Concludes DEA ignored critical data supporting safety and efficacy for therapeutic use
WASHINGTON, Sept. 1, 2016 /Weed Wire/ — Today, Americans for Safe Access (ASA) disseminated a report comparing the body of research the Drug Enforcement Administration (DEA) used as a basis for their decision to keep cannabis (marijuana) as a Schedule I substance, as defined by the Controlled Substances Act (CSA), with available data, including the research ASA used in its independent, peer-reviewed 8-Factor Analysis. The report provides a thorough analysis of the scientific data the DEA relied upon in making its scheduling decision and relevant data they did not include. The comparative analysis was sent to all members of Congress as a way of educating them on the body of available evidence supporting cannabis’s safety and efficacy for therapeutic use.
On August 10, the DEA announced they were denying two petitions to reschedule marijuana under the CSA, saying it has no accepted medical use in the United States, has a high potential for abuse, and lacks an acceptable level of safety for use, even under medical supervision. In accordance with CSA rescheduling provisions, the DEA requested a scientific and medical evaluation and scheduling recommendation from the Department of Health and Human Services (HHS). Based on the HHS evaluation, including the 8-Factor Analysis and other data, the DEA concluded that there is no substantial evidence that marijuana should be removed from Schedule I.
“Our analysis shows that the DEA failed to take into account over 9,000 patient/years of placebo-controlled clinical research with standardized cannabis-based medicines. Instead, nearly one third of the data cited in their report was derived from survey-based research, much of which does not bare clinical significance, and almost 40% of the agency’s report relies on outdated research articles,” commented ASA’s Senior Scientist, Dr. Jahan Marcu.
While the DEA did not conclude that cannabis should be removed from Schedule I status, they were in agreement with ASA’s analysis that cannabis satisfies Factors 1b, 1d, 2, 3, 6, and 8 of the HHS’s 8-Factor Analysis, which is a step forward from their position in previous rescheduling decisions. They agree that there is no significant diversion of the substance from legitimate channels (Factor 1b), cannabis is related to other approved drugs with acceptable safety profiles (Factor 1d), there is no evidence for long term harms associated from the chronic use of cannabis (Factors 2 & 3), the gateway hypothesis is not supported by scientific evidence (Factor 6), and cannabis is not a precursor to another controlled substance (Factor 8).
Despite cannabis being a Schedule I substance, 41 states plus the District of Columbia have adopted medical cannabis programs, and the disconnect between state and federal law creates a host of problems for legitimate cannabis businesses and the ability to conduct clinical research. At its annual summit in August, the National Conference of State Legislators passed a resolution urging the Obama administration to amend federal law, including the Controlled Substances Act, to allow states to set their own marijuana and hemp policies without federal interference, and to enable financial institutions to provide banking services to legal cannabis businesses. Patient advocacy groups like ASA, the Epilepsy Foundation, and several others have been appealing to members of Congress to reclassify cannabis for medical use for many years.
“It’s very disappointing that the DEA failed to include much of the current clinical data in their analysis, and by maintaining schedule I status they have done nothing to remedy the current conflict between state and federal medical cannabis laws,” said ASA Executive Director Steph Sherer.“ It is clear that the administrative process for rescheduling cannabis is broken and unworkable. It is up to Congress to rectify this situation by passing the CARERS Act.”
The Compassionate Access, Research Expansion, and Respect for States (CARERS) Act (S. 683, H.R. 1538) was introduced in 2015, and in addition to rescheduling cannabis and removing cannabidiol (CBD) from the schedule entirely, allows states to establish medical cannabis access laws and product safety regulations without interference by the federal government, and removes current obstacles to research. The CARERS Act is currently stalled in the Senate Judiciary Committee, with Chairman Chuck Grassley (IA) refusing to hold a vote.
ASA’s 8-Factor Analysis
DEA’s 8-Factor: Rescheduling Denial
DEA’s Rescheduling Denial Press Release
Medical Cannabis Access for Pain Treatment: A Viable Strategy to Address the Opioid Crisis
CARERS Act Fact Sheet
American Academy of Pediatrics Statement on Rescheduling
American College of Physicians position paper
ASA Communications Specialist