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.
Oregon Psilocybin Initiative Gets Boost From New TV Ad But Draws Opposition From Unlikely Source
An Oregon ballot initiative to legalize psilocybin for therapeutic purposes is getting a boost from a nonprofit veterans group’s new TV ad. But meanwhile, the campaign is seeing pushback from an unexpected source.
On the one side, the Heroic Hearts Project—which helps connect veterans to entheogenic-based healing and provides complementary counseling—is airing an advertisement in the state that highlights the therapeutic potential of taking psilocybin in a clinical setting.
The 30-second spot doesn’t explicitly mention the reform measure that will appear on Oregon’s November ballot, but it could help inform how voters approach that question when they head to the polls nonetheless. According to the group, it will play on television frequently enough that the average viewer should see it about seven or eight times.
Here’s the script of the ad:
“As a scientist, I’m impressed by the research. Major universities findings show psilocybin therapy can be effective for depression and anxiety.
It’s plant medicine [the Food and Drug Administration] calls breakthrough therapy, meaning it can be an improvement over available options.
The psilocybin therapy program: Research-based with patient safety top of mind, strictly regulated.
We’re in a mental health crisis. The science is real, the restrictions smart. Psilocybin therapy: Healing, providing hope.”
Heroic Hearts Project is largely focused on the plant ayahuasca. But the group says psilocybin is another treatment option that’s shown promise in mitigating symptoms of post-traumatic stress disorder.
“In Oregon and across the country there has been a big decriminalization movement, there’s been a big push to do similar to what we’re doing but also allow for access within the U.S. because there’s a lot of people that understand the power and the efficacy of these treatments,” Jesse Gould, founder of the organization, told Marijuana Moment.
“Within Oregon, there is this historic opportunity where they’re trying to create licensed and regulated psilocybin and therapy—and there’s a lot of veterans in Oregon—so just having that availability of it in a place that they can rely on, that they know it’s safe, is a tremendous value to the veterans in Oregon,” he said. “I think it will also be a model for other states and other localities to adopt it.”
Again, the ad doesn’t explicitly promote the psilocybin legalization initiative that will appear on Oregon’s November ballot—but there has been a strong push from a wide range of experts and advocates to pass the historic measure. The Oregon Democratic Party also formally endorsed the psychedelic therapy proposal earlier this month.
“Oregonians are suffering from the most severe mental health crisis in the country,” Sam Chapman, campaign manager for the psilocybin measure, told Marijuana Moment. “We know that if we want to help terminally ill cancer patients, veterans, and so many others who are struggling to combat depression and anxiety due to COVID, we need a licensed and regulated system that people can trust.”
But while these developments could help bolster the campaign, there’s also been surprising dissent from certain psychedelics reform advocates who argue that the proposed legal therapeutic model for psilocybin would threaten equitable access to entheogens.
Decriminalize Nature (DN), the group advancing a localized psychedelics decriminalization movement across the country, is urging Oregonians to vote “no” on the initiative.
“M109 threatens equitable access by not ending the prohibition of personal use and establishing supremecy [sic],” DN said in a tweet.
DN groups in OR are taking a No position on the Oregon Psilocybin Service measure. M109 threatens equitable access by not ending the prohibition of personal use and establishing supremecy. Therefore, in solidarity with our local groups in Oregon, we share this with our DN network https://t.co/Q8cqJF7iPh
— Decriminalize Nature (@DecrimNature) September 30, 2020
The group’s Portland chapter, which said earlier this year that it would pursue psychedelics decriminalization through the City Council, announced last week that it’s now against the psilocybin measure and declining to endorse a separate proposal to decriminalize possession of all currently illicit drugs and fund treatment services that will also appear on the state’s ballot.
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Decrim Nature Oregon Groups Encourage No on M109 Oregon Psilocybin Services Measure . . DN Nature lovers, When Oregon first created it’s statewide initiative, decriminalization language was included and all signatures were accounted for. After a sizeable donation, the #Oregon Psilocybin Service measure removed the decriminalization language thereby continuing the prohibition of psilocybin mushroom gathering, growing, or having an experience in the safety of one’s own home. Negotiations broke down with the key sponsor of this initiative last week to ensure the protection of equitable access to entheogenic plants for the most vulnerable. M109 threatens this due to sections that do nothing to end the prohibition of personal use and also establishes statewide supremacy. Therefore, Decrim Nature groups in Oregon are taking a No position on the Oregon Psilocybin Service measure. In solidarity with our local groups in Oregon, we share this with our DN network.
DN Portland said they are “advocating that all people who care about ensuring access to entheogenic medicines for all people regardless of financial status, those who care about protecting these medicines from the profit motives of capital, and those who wish to see big money removed from the equation of psychedelic medicines.”
David Bronner, CEO of the soap company Dr. Bronner’s, has helped finance a slew of marijuana and psychedelics reform campaigns for years, including the psilocybin legalization initiative. Private messages that DN decided to release show the executive expressing concern about certain internal politics within the movement, including disputes between DN and the Indigenous Peyote Conservation Initiative about including peyote within the scope of decriminalization measures.
In a blog post, he wrote that Dr. Bronner’s “is fully committed to the Decriminalize Nature (DN) movement, but have recently lost faith in its national leadership.” Regardless, “we still fully support regional DN campaigns such as DC’s effort to decriminalize plant medicines.”
In turn, DN alleged that Bronner “is resorting to divide and conquer tactics to control the Decriminalize Nature movement. ”
Under the Oregon psilocybin ballot measure, adults would be able to access the psychedelic in a medically supervised environment. There aren’t any limitations on the types of conditions that would make a patient eligible for the treatment.
Rep. Earl Blumenauer (D-OR) told Marijuana Moment in January that he was in favor of the psilocybin reform proposal and that he would be working to boost the campaign as the election approaches. Last month, he wrote in an email blast that passing the measure is necessary “because it tackles an important issue in our community, mental health, and it does so in an innovative and responsible way.”
The campaign behind the separate drug decriminalization and treatment funding initiative recently released its first ad urging Oregonians to support it.
Photo courtesy of Wikimedia/Mushroom Observer.
Colorado Governor Grants Thousands Of Marijuana Pardons With New Clemency Powers
The governor of Colorado on Thursday signed an executive order granting nearly 3,000 pardons for people convicted of possession one ounce of less of marijuana.
Pursuant to a new law that he signed in June, Gov. Jared Polis (D) made the pardons on the first day the policy took effect. While the law gives him authority to grant clemency for cases of possession of up to two ounces, his office explained that he limited it to one ounce because that’s the legal possession limit under Colorado’s cannabis program.
“We are finally cleaning up some of the inequities of the past by pardoning 2,732 convictions for Coloradans who simply had an ounce of marijuana or less,” Polis said in a press release. “It’s ridiculous how being written up for smoking a joint in the 1970’s has followed some Coloradans throughout their lives and gotten in the way of their success.”
Thank you to @repjamescoleman, Sen. Julie Gonzales (@SenadoraJulie), and Sen. @VickiMarble for sponsoring this historic bill. Rep. @leslieherod and Rep. Jonathan Singer (@Singer4BoCo) were also champions of passing this legislation.
— Governor Jared Polis (@GovofCO) October 1, 2020
Convictions impacted by the governor’s action range from those that took place in 1978 though 2012.
“Too many Coloradans have been followed their entire lives by a conviction for something that is no longer a crime, and these convictions have impacted their job status, housing, and countless other areas of their lives,” he added. “Today we are taking this step toward creating a more just system and breaking down barriers to help transform people’s lives as well as coming to terms with one aspect of the past, failed policy of marijuana prohibition.”
The new law allows the governor to use his clemency power for cannabis offenses without consulting with prosecutors and judges involved in the cases, as is typically required under statute.
“For the individuals pardoned in this Executive Order, all rights of citizenship associated with the pardoned conviction are restored in full without condition,” the order states. “All civil disabilities and public sufferings associated with the pardoned conviction are removed.”
People who are eligible for the pardons don’t have to do anything to clear their own records; it’s automated, and individuals can check a website to see if they’ve been processed.
Those who have municipal marijuana convictions, or who were arrested or given a summons, don’t qualify for the pardon. The action only applies to state-level convictions.
A frequently asked questions document states that while Polis has declined for now to use the full extend of his pardon power by applying it to people with convictions of up one to two ounces, the “administration will continue to evaluate” cases that could receive clemency. A representative from the governor’s office did not immediately respond to a question from Marijuana Moment about whether plans are imminent to expand the pardon pool.
The governor’s action also calls on the state Department of Public Health to “develop a process to indicate on criminal background checks which individuals’ convictions have been pardoned pursuant to this Executive Order.”
Colorado isn’t alone in pursuing opportunities to enact marijuana-focused restorative justice policies.
In June, more than 15,000 people who were convicted for low-level marijuana possession in Nevada were automatically pardoned under a resolution from the governor.
Polis told Westword that beyond the practical benefits of having these records cleared, the move is “also symbolically important, because it shows that as a state and nation, we’re coming to terms with the incorrect discriminatory laws of the past that penalized people for possession of small amounts of marijuana.”
Photo courtesy of Martin Alonso.
Marijuana Arrests Decline Nationally For First Time In Four Years, FBI Data Shows
Marijuana arrests in the U.S. declined in 2019 for the first time in four years, a new federal report shows.
While many expected the state-level legalization movement to reduce cannabis arrests as more markets went online, that wasn’t the case in 2016, 2017 or 2018, which each saw slight upticks in marijuana busts year-over-year. But last year there was a notable dip, the data published this week shows.
There were a total of 545,601 marijuana arrests in 2019—representing 35 percent of all drug arrests—according to FBI’s Uniform Crime Reporting program. That’s down from 663,367 the prior year and 659,700 in 2017.
Put another way, police across the country made a cannabis bust every 58 seconds on average last year. Of those arrests, 500,394 (92 percent) were for possession alone.
“A decline in cannabis related arrests is better than seeing an increase for a fourth year in a row, but the amount of these arrests is still abhorrent,” Marijuana Policy Project Executive Director Steve Hawkins told Marijuana Moment. “There is no reason to continue punishing adults for consuming a substance that is less harmful than alcohol. Arresting adult cannabis consumers has a dramatically disproportionate impact on communities of color, is a massive waste of law enforcement officials’ time and resources and does nothing to improve public health or safety.”
Overall, arrests for drug sales, manufacturing and possession amounted to 1,558,862 for the year—approximately 15 percent of all busts reported to FBI from local and state law enforcement agencies. That’s one new drug case every 20 seconds.
Before 2016, the country had seen a consistent decline in marijuana arrests for roughly a decade. It should be noted, however, that not all local police participate in the federal agency’s program, so these figures are not holistic.
Nonetheless, this data shows that American law enforcement carried out more arrests for marijuana alone than for murder, rape, robbery, burglary, fraud and embezzlement combined.
“At a time when a super-majority of Americans support marijuana legalization, law enforcement continues to harass otherwise law abiding citizens at an alarming rate,” NORML Political Director Justin Strekal told Marijuana Moment. “Now is the time for the public to collectively demand that enough is enough: end prohibition and expunge the criminal records to no longer hold people back from achieving their potential.”
While there’s no solitary factor that can explain the recent downward trend in cannabis cases, there are one-off trends that could inform the data. For example, marijuana possession arrests fell almost 30 percent in Texas from 2018 to 2019, and that seems to be connected to the legalization of hemp and resulting difficulties police have had in differentiating the still-illegal version of the cannabis crop from its newly legal non-intoxicating cousin.
At the federal level, prosecutions for marijuana trafficking declined in 2019, and drug possession cases overall saw an even more dramatic decline, according to a report published by the U.S. Sentencing Commission in March.
Federal prosecutions of drug-related crimes increased in 2019, but cases involving marijuana dropped by more than a quarter, according to an end-of-year report released by Supreme Court Chief Justice John Roberts in December.
A study released by the Cato Institute in 2018 found that “state-level marijuana legalization has significantly undercut marijuana smuggling.”