As the relaxing, calming medicinal effects of CBD wins it the heart of many, there’s an avalanche of research on its overall medical implications and unearthing new grounds for its optimal benefits. However, efforts to conduct this research are being frustrated by barriers to CBD research. Often, this has a tremendous effect on medication prices, and may sometimes discourage patronage and CBD use.
So, what are these barriers?
First, investigators seeking to conduct on cannabis or CBD research must embark on a series of review processes that may involve the National Institute on Drug Abuse (NIDA), the U.S. Food and Drug Administration (FDA), the U.S. Drug Enforcement Administration (DEA), institutional review boards, offices or departments in state government, state boards of medical examiners, the researcher’s home institution, and potential funders. For example, researchers conducting clinical research on cannabis must submit an investigational new drug (IND) application to the FDA.
Next, the investigator may contact NIDA, to obtain an administrative letter of authorization (LOA), which describes the manufacturer’s facilities, as well as the availability and pertinent characteristics of the desired cannabis product (e.g., strains, quality, strength, pharmacology, toxicology). To safeguard against the acquisition of cannabis or cannabinoids for non-research purposes, investigators must apply for a DEA registration and site licensure before conducting studies involving cannabis.
Also, the classification of cannabis under the Controlled Substances Act of 1970 as a Schedule I substance represents a huge regulatory barrier. As defined by the Act, Schedule I substances are those that (1) have a high potential for abuse; (2) have no currently accepted medical use in treatment in the United States; and (3) have a lack of accepted safety for their use under medical supervision.
Population studies on the health effects of cannabis require a detailed ascertainment of exposure to cannabis to arrive at valid and meaningful results. However, obtaining such a detailed exposure history can be difficult. This is especially true for recreational cannabis use due to the lack of a standardized dose and the existence of diverse routes of administration, including multiple modes of inhalation.This is why most observational studies, particularly case-control and cohort studies, depend on self-report to assess cannabis exposure. These reports may be incomplete, inaccurate, or imprecise due to failure on the part of investigators to ask cannabis users detailed questions about their cannabis exposure history and source of their cannabis exposure.
It may also be because users themselves may have limited knowledge of some aspects of their exposure or may be resistant to reporting some information. Personal recall of substance use may also be affected by other factors. For example, memory problems have been identified as a cause of inaccuracies in reporting drug use. In other cases, study participants may not report illicit substance use to conform to perceived social norms. Similarly, individuals with substance dependency syndromes may have psychiatric comorbidity that affects the accuracy of reporting.
Drug Delivery Challenges
Studies suggest barriers posed by the identification of a method of administering the drug that is accepted by study participants, can be performed at most research sites and ensures standardized dosing. For instance, smoking as a route of administration is particularly challenging, as some study participants may not view it as an acceptable drug administration method.
Also, academic medical centers or other locations where cannabis or cannabinoid research takes place may lack facilities where study participants can smoke under controlled conditions. Furthermore, variations among individuals in terms of their cannabis smoking techniques make it difficult to ensure that study participants reliably receive the drug’s targeted dose. Notably, devices for providing a metered cannabis dose via inhalation exist, but the FDA has not approved such devices for use. Similarly, standardized smoking techniques have also been developed but can be challenging to perform correctly. These difficulties may be partly attributed to differences among individuals in their tolerance of the drug’s potential psychoactive effects.
Barriers to Cannabis Supply
In the United States, cannabis for research purposes is available only through the NIDA Drug Supply Program. NIDA’s mission is to “advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health” rather than to pursue or support research into the potential therapeutic uses of cannabis or any other drugs. This is why less than one-fifth of cannabinoid research funded by NIDA in the fiscal year 2015 concerns the therapeutic properties of cannabinoids.
Due to NIDA’s funding of the majority of all the National Institutes of Health (NIH) sponsored cannabinoid research in the fiscal year 2015, its focus on the consequences of drug use and addiction constitutes an impediment to research on the potential beneficial health effects of cannabis and cannabinoids. Worse, all of the cannabis that NIDA provides to investigators is sourced from the University of Mississippi, which is currently the sole cultivator of the plant material. It has been since 1968.
Because of restrictions on production and vicissitudes in supply and demand, federally produced cannabis may have been harvested years earlier and stored in a freezer (a process that may affect the quality of the product). It is difficult for a single facility at the University of Mississippi to replicate the array and potency of products available in dispensaries across the country.
Funding for research is another critical barrier. Where there’s no adequate financial support, cannabis research will be unable to inform health care or public health practice or to keep pace with changes in cannabis policy and patterns of cannabis use. NIH is responsible for funding research across several health domains. In 2015, NIH spending on all cannabinoid research totaled $111,275,219.
NIDA is a member institute of NIH and its mission to study factors related to substance abuse and dependence and conducts research on the adverse health effects and behavioral consequences associated with the abuse of cannabis and other drugs. So, as cannabis was historically perceived to have only negative effects, most CBD research was conducted under the auspices of NIDA. This constitutes a barrier and de-incentivizes CBD research.
In the end, an appraisal of the highlighted barriers will show that they echo their respective solutions. Although some barriers are being lifted already, it is suggested that stakeholders and concerned persons should make concerted efforts to ease them. This will help normalize medication prices, and to a large extent, incentivize channels for medical inquiry on CBD.