Industry

An Overview of the Psychedelic Landscape

An initial rush on the part of the psychedelics business space has been full of promise for the future of mental health and personal wellness. While Optimi shares in that vision, we believe that there are crucial steps yet to be taken before it becomes a reality.

We are already beginning to see the inevitable consolidation from so many companies entering a shared space in such a short period of time. Optimi Health was founded to meet the industry where it exists today, in its nascent stages, supplying psilocybin for authorized research, clinical trials, and most importantly, patients, while growing the infrastructure that will make us an industry leader in establishing a brighter future possible with these medicines.

Among the hundreds of new public and private entities now involved in this process, we’re carving out a network of supply agreements, strategic partnerships, and relationships with clinics and practitioners that keeps us on the cutting edge of this new field while maintaining an ongoing dialogue with governments and health regulators.

The State of Psychedelic Policy

A better future for mental health through psychedelics doesn’t happen overnight.

Clinical research from world-renowned institutions such as Johns Hopkins and Imperial College London was followed, here in North America, by a cultural shift that led to psychedelic decriminalization initiatives in major cities such as Denver, Oakland, Washington D.C., Seattle, and Detroit, along with countless smaller municipalities.

A state-level ballot initiative legalizing psilocybin was successful in Oregon in 2020, and similar legislation is actively being developed in California, Michigan, and Colorado, to name just a few.

Still more States, such as Texas and Utah, have authorized research into mental healthcare, more often focused on helping veterans focus on PTSD.

Here in Canada, we’ve led the way for psychedelics in personal care with Section 56 Exemptions and Special Access Program applications for psilocybin.

While not explicitly directed at psychedelics, the widespread decriminalization of controlled substances in the Province of British Columbia presents an opportunity to demonstrate the positive outcomes of harm reduction approaches, while setting an important legal precedent. 

Psychedelic Legalization & Decriminalization Tracker

The Cost of Doing Nothing

Mental Health

Globally, we spend $2.5 trillion/year today (direct and indirect) on mental illness and are expected to spend $6 trillion by 2030 worldwide.

Mental illness accounts for 20% of the global burden of disease.

$2.5T

Cost of mental health

80%

Patients with advanced cancer are likely to suffer distressing thoughts around death

$1T

The global cost in lost productivity from depression and anxiety disorders.

Opioid Addiction

Toxicity of supply continues to be a major driver of the crisis. Opioid use disorders affect over 16 million people worldwide, over 2.1 million in the United States, and there are over 120,000 deaths worldwide annually attributed to opioids.

$46B

Cost of substance use in Canada

Suicide

More than 700,000 people die due to suicide every year. For every suicide there are many more people who attempt suicide. Suicide is the fourth leading cause of death among 15-19 year olds. Suicide is an occupational hazard for physicians and is the only cause of mortality that is higher in physicians than non-physicians.

292

Canadian military personnel that have died by suicide since 2004

Health and Wellness

The global functional mushroom market is expected to grow at a compound annual growth rate of 9.5% from 2022 to 2028 to reach USD 47.2 billion by 2028. 

This can be credited to the rising adoption of these mushrooms as superfoods, owing to their various health benefits.

Functional mushrooms have a variety of applications in pharmaceutical and healthcare products. Owing to this, their demand will be on the rise in the coming years. Also, increasing product application in the medicinal industry as a health supplement is further driving the market growth.

Driving Demand

Key factors that are driving the functional mushroom market growth include rising demand for functional mushrooms from various end-use industries, anticipated growth in dietary supplements, along with the growing trend of functional food consumption.

Lion's Mane

Known to increase mental focus and memory, lion's mane is a powerful brain protector. It lowers stress-induced cell death while supporting nerve generation and repair. Lion's mane also helps remove harmful debris from the brain.

Cordyceps

Cordycepin in this mushroom activates AMPK to promote ATP (cellular energy). Cordyceps reduces fatigue, boosts stamina and improves cardiovascular, muscle and reproductive health. Immune system activation supports healthy aging.

Reishi

Known as the Mushroom of Immortality, reishi is the only source of ganoderic acids and provides the right beta-glucans for immune support with cancer suppression, healthy metabolism and protection from stress.

Turkey Tail

Turkey tail promotes immune system T-cells and white blood cells that protect against disease and support pain relief. Prebiotic turkey tail supports the gutbrain-immunity pathway and may have anti-tumour effects.

Chaga

Nutrient-rich chaga provides antioxidants that assist in calming inflammation. Chaga helps the body target abnormal cells, manages upper respiratory infection and supports metabolic health.

Shiitake

Containing sterols, betaglucans, and eritadenine that inhibits cholesterol production, shiitake may reduce blood cholesterol and support heart health. Shiitake may help to reverse age-related immune system declines.

Resources

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FAQs

After decades of stigma, psychedelics are emerging into the medical limelight as potential treatments for a wide variety of mental health disorders.

The Multidisciplinary Association for Psychedelic Studies, or MAPS, dates all the way back to 1986 and has helped move psychedelic science from the fringe back to the laboratories of major institutions while pioneering MDMA-assisted psychotherapy for sufferers of PTSD.

The groundbreaking research undertaken by Johns Hopkins University since the early 2000s has led investigations into the medical potential of psilocybin. The Johns Hopkins Center for Psychedelic and Consciousness Research was formally launched in 2019, and continues to conduct research into indications such as major depressive disorder and smoking cessation, among more esoteric inquiries into spiritual fulfillment.

On the other side of the Atlantic, UK non-profits and academic institutions such as the Beckley Foundation and the Centre for Psychedelic Research at Imperial College London have been responsible for landmark developments in brain imaging and psychedelic neuroscience and investigations into the use of psilocybin for depression, as well as investigating substances such as LSD and Mescaline.

All of this is only the beginning. Hundreds of clinical trials are underway into the use of psychedelic substances for mental health treatments.

Psilocybin is a Schedule III Controlled Substance under Canadian Law. It is also an approved medicine for these select few patients.

Thanks to Section 56 exemptions to the Controlled Drugs and Substances Act as well as recent amendments by Health Canada to the Special Access Program, Canadians with urgent, unmet medical needs have been allowed to access psilocybin mushrooms for medical, therapeutic and mental health purposes.

Internationally, research into psychedelic medicine for mental health treatments has never been more robust, with hundreds of clinical trials in progress.

Through the Special Access Program, health care professionals may request access to drugs that are not currently authorized for sale in Canada to treat patients with serious or life-threatening conditions. Access to these drugs is only considered when conventional therapies have failed, are unsuitable or are unavailable. Patients can apply to the Special Access Program through a qualified medical practitioner. For more information, please click here.

We encourage qualified medical practitioners to review the Special Access Program application process here.

Patients consuming psilocybin for therapeutic purposes are best served by a safe consistent dosage to manage treatment outcomes. A safe supply of psilocybin means that these naturally-sourced medicines are held to the same standards as all other approved pharmaceuticals, namely GMP standards.

Patients allowed to consume psilocybin by federal health authorities deserve the same level of transparency, scientific rigour and accountability in terms of the sourcing and processing of their medicine that they would receive from any other approved medication.

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

According to the World Health Organization, “Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.”

Our psilocybin products are available for medicinal use only, meaning we are legally able to supply clinical trials and Special Access Program requests.

However, we do have a robust catalog of natural functional supplements which we are selling through our nutraceutical line. Functional mushroom nutraceuticals are known for their wide range of benefits in areas such as immunity, anti-inflammation, mood, cognition.

For more information or to make a purchase, please visit www.optimilife.com

We have legitimate concerns about the message being filtered in the media which suggests black or grey market psilocybin (and other synthetic psychedelics) is Canada’s best pathway to legalization. While we support Health Canada’s policy on access through clinical trials and the Special Access Program, we do believe that more needs to be done to provide safe supply to patients, consumption sites, and trials operating through the Section 56 (1) process.

Based on current science and research, Optimi believes at minimum patients at end-of-life deserve unfettered access to psilocybin through a qualified medical practitioner. We support the Psychedelic Association of Canada’s Memorandum of Regulatory Analysis (MORA) which would provide this level of access.

Because it only takes one toxic, designer drug laced with other contaminants or microbial adulterants to put someone at risk of serious harm. Properly sourced, pharmaceutical grade psilocybin is the only way to know for sure that you’re giving your body the highest, purest, and most bioavailable form of an ingredient possible. Our psilocybin and functional mushrooms are analyzed in our state-of-the-art laboratory and sent for third party analytical testing to ensure an extremely high standard of purity and maximum absorption.

Distributors and retailers who sell these products illegally are putting Canadian consumers and their businesses at risk, and that is why Optimi is 100% committed to taking the time to cultivate, research, and test our products for when the regulatory environment improves.

Strong evidence suggests yes. Fully legal, well-funded research programs in the mid-20th century found that carefully monitored and controlled use of psilocybin may be beneficial for many psychiatric disorders, personal and spiritual development, and creative enhancement.However, after psilocybin was banned in 1970, clinical research to evaluate its medical safety and efficacy of psychedelics was effectively halted until the late 90s and early 2000s.

Today, there are dozens of studies taking place to evaluate the medical safety and efficacy of psychedelics, including psilocybin. Much of the early research did not stand up to today’s standards, as they often lacked a placebo control group or double-blinding procedures (in which neither the subject of the research nor the investigators knew whether the subject received psilocybin or placebo). Nevertheless, their promising findings have been revisited and spurred a resurgence of new, more rigorous research on the potential benefits of psychedelics as a treatment for cluster headaches, anxiety, addiction to alcohol and other drugs, depression, obsessive-compulsive disorder, as well as neuroimaging experiments furthering the understanding of its effects on the brain.

Because of the expensive and time-consuming approval process for research with Schedule I drugs, as well as the political influence of the war on drugs, research evaluating psilocybin’s beneficial uses does not receive funding from academic or government institutions, and instead relies on non-profit organizations like the Multidisciplinary Association for Psychedelic Studies, the Beckley Foundation, and the Heffter Research Institute.

Knowing the actual effects of psilocybin mushrooms, information on dosing, and resources for handling difficult experiences can help prevent dangerous situations, while enhancing their potential benefits. Mushrooms used non-medically are usually taken orally either by eating dried caps and stems, or steeped in hot water and drunk as a tea, with a common dose around 1-2.5 grams, though potency may vary regardless of the amount. Dried mushrooms are typically more potent than fresh ones. Due to the lack of quality control regulations under prohibition and the risk of consuming things growing in nature, there is potential for people attempting to pick psilocybin mushrooms in the wild to accidentally take poisonous mushrooms instead. Similarly, though also very unlikely, poisonous mushrooms are sometimes misrepresented and sold as psilocybin, and these do come with more physical risks, including fatal overdose.

Source Link: Psilocybin_Mushrooms_Fact_Sheet.pdf

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