Every day, healthcare providers across therapeutic specialties are being asked about the use of cannabis as an alternative treatment option or in addition to traditional therapies. In many cases, these providers are discussing cannabidiol (CBD) or medical marijuana without complete knowledge of the risks and benefits.1,2 The plethora of unregulated CBD products and the proliferation of medical marijuana laws driven by legislatures - not healthcare professionals - contributes to this issue. But in reality, there is a significant dearth in randomized, placebo-controlled clinical research of cannabis-derived products…data that are demanded of any other drug therapy.
Complicating this issue is the fact that many patients aren’t aware that CBD products and medical marijuana are not regulated at a federal level by the U.S. Food and Drug Administration (FDA). For example, a recent survey by the Consumer Brands Association found that an overwhelming majority (92%) of Americans incorrectly assume or do not know that CBD is not federally regulated.3 This puts a bigger burden on all healthcare providers, including medical doctors, advanced practice providers, and pharmacists. All providers need to be prepared to offer honest, scientifically informed advice, along with potential risks; currently they are being asked to do that with medical marijuana without the data to support these recommendations.
States with medical marijuana laws have created medical cannabis certification programs that authorize a healthcare provider to recommend state-regulated dispensary medical cannabis products for any ailment that a state law has deemed as treatable with cannabis. Unlike FDA-approved formulations, these certifications, as well as state laws, provide no specifications as to what type of cannabis-derived products should be used, at what dose, nor for how long. It also doesn’t advise on safety monitoring of side effects nor drug-drug interactions. These data simply don’t exist. This simple difference in terminology, recommend vs prescribe, also allows for dispensary staff to interchange products based on “experience” or patient preference without consideration of medical history, potential drug interactions, and other risk factors…all without any obligation to consult with the healthcare provider who is overseeing the care of this patient.4,5
The FDA approval process allows healthcare providers to have an innate trust in the medicines they prescribe. Drug manufacturing and development is a rigorous, step-by-step process. Without appropriate oversight, regulations, and inspections, one can imagine the inconsistencies that can occur in every part of the process. That is the current situation with non-FDA approved cannabis-based products. There is no standard federal testing, dose labeling or consistency requirements, nor a requirement for placebo-controlled clinical trials to evaluate efficacy and safety. This leaves the possibility that a patient receives a different product at every purchase, with unknown quantities of active ingredient, unknown potential drug interactions, and unknown contaminants.6,7,8,9
Healthcare providers should be aware of professional medical society positions (see Table 1) on the medical use and recommendation of cannabis-based products. While not always by choice, all healthcare providers find themselves on the front lines of this issue. Given the obligation to do no harm, healthcare providers must demand more regulations and protections along with randomized, placebo-controlled clinical data to substantiate the benefits versus risks before making any recommendations.10
Table 1: Examples of Medical Society Positions on Marijuana and Cannabinoids
|
Society |
Position |
| American Medical Association (AMA) |
“The AMA believes that scientifically valid and well-controlled clinical trials conducted under federal investigational new drug applications are necessary to assess the safety and effectiveness of all new drugs, including potential cannabis and cannabinoid products for medical use. Due to legal and regulatory barriers to cannabis and cannabinoid research, physicians and patients do not currently have the evidence needed to understand the health effects of these products and make sound clinical decisions regarding their use.”11 Read the entire statement here |
| American Association of Pediatrics (AAP) |
“Ultimately, the behavioral and health risks associated with marijuana use by youth should be the most salient criteria in determining whether policies that are enacted are effective in minimizing harm.” Of their 10 recommendations, these cover the use of “medical marijuana”: 2. The AAP opposes “medical marijuana” outside the regulatory process of the US Food and Drug Administration. Notwithstanding this opposition to use, the AAP recognizes that marijuana may currently be an option for cannabinoid administration for children with life-limiting or severely debilitating conditions and for whom current therapies are inadequate. 5. The AAP strongly supports research and development of pharmaceutical cannabinoids and supports a review of policies promoting research on the medical use of these compounds. The AAP recommends changing marijuana from a Drug Enforcement Administration Schedule I to a Schedule II drug to facilitate this research.12 Read all 10 recommendations here |
| American Academy of Family Physicians (AAFP) |
“Family physicians have a vested interest in policies that advance and protect the health of their patients and the public. The regulatory environment surrounding cannabis, medical and recreational marijuana, and cannabidiol (CBD) is rapidly changing, along with the retail environment. This shift has not been accompanied by robust scientific research regarding the health effects of cannabis, both therapeutic or detrimental. The AAFP recognizes the need for substantial clinical, public health, and policy evidence and research regarding cannabis, marijuana, cannabinoids, and CBD to inform evidence-based practice and the impact on public health.”13 Read the entire statement here |
| American Association of Neurology (AAN) |
“The AAN does not support or advocate for the legalization of medical marijuana for use in neurologic disorders at this time as further research is required to determine the safety and potential benefits of such products.” “The AAN recommends that each product and formulation of cannabis used in treating medical conditions demonstrate safety and efficacy via scientific study similar to the process required by the Food and Drug Administration (FDA) for the approval of any drug.”14 Read the entire statement here |
| American Psychiatric Association (APA) |
“There is no current scientific evidence that cannabis is in any way beneficial for the treatment of any psychiatric disorder. In contrast, current evidence supports, at minimum, a strong association of cannabis use with the onset of psychiatric disorders. Adolescents are particularly vulnerable to harm, given the effects of cannabis on neurological development.”15 Read the entire statement here |
References
1Morris NP. Educating Physicians About Marijuana. JAMA Intern Med. 2019;179(8):1017–1018.
2“Survey Identifies Gaps in Physician Knowledge About Cannabis and Cannabinoids.” Rare Neurological Disease Special Report, Supplement to Neurology Reviews. 2020 Mar. pg 56-57.
3Consumer Brands Association, “The Urgent Need for CBD Clarity,” Page 1. Available at https://consumerbrandsassociation.org/research/ Accessed February 11, 2020.
4Haug, Nancy A. et al. “Training and Practices of Cannabis Dispensary Staff.” Cannabis and Cannabinoid Research Volume 1.1, 2016. DOI: 10.1089/can.2016.0024.
5Peiper, Nicholas et al. “Medical Decision-Making Processes and Online Behaviors Among Cannabis Dispensary Staff.” Substance Abuse: Research and Treatment. Volume 11: 1–9. 2017.
6Bonn-Miller MO, Loflin MJE, Thomas BF, Marcu JP, Hyke T, Vandrey R. Labeling accuracy of cannabidiol extracts sold online. JAMA. 2017;318(17):1708-1709
7Vandrey R, Raber JC, Raber ME, Douglass B, Miller C, Bonn-Miller MO. Cannabinoid Dose and Label Accuracy in Edible Medical Cannabis Products. JAMA. 2015;313(24):2491–2493.
8Clean Label Project: CBD. Available at https://www.cleanlabelproject.org/cbd/. Accessed March 19, 2020.
9Legit Script “Online CBD Sales: Why It’s Still Buyer Beware” Oct 2019
10Caputi TL “The Medical Marijuana Industry and the Use of “Research as Marketing.” AJPH. 2020 Feb: 110(2):174-175.
11AMA Statement by Dr. Patrice A. Harris “AMA applauds Surgeon General’s advisory on cannabis” August 29, 2019 https://www.ama-assn.org/press-center/ama-statements/ama-applauds-surgeon-general-s-advisory-cannabis (Sourced March 19, 2020)
12Ammerman S et al. “The impact of marijuana policies on youth: clinical, research, and legal update.” Pediatrics. 2015 Mar;135(3):e769-85.
13American Academy of Family Physicians: Policies. Available at https://www.aafp.org/about/policies/all/marijuana-cannabinoids.html. Accessed March 20, 2020.
14AAN Position Statement: Medical Marijuana. Available at https://www.aan.com/policy-and-guidelines/policy/position-statements/medical-marijuana/. Accessed March 19,2020.
15APA Official Actions “Position Statement in Opposition to Cannabis as Medicine” Approved by the Board of Trustees, July 2019 Available at: https://www.psychiatry.org/File%20Library/About-APA/Organization-Documents-Policies/Policies/Position-Cannabis-as-Medicine.pdf. Accessed March 19,2020.
