#NORML #News @WeedConnection

POTUS Signs Law Amending Federal Rules Governing Cannabis Research and Drug Development

Washington, DC: President Joe Biden has signed legislation into law, The Medical Marijuana and Cannabidiol Research Expansion Act, facilitating the federal approval of cannabis-specific clinical research and drug development. It is the first time in over 50 years that a President has signed a stand-alone piece of legislation loosening federal marijuana prohibitions.

Under the new law, the US Attorney General is provided with a 60-day timeline to either approve or deny applications from scientists wishing to conduct clinical trials involving the use of cannabis by human subjects. (Protocols must first be reviewed and approved by both the Secretary of the US Department of Health and Human Services and by the National Institutes of Health prior to the AG's authorization. Those agencies do not have an explicit timeline with which to complete their reviews.)

The law also mandates the US Attorney General to solicit applications from those seeking to grow cannabis for either research purposes or for purposes of potential drug development, and it provides a timeline for the AG to approve those applicants. It also calls upon federal agencies, including HHS, to provide a report on the "potential therapeutic effects of cannabidiol or marijuana on serious medical conditions."

Under current regulations, the US Drug Enforcement Administration is primarily tasked with reviewing and licensing marijuana cultivators, as well as granting Schedule I licenses to scientists wishing to study cannabis in clinical settings. In 2016, the agency announced that it would expand the pool of federally licensed growers beyond just the University of Mississippi (which was initially granted a federal cannabis cultivation license in 1968). In May 2021, the agency announced that it had reached agreements with a handful of third-party applicants to allow them to grow cannabis for use in federally approved clinical trials, but progress towards these official partnerships has been slow to materialize.

For decades, scientists wishing to work with marijuana have complained that it often takes years before their research protocols are approved by federal agencies, and that the quality of cannabis provided by the University of Mississippi's cultivation program is of inferior quality and is not representative of the products available in state-legal markets.

In response to those complaints, House members earlier this year passed legislation, HR 5657: The Medical Marijuana Research Act, permitting authorized scientists for the first time to access cannabis flowers and other products manufactured in accordance with state-approved marijuana programs. However, those explicit provisions were not included in The Medical Marijuana and Cannabidiol Research Expansion Act.

NORML's Deputy Director Paul Armentano criticized this omission. "While the Expansion Act is a step in the right direction, the limited variety of cannabis cultivars accessible to federally licensed researchers does not represent the type or quality of cannabis products currently available in legal, statewide markets," he said. "The fact that nearly one-half of US adults have legal access to these multitude of cannabis products, but our nation's top scientists do not, is the height of absurdity and highlights the need for continued legislative action if we want to more easily study the state-legal products that millions of Americans are actually using."

NORML's Political Director Morgan Fox said, "While the significance of POTUS signing the first stand-alone cannabis policy reform bill should not be overlooked, in truth, we don't need more research to know definitively that prohibition is a misguided and disastrous policy." He added: "That said, this legislation is certainly a step in the right direction that shows there can be bipartisan cooperation on this issue. We commend Senate Majority Leader Schumer for prioritizing cannabis policy, and we remain hopeful for the passage of even more substantial legislation before the end of the current session."

Study: Medical Cannabis Legalization Associated with Lower Rates of Opioid Use Among Cancer Patients

New York, NY: The adoption of statewide medical cannabis access laws is associated with lower rates of opioid use and with a reduction in the number of pain-related hospitalizations among newly diagnosed patients with cancer, according to data published in the journal JAMA Oncology.

Investigators affiliated with Cornell University's Weill Medical College assessed the relationship between medical cannabis legalization and opioid-related and pain-related outcomes for adults receiving cancer treatment.

Authors determined that medical marijuana legalization was "associated with a five percent to 20 percent relative reduction in the rate of opioid dispensing to adults younger than 65 years receiving cancer treatment after a new cancer diagnosis. Medical marijuana legalization with dispensary allowances was associated with a larger reduction in opioid dispensing compared with legalization without dispensary allowances." Legalization was also associated with reductions in patients' total number of pain-related hospital events.

Researchers concluded: "This cross-sectional study found that medical marijuana legalization between 2012 and 2017 was associated with reductions in the rate of opioid dispensing and pain-related hospital events in some privately insured patients aged 18 to 64 years receiving anticancer treatment. The findings suggest that medical marijuana could be serving as a substitute for opioids to some extent."

The findings are consistent with numerous other studies showing reduced rates of opioid consumption and dispensing in jurisdictions where cannabis is legally accessible.

Full text of the study, "Medical marijuana legalization and opioid- and pain-related outcomes among patients newly diagnosed with cancer receiving anticancer treatment," appears in JAMA Oncology.

Study: Plant-Derived CBD Extracts Significantly Improve Symptoms in Autistic Children

Melbourne, Australia: Children with autism spectrum disorder (ASD) show significant improvements in their symptoms following the use of plant-derived CBD dominant extracts, according to phase 1 trial results reported by Australian media.

Patients in the trial consumed extracts containing CBD and other non-THC phyto-cannabinoids twice daily for a period of at least two months. Researchers affiliated with the study said that patients experienced significant changes in communication and socialization skills, among other symptom improvements. Side-effects were minimal.

The findings are consistent with several other studies similarly reporting improvements in pediatric patients' ASD symptoms following the use of cannabinoid products, particularly CBD-rich extracts. Survey data published in 2021 by Autism Parenting Magazine reported that 22 percent of US caregivers or parents have provided CBD to an autistic child. Survey data from the United Kingdom recently reported that autistic adults were nearly four times as likely as controls to report having used CBD within the past year.

Review: Medical Cannabis Retail Access Associated with Lower Rates of Drug Overdose Mortality

San Antonio, TX: Medical cannabis retail access is inversely associated with drug overdose mortality rates, according to the findings of a literature review published in the journal Drug and Alcohol Dependence.

Investigators affiliated with the University of Texas and Arizona State University reviewed data from over 50 studies highlighting county-level predictors of overdose mortality.

"[M]easures related to cannabis dispensaries, substance use treatment, social capital, and proportions of family households, were generally consistently associated with lower drug overdose mortality outcomes across multiple studies," authors concluded. "Findings support the need for additional research to elucidate the pathways by which the county context shapes residents' risk of fatal overdose, in order to translate data into contextual interventions to reverse the rising rates of overdose deaths across the US."

Numerous studies have documented lower rates of opioid use over time among populations who either have legal access to retail cannabis products or who possess recommendations for medical cannabis.

Full text of the study, "County-level predictors of US drug overdose mortality: A systematic review," appears in Drug and Alcohol Dependence.

Clinical Trial: CBD Gel Is Safe and Effective in Fragile X Syndrome Patients

Chicago, IL: The administration of a proprietary transdermal CBD gel (aka ZYN002) is safe and effective in patients with Fragile X syndrome (FXS), according to phase 3 clinical trial data published in the Journal of Neurodevelopmental Disorders. FXS is a genetic disorder resulting in developmental delays, learning disabilities, and behavioral problems, such as aggression and attention deficits.

Over 200 pediatric patients (mean age 9.7 years) participated in the 12-week trial. Subjects received either CBD or placebo in addition to their prescribed medications. The study is the largest double-blind, randomized, placebo-controlled clinical trial ever conducted involving FXS patients.

Consistent with prior studies, investigators reported that CBD treatment was effective, safe, and well-tolerated. No serious adverse events were reported.

"In this trial, ZYN002 was well tolerated in patients with FXS and demonstrated evidence of efficacy with a favorable benefit risk relationship," they concluded. "A confirmatory phase 3, randomized, controlled trial is being conducted in children and adolescent patients with FXS."

Full text of the study, "A randomized, controlled trial of ZYN002 cannabidiol transdermal gel in children and adolescents with Fragile X Syndrome," appears in the Journal of Neurodevelopmental Disorders.