It’s possible that I shall make an ass of myself. But in that case one can always get out of it with a little dialectic. I have, of course, so worded my proposition as to be right either way (K.Marx, Letter to F.Engels on the Indian Mutiny)
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.
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.
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.
Thursday, May 23, 2024
Psychedelic drug-induced hyperconnectivity in the brain helps clarify altered subjective experiences
A first of its kind imaging study in Biological Psychiatry: Cognitive Neuroscience and Neuroimaging provides insights into how the brain works on psychedelic drugs and their potential use to treat psychiatric disorders
HEY MAN AM I IN YOUR HEAD OR ARE YOU IN MINE?!
ELSEVIER
IMAGE:
A NEW STUDY FINDS A PATTERN OF PSILOCYBIN-INDUCED DYNAMIC HYPERCONNECTIVITY IN THE BRAIN, WHICH IS LINKED TO OCEANIC BOUNDLESSNESS.
CREDIT: BIOLOGICAL PSYCHIATRY: COGNITIVE NEUROSCIENCE AND NEUROIMAGING
Philadelphia, May 23, 2024 – A new study shows that the use of psilocybin, a compound found in the widely known “magic mushrooms,” initiates a pattern of hyperconnectivity in the brain linked to the ego-modifying effects and feelings of oceanic boundlessness. The findings, appearing in Biological Psychiatry: Cognitive Neuroscience and Neuroimaging, published by Elsevier, help explain the so-called mystical experiences people report during the use of psychedelics and are pertinent to the psychotherapeutic applications of psychedelic drugs to treat psychiatric disorders such as depression.
The concept of oceanic boundlessness refers to a sense of unity, blissfulness, insightfulness, and spiritual experience often associated with psychedelic sessions.
In one of the first brain imaging studies in psychedelic research, investigators found a specific association between the experiential, psychedelic state and whole-brain dynamic connectivity changes. While previous research has shown increases in static global brain connectivity under psychedelics, the current study shows that this state of hyperconnectivity is dynamic (changing over time) and its transition rate coincides with the feeling of oceanic boundlessness, a hallmark dimension of the psychedelic state.
Lead investigator Johannes G. Ramaekers, PhD, Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, says, "Psilocybin has been one of the most studied psychedelics, possibly due to its potential contribution in treating different disorders, such as obsessive-compulsive disorder, death-related anxiety, depression, treatment-resistant depression, major depressive disorder, terminal cancer-associated anxiety, demoralization, smoking, and alcohol and tobacco addiction. What was not fully understood is what brain activity is associated with these profound experiences."
Psilocybin generates profound alterations both at the brain and the experiential level. The brain's tendency to enter a hyperconnected-hyperarousal pattern under psilocybin represents the potential to entertain variant mental perspectives. The findings of the new study illuminate the intricate interplay between brain dynamics and subjective experience under psilocybin, providing insights into the neurophysiology and neuro-experiential qualities of the psychedelic state.
Dr. Ramaekers adds, "Taken together, averaged and dynamic connectivity analyses suggest that psilocybin alters brain function such that the overall neurobiological pattern becomes functionally more connected, more fluid, and less modular."
Previously acquired functional magnetic resonance imaging (fMRI) data were analyzed for two groups of people; one group of 22 individuals received a single dose of psilocybin, the other 27 participants received a placebo. During the drug's peak effects, participants who received psilocybin reported substantial phenomenological changes compared to placebo. Also, brain connectivity analysis showed that a pattern characterized by global region-to-region connectivity was re-appearing across the acquisition time in the psilocybin group, potentially accounting for the variant mental associations that participants experience.
Moreover, this hyperconnected pattern was linked to oceanic boundlessness and unity, which indicates an important mapping between brain dynamics and subjective experience, pointing towards “egotropic effects” (vs hallucinergic) of the drug.
PhD candidate and co-author of the paper Larry Fort, University of Liège, emphasizes: “Psychedelic drugs like psilocybin are often referred to as hallucinogens both scientifically and colloquially. As such, we expected that the hallucinatory dimensions of experience would correlate the highest with psilocybin’s hyperconnected pattern. However, hallucinatory experience had a strong, but weaker correlation with this pattern than ego-modifying experiences. This led us to formulate the term ‘egotropic’ to draw attention to these ego-modifying effects as important, perhaps even more so than their hallucinogenic counterparts.”
Editor-in-Chief of Biological Psychiatry: Cognitive Neuroscience and Neuroimaging Cameron S. Carter, MD, University of California Irvine, comments, “This study uses readily available resting state fMRI images acquired after psilocybin ingestion to provide new insights into the neurophysiological mechanisms underlying the subjective and clinical effects of the drug. It sets the stage for future studies using other psychedelic agents to examine whether the dynamic connectivity effects reflect a general mechanism for the therapeutic effects of these compounds.
Lead investigator Athena Demertzi, PhD, Physiology of Cognition, GIGA-CRC In Vivo Imaging Center, University of Liège, adds, "We were pleasantly surprised to learn that the brain pattern of hyperconnected regions was further characterized by lower global signal amplitude, which works as a proxy to heightened cortical arousal. So far, this is the first time that such approximation of arousal levels using fMRI was attempted in psychedelic research. This might be an important correlation as we move towards a full characterization of brain states under psychedelics."
She concludes, "Given the resurgence in research regarding the psychotherapeutic applications of psychedelic drugs, our results are pertinent to understanding how subjective experience under psychedelics influences beneficial clinical outcomes. Is the effect driven by ego-dissolution? By hallucinations? As such, our work exemplifies how the strong inter-relatedness between egotropic effects of moderate dose psilocybin and its hyperconnected brain pattern can inform clinical focus on specific aspects of phenomenology, such as ego-dissolutions. With this information, healthcare professionals may learn how to best engineer psychedelic therapy sessions to produce the best clinical outcomes."
JOURNAL
Biological Psychiatry Cognitive Neuroscience and Neuroimaging
Dynamic Functional Hyperconnectivity after Psilocybin Intake Is Primarily Associated with Oceanic Boundlessness
ARTICLE PUBLICATION DATE
6-Apr-2024
COI STATEMENT
The authors’ affiliations and disclosures of financial and conflicts of interests are available in the article. Cameron S. Carter, MD, is Chair of the Department of Psychiatry & Human Behavior at the University of California, Irvine School of Medicine. His disclosures of financial and conflicts of interests are available at http://www.biologicalpsychiatrycnni.org/bpsc-editorial-disclosures.
Friday, May 10, 2024
FunGuyz mushroom dispensary in Chatham-Kent raided days after opening
CBC Thu, May 9, 2024 Chatham-Kent police say they seized more than $20,000 worth of product after executing a search warrant at a storefront on King Street West in Chatham, Ont., on Wednesday. (Chatham-Kent Police Service - image credit)
Chatham-Kent police have raided a FunGuyz psilocybin mushroom store that opened on King Street West in Chatham, Ont., a few days prior.
Officers who had a warrant to search the property seized more than 370 packages of psilocybin, worth over $20,000, police said in a media release on Thursday.
No arrests have been made at this point.
The raid took place on Wednesday. Police said the business opened four days before that. The location is less than a kilometre away from the police station.
"The Chatham-Kent Police and our community remain committed to actively combatting unlawful businesses," the police service said. "It is important to note that the possession, sale, and production of magic mushrooms, psilocybin, and psilocin are illegal." FunGuyz is a magic mushroom dispensary that opened on Ouellette Avenue in Windsor's downtown. It's one of a few chains that have popped up across Ontario.
FunGuyz has a magic mushroom dispensary on Ouellette Avenue in Windsor's downtown. (Lamia Abozaid/CBC)
Despite operating illegally, FunGuyz has a growing list of stores, largely in Ontario. There are 23 locations listed on the FunGuyz website, which does not yet mention the Chatham store.
The downtown Windsor's location has been raided by police multiple times since it opened last summer.
Spokespeople for the business have previously told CBC News that they are fighting for legalization and will reopen locations that get raided.
"We're not out here selling to kids, you know, we're not bothering anyone, we open up doors... to the public. That's all," said one spokesperson who gave the name Edgars Gorbans in a July 2023 interview.
Gorbans later admitted he gave CBC News a fake name.
Wednesday, April 24, 2024
Side effects of 'magic mushrooms' similar to regular antidepressants
By Ernie Mundell, HealthDay News People in a new study who took psilocybin often experienced headache, nausea, anxiety, dizziness and elevated blood pressure -- side effects similar to those seen with regular antidepressants. Photo by Adobe Stock/HealthDay News
Many people with tough-to-treat depression may be trying psilocybin, the active ingredient in magic mushrooms, as an alternative to antidepressants.
Thinking that it's a "natural" drug, folks might assume it comes without side effects.
That assumption would be wrong.
People in a new study who took psilocybin often experienced headache, nausea, anxiety, dizziness and elevated blood pressure -- side effects similar to those seen with regular antidepressants, according to a team from the University of Georgia in Athens (UGA).
The good news: Such side effects were only temporary. It's less clear if longer-term side effects might emerge with time, the researchers noted.
The short-term side effects "are what we may expect from your traditional antidepressants because those medications work in a similar fashion to psilocybin. They both target serotonin receptors," explained senior study author Dr. Joshua Caballero, an associate professor in UGA's College of Pharmacy.
"It's very encouraging," he added in a university news release, "because the studies we examined consist of just one or two doses per patient, and we're finding that the beneficial effects of psilocybin may stay for months when treating depression."
Psilocybin was shunned by the medical community for decades because, at higher doses, it can have hallucinatory properties. But used under the guidance and supervision of a therapist, the drug is having a comeback as a new form of antidepressant.
But what about any side effects?
To answer that question, Caballero's group looked at data from six different studies on the supervised use of single doses of psilocybin against depression. The studies included a total of 528 people.
They found a number of side effects, among which nausea, dizziness and elevated blood pressure were most common. These effects appeared to dissipate within 48 hours.
Importantly, "psilocybin use was not associated with risk of paranoia and transient thought disorder," the researchers said.
The findings were published recently in the journal JAMA Network Open.
"At some point, I do think that psilocybin will become a treatment option, and when it does, we need to know what the side effects and potential long-term complications are," Caballero said.
Always use the drug under the supervision of a trusted therapist, he said. One recent study found this was key to successful treatment.
"I would urge caution for people that are thinking this is a magic cure and then go out and take excess mushrooms," Caballero said. "Without proper monitoring, you won't know the concentration of psilocybin in those mushrooms and you could have a bad trip or other negative outcome."
The researchers added that the longer-term effects, if any, of psilocybin therapy are unknown.
"There is still a lot we don't know about the potential long-term side effects and more serious rare side effects of psilocybin use," Caballero said. He noted that standard antidepressants already carry a boxed warning from the U.S. Food and Drug Administration regarding the potential for an increased risk of suicidal thoughts and suicide in young adults.
Could psilocybin use have a similar risk? It's just not clear yet, Cabellero and colleagues said.
Still, the overall news is good for folks battling tough depression.
"If we can safely use this drug in a controlled environment, I think it could be groundbreaking for a lot of patients that need it," Caballero said.
COLUMBUS, Ohio – Drug effects have dominated the national conversation about psychedelics for medical treatment, but a new study suggests that when it comes to reducing depression with psychedelic-assisted therapy, what matters most is a strong relationship between the therapist and study participant.
Researchers analyzed data from a 2021 clinical trial that found psilocybin (magic mushrooms) combined with psychotherapy in adults was effective at treating major depressive disorder.
Data included depression outcomes and participant reports about their experiences with the drugs and their connection with therapists. Results showed that the stronger the relationship between a participant and clinician – called a therapeutic alliance – the lower the depression scores were one year later.
“What persisted the most was the connection between the therapeutic alliance and long-term outcomes, which indicates the importance of a strong relationship,” said lead author Adam Levin, a psychiatry and behavioral health resident in The Ohio State University College of Medicine.
Past research has consistently found that as mental health treatments changed, a trusting relationship between clients and clinicians has remained key to better outcomes, said senior author Alan Davis, associate professor and director of the Center for Psychedelic Drug Research and Education in The Ohio State University College of Social Work.
“This concept is not novel. What is novel is that very few people have explored this concept as part of psychedelic-assisted therapy,” Davis said. “This data suggests that psychedelic-assisted therapy relies heavily on the therapeutic alliance, just like any other treatment.”
The study was published recently in the journal PLOS ONE.
Twenty-four adults who participated in the trial received two doses of psilocybin and 11 hours of psychotherapy. Participants completed the therapeutic alliance questionnaire, assessing the strength of the therapist-participant relationship, three times: after eight hours of preparation therapy and one week after each psilocybin treatment.
Participants also completed questionnaires about any mystical and psychologically insightful experiences they had during the drug treatment sessions. Their depression symptoms were assessed one week, four weeks, and up to one year after the trial’s end.
The analysis showed that the overall alliance score increased over time and revealed a correlation between a higher alliance score and more acute mystical and/or psychologically insightful experiences from the drug treatment. Acute effects were linked to lower depression at the four-week point after treatment, but were not associated with better depression outcomes a year after the trial.
“The mystical experience, which is something that is most often reported as related to outcome, was not related to the depression scores at 12 months,” Davis said. “We’re not saying this means acute effects aren’t important – psychological insight was still predictive of improvement in the long term. But this does start to situate the importance and meaning of the therapeutic alliance alongside these more well-established effects that people talk about.”
That said, the analysis showed that a stronger relationship during the final therapy preparation session predicted a more mystical and psychologically insightful experience – which in turn was linked to further strengthening the therapeutic alliance.
“That’s why I think the relationship has been shown to be impactful in this analysis – because, really, the whole intervention is designed for us to establish the trust and rapport that’s needed for someone to go into an alternative consciousness safely,” Davis said.
Considering that psychedelics carry a stigma as Schedule I drugs under the Controlled Substances Act, efforts to minimize negative experiences in future studies of their therapeutic potential should be paramount – and therapy is critical to creating a supportive environment for patients, the authors said.
This study ideally will help clearly position psychedelics treatment as a psychotherapeutic intervention moving forward – rather than its primary purpose being administration of a drug, Levin said.
“This isn’t a case where we should try to fit psychedelics into the existing psychiatric paradigm – I think the paradigm should expand to include what we’re learning from psychedelics,” Levin said. “Our concern is that any effort to minimize therapeutic support could lead to safety concerns or adverse events. And what we showed in this study is evidence for the importance of the alliance in not just preventing those types of events, but also in optimizing therapeutic outcomes.”
This work was supported by the Center for Psychedelic and Consciousness Research, funded by the Steven & Alexandra Cohen Foundation, the RiverStyx Foundation and private donors. It was also supported by the Center for Psychedelic Drug Research and Education (CPDRE), funded by anonymous donors.
Additional co-authors are Rafaelle Lancelotta, Nathan Sepeda and Theodore Wagener of Ohio State, and Natalie Gukasyan, Sandeep Nayak, Frederick Barrett and Roland Griffiths of the Center for Psychedelic and Consciousness Research at Johns Hopkins University, where Davis is an affiliate.
The therapeutic alliance between study participants and intervention facilitators is associated with acute effects and clinical outcomes in a psilocybin-assisted therapy trial for major depressive disorder
Sunday, March 10, 2024
Harnessing the mechanisms of fungal bioluminescence to confer autonomous luminescence in plants and animal cells
Many tropical mushroom species glow in the dark. When scientists discovered the mechanism of luminescence, they found similarity to healthy plant metabolism. New research reveals plants might possess the native capability to emit light themselves
In a striking new study published today in Science Advances, a team of synthetic biologists led by Karen Sarkisyan at the MRC Laboratory of Medical Sciences, have reported the discovery of multiple plant enzymes – hispidin synthases – that can perform the most complex reaction of the bioluminescence pathway. This discovery is a significant milestone towards figuring out whether plants can natively produce all the molecules required for light emission. It also means that the glow of bioluminescent plants can now be more closely aligned with their internal biology.
The technology reported in the paper is a hybrid pathway that couples the newly found plant hispidin synthases to other necessary bioluminescence enzymes found in mushrooms. This hybrid pathway allows the subtle inner rhythms and dynamics within plants to be unveiled as an ever-changing display of living light. “This technology is a plug-and-play tool to visualise virtually any molecular physiology at the organismal level, completely non-invasively” Sarkisyan states. His work also revealed that not only does a single indigenous plant gene effectively substitute for two fungal genes, the plant gene is notably smaller and has simpler biological requirements for luminescence. The gene's reduced size also enhances its usability and flexibility, making it more adaptable for extended applications.
This research was sponsored by Light Bio, a plant synthetic biology company co-founded by Sarkisyan, which aims to transform the horticulture industry with beautiful biotech creations, such as glowing plants. The first product to exploit the hispidin-based pathway is Firefly Petunia, so named because its bright light-emitting flower buds resemble fireflies.
Beyond the advances in aesthetics that luminous vegetation may provide to plant-lovers, the foundational science offers profound insights into plant molecular physiology. By enabling continuous monitoring of plant responses to various stresses, such as drought stress or attacks by pests, the technology may lead to significant progress in fields such as crop development and disease resistance.
Sarkysian’s bioluminescence pathway has been replicated in other species including yeast and even in human cells. “We love growing our bioluminescent petunias, they are truly magical. But beyond aesthetics, understanding how we can adapt self-sustained luminescence to monitor disease progression and assist in the screening of drug candidates will make this technology even more impactful”, says Sarkysian.
MRC Laboratory of Medical Sciences synthetic biologist Karen Sarkysian observes his glowing plants which could one day be used to signal health or disease.
By exploiting the hispidin synthase pathway in plants, MRC Laboratory of Medical Sciences scientists have created Chrysanthemums that glow in the dark.
By exploiting an enzyme pathway found in bioluminescent fungi, MRC-LMS scientist Karen Sarkysian has created glow in the dark Firefly Petunias™️ with biotech company LightBio
This timelapse film shows the growth and movement of different plants that have been bioengineered by MRC LMS scientist Karen Sarkysian to glow in the dark sustainably without the need for chemicals or UV light.
This study was partially funded by Light Bio and Planta. The Synthetic biology Group is funded by the MRC London Institute of Medical Sciences (UKRI MC-A658-5QEA0). Cloning and luminescent assays performed in BY-2 were partially supported by RSF, project number 22-14-00400, https://rscf.ru/project/22-14-00400/. Plant transformations were funded by RFBR and MOST, project number 21-54-52004. Plant imaging experiments were funded by RSF, project number 22-74-00124, https://rscf.ru/project/22-74-00124/. Viral delivery experiments were funded by the grant PID2019-108203RB-I00 Plan Nacional I+D from the Ministerio de Ciencia e Innovación (Spain) through the Agencia Estatal de Investigación (co-financed by the European Regional Development Fund).
Glowing flowers illuminate homes and gardens with organic light
THE FIREFLY PETUNIA EMITS A CONTINUOUS GLOW SIMILAR TO MOONLIGHT. ITS ENCHANTING LIGHT IS PRODUCED BY GENES ISOLATED FROM BIOLUMINESCENT MUSHROOMS. THE PETUNIA HAS PROVEN TO BE HUGELY POPULAR, OFFERING A NATURAL SOURCE OF ILLUMINATION FOR HOMES, GARDENS, AND BEYOND.
Sun Valley, ID - March 8, 2024 – Recent discoveries published in Science Advances have unveiled a native plant gene that enables researchers to more effortlessly harness the captivating glow of bioluminescent plants. This gene, which varies across different plant species, allows for the redirection of living energy into organic light. The advancement reveals the intricate inner rhythms and dynamics of plants through continuously evolving luminosity, offering a natural source of illumination for homes, gardens, and beyond.
The study received support from Light Bio, a pioneer in the development of bioluminescent plants. Light Bio is dedicated to fostering greater connection and enjoyment of plants through the enchanting appeal of living light.
The latest research builds upon earlier findings, showing that the natural glow of luminous mushrooms aligns seamlessly with central metabolic processes in plants. Utilizing a gene native to plants further amplifies this bioluminescent harmony, optimizing the interplay between light production and energy utilization.
Prior approaches for creating bioluminescent plants involved incorporating five genes derived from fungi. In the new findings, a solitary gene indigenous to plants can effectively substitute for two of the fungal genes. The plant gene's compact size and simpler biological requirements enhance its versatility for diverse applications.
The compact gene plays a pivotal role, acting as a bridge between plant metabolism and light production. This connection allows the plant’s inner dynamics to be translated into a constantly changing spectacle of natural light.
Bioluminescent plants have garnered immense popularity among the public. Light Bio recently began taking orders for a bioluminescent petunia under the brand Firefly™ Petunia, so named because the bright buds resemble fireflies. The petunia emits a soft glow similar to moonlight.
Keith Wood, the CEO of Light Bio, reports that the Firefly Petunia is selling fast. He says that “sales for this remarkable plant have been impressively robust. We've had to ramp up production twice already to keep pace with the demand."
The company selected the petunia as its inaugural offering due to its popularity as an ornamental plant. Light Bio recently announced that their plants glow up to 100 times brighter than previously possible, with the petunia standing out as the most radiant. Known for their ease of cultivation and prolific flowering, petunias make an ideal choice for this innovative enhancement.
In September, following an independent review, the USDA concluded that the Firefly Petunia is safe for cultivation and breeding across the United States. Available for purchase at $29 USD per plant from Light Bio's website (www.light.bio), the petunia is set to start shipping in April to all 48 contiguous US states.
In partnership with Ginkgo Bioworks, Light Bio envisions future plants to be at least ten times brighter, with an expanded range of varieties and colors. Beyond the sheer delight these luminous plants provide, the foundational science offers profound insights into plant molecular physiology. The collaborative teams are confident that discoveries from this research will lead to significant progress in essential fields such as crop development and disease resistance.
For more information on Light Bio and the Firefly Petunia, please visit
Founded in 2019, Light Bio is a pioneering synthetic biology startup focused on cultivating vibrant bioluminescent plants. Through the melding of proprietary technology and advanced genetic engineering, Light Bio is bringing the magic of living light to ornamental horticulture. The company enjoys robust backing from industry leaders such as NFX, Ginkgo Bioworks, and others. To learn more, please visit www.light.bio and follow on X (formerly known as Twitter) @Light_Bio, Instagram @Light.Bio, and LinkedIn.
About Ginkgo Bioworks
Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. For more information, visitginkgobioworks.com andconcentricbyginkgo.com, read ourblog, or follow us on social media channels such as X (formerly known as Twitter) (@Ginkgo and @ConcentricByGBW), Instagram (@GinkgoBioworks and @ConcentricByGinkgo), Threads (@GinkgoBioworks) orLinkedIn.
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This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the capabilities and potential success of the partnership and Ginkgo's cell programming platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) volatility in the price of Ginkgo's securities due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, and changes in laws and regulations affecting Ginkgo's business, (ii) the ability to implement business plans, forecasts, and other expectations, and to identify and realize additional business opportunities, (iii) the risk of downturns in demand for products using synthetic biology, (iv) the uncertainty regarding the demand for passive monitoring programs and biosecurity services, (v) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, (vi) our ability to realize the expected benefits of merger and acquisition transactions, (vii) the outcome of any legal proceedings against Ginkgo, including as a result of recent acquisitions, (viii) our ability to realize the expected benefits from and the success of our Foundry platform programs, (ix) our ability to successfully develop engineered cells, bioprocesses, data packages or other deliverables, and (x) the product development or commercialization success of our customers. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on November 8, 2023 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.
A research team from the University of St Andrews and the University of Cologne has developed a new wireless light source that might one day make it possible to 'illuminate' the human body from the inside. Such light sources could enable novel, minimally invasive means to treat and better understand diseases that today require the implantation of bulky devices. The study was published under the title ‘Wireless Magnetoelectrically Powered Organic Light-Emitting Diodes’ in Science Advances.
The new approach presented by the scientists from Germany and Scotland is based on the integration of organic light-emitting diodes (OLEDs) on ‘acoustic antennas’. Acoustic antennas are currently being explored for various applications such as the detection of low magnetic fields. As a major advantage over electric antennas, acoustic antennas can be designed to be much smaller. OLEDs are commonly found in modern smartphones and high-end televisions and consist of thin layers of organic materials that can be applied to almost any surface. In their work, the researchers exploit this property to deposit OLEDs directly onto the acoustic antenna, thus merging the unique properties of both platforms into a single extremely compact device. In this way, the acoustic antennas serve as substrate and power source for the custom-developed OLED. They convert energy from a magnetic field into a mechanical oscillation and subsequently into an electric current by means of an effect known as the composite magnetoelectric effect.
The new devices operate at sub-megahertz frequencies, a frequency range used for example for submarine communication, as electromagnetic fields at this frequency are only weakly absorbed by water. However, unlike in submarines, the intended application in biomedicine requires a small device in order to avoid a negative impact on the tissue.
In recent years, optical stimulation techniques have emerged as a promising alternative to electrical stimulation because they can be more cell selective and even enable the stimulation of individual cells. Such techniques have already shown promising results in early clinical trials, for instance, to treat an otherwise untreatable eye disease.
“Our novel wireless light source combines minimal device size, low operation frequency and optical stimulation,” said Humboldt Professor Dr Malte Gather, head of the Humboldt Centre for Nano- and Biophotonics at the Department of Chemistry of the University of Cologne’s Faculty of Mathematics and Natural Sciences. “Many emerging applications require multiple sites to be stimulated independently, which is why modern brain stimulators often incorporate a large number of electrodes. In the case of our wireless light sources, the devices can be independently controlled and operated without the need of additional and potentially bulky electronics.”
This is possible because the operation frequencies of different acoustic antennas can be tuned to different values. In the future, this could allow for the individual control of multiple stimulators in different parts of the body, for example to treat tremor in the late stages of Parkinson's disease. As a next step, the researchers aim to further reduce the size of their wireless OLEDs and to test their technology in an animal model.
