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By: Robert G. Bell

bell-headshotLast week, the Health and Medicines Division (HMD), formerly the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering and Medicine, released their report “The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research (2017),” which entails a comprehensive review of the literature (>10,000 citations reviewed) regarding the health effects and potential therapeutic uses of cannabis and its constituents on 11 groups of health outcomes.  These 11 health outcomes groups include many of the topics discussed in previous High Hopes or Smoke and Mirrors posts such as the pharmacologic/therapeutic effects, cancer, cardiometabolic risk, respiratory disease, immunity, injury and death, pre-, peri-, and post-natal exposure, psychosocial, mental health, problem use, and abuse. The HMD report is an excellent discussion of  marijuana’s history, pharmacology, current regulations, therapeutic use, safety, use, and abuse. The report indicates there is conclusive or substantial evidence that cannabis or cannabinoids are effective in the treatments of:

And there is moderate evidence for improving short term sleep outcomes.

The report authors formulated four recommendations to address marijuana research gaps, improve research quality, improve surveillance, and improve research barriers. These recommendations include:

  • Developing a comprehensive long and short term evidence base and funding mechanisms for short and long term safety assessment of marijuana and its constituents that examine both beneficial and harmful effects of cannabis.
  • Develop a workshop to develop a set of research standards and benchmarks to guide and ensure the production of high-quality cannabis research.
  • Collect and disseminate the appropriate cannabis short and long term safety (and efficacy) data.
  • Establish a committee of experts tasked to characterize the regulatory barriers to cannabis research and propose strategies for supporting resources and infrastructure needed for a comprehensive cannabis agenda.

In order to establish this data base, regulatory barriers associated with marijuana research need to be addressed. The Drug Enforcement Adminibellstration (DEA) classifies cannabis as a schedule 1 substance, having no currently accepted medical use and a high potential for abuse. The additional regulatory requirements associated with schedule 1 substance research can be prohibitive for researchers and clinicians. In addition, there is a dire need for cannabis standards and standardized validated analytical methods to ensure the quality and consistency of cannabis products. Although marijuana can be abused, the report clearly identifies medical uses for marijuana, which should allow the DEA to reschedule cannabis as a schedule 2 or schedule 3 product as is Marinol (synthetic THC) which is listed as a DEA schedule 3 substance.

I am in agreement with many of the recommendations and suggestions put forth in the HMD/IOM’s Health Effects of Cannabis and Cannabinoids report, and AAPS should try to participate in the planned workshop and committee. However, I am not in agreement with the conclusions reached in the report regarding cannabis-related health risks and abuse.

The authors conclude there is moderate evidence of no statistical association between cannabis use and the incidence of lung or head and neck cancers or asthma. Regardless of the literature’s lack of evidence, it is my opinion that if you are smoking marijuana, the same adverse effects associated with tobacco use will be associated with marijuana use, which include lung, neck, and head cancers. In addition, we are starting to see increases of uncommon disease states in marijuana users such as takotsubo syndrome (stress cardiomyopathy) and cannabinoid hyperemesis syndrome as marijuana use expands—about 22.2 million American adults have used marijuana in the last month. The committee does point out that driving under the influence of cannabis “increases the risk of being involved in a motor vehicle accident” and cited evidence that increasing numbers of young children may be accidentally ingesting marijuana products now, particularly in states where cannabis use is legal. These are serious issues that need to be addressed.

The authors also conclude that there is moderate evidence of a statistical association between cannabis use and the development of substance dependence or abuse disorder and limited evidence of changes in the rates and use patterns of licit and illicit substances. In my professional experience of developing therapies for addiction as well as personal experiences of losing loved ones to drugs, marijuana was always part of the path or “gateway” to drug addiction—ask any addict. So regardless of the lack of published statistical association of cannabis use and effects on health, there are adverse health effects and the potential for abuse that can lead to other forms of health issues, drug abuse, and addiction that should not be minimized.

One other issue that has not been addressed—how long should one use marijuana? Usually pharmacotherapies with the possibility for dependence are limited in their duration of use, from days to weeks, to possibly several months. However, the use of marijuana has no dosing guidelines or dose response and is typically used ad libitum on a continual basis. This causal use of marijuana can become continual and dependence tends to follow.

The HMD/IOM’s report manages to cut through most of the smoke and haze associated with the current state of cannabis research in the United States; however, conclusive evidence about its positive and negative medical effects is scant. Even though marijuana has been with us over 5,000 years, there is so much more that needs to be done regarding elucidating the many properties of this ancient medicinal plant. Stay tuned!

Robert G. Bell, Ph.D., is president and owner of Drug and Biotechnology Development LLC, a consultancy to the pharmaceutical industry and academia for biological, drug, and device development.