Magic mushrooms are the most-used psychedelic drug

As states change laws, federal policymakers face urgent questions

Reports and Proceedings

RAND CORPORATION

Psilocybin mushrooms are the psychedelic substance most often used in the U.S., with its popularity outpacing other psychedelic drugs such as MDMA (known as ecstasy), according to a new RAND report.

 

Based on a new national survey, researchers found that about 12% of respondents reported using psilocybin at some point over their lives and 3.1% reported using the substance over the past year. An estimated 8 million American adults used psilocybin in 2023.

 

Psychedelic substances such as psilocybin mushrooms and MDMA long have been touted as holding promise for treating various mental health conditions, with enthusiasm about the substances growing during the past decade. Although clinical research continues to grow, less attention has focused on the changing policy landscape for some psychedelics.

 

The report, which looks broadly at emerging issues involving the use and supply of psychedelics for nonclinical purposes, suggests that as state and local officials ease regulations on the substances, federal policymakers must decide whether they want psychedelics to follow in the footsteps of the for-profit cannabis model or take another path.

 

“The current situation with psychedelics reminds me of where we were with cannabis policy 12 years ago” said Beau Kilmer, lead author of the report and a senior policy researcher at RAND, a nonprofit research organization. “Now is the time for federal policymakers to decide if they want to shape these policy changes or stay on the sidelines.”

 

Researchers caution that there is concern that if efforts to expand non-clinical supply of psychedelics do not go well, it could generate a backlash that may have a chilling effect on research and potential therapeutic uses.

 

“Based on what happened with clinical research on psychedelics after the 1960s, this is not an idle concern,” said Kilmer, codirector of the RAND Drug Policy Research Center.

 

The RAND report is based on several sources of information, including a December 2023 survey of a representative sample of 3,791 American adults who were asked about their use of a variety of substances, including psychedelics. The survey included several questions specific to psilocybin use and how it was obtained. The researchers also analyzed data from the National Survey on Drug Use and Health and the National Incident-Based Reporting System.

 

Researchers interviewed legal experts, policy advocates, regulators, clinical researchers, mental health providers, and representatives from organizations working in the emerging psychedelics industry for the U.S. and abroad. The work also included discussions with members of Indigenous communities about their spiritual medicines.

 

“Policy changes may affect Indigenous people who have longstanding traditions with certain spiritual medicines that are commonly referred to as psychedelics,” said Michelle Priest, coauthor of the report and an assistant policy researcher at RAND. “Engaging respectfully with Indigenous community members who are authorized to speak on these topics can help craft policies that benefit from generations of wisdom while protecting Indigenous rights.”

 

Despite the federal prohibition on supply and possession outside approved clinical research and some religious exemptions, some state and local governments are loosening their approaches to psychedelics, including approaches that legalize some forms of supply to adults for any reason.

 

For states considering alternatives to prohibiting the supply of psychedelics, the report highlights how there are many options besides the for-profit approach. For example, states could allow people to forage or grow their own, or allow them to join non-profit collectives or cooperatives. There also is the supervised use model that’s operating in Oregon for psilocybin and is expected to be up and running in Colorado in 2025.

 

One difference from cannabis policy debates, the researchers note, is the role of supervision in policy discussions surrounding psychedelics. Even in places that do not adopt the supervision model being implemented in Oregon and Colorado, policymakers will likely confront many decisions surrounding the regulation of facilitators and supervision settings.

 

The RAND report found that unlike people who use cannabis and many other drugs, those who use psychedelics typically do so infrequently. The RAND survey found that 0.9% of respondents reported using psilocybin during the past month, compared to 20% of respondents reporting cannabis use during the past month.

 

Researchers estimate that among all American adults, the total number of use days in the past month for cannabis was on the order of 650 million, whereas the comparable figure for hallucinogens was closer to 7 million.

 

Among those reporting past year use of psilocybin in the RAND survey, 47% reported microdosing the last time they used. Microdosing involves using small amounts of psilocybin or other psychedelics -- often 1/10th to 1/20th of a typical dose.

 

Researchers say one takeaway from the analysis is the extent to which infrequent users drive the market for psychedelics. For cannabis, the market for infrequent users is negligible, accounting for about 5% of the total use days in the past month. For psychedelics, that figure is closer to 60%.

 

“While price is a major policy lever when we think about regulating cannabis and alcohol, it will likely play a much smaller role for psychedelics since infrequent users currently drive the market and they tend to spend relatively little on these substances,” said Rajeev Ramchand, coauthor of the report and codirector of the RAND Epstein Family Veterans Policy Research Institute.

 

The researchers found that when they were writing the report, it became clear how little has been published about the markets and patterns of use for many psychedelics -- especially psilocybin. They offer ideas for improving existing surveys such as the National Survey on Drug Use and Health, and recommend conducting qualitative research (ideally longitudinally) with those who use psychedelics and those who produce and distribute these substances in legal or illegal settings.

 

Support for the study was provided by a gift to RAND from the Sergey Brin Family Foundation and internal RAND support.

 

Other authors of the study are Rhianna C. Rogers, Ben Senator and Keytin Palmer.

 

The RAND Social and Economic Well-Being division seeks to actively improve the health, and social and economic well-being of populations and communities throughout the world.

 

RAND Health Care promotes healthier societies by improving health care systems in the United States and other countries.

---

DOI

10.7249/RRA2825-1 

METHOD OF RESEARCH

Survey

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Considering Alternatives to Psychedelic Drug Prohibition

ARTICLE PUBLICATION DATE

27-Jun-2024

 

Unregulated sales of a toxic and hallucinogenic mushroom endanger public health

UNIVERSITY OF CALIFORNIA - SAN DIEGO

Americans’ interest in a potentially harmful “magic mushroom” is soaring, with Google searches skyrocketing 114 percent from 2022 to 2023, according to a new study by researchers at the University of California San Diego Herbert Wertheim School of Public Health and Human Longevity Science. In a paper published in the American Journal of Preventive Medicine, the scientists suggest that the growing market for Amanita muscaria may be sparked in part by emerging clinical research supporting the safety and efficacy of psilocybin as a treatment for depression. 

Like psilocybin mushrooms, Amanita muscaria mushrooms have psychotropic effects. These include a feeling of weightlessness, visual and auditory hypersensitivity, space distortion, unawareness of time, and colored hallucinations. The psychotropic effects are produced by compounds that naturally occur in the mushroom called muscimol and ibotenic acid, its biosynthetic precursor. 

However, in addition to being psychotropic, these compounds can also be more toxic than fentanyl, cocaine, and PCP, according to the scientists’ review of estimates from published mouse studies. Nevertheless, gummies and chocolates containing these compounds are being marketed with health-related claims such as mitigation of anxiety, depression, and other conditions, often by vague references to clinical studies related to psilocybin, which is not as toxic and produces different psychotropic effects. 

“There is a lot of interest in the therapeutic potential for psilocybin and for good reason. But at the same time, a growing industry may be trying to capitalize on this interest by marketing other mushrooms.  For example, some manufacturers are calling Amanita muscaria products ‘magic mushroom gummies’ and not disclosing what mushroom they contain, or not making it clear Amanita muscaria is a different mushroom than psilocybin and has essentially no clinical evidence supporting its use as a therapy,” said Eric Leas, Ph.D., M.P.H., assistant professor in the UC San Diego Herbert Wertheim School of Public Health and Human Longevity Science and senior author on the paper.

Psilocybin and muscimol work in different ways. Psilocybin is an antidepressant that primarily binds to serotonin receptors, activating a neural pathway that mediates happiness and optimism. Amanita muscaria however is a depressant, similar to alcohol and benzodiazepines, which suppress the central nervous system. Leas believes that marketing Amanita muscaria as a psilocybin-type product violates consumers’ right to informed consent. 

“There may be some pharmaceutical potential to Amanita muscaria, but muscimol does not have the same effects on the body as psilocybin, so it probably would not have the same treatment applications if it ever went through drug development. For this reason, it is misleading not to clearly distinguish between muscimol and psilocybin. If someone is consenting to a psychedelic experience, they have a right to know what substance they are taking and receive accurate information about its potential health benefits and health risks.”

False marketing may be enabled by lack of federal regulation of Amanita muscaria. Under the 1970 Controlled Substances Act, psilocybin is a Schedule 1 drug, making its manufacture, distribution, import/export, possession and use illegal. In 2017, the FDA designated psilocybin as a “breakthrough therapy” and in 2023 loosened restrictions to allow drug developers and scientists to conduct clinical trials with psilocybin, including some that are taking place at UC San Diego. Nevertheless, it continues to be a Schedule 1 controlled substance, and, therefore its use is disallowed out of the context of clinical trials.

Not so for Amanita muscaria. Although there are several published case studies of hospitalizations and deaths resulting from Amanita muscaria consumption, to date it is not included on a Controlled Substances list (except for the State of Louisiana, where sales are restricted). However, it is often marketed as a dietary supplement, products covered by regulations enforced by the U.S. Food and Drug Administration and the Federal Trade Commission. 

“We have found that many manufacturers use supplement labeling, including ‘Supplement Facts’ panels,” said Leas. “However, there is a process for bringing a supplement to market that involves presenting safety data and filing an application, and we cannot find any evidence that any of these manufacturers have gone through this process, and this makes the current products sold in this manner illegal.

“In my view, if a manufacturer wanted to develop a dietary supplement from Amanita muscaria, the application probably would not be approved because of muscimol and ibotenic acids’ inherent risks,” he added. “But right now it is the ‘Wild West,’ and companies are profiting from delayed enforcement while putting consumers at risk.” 

The authors are making several general recommendations. The most restrictive would be to put Amanita muscaria on the Controlled Substances list, where it could first be evaluated for its medical potential and abuse liability before it is widely sold. However, if Amanita muscaria is not placed on a drug schedule, they recommend commonsense precautions, such as setting age restrictions, accurate dosing standards, childproof packaging, and marketing aimed at adults rather than children, all now required for legal sales of recreational cannabis. The authors would also like to see mental health professionals help their patients distinguish between psilocybin and Amanita muscaria. 

The authors’ key takeaway is that “companies who are making these products are pushing the limits of our regulations. They are getting away with making a buck until someone tells them they can't. Given the substantial risks associated with using Amanita muscaria products, it is a buyer beware marketplace where consumers are at risk and are not accurately informed. The time for a public health first response is now.”

Co-authors include: Nora Satybaldiyeva, Wayne Kepner, Kevin H. Yang, Raquel M. Harati, Jamie Corroon, and Matthieu Rouffet, of UC San Diego.

The work is supported in part by grant T32IP4684 from the California Tobacco Related Disease Research Program and grant K01DA054303 from the U.S. National Institute on Drug Abuse.

# # #

---

JOURNAL

American Journal of Preventive Medicine

DOI

10.1016/j.amepre.2024.05.006 

ICYMI

Psychedelic Stocks Tank After FDA Advisors Shoot Down MDMA Therapy For PTSD

Robert Hart

Forbes Staff

Robert Hart is a London-based Forbes senior reporter.

Jun 5, 2024

TOPLINE

Shares for companies focused on psychedelic medicines plummeted during premarket trading on Wednesday after independent experts advised the Food and Drug Administration against approving psychedelic and stimulant drug MDMA, commonly known as ecstacy or molly, for post-traumatic stress disorder, a major setback for those hoping to open a new era of medicine for the often-outlawed substances

KEY FACTS

An advisory panel of the FDA voted to reject the use of MDMA to help treat patients with PTSD on Tuesday amid concerns available evidence does not show the drug is effective or that its benefits outweigh the risks.

While the vote does not dictate the FDA’s ultimate decision on the drug, the agency tends to put great stock in the advice it gets from its expert panels, and it marks a major setback for companies and clinicians in the U.S. hoping to harness the therapeutic potential of psychedelics.

It’s a blow to the drug’s sponsor, Lykos Therapeutics, a private, California-based company registered as a public benefit corporation, but the setback has also hit investor confidence in an array of publicly traded companies working to bring psychedelics to clinics.

This includes top psychedelics firms like New York-based Mind Medicine (also known as MindMed), Berlin-based Atai Life Sciences, Canadian firm Cybin and British biotech Compass Pathways, which are all down between 10% and 15% during premarket trading (Atai, Cybin and Compass are listed on the Nasdaq).

Others hit include Relmada Therapeutics, which targets central nervous system conditions and was down around 5%, and Dublin drug developer GH Research, down around 3.5%.

Seelos Therapeutics, which has been testing whether psychedelics can treat neurological diseases, appears to be a notable exception, with shares up nearly 2% during premarket trading.

Many are relatively small firms, which makes it less abnormal to witness large fluctuations in share price in a short space of time.

KEY BACKGROUND

Psychedelics are a broad class of drugs that can alter mood, thoughts and perception. Many drugs in the category, which includes substances like MDMA, LSD and psilocybin — the active compound in “magic mushrooms” — are deemed illegal in many parts of the world, though they are increasingly viewed by experts as potentially promising treatments for an array of conditions that have largely proven hard or impossible to treat reliably. Especially promising are the potential for the drugs to impact the trajectory of mental health conditions like depression, anxiety and addiction. If approved, Lykos’ MDMA therapy would mark the first such approval in the U.S. and it is the first psychedelic therapy to be considered by the FDA. One clinical trial by Lykos showed MDMA reduced most PTSD patients' symptoms with few severe side-effects, though some experts have warned the drug could carry cardiovascular risks and questioned how the study was designed.

SEE

Magic mushrooms get Canadian export license in psychedelic race

BAD NEWS

Supporters think ecstasy has potential to treat PTSD, but FDA panel rejects psychedelic drug

ByDenise Dador 
Tuesday, June 4, 2024 


Federal health advisers have rejected the first-ever proposal to use MDMA as a treatment for PTSD, but supporters of MDMA therapy praise its effectiveness.

Federal health advisers have rejected the first-ever proposal to use MDMA as a treatment for PTSD. The nonbinding vote is a potential setback for psychedelic advocates hoping to move the banned drugs into the mainstream.

A panel of advisers to the Food and Drug Administration cited flawed study data, questionable research conduct and significant drug risks, including the potential for heart problems, injury and abuse.

However, strong supporters of MDMA therapy continue to praise its effectiveness, including advocate Lori Tipton who took part in the drug's clinical trials.

Doctors diagnosed the New Orleans resident with post traumatic stress disorder after Hurricane Katrina hit her hometown.

"My brother passed away from an overdose. And then after that, my mother took the lives of two women and then took the life of herself. And I was the person who discovered their bodies within the house," Tipton said. "I had crazy mood swings, panic attacks, insomnia. I had intrusive thoughts, suicidal ideation."

Various forms of therapy didn't help. In 2018, she enrolled in a clinical trial to test the psychedelic drug MDMA, which is also known as ecstasy or molly.

Tipton underwent three supervised sessions where she was given microdoses followed by patient-guided talk therapy. She says reconnecting with buried memories opened an avenue for self healing.

"It allowed me to see that from a very different perspective, and to understand, like the amount of shame that I was holding on to and fear," Tipton said.

For now, the panel is not recommending MDMA move into the medical mainstream and felt the risks didn't outweigh the benefits.

"The only way to obtain this treatment legally in this country at this time is through clinical trials," Lalim Health founder Dr. April Soto said.

Dr. Soto says mind altering medications can help patients come to terms with their trauma.

Lykos Therapeutics, the company sponsoring the study, presented two late stage study results.

"67% of patients who had the MDMA no longer met criteria for PTSD," Dr. Soto said, compared to 32% of patients on the placebo.

She emphasizes the need for a meticulous medical evaluation due to the known safety risks that include hypertension, elevated blood pressure and tachycardia.

After six years, Tipton has not needed more MDMA therapy and remains an advocate.


"Unbelievable, the amount of lives that can save, unbelievable, you know, that's my experience with it at least," Tipton said.

MDMA is the first in a series of psychedelics - including LSD and psilocybin - that are expected to come before the FDA for review in the next few years as part of a resurgence of interest into the drugs' medical potential, which advocates claim could transform the treatment of mental health disorders.

The FDA usually follows the panel's recommendation, but they're not required to. Their final decision is expected Aug. 11.

The Associated Press contributed to this report.

Magic mushrooms get Canadian export license in psychedelic race

Thomas Seal, BNN Bloomberg

The market today is clinical rather than recreational. (Moriah Ratner/Bloomberg)

Canada has licensed a startup to export psychedelics to Australia for patient use, the latest milestone in a contest to supply the potential growth of medical psychedelic drugs.

Canada’s health department awarded a drug establishment license to Optimi Health Corp., a spokeswoman for the company said, allowing it to ship pills containing the magic-mushroom extract psilocybin and MDMA — controlled and otherwise-illegal substances — to a provider in Australia.

The small Vancouver-based company hopes the certificate will help pave the way to an expanded market for psychedelic drugs as pharmaceuticals while giving it an early-mover advantage. 

Seven companies have legally exported psilocybin, MDMA or both from the country so far, all for clinical trial purposes, a spokeswoman for Canada’s health department said. She wasn’t able to say if any has ever been exported for regular patient use before; she declined to name the seven companies, citing security reasons.

The milestone puts Optimi among a small club of legal, international suppliers of psychedelic drugs, according to Chairman John James ‘JJ’ Wilson, its co-founder and the son of billionaire Lululemon Athletica Inc. founder Chip Wilson. 

Optimi’s vision is “to be the largest scalable quality manufacturer made available globally of psilocybin and MDMA,” JJ Wilson said in an interview. “The world is taking this more seriously as an alternative to traditional pharmaceuticals, to treat these mental health disorders.”

The market today is clinical rather than recreational, Wilson said, downplaying parallels to the legalization of cannabis in Canada and many U.S. states.

Optimi’s bet is that, even though magic mushrooms are naturally occurring, demand for a pharmaceutical-grade version of the substance will be robust, and the company will have the credentials and scale to supply it. 

As it seeks to carve out this niche, refine processes and strike early supply deals, it’s losing more than C$1 million ($733,000) per quarter and regularly raising funds, filings show. Chip Wilson, who sits on its advisory board, acquired shares with options worth as much as C$3.3 million in late 2022, and since then the company has closed small private placements.

To grow, test, and extract its trippy crop, Optimi has set up 20,000 square feet of facilities in Princeton, British Columbia, a mining and lumber town with a population of about 3,000 in the mountains three hours’ drive east of Vancouver. The nondescript blue warehouses are set behind high security fences.

Visitors must show government ID, don protective clothing, and pass through air jets to prevent contamination. Although warehoused mushroom strains have zany and obscene names like “Albino Penis Envy,” Optimi has built facilities to pass stringent manufacturing-quality tests set by authorities. Staff have to undergo background checks. 

‘Initial Promise’

All this effort and investment is part of jostling to be in prime position for a possible psychedelic renaissance. 

Although many jurisdictions have now relaxed rules around cannabis, the regular possession, sale and distribution of potent psychedelics remains illegal in Canada and the US. But attitudes are shifting, and there’s increased talk of potential benefits in treating psychiatric conditions. Research has increased — and in some cities like Vancouver, rebellious entrepreneurs have even opened brick-and-mortar stores, which sell psychedelics with apparent impunity. 

Optimi says it’s ready to step in first wherever MDMA and mushrooms become rescheduled, and points to regulatory developments.

Last June, the U.S. Food and Drug Administration published its first draft guidance on psychedelic clinical trials, saying they showed “initial promise”. A month later, Australia opened a world-first pathway for authorized psychiatrists to access MDMA and psilocybin, saying they can be used for the treatment of post-traumatic stress disorder and treatment-resistant depression, respectively. 

Outside advisers to the FDA are preparing to meet this week to weigh Lykos Therapeutics Inc.’s MDMA drug for post-traumatic stress disorder. A report from the agency scientists, posted Friday, focused on the difficulties of evaluating the drug and potential risks. 

Still, untested business models and regulation in flux means that investment prospects are highly uncertain. 

As with cannabis companies, psychedelic startups have gone through a shakeout. Optimi’s stock price is down 43 per cent since its 2021 initial public offering. Others including Lucy Scientific Discovery Inc., Psyence Biomedical Ltd. and AWAKN Life Sciences Corp. have also seen their shares plummet since listing.

“In 2024 we’ll develop a capital strategy for how we want to go to the next phase,” Wilson said.

WAR PAST

Drawn By War: Crimea In The 1800s

May 31, 2024 
By Amos Chapple

During the Crimean War of 1853-56, a London printing house compiled one artist's paintings of Crimean towns and landscapes to satisfy British curiosity about the peninsula. Nearly 200 years later, many of the sites remain in the headlines amid the latest conflict over the territory.


1This painting of the beach at Eupatoria, western Crimea, is one of 52 illustrations of the peninsula made by Swiss-Italian artist Carlo Bossoli (1815-84).

2The ruins of an unidentified church in Crimea

Bossoli spent most of his youth in Odesa in what was then the Russian Empire. From 1840 until 1842, he traveled throughout Crimea to capture its culture and landscape before cameras were widely available.

3Crimean Tatars dancing in Massandra, southern Crimea

In 1853, war broke out on the Crimean Peninsula between Russia and an alliance of the Ottoman Empire, Britain, France, and Sardinia, sparking intense public interest in the little-known region.

4A view of the southern Crimean town of Yalta

With the war ongoing, a London publishing house approached the well-established Bossoli with an offer to reproduce his early Crimea paintings into a book with explanatory captions.


5A caravan of Tatars traveling across the plain of an unspecified region of Crimea

The book, titled Beautiful Scenery And Chief Places Of Interest Throughout The Crimea, was published in 1856. The same year, Bossoli's Crimea paintings were exhibited to a curious public in London.


6A Crimean Tatar school depicted at an unspecified location in Crimea

From around 500 copies of the book that were published, one is today held by the DeGolyer Library of the Southern Methodist University in Texas. The images inside are striking for the largely lost world they capture, as well as the continued geopolitical importance of many of the landmarks Bossoli painted.

7Snake Island depicted on a stormy day

The island became famous as the position of Ukrainian troops who defied a Russian warship at the opening of the 2022 Russian invasion of Ukraine, but its turbulent history stretches back to early Greek civilization.

A temple to Achilles once stood on the island, which was later fought over by the Ottoman and Russian empires, then controlled by Romania. The Soviet Navy captured the island in World War II, then Ukraine inherited it following the collapse of the Soviet Union.

8Sevastopol viewed from a “watchtower” in the center of the town

The port city has been under Russian control since Crimea was forcibly annexed in 2014 and has repeatedly been targeted by missile strikes since the 2022 Russian invasion of Ukraine.

9The town of Bakhchysarai, which was the capital of the Crimean Khanate until the entity’s annexation by Russia in 1783

Bakhchysarai was emptied of Muslim Tatars after Stalin’s Soviet Union forcibly deported the ethnic minority en masse as collective punishment for some Tatars fighting on the side of the Nazis in WWII.


10A Crimean Tatar house in Alupka village

According to Bossoli, such village houses were often built against rocky outcrops that served as one wall of the residence.

“The roof is flat, and upon it, when the weather is fair, the inhabitants commonly assemble, working or enjoying one another's society,” the artist wrote.


11The tomb of Mithridates on the coast of Crimea near Kerch

This otherworldy chamber is believed to have been built for the remains of a king of the Spartocids, a Thracian dynasty who ruled the Crimean Peninsula around 2,200 years ago. By the time Bossoli painted it, it had long since been looted by tomb raiders.

12A view of Mt. Mithridates from a waterfront road through Kerch

From this viewpoint today, the Kerch Bridge to Russia would be visible at left, some 2.5 kilometers behind the mountain.

13A view over Kerch from Mt. Mithridates

The monument on the right was a mausoleum to Russian archaeologist Ivan Stempkovsky that was damaged in fighting, then demolished by the Soviets, after Kerch was recaptured from Nazi control in 1944.

14Bilohirsk, which was known by Crimean Tatars as Karasubazar, meaning “market on the Karasu river”

The Crimean name references the town’s bazaar that included a major slave market for kidnapped Slavs during the Crimean Khanate.

15Balaklava seen from the Genoese-era fortifications that overlook the natural harbor

Balaklava became emblematic of the Crimean War in Britain due to the costly battle fought for control of the bay.

16The Khan's Palace in Bakhchysarai

The book of Crimean paintings provided a payday for Bossoli, but probably did little to advance his standing in the art world. By the time his 1856 book was published, the artist's technical prowess had advanced significantly from his youthful Crimean work, as can be seen in this 1857 painting of Bakhchysarai. Bossoli died in 1884 and is buried in Lugano, Switzerland.

TENNYSON'S POEM; CHARGE OF THE LIGHT BRIGADE

  

The Charge of the Light Brigade


BY ALFRED, LORD TENNYSON

I

Half a league, half a league,

Half a league onward,

All in the valley of Death

Rode the six hundred.

“Forward, the Light Brigade!

Charge for the guns!” he said.

Into the valley of Death

Rode the six hundred.



II

“Forward, the Light Brigade!”

Was there a man dismayed?

Not though the soldier knew

Someone had blundered.

Theirs not to make reply,

Theirs not to reason why,

Theirs but to do and die.

Into the valley of Death

Rode the six hundred.



III

Cannon to right of them,

Cannon to left of them,

Cannon in front of them

Volleyed and thundered;

Stormed at with shot and shell,

Boldly they rode and well,

Into the jaws of Death,

Into the mouth of hell

Rode the six hundred.



IV

Flashed all their sabres bare,

Flashed as they turned in air

Sabring the gunners there,

Charging an army, while

All the world wondered.

Plunged in the battery-smoke

Right through the line they broke;

Cossack and Russian

Reeled from the sabre stroke

Shattered and sundered.

Then they rode back, but not

Not the six hundred.



V

Cannon to right of them,

Cannon to left of them,

Cannon behind them

Volleyed and thundered;

Stormed at with shot and shell,

While horse and hero fell.

They that had fought so well

Came through the jaws of Death,

Back from the mouth of hell,

All that was left of them,

Left of six hundred.



VI

When can their glory fade?

O the wild charge they made!

All the world wondered.

Honour the charge they made!

Honour the Light Brigade,

Noble six hundred!

n/a
Source: 2017-11-01

Scene from Charge of light brigade (1936) 

The Charge of the Light Brigade was a charge of British light cavalry led by Lord Cardigan against Russian forces during the Battle of Balaclava on 25 October 1854 in the Crimean War. Lord Raglan, overall commander of the British forces, had intended to send the Light Brigade to prevent the Russians from removing captured guns from overrun Turkish positions, a task well-suited to light cavalry.

However, there was miscommunication in the chain of command, and the Light Brigade was instead sent on a frontal assault against a different artillery battery, one well-prepared with excellent fields of defensive fire. They reached the battery under withering direct fire and scattered some of the gunners, but they were forced to retreat immediately. Thus, the assault ended with very high British casualties and no decisive gains.

The events are best remembered as the subject of Alfred, Lord Tennyson's narrative poem "The Charge of the Light Brigade" (1854), published just six weeks after the event. Its lines emphasise the valour of the cavalry in bravely carrying out their orders, regardless of the obvious outcome. Blame for the miscommunication has remained controversial, as the original order itself was vague, and the officer who delivered the written orders with some verbal interpretation died in the first minute of the assault.

The Charge Of The Light Brigade: The Crimean War's Greatest Blunder |

 History of Warfare | Timeline

 

Pearls Before Swine - Balaklava 1968 Full Album Vinyl

Psychedelic Folk band formed by Tom Rapp in 1965 in Eau Gallie, Florida. A1 Trumpeter Landfrey... A2 Translucent Carriages A3 Images Of April A4 There Was A Man A5 I Saw The World A6 Guardian Angels B1 Suzanne-----------------------16:44 B2 Lepers And Roses B3 Florence Nightingale... B4 Ring Thing

Psychedelic drug MDMA faces questions as FDA considers approval for PTSD

Federal health regulators are set to review the first request to approve the mind-altering club drug MDMA as a treatment for PTSD

MATTHEW PERRONE 

AP health writer

May 31, 2024, 

WASHINGTON -- Federal health regulators are questioning the safety and evidence behind the first bid to use MDMA, the mind-altering club drug, as a treatment for PTSD, part of a decadeslong effort by advocates to move psychedelic drugs into the medical mainstream.

The Food and Drug Administration posted its initial review of the drug Friday, ahead of a meeting of outside advisers who could help decide whether MDMA — currently illegal under federal law — becomes the first drug of its kind to win U.S. approval as a medication. The experts will discuss the quality of the evidence and safety concerns Tuesday, including MDMA's potential for abuse, before taking a nonbinding vote on the drug's overall benefits and risks. The FDA will make the final decision, likely in August.

In their assessment, FDA scientists said that patients who received MDMA and talk therapy showed “rapid, clinically meaningful, durable improvements in their PTSD symptoms,." But they also called the research “challenging to interpret,” and questioned how long the benefits might last. They said it’s difficult to know how much of the improvement came from MDMA versus simply undergoing intensive therapy, and also raised several safety concerns, including MDMA's potential to cause heart problems.

Post-traumatic stress disorder is closely linked to depression, anxiety and suicidal thinking and is more prevalent among women and veterans. Currently antidepressants are the only FDA-approved drugs for the condition.

If approved, MDMA would be reclassified as a prescription medicine and made available to specially certified doctors and therapists. Currently the drug is in the same ultra-restrictive category as heroin and other substances the federal government deems prone to abuse and devoid of any medical use.

MDMA, also known as ecstasy or molly, is the first in a series of psychedelics that are expected to be reviewed by the FDA in coming years. It’s part of a resurgence of research into the potential of psychedelics for hard-to-treat conditions like depression, addiction and anxiety. MDMA's main effect is triggering feelings of intimacy, connection and euphoria.

Companies are studying MDMA, psilocybin, LSD and other mind-expanding drugs for numerous mental health problems.

Until recently, psychedelic research was mainly funded by a handful of nonprofit advocacy groups, including Multidisciplinary Association for Psychedelic Studies, or MAPS. The company seeking approval for MDMA, Lykos Therapeutics, is essentially a corporate spinoff of MAPS, which conducted all the studies submitted for FDA review.

In two MAPS studies, patients received MDMA as part of an intensive, four-month course of talk therapy lasting more than a dozen sessions, only three of which involved taking the drug. The drug is thought to help patients come to terms with their trauma and let go of disturbing thoughts and memories.

The group studied its approach in 195 adults with moderate-to-severe PTSD who were randomly assigned to undergo the therapy with MDMA or with a dummy pill. Following treatment, patients who received MDMA had significantly lower PTSD scores and were more likely to be in remission.

But FDA reviewers noted that the vast majority of patients correctly guessed whether they had received MDMA or a dummy pill, making it “nearly impossible” to maintain the so-called “blinded” objectivity considered essential for high-quality drug research. The agency also questioned how long the drug's benefits might last. MAPS tracked some patients for up to two years, but reviewers noted that about a quarter of patients quickly dropped out of the follow-up study, limiting the usefulness of the results.

The most common side effects of MDMA included headache, nausea, muscle tightness and decreased appetite. More serious issues included heart palpitations and elevated blood pressure, which FDA reviewers said had the “potential to trigger” life-threatening heart problems.

They also raised concerns about the potential for patients to abuse MDMA, which functions similarly to amphetamines and other stimulants.

While MDMA would be a first-of-a-kind approval, U.S. doctors and the FDA itself have already laid some of the groundwork for working with drugs that can cause intense, psychological experiences.

Hundreds of clinics across the U.S. already offer ketamine — the powerful anesthetic sometimes used as a party drug — to treat a host of ailments, including depression, anxiety, chronic pain and PTSD. The FDA has only formally approved the drug for use during surgery, but its availability allows doctors to prescribe it “off-label” for various mental and physical ailments.

In 2019, the FDA approved Johnson & Johnson’s proprietary form of the drug, Spravato, a nasal spray that treats severe depression. Similar to ketamine, the drug is offered at doctor’s offices and clinics where patients usually spend several hours reclining in a chair.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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