FDA Recognizes Psilocybin As ‘Breakthrough Therapy’ for Depression

The designation could be a prelude to approving the forbidden psychedelic drug as a medicine.

Jacob Sullum|Oct. 25, 2018 1:45 pm
WikipediaThe only reference to psilocybin on the Food and Drug Administration’s website appears in the agency’s Bad Bug Book: Handbook of Foodborne Pathogenic Microorganisms and Natural Toxins, where the psychedelic compound is described as a “neurotoxin” found in mushrooms. But according to the FDA, psilocybin is also a “breakthrough therapy” for major depression.
That designation, which the company seeking approval of psilocybin as a medicine announced this week, means “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies.” Based on that evidence, the FDA agrees to “expedite the development and review of such drug.”
The FDA’s dueling portrayals of psilocybin as a scary fungal neurotoxin and a promising treatment for depression are part of a broader story about forbidden drugs, including MDMA, marijuana, and LSD, whose benefits scientists are once again studying with government approval after decades of neglect. The rehabilitation of these substances, which may ultimately make them available as prescription drugs, is a far cry from the pharmacological freedom that libertarians favor. But it represents a welcome return to empiricism in an area of public policy long driven by irrational prejudice.
A preliminary 2016 study sponsored by COMPASS Pathways, a British life sciences company, found big improvements in a dozen subjects with “treatment-resistant major depression” who received psilocybin in a “supportive setting.” After one week, their mean score on the Quick Inventory of Depressive Symptoms, which has scale ranging from 0 to 27, had fallen from 19.2 to 7.4, a 61 percent drop. Most of that progress was still apparent at three months, when the mean score was 10, or 48 percent lower than the baseline. Last August the FDA approved COMPASS Pathways’ plan for Phase 2 clinical trials, which will involve 216 subjects at 12 to 15 research sites in Europe and North America.
Psilocybin research involving patients with life-threatening illnesses has found even more dramatic psychological improvements. A randomized, double-blind study reported in 2016 found that cancer patients who received active doses of psilocybin experienced an average reduction of 78 percent in depression and 83 percent in anxiety, based on an evaluation six months after their sessions. A similar study reported at the same time found that psilocybin-assisted psychotherapy “produced rapid, robust and enduring anxiolytic and anti-depressant effects in patients with cancer-related psychological distress.”
Like MDMA, which the FDA also has deemed a “breakthrough therapy” and may approve as a treatment for posttraumatic stress disorder as soon as 2021, psilocybin is a psychotherapeutic catalyst that is meant to be taken no more than a few times, as opposed to a mood-adjusting drug taken every day. The striking results of these studies suggest the former approach may hold more promise of substantial, long-term improvement.
“This is great news for patients,” COMPASS Pathways Executive Chairman George Goldsmith said in the press release announcing the FDA’s “breakthrough therapy” designation. “We are excited to be taking this work forward with our clinical trial on psilocybin therapy for treatment-resistant depression. The FDA will be working closely with us to expedite the development process and increase the chances of getting this treatment to people suffering with depression as quickly as possible.”
If the FDA does approve psilocybin as a medicine, the drug will have to removed from Schedule I of the Controlled Substances Act, which is supposed to be reserved for drugs that have no accepted medical use. In a 2018 Neuropharmacology review, Johns Hopkins psychologist Matthew Johnson and three co-authors argue that psilocybin should be placed in Schedule IV, which is for medically useful drugs with a relatively low abuse potential. They conclude that “psilocybin appears to offer potential benefits to patients and little risk to public health.”

John Dee and the Empire of Angels: Enochian Magick and the Occult Roots of the Modern World

jason louv


A comprehensive look at the life and continuing influence of 16th-century scientific genius and occultist Dr. John Dee

  • Presents an overview of Dee’s scientific achievements, intelligence and spy work, imperial strategizing, and his work developing methods to communicate with angels
  • Pieces together Dee’s fragmentary Spirit Diaries and examines Enochian in precise detail and the angels’ plan to establish a New World Order
  • Explores Dee’s influence on Sir Francis Bacon, modern science, Rosicrucianism, and 20th-century occultists such as Jack Parsons, Aleister Crowley, and Anton LaVey

Dr. John Dee (1527-1608), Queen Elizabeth I’s court advisor and astrologer, was the foremost scientific genius of the 16th century. Laying the foundation for modern science, he actively promoted mathematics and astronomy as well as made advances in navigation and optics that helped elevate England to the foremost imperial power in the world. Centuries ahead of his time, his theoretical work included the concept of light speed and prototypes for telescopes and solar panels. Dee, the original “007” (his crown-given moniker), even invented the idea of a “British Empire,” envisioning fledgling America as the new Atlantis, himself as Merlin, and Elizabeth as Arthur.

But, as Jason Louv explains, Dee was suppressed from mainstream history because he spent the second half of his career developing a method for contacting angels. After a brilliant ascent from star student at Cambridge to scientific advisor to the Queen, Dee, with the help of a disreputable, criminal psychic named Edward Kelley, devoted ten years to communing with the angels and archangels of God. These spirit communications gave him the keys to Enochian, the language that mankind spoke before the fall from Eden. Piecing together Dee’s fragmentary Spirit Diaries and scrying sessions, the author examines Enochian in precise detail and explains how the angels used Dee and Kelley as agents to establish a New World Order that they hoped would unify all monotheistic religions and eventually dominate the entire globe.

Presenting a comprehensive overview of Dee’s life and work, Louv examines his scientific achievements, intelligence and spy work, imperial strategizing, and Enochian magick, establishing a psychohistory of John Dee as a singular force and fundamental driver of Western history. Exploring Dee’s influence on Sir Francis Bacon, the development of modern science, 17th-century Rosicrucianism, the 19th-century occult revival, and 20th-century occultists such as Jack Parsons, Aleister Crowley, and Anton LaVey, Louv shows how John Dee continues to impact science and the occult to this day.

Data guru living with ALS modernizes industries by typing with his eyes

By Susanna Ray 10 September, 2018
The self-proclaimed “oldest nerd of Guatemala,” Otto Knoke is an admitted workaholic, glued to his computer screen from 4 a.m. to 8 p.m. as he analyzes data and creates business-intelligence dashboards for customers ranging from restaurants to hotels and real-estate companies.
The 60-year-old data analyst is well-known in Guatemala’s business community, especially after he helped modernize the banking industry by bringing ATMs to the country 20 years ago. But even as the then-40-year-old’s career was blossoming, his muscles were beginning to fail him. In 1998, Knoke (pronounced kuh-NO-kuh) was diagnosed with amyotrophic lateral sclerosis, or ALS, and was told he had two years to live.
Always an early adopter of new technology, Knoke persistently researched ways tech advances could help him thrive even as the disease has progressed. Two decades later, he has become the first person in Guatemala to use Microsoft’s new eye-tracking software for Windows 10, called Eye Control. That’s given him access to pivotal tools, helping his mind overcome the restrictions of his body, and his business is booming.
“Technology has permitted me to work and communicate with my loved ones, with the people who help me and with my friends,” Knoke said in an interview conducted over email, his responses typed using his eyes. “And now that I’ve learned to use Eye Control and a foot mouse at the same time, my productivity at work has skyrocketed and my relationships have improved.”
Otto Knoke, who has lived with ALS for 20 years, “always has a big smile on his face, because he’s got his independence back” thanks to new technology that helps him communicate, says his wife Pamela Knoke.
ALS, also known as Lou Gehrig’s disease, erodes muscular functions until a person is unable to walk, talk or breathe. There’s no known cause or cure, and it usually results in death within five years, according to the ALS Association, although physicist Stephen Hawking lived with the disease for 55 years until he died earlier this year – one of just 5 percent of patients, including Knoke, to survive for more than 20 years.
Once an avid cyclist, weightlifter and tennis player, Knoke lost use of his hands and arms first, which meant he couldn’t hold a cane to support his weakening legs. So he’d tuck his arm under his wife’s, and she propelled him forward. His symptoms progressed slowly, allowing him to keep his job as a chief executive officer in the banking industry for 12 years. He retired in 2010 when he began losing his voice, making it difficult to communicate with his board of directors.
But he didn’t stop working; he simply moved his office home and became a data analyst, helping nonprofits and small- to medium-sized companies use new business intelligence tools to get value from their data.
“He’s not retired – he doesn’t know the meaning of that word – he just doesn’t go to the office anymore,” said his wife of 32 years, Pamela Knoke, who quit her job as a bank process manager to become his business partner – and his voice.
The couple remodeled their two-story townhouse near Guatemala City so he had everything he needed on the first floor and didn’t have to navigate stairs. Otto learned to use a trackball mouse with his foot to type with an on-screen keyboard. But it was cumbersome, and he needed Pamela nearby to move the cursor from one corner of his two 32-inch screens to another as he navigated Excel spreadsheets and Power BI dashboards.
A tracheotomy was put in his throat to help him breathe, taking away his limited speech and increasing his isolation. But when Knoke, who spends two hours a day reading blogs and researching, saw his friend Juan Alvarado’s post about the new Eye Control feature in Windows 10, he let loose with his version of a shout and immediately ordered the Tobii Eye Tracker hardware to use with the software.
Otto Knoke with his wife, daughters and sons-in-law. Photo provided by Pamela Knoke.
Alvarado, who met Knoke as a database consultant working on the ATM system Knoke had implemented, hadn’t known about Knoke’s condition until he suddenly saw him in a wheelchair one day. And fittingly, Eye Control itself began with a wheelchair.
Microsoft employees, inspired by former pro football player Steve Gleason, who had lost the use of his limbs to ALS, outfitted a wheelchair with  electronic gadgets to help him drive with his eyes during the company’s first Hackathon, in 2014. The project was so popular that a new Microsoft Research team was formed to explore the potential of eye-tracking technology to help people with disabilities, leading to last year’s release of Eye Control for Windows 10.
Knoke said it was “a joy” to learn how to type with his eyes, getting the feel of having sensors track his eye movements as he navigated around the screen and rested his gaze on the elements he wanted to click. Using Eye Control and the on-screen keyboard, he now can type 12 words a minute and creates spreadsheets, Power BI dashboards and even PowerPoint presentations. Combined with his foot-operated mouse, his productivity has doubled. He plans to expand his services to the U.S., where he spent six years studying and working in the 1970s. He no longer relies on his wife’s voice, because Eye Control offers a text-to-speech function as well.
“It was frustrating trying to be understood,” Knoke said in the email interview. “After a few days of using Eye Control I became so independent that I did not need someone to interact with clients when there were questions or I needed to explain something. We have a remote session to the client’s computer, and we open Notepad and interact with each other that way.”
His wife and his nurse had learned to understand the sounds he was able to make, even with the tracheotomy restricting his vocal chords. But now he can communicate with his three grown daughters, his friends and all his customers.
Using a foot-operated mouse, Eye Control for Windows 10 and the text-to-speech function, Otto Knoke is able to communicate with his family — including his daughter, seen here — as well as with clients.
“Now when our children visit, he can be not just nodding at what they say, but he can be inside the conversation, too,” Pamela Knoke said. “He always has a big smile on his face, because he’s got his independence back.”
He’s also started texting jokes to friends again.
“It’s kind of like it brought my friend back, and it’s amazing,” Alvarado said. “Otto told me that for him, it was like eye tracking meant his arms can move again.”
Being able to text message with Eye Control has helped his business as well.
Grupo Tir, a real-estate development and telecommunications business in Guatemala, hired Knoke for several projects, including streamlining its sales team’s tracking of travel expenses with Power BI.
“Working with Otto has been amazing,” said Grupo Tir Chief Financial Officer Cristina Martinez. “We can’t really meet with him, so we usually work with texts, and it’s like a normal conversation.
“He really has no limitations, and he always is looking for new ways to improve and to help companies.”
Otto Knoke uses Eye Control in Windows 10 to create spreadsheets and interactive Power BI reports, such as this one, for his clients.
Knoke’s ready feedback on the Microsoft products he works with every day, such as Power BI, led to improvements in the software’s features, along with a job offer that he calls “a dream come true.” The company hired him as a contractor this month to serve as a community manager for Power BI’s customer advisory team.
“I was really inspired,” said Cesar Cernuda, the president of Microsoft Latin America, who visited Knoke at his home earlier this year. “And it’s not that we’re helping him, but that he’s helping all of his customers, as an expert on Power BI.”
Knoke’s pioneering use of Eye Control in Guatemala and the way he’s been able to harness technology to enrich his personal life spoke volumes to Mario Ibarguen, the general manager of Taco Bell Guatemala. The fast-food franchisee has been growing in the country, opening 54 restaurants including the world’s largest Taco Bell, housed in a former bank in Guatemala City. When Ibarguen needed a tool for the restaurant managers to measure growth and sales in real time, he knew Knoke would have the answer.
“All these tools that Otto has have helped him a lot, so it’s good to have someone like Otto helping us,” Ibarguen said.
Knoke credits his family, work, faith and attitude as the “winning ticket” that has sustained him as his disease progressed over the past two decades. And with his renewed ability to communicate, he said, “I’m so busy that I don’t have time to think about my disease.”

Top photo: Otto Knoke and Juan Alvarado discuss a Power BI report Knoke created using eye-tracking software for Windows 10.