Is the end in sight for the gross lack of clinical research regarding medical marijuana in the United States, including human trials, that’s been enabled by the federal government’s Schedule I status of the herb? The short answer: Maybe.
An amendment proposal has been made in Congress for a bill intended to accelerate development of new medicines. If passed, this bill would include creation of a new section of the Controlled Substances Act called Schedule IR. Any drug falling under Schedule IR would necessarily be cannabis, because the category is intended to “facilitate credible research on the medical efficacy of marihuana.”
According to the language of the amendment (note the spelling of “marijuana” as marihuana):
“The National Institutes of Health should initiate credible research on the medical efficacy of marihuana, including cannabidiol, as a treatment for patients.”
The amendment calls for the National Institutes of Health and the Drug Enforcement Administration (DEA) to work together to study the pros and cons of the use of cannabis as medicine. This bi-partisan legislation is sponsored by California Democrat Sam Farr, Maryland Republican Andy Harris, Virginia Republican Morgan Griffith, and Oregon Democrat Earl Blumenauer.
Republican Harris is a unusual sponsor for the bill; he led an unsuccessful efforts to block Washington, D.C. from implementing marijuana legalization. His opposition to the District’s legalization was especially controversial and attracted harsh criticism based on the fact that D.C.’s law was passed by a ballot initiative and, thus, directly reflected the will of the voters. It is possible that Harris is hoping research resulting from the amendment might uncover health risks or other fuel for the war on drugs.
This legislation cites the need for research at the federal level due to the legalization of medical marijuana in nearly half of U.S. states.
“As some States have begun to allow patients suffering from diseases such as cancer, epilepsy, glaucoma, and post-traumatic stress disorder (PTSD) to be treated with marihuana, it is imperative that the NIH, in consultation with the Drug Enforcement Administration, study the benefits and risks of marihuana and its derivatives and whether they are safe and effective forms of treatment for patients.”
If passed, the actual effect of this legislation is unknown. It cannot be assumed that the rescheduling of cannabis, strictly for research purposes and as directed by the federal government, will result in more open research and possibly human trials in the U.S. In fact, the regulations surrounding the new Schedule IR drug category would be written after passage of the law.
And guess who would be writing them? The DEA.
It should be noted that Schedule IR would apply strictly to marijuana research, not sales or any activity regarding recreational applications of the herb. For all uses of marijuana outside of research, the United States government and the attorney general would continue to apply the draconian regulations of Schedule I to their enforcement strategies and activities.
According to the language of the proposed amendment, Schedule IR would be a subset of Schedule I, with the “R” denoting the research focus of this new designation. According to the language of the bill:
“Except to the extent to which marihuana is intended to be used exclusively for research…shall treat marihuana in such Schedule IR as a Schedule I controlled substance.”
Between maintaining the Schedule I status of cannabis for all uses unrelated to research and the fact that the regulations for Schedule IR would be crafted by the DEA, this legislation leaves cannabis patients and advocates with little to celebrate. This bill’s passage would probably result in limited research, most or all of which was conducted by the NIH — and closely regulated and monitored by the DEA. There are also no guarantees of human trials.
Until the passage of bi-partisan bills like the CARERS act — which would re-categorize marijuana as Schedule II — objective, robust research in the United States will largely be a fantasy. Countries such as Italy, Israel, Germany, Spain, Canada, and the United Kingdom will continue to conduct the bulk of clinical studies and human trials involving cannabis.