Monday, June 10, 2024

Multicenter clinical study supports safety of deep general anesthesia

Minimizing anesthesia during surgery for older adults does not prevent post-op delirium

WASHINGTON UNIVERSITY SCHOOL OF MEDICINE

Multicenter clinical study supports safety of deep general anesthesia — IMAGE:
MICHAEL S. AVIDAN, MBBCH (RIGHT), ADMINISTERS ANESTHESIA DURING A SURGERY. HE MONITORS THE ELECTRICAL ACTIVITY OF THE PATIENT'S BRAIN WITH CHIEF ANESTHESIOLOGY RESIDENT KARAM ATLI, MD, TO GUIDE ANESTHESIA DOSAGE AND ENSURE THE PATIENT DOES NOT EXPERIENCE UNINTENDED WAKING DURING SURGERY. NEW RESEARCH FROM WASHINGTON UNIVERSITY SCHOOL OF MEDICINE IN ST. LOUIS AND OTHER INSTITUTIONS SUPPORTS EARLIER FINDINGS THAT INDICATE THAT ANESTHESIA IS NO MORE HAZARDOUS FOR THE BRAIN AT HIGHER DOSES THAN AT LOWER DOSES.
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CREDIT: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE

General anesthesia makes it possible for millions of patients each year to undergo lifesaving surgeries while unconscious and free of pain. But the 176-year-old medical staple uses powerful drugs that have stoked fears of adverse effects on the brain — particularly if used in high doses.

New findings published June 10 in the Journal of the American Medical Association (JAMA), however, support an earlier study that indicates that anesthesia is no more hazardous for the brain at higher doses than at lower doses, according to the researchers.

The new study reports results of a multicenter clinical trial of more than 1,000 older patients who underwent cardiac surgery at four hospitals in Canada. Researchers at these hospitals, in partnership with colleagues at Washington University School of Medicine in St. Louis, found that the amount of anesthesia used during surgery did not affect the risk of postoperative delirium — a state that may contribute to long-term cognitive decline.

“Concern that general anesthesia harms the brain and causes both early and lasting postoperative cognitive disorders is a major reason that older adults avoid or delay life-enhancing procedures,” said Michael S. Avidan, MBBCh, the Dr. Seymour and Rose T. Brown Professor of Anesthesiology and head of the Department of Anesthesiology at Washington University. “Our new study contributes to other compelling evidence that higher doses of general anesthesia are not toxic to the brain. Dispelling the misleading and pervasive message that general anesthesia causes cognitive disorders will have major public health implications by helping older adults make wise choices regarding essential surgeries, which will promote and sustain healthier lives.”

The dose of administered anesthesia historically has been a carefully calculated balance between too little and too much. Administering an inadequate amount puts patients at risk of experiencing intraoperative awareness. Despite advances in anesthesia care, about 1 in 1,000 people still experience unintended waking during surgery without being able to move or indicate their pain or distress. This can lead to suffering and lifelong emotional trauma.

“The good news is that the distressing complication of intraoperative awareness can be more reliably prevented,” said Avidan, the study’s senior author. “Anesthesia clinicians can now confidently administer a sufficient dose of general anesthesia, providing a margin of safety for unconsciousness, without being concerned that this will put their patients’ brains at risk. The practice of general anesthesia should change based on mounting reassuring evidence.”

Previous smaller studies have suggested that too much anesthesia could be to blame for postoperative delirium, a neurological problem involving confusion, altered attention, paranoia, memory loss, hallucinations and delusions, among other symptoms. A common postoperative complication affecting about 25% of older patients after major surgeries, delirium can be distressing to patients and family members. It is typically temporary but has been linked to longer intensive care and hospital stays, other medical complications, persistent cognitive decline and higher risk of death.

To study the impact of minimizing anesthesia on postoperative delirium, Avidan and colleagues previously conducted a similar clinical study in more than 1,200 older surgical patients at Barnes-Jewish Hospital in St. Louis. The researchers used an electroencephalogram (EEG) to monitor electrical activity in the brains of patients during major surgery and adjusted anesthesia levels to prevent brain activity suppression, considered a sign of excessive anesthesia levels. They found that minimizing anesthesia administration did not prevent postoperative delirium.

To expand upon the results of their single-hospital clinical trial, Avidan collaborated with Alain Deschamps, MD, PhD, a professor of anesthesiology at Universitè de Montreal in Montreal, and a team of Canadian clinical researchers, to conduct the multicenter trial involving patients at four hospitals in Canada — in Montreal, Kingston, Winnipeg and Toronto.

This randomized clinical trial enrolled 1,140 patients undergoing cardiac surgery, high-risk procedures with a high rate of postoperative complications. Roughly half of the patients had their anesthesia adjusted based on electrical activity in the brain, and the other group of patients received the usual care without EEG monitoring. The former group was exposed to almost 20% less anesthesia than the latter group and also had 66% less time with suppressed electrical brain activity, but in both groups, 18% of the patients experienced delirium in the first five days after surgery. Additionally, the length of hospital stays, the incidence of medical complications and the risk of death up to one year postoperatively were no different between patients in the two study groups. However, almost 60% more patients in the group that received less anesthesia had undesirable movements while their surgeons were operating, which could have negatively affected the surgeries.

“The thinking has been that deep general anesthesia excessively suppresses electrical brain activity and causes postoperative delirium,” Avidan said. “Taken together, our two clinical trials, including almost 2,400 high-risk older surgical patients at five hospitals in the United States and Canada, dispel the concern that higher general anesthetic dosing incurs a neurotoxic cost. Delirium is likely to be caused by factors other than general anesthesia, such as the pain and inflammation associated with surgery. Future research should explore other avenues to prevent postoperative delirium. But we can now confidently reassure our patients that they can request and expect to be oblivious, immobile and pain-free during surgical procedures, without worrying about general anesthesia damaging their brains."

JOURNAL

JAMA

DOI

10.1001/jama.2024.8144

METHOD OF RESEARCH

Randomized controlled/clinical trial

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Electroencephalography-Guided Anesthesia and Delirium in Older Adults After Cardiac Surgery: the ENGAGES-Canada Randomized Clinical Trial

ARTICLE PUBLICATION DATE

10-Jun-2024

JAMA NETWORK

Global prevalence of overweight and obesity in children and adolescents

JAMA Pediatrics

About The Study: This study’s findings indicated 1 of 5 children or adolescents experienced excess weight and that rates of excess weight varied by regional income and Human Development Index. Excess weight among children and adolescents was associated with a mix of inherent, behavioral, environmental, and sociocultural influences that need the attention and committed intervention of primary care professionals, clinicians, health authorities, and the general public.

Corresponding Author: To contact the corresponding authors, email Kewei Li, Ph.D. (vivian5225133@outlook.com) and Zhihui Li, Ph.D. (rockoliver@vip.sina.com).

To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/

(doi:10.1001/jamapediatrics.2024.1576)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

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Embed this link to provide your readers free access to the full-text article This link will be live at the embargo time https://jamanetwork.com/journals/jamapediatrics/fullarticle/10.1001/jamapediatrics.2024.1576?guestAccessKey=cdd334fe-87b9-482a-a596-5199964b888b&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=061024

Cancer incidence trends in successive social generations in the US

JAMA Network Open

About The Study: In this model-based cohort analysis of incident invasive cancer in the general population, decreases in lung and cervical cancers in Generation X may be offset by gains at other sites. Generation X may be experiencing larger per-capita increases in the incidence of leading cancers than any prior generation born in 1908 through 1964. On current trajectories, cancer incidence could remain high for decades.

Corresponding Author: To contact the corresponding author, Philip S. Rosenberg, Ph.D., email rosenbep@mail.nih.gov.

To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/

(doi:10.1001/jamanetworkopen.2024.15731)

# # #

Embed this link to provide your readers free access to the full-text article This link will be live at the embargo time http://jamanetwork.com/journals/jamanetworkopen/fullarticle/10.1001/jamanetworkopen.2024.15731?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=061024

About JAMA Network Open: JAMA Network Open is an online-only open access general medical journal from the JAMA Network. On weekdays, the journal publishes peer-reviewed clinical research and commentary in more than 40 medical and health subject areas. Every article is free online from the day of publication.

JOURNAL

JAMA Network Open

Elephants have names for each other like people do, new study shows

COLORADO STATE UNIVERSITY

Two juvenile elephants — IMAGE:
TWO JUVENILE ELEPHANTS GREET EACH OTHER IN SAMBURU NATIONAL RESERVE IN KENYA. CREDIT: GEORGE WITTEMYER
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CREDIT: GEORGE WITTEMYER

Colorado State University scientists have called elephants by their names, and the elephants called back.

Wild African elephants address each other with name-like calls, a rare ability among nonhuman animals, according to a new study published in Nature Ecology and Evolution.

Researchers from CSU, Save the Elephants and ElephantVoices used machine learning to confirm that elephant calls contained a name-like component identifying the intended recipient, a behavior they suspected based on observation. When the researchers played back recorded calls, elephants responded affirmatively to calls that were addressed to them by calling back or approaching the speaker. Calls meant for other elephants received less of a reaction.

“Dolphins and parrots call one another by 'name' by imitating the signature call of the addressee,” said lead author Michael Pardo, who conducted the study as an NSF postdoctoral researcher at CSU and Save the Elephants, a research and conservation organization based in Kenya. “By contrast, our data suggest that elephants do not rely on imitation of the receiver's calls to address one another, which is more similar to the way in which human names work.”

The ability to learn to produce new sounds is uncommon among animals but necessary for identifying individuals by name. Arbitrary communication – where a sound represents an idea but does not imitate it – greatly expands communication capability and is considered a next-level cognitive skill.

"If all we could do was make noises that sounded like what we were talking about, it would vastly limit our ability to communicate,” said co-author George Wittemyer, a professor in CSU’s Warner College of Natural Resources and chairman of the scientific board of Save the Elephants.

Wittemyer said that the use of arbitrary vocal labels indicates that elephants may be capable of abstract thought.

What’s in a name?

Elephant and human evolution diverged tens of millions of years ago, but both species are socially complex and highly communicative. Elephants function within family units, social groups and a larger clan structure similar to the complex social networks humans maintain.

Similar needs likely drove development of arbitrary vocal labeling – the naming of other individuals with abstract sounds – in both species, the researchers proposed.

"It's probably a case where we have similar pressures, largely from complex social interactions,” Wittemyer said. “That's one of the exciting things about this study, it gives us some insight into possible drivers of why we evolved these abilities.”

Elephants are talkative, communicating with one another vocally in addition to sight, scent and touch. Their calls convey a lot of information, including the caller’s identity, age, sex, emotional state and behavioral context.

Vocalizations – from trumpeting to low rumbling of their vocal cords – span a broad frequency spectrum, including infrasonic sounds below the audible range of the human ear. Elephants can coordinate group movements over long distances using these calls.

Kurt Fristrup, a research scientist in CSU’s Walter Scott, Jr. College of Engineering, developed a novel signal processing technique to detect subtle differences in call structure, and Fristrup and Pardo trained a machine-learning model to correctly identify which elephant a call was addressed to based only on its acoustic features.

“Our finding that elephants are not simply mimicking the sound associated with the individual they are calling was the most intriguing,” Fristrup said. “The capacity to utilize arbitrary sonic labels for other individuals suggests that other kinds of labels or descriptors may exist in elephant calls.”

Eavesdropping on elephants

Elephants are expressive animals, Wittemyer said, and their reactions are easy to read to those familiar with them. When the researchers played back samples, the elephants responded “energetically” and positively to recordings of their friends and family members calling to them but did not react enthusiastically or move toward calls directed to others, demonstrating that they recognized their names.

How did the elephants react when they discovered they’d been prank called?

“They were probably temporarily confused by the playback but eventually just dismissed it as a strange event and went on with their lives,” said Pardo, now at Cornell University.

The study also found that elephants, like people, don’t always address each other by name in conversation. Calling an individual by name was more common over long distances or when adults were talking to calves.

Research spanned four years and included 14 months of intensive fieldwork in Kenya, following elephants in a vehicle and recording their vocalizations. About 470 distinct calls were captured from 101 unique callers corresponding with 117 unique receivers in Samburu National Reserve and Amboseli National Park.

Could we someday talk with elephants?

The scientists said much more data is needed to isolate the names within the calls and determine whether elephants name other things they interact with, like food, water and places.

"Unfortunately, we can't have them speak into microphones," Wittemyer said, noting the barriers to collecting sufficient data.

New insights into elephant cognition and communication revealed by the study strengthen the case for their conservation, the researchers said. Elephants are classified as endangered, due to poaching for their ivory tusks and habitat loss from development. Because of their size, they need a lot of space and can be destructive to property and hazardous to people.

While conversing with pachyderms remains a distant dream, Wittemyer said that being able to communicate with them could be a gamechanger for their protection.

"It's tough to live with elephants, when you're trying to share a landscape and they're eating crops," Wittemyer said. “I'd like to be able to warn them, ‘Do not come here. You're going to be killed if you come here.’”

As several families cross the Ewaso Ngiro River, a female elephant responds to her calf’s distress call.

An elephant family forages together during the rainy season. Credit: George Wittemyer

An elephant family comforts their calf during an afternoon nap under a tree in Samburu National Reserve, Kenya. Credit: George Wittemyer

A mother elephant leads her calf away from danger in northern Kenya. Credit: George Wittemyer

JOURNAL

Nature Ecology & Evolution

DOI

10.1038/s41559-024-02420-w

METHOD OF RESEARCH

Experimental study

SUBJECT OF RESEARCH

Animals

ARTICLE TITLE

African elephants address one another with individually specific name-like calls

ARTICLE PUBLICATION DATE

10-Jun-2024

When is genome sequencing advisable?

UNIVERSITÄT LEIPZIG

Genetic mutations in human DNA can prevent proteins that perform important functions in the body from being formed correctly. This can lead to serious disorders that cause disease or even disability. Many of these diseases are already known and can be attributed to specific genes. To diagnose them, clinicians use a standard procedure known as exome sequencing. This involves analysing those segments of human DNA that are directly responsible for the correct formation of proteins. This coding part, the exome, makes up only around 1 per cent of the total DNA, but is particularly relevant.

“However, in two-thirds of cases, exome analysis does not lead to a diagnosis, which raises the question of what to do next,” says Professor Rami Abou Jamra. He is Professor of Medical Genomics at Leipzig University and Head of Genetic Diagnostics at the Institute of Human Genetics at the University of Leipzig Medical Center (UKL). “For patients and their families, a clear diagnosis means a great deal: not only does it confirm that the disease is not their own fault – it also paves the way for public recognition and, where possible, personalised treatment,” says the doctor.

In order to assess the benefits of genome sequencing compared to exome sequencing, scientists from the Broad Institute of MIT and Harvard and Harvard Medical School in Boston analysed 744 families. These were sick children with a suspected genetic disease, and their parents. In some of whom exome sequencing was already performed and failed to provide a diagnosis. The Institute of Human Genetics in Leipzig used genome sequencing to analyse 350 families in an independent patient cohort where exome sequencing had not shed any light. The first 78 cases were included in the joint study with the researchers in Boston.

Using a technique called short-read sequencing, the entire DNA, i.e. the genome, of all the families was cut into billions of small pieces and read. The researchers analysed the data using bioinformatics software and algorithms.

“Compared to exome sequencing, genome sequencing provided clarity in an additional 8% of cases: that is significantly more,” explains Professor Rami Abou Jamra, who led the study in Leipzig. “This method is particularly helpful if a genetic mutation that causes a disease is due to the absence of very small segments of DNA, the elongation of unspecific sequences, or if the mutation is not located in the coding part at all,” says the researcher, adding: “In exome sequencing, the coding regions are extracted from the DNA in the laboratory and chemically enriched, which unfortunately leads to a loss of quality and information.” But it is precisely this information that could provide crucial clues. In addition, gene segments outside the exome also have important functions, such as regulating mechanisms that control protein synthesis. These segments are completely overlooked by exome analysis. Ultimately, the researchers hope to identify new disease patterns and mechanisms by taking a comprehensive look at the entire genome.

“Our data suggests that genome sequencing should be used more quickly, especially when exome sequencing has not provided clarity,” says Professor Rami Abou Jamra. “In the past, there was a lack of certainty in the literature as to when genome sequencing was advisable. Now, thanks in part to the work carried out in Leipzig, the large dataset obtained shows that the results are definitely viable for clinical application,” says the scientist.

As Professor Rami Abou Jamra points out, another advantage of genome sequencing, although it is currently still around two and a half times more expensive than exome sequencing, is a long-term one: new genetic mutations associated with diseases are being discovered and documented all over the world, which means that once the genome sequencing data is available, it can easily be re-examined in the light of new knowledge.

And what’s next? “We will read more genomes, and we will do it all with an even more revealing technique called long-read sequencing” says a delighted Professor Abou Jamra. “We want to decode all genetic diseases.”

JOURNAL

New England Journal of Medicine

DOI

10.1056/NEJMoa2314761

METHOD OF RESEARCH

Experimental study

ARTICLE TITLE

Genome Sequencing for Diagnosing Rare Diseases

Researchers use 3D visualization to predict, prevent hurricane damage

Galveston Island was used as an example to predict damage that would occur as a result of hurricanes of varying intensities.

TEXAS A&M UNIVERSITY

Hurricane Ike Damage — IMAGE:
DAMAGE ON GALVESTON ISLAND IN THE WAKE OF HURRICANE IKE.
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CREDIT: TEXAS A&M UNIVERSITY AT GALVESTON

Beginning annually on June 1, hurricane season poses a major threat to Texas coastal communities, causing both physical and financial damage to the areas they hit. This damage can be staggering; when Hurricane Harvey hit in 2017, it cost Galveston $132.73 billion in damages. Texas A&M University researchers have collaborated to understand the impacts of storm surge floods before they occur to potentially reduce the level of damage. Their study was published in “Urban Informatics.”

The researchers have implemented 3D visualization technology to identify the potential outcomes of hurricane flooding before it occurs. According to researchers, severe weather has been increasing over the last several years due to global climate change. If severe storms and flooding continue to increase in the future, implementing 3D visualization based on real-time weather forecasts could result in improved safety and less damage-inflicted costs.

The 3D modeling technique also allows researchers to examine the effects of damage-preventing infrastructure, such as the proposed Galveston “Ike Dike,” a dike designed to shield Galveston Island from future storm surge and flood events.

Using Galveston Island as an example, researchers used 3D visualization to model the damage that would occur to residential buildings as a result of hurricanes of varying intensities. They also modeled damage with preventative infrastructure — the “Ike Dike” — in place.

An advantage of 3D visualization over other damage modeling methods is that it allows researchers to model specific buildings, accounting for basements, back entrances, and windows. By identifying a residential building’s first-floor elevation level, researchers can predict the physical and financial damage that a hurricane will cause to the specific building.

“3D visualization of hurricanes and storm surges allows us to understand how flooding will impact our coastal communities by allowing us to vividly see how each building and road might be impacted by a given flood,” said Dr. Xinyue Ye, the Harold Adams Endowed Professor of Landscape Architecture and Urban Planning and affiliated faculty member in the Department of Computer Science and Engineering, the Department of Multidisciplinary Engineering, the Department of Geography, and the Section of Visual Computing & Interactive Media.

Faculty collaborators on the project include Dr. David Retchless, associate professor in the Department of Marine and Coastal Environmental Science at Texas A&M University at Galveston, Dr. Galen Newman, professor and head of the Department of Landscape Architecture and Urban Planning and the Nicole and Kevin Youngblood Professor of Residential Land Development at Texas A&M, and Dr. Nick Duffield, the Royce E. Wisenbaker Professor I in the Department of Electrical and Computer Engineering and director of the Texas A&M Institute of Data Science.

Critical Information For Homeowners

Since 3D visualization highlights the potential damages hurricane flooding may cause, it can give homeowners a better understanding of what to invest in as far as insurance and preventative infrastructure. This technology also creates an increased community awareness around potential outcomes of hurricanes and flooding.

“Having used Galveston as an example, the next step would be to expand that to other coastal communities in Texas,” Ye noted. “In this study, we mainly used residential houses, but we can expand it to other business properties as well.”

Effective use of 3D models can protect Texas residents. By implementing this technology on other coastal communities or community buildings, such as schools and stores, researchers can help residents and officials create a plan for hurricane season. As real-time weather forecasts are implemented into the models, researchers may be able to determine when evacuation is necessary and use this data to alert residents.

“3D visualization serves as a universal language, bridging diverse disciplines and fostering communication between academia and the general public,” said Ye, who also serves as the director of the Texas A&M Center for Geospatial Sciences, Applications, and Technology and the founding director of Urban AI Lab at the Texas A&M Institute of Data Science.

Duffield adds that this project shows how the work at the intersection between geospatial data science and visualization can raise awareness for individuals, communities and government on the consequences of extreme weather and make informed planning decisions for responses.

This study combines the expertise of researchers in multiple fields, including computer engineering, landscape architecture, urban planning, geography, and marine and coastal environmental science. The positive impacts of this research highlight the importance of collaboration between computational science and domain-specific disciplines.

By Alyssa Schaechinger, Texas A&M University Engineering

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JOURNAL

Urban Informatics

DOI

10.1007/s44212-024-00043-x#Sec12

ARTICLE TITLE

3D visualization of hurricane storm surge impact on urban infrastructure

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.

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JOURNAL

American Journal of Preventive Medicine

DOI

10.1016/j.amepre.2024.05.006

Case studies show how quasi-governmental organizations could strengthen climate adaptation governance

PRINCETON SCHOOL OF PUBLIC AND INTERNATIONAL AFFAIRS

The politicization of climate issues and the unsynchronized efforts of stakeholders are hindering the effectiveness of climate adaptation governance in the U.S. According to a new study(Link is external) published by Princeton researchers, the design characteristics of quasi-governmental organizations (QGOs) could provide insights on how to depoliticize climate information sources and foster multi-level stakeholder coordination.

Quasi-governmental organizations are entities that have a combination of public and private characteristics, utilizing both for-profit and not-for-profit modes of operation. Though these organizations already play a role in overcoming non-climatic governance challenges — e.g. providing apolitical management in municipal utility services, or resolving port development policy conflict between states —there are few studies that look at how the design of quasi-governmental organizations could be used for climatic purposes.

“The literature on quasi-governmental organizations is sparse — we know little about how their design characteristics vary and what this implies for their ability to overcome governance challenges,” explains lead author Paul Nix, a Ph.D. student at Princeton’s School of Public and International Affairs. “Consequently, there is a significant research gap on QGOs that limits our ability to assess the U.S.’ projected institutional capacity to address climate adaptation.”

To close this gap in the literature, Paul Nix(Link is external), Adam Goldstein(Link is external), and Michael Oppenheimer examined six QGO case studies from a variety of fields and with varying organizational structures. Some of the key characteristics they studied for each organization included the structure and operation of their board of directors, board composition (i.e. public vs. private sector members), and the financial resources available to the organization.

“The landscape of institutions in the climate adaptation domain is rich,” says Nix. “Scholars have given much attention to emergent and experimental partnerships of different public and private sector actors, as well as to those actors individually. What makes QGOs unusual is that they sit in the space between the public and private sectors by simultaneously embodying characteristics of both.”

The results suggest that some quasi-governmental organizations are useful for overcoming politicization or for fostering multi-level stakeholder coordination, but none of the organizations examined in this study proved optimal for both at the same time.

For example, the researchers studied the San Francisco Bay Conservation and Development Commision (SFBCDC) and found that its diverse board of public and private actors would be the ideal circumstance for bringing stakeholders together, but it was likely politicized from past conflicts with local and state politicians. The Regents of the University of California (UC) provides a case with the opposite dynamic. The large size of their board and wide range of financial resources make their decision-making process less amenable to the political influence of a single person or organization. However, the UC Regents is not composed of as wide of a variety of decision-makers and stakeholders as the SFBCDC.

“Our data suggests the socio-political context quasi-governmental organizations emerge from bears a mark on how legislators design these organizations,” says Nix. “However, we don’t yet fully understand legislators’ decision-making process with respect to this design, and therefore it’s hard to determine why some of our cases are either better at depoliticizing policy or fostering stakeholder coordination. More research is needed.”

Though more data is needed to fully understand how climate policy decisions would be impacted under quasi-governmental designs, co-author Michael Oppenheimer makes it clear that simply improving upon existing institutions is not likely to solve nuanced and complex climate issues.

“The climate problem and its solutions are so pervasive and complex that we need not merely improved responsiveness from existing institutions,” says Michael Oppenheimer, director of the Center for Policy Research on Energy and the Environment and Albert G. Milbank Professor of Geosciences and International Affairs and the High Meadows Environmental Institute. “Society must innovate by building new institutions like quasi-governmental organizations that can respond more quickly and effectively as new threats from climate change continually emerge over coming decades.”

The paper, “Models of Sub-national U.S. Quasi-Governmental Organizations: Implications for Climate Adaptation Governance,” was co-authored by Paul Nix (School of Public and International Affairs, Princeton University), Adam Goldstein (School of Public and International Affairs and the Department of Sociology, Princeton University), and Michael Oppenheimer (School of Public and International Affairs, Department of Geosciences, and the High Meadows Environmental Institute, Princeton University). The paper appeared in Climatic Change on June 10th, 2024.

JOURNAL

Climatic Change

DOI

10.1007/s10584-024-03728-z

METHOD OF RESEARCH

Case study

SUBJECT OF RESEARCH

Not applicable

ARTICLE TITLE

Models of sub-national U.S. quasi-governmental organizations: implications for climate adaptation governance

ARTICLE PUBLICATION DATE

10-Jun-2024

COI STATEMENT

Michael Oppenheimer is a member of the Editorial Board of Climatic Change. Otherwise, the authors have no relevant financial or non-financial interests to disclose.