An Edinburgh mum whose son hasn't had a seizure in over four years, after being given cannabis oil, is pushing for change with the family currently paying £1000 a month for the treatment. A mother in Edinburgh whose son had "hundreds" of seizures a day has said his life changed since receiving medicinal cannabis treatment. Karen Gray told Edinburgh Live her son started the treatment back in 2019, and hasn't had one seizure since. Laws…
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Lee Dalgetty, Edinburgh Live, KahliBuds, 420GrowLife
A California campaign has withdrawn its proposed ballot initiative to create a $5 billion state agency tasked with funding and promoting psychedelics research. That leaves two separate campaigns left to put psychedelics reform on next year’s ballot after the governor vetoed a bill to legalize possession of substances like psilocybin and begin work to establish regulated access.
The decision was informed by recent polling from the firm FM3 Research, which showed 60 percent of likely California voters oppose state funding for psychedelic therapies. Three in five Democrats supported the initiative after being presented with the summary language approved by the state attorney general’s office, but most independents and Republicans opposed it.
Seventy-four percent of California voters did agree that the state needs to address mental health issues like post-traumatic stress disorder (PTSD), but 45 percent were opposed to the idea of having the state fund therapies involving psychedelics to that end.
Accordingly, the campaign won’t be continuing to collect signatures for the initiative as planned, but it did announce the launch of a new TREAT Humanity campaign to more broadly explore mental health solutions for the state. The non-profit will be “committed to furthering treatments, research, education, access, and therapies to treat mental health and optimize wellbeing,” a press release says.
“We are in a mental health catastrophe. Millions are screaming for help, not just in California, but across the country,” Jeannie Fontana, CEO of TREAT California and founder of TREAT Humanity, said. “This polling shows people are in violent agreement about the problem, and we all need it solved. TREAT Humanity arises from this shared conviction. Our mental health crisis will not go away until we solve it.”
“This polling is not a sign of defeat. It is clarity about our path forward, illuminating our way with vision, hope, dedication, and determination,” she said. “The resolve of our team and coalition is unwavering. We need a path through these dark times in our country. We are all in this together, all part of the same human family, each of us a thread in the tapestry of humanity.”
The psychedelics institute that initiative supporters hoped to establish would have been designed to identify opportunities for advancing scientific research and development into the therapeutic potential of psychedelics. It would have created a state constitutional right to conduct research in California using all psychedelic substances except peyote. Among them are psilocybin, ibogaine, LSD, MDMA, ketamine and cannabis.
While the campaign was led by a team of seasoned strategists who previously championed successful ballot initiatives related to stem cell research, signaling a level of confidence about the psychedelics measure’s prospects, the polling ultimately raised questions about the path to passage.
The idea was to have voters approve $500 million in annual funding through government agency revenue bonds—rather than tax revenue—over the span of ten years, allowing the institute to provide grants and loans for psychedelics research. The intention was for the agency to be self-funded, with the institute reaching deals with grant recipients to hold intellectual property rights for what the research produces.
Grants would have needed to support research into the risks and benefits of psychedelic-assisted therapy for addiction, anxiety, depression, suicidality, post-traumatic stress disorder (PTSD), chronic and acute pain and other disorders such as obsessive compulsive disorder (OCD) and anorexia.
The state agency would have also facilitated the creation of “care programs” in California for psilocybin and MDMA once the psychedelics are approved for therapeutic use by the FDA.
“This movement is bigger than any single ballot initiative,” Guy McDermott, a former U.S. Navy SEAL and California firefighter, said. “Safe and effective psychedelic-assisted therapies are necessary to help us get through this mental health crisis. Our military should not have to leave our country to receive life-saving therapies. We will not stop until people who are suffering get the help they need and deserve. We absolutely must treat humanity.”
In order to qualify the constitutional amendment for next year’s ballot, the campaign would have needed at least 874,641 valid signatures from registered voters.
Deb Hubers, COO of TREAT, told Marijuana Moment in July that she was confident Californians would support the measure if it makes it to the ballot, pointing to recent national polling showing that a majority of Americans back legalizing psychedelic-assisted therapy.
Another new psychedelics campaign has also emerged in California, with advocates recently filing a ballot initiative with state officials that would create a right “to obtain and use psychedelics for medical, therapeutic and spiritual purposes” with the recommendation of a doctor. It would also allow adults to possess and use the substances in their home as well as cultivate entheogenic plants and fungi on private property.
Meanwhile, Gov. Gavin Newsom (D) recently vetoed a bill to legalize certain psychedelics and create a pathway to regulated access. In a veto message, however, he wrote that he wants the legislature to send him a new bill next year establishing guidelines for regulated therapeutic access to psychedelics and also consider a “potential” framework for broader decriminalization in the future.
Home values in states that have legalized adult-use cannabis or medical marijuana rose faster than real estate prices in other states, according to new research. Home values in states that have legalized cannabis were higher and grew at a faster rate than in non-legal states, according to a recently
For nearly as long as the federal government has classified marijuana as a Schedule I controlled substance, the Food and Drug Administration (FDA) has been evaluating applications from researchers seeking to develop therapeutic drugs from the plant. In a pair of newly published documents, the agency looks back on more than half a century of investigational cannabis-based drugs and offers its perspective of what the future of drug development might hold.
That includes studying a broader range of methods of consuming marijuana such as edibles as well as investigating lesser-known cannabinoids and other components like terpenes.
Over the past 50 years, FDA has evaluated more than 800 investigational new drug applications (INDs) involving cannabis and cannabis-derived products (CCDPs), agency officials said in both a blog post and an article in the journal Exploration of Medicine. That period has seen profound changes in product form factors, cultural views and the legal landscape around cannabis—all of which have been felt at FDA.
What began as a trickle of applications soon after the passage of the federal Controlled Substances Act (CSA) in 1970 has become a deluge in recent years, authors said, as more states legalize the drug for medical and adult use. The past decade alone has brought a “nearly identical” number of cannabis-related drug applications as the previous 40 years combined, for example, and currently the agency is considering than 150 active INDs involving cannabis-based drugs and related synthetics.
“The FDA continues to support robust scientific research needed to develop new drugs from cannabis,” agency authors wrote in the Exploration of Medicine article, “and is committed to supporting the development of these new drugs through the IND and drug approval processes.”
INDs have typically focused on four major clinical areas over the years, FDA said. The bulk of them (53 percent) center on addiction and pain medicine, while 19 percent involve neurology, 14 percent involve immunology and inflammation and 9 percent involve psychiatry.
Product form factors have also changed radically since evaluations of cannabis-based drugs began. Early on, in the 1970s, INDs were mostly around smokable forms of marijuana, FDA said. But as more types of products have been developed—fueled in part by state-level legalization—the agency has received more drug applications around oral, vapor and infused-food products like baked goods and sweets.
“The past 10 years have brought a proliferation of new product types proposed for use in human clinical trials as well as an increase in applications,” the journal article says. “Other oral product types began to be proposed for clinical trials in the 1990s and 2000s, but inhalation via cigarette remained the primary [route of administration] studied. However, in the 2010s the variety of product types dramatically expanded in clinical trials to include a wider array of oral product types and other ROAs. Broadly, the product types proposed for use included baked goods, botanical extracts, capsules and tablets, oils, purified (or semi-purified) extracts, sweets (e.g., candies), tinctures, and vaporized products (e.g., vapes).”
The shift in form factors, FDA notes, is largely the result of cannabis consumers themselves. “The emergence of interest in studying these various ROAs under clinical trials is likely due to changes in the cannabis consumer in the United States,” authors wrote. “In recent years, consumers have transitioned from exclusively smoking dried cannabis flower to consuming other non-flower forms, such as edibles.”
Amid the changes, FDA authors said that challenges remain around developing cannabis-related drugs for clinical trials, especially around safety and the unknown qualities of lesser-known chemicals.
“These research challenges include, but are not limited to, absent and/or inadequate quality and manufacturing information, unknown safety profiles and unknown benefits/risks for emerging compounds [e.g., hexahydrocannabinol (HHC), THC acetate (THC-O)], and the complex matrix effects on testing of final product formulations,” the journal article says.
Nevertheless, the authors note that the broadening of form factors being studied “correlates with the drug approvals “correlates with the drug approvals of Syndros (2016) and Epidiolex (2018), which are both oral formulations. This expansion also tracks with the increased availability of products in the state-level marketplace, along with the passage of the Agricultural Improvement Act (i.e., the Farm Bill) on December 20, 2018.”
In FDA’s blog post about the past 50 years of evaluating cannabis-based drugs, authors say they “expect there will be new increased interest in clinical research to study CCDPs.”
In addition to new products and form factors, they also expect “the use of newly identified or less common cannabinoids, as well as other components of the cannabis plant, such as terpenes.”
FDA recognizes the uniqueness of CCDPs and botanical drug research, the post says, and the agency “will continue to support sound, scientifically based research into the therapeutic uses of CCDPs and will work with companies interested in bringing safe, effective, and quality drugs to market through our drug development and approval process.”
Despite the shifting legal landscape and growing diversity of product types, research into cannabis remains difficult as the result of its Schedule I status as well as laws specifically limiting study into marijuana.
DEA is also currently carrying out a review of marijuana’s CSA scheduling status after receiving a recommendation from the Department of Health and Human Services (HHS) to move marijuana from Schedule I to Schedule III.
DEA has touted its Schedule I drug production quotas as evidence that is supports rigorous research into the substances, but it’s faced criticism from advocates and scientists over actions that are viewed as antithetical to promoting studies.
FDA has approved a small number of cannabis-derived medications and similar synthetics, but the agency generally does not approve holistic or plant-based medicines. If marijuana was rescheduled, as HHS has proposed following a scientific reviewed directed by President Joe Biden, it would remain federally illegal except for medical use with a prescription from a doctor.
As for CBD—one of the few parts of the cannabis plant no longer scheduled under the CSA—FDA has been slow to issue rules following Congress’s legalization of the cannabinoid through the 2018 farm bill. FDA said it carried out a comprehensive review before reaching the conclusion, in January, that it couldn’t effectively regulate the complex market.
The resulting uncertainty is widely blamed as a primary driver of the hemp industry’s recent economic woes. It’s also led to confusion within the marketplace as businesses continue to sell a widening variety of cannabis products, including intoxicating cannabinoids such as delta-8 THC, without meaningful oversight.
In response to the ongoing inaction, bipartisan congressional lawmakers have introduced legislation to fill the regulatory gap and provide for the lawful marketing of CBD as food items or dietary supplements. A recent House subcommittee hearing specifically focused on the impact of the lack of FDA rules, and a separate pair of bicameral health committees has solicited expert input on the issue as they consider potential legislative fixes.
State marijuana regulators, as well as hemp industry associations, are among those who responded to the House and Senate committee requests for information. And while there was some disagreement about the scope of FDA’s current regulatory authority, they largely agreed that Congress needs to take a more holistic approach to the issue and consider rules for all hemp-derived cannabinoids, including delta-8 THC.
House Oversight Committee Chairman James Comer (R-KY) said in April that his panel would be launching an investigation into FDA’s CBD review. He requested that the agency turn over documents related to its decision not to regulated the cannabinoid. Even before the agency made that decision, the congressman expressed his intent to address the lack of rules.
Willie’s Reserve is now available at Puff dispensaries and several other retailers throughout Michigan. Country cannabis outlaw and icon Willie Nelson entered the Michigan cannabis market, debuting his cannabis brand in the state last week. Michigan is the eighth state so far to sell flower from the
