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Bill On Trump’s Desk Would Allow Marijuana (And Maybe MDMA) For Some Patients

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Seriously ill patients would finally be allowed to use marijuana — and potentially MDMA and psilocybin — without violating federal law under a congressionally approved bill now heading to President Trump’s desk.

The bill, know as the “Right to Try Act,” would give certain patients access to drugs that have not yet received U.S. Food and Drug Administration approval for broad use. The House voted 250 – 169 to pass the legislation on Tuesday, and it cleared the Senate by unanimous consent last August.

In order to qualify under the new program, a drug must have completed a phase 1 clinical trial, be under active development, and meet certain other criteria:

“(2) the term ‘eligible investigational drug’ means an investigational drug (as such term is used in section 561)—

“(A) for which a Phase 1 clinical trial has been completed;

“(B) that has not been approved or licensed for any use under section 505 of this Act or section 351 of the Public Health Service Act;

“(C) (i) for which an application has been filed under section 505(b) of this Act or section 351(a) of the Public Health Service Act; or

“(ii) that is under investigation in a clinical trial that—

“(I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 505 of this Act or section 351 of the Public Health Service Act; and

“(II) is the subject of an active investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, as applicable; and

“(D) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 505(i); and

Marijuana meets all of those criteria, thanks to research on medical cannabis use by military veterans with post-traumatic stress disorder that is being funded by the Multidisciplinary Association for Psychedelic Studies (MAPS). That research is currently in Phase 2.

MDMA, commonly known as “ecstasy,” and psilocybin, the active ingredient in psychedelic mushrooms, have undergone Phase 1 and 2 clinical trials, with Phase 3 research on the way.

But while marijuana and potentially the other substances would be eligible for limited legal use under the new law once it is enacted, only patients who are seriously ill would be allowed to participate.

The legislation specifies that a qualifying patient must have been diagnosed with a life-threatening disease or condition, have exhausted approved treatment options and be unable to participate in the clinical trials themselves. A physician who is in good standing with a licensing board would then be able to certify the patient for access.

While the short title of the bill summarizes that it provides for the use of “unapproved medical products by patients diagnosed with a terminal illness in accordance with State law” (emphasis added), the legislative text itself provides no specific limitation concerning state laws. Thus, while patients who would otherwise qualify for medical cannabis access in their states would be clearly protected from federal harassment, it is somewhat of an open question as to whether the the use of psilocybin and MDMA, which are not legal for any use in any state, would be federally shielded.

That caveat aside, advocates are hopeful that the new law, when it is signed, could allow more patients to access substances that have until now only been available in limited clinical trials or through underground, unregulated therapy sessions.

“It seems passing Right to Try would grant people facing death across the country tremendous relief by allowing access to MDMA-therapy and psilocybin-therapy,” Natalie Lyla Ginsberg, MAPS’s policy and advocacy director, told Marijuana Moment in an email. “Both forms of psychedelic-therapy have been specifically researched as a treatment for anxiety associated with life-threatening illnesses, and have produced incredibly promising results, both for the patients and for their families and loved ones. We are hopeful Right to Try would inspire hospice centers to start integrating psychedelic therapy into their treatment.”

President Trump called on lawmakers to pass the legislation during his State of the Union address earlier this year.

“We also believe that patients with terminal conditions — terminal illness — should have access to experimental treatment immediately that could potentially save their lives,” he said. “People who are terminally ill should not have to go from country to country to seek a cure. I want to give them a chance right here at home. It is time for the Congress to give these wonderful, incredible Americans the right to try.”

The House previously passed a similar bill in March (after it failed during a prior attempt). Rather than seek to reconcile the differences between the two chambers’ proposals via a conference committee, a process that would require further Senate action that seems doubtful given broad Democratic opposition, House GOP leaders decided to simply pass the other chamber’s bill in order to get it to the president.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Tom Angell is the editor of Marijuana Moment. A 15-year veteran in the cannabis law reform movement, he covers the policy and politics of marijuana. Separately, he founded the nonprofit Marijuana Majority. Previously he reported for Marijuana.com and MassRoots, and handled media relations and campaigns for Law Enforcement Against Prohibition and Students for Sensible Drug Policy. (Organization citations are for identification only and do not constitute an endorsement or partnership.)

Politics

Feds Award $3 Million In Grants To Study Marijuana Ingredients As Alternatives To Opioids

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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.”

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)

Senate Report Slams Drug Scheduling System For Blocking Marijuana Research

 

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Beto O’Rourke Proposes Drug War Reparations Funded By Marijuana Taxes

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Marijuana would not only be legalized under a plan proposed on Thursday by Democratic presidential candidate Beto O’Rourke, but cannabis tax revenue would be used to directly repay formerly incarcerated people through a new “Drug War Justice Grant” program.

Unlike other contenders who have come around to supporting marijuana legalization in just the past couple of years, the former Texas congressman has long called for ending prohibition—and his new plan in many respects goes further than those rolled out by other campaigns.

Please visit Forbes to read the rest of this piece.

(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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Support Grows For Marijuana Legalization Bill In Colombia

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Colombia’s legislature will soon take up a bill to legalize and regulate the production and consumption of marijuana for adults.

The legislation, which is being filed by Sen. Gustavo Bolivar of the opposition Colombia Humana party, seeks to end prohibition as a means of curtailing crime and supporting a public health-focused approach to drug policy.

Bolivar, an author who has written several books centered on drug trafficking, has characterized the bill as being about “regularization, not legalization,” but it would provide for legal sales to adults with restrictions similar to those imposed for tobacco and alcohol. There would be penalties for selling to underage individuals and smoking wouldn’t be permitted in public spaces.

The senator pointed to Uruguay, Canada and states in the U.S. as regulatory models for legalization.

“It has been proven that crime levels are lowered and public health is improved,” he said, according to Colombia Reports.

Sen. Alberto Castilla Salazar of the leftist Polo Democrático party said that his coalition supports the reform measure.

“Colombia must overcome prohibitionism and break the ties of illegal groups with the control of cannabis, so that it is the State that regulates, defines the forms and understands consumption as a public health problem,” he said on Tuesday.

Sen. Julián Gallo Cubillos of the FARC party said his coalition supports the legislation and that it represents “a new way to fight the scourge of drug trafficking.”

The proposal has also garnered the support of former President Juan Manuel Santos, who has been an outspoken advocate for ending the war on drugs. His Liberal party could make or break the legislation depending on where members fall.

While left and center-left lawmakers seem largely united around legalizing marijuana, the issue will likely face resistance from President Ivan Duque, who last year signed a decree banning low-level possession of cannabis and cocaine despite court rulings that such activity is permissible.

As Colombia Reports noted, however, Duque’s far-right Democratic Center party is in the minority.

“We’ll have to see how many senators are left to former president Juan Manuel Santos and see how public opinion receives the idea that marijuana can be consumed in public spaces,” Sen. Paloma Valencia, a member of the president’s party, said.

If the country does opt to pursue a regulated cannabis program, it will join Mexico, where lawmakers are readying legislation to legalize marijuana for adult use following a Supreme Court ruling establishing that a ban on possession and cultivation for personal use is unconstitutional.

Former White House Drug Czar Offers Marijuana Legalization Advice To Mexico

Photo courtesy of Brian Shamblen.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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