Monday, August 29, 2022

Reveal the fate of microplastics in a coastal wastewater treatment plant by the integrated membrane system

Peer-Reviewed Publication

HIGHER EDUCATION PRESS

Reveal the fate of microplastics in a coastal wastewater treatment plant by the integrated membrane system 

IMAGE: NONE view more 

CREDIT: YING CAI, JUN WU, JIAN LU, JIANHUA WANG , CUI ZHANG

Microplastic (defined to be less than 5 nm) is growing environmental pollution problem. The increase of plastics waste from the plastic industry or personal care products could cause the accumulation of microplastics in various ecosystem and environments. Microplastics are ubiquitous and have been detected in more than 2,000 marine organisms. The large amount of chemicals released by microplastics can affect living organisms and threaten their health. In addition, hydrophobic microplastics could adsorb on endocrine disruptors, antibiotics and other organic pollutants in water, which is undoubtedly aggravated the aquatic environment pollution. Therefore, how to prevent microplastics from entering the environment is still a challenge. 

Various studies have shown that waste treatment plant is the most important way for the discharge of various emerging contaminants including microplastics into the environment. Among them, the rapidly growing membrane technology is a prospective treatment method for various pollutants removal in wastewater treatment process. Membrane technology has an excellent removal rate for COD, NH4+-N, bacteria, organic pollutants and antibiotic resistance genes. With the shortage of water resources and water pollution, the integrated membrane system (IMS) technology for reclaimed water reuse has attracted more and more attention. Can the wastewater treatment plant prevent the microplastics from entering the marine environment? And what is the fate of microplastics in the IMS system used for water reclamation?

To answer these questions, Prof. Jian Lu and Dr. Ying Cai from Chinese Academy of Sciences and their team members have worked jointly and investigated systematically the fate of microplastics in conventional activated sludge system (CAS) and IMS system in a coastal reclaimed water plant. Their work identified IMS system could prevent the re-entry of most of the microplastics into the marine environment and convert the wastewater into renewable water, which can subsequently reduce pollution to the ocean and solve the shortage of water resources. This study entitled “Fate of microplastics in a coastal wastewater treatment plant: Microfibers could partially break through the integrated membrane system” is published online in Frontiers of Environmental Science & Engineering in 2022.

In this study, the fate of microplastics in IMS in a coastal reclaimed water plant was investigated. The removal rate of microplastics in the IMS system reached 93.2% after membrane bioreactor (MBR) treatment while that further increased to 98.0% after the reverse osmosis (RO) membrane process. The flux of microplastics in MBR effluent was reduced from 1.5×1013 MPs/d to 10.2 ×1011 MPs/d while that of the RO treatment decreased to 2.7×1011 MPs/d. The application of the IMS system in the reclaimed water plant could prevent most of the microplastics from being discharged into coastal water. These findings suggested that the IMS system was more efficient than CAS in removing of microplastics. However, small scale fiber plastics (< 200 μm) could break through RO system, which is not ignored.

This study investigated comprehensively and systematically the fate of microplastics in traditional water treatment process and in the membrane technology of typical reclaimed water plant in coastal zone. The results show that the removal rate of microplastics by IMS is much higher than that by traditional wastewater treatment process. The introduction of IMS into coastal wastewater treatment plants could prevent the re-entry of most of the microplastics into the marine environment and convert the wastewater into renewable water, which can subsequently reduce pollution to the ocean and solve the shortage of water resources.

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About Higher Education Press

Founded in May 1954, Higher Education Press Limited Company (HEP), affiliated with the Ministry of Education, is one of the earliest institutions committed to educational publishing after the establishment of P. R. China in 1949. After striving for six decades, HEP has developed into a major comprehensive publisher, with products in various forms and at different levels. Both for import and export, HEP has been striving to fill in the gap of domestic and foreign markets and meet the demand of global customers by collaborating with more than 200 partners throughout the world and selling products and services in 32 languages globally. Now, HEP ranks among China's top publishers in terms of copyright export volume and the world's top 50 largest publishing enterprises in terms of comprehensive strength.

The Frontiers Journals series published by HEP includes 28 English academic journals, covering the largest academic fields in China at present. Among the series, 13 have been indexed by SCI, 6 by EI, 2 by MEDLINE, 1 by A&HCI. HEP's academic monographs have won about 300 different kinds of publishing funds and awards both at home and abroad.

About Frontiers of Environmental Science & Engineering

Frontiers of Environmental Science & Engineering (FESE) is the leading edge forum for peer-reviewed original submissions in English on all main branches of environmental disciplines. FESE welcomes original research papers, review articles, short communications, and views & comments. All the papers will be published within 6 months since they are submitted. The Editors-in-Chief are Prof. Jiuhui Qu from Tsinghua University, and Prof. John C. Crittenden from Georgia Institute of Technology, USA. The journal has been indexed by almost all the authoritative databases such as SCI, Ei, INSPEC, SCOPUS, CSCD, etc.

Efficacy, cash and more will increase booster shot acceptance

Peer-Reviewed Publication

CORNELL UNIVERSITY

ITHACA, N.Y. -- The more effective the COVID-19 booster, the more likely people are to get it, according to new Cornell research. And they are more likely to accept the booster shot with cash incentives and if it is made by Moderna or Pfizer.

As the Omicron variant of COVID-19 emerged, Cornell researchers conducted the public opinion survey – thought to be one of the first to assess the factors that affect people’s willingness to receive a vaccine booster.

“We know little about why individuals would receive a booster compared to the initial willingness to vaccinate,” said lead author Shyam Raman, a Ph.D. candidate in the Cornell Jeb E. Brooks School of Public Policy. “Because more variants will likely emerge and fewer than half of all eligible Americans have received even one booster shot, it’s important to understand what goes into that crucial decision.”

The paper, “COVID-19 Booster Uptake among U.S. Adults: Assessing the Impact of Vaccine Attributes, Incentives, and Context in a Choice-Based Experiment” – was published on Aug. 15 in Social Science & Medicine.

The paper was written by Raman and three other Cornell researchers: Douglas Kriner, Clinton Rossiter Professor in American Institutions in the Department of Government in the College of Arts and Sciences (A&S) and a professor in the Brooks School; Nicholas Ziebarth, associate professor in the Department of Economics and in the Brooks School; and Sarah Kreps, John L. Wetherill Professor in the Department of Government (A&S) and a professor in the Brooks School; as well as Kosali Simon of Indiana University.

As of August, the Centers for Disease Control and Prevention estimates just over 48% of fully vaccinated Americans have received a booster. Understanding the basis of attitudes toward boosters is critical to accelerate lagging public health campaigns, according to the researchers.

The researchers conducted a survey of 548 fully vaccinated but not yet boosted participants in December 2021 as the vaccination rate was plateauing, evidence was mounting that initial vaccine immunity was waning, and the new variant – omicron – was emerging amid considerable scientific uncertainty about its scope and lethality.

Against that backdrop, the researchers found:

  • The booster’s efficacy, its manufacturer and cash incentives all contribute to a positive decision. Moderna and Pfizer boosters were more desirable than those manufactured by Johnson & Johnson.
  • Information that the omicron variant may be less lethal but more contagious also upped acceptance.
  • Protection duration and protection against future variants proved to be less persuasive.

Participants in the survey said they would be most swayed by evidence of a booster shot’s effectiveness. If a booster shot were 50% effective, about half the participants would receive it. That climbed to 59% for a 70% effective booster and to 73% for a booster that was 90% effective.

A significant partisan political divide persists in the booster shot decision, the researchers found. When compared to participants identifying as politically independent, Democrats were more willing to receive a booster and Republicans were significantly less willing. Republican participants remain skeptical of vaccination and hesitant about booster shots. The researchers call for continued targeted outreach to that group, they said.

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Spring forward: Changing climate’s early winter wakeup call is a buzz kill for bumblebees

Ottawa Biology study finds climate change is waking bumblebees earlier from winter hibernation, putting the species at risk with impact on human agricultural crops

Peer-Reviewed Publication

UNIVERSITY OF OTTAWA

Spring forward: Changing climate’s early winter wakeup call is a buzz kill for bumblebees 

IMAGE: CONCEPTUAL REPRESENTATION OF HOW CLIMATE CHANGE EFFECTS CAN BE MITIGATED VIA A RANGE SHIFT view more 

CREDIT: BIOLOGICAL CONSERVATION / UNIVERSITY OF OTTAWA

New research from the University of Ottawa has found the earlier arrival of spring in parts of North America negatively impacts bumblebee survival, which could potentially threaten bee-pollinated agricultural crops and other plant sources.

Published in Biological Conservation, this paper is among the first to study climate change’s influence on seasonal weather changes in relation to bumblebees. Researchers from the Faculty of Science found the bees are not correspondingly shifting their activity timing earlier in the year, threatening their ability to find food sources or causing bees to miss out on them altogether.

“This study represents crucial groundwork for understanding that climate can impact the seasonal timing of biological events,” says lead author Olga Koppel, a PhD student in the Faculty of Science’s Department of Biology.

“Bumblebee survival is strongly in our best interest, as we rely heavily on bee-pollinated agricultural crops, including vegetables, fruits, and even clothing fibres such as cotton. The over 40 bumblebee species that are native to North America provide this invaluable economic service.”

Climate change is being linked to global biodiversity decline and its impact on species is a quickly growing field of research. Climate change increases the likelihood of earlier spring onset and flowering in many areas including spring plants, wild plants and trees. These are a necessary food source for winter hibernating bumblebee queens, who search for pollen and nectar after waking up hungry in need of energy.

Being able to match the timing of floral resources gives bumblebee species an edge. Survival, however, for those emerging from hibernation before the arrival of spring flowers – their main food source –is unlikely and leads to smaller colonies with lower odds of persisting in that area the following year. Bumblebees who sync with the changing timing of spring take full advantage of the season’s floral resources and are more likely to persist over time.

Lead authors Koppel and Jeremy Kerr, a Full Professor and Chair in the Department of Biology, examined the relationship between climate and bumblebee spring emergence in a database of specimens from museum collections across North America, comprising 21 species and 17,000 individuals. The authors found climate strongly explained variation in spring emergence timing in 15 of the 21 bumblebee species.

“This research has demonstrated that bumblebee emergence timing can be biased heavily in the direction of climate changes, which has implications for similar research on other species, as well as for the urgent conservation of these valuable pollinator species,” says Koppel. “This study provides a roadmap for evaluating large-scale temporal responses to climate change for many insects and other animals.”

Strong phenological shifts among bumblebee species in North America can help predict extinction risk’ by Olga Koppel and Jeremy Kerr, Department of Biology, Faculty of Science, is published in August’s Biological Conservation. DOI: 10.1016/j.biocon.2022.109675

CAPTION

Climate change climate change is waking bumblebees earlier from winter hibernation, putting the species at risk with impact on human agricultural crops.

CREDIT

Olga Koppel, University of Ottawa

CAPTION

Phenology-Climate Correlation

CREDIT

Biological Conservation / University of Ottawa

There's finally (peer reviewed) chemistry in wine and food pairings (video)

Business Announcement

AMERICAN CHEMICAL SOCIETY

There's finally (peer reviewed) chemistry in wine and food pairings (video) 

IMAGE: RED WINE GOES WITH MEAT; WHITE WINE GOES WITH FISH. PORT GOES WITH STILTON. NEVER DRINK WINE AFTER EATING ARTICHOKES. THESE RULES ABOUT HOW TO PAIR WINE WITH FOOD HAVE SOLID CHEMICAL UNDERPINNINGS — BUT MANY OTHERS DON’T. THE HOLY GRAIL OF FOOD AND WINE PAIRING SCIENCE WOULD BE A FRAMEWORK FOR UNDERSTANDING WHY SOME PAIRINGS WORK AND PREDICTING THE RESULTS OF NEW ONES. FIND OUT HOW CLOSE WE ARE TO DISCOVERING THAT FRAMEWORK AND LEARN ABOUT SOME HIGHLY UNEXPECTED PAIRINGS (COFFEE, CHOCOLATE AND … GARLIC!?): HTTPS://YOUTU.BE/PITGSXIDFXS. view more 

CREDIT: THE AMERICAN CHEMICAL SOCIETY

WASHINGTON, Aug. 29, 2022 — Red wine goes with meat; white wine goes with fish. Port goes with Stilton. Never drink wine after eating artichokes. These rules about how to pair wine with food have solid chemical underpinnings — but many others don’t. The holy grail of food and wine pairing science would be a framework for understanding why some pairings work and predicting the results of new ones. Find out how close we are to discovering that framework and learn about some highly unexpected pairings (coffee, chocolate and … garlic!?): https://youtu.be/pITgSxidfXs.

Reactions is a video series produced by the American Chemical Society and PBS Digital Studios. Subscribe to Reactions at http://bit.ly/ACSReactions and follow us on Twitter @ACSReactions.

The American Chemical Society (ACS) is a nonprofit organization chartered by the U.S. Congress. ACS’ mission is to advance the broader chemistry enterprise and its practitioners for the benefit of Earth and all its people. The Society is a global leader in promoting excellence in science education and providing access to chemistry-related information and research through its multiple research solutions, peer-reviewed journals, scientific conferences, eBooks and weekly news periodical Chemical & Engineering News. ACS journals are among the most cited, most trusted and most read within the scientific literature; however, ACS itself does not conduct chemical research. As a leader in scientific information solutions, its CAS division partners with global innovators to accelerate breakthroughs by curating, connecting and analyzing the world’s scientific knowledge. ACS’ main offices are in Washington, D.C., and Columbus, Ohio.

A new type of defibrillator met safety, effectiveness goals in global clinical study

Peer-Reviewed Publication

MAYO CLINIC

 A new type of extravascular implantable cardioverter-defibrillator (ICD) using a lead (thin wire) placed behind the sternum met safety and effectiveness goals for participants in a premarket global clinical study. The device effectively terminated acute and chronic life-threatening ventricular arrhythmias. The findings were presented during a late-breaking session at the European Society of Cardiology Congress and were simultaneously published in The New England Journal of Medicine.

Arrhythmias such as ventricular fibrillation and ventricular tachycardia happen in the lower heart chambers, or ventricles. They are dangerous because they interfere with the normal coordinated filling and pumping of blood through the heart. These arrhythmias can cause collapse and death if not rapidly treated. The ability of ICDs to accurately detect and terminate ventricular arrhythmias in high-risk patients saves lives.

For study participants, the lead of the extravascular ICD was inserted under the sternum, compared to transvenous ICD leads that are inserted through the veins into the heart, or subcutaneous ICDs that have a lead placed beneath the skin above the sternum. Patients with prior open-heart surgery, or who required pacing for a slow heart rate or had a pacemaker, were not candidates for this study.

This study is encouraging. By placing the lead in this new position behind the sternum, the uncommon but serious risks associated with transvenous ICDs, such as lung collapse, damage to heart valves and heart perforation, can be avoided. Limitations of the subcutaneous ICD are also overcome. Since the lead is behind the sternum and close to the heart, pacing can be delivered, and defibrillation requires less energy with a longer battery life than with the subcutaneous ICD, says Paul Friedman, M.D., a cardiac electrophysiologist, and principal global investigator and first author of the study. Dr. Friedman chairs the Department of Cardiology at Mayo Clinic in Rochester.

The new extravascular ICD delivered anti-tachycardia pacing — rapid pacing — to painlessly terminate 70% of ventricular tachycardia episodes for which it was applied, (which is) at least as good as transvenous ICDs and not available in the subcutaneous ICD," says Dr. Friedman. "The extravascular ICD was also able to provide backup pacing to prevent pauses and was able to effectively defibrillate using a device half the size of the subcutaneous ICD."

Researchers from 17 countries participated in the study. Of the 316 patient participants with an attempted implant, 299 were discharged with a working extravascular ICD system. The defibrillation success rate was 98.7%. At six months, 92.6% of participants had no major system or procedure-related complications.

"It is important to note that electrophysiologists do not routinely place device leads behind the sternum. However, we found that with a robust training program, we could safely do so in the electrophysiology lab. Initial implantations at each site included a cardiologist and a cardiac surgeon. The average procedure time was 74 minutes, similar to that of the early subcutaneous ICD experience," says Yong-Mei Cha, M.D., director of the Implantable Device Lab at Mayo Clinic and site principal investigator of the study.

"While encouraging, these results reflect an early experience, and there is more to be learned with longer follow-up and greater usage," says Dr. Friedman. "The rates of inappropriate shock are higher than with current devices but similar or lower than the early experience with other types of defibrillators, and steps have already been taken to lower it. Additionally, this new device is not for everyone. Patients with previous open-heart surgery were excluded from the study and would not be candidates for this treatment at present."

The study was sponsored by Medtronic Inc., which also developed the device. The extravascular ICD is premarket and has not been approved by the Food and Drug Administration. But it can be available, pending review, through a continued access study.

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

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How the brain’s housekeeper malfunctions during bacterial meningitis

Peer-Reviewed Publication

KAROLINSKA INSTITUTET

Bacterial meningitis is a life-threatening infectious disease of the brain that leaves many survivors with long-lasting neurological impairments. Now, researchers at Karolinska Institutet in Sweden show in a study on rats that the brain’s tool for waste clearance, the glymphatic system, malfunctions during bacterial meningitis, causing a buildup of toxic garbage that damages brain cells. The findings are published in the journal mBio.

“Our study shows that the glymphatic system loses its functionality when an infection occurs in the brain,” says Federico Iovino, associate professor (docent) and group leader at the Department of Neuroscience, Karolinska Institutet and leading author of the study. “Even though we’ve only studied rats so far, we believe it’s possible that the same mechanisms are at play in humans and that the glymphatic system could be a new avenue to explore in the hopes of finding treatments to prevent neurological disabilities caused by bacterial meningitis.”

The glymphatic system was first described in 2013 as a sort of washing-machine that clears waste from the central nervous system, which comprises the brain and the spinal cord. Several neurological diseases, including Alzheimer’s and Parkinson’s disease, have since been associated with its dysfunction.

In this study, the research group of Dr. Federico Iovino and collaborators at the University of Texas Health Science Center at Houston in the U.S. and the University of Southern Santa Catarina in Brazil examined the glymphatic system in rats infected with the bacteria Streptococcus pneumoniae. S. pneumoniae is the leading pathogen causing bacterial meningitis, a potentially deadly infection that in many cases leads to permanent disabilities.

The researchers found higher amounts of bacterial waste products in the brains of rats with meningitis than in a control group. The concentrations were highest in the brain’s cerebrospinal fluid compartments. In contrast, blood tests revealed low levels of bacterial components, indicating the glymphatic system had failed to drain the brain from bacteria and associated rest products. Over time, increased signs of neuroinflammation and neuronal damage were observed, with a corresponding loss of cognitive abilities.

“About half of pneumococcal meningitis survivors suffer from neurological impairments, such as hearing loss, motor and cognitive delay and psychiatric disorders, because of neurons damaged by the infection,” Federico Iovino says. “Since damaged neurons often cannot be repaired or replaced, it is important to find ways to prevent the injury, and the first step in that direction is to understand the molecular mechanisms.”

To further their understanding, the researchers examined brain tissues and cells in detail. They zeroed in on a key fluid transporter, the aquaporin-4 (AQP4)-water channel located at the end-feet of the strings of astrocytes, which are star-shaped cells that act as housekeepers of the glymphatic system.

This water channel normally regulates fluid exchanges between the cerebrospinal fluid compartments and other areas of the brain. But what the researchers found was that during pneumococcal meningitis, the AQP4-water channel lost its natural place and connection with the blood-brain barrier vessel wall. The astrocytic end-feet had detached from the vessel walls after the astrocytes swelled in response to the neuroinflammation caused by the bacterial infection.

“It’s like a snowball effect,” Federico Iovino says. “The infection causes a buildup of toxic bacterial products which activates an immune response that leads to neuroinflammation. The inflammation triggers cellular processes that lead to a detachment of astrocytic end-feet from the blood-brain barrier walls with consequent misplacement and loss of function of the important AQP4-water channel. Combined these events result in a malfunctioning glymphatic system and consequent neuronal damage.”

The study was funded by the Karolinska Institutet Committee for Research, the Karolinska Institutet Research Foundation Grants, the Swedish Research Council, the Bjarne Ahlström Foundation for research in Clinical Neurology, the Clas Groschinsky Foundation, the HKH Crown Princess Lovisa Association for Child Care, the Magnus Bergvall Foundation, the Tore Nilson Foundation, the McGovern Medical School, The University of Texas Health Science Center at Houston, the University of Southern Santa Catarina in Brazil, the Alzheimer's Association and the National Institutes of Health/National Institute on Aging.

Publication: “Dysfunctional glymphatic system with disrupted aquaporin-4 expression pattern on astrocytes causes bacterial product accumulation in the CSF during pneumococcal meningitis.” Jaqueline S. Generoso*, Sigrun Thorsdottir*, Allan Collodel, Diogo Dominguini, Roberta R. E. Santo, Fabricia Petronilho, Tatiana Barichello, Federico Iovino, mBio, online Aug. 29, 2022, doi: 10.1128/mbio.01886-22
* Equal contribution

THIRD WORLD U$A

Older homeless people are at great risk of dying


Peer-Reviewed Publication

UNIVERSITY OF CALIFORNIA - SAN FRANCISCO

Research Describes a “Health Shock” from Losing Housing Later in Life 

A quarter of the participants in a long-term study of older people experiencing homelessness in Oakland died within a few years of being enrolled, UC San Francisco researchers found. 

The study, funded by the National Institute on Aging, recruited people who were 50 and older and homeless, and followed them for a median of 4.5 years. By interviewing people every six months about their health and housing status, researchers were able to examine how things like regaining housing, using drugs, and having various chronic conditions, such as diabetes, affected their risk of dying.  

They found that people who first became homeless at age 50 or later were about 60 percent more likely to die than those who had become homeless earlier in life. But homelessness was a risk for everyone, and those who remained homeless were about 80 percent more likely to die than those who were able to return to housing. 

The median age of death was 64.6 years old, and the most common causes of death for people in the study were heart disease (14.5 percent), cancer (14.5 percent), and drug overdose (12 percent). 

“Becoming homeless late in life is a major shock to the system,” said Margot Kushel, MD, who directs the Benioff Housing and Homelessness Initiative and is a professor of medicine at UCSF and senior author of the study published August 29, 2022 in JAMA Internal Medicine

 “These untimely deaths highlight the critical need to prevent older adults from becoming homeless — and of intervening and rehousing those that do, quickly,” she said.

The study is unique for its prospective design. Previous studies of mortality in homeless populations were retrospective and drew information from medical records. By contrast, the current study — Health Outcomes of People Experiencing Homelessness in Older Middle agE (HOPE HOME) — followed a group of people, whether or not they received health care.

Many study participants had serious conditions that went untreated.

“We looked at how frequently people reported diagnosis of heart disease or cancer before dying of these diseases. It was really low,” said Rebecca Brown, MD, affiliated assistant professor of medicine in the Division of Geriatrics at UCSF. “We think this represents a lack of access to care and delayed diagnosis. Often, we didn’t even know people were ill because they didn’t report it in their six-month interviews. But we found it on their death certificates.”

Researchers went to great lengths to track down what happened to the people in the study when they missed check-ins and couldn’t otherwise be accounted for, including looking at photos of unidentified deaths at the coroner’s office, reviewing California state death records to match their participants’ names and dates of birth, querying emergency contacts, searching social media, and reading online obituaries.

They found that as of Dec. 31, 2021, 117 of the 450 people had died since the study began enrolling in 2013. Nearly 40 percent (45) occurred after the pandemic started in March of 2020, but just three of those deaths were from COVID-19. Participants entered the study in two waves, with 350 enrolled in 2013-14 and another 100 enrolled in 2017-18; 101 of the deaths were from the first wave, and 16 were from the second.

Mortality rates were high compared to the general Oakland population. The risk of dying was 3 times higher for men and 5 times higher for women, compared to people of the same age and sex in Oakland. The median age for participants entering the study was 58, and 80 percent were black; 76 percent were male, and 24 percent were female.

The study also contained detailed information about people’s use of drugs and alcohol, as well as their mental health. But drug and alcohol use itself was not independently associated with death. 

“The streets are just no place to live,” said Johná Wilcoxen, 72, who spent more than a decade living in his car when he lost Section 8 housing because his children moved out. Through his ordeal he continued working as a plumber, which gave him a place to go during the day and money for food. “The more people as we can get off the street, the better,” he said.

Authors: In addition to Kushel and Brown, the study authors include Jennifer L. Evans, MS; Karen Valle, MS; and David Guzman, MSPH, of the Benioff Homelessness and Housing Initiative at UCSF; and Yea-Hung Chen, PhD, of the UCSF Department of Epidemiology and Biostatistics.

Funding: National Institute on Aging at the National Institutes of Health grants R01AG041860 and K24AG046372, and the UCSF Benioff Homelessness and Housing Initiative.

Disclosures: None
 

About UCSF: The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. UCSF Health, which serves as UCSF's primary academic medical center, includes top-ranked specialty hospitals and other clinical programs, and has affiliations throughout the Bay Area. UCSF School of Medicine also has a regional campus in Fresno. Learn more at https://ucsf.edu, or see our Fact Sheet.

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Research reveals widespread use of ineffective COVID-19 treatments after FDA deauthorized their use

Products unlikely to provide benefit given to over 150,000 patients

Peer-Reviewed Publication

BETH ISRAEL DEACONESS MEDICAL CENTER

BOSTON – Monoclonal antibodies are laboratory-designed treatments tailor-made to fight specific infections. In early 2021, the U.S. Food & Drug Administration issued emergency use authorization for two monoclonal antibodies (bamlanivimab/etesevimab and casirivimab/imdevimab) for the treatment of mild to moderate COVID-19 in high-risk, non-hospitalized patients. However, these treatments were shown not to work against the Omicron variant of COVID-19, which emerged in the United States in December 2021 and was responsible for a record-breaking COVID-19 surge in the winter of 2021-22. As a result of the monoclonal antibodies’ reduced efficacy against the variant, the FDA deauthorized their use in early January 2022.                                                                     

In a paper published in JAMA Network Open, physician-scientists at Beth Israel Deaconess Medical Center (BIDMC) assessed the use of these two monoclonal antibodies for patients with COVID-19 before and after FDA deauthorization. The team observed that though overall use of the two monoclonal antibodies declined gradually following deauthorization, a large number of doses were administered to patients well into 2022. Altogether, over 158,000 doses of monoclonal antibodies were administered, providing little to no benefit to patients and potentially contributing millions of dollars in costs. Whether the FDA will take regulatory action against those violating guidance remains unknown at this time. 

“Continued use of these treatments represents low value care and may reflect conflicting state government guidance or a lack of hospital awareness of deauthorization,” said lead author Timothy Anderson, MD, MAS, Lead for Improving Value in Healthcare at Center for Healthcare Delivery Science at BIDMC and assistant professor of medicine at Harvard Medical School. “Though the FDA clearly stated these treatments were no longer authorized for use, the FDA did not fully revoke their emergency use authorizations based on the possibility that they may work to treat future COVID-19 variants. This could have led to confusion and misinterpretation.” 

Anderson and colleagues examined mandatory public reporting by hospitals to the U.S. Department of Health and Human Services from October 2021 to June 2022. They observed that in early 2022, hospitals administered more than 158,000 doses of the deauthorized monoclonal antibody treatments bamlanivimab/etesevimab and casirivimab/imdevimab. The researchers also saw wide variability by state in the treatments’ use following deauthorization.  

While use of the ineffective medications steadily declined after deauthorization, the proportion of COVID-19 cases for which the unauthorized treatments were used did not peak until late March. Moreover, usage following deauthorization varied widely by state, with Florida and New York accounting for 24 percent and 20 percent of monoclonal antibody use in 2022 respectively. Eleven states administered more than half of their remaining supply after deauthorization, while 14 states used less than 10 percent of their remaining supply.  

“We believe these findings are quite surprising and indicate a need for the FDA to investigate the continued use of treatments found to not be effective for COVID-19,” said senior author Jennifer Stevens, MD, director of the Center for Healthcare Delivery Science at BIDMC and associate professor of medicine at Harvard Medical School. “Efforts to improve transparency, equity and value in the COVID-19 response should include public facility-level reporting for all COVID-19 therapies. We hope that our findings will lead to greater attention and more diligent regulation by health care providers and government agencies to prohibit the use of unauthorized treatments.”   

Co-authors included Ashley O’Donoghue, PhD, Oren Mechanic, MD, MPH, and Tenzin Dechen, MPH, of BIDMC. 

This study was funded by an unrestricted philanthropic gift from Google.org.   

Anderson reports receiving grants from the National Institute on Aging, American College of Cardiology and Boston Claude D. Pepper Older Americans Independence Center outside the submitted work, and honoraria from Alosa Health, a nonprofit educational organization with no relationship to any drug or device manufacturers.   

About Beth Israel Deaconess Medical Center  

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. BIDMC is the official hospital of the Boston Red Sox.  

Beth Israel Deaconess Medical Center is a part of Beth Israel Lahey Health, a health care system that brings together academic medical centers and teaching hospitals, community and specialty hospitals, more than 4,800 physicians and 36,000 employees in a shared mission to expand access to great care and advance the science and practice of medicine through groundbreaking research and education.  

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