Psychedelics

Law Firm Article: A Wake-up Call from Down Under: Australia’s Therapeutic Goods Administration Reschedules Psilocybin and MDMA

Published

1 year ago

March 4, 2023

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Originally posted on On Drugs, which offers “Cutting Edge Thoughts on Drug Regulation by Matt Zorn and Shane Pennington.”

As Matt Zorn discussed here and in this opinion piece with Chris Koddermann, Australia’s Therapeutic Goods Administration (TGA) recently approved a request to reschedule psilocybin and MDMA under that country’s drug classification scheme, making Australia the first country in the world to recognize the psychedelic drugs as medicines. Effective July 1, 2023, the TGA will add psilocybin and MDMA to Schedule 8 of Australia’s list of Controlled Drugs, permitting qualified psychiatrists to prescribe MDMA to treat post-traumatic stress disorder and psilocybin for treatment-resistant depression.

Access will be limited at first, but still—this is big news. For starters, rescheduling will make it easier for scientists in Australia to research these promising treatments. Further, Australia’s unexpected decision appears to be a regulatory first. Aside from medical cannabis, no country has rescheduled such a restricted compound before approving it for marketing—that is, before drug companies are permitted to profit from it.

I’m working on another piece that will address various criticisms of the TGA’s decision. My purpose here is to underscore how the TGA’s decision provides an especially dramatic illustration of the tragic consequences the DEA’s unlawful, anti-science approach to drug control has here at home.

To support its decision, the TGA relied heavily on studies conducted in the U.S. and recent U.S. Food and Drug Administration (FDA) decisions recognizing psilocybin and MDMA’s extraordinary therapeutic potential. Around the same time, the DEA shot down a petition—based on those same arguments and evidence—that Matt and I submitted on behalf of a palliative-care doctor, requesting rescheduling of psilocybin under U.S. law. The DEA’s four-sentence analysis completely ignored the same studies and FDA decisions that persuaded the Australian regulator to reschedule.

The dramatically different fates of these similar petitions reveal a troubling reality about U.S. drug law: Under the DEA’s watch, the scientific and medical determinations of the nation’s leading public health agency carry considerable weight around the world but are often ignored at home. That revelation should terrify anyone interested in rational, evidence-driven drug policy.

Those committed to the rule of law should be alarmed, too. Unlike Australia, which is under no obligation to consider the FDA’s views when making its own scheduling decisions, the DEA is obligated by statute to seek out the FDA’s expert judgment before taking action on a rescheduling petition. (See 21 U.S.C. 811(b) (requiring DEA to request a medical and scientific evaluation and scheduling recommendation from FDA, prohibiting DEA from diluting FDA’s scheduling recommendation, and making FDA’s recommendations binding on DEA with respect to scientific and medical questions)) In other words, Congress made the FDA’s views on scientific and medical issues binding on DEA. Thus, the DEA’s refusal to acknowledge—much less follow—FDA’s scientific and medical judgments in the scheduling context is unlawful and inexcusable.

Matt and I submitted that rescheduling petition on behalf of Dr. Sunil Aggarwal. Dr. Aggarwal has spent years seeking access to psilocybin to treat terminally ill cancer patients who suffer from debilitating depression that does not respond to any approved drugs on the market. His patients are out of options, and they are running out of time. The DEA’s flip rejection of Dr. Aggarwal’s petition likely deprives his patients of a promising treatment that their physician, the FDA, and, most importantly, they themselves believe should be available to them.

Dr. Aggarwal has challenged the DEA’s decision in the U.S. Court of Appeals for the Ninth Circuit. He hopes (and deserves) to prevail. Yet, whichever way the Ninth Circuit rules, the deeper problem—having a law-enforcement agency like the DEA in charge of the scheduling process—will remain.

Since that’s a problem Congress created, Congress should take action to address it. Passing the Breakthrough Therapies Act—a bipartisan bill introduced by Senators Booker and Paul that would require the DEA to move any schedule I substance granted breakthrough therapy status by the FDA to schedule II—would be a good start.

Next, it could take the problem head-on by stripping the DEA of its authority over scheduling. Among other things, this would ensure that Americans benefit from the FDA’s scientific and medical expertise at least as much as Australians.

Finally, Congress should consider jettisoning schedule I altogether. As Matt has explained in greater detail, there are only two practical differences between schedules I and II under the Controlled Substances Act (CSA). First, schedule II substances may be made available for prescription, whereas schedule I substances may not. Second, schedule I substances are subject to research restrictions that don’t apply to substances in any other schedule.

If decades of experience under the CSA have taught us anything, it is that drug policy should promote—not deter—science and research. This is especially true when it comes to unapproved-but-widely-used drugs like psilocybin, MDMA, cannabis, etc. Schedule I is anti-science. It delays—and sometimes blocks outright—access to lifesaving therapies. Even accepting the DEA’s ridiculous definitions of “abuse” and “diversion” (basically any use whatsoever outside of heavily regulated government-approved research), schedule I does virtually nothing that schedule II doesn’t already do to prevent either. In other words, it does a ton of harm and has no countervailing benefits—the very essence of bad policy.

We know schedule I is causing real and completely preventable harm to untold numbers of innocent people. How long will we continue to let them suffer?

Source:

https://www.jdsupra.com/legalnews/a-wake-up-call-from-down-under-8440200/

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individualized treatment

Risks of Psychedelics for People with Personality Disorders

Published

1 week ago

May 9, 2024

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While psychedelics have shown promise in treating certain mental health conditions, a recent study suggests they may pose risks for individuals with personality disorders. The findings underscore the importance of careful screening and personalized approaches in psychedelic-assisted therapy.

Navigating the Psychedelic Landscape: Potential Risks for Individuals with Personality Disorders

Psychedelics, including substances like psilocybin and LSD, have gained significant traction in recent years for their potential therapeutic benefits in treating mental health conditions such as depression, anxiety, and PTSD. However, a recent publication in the Journal of Psychopharmacology has raised concerns about the suitability of these substances for individuals with personality disorders.

The study surveyed individuals who had used psychedelics and who were also diagnosed with personality disorders. A considerable number of respondents reported negative and persistent psychological impacts following their psychedelic experiences. Notably, these included heightened anxiety, paranoia, mood instability, and an exacerbation of existing personality disorder symptoms.

Researchers suggest that the vulnerability of individuals with personality disorders to the adverse effects of psychedelics may stem from pre-existing challenges in emotional regulation, self-identity, and interpersonal relationships. The profound and introspective nature of psychedelic experiences can intensify these issues, potentially leading to psychological distress and symptom aggravation.

This research highlights the critical need for thorough screening and assessment in the context of psychedelic-assisted therapy. It suggests that individuals with personality disorders might require tailored therapeutic approaches and robust support systems to navigate potential risks and to secure safe and positive outcomes.

Why It Matters

The burgeoning interest in psychedelic therapy underscores the necessity to discern both the potential benefits and risks across different demographic groups. This study contributes valuable insights, particularly for clinicians and researchers, stressing the importance of personalized treatment plans and the cautious consideration of individual vulnerabilities when administering psychedelic-assisted therapy.

Potential Implications

The findings from this study emphasize the need for ethical and responsible practices within the field of psychedelic-assisted therapy. There is a pressing requirement for the development of detailed screening protocols that can identify individuals who may be more susceptible to the adverse effects of psychedelics. Furthermore, crafting specialized therapeutic strategies that cater specifically to the needs of individuals with personality disorders is essential for ensuring their safety and overall well-being during and after undergoing psychedelic experiences.

The Bigger Picture

The debate surrounding the therapeutic use of psychedelics is complex, with various factors influencing the suitability of these treatments for different individuals. While there are promising results in general populations, the nuanced needs and potential vulnerabilities of those with personality disorders require careful consideration to prevent harm and maximize therapeutic outcomes. This necessitates ongoing research, improved clinical protocols, and a commitment to patient-centered care in the burgeoning field of psychedelic medicine.

Source: Science Alert

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antidepressants

Treating Depression: Psychedelics vs. Antidepressants

Published

1 week ago

May 9, 2024

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Recent research suggests that psychedelics and traditional antidepressants, while both potentially effective in treating depression, work through distinct mechanisms. Understanding these differences could lead to more personalized and effective treatment approaches. Psychedelics vs. Antidepressants: What are the key differences?

Unlocking the Mysteries of Depression Treatment: Psychedelics vs. Antidepressants

The quest for effective depression treatments continues to be a significant focus in mental health research. Traditional antidepressants, like selective serotonin reuptake inhibitors (SSRIs), have been a mainstay in treatment, prescribed widely despite varying efficacy among individuals and often accompanying unwanted side effects. In contrast, psychedelics have recently garnered attention for their rapid and enduring antidepressant effects observed in clinical trials.

A recent study has delved into the distinct mechanisms of action of SSRIs and psychedelics, illuminating how they uniquely influence the brain and potentially alleviate symptoms of depression. SSRIs primarily increase serotonin levels in the brain, which is believed to enhance mood and diminish depressive symptoms. However, this process can require several weeks to manifest noticeable effects, and not all patients respond favorably to SSRIs.

Conversely, psychedelics such as psilocybin, found in “magic mushrooms,” operate through a different mechanism. Research indicates that psilocybin’s antidepressant effects are not directly due to elevated serotonin levels. Instead, psilocybin is thought to promote neuroplasticity, the brain’s capacity to reorganize and form new neuronal connections. This heightened neuroplasticity may facilitate more adaptable thought patterns and an improved ability to process emotions, contributing to the rapid and sustained antidepressant effects seen in clinical trials.

Moreover, the study examined the role of the 5-HT2A serotonin receptor, a primary target for both SSRIs and psychedelics. While SSRIs inhibit this receptor’s activity, psychedelics activate it. Intriguingly, blocking the 5-HT2A receptor did not reduce psilocybin’s antidepressant effects, suggesting that its therapeutic benefits originate from other pathways.

Psychedelics vs. Antidepressants: Why It Matters?

Understanding the distinct mechanisms by which psychedelics and antidepressants affect the brain is crucial for the development of more personalized and effective treatment strategies for depression. This knowledge could lead to enhanced patient selection for specific treatments, reducing trial and error while optimizing outcomes. Furthermore, exploring the unique properties of psychedelics may pave the way for novel antidepressant medications that are quicker acting and have fewer side effects.

Potential Implications

This research could catalyze a shift in depression treatment paradigms, moving from a one-size-fits-all approach to more targeted therapies. By pinpointing the specific mechanisms that underlie different antidepressant interventions, clinicians can customize treatment plans based on individual patient profiles and needs. This personalized approach could improve treatment success rates and enhance the quality of life for individuals battling depression.

What Next?

While the study of psychedelics for therapeutic purposes is still in its nascent stages, the initial findings are promising and suggest that psychedelics may offer a valuable addition to the arsenal of tools for combating depression and other mental health conditions.

Source: Neuroscience News

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5-MeO-DMT

Mike Tyson Credits Psychedelics for His Recovery

Published

1 week ago

May 9, 2024

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Boxing legend Mike Tyson attributes his remarkable recovery from physical and mental health challenges, as well as his return to the boxing ring, to the therapeutic use of psychedelics.

From Champion to Advocate: Mike Tyson’s Psychedelic Journey to Healing and Comeback

Mike Tyson, the former heavyweight champion renowned for his formidable boxing style and tumultuous personal life, has recently become a vocal advocate for the therapeutic potential of psychedelics. He credits these substances with playing a pivotal role in his recovery from physical ailments, addiction, and mental health struggles, ultimately paving the way for his return to boxing.

Tyson’s journey with psychedelics began with his exploration of psilocybin mushrooms, commonly referred to as “magic mushrooms.” He describes profound experiences that led to personal insights, emotional healing, and a renewed sense of purpose. These transformative experiences inspired him to incorporate other psychedelics, such as DMT (dimethyltryptamine) and 5-MeO-DMT (5-methoxy-dimethyltryptamine), into his wellness regimen.

The therapeutic effects of psychedelics have gained increasing recognition in recent years, with research suggesting their potential to effectively treat various mental health conditions, including depression, anxiety, and PTSD. Tyson’s personal experiences align with these findings, as he reports significant improvements in his mental well-being, including reduced anxiety and a heightened sense of inner peace.

In addition to mental health benefits, Tyson also attributes his physical recovery to the use of psychedelics. He asserts that these substances have helped alleviate chronic pain resulting from injuries sustained during his extensive boxing career. This pain relief, coupled with the mental clarity and motivation he gained, enabled him to return to training and eventually step back into the ring for exhibition matches.

Tyson’s advocacy for psychedelics extends beyond his personal experiences. He has invested in psychedelic research and companies, aiming to promote awareness and access to these potentially life-changing substances. His openness about his own journey has helped reduce stigma surrounding psychedelic use and has sparked broader conversations about their therapeutic potential.

Why It Matters

Mike Tyson’s story illuminates the growing recognition of psychedelics as valuable therapeutic tools. His celebrity status and candidness in sharing his experiences contribute to the destigmatization of these substances and encourage further research into their benefits. As more public figures like Tyson come forward, the public perception of psychedelics is evolving, paving the way for increased acceptance and accessibility.

Potential Implications

Tyson’s advocacy, coupled with ongoing research, could contribute to the broader acceptance of psychedelics in mainstream medicine. This may lead to the expanded availability of psychedelic-assisted therapy for various mental and physical health conditions. As the stigma surrounding psychedelics diminishes, more individuals may explore their therapeutic potential, leading to advancements in mental health treatment and a deeper understanding of human consciousness.

The Bigger Picture

The use of psychedelics for therapeutic purposes dates back centuries in various cultures around the world. Modern research is rediscovering and validating the potential of these substances to treat a range of conditions. However, it’s important to note that psychedelic experiences can be intense and should be approached with caution and ideally under professional guidance.

Source: The Sportster

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