At the beginning of this year, the National Academies of Sciences, Engineering, and Medicine issued a comprehensive review of available cannabis research regarding marijuana and human health. There review showed that while there is a great deal of potential for cannabis in the realm of medicine, they cannot make conclusive claims due to a woeful lack of adequate research. You may be wondering, why isn’t anyone doing the research then? Well, the answer is that researching cannabis is not as easy as loading up on product from your local dispensary and running experiments. As a Schedule I drug under federal law, cannabis research is heavily regulated in every aspect, from funding to product procurement.
HIV and Medical Cannabis Research
Dr. Donald Abrams, chief of the Hematology-Oncology Division at San Francisco General Hospital and Professor of Clinical Medicine at the University of California San Francisco, was a part of the team responsible for reviewing the available research and has been researching the safety of cannabis in HIV patients for over 20 years. Dr. Abrams received funding from the National Institute on Drug Abuse (NIDA) in 1997 to research the safety of cannabinoids in HIV infection and was subsequently awarded funds from the University of California Center for Medicinal Cannabis Research to continue his studies of cannabis use in a number of conditions. His most recent NIDA funded research evaluated interactions between cannabis and opioids.
In a talk at the Exploratorium in San Francisco, CA, in April, Dr. Abrams discussed the hurdles conducting research on the benefits of cannabis. One of the major points Dr. Abrams addressed was the ability to gain funding. The NIDA, a member of the National Institutes of Health, is the agency under which the majority of marijuana research is conducted.
However, it is the NIDA’s mission to study issues arising from substance abuse and dependence and its research focuses on the negative health effects and behavioral consequences associated with these issues.
In layman’s terms, if your proposed research revolves around looking at the benefits of cannabis rather than the negative effects, funding is going to be extremely difficult to obtain through the NIDA
Unfortunately, other sources of funding are scarce too. In fact, one of the recommendations of the National Academies of Sciences, Engineering, and Medicine’s review was that a diverse network of funders be created specifically for the support of cannabis research, for research of both benefits and harms caused by cannabis.
Cannabis Research and Federal Regulations
Unfortunately, money is not the only issue at hand though. Regulatory barriers to research, due to marijuana’s status as a Schedule I, are exceptionally difficult to navigate. This year’s review put it this way:
Researchers conducting clinical research on biological products such as cannabis must submit an investigational new drug (IND) application to the FDA. As a next step, the investigator may contact NIDA, an important source of research-grade cannabis, to obtain an administrative letter of authorization (LOA). A LOA 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 also apply for a DEA registration and site licensure before conducting studies involving cannabis or any of its cannabinoid constituents, irrespective of their pharmacologic activity. The investigator must submit the IND and LOA to the FDA and the DEA for review .
After submitting an IND application, researchers must wait at least 30 days before initiating research, during which period the FDA reviews the application to ensure that research participants will not be exposed to unreasonable risk. If the FDA determines that the proposed research would expose study participants to unreasonable risk or that the IND application is in some other way deficient, a clinical hold postponing the research may be imposed. This hold is not lifted until and unless the sponsoring researchers have resolved the deficiencies.
Researchers conducting trials of Schedule I substances must additionally submit a research protocol to the DEA that includes details regarding the security provisions for storing and dispensing the substance….To ensure that controlled substances obtained for research purposes will be stored and accessed in accordance with DEA security requirements, local DEA officials may perform a pre-registration inspection of the facility where the proposed research will take place .
DEA security requirements include storing cannabis in a safe, steel cabinet, or vault, and limiting access to the storage facility to “an absolute minimum number of specifically authorized employees.
The extent of the security measures required by DEA varies with the amount of cannabis being stored and among local DEA jurisdictions. Funders must bear the costs of meeting the necessary security requirements. Additionally, as with any human clinical trial, approval from an institutional review board must be sought.
The Future of Medical Cannabis Research
Feeling overwhelmed? You were just reading an overview of the steps! Can you imagine if you were actually trying to conduct the research?!?! According to Dr. Abrams, the number one thing we can do to address these barriers to research is to remove cannabis from the list of Schedule I drugs.
Finally, research is also being grossly inhibited by barriers to the cannabis supply itself. Like I said, you can’t just go to the local dispensary to procure product for research purposes. In fact, there is only one source for approved product for research and that is the NIDA. Again, the NIDA is not in the business of examining the therapeutic benefits of cannabis. In fact, their mission is to study drug abuse causes and consequences, or the “negatives”. That doesn’t exactly open the door for medical studies. To add insult to injury, the product that is available through the NIDA is all sourced from the University of Mississippi and is known for it’s poor quality and limited scope of strains and potencies.
And there you have it folks- the reasons why, despite breaking scientific barriers everyday, we are decades behind the times in cannabis research
It’s time to lend our voices and get the feds on board to remove these barriers to research. Who knows what advances we could make if marijuana was simply removed from the Schedule I category?! So, get on the phone, write a letter, hell, take a field trip to your local representative’s office- just put the pressure on and let’s get this done!