Cannabis News
Australia Legalizes Medical Psychedelics – Psilocybin and MDMA Approved for Medical Treatments
Published
2 years agoon
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The government of Australia has made a bold move to improve the mental health of its citizens by granting access to two groundbreaking therapies in the form of psilocybin and MDMA. The rescheduling of these psychedelics is aimed at helping those struggling with debilitating conditions such as post-traumatic stress disorder (PTSD) and depression that have proven resistant to traditional treatments.
The Australian government has made a progressive decision to prioritize the mental wellness of its citizens by reclassifying psilocybin and MDMA under the country’s drug code. While these substances won’t be made available for general use, they will now be listed in Schedule 8 for therapeutic purposes, allowing authorized psychiatrists to prescribe them to needy patients. However, it’s important to note that these drugs will remain under the stricter Schedule 9 classification for unauthorized use.
The Australian Therapeutic Goods Administration (TGA) made a groundbreaking announcement on Friday, recognizing the critical need for better options in treating certain treatment-resistant mental illnesses. The decision highlights the pressing issue of limited options available to patients and marks a significant step toward improving their mental well-being. The TGA stated in its notice that this is a crucial step towards addressing the current unmet medical needs of those struggling with these debilitating conditions.
Starting July 1st, psilocybin and MDMA will become accessible in a controlled medical setting for therapeutic purposes, as stated by the Australian Therapeutic Goods Administration (TGA). The decision resulted from numerous applications to reclassify the substances in the Poisons Standard, public consultation, a thorough report from an expert panel, and guidance from the Advisory Committee on Medicines Scheduling. However, the TGA also recognizes the inherent vulnerability of patients undergoing psychedelic-assisted psychotherapy and has put in place the necessary controls to safeguard them during this process.
However, the Australian Therapeutic Goods Administration (TGA) has not evaluated any products containing psilocybin or MDMA for their quality, safety, and efficacy. Nevertheless, this amendment allows authorized psychiatrists to legally provide a designated “unapproved” medicine containing these substances to their patients for specific therapeutic purposes. This change represents a significant milestone in improving access to innovative treatments for those struggling with mental health conditions.
Australia Setting The Pace
The recent policy change in Australia has been widely celebrated by advocates in the United States and globally. The Food and Drug Administration’s (FDA) designation of MDMA and psilocybin as breakthrough therapies only adds to the excitement around this development. Rick Doblin, the executive director of the U.S.-based Multidisciplinary Association for Psychedelic Studies, expressed his hope that this move will inspire other countries to follow suit, providing suffering individuals with more opportunities to access novel treatments. He further emphasized that access to psychedelic therapies and comprehensive drug policy reform should be a global conversation and collaboration.
California State Senator Scott Wiener, who has been a driving force behind legislation to legalize the possession of certain psychedelics, hailed the news as “fantastic.”
However, the journey toward accessing psychedelics in the U.S. has not been easy. The Drug Enforcement Administration (DEA) recently rejected a petition to reschedule psilocybin and a doctor’s request for a federal waiver to obtain and administer the psychedelic to terminally ill patients. This has led to a series of legal challenges in federal court. Sunil Aggarwal, a palliative care specialist in Washington State, has been battling the DEA for over a year to gain access to psilocybin. Despite his efforts, the DEA has denied his petition to place the substance in a lower drug schedule and the doctor’s waiver request under the federal “Right to Try” (RTT) law.
Matt Zorn, an attorney working on this case, said in a blog post that the process by which the Australian reform happened is precisely what they are striving to achieve in their legal battle against the DEA.
DEA Faces More Pressure
Amid mounting pressure from bipartisan lawmakers, the Drug Enforcement Administration (DEA) has come under increased scrutiny over its stance on psychedelics such as psilocybin. This has led to a series of congressional actions to clarify the use of these substances in medical treatments. It includes filing companion bills in the House and Senate to reaffirm that the “Right to Try” (RTT) policy includes Schedule I drugs like psilocybin.
The proposed amendment would make a technical change to the existing statute. It clarifies that terminally ill patients can use investigational drugs that have undergone clinical trials, regardless of their scheduling status, provided they have their doctor’s approval. This follows a letter sent by bipartisan members of Congress, led by Rep. Earl Blumenauer (D-OR), calling on the DEA to allow terminally ill patients to use psilocybin without fear of federal prosecution.
Amid the surge of research revealing the therapeutic benefits of psychedelics, Sen. Brian Schatz (D-HI) and Sen. Cory Booker (D-NJ) have taken a stand to shed light on the potential of these substances. Despite being labeled as Schedule I drugs, which restricts research and development, psilocybin and MDMA have shown remarkable results in treating PTSD, trauma, anxiety, and depression.
However, federal prohibition has impeded the study of these substances. To address the issue, Sen. Booker released a video in October where he spoke about the limitations imposed on psychedelics and the need to advance their research.
Conclusion
With the recent decision by the Australian government to reschedule psilocybin and MDMA for therapeutic use, the world is beginning to take notice of the immense potential these substances hold for treating mental illness. This move highlights the need to reconsider current drug policies and regulations to provide better care for patients who have PTSD and other treatment-resistant mental health issues.
As more and more studies point to the effectiveness of psychedelics in treating mental health disorders, the pressure continues to mount for countries to re-evaluate their stance on these substances. The future of psychedelics in medicine is looking brighter. Hopefully, this change in Australia will inspire other nations to follow suit and provide suffering individuals with access to the treatments they desperately need.
MORE ON AUSTRALIA LEGALIZING, READ ON…
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Cannabis News
California Appeals Court Rejects Marijuana Grow Permit, Citing Federal Illegality
Published
58 minutes agoon
November 22, 2024By
admin
In a landmark decision that highlights the tension between state and federal cannabis laws, a California appellate court ruled on October 29th that property owners can refuse to allow the transportation of cannabis across their land via easements, even when the cannabis operation is approved by local authorities.
The Second District Court of Appeal’s unanimous decision draws attention to private property rights in a context where cannabis remains federally illegal, but state law allows licensed cultivation, distribution and sale. Presiding Justice Albert Gilbert stated, “No matter how much California voters and the Legislature might try, cannabis cultivation and transportation are illegal in California as long as it remains illegal under federal law.” JCCrandall LLC v. County of Santa Barbara, Case No. B333201, 2024 WL 4599304, Oct. 29, 2024.
Unless the California Supreme Court grants review – which I would not rule out – the decision empowers private property owners to refuse to contract with cannabis businesses, and restricts local government from approving cannabis operations that implicate the property rights of neighbors who object.
The case at hand
The dispute centered around a cannabis cultivation operation in Santa Barbara County, where JCCrandall LLC challenged a conditional use permit granted by the County to its neighbor, Santa Rita Holdings Inc. The critical issue was that Santa Rita Holdings could only access its 2.5-acre cannabis farm via an unpaved road crossing JCCrandall’s property through a pre-existing easement. JCCrandall grows oats and barley.
JCCrandall’s primary concern? It raised a number of complaints with the Santa Barbara County Supervisors about truck traffic and night operations, which did not gain traction, but in the Court of Appeal JCCrandall focused on what it claimed was potential liability associated with having federally illegal substances transported across its property, even though County regulators found that the Santa Rita operation was fully compliant with state and local laws.
Key legal findings
The appellate court’s decision hinged on several crucial points:
- Property Rights: The court emphasized that “the right to exclude others is the essence of the right of property ownership” and classified it as a fundamental vested right.
- Federal Supremacy: The panel determined that allowing cannabis transportation across private property “defies the Supremacy Clause” of the U.S. Constitution.
- State vs. Federal Law: While cannabis might be legal under California law, the court ruled that federal law’s prohibition takes precedence in this context.
California cannabis industry implications
Legal experts suggest this ruling could have far-reaching consequences for California’s cannabis industry. Section 1550.5(b) of the California Civil Code makes contracts within California involving cannabis lawful and enforceable, and Santa Rita Holdings bet the ranch on that argument. But the Court of Appeal held that the statute could not compel a landowner to allow cannabis to travel across its property on a pre-existing easement. Licensed operators may find it harder to do business because neighbors who have property rights affected by a cannabis business can object, and, under the JCCrandall ruling, local government must yield to those objections.
An example might be a cannabis dispensary that depends on access to its parking lot via an easement or is located in a shopping center where other lessees have rights to object to tenants notwithstanding the approval of the landlord. In cultivation, many cannabis farms depend on vehicular access through easements because they are remote and do not always have direct access to public thoroughfares, or they depend on water sourced from other properties pursuant to agreements made by prior owners who grew traditional crops. These neighbors might not need to show any negative impact on their property, but can argue that they could be found complicit in federally illegal activities.
I think the most problematic language in the JCCrandall ruling is the following, which might draw the attention of the California Supreme Court and cause it to grant review: “For as long as an easement is enjoyed, its mode and manner of use shall remain substantially the same as it was at the time the easement was created. The County argues the easement was used for agricultural purposes. But there is a vast difference between legal and illegal agricultural purposes.” (Emphasis added.) If California has determined that cannabis cultivation is legal – as it has – and state courts routinely enforce contracts involving cannabis, it is a pretty bold step to declare the use of a lawful pre-existing easement illegal simply because the agricultural crop is cannabis and take away easement access from Santa Rita.
Looking ahead
This decision creates new challenges for cannabis businesses in California, and will result in more disputes among neighbors. While the Biden administration has shown signs of easing federal marijuana restrictions, this ruling demonstrates that the federal-state law conflict continues to create significant legal hurdles for the cannabis industry.
California court decisions also can be persuasive authority in other states, so we might see similar litigation (and decisions) elsewhere in the country where cannabis has been legalized.
The case serves as a reminder that despite California’s progressive stance on cannabis, federal prohibition continues to cast a long shadow over the industry’s operations and development. As the cannabis landscape continues to evolve, this ruling may prompt businesses to reassess their property arrangements and local governments will certainly have to reconsider their permitting processes to give more careful consideration to objections by neighbors who claim that their property rights are implicated by cannabis operations.
Note: This post was first published earlier this month on the Alger ADR Blog.
Cannabis News
Autoimmune Conditions Are Rising Fast in American Medicine, Can Cannabis Help?
Published
1 day agoon
November 21, 2024By
admin
Why Are Autoimmune Conditions On The Rise? And How Cannabis Can Help
Autoimmune diseases refer to a group of medical conditions that occur as a result of the immune system attacking your own tissues.
In a normal human body, the immune system is responsible for protecting the body by producing antibodies that prevent toxins, cancer cells, and viruses from harming the body. However, when one is struck by an autoimmune disorder, the immune system is no longer able to distinguish the difference between dangerous cells and healthy cells. As a result, the healthy cells are attacked, too.
Today, we know of around 100 different kinds of autoimmune conditions. Some of the most common examples of autoimmune conditions include rheumatoid arthritis (RA), lupus, inflammatory bowel disease, celiac disease, Type 1 diabetes, multiple sclerosis (MS), and the Guillain-Barre syndrome (GBS) to name a few. Others include Graves’ disease, Hashimoto’s thyroiditis, psoriasis, and vasculitis.
According to the National Health Council, around 50 million Americans are affected by autoimmune diseases today. This is a conservative estimate, considering that several autoimmune conditions are tricky to treat and so many people go undiagnosed for long periods of time. It’s worrisome to note that there are more people developing autoimmune diseases these days, many of which have reached levels comparable to epidemics.
But cannabis can help!
How Cannabis Can Help Curb And Manage Autoimmune Diseases
Not one single cause is responsible for the alarming growth of autoimmune diseases, though there are several factors at play. While there isn’t just one cause we can point at, it’s certain the reasons lie in our environment. After all, human genetics haven’t changed significantly yet the chemicals, toxins, and pollutants in our food and everyday items have risen dramatically.
In addition, people are getting less sleep than ever; stress rates are through the roof, and people are constantly worried. There is a clear link between psychological stress and physical health as well as immunity, which is why it isn’t unusual – it’s even common – to see many autoimmune disease cases flare up after people experience severe stress caused by grief, an accident, job loss, or the death of a loved one. These highly stressful and traumatic conditions wreak havoc on the body’s immune response, causing inflammation all over the body.
Conventional treatments prescribed to treat autoimmune conditions are focused on taming inflammation; these usually include steroids but also some non-steroidal drugs. These drugs often come with unwanted side effects, but research has shown that cannabis can work with the endocannabinoid system through THC and CBD, as well as other cannabinoids, to simulate similar results. In one study for example, we can see the clear association of the endocannabinoid system for neurodegenerative and inflammatory processes seen in Multiple Sclerosis and Amyotrophic Lateral Sclerosis.
There has also been an increasing number of studies proving the efficacy of cannabis for treating several autoimmune conditions.
Cannabis For Multiple Sclerosis
Multiple sclerosis is one of the autoimmune conditions where a growing number of studies have come out supporting the therapeutic benefits of cannabis for. In a 2024 study, patients with multiple sclerosis reported several improvements in quality of life after using cannabis-based medical products (CBMPs). For the study, British investigators analyzed the impact of cannabis based medicinal products made from either oil or extracts in 141 patients who were enrolled in the UK Medical Cannabis Registry.
The researchers then analyzed the changes in patient outcomes after a month, then three and 6 months after. According to the patients themselves, they were able to sustain improvements in their mental and physical health after marijuana therapy.
“This case series demonstrates a potential association between the initiation of CBMPs and improved patient reported outcomes in sleep, anxiety, and general HRQoL [health-related quality of life] measures, over six months,” said the study authors. “Additional measures for HRQoL, including various physical and mental health subdomains, also exhibit improvements up to six months when compared to baseline,” the authors concluded.
In another study from 2023, patients with multiple sclerosis reported significant improvements in symptoms after cannabis use. For the study, researchers from the Dent Neurologic Institute in Buffalo, New York, analyzed the medical records of 141 patients with multiple sclerosis, who were also legally authorized to consume medical marijuana products. They then analyzed data from the patients after one up to 4 follow-up sessions after the initial session of cannabis therapy. Sixty-five percent of patients consumed 1:1 THC:CBD tinctures.
According to the authors: “The results of this study indicate that use of MC [medical cannabis] to alleviate symptoms of MS is largely efficacious, with improvement in pain (72 percent of patients), muscle spasticity (48 percent of patients), and sleep disturbance (40 percent of patients) frequently reported.”
“More than half of opioid users at baseline were able to either discontinue or decrease their opioid use after starting MC. The mean daily MME [morphine milligram equivalents] was significantly reduced from the initial visit (51 mg) to the last follow-up visit (40 mg). This is consistent with previous literature showing that MC legalization is associated with decreased opioid use and that MC use is associated with decreased opioid use in patients with chronic pain. These findings indicate that MC may represent an alternative analgesic to opioids for some patients,” they wrote.
Anecdotal Evidence
While more studies are needed to determine cannabis’ effect on other autoimmune conditions such as rheumatoid arthritis, we can rely on anecdotal evidence. In 2020, data from the medical journal, Rheumatology, revealed that patients who have this condition, along with those who have lupus and fibromyalgia, consume cannabis.
In fact, it was reported that marijuana was extremely common especially for patients with fibromyalgia. “In this meta-analysis, we found that one in six patients suffering from rheumatologic disease actively consumes cannabis, reducing pain reduction… A favorable effect of cannabis on pain in our meta-analysis reinforces the idea that cannabis could be used for analgesic purposes,” the authors concluded.
Conclusion
Cannabis is a safe and natural way to help prevent and treat the symptoms of autoimmune disease. It targets inflammation at its root, and is a proven natural way to help cope with stress, pain, insomnia, and inflammation all while protecting the brain. However, it’s important to ensure you medicate with clean, organic sources of marijuana.
AUTOIMMUNE AND CANNABIS, READ ON…
The U.S. Senate’s version of the Farm Bill finally landed this week. They’re calling it the Rural Prosperity and Food Security Act of 2024 (the “Senate bill”). The Senate bill follows on the House’s proposal, called the Farm, Food and National Security Act of 2024 (the “House bill”), offered in May. Neither the Senate bill nor the House bill would preempt state or Indian law regarding hemp or the regulation of hemp products. This means states and tribes will retain a lot of latitude in regulating hemp and hemp-derived products– which gets people fired up.
Aside from giving states some runway, the Senate bill and the House bill differ in key respects regarding hemp. Therefore, these august bodies must confer and reconcile their sundry proposals. That could happen in 2024, but seems more likely in 2025 when the new Congress convenes. As of this week, though, we finally have a framework.
The Senate Bill re-defines “hemp” and defines “industrial hemp”
Section 10016 of the Senate bill (“Hemp Production”) amends the definition of “hemp.” Hemp was defined in the 2018 Farm Bill and removed from the federal Controlled Substances Act (CSA), taking us on a truly wild ride. See: What Happened to Hemp? (“What Happened”). The Senate bill also gives us a definition for “industrial hemp.” Here are those definitions, with points of emphasis in bold:
(1) Hemp. The term “hemp” means (A) the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 total tetrahydrocannabinol concentration (including tetrahydrocannabinolic acid) of not more than 0.3 percent on a dry weight basis; and (B) industrial hemp.
(3) Industrial Hemp. The term “industrial hemp” means the plant Cannabis sativa L. if the harvested material (A) is only (i) the stalks of that plant, fiber produced from those stalks, or any other manufactured product, derivative, mixture, or preparation of those stalks (except cannabinoid resin extracted from those stalks); (ii) whole grain, oil, cake, nut, hull, or any other compound, manufactured product, derivative, mixture, or preparation of the seeds of that plant (except cannabinoid resin extracted from the seeds of that plant); or (iii) viable seeds of that plant produced solely for production or manufacture of any material described in clause (i) or (ii); and (B) will not be used in the manufacturing or synthesis of natural or synthetic cannabinoid products.
The new regime
Again, the definitional stuff in bold is what I want to emphasize.
First, the Senate bill keeps the THC threshold at 0.3 percent, which is an arbitrary number we’ve been advocating against for years. The Senate bill mirrors the House bill in this respect, though, so we are stuck with this, unless Ron Paul gets his way.
Second, the Senate bill keeps the 2018 Farm Bill’s total THC standard, including THCA. The House bill does this too. This was fairly predictable: in What Happened, I wrote that we could “expect the total THC standard to remain, which means that actual Delta-9 THC won’t be the only metric for calculating THC content.”
We’ve also explained on this blog that the 2018 Farm Bill and USDA rules mandate total THC testing on pre-harvest hemp batches, but do not mandate such testing on post-harvest hemp or hemp products. The Senate bill doesn’t change this paradigm, which means the “loophole” for gas station weed remains open. This proposal is a big win for opponents of the House bill’s “Miller Amendment,” which would narrow the definition of “hemp” to exclude intoxicating hemp-derived substances.
Third, the Senate bill introduces a new definition and framework for industrial hemp. The House bill does this too, albeit slightly differently. The idea here is to invite farmers to grow hemp for fiber and grain purposes, while freeing them from regulatory burdens with the Department of Agriculture and criminal exposure with the Department of Justice. More specifically, for “industrial hemp” growers, the Senate bill:
- removes background check requirements;
- instates “relaxed regulatory requirements” for sampling and inspection methodologies (which will need to be adopted by rule); and
- develops a certified seed program.
The Senate bill also makes any hemp producer ineligible to grow hemp for five years if that producer, “with a culpable mental state greater than negligence, produces a crop of hemp that is inconsistent with that license.”(Hint: use the seed program.) The proof standard here seems like it could be an issue, and even if anyone has been adjudicated as growing marijuana under the guise of hemp, Farm Bill ineligibility seems like a far-off concern.
Bottom line
The big takeaway for me is that the Senate bill leaves the door open for intoxicating hemp products, whereas the Miller Amendment to the House bill does not. Something’s gotta give. And it needs to happen soon, because we’re already long overdue. As I explained in a webinar last week, the Farm Bill deals with the nation’s entire food supply, not just hemp. Therefore, this is not like with the SAFE Banking Act, where we have a proposed law specific to cannabis that may or may not ever pass. The Farm Bill must pass, and soon.
Stay tuned and we’ll keep you updated on any major happenings. For more on this topic, check out our massive hemp and CBD archive, or these specific, recent posts:
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