Monthly Archives: May 2022

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.

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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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Continued here:

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

A new study has compared the effects of varied doses ofpsilocybin and LSD for the first time. These two popular psychedelics have been of increasing interest in clinical research. The new paper, which detailed a double-blinded, randomized and placebo-controlled study of 28 healthy volunteers, compared the impact of placebo, LSD (100 and 200g) and psilocybin (15 and 30mg). The study was a collaboration between the Liechti Lab at Switzerlands University Hospital Basel and MindMed, an established player in the psychedelics drug development industry.

Technology Networks caught up with Rob Barrow, CEO of MindMed, to discuss the findings in more detail and explore pressing issues around blinding in psychedelic drug development.

Barrow spent 10 years as the chief operating officer of a clinical stage private pharma company before joining the psychedelic non-profit Usona Institute, followed by a move to MindMed in 2020. Barrow says that his vision for MindMed was of a psychedelics company that can operate at scale and juggle multiple assets. It's an ambitious goal. In this interview, he discusses how this aim has been realized in 2022.

Ruairi J Mackenzie (RM): How are doses in psychedelic drug studies decided upon and measured?

Rob Barrow (RB): As in most drug development programs, dosing is one of the key aspects you need to fully characterize throughout early development. When you go into your pivotal phase III studies, you need to have your dose nailed down. There are a number of elements that can factor into dosing on an individual basis, but you're arriving at a dose that you feel is reliably going to induce the pharmacology that you want, to lead to the clinical outcomes that you're seeking to provide to patients.

When we think about dosing with psychedelics, there has been, fortunately, decades of research to well characterize the pharmacokinetics and dynamics and we really have a good understanding of how those interactions play out.

To have a drug that you can bring out to market at scale, you typically end up at a fixed dose regimen unless there's a particular concern, often more of a concern for safety, which tends to not be the case with this drug class. Most of the studies look at metabolic phenotyping and genotyping and drug-drug interactions with LSD; all these things are important in terms of labeling. But often it's not the case that they're labeled for an efficacy or pharmacodynamic reason, they're labeled because of safety. When you think about psychedelics, at this point we feel like we're confident enough in the safety that we are aiming for a fixed dose regimen.

We have launched a phase IIb dose optimization study of LSD. That's really to explore which of those fixed doses reliably gives you the activity that you're seeking to generate both acutely, but also more importantly, in terms of clinical outcomes over the course of several weeks.

RM: You compared LSD and psilocybin doses in a new study. What were the key findings?

RB: The key finding is that LSD is much more potent than psilocybin (which we knew previously) but also that it does appear to induce the same acute psychoactivity and acute perceptual effects as psilocybin. What we don't know this is the key question that remains from this work what we aren't certain of is whether that acute activity directly modulates the clinical response. Whether the acute, perceptual effects are directly causative to antidepressant or anxiolytic effects of these molecules. Nonetheless, we certainly think that this study provides a solid evidence base to allow us to read across the assets.

As we look at data from psilocybin, it gives us increased confidence that we can learn from those results and that they would be applicable to LSD, for instance, which gives us an enormous additional opportunity to learn from research outside of our own programs. And it continues to de-risk our approach and give us more opportunities for expansion of our label and where we might go with marketing one day if we get these therapies approved.

RM: Were these results surprising to you?

RB: It wasnt terribly surprising, given the thousands of patients that have been administered LSD and psilocybin, and anecdotally, you can certainly look at the evidence and say, these are going to behave similarly. But it's important to definitively establish these things. Having scientific evidence to link the two is much more valuable than just anecdotal observation. At the end of the day, its not particularly surprising that there's quite similar activity.

One remaining question is, based on the differences between LSD and psilocybin, and based on the doses that we are exploring between the two molecules, does LSD more reliably induce a certain response at a certain dose? There's a lot more to be discovered about that translation in terms of clinical activity.

This was not done in a population with a diagnosis. We need to understand if there's a similar response in the clinic or how they differentiate. Some of the observational evidence we have from our colleagues who have been working with LSD for a long time is that it very well may be even better at treating the clinical outcomes. Now, we have to prove that.

RM: Theres been a lot of discussion in the field recently about the issue of blinding in clinical trials. In your new study, which was double-blinded, participants were able to guess whether they were taking a drug or a placebo96% of the time. What are the ways forward to try and minimize these issues with blinding?

RB: Its a fascinating topic, I've personally had a lot of interesting engagement, both with researchers and the FDA about this. The FDA and other researchers have preferences in terms of what we're using as control conditions; niacin has been offered up many times, some studies have used diphenhydramine. At the core, the reality is that it is going to be very difficult to fully blind LSD or psilocybin in a two-armed randomized controlled study. We're doing this study with four active doses of LSD plus a placebo. That probably gives you the best quality of the blind if you're looking at dose response, because it's going to be harder to differentiate 50 g from 100 g or 200 g, and 100 g from 200 g. That gives you some complexity that will aid in blinding, but in a two-arm study, it's going to be very difficult.

That said, it's also important for us to not forget that this is not a unique problem to psychedelics. If you look at think of any other CNS-active drug, very often, there is a clear perceptual effect that is going to make it more difficult to blind.

That may be more profound with psychedelics. But consider ketamine, which is a dissociative agent. If you look at the adverse event tables for esketamine versus placebo in the esketamine approval [esketamine is one of the two molecules that make up the racemic mixture of ketamine and was approved by the FDA for treatment resistant depression in 2019], the rate of dissociation in the esketamine arm was many-fold higher than in the placebo group.

RM: Two years is a long time in psychedelics research how do you feel MindMed has moved closer to your goals of making psychedelic research more high-throughput since you joined?

RB: Weve been building substantially over the last year. When I came into the organization, we had only about 10 employees and now we're at about six times that. We've been bringing in the talent and the people from pharma who know how to build big organizations and how to take on challenges in a scalable way and take on multiple programs at the same time. We have been absolutely delivering on that vision internally. In drug development, clinical trials do take a long time, this is just the reality of any development program is that a single trial can often take several years. Were still in a phase where we're continuing to build and have announced new programs over the last year. We also have a number of the studies with our collaborators in the Liechti lab at University Hospital Basel. There are a number of studies they have ongoing with LSD and other indications with other molecules. These give us good evidence to make decisions about how well continue to grow and how we think about potential label expansion and new programs. All of that has been progressing very well.

As we look out over the next year or two years, there are going to be many data sets coming out that are going to be quite informative to us and to the wider world about where the potential lies with LSD and where we think other molecules may fit into the pipeline.

We added a program in the second half of last year, which is the R-enantiomer of MDMA for treatment of autism spectrum disorder. We're making sure to remain laser focused on executing what is in front of us and what we've already taken on, but we are continuing to see an enormous opportunity and one that spans far beyond just a single asset and a single indication and we're continuing to make advancements across all our programs to achieve that goal.

Rob Barrow was speaking to Ruairi J Mackenzie, Senior Science Writer for Technology Networks

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Behind the Scenes on the First Study To Compare the Effects of LSD and Psilocybin - Technology Networks

VANCOUVER, British Columbia--(BUSINESS WIRE)--REVITALIST LIFESTYLE AND WELLNESS LTD. (Revitalist or the Company) (CSE: CALM) (OTCQB: RVLWF) (FSE: 4DO), one of the largest publicly listed US based ketamine clinic operations, is pleased to report updates on strategic initiatives accomplished in April including becoming a founding partner with the American Association of Psychedelics.

Revenue April 2022 sales of approximately $480,000 CAD represented a 319% increase from the same month in 2021 and a 15% increase compared to March 2022.

Insurance Over 80 medical and mental health providers directly associated with Revitalist have now been accepted and considered to be in-network with top commercial insurance payers including Blue Cross Blue Shield, Aetna, Cigna, Humana, Optum, United Healthcare, and federal insurers including Veterans Affairs Community Care Network and Medicare. In network verifies the providers have met the insurers quality standards giving greater financial security to consumers and payers.

Research Revitalist receives acceptance to present at the American Psychiatric Nursing Associations National Conference discussing its findings on Case Report: Adult with Bipolar Disorder and Autism treated with Ketamine. To request a copy of this report, please email us at corporate@Revitalist.com

Education Revitalist becomes founding partner with the American Association of Psychedelics. The inaugural conference, Ethics Safety, Science takes place in Knoxville, TN, November 17-20, 2022. To learn more visit AAPsychedelics.org

Metaverse Revitalists partnership with Metachain Technologies Inc. to create virtual mental health and wellness clinic chains through its subsidiary, Revitaland, enters alpha testing phases.

CEO Speaking Engagements Gatherverse Mental Wellness Summit, May 24-25, Virtual Conference, gatherverse.org

H.C. Wainwright & Co Global Investment Conference, Miami, FL, May 23-26, 2022,https://hcwevents.com/globalconference/

Athletes Unite Conference, Atlanta GA, July 15 & 16,http://www.shakeoutllc.com/athletes-unite-conference2022

American Psychiatric Nursing Association, Long Beach, CA, October 19-22,https://www.apna.org/apna-annual-conference/

American Association of Psychedelics, Knoxville, TN, November 17-20AAPsychedelics.org

Treatment Center Investment and Valuation Retreat, Phoenix, AZ, December 5-7https://www.treatmentcenterretreat.com

Revitalist CEO, Kathryn Walker, states: April was a terrific month for the Company. We closed the first tranche of our financing for $3,869,000 and ended the month with our best sales performance yet. Considering the barriers many companies are facing at this time with inflation and market fluctuations, this proves the strength of our company even in trying times. I am continuously amazed as we continue to trail blaze this industry executing at accelerated speeds in various revenue producing capacities changing and saving lives every day.

ABOUT REVITALIST LIFESTYLE AND WELLNESS LTD.Revitalist Lifestyle and Wellness Ltd. (CSE: CALM) (OTCQB: RVLWF) (FSE: 4DO) is one of the largest publicly listed, ketamine focused clinic operations operating in the United States. Revitalist proudly offers hope to patients suffering from treatment resistant pain and mood conditions through ketamine assisted psychotherapy (KAP). Each clinic enables access to psychedelic medicine, vitamin infusions and other lifestyle optimization services provided by medical professionals, mental health experts, and chronic pain specialists. Since opening their first clinic in 2018, Revitalist has provided thousands of ketamine infusions through its network of 9 clinics operating in 6 states. Its founder and CEO, Kathryn Walker, has witnessed firsthand the transformative impact of KAP and intends on offering other psychedelic treatments as they become available. For additional information and to be added to the Companys mailing list, please click here.

Twitter: @RevitalistCorp Facebook: @RevitalistLifestyleandWellnessLtd.Instagram: @RevitalistCorp LinkedIn: @RevitalistLifestyleAndWellnessLtd

On Behalf of the BoardKathryn WalkerChief Executive Officer

Forward Looking StatementsThis news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Revitalist to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release.

Risks, uncertainties, and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

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Revitalist's Strategic Initiatives Continue to Exceed Expectations for Execution Giving Company Record High Revenues Since Opening in 2018. - Business...

In the cold dark streets with tears streaming down his face, he sought them out, but he was really in search of something more solace from the post-traumatic stress disorder hed acquired while serving in a combat zone in the United States Army.

Until recently PTSD wasnt well understood. Until very recently it wasnt taken seriously. There werent many options for people like Lubecky, who had been home from Iraq for less than 60 days.

When Lubecky finally found the bells of Sacred Heart, the century-old neo-gothic cathedral was so full that he was turned away.

He lingered near the North Carolina Veterans Monument for a time, staring up at the solitary white obelisk of Mt. Airy granite topped by a dark bronze Lady Liberty hoisting a tobacco leaf high above her head.

He was trying to figure out the best way to kill himself.

Something from his training popped into his thoughts, so Lubecky hopped in his car and drove to the Womack Army Medical Center at Fort Bragg.

He told them he wanted to take his own life.

They gave him six Xanax and said not to take them all at once or he would succeed.

Instead Lubecky drove home, downed a fifth of vodka, put a Beretta to his temple and pulled the trigger.

More than 15 years later, an estimated 22 American veterans still commit suicide each day as thousands more are left searching for something Jonathan Lubecky couldnt find on that Christmas Eve.

Stigma associated with seeking mental health assistance and a general lack of education about PTSD both contribute to the death toll, as do palliative treatments that dont nearly help all of the people all of the time.

That may soon change, and Western North Carolina is at the tip of the spear thanks to a promising new treatment that involves an overlooked psychedelic compound called MDMA.

Jonathan Lubecky, seen here outside the White House in 2019, continues to advocate for increased access to psychedelics like MDMA for PTSD patients. Donated photo

Miraculously, Jonathan Lubecky didnt die on Christmas Eve in 2006. A manufacturers defect in the cartridge prevented the round from leaving the barrel.

You still get a bang, Lubecky said. And I did it in front of a mirror. I thought I was dead. And I was like, This is what dead is?

Born in Ohio, Lubecky reported to Marine Corps Recruit Depot, Parris Island nine days after graduating high school in 1995 and served as a C-130 loadmaster until he left the Marines in 1999. He returned after the Sept. 11 terror attacks, and was sworn into the North Carolina National Guard three days after the initial invasion of Iraq in 2003.

Iraqs Balad Air Base, where Lubecky was stationed in 2005 and 2006, was the target of thousands upon thousands of mortar attacks. Each and every day, Lubecky said, the dry desert air rained steel. Sirens blared. Soldiers scrambled. Defensive weapons roared as explosions peppered the base, leaving the distinct smell of cordite wafting over them all.

Theres also one specific incident Lubecky doesnt want to talk about.

Then, as he prepared to return home in late 2006, his life rapidly became a country music song.

His wife took their dog, sold his motorcycle and moved in with another man, leaving him only an empty house in Sanford, not far from Fort Bragg.

Occasionally you could hear helicopters flying overhead or impacts from artillery. When I started hearing those and they werent there, he said, I realized I was starting to have a problem. Things devolved rapidly from there.

Thats what led Lubecky, weeks later, to that lonely Christmas Eve at the bar and the church and the monument and the hospital and his face in the mirror with a gun against his head.

It was his first suicide attempt, and hed try four more times over the next eight years, all the while still searching.

They had me on I think a total of 42 pills a day for mental health and chronic pain and stuff like that, said Lubecky of his experience with the VA. And then on Nov. 4, 2013, I slit my wrists, which was my final suicide attempt.

The history of ineffective treatments for PTSD parallels the history of PTSD itself. First described by the ancient Greeks, PTSD has been known for millennia by different names shell shock, war nerves, combat neurosis, soldiers heart.

Its not limited to combat veterans or veterans in general and can affect anyone whos been through acute or chronic trauma, be it emotional, physical or sexual.

Roughly 12 million Americans are walking around with PTSD in any given year, according to the U.S. Department of Veterans Affairs .

Civilians experience comparatively less trauma than members of the armed forces. Studies from the VA suggest that 15% of Vietnam veterans, 12% of Gulf War veterans and somewhere from 11-20% of veterans from operations Iraqi Freedom and Enduring Freedom have PTSD.

In 2019, about 17 civilians per 100,000 committed suicide, while the rate for veterans was closer to 27.

Jonathan Lubecky may have continued on his path to becoming one of them, but after his last unsuccessful suicide attempt, someone at the Charleston VA slid a folded up note across the table, told him not to tell anyone about it and not to open it until he got home.

Published data suggest that MDMA has value as a post-traumatic stress disorder treatment. Multidisciplinary Association for Psychedelic Studies infographic

In his Waynesville office, the bearded, bespectacled Dr. Raymond Turpin sits behind a modest desk piled with papers, folders and a webcam. The place screams calm, with soothing natural light streaming through the partially drawn window shades, casting sepia hues over the rich wood trim.

Strewn about the high-ceilinged room are several chairs and couches where patients of the Pearl Psychedelic Institute come to discuss their trauma with Turpin.

A Georgia native, Turpin was an advertising major at the University of Georgia in the mid-1980s until he had his first encounter with psilocybin, the active ingredient in hallucinogenic mushrooms. The experience led him to change his major to psychology and earn a masters degree at West Georgia College, and then a PhD at the California Institute of Integral Studies. He moved to Waynesville in 2001.

All along, Ive been interested in psychedelics as medicines and being used for mental health treatment, Turpin said.

Psychedelics are a class of compounds that trigger dramatically altered states of consciousness. Natural psychedelics like peyote and psilocybin have been known to humans for thousands of years and were sometimes utilized in religious or spiritual ceremonies.

Recreational users also consumed them for the pleasant physical and emotional effects they can produce, alongside auditory and visual hallucinations.

More than a century ago, the pharmaceutical industry began to study these compounds and isolate or synthesize new ones, hoping to find some commercial use for the relatively potent substances.

Swiss chemist Albert Hoffman first synthesized LSD in 1938 but experienced the psychedelic effects firsthand on April 19, 1943 now called Bicycle Day , because of Hoffmans interesting ride home from work. Bicycle Day is also recognized as the dawn of the modern psychedelic age.

Wayne State University professor Dr. Calvin Stevens invented ketamine in the early 1960s, which ended up being a go-to surgical anesthetic on the battlefields of Vietnam. Now, its an FDA-approved nasal spray that treats depression.

MDMA, discovered by Dr. Anton Kllisch of Merck Pharmaceuticals in 1912, sat on a shelf until a Dow chemist named Dr. Alexander Shulgin rediscovered it in 1976, and began testing it on himself.

Through ever-increasing dosages, Shulgin eventually experienced the psychoactive effects of MDMA and suggested to his friend, Oakland psychologist Leo Zeff , that it might be good for psychotherapy.

Dr. Raymond Turpin sees hope in a new treatment for PTSD. Jeffrey Delannoy photo

At one time, Turpin said, there were around 4,000 mental health professionals legally using MDMA in their psychotherapy practices.

But MDMA had also been adopted by the early-1980s underground party culture, where it was used recreationally as a supplement to the loud music, colorful flashing lights and gyrating revelers.

Users reported feelings of euphoria, increased energy, sensory elevation and tactile stimulation that earned MDMA the moniker of ecstasy, or simply, X. More recently, its been called Molly.

Blowback ensued, and by 1988, MDMA was classified as a Schedule I narcotic by the U.S. Drug Enforcement Agency, along with heroin, LSD, marijuana, methaqualone (quaaludes) and peyote. Schedule I substances are defined as drugs with no currently accepted medical use and a high potential for abuse.

In the mid-1990s, Dr. Charles Grob of UCLA received FDA permission to conduct the first phase-one study on the physiological and psychological effects of MDMA in healthy volunteers.

Other than a temporary elevation in heart rate and blood pressure, and maybe body temperature, people could tolerate it well and there werent any adverse effects, Turpin said. That opened the door to phase two, which was where they actually started to look at it for PTSD. And there was a lot of evidence from the legal period there during those 10 years in the late 1970s/early 1980s that it might be very effective with people who had traumatic histories.

In 2017, Turpin returned to the California Institute of Integral Studies for a certificate program in psychedelic studies and research, where he met Dr. Michael Mithoefer and his wife Annie , a registered nurse. Mithoefer conducted one of the seminal phase two studies testing MDMAs suitability for treating PTSD.

The results were really pretty strong, said Turpin. These were folks that had severe chronic PTSD for an average of 17 or 18 years. One year after the protocol, 67% of the people that had entered the study with PTSD no longer qualified for [a diagnosis of] PTSD.

When Lubecky got home, unfolded the note and read it, it simply said, Google MDMA PTSD.

Once he did, he learned that the Multidisciplinary Association for Psychedelic Studies was conducting a phase two clinical trial, run by the Mithoefers. Founded in 1986, MAPS is a 501(c)(3) nonprofit focusing on the development of cultural, legal and medical shifts in the careful use of psychedelics for mental and spiritual healing.

Interestingly enough, I returned from Iraq on Nov. 22, 2006, and I took my first dose of MDMA on Nov. 22, 2014, Lubecky said. So, on Nov. 22 of this year, I will have been healed of PTSD as long as I had it.

But its not as simple as just taking a single pill and walking away feeling better.

Theres a strict screening process meant to weed out people who could experience an adverse reaction from MDMAs known side effects elevated blood pressure and heart rate. Then, there are three 90-minute prep sessions where therapists get to know the patient and answer questions about the treatment.

Next comes the dosing session, during which two therapists administer the drug via a pill and sit with the patient for between six and eight hours. Sometimes the patient will don eyeshades, or headphones, and listen to calming instrumental music. Other times, theyll talk with therapists as they go through the experience.

It kind of felt like I was in a tight wetsuit in a hot tub, Lubecky said. Its like doing therapy while being hugged by everyone in the world who loves you in a bathtub full of puppies licking your face.

The patient will go on to spend the night and then participate in an integration session following breakfast the next morning, trying to make sense of what was happening during the dosing session.

Typically, three dosing sessions followed by integration sessions will take place over the course of four to six months. After that, no further MDMA use by the patient is anticipated.

Whats actually happening during those dosing sessions is the untangling of complicated processes in the brain that have become dysfunctional due to trauma.

When somebody is undergoing an overwhelming psychological emotional experience, certain higher functions of the brain shut down, and the brain reverts to more primitive processing, Turpin said. The information thats coming in from the traumatic memory the things people are seeing, what theyre hearing, what theyre smelling they dont go through proper processing channels, like a normal memory would. It basically gets stuck in the brain in an improper area where it just sits there. And thats why people have intrusive memories, nightmares, flashbacks. Its all this highly charged, fragmented information.

That information tends to pop up randomly, or when external sensations trigger a re-experiencing of the traumatic event.

Its just kind of living in a state of fear, said Turpin. There could be a car backfiring. They could smell somebodys cologne that reminds them of the smell of the person that raped them. It tends to really throw the body into a state of shock almost.

Such episodes can leave those suffering from PTSD with hypervigilance, but they can also result in the desire for physical seclusion and mental isolation with or without the use of alcohol or other illicit drugs.

The only two FDA-approved drugs for the treatment of PTSD, Paxil and Zoloft, are antidepressants and dont really treat the underlying cause of PTSD. Theyre often prescribed in conjunction with other drugs to combat the effects of PTSD, like sleeplessness and nightmares.

A 2009 study pegged their effectiveness at between 20-30%, although Turpin said its maybe 50% at best.

What weve done for years in treatment is try to give people drugs that have tried to basically throw a blanket on those symptoms and to mitigate those symptoms so that people can go out and function, Turpin said. Unfortunately, we havent done a very good job with those drugs.

What MDMA does, according to Turpin, is shut down the amygdalae the fire alarm of the brain that triggers the normal fight-or-flight response to trauma. That allows the trauma to be processed by the prefrontal cortex, the way it should have happened in the first place.

The positive results from Mithoefers phase two trial, in which Lubecky was a participant, led to the third phase of trials conducted by MAPS .

I think theyre expected to probably do phase three through this year and then wrap it up and turn in hopefully a new drug application to the FDA early next year, Turpin said. The hope is that itll be approved, but theres a special program that the FDA has, called expanded access or compassionate use.

The FDA has approved 10 sites nationwide for the compassionate use program, effectively clearing the way for 50 people to receive the MDMA treatment. Four sites are expected to be up and running soon, but Turpins Waynesville practice has a bit of a head start on the other three.

Mithoefer was my mentor for that [certificate] program, and they were moving to Asheville, Turpin said. Thats how the conversation got started about maybe getting an expanded access site in Asheville, and since I was over here in Waynesville, I was kind of interested to see if we could pull it off in Waynesville, too.

Currently, two patients are in the screening process and on track for treatment later this year, which would make Waynesville the first expanded access site in the world for the compassionate use of MDMA to treat PTSD.

Ill be honest, Lubecky said. I didnt think this was going to work. Thats entirely why I volunteered. Im like, Im going to die any day, I might as well try this. And then it was a miracle.

Marine Michael Ferguson (left) rides out of Fallujah after 28 days of near-constant firefights. Donated photo

Lubecky hasnt taken MDMA since his initial doses in 2016 and continues to advocate for the treatment he thinks saved his life, which is good news for other veterans like Waynesville resident Michael Ferguson, who hasnt yet had the opportunity to go through the MDMA treatment process.

Ferguson joined the Marine Corps just before the terror attacks of Sept. 11, and became part of a FAST company Fleet Anti-terrorism Security Team.

After the invasion of Iraq, he spent 28 days fighting in the Battle of Fallujah.

Fallujah was kind of, firefight, break. Firefight, break. Youd hear morning prayer about 5 a.m. and youd know everybody was getting up and pretty soon they were going to come find where you are today. At times I remember being on rooftops and looking out over the city and it looked like the entire city was on fire, Ferguson said. Its hard for me to explain it or put it into words and grasp it. Its still odd to me that thats what I did.

Ferguson said he had trouble adjusting when he returned home and was fired from his first nine jobs for his quarrelsome behavior. He still sees snipers lurking in open windows and improvised explosive devices on the sides of Western North Carolinas roads.

Finally, a Vietnam veteran recognized Fergusons symptoms and encouraged him to visit the VA. From 2006 until he was formally diagnosed with PTSD in 2014, he went through several different therapy programs and was on 11 different medications.

I never really found one that even came close to working. Most of what I was given at the time had a side effect of suicidal ideation, he said. Thats the last thing that a person in my position needs is more encouragement towards that.

Ferguson stopped taking medications for PTSD several years ago. He said he still contemplates self-harm but continues to fight it, in hopes that one day soon hell find the solace that Lubecky found perhaps in the research and treatment Turpin and MAPS are currently conducting. When you deal with death that much at such a young age, once somethings on the table, its hard to remove it off the table, he said. Even today I definitely dont have an intent or a will [to commit suicide] but its still something I think about. Its always going to be on the table. The process is just keeping it on the table and not putting it into action. And every day that we do that, we win.

If you or someone you know is contemplating self-harm, call the National Suicide Prevention Lifeline at 800.273.8255. The work of MAPS and the Pearl Psychedelic Institute, both of which are nonprofits, is primarily funded through donations. To learn more or to help, visit pearlpsychedelicinstitute.org/donate.

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MDMA as medicine: Stemming the tide of veteran suicides in Western North Carolina - Smoky Mountain News