The United States Drug Enforcement Administration has rejected a pair of administrative petitions that sought to initiate rulemaking proceedings to reschedule marijuana under federal law.
Although the DEA’s ruling continues to classify marijuana in the same category as heroin, the agency also announced in a separate decision that it is adopting policy changes designed to expand the production of research-grade cannabis for FDA-approved clinical studies.
Presently, any clinical trial involving cannabis must access source material cultivated at the University of Mississippi — a prohibition that is not in place for other controlled substances. Today, the agency announced for the first time that it will be seeking applications from multiple parties, including potentially from private entities, to produce marijuana for FDA-approved research protocols as well as for “commercial product development.” This change was initially recommended by the DEA’s own administrative law judge in 2007, but her decision was ultimately rejected by the agency in 2011.
Below is a statement from NORML Deputy Director Paul Armentano regarding the DEA’s decisions:
For far too long, federal regulations have made clinical investigations involving cannabis needlessly onerous and have placed unnecessary and arbitrary restrictions on marijuana that do not exist for other controlled substances, including some other schedule I controlled substances.
While this announcement is a significant step toward better facilitating and expanding clinical investigations into cannabis’ therapeutic efficacy, ample scientific evidence already exists to remove cannabis from its schedule I classification and to acknowledge its relative safety compared to other scheduled substances, like opioids, and unscheduled substances, such as alcohol. Ultimately, the federal government ought to remove cannabis from the Controlled Substances Act altogether in a manner similar to alcohol and tobacco, thus providing states the power to establish their own marijuana regulatory policies free from federal intrusion.
Since the DEA has failed to take such action, then it is incumbent that members of Congress act swiftly to amend cannabis’ criminal status in a way that comports with both public and scientific opinion. Failure to do so continues the federal government’s ‘Flat Earth’ position; it willfully ignores the well-established therapeutic properties associated with the plant and it ignores the laws in 26 states recognizing marijuana’s therapeutic efficacy.
Under the U.S. Controlled Substances Act of 1970, the cannabis plant and its organic cannabinoids are classified as Schedule I prohibited substances — the most restrictive category available under the law. By definition, substances in this category must meet three specific inclusion criteria:
The substance must possess “a high potential for abuse”; it must have “no currently accepted medical use” in the United States; and, the substance must lack “accepted safety for use … under medical supervision.”
Substances that do not meet these criteria must, by law, be categorized in less restrictive federal schedules (Schedules II through V) and are legally regulated accordingly. Alcohol and tobacco, two substances widely acknowledged to possess far greater dangers to health than does cannabis, are not classified under the Controlled Substances Act.
A recent review of FDA-approved clinical studies evaluating the safety and efficacy of herbal cannabis concluded: “Based on evidence currently available the Schedule I classification is not tenable; it is not accurate that cannabis has no medical value, or that Information on safety is lacking.”
Added Armentano: “The DEA’s decision is strictly a political one. There is nothing scientific about willful ignorance.”
The DEA has previously rejected several other rescheduling petitions, including a 2002 petition filed by a coalition of marijuana law reform and health advocacy organizations, and a 1972 petition filed by NORML. The petitions that triggered this latest DEA action were filed in 2009 by a nurse practitioner and in 2011 by then-Govs. Christine Gregoire of Washington and Lincoln Chafee of Rhode Island.
Marijuana consumers do not access health care services at rates that are higher than non-users, according to data published online ahead of print in the European Journal of Internal Medicine.
Researchers at the Medical College of Wisconsin assessed the relationship between marijuana use and health care utilization in a nationally representative sample of 174,159,864 US adults aged 18 to 59 years old.
Authors reported “no significant increase in outpatient health care visits and overnight hospital admissions in marijuana users compared to non-users.” They also reported that those who consumed cannabis multiple times per day were no more likely to seek health care patient services as compared to those who used the substance less frequently.
They concluded, “[C]ontrary to popular belief, … marijuana use is not associated with increased healthcare utilization, [and] there [is] also no association between health care utilization and frequency of marijuana use.”
A previous assessment, published in 2014 in the Journal of General Internal Medicine, similarly reported that the use of marijuana within the past three months was not associated with adverse effects on health, comorbidity, ER visits, or hospitalization.
An abstract of the study, “Marijuana users do not have increased healthcare utilization: A National Health and Nutrition Examination Survey (NHANES) study,” appears here.
The enactment of statewide medicinal cannabis laws is associated with a quantifiable decline in the use of traditional prescription drugs, according to data published in the July edition of the scientific journal Health Affairs.
Investigators at the University of Georgia assessed the relationship between medical marijuana legalization laws and physicians’ prescribing patterns in 17 states over a three-year period (2010 to 2013). Specifically, researchers assessed patients’ consumption of and spending on prescription drugs approved under Medicare Part D in nine domains: anxiety, depression, glaucoma, nausea, pain, psychosis, seizures, sleep disorders, and spasticity.
Authors reported that prescription drug use fell significantly in seven of the nine domains assessed.
“Generally, we found that when a medical marijuana law went into effect, prescribing for FDA-approved prescription drugs under Medicare Part D fell substantially,” investigators reported. “Ultimately, we estimated that nationally the Medicare program and its enrollers spent around $165.2 million less in 2013 as a result of changed prescribing behaviors induced by … jurisdictions that had legalized medical marijuana.”
Investigators estimated that prescription drug savings would total more than $468 million annually were cannabis therapy to be accessible in all 50 states.
They concluded, “Our findings and existing clinical literature imply that patients respond to medical marijuana legislation as if there are clinical benefits to the drug, which adds to the growing body of evidence suggesting that the Schedule I status of marijuana is outdated.”
An abstract of the study, “Medical marijuana laws reduce prescription medication use in Medicare Part D,” is available online here.
The passage of statewide laws regulating the consumption of cannabis by adults and/or qualified patients is not associated with increased rates of teen marijuana use, according to a statistical analysis of results from the Centers for Disease Control and Prevention’s 2015 Youth Risk Behavior Survey.
CDC data reports that the percentage of high-schoolers ever reporting having used cannabis fell from an estimated 43 percent in 1995 to just under 39 percent in 2015. The percentage of teens currently using cannabis (defined as having used marijuana at least once in the past 30 days) also declined during this same period, from 25 percent in 1995 to just under 22 percent in 2015.
During this time period, two-dozen states enacted statutes permitting qualified patients to consume cannabis, and four states enacted laws permitting the commercial production and retail sale of marijuana to adults.
The Youth Risk Behavior Survey results are consistent with those of numerous other studies — such as those here, here, here, here, here, here, here, here, here, and here — finding that changes in cannabis’ legal status are not associated with increased use among adolescents.
More than nine in ten pediatric oncology providers with opinions favor patients’ access to cannabis therapy, according to survey data provided this week at the 2016 annual meeting of the American Society of Clinical Oncology.
Investigators from various US cancer treatment centers surveyed 654 pediatric oncology providers, including physicians and nurses, at three National Cancer Institute-designated cancer centers in Illinois, Massachusetts, and Washington. Over 300 providers (46 percent) completed the survey.
Of those, 92 percent said that they were “willing to help pediatric cancer patients access medical marijuana,” and just over one-third (34 percent) acknowledged that cannabis therapy “is appropriate in the early stages of cancer treatment.”
Thirty percent of respondents reported receiving requests from patients or their families to access medical marijuana therapy at least once per month.
Overall, pediatric oncology providers hold “predominantly favorable attitudes toward medical marijuana use in pediatric cancer patients,” authors concluded.
Previous surveys of physicians and health care providers report similar attitudes. Survey results published in 2013 in the New England Journal of Medicine reported that 76 percent of respondents supported the use of cannabis therapy in the treatment of metastatic breast cancer. A 2014 poll of over 1,500 physicians commissioned by Web MD similarly reported that 82 percent of oncologists believed that marijuana treatment provides legitimate therapeutic benefits.
An abstract of the survey data, “Pediatric oncology providers and use of medical marijuana in children with cancer,” appears online here.