psychedelics

more-bad-news-for-psychedelic-drug-company:-fda-expands-probe-after-rejection

More bad news for psychedelic drug company: FDA expands probe after rejection

health, lykos, maps, mdma, psychedelics, PTSD, Science / /

trippy trip up —

Psychedelic drug company Lykos already slashed staff and overhauled leadership.

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President of Multidisciplinary Association for Psychedelic Studies (MAPS) Rick Doblin speaks onstage during the 2023 Concordia Annual Summit at Sheraton New York on September 18, 2023, in New York City.

Enlarge / President of Multidisciplinary Association for Psychedelic Studies (MAPS) Rick Doblin speaks onstage during the 2023 Concordia Annual Summit at Sheraton New York on September 18, 2023, in New York City.

There’s more bad news for the company behind an experimental MDMA therapy for post-traumatic stress disorder, which the Food and Drug Administration roundly rejected earlier this month.

According to a report from The Wall Street Journal, the FDA is now expanding an investigation into clinical trials behind the experimental psychedelic therapy—even though the agency has already rejected it. Agency investigators reportedly interviewed four additional people last week, asking questions regarding whether the trials underreported side effects.

People involved in the trial have previously alleged, among other things, that ill effects, such as suicidal thoughts, went undocumented, and trial participants were discouraged from reporting them to bolster the chances of FDA approval. Overall, the MDMA trials faced crushing criticism amid the FDA’s review, with outside experts and agency advisors calling out allegations of sexual misconduct at one trial site, as well as flaws in overall trial designs, multiple sources of biases, and claims of that the company behind the therapy, Lykos, fostered a cult-like belief in psychedelics.

According to the Journal, the recent interviews were being conducted by the FDA’s Office of Regulatory Affairs, which oversees inspections, and a subdivision of that office called Biomedical Research Monitoring Program, which works to ensure the quality and integrity of data submitted to FDA. Notably, when the agency rejected MDMA, it advised Lykos to conduct a new trial.

While the FDA’s rejection and expanded investigation are bad enough for Lykos, the company announced this month that it’s laying off 75 percent of its staff and overhauling its leadership. The moves were in response to the FDA’s rejections, the company said. Additionally, a scientific journal retracted three of the company’s MDMA studies, citing “protocol violations amounting to unethical conduct” in its trials, echoing claims raised amid the FDA review.

Troubling roots

Underpinning the allegations and criticisms against Lykos is its roots in drug advocacy. Lykos is a commercial spinoff of the psychedelic advocacy nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS). For decades, MAPS has worked to legalize psychedelics and research their use as potential treatments, particularly mental health conditions, including PTSD, anxiety, and substance use disorders. MAPS was founded by Rick Doblin, a longtime psychedelic activist and advocate who openly believes the use of psychedelics will lead to world peace. Amid the leadership overhaul this month, Doblin left his position on Lykos’ board.

“After 38 plus years of work, I’m profoundly saddened by the FDA decision around this critically needed therapy, but am heartened that Lykos will still move forward continuing clinical research that addresses the FDA’s questions,” Doblin said in a statement. “I can speak more freely as a public advocate by resigning from the Lykos Board. The FDA delays make it more important than ever that I work at MAPS toward developing global legal access to MDMA and other psychedelics for public benefit through MAPS’ multidisciplinary research, education, and drug policy reform.”

Lykos did not immediately respond to Ars’ request for comment on the FDA’s investigation. In a response to the Journal, a company spokesperson said that “Lykos is committed to engaging with the FDA and addressing any questions it raises.” The spokesperson also noted that the company is planning to meet with the FDA about the rejection, which it is appealing.

But, trial participants and outsiders have levied heavy criticism against the company that will likely be hard to move beyond.

“The prospect of a therapy cult guiding a suggestibility-enhancing drug through clinical trials highlights unique risks that have never been publicly discussed,” Neşe Devenot, a Johns Hopkins University senior lecturer in the university’s writing program who focuses on the issue of drugs in society, said in public comments prior to the FDA rejection. “The trials should be scrutinized as if Scientology or NXIVM had submitted a new drug application to the FDA.”

Those public comments appeared in a damning report from Institute for Clinical and Economic Review, which concluded that there was insufficient evidence to back MDMA-based therapy. According to the Journal report, Devenot was among the people interviewed by FDA investigators recently.

Lykos’ saga has been a blow to the psychedelic community in general and to many patients, particularly veterans, who have reported benefits from using MDMA to treat PTSD, a condition in desperate need of effective treatments.

Amid Lykos’ troubles, the company has brought in David Hough as senior medical advisor to oversee clinical and regulatory work. Hough is a former vice president at Johnson & Johnson, where he notably helped develop Spravato—esketamine—a compound related to ketamine that was approved for use against treatment-resistant depression in 2019.

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Illegal drug found in Diamond Shruumz candies linked to severe illnesses

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More drugs —

New testing finds psilocin, related to psilocybin, in gummies purchased in 2023.

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Illegal drug found in Diamond Shruumz candies linked to severe illnesses

Newly released testing data of Diamond Shruumz-brand gummies purchased in 2023 identified the presence of psilocin, a hallucinogenic drug closely related to the magic-mushroom drug psilocybin that is classified as a Schedule I drug, alongside psilocybin, heroin, and LSD.

The finding comes as Diamond Shruumz’s current line of gummies, chocolates, and candy cones is being recalled and are under active investigation in connection to a nationwide rash of severe illnesses, which have involved seizures, intubation, and intensive care. As of the latest update on July 15, 69 people in 28 states have been sickened after eating a Diamond Shruumz product. Sixty of the 69 sought medical care, 36 were hospitalized, and there is one potentially associated death under investigation.

The new finding of psilocin in the products, published by researchers at the University of Virginia, adds to growing concern about psychedelic mushroom candies generally. Although the candies are marketed as being legal, they have often been found to contain various undisclosed illegal drugs, gray market synthetic versions of drugs, as well as dangerous adulterants and contaminants.

In the ongoing investigation of Diamond Shruumz candies—led by the Food and Drug Administration and the Centers for Disease Control and Prevention, with the help of America’s Poison Centers and state and local partners—researchers have not identified psilocin in products linked to the illnesses. Instead, they have found a closely related synthetic hallucinogenic compound called 4-acetoxy-N,N-dimethyltryptamine, also known as psilacetin or 4-AcO-DMT. Psilacetin is thought to be metabolized into psilocin in the body and is said to have similar effects as taking magic mushrooms or psilocybin. The different testing results between the FDA-led investigation and the new UVA study may be due to possible formulation changes between 2023 and 2024 or simply differences in the products or batches of candies tested so far.

The UVA researchers, who published their findings in the CDC’s Morbidity and Mortality Weekly Report, looked into the mushroom candies after four adults reported illnesses to a local poison control center between September and November 2023. The people went to the emergency department with tachycardia, confusion, anxiety or somnolence, and nausea after eating gummy candies labeled as containing Amanita muscaria mushrooms. Amid their investigation into those cases, a 3-year-old also fell ill in June 2024 after accidentally eating two gummies sold as containing A. muscaria. All of the adults and the toddler recovered from their illnesses quickly, though the toddler was hospitalized for a day for observation.

Not legal or safe

A. muscaria is a legal hallucinogenic mushroom that contains psychoactive compounds ibotenic acid and muscimol. These resemble neurotransmitters in the brain and can cause gastrointestinal symptoms, agitation, and seizures.

The UVA researchers couldn’t track down the specific brands or products the sickened adults took, but they collected six similar products from nearby gas stations and smoke shops. Those six products included two Diamond Shruumz products, which were not sold as containing A. muscaria. Using liquid chromatography-mass spectrometry, the researchers found that the two Diamond Shruumz gummy products (Sour Peach Apple and Rainbow flavors) contained psilocin. The Rainbow flavor also contained caffeine.

In addition, a product labeled as “Wonderland Legal Psychedelics Cherry Nirvana” contained psilocin, the synthetic hallucinogen N,N-dimethyltryptamine, a compound found in kratom called mitragynine, and caffeine.  A product labeled as “Urb Magic Amanita Mushroom Watermelon” contained psilocybin, psilocin, and the stimulant 2-phenethylamine. A product called “Psilly’s Legal Psychedelic Mushrooms Fruit Punch” contained the stimulant ephedrine, and the product “Tryp mushroom gummies” wasn’t found to contain any concerning compounds.

The UVA study was not able to test for ibotenic acid or muscimol. In Diamond Shruumz’s recall notice, the company said it had found higher than normal levels of muscimol in its products. FDA testing has not identified muscimol in product testing, according to results released so far.

“People tend to equate ‘legal’ with ‘safe,’ which is not necessarily the case. These products are not regulated and can contain any number of unlabeled substances which, when consumed, can cause undesired symptoms,” lead author of the UVA study Avery Michienzi said in a statement. “Some packages will have QR codes showing that the products were tested in a lab and contain only what they are labeled to contain. These have been found to be inaccurate.”

The FDA this week warned that even though all of Diamond Shruumz’s products have been recalled, they remain on the shelves of stores nationwide. The agency said it is reaching out to industry partners to raise awareness of the recall and monitoring the effectiveness of Diamond Shruumz’s recall efforts.

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What we know about microdosing candy illnesses as death investigation underway

cases, diamond shruumz, health, microdosing, muscimol, mushrooms, psychedelics, Science, seizures, Toxicology / /
The Birthday Cake flavored bar.

Enlarge / The Birthday Cake flavored bar.

One person may have died from eating Diamond Shruumz microdosing candies, which were recalled last week amid a rash of severe illnesses involving seizures, intubation, and intensive care stays.

According to an update this week from the Food and Drug Administration, the cluster of cases continues to increase across the country. To date, 48 people across 24 states have fallen ill after eating the candies, which include chocolate bars, gummies, and candy cones that were sold online and in retail locations, such as smoke and vape shops. Of the 48 people sickened, 46 were ill enough to seek medical care, and 27 were admitted to a hospital.

For now, the death noted in the FDA’s latest update is only “potentially associated” with the candies and is still under investigation. No other information is yet available.

But in an interview with Ars, medical toxicologist Michael Moss was not surprised that the candies may have turned deadly. Moss, who is the medical director of the Utah Poison Control Center, cared for one of the first people reported to be sickened in the cluster.

An early case

The person was sickened in Nevada and transferred to a hospital in Utah, where Moss was a member of his care team. After the person came out of intensive care, Moss sat down with him and tried to piece together what happened. According to Moss, the person had bought a Birthday Cake-flavored chocolate bar at a local store. The bars are sold as “microdosing” candies, suggesting they contain psychedelic compounds, but the exact components and dosages aren’t listed.

Though the person told Moss he had some experience with psychedelics before, it was only with actual mushrooms. This was the first time he had eaten such a bar. And the bar’s packaging had only vague instructions of how much to eat at one time to achieve certain effects. For instance, eating nine or more squares of the bar was described with an image of an eye with lots of rainbow colors.

“What does that dose mean? And how many milligrams of what is that? Nobody knows,” Moss said. “So, he decided, ‘It’s a chocolate bar.’ So why wouldn’t you just eat the chocolate bar? Pretty reasonable thing to do.”

But, within minutes of eating the bar, the person felt nauseated and very dizzy and tired. He went to lie down and doesn’t remember much after that. Fortunately, a family member came home soon after and found him. The family member saw that he had vomited and was possibly aspirating or choking. By the time paramedics arrived, he was having a seizure. He had another in the emergency room. Doctors gave him anti-seizure medications and a breathing tube and put him on ventilation before transferring him to the hospital in Utah.

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The nature of consciousness, and how to enjoy it while you can

altered, consciousness, Neuroscience, psychedelics, psychology, Science / /

Remaining aware —

In his new book, Christof Koch views consciousness as a theorist and an aficionado.

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A black background with multicolored swirls filling the shape of a human brain.

Unraveling how consciousness arises out of particular configurations of organic matter is a quest that has absorbed scientists and philosophers for ages. Now, with AI systems behaving in strikingly conscious-looking ways, it is more important than ever to get a handle on who and what is capable of experiencing life on a conscious level. As Christof Koch writes in Then I Am Myself the World, “That you are intimately acquainted with the way life feels is a brute fact about the world that cries out for an explanation.” His explanation—bounded by the limits of current research and framed through Koch’s preferred theory of consciousness—is what he eloquently attempts to deliver.

Koch, a physicist, neuroscientist, and former president of the Allen Institute for Brain Science, has spent his career hunting for the seat of consciousness, scouring the brain for physical footprints of subjective experience. It turns out that the posterior hot zone, a region in the back of the neocortex, is intricately connected to self-awareness and experiences of sound, sight, and touch. Dense networks of neocortical neurons in this area connect in a looped configuration; output signals feedback into input neurons, allowing the posterior hot zone to influence its own behavior. And herein, Koch claims, lies the key to consciousness.

In the hot zone

According to integrated information theory (IIT)—which Koch strongly favors over a multitude of contending theories of consciousness—the Rosetta Stone of subjective experience is the ability of a system to influence itself: to use its past state to affect its present state and its present state to influence its future state.

Billions of neurons exist in the cerebellum, but they are wired “with nonoverlapping inputs and outputs … in a feed-forward manner,” writes Koch. He argues that a structure designed in this way, with limited influence over its own future, is not likely to produce consciousness. Similarly, the prefrontal cortex might allow us to perform complex calculations and exhibit advanced reasoning skills, but such traits do not equate to a capacity to experience life. It is the “reverberatory, self-sustaining excitatory loops prevalent in the neocortex,” Koch tells us, that set the stage for subjective experience to arise.

This declaration matches the experimental evidence Koch presents in Chapter 6: Injuries to the cerebellum do not eliminate a person’s awareness of themselves in relation to the outside world. Consciousness remains, even in a person who can no longer move their body with ease. Yet injuries to the posterior hot zone within the neocortex significantly change a person’s perception of auditory, visual, and tactile information, altering what they subjectively experience and how they describe these experiences to themselves and others.

Does this mean that artificial computer systems, wired appropriately, can be conscious? Not necessarily, Koch says. This might one day be possible with the advent of new technology, but we are not there yet. He writes. “The high connectivity [in a human brain] is very different from that found in the central processing unit of any digital computer, where one transistor typically connects to a handful of other transistors.” For the foreseeable future, AI systems will remain unconscious despite appearances to the contrary.

Koch’s eloquent overview of IIT and the melodic ease of his neuroscientific explanations are undeniably compelling, even for die-hard physicalists who flinch at terms like “self-influence.” His impeccably written descriptions are peppered with references to philosophers, writers, musicians, and psychologists—Albert Camus, Viktor Frankl, Richard Wagner, and Lewis Carroll all make appearances, adding richness and relatability to the narrative. For example, as an introduction to phenomenology—the way an experience feels or appears—he aptly quotes Eminem: “I can’t tell you what it really is, I can only tell you what it feels like.”

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MDMA—aka ecstasy—submitted to FDA as part of PTSD therapy

fda, health, maps, mdma, psychedelics, PTSD, Science, therapy / /

Groovy —

If FDA approved, it would require the DEA to reclassify MDMA.

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Girl with an ecstasy tablet on her tongue.

Enlarge / Girl with an ecstasy tablet on her tongue.

A corporation dedicated to studying the benefits of psychedelic drugs filed an application with the Food and Drug Administration this week for approval to use MDMA—aka ecstasy or molly—in combination with talk therapy to treat post-traumatic stress disorder.

If approved, it would be the first-of-its-kind combination treatment—a psychedelic-assisted therapy. An approval would also require the Drug Enforcement Administration to reclassify MDMA, which is currently in the DEA’s most restricted category, Schedule I, which is defined as drugs “with no currently accepted medical use and a high potential for abuse.” The category also includes LSD, heroin, and marijuana.

The public benefit corporation (PBC) that filed the FDA application was created by MAPS, The Multidisciplinary Association for Psychedelic Studies, which has been supporting this type of work since 1986. The application is based on positive data from two randomized, double-blind, placebo-controlled Phase III studies, which were funded and organized by MAPS and MAPS PBC.

The first study, published in Nature Medicine in 2021, involved a total of 90 participants with moderate PTSD. It found that MDMA-assisted talk therapy (aka psychotherapy) significantly improved Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores compared with participants who were given talk therapy with a placebo. In the second study, published in September in Nature Medicine, the finding held up among 104 participants with moderate or severe PTSD (73 percent had severe PTSD).

In both trials, participants took 80 to 180 mg doses of MDMA or a placebo at the start of three eight-hour sessions, which were spaced around a month apart. Between those experimental treatment sessions, participants also had three 90-minute sessions for participants to process the experimental experience.

MDMA—3,4-methylenedioxymethamphetamine—affects neurotransmitters in the brain, increasing the activity of serotonin, dopamine, and norepinephrine, to be specific. This leads people who take the drug to experience euphoria, hallucinations, sharpened sensory perception, and sociability, but it can also induce confusion, depression, and paranoia. Its use in psychotherapy has been explored for decades.

In a statement this week, MAPS PBC CEO Amy Emerson celebrated the FDA submission. “The filing of our [new drug application] is the culmination of more than 30 years of clinical research, advocacy, collaboration, and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” she said.

MAPS founder and President Rick Doblin also celebrated the submission this week, saying in a statement: “When I started MAPS in 1986, the FDA was still blocking all research with psychedelics. … By breaking that barrier, we have opened doors for others to conduct their own promising research into psychedelic-assisted therapies with psilocybin, ayahuasca, ketamine, and more. The novel approaches undertaken in psychedelic-assisted therapy research have led to fundamental shifts in our understanding of how these devastating mental health conditions can be treated.”

So far, the MDMA-assisted therapy has drawn criticism for its expected inaccessibility. The treatment outlined in the two MDMA trials involves lengthy—and likely pricey—therapy sessions with highly trained therapists. The Washington Post published an estimated price of between $13,000 to $15,000 per treatment round, and it’s unclear for now whether it would be covered by health insurance if approved by the FDA. “Most people in the world won’t be able to afford these clinics,” Allen Frances, a Duke University professor emeritus of psychiatry, told the Post.

Now that the NDA is submitted, the FDA has 60 days to determine whether it will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively), MAPS PBS noted. MAPS is seeking a priority review. In 2017, the FDA granted MDMA “Breakthrough Therapy,” designed to help hasten the development and review of drugs for serious conditions when evidence indicates they may substantially improve upon current therapies.

The only psychedelic with FDA approval to date is esketamine, a variation of ketamine, which was approved in 2019 to treat treatment-resistant depression.

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