cancer treatments. In the pastdecade, scores of studies,both in vivo and in vitro,have demonstrated thatvarious cannabinoidshave a significant effectfighting cancer cells. Todate, studies have shownthat cannabinoids arrestmany kinds of cancergrowths through promo-tion of apoptosis (programmed cell death)that is lost in tumors, and by arresting angio-genesis (increased blood vessel production).Unlike conventional chemotherapy treat-ments which work by creating a toxic environ-ment in the body that frequentlycompromises overall health, cannabinoidshave been shown to selectively target onlycancer tumor cells.

Cannabinoids and Tumor Reduction

The direct anti-tumor and anti-proliferationactivity of cannabinoids, specifically CB1 andCB2 agonists, has now been demonstrated indozens of studies across a range of cancertypes, including brain (gliomas), breast, liver,leukemic, melanoma, phaeochromocytoma,cervical, pituitary, prostate and bowel.23-40 Theanti-tumor activity has led in laboratory ani-mals and in-vitro human tissues to regressionof tumors, reductions in vascularisation (bloodsupply) and metastases (secondary tumors), aswell as the direct destruction of cancer cells

(apoptosis).41-45 Indeed, research on the com-plex interactions of endogenous cannabinoidsand receptors is leading to greater scientificunderstanding of the basic mechanisms bywhich cancers develop.46

In multiple studies published between 2001and 2003, cannabinoids inhibited tumorgrowth in laboratory animals.47-50 In anotherstudy, injections of synthetic THC eradicatedmalignant brain tumors in one-third of treat-ed rats, and prolonged life in another third byas long as six weeks.51, 52 And, research onpituitary cancers suggest that cannabinoidsmay be the key to regulating human pituitaryhormone secretion.53-56 A 2009 review of recent

studies that have focusedon the role of cannabi-noids and cannabinoidreceptors in the treat-ment of breast cancernotes that cannabinoidshave been shown in lab-oratory models to beeffective fighting manytypes of cancers.57

Recent research published in 2009 has foundthat the non-psychoactive cannabinoidcannabidiol (CBD) inhibits the invasion ofboth human cervical cancer and human lungcancer cells. By manipulating cannabidiol'sup-regulation of a tissue inhibitor, researchersmay have revealed the mechanism of CBD'stumor-fighting effect. A further in vivo studydemonstrated "a significant inhibition" oflung cancer metastasis in mice treated withCBD.58 The mechanism of the anti-canceractivity of CBD and other cannabinoids hasalso been repeatedly demonstrated withbreast cancers.59-63

Also in 2009, scientists reported on the anti-tumor effects of the cannabinoid THC oncholangiocarcinoma cells, an often-fatal typeof cancer that attacks the liver's bile ducts.They found that "THC inhibited cell prolifera-tion, migration and invasion, and induced cellapoptosis." At low levels, THC reduced themigration and invasion of cancer cells, while

33

AMERICAN ACADEMY OF FAMILY PHYSICIANS

"The American Academy of FamilyPhysicians [supports] the use of marijuana... under medical supervision and controlfor specific medical indications."

1996-1997 AAFP Reference Manual


at high concentrations, THC triggered cell-death in tumors. In short, THC reduced theactivity and number of cancer cells. This dose-dependent action of cannabinoids on tumorshas also been demonstrated in animal studies.

Research on cannabinoids and gliomas, a typeof aggressive brain cancer for which there isno cure, holds promise for future treatments.A study that examined both animal andhuman glioblastoma multiforme (GBM)

tumors, the mostcommon andaggressive formof brain cancer,describes howcannabinoidscontrolledglioma growthby regulatingthe blood vesselsthat supply thetumors.64 Inanother study,researchersdemonstratedthat the adminis-tration of thenon-psychoactivecannabinoid

cannabidiol (CBD) significantly inhibited thegrowth of subcutaneously implanted U87human glioma cells in mice. The authors ofthe study noted that "... CBD was able to pro-duce a significant antitumor activity both invitro and in vivo, thus suggesting a possibleapplication of CBD as an antineoplasticagent.65

The targeted effects of cannabinoids on GBMwere further demonstrated in 2005 byresearchers who showed that the cannabinoidTHC both selectively inhibited the prolifera-tion of malignant cells and induced them todie off, while leaving healthy cellsunaffected.66 While CBD and THC have eachbeen demonstrated to have tumor-fightingproperties, research published in 2010 showsthat CBD enhances the inhibitory effects ofTHC on GBM cell proliferation and survival.67

Similarly, researchers reported in 2010 thatthe way cannabinoid and cannabinoid-likereceptors in brain cells "regulate these cells'differentiation, functions and viability" sug-gests cannabinoids and other drugs that tar-get cannabinoid receptors can "manageneuroinflammation and eradicate malignantastrocytomas," a type of glial cancer.68 Theserecent studies confirm the findings of multiplestudies that indicated the effectiveness ofcannabinoids in fighting gliomas.69-76

Indications of the remarkable potential ofcannabinoids to fight cancer in humans havealso been seen in three large-scale populationstudies done recently. The studies weredesigned to find correlations between smok-ing cannabis and cancers of the lung, throat,head and neck. Instead, the researchers dis-covered that the cancer rates of cannabissmokers were at worst no greater than thosewho smoked nothing at all or even better.77

One study found that 10-20 years of cannabisuse significantly reduced the incidence ofhead, neck and throat cancers.78 Researcherssuggest that cannabinoids my produce a pro-phylactic effect against cancer development,as seen in the anti-proliferation effect thathas been demonstrated in vitro and in vivo.

CANNABIS & HIV/AIDS AND HEP-C

Cannabis helps to improve the lives of manypeople living with HIV/AIDS; it helps manageappetite loss, wasting, nausea, vomiting, pain,anxiety, stress, depression and other symp-toms of both the disease and the anti-retrovi-ral regimes used to treat it. As many as 1 in 4people living with HIV/AIDS use cannabis formedical purposes.79

An international group of nursing researchershas determined from a longitudinal, multi-country, multi-site, randomized-control clinicaltrial that cannabis is frequently used to man-age the six common symptoms of HIV/AIDS.The study, published in 2009, found that a sig-nificant percentage of those with HIV/AIDSfind cannabis effective for anxiety, depression,fatigue, diarrhea, nausea, and peripheral neu-

34

Cannabinoid receptors in the brain


ropathy. Researchers note that "those whodid use marijuana rate it as effective as pre-scribed or over the counter medicines for themajority 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 totreat HIV/AIDS. People living with HIV/AIDSwho use cannabis to combat the side-effectsof HAART therapy are approximately 3 timesmore likely to remain on their prescribed drugtherapies than those who do not usecannabis, according to a 2007 study.81

In the 1970s, a series of human clinical trialsestablished cannabis' ability to stimulate foodintake and weight gain in healthy volunteers.In a randomized trial in people living withAIDS, THC significantly improved appetite andnausea in comparison with placebo. Therewere also trends towards improved mood andweight gain. Unwanted effects—dry mouth,drowsiness and anxiety—were generally mildor moderate in intensity.82-85

After a comprehensive review of the thera-peutic potential of cannabis, the Institute ofMedicine concluded, "For patients such asthose with AIDS or who are undergoingchemotherapy and who suffer simultaneouslyfrom severe pain, nausea, and appetite loss,cannabinoid drugs might offer broad-spec-trum relief not found in any other singlemedication."

An FDA-approved preliminary safety trial ofsmoked cannabis was conducted in 2003 at theUniversity of California at San Francisco. Thestudy concluded that neither synthetic THC norinhaled cannabis had any significant effect onthe immune system or viral load. Moreover, theresearchers noted that study participants whoused cannabis gained weight.86

The Clinical Trials: Neuropathic Pain

More than one-third of people living withHIV/AIDS suffer from excruciating pain in thenerve endings, many in response to the anti-retroviral therapies that constitute the first lineof treatment for HIV/AIDS.87 As a result, some

individuals reduce or discontinue theirHIV/AIDS therapy because they can neither tol-erate nor diminish the debilitating side effectsof the antiretroviral first-line medications.

The effectiveness of cannabis and cannabi-noids in relieving neuropathic pain has beendemonstrated in more than three dozen pre-clinical and clinical trials, a 2009 review byresearchers at the University of Georgia hasfound. The scientists note that "a large num-ber of research articles have demonstratedthe efficacy of cannabinoids" and concludethat "cannabinoids show promise for treat-

35

"BROWNIE MARY” RATHBUN“Brownie Mary,” as Mary Rathbun was affectionately

called, was well known around the city of San

Francisco for her courageous work as a volunteer at

San Francisco General Hospital AIDS Ward 86.

Mary baked marijuana brownies for "her kids" for

many years before Proposition 215 made it legal in

California. Three times she was arrested for the crime

of giving free medicine to people with AIDS, but she

remained committed to her work. The last time she

was arrested was July 21, 1992, while delivering med-

icine to patients in Sonoma County. Before she came

to trial, The City and County of San Francisco pro-

claimed a special day in her honor that coincided with

her trial date. The charges were dropped.

Mary also used cannabis herself, to help cope with the

discomfort of having two artificial knees as a result of

arthritis, which crippled her in her late years. Despite

this, she kept delivering brownies of compassion for as

long as she could.

“Brownie Mary” died April 10, 1999, having seen

medical marijuana legalized in California and several

other states.


ment of neuropathic pain."88

A series of double-blind, placebo-controlled

studies of people living with HIV/AIDS have

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 whohad experienced neuropathy pain for an aver-age of six years. Results showed that smokedcannabis was well-tolerated and effectivelyrelieved chronic neuropathic pain from HIV-associated sensory neuropathy.90

Another double-blind, placebo-controlled,crossover trial evaluated concentration-response effects of low-, medium-, and high-dose smoked cannabis, concluding that thereis a window of modest analgesia for smokedcannabis, with lower doses decreasing painand higher doses increasing pain.91

A separate clinical trial indicated that low-and high-dose cannabis produced similar lev-els of pain relief, reducing both the intensityand unpleasantness of unbearable nerve pain.Researchers found that cannabis may interactwith opiate-based painkillers to increase theireffectiveness, particularly in neuropathic pain,but that using isolated synthetic cannabinoidssuch as THC (dronabinol) did not provide thesame degree of efficacy as a whole-plantpreparation of cannabis.92

A double-blind, placebo-controlled clinicaltrial on the impact of smoked cannabis on 28people living with HIV who experience neu-ropathy pain not adequately controlled byother pain-relievers, including opiates, foundthat cannabis provided pain relief.93

HEPATITIS-C VIRUS

Cannabis may improve the effectiveness ofdrug therapy for the hepatitis C virus (HCV), apotentially deadly viral infection that affectsmore than 3 million Americans. Treatmentfor Hepatitis-C virus (HCV) involves months oftherapy with two powerful drugs, interferonand ribavirin, that have severe side effects,including extreme fatigue, nausea, muscleaches, loss of appetite and depression. Due to

36

BARB & KENNY JENKSKenny Jenks was a hemophiliac who contracted AIDS

through contaminated blood in 1980 and then

unknowingly infected his wife, Barbara. Both became

too sick to work, and they lived on disability. Like

many AIDS patients, they discovered cannabis helped

them eat and gain strength.

After they were arrested and charged with three

felonies for cultivating cannabis, their lawyer argued

this was a case of medical necessity. Cannabis was the

only medicine that lessened the vomiting and nausea

caused by AIDS and the drugs used to fight the dis-

ease. The Court of Appeals in Tallahassee, Florida

ruled in their favor in 1991.

After that lengthy legal struggle, the DEA allowed

them into the federal Compassionate IND program. At

the time, more than 30 people suffering from serious

illnesses had successfully proven their medical neces-

sity and were approved to receive federal cannabis.

The Jenks went public with their story, and soon more

than 300 other AIDS patients had applied to the pro-

gram. The sudden surge in applicants prompted the

Bush Administration to shut down the intake program

in 1992. Even those who had already been approved

were denied access to the medicine, and only the few

patients who were previously receiving government

cannabis at that time have been allowed to continue to

do so.

The Jenks' crusade for justice and compassion had

been wiped out at the moment of its triumph. The

stress of their personal ordeal took a toll on the cou-

ple's health. Both Barb and Kenny died soon after the

IND program was closed to new patients.


these side effects, people often do not finishtreatment, which worsens their symptomsand can promote harm to the liver.

Researchers from the University of California,San Francisco medical school and theOrganization to Achieve Solutions inSubstance-Abuse (OASIS) found that "modestcannabis use may offer symptomatic and viro-logical benefit to somepatients undergoing HCVtreatment by helpingthem maintain adher-ence to the challengingmedication regimen."94

Other research suggeststhat people combatingHCV who used cannabiswhile undergoing combi-nation ribavirin andinterferon treatmentwere about 3 times morelikely to complete theirconventional medical treatment than thoseparticipants who did not use cannabis.

While cannabis may have a specific, positivebiomedical effect, it is more likely that itimproves appetite and offers psychologicalbenefits such as reduced depression that helpindividuals tolerate the treatment's unpleas-ant side effects.95

CHRONIC PAIN

According to the American Academy of Pain,nearly 50 million Americans suffer from per-sistent pain. Unfortunately, it is estimatedthat four out of every ten people living withmoderate-to-severe pain have yet to experi-ence relief. After reviewing a series of trialsin 1997, the U.S. Society for Neuroscience con-cluded that "substances similar to or derivedfrom marijuana could benefit the more than97 million Americans who experience someform of pain each year."96

Although a wide variety of prescription anal-gesic drugs are available to treat pain—fromaspirin to oxycontin—none of these drugs arecompletely adequate and many cause severe

side-effects with continued use. Drugs such asaspirin can cause stomach irritation and insome cases ulceration. Prolonged use of acet-aminophen can result in liver damage.Ibuprofen can cause kidney failure. Opiatesare notorious for triggering severe nausea, dis-orientation and drowsiness, while prolongeduse can increase tolerance and, in some cases,

result in severe depend-ence or addiction to themedication. Each ofthese analgesics can pro-duce fatal overdose.

The historical use ofcannabis as an analgesicis well documented, as isits remarkable safetyrecord.97, 98 In theirmeta-analysis of theavailable data, theInstitute of Medicine

acknowledged the wideuse of cannabis for pain, noting that "afternausea and vomiting, chronic pain was thecondition cited most often to the IOM studyteam as a medicinal use for marijuana."99

Currently, pain relief is by far the most com-mon condition for which physicians recom-mend the use of cannabis.

Many well-designed, double-blind placebo-controlled clinical trials clearly demonstratethat cannabis can reduce neuropathic pain,as noted above. In advance of these clinicaltrials involving smoked cannabis, years ofclinical studies confirmed that the activeingredients in cannabis have powerful anal-gesic effects, sometimes equivalent tocodeine or morphine.100-104 A review of thebody of scientific research concerning theanalgesic effects of cannabis concluded that"[t]here is now unequivocal evidence thatcannabinoids are antinociceptive [capable ofblocking the transmission of pain] in animalmodels of acute pain."105

Research shows that cannabinoids also pro-duce an entourage effect that enhances theeffectiveness of opiate painkillers. One animal

37

INSTITUTE OF MEDICINE

"Nausea, appetite loss, pain and anxiety . .all can be mitigated by marijuana.... Forpatients, such as those with AIDS or under-going chemotherapy, who suffer simultane-ously from severe pain, nausea, andappetite loss, cannabinoid drugs mightoffer broad spectrum relief not found inany other single medication.”

Marijuana and Medicine:Assessing the Science Base, 1999


study found morphine was 15 times moreactive with the addition of a small dose ofTHC. Codeine was enhanced on the order of900 fold.106 Human studies have repeatedlyshown that cannabinoids work in concertwith opiod drugs in relieving neuropathicpain. Researchers suggest that direct and indi-rect interactions between opioid and cannabi-noid receptors not only enhance analgesiabut may also reduce the development of tol-erance to opiates. The authors of a 2009 studyconclude that further research on such inter-actions is "critical forunderstanding how thereceptor systems involvedin pain relief are alteredduring acute or chronicpain," as well as design-ing better therapies that"directly target thealtered neurophysiologyof patients experiencingpain."107

Decades of research oncannabis' effectiveness inpain managementinclude clinical humantrials and volumes ofanecdotal evidence, as well as new under-standing of how activation of the cannabi-noid system in the central nervous systemreduces sensitivity to pain.108-112 Some of themost encouraging clinical data on the effectsof cannabinoids on pain involve the treat-ment of intractable cancer pain and hard-to-treat neuropathic pain. Somewhere between25% and 45% of cancer patients experienceneuropathic pain, a type of chronic pain thatfrequently results from nerve injury and resiststreatment.

The effectiveness of cannabis and cannabi-noids in relieving neuropathic pain has beendemonstrated in more than three dozen pre-clinical and clinical trials, as noted in a 2009review. The review notes that "a large num-ber of research articles have demonstratedthe efficacy of cannabinoids" for treating neu-ropathic pain and concludes that "cannabi-

noids show promise for treatment."113

Multiple clinical trials have shown that adosage-controlled whole-plant extract of mar-ijuana (Sativex) relieves intractable cancerpain, and does so better than THC alone. Arecent double blind, randomized, placebo-controlled trial of 360 cancer patients in 14countries found that pain scores improved sig-nificantly with a cannabis extract. Research-ersreport that the combination of naturalcannabinoids in Sativex "is an efficaciousadjunctive treatment for cancer-related pain"

for patients who do notget relief from opiatepainkillers such as oxy-contin or vicodin. 114

Pain from spinal injuriesmay also be treatablewith cannabis. Severalsets of researchers haverecently published find-ings on the efficacy ofcannabinoids in treatingpain resulting fromspinal cord injuries (SCI).A French team, notingthat "very few pharma-

cological studies have dealt specifically withneuropathic pain related to SCI," suggeststhat for "refractory central pain, cannabinoidsmay be proposed on the basis of positiveresults in other central pain conditions (e.g.multiple sclerosis)."115 Researchers havedemonstrated in an animal model of SCI painthat cannabinoids yield more consistent posi-tive results than conventional analgesics suchas opiates, which "decrease in efficacy withrepeated treatment over time," concludingthat drugs targeting the body's cannabinoidreceptors "hold promise for long-term use inalleviating chronic SCI pain."116

Researchers have also determined that neuro-pathic pain may be treatable via bolsteringthe body's natural cannabinoids. A study thatinhibited the two enzymes that break downthe body's natural cannabinoids found thatpreserving them "reduces neuropathic pain

38

NEW ENGLAND JOURNAL OF MEDICINE

"A federal policy that prohibits physiciansfrom alleviating suffering by prescribingmarijuana to seriously ill patients is mis-guided, heavy-handed, and inhumane.... It isalso hypocritical to forbid physicians toprescribe marijuana while permitting themto prescribe morphine and meperidine torelieve extreme dyspnea and pain…there isno risk of death from smoking marijuana....To demand evidence of therapeutic efficacyis equally hypocritical"

Jerome P. Kassirer, MD, editor N Engl J Med 336:366-367, 1997


through distinct receptor mechanisms ofaction" that "present viable targets" fordeveloping new analgesic drugs.117-118

MULTIPLE SCLEROSIS

A survey of people living with MultipleSclerosis reported that more than 40 percentof respondents used cannabis to relieve symp-toms of the disease. Among them, nearlythree quarters said that cannabis mitigatedtheir spasms, and more than half said it allevi-ated their pain. Similar results were publishedin the Canadian Journal of NeurologicalSciences where is was observed that 96% ofCanadians living with MS believe thatcannabis is therapeutically useful for treatingthe disease. Of those who admitted usingcannabis to treat symptoms of MS, the majori-ty cited relief of chronic pain, spasticity, anddepression.119

Numerous case studies, surveys and double-blind studies have reported improvement inthose treated with cannabis and relatedcannabinoids for symptoms including spastici-ty, chronic pain, tremor, sexual dysfunction,bowel and bladder dysfunctions, vision dim-ness, dysfunctions of walking and balance(ataxia), and memory loss.120-124 In fact,cannabinoids have been shown in animalmodels to measurably lessen MS symptomsand may also slow or halt the progression ofthe disease.125 Researchers have discoveredthat persons with multiple sclerosis haveincreased levels of endocannabinoids in theirblood, indicating that the endocannabinoidsystem "may be dynamically modulateddepending on the subtype of the disease."126

Previous studies of the pharmacology ofcannabis have identified effects on motor sys-tems of the central nervous system that havethe potential of affecting tremor and spastici-ty. A controlled study of the efficacy of THCin experimental allergic encephalomyelitis,the animal model of MS, demonstrated signif-icant amelioration of these two MS symp-toms. A review of six randomized controlledtrials of a cannabis extracts that combines

39

ED ROSENTHALThe then-head of the DEA, Asa Hutchinson, flew in to

San Francisco to personally announce the arrest of

best-selling author Ed Rosenthal, the man millions of

readers knew as “Ask Ed”, the grow-your-own advice

columnist for High Times magazine.

As Hutchinson announced the arrest during a speech at

the Commonwealth Club, the city’s district attorney,

Terence Hallinan, was outside with a bullhorn leading

the protest against the federal raids on Rosenthal, a San

Fransico dispensary, and the dispensary’s manager.

Rosenthal had been deputized an officer of the City of

Oakland for the purpose of growing cannabis for

patients, and everything was done in cooperation with

local law enforcement and city officials, but the jury

was kept in the dark. Under federal law, why he was

growing the plants, or for whom, was considered irrel-

evant as evidence.

As soon as the trial ended, the jurors heard the whole

truth, and within 24 hours nine of them had publicly

recanted their verdict, igniting another flurry of media

stories. They wrote a letter in support of Rosenthal to

the judge and sat with his family at sentencing.

Though he was facing a mandatory 5 years in federal

prison and the prosecution was seeking 6-1/2 years,

the judge ruled that Rosenthal had reasonably relied on

city officials who had tried to provide immunity under

federal law. Rosenthal was sentenced to a single day in

jail, with credit for time served.

The defense appealed the conviciton, and prosecutors

appealed the sentence. The conviction was overturned

for juror misconduct, and Rosenthal was retried. The

U.S. Attorney attempted to pile on 11 additional felony

charges in addition to the original three, but all addi-

tional charges were dismissed as vindictive prosecu-

tion. Rosenthal was retried in 2007, becoming the first

federal defendant to be tried again after already serv-

ing his sentence. He was convicted a second time.


delta-9-tetrahydrocannabinol (THC) andcannabidiol (CBD) finds "a trend of reducedspasticity in treated patients" and "evidencethat combined THC and CBD extracts mayprovide therapeutic benefit for MS spasticitysymptoms."127

One such dosage-controlled THC-CBD extract,GW Pharmaceuticals' Sativex®, has beenshown in numerous clinical trials to ease painand improve spasm frequency, bladder con-trol, and sleep. Clinical trials of Sativex foundthat it "demonstrated a statistically significantand clinically relevant improvement in spastic-ity and was well tolerated in MS patients."128

Sativex has been approved in Canada, Spain,New Zealand, and Great Britain for the symp-tomatic relief of spasticity, neuropathic painor both in adults with Multiple Sclerosis.129

MS patients frequently report cannabis helpswith bladder control, and a review of studieson cannabinoid receptors in the bladder notesthat non-psychoactive cannabinoids are alsoeffective, and psychotropic effects of THC canbe mitigated by delivering cannabinoidsdirectly into the bladder.130

Research on the distribution of cannabinoidreceptors in the brain suggests that they mayplay a role in movement control. Only recent-ly have scientists found an animal model forMS, called experimental allergicencephalomyelitits (EAE), allowing testing forsymptom suppression. Recent pre-clinicalreports found that cannabinoids lessenedboth tremor and spasticity in mice sufferingfrom EAE.131 Moreover, cannabinoids havedemonstrated effects on immune functionthat also have the potential for reducing theautoimmune attack that is thought to be theunderlying pathogenic process in MS.

In addition to studying the potential role ofcannabis and its derivatives in the treatmentof MS-related symptoms, scientists are explor-ing the potential of cannabinoids to inhibitneurodegeneration. A 2003 study that theNational MS Society called "interesting andpotentially exciting" demonstrated thatcannabinoids were able to slow the disease

40

CHERYL MILLERCheryl Miller was diagnosed with chronic, progressive

Multiple Sclerosis (MS) in 1971. She tried all the med-

ications that were prescribed for her, but many had

such harmful side effects and were so toxic to her liver

that she had to stop using them. Eventually she and her

husband Jim heard that cannabis might help ease some

of her symptoms, and they decided she should give it

a try. They were amazed how Cheryl's normally stiff-

as-a-board body became relaxed and pliant.

Soon after discovering the helpful properties of

cannabis, the Millers became tireless activists in sup-

port of the legalization of cannabis for medical use.

Beginning in 1993, after failed attempts to get law-

makers' attention to address this matter through lobby-

ing, they found that protesting had more of an impact.

Jim pushed Cheryl’s wheelchair 58 miles across their

state of New Jersey, and the media began to pay atten-

tion. In 1997, even though she had been homebound

by her condition for over 10 years, she and her hus-

band participated in that year's Boston-to-Washington

"Wheelchair Crusade" for medical cannabis.

As Cheryl's MS progressed, they took their activism to

the next level, committing public acts of civil disobe-

dience at the Capitol that led to their arrest, though

charges were dropped.

Cheryl Miller died June 7, 2003 from pneumonia and

other MS-related complications. She was 57 years old.

As a tribute to Cheryl and her advocacy, her friends

and supporters created the Cheryl Miller Memorial

Project to continue her legacy.


process in mice by offering neuroprotectionagainst EAE.132

OTHER MOVEMENT DISORDERS

Muscular spasticity is a common condition,affecting millions of people in the UnitedStates. It afflicts individuals who have sufferedstrokes, as well as those with multiple sclero-sis, cerebral palsy, paraplegia, quadriplegia,and spinal cord injuries. Conventional medicaltherapy offers little relief for spasticity.Phenobarbital and diazepam (Valium) arecommonly prescribed, but they rarely providecomplete relief, and many patients develop atolerance, become addicted, or complain ofheavy sedation. These drugs also cause weak-ness, drowsiness andother side-effects thatpeople find intolerable.

The therapeutic use ofcannabis for treatingmuscle problems andmovement disorders hasbeen known to westernmedicine for nearly twocenturies. In 1839, Dr.William B.O'Shaughnessy noted the plant's muscle relax-ant and anti-convulsant properties, writingthat doctors had "gained an anti-convulsiveremedy of the greatest value."133

Contemporary animal and human clinicalstudies reveal that cannabis and its con-stituent cannabinoids may effectively treatmovement disorders affecting older patients,such as tremors and spasticity, becausecannabis has antispasticity, analgesic,antitremor, and antiataxia actions.134-146

As noted previously, the contemporary under-standing of the actions of cannabis wasspurred by the discovery of an endogenouscannabinoid system in the human body. Thissystem appears to be intricately involved innormal physiology, specifically in the controlof movement.147-151 Central cannabinoid recep-tors are densely located in the basal ganglia,the area of the brain that regulates body

movement. Endogenous cannabinoids alsoappear to play a role in the manipulation ofother transmitter systems within the basalganglia-increasing transmission of certainchemicals, inhibiting the release of others,and affecting how still others are absorbed.Most movement disorders are caused by adysfunction of the chemical loops in this partof the brain. Research suggests that an endo-genous cannabinoid tone participates in thecontrol of movements.151-153

Endocannabinoids have paradoxical effects onthe mammalian nervous system: Sometimesthey block neuronal excitability and othertimes they augment it. As scientists are devel-oping a better understanding of the physio-

logical role of thosenatural cannabinoids, orendocannabinoids, it isbecoming clear thatthese chemicals may beinvolved in the patholo-gy of several neurologi-cal diseases. Researchersare identifying an arrayof potential therapeutictargets within thehuman nervous system.

They have determined that various cannabi-noids found in the cannabis plant interruptthe synthesis, uptake or metabolism of theendocannabinoids that drive the progressionof Huntington's disease, Parkinson's disease,and tremor.154

Cannabis also has enormous potential for pro-tecting the brain and central nervous systemfrom the damage that creates various move-ment disorders. Researchers have found thatcannabinoids fight the effects of strokes, aswell as brain trauma, spinal cord injury, andmultiple sclerosis. More than 100 researcharticles have been published on how cannabi-noids act as neuroprotective agents to slowthe progression of such neurodegenerativediseases as Huntington's, Alzheimer's and par-ticularly Parkinson's, which affects more than52% of people over the age of 85.155-158

41

AMERICAN NURSES ASSOCIATION

In 2003 the American Nurses Associationpassed a resolution that supports thosehealth care providers who recommendmedicinal use, recognizes "the right ofpatients to have safe access to therapeuticmarijuana/cannabis," and calls for moreresearch and education, as well as a resched-uling of marijuana for medical use.


ARTHRITIS

According to the Arthritis Foundation arthritisis one of the most prevalent chronic healthproblems and the nation's leading cause ofdisability among Americans over age 15. A2006 report estimated that 46 millionAmericans—nearly 1 in 5 adults—live withchronic joint pain and arthritis.

The use of cannabis as a treatment for mus-clo-skeletal pain in western medicine dates tothe 1700s.159 New evidence suggests thatcannabis and related therapies can relieve thepain associated with arthritis and the otherrheumatic and degenerative hip, joint andconnective tissue disorders. Not only iscannabis an effective pain reliever, as notedabove, it may also enhances the efficacy ofopiate-based painkillers. In their 1999 meta-analysis of the data available, the IOM specifi-cally noted that cannabinoids may also have

anti-inflammatory properties which could pre-vent and reduce pain caused by swelling (suchas arthritis).160

Twenty years ago research suggested thatcannabis and its constituents were powerfulimmune-modulation and anti-inflammatoryproperties indicating it may treat chronicinflammatory diseases directly.161-164 Since then,cannabis has proven an effective treatmentfor rheumatoid arthritis, and it is one of therecognized conditions for which many statespermit medical use. Specifically, cannabis has ademonstrated ability to improve mobility andreduce morning stiffness and inflammation,and research suggests that individuals canreduce their use of potentially harmful Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)when using cannabis as an adjunct therapy.165-166

A growing compendium of research suggeststhat safe and effective treatment for arthritis

42

VALERIE & MIKE CORRALIn 1973, Valerie Corral was

involved in a freak accident that

changed her life. A P-51 Mustang,

a converted W.W.II fighter plane,

"buzzed" her car. The resulting

accident left her with a head injury

and a friend badly injured. Valerie's

injury precipitated an epileptic con-

dition with as many as five gran

mal seizures a day.

Valerie tried using prescription

drugs to control her seizures, but

the side effects were devastating.

But she found she could control the

seizures using cannabis alone. For

years, the couple grew their own

cannabis and began distributing it

to terminally ill patients.

Five times over the years they were

visited by local law enforcement

officers. During each visit, they

explained her medical cannabis

use. The sixth time, they were

arrested. At tiral, Valerie became

the first to successfully argue a

medical necessity defense in

California. The district attorney

told the sheriff that he would not

press charges if they were re-arrest-

ed. The next spring, they planted

again; and a few months later they

were raided and arrested. The com-

munity rallied around the Corrals,

and the citizens of Santa Cruz

County voted in a measure calling

for the non-prosecution of medical

cannabis patients.

Along with the other members of

their collective, the Wo/Men's

Alliance for Medical Mari-juana

(WAMM), Valerie and Mike con-

tinued research on different strains

of cannabis and provided medicine

to approximately 250 members,

85% of whom are terminally ill.

Then on September 5, 2002,

dozens of heavily armed DEA

agents stormed the Corral’s home

and held guns to their heads. A

paraplegic WAMM member who

was staying with them at the time

was handcuffed to her bed and

abandoned.

Less than two weeks later, the

Mayor and City Council of Santa

Cruz joined WAMM to distribute

medical cannabis to thirteen

patients at Santa Cruz City Hall.

Before 200 members of the media,

1,300 people gathered in solidarity.

This crisis prompted the City and

County of Santa Cruz to join with

WAMM in suing the federal gov-

ernment over the raids.

Remarkabluy, they won a prelimi-

nary injunction protecting them

from any future raids or arrests.


may be developed from cannabis. One of thenon-psychoactive components of cannabis,cannibidol (CBD), has also been shown tohave numerous medical applications as ananti-inflammatory and neuroprotective agentand as a treatment for rheumatoid arthritis.167-

170 CBD research also indicates that thecannabinoid suppresses the immune responsein mice and rats that is responsible for a dis-ease resembling arthritis, protecting themfrom severe damage to their joints, andmarkedly improving their condition.171-172

ALZHEIMER'S DISEASE

Alzheimer's disease is a neuro-degenerativecondition for which cannabis and cannabinoidtherapies show promise, both for treating thesymptoms and the underlying disease.

Agitation is the most common behavioralmanagement problem in people withAlzheimer's and affects an estimated 75 per-cent of people with the disease. It may leadto a variety of symptoms ranging from physi-cal and/or verbal abusive postures, physicallynon-aggressive conduct including pacing andrestlessness, as well as verbally disturbedbehaviors such as screaming and repetitiverequests for attention. Clinical researchinvolving THC indicates that the cannabinoidreduced the agitation common to Alzheimer'ssufferers. THC is also proven effective in com-bating anorexia or wasting syndrome, a com-mon problem for people with Alzheimer'sdisease.173-175

Alzheimer's disease is widely held to be associ-ated with oxidative stress due, in part, to themembrane action of beta-amyloid peptideaggregates. Studies have indicated that oneof the cannabis plant's primary components,cannabidiol (CBD), exerts a combination ofneuroprotective, anti-oxidative and anti-apop-totic effects by inhibiting the release of thetoxic beta-amyloid peptide.176-177

This new research coupled with the extensivework done on other neuroprotective qualitiesof cannabis and its components indicates thatcannabis or cannabis-based therapy may

become the source of the most effectivetreatments for battling the Central NervousSystem diseases that afflict millions of elderlyAmericans.178-181

IS CANNABIS SAFE?

Cannabis and its active psychoactive cannabi-noid, THC, have an excellent safety profile.The Drug Awareness Warning NetworkAnnual Report, published by the SubstanceAbuse and Mental Health ServicesAdministration (SAMHSA), contains a statisti-cal compilation of all drug deaths which occurin the United States. According to this report,there has never been a death recorded fromthe use of cannabis by natural causes.Pharmacology expert and author Dr. Iversonexplains:

Laboratory animals (rats, mice, dogs andmonkeys) can tolerate does of up to1000mg/kg. This would be equivalent to a70-kg person swallowing 70g of thedrug—about 5,000 times more than isrequired to produce a high. Despite wide-spread illicit use of cannabis, there arevery few if any instances of people dyingfrom an overdose.182

DEA Chief Administrative Law Judge, FrancisYoung, in response to a petition to reschedulecannabis under federal law concluded in 1988that, "In strict medical terms marijuana is farsafer than many foods we commonly con-sume...Marijuana in its natural form is one ofthe safest therapeutically active substancesknown to man. By any measure of rationalanalysis marijuana can be safely used withinthe supervised routine of medical care."183

More than a decade later, IOM investigatorsconsidered the physiological risks of usingcannabis and concluded that "Marijuana isnot a completely benign substance. It is apowerful drug with a variety of effects.However, except for the harms associatedwith smoking, the adverse effects of marijua-na use are within the range of effects tolerat-ed for other medications."184

Toxicity, Risk of Overdose

43


Cannabis has a very high lethal dose, estimat-ed at LD50 (about 1500 lbs smoked in approx-imately 15 minutes).185 Therefore it iscomparatively difficult to die from an over-dose of natural cannabis. Dr. LesterGrinspoon, a professor emeritus at HarvardMedical School and author of several bookson the medical use of cannabis, had this tosay in an article in the Journal of theAmerican Medical Association (1995):

"One of marihuana's greatest advantagesas a medicine is its remarkable safety. Ithas little effect on major physiologicalfunctions. There is no known case of alethal overdose; on the basis of animalmodels, the ratio of lethal to effectivedose is estimated as 40,000 to 1. By com-parison, the ratio is between 3 and 50 to 1for secobarbital and between 4 and 10 to1 for ethanol. Marihuana is also far lessaddictive and far less subject to abusethan many drugs now used as musclerelaxants, hypnotics, and analgesics. Thechief legitimate concern is the effect ofsmoking on the lungs. Cannabis smokecarries even more tars and other particu-late matter than tobacco smoke. But theamount smoked is much less, especially inmedical use, and once marihuana is anopenly recognized medicine, solutionsmay be found; ultimately a technology forthe inhalation of cannabinoid vaporscould be developed."186

Dr. Grinspoon concludes, "the greatest dangerin medical use of marihuana is its illegality,which imposes much anxiety and expense onsuffering people, forces them to bargain withillicit drug dealers, and exposes them to thethreat of criminal prosecution."

However, cannabis should not be considered aharmless substance. Cannabis has a numberof physiological effects that in limited casescould be hazardous, but most adverse effectsare within the range tolerated for most FDA-approved medications.187

The Acute Effects of Cannabis

The acute, or short-term, effects of cannabismay begin when the drug is first ingested,and can last between one and three hours.Individual response varies, depending uponwhether cannabis is ingested or inhaled, andmany of the effects will decrease with pro-longed use. Short-term adverse effects fromusing herbal cannabis may include: coughingor wheezing if cannabis is inhaled, euphoria,dry mouth, reddening of the eyes, increasedappetite, blurred vision, dizziness, headache,delayed reactions, sedation, and anxiety. Inmost cases, effects are mild and can be con-trolled with careful titration.

In rare cases, usually as a result of taking largedoses of cannabis in food or drink, individualsmay experience acute complications such aspanic attacks, psychosis, or convulsions.Referred to in medical literature as marijuanapsychosis, it can be severe enough to compeladmission to an emergency hospital.188

Effects of Prolonged Use of Cannabis

Cannabis is a psychoactive drug and legiti-mate concerns have been raised about theeffects of prolonged use. Although cannabisremains a tightly controlled substance, evenfor medical purposes, the FDA has approvedsynthetic derivatives of cannabis' psychoactivecannabinoid, THC.

In considering the consequences of cannabisuse, the Institute of Medicine concluded thatthese concerns fall into two categories: theeffects of chronic smoking of cannabis andthe effects of THC. What follows is a briefreview of some of the more serious concernsoften attributed to smoking cannabis and itspsychoactive cannabinoid, THC.

Hazards of Smoking Cannabis

Smoking cannabis raises concerns andresearch has suggested that because cannabisshares many of the same dangerous com-pounds found in tobacco that smokingcannabis can lead to increased risk of lungcancer and other chronic respiratory disease.However, the body of research is controversialbecause it is not conclusive.

44


Population studies have found mild lungfunction 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 anycausal relationship between smoked cannabisand the development of respiratory infec-tions, it is therefore recommended that med-ical users of cannabis be cautious of heavyuse, especially in concurrence with tobaccosmoking.

While research has historically suggested thatheavy cannabis smokers are at higher risk ofcontracting cancer, new research casts doubton these claims.191 Research on this matter isoften complicated by the fact that manycannabis smokers are also tobacco smokersand it is often difficult to differentiate thetrue cause. Studies at the cellular and molec-ular level have also suggested that smokedcannabis may cause cancer, however, new evi-dence indicates that cannabinoids themselvesmay decrease the cancer causing effect of thecarcinogens and particles typically inhaledfrom smoking cannabis and therefore makecannabis smoke inherently less dangerousthan tobacco smoke.192

In 2006, the results of a five year case-con-trolled investigation and the largest study ofits kind unexpectedly concluded that smokingcannabis, even regularly and heavily, does notlead to lung cancer or other types of head,neck or throat cancers. Lead investigator Dr.Donald Tashkin of the David Geffen School ofMedicine, Division of Pulmonary and CriticalCare Medicine, at the University of California-Los Angeles, further concluded that cannabismay contain key components that kill agingcells and keep them from becoming cancer-ous.193 Dr. Tashkin's findings reaffirm theresults of prior case-control studies dismissinga causal link between cannabis use and cer-tain types of lung and upper aerodigestivetract (UAT) cancers.194-196

No data exists suggesting that orally ingestedcannabis, like in food or drink, may cause can-

45

ANGEL MCCLARY RAICHOn December 16, 2003, Angel McClary Raich

became the first medical marijuana patient to success-

fully sue the federal government. Joined by another

patient, Diane Monson, and the two anonymous care-

givers who provide Angel the marijuana that sustains

her life, she sued Attorney General John Ashcroft and

the DEA, seeking an injunction against any future

arrests or prosecutions.

The Ninth Circuit Court of Appeals in San Francisco

ruled that it was unconstitutional to apply the federal

ban on marijuana to patients, so long as they use it for

medical purposes on their doctors' advice, obtain the

drug without buying it, get it within their state's bor-

ders, and comply with state law. The U.S. Supreme

Court overturned the ruling in a 6-3 decision, with a

scathing dissent defending the rights of patients.

Angel has been permanently disabled since September

1995. In late 1997, Angel's doctor recommended

cannabis as a possible medication to treat her complex

medical conditions. Confined to a wheelchair from

January 1996 to August 1999, Angel regained her

mobility with the help of cannabis.

Angel also suffers from several conditions that cause

severe, chronic pain, including fibromyalgia,

endometriosis, scoliosis, uterine fibroid tumors and

rotator cuff syndrome. She is battling a brain tumor,

seizures, and life-threatening wasting syndrome

accompanied by near-constant nausea.

These interlocking medical problems have been a

huge challenge for her doctors. Complicating her

treatment has been the fact that she has severe chemi-

cal sensitivities and is allergic to almost all of the drugs

that are modern medicine's defense against most of

her illnesses. Even the federal government does not

dispute that cannabis is essential to her health, but it

nonetheless insists she is a criminal who can be arrest-

ed and imprisoned at will.


cer. If smoke inhalation is a concern, cannabiscan be used with a vaporizer, orally in bakedgoods and other food product, topically inoils and lotions, in oral sprays like a tincture,or in a suppository.

Effects on Cognition

Cannabis use appears to impair cognitioninvolving short-term memory, performance,attention and concentration among long-term heavy smokers.197 Most studies suggestthat chronic users of cannabis suffer varyingdegrees of cognitive impairment that cansometimes be long lasting. Studies have alsoshown that these deficits in attention andmemory occur more often with heavycannabis use, and that these deficits canextend beyond the period of intoxication.198

These effects can also be cumulative withlonger periods of use, but are to some degreereversible after a period post-cessation of use.

A recent meta-analysis of the long-termeffects of cannabis use "failed to demonstratea substantial, systematic, and detrimentaleffect of cannabis use on neuropsychologicalperformance. It was surprising to find suchfew and small effects given that most of thepotential biases inherent in our analyses actu-ally increased the likelihood of finding acannabis effect."199

Effects on psychomotor performance

The most common types of psychomotorfunctions impaired by cannabis use includebody sway, hand steadiness, rotary pursuit,driving and flying simulation, divided atten-tion, sustained attention, and the digit-sym-bol substitution test.200 The effects aregenerally short-lived and do not appear to beaffected over the long-term. Individuals areaffected differently by prolonged use ofcannabis: it is still controversial whether ornot tolerance to psychomotor effects increas-es with chronic use. Research clearly indicatesthat cannabis exposure impairs psychomotorperformance and people should be warnednot to drive or operate dangerous machinery,especially if they feel intoxicated after smok-ing cannabis.201

Effects on the immune system

The effects of cannabis smoking on theimmune system are inconclusive. The IOMnotes that the relationship between cannabis

46

MYRON MOWER

Myron Mower was ill in the hospital fromcomplications of his diabetes, when sheriff’sdeputies searched his home and found 31cannabis plants. The sheriff had adopted apolicy that no patient could grow than threeplants,so they uprooted all but three. Laterthat day, a deputy questioned Mower in thehospital while he was under the influence ofmorphine. Weeks later, Mower was arrestedand charged with felony cultivation.

During his trial, the prosecutor even acknowl-edged, "if there is a person in the state ofCalifornia for whom Prop. 215 was enacted, itis Myron Mower." But, he urged the jury toconvict anyway, based solely on the numberof plants. An expert testified the garden wasappropriate for Mower’s need, but the jurytook only 90 minutes to convict.

Mower appealed. In 2002, the CaliforniaSupreme Court ruled patients should be pro-tected from unnecessary prosecution forgrowing and possessing marijuana. The courtruled that Prop. 215 provides qualified immu-nity from prosecution, and shifted the burdenof proof to the prosecution.

That landmark decision changed the legallandscape in California, extending patientprotections.

The charges against Mower were dropped.


and the immune system presents interesting

issues, including potential benefit and sus-

pected harm.202

The discovery of the CB-2 receptor, located

primarily in the various cell types of the

immune system has renewed interest in the

interaction of cannabinoids and immune

function. As a result, several pharmaceutical

have expressed interest in developing CB-2-

selective drugs which might have utility as

immunosuppressants or in the treatment of

arthritis, multiple sclerosis and other serious

illness thought to be related to immune sys-

tem response.203

In 2001, there were some studies that sug-

gested people living with AIDS experienced

increased mortality and opportunistic bacteri-

al and fungal infections associated with con-

taminated cannabis material.204 However, it is

unclear if the increase in infections is a result

of suppression of the immune system by

cannabis or because the individuals are

exposed to more potential pathogens from

smoking cannabis.205

In 2003, concerns that cannabis-induced

immune suppression may adversely effect

people living with HIV/AIDS were addressed in

a randomized, placebo-controlled clinical trial

which concluded that concurrent administra-

tion of smoked or oral cannabis did not effect

HIV RNA levels, CD4+ and CD8+ cell counts or

protease inhibitor levels over a 21-day treat-

ment.206 In another randomized, placebo-con-

trolled study the administration of oral THC

or smoked cannabis did not significantly alter

pharmacokinetic properties of the protease

inhibitors tested and had no effect on anti-

retroviral efficacy.207

Although people with weakened immune sys-

tem, like those with HIV/AIDS, might be

expected to have increased risk, there is no

evidence that the long-term recreational or

medical use of cannabis renders users more

susceptible to bacterial or viral infection.208

CANNABIS-BASED MEDICINES: THE'PHARMACEUTICALIZATION' OF CANNABIS

Dr. Lester Grinspoon has defined the "phar-maceuticalization of cannabis" as the pre-scription of isolated individual cannabinoids,synthetic cannabinoids, and cannabinoidanalogs. In what Dr. Grinspoon describes asthe federal government's desire to introducea cannabis-like pill to replace natural cannabisuse, the first efforts to "pharmaceuticalize"cannabis occurred in 1985 when dronabinol(Marinol) was approved by the FDA.209

Dronabinol (Marinol)

Dronabinol (Marinol) is a synthetic prepara-tion of THC encapsulated in sesame oil.Designed and marketed by SolvayPharmaceuticals and its subsidiary Unimed,Marinol was first indicated for treatment ofnausea and vomiting associated with cancerchemotherapy in people who failed torespond adequately to conventionalantiemetic treatments and later available forthe treatment of anorexia associated withweight loss for people living with HIV/AIDS.

When first approved for medical use, dronabi-nol was placed in Schedule II according to theControlled Substances Act where it was tight-ly controlled. In 1999, in response to arescheduling request by Unimed, it wasmoved by administrative rule to Schedule IIIto make it more widely available. CurrentlyMarinol is available in three dosage strengths:2.5, 5, and 10mg to ensure optimal responseby the broadest number of people. Despitethe well-documented therapeutic value ofTHC, dronabinol has been met with moderatesuccess.

It is widely acknowledged that Marinol's oralroute of administration hampers its effective-ness because of slow absorption and patients'desire for more control over dosing. In theirreview of Marinol the Institute of Medicinespecifically noted that only about 10-20% ofan oral dose is absorbed by the human bodyand onset of action is obtained between twoand four hours after dosing. 210

47


48

Nabilone (Cesamet)

Nabilone (Cesamet) is a synthetic derivative ofTHC with and has slightly modified molecularstructure from dronabinol. Currently availablefor medical use in Canada, United Kingdom,and Mexico, it was approved by the FDA in1985 for treatment of chemotherapy-inducednausea and vomiting that has not respondedto conventional medication. Althoughnabilone was approved more than twentyyears ago, it began marketing in the UnitedStates as Cesamet in 2006 and used for treat-ment of anorexia and weight loss in peoplewith HIV/AIDS and as an adjunct therapy forchronic pain management.

Cannabis-Extract (Sativex)

THC is the most familiar cannabinoid, and itstherapeutic effects have been well estab-lished. However, cannabis contains aboutsixty other cannabinoids, like CBD, which notonly offset the psychoactive effect of THC, butmay contain therapeutic benefits of theirown. In fact, research suggests that the ther-apeutic affect of cannabis might be linked towhat researchers call an "entourage effect,"the synergistic relationship between multiplecannabinoids which may make them moretherapeutically beneficial in combination thenthey are individually.

Building on this theory, researches affiliatedwith GW Pharmaceuticals (GW Pharma) havenoted that in practice medicines or extractsderived from the cannabis plant providegreater relief of pain than the equivalentamount of synthetic cannabinoid given as asingle chemical entity like dronabinol.Licensed in the UK, and founded in 1998, GWPharma is a pharmaceutical company commit-ted to developing a portfolio of cannabinoidand botanical medicines to meet the needs ofpatients around the world.

Sativex is GW Pharma's lead cannabinoidproduct, and in 2005 became the world's firstpharmaceutical prescription medicine derivedfrom extracts of the cannabis plant.Specifically, Sativex is a cannabis extract con-taining equal amounts of dronabinol (THC)

and cannabidol (CBD), which is administeredas an oral spray absorbed in the patient'smouth.

Sativex has been approved for medical use inCanada for symptomatic relief of neuropathicpain in Multiple Sclerosis and as adjunctiveanalgesic treatment in people with advancedcancer who experience moderate to severepain during the highest tolerated dose ofstrong opioid therapy for persistent back-ground pain. GW Pharma is currently under-going late stage clinical development ofSativex in Europe and the United States. Uponapproval in the United States, Sativex will bemarketed by Otsuka Pharmaceuticals.

According to Dr. Grinspoon's theory, the "phar-maceuticalization" of cannabis will only suc-ceed if the pharmaceutical derivatives andextracts displace cannabis as medicine.Although a few individuals will prefer doseconsistent pharmaceutical alternatives it seemsunlikely that these drugs will completelyreplace the use of cannabis especially given itslimited toxicity, easy availability, low cost rela-tive to pharmaceuticals, ease with which it canbe self-titrated, growing access to vaporizationdevices, and its remarkable medical versatility.211

INVESTIGATIVE ROADBLOCKS: THE U.S.RESEARCH EXPERIENCE

In the past three decades there has been anexplosion of international research to investi-gate the therapeutic value of cannabis.Restrictions on cannabis research in the U.S.have resulted in very few clinical trials con-ducted domestically. Meanwhile, researchteams in Great Britain, Spain, Italy, Israel, andelsewhere have confirmed—through casestudies, basic research, pre-clinical and clinicalinvestigations—the medical value of cannabis.Equally important, numerous studies have pro-vided strong indications of the potential formore targeted drugs, whole-plant cannabisderivatives and synthetics. The current researchchallenge is to conduct human clinical trialsthat apply the remarkable range of potentialapplications for cannabis-based treatments


applied to specific medical conditions.

That challenge was identified in Marijuanaand Medicine, however there has been noadditional effort to review or fully implementthe IOM's recommendations. Moreover, theunfortunate result of the federal prohibitionof cannabis is limited clinical research to inves-tigate the safety and efficacy of cannabis tocontrol symptoms of serious and chronic ill-ness. In the United States research is stalled,and in some cases blocked, by a complicatedfederal approval process and restricted accessto research grade cannabis for research.

The Failure of a Federal Monopoly

The only way for cannabis to be evaluated bythe FDA to determine whether it meets thestandards necessary to become a medicineunder federal law is for privately-fundedsponsors to conduct clinical trials.

Despite the fact that federal law clearlyrequires adequate competition in the manufac-ture of Schedule I and II substances, since 1968the National Institute on Drug Abuse (NIDA)has been the sole supplier of cannabis used forlegitimate research purposes. DEA helps to pro-tect NIDA's monopoly by refusing to grantcompetitive licenses for cannabis production.

NIDA's mission is to support research on thecauses, consequences, prevention and treat-ment of drug abuse and drug addiction andofficials from the Institute have testified thatit is not NIDA's mission to study medicinaluses of cannabis or to advocate for suchresearch.212 Consequently, research whichaims to investigate or prove the therapeuticvalue of cannabis is often obstructed or other-wise altered to accommodate suggestions byNIDA in order to satisfy the limitations oftheir mission.

DEA obstructs research by protecting anunnecessary federal monopoly on the supplyof cannabis available for FDA-approvedresearch. As a result, some medical cannabisresearchers (who possess the appropriatelicenses and requisite approval) have beenunable to conduct their research because

NIDA has refused to provide the cannabis.213

For seven years, Professor Lyle Craker, UMass-Amherst, has been struggling to obtain a DEAlicense for a privately-funded facility to grow

49

BRYAN EPISBryan Epis discovered the medical value of marijuana

when he tried using it to treat the chronic back and

neck pain that resulted from fracturing two vertebrae

in a near-fatal car accident. When California made

medical cannabis legal, Epis saw an opportunity to

serve others by starting a medical cannabis collective

that would be safe, accessible and affordable.

Chico Medical Marijuana Caregivers had approxi-

mately 40 patients, all carefully screened, and Epis

personally provided money for five indigent patients

to see physicians. He was in the process of starting

another collective in San Jose, California when the

federal government arrested him.

Because he had allowed four other physician-

approved patients to grow at his house, Epis was

charged with, and ultimately convicted of, conspiracy

to manufacture more than 1000 plants. They were

growing far less, but prosecutors convinced the jury he

had plans to grow more, and Epis received a 10-year

federal prison sentence.

At his trial, the judge refused to allow any mention of

California's medical marijuana law or that the cannabis

was for medical purposes. The jury was instructed, like

all federal juries in states with medical marijuana laws,

to disregard any references to the medical circum-

stances that slipped into witness testimony,.

Afterward, members of the jury said they had no idea

that such a stiff sentence might be imposed, and would

have voted differently had they known. Epis is cur-

rently serving the remainder of his sentence.


cannabis exclusively for FDA-approved studiesdesigned to evaluate cannabis's potentialmedical value.

In February 2007, after a lengthy hearing thatincluded two weeks of testimony from 12 wit-nesses, U.S. Department of Justice-appointedAdministrative Law Judge Mary Ellen Bittnerissued an 87-page opinion, findings of fact,and recommended ruling urging the end ofthe federal monopoly on the supply ofcannabis that can be used in FDA-approvedresearch. In her opinion, Judge Bittner sug-gests that "respondent's registration to culti-vate marijuana would be in the publicinterest" and recommended that DEA grantProfessor Lyle Craker the license.214

Unfortunately, DEA is under no obligation toaccept Judge Bittner's administrative ruling.

When it became apparent that the DEA wasresisting acting on the ruling, as it did in thecase of the 1988 ruling on rescheduling, 45Members of Congress wrote to DEAAdministrator Karen Tandy in support ofJudge Bittner's decision, urging her toapprove the application. The DEA has yet toissue a license for the production of researchcannabis. Nearly two years have passed sinceJudge Bittner issued her ruling, and DEA hasyet to provide any response or take anyaction on the recommendation.

Arbitrary and Lengthy Delays

Despite the fact that it is not NIDA's missionto study the potential therapeutic value ofcannabis or to advocate for such research, themonopoly on the supply of cannabis availablefor research results in arbitrary and lengthydelays. Ordinarily, once a protocol has beenapproved by the FDA, researchers obtain theirresearch material and proceed with theapproved course of study.

In one extraordinary example of interference,not only did NIDA refuse to accept FDA'sapproved protocol, but the agency took ninemonths to provide an initial response andmade no attempt at discussing the study ortheir concerns before denying the request for

cannabis.

In 1994, Dr. Donald Abrams, a longtime clini-cal faculty member at the University ofCalifornia San Francisco, submitted a pilotstudy protocol designed to evaluate high,medium and low potency smoked cannabis ordronabinol in stimulating appetite and reduc-ing weight loss associated with HIV-relatedwasting syndrome. Following approval by theFDA, Dr. Abrams submitted an application toNIDA for cannabis to be used in the study.

Nine months later, NIDA rejected the applica-tion for cannabis, despite the fact the FDAhad already approved the protocol.215 In June1995, NIDA announced a new policy thatrequired all medical cannabis protocols to besubmitted to the National Institutes of Health(NIH) for peer review in the context of a grantapplication. One year later, Dr. Abrams resub-mitted a revised protocol to evaluate the safe-ty and efficacy of smoked cannabis as anappetite stimulant for HIV-associated anorexiaand weight loss, and, in August 1996, NIHrejected the protocol.216

The research protocol would be submitted acouple more times before, under intensescrutiny, NIDA awarded Dr. Abrams a grantfor his protocol. The results of his two-yearclinical determined that using cannabis didnot compromise to the immune systems ofpeople living with HIV/AIDS.

In another example, a DEA-licensed analyticallab, Chemic Labs, was made to wait morethan two years for a reply to its initial requestto purchase 10 grams of cannabis for a pri-vately sponsored research protocol to investi-gate the safety of vaporizers, a non-smokingdelivery system which the Institute ofMedicine report recommended be developed.After two years of delay processing therequest, the application was rejected. NIDAhas also refused to provide cannabis to twoother privately sponsored, FDA-approved pro-tocols that sought to evaluate cannabis forAIDS wasting syndrome (IND #43-542) andanother for an investigation of migraines (IND#58-177).

50


A Movement in Public Health

Despite barriers to research, a growing bodyof clinical data supports the use of cannabisfor medical purposes. While there is stillmuch to learn, the medical value of cannabisis indisputable. As a result, a growing num-ber of public health organizations haveendorsed policies the use of cannabis and pro-grams that advance medical and scientificresearch.

In 1994, the Federation of American Scientistsrecommended that the President instruct theNational Institutes of Health and the FDA toreopen investigation protocols to enroll seri-ously ill patients who physicians believed thatcannabis could ease symptoms of a variety ofdiseases. The following year, the AmericanPublic Health Association passed a resolutionwhich encourages vigorous research and"urges the Administration and Congress tomove expeditiously to make cannabis avail-able as a legal medicine."

In 1996, the American Academy of FamilyPhysicians offered their support for medicalcannabis for specific medical conditions solong as use was in accordance with medicalsupervision by a licensed professional. And, in1997, two years prior to the publication of theInstitute of Medicine's report, the NewEngland Journal of Medicine editorialized thefollowing:

A federal policy that prohibits physiciansfrom alleviating suffering by prescribingmarijuana to seriously ill patients is mis-guided, heavy-handed, and inhumane...Itis also hypocritical to forbid physicians toprescribe marijuana while permittingthem to prescribe morphine and meperi-dine to relieve extreme dyspnea andpain...there is no risk of death from smok-ing marijuana...

Citing the 1999 Institute of Medicine reportand studies published since which indicatethat the use of cannabis to alleviate the debil-itating symptoms of cancer chemotherapyand wasting, the Lymphoma Foundation ofAmerica passed a resolution urging Congress

51

PETER MCWILLIAMSPeter McWilliams was a best-selling writer and pub-

lisher of numerous self-help and other books. Having

repeatedly pulled his life together after personal hard-

ships, he wrote and published books to help others.

In March 1996, McWilliams was diagnosed with both

AIDS and cancer. Prescribed chemotherapy and radia-

tion to fight the cancer and combination drug therapy

for the AIDS, he found that the treatment was almost

worse than the disease. Nauseous, unable to eat, and

without appetite, McWilliams began to waste away,

despite the medications his doctors prescribed .

After some research, McWilliams discovered cannabis

allowed him to keep down the drugs that were helping

fight his diseases. He made a remarkable recovery and

was once again his positive, vivacious, productive self.

Then, in 1996, California voters legalized medical

cannabis. McWilliams became an outspoken advo-

cate, and he commissioned Todd McCormick, an

activist and patient, to write a book on cultivating dif-

ferent strains for different illnesses. McCormick began

his research, but was soon raided by the DEA.

McWilliams, McCormick, and others were charged

with conspiracy to cultivate marijuana. Since federal

law does not recognize medical cannabis, the judge

forced them to stop using medical cannabis as terms of

their release while they awaited trial.

With no legal defense available under federal law and

facing a mandatory 10-year sentence, McWilliams

pled to a lesser charge that reduced his possible sen-

tence to a maximum of five years.

But while awaiting sentencing he was still unable to

use the cannabis that had proven effective in control-

ling his nausea where other drugs had not. Peter

McWilliams died in his home on June 14, 2000 at the

age of 50, asphyxiating on his own vomit.


and the President to enact legislation toreschedule cannabis to allow doctors to pre-scribe cannabis for their patients in accor-dance with need. The Leukemia &Lymphoma Society also "supports legislationto remove criminal and civil sanctions for thedoctor-advised, medical use of marijuana bypatients with serious physical medical condi-tions" and has encouraged "the federal gov-ernment to authorize the Drug EnforcementAdministration to license privately fundedproduction facilities that meet all regulatoryrequirements to produce pharmaceutical-grade marijuana for use exclusively in federal-ly approved research."

Following the lead of several state nursesorganizations, the American NursesAssociation passed a resolution in support ofhealth care providers who recommend theuse of cannabis and further acknowledgedthat "the right of patients to have safe accessto therapeutic cannabis. The ANA specificallycalled for more research and urged theremoval of cannabis from the list of ScheduleI controlled substances.

Recently, the Assembly of the AmericanPsychiatric Association unanimously approveda strongly worded statement championinglegal protections for individuals usingcannabis in accordance with a physician's rec-ommendation. Representing 40,000 membersand 16 allied organizations (including theAmerican Academy of Psychiatry and the Law,American Academy of Child and AdolescentPsychiatry, American Association for SocialPsychiatry, American Academy of AddictionPsychiatry, and the American Association ofEmergency Psychiatrists) the AmericanPsychiatric Association is the main professionalorganization for psychiatrists in the UnitedStates.

In 2008, the American College of Physicians(ACP) published a position paper underscor-ing the therapeutic value of cannabis andspecifically recommends the federal govern-

ment consider "reclassification [of cannabis]into a more appropriate schedule, given thescientific evidence regarding marijuana's safe-ty and efficacy in some clinical conditions."The ACP is the largest medical specialtyorganization and the second largest physiciangroup in the United States. Its 124,000 mem-bers are doctors specializing in internal medi-cine and related subspecialties, includingcardiology, neurology, pulmonary disease,oncology and infectious diseases. The Collegepublishes the Annals of Internal Medicine, themost widely-cited medical specialty journal inthe world.

Regarding the growing support by publichealth organization, former Surgeon GeneralDr. Jocelyn Elders observed that "large med-ical associations are by their nature slow andcautious creatures that move only when theevidence is overwhelming." She continued,"The evidence is indeed overwhelming that,as ACP put it, there is 'a clear discord'between what research tells us and what ourlaws say about medical marijuana."217

The ACP position is reflected by the numerousprofessional health organizations which haveendorsed the medical use of cannabis. Theyinclude the American Medical Association,American Public Health Association, theAmerican Academy of Family Physicians, theAmerican Nurses Association, the NationalAssociation of Boards of Pharmacy, theCalifornia Medical Association, the AmericanPreventive Medical Association, the AmericanSociety of Addiction Medicine, the IowaBoard of Pharmacy, and many more.

The current acceptance of cannabis as medi-cine in the United States is further evidencedby the thousands of American doctors whohave recommended its use to their patients,the tens of thousands of individuals who areusing it safely and effectively, and millions ofAmerican voters and several state legislaturesthat have approved its legal use as medicine.

52


THE STRUGGLE FOR SAFE ACCESS

At the time the Controlled Substances Actwas being drafted in 1970, Assistant Secretaryof Health Roger O. Egeberg recommendedthat cannabis temporarily be placed inSchedule I, the most restrictive category ofdrugs, pending the findings of the NationalCommission on Marihuana and Drug Abuse.Despite the Commission's recommendationsto permit the medical and personal use ofcannabis, President Nixon enacted theComprehensive Drug Abuse Prevention andControl Act.218

Title II of the act, formally known as theControlled Substances Act, places drugs intoone of five categories, or schedules. Cannabiswas restricted to Schedule I, reserved for sub-stances with no medical value and a highpotential for abuse; all use of the substance isstrictly prohibited. Examples of otherSchedule I drugs include heroin and LSD.

Paradoxically, synthetic forms of THC, themost powerful psychoactive chemical compo-nent of cannabis, are classified as Schedule III.Schedule III is reserved for drugs that exhibitmedical value and have a mild potential forabuse. Other Schedule III drugs include keta-mine, buprenorphine, hydrocodone andcodeine.

Cannabis may be reclassified in one of twoways; by an act of Congress or via administra-tive channels. The Drug EnforcementAdministration could remove cannabis fromthe list of Schedule I drugs through the rule-making process in the same way they havehandled dronabinol and other substances.However, the Controlled Substances Act alsoprovides for a rulemaking process by whichthe general public could petition the UnitedStates Attorney General to reclassify cannabisin accordance with the relevant scientific data.

For 30 years, advocates have exhausted con-gressional, administrative and judicial chan-

nels seeking to remove cannabis fromSchedule I. The following is a summary ofmilestones in the movement to secure safeaccess to cannabis for therapeutic use.

ADMINISTRATIVE APPEALS

Petition to Reschedule (1972-1994)

The first petition to reschedule cannabis wasfiled by the National Organization for theReform of Marijuana Laws (NORML) in 1972.More than a decade later and following twoyears of administrative hearings which includ-ed testimony from more than 60 researchers,doctors, and their patients, the DEA's ChiefAdministrative Law Judge, Francis L. Young,ruled in 1988 that "Marijuana, in its naturalform, is one of the safest therapeuticallyactive substances known... It would be unrea-sonable, arbitrary and capricious for the DEAto continue to stand between those sufferersand the benefits of this substance..."219

Although Judge Young recommended thatcannabis be rescheduled, the DEA rejectedthe opinion and published their denial in theFederal Register on December 29, 1989.220 In1991, Alliance for Cannabis Therapeutics(ACT), the first non-profit organization dedi-cated to reforming the laws which prohibitmedical access to cannabis, petitioned the U.S.District Court of Appeals for the District ofColumbia seeing review of the denial.221

After further review, DEA issued a final orderin 1992 underscoring the agency's opinionthat cannabis has no accepted medical use.222

In 1994, the D.C. Circuit Court of Appealsdenied a second petition to reconsider thefinal order, effectively ending any furthermovement on the petition.

2nd Petition to Reschedule (1995-2001)

The second attempt began in 1995, when JonGettman, the former National Director forNORML, submitted a personal petition

53

THE ROAD TO REFORM


requesting that cannabis and all relatedcannabinoids be removed from Schedules Iand II of the CSA. The petition argued thatcannabis did not meet the abuse potentialrequired by statute. Jon Gettman, PhD,explains,

The first attempt to have marijuanarescheduled eventually became focusedsolely on whether marijuana had anaccepted medical use in the United States.Unlike the first proceedings the 1995rescheduling petition hinges on whethermarijuana's abuse potential is significantenough to justify its current Schedule I sta-tus. In this respect the 1995 petition goesto the heart of the issue Hollister raisedbefore Congress in 1970 -- whether scien-tific evidence will support the integrity ofCSA scheduling of heroin, LSD and mari-juana in the same schedules, and whethermarihuana prohibition can be perpetuat-ed given rapid social change in its use.223

In April, 2001, pursuant to the results of areview of scientific literature conducted bythe Department of Health and HumanServices (HHS) and their own review of rele-vant information, DEA denied the petition.224

An appeal of DEA's decision was filed withthe District of Columbia circuit of the U.S.Court of Appeals, but in May 2002, the Courtdenied the appeal citing concerns that thepetitioners did not have standing to subjectDEA's denial of the petition to review by thefederal courts because the petitioners werenot injured parties.225

Current Petition to Reschedule Cannabis(2002-present)

The current petition to reschedule cannabiswas filed in October 2002 by the Coalition forRescheduling Cannabis (CRC). The CRC is anassociation of public-interest groups, individu-als who use medical cannabis, and advocateswho support removing cannabis fromSchedule I.

The CRC petition is almost identical to the1995 petition, but includes important devel-

opments. Notably, the current petitionincludes a compendium of research contain-ing the Institute of Medicine's 1999 reportand other research published between 1995and 2002. Moreover, the current petitionacknowledges the growing number of statespermitting the use of cannabis in accordancewith a physician's recommendation.

DEA formally accepted the petition for filingon April 3, 2003, and per the provisions of theCSA referred the petition to HHS in July 2004for a full scientific and medical evaluation.This review is still pending.

Data Quality Act Petition (2004-2010)

The Data Quality Act (DQA) requires federalagencies to use reliable science when makingregulations and disseminating information.Specifically, the DQA requires that the infor-mation circulated by federal agencies is fair,objective, and meets certain quality guide-lines. It also permits citizens to challenge gov-ernment information believed to beinaccurate or based on faulty, unreliable data.Business, consumer, environmental and con-servation groups have all used the DQA topursue changes in federal policy.

In 2004, Americans for Safe Access (ASA) fileda petition with the U.S. Department of Healthand Human Services (HHS) to correct misinfor-mation published in the Federal Registerabout the accepted medical value of cannabis.ASA's petition asserts that the informationHHS provided in the Federal Register wasinaccurate and did not consider all the scien-tific evidence available.

In 2005, HHS denied the petition, citing con-cerns that accepting the petition would setthe preconditions for rescheduling cannabisand the agency was already engaged in a sci-entific review of the literature in response tothe 2002 rescheduling petition. ASA filed anappeal, and in response to a letter of intentto sue from ASA, HHS denied the appeal. In2007, pursuant to provisions of theAdministrative Procedures Act, ASA filed suitin the U.S. District Court for the Northern

54


District of California. On December 29, 2010,the Ninth Circuit denied ASA's petition forrehearing, effectively bringing to a closeASA's six year struggle to force the FederalGovernment to acknowledge the truth aboutthe accepted medical value of cannabis.

ADMINISTRATIVE ACTIONS

The Creation and Termination of theCompassionate Investigational New DrugProgram (IND): (1978-1992)

Started in 1978 as part of a lawsuit settlementby the Department of Health and HumanServices, the Compassionate IND programallowed registered patients to receive govern-ment supplied medical cannabis from theFDA. In response to a flood of applicationsfrom HIV/AIDS patients in the 1980s, theSecretary of Health and Human Servicesunder George H.W. Bush closed the programin 1992. Today, only the six surviving approvedpatients still receive medical cannabis fromthe federal government.

DOJ Memo (2009)

On October 19, 2009, Deputy AttorneyGeneral David Ogden issued a memorandumto US Attorneys in states that have enactedlaws allowing for the medical use of cannabis.Specifically, the memo discourages the use offederal enforcement resources to investigateindividuals who are in "clear and unambigu-ous compliance with state law" regardingmedical cannabis. The memo also notes thatthe commission of crimes not related to med-ical cannabis should not be ignored.

The memo's tacit recognition that cannabishas legitimate medical applications and thatallowance should be made for patients whosephysicians have advised them to use it marksa significant policy departure from previousadministrations. Although the memo doesnot have the force of law, it did appear toease the conflict between the federal lawenforcement officials and state-authorizedindividuals who use or provide cannabis fortherapeutic use. However, it was a false sense

of security, as federal raids on medicalcannabis dispensaries and cultivation centerscontinue to this day.

Victory for Veterans (July, 2010)

Under the rules of the Department ofVeterans, veterans can be denied pain med-ications if they are found to be using illegaldrugs. Until July, 2010, the department hadno written exception for medical marijuana.On July 22, 2010, veterans who had soughtresolution between federal and state law foryears were finally rewarded. TheDepartment's current policy now formallyallows patients treated at its hospitals andclinics to use medical cannabis in states whereit is legal.

CONGRESSIONAL ACTIONS

In 1981, U.S. Representatives StewartMcKinney (R-CT) and Newt Gingrich (R-GA)co-sponsored the first of a succession of billsto provide for the therapeutic use of cannabisin situations involving serious illness and toprovide adequate supplies of cannabis to indi-viduals who qualify for such use. Specifically,the legislation required the Secretary of theDepartment of Health and Human Services tosecure and maintain a supply of cannabis tomeet the medical, research, scientific, andexport needs of the United States. The billswere referred to committee and no furtheraction was taken on these bills.

During the next decade, no legislation wasintroduced in Congress. However, in responseto efforts in the various states to authorizethe use of cannabis to treat serious andchronic illness, Congress introduced severalpieces of legislation designed to underminereformation in the states.

Undermining Reform: The 105th Congress(1998)

In 1996, voters in California and Arizona*became the first state to authorize the use ofcannabis in accordance with a physician's rec-ommendation. In 1998, Oregon, Alaska, andWashington State enacted similar laws. The

55


adoption of these laws fascinated nationalmedia prompting Congressional action. Infact, the first pieces of legislation introducedduring the 105th Congress sought to penalizeindividuals participating in state reforms.226

During the fall of 1998, the U.S. House ofRepresentatives debated and passed a resolu-tion expressing the sense of Congress that"marijuana is a dangerous and addictive drugand should not be legalized for medicinaluse."227 No action was taken by the U.S. Senate,but the language was incorporated into theFY1999 omnibus appropriations legislation.228

A separate amendment to the same legisla-tion instructed that the District of Columbiacould not spend appropriations money toadminister a ballot initiative authorizing theuse of cannabis for medical purposes. Theamendment was successfully challenged, and69% of voters in the nation's capital approvedthe measure. However, Congress has effective-ly used the appropriations process to bar theimplementation of the D.C. ballot initiative.

Ending the Raids: The Hinchey-RohrabacherAmendment (2003-2007)

Within weeks of the terror-ist attacks on September 11,2001, dozens of federaldrug enforcement agentsraided and closed the WestHollywood-based Los

Angeles Cannabis Resource Center (LACRC), anon-profit dispensing collective that providedcannabis to approximately 1,000 people livingwith AIDS, cancer, and other terminal illnesses.Despite the fact that the LACRC was legalunder state law and operated with the full sup-port of local elected officials and law-enforce-ment officers, federal agents seized cannabisplants, business documents, bank accounts, andabout 3,000 confidential medical records. Sincethe raid, the Drug Enforcement Administrationhas continued to conduct paramilitary-styleraids across the state of California.

In 2003, in an effort designed to put scarcelaw enforcement resources to better use, U.S.

Representatives Maurice Hinchey (D-NY) andDana Rohrabacher (D-CA) introduced the firstin a succession of bipartisan amendments tothe Commerce, Justice, State appropriationsbill to prohibit the Department of Justicefrom using appropriated funds to interferewith the implementation of medical cannabislaws in the states that have authorized suchuse. The amendment has been offered ahandful of times, with marginal gains.

Fighting for Truth in Trials

The unfortunate result of the U.S. SupremeCourt's decision in Gonzales v. Raich is thatfederal defendants who are authorized touse, possess and cultivate cannabis in accor-dance with state law are prohibited from pre-senting evidence in federal court related totheir therapeutic use of cannabis or theircompliance with local and state laws.Consequently, most individuals indicted onfederal counts plead to lesser charges. In fact,since the Raich decision, at least two-dozenindividuals have been convicted and sen-tenced to several years in prison, despite notbreaking any local or state laws.229

In 2005, U.S. RepresentativeSam Farr (D-CA) introducedThe Steve McWilliams Truthin Trials Act (H.R. 4272) toamend the ControlledSubstances Act both to pro-vide an affirmative defensefor the medical use of cannabis in accordancewith the laws of the various states and tolimit the authority of federal agents to seizecannabis authorized for use under state law.The bill originated in the 108th Congress andwas reintroduced in the 111th Congress andevery year since then through 2010. It wasnamed in honor of a Californian who took hisown life while awaiting sentencing for feder-al cannabis distribution charges. During histrial, jurors were not informed that he wasproviding medical cannabis to individuals withseriously illness as part of a small collective inSan Diego.

The "Truth in Trials" Act enables individuals

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facing federal prosecution for marijuana-related offenses to provide evidence duringtrial that the activities they were engaged inwere performed in compliance with theirstate's duly-enacted medical marijuana laws.The "Truth in Trials" Act is not about the mer-its of medical cannabis. Instead, the bill wouldrestore fundamental fairness in federal trialsconcerning the use or provision of marijuanasolely for medical purposes and in accordancewith state law.

Protecting States' Rights: The MedicalMarijuana Patient Protection Act

During the 110th Congress, U.S.Representative Barney Frank (D-MA) and sev-

eral co-sponsors introducedthe "Medical MarijuanaPatient Protection Act of2008" (H.R. 5842). This legisla-tion makes necessary changesto federal law to provide forthe medical use of cannabis in

accordance with the laws of the variousstates. Specifically, H.R. 5842 would havereclassified cannabis from a Schedule I drug toa Schedule II drug, which would acknowledgethe medical value of cannabis and create aregulatory framework for the FDA to begin adrug approval process for cannabis. The"Medical Marijuana Patient Protection Act"would have also prohibited federal agenciesfrom interfering with the implementation ofstate-authorized medical cannabis programs.

In addition, the Medical Marijuana PatientProtection Act would provide protection fromprovisions of the federal ControlledSubstances Act (CSA) and the Food, Drug, andCosmetic Act (FDCA) for those qualified to useor obtain cannabis in states that have author-ized the use of medical cannabis. In particu-lar, the act prevents the CSA and FDCA fromprohibiting or restricting: (1) a physician fromprescribing or recommending cannabis formedical use, (2) an individual from obtaining,possessing, transporting within their state,manufacturing, or using cannabis in accor-dance with their state law, (3) an individual

authorized under state law from obtaining,possessing, transporting within their state, ormanufacturing cannabis on behalf of anauthorized patient, or (4) an entity authorizedunder local or state law to distribute medicalcannabis from obtaining, possessing, or dis-tributing cannabis to qualified individuals.

Similar versions of this bill (also known as theStates' Rights to Medical Marijuana Act) havebeen introduced in every Congress since the105th in 1997, but have not yet seen actionbeyond the committee referral process.

LANDMARK FEDERAL CASES

In the past decade, a dozen states have enact-ed laws that afford legal protections on indi-viduals who use medical cannabis and thepeople who provide care to them. Howeverthe federal government has never directlychallenged the legitimacy of these laws incourt. While the state laws differ from federallaw and stand contrary to the claim thatcannabis has "no accepted medical value",these laws do not directly or positively "con-flict" with federal law so as to trigger aSupremacy Clause challenge. Federal case lawmaintains that individual federal agenciesremain free to enforce federal marijuanalaws, even in jurisdictions that have enactedmedical cannabis laws.

Conant v. McCaffrey

(2000): In the wake of statelaws authorizing the use ofcannabis in accordance with arecommendation from a physi-cian, federal officials threat-ened to revoke the prescribingprivileges of any physician who

provided a recommendation to their patientsfor medical use. In response, a group of doc-tors led by AIDS specialist Dr. Marcus Conantfiled suit in federal court contending thatsuch a policy violates guarantees under theFirst Amendment to freedom of speech. Thegovernment was enjoined by the U.S. DistrictCourt in San Francisco from penalizing physi-cians who recommend the medical use of

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cannabis. The ruling states that physicianshave a First Amendment right to make rec-ommendations, but may not aid or abetpatients in actually obtaining cannabis.230

U.S. v. Oakland Cannabis Buyers Cooperative(OCBC)

(2001): In an opinion rendered on May 14,2001, the U.S. Supreme Court dealt a blow tomedical cannabis advocates by declaring thata person in federal court may not argue thatdistribution of cannabis to those with a rec-ommendation is a medical necessity. As aresult, a federal district court in Californiaissued a permanent injunction against theOakland Cannabis Buyers Cooperative, pro-hibiting it from distributing medical cannabisto authorized persons. While the Court wasadamant that federal law still criminalizes theuse and distribution of medical cannabis, theopinion left open several questions, such asconstitutional limitations on federal authority,which will be litigated in the OCBC's pendingappeal in the Ninth Circuit.231

Conant v. Walters

(2002): On appeal, the Ninth Circuit Court ofAppeals held that the federal authoritiescould not punish, or threaten to punish, adoctor merely for telling a patient that his orher use of cannabis for medical use is appro-priate. However, because it remains illegal fora doctor to "aid and abet" a patient to obtaincannabis or conspire with him or her to do so,the court drew the line between protectedFirst Amendment speech and prohibited con-duct as follows: A physician may discuss thepros and cons of medical cannabis with his orher patient, and issue a written or oral recom-mendation to use cannabis within a bona fidedoctor-patient relationship without fear oflegal reprisal. This is so regardless of whethers/he anticipates that the patient will, in turn,use this recommendation to obtain cannabisin violation of federal law. On the other hand,the physician may not actually prescribe ordispense cannabis to a patient, or recommendit with the specific intent that the patient willuse the recommendation like a prescription to

obtain cannabis. There have been no suchcriminal or administrative proceedings againstdoctors to date.232

U.S. v. Ed Rosenthal

(2006): A jury in San Franciscofederal court found Oaklandresident Ed Rosenthal guilty ofcultivating cannabis, conspira-cy to cultivate, and maintain-ing a place where drugs aremanufactured. Members ofthe jury were not permitted tohear evidence regarding Mr.Rosenthal's deputization bythe city of Oakland to grow

medical cannabis in accordance with statelaw. Rosenthal was deemed guilty and sen-tenced to one-day, time served. After the trial,jurors publicly recanted their "guilty" verdictafter learning facts that were omitted at trial.Mr. Rosenthal appealed to the Ninth Circuit,which reversed his conviction in April 2006,citing jury misconduct.233

(2007): Unhappy with the one-day, time-served sentence and subsequent reversal, theDepartment of Justice re-indicted Mr.Rosenthal, this time adding new (and frivo-lous) charges for money laundering and taxevasion. Because the prosecutor admittedthat these new charges were added inresponse to Rosenthal's statements againstthe government, the additional charges weredismissed by the court as a form of vindictiveprosecution. Mr. Rosenthal was, again, con-victed of cultivating cannabis and, again, wasgiven a sentence of one-day, time-served.234

Alberto Gonzales v. Angel Raich

(2006): After federal drug enforcementagents seized and destroyed medical cannabisplants belonging to authorized patients andproviders in California, filed a lawsuit andsought a preliminary injunction barring theDepartment of Justice from further interfer-ence. The suit argued that application of theControlled Substances Act in cases wheremedical cannabis was being cultivated and

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consumed for noremuneration entirelywithin and in accor-dance with state lawexceeded Congress'sauthority under theCommerce Clause. InDecember 2003, theNinth Circuit Court ofAppeals held that so

long as the medical cannabis-related activitiesoccur entirely within a state, the ControlledSubstances Act shall not apply.235

The case reached the Supreme Court afterAttorney General John Ashcroft appealed theDecember 2003 federal Ninth Circuit Court ofAppeals decision. On June 6, 2005, the U.S.Supreme Court ruled that federal lawenforcement officials may prosecute individu-als who use medical cannabis, even if they cul-tivated their own cannabis and even if theyreside in a state where such activity is protect-ed under state law. The decision does notinvalidate the laws of California or any otherstate that authorizes the use of cannabis inaccordance with a physician's recommenda-tion nor does it suggest that federal officialsare required to prosecute those authorized bystate law to use or obtain medical cannabis.Decisions about prosecution are still left tothe discretion of U.S. Attorneys. The Courtindicated that Congress and the Food andDrug Administration should work to resolvethis issue.236

McClary-Raich v. Gonzales

(2007): In 2007, the Ninth Circuit Court ofAppeals resolved the remaining issues raisedin Raich. In McClary-Raich v. Gonzales, theNinth Circuit held that McClary-Raich: (1)could not obtain a preliminary injunction tobar enforcement of the Controlled SubstancesAct (CSA) based on common law medicalnecessity, although she appeared to satisfythe factual predicate for such claim; (2) appli-cation of the CSA to medical cannabis cultiva-tors and users did not violate substantive dueprocess guarantees; and (3) the Tenth

Amendment does not bar enforcement of theCSA.

Despite the unfavorable outcome, the courtunderscores the accepted medical value ofcannabis and specifically indicated that therecould a fundamental liberty interest to usecannabis for medical purposes deserving pro-tection. The Court notes, "We agree withRaich that medical and conventional wisdomthat recognizes the use of marijuana for med-ical purposes is gaining traction in the law aswell. But that legal recognition has not yetreached the point where a conclusion can bedrawn that the right to use medical marijua-na is 'fundamental' and 'implicit in the con-cept of ordered liberty." The court concluded,"For now, federal law is blind to the wisdomof a future day when the right to use medicalmarijuana to alleviate excruciating pain maybe deemed fundamental. Although that dayhas not yet dawned, considering that duringthe last ten years eleven states have legalizedthe use of medical marijuana, that day maybe upon us sooner than expected."237

In re: Grand Jury Subpoena for THCF MedicalClinic Records

(2007): The United States District Court for theEastern District of Washington quashed a sub-poena directed to the State of Oregon toreveal information about 17 individualsenrolled in the state medical cannabis pro-gram. The court found that the subpoenaissued by a federal court to prove criminal vio-lations against a medical cannabis clinic wasunreasonable, since the government did nothave strong need for the information and thestate would be violating its own laws regard-ing confidentiality to reveal the informationsought, which, in addition, would deter peo-ple from participating the state's medicalcannabis program. Balancing these interests,the court concluded that the subpoenashould be quashed.238

STATES WITH MEDICAL CANNABIS LAWS

After exhausting attempts to removecannabis from Schedule I of the Controlled

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Substances Act in a series of petitions, frus-trated patients and advocates turned to thestates for protection. Since 1996, fourteenstates and the District of Columbia haveadopted laws which authorize the use ofcannabis as recommended by a licensed physi-cian without legal sanction: Alaska, Arizona,California, Colorado, Hawaii, Maine,Montana, Nevada, New Jersey, New Mexico,Oregon, Rhode Island, Vermont, andWashington.

Considerable disparities exist among the statelaws regarding the specific medical conditionsfor which physicians may provide a recom-mendation. California's medical cannabislaws leave treatment decisions to the trainedprofessional judgment of physicians, butmany states limit the legal use of medicalcannabis to narrow lists of conditions, exclud-ing serious and chronic illness for whichresearch has shown cannabis to be helpful.

The vast majority of arrests and prosecutionof cannabis offenses occur at the state andlocal level. If nothing else, state medicalcannabis laws offer individuals authorized touse medical cannabis specific protection fromarrest and criminal prosecution in their state.Some also provide civil protections for thosewho use medical cannabis so these individualsdo not lose their parental rights, their proper-ty or housing, their jobs or health insurancebenefits. A few states establish mechanismsfor individuals to obtain medical cannabisfrom licensed distributors. All of these lawsoperate in conflict with the federal law andleave patients and their providers vulnerableto federal enforcement raids, arrest, and pros-ecution by U.S. attorneys.

California (1996)

Proposition 215, also known as TheCompassionate Use Act, was

approved by 56% of voters. It exempts quali-fied individuals and their caregivers fromcriminal liability under state law for the culti-vation, possession and use of cannabis

In 2004, California enacted the Medical

Marijuana Program (MMP), pursuant toSenate Bill 420. This bill was adopted by thestate legislature in with the following pur-pose: "(1) Clarify the scope of the applicationof the act and facilitate the prompt identifica-tion of qualified patients and their designatedprimary caregivers in order to avoid unneces-sary arrest and prosecution of these individu-als and provide needed guidance to lawenforcement officers. (2) Promote uniformand consistent application of the act amongthe counties within the state. (3) Enhance theaccess of patients and caregivers to medicalmarijuana through collective, cooperative cul-tivation projects."

The MMP included provisions requiring theCalifornia Department of Health to establishand maintain a voluntary registry programwhereby qualified individuals could acquire astate-wide identification card verifying thatthe cardholders are enrolled in the state pro-gram and authorized to use, possess, cultivateand transport cannabis.

Oregon (1998)

Ballot Measure 67, The OregonMedical Marijuana Program Act,

was approved by 55% of voters. It removesthe state's criminal penalties for use, posses-sion, and cultivation of cannabis by individu-als whose physicians have advised that the useof cannabis "may mitigate the symptoms ofeffects" of debilitating medical conditions.The measure also created and mandatory reg-istry program and permitted licensed individu-als to cultivate up to seven plants inaccordance with medical need. Later, the statelegislature increased the limit to 24 plants perpatient.

Alaska (1998)

Ballot Measure 8 was approved by58% of voters in Alaska. The meas-

ure removed criminal penalties for individualswho suffer from a debilitating medical condi-tion for which approved medicines havefailed and possess a recommendation for aphysician to use cannabis. In 1999, the state

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legislature passed Senate Bill 94 which createda mandatory state registry system andremoved legal protections for those whorefuse to register with the state healthdepartment, or who possess greater amountsof cannabis than authorized by state law.

Washington (1998)

Initiative 692 was approved by 59%of voters. The law permits individu-

als with terminal illnesses and persons with spe-cific chronic diseases to use and possesscannabis once they've received appropriatedocumentation from their physician. The lawfurther protects their physicians and primarycaregivers against criminal prosecution and/orpenalizing administrative actions by the state ofWashington. The law only gives an affirmativedefense at trial, not a protection from arrest.

Maine (1999)

The Maine Medical Marijuana Actof 1998 was enacted to protect

individuals who find therapeutic and pallia-tive benefits from using cannabis from civil orcriminal penalties when their doctors advisethat such use may provide a medical benefitto them and when other reasonable restric-tions are met regarding that use. In 2009, thelaw was amended to increase the number ofconditions covered under this law. Theamendment also instructed the Departmentof Health and Human Services to establish aregistry identification program for patientsand caregivers.

Hawaii (2000)

This was the first state in which thelegislature debated and adopted a

law later signed by the governor whichauthorized the use of medical cannabis.Specifically, the legislation removes state-levelcriminal penalties for medical cannabis use,possession, and cultivation of up to sevenplants. A physician must certify that thepatient has a debilitating condition for which"the potential benefits of the medical use ofcannabis would likely outweigh the healthrisks." Hawaii's mandatory state registry pro-

gram is housed in the state's Department ofPublic Safety, one of the few states where lawenforcement is responsible for administeringthe medical cannabis program.

Colorado (2000)

Amendment 20 to the state consti-tution was approved by 54% of the

voters. As adopted, the law authorizes indi-viduals diagnosed by a physician as having adebilitating condition to use cannabis inaccordance with a recommendation from aphysician. The Board of Health has estab-lished a mandatory registry program wherebyindividuals and a caregiver may possess twousable ounces of cannabis and up to sixplants. Colorado's law was amended in Juneof 2010 to provide a regulatory frameworkfor dispensaries, including giving local com-munities the ability to ban or place controlson the operation, location and ownership ofthe dispensaries.

Nevada (2000)

Question 9 amended the state con-stitution and was approved by 65%

of voters. The law removes state-level criminalpenalties against those who have obtained a"written documentation" from their physicianaffirming that the use of cannabis may allevi-ate his or her condition. The law establishes aconfidential state registry that issues identifi-cation cards to qualified patients.

Vermont (2004)

Vermont became the second stateto pass a medical cannabis law by

the legislative process. The law was enacted in2004 without the Governor's signature. Inaccordance with the law, individuals qualifiedto use cannabis are authorized to cultivate upto nine cannabis plants in a locked room andto possess two ounces of dried cannabis underthe supervision of the Department of PublicSafety, which maintains a patient registry.

Montana (2004)

Ballot initiative 148 was approvedby 62% of voters. The law permits

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qualified individuals to use cannabis undermedical supervision. Eligible medical condi-tions include cancer, glaucoma, HIV/AIDS,wasting syndrome, seizures, and severe orchronic pain. A doctor must certify that thepatient has a debilitating medical conditionand that the benefits of using cannabiswould likely outweigh the risks. The patientmay grow up to six plants and possess oneounce of dried cannabis. The state publichealth department maintains a mandatoryregistry system.

Rhode Island (2006)

In a gubernatorial veto override,the Rhode Island state legislature

enacted The "Edward O. Hawkins andThomas C. Slater Medical Marijuana Act" in2006. Rhode Island's law allows individuals topossess up to 12 plants or 2-1/2 ounces totreat cancer, HIV/AIDS, and other chronic ail-ments. The law included a sunset provisionand was set to expire on July 1, 2007, but thelaw was made permanent in 2007. In 2009,the law was amended by substituting TheEdward O. Hawkins and Thomas C. SlaterMedical Marijuana Act for the original bill.Though the Governor vetoed this bill, boththe Senate and House overrode this veto andthe new law was adopted.

New Mexico (2007)

The Lynn and Erin CompassionateUse Medical Marijuana Act was

adopted by the state legislature, and enact-ed by Governor Bill Richardson in 2007. Thelaw requires the state's Department ofHealth to set rules governing the distributionof medical cannabis to state-authorizedpatients. Unlike other state programs, thelegislation directed the establishment ofstate-licensed "cannabis production facili-ties." In 2008, after abandoning a plan tohave state officials cultivate cannabis for dis-tribution to program participants, the NewMexico Department of Health has proposedlicensing private growers and non-profit dis-tributors.

Michigan (2008)

After numerous Michigan cities,including Detroit and Ann Arbor,

had passed medical cannabis measures, thestate’s voters in 2008 passed the "MichiganMedical Marihuana Act" by 63% of the vote.Patients may qualify for protections with adoctor’s recommendation for a number ofdebilitating conditions. Patients may possessup to 2.5 ounces of usable marijuana and maycultivate up to twelve marijuana plants in anenclosed, locked area.

New Jersey (2010)

The New Jersey Compassionate UseMedical Marijuana Act, was signed

into law by outgoing Governor John Corzineon January 18, 2010. The purpose of the lawis to protect "patients who use marijuana toalleviate suffering from debilitating medicalconditions, as well as their physicians, primarycaregivers, and those who are authorized toproduce marijuana for medical purposes"from "arrest, prosecution, property forfeiture,and criminal and other penalties."The NewJersey Department of Health and SeniorServices released draft rules outlining the reg-istration and application process in October of2010. Finding these rules to be too restrictive,the New Jersey State Legislature ultimatelysent them back to Governor Christie, orderinghim to rewrite the proposed regulations.

Washington, DC (1998 & 2010)

In 1998, voters in Washington, DCapproved a ballot measure to

authorize the use of medical cannabis inaccordance with a physician's recommenda-tion. During the 105th Congress, an amend-ment to the Consolidated and EmergencySupplemental Appropriations Act, 1999,instructed that the District of Columbia couldnot spend appropriations money to adminis-ter a ballot initiative. The amendment wassuccessfully challenged, and 69% of voters inthe nation's capital approved the measure.The "Legalization of Marijuana for MedicalTreatment Amendment Act of 2010" wasapproved 13-0 by the Council of the District of

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Columbia on May 4, 2010 and signed by theMayor on May 21, 2010, becoming effectiveon July 27, 2010. After being signed by theMayor, the law underwent a 30-dayCongressional review period. Congress did notact to stop the law, so it became effectivewhen the review period ended.

Arizona (2010)

Ballot proposition 203, The ArizonaMedical Marijuana Act, was

approved by 50.13% of voters in Novemberof 2010. It allows registered qualifyingpatients to obtain cannabis from a registerednon-profit dispensary, and to possess and usemedical cannabis to treat the condition.Registration is mandatory. Unlike other statelaws, Arizona's law specifies that a registeredpatient's use of medical cannabis is to be con-sidered equivalent to the use of any othermedication under the direction of a physicianand does not disqualify a patient from med-ical care, including organ transplants.

The law also states that employers may notdiscriminate against registered patients unlessthat employer would lose money or licensingunder federal law. Employers may not penal-ize registered patients solely for testing posi-tive for cannabis in drug tests, although thelaw does not authorize patients to use, pos-sess, or be impaired by cannabis on the prem-ises or during the hours of employment.

SPECIAL CASES AND OTHER STATE LAWS

Maryland (2003)

In 2003, Maryland enacted theDarrell Putnam Compassionate UseAct. The bill applies to defendants

possessing less than one ounce of cannabisand who can prove that their cannabis-relat-ed activities were in pursuit of a medicalnecessity and with a doctor's recommenda-tion. Under Maryland's law, individuals areprotected from a criminal record and possibleimprisonment. The maximum penalty for pos-session of cannabis by a patient with a validdoctor's recommendation is $100. Governor

Ehrlich, the first Republican governor to sign abill relaxing penalties for medicinal use ofcannabis, signed the measure despite pressurefrom the Bush administration to veto it.

Connecticut (2007)

In 2007, after five legislative committees andthe full Connecticut House and Senate passedH.B. 6715, Gov. M. Jodi Rell (R) vetoed the leg-islation which would have permitted seriouslyill individuals to use medical cannabis withtheir doctor's recommendation. Althoughmore than 60% of Connecticut's legislatorsvoted in favor of the bill, two-thirds of eachchamber is necessary to override a veto, aveto-override vote never occurred.

Other state laws

Between 1978 and 1997, 35 states and theDistrict of Columbia passed legislationacknowledging the potential medical value ofcannabis. These states include: Alabama,Arizona, Arkansas, California, Colorado,Connecticut, Florida, Georgia, Illinois, Iowa,Louisiana, Massachusetts, Maine, Minnesota,Missouri, Montana, Nevada, New Hampshire,New Jersey, New Mexico, New York, NorthCarolina, Ohio, Oklahoma, Oregon, RhodeIsland, South Carolina, Tennessee, Texas,Vermont, Virginia, Washington, West Virginia,and Wisconsin.

Except for the District of Columbia and thefourteen states that explicitly grant protectionfrom arrest, most of these state laws do notcurrently protect medical cannabis users fromstate prosecution. Some of these laws permitindividuals to acquire and use cannabisthrough therapeutic research programs, how-ever, none of these programs has been opera-tional since 1985. Other state laws allowdoctors to prescribe cannabis or allow peopleto possess cannabis if it has been obtainedthrough a prescription, but the federalControlled Substances Act prevents these lawsfrombeing implemented. A few states haveplaced cannabis in a controlled drug schedulethat recognizes its medical value.

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THE CROSSFIRE OF STATE & FEDERAL LAW

Despite hundreds of peer-reviewed scientificresearch studies, including dozens of double-blind, placebo-controlled clinical trials, all ofwhich demonstrate cannabis can effectivelytreat symptoms of HIV/AIDS, muscle spasticity,and severe neuropathic and chronic pain,among other conditions, the federalDepartment of Health and Human Servicescontinues to maintain the position thatcannabis "has no currently accepted medicaluse in treatment in the United States."

The federal government's dogmatic approachto marijuana is dangerous and causes unnec-essary suffering by deterring individuals whosuffer from serious and chronic illness fromobtaining and using cannabis, a remedy thatcould provide needed relief and significantlyimprove quality of life. Worse still, it allowsthe Department of Justice and the DrugEnforcement Administration to conduct acampaign of intimidation against individualsauthorized in the various states to use or pro-vide medical cannabis in accordance withstate law.

For more than 30 years, advocates have usedthe appropriate administrative channels topetition the United States to remove cannabisfrom the list of Schedule I drugs, those withno medical use. After exhaustive hearings,the DEA's Chief Administrative Law Judgeruled in 1988 that cannabis should be madeavailable for medical use. But despite over-whelming evidence of the therapeutic efficacyof cannabis, federal law continues to prohibitits use for medical purposes.

As a consequence of this longstanding federalintransigence, advocates sought legal protec-tions within the various states. Since thefounding of the nation, state and local gov-ernments have long been "laboratories ofdemocracy," particularly in cases when federalobstruction was borne of political cowardiceor ignorance. More than one-third of the U.S.population currently lives in a state that hasauthorized the use of medical cannabis, andmore states consider similar laws each year.

To the extent that the vast majority of arrestsfor cannabis-related activity occur at the stateand local level, these state laws offer substan-tial protection. However, while these lawsshield authorized persons from arrest andprosecution, many individuals who usecannabis to relieve symptoms of serious orchronic illness continue to suffer pervasive dis-crimination in employment, child custody,housing, public accommodation, education,and medical care. Moreover, the conflictbetween state and federal laws leaves someindividuals - usually those providing a safepoint of access or engaged in the cultivationof medical cannabis - vulnerable to federalprosecution and lengthy prison sentences.And the majority of Americans do not enjoyany legal protection if their doctors recom-mend cannabis for treatment.

The Community-Based Solution to Access:Medical Cannabis Dispensing Centers

So long as research supports the therapeuticvalue of cannabis and physicians recommendit to control symptoms of serious and chronicillness, patients will seek safe and consistentaccess to quality cannabis. Many individualssuffering from a serious or chronic illness maynot have the time or resources to cultivatetheir own cannabis, or might not know peoplewilling and able to act as a caregiver and growcannabis on their behalf. As a result, individu-als are forced to break the law and risk unnec-essary and potentially harmful entanglementswith illicit dealers and law enforcement offi-cers in order to gain access to cannabis.

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Medical cannabis dispensing centers haveemerged as a sensible, community-basedresponse designed to provide a safe place forqualified individuals to access a consistentsupply of medical cannabis. These points ofaccess represent an effort in various states tofully implement state law. Moreover, theimportance of these facilities is underscoredby the reluctance of the federal governmentto address the issue of medical cannabis in ameaningful way.

While most of these facilities operate likewellness facilities, medical cannabis dispensingcenters exist specifically to provide qualifiedindividuals exclusive and reliable access tocannabis, much as a pharmacy exists to pro-vide prescribed medication. Moreover, theregulations that permit and control dispens-ing centers ensure local governance and over-sight of the cultivation and distribution ofmedical cannabis in accordance with statelaw. By requiring compliance with compre-hensive regulatory ordinances, local officialscan monitor the operation of medicalcannabis dispensing centers to be certain thatproper verification procedures are followed,to assure that the place and hours of opera-tion are consistent with community needs,and to minimize diversion of medical cannabisto the illicit market.

In California, Colorado, and a few otherstates, locally regulated patient-collectiveshave been widely successful. In most cases,these collectives pool the resources of quali-fied members to cooperatively cultivate med-ical cannabis and distribute it to othermembers who may not be able to provide itfor themselves. For these individuals, particu-larly those most in need, dispensing centersprovide more than reliable access; they alsooffer alternative forms of cannabis extractsand experienced guidance on dosage andefficacy for different cannabis varieties. Manyeven have social services and support net-works that assist those who would otherwisebe isolated by their conditions.

In many cases, these dispensing centers subsi-

dize access to other natural or complimentaryhealth care services that would otherwise beunavailable to their clients. Whether dispens-ing centers are regulated by the state or(someday) the federal government, local poli-cymakers still have an important role to playto the extent any proper regulation willrequire zoning, permitting, policing, fees, andother issues which will remain the prerogativeof local governments.

Since the U.S. Supreme Court issued the deci-sion in Gonzales v. Raich, which did not invali-date state medical cannabis laws, and upheldKha v. Garden Grove, which clarified theresponsibility of the states to uphold stateand local laws even when they are in conflictwith federal law, many local and state gov-ernments have been working overtime toimplement their state laws to curb abuse andto set up the appropriate systems to carefullyregulate and control the distribution of med-ical cannabis to authorized individuals in theircommunities. Community-based medical mari-juana access centers are beginning to takeroot in locations outside of California.Oregon, Washington, Colorado, New Mexico,Maine, Michigan, Montana, Rhode Island, andthe District of Columbia are just a few of thejurisdictions seeking to appropriately controland regulate the production and distributionof medical cannabis.

The Federal Response: Interrupt Access,

Intimidate Providers, Undermine Authority

Despite the affirmative implementationefforts in 15 states and the District ofColumbia, the Department of Justice and theDrug Enforcement Administration have cho-sen to use their discretion to undermine theeffective implementation and authority ofstate law, instead of working to bridge thegap between legitimate state laws and out-dated federal laws. In 1999, federal agenciesinitiated a series of paramilitary style enforce-ment raids on individuals and collectivesauthorized to use or provide medical cannabisin accordance with California state law thatcontinues today.

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Following the Supreme Court's decision inRaich, federal agencies intensified theirenforcement tactics. Between 2007 and 2008,national advocates recorded an unprecedent-ed number of enforcement raids against indi-viduals authorized to use or dispense medicalcannabis in accordance with their state law,and currently, the Department of Justice isseeking to prosecute more than 100 of theseindividuals even though they were adheringto state law. These campaigns to circumventstate law happened despite inquiries frommembers of the U.S. House JudiciaryCommittee and requests from local policy-makers to halt raids in deference to local reg-ulators.

Federal enforcement activity against individu-als qualified to use or possess medicalcannabis has not been restricted to California.In Washington, federal law enforcementagents in 2007 raided the offices of a medicalcannabis advocacy group that was supplyinghundreds of authorized individuals withstarter plants. In New Mexico a few monthslater, the DEA threatened state officials withfederal prosecution if they proceeded toimplement a state-mandated medicalcannabis distribution program. In Oregonthat same year, a federal grand jury subpoe-naed the medical records of 17 qualified indi-viduals enrolled in the Oregon MedicalMarijuana Program. A federal court laterdenied the subpoena of patient records, butas of March 2011, federal authorities areattempting to subpoena the confidentialrecords of seven patients enrolled inMichigan's medical cannabis program, despitea provision of state law that makes it a crimeto release such information.

In 2008, the Department of Justice began tolevy threats against property owners wholeased property to medical cannabis dispens-ing collectives. On June 30, the U.S. Attorneyfor the Central District of California andSpecial Assistant U.S. Attorney, AssetForfeiture Section, sent letters to multipleproperty owners requesting that they attenda meeting in August at which the U.S.

Attorney delivered an ultimatum: evict thecollectives within 45 days or face federal assetforfeiture, prosecution, and DEA raids at thefacilities.

Another tactic employed by the federal gov-ernment is designed to interrupt safe accessby preventing collective operators fromdepositing their funds into bank accounts.Forcing collectives to carry large sums of cashon hand makes them an attractive risk forcriminal activity which risks the safety ofpatients and providers affiliated with theseestablishments. To remedy the situation, ASAis engaging congressional allies.

In May 2010, 15 Members of Congress, includ-ing members from both the Banking andJudiciary committees, sent a letter to TreasurySecretary Timothy Geithner urging him toissue "written guidance for financial institu-tions," which would commit the TreasuryDepartment to not targeting those institu-tions whose account holders are in compli-ance with state medical marijuana laws. Thisdialogue with Treasury and Congress is ongo-ing, and if history is any indication, is not like-ly to be resolved until the federal governmentends the conflict between state and federalmedical marijuana laws.

The latest federal interference tactic utilizesan antiquated tax code (IRS provision 280E) toprohibit medical marijuana dispensing centersfrom taking standard business deductions andcredits. Several medical cannabis centers havebeen targeted under the guise of federal taxaudits. These "audits" appear to target cen-ters serving the greatest percentage of thepopulation.

For the patients who rely on access to the med-icine these centers provide, enforcement of thistax provision could result in a number of conse-quences. First, collectives will significantly raisethe cost of medicine and services in order tocompensate for the loss of standard businessdeductions and credits. Second, it's possiblethat some collectives may simply stop filingfederal tax returns, which may jeopardize theintegrity of the centers and put patients in

66


harm's way. And finally, in the worst case,medical cannabis dispensing centers will simplyshut their doors, forcing what are otherwisewell regulated facilities underground.

Despite these tactics, the movement for safeaccess continues to thrive across the country.Heightened federal enforcement efforts andprosecutions have had a negligible impact onthe distribution of medical cannabis in Cali-fornia and other states. In fact, more jurisdic-tions, not fewer, are seeking to create theregulations necessary to control safe produc-tion and distribution of marijuana for med-ical purposes.

The Obama Administration recently issuedwritten guidelines to U.S. Attorneys discour-aging the prosecution of patients andproviders who are in compliance with existingstate laws. These guidelines are an importantstep in the right direction and a welcome andsignificant departure from the policies of pre-vious Administrations. Of course, much moreneeds to be done to ensure that all patientswho might benefit from medical cannabishave access to it.

The Advocates Solution:

ASA's Federal Policy Agenda

ASA's National Office opened in April 2006 tobring the patients' voice to Washington, D.C.,to end the arrests and prosecutions ofpatients using medical cannabis therapeutics,to end the ban on research, and to create anaccess plan for the entire nation. ASA workson Capitol Hill and within the Administrationto improve the federal government's under-standing of the therapeutic uses of cannabisand the immediate and long-term needs ofour members. ASA's advocacy in DC is basedon the following Federal Policy Agenda.When implemented, these policies will finallyfree state and local governments to adopteffective, compassionate access models.

1. End Federal Raids, Intimidation, andInterference with State Law.

Fifteen states and the District of Columbiahave passed laws authorizing individuals liv-

ing with a serious or chronic illness to use andobtain cannabis as recommended by a physi-cian. However, these state laws differ fromthe federal law and leave patients and theirproviders vulnerable to federal raids, arrest,and prosecution. Since 2006, many state andlocal governments have been working over-time to fully implement their state laws inorder to curb abuse and create the appropri-ate systems to carefully regulate and controlthe distribution of medical cannabis toauthorized individuals in their communities.

Effective implementation of state medicalcannabis laws is stymied by federal interfer-ence. The U.S. Department of Justice, togeth-er with the Drug Enforcement Administration,has conducted scores of enforcement raidsand employed intimidation tactics designedto undermine the implementation of stateand local law. The importance of state laws,and the protection they provide, is under-scored by the reluctance of the federal policy-makers to address the issue of medicalcannabis in a meaningful way. Until Congressand the Administration create a comprehen-sive national medical cannabis strategy, indi-vidual states should not be obstructed fromresponding to the public health needs of theircitizens.

2. Permit an affirmative defense andestablish federal legal protection forindividuals authorized by state or locallaw to use or provide cannabis fortherapeutic use.

Currently, the Department of Justice has pros-ecuted more than 100 licensed medicalcannabis patients and providers.Unfortunately, federal defendants are forbid-den from presenting evidence at trial thattheir marijuana-related activities were fortherapeutic purposes and in compliance withstate law, limiting their ability to present adefense in federal court. Congress and theAdministration should amend the ControlledSubstances Act to provide an affirmativedefense in federal court and establish legalprotections for individuals who use or providecannabis for therapeutic use in accordance

67


with state and local law.

3. Encourage advanced clinical research trialsthat meet accepted scientific standards.

Federal law clearly requires adequate compe-tition in the manufacture of Schedule I and IIsubstances, but since 1968 the NationalInstitute on Drug Abuse (NIDA) has main-tained a monopoly on the supply of cannabisused for legitimate research purposes. TheDrug Enforcement Administration helps toprotect NIDA's monopoly by refusing to grantcompetitive licenses for the production ofresearch-grade cannabis. In 2007, U.S.Department of Justice-appointedAdministrative Law Judge Mary Ellen Bittnerissued an Opinion and Recommended Rulingwhich concluded that granting competitivelicenses would be "in the public interest."However, the Administration has taken noaction, and the AdministrativeRecommendation remains pending.

Congress and the Administration should workto remove the political and bureaucraticobstacles that inhibit clinical research and

instead should create incentives to conductresearch in accordance with the Institute ofMedicine's recommendations.

4. Create a national medical cannabisstrategy that includes a safe and legalaccess plan.

A scientific consensus supports the therapeu-tic use of cannabis to control symptoms ofserious and chronic illness. In the past decade,clinical research has clearly demonstrated thatthe use of cannabis and its constituents cansafely and effectively treat symptoms of seri-ous and chronic illness like nausea and vomit-ing, loss of appetite, pain and spasticity.

The science and policy regarding the medicaluse of cannabis should not be obscured orhindered by the debate surrounding thelegalization of marijuana for general use.Scientific consensus coupled with state leader-ship has provided a solid foundation for fed-eral policymakers to create a comprehensiveplan to support long-term solutions for safeand legal access to cannabis for therapeuticuse and research.

68

MODEL LEGISLATION

For model state legislation on medical cannabis anda model local ordinance for regulating medicalcannabis dispensing centers, see the Appendix.

APPENDIX

The Medical Cannabis Advocates’ Handbook

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

—-Canadian Medical Association


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27. Casanova et al. Inhibition of skin tumor growth andangiogenesis in vivo by activation of cannabinoidreceptors. 2003. Journal of Clinical Investigation 111:43-50.

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219. Young, F. 1988. Opinion in the matter ofMarijuana Rescheduling Petition. Docket No. 86-22

220. 54 FR 53767. Dec 29, 1989221. ACT v. DEA 930 F. 2nd 936 (1991)222. U.S. Dept of Justice, Drug Enforcement

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224. US DOJ. DEA. Denial of Petition; Notice. FederalRegister, v. 66, no. 75, April 18, 2001. p. 20037.

225. No. 01-1182, United States Court Of Appeals ForThe District Of Columbia Circuit, March 19, 2002,Argued, May 24, 2002, Decided.

226. H.R. 1265, The Medical Marijuana Deterrence Act1997, sought to deny federal benefits to individualsconvicted of a state offense in a state that permitsthe medical use of marijuana; H.R. 1310, TheMedical Marijuana Prevention Act, would havegiven the Attorney General authority to revoke aphysicians right to prescribe controlled substances ifthey recommended smoking marijuana fortherapeutic use; and, H.R. 3184, would haveclarified that federal controlled substances laws stillapply, even in situations were the state law hasauthorized the use and distribution of marijuanafor medical purposes. These bill were referred tocommittee where no action was taken.

227. H.J. Res 117, House Vote #435 in 1998228. Omnibus Consolidated and Emergency

Supplemental Appropriations Act, 1999. P.L. 105-277, October 21, 1998, St. 2681-760

229. For complete list of approximately two dozenfederal convictions, seewww.AmericansForSafeAccess.org/article.php?list=type&type=184

230. www.AmericansForSafeAccess.org/downloads/Conant_Ruling.pdf

231. www.AmericansForSafeAccess.org/downloads/US_v_OCBC.pdf

232. www.AmericansForSafeAccess.org/downloads/conantvwalters.pdf

233. www.AmericansForSafeAccess.org/downloads/Rosenthal_Ninth_Circuit_Ruling.pdf

234. www.AmericansForSafeAccess.org/downloads/Rosenthal_Ninth_Circuit_Ruling.pdf

235. Raich v. Ashcroft, 352 F. 3d. 1222 (9th Cir. 2003)236. Gonzales v. Raich, 125 S.Ct. 2195, 2205 (2005)237. www.AmericansForSafeAccess.org/downloads/

Raich_v_Gonzales.pdf 238. www.AmericansForSafeAccess.org/downloads/

landmark.in.re.grand.jury.pdf

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