Monday, May 26, 2014
Earlier this month, the Drug Enforcement Administration issued notice that it would be increasing the 2014 production quota for marijuana from 21 kilograms to 650 kilograms – an almost 3000% increase. In the words of DEA spokeswoman Barbara Carreno, “That’s a lot of marijuana.” This step, according to the National Institute on Drug Abuse (NIDA), was a necessary response to a dramatic increase in current and proposed marijuana research.
The current approval process for clinical research of the effects of marijuana differs significantly from traditional research approval processes. If funded by the NIH, proposals to research marijuana must undergo traditional peer review; however, non-NIH-funded proposals must first be reviewed by a scientific review panel within the Department of Health and Human Services (an unusual step). Researchers must then submit an Investigational New Drug Application with the FDA and obtain DEA registration, as would be the case for any research on controlled substances. And finally, researchers must seek approval from NIDA in order to obtain a supply of research-grade marijuana. NIDA, a part of the NIH, is the sole entity responsible for overseeing the cultivation and distribution of all legal marijuana in the U.S., which is grown at the University of Mississippi.
NIDA has been widely criticized in recent years for not being receptive enough to research on marijuana and other Schedule I drugs. Researchers whose HHS-approved proposals have been denied by NIDA allege that NIDA has only been willing to approve research that studies the risks, not the benefits, of illegal drugs.
But perhaps these criticisms are about to change. This year, NIDA updated its website to clarify that it does indeed approve studies on the therapeutic benefits of marijuana. NITA identified 28 active grants that it has funded in the past few years to study marijuana’s effects on autoimmune disease, inflammation, pain, psychiatric disorder, seizures, and drug dependence; as well as a number of independently funded studies that received NIDA’s approval to obtain research-grade marijuana. It is in response to these approved studies that the DEA approved NITA’s request to dramatically increase the marijuana production quota.
If this trend continues, then perhaps the United States will finally be able to achieve the goals set out fifteen years ago in the Institute of Medicine’s 1999 report, Marijuana and Medicine: Assessment of the Science Base, which strongly recommended that clinical trials be conducted to study the medicinal effects of cannabinoid drugs.