Roadblocks to Cannabis Research


The legalization of cannabis has been an issue of great debate in recent decades. With medical legalization now widespread throughout the United States, one is left to ponder the future of the new industry surrounding cannabis and the future of cannabis medical applications. However, with a growing number of states choosing to legalize the use of medical cannabis, research restrictions under current laws must change to accommodate a rapid shift in pharmacological interventions toward cannabis products. As such, federal restrictions at Schedule I control must change to allow the efficiency of scientific research concerning such drugs. This proposal intends to advocate for legislative change concerning Schedule I research controls at the federal level.

History  

With a history of use reaching as far back as 2737 B.C.E., cannabis has seen a robust history of relatively safe human consumption (Brecher, 1972; Holland 2010; Rtsch, 2005). However, due to special interest groups and minority stigmatization, cannabis came under governmental scrutiny in the years succeeding the prohibition of alcohol (Brecher, 1972). By 1937, the first prohibitory regulations were established (Brecher, 1972). Over the years, cannabis regulations continued to evolve, to the point that cannabis is currently scheduled under priority control under Schedule I of the Controlled Substances Act of 1971 (U.S. Drug Enforcement Agency, 2020).

Schedule I Research 

Under current regulations, researchers who wish to study cannabis, or any other controlled substance under Schedule I must obtained a registration issued by the DEA (U.S. Drug Enforcement Administration, 2020). This process includes the issue of a registration number that must be assigned to every handler of the controlled substance to be studied, including the manufacturer and the researchers. Thus, multiple parties must coordinate with the DEA in order for Schedule I research to be conducted legitimately. Such includes any importer, exporter, manufacturer, distributor, pharmacy, and researcher (U.S. Drug Enforcement Administration, 2020). According to the DEA, “This number must be made available to the supplier by the customer prior to the purchase of a controlled substance, and its validity can be verified online through the Diversion Control Division website at www.DEAdiversion.usdoj. gov. Thus, the opportunity for unauthorized transactions is greatly diminished” (U.S. Drug Enforcement Administration, 2020, p. 11).

Federal scheduling poses strict obstacles that stand in the way of scientific research concerning any substance listed under Schedule I of the Controlled Substances Act. Such obstacles are touched upon by Rick Strassman (1991), who describes the daunting process of working under Schedule I licensing, as required by the DEA, “One will need to deal with at least two federal agencies in the application process: the DEA and the FDA. At times, their responsibilities overlap in vague and poorly defined ways. (p. 33)”

One should note that Strassman’s work focused on research into the physiological effects of DMT; rather than cannabis (Strassman 2001). Nevertheless, both cannabis and DMT are subject to the same prohibitory controls under Schedule I (U.S. Drug Enforcement Administration (2020). However, Schedule II of the Controlled Substances Act is less restrictive, yet also lists drugs of high potential for abuse, such as cocaine (U.S. Drug Enforcement Administration, 2020). The primary contrast between Schedule I and schedule II is that the former lacks any currently accepted medical value, whereas drugs classified under the latter have some accepted medical application (U.S. Drug Enforcement Administration, 2020). Of course, establishing medical value requires extensive research that the DEA heavily restricts.

David Nutt, a pharmacologist and researcher has authored and co-authored several books and papers concerning international drug policy. Nutt et al. (2013) highlight how even a minuscule shift in scheduling can allow researchers the flexibility to make scientific progress concerning controlled chemicals, “In the United States, simply moving these substances from Schedule I to Schedule II would make them much more accessible for research. (p. 583)”

Perhaps nobody can speak of DEA research restrictions than the late Alexander Schulgin, a chemist who had worked alongside law enforcement while simultaneously conducting research concerning Schedule I drugs and their analogs. Critical of the barriers to research, Shulgin and Shulgin (1997) write,

In an effort to facilitate law enforcement, and in the pursuit of an ideal of rational social behavior, we have allowed laws to be passed which have robbed us of our freedom to inquire. To accept these laws without argument and without protest means not only a further loss of our integrity but also a continuing loss of essential information to the scientific community and society at large. (p. 358)

Research Stigma

Alas, the frustrations of researchers working to study the psychological and physiological effects of controlled substances, such as cannabis, can be heard throughout the halls of academic conferences concerned with such issues. According to Rick Doblin (2018), founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), research concerning cannabis is stigmatized more than research concerning other controlled substances, such as psilocybin and MDMA.

MDMA is in phase three clinical trials to treat post-traumatic stress disorder (U.S. Library of Medicine, 2020). However, cannabis is lagging far behind, as little progress has been made regarding FDA approval of cannabis (Mead, 2019). Moreover, the recent approval of ketamine (a psychedelic dissociative) for treating major depressive disorder speaks to the lack of consideration of cannabis as a valuable pharmacologic intervention. Ironically, a pilot survey conducted by the author showed that college students are less likely to report the use of psychedelic drugs than cannabis, though results from this survey are preliminary (Teets, 2021). Such highlights the ongoing and longstanding stigmatization of cannabis, even when placed alongside drugs with significantly stronger experiential effects. A touch of irony, considering the widespread social acceptance of cannabis use for medical and recreational purposes.

Schedule I poses an issue that transcends the opinions concerned with casual use and the right of adults to have total bodily autonomy. Without research, little progress can be made to expand the body of knowledge concerning the potential benefits and dangers of psychoactive drugs. Moreover, as of December 2020, thirty-six states have chosen to accept the legalization of cannabis for medical purposes (Newman et al., 2021). With such a shift in social attitudes toward legalization at the state level, changes at the federal level are needed to allow researchers the freedom to investigate the pharmacological properties and applications of the phytochemical constituents of cannabis.

A Lack of Scientific Confirmation  

With purported applications, including everything from pain management to Alzheimer’s dementia, cannabis appears to be emerging as a modern “cure-all” (Holland, 2010). It should require no citation to address the rich history of unfounded medicine that plagued Victorian markets of the nineteenth century (Weatherall, 1996). The fact of the matter is that rigorous scientific evaluation is needed to assess the potential harms and benefits of cannabis and other Schedule I drugs, evaluations that the current legislative framework all but prohibits. 

Addressing the current structure of such legislative frameworks concerning research under Schedule I, Nut et al. (2013) point to the impracticality of such regulations stating, “Governments maintain that current drug regulations do not prevent research because people have the opportunity to obtain licenses. In practice, however, there has been a de facto ban on research into many psychoactive drugs over the past 50 years. (p. 583)” 

The benefits of potential cannabis legalization at the federal level are vast. Such include economic benefits resulting from taxation; others include the availability of novel treatments for various conditions (Newman et al., 2021). However, one of the most important benefits of legalizing cannabis is that scientific research can be conducted to evaluate the truly effective applications of cannabis products. Without a robust body of knowledge acquired under scientific scrutiny, the true potential of cannabis will go unknown, reducing the emerging medical cannabis industry to that of a Victorian market of unconfirmed treatments and cures. As such, efforts to amend current statutes that restrict research under Schedule I should prioritize exemptions for professional research. Additionally, researchers may benefit from dedicating their voices as scientists to inform legislators of the importance of research concerning controlled substances.

Conclusion

Scientific research should go unhindered by excessive regulatory measures, so long as ethical research methods are adhered to according to laws concerning the treatment of human participants and animal subjects. Moreover, prohibitory legislation should make exceptions for research concerning the substances they elect to ban. The excessive research restrictions under Schedule I only hinder scientific progress, as drugs such as cocaine are effectively prohibited under Schedule II without excessive restrictions for professional researchers. As such, a reasonable prohibitory framework may limit restrictions to that of Schedule II of the Controlled Substances Act.


Page Author: Ryan M. Teets (2022)