Why is Research into Marijuana's Potential Therapeutic Effects so Hard?
Lets dive into the road blocks the government puts up in order to conduct basic, clinical and population health research into cannabis. If you want more on the history of marijuana regulation there is article on this site. If you would like a little info on common facts and myths go the article prior to this one.
There are many MANY hoops one has to jump through in order to conduct research into cannabis due to it being scheduled as a class 1 substance. This includes but is not limited to review processes of 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.
If you want to conduct clinical research on biological products you must submit an investigational new drug (IND) application to the FDA, The next step includes the possible contacting of NIDA, a source for research-grade cannabis in order to obtain an administrative letter of authorization (LOA). An LOA gives all kinds of details about the manufacturers facilities and their products. If you want to conduct research you would also have to, “apply for a DEA registration and site licensure before conducting studies involving cannabis or any of its cannabinoid constituents, irrespective of their pharmacologic activity.” You must also submit research protocol as well to the DEA including where the substance is stored and how it is stored for safety measures.
In states like Alabama or California, extra certifications and approvals may be needed for clinical research.
On top of the aforementioned barriers, gaining NIDA approved product to conduct research with is a huge challenge. A researcher MUST get the drug from NIDA, which is solely sourced from Mississippi University and has been since 1968. I would really like to know a giant WHY and what the heck when it comes to this fact. NIDA stores weed for long durations of time by freezing it which may diminish the quality and potency. It has been proven in the past that the limited varieties of marijuana available through NIDA were not comparable in potency to that which can be procured from dispensaries rendering it insufficient for adequate research.
Assuming NIDA does have the proper product needed for research, their goal is not to determine if marijuana can be used for the wealth of medical purposes some research has alluded to, but instead to, “advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health.” As a result, less than one-fifth of funding from NIDA in 2015 has gone towards concerns about the therapeutic properties of cannabinoids.
Fun Fact # 7 The War of 1812 was fought over hemp. Napoleon wanted to cut off Moscow’s export to England. (Jack Herer. Emperor Wears No Clothes.)
Funding poses another barrier as the bulk of research is funded from outside grants. The organization that provides the most funding is the National Health Institute (NIH). NIDA is a member institute of the NIH and because NIDA’s view on cannabis are that of negative health effects and not therapeutic ones, that is where the bulk of the available funds go. In 2015, ~111 million dollars was spent on cannabinoid research with 59.3% or ~66 million of the research funds supported by NIDA and only 16.5 percent or 11 million of that, going towards investigating therapeutic effects of cannabinoids.
The last barrier in investigating cannabis scientifically that I want to discuss is drug delivery. The primary delivery of cannabis is smoking it which poses a lot of challenges including, cannabis smoking techniques, dosage, and diversity of tolerance among participants. These are things that when investigating scientifically, must be controlled to a T. There are devices for giving metered doses, but the FDA has not approved devices for use. Researchers have explored vaporization as a method of introduction, however the research on this matter is scarce causing further research to remain stagnant due to apprehension and lack of data pertaining to pulmonary effects of inhalation of plant material.
Other Barriers the exist but are not discussed:
- Placebo effect
- Exposure Assessment
- Cannabis-Related Study Designs
Due to the regulatory, financial, access, and methodological challenges, comprehensive research into the potential health effects of cannabis use are at a stand still. Because of the lack of available data and knowledge we put our population at risk. On one hand this plant can be a health hazard and states are legalizing it regardless, therefore we need adequate research to prove anti-marijuana stances. On the other hand this can be an amazing alternative to many pharmacological drugs that can reap havoc on ones body. We have a responsibility to the public and to science to allow proper research into cannabis.
Want to know about the United States History with Marijuana? Click HERE
Want to know about the common Myths and Facts about Marijuana? Click HERE
Want to know more about MAPS- Multidisciplinary Association for Psychedelic Studies ( MAPS) is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Click HERE
Please see: https://www.ncbi.nlm.nih.gov/books/NBK425757/ For comprehensive details.