Photo of Cannabis plants courtesy of A7nubis and commons.wikimedia.org
Note from Vince: This is am extremely important change as the Cannabis grown by NIDA is an uncommon variety and apparently low in THC. The FDA could approve a Medical Study of the use of high THC Cannabis in the treatment of Cancer, but NIDA always had the final word. If they approved a medical study (their usual common response was “No”) the study had to use the NIDA supplied Cannabis variety.
WASHINGTON, D.C. — Today, the Drug Enforcement Administration (DEA) announced their intention to grant licenses to additional marijuana growers for research, thereby ending the DEA-imposed 48-year monopoly on federally legal marijuana. Since 1968, the University of Mississippi, under contract to the National Institute on Drug Abuse (NIDA), has maintained the only facility in the United States with federal permission to grow marijuana for research.
“It’s a complete and total end of the NIDA monopoly! There has been no production monopoly on any other Schedule I substance, like MDMA or LSD—only the cannabis plant. Licensing non-government cannabis producers, and thereby creating a path to FDA approval, will finally facilitate the removal of marijuana from Schedule I, and ultimately allow patients to receive insurance coverage for medical marijuana,” said Rick Doblin, Ph.D., Founder and Executive Director of the Multidisciplinary Association for Psychedelic Studies (MAPS).
MAPS has been working to eliminate this cannabis research blockade since 1999. NIDA’s marijuana is eligible for research, but cannot be sold as a prescription medicine, making it unacceptable to the Food and Drug Administration (FDA) for use in future Phase 3 studies. Ending the monopoly finally allows for a pathway to FDA approval for marijuana, which would thereby trigger rescheduling.
In 2001, MAPS partnered with University of Massachusetts-Amherst Professor Lyle Craker, Ph.D., to apply for a DEA license and end the monopoly. In 2007, after years of bureaucratic delays and lengthy legal hearings, a DEA Administrative Law Judge (ALJ) recommended that it would be in the public’s interest to grant Craker the license. In 2009, after almost two more years of delays and less than a week before the inauguration of President Obama, former DEA Administrator Michelle Leonhart rejected the ALJ recommendation. In 2011, Craker sued the DEA in the U.S. First Circuit Court of Appeals. In its 2013 decision, the Court uncritically accepted the DEA’s arguments that NIDA’s monopoly provided “an adequate supply produced under adequately competitive conditions.”
Since the 2013 decision, Craker’s argument that NIDA does not have an adequate supply has become significantly more apparent. NIDA has been unable to provide the strains requested for MAPS’ long-delayed Phase 2 clinical trial of smoked marijuana to treat symptoms of posttraumatic stress disorder (PTSD) in 76 U.S. veterans. As a result, the study is proceeding with lower potency marijuana than what MAPS researchers requested.
The DEA has previously claimed that U.S. international treaty obligations under the United Nations Single Convention on Narcotic Drugs (Single Convention) require a federal monopoly, but in April 2016, the State Department released a statement clarifying that the Single Convention does not in fact limit the number of U.S. marijuana producers.
Furthermore, the DEA’s 2009 rejection of the ALJ recommendation to license Craker relied heavily on a U.S. Department of Health and Human Services (HHS) protocol review process, which was eliminated in 2015.
MAPS’ upcoming Phase 2 clinical trial of marijuana for PTSD in veterans is in collaboration with investigators in Phoenix, Arizona, and at Johns Hopkins University, the University of Colorado, and the University of Pennsylvania. The study is funded by a $2.15 million grant to MAPS from the State of Colorado. The study has received full regulatory approval, and will be the first randomized controlled trial of whole plant marijuana as a treatment for PTSD.
Founded in 1986, MAPS is a non-profit research and educational organization working to evaluate the safety and efficacy of botanical marijuana as a potential prescription medicine for specific medical uses approved by the FDA.
- Official Statement from DEA
- 2007 DEA Administrative Law Judge Findings
- 2013 First Circuit Court Decision
- 2015 HHS Statement Ending PHS Protocol Review
- Legal analysis to be submitted in support of Craker’s new application
Additional information can be found at maps.org/research/mmj/dea-license.
Rick Doblin, Ph.D., MAPS Executive Director
Natalie Ginsberg, MAPS Policy & Advocacy Manager
Founded in 1986, the Multidisciplinary Association for Psychedelic Studies (MAPS) is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.
The above link is from our new blog called Uniquely Cannabis. It’s the first post, with more to come.
Main focus of Uniquely Cannabis will be Medical Cannabis / Marijuana. The reason for creating it was that I had read that Cannabis could help those suffering from different Cancers including Leukemia.
I hope that the site will become an infobase about Medical Cannabis / Marijuana to help inform people. I had watched someone take their final breath, because they had Leukemia and nothing helped. Wish that I had known about Cannabis Oil. It might have helped. If it did, then life would have been vastly different.
Posted by Vincent Banial
Medical Cannabis could possibly halt Alzheimer’s and could maybe even reverse the damage caused by Alzheimer’s. That is my interpretation of the results from a medical study conducted by Salk Institute Scientists.
The following is from their News Release:
“Salk Institute scientists have found preliminary evidence that tetrahydrocannabinol (THC) and other compounds found in marijuana can promote the cellular removal of amyloid beta, a toxic protein associated with Alzheimer’s disease.”
“Although other studies have offered evidence that cannabinoids might be neuroprotective against the symptoms of Alzheimer’s, we believe our study is the first to demonstrate that cannabinoids affect both inflammation and amyloid beta accumulation in nerve cells,” says Salk Professor David Schubert, the senior author of the paper.”
I am not giving any medical Advice with the following statements. Maybe discuss with the Medical Doctor taking care of a family member suffering from Alzheimer’s. Ask the Doctor for a prescription for Medical Cannabis, which is available in Canada and many states in America. Working with their Medical Doctor, one could maybe create your own private human trial under your Doctor’s supervision. In my mind, the risk is extremely low. Keep notes and search the internet for Cogniition Tests (Alzheimer’s Associations are a good resource) . Under the care of a Medical Doctor, testing to see if Medical Cannabis could reduce the effects of Alzheimer’s and improve cognition, in my opinion, has a high safety factor. For example, no one has died from smoking or eating too much Cannabis. On the other hand, thousands of people have died due to major Liver damage caused by overdosing on medication such as Tylenol.
Click on the following link to read the News Release about the new finding from the Salk Institute website.
Click on this link to visit the Journal Aging and Mechanisms of Disease to read the published Salk Institute Study titled : “Amyloid proteotoxicity initiates an inflammatory response blocked by cannabinoids“
|Title:||Amyloid proteotoxicity initiates an inflammatory response blocked by cannabinoids|
|Author:||Antonio Currais, Oswald Quehenberger, Aaron M Armando, Daniel Daugherty, Pam Maher et al.|
|Publication:||npj Aging and Mechanisms of Disease|
|Publisher:||Nature Publishing Group|
|Date:||Jun 23, 2016|
|Copyright © 2016, Rights Managed by Nature Publishing Group|
Click on this link to download a PDF copy of the study from the site of the Journal