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When Will Medicinal ‘Magic Mushrooms’ Be Legalized?

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Psilocybin, the psychoactive compound in magic mushrooms, is proving a prodigious treatment for anxiety, depression, addiction, and one study even found it may lead to neurogenesis, or the regrowth of brain cells.   So when will doctors finally be able to write prescriptions for psilocybin?  In this opinion piece, Dr. David E. Nichols, psychedelic research expert and co-founder of The Heffter Research Institute, explains what steps it will take to get medicinal psilocybin legalized.  

Many people have now seen media stories about the renewed research interest in psychedelics as medicines, often called a “renaissance” in psychedelic research, over perhaps the past five years or so. Although many psychedelic substances have been used safely as medicines in indigenous cultures for millennia, we are now seeing renewed interest in these substances in Western cultures. As a co-founder of the Heffter Research Institute  I have watched with an increasing sense of both amazement and gratitude — that we have been able to accomplish so much in such a relatively short time. We are on the path to make psilocybin into a prescription medicine! The Heffter Institute has been a key driver of this “renaissance,” utilizing most of the donations we receive directly to support clinical research.

Heffter initially provided major funding for a small study of psilocybin treatment for obsessive-compulsive disorder (OCD) patients, at the University of Arizona. That study provided mixed but encouraging results that have yet to be pursued due to funding limitations.

Our first truly successful study was treatment of 12 terminal cancer patients who suffered from anxiety and depression. They were treated with a program of therapy that included psilocybin, the active component in so-called magic mushrooms. Participants showed a significant reduction in anxiety at one and three months after treatment, with no significant adverse events. That study, led by Dr. Charles Grob at the UCLA Harbor Medical Center, was published in 2011 in Archives of General Psychiatry, widely recognized as perhaps the top psychiatry journal in the world.

Subsequently, two additional studies were begun using psilocybin to treat anxiety and depression in cancer patients, one at Johns Hopkins University led by Dr. Roland Griffiths, and the other at New York University (NYU) directed by Dr. Stephen Ross. The patients in both studies have almost completed their treatments, then the studies will start the follow-up and data analysis stage. Preliminary analysis points again to significantly decreased anxiety and depression.

Research shows psilocybin attenuates anxiety, slows down activity in areas over active in people with depression, can induce mystical, life-changing experiences and enhance mood and personal relationships.

In addition, the Heffter Institute recently sponsored a study of psilocybin-assisted therapy in a pilot study of 10 volunteers with alcohol dependence. The principal investigator for this study was Dr. Michael Bogenschutz, at the University of New Mexico (UNM). Drinking decreased significantly beginning in the second month of treatment, after psilocybin was administered, and improvement remained significant for an additional six months of follow-up. There were strong correlations between the intensity of the experience in the first psilocybin session and clinical improvement following the session. Based on the positive findings from this pilot study, we are now implementing a larger randomized trial at UNM and NYU.

We also recently supported a pilot study by Dr. Matthew Johnson at Johns Hopkins, administering psilocybin within a 15-week smoking cessation treatment. Participants were 15 healthy smokers with a mean of six previous lifetime quit attempts who were smoking an average of 19 cigarettes per day for 31 years. Measures of smoking behavior showed that 12 of the 15 participants (80%) were no longer smoking at six-month follow-up. This smoking cessation rate substantially exceeds rates commonly reported for other types of therapies (typically less than 35%). These findings suggest that psilocybin may be a useful and potentially efficacious adjunct to current smoking cessation treatment approaches, and warrant a follow-up clinical trial. Results also illustrate a framework for research on the efficacy and mechanisms of psychedelic-facilitated addiction treatment.

When people hear that we are sponsoring medical research with psilocybin, they often ask, “How long before doctors will be able to prescribe it?” The process to get there is both expensive and time-consuming. To get a drug to market, that is, to make it into a medicine, there are three clinical phases that must be completed. Phase 1 involves giving a new drug to humans to determine whether it can be tolerated, if it is safe, and what doses are acceptable. For psilocybin, there are extensive data with respect to doses and safety of psilocybin, particularly as it has been used in the form of psychedelic mushrooms since prehistoric times. Further, none of the participants in our treatment studies has required medical or psychiatric intervention.

After passing Phase 1, the drug is then moved to Phase 2, where it is administered to patients suffering from the medical condition one wishes to treat. In our case, it is cancer patients who have severe anxiety and depression as a result of their cancer diagnosis, including those who are near the end of life. Although Phase 1 can be relatively small, Phase 2 studies must be large enough to demonstrate a statistically significant improvement in the condition being treated; in this case it is anxiety and depression.

Once Phase 2 studies have demonstrated that the medicine reduces the patients’ symptoms, called efficacy, a Phase 3 trial must be completed. Phase 3 studies are much larger, but use the same medication and essentially the same treatment paradigm that was used in Phase 2. Also, Phase 3 studies are typically conducted at several different clinical sites to show that the improvement observed in the Phase 2 studies can be repeated by other clinical scientists. When the Phase 3 studies are completed, if significant safety and efficacy can be shown, the FDA can then approve the medicine as safe and effective for the indicated condition.

One important implication of such a finding by the FDA concerns drugs that are controlled substances. Psilocybin is a controlled substance and is placed in the most restrictive category of drugs, Schedule I. Schedule I drugs can only be used in research; they cannot be prescribed as medicines. Drugs are placed into Schedule I if they meet three criteria, if they have: 1) A high potential for abuse; 2) No recognized medical use and; 3) No safety when used under medical supervision. All three of these criteria must be met when placing a drug into Schedule I.

To make psilocybin into a prescription drug, these factors must be addressed. First, the safety of psilocybin is being established not only by our studies, but also by studies in Switzerland and the U.K. The key point that needs to be addressed, however, is the issue of psilocybin having a recognized medical use. If our Phase 3 studies show efficacy in alleviating anxiety and depression in cancer patients, and the FDA recognizes that finding, we will have established a medical use for psilocybin. It then can no longer remain in Schedule I and will have to be placed into a lower schedule such as Schedule II or Schedule III. Although substances in Schedules II and III are still controlled, this rescheduling will allow psilocybin to be used by qualified physicians as a medical treatment for anxiety and depression.

How long will it be before psilocybin can reach the status of being a recognized medical treatment? Assuming that we can demonstrate efficacy in the Phase 3 studies, as it appears we have in the current Phase 2 studies, the timing largely depends on how quickly we can complete the Phase 3 studies. Our most efficient recruiting so far has been at NYU, where the study team has recently averaged 15 patients per year. We would plan to recruit patients across several clinical sites – optimistically up to five, and would expect that with average to good recruitment rates we might complete recruitment, study procedures, and data analysis in four to five years.

How much will the Phase 3 studies cost? As a not-for-profit institute, our costs have been lower than they might be if we were a for-profit pharmaceutical company. Even so, as an average, treatment is costing us approximately $25,000 per patient. That includes costs for clinical treatment rooms, medication, therapists, and many other ancillary costs required to carry out a clinical study. It would be reasonable to expect total costs for a Phase 3 trial of this nature to be on the order of $7.5-8 million.

Many people also ask, “Aren’t drug companies interested in psychedelic medicine?” The answer, unfortunately, is no. Psychedelic medicines have been around so long that they are no

longer patentable, and they work after one or sometimes two treatments. There is no money to be made with a non-patentable drug that is given only once or twice in a lifetime. Typical drug treatments are given daily, sometimes two or more times a day, and for many medical conditions the treatment can last years, or even a lifetime.

The next question they often ask is, “Isn’t there any government funding for this work?” Again, sadly, the answer has been no, although we hope that may change as our studies progress. We must still overcome the echoes of the past, where psychedelics were considered dangerous and unpredictable. Fortunately, more enlightened voices are beginning to prevail and the landscape is slowly changing. If you would like to become a part of this powerful and emerging medical science, go to our web site www.heffter.org and make a donation to support our work.

This article originally appeared on reset.me, and is reposted here with permission as a contribution from Emmy Award winning investigative journalist Amber Lyon. 

Credits: Article Written By David E. Nichols, PhD. Used here with permission.

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Adam Toledo: Chicago Police Video Shows 13-Year-Old’s Hands Were Up When Cops Shot Him

Elias Marat

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The Chicago Police Department has released gruesome footage depicting the moment that police officers fatally shot 13-year-old Adam Toledo while his hands were up.

In new bodycam footage from the March 29 slaying, an officer pursuing Toledo can be heard shouting at the young boy to show his “f*cking hands” before shooting him a single time, leaving the boy covered in blood and gasping for air.

While the officer can be heard shouting “drop it,” the teenager appeared to have empty hands when he raised his arms in the moment before he was shot. Video also shows officers discovering a handgun near the scene.

Adam was later pronounced dead at the scene.

The video released Thursday by the Civilian Office of Police Accountability the footage from the officer who shot Toledo, along with 16 other body-warn camera video clips, two recordings of 911 calls, an incident report, and a response report, along with other materials.

The mother of Adam, Elizabeth Toledo, reported the boy one week prior to the shooting, although he did return hom on March 27 before leaving that night, reports WBEZ.  Because Adam did not have any form of identification, the family wasn’t informed by police about his death until March 31. In a GoFundMe page set up by Elizabeth, it was noted that one of Adam’s “dreams was to become a police officer.”

“It weighs heavy on our hearts to be planning our last goodbyes instead of watching him grow up and live out those dreams,” the family noted on the page.

The child has been described as having a “big imagination” and was a fan of children’s shows and zombie movies.

“Adam was really into zombies. And the zombie apocalypse. He even had this zombie apocalypse bag packed and ready to go. Some of his favorite movies and TV shows were ‘Cloudy with a Chance of Meatballs,’ ‘Ghostbusters,’ ‘SpongeBob SquarePants,’ ‘Toy Story,’ ‘Cars,’ ‘The Walking Dead,’” Elizabeth told the Chicago Sun-Times.

Chicago Mayor Lori Lightfoot has appealed for calm over the release of the gruesome footage while businesses in the area have boarded up their windows in anticipation of large protests.

“We live in a city that is traumatized by a long history of police violence and misconduct,” the mayor told reporters. “So while we don’t have enough information to be the judge and jury of this particular situation, it is certainly understandable why so many of our residents are feeling that all too familiar surge of outrage and pain.”

The release of the video comes amid continuing anger and grief over the April 11 shooting of Daunte Wright by an officer in a Minneapolis suburb.

It also comes as authorities fear a new wave of protests as communities await the outcome of the trial of Derek Chauvin, the former Minneapolis Police officer accused of killing George Floyd last May after kneeling on his neck for 9 minutes and 29 seconds.

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Music

Lil Nas X Song Is #1 In Saudi Arabia, Where Homosexuality Is Illegal Under Sharia Law

Elias Marat

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Lil Nas X has been on top of the world for weeks now, whether it’s living rent-free in the heads of homophobes or topping the Billboard charts after his smash hit “Montero (Call Me By Your Name)” dominated playlists.

And ironically, the anthem has become the most-played song in Saudi Arabia, the conservative kingdom where open expressions of same-sex love and even private acts of gay sex are punishable by death.

The song, whose video features the artist giving Satan himself a lap dance have dominated news conversations all over the globe, smashed through to the top of the Billboard Global 200, which ranks top tracks in over 200 territories, on Monday.

According to Apple Music, the song is also leading Saudi Arabia’s top 100 charts as the most-played song in the country.

Apparently overjoyed by the ranking, Lil Nas X tweeted: “WE NUMBER 1 IN SAUDI ARABIA WTF LETS GOOOO”

The autocratic kingdom, which has long been governed by a strict yet uncodified interpretation of Sharia law, has an atrocious record on LGBTQ rights and classifies homosexuality as a variety of extremism. N many circumstances, gay sex is punishable by death.

As the Human Dignity Trust explains, “The punishment varies depending on the circumstances: married men and interfaith sex are punished with the death penalty, while non-married men are punished with flogging. Sharia law principles underpinning the criminal law in Saudi Arabia also impose strict dress codes that impact on the gender expression of transgender people.”

However, this does not mean that Saudi citizens abstain from these “illicit” acts. As one fan wrote on Twitter: Period!!!! Let’s correct the narrative about the Middle East! Shoutout Saudi Arabia.”

However, another user responded: “I lived in Saudi Arabia my whole [life] and if I come out I will literally get stoned and people will be happy about it, saying it’s a ‘narrative’ doesn’t help anyone in the contrary, the middle IS homophobic and change NEEDS to happen.”

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Corruption

Cop Who ‘Accidentally’ Killed Daunte Wright Arrested on 2nd-Degree Manslaughter Charges

Elias Marat

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The former Minnesota cop who shot and killed Daunte Wright, a 20-year-old unarmed Black man, during a traffic stop will now face charges of second-degree manslaughter, a prosecutor announced on Wednesday.

The brutal killing of Wright, which comes amid the trial of former Minneapolis police officer Derek Chauvin for last May’s killing of George Floyd, threatens to spark a new round of nationwide protests against police brutality and discriminatory policing.

On Wednesday, Washington County Attorney Pete Orput confirmed that Potter, a 26-year veteran of the Brooklyn Center Police Department, would be charged.

On Wednesday morning, agents with the Minnesota Bureau of Criminal Apprehension arrested Potter, the bureau announced in a statement.

Potter was taken into custody in St. Paul and will be booked at Hennepin County jail.

On Tuesday, Potter resigned as demands for justice for Wright reverberated nationwide. Her resignation coincided with that of the city’s former police chief, who claims that Potter accidentally grabbed her Glock when she thought she was reaching for her Taser during the Sunday traffic stop.

Wright’s family and attorneys have rejected the claim that Wright’s death was merely the result of an “accident” and are demanding accountability and sweeping reforms of policing in Minnesota.

Potter could face up to 10 years in prison along with a $20,000 fine, per Minnesota law.

“While we appreciate that the district attorney is pursuing justice for Daunte, no conviction can give the Wright family their loved one back,” said Wright family attorney Ben Crump in a statement.

“This was no accident. This was an intentional, deliberate and unlawful use of force,” the statement added.

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