Abstract
Despite many decades of warnings about the safety and effectiveness of marijuana for medical treatment, public policy in recent years has moved steadily towards loosening restrictions on its use. In 2000, a ballot initiative to change Colorado's constitution was passed by 54% of voters in the general election, thereby legalizing marijuana for specific disabling conditions. After the Obama administration indicated in 2009 that medical marijuana prosecution would have a low priority and arrests would not be sought, provided medical marijuana users and providers conformed strictly to state laws, the issuance of cards for the medical use of marijuana in the state increased dramatically. By 2013, the state had changed its laws to allow not just medicinal use of marijuana, but recreational use as well. Since that decision, a variety of public health and safety trends and statistics have been published, raising questions about the long-term impacts of marijuana use in the state on health care, medical regulation and public safety. Medical regulators and policy makers in other states should review data from Colorado as they assess their own states' approaches to marijuana, including carefully balancing physicians' responsibilities to their patients with the need for wise public health and safety decision-making. Three factors are particularly important as regulators develop policy: 1) the impact of liberalized marijuana laws on public health and safety; 2) limitations in the scope and availability of evidence-based research on the efficacy of marijuana; and 3) the wide gulf between federal and state laws and procedures regarding marijuana use. By being cognizant of trends and developments in all three areas, regulators can make better decisions regarding their own policies. In today's rapidly changing marijuana policy environment, medical regulators should encourage their licensees to follow practical steps aimed at ensuring that when medical marijuana prescribing does occur, it is based on established standards of care and adherence to the basic tenets of the patient-physician relationship.
Introduction and Historical Background
Those in the healing profession have prescribed cannabis, known in the vernacular as marijuana, for at least five millennia. Marijuana was prescribed in China as early as 2737 B.C. for ailments ranging from “absentmindedness” to “female weakness.” In the United States, physicians routinely prescribed marijuana until the late 1930s when it began to fall out of favor. It was not until 1970 that the law would intervene and proscribe all use. In 1975 the Compassionate Use Program for marijuana was established by the Food and Drug Administration (FDA) and reserved for patients suffering from cancer, glaucoma and multiple sclerosis. Importantly, this program was not based on research, only recognition that glaucoma was the number one cause of blindness in the world and that patients with either terminal or refractory diseases were suffering enormously. However, in 1992, members of the American Academy of Ophthalmology's Committee on Drugs argued that no scientific verifiable evidence exists that the use of marijuana is safe and effective in the treatment of glaucoma. Seven years later, the Institute of Medicine noted that there were too many side effects (primarily cognitive) to recommend lifelong use for the treatment of glaucoma, particularly when a variety of FDA-approved drugs were already on the market. Four years later, the Controlled Substance Act was established and classified marijuana as having a high abuse potential and no safe medical use.23
In 1986 a synthetic form of tetrahydrocannibanol (THC), the main psychoactive substance in marijuana, was offered in an oral form. Marinol was classified as a Schedule II drug by the Drug Enforcement Administration (DEA), making it accessible to patients in need and also for research purposes.23 Sativex, an oraomucuosal spray which delivers a mix of THC and cannabidiol effective for neuropathic pain, sleep disturbance and spasticity, is currently in phase III trials in the United States to gain approval from the FDA.12 However, proponents of the legalization of marijuana for medicinal purposes argue that Marinol is less effective than the natural herb and have lobbied hard to have the botanical legalized in every state.
In November 2000, a ballot initiative to change Colorado's constitution (Amendment 20), was passed by 54% of voters in the general election, thereby legalizing marijuana for specific disabling conditions.14 The Colorado Department of Public Health and Environment (CDPHE) was tasked with implementing and administrating the “medical” marijuana registry program. In March 2001, the CDPHE approved rules and regulations for the registry and began accepting applications in June 2001.
In Colorado, in order to qualify for a medical marijuana card, patients must establish an affirmative defense for the possession of marijuana (e.g. have been previously diagnosed by a physician as having a debilitating condition). Debilitating conditions include glaucoma, cachexia, cancer, HIV/AIDS, seizures, severe pain, severe nausea and persistent muscle spasms/spasticity. Additionally, the patient, in the context of a bona fide physician-patient relationship, must receive a recommendation to use marijuana from the treating physician.23
Many voters intended to decriminalize the possession of marijuana for patients afflicted with conditions refractory to conventional treatments and a small scale enterprise was envisioned. Instead, storefront marijuana dispensaries sprouted like weeds (pun intended). The medical marijuana industry proved to be a lucrative endeavor at a time when the rest of the country experienced a serious recession. Money could be made by attorneys providing legal counsel, physicians making recommendations, businesses selling paraphernalia (e.g., grow lights, pipes, vaporizers), and marketers, not to mention through growing marijuana and baking edibles. Festivals and delivery services emerged. Tourism flourished, and gave the state's “Rocky Mountain High” branding new meaning. Finally armored trucks were employed to transfer profits from a cash-only industry. No matter how tempting, federally insured banks did not accept marijuana dispensary earnings given that marijuana remained illegal under federal law. A bill was proposed to create a state credit union for the industry.
MANY VOTERS INTENDED TO DECRIMINALIZE THE POSSESSION OF MARIJUANA FOR PATIENTS AFFLICTED WITH CONDITIONS REFRACTORY TO CONVENTIONAL TREATMENTS AND A SMALL SC ALE ENTERPRISE WAS ENVISIONED. INSTEAD, STOREFRONT MARIJUANA DISPENSARIES SPROUTED LIKE WEEDS.
The real acceleration of medical marijuana use in Colorado began in 2009, after the Obama administration indicated that medical marijuana prosecution would have a low priority and arrests would not be sought provided medical marijuana users and providers conformed strictly to state laws. Between 2009 and 2014, the number of medical marijuana cards issued in the state grew exponentially. While objectively diagnosable conditions such as cachexia, cancer, glaucoma, HIV/AIDS and seizures accounted for one to three per cent of all cards issued, 94% of card carriers were diagnosed with severe pain, a highly subjective condition. Moreover, 70% of medical marijuana cards have been obtained by relatively young men (the majority being between the ages of 25 and 34) living in metro Denver. Either Colorado experienced an epidemic of severe pain in youthful males or Amendment 20 was being exploited by recreational users and financial opportunists, undercutting the practice of responsible medicine.23
By the fall of 2009, approximately 7% (900) of physicians licensed in Colorado had made medical marijuana recommendations to patients. However only 15 physicians accounted for 75% of the recommendations and, of this number, five physicians were responsible for 50% of all of the recommendations. A third of the 15 physicians had disciplinary histories. One physician practicing in Colorado was forced to relinquish his license after writing 7,000 recommendations for marijuana over the course of one year. Clearly, only a small number of physicians are making the majority of recommendations for medical marijuana. Many of these physicians' practices consist solely of evaluating patients for medical marijuana, a significant conflict of interest when considering the fiduciary principles established for physicians.14
In 2010, Senate Bill 109 (SB109) was introduced to tighten the rules and regulations governing the medical marijuana industry. SB109 defines a bona fide relationship between a physician and patient. It requires physicians making marijuana recommendations to have unrestricted medical and DEA licensure and allows the Colorado Medical Board to examine the care provided to patients receiving marijuana recommendations. It also addresses physician conflicts of interest by not allowing physicians to be employed by or profit from dispensaries. Finally, SB109 requires that two physicians need to independently examine those patients under the age of 21 for whom marijuana treatment is being considered. SB109 has cut down on the abuses reported by the CDPHE of some physicians making medical marijuana recommendations in the absence of adequate evaluation or continuity of care.
In retrospect, it is clear that the passage of Amendment 20 was the proverbial Trojan horse to pave the way for the full legalization of marijuana for recreational purposes. On November 6, 2012, ballot initiative Amendment 64 passed and, effective January 1, 2013, marijuana could be legally obtained for recreational use in Colorado. Colorado is the first place in the world to actually legalize commercial sales of marijuana to anyone over 21 years of age.15
IN THE STATE'S SCHOOLS, MARIJUANA USE IS HIGHER THAN NATIONAL AVERAGES. IN 2012, COLORADO RANKED FOURTH IN THE NATION FOR MARIJUANA USE AMONG 12 TO 17 YEAR OLDS AND 39% HIGHER THAN THE NATIONAL AVERAGE.
The Impact of Marijuana Legalization on Public Health and Safety
The United States is clearly divided over the legalization of marijuana. Those in favor argue that legalization of marijuana protects individual rights and eliminates criminal convictions and incarceration for minor offenses. Those in support of legalization also maintain that it would do away with the black market and provide significant tax revenue to each state. Those in opposition express concern about a possible escalation in use with concomitant adverse mental and physical health effects, increased medical costs, and negative societal consequences.3 Many of these concerns appear to be unfolding today in Colorado.
In August 2014, the Rocky Mountain High Intensity Drug Trafficking Area Investigative Support Center released a report summarizing the impact of the recent easing of federal marijuana arrests and the eventual legalization of marijuana in Colorado.1 According to the report, the ramifications of these developments in the state are widening.
Public health and safety impacts, for example, include an increase in traffic fatalities involving drivers testing positive for marijuana. The majority of driving-under-the-influence-of-drugs arrests in Colorado involve marijuana. In 2013, 48% of Denver adult arrestees tested positive for marijuana, a 16% increase from 2008. From 2011 through 2013 there was a 57% increase in marijuana-related emergency room visits. Hospitalizations related to marijuana have also increased.
In the state's schools, marijuana use is higher than national averages. In 2012, Colorado ranked fourth in the nation for marijuana use among 12 to 17 year olds and 39% higher than the national average. Drug-related school suspensions/expulsions increased by 32% between 2009 and 2013; the vast majority were for marijuana violations.
The use of marijuana among adults in Colorado is also much higher than national norms, with the state ranking third in the nation in 2012 — 42% higher than the national average.
The report also shows an increase in the flow of marijuana from Colorado destined for other states. U.S. mail parcel interceptions of marijuana destined for 33 other states increased by 1,280% from 2010 to 2013, for example.
Other concerning trends have been observed since the de facto and actual legalization of marijuana. Butane hashish oil (aka BHO) labs are emerging. Infusing hashish oil with butane and smoking or vaporizing the concoction produces an an intense mind-altering experience. Whereas an average-size marijuana “joint” contains 10 to 15% THC, BHO can contain up to 90% THC. The emergence of these THC-extraction labs has posed unique challenges to law enforcement officials and physicians alike. Flash fire explosions have originated from the butane used in the extraction process. In 2013, there were 12 THC extraction lab explosions. In the first half of 2014, the number of explosions more than doubled. In 2013 there were 18 documented injuries from THC extraction labs and in the first half of 2014 there were 27 documented injuries. While “dabbing” (e.g., smoking BHO) has gained popularity in recent years, others consider it the “crack of pot” and fear it could jeopardize the marijuana legalization movement.1
“Black market” marijuana was expected to disappear once the substance was legalized in the state of Colorado. However, marijuana illegally cultivated on federal land in Colorado is a thriving business. There is no evidence to suggest that the legalization of recreational marijuana has diminished the illegal production of marijuana on national forest system lands.1 Given the high taxation on legal marijuana and demand for the drug in neighboring states, it is unlikely that this underground business will disappear.
Similarly, the applications for medical marijuana cards were expected to diminish with the passage of Amendment 64. Instead, Colorado's Medical Marijuana Registry reveals that the CDPHE's issuance of medical marijuana cards almost tripled between December 2009 and April 2014. A possible cause is the fact that marijuana dispensed for medicinal purposes is taxed at a lower rate than that purchased for recreational use.1
Proponents theorized that legalizing marijuana would reduce alcohol consumption in the state of Colorado. However, the data does not support that this is occurring. Alcohol consumption in Colorado is consistently above the U.S. average of gallons of alcohol consumed per year.1
When recreational marijuana became legal on January 1, 2014, a flood of consumers began to visit dispensaries. The proliferation of marijuana “edibles” surprised state officials and industry alike. Cookies, candies and drinks (e.g., “soda pot”) infused with THC became quickly popular, accounting for 45% of the legal marijuana marketplace. Unfortunately, of those new consumers, many were not aware of the potent THC content in edibles. Three deaths resulted. A 19-year-old college student, after consuming a marijuana-infused cookie, became agitated and jumped off a hotel balcony. An adult male Denverite shot and killed his wife after eating a THC-containing piece of candy. A 23-year-old skier visiting from out of state shot and killed himself after ingesting edibles. Hospital emergency rooms continue to treat children, adolescents and adults who develop paranoia, anxiety and/or psychosis following intentional or accidental exposure to these edibles. In addition to unpleasant psychiatric effects, more hospitals are treating chronic marijuana users for Cyclic Vomiting Syndrome, a cannabinoid-induced hyperemesis that has created a burden to the health-care system as it often leads to costly gastrointestinal workups and hospitalizations.1
THE PROLIFERATION OF MARIJUANA “EDIBLES” SURPRISED STATE OFFICIALS AND INDUSTRY ALIKE. COOKIES, C ANDIES AND DRINKS (E.G., “SODA POT”) INFUSED WITH THC BECAME QUICKLY POPULAR, ACCOUNTING FOR 45% OF THE LEGAL MARIJUANA MARKETPLACE.
The promise of large state tax revenues from the sale of marijuana may have served as an enticement for the legalization of marijuana. However, tax revenue from marijuana sales has fallen short of what was anticipated. In December 2014, state tax revenues received from marijuana sales were predicted to top $100 million but in reality were on pace for a little more than half that amount.24
Limitations in Marijuana Research
Clearly, the legalization of marijuana has increased the acceptability, accessibility and use of this drug, and it should be noted that some results from medicinal marijuana use appear to show promise. A few families, for example, have traveled to Colorado to legally obtain cannabidiol tinctures for their children who suffer from intractable epilepsy and, more specifically, Dravet Syndrome — and for some, the results have been encouraging. In a recent study of 19 children with epilepsy, two children experienced complete remission from seizures. Another eight children experienced a significant reduction in seizures and six experienced a reduction of 25% to 60% in their symptoms.8
While promising, however, this small sample size does not provide the kind of efficacy and safety data the FDA would demand before introducing a new drug to the public.
What is more common, and more troubling, is a general murkiness that can cloud scientific discovery when the availability of medicinal marijuana is exploited by recreational users and financial opportunists — as in the spike in diagnosis of “severe pain” among young men in Colorado between 2009 and 2014. Effective public health policy depends on accurate health reporting and scientific analysis — neither of which is possible when bad actors, whether they are patients or the physicians who treat them, are distorting health care decision-making for personal benefit.
THE PROMISE OF LARGE STATE TAX REVENUES FROM THE SALE OF MARIJUANA MAY HAVE SERVED AS AN ENTICEMENT FOR THE LEGALIZATION OF MARIJUANA. HOWEVER, TAX REVENUE FROM MARIJUANA SALES HAS FALLEN SHORT OF WHAT WAS ANTICIPATED.
It is ironic that at a time when we are emphasizing evidence-based medicine and conducting vigorous smoking cessation campaigns, marijuana is being promoted — despite the known health hazards, such as pulmonary disease, vascular complications, neurotoxicity to the developing brain, cognitive deficits in adults, addiction and other psychiatric problems, including psychosis.8
While the Institute of Medicine's 2003 authoritative report identifies potential benefits of marijuana related to its anti-inflammatory, antiemetic, antispasmodic and analgesic properties, in addition to its ability to lower intraocular pressure, studies conducted in the past had several limitations. Research on the use of marijuana for medical purposes is lacking, partly because it is currently classified as a Schedule I drug, making it virtually impossible to conduct the randomized, double-blind, placebo-controlled prospective studies that are normally employed to assess efficacy and safety. Studies thus far have been retrospective in nature with small subject numbers. Differing cannabinoid concentrations, differing exclusion criteria and confounding variables limit the reliability of earlier study outcomes.8 ,11 ,14 ,25
IT IS IRONIC THAT AT A TIME WHEN WE ARE EMPHASIZING EVIDENCE-BASED MEDICINE AND CONDUCTING VIGOROUS SMOKING CESSATION C AMPAIGNS, MARIJUANA IS BEING PROMOTED — DESPITE THE KNOWN HEALTH HAZARDS.
Complicating matters, the THC potency, as measured in marijuana obtained through interdiction seizures, has steadily increased from approximately 3% in the 1980s to 12% or higher in 2014. Thus, the marijuana available today may be associated with more hazards than previous studies reflect.
In short, for medical professionals and public health officials, we are clearly putting the cart before the horse in terms of public policy and our ability to provide the most accurate scientific information about any associated health risks or benefits related to marijuana use.
Federal and State Marijuana Laws: A Complication for Regulators
Complicating matters is the fact that marijuana remains illegal under federal law. While the Obama administration recently indicated in 2013 that it would not challenge laws legalizing marijuana in Colorado, inherent conflicts remain between the states and the federal government. At Denver unemployment offices, for example, medical marijuana users have lost their jobs after failing drug testing. Marijuana has been confiscated from medical marijuana users at border patrol check points. Individuals who have federal rent subsidies are being revoked of this benefit for using marijuana. Federally insured banks are reluctant to provide accounts to those working in the marijuana industry because of the drug's illegality under U.S. law. Medical marijuana users encounter difficulties at airport security check points because baggage screeners employed by the federal Transportation Security Administration turn marijuana carriers over to local police for prosecution. While the Justice Department ordinarily does not prosecute medical marijuana users, other federal agencies have been instructed to treat any marijuana as an illegal drug.26
What Path Forward for Regulators?
All of this creates great challenges for state medical boards. If public health and safety is potentially impacted by marijuana use, how can regulators ensure that the actions of licensees are not contributing to public harm? How do regulators ensure the safety of patients when much-needed, large-scale research is lacking, and when, at the same time, public opinion seems to be colliding with the medical evidence we currently have? How do regulators best navigate the conflict between state and federal laws? As more states move in the direction of legalizing marijuana for medicinal purposes, we can anticipate more patients inquiring about its risks and benefits — and in the current atmosphere it is likely they will receive conflicting advice. This will create difficulty in making judgments about medical competence.
IF PUBLIC HEALTH AND SAFETY IS POTENTIALLY IMPACTED BY MARIJUANA USE, HOW CAN REGULATORS ENSURE THAT THE ACTIONS OF LICENSEES ARE NOT CONTRIBUTING TO PUBLIC HARM?
We can also anticipate more patients requesting marijuana for treatment, and regulators in medical marijuana states should consider identifying a core set of practices to guide physicians as prescribing continues to increase. For physicians choosing to recommend marijuana for medicinal purposes, it should only be done in the context of a patient-physician relationship that includes regular follow up and reassessment. Physicians should also:
Obtain a thorough clinical history and any needed laboratory evaluation before making a recommendation for marijuana.
Provide informed consent based on the most current literature available about the benefits, risks and alternative treatments to marijuana.
Maintain a chart on every patient and have regular follow up with the patient to monitor progress and identify any unintended consequences or side effects from the marijuana treatment.
Recommend a patient not drive or operate machinery when under the influence of the drug to avoid accidents.
Caution patients to keep their marijuana in a secure place to reduce the risk of child and adolescent exposures.
Screen for contraindications. Any physician recommending marijuana for medicinal purposes should be able to diagnose substance use disorders and recognize mental illnesses that have the potential to be aggravated by the use of marijuana.
Stay abreast of advancing science and adjust practice accordingly.
Check with their malpractice carrier to make sure they are covered adequately for this practice.
Conclusion
The CDPHE has established a Medical Marijuana Scientific Advisory Council in an effort to gather new scientific evidence about marijuana. Grants will be awarded to seasoned researchers in Colorado and other states with the hope of delineating more sharply the benefits and risks associated with its use. Until then, other states facing legislative efforts to legalize marijuana should consider Colorado's experience as a cautionary tale. Approving medical treatments by ballot initiatives sets a dangerous precedent for public health. This will be, by far, one of the great social experiments of the century.
About the Author
↵Doris C. Gundersen, MD, is an Assistant Clinical Professor in the Department of Psychiatry, University of Colorado Health Sciences Center. She also serves as the President of the Federation of State Physician Health Programs.
- Copyright 2015 Federation of State Medical Boards. All Rights Reserved.
References
- 1.↵Rocky Mountain High Intensity Drug Trafficking Area (RMHIDTA) Investigative Support Center, “The Legalization of Marijuana in Colorado: The Impact,” Volume 2, August2014.
- 2.The American Lung Association, “Marijuana and Lung Health,” March 23, 2015. [Online]. Available at: http://www.lung.org/stop-smoking/about-smoking/healtheffects/marijuana-smoke.html.
- 3.↵Richter KP , LevyS. Big Marijuana — Lessons from Big Tobacco New England Journal of Medicine 371;5, July31, 2014.
- 4.Calabria B , DegenhartdtL, HallW, LynskeyM. Does cannabis use increase the risk of death? Systematic review of epidemiological evidence on adverse effects of cannabis use. Drug Alcohol Rev2010, 29:318–30.
- 5.Hall W , RoomR, BondyS. Comparing the health and psychological risks of alcohol, cannabis, nicotine and opiate use. InKalantH, CorriganW, HallW, SmartR(Ed). The health effects of cannabis (pp475–506) Toronto: Addiction Research Foundation.
- 6.Milmore BK , ConoverAG. Tobacco consumption in the United States, 1880 to 1955. Public Health Monogram1956;45: 107–11.
- 7.McLaren J , SwiftW, DillonP, AllsopS. Cannabis potency and contamination; a review of the literature. Addiction2008; 103:1100–9.
- 8.↵Volkow ND , BalerRD, ComptonWM, WeissSRB. Adverse Health Effects of Marijuana Use, New England Journal of Medicine370;23June5, 2014.
- 9.Lutge EE , GrayA, SiegfriedN. The Medical Use of Cannabis for Reducing Morbidity and Mortality in Patients with HIV/AIDS. Cochrane Database Syst Rev2013.
- 10.Wilsey B , MarcotteT, TsodikovA, et al. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain2008; 9:506–21.
- 11.↵Wallace M , SchulteisG, AtkinsonJH, et al. Dose-dependent effects of smoked cannabis on capsaicin-induced pain and hyperalgesia in healthy volunteers. Anesthesiology2007;107:785–96.
- 12.↵Esposito G , FilippisDD, CirilloC, et al. Cannabidiol in inflammatory bowel disease: a brief overview. Phytother Res2013;5:633–6.
- 13.Hill TD , CascioMG, RomanoB, et al. Cannabidivarin-rich cannabis extracts are anticonvulsant in mouse and rat via a CB1 receptor-independent mechanism. Br J Pharmacol2013;170:679–92.
- 14.↵Nussbaum AM , BoyerJA, KondradEC, “But my Doctor Recommended Pot”: Medical Marijuana and the Patient-Physician Relationship, J Gen Intern Med, August24, 2011[Online]. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3208453/.
- 15.
- 16.Bates J. Teen Cannabis Use Predicts Depression. Clinical Psychiatry News, 38(2):1. 2010.
- 17.Campbell F , et al. Cannabinoids for Control of Chemotherapy Induced Nausea and Vomiting: Quantitative Systematic Review, British Medical Journal, 323(16). 2001.
- 18.Cohen M , et al. Cannabis, Cannabinoids and Schizophrenia: Integration of the Evidence. Australian and New Zealand Journal of Psychiatry, 42(5):357–368. 2008.
- 19.Ellis R , et al. Smoked Medicinal Cannabis for Neuropathic Pain in HIV: A Randomized, Crossover Clinical Trial. Neuropsychopharmacology, 34(6) 672–680. 2002.
- 20.Gfroerer JC , et al. Initiation of Marijuana Use: Trends, Patterns, and Implications. Department of Health and Human Services. Substance Abuse and Mental Health Services Administration Office of Applied Studies. (Analytic Series: A-17, DHHS Publication No. SMA 02-3711). 2002.
- 21.Moran, M. Cannabis Use, Psychosis Symptoms Show Strong Link. Psychiatry News, 45(10):21. 2010.
- 22.United States Department of Transportation Fact Sheet on Cannabis. Does Marijuana Use Significantly Impair Driving Ability Even When Not Under the Immediate Effects of the Drug? [Online]. Available at: http://medicalmarijuana.procon.org.
- 23.↵Gundersen DC. “Medical Marijuana — A Prescription for Trouble?” Newsletter of the Colorado Physician Health Program, Volume 9, Issue I, 2010.
- 24.↵Marijuana Policy Group. Market Size and Demand for Marijuana in Colorado. A study for the Colorado Department of Revenue, National Survey on Drug Use and Health, marillow.com, Colorado Department of Revenue.
- 25.↵Institute of Medicine. Marijuana and Medicine: Assessing the Science Bases. [Online]. Available at: www.com.edu/REPORTS/2003/Marijuana-and-Medicine.
- 26.
