Daily Archives: July 18, 2021

Florida startup treating illness with magic mushrooms receives $2.5 million – The Register-Guard

Posted: July 18, 2021 at 5:46 pm

Diti Kohli| Tampa Bay Times (TNS)

Researchers think psychedelic drugs might do more than get you high

Researchers are looking into psychedelics as possible treatments for depression, anxiety and even PTSD.Video provided by Newsy

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A Tampa, Floria, biotech startup studying whether magic mushrooms could treat illnesses has received $2.5 million from investors led by a Florida venture capital firm.

Psilera Bioscience researches whether there are healing properties in psychedelics, which trigger hallucinations and intensified feelings. Some scientists believe its ingredients DMT, psilocybin and psilocin may alleviate conditions that plague millions of Americans.

Think mental illness, addiction and even Alzheimer's disease.

"Current treatments for those illnesses aren't very effective," co-founder and CEO Chris Witowski said. "Psychedelics haven't been explored as an option since the 1970s. We now have the tools to see how the drugs function in the brain, and analyze if they're actually working."

The unconventional research caught the eye of Iter Investments, an 11-month-old Fort Lauderdale venture capital firm.

Managing partner Dustin Robinson said its portfolio boasts seven psychedelics-focused companies. Most operate outside U.S. borders, but Psilera is uniquely near home.

"I see them as a leading company in the psychedelics ecosystem, right in our neighborhood," Robinson said. "It was an amazing opportunity to operate within Florida."

Baird Inc., JLS Fund, Receptor, What If Ventures, and Psilera founders and board members also contributed to the investment.

Previous coverage: Oregon spearheading drug decriminalization: Here's what you need to know

They are placing a bet on Psilera's "research and development" efforts, Witowski said.

That includes creating analogs, slightly altered psychoactive compounds the startup formulates to see if they can treat nervous system disorders.

Since its inception in 2019, Psilera has also worked with computational chemistry a mixture of computer models and functional MRIs to simulate how those compounds prompt molecular changes.

Its focus has now shifted to developing delivery systems for getting the psychoactive compounds into patients, with five full-time employees and a gaggle of interns dedicated to the task.

The team is in the midst of formulating a nasal gel that would eliminate the use of needles, which have a negative association with drug abuse. It's probably wise, Witowski said, to remove sharp objects during treatment.

"Who wants a needle in their arm when they're hallucinating?" he said.

Transdermal patches also show promise.

Drugs would flow through the skin and to the brain gradually in low doses. The slow process could subdue the psychedelic effects, allowing patients to shorten or forgo experiencing a "trip," or an hours-long sensory episode.

Good trips elicit euphoria and a sense of connection to others. But bad trips can cause mental confusion, anxiety and psychotic episodes that cause people to see bizarre images or experience severe paranoia.

The patch will be tested on around 100 healthy people early next year in a Phase 1B trial, in order to gauge its safety and side effects.

When administered medically, psychedelics can alter how people think and potentially dissipate effects from neurological disorders.

How? "We can't pinpoint it exactly," Witowski said.

But the theory is based upon erasing and re-paving connections between nerve cells, called neural pathways.

The pathways in a patient with a neurological disorder reinforce one pattern of thought. A depressed person, for example, cycles through the same negative ideas about their life. Perhaps they suffer from prolonged loneliness or work stress. Those feelings dwell inside them, day after day.

"It's like if you're out on a sled," Witowksi said. "You slide down one day and then follow that same path because it's already laid. It's just easier because you don't have to go through fresh snow."

Drugs, like DMT or dimethyltryptamine, may simulate a storm. The substance brings on hallucinations and out-of-body experiences.

"Psychedelics lay down a fresh layer of snow," he said. "Now you don't have the same trodden path. It disrupts that introspective voice you have, and this creates an opportunity for clinicians."

Federal level: House votes to decriminalize marijuana at federal level, supported by Oregon Rep. Blumenauer

Psilera researchers believe that, combined with talk therapy, positive and forward-thinking thought patterns can then blossom. This change could potentially relieve triggers and trauma.

It's too early to say which disorder will respond best to psychedelic therapy and to what specific substances, Witowski said.

Other companies are implementing psychedelics to treat traumatic brain injury or to improve emotional well-being. Multiple clinical trials exploring therapeutic uses of psilocybin are underway with approval from the Food and Drug Administration.

And Witowski said a Phase 3 clinical trial into MDMA, commonly known as ecstasy, revealed its possible effect on Post-Traumatic Stress Disorder patients. It could aid those with common PTSD symptoms such as nightmares or unwanted memories of the trauma, the May 2021 study found.

The federal government labels psychedelics as Schedule 1 drugs, meaning they may not be prescribed or used clinically. Like heroin, peyote and LSD, the drugs have a high potential for abuse and no approved medical application, the government says.

Those restrictions have limited research into the substances.

A stain also fell over psychedelics in the 1970s, when recreational use overshadowed its medicinal potential. Thanks to strides in cannabis research and legalization at the state level, "the stigma has been lifted," Witowski said.

The Drug Enforcement Administration has granted a handful of universities permission to research psychedelics.

The University of South Florida is one of them, and Psilera is an early beneficiary.

The company operates as a member of USF Connect's incubator program, which permits nearly 70 startups to take advantage of its research equipment, students and faculty. Its co-founders Witowski and Jackie von Salm completed their doctoral degrees in natural products chemistry from USF.

The university earned DEA approval in February.

"That was a great development for the company," said Michael Bloom, USF vice president for corporate partnerships and innovation. "But it was also great for the university and for the biotech sector in Tampa Bay."

He said Psilera's "work goes beyond a scientific challenge to truly addressing devastating diseases that touch nearly every family in some way." That includes Witowski's.

In the past two decades, his brother cycled through almost every available anti-depressant. His grandmother died after 15 years of battling Alzheimer's.

The majority of Americans know someone who faces similar burdens. One in five people in the U.S. experience mental illness, according to the National Alliance on Mental Illness. The number of substance abuse and Alzheimer's patients is in the millions.

To Witowski, the research offers a path to explore medicinal possibilities for ailments that have proven hard and even impossible to solve.

He partially thanks the pandemic for the recent progress.

"The COVID-19 pandemic almost caused a mental health pandemic concurrently," he said. "In a lot of ways, that could be a catalyst for people to see these drugs more favorably, to see their potential."

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Florida startup treating illness with magic mushrooms receives $2.5 million - The Register-Guard

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Another Psychedelic and Its Potential Psychiatric Promise – Technology Networks

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Psychedelics potential is rivaled only by their power. They are extremely potent substances that have been used in various cultures dating back thousands of years, largely for ritualistic and spiritual purposes. In addition, they have traditionally been called upon to offer those who wish to gain insight into realms believed to be inaccessible to the conscious mind.This is more or less the same reason why interest in psychedelics has skyrocketed among clinicians, researchers, and the general public. For clinicians, these drugs are being touted as potential groundbreaking treatment options for a host of psychiatric and inflammatory conditions as they can potentially treat symptoms that are extremely difficult to manage with conventional medicines. For researchers, studying psychedelics can help them understand how these substances can eliminate the interference of ego structures and conscious experiences in their subjects to unveil the most fundamental dynamics of the mind, thereby offering new insights into our understanding of neuroscience, consciousness, and how the two intersect. For the general public, they offer relief from symptoms of hobbling psychiatric conditions, fuel for philosophical musings, and the opportunity to take part in deeply meaningful experiences. As has been frequently reported in research dating back to at least 2006, psychedelic sessions are frequently ranked among the top five most meaningful experiences in individuals lives even more than a year later.1Psychiatrists are very excited about the potential of psychedelics, particularly with respect to drugs like psilocybin, LSD (lysergic acid diethylamide), and MDMA (3,4-methylenedioxymethamphetamine). Despite the excitement about adding these substances to psychiatrists toolkits, one of the most potent psychedelic compounds available, DMT (N,N-dimethyltryptamine), has received very little attention from clinicians until recently.

While there is no question that DMT holds enormous potential, as clinicians we must first understand how to harness it.

Though DMT acts upon the same serotonin receptors as other classical psychedelics, the DMT experience is unique. With smoked DMT, the ego is not just dissolved in a transcendent experience; it is obliterated.

According to DMT users, the visible world is often replaced by extremely vivid kaleidoscopic patterns of color. Furthermore, users report being transported to what they describe as another plane of reality with the presence of godlike creatures, and many of those who have taken DMT have reportedly interacted with these creatures. An online survey conducted by researchers at Johns Hopkins School of Medicine involving 2,561 individuals (median age 32 years; 77% male) who reportedly had encounters with these ostensibly autonomous beings found that half of participants who considered themselves atheists before the experience no longer did afterwards, and more than half of total participants believed that these beings are conscious, intelligent, benevolent and continued to exist after the encounter in a real but different reality.2Characterized by Davis as an ontological shock, over half of the participants claimed that the DMT experience was one of the most spiritually significant and meaningful moments in their lives. Many respondents also reported profound changes in outlook and positive changes in life satisfaction and subjective well-being.2

Theoretically, yes.

Like other psychedelics, it may prove capable of easing existential distress among terminally ill patients and promoting subjective well-being. It may even help individuals with substance use disorders overcome their dependence. A pharmaceutical company based in the United Kingdom, in conjunction with Imperial College Londons Centre for Psychedelic Research, initiated a phase I trial earlier this year to see if DMT could be used to treat major depressive disorder.

However, there are potential roadblocks to DMTs use in a clinical setting, tooat least in its smoked or vaped form. As Stephen Ross, one of my colleagues at New York University who has studied psychedelics extensively, observed during a conversation we had about frontiers of psychedelic research, psychedelics are only part of the equation in a larger model of medication-assisted psychotherapy. Patients should not simply be given these extremely potent drugs, and then left on their own to process the experience. They need guidance from people who have the tools and training to place it into a larger narrative.

To properly provide care, staff members need to be trained to be effective guides to patients who are experiencing the acute effects of the drugs and to help them contextualize and absorb the experience. Furthermore, patients need to be psychologically prepared for the experience and will likely require several sessions before and after the experience to effectively process it. Given the enormous difference between the acute effects of DMT and LSD or psilocybin, it stands to reason that protocols and models that provide the best therapeutic experience are not even remotely interchangeable.

To fully harness the therapeutic power of DMT, as well as psychedelics in general, research will need to focus not only on the potential conditions it can help treat or the neurophysiological effects of the drug, but how the drug is administered and how patients are guided through the experience. We will need to embrace the role of navigator, rather than simply impartial facilitator of awareness, growth, and psychological development of our patients.About the author:Samoon Ahmad, M.D., is Professor of Psychiatry at NYU Grossman School of Medicine.

References:

1: Griffiths RR, Richards WA, Johnson MW, McCann UD, Jesse R. Mystical-type experiences occasioned by psilocybin mediate the attribution of personal meaning and spiritual significance 14 months later. J Psychopharmacol. 2008;22(6):621-632. doi:10.1177/0269881108094300.

2: Davis AK, Clifton JM, Weaver EG, Hurwitz ES, Johnson MW, Griffiths RR. Survey of entity encounter experiences occasioned by inhaled N,N-dimethyltryptamine. J Psychopharmacol. 2020;34(9):1008-1020. doi: 10.1177/0269881120916143.

3: Carbonaro TM, Gatch MB. Neuropharmacology of N,N-dimethyltryptamine. Brain Research Bulletin. 2016;126:74-88. doi: 10.1016/j.brainresbull.2016.04.016.

4: Pollan M. How to change your mind: what the new science of psychedelics teaches us about consciousness, dying, addiction, depression, and transcendence. 2018.

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MindMed Studies the Role of Psychedelics in Treatments – TechAcute

Posted: at 5:46 pm

Over the last few months, weve seen the levels of stress, mental health issues, and addiction rise to unprecedented levels. The high costs of medicine and therapy, coupled with most countries imposing restrictions have had a severe impact on peoples mental health, much of which is likely to stay with them for a long time.

To combat this issue and meet the new challenges to mental healthcare, new research is needed. US biotech company MindMed works to research and develop medicines and therapies involving psychedelic drugs.

Psychedelic drugs such as LSD, DMT, psilocybin, MDMA, and mescaline can be harnessed to have therapeutic effects for patients. MindMeds experimental therapy projects include Project Lucy (addressing anxiety with LSD-assisted therapy) which is in Phase 2B, the development of 18-MC to treat causes of addiction, and LSD Microdosing to treat ADHD.

Image: MindMed

Last month, MindMed has also announced the approval of a new study on the effects of different doses of mescaline. The study is to be conducted in Switzerland, at the University Hospital Basel Liechti Lab. This study will, we believe, provide the first modern research data on mescaline regarding dosing and mechanism of action in humans, said Dr. Matthias Liechti, Ph.D. and M.D. of the University of Basel.

According to the president of MindMed Dr. Miri Halperin Wernli, mescaline can have a powerful effect on enhancing communication within the brain. That does seem to be how psychedelics work even the American regulators agree. Unlike the SSRIs, they dont appear to present any negative side effects but do have long-lasting anti-depressant effects.

According to Dr. Sara Tai, they arent the answer on their own. Many mental health issues occur as a result of our environment and treating them requires more than making changes in the brain. She explains that A drug-centered, dose-response approach in psychedelic research may, misleadingly, communicate that mental health issues are simply the result of some deficit that needs to be rectified and the drug alone is the vehicle of change.

Image: MindMed

Indeed, theres no magic wand solution to mental health issues as they vary from person to person, and that means that effective solutions are individual-focused. However, psychedelics can act as a catalyst for creating conditions that allow a patient to approach their issues from another perspective, according to Dr. Tai. Thought leader Deepak Chopra, whose foundation has formed a partnership with MindMed earlier this year, seems to agree.

Whether on its own or combined with CBT or other therapies, it does seem that psychedelic drugs can play a significant role in helping people deal with their mental health problems. Im looking forward to seeing what comes out of MindMeds research and seeing the extent of its practical applications.

YouTube: Understanding The Psychedelic Medicine Industry Q&A with Kevin OLeary and JR Rahn

Photo credits: The images used are owned by MindMed and have been provided for press usage.Sources: Kimberly Drake (MedicalNewsToday) / National Center for Biotechnology Information / Allie Nawrat (Pharmaceutical Technology) / Dr. Sara Tai (MentalHealthToday) / David E. Carpenter (Forbes)

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LSD and nicotine could be more important to healthcare than we think – Euronews

Posted: at 5:46 pm

The views and opinions expressed in this article are those of the author.

As a global society, we are living in reliably unreliable times, bathed in the dubious glow of a bonfire of certainties. Please allow me to add another set of conventions to the pyre: our most maligned and restricted drugs might heal us.

Consumers, the medical community and regulators are beginning to re-examine taboo substances through the fresh light of evidence and experience. Cannabis, nicotine and psychedelics will create a new, transgressive wellness and form part of our collective health and wellbeing in the years to come.

There are many drivers for this. On the consumer side, we have become more nuanced in our use of substances. We are increasingly disenchanted with legacy solutions and - as a result of man-made catastrophes such as the USs opioid crisis - less inclined to blindly outsource our health to the pharmaceutical industry.

The medical and regulatory communities are also skeptical. Clinicians are increasingly aware of the limits of existing official treatment for conditions as diverse as chronic pain (including palliative care), epilepsy, depression, and sleep disorders. There is appetite for change.

Equally, many governments are defining public health more broadly. They are counting the cost of public health issues and the ineffective responses to them. This is opening up dialogue amongst several administrations around exploring the role demonised substances could play.

Cannabis, nicotine, and psilocybin, for example, are all naturally occurring organisms with millennia of holistic human use. Whereas man-made substances such as LSD and MDMA have a technical origin, within pharmaceutical or military research, which tends to confer a kind of native legitimacy.

Of course, none of this is to say that these substances are risk-free or will prove to be beneficial. Depressants, psychedelics and stimulants are compounds with unique properties and evidence. What is clear however is that the reframing from agents of chaos into facilitators of transgressive wellness is underway.

In fact, in the case of cannabis, that rehabilitation is already maturing. The modern consumer is using the drug in different ways and in doing so, dissolving the traditional image of recreational consumption.

According to Euromonitor, this will drive growth in the global legal market from around $30 billion (25.3 billion) in 2020 to more than $90 billion (76 billion) in 2025.

The credibility of cannabis as a medical treatment has grown to a point where large sections of the public increasingly believe in its therapeutic potential. Once this Rubicon is crossed, wider legalisation is sure to follow.

The US Federal Drug Agency (FDA) has designated psilocybin as a breakthrough therapy for major depressive disorder and MDMA for post-traumatic stress disorder, indicating widespread conviction that these therapies will prove superior to existing treatments.

These are powerful substances which leading researchers say "increase entropy in spontaneous neural activity" and can create permanent or semi-permanent changes in mindsets and patterns of thinking.

But there is currently no certainty that they can be effective enough at low doses or safe enough at higher doses to be taken out of the clinical setting.

However, even if psychedelics were to be 'confined' to the treatment room, their wider use looks set to be revolutionary.

Despite being the most widely available of the compounds discussed, its path to rehabilitation is arguably the longest and steepest.

Public misunderstanding of the properties and impact of nicotine consumption is shaped by its predominant delivery system, the combustible cigarette.

But awareness of nicotine as a possible cognitive function enhancer, potentially to treat conditions such as Parkinson's disease, has been present in the background for some time.

More recently, some research suggests there is a putative link between the consumption of nicotine and resistance to transmission of COVID-19. It is also likely to be less addictive when consumed in formats other than the traditional cigarette.

Combined, these point to a scenario of nicotine being delivered as one of a stack of ingredients in say a tablet, shot, or gel to improve immunity, focus, and cognitive function.

Not quite 'Tobacco Saves' perhaps but certainly 'Nicotine Improves'.

Ultimately, the rehabilitation journey of these drugs has a way to go - not all will reach the end.

Yet a combination of public disenchantment, our collective curiosity, and the compulsion of experts and governments to do more good and less harm at lower cost, will ensure one eras transgression, is anothers wellness.

What do you think about the arguments expressed in this opinion piece? Send us your thoughts at annabel.murphy@ext.euronews.com

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LSD and nicotine could be more important to healthcare than we think - Euronews

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Ready to Tap into the US$7.6 billion Psychedelics Market – Stockhouse

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The psychedelics space is well on its way to becoming dominant in terms of treating a range of medical conditions similar to the cannabis boom we’ve seen over the last decade or so, and companies in the space are vying for a top spot in the capital markets.

Psychedelics are known for changing or enhancing sensory perceptions and thought processes while also amplifying spiritual experiences. Utilizing psychedelics to treat mental health-related concerns has risen in prominence for disorders such as anxiety, depression, obsessive-compulsive disorder, and other psychiatric conditions.

As the prominence of these conditions continues to rise, so too does the psychedelics market. According to a from Data Bridge Market Research, the industry is expected to grow at a compound annual growth rate of 13.1 per cent to US$7.56 billion by 2028.

Driving this growth will be an increase in anxiety and depression and the a renaissance of utilizing psychedelic drugs to treat the afflictions as they continue to show promise of increased efficacy compared to the currently prescribed medications.

One of the challenges of commercializing psychedelic medications is that the well-known psychedelic drugs are all in the public domain and cannot be patented.

Companies like Mindset Pharma Inc. (CSE.MSET, OTCMKTS: MSSTF, Forum) are ramping up efforts to tap into this growing market by developing next generation, patent pending psychedelic drug candidates that are specifically designed to be used as medications.

The company, which is based out of Toronto, Ontario, is currently advancing its next-generation psychedelic medications and chemical synthesis processes; however, it differs from other psychedelics companies in that it has invented completely new psychedelic drug candidates that have been optimized for increased efficacy and safety and are currently awaiting patent approval,.

More specifically, the company owns three patent-pending psilocybin-inspired drug families, and a fourth inspired by DMT & 5-MeO-DMT.

Mindset Pharma recently chose its first lead drug candidate, MSP-1014, is from its Family 1 of novel psychedelic compounds. The drug is now moving into current good manufacturing practice (cGMP) compliant manufacturing and investigational new drug (IND)-enabling studies which are required to be completed before entering clinical trials.

Advancing MSP-1014

Mindset Pharma’s Family 1 psilocybin-inspired drug family is gearing up for movement into clinical trials, and selecting its lead candidate MSP-1014 is a step closer in the company’s journey in doing so.

The company said that the drug candidate has shown superior characteristics in direct comparison to psilocybin and its active metabolite psilocin. The advantages of MSP-1014 include increased safety and efficacy.

MSP-1014 has the potential to be a safer, more efficacious analog to psilocybin, with reduced potential side effects. Given its chemical profile, we anticipate that MSP-1014 will have the potential to treat mood disorders, including major depressive disorder, substance misuse disorders and end-of-life angst associated with terminal illnesses, including cancer,” James Lanthier, CEO of Mindset, said in a press release.

Lanthier said the company believes MSP-1014 has what it takes to be a first-in-class psychedelic drug candidate. He added that Mindset Pharma can now continue advancing its position in the development of life-changing innovative psychedelic therapeutics that are safer than first-generation psychedelics.

Our next-generation psychedelic compounds represent the flourishing evolution of therapeutics to effectively address neurological and neuropsychiatric disorders,” he said.

Mindset Pharma’s Family 1 compounds

Mindset’s Family 1 compounds leverage modern drug design practices to create proprietary psychedelic drugs that have the potential to be less toxic and more effective.

In previous rodent preclinical studies of MSP-1014, the drug candidate showed superior in vivo and safety profiles in mice compared to psilocybin in various doses and 5-HT2A (the serotonin receptor widely believed to be responsible for the psychedelic experience) receptor activation in rats.

According to the company, the superiority when compared to psilocybin is largely in part due to the incorporation of a conjugated amplification moiety (CAM) which enhances the 5-HT2A specific effects while reducing non-specific effects.

In addition to the lead candidate, Mindset Pharma’s Family 1 includes several other patent-pending compounds with patent-filing priority dates of February of last year. Mindset has completed a range of specialized in vitro and in vivo tests on its novel compounds to choose the best psychedelic drug candidate to be used in human trials.

Moving ahead with its other family compounds, Mindset Pharma aims to develop drug candidates from Families 2 to 4 and selecting additional lead candidates down the line.

The investment Opportunity

Investors need to keep in mind that because the psychedelics space is still young, it will naturally go through periods of fluctuation just like any other up-and-coming market.

With that in mind, however, Mindset Pharma is poised to be a game-changer in the next generation of psychedelic medicine thanks to its early dates on patent filings, strong data which indicates efficacy of its 4 drug families and, of course, a broad portfolio full of patent-pending drugs that investors should be watching for down the line.

FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.

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Triple Your Money in 6 Months With This Top Biotech Stock to Buy Right Now – InvestorPlace

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The times they are a-changing, folks.

Ten years ago, the only so-called drugs you could legally take in public were alcohol and tobacco.

Over the past decade, marijuana got added to that list across a variety of states in America as well as multiple countries across the globe, including Canada and Mexico.

And just last week, psychedelics were added to the list in California.

Thats right. In a landmark ruling last week, California bill SB519 to decriminalize possession of psychedelics passed the state senate by a 21-16 vote. Going forward, persons aged 21 years and older in Americas most populous state can legally possess psychedelics for personal use and social sharing.

Thats pretty wild

We went from having just two legally accessible drugs for decades, to having more than half a dozen in just five years. And that half a dozen includes stuff like magic mushrooms that, for years, were frowned upon in society as taboo.

Whats going on here?

The scientific truth is emerging.

You see things like marijuana and magic mushrooms werent always considered bad for you and the emergence of their negative stigma was not rooted in good science, but rather in bad politics.

Lets rewind 70 years.

Back in the 1950s, a group of pioneering psychiatrists in California led by Humphry Osmond were actively experimenting with psychedelics. They found that the hallucinogenic drugs had immense therapeutic potential.

But, for various reasons, psychedelics and marijuana became staples of the emergence of hippie culture in the 1960s. And the government didnt like hippie culture. It was a direct threat to their power. So, then-U.S. President Richard Nixon declared a war on drugs which was basically just a war on hippie culture to preserve government power and in 1970, both marijuana and psychedelics landed on the U.S. governments Schedule 1 drug list.

Everyone listened to the government, and over the next several decades, the world just assumed that marijuana and psychedelics were bad for you even though early science said the opposite.

But things started to change in the early 2010s.

It was around this time that the academic world began to re-explore the therapeutic potential of psychedelics, amid a broader movement to legalize and destigmatize marijuana.

And what the academic world uncovered was stunning

A pair of recent Johns Hopkins studies have found that the active ingredient in magic mushrooms (something called psilocybin) can significantly help with smoking cessation and reducing alcohol dependence.

An even more recent Johns Hopkins study published in 2020 found that psilocybin can relieve anxiety and depression levels in people with life-threatening cancer diagnoses four-times better than traditional antidepressants on the market.

That finding corroborates a previous NYU study, which found that psilocybin causes a rapid and sustained reduction in anxiety and depression levels in cancer patients.

Meanwhile, a recent UC Davis study found that psychedelic micro-dosing can produce beneficial behavioral effects in patient with mental health disorders.

And, most recently, an Imperial College London study published just two months ago found that psilocybin is better and faster at treating depression than Lexapro, a leading antidepressant treatment today.

The list of academic studies goes on and on.

They are all coming to the same conclusion: Psychedelic-inspired medicines particularly psilocybin have robust therapeutic potential.

Magic mushrooms arent just drugs that hippies took back in the 1960s. Thats a bad, antiquated political take. The science here shows that they are the key to curing mental health disorders, eradicating depression, fixing PTSD, and alleviating addiction.

Folks this is major science is trumping politics and as a result, we could be on the cusp of fixing mental health disorders once and for all.

But one big hurdle remains: The long arm of the law.

Fortunately, this isnt 1970 anymore. And with the academic research coming to an indisputable conclusion and mental health awareness on the rise, the legal landscape is starting to peel back antiquated laws that were put in place 50 years ago

As stated above, California just decriminalized possession of psychedelics. That state isnt alone. Before them, Oregon and Washington D.C. did the exact same thing during in November of 2020.

Canada is on the cusp of doing the same thing. The governor of Connecticut just signed legislation to carry out a study into the therapeutic potential of psilocybin mushrooms. The Seattle City Council asked the Overdose Emergency and Innovative Recovery Task Force to explore creating more open policies on psychedelics.

The sands are shifting. The Shroom Boom is coming.

This is great news for the world, because it means that tens of thousands of lives will be saved every single year as pysch-inspired medicines give those people a better chance at beating depression, addiction, PTSD, and anxiety.

But this is also great news for you as a hypergrowth investor.

Because in creating a superior treatment for mental health disorders, the Shroom Boom will give birth to a multi-hundred-billion-dollar industry and you can get in on the ground-floor of this investment megatrend by buying the right stocks today.

But, alas, heres the million-dollar question: What are the best psychedelic stocks to buy today?

Actually, Ill one-up you there why dont I just tell you about the #1 stock to buy for this Shroom Boom?

Because, truth be told, there is one company that is head and shoulders above everyone else in this space.

This is the largest company in the psychedelic-inspired medicine space

It has the industrys leading psilocybin treatment which is currently going through Phase 2B trials

Its board includes the former Chairman of Johnson & Johnson, the former Director of the U.S. National Institute of Mental Healthy, and the former executive director of the EMA, as well as leading psychiatry professors from Stanford, Harvard, and Imperial College London

It has won the backing of legendary VC investor Peter Thiel, who is famously known as Facebooks first investor.

This company is the golden goose in the psychedelic-inspired medicine industry.

And its stock is the #1 stock to buy to play the Shroom Boom I actually think this stock is going to more than triple over the next ~6 months alone.

To get the name, ticker symbol, and key business details of this explosive investment opportunity and potentially triple your money before the end of the year, click here.

Your next big stock market winner is hiding right behind that link

On the date of publication, Luke Lango did not have (either directly or indirectly) any positions in the securities mentioned in this article.

By uncovering early investments in hypergrowth industries, Luke Lango puts you on the ground-floor of world-changing megatrends. Its the theme of his premiere technology-focused service, Innovation Investor. To see Lukes entire lineup of innovative cutting-edge stocks, become a subscriber of Innovation Investor today.

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The Newly Institute Announces the Execution of a Joint Working Agreement with Drug Science for the Drug Science Medical Psychedelics Working Group -…

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The Newly Institute is honoured to be a member of this prestigious organization. The Drug Science Medical Psychedelics Working Group is a consortium of Drug Science experts, industry partners, patient representatives and policy makers that aims to break the barriers of 50 years of medical censorship by creating a rational and enlightened approach to psychedelic research and clinical treatment.

Calgary, Alberta--(Newsfile Corp. - July 15, 2021) - Aspen Island Therapeutics Inc. DBA the Newly Institute ("The Newly Institute" or the "Company") is pleased to announce that it has entered into a joint working agreement with Drug Science and membership into the Drug Science Medical Psychedelics Working Group. Drug Science's mission is founded on their efforts, and their many hours of work delivering, reviewing and investigating evidence relating to psychoactive drugs with one single minded message - to tell the truth about drugs. Led by Professor David Nutt, the committee is made of international accomplished, respected and authoritative individual in science, academia and policy, united with a passionate belief in the pursuit of knowledge.

Professor Jo Neill, Chair of the Medical Psychedelics Working Group, stated: "We are delighted to welcome The Newly Institute to the Drug Science Medical Psychedelics working group as an International Industry partner. Psychedelic medicine is a much needed paradigm shift in global health care and we welcome international partners and expertise."

In addition, the Company also is pleased its Chief Medical Officer, Dr. R. Tanguay, has joined the UK-based Scientific Committee of Drug Science. Dr. Tanguay noted upon joining the Drug Science team, "To join the Drug Science team, led by Professor David Nutt and scientists from around the world, is an incredible honour. As The Newly Institute places itself as a leader in mental health, pain, and addictions treatment, psychedelics may play an important role for those not responding to traditional treatment. Working with Drug Science and Professor Nutt to provide high quality, scientifically based information and evidence-based comment and analysis of new research, The Newly Institute will be at the forefront of treatment and cements its place as Canada's leader in helping people recover and get their lives back."

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About The Newly Institute

The Newly Institute believes that mental health treatment is in drastic need of a paradigm shift, and our practice was founded to provide long-lasting change within this industry, our community, and with our clients. By fusing a bio-psycho-social-spiritual treatment model with psychedelic-assisted therapies, patients can overcome deeply embedded traumas that prevent them from living fully in their everyday lives. Our programs are based on evidence and data, but our approach is personal because we know it is vital that people feel safe to be vulnerable during this process.

With locations opening in Calgary, AB, Fredericton, NB, Edmonton, AB, as well as several more Canadian cities, The Newly Institute's is on-track to become Canada's largest and premier operator of psychedelic assisted psychotherapy clinics.

SOURCE: The Newly Institute

For further information: Investor, Media, and General Inquiries: ir@thenewly.ca

Related Links:www.thenewly.cawww.drugscience.org.uk

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/90334

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Former NSA director: U.S. needs a new approach to ransomware response – Healthcare IT News

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The United States, along with much of the world, finds itself battling two pandemics: the COVID-19 crisis, of course, but also the cyber pandemic that has also proliferated across the globe.

In the healthcare industry, some hospitals have been hobbled for weeks at a time and at least one patient has died because of the scourge of ransomware.

The cyberattacks have become so frequent and commonplace that it's worth asking whether ransomware, like many suspect is already happening with SARS-CoV-2, is already moving from pandemic to endemic status.

"Ransomware, I think, has become the greatest challenge for most organizations," said retired Admiral Michael Rogers, former director of the National Security Agency and the former commander of U.S. Cyber Command in a recent interview with Healthcare IT News.

"Healthcare [is] an incredibly attractive target in the middle of a pandemic," said Rogers, who will be speaking next month at HIMSS21 in Las Vegas. "And criminals are aware. That's one reason why you've seen a massive uptick, particularly focused on healthcare in the past 18 months from a ransomware activity perspective."

Indeed, since the early days of the pandemic not counting the vanishingly small window when the prospect of a hacker "ceasefire" was dangled the bad guys have been hard at work, targeting the World Health Organization and COVID-19 testing sites, academic research facilities and vaccine distribution supply chains.

Their targets have also included hospitals and health systems of all shapes and sizes. Meanwhile, the size of the ransom demands is climbing skyward.

"It's gotten worse," said Rogers, who served under Presidents Barack Obama and Donald Trump. Rogers served at NSA and U.S. Cyber Command concurrently for four years before retiring in 2018.

"For a couple of reasons. Number one, the criminal segment has become much more aggressive," he said. "Why? There's a lot of money. There's a lot of money for criminal groups to be made. I may not want to pay the ransom, but I can't afford interruption or degradation of my services or operating ability to help in the middle of a pandemic. I've got to keep going."

Number two? "In the last three years since I left, nation states' risk calculus has become even more aggressive. They are willing to take even greater risks."

That's not just with ransomware. Recent headlines have shown just how far foreign cyber crooks have been willing and able to intrude upon U.S.-based information networks not just the DNC and the RNC, or Sony, but a wide array of federal agencies and private companies large and small.

Rogers points specifically to the SolarWinds and Microsoft Exchange server exploits, which stunned even seasoned cybersecurity professionals in their sheer size, scope and brazenness.

Meanwhile, ransomware seizures such as the Colonial Pipeline hack have helped bring the threat into sharp focus.

Finally, the president and Congress are paying attention, and federal security agencies seem willing to give as good as they get.

"On the positive side, there is clearly a sense that we are not where we need to be,and that it's going in the wrong direction," said Rogers.

But he says he is frustrated that the cybersecurity problems are not only persisting, but worsening.

A big reason for that is the current state of incident prevention and response especially when it comes to interrelation of the public and private sectors "has failed to deliver for over a decade," said Rogers. "I only speak for myself. But my frustration is: Why do we keep doing the same things and expect a different result?"

Sure, there are valuable organizations such as H-ISAC, the Health Information Sharing and Analysis Center, which specializes in "crowdsourced" cybersecurity, sharing threat intelligence and other best practices for protection and risk mitigation. And yes, the CISA, FBI, HHS and other agencies are good about getting out alerts and warnings to the healthcare stakeholders that need to hear them.

But too often, "the government will do its thing, the private sector will do its thing," said Rogers. "As we see things we think might be of interest to the other, as we have the time, and as we have the inclination, we'll share those insights.

"Everyone is so busy, quite frankly. Most organizations don't have time to think about it. They are just trying to defend their own systems, their own intellectual property, their own data."

To truly measure up against the scope of the cyber threatto healthcare and all industries, "I just think we've got to have a different model," he said.

"It's not about collaboration," Rogers explained. "To me, it's about integration. We've got the government and the private sector. We've got to team together 24 hours a day, seven days a week."

He acknowledged, "You can't do this at scale across every business within the private sector. But can't we start with a few sectors where the risks to our economy, to the safety and wellbeing of our citizens, to the security of our nation?Let's pick a few areas,and do some test cases, and see if a different model might produce a different result."

There are some "great examples out there where we have applied a government and private-sector model and achieved some amazing results," said Rogers.

For instance,he said, "We decided as a society that the potential loss of literally hundreds of people in an aviation accident represented such a risk that we needed to do something different," he said.

"So we created mechanisms: Every time there is an aviation accident, the federal government steps in. It partners with the airplane manufacturer, the airline that operated the aircraft, the union, et cetera. It pores over all the maintenance records. It pores over the production history of the aircraft. It looks at all the software and the hardware. It looks at how it was operated. It determines the cause of the crash.

"And then it goes a step further," he added. "It mandates that we're going to change maintenance. Sometimes we're going to change production. We're going to change the way we do software, we're going to change how the aircraft is operating.

"The net impact is we are flying more aircraftwith more people than we ever have, and yet aviation safety has actually been very strong. While we have aviation accidents, they tend not to be recurring patterns, the same cause over and over."

Compare that with cybersecurity, where we've been seeing the same techniques used by the bad guys "working over and over and over," he said.

"We have got to get to a point where the pain of one leads to the benefit of the many," said Rogers. "And yet what is happening now? The pain of the one is not shared. We don't learn from it. And so it is repeated over and over and over again. We have got to change that dynamic."

Admiral Michael S. Rogers will offer more insights at HIMSS21 as a participant in the keynote panel discussion, Healthcare Cybersecurity Resilience in the Face of Adversity. Its scheduled for Tuesday, August 10 from 8:30-9:30 a.m. in Venetian, Palazzo Ballroom.

Twitter:@MikeMiliardHITNEmail the writer:mike.miliard@himssmedia.comHealthcare IT News is a HIMSS publication.

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Rep. Bill Posey Signs GOP Letter to Demand Answers From NSA About Illegally Spying on Fox News Host Tucker Carlson – SpaceCoastDaily.com

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Posey: this abuse of power must stop

ABOVE VIDEO: Tucker Carlson discusses latest developments with journalist Glenn Greenwald on Tucker Carlson Tonight

BREVARD COUNTY, FLORIDA Rep. Bill Posey (FL-08) and Rep. Louie Gohmert (TX-01) led a letter to NSA Director Paul Nakasone demanding information on reports that the Agency illegally spied on Fox News host Tucker Carlson and planned to leak his personal emails to media outlets.

The letter requests that the NSA provide all documents the Agency may have involving Tucker Carlson as well as the following information:

A detailed description of the limited exceptions that would permit the NSA to target a US citizen without a court order, as the Agency understands the term as it is used in its own tweet;

A detailed description of what constitutes an emergency that would permit the NSA to target a US citizen without a court order, as the Agency understands the term as used in its own tweet;

A detailed description of the foreign activities that could harm the United States, as the Agency understands the phrase as used in its own tweet;

A full explanation of when the Agency understands it is lawful to monitor, surveil, collect, unmask, or receive data on a US citizen without a court order explicitly authorizing such targeting, including while conducted in the course of targeting foreign powers;

A detailed description of how the Agency defines domestic terrorist and when its mission could extend to targeting foreign powers who are corresponding with individuals defined as such;

A detailed description of your understanding of the term clandestine intelligence activities; and

What specific actions have been taken to hold accountable those who unmasked, approved unmasking, or shared information on unmasked U.S. citizens?

The letter is co-signed by 15 other Members: Andy Biggs (AZ-05), Rep. Lauren Boebert (CO-03), Rep. Marjorie Taylor Greene (GA-14), Rep. Matt Gaetz (FL-01), Rep. Jeff Duncan (SC-03), Rep. Chip Roy (TX-21), Rep. Andy Harris, M.D. (MD-01), Rep. Greg Steube (FL-17), Rep. Tom McClintock (CA-04), Rep. Randy K. Weber (TX-14), Rep. Diana Harshbarger (TN-01), Rep. Mo Brooks (AL-05), Rep. Bob Good (VA-05), Rep. Mary E. Miller (IL-15), Rep. Jody Hice (GA-10)

Spying, unmasking, and leaking the private communications of American citizens weaponizes our intelligence agencies, and this abuse of power must stop. Protecting national security is not only about deterring enemy threats, but it also involves safeguarding our liberties, said Rep. Bill Posey.

After the disturbing treatment of Donald Trump by the Deep State, it should come as no surprise that intelligence agencies are continuing their illegal surveillance of Americans who dare to challenge power-hungry elites in Washington, D.C. Reports about the NSA spying on Tucker Carlson are reminiscent of something one would expect to see in a tyrannical dictatorship, not the United States of America where citizens supposedly still have Constitutional rights. The Agencys attempt to explain itself thus far has only raised more questions that Mr. Carlson and every citizen of this country deserve to have answered. Rep. Louie Gohmert.

Text of the letter can be found HERE.

ABOVE VIDEO: Fox News host Tucker Carlson says he feels threatened after ousting the NSA for allegedly spying on him. Carlson discusses the acts potential threat to journalists, social media censorship and his new Fox Nation show on Mornings with Maria.

General Paul M. Nakasone assumed his present duties as Commander,U.S. Cyber Commandand Director, National Security Agency/Chief, Central Security Service in May 2018.

He previously commanded U.S. Army Cyber Command from October 2016 April 2018.

A native of White Bear Lake, Minnesota, GEN Nakasone is a graduate of Saint Johns University in Collegeville, Minnesota, where he received his commission through the Reserve Officers Training Corps.

GEN Nakasone has held command and staff positions across all levels of the Army with assignments in the United States, the Republic of Korea, Iraq, and Afghanistan.

GEN Nakasone commanded the Cyber National Mission Force at U.S. Cyber Command. He has also commanded a company, battalion, and brigade, and served as the senior intelligence officer at the battalion, division and corps levels.

GEN Nakasone has served in Joint and Army assignments in the United States, the Republic of Korea, Iraq, and Afghanistan. His most recent overseas posting was as the Director of Intelligence, J2, International Security Assistance Force Joint Command in Kabul, Afghanistan.

GEN Nakasone has also served on two occasions as a staff officer on the Joint Chiefs of Staff.

GEN Nakasone is a graduate of the U.S. Army War College, the Command and General Staff College, and Defense Intelligence College. He holds graduate degrees from the U.S. Army War College, the National Defense Intelligence College, and the University of Southern California.

ABOVE VIDEO: Rep. Matt Gaetz Discusses Tucker Carlsons Claims NSA Spied On Him After Agencys Denial.

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Home, But Not Free: NSA Whistleblower Reality Winner Adjusts to Her Release From Prison – The Texas Observer

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By Taylor Barnes. Originally published on July 10, 2021. Republished with permission from The Intercept, an award-winning nonprofit news organization dedicated to holding the powerful accountable through fearless, adversarial journalism. Sign up for The Intercepts Newsletter.

In the latest phase of her record sentence for whistleblowing, former National Security Agency linguist Reality Winner is a short drive to the blazing hot summertime beaches on Texass Gulf coast. But she cant get near them. She cant even go into the yard of a neighbor who invited her to aid in his beekeeping project.

Convicted under the Espionage Act for having shared a classified document on threats to election security with the media, Winner has been released to home confinement but wears an unwieldy ankle bracelet. It beeps even if she strays too far within her familys yard.

Not wanting her to miss out, a high school friend showed up on a recent day with a kiddie swimming pool and some sand. Mom, Im going to the beach today, Winner said, her mother Billie Winner-Davis recalled. The pair filled the kids toy and Winner waded in.

Winners family and friends are thrilled to have her home after four years behind bars a stint that took miserable turns as her release date neared. Shecontracted COVID-19as part of a mass infection in her prison, filed asexual assault complaintagainst a guard, and wentthirsty and cold when her facility lost heat and water in February during Texass deadly winter storm.

Despite their elation that she is out of prison, though, Winners family and friends say she is far from free. Every day is still marked by intrusions, like the app carceral authorities require her to put on her phone to monitor her and needing prior approval to go to Walmart with her mother for errands. Winner is projected to be transferred from home confinement to supervised release in November.

Thats why they are continuing theiryear-and-a-half-long campaignfor a presidentialpardon or clemency, saying the whistleblower is being gagged from telling her own story.

I really want the public to know that theyre not seeing Reality Winner, theyre not hearing from Reality Winner, because she is under some serious restrictions, Winner-Davis said.

Winner-Davis added that Reality, who is under a gag order, is also banned from using social media, a condition her attorney, Alison Grinter, said is normal and up to the discretion of halfway house authorities.

Grinter,speakingrecently on Democracy Now, said a pardon for Winner is both something she and her country deserve.

Reality released a document that gave us information that we needed to know at a time that we absolutely needed to know it, Grinter said. And she was in prison not because the information was a danger or put anyone in danger. She was in prison to salve the insecurities of one man who was concerned about the validity of his election win.

*

Winner is currentlyserving thelongestprison sentence of its kind under the Espionage Act, a World War I-era law used in recent years to send journalists sources to prison, even as comparable defendants have simply gotten probation for charges of mishandling classified information.

The government itself acknowledges that Winners intent was to send the document she leaked to journalists and therefore warn the American public, rather than use it for personal gain. The NSA report detailed phishing attacks by Russian military intelligence against local U.S. election officials and was published in a June 2017articleby The Intercept. (The Press Freedom Defense Fund which is part of The Intercepts parent company, First Look Institute supportedWinners legal defense.)

Released from a Fort Worth, Texas, federal prison one day shy of the four-year anniversary of her June 3 arrest, Winners path to her parents remote southern Texas home was a bumpy one. The journey began with a 23-day quarantine with five other women in a hospital patient-sized room. After that, her family picked her up for a long drive down through Texas in which they had a matter of hours to deliver her to a halfway house, where she stayed for a week before being released toher rural childhood home. There, paper labels with Arabic vocabulary words are still taped to household items early remnants from the series of events that would lead her to prison when, as a teenager eager to learn foreign languages, she signed up for the military.

Taking advantage of the window of time they had with her as they drove her to the halfway house, her family and close friends planned a series of surprises. Winner met her infant niece, whom the whistleblower had only seen on video chats and Shutterfly-printed postcards, due to visitation bans at prisonamid the pandemic.

While sitting in her parents car and sorting through her belongings, she saw the blond hair of her sister, Brittany Winner, in the distance in a park and tried to jump out of the moving vehicle. She dropped everything on her lap and just ran, her mother said. She ran to Brittany and the baby.

Her sister said the whistleblower was trembling, still unnerved by a guard who had told her that morning that she would not be released. Just the look in her eyes, she almost looked, like, dead, so traumatized and not really believing that everything was happening, Brittany Winner said. And, at some point, I was talking to her, she just reached up in the middle of my sentence to touch my face, and she said, Youre real, right?

At the southernmost point in their trip toward home, two other loved ones were waiting for her: Wendy Collins, a family friend from Philadelphia who spearheads a social media campaign calling for her pardon, and Collinss partner.

They ate at a Thai restaurant as they counted down the minutes to her report time to the halfway house. Collins hugged the whistleblower for the first time since their friendship and Collinss tireless advocacy began.

Collins said, I flew for the hug.

*

At her familysquiet home, Winner schedules her days in an orderly way, similar to her life before the arrest time slots for online yoga courses, cycling exercise routines, and a new part-time job as a researcher for a documentary filmmaker. She relishes spending time with her family dog, Domino, and cat, Fiona, since Winner lost ownership of her own pets, a dog named Mickey and cat named Mina, in the chaos after her arrest. In her down time, she sorts through books supporters have sent her and boxes of belongings from her Augusta, Georgia, home, which was raided by a fleet of armed federal agents whoseinterrogationof Winner would later be characterized by the government as a voluntary interview one in which she wasnever read her Miranda rights.

When the heat breaks in the evenings, her mother says Reality prefers to not watch TV, opting instead to breathe in fresh air on the back patio.

Looking toward the future, when she can speak publicly and take more control over her life, her sister said she expects the whistleblower to advocate for incarcerated people. Shes seen people from all walks of life just be completely taken advantage of by the system, especially people of color, Brittany Winner said. And that is something that she just cant tune out. She cant just live her quiet life.

When shes free to go to the water the Gulf of Mexico, not the kiddie pool out back the whistleblower hopes to go the Texas shoreline to plant mangroves, something Winner, long an environmental advocate, told her sister she wants to do in order to heal coastal ecosystems.

Grateful for even this incomplete freedom, the sisters send each other a near-constant flurry of updates. Not a day goes by when she and her sister dont exchange50 or more text messages and phone calls, including baby photos and videos of Reality practicing yoga with her ankle bracelet in her parents garage. I feel lucky to have my sister back, Brittany Winner said. And one of the things that I was scared of was that she was going to be changed you know, like damaged, like she wasnt going to be the same person because of four years in prison.

How can that not mess you up? But despite the trauma, I feel like shes the same,she said. At least with me. Shes the same person.

By Taylor Barnes. Originally published on July 10, 2021. Republished with permission from The Intercept, an award-winning nonprofit news organization dedicated to holding the powerful accountable through fearless, adversarial journalism. Sign up for The Intercepts Newsletter.

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