Category Archives: Psychedelics

MIAMI, June 01, 2022 (GLOBE NEWSWIRE) -- Ehave, Inc. (OTC Pink: EHVVF) (the Company”), a leading healthcare services and technology company, announced today its KetaDASH subsidiary will begin using precision medicine to improve patient outcomes through its partnership with Entheon Biomedical Corp.’s (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) ("Entheon") wholly-owned subsidiary, HaluGen Life Sciences Inc. (HaluGen”) to use its psychedelics genetic test kit. KetaDASH will become one of the first psychedelic companies to use precision medicine to test patients by using HaluGen’s expanded psychedelics genetic testing panel, which analyzes a series of relevant DNA biomarkers and utilizes pre-screening mental health surveys in order to provide insights into an individual's risk and potential of adverse reactions with the use of ketamine.

By utilizing precision medicine, medical professionals will be able to test patients for genetic, personal and familial insights to better inform each patient’s psychedelic assisted therapy experience. KetaDASH believes that DNA test results, and data from mental-health surveys, will allow individuals to make more informed decisions around psychedelic assisted therapy, potential side effects and risk profile.

Genetics can play a key role in determining how an individual may respond to psychedelic-assisted psychotherapy. The gene mutation CYP2B6 can influence the metabolism of ketamine for the 10-20% of people that carry a specific CYP2B6 gene variant. Similarly, the HTR2A gene mutation, which is carried by approximately 20% of the population, can impact how a person responds to serotonin, which is the primary mechanism of action for serotonergic psychedelics such as psilocybin, LSD and DMT. Precision medicine will provide KetaDASH with the ability to tailor the treatment based on an individual or sub-groups variability in genes and lifestyle choice.

Ben Kaplan, CEO of Ehave, said, The benefit of the psychedelic profile is that it will enable the individuals and healthcare professionals at KetaDASH to personalize psychedelic therapy by providing an individual’s metabolic status for ketamine with their CYP2B6 genotype. We are pleased with the results from the initial launch of KetaDASH in the San Francisco and Sacramento area. Having the ability to personalize psychedelic therapy will prove beneficial and set us apart from our competitors as we expand KetaDASH into other markets.”

Timothy Ko, CEO of Entheon, commented, We are thrilled to support Ehave and KetaDASH with the use of our genetic test kits. We believe that personalization will become an increasingly important feature of the psychedelic therapeutics landscape and applaud the pioneering steps that they are taking to deliver a standard of care that takes into account the individual nuance of every patient.”

About Ehave, Inc.

Ehave is a leading healthcare services and technology company, focused on progressing psychedelics-to-Therapeutics by engineering novel compounds and new treatment protocols for treating brain health. Together with our network of scientists and mental health professionals, we are on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues, leveraging clinical data to help us achieve optimal patient outcomes. Ehave’s operations span across the entire USA, Canada, Jamaica, and Australia. Additional information on Ehave can be found on the Company’s website at: http://www.ehave.com.

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective Dimethyltryptamine based psychedelic therapeutic products ("DMT Products") for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada. https://www.entheonbiomedical.com

About HaluGen Life Sciences Inc.

HaluGen has developed a DNA testing and personalized psychedelic pre-screening platform that provides genetic, personal and familial insights to better inform the psychedelic experience, with the goal of improving patient care and reducing side effects and risk. HaluGen's genetic-based psychedelic pre-screening platform helps evaluate an individual's overall sensitivity and risk profile when using hallucinogenic drugs. This platform is the first of its kind with test results within days. https://www.halugen.com

Forward-Looking Statement Disclaimer

This press release contains forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words intends,” may,” will,” plans,” expects,” anticipates,” projects,” predicts,” estimates,” aims,” believes,” hopes,” potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading "Risk Factors" in Ehave, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC's website, http://www.sec.gov.

For Media and Investor Relations, please contact:

David L. Kugelman

(866) 692-6847 Toll Free - U.S. & Canada

(404) 281-8556 Mobile and WhatsApp

Email: Ir@Ehave.com

Skype: kugsusa

LinkedIn: https://www.linkedin.com/in/davidkugelman

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2022-06-01 | PINL:EHVVF | Press Release | ehave Inc - Stockhouse

Welcome to my latest video presentation. The article below is a condensed transcript; the video provides additional details as well as several charts.

For decades, the establishment waged a relentless propaganda war against marijuana. Consider this 1905 Washington Post article, in which an anthropology professor describes his experimental smoking of marijuana and the symptoms that he claims to have experienced:

Everything seems to move around the smoker, this whirl becoming faster and faster, until all sense of his surroundings is lost

The next step of his intoxication is full of terrors. Troops of ferocious wild animals march before the vision of the smoker. Lions, tigers, panthers, and other wild beasts occupy his vision. The wild animals are then attacked by hosts of devils and monsters of unheard of shapes. The smoker becomes brave and possessed of superhuman strength. It is at this stage of the debauch that murders are committed by the smoker.

Mmmkay! Fast forward to 2022, and marijuana is increasingly legal, as well as lucrative and socially accepted. Based on New Frontier Datas latest analysis of state legalization campaigns, U.S. legal sales of recreational and medical pot (combined) are on track to exceed $72 billion on an annual basis in 2030. Lets look at the latest news in the mainstreaming of what used to be called the devils weed.

Marijuana and Federal Law. Several major cannabis companies, lobbyists, and investors are joining forces to sue the federal government over what they decry as unconstitutional policies harming their operations. Theyve retained a prominent law firm led by attorneys who have been involved in several highly publicized federal cases.

The marijuana companies, many of them large multi-state operators (MSOs), have retained the high-powered law firm of Boies Schiller Flexner LLP. David Boies, the firms chairman, boasts a long list of famous and powerful clients, including Al Gore and Jeff Bezos.

One of the goals of the coalition is repeal of a tax provision called 280E that prevents the marijuana industry from taking tax deductions that are available to any other non-marijuana company.

Among members of the coalition is The American Trade Association for Cannabis and Hemp (ATACH). The plan is to file lawsuits in federal district court sometime this summer.

Massachusetts. Adult-use marijuana sales in the Bay State have officially surpassed $3 billion (as of May 14), since the market launched in 2018, the states Cannabis Control Commission reported last week.

Massachusetts marijuana tax revenue is now exceeding that being generated from alcohol sales. Thats a welcome development for marijuana advocates who have long argued that marijuana is less harmful than alcohol and should be viewed as a favorable substitute.

Michigan. In a minor setback for the movement to legalize psychedelics, the East Lansing, Michigan City Council last week rejected a resolution to decriminalize psychedelics in the jurisdiction. The mayors office, city attorney, and local lawmakers expressed concerns about legal blowback of the reform proposal.

But the vote in Michigan represents a mere speed bump for the fast-growing psychedelics industry. A slew of jurisdictions across the nation have decriminalized psychedelics, laying the groundwork for a new industry. In coming years, the psychedelics industry could capture a major slice of the $28.6 billion global antidepressant market.

New Jersey. One month into the implementation of legal marijuana in the Garden State, consumers have bought $24 million in recreational marijuana, state regulators reported last week. Jeff Brown, executive director of the states Cannabis Regulatory Commission, stated: Its really only a beginning, and I think it shows that theres a lot of growth left in this market.

Rhode Island. The governor of Rhode Island signed a bill last week to legalize marijuana, making it the 19th state to end prohibition. Gov. Dan McKee (D) signed the measure just one day after the legislature sent it to his desk. Adults 21 and older can now legally possess up to one ounce of cannabis in the Ocean State and grow up to six plants for personal use, only three of which can be mature.

Consumer Behavior. A recent study shows that younger generations are purposely choosing cannabis over alcohol. The study, conducted by New Frontier Data, underscores the argument of pro-marijuana advocates that pot is better for public safety and health than alcohol. Indeed, physicians increasingly make the claim that weed is far healthier than booze.

Read This Story: Marijuana and Money: An Insider Interview

Worried about inflation, recession, and rising interest rates? The trends Ive just described are resistant to short-term ups-and-downs. The mainstreaming of marijuana is making investors rich, in good times or bad.

Your portfolio needs exposure to marijuana stocks, but selectivity is key. Thats why I urge you to read my new book: The Wide World of Weed and Psychedelics. Its your definitive guide for making money in the thriving cannabis and psychedelics industries. Click here to get your free copy.

John Persinos is the editorial director of Investing Daily.

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The rest is here:

VIDEO: The Weekly Weed Report (05-31-22) - Investing Daily - Investing Daily

For years, US cannabis executives have protested a law that they say is obscure and outdated, and that makes it hard for them to turn a profit.

The law, a section of the federal tax code known as 280E, could now hamper psychedelics companies that want to enter the first state market for magic mushrooms in the US, similarly to how it affects cannabis firms.

Congress passed 280E to aid President Ronald Reagan's war on drugs. The law prohibits companies that illegally sell Schedule I and Schedule II drugs from deducting regular business expenses like office supplies or health-insurance premiums. Effectively, those companies have to pay more in taxes. Because cannabis and psilocybin are federally illegal, 280E affects businesses even in areas where the substances are locally legal.

Psychedelics companies haven't had to contend with the tax-related hassles associated with 280E because they've focused on pharmaceutical research and development or conducted their business in countries where the drugs aren't federally prohibited.

But now, as Oregon prepares to create the first legal-psychedelics market in the US, many psychedelics companies will have to grapple with the complicated tax implications for the first time.

According to Harris Bricken, an international law firm, psilocybin businesses in Oregon could face challenges like those that cannabis companies faced. Because psilocybin is illegal under federal law, it will likely be difficult for the companies to find banks or credit unions to work with them. It also makes securing funding more difficult.

Sam Chapman, the executive director for the Healing Advocacy Fund, a nonprofit focused on the implementation of Oregon's psilocybin program, told Insider that he expects the 280E tax issue to catch a lot of operators by surprise.

"There's still a pretty big cloud around how to successfully manage a 280E tax liability," he said.

Dina Burkitbayeva, a cofounder of Psymed Ventures, a psychedelics-focused venture-capital firm, said 280E would make doing business extremely challenging for a lot of the companies in Oregon, therefore making it difficult for investors like herself to deploy capital in the state.

"You're really not running a very sexy business," she said. "We're excited that these efforts are happening in Oregon, but from a venture-investment standpoint, we're not really seeing a lot of opportunity."

Mason Marks, an attorney who was the chair of the licensing subcommittee for Oregon's Psilocybin Advisory Board, said he expects 280E to affect most, if not all, of the psychedelics companies looking to operate in Oregon. He added that bigger businesses able to scale would have an advantage.

"Those are the ones that are going to be the most profitable, because the tax situation is really eating into your profits," Marks said. "You need to operate at a certain scale that keeps your overhead down."

Marks said operators from the cannabis industry would also have an edge because they've dealt with the same law.

It's still unclear which companies in Oregon 280E would directly affect. While cultivators who grow the mushrooms would undeniably be subject to the law, it likely would not affect data companies and other ancillary businesses.

Startups focused on training practitioners may also be exempt, though that may depend on whether the state's training criteria require training firms to supply psilocybin to trainees.

Elana Tamas, a tax advisor at the New York accounting advisory firm Anchin who has helped cannabis companies navigate 280E for years, said companies working with cannabis or psilocybin could restructure to limit the harm of 280E.

If a psychedelics-retreat firm, for example, can prove that its psilocybin-administering operation is separate from the retreat operation, it would be able to file separate taxes for those two entities. In this case, only the company that administers psilocybin would face elevated taxes.

"It's an analysis that you have to make based on what the economic realities are, so it's not something that you can just say and create. It's something that really needs to be economically true," Tamas said. "There really needs to be a really strong paper trail to support the differentiation between the expenses relating to one business and the income relating to one business."

Excerpt from:

Psychedelics Companies in Oregon Will Have to Grapple With 280E - Business Insider

Welcome to TDRs review of the Top 5 Psychedelic developments for the week of May 9. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.

5. Biden Administration Announces $1.5 Billion Funding Opportunity for State Opioid Response Grant Program

The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), is announcing a State Opioid Response (SOR) grant funding opportunity that will provide nearly $1.5 billion to states and territories to help address the Nations opioid addiction and overdose epidemic. In President Bidens State of the Union, he named beating the opioids epidemic as a pillar of his Unity Agenda. Todays announcement is a critical step forward in that work, and the SOR program, along with theTribal Opioid Responsegrant funding opportunity announced recently, are critical tools in President Bidens inaugural National Drug Control Strategy released last month and the Health and Human Services (HHS)Overdose Prevention Strategy.

The State Opioid Response grant program delivers crucial aid to states and territories to help address in the crisis of overdose and death in our nations communities, said HHS Secretary Xavier Becerra. And, in line with HHS Overdose Prevention Strategy, this funding helps facilitate state- and territory-level efforts to ensure the full continuum of prevention, harm reduction, treatment and long-term recovery supports are in place and accessible to all who need them.

TheSOR grant programprovides formula funding to states and territories for increasing access to FDA-approved medications for the treatment of Opioid Use Disorder (OUD), and for supporting prevention, harm reduction, treatment, and recovery support services for OUD and other concurrent substance use disorders (SUD). The SOR program also supports care for stimulant misuse and use disorders, including for cocaine and methamphetamine. The SOR program helps reduce overdose deaths and close the gap in treatment needs across America by giving states and territories flexibility in funding evidence-based practices and supports across different settings to meet local community needs.

4. Awakn Life Sciences Completes Worlds First Ketamine Treatment Study for a Range of Behavioral Addictions

Awakn Life Sciences Corp.(NEO: AWKN)(OTCMKTS:AWKNF) announced today the completion of the worlds first ketamine treatment study for behavioral addictions. The behavioral addictions included in the study were Gambling Disorder, Internet Gaming Disorder, Binge Eating Disorder and Compulsive Sexual Behavior.

Results from Awakn's #ketamine treatment study for behavioral #addictions indicate the desired effects via potentially novel mechanisms and these results merit a larger study and further exploration, which Awakn is now initiating. Learn more: https://t.co/7DW4Tu3RCF $AWKN $AWKNF

The study was led by Prof. Celia Morgan, Awakns Head of Ketamine-Assisted Therapy, Professor of Psychopharmacology at the University of Exeter, U.K., and an internationally respected expert in the therapeutic use of ketamine. The study investigated ketamine as a new treatment approach for these behavioral addictions by opening a window in which the brain can make new connections to change behavior.

The results from the study indicate the desired effects via potentially novel mechanisms and these results merit a larger study and further exploration, which Awakn is now initiating. The study also supports Awakns Intellectual Property (IP) strategy and existing filed patent applications, positioning Awakn as a leading company in the behavioral-addiction therapeutic research and development industry. The company expects to update investors further on its IP strategy in the coming weeks.

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Antidepressants And Psychedelics Drug Interaction Chart

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3. Big Rebound As Psychedelic Stocks Outperform BioPharma Indexes

The biggest psychedelic stocks mostly rose this past week, noticeable outperforming peer biopharma indexes. TheHorizon Psychedelic Stock Index ETF(PSYK) climbed12.80%, which was materially stronger than both theNasdaq Junior Biotechnology Index(2.42%) andNasdaq Biotechnology Ishares ETF(2.18%). This occurred despite broad markets which slumped for a seventh consecutive weekNASDAQ1004.40%andS&P 5002.93%. This was the seventh consecutive week of decline in both of these indexes, which hasnt occurred since the Great Financial Crisis of 2008. Heres how the Health Care (Biotechnology) sector performed:

Weekly technical snapshot, PSYK ETF:

In the news

atai Life Sciences reported financial results for the quarter ended March 31, 2022 and provided a business update. Ended the first quarter with $335 million cash, maintaining atais position as a well-funded, leading mental health company.

TDRs Take: Atai Life Sciences: Optimizing Drug Development By Avoiding Big Pharmas Past Missteps

Australias national science agency CSIRO is aiming to develop new psychedelics for a variety of mental health conditions including depression, addiction, end-of-life anxiety and PTSD.

Awakn Life Sciences announced that Dr. ArunDhandayudham is joining Awakn as its Chief Medical Officer. Dr. Ben Sessa is stepping back from his role as CMO to become Awakns Head of Psychedelic Medicine, allowing him to continue his work in research, academic and training activities, as well as a greater focus on the day-to-day treatment of his clients as the Lead Physiatrist for Awakn Clinics Bristol.

Braxia Scientific receives Special Access Program (SAP) approval for use of psilocybin inOntario. Health Canada approval is for patients with Major Depressive Disorder in the absence of terminal medical illness or end of life distress.

CB Therapeutics has been granted a new patent covering the use of microorganisms to produce tryptamines and their analogs, such as psilocybin and various other molecules found in magic mushrooms.

Clearmind Medicine announced positive safety results of its proprietary molecule, MEAI, to treat alcohol abuse.

Clerkenwell Health opening Europes first commercial psychedelic research facility.

Davos 2022: The first ever medical psychedelics series will be hosted by Energia Holdings Incorporated. The worlds most prominent psychedelic industry leaders, drug development experts, clinicians, nonprofit organizations, advocates, and influencers will gather separately inDavosat the inauguralMedical Psychedelic Seriesto help shape the future of mental health.

Havn Life Sciences announced a partnership withTheraPsil a non-profit coalition dedicated to helping Canadians in medical need access legal psilocybin-assisted psychotherapy and GMP-quality psilocybin. Under the Partnership, TheraPsil will support prescribing healthcare professionals in requesting psilocybin from HAVN Life, and other licensed dealers enrolled in TheraPsils Project Solace, through the Special Access Program. TDR interviews CEO Tim Moore:

Mind Medicine announced that the registration statement on Form S-3, filed onMay 4, 2022, was declared effective by the U.S. Securities and Exchange Commission, which includes a prospectus for an at-the-market equity offering under which the company may offer and sell its Subordinate Voting Shares or common shares re-designated from the Companys Subordinate Voting Shares for up to$100,000,000in aggregate sales proceeds.

Nirvana Life Sciences announced the appointment of Mr. Jakson Inwentash to the companys Board of Directors.

Optimi Health has completed the acquisition of a diverse catalog of psilocybin and functional mushroom strains intended for cultivation in its 20,000 square foot, EU-GMP compliant facility in Princeton, British Columbia.

Red Light Holland has completed the third export of psilocybe truffles, from the Netherlands to Canada, under a Health Canada psilocybin import permit awarded to CCrest Laboratories Inc. in partnership with Shaman Pharma Corp.

Silo Pharma announced that it in conjunction with the University of California San Francisco (UCSF), researchers have successfully dosed patients suffering from Parkinsons disease. As part of this study, the researchers are collecting blood samples to determine the effects of psilocybin on inflammatory markers of patients who have exhibited signs of Parkinsons.

2. MindMed Reports Topline Data From Phase 1 Trial of MM-110 in Development for the Treatment of Opioid Withdrawal

Mind Medicine (NASDAQ: MNMD), (NEO: MMED) announced topline results from the Phase 1 placebo-controlled trial designed to assess the safety, tolerability, pharmacokinetics and neurocognitive effects of MM-110 in 108 healthy volunteers. The results showed favorable safety and tolerability, support the advancement of MM-110, and have guided the Phase 2a dose, schedule, and design in individuals undergoing supervised opioid withdrawal. MM-110 (also known as zolunicant HCl or 18-MC) is an 34 nicotinic cholinergic receptor antagonist and non-hallucinogenic proprietary congener of ibogaine.

MindMed today announced topline results from the Phase 1 trial of MM-110. The results showed favorable safety and tolerability, and have guided the Phase 2a trial design in individuals undergoing supervised opioid withdrawal. https://t.co/ax7DSiDT1Q

A total of 72 participants received up to 325 mg of MM-110 (n=51) twice on a single day or placebo (n=21), and 36 participants were administered up to 90mg of MM-110 (n=26) twice daily for seven days or placebo (n=10). The topline results and observations include the following:

1. First Patient In Quebec Gets Approval From Health Canada For Magic Mushroom Therapy

In Montreal, meanwhile, a pioneering clinic in the emerging field of psychedelic-assisted psychotherapy is about to become the first health-care facility in Quebec to legally treat depression with psilocybin. Bui-Nguyen said his Mindspace by Numinus clinic received Health Canadas approval on May 5 to care for a patient who had undergone several unsuccessful treatments for depression.

Mindspace by Numinus CEO Payton Nyquvest said psychedelics have the potential to become a widespread treatment. As Health Canada continues to approve more requests, he hopes the recognition will make the treatment much more accessible.

Health Canada on Jan. 5 restored its Special Access Program abolished under former prime minister Stephen Harper in 2013 allowing health-care experts to request access to restricted drugs that have not yet been authorized for sale in the country.

Related: Numinus Wellness Receives Health Canada Special Access Program Applicant Approval to Provide Psychedelic-assisted Therapy Treatment

See more here:

TDR's Top 5 Psychedelic Developments For The Week Of May 16 - The Dales Report

Throughout history, groups, cultures, religions, and spiritual traditions, worldwide, have looked to breathwork and the use of psychedelic plant medicines to heal, grow, and transform the human experience. In this article, we look at the sacredness of the breath, and recent scientific studies that help us further understand the impact of breathing with Mindfulness Based Interventions (MBIs), combined with psychedelics.

Breathwork is a powerful tool to alter the neurology and psychology of human beings. It helps to regulate and balance the nervous system. When combined with plant medicine the breath can deeply alter, direct, and focus the mind to reset and change perceptions.

The root word for breath in Latin is Spir as in aspire, conspire, expire, inspire, perspire, respiration, respire, spiracle, spirit, transpire, etc. So, its easy to see why the breath has taken center stage historically, in religious and spiritual ceremonies that use chants, prayers, music, ecstatic dance, and symbolism to transcend dogma.

Modern day research has confirmed what sages have known for centuries. Sacred plant medicines and breathwork can help individuals reset, reboot, and reframe traumatic events and connect them with divine intention. We know that trauma challenges, inhibits, and triggers hyperarousal or hypoarousal modes and can dysregulate the autonomic nervous system. A recent study published in the Journal of Psychopharmacology shows that psychedelics and mindfulness-based interventions and breathwork, practiced together could be the future of mental health treatment. [1]

Researchers at Johns Hopkins University conducted[2] both psilocybin and MBI practices. These studies had a combined positive effect on participants who had chronic post-traumatic stress disorder (PTSD). The results of the study are promising and suggest that the combined use can further help people suffering from PTSD. Furthermore, the use of psychedelics in combination with MBIs could be an especially powerful tool to address both the cognitive and emotional aspects of mental illness. The synergistic effect offers both deep personal insights and improved self-regulation to help people recover from mental illness and live happier healthier lives.

MBIs and psychedelics have been shown to affect key aspects of mental health, such as depression, anxiety, and addiction. For example, a recent meta-analysis of 47 clinical trials found that mindfulness meditation is an effective treatment for reducing symptoms of anxiety[3](Creswell et al., 2017). Similarly, multiple studies have shown that psychedelic drugs are effective in treating a variety of mental health disorders such as depression[4](Carhart-Harris et al., 2016), anxiety[5](Grob et al., 2011), and addiction[6](Mithoefer et al., 2011).

Given the promising evidence for both MBIs and psychedelic drugs in the treatment of mental health disorders, it is not surprising that there is growing interest in combining these two approaches. One early study found that a single session of psilocybin-assisted coaching and MBIs were associated with reductions in depression and anxiety, as well as increases in self-compassion and mindfulness[7](Davis et al., 2016). These findings suggest that the combination of psychedelics and MBIs has the potential to powerfully treat mental health disorders.

MBIs and psychedelics help to reset the brains Default Mode Network (DMN), the self-referential side of the brain, which is active during passive rest and mind-wandering, by helping to throttle its activity. A beneficial outcome for people with mental disorders characterized by impaired DMN function. For example, PTSD is associated with reduced activity in the DMN, and psilocybin can increase activity in the DMN in people with PTSD. This suggests that psychedelics could be used to treat a wide range of mental disorders characterized by impaired DMN function. In addition to PTSD, these disorders include depression, anxiety, and addiction. When combined with focused MBIs, individuals can throttle arousal and better regulate.

These studies confirm and lift earlier research done by psychiatrist Stanislav Grof, with his LSD experimentation which focused on healing patients through altered states of consciousness using breathwork. Grofs research into consciousness and healing is still at the heart of modern-day breathwork.

Using an altered state technique called holotropic breathing, patients could self-regulate and achieve altered states of perception without psychedelics, drugs, or medicine. Indigenous, ancient wisdom cultures have seen the power of deep breathing, which scientifically regulates the autonomic nervous system. We humans naturally breathe. Its a part of our autonomic, sympathetic, nervous system, which helps to regulate our bodies. We dont need to think about it. But, when practiced with intention and focus, breathing takes on another role, as the mind is directed to regulate and manage stress levels, as well as recognize, accept, investigate, inquire, and nurture altered states of consciousness for longer periods of time.

MBIs and somatic practices used with psilocybin have effectively treated many individuals with depression. The complementary effects of these treatments are certainly an exciting prospect for future research on this topic.

Authors note:Breathing is a powerful way to change your brain chemistry when used in conjunction with psychedelics. But, you must consider intention, set, setting, and integration when practicing. Seek out help and support. If you are looking for ways to improve your mental health, start by being more mindful of your breath.

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Psychedelics and Mindfulness: The Future of Mental Health? | Microdose - Microdose Psychedelic Insights

The Catalyst Summit on psychedelic medicine returns for its third iteration today, running through Sunday, and its all taking place live, in glorious in-person 3D at Queens University in Kingston, Ontario.

But have no fear. If youre nowhere near Kingston, the event is being live streamed and tickets are still available for that option.

Taking a look at the lineup of attending speakers, one finds myriad domestic and international policymakers, business leaders, academic researchers, scientists, mental health practitioners, and consumers of psychedelic medicine.

Whether attending in person or partaking of the online remote options, here are three speakers you wont want to miss.

At this point, most everyone with a remote interest in mushrooms has likely heard of this mycologist, but thats no reason to turn down the chance to hear him speak.

Stamets is the author of seven books, an Invention Ambassador for the American Association for the Advancement of Science, and was inducted into The Explorers Club in 2020. He has received numerous awards, including the National Mycologist Award from the North American Mycological Association, and the Gordon & Tina Wasson Award from the Mycological Society of America. His work has entered the mainstream of popular culture. In the new Star Trek: Discovery series on CBS, the Science Officer is portrayed by an Astromycologist as Lt. Paul Stamets. Pauls work with mycelium became a central theme of this series.

And dont forget, the unforgettable documentary Fantastic Fungi, currently streaming on Netflix.

As former Clinical Lead of the Psilocybin for Depression trial at Imperial College London, Rosalind Watts, PhD, led a clinical team that facilitated over a hundred psilocybin treatment sessions.

She developed the ACE model (Accept, Connect, Embody) for psychedelic-assisted therapy, which has been used in clinical trials of psilocybin and DMT. Having recognized that safe and effective use of psychedelics requires substantial integration support, Rosalind co-founded the UKs first psychedelic integration group, and is now launching a global online integration community, Accept, Connect, Embody, Restore (ACER) where members will follow a 12-month process together. She has developed a psychometric tool for measuring outcomes of psychedelic therapy (the Watts Connectedness Scale), is clinical track lead on the Synthesis Institutes Psychedelic Practitioner Training, and sits on the clinical advisory board of the Usona Institute, a not-for-profit psilocybin manufacturer and research organization.

You can find out more about Dr. Watts by visiting her website.

Something a little off the beaten path here, but highlighting how psychedelics can help us view societal actions from a macro view. Dr. Dycks chief interests are in the history of psychiatry, mental health, deinstitutionalization and eugenics. She is the author of Psychedelic Psychiatry which examines the history of LSD experimentation and how it fit within broader trends in the changing orientation of psychiatry during the post-World War II period. She is currently working on a CIHR-funded project with Megan Davies (York University) called Open Doors/Closed Ranks. This project relies on an interdisciplinary team of researchers who are comparing processes and experiences related to deinstitutionalization or the closure of long-stay mental hospitals in Nova Scotia, Saskatchewan and British Columbia.

Events like these serve to continue to bring visibility and momentum to the sea change occurring around pubic policy and public perception on psychedelics. As I was reminded recently in a conversation with MindMed CEO Robert Barrow, legislation for drug policy is all about the Congress. And the Congress is made up of impressionable human beings. Data drives decisions, and events like the Catalyst Summit present data by the deluge.

Being based here in the United States, its easy to misunderstand just how different the psychedelic landscape is in Canada, our North Star example of just some of what may ultimately be possible. The CATALYST Summit serves to showcase Canadas psychedelic journey into medicine, society, and commerce through keynote presentations, intimate panel discussions, and networking events.

Even if you cant be there in person, its not too late to get a discounted pass to tune in online.

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CATALYST Summit: 3 Psychedelic Speakers to Catch This Weekend - Psychedelic Spotlight

In early 2021, Rhys Edwards received a Google alert that would transform his life, possibly hopefully for ever. The alert had been set for news about David Nutt, a professor of neuropsychopharmacology. Edwards was interested in Professor Nutts unconventional ideas as an expert in how drugs affect the mind, and particularly on the therapeutic potential of psychedelics.

If youve heard of Prof Nutt, its probably from his most infamous hour, when he was forced to resign as the Labour governments drugs tsar, in 2009. His offence was to say that illegal substances such as cannabis, ecstasy and LSD were less harmful than alcohol and tobacco, a statement he stands by to this day.

The Google alert Edwards opened contained news of a radical treatment for mental health and addiction. The treatment came with Nutts seal of approval and would be available from a private clinic in Bristol run by Canadian biotechnology company Awakn Life Sciences, to any suitable candidates in the UK.

Edwards was immediately interested and eager to know more. He has suffered from depression for most of his life, leading to suicide attempts, stays in psychiatric hospitals and episodes of shockingly brutal self-harm. He tells me hes had a go at pretty much every kind of treatment going.

The approach, which combines medication and psychotherapy delivered to outpatients over a number of weeks, shows startling potential in a field which has made little progress in many decades.

Existing antidepressants are only cleaner versions of those first developed in the 50s, according to Nutt, and there has been no revision of the standard pill a day model. Only 10 per cent of those who may benefit from alcohol intervention treatment receive help and while most stop drinking at first, three-quarters relapse within six months.

We need to do better, says Nutt. Its a maintenance model. Its protecting people from the symptoms but its not getting rid of the cause, and thats something that our new therapy may be able to do.

Ive been invited to a low-key, high-stakes meeting with Nutt, who is also Awakns chief research officer, and other experts as they launch a flagship London clinic, following success in Bristol. All are convinced that it is time to properly explore new options to tackle rising levels of depression and addiction. Nutt, 71, has devoted his career to this.

Psychedelic drugs are the most interesting and innovative developments in this field, he explains.

My own view is that theyre going to revolutionise psychiatry. I dont think theres any doubt about that. I gave a talk to the Royal College of GPs this morning, and they seemed to believe me. The message is getting out there.

As a retired lawyer who made a comfortable sum after selling a consultancy business, Rhys Edwards had plenty of time to read up on the subject from his Somerset home adjacent to the Glastonbury festival site, which he shares with his wife, 10 dogs and a few other animals.

After further research a considerable amount given its unusual nature and the 6,000 price tag he underwent treatment between December 2021 and February this year.

I was on ridiculous amounts of antidepressants, Edwards says. I was pretty stable but it was like being anaesthetised. The only thing they hadnt given me was ECT (electroconvulsive therapy). I was certainly grasping for something that might be my last chance.

He has also drastically cut back on his other medication, giving up one of two heavy duty antidepressants, almost halving the dosage of the other and drinking far less alcohol.

Im not saying Im cured. I still have bad days and I still have depressive episodes. But I can deal with them and put them into context. I feel like Ive got a good life.

But this wonder treatment is ketamine, a drug with a very dark reputation. One of the reasons that it is the first psychedelic legally available for therapeutic use is that we already know so much about it.

Although often dismissed as a horse tranquilliser or party drug, it is a widely used anaesthetic, commonly chosen for use with children and short operations such as fixing dislocated shoulders. A variation called esketamine is already available through the NHS, prescribed as a nasal spray and not offered alongside therapy, which Awakn believes is the key to long-term benefits.

This combination has unique effects on the brain circuitry associated with unhelpful thinking and behavioural patterns, Awakns website states.

It may allow you to work through issues in ways that have not been possible with therapy alone, and help you to relearn the behaviours and thought patterns that hold you back.

The company researches ketamine and MDMA (ecstasy) treatments for alcohol use disorder (AUD). Professor Celia Morgan, who made the ketamine breakthroughs and is head of Awakns ketamine-assisted therapy, runs the Ketamine for Reduction of Alcohol Relapse trial at the University of Exeter. During the Phase II trial involving 96 participants between 2016 and 2020, her findings revealed that low doses of ketamine combined with psychological therapy can help prevent relapse, showing 87 per cent abstinence at six months compared with the usual one quarter.

AUD is a prime focus given its prevalence it affects 400 million people globally but it is hoped that behavioural addictions such as gambling, food and sex may also be candidates.

Whats so exciting is it brings psychology and psychiatry back together, says Nutt.

I certainly think psychiatrists are ready for it. Im not sure about psychologists. It challenges what theyve been telling their patients for a long time that you should never take drugs. Ive had flak for even talking about these treatments.

Other psychedelics including psilocybin (magic mushrooms) and MDMA are also being trialled. There is little evidence of addiction to psychedelics but opiates such as morphine and fentanyl, which are known to be highly addictive, are routinely prescribed by doctors.

When I was invited to attend the opening of the flagship London clinic last month, where the course costs 7,500, the concept still felt somewhat cloak-and-dagger.

Psychedelics have been around for a long time, but the approach is young and the potential dangers of mind-bending drugs and bad trips are embedded into Western culture.

The clinic space is warm and contemporary. It could be a tech start-up or an independent caf as much as a therapy clinic. The name, Awakn, puts me in mind of the TV series Nine Perfect Strangers, in which Nicole Kidmans mysterious guru character invites struggling guests to her unconventional wellness centre. I suppose we are hard-wired to associate anything related to psychedelics as woo-woo. Certainly, Britons will need to lay down some new neural pathways to get on board.

Scientists such as Nutt and Morgan have long suspected the potential of psychedelics. But theyve found it almost impossible to run trials, even though it has been an area of interest for scientific researchers since the 50s, especially in the US.

Alcoholics Anonymous (AA) co-founder Bill Wilson even intended LSD as the 13th step in the organisations approach to addiction, and credits it for his own recovery. Ultimately, he was ostracised for these views.

Psychoactive plants such as ayahuasca and datura have been used therapeutically by those living close to them for centuries.

Wilson took LSD with the psychologist Betty Eisner and psychiatrist Sidney Cohen. Both were at the forefront of American research into how psychedelics could work alongside talking therapy to treat depression and addiction.

But with the war on drugs in the US came the demonisation and criminalisation of these drugs and practices. Most illegal substances were lumped together, bureaucratically and in the general psyche, as public enemy No 1. Eisner and Cohens work was kneecapped.

It remained legal to use MDMA therapeutically until the mid-80s, when the authorities caught up with its popularity as a party drug. Decades on, Nutt and Morgan seem as surprised as anyone that their work is finally available to the public at large. When had they expected this to happen? They laugh. From Nutt it is more of a guffaw. Never, he replies.

In March, the Royal College of Psychiatrists announced a record 4.1 million referrals to mental health services in 2021, urging the Government to publish a fully funded recovery plan. Awakn, of course, plans to be part of that.

Theres no question places like this are going to be important, says Nutt. The cost burden of severe depression is enormous and clinics like this are going to provide better outcomes at a lower cost.

This is no quick fix though. Theyre not having fun, says Nutt of those who have undergone the treatment. Theyre dealing with the damage theyve done to themselves and their families with alcohol or depression, going back to places where theyve been abused.

I viewed it as work from the outset, confirms Edwards. I think it works on a whole lot of levels. Its great fun in places, it can be very intense in others.

Id gone into it wanting to explore my relationship with my parents and I had the experience of meeting them and was able to clear the air. I wrapped them up in my love and sent them off.

The Awakn programme typically takes place over eight weeks and includes 11 psychotherapy sessions, four ketamine sessions of around two hours each (given by injection) and a final post-course evaluation.

During the ketamine sessions clients are settled under a blanket with music and assisted by a clinical specialist, although it is unusual to talk during thispart.

Psychotherapy sessions follow about 24 hours after the ketamine, when the brain is at its optimum plasticity. This is the time when we are best able to create new ways of thinking.

The ketamine allows users to gain a fresh some call it a fully objective or out of body perspective on their lives and past experiences. The psychotherapy which follows gives them the tools to embed this new outlook into their neural pathways.

Each potential client is assessed individually and will have previously tried other treatments such as antidepressants or substance detoxes. The markers for AUD relate more to how alcohol use is affecting someones life than the volume drunk.

Clients include a photographer who had been drinking three or four beers a night but couldnt stop, a retired civil servant who had struggled with drinking for 40 years and a nurse who didnt want her children to grow up using alcohol as she was.

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'I took ketamine to treat my severe depression' - iNews

Welcome to TDRs review of the Top 5 Psychedelic developments for the week of May 9. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.

5. FDA Gives Expanded Access To MDMA As A Treatment For PTSD

Clinics in 10 U.S. cities including one in Western North Carolina have been approved by the FDA to expand patient access to MDMA. The recreational drug also known as Ecstasy, will be a treatment for post-traumatic stress disorder. The program is currently in phase three trials, but the safety and efficacy demonstrated thus far will allow forcompassionate use, with an eye on possible FDA approval next year.

What weve done for years in treatment is try to give people drugs that have tried to basically throw a blanket on those symptoms. Unfortunately, we havent done a very good job with those drugs.

Post-traumatic stress disorderhas been aroundas long as trauma has, but its only recently been recognized as a formal diagnosis, especially for members of the armed forces exposed to intense or prolonged violence. Left untreated, PTSD can lead to self-harm, and is considered a major contributing factor to the epidemic of veteran suicides.

4. Colorado Activists Collect Tens Of Thousands Of Signatures To Put Psychedelics Reform On Ballot

Colorado activists have wasted no time working to place competing initiatives to legalize psychedelics on the states November ballot, with one campaign saying that its already collected nearly half of the required signatures needed to qualify its measure.

Colorado Activists Collect Tens Of Thousands Of Signatures To Put Psychedelics Reform On Ballot: "We're excited to finalize our signature collection in the coming months and hit the ground running this fall." https://t.co/rwWhCUyWaB

Natural Medicine Colorado, a campaign backed by the national New Approach PAC, filed several versions of reform initiativesbefore deciding on one to pursuein March. It would legalize psilocybin, create licensed healing centers where people can use the psychedelic for therapeutic purposes and provide a pathway for record sealing for prior convictions.

__________

Recently Released Data Shows LSD Produced A Lasting And Rapid Reduction And Anxiety

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3. Psychedelic Stocks Swoon As Key Biotech ETF Makes Multi-Year Lows

The biggest psychedelic stocks mostly declined this past week, noticeable underperforming peer biopharma indexes. TheHorizon Psychedelic Stock Index ETF(PSYK) shed9.70%, while theNasdaq Junior Biotechnology Index(2.64%) andNasdaq Biotechnology Ishares ETF(0.02%) were materially stronger. The broad market slumped for a sixth consecutive week, withNASDAQ1002.54%andS&P 5002.49%falling hard, although finishing Friday on an up note. Heres how the Health Care (Biotechnology) sector performed:

Weekly technical snapshot, PSYK ETF:

In the news

A national drug policy advocacy organization is condemning how a prominent psychedelic research body responded to a B.C. womans allegations of sexual and physical abuse during clinical trials for MDMA-assisted psychotherapy.

Beckley Psytech Limited and Lophora ApS have entered into a research and development collaboration. Under the terms of the agreement Beckley Psytech will jointly fund continuing development of the Lophora pipeline and collaborate broadly on R&D.

Bright Minds Biosciences will host a symposium with Key Opinion Leaders on Dravet Syndrome and recent therapeutic developments within the competitive landscape.

Clearmind Medicine announced the filing of a provisional patent application, related to a psychedelic combination therapy treating binge behaviors that results from its recently launched collaboration with SciSparc Ltd. (NASDAQ: SPRC).

COMPASS Pathways to explore how psilocybin affects specific brain pathways in autistic adults. This will be the first ever mechanistic study of psilocybin in autistic adults.

COMPASS Pathways reported its financial results for the first quarter 2022 and gave an update on recent progress across its business. Cash and cash equivalents were $243.7 million as of 31 March 2022 compared with $273.2 million as of 31 December 2021.

Enveric Biosciences announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets to a wholly-owned subsidiary, Acanna Therapeutics Inc. by way of dividend to Enveric shareholders.

Field Trip Health announced the launch of Field Trip at Home Powered by Nue Life, which provides ketamine treatments from the comfort of a persons home.

FSD Pharma announced the closing of the sale of the Companys former cannabis processing facility located in Cobourg, Ontario, Canada for gross proceeds of CAD$16,400,000 in cash.

Kernel, a leader in non-invasive neuroimaging, and Cybin Inc. announce pilot results from a Cybin-sponsored feasibility study evaluating Kernels quantitative neuroimaging technology, Flow, to measure cortical hemodynamics while experiencing an altered state of consciousness.

Ketamine Wellness Centers announced a new partnership with the Veterans Administration (VA) inArizona. Veterans suffering from treatment-resistant depression, PTSD and anxiety will have access to ketamine therapy at the KWC Arizona clinics inPhoenix,TucsonandMesa-Gilbertat no out-of-pocket cost with prior authorization from the VA.

Mind Medicine will host a key opinion leader webinar on substance use disorders and withdrawal management onThursday, May 19, 2022at11:00am EDT.

Mindset Pharma announced that it is making headway in progressing its Family 1 lead clinical candidate, MSP-1014, towards clinical trials.

Novamind has been selected to host a clinical trial for the acute treatment of social anxiety disorder (SAD), an understudied and common mental health condition that affects nearly 15 million American adults. The phase II randomized clinical study for the acute treatment of SAD is sponsored by Bionomics Limited, a clinical-stage biopharmaceutical company listed on NASDAQ.

Ohio State University launches center to study therapeutic potential of psychedelics.

Optimi Health has completed a planned expansion of the on-site analytical laboratory at its Princeton, British Columbia facility.

Red Light Holland has engaged Akwasi Owusu-Bempah to serve as an Advisor to its Advisory Board.

Red Light Holland has submitted a Patent Cooperation Treaty application based on the provisional application it filed last year for the customization and personalization of microdosing kits and protocols based on biometric and movement data.

Revitalist Lifestyle And Wellness reported updates on strategic initiatives accomplished in April including becoming a founding partner with the American Association of Psychedelics.

Wesana Health Holdings announced that following the completion of a successful Pre-IND meeting with the United States Food and Drug Administration, the company is expanding its lead indication for SANA-013 to Major Depressive Disorder and exploring other complementary orphan indications.

2. Senators Want Psychedelics Research Review From Federal Agencies

Sens. Brian Schatz (D-HI) and Cory Booker (D-NJ) are pushing top federal officials to provide an update on research into the therapeutic potential of psychedelics, arguing that ongoing federal prohibition has stymied studies.

Senators Want Psychedelics Research Review From Federal Agencies: "Whatadditional regulatory barriers or requirements are there to studying natural or botanical psychedelics, such as psilocybin?" Sens. Brian Schatz and Cory Booker asked NIH and FDA. https://t.co/bclWfxC462

In a letter sent to the heads of the National Institutes on Health (NIH) and Food and Drug Administration (FDA) on Wednesday, the senators said that the agencies are critical to ensuring a comprehensive, rigorous, and deliberative science-based approach to the study of psychedelics. That includes the potential development of medication and therapeutics derived from these substances, they wrote.

The senators said that theyre encouraged that NIH hosted a workshop in January to explore regulatory challenges that areimpeding research into psychedelicslike psilocybin and MDMA. And they want the agencies to further expand their role in identifying research gaps, potentially promising therapeutic uses of psychedelics, and regulatory hurdles in the field of psychedelic research.

1. MindMed Collaborators Prof. Liechti And Dr. Holze Announce Positive Topline Data From Phase 2 Trial Evaluating LSD in Anxiety Disorders

Mind Medicine(NASDAQ: MNMD), (NEO: MMED) announced that Prof.Matthias Liechtiand Dr.Friederike Holze, MindMed collaborators at University Hospital Basel (UHB), have released positive topline data from a Phase 2 placebo-controlled investigator-initiated clinical trial evaluating LSD in the treatment of anxiety disorders. These findings were presented in an oral presentation atLondonsPSYCH Symposium onMay 11, 2022.

The topline data demonstrate the significant, rapid, durable, and beneficial effects of LSD and potential to safely mitigate symptoms of anxiety and depression. LSD (200 g) treatment resulted in significant and strong reductions of STAI-G scores 16 weeks after treatment in the between-subjects analysis (least square mean ( SE) change from baseline difference = -16.2 (5.8), 95% CI=-27.8 to -4.5, p=0.007). LSD was well-tolerated.

Said Dr. MiriHalperin Wernli, Executive President of MindMed These results represent the highest quality research ever conducted with LSD in anxiety disorders and provide contemporary confirmation of the preliminary findings of the anxiolytic and antidepressant effects of LSD in over 500 patients to date. The statistically significant, strong and long-lasting reductions in STAI-G scores, combined with similarly rapid and sustained responses in all secondary endpoint measurements, are extremely encouraging. These results further support MindMeds clinical development strategy.

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TDR's Top 5 Psychedelic Developments For The Week Of May 9 - The Dales Report

The chemical makeup of naloxone has been known since 1961; its an old and cheap life-saving drug that can quickly reverse an opioid overdose. But Evzio, a naloxone auto-injector made by pharmaceutical company Kalo, has regularly undergone dramatic price increases, at one point costing $4,500 for a two-pack. Because of its steep cost, insurance companies often require submission of prior authorization requests before they approve coverage for itputting it out of reach for those who might need it.

Its a common story in the U.S.: An old and cheap drug was transformed into an expensive, inaccessible product. This happened through patents, legally granted rights to exclude others from making or selling an invention. Kalo has 25 patents on Evzio in total, the latest of which expires in July 2034.

What exactly did Kalo invent? A closer look reveals that not only are the patents overlapping, rather than distinct, but that nine of the inventions have the exact same name and are part of the same patent family, covering modified versions of the same invention with slightly different dates of expiration, wrote Colleen Chien, a law professor at Santa Clara University School of Law, in a 2022 paper titled "The Inequalities of Innovation."

Kalo isnt doing anything very special with Evzio. Its using patents as many companies, especially drug companies, have for decades. While patents were intended to encourage innovation, thats not always how it works in practice, especially when it comes to medicine. Instead, patents are used to extend ownership over inventions well beyond a period of initial exclusivity, creating monopolies and driving up drug prices.

These glaring issues with the patent system should be a concern for the emerging psychedelic industry, which is entering into the world of patenting at scale for the very first time. In 2016, the psychedelic patent landscape was, according to one psychedelic CEO, wide open. But no longer. Hundreds of psychedelic patents are being filed, and many granted, with hundreds still secret since patent applications arent made public until 18 months after filing.

Perhaps this shouldnt come as a surprise, not because of psychedelics, but because of the problems with the patent system as a whole. For decades, advocates have been ringing alarm bells about bad patent practices. In April, the New York Times editorial board published an opinion piece titled Save Americas Patent System. Put simply: The United States Patent and Trademark Office is in dire need of reform, the board wrote.

There is now, potentially, a patent reckoning. There is a new United States Patent and Trademark Office (USPTO) director, after the organization was absent a leader for over a year. In 2021, President Biden called for the FDA and the USPTO to work together to understand the scope of the problem of drug pricing, and address solutions. And theres been widespread attention on how the patents on the COVID-19 vaccines impeded global access.

The patent system is a stark example of how, even if medical psychedelics could be beneficial to some people for some uses, the process of implementing these treatments requires working within deeply flawed existing structures. It would be wrong to assume that psychedelic companies, because they deal in psychedelics, will be immune to those flaws.

The psychedelics industry is maturing. Initially, venture capital (VC) groups dedicated to psychedelics were providing most of the funds, but as Yeji Jesse Lee recently reported in Business Insider, mainstream healthcare VCs are now entering the market. With FDA approval for psilocybin and MDMA looming, its reasonable to guess that larger pharmaceutical companies will follow eventually. Many psychedelic companies are already boasting about building up their IP portfolios, or their aggressive patent estates. In audio shared with Motherboard from an investor meeting in April, executives from the mental health company Compass Pathways and Atai Life Sciences discussed patent strategy.

You obviously give it to the lawyers and say, make it as broad as possible because, you know, some things are taken out in the approval anyway, said Christian Angermayer, the founder of Atai.

Psychedelic companies can choose to position themselves within existing structures, maintaining the current state of affairs. There is an opportunity, though, for a new industryone that claims to exist for the sake of improving well-being and at its most grandiose claims to be capable of ushering in utopiato be part of the call for patent reform. Psychedelics cannot foster a revolution in well-being if they replicate the abuses of power and inequities that already exist in our world. Psychedelics could better the systems they enter into, rather than just playing by their rules.

With a new industry, like psychedelics, we are setting the pathway for the future, said Robin Feldman, a professor of law and the director of the University of California Hastings Center for Innovation. Improper patent behavior now can determine the direction of this industry: Access for patients, or the ability of generics to enter for a long period of time.

Patents are meant to promote innovation by restricting competition for a limited period of time. In the pharmaceutical industry, patents are meant to give companies incentive to undertake financially risky research and development. In return for doing so, the reward is that they get to exclude others from using the innovation and make back their, and others, investment.

Im definitely not a person who would say, No patents anywhere, Feldman said.

The problem isnt with patents; its with how patents have been used and abused. Eventually, a patent is supposed to expire so there can be broader use of that invention. In pharmaceuticals, that means generic versions, which is really the only known mechanism to meaningfully lower drug prices, said Ameet Sarpatwari, an epidemiologist and lawyer at the Harvard Medical School Center for Bioethics.

The drug industry, which psychedelics are hoping to join, comprises some of the worst patent offenders. Feldmans research found that 78% of drugs associated with new patents between 2005 and 2015 were not actually new. If patents are supposed to drive innovation, thats not what happens in practice. Focus shifts from developing new, transformative drugs to trying to develop modifications to existing drugs to secure patents. Not all inventions add that much to what we can already do, said Lee Vinsel, an associate professor of science, technology, and society at Virginia Tech and the co-author of The Innovation Delusion.

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Similar trends are already at play in psychedelics, with companies filing and getting applications for minute modifications in known or existing molecules, like, to take just two examples of many, a patent for a different solid crystal form of psilocybin, or a deuterated version of psilocybin, which is the same molecule except with slightly different hydrogen atoms.

There are clear cases where patents protect innovation, but those tend to be a relatively small number of patents, said Jim Bessen, an economist at Boston University, and the author of Patent Failure. Its about building up moats that companies can use to protect markets, and protect whole classes of ideas.

What companies do (if they can afford it) is build large patent portfolios so that they can threaten to sue and counter-sue others. For the top-grossing 12 drugs in the US, there are 125 patents filed, and 71 granted patents, per drug. Over half have more than 100 attempted patents per drug. These are called patent thickets: When a company creates a thick bramble of patents to keep competitors and generics out.

The threat of litigation from patents can cause others to reduce or divert R&D spending. In 2019, research found that when there are an increasing number of patents in a given field, startup inventors reduce their research and development spending.

The company AbbVie has filed more than 250 patents on Humira, its rheumatoid arthritis drug. A lot of patents are arguably on peripheral aspects of molecules that are less innovative than the chemical entity itself, said Bhaven Sampat, an economist at Columbia University, who studies the effects of patents on innovation, prices, and access to medicines. Its sometimes called life cycle management, which means extending the protections around a product into the distant future. The more pejorative term would be product hopping" or "evergreening."

It shows how the real innovation that's coming out of some of these companies is coming from the legal department, not from the scientists, Sarpatwari said.

There's a seemingly endless pit of examples of bad patent practices related to drugs. Companies often make slight modifications to a drugs dosage or delivery mechanism just before the patent expires and then shift the market to the version thats protected by new patents, Feldman said. When the patents were nearing expiration for the colitis drug Asacol, for example, the company developed and introduced Delzicol, which was just an Asacol tablet surrounded by a cellulose capsule.

If the capsule was cut open, the original Asacol tablet fell out, Feldman said. Even the FDA agreed that the two drugs were completely the same. But the company still got a shiny new patent. Then, the company removed Asacol from the market, redirecting patients only to the drugs it had new patents on.

The drug Revlimid, from drug manufacturer Celgene, is an analogue of thalidomide, a drug that caused birth defects when given to pregnant people in the 1950s and 60s. It was repurposed as a cancer treatment, but the company had to set up a safety protocol to use it, so that no pregnant person would take the drug.

Celgene then patented its safety plan. When a generic company applied for approval, Celgene filed a citizen petition asking the FDA to deny the application. Celgene said that no generic could use its safety plan because it owned it, and since there was no other way to ensure safe use of the drug, this ensured their monopoly on it.

This is directly relevant to psychedelics because its possible the FDA could approve psilocybin or MDMA with a set of safety instructions, called a Risk Evaluation and Mitigation Strategy (REMS). A company with a patent around mandatory safety practices could thus own the therapy.

Over the past two decades, patents have been used to forestall competition, which resulted in raised drug prices. Humira, the rheumatoid arthritis drug, has 132 granted patents attached to it, 90 of which were issued 12 years after the drug came out. These patents arent just directed to the drug itself but to ingredients and formulations AbbVie anticipated its competition might seek to employ. The drugs gross over $12 billion in U.S. sales per year which, as the non-profit Initiative for Medicines, Access & Knowledge noted, is more money annually than all of the NFL teams, combined.

To get those patents, AbbVie used prophetic examplesmeaning they guessed on experiments and made up data that others might one day want to do or use, and got patents on those fictitious examples. Weve already seen prophetic examples used in psychedelic patents, like in a granted patent for LSD for food allergies, despite the fact that no clinical research has been done on that topic.

Though a number of AbbVies patents have proven to be invalid, each challenge is costly, Chien wrote. Rather than try to cut through the thicket, competitors have in some cases settled with AbbVie translating into delayed dates of generic entry.

Starting to see psychedelic patents follow in these other patents' footsteps should be alarming, said Sarpatwari. It should be surprising and concerning that people who have been in the field for decades are seeing companies come in and get patents for what seem to be very obvious modifications, he said. This is a problem with our patent system and it's a pronounced problem in the pharmaceutical industry.

We can hope that the psychedelic industry will be different. But the patent system has proven that it allows this behavior, and that those who partake in it reap financial rewards. That gives anyone participating in the system an incentive to do the same.

In audio of an investor meeting from April that was shared with Motherboard, executives from the mental health company Compass Pathways and Atai Life Sciences discussed the companys patent strategy and philosophy.

George Goldsmith, CEO and co-founder of Compass, said that early on, the company looked to patent successes to shape their own actions. Specifically it turned to GW Pharmaceuticals, a British pharma company, that took CBD and THC into different development paths and they patented their approach to this.

Our first port of call was who did that and who was successful and able to get those initial patents, Goldsmith said, adding that Compass sought out the same counsel for its patents on synthetic psilocybin. Compass currently has 10 patents, five in the US, and Goldsmith said, We have quite a number of others that we're developing.

Christian Angermayer, the CEO of Atai and a funder of Compass, asked if anyone else could synthesize psilocybin the way Compass does it. George responded that, No one else can do it without violating our patent. (In an email obtained by Motherboard from last year, Angermayer similarly wrote, Many psychedelic companies out there will never be able to bring a product to market, as they will hit the patents of Compass and Atai.)

In the meeting, Angermayer also said, when describing patent strategy more generally, that the directive to lawyers would be to make claims as broad as possible. When reached, Compass did not have additional comments to add.

As patent lawyer David Casimir previously told Motherboard, its not unusual for patent applications to include extremely broad claims, even if applicants know they are not patentable. Once patent examiners respond, an application can be amended with narrower claims, but this process might allow claims that examiners dont catch to slip through. This can lead to bad patents, Casimir told Motherboard. If the patent office doesn't do a good job, then they'll say, 'Okay, you can have this broad claim.'

Though Compass has had the most attention directed to its patents, this mentality is not unique. Besides filing broad applications, filing patents on small modifications to known molecules, novel delivery systems, or different solid forms is abundant in the field. The top five public psychedelics companies by market capAtai Life Sciences, Compass Pathways, GH Research, MindMed, and Cybinhave submitted or already own the rights to at least 157 patents, as Lee has reported. And since most psychedelic companies were founded in the early-to-mid 2020s, many patents are still undisclosed; there are hundreds we dont know about. This threatens to create patent thickets very early on in the industry.

Money plays a key role here in another way: We want psychedelics to be put through clinical trials, and someone needs to pay for it. Rigorous testing is necessary to learn whether psychedelics truly can be treatments for conditions like PTSD, depression, or addiction, and so that patients know that what they're signing up for, in the medical context, has efficacy and safety data backing it.

One reason for the predominant role patents are already playing in psychedelics is the lack of federal funding for such research, which has pushed nearly the entire field into privately-owned companies. Its also partly due to the Drug Enforcement Administration's scheduling of psychedelic compounds as Schedule 1, which makes research logistically difficult.

Using public sector funding to develop these products is another reasonable policy approach that might avoid some of the patent tradeoffs, Sampat said.

But barreling ahead with VC money, patents, and ROI alone opens up the field to the systemic problems with the patent system. For instance, a patent examiner cant ever really reject a patent. They can reject an application, but the applicant can then file whats called a continuation and go through the whole process again.

Then, the applicant can change the words within the patenteven if the invention remains the sameand keep filing it until it gets granted. People with the most capital are the ones able to do this, widening the gap between who is able to get psychedelic patents and who isnt. Companies can also file continuations when they see a competing product coming onto the market, and they can tweak an application so it covers that product and sue the other party.

This is just one way in which patents can also reinforce pre-existing inequalities before a drug is even approved. Who has the money to lawyer up and file for these patents? According to Chiens research, in 2020 over half of new U.S. patents went to the top 1% of patentees, and more than half of all U.S. patents of U.S. came from five states, all coastal. Less than 13% of inventors were women. When researchers looked at how patenting affected income inequality between 1980 and 2015, they found that increase in patenting was correlated with increases in top income inequality, meaning patents helped the rich get richer.

Alongside the medical pipeline, psychedelics are also being decriminalized and in some places legally regulated by states. This creates a unique situation where if psychedelic treatments are inaccessible in the medical model, people might turn to legal or decriminalized alternatives.

This isnt the case for pharmaceutical drugs, so we dont know how legal competition will affect medical psychedelics. But while psychedelics can be used for many purposes recreational, spiritual, or general well-beingthere are reasons to want to ensure that people who prefer medical psychedelics can choose that if they want to, rather than have people be priced out of certain options.

People seeking out psychedelics for mental health indications may wish to see providers with expertise in those conditions, and be protected by medicines accountability frameworks of practitioner licensing and malpractice insurance. Though its unclear whether and how insurance companies will cover psychedelic-assisted therapy, insurers definitely won't reimburse psychedelic care accessed outside the medical model.

For those in communities where psychedelic drugs still carry a lot of stigma, they might only be comfortable trying these treatments by getting a prescription for an FDA-approved medication. Too many broad patents too soon, and bad patent practices will threaten the cost and accessibility of care.

You basically get a two-tiered society, which we already have, but this exacerbates that, Sarpatwari said.

The last meaningful attempt at patent policy reform was in 2014, when the Patent Transparency and Improvements Act, which would have made a number of reforms to how patents are used, was pulled from the Senate agenda.

Experts Motherboard consulted said that the demand for reform is currently strong again. The patent office hasnt had a permanent director for the past year, but the Senate recently confirmed Kathi Vidal, a Silicon Valley patent attorney to lead the USPTO. (She did not respond to requests for an interview.)

There has been some pushback on psychedelic patents, like from the nonprofit Freedom to Operate, and through the creation of Porta Sophia, a psychedelic prior art repository. But Tahir Amin, a lawyer and co-founder of Initiative for Medicines, Access & Knowledge (I-MAK), doesnt think that challenging patent by patent, or even drug by drug, can successfully address the larger, systemic concerns. Who has the resources to spend to challenge those patents? As Motherboard has reported, it cost nearly a million dollars for Freedom to Operate to challenge two of Compass Pathways psilocybin patents.

Whats needed are new policies around what patents are actually allowed, Amin said. Its not shocking that companies act in their own interest, Feldman said. We cant expect them to act in any other way if we want to curb this behavior, she said. Our government has to change the incentives in the system and the opportunities for behavior that's bad for consumers.

There are a number of basic reforms that Priti Krishtel, a lawyer and co-founder of I-MAK, said could help with patent misuse. Officials could make it easier and cheaper to challenge patents, and require that certain secondary pharmaceutical patents be forced to undergo a review. There could also be a maximum to the amount of times an applicant can resubmit their application.

Patent examiners could be given more time to review applications. Its been shown that even very complex applications on average get 19 hours of review; some get much less. (Like the granted patent for a DMT vape pen where the examiner only looked for prior art for seven minutes.) Chien has written that licensing patents or donating them to the public domain could be rewarded with tax breaks. She is also researching now whether there are ways to predict risky patents before they get granted, by identifying patents that have a lot of legal heft behind them.

For years, advocates and academics have been raising concerns about bad patent practices and how they affect drug prices, access, and social equality. These are immense resources and experts that the psychedelics industry should be collaborating with and turning to. For if the psychedelic industry establishes itself on a bedrock of broad and secondary patents now, its unclear what effect that might have on the future of these treatments.

After decades of huge revenue growth, branded pharmaceuticals began to lose money around 2009 in whats been called the patent cliff, when patents began to expire and people began to produce and buy generics instead. In response, companies started to raise prices to make up for the revenue. Will companies getting psychedelic patents now let their patents expire in 20 years, and let generics enter the market? Or will companies engage in the practices that are common in pharma right now, which could have implications on cost and access for decades to come? "Patent trolls" are another blight in the current patent system: entities that use patents to sue others for profit, rather than developing products themselves. It's too early in psychedelics for such trolling, but as companies go out of business, what will happen to their IP? Will they try to recoup investment by litigating against others?

People in psychedelics are often posturing about how these compounds will make the world a better place. Psychedelics are one of the rare cases where profit and impact work together synergistically, Tim Schlidt, the co-founder and partner of VC fund Palo Santo said in a recent interview with TechCrunch. Filing patents as business as usual runs counter to that ethos.

Feldman agreed that its an important moment for patent reform. The psychedelics industry just so happens to be maturing at the same time. Whether or not psychedelic companies will adhere to the status quo or take advantage of the need for change is yet to be seen.

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Psychedelic Patents are Broken Because the Patent System Is Broken - VICE

If you get caught with psychedelic mushrooms in WeHo, dont trip the city might back off on enforcing the laws that prohibit possession of the drug.

Councilmember John Ericksons agenda item, set to be discussed during City Councils meeting on Monday, would designate investigations, citations, arrests, property seizures and prosecutions of psilocybin mushrooms a low priority for the city and the law enforcement agencies it contracts.

Psilocybin is a chemical obtained from certain types of fresh or dried mushrooms that produces a hallucinogenic effect. Indigenous cultures have used it for ritual and religious purposes for centuries. After a period of interest in psilocybin for use as a psychotherapy tool in the 1950s and 60s, political backlash and social stigma marginalized mainstream scientific research into the drug. Psilocybin, like cannabis, remains a Schedule 1 substance under the Controlled Substances Act and is illegal under federal law.

But things are changing, according to the staff report:

Modern research has reinitiated an interest in the use of psychedelics, including psilocybin, as an effective treatment for a broad range of health issues. Psilocybin has the potential to treat a range of psychiatric and behavioral disorders, including depression, obsessive-compulsive disorder, smoking cessation and other addictions, cocaine addiction, and cancer-related or other end-of-life psychological distress.

Voters in Denver and Oregon have approved measures to decriminalize and regulate the possession and sale of psilocybin, and while an effort to do so in California failed last year, the movement is still gaining momentum.

This wouldnt be the first time West Hollywood has declared certain crimes a low priority.

In the mid-1990s, City Council relaxed enforcement of laws related to marijuana. Last year, offenses related to sex work were also named a low priority for officers to enforce.

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Magic mushrooms are on WeHos mind - WEHOville