Thank you Thea, Allison, Laurel, Shelly, Kathy, Terry, Randy, Annie, Chris, Bruce, Cherie, Lee, Holly, Jim and Evie, Jonelle, Ellen, Joan, Sarah, Jessie, Jim P, Laura, Barb and Bill for submitting comments to Regulations.gov about the DEA's proposal to regulate Cannabis Research. Maybe some of you submitted comments anonymously or your comments are still in review? There is still time! A few of you asked for suggestions in writing comments. It only needs to be 2 sentences. Here are 2 background articles from NORML
Here is a summary of NORML's talking points,
To conclude, NORML opposes the DEA’s proposed rules and, instead, proposes a more practical alternative to facilitate clinical cannabis research in the United States. To date, 33 states and the District of Columbia license private entities to commercially produce lab-tested, medical grade cannabis and cannabis-infused products for qualifying patients. These entities and their manufacturing practices are regulated by state agencies, and their products are representative of the types and varieties of cannabis currently consumed by the public. Rather than compelling scientists to access marijuana products of questionable quality manufactured by a limited number of federally licensed producers, NORML believes that federal regulators should allow investigators to access the cannabis that is currently being produced by the multitude of state-sanctioned growers and retailers throughout the country. Last year, Maryland lawmakers became the first in the nation to sign such a measure into law.7 It is NORML’s belief that federal regulators, including the FDA, ought to embrace this more practical, streamlined plan. Doing so would not only facilitate and expedite clinical cannabis research in the United States, but it would also bring about a long overdue end to decades of DEA stonewalling and interference with respect to the advancement of our scientific understanding of the cannabis plant.
Here are talking points from National Cannabis Industry Asso.
The federal government should be incentivizing research, not discouraging it. On behalf of its nearly 2,000 members, NCIA hereby requests that these proposed regulations be amended and/or withdrawn in accordance with our concerns as articulated herein and that a qualified public health agency be appointed to serve as the coordinating agency instead. We also request that the applicant pool be expanded to include companies that are or have cultivated cannabis in accordance with the laws of any state, regardless of whether the DEA concludes such actions did or did not technically violate the CSA. Most importantly, NCIA requests that the U.S. Government incentivize research and create a pathway for less restrictive means by which the country can access important information about the medicinal properties of cannabis.
Here is my emotional letter......
The Endocannabinoid system is a novel target for cancer. The Endocannabinoid system, as the master regulator of our bodies, shows amazing potential to manage dozens of diseases: Cancer, MS, Epilepsy, PTSD, IBS, chronic pain, and so many others.
The DEA is a law enforcement agency with a long history of ignoring the science of this plant. The first scientific paper to show the anti-tumor properties was published in 1974! Stop stonewalling, stop lying, stop regulating this plant as if it's plutonium. The DEA is not a research or science agency. The DEA is not a health care agency. The DEA needs to get out of the way of medical progress.
Let researchers, scientists and physicians find cures as quickly as possible. How will history judge you when the world learns you have been blocking life-saving science for decades. So just stop!
I use cannabis to shrink and manage my terminal cancer. I am not a felon. I am a hero.
Michelle Kendall
And here is Bruce's technical letter...
In recent decades, the endocannabinoid system (ECS) has been found to play an important role in many diseases, including cancer (Fraguas-Snchez et al. 2018). Pre-clinical research dating back to the 1970s has shown that individual phytocannabinoids and whole-plant cannabis extracts can affect the ECS and have potential curative effects, including killing cancer cells (e.g., Hinz and Romer 2019). Thus, it is critical that cannabis and cannabis extracts be made available to medical researchers to perform clinical trials.
Cannabis contains hundreds of compounds, including cannabinoids, terpenes, and flavonoids. Cannabis is far more than THC and CBD! In fact, whole-plant extracts can have much greater impact on tumor cells than does THC alone (Baram et al. 2019), suggesting important therapeutic roles for other compounds produced by the cannabis plant. However, different cultivars of cannabis have dramatically different chemical constituents (Baram et al. 2019), and the expression of many compounds can be affected by cultivation conditions as well. Thus, robust investigations into the therapeutic value of cannabis requires the availability of hundreds of cannabis cultivars.
Therefor, the regulation should be revised to direct that the DEA
(a) will approve the registrations of as many different producers of research grade cannabis as possible,
(b) will maintain a catalog of the cultivars or strains being produced, and
(c) will prioritize the approval or renewal of registrations for producers who propose to produce strains not already in the catalog.
Furthermore, I note that the DEA has failed to attain the approval timelines set forth in existing regulations. Per 21 CFR 1301.32, the Administrator should forward each completed application to the Secretary within 7 days, and the Secretary shall make a determination within 21 days (or 30 days for clinical investigations). For positive determinations, the Administrator shall issue the certificate of registration within 10 days. Thus, the entire procedure should take less than two months. However, per 84 FR 44920-44923, as of August 2019 there were outstanding applications that had been submitted as much as two years previously!
To prevent bureaucratic stonewalling, the regulation should be revised to state that complete applications that have not been acted upon within the specified time frame will be automatically approved, or to provide clear procedures for timely redress to applicants whose applications have not been acted upon within the specified time frame.
Professor Bruce Kendall, PhD
University of California, Santa Barbara
References
Baram L, Peled E, Berman P, et al. The heterogeneity and complexity of Cannabis extracts as antitumor agents. Oncotarget. 2019;10(41):40914106. doi:10.18632/oncotarget.26983
Fraguas-Snchez AI, Martn-Sabroso C, Torres-Surez AI. Insights into the effects of the endocannabinoid system in cancer: a review. Br J Pharmacol. 2018;175(13):25662580. doi:10.1111/bph.14331
Hinz, B., and Ramer, R. (2019) Antitumour actions of cannabinoids. British Journal of Pharmacology, 176: 1384- 1394. https://doi.org/10.1111/bph.14426.
A day later I had more to say.....
How can the US possibly do ground breaking science, see attached paper "The Heterogeneity and Complexity of Cannabis Extracts as Anti-tumor Agents" (Baram, et all, 2019) if all the Cannabis comes from one farm producing poor quality and homogeneous plants. The Baram paper shows that some very minor and uncommon cannabinoids are critical to neoplastic effects. How can you guarantee you can grow those molecules?
The preclinical data is clear, for some tumor types the Endocannabinoid system is a novel target for cancer treatment. The anecdotal case reports show it can work in humans. I know it works because I shrank my HGSC, BRCA1/2- P53+ ovarian cancer on Cannabis.
Stop stonewalling, stop blocking progress with onerous regulations. There is no reason researchers need a special license to study Cannabis or need to use U of Mississippi material when they could buy state licensed products in over half of all states.
DEA, it could not be more clear, you are stalling life saving medical research. History will not look kindly on your previous decades of ignoring science.
Michelle Kendall
I use Cannabis to maintain remission from terminal cancer.
I am not a felon, I am a hero!
And then again.....Yeah, ok, I have some anger issues with the DEA, I'll admit it.
Let's think through two scenarios.... 1. You, DEA, don't know about all this peer reviewed science showing the Endocannabinoid system is a novel target for cancer. This list of peer reviewed Oncology papers can be found in PubMed or Google Scholar. A Promising Bioactive Molecule with Multi-Target Effects in Cancer. Endocannabinoids as Guardians of Metastasis Cannabinoids for Cancer Treatment: Progress and Promise Endocannabinoid system as a regulator of tumor cell malignancy Anticancer mechanisms of cannabinoids Cannabis for Cancer Insights into the effects of the endocannabinoid system in cancer The Endocannabinoid System: A Target for Cancer Treatment The role of the endocannabinoid system in female reproductive tissues The evolving role of the endocannabinoid system in gynaecological cancer Ligands for cannabinoid receptors, promising anticancer agents Antitumor Cannabinoid Chemotypes: Structural Insights The heterogeneity and complexity of Cannabis extracts as antitumor agents Cannabinoids in cancer treatment: Therapeutic potential and legislation Cannabinoid pharmacology: the first 66 years Cannabis...Cannabinoids: Their Chemistry and Role against Oxidative Stress, Inflammation, and Cancer Cannabinoids and cancer: pros and cons of an antitumour strategy The current state and future perspectives of cannabinoids in cancer biology Cannabinoids in Gynecological Diseases The endocannabinoid system and cancer: therapeutic implication Anti-tumour actions of cannabinoids Cannabinoids and omega-3/6 Endocannabinoids as cell death and anticancer modulators Cannabinoid receptors as a target for therapy of ovarian cancer Cannabinoids for Cancer Treatment: Progress and Promise If this is true, I conclude DEA should not be in charge of this medicinal plant as it is clear you are profoundly unqualified to manage theses amazing healing molecules. 2. You, DEA, are aware of this science and yet continue to stonewall and block research with onerous regulations. If this is true I conclude, you are not only unqualified to manage medical Cannabis but you need to evaluate your moral compass. How heartless, inhumane and possible criminally negligent? It seems clear to me the DEA cares more about using Cannabis as a law enforcement weapon than helping terminal cancer patients, MS patients, Epilepsy patients, PTSD patients, chronic pain patients, and on and on. I shrank my terminal cancer on Cannabis, just like the pre-clincal data suggested. I am not a felon, I am a hero. Michelle Kendall