Realm of Caring Appoints Research Director to Oversee Groundbreaking Cannabis Data Registry and Medical Studies

Under the Leadership of Nicolas Schlienz, Ph.D., and its Scientific Advisory Board, the Organization Publishes New Real-World Study on Epilepsy and CBD

 

COLORADO: –Realm of Caring, a nonprofit dedicated to cannabinoid research, has appointed Nicolas Schlienz, Ph.D., as its Research Director, a new role in the organization’s leadership. His first initiative is co-authoring an original study on epilepsy using survey data gathered from RoC’s innovative Observational Research Registry.

Schlienz, a clinical psychologist, led the development of the ORR as a postdoctoral research fellow at Johns Hopkins University. The ORR is a web-based research platform open to adults and adult caregivers of dependents who are, or are considering, the use of cannabis or hemp products for therapeutic purposes. The aim is to better understand the impact that therapeutic use of such products has on individual health, functioning and quality of life.

“There are numerous obstacles to exploring the therapeutic potential of cannabis due to its classification as a Schedule I controlled substance,” Schlienz said. “Research opportunities such as the ORR expand the existing scientific knowledge base to better inform clinical decision making, and also dispels the stigma surrounding medicinal cannabis use.”

Schlienz and colleagues have published a paper summarizing ORR data from individuals with epilepsy in the medical journal Epilepsy & Behavior. The longitudinal study showed that individuals who used artisanal cannabidiol (CBD) products reported better quality of life, lower psychiatric symptom severity and fewer medication-related adverse events compared with those not using CBD.

“This study represents a refreshing collaboration of scientists, clinicians, patients and advocates. The results affirm what has been suspected for a long time, that cannabinoid products have value in the treatment of epilepsy as well as associated neuropsychiatric conditions,” said Jay Salpekar, MD, an Associate Professor of Psychiatry and Neurology at Johns Hopkins University. “It is our hope that this study may embolden clinicians and patients to effectively partner in considering these treatments.”

Based on these findings, he and study co-author Ryan Vandrey, Ph.D., plan to conduct a controlled clinical trial to further understand the effects of CBD in epilepsy treatment.

Segra International Completes First Export of Cannabis Plantlets from Canada to the USA

CANADA: Segra International Corp, a leading cannabis agriculture technology company, is pleased to announce its first successful export of Verified Segra Stock™ Cannabis plantlets to the Biopharmaceutical Research Company (BRC), one of the first groups in the USA to receive approval from the DEA to cultivate Cannabis for scientific research purposes.

This shipment marks a tremendous milestone in the evolution of the US cannabis industry, as it represents one of the first imports of live Cannabis plants to a federally licensed US cultivator. In recent months, the DEA has issued a select number of licenses to several groups in the US to allow for the cultivation of Cannabis for scientific research purposes. BRC, based in California, is among the first companies granted a license and is now operational. Segra’s Verified Segra Stock™ plantlets will provide BRC with standardized and validated starting materials produced through plant tissue culture, and backed by extensive agronomic data and Cannabis plant pathogen screening.

BRC works with research groups studying Cannabis and Cannabis flower to understand the plant in a scientific and federally regulated environment. Under the federal licensing regime, BRC is only allowed to source genetics and starting material from DEA-compliant or federally legal sources.

“Segra’s Verified Segra Stock™ guarantee means our plantlets are DNA fingerprinted and pathogen-free with virtually no risk of pathogen introduction to the receiving grow facility.

Starting with this input material is critical to effectively grow replicable crops, something highly valued by researchers who are studying the finished product of the Cannabis plant and its derivatives,” said Jamie Blundell, CEO of Segra International. “Furthermore, Segra’s VNTR DNA Fingerprinting technology allows BRC to order plantlets and cultivars with certainty, knowing they are receiving the same input material with each shipment. The application of VNTR DNA fingerprinting technology can be used throughout the supply chain for track and trace purposes, from plantlet to flower, translating this certainty to researchers who can study the same product repeatedly.”

“At BRC, we are focused on developing federally compliant active pharmaceutical ingredients for federally compliant researchers examining the therapeutic effects of cannabis,” said George Hodgin, CEO of Biopharmaceutical Research Company. “We’re fortunate to be working with Segra to offer our clients a wide range of clean, high-quality Cannabis of specific chemical expressions and flower types to help them better understand the applications of the Cannabis plant.”

Learn more about Segra’s services and premium cultivars by viewing the 2021 Cultivar and Services Catalogue.

 

 

DEA Announces Steps Necessary To Improve Access To Marijuana Research

DISTRICT OF COLUMBIA: The Drug Enforcement Administration today announced that it is moving forward to facilitate and expand scientific and medical research for marijuana in the United States. The DEA is providing notice of pending applications from entities applying to be registered to manufacture marijuana for researchers. DEA anticipates that registering additional qualified marijuana growers will increase the variety of marijuana available for these purposes.

Over the last two years, the total number of individuals registered by DEA to conduct research with marijuana, marijuana extracts, derivatives and delta-9-tetrahydrocannabinol (THC) has increased by more than 40 percent from 384 in January 2017 to 542 in January 2019. Similarly, in the last two years, DEA has more than doubled the production quota for marijuana each year based on increased usage projections for federally approved research projects.

“I am pleased that DEA is moving forward with its review of applications for those who seek to grow marijuana legally to support research,” said Attorney General William P. Barr.  “The Department of Justice will continue to work with our colleagues at the Department of Health and Human Services and across the Administration to improve research opportunities wherever we can.”

“DEA is making progress in the program to register additional marijuana growers for federally authorized research, and will work with other relevant federal agencies to expedite the necessary next steps,” said DEA Acting Administrator Uttam Dhillon.  “We support additional research into marijuana and its components, and we believe registering more growers will result in researchers having access to a wider variety for study.”

This notice also announces that, as the result of a recent amendment to federal law, certain forms of cannabis no longer require DEA registration to grow or manufacture. The Agriculture Improvement Act of 2018, which was signed into law on Dec. 20, 2018, changed the definition of marijuana to exclude “hemp”—plant material that contains 0.3 percent or less delta-9 THC on a dry weight basis. Accordingly, hemp, including hemp plants and cannabidiol (CBD) preparations at or below the 0.3 percent delta-9 THC threshold, is not a controlled substance, and a DEA registration is not required to grow or research it.

Before making decisions on these pending applications, DEA intends to propose new regulations that will govern the marijuana growers program for scientific and medical research. The new rules will help ensure DEA can evaluate the applications under the applicable legal standard and conform the program to relevant laws. To ensure transparency and public participation, this process will provide applicants and the general public with an opportunity to comment on the regulations that should govern the program of growing marijuana for scientific and medical research.

The Notice of Application is available here:

Study: No Link Between Cumulative Cannabis Use And Kidney Disease

CALIFORNIA:  Neither current nor the long-term cumulative use of cannabis is associated with negative effects on the kidneys, according to longitudinal data published online ahead of print in the Clinical Journal of the American Society of Nephrology.

New Rules On Medical Marijuana Research Could Play Into Pennsylvania Legislative Process

PENNSYLVANIA:  Last week the U.S. Drug Enforcement Administration relaxed regulations on medical marijuana research, with potential implications for approval of laws in Pennsylvania.

Loosening regulations on medical marijuana research should streamline the process for researchers conducting FDA-approved clinical trials on cannabidiol, or CBD, an extract of the marijuana plant, according to a news release from the DEA.

While good news for researchers, who have the potential to provide more information on its uses, the change in research protocols could affect the timetable for approving legislation to legalize medical marijuana for certain illnesses.

Pennsylvania’s medical marijuana bill was approved by the Senate last year and is currently being amended in the House.

 

DEA Eases Requirements For FDA-Approved Clinical Trials On Cannabidiol

WASHINGTON: The United States Drug Enforcement Administration (DEA) recently eased some of the regulatory requirements imposed by the Controlled Substances Act (CSA) for those who are conducting FDA-approved clinical trials on cannabidiol (CBD), an extract of the marijuana plant.  These modifications will streamline the research process regarding CBD’s possible medicinal value and help foster ongoing scientific studies.  The DEA notified affected researchers by letter of the changes, which take effect immediately.

Federal Regulation (21 CFR 1301.18) requires researchers conducting CBD-based clinical trials under an FDA Investigational New Drug Application to have a DEA research registration.  This registration permits the possession of an approved amount of CBD for a specific research protocol.  Prior to now, researchers who expanded the scope of their studies and needed more CBD than initially approved for had to request, in writing, a modification to their DEA research registrations – potentially delaying that research while the modification underwent an approval process that includes both the DEA and the Food and Drug Administration (FDA).  Under these changes, a previously registered CBD clinical researcher who is granted a waiver can readily modify their protocol and continue their research seamlessly.  This waiver effectively removes a step from the approval process.

Marijuana is a Schedule I controlled substance because of the presence of tetrahydrocannabinol (THC), marijuana’s psychoactive ingredient.  Because CBD contains less than 1 percent THC and has shown some potential medicinal value, there is great interest in studying it for medical applications.  Currently, CBD is a Schedule I controlled substance as defined under the CSA.  Though the FDA approves drugs for medical use in the United States, the DEA regulates the handling of all controlled substances, including those being used by researchers to conduct studies.

House Republicans Say No To Allowing Federal Studies Of Medical Marijuana

DISTRICT OF COLUMBIA: Medical marijuana is now sold in nearly half of all states, and even one red state has legalized it for recreational use. Veterans of wars in Iraq and Afghanistan are clamoring for access to treat post-traumatic stress disorder. Loosening pot laws polls better in three swing states than any 2016 presidential candidate.

But House Republicans have so far declined to keep pace with shifting public opinion. They did so again late Wednesday, when a rare bipartisan pot proposal died a quiet death in the House that would have reclassified marijuana so that national laboratories could conduct “credible research on its safety and efficacy as a medical treatment.”

The amendment to a bill scheduled for debate Thursday on the House floor would have encouraged the National Institutes of Health and the Drug Enforcement Administration to work together to allow studies of the benefits and risks of marijuana to treat cancer, epilepsy, glaucoma and post-traumatic stress disorder, among other conditions.

Is Israel’s Medical Marijuana Leader Coming To America?

ISRAEL:  Israel’s leading producer of medical marijuana is joining a local group vying for a coveted license to distribute the drug in New York State.

Tikun Olam, which serves about a third of Israeli medical marijuana patients, has joined forces with the Compassionate Care Center of New York (CCCNY) in hopes of winning one of five licenses. If the state grants CCCNY the license, Tikun Olam will ship their products and conduct research through the group starting in January.

Forty-two other companies applied for the licenses, including a handful of health groups with Jewish ties.

“We’re looking for occasions to be involved,” said Tikun Olam’s CEO, Aharon Lutzky. “We found [in] CCC in New York a wonderful team and very serious people.”

U.S. Anti-Legalization Group Urges More Access To Marijuana Research

DISTRICT OF COLUMBIA:  A group opposed to pot legalization is unveiling proposals on Thursday for the U.S. government to ease restrictions on scientific research into marijuana’s potential as medicine, in a first step for an organization of its kind.

The plan from Smart Approaches to Marijuana, which is co-founded by former U.S. Congressman Patrick Kennedy, comes after three U.S. Senators this year introduced a bill that would require the federal government to recognize pot’s medical value and allow states to set their own medical cannabis policies.

Kennedy will present his group’s plan on Thursday to officials in Washington, said Kevin Sabet, the group’s president and chief executive.

Marijuana Gears Up For Production High In US Labs

MARYLAND: Residents of 23 US states can buy medical marijuana to treat everything from cancer pain to anxiety, but US scientists must wade through onerous paperwork to score the drug for study. Their sole dealer is the National Institute on Drug Abuse (NIDA), which has a contract with the University of Mississippi in Oxford to produce marijuana for research purposes.

The agency has long faced complaints that its marijuana is too weak to represent what is sold on the street, and contains low levels of the non-psychedelic chemicals that show therapeutic promise for conditions such as epilepsy and chronic pain. Now, with legal marijuana increasingly available to the US public, NIDA is quietly changing course — working to expand the amount and variety of the drug available for study.

“We want to be able to evaluate the claims that marijuana is therapeutically beneficial” and to explore treatments for addiction, says Nora Volkow, director of NIDA in Rockville, Maryland.