The federal government has awarded $3 million in grants for research into the therapeutic benefits of ingredients in marijuana other than THC, emphasizing their potential as alternatives to prescription opioids.
In a notice published on Thursday, the National Institutes of Health (NIH) explained why the studies were necessary and listed grant recipients and the subjects they will investigate. That includes research into the use of CBD for arthritis pain, which will be led by New York University School of Medicine.
“The treatment of chronic pain has relied heavily on opioids, despite their potential for addiction and overdose and the fact that they often don’t work well when used on a long-term basis,” Helene Langevin, director of the National Center for Complementary and Integrative Health (NCCIH), said in a press release. “There’s an urgent need for more effective and safer options.”
A total of nine grants were issued, with NIH stating that the funds will help identify alternative treatment options for pain and provide information about the impact of consuming cannabis compounds such as CBD and other lesser-known cannabinoids as well as terpenes found in the plant.
“The cannabis plant contains more than 110 cannabinoids and 120 terpenes, but the only compound that’s been studied extensively is THC,” the press release said.
But while THC is known to treat certain forms of pain, NIH is concerned that its intoxicating effects limit its medical applicability.
“THC may help relieve pain, but its value as an analgesic is limited by its psychoactive effects and abuse potential,” David Shurtleff, deputy director of NCCIH, said. “These new projects will investigate substances from cannabis that don’t have THC’s disadvantages, looking at their basic biological activity and their potential mechanisms of action as pain relievers.”
Just released: Nine new research awards, funded by our Center, will investigate the potential pain-relieving properties and mechanisms of actions of the diverse phytochemicals in cannabis, including both minor cannabinoids and terpenes. https://t.co/03MxrycfFa
— NIH NCCIH (@NIH_NCCIH) September 19, 2019
NIH first announced that it would be issuing grants for studies into minor cannabinoids and terpenes last year.
Federal health agencies aren’t the only institutions interested in learning about marijuana compounds other than THC. On Wednesday, a Senate committee issued a spending report that called for research into CBD and CBG while also criticizing the federal drug scheduling system for inhibiting such research.
Read descriptions of the federal cannabinoid and terpene research grant awards below:
Mechanism and Optimization of CBD-Mediated Analgesic Effects; Boston Children’s Hospital, Boston,; Zhigang He, Ph.D., B.M., and Juan Hong Wang, Ph.D. This project will investigate how the pain-relieving effects of cannabidiol (CBD) and other minor cannabinoids may be modulated by the activity of potassium-chloride cotransporter 2 (KCC2), a chloride extruder expressed in most neurons. (Grant 1R01AT010779)
Neuroimmune Mechanisms of Minor Cannabinoids in Inflammatory and Neuropathic Pain; University of California, San Francisco; Judith Hellman, M.D., and Mark A. Schumacher, M.D., Ph.D. This project will explore the effects of minor cannabinoids on inflammatory and neuropathic pain in vitro and in vivo, focusing on the interactions of the cannabinoids with the peripheral receptor called TRPV1 and a cannabinoid receptor, CB1R. (Grant 1R01AT010757)
Minor Cannabinoids and Terpenes: Preclinical Evaluation as Analgesics; Research Triangle Institute, Research Triangle Park, North Carolina; Jenny L. Wiley, Ph.D. This project will evaluate purified biosynthesized minor cannabinoids and selected terpenes alone and in planned combinations to determine their potential efficacy as pain relievers against acute thermal, inflammatory, neuropathic, and visceral pain. (Grant 1R01AT010773)
Identifying the Mechanisms of Action for CBD on Chronic Arthritis Pain; New York University School of Medicine, New York City; Yu-Shin Ding, Ph.D. This project will use neuroimaging studies and behavioral assessments to investigate the mechanisms of action of CBD in the modulation of chronic pain associated with osteoarthritis in a mouse model. (Grant 1R21AT010771)
Synthetic Biology for the Chemogenetic Manipulation of Pain Pathways; University of Texas, Austin; Andrew Ellington, Ph.D. This project will use a novel method to evolve individual variants of cannabinoid receptor type 2 (CB2) that interact with high affinity with minor cannabinoids and evaluate the new variants in a mouse model of pain. (Grant 1R21AT010777)
Exploring the Mechanisms Underlying the Analgesic Effect of Cannabidiol Using Proton Magnetic Resonance Spectroscopy; University of Utah, Salt Lake City; Deborah A. Yurgelun-Todd, Ph.D. This project will use proton magnetic resonance spectroscopy (1H-MRS) to evaluate changes in brain chemistry in critical pain-processing regions after short-term administration of a cannabis extract enriched in CBD. (Grant 1R21AT010736)
Mechanistic Studies of Analgesic Effects of Terpene Enriched Extracts from Hops; Emory University, Atlanta; Cassandra L. Quave, Ph.D. This project will take a multidisciplinary approach to investigate the analgesic effects of terpenes from Humulus lupulus (hops), a plant that is closely related to cannabis and has a very similar terpene profile. (Grant 1R21AT010774)
Systematic Investigation of Rare Cannabinoids With Pain Receptors; University of Illinois at Urbana-Champaign; David Sarlah, Ph.D. This project involves synthesizing several classes of rare phytocannabinoids, systematically evaluating their anti-inflammatory potential, and examining the effects of the compounds with the strongest anti-inflammatory potential on the major receptors involved in pain sensation. (Grant 1R21AT010761)
Analgesic efficacy of single and combined minor cannabinoids and terpenes; Temple University, Philadelphia; Sara J. Ward, Ph.D. This project will use rodent models of pain to evaluate the effects of four biologically active components of cannabis that may act synergistically to protect against pain development and to assess the interactions of these four substances with morphine. (Grant 1R01AT010778)
White House Completes Review Of CBD Guidance From FDA
The White House recently completed its review of pending Food and Drug Administration (FDA) guidance on marijuana and CBD research—though it remains to be seen whether the draft document will ultimately be released to the public.
FDA submitted its proposed plan—titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”—to the Office of Management and Budget (OMB) in May. Few details are known about its contents, but an FDA spokesperson previously told Marijuana Moment that it could inform the agency’s approach to developing regulations for the marketing of CBD.
OMB finished its review last week, as first reported by InsideHealthPolicy. This comes days after a spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”
Despite the review being finalized, however, an FDA representative told Marijuana Moment on Friday that the agency “cannot provide an update of when (or even if) this guidance will issue.”
“It will be announced via the Federal Register should it move to publication,” they said.
It’s not entirely clear why the guidance wouldn’t be published in the end, but it may take some time for FDA to implement any edits suggested by the White House over the past month, and it’s possible there are additional layers of review beyond OMB that could determine when and whether it will be finalized.
It also remains to be seen whether FDA plans to wait for this specific guidance to be finalized and for the resulting research to be completed before it gets around to issuing final rules for CBD products in general. Stakeholders have been eagerly awaiting those regulations so they can fully take advantage of the legalization of hemp and its derivatives.
Former FDA Commissioner Scott Gottlieb said in May that White House policies requiring OMB to review scientific documents in the first place represent an onerous step that’s delayed the issuance of guidance.
Beyond sending the draft research plan to the White House for review, FDA is also soliciting public input about the safety and efficacy of CBD in comment period it has decided to keep open indefinitely. The agency said in an update to Congress in March that it has several specific questions it wants answered before deciding whether the cannabidiol can be lawfully marketed. That includes questions about the impact of different methods of consumption and drug interactions.
This week, FDA submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.
In the meantime, FDA is maintaining enforcement discretion when it comes to action against companies that sell CBD products regardless of the lack of regulations and has said it is currently targeting sellers that make especially outlandish or unsanctioned claims about the therapeutic value of their products.
It sent a warning letter to a CBD company owned by a former NFL player after advertisements it displayed suggested its products could treat and prevent a coronavirus infection, for example.
FDA sent a letter warning to a company about its marketing of injectable CBD products that led to a voluntary recall in May.
The agency also publicized a voluntary recall of another CBD product from a different company, notifying consumers about potentially high levels of lead in a batch of tinctures.
FDA has previously issued warnings to other CBD companies that have made unsubstantiated claims about the therapeutic potential of their products.
Photo by Kimzy Nanney.
Veterans Working In Marijuana Industry Aren’t Automatically Blocked From Home Loans, VA Says
The U.S. Department of Veterans Affairs (VA) recently clarified to Congress that it does not have a policy automatically barring veterans from receiving home loans solely because they work in the marijuana industry—and now a key House committee is asking the department to better communicate that to lenders and would-be borrowers.
For the past year, Rep. Katherine Clark (D-MA) and other lawmakers have been pressing VA on difficulties some veterans have faced in securing the benefit, with at least one constituent telling Clark that they were denied a home loan because of their work in the state-legal cannabis market. That prompted the congresswoman to circulate a sign-on letter and introduce an amendment to resolve the problem.
However, in a report submitted to Congress last month that was obtained by Marijuana Moment, VA said there is no policy on the books that calls for home loan denials due to employment at a cannabis business. Instead, the department clarified that conflicting state and federal laws makes it “difficult to prove the stability and reliability of cannabis-derived income,” which are key factors in determining loan eligibility.
“VA is committed to working diligently to serve our Nation’s Veterans by providing eligible Veterans with home loan guaranty benefits,” VA said. “There is nothing in VA statutes or regulations that specifically prohibits a Veteran whose income is derived from state-legalized cannabis activities from obtaining a certificate of eligibility for VA home loan benefits. However, given the disparity between Federal and State laws on cannabis, determining whether such a Veteran is able to obtain a loan has become a complex issue.”
A person’s “reliance on [marijuana-derived] income may hinder a Veteran’s ability to obtain a VA-guaranteed home loan, a result that is consistent with other federal housing programs,” the report states. “VA also notes that many lenders have established their own income thresholds and policies on overlays, which are often more stringent than VA’s requirements, to ensure that the VA-guaranteed loan will be purchased by an investor in the secondary mortgage market.”
In other words, individual lending companies may be denying home loans to veterans because the cannabis industry-derived income they would use to pay back loans isn’t necessarily stable and reliable due to the fact that federal officials could shut down their employers at any time.
If that’s the case, then it doesn’t appear it would be necessary to pass legislation targeting the narrow issue in the way lawmakers did last year. Clark’s amendment to address the problem was approved by the House as part of a defense spending bill—though leaders in the chamber agreed to scrap it after the Senate didn’t include it in its version of the legislation.
The House Appropriations Committee also approved report language last year attached to the bill that funds VA expressing concern that the department “has never publicly stated its position on this matter, hindering Veterans’ ability to fully understand and consider how employment decisions could affect future eligibility for earned benefits.”
The newly released explanation from VA is a result of that provision.
Now, for the next fiscal year, a new report attached to the latest Military Construction, Veterans Affairs, and Related Agencies spending bill acknowledges VA’s recent policy clarification—but lawmakers are asking the department to do more.
“The Committee understands that as directed by House Report 116–63, VA has clarified that nothing in VA statutes or regulations specifically prohibits a Veteran whose income is derived from state-legalized cannabis activities from obtaining a certificate of eligibility for VA home loan benefits,” the report states. “The Committee directs the VA to improve communication with eligible lending institutions to reduce confusion among lenders and borrowers on this matter.”
Clark told Marijuana Moment that “no veteran should be denied benefits simply because they work within the legal cannabis industry.”
“This must be crystal clear in our laws and communicated directly to both borrowers and lenders,” the congresswoman said. “By including this language, we’re eliminating any doubt about the rights of our service members and protecting their ability to access what they’ve rightfully earned.”
In other veterans and cannabis news this year, the Congressional Budget Office released an analysis on a marijuana research bill for veterans and determined that it would have no fiscal impact. And a federal commission issued recommendations to promote research into the therapeutic potential of both cannabis and psychedelics such as psilocybin mushrooms and MDMA.
Read VA’s report on its home loan policy for veterans working in the marijuana industry below:
Photo courtesy of Mike Latimer.
Idaho Medical Marijuana Activists Ask State For Electronic Signature Gathering Option Following Court Ruling
Idaho activists have formally requested that the state allow them to collect signatures electronically for a medical cannabis legalization initiative following a series of federal court rulings on the issue in a case filed by a separate campaign.
While the signature submission deadline passed in May, advocates for an education funding campaign filed a suit against the secretary of state, arguing that social distancing restrictions that were put in place due to the coronavirus pandemic meant the state should give them more time to digitally petition. The judge agreed and ordered the state to allow them to do so for 48 days starting Thursday.
The marijuana reform campaign feels that the same relief should be extended to them as well, and an attorney representing the group sent a letter to the secretary of state this week, asking that the Elections Division also provide cannabis activists with the digital petitioning and deadline extension concessions that the federal judge granted to the education funding group.
In one of the latest developments, the state’s request to the U.S. Court of Appeals for the Ninth Circuit to temporarily force the suspension of electronic signature gathering was denied on Thursday, though the appeal on the broader case is ongoing. That’s given the cannabis activists more hope as they pursue legal routes to have the lower court’s ruling apply to them.
BREAKING: State of Idaho's request to block our e-signature drive for K-12 funding DENIED by the Ninth Circuit Court of Appeals. It's time to give Idaho voters a chance to do what those in power refuse to do: Save our schools from deep budget cuts & invest in our children. #idpol
— Luke Mayville (@lukemayville) July 9, 2020
Russ Belville, campaign spokesperson for the Idaho Cannabis Coalition, told Marijuana Moment that the group was “thrilled” to see the appeals court refuse to stay the electronic signature gathering decision.
“Our attorneys are working to convince the state to provide our Idaho Medical Marijuana Act petition the same electronic signature gathering relief, as we have suffered the same infringement of our petitioning rights,” he said. “It’s a shame it takes a pandemic to even consider allowing electronic signatures on petitions. Idaho should make every effort to make exercising our rights as easy as possible, especially for sick, disabled, elderly, infirm and rural folks without easy access to an in-person petitioner.”
In the new letter to Idaho Secretary of State Lawerence Denney, attorney Bradley Dixon said his client “has standing to pursue a remedy given the impact that the COVID-19 restrictions have had upon it.” The campaign “can show (1) they have suffered an injury in fact, which is both concrete and particularized, and actual or imminent; (2) their injury is fairly traceable; and (3) their injury will likely be redressed by a favorable outcome.”
“Moreover, just like Reclaim Idaho, as illustrated above, our client can show that it was diligent in collecting signatures and had adopted a thorough plan to achieve ballot success in advance of the unforeseeable coronavirus outbreak. Considering the merits of a possible case, our client’s First and Fourteenth Amendments rights have been harmed because the State of Idaho and its agents did not provide an alternative means to signature collection during the stay at home order, or during any of the phased reopening stages.”
The state’s stay-at-home order “made it impossible to retrieve all statutorily-required signatures because of both the reduction in time to collect such signatures, and the deadline date to obtain signatures falling on the same day as the end of the stay at home order,” the attorney said.
If the campaign is ultimately allowed to proceed with signature gathering, they will need 55,057 valid signatures to qualify for the November ballot. Activists said they have about 45,000 unverified signatures on hand at this point, and they’re confident that can fill the gap if they get the deadline extension and electronic petitioning option.
The group has indicated it is prepared to seek relief directly from the courts if the secretary of state does not comply with their request to his office.
Under the proposed ballot measure, patients with qualifying conditions could receive medical cannabis recommendations from physicians and then possess up to four ounces of marijuana and grow up to six plants.
Advocates say that passing medical cannabis in one of the remaining states without such policies on the books would be a significant victory for patients in its own right—but it could also have outsized federal implications. A House-passed bill to protect banks that service state-legal cannabis businesses from being penalized by federal regulators is currently pending action in a Senate committee chaired by a senator who represents the state.
Creating a medical marijuana program in Idaho, which is one of small handful of states that don’t yet even have limited CBD laws, could put additional pressure on Senate Banking Committee Chairman Mike Crapo (R-ID) to move the financial services legislation in Congress.
Read the letter to the secretary state on allowing electronic signature gathering for medical marijuana below: