Investigation raises concerns about poor FDA oversight of clinical trials

Peer-Reviewed Publication

BMJ

Covid-19 vaccines and drugs were developed at “warp speed” and now experts are concerned about the US Food and Drug Administration’s (FDA) inadequate surveillance of clinical trial sites, reports an investigation published by The BMJ today.

Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection prior to licensing its covid-19 mRNA vaccine. Similarly, 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected, writes investigative journalist Maryanne Demasi.  

Notably, the FDA received a complaint from whistle-blower Brook Jackson, about misconduct at three clinical trial sites that were testing Pfizer’s covid-19 vaccine, while she was employed as a regional director. Jackson observed a range of problems including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events. “I thought that the FDA was going to swoop in and take care of everything,” said Jackson. The FDA did not, however, inspect the trial sites in question.

Experts have criticised the FDA’s oversight of clinical trials, describing it as “grossly inadequate.” They say the problem, which predated covid-19, is not limited to a lack of inspections, but also includes failing to proactively notify the public or scientific journals when violations are identified, effectively keeping scientific misconduct from the medical establishment.

The FDA is “endangering public health” by not being candid about violations that are uncovered during clinical trial site inspections, says David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer between 2007 and 2011 and then as a senior advisor to the FDA commissioner in 2019-2021.

The FDA oversees clinical research of FDA-regulated drugs and devices in the US and abroad, if the product is intended for the US market. It conducts routine visits for trials, reviews records of those sites or the institutional review boards (IRBs) that oversee trials locally and follows up on complaints of violations. The FDA does not have a target for the proportion of trial sites it inspects.

Despite the estimated hundreds of thousands of clinical trial sites in operation across the US and abroad, the FDA told The BMJ that it only has 89 inspectors for its bioresearch monitoring programme, which assures the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications, but that it is recruiting more inspectors to reach its yearly average of 100.

“I don’t think that it is a sufficient number of staff to do that kind of level of oversight,” says Jill Fisher, professor of social medicine at the University of North Carolina. “The FDA must have enough of a presence to dissuade investigative sites from committing fraud,” she continues.

Between March and July 2020, at the peak of pandemic restrictions, the FDA paused its site inspections and only “mission critical” inspections were carried out. However, Gortler says this was the precise time that the FDA should have ramped up its oversight, not scaled back, especially since covid-19 products were being developed at warp speed and intended for millions of people.

The FDA told The BMJ it takes oversight of clinical trials seriously and had adapted to travel restrictions, publishing draft guidance for remote regulatory assessments, which describes virtual inspections using live streaming and video conferencing and requests to view records remotely.

The FDA has a long history of failing adequately to oversee clinical trial sites, notes Demasi. For example, a 2007 report by the Department of Health and Human Services’ Office of the Inspector General found the FDA audited less than 1% of the nation’s clinical trial sites between 2000 and 2005 and was highly critical of the agency because it did not have a database of operational clinical trial sites.

In response, the FDA said it created a dedicated task force and “developed new regulations and guidance further to improve the conduct of clinical trials and enhance the protection of people participating in clinical trials,” but denied The BMJ an interview with a member of the task force. 

Further, a 2020 investigation by the journal Science into the FDA’s enforcement of clinical research regulations between 2008 and 2019 concluded that the agency was often light handed, slow moving, and secretive. It said that the FDA rarely levelled sanctions and when it did formally warn researchers about breaking the law, it often neglected to ensure that the problems were remedied.  

Although the FDA publishes its inspection reports, they are not proactively disclosed. Nor does it typically notify journals when a site participating in a published clinical trial receives a serious warning or alert the public about the research misconduct it finds. 

Demasi points to reports of insufficient staff and low morale at the FDA. Fisher says the FDA “needs to be better funded and staffed to conduct inspections. At a minimum, the agency needs to inspect sites when complaints or concerns have been filed.”

Gortler doesn’t agree, however, that the FDA is under-resourced. With a total budget of $6.1bn in 2021, he suggests the agency needs to be leaner and more efficient, with employees interested in improving public health. “Half of its budget, about $3bn, is discretionary, which means it could have hired contractors, retirees, or repurpose existing workers. It chose not to. The FDA was just yawning its way through the pandemic. The entire agency is broken.”

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JOURNAL

The BMJ

DOI

10.1136/bmj.o2628 

METHOD OF RESEARCH

News article

SUBJECT OF RESEARCH

Not applicable

ARTICLE TITLE

Investigation: FDA oversight of clinical trials is “grossly inadequate,” say experts

ARTICLE PUBLICATION DATE

16-Nov-2022

THE LANCET CHILD & ADOL. HEALTH: Study suggests need for improved support for transgender and non-binary young people after hospitalization

Peer-Reviewed Publication

THE LANCET

Peer-reviewed / Observational study / People

• First nationally representative study estimates that, among young people who have been hospitalised in the USA, those with a gender dysphoria diagnosis are four to five times more likely to have been admitted for a suicide attempt or self-harm than those without gender dysphoria.
• The authors call for reducing discrimination towards transgender and non-binary youth, providing them with care that is gender-affirming when they are hospitalised, particularly if admitted for suicide or self-harm, and then linking them to ongoing gender-affirming medical and mental health services.

Among hospitalised young people in the United States, 66% of those with a gender dysphoria diagnosis were admitted for suicide attempts or self-harm in 2019, compared to 5% without gender dysphoria, according to a study published in The Lancet Child & Adolescent Health.

The study looked at over 2 million instances of young people (6 to 20 years old) hospitalised for any reason and determined how many of those hospitalisations were related to suicide or self-harm attempts, for those with and those without a gender dysphoria diagnosis. The authors emphasise that young people who have been hospitalised are likely to be at higher risk of suicidal thoughts and self-harm than young people in general.

Transgender and non-binary young people experience discrimination that has been linked with suicidal thoughts or suicide attempts and self-harm in prior studies surveying outpatient populations, but existing evidence on how many individuals end up hospitalized is limited. This study is the first to use a large nationally representative inpatient database to understand the relationship between gender dysphoria and attempted suicide and self-harm.

Dr Nadir Yehya, of Children’s Hospital of Philadelphia (CHOP), USA, says, “Sadly, our study confirms existing evidence that suicide and self-harm attempts are more common among transgender or non-binary young people. To help this vulnerable group and prevent adverse outcomes, we need to reduce discrimination. As healthcare providers, we have a unique opportunity to do this by providing care that is more gender-affirming to these children when they are hospitalised. This includes addressing patients using their affirmed names and pronouns, linking them to gender-affirming medical care and social support services, and implementing targeted follow-up services for self-harm.” [1]

The study used the nationally representative Kids’ Inpatient Database (KID) in the two most recent available years, 2016 and 2019. It included 80% of all paediatric discharges in the USA, amounting to over 3 million patients in both years. To identify transgender or non-binary youth, the authors searched for any patients who had been diagnosed with gender dysphoria, or any other label that referred to gender dysphoria. Then, they estimated the number of children who had been hospitalised for suicide attempts, self-harm, and a combination of suicide attempts and self-harm, comparing rates in young people with and without gender dysphoria. Additionally, they investigated differences in the prevalence of gender dysphoria according to certain characteristics, including race, type of medical insurance, and the median income in the patient’s area of residence.

Hospitalised young people with gender dysphoria had a higher prevalence of suicide attempts compared to those without gender dysphoria in both 2016 (36% versus 5%) and 2019 (55% versus 4%). Similarly, prevalence of self-harm was higher in hospitalised young people with gender dysphoria in both years (13% versus 1% in 2016 and 15% versus 1% in 2019).

Looking at both combined, hospitalised young people with gender dysphoria were four to five times more likely to experience self-harm or suicide attempts compared to those without gender dysphoria. In 2016, 41% of hospitalised young people with gender dysphoria experienced suicide attempts or self-harm compared to 6% without; in 2019 that rose to 66% versus 5%. See table 1 for numbers of individuals.

Although the overall proportion of young people with gender dysphoria remained low, it increased significantly from 2016 (0.16%) to 2019 (0.48%). The authors say this is likely due to increasing societal understanding and acceptance of diverse gender identities as well as increased access to gender-affirming medical and mental health services.

Young people who were Black, Hispanic or Latinx, or other minority ethnic and racial groups, publicly insured, or from low-income households were less likely to be diagnosed with gender dysphoria. The authors say that this does not necessarily mean that gender dysphoria is less common among these groups. It may reflect inequities in access to gender-affirming care, or heightened discrimination in certain settings, which make young people from economically disadvantaged or racial minority backgrounds less likely to be diagnosed.

Those with a gender dysphoria diagnosis were also less likely to be from the South in the USA or from rural hospitals. The authors say these regional inequities raise concerns about increased levels of discrimination within and outside of healthcare settings in certain locations, which might be preventing young people from self-identifying. It may also mean that healthcare providers in Southern or rural hospitals are less well equipped to provide gender-affirming care. This highlights the impact that regional- and state-level culture and policy can have on determining health outcomes.

The authors note some limitations of their study. It relied on formal diagnoses of gender dysphoria to identify transgender and non-binary youth, which could have biased the estimates in various ways. For example, not all transgender and non-binary young people experience gender dysphoria, which could have led to an underestimation in the size of this group. In addition, some transgender and non-binary youth might not be formally diagnosed with gender dysphoria due to lack of access to a provider who would make the diagnosis. Nonetheless, the authors say this was the most effective way to identify transgender and non-binary youth using this large national dataset and emphasise that their results are consistent with previously reported high rates of suicidal ideation among transgender and non-binary young people.

NOTES TO EDITORS

This study was funded by National Institutes of Health (NIH). It was conducted by researchers from Children's Hospital of Philadelphia, USA.

[1] Quote direct from author and cannot be found in the text of the Article.

The labels have been added to this press release as part of a project run by the Academy of Medical Sciences seeking to improve the communication of evidence. For more information, please see: http://www.sciencemediacentre.org/wp-content/uploads/2018/01/AMS-press-release-labelling-system-GUIDANCE.pdf if you have any questions or feedback, please contact The Lancet press office pressoffice@lancet.com  

If you are reporting on this study, please consider including a link to information and support for your readers. In the USA, the National Suicide Prevention Lifeline can be contacted on 1-800-273-TALK (8255) or visit https://suicidepreventionlifeline.org/. In the UK, the number is 116 123, or email: jo@samaritans.org or visit www.samaritans.org For those outside the USA and UK, there is http://www.befrienders.org/ and https://findahelpline.com/.

IF YOU WISH TO PROVIDE A LINK FOR YOUR READERS, PLEASE USE THE FOLLOWING, WHICH WILL GO LIVE AT THE TIME THE EMBARGO LIFTS: https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00280-2/fulltext

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JOURNAL

The Lancet Child & Adolescent Health

METHOD OF RESEARCH

Observational study

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Prevalence of gender dysphoria and suicidality and self-harm in a national database of paediatric inpatients in the USA: a population-based, serial cross-sectional study

ARTICLE PUBLICATION DATE

16-Nov-2022

COI STATEMENT

NY reports funding from Pfizer, outside of the scope of this manuscript. All other authors declare no competing interests.

Is your child in a center-based day care? Research shows no need for concerns about behavioral issues

Peer-Reviewed Publication

SOCIETY FOR RESEARCH IN CHILD DEVELOPMENT

Previous research indicates that extensive time in early center-based day care is correlated with high levels of behavior problems in young children. However, the validity of this work has been controversial and its relevance outside of the United States has been called into question. New research used longitudinal databases from Germany, Netherlands, Norway, Canada, and the United States to better understand whether time in early center-based child care centers harms children. The study was released in Child Development by researchers at Boston College, the University of Oslo, the University of Minnesota, the German Youth Institute, the German Institute for International Educational Research, the University of North Carolina at Chapel Hill, Utrecht University, the University of Montreal, the University of Bordeaux, and the Norwegian Center for Behavioral Development.

“This is the first study on the topic to bring together analyses of data from multiple countries with diverse sociopolitical contexts, allowing us to address concerns of generalizability and replicability in the literature,” as explained by lead author Catalina Rey-Guerra, Codirector of Fundación Apapacho and Fellow of the Institute of Early Childhood Policy at Boston College. “Testing and research showed almost no evidence that extensive time in early child care centers causes behavior problems in young children. The results are reassuring for parents whose children spend time in center-based care while they are working.” 

Researchers examined whether within-child changes in center-based care predicted changes in externalizing problems, such as arguing, biting, or fighting, in 10,105 toddlers and preschoolers (49% female) across data collected from 1993 to 2012. The data were analyzed across seven studies including Germany, the Netherlands, Norway, two from Canada and two from the United States. The countries vary in their relevant social policies for family leave and public provision and regulation of Early Childhood Education and Care (for example center-based care enrollment and maternity leave varies by country). Race/ethnicity data were only collected in the United States (57% and 80% White; 42% and 13% African American; 1.2% and 5% Latinx).

Information from teacher externalizing problems reports were used when available, otherwise parent reports were drawn on. Teacher and/or parent reports varied across country and included assessments of behaviors such as hits, bites, kicks other children” and “fights more,” “fights or bullies other children” and “can be spiteful to others,” “restless and can’t sit still,” and “child argues a lot.” In most studies, care quantity was measured by the number of hours per week that children attended center-based care excluding any other types of care arrangements (such as home care by a parent, group care by a relative or a nonrelative) reported by the main caregiver (most of the times mothers) at each time point.

Across a variety of statistical tests and across seven datasets from five countries, researchers found almost no evidence that extensive time in early center-based child care causes behavior problems in young children.Additionally, the studies showed no evidence that the association between center-based care and externalizing problems differed as a function of family income or parent education, despite considerable socioeconomic variation in each of the seven samples. 

The authors acknowledge several limitations in their research. The research only examined short-term effects so they are unable to address whether longer term harm from center-based care might emerge. Additionally, the samples in the current study were not nationally-representative, although, they represented different populations across the socioeconomic status distribution. Further research needs to explore whether these results might generalize to children living in sociopolitical contexts that are different from those in high-income countries. Researchers were unable to examine what would have happened if children in the studies were not enrolled in center-based care entered care and those with disadvantaged backgrounds (i.e., unemployed parents, low income, and single-parent households) were over-represented among those who never entered center care. Thus, an added measure of caution is needed when generalizing the current study’s results to these children. 

“Understanding whether time in early child care harms children and how pervasive any such harm may be, is critical for guiding global social and economic policy,” said Rey-Guerra. “Healthy economies depend on parents of young children participating in the workforce in ways that ensure healthy development for their children and the future economy. Considering this, continued research into practices and policies that ensure early child care supports the well-being of children, and families should remain an international priority.”

###

This work was funded by the National Institutes of Health, the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Research Council of Norway, and the European Research Council Consolidator Grant.

Summarized from Child Development, Do More Hours in Center-based Care Cause More Externalizing Problems? A Cross-National Replication Study by Rey-Guerra, C. (Boston College), Zachrisson, H.D. (Boston College and University of Oslo), Dearing, E. (Boston College and University of Oslo), Berry, D. (University of Minnesota), Kuger, S. (German Youth Institute and German Institute for International Educational Research), Burchinal, M.R. (University of North Carolina at Chapel Hill), Nærde, A. (The Norwegian Center for Child Behavioral Development), van Huizen, T. (Utrecht University), and Côté, S. M. (University of Montreal and University of Bordeaux). Copyright 2022 The Society for Research in Child Development, Inc. All rights reserved. 

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JOURNAL

Child Development

DOI

10.1111/cdev.13871 

METHOD OF RESEARCH

Data/statistical analysis

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Do more hours in center-based care cause more externalizing problems? A cross-national replication study

ARTICLE PUBLICATION DATE

17-Nov-2022

The Affordable Care Act linked to reduced smoking among US adults with mental health and substance use disorders

Peer-Reviewed Publication

SOCIETY FOR THE STUDY OF ADDICTION

During the first decade following passage of the Affordable Care Act (enacted March 2010), US adults with mental health and substance use disorders (MH/SUD) experienced significant increases in health insurance coverage. They also showed significant reductions in smoking and increases in recent smoking abstinence.  A new study published by the scientific journal Addiction has found that those two changes -- increased health insurance coverage and improved smoking outcomes – appear to be linked. 

This study, by a team that included researchers at Harvard Medical School/Cambridge Health Alliance, compared smoking and insurance coverage trends among almost 450,000 US adults with and without MH/SUD, using 2008-19 data from the National Survey on Drug Use and Health, an annual, cross-sectional survey. 

The study’s findings are among the first to identify meaningful, population-level reductions in smoking and increases in abstinence among adults with MH/SUD, a group that has maintained significantly higher smoking rates in recent decades despite public health measures and interventions that have driven change in the general adult population. A substantial proportion of the estimated improvements in smoking and abstinence outcome for those with MH/SUD can be explained by increases in health insurance coverage.

Changes in smoking:  From 2008 to 2019, US adults with MH/SUD reduced their smoking and increased their abstinence rates more than those without MH/SUD.* 

Changes in health insurance availability:  People with MH/SUD have historically had more limited access to care.  Health insurance coverage for people with MH/SUD increased after 2014, when ACA provisions expanded the potential pool of individuals able to afford insurance coverage and improved evidence-based treatment options for those with insurance.**

The link between changes in smoking and changes in health insurance availability:  This study found that in 2018-19, 11% of net reductions in current smoking, 12% of net reductions in daily smoking, and 12% of net increases in recent smoking abstinence coincided with greater gains in insurance coverage for adults with MH/SUD compared with adults without MH/SUD.

The study excluded adults who were 65 years or older and most likely to be covered by Medicare (public health insurance covering the elderly) and therefore less subject to most ACA provisions.

* Specifically, current smoking rates of adults with MH/SUD decreased from 37.9% to 27.9% while current smoking rates of adults without MH/SUD decreased from 21.4% to 16.3%, a significant difference in decrease of 4.9%. Daily smoking followed a similar pattern, with a difference in decrease of 3.9%.   Recent smoking abstinence rates for adults with MH/SUD increased from 7.4% to 10.9% while recent smoking abstinence rates for adults without MH/SUD increased from 9.6% to 12.0%, a difference in increase of 1.0%.

** In 2008-09, the prevalence of insurance coverage was 6.2 percentage points lower for adults with MH/SUD (71.9%) than for adults without MH/SUD (78.2%). By 2018-19, that difference had shrunk to 2.0 percentage points.

-- Ends –

For editors:

This paper is free to read for one month after publication from the Wiley Online Library: https://onlinelibrary.wiley.com/doi/10.1111/add.16052 or by contacting Jean O’Reilly, Editorial Manager, Addiction, jean@addictionjournal.org.

To speak with co-author Benjamin Cook, please contact him at Cambridge Health Alliance/Harvard Medical School by email (bcook@cha.harvard.edu) or telephone (+1 617 806 8741).

Full citation for article: Creedon TB, Wayne GF, Progovac AM, Levy DE, Lê Cook B. Trends in cigarette use and health insurance coverage among US adults with mental health and substance use disorders. Addiction. 2022. https://doi.org/10.1111/add.16052

Funding: This project was supported by the National Cancer Institute (R01CA229355-03).

Declaration of interests: None.

Addiction (www.addictionjournal.org) is a monthly international scientific journal publishing peer-reviewed research reports on alcohol, substances, tobacco, and gambling as well as editorials and other debate pieces. Owned by the Society for the Study of Addiction, it has been in continuous publication since 1884.

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JOURNAL

Addiction

DOI

10.1111/add.16052 

METHOD OF RESEARCH

Observational study

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Trends in cigarette use and health insurance coverage among US adults with mental health and substance use disorders

ARTICLE PUBLICATION DATE

17-Nov-2022

Student-based contact-tracing program prevented COVID-19 exposures and infections among university students and staff

Results published in AJIC demonstrate University of Illinois Chicago campus-based model effectively augmented local public health pandemic-response efforts

Peer-Reviewed Publication

ASSOCIATION FOR PROFESSIONALS IN INFECTION CONTROL

Arlington, Va., November 17, 2022 – Epidemiologists at the University of Illinois Chicago (UIC) developed and implemented a novel, student-driven, contact-tracing program that reduced COVID-19 exposures and infections on the campus during the 2020-2021 school year. Results from the program, which deployed UIC students to conduct both COVID-19 case investigations and contact tracing among non-clinical campus members, were published today in the American Journal of Infection Control (AJIC).

“Although population-based contact-tracing approaches to help control COVID-19 transmission in U.S. cities have faced significant challenges, our findings suggest that universities are a unique setting where it can be highly effective, particularly when there is strong institutional buy-in for public health interventions,” said Jocelyn Vaughn, MS, MA, research data scientist at the University of Illinois Chicago School of Public Health and one of the paper’s lead authors. “Universities should consider utilizing students in COVID-19 and other infectious disease response efforts.”

Contact tracing is a critical strategy to control infectious disease transmission, including SARS-CoV-2, though program costs often hinder efforts by U.S. health departments to expand these programs. There is little literature on models that mobilize students as contact tracers.

During August 2020, Vaughn and colleagues created the UIC COVID-19 Contact Tracing & Epidemiology Program (CCTEP) to perform case investigation and contact tracing among campus members with a COVID-19 infection or exposure, and to monitor and report on the evolving epidemiology of COVID-19 at UIC. Staffed by a fully remote workforce of public health practitioners and trained students who were indigenous to UIC, the program was approved by the Chicago Department of Public Health (CDPH) and functioned as an independent unit within UIC.

“We trained students to conduct both case investigations and contact tracing, which contrasted with the approach taken by most Illinois health departments, but provided both flexibility and cost-effectiveness advantages that contributed to our program’s success,” Vaughn said. “Routine data translation and dissemination, as well as the partnerships we established with CDPH and departments across the university were also essential.”

Using REDCap, a HIPAA-compliant data-capture and reporting system hosted at UIC, CCTEP contact tracers promptly interviewed non-clinical students and employees who tested positive for COVID-19  through UIC’s surveillance program, a UI Health clinical site, or off-campus (once self-reported). The goal was to reach all cases and contacts within 48 hours of specimen collection or exposure notification, respectively, the standard benchmark of contact tracing timeliness.

From August 31, 2020, to May 22, 2021, CCTEP served 1,009 confirmed COVID-19 cases and 746 contacts. Contact tracers reached 96% of cases in about one day from specimen collection, effectively quarantining 120 cases prior to converting, and preventing an estimated 132 downstream exposures and 22 COVID-19 infections. Among 18 identified clusters (>2 cases epidemiologically linked through a non-household setting), data suggest that CCTEP avoided more than 100 infections by preventing them from propagating beyond the initial group of exposed  contacts.

“This program provides exciting evidence that non-clinical university students can be efficiently engaged to provide rapid, thorough and cost-effective investigation and contact tracing to supplement local public health departments’ pandemic response efforts,” said Linda Dickey, RN, MPH, CIC, FAPIC, 2022 APIC president.

About APIC

Founded in 1972, the Association for Professionals in Infection Control and Epidemiology (APIC) is the leading association for infection preventionists and epidemiologists. With more than 15,000 members, APIC advances the science and practice of infection prevention and control. APIC carries out its mission through research, advocacy, and patient safety; education, credentialing, and certification; and fostering development of the infection prevention and control workforce of the future. Together with our members and partners, we are working toward a safer world through the prevention of infection. Join us and learn more at apic.org.

About AJIC

As the official peer-reviewed journal of APIC, The American Journal of Infection Control (AJIC) is the foremost resource on infection control, epidemiology, infectious diseases, quality management, occupational health, and disease prevention. Published by Elsevier, AJIC also publishes infection control guidelines from APIC and the CDC. AJIC is included in Index Medicus and CINAHL. Visit AJIC at ajicjournal.org.

 

NOTE FOR EDITORS

“Implementation and Effectiveness of a COVID-19 Case Investigation and Contact Tracing Program at a Large, Urban Midwestern University,” by Jocelyn Vaughn, MS, MA; Evgenia Karayeva, MPH; Natalia Lopez-Yanez, MPH; Ellen M. Stein, MS; and Ronald C. Hershow, MD was published online in AJIC on November 17, 2022. The article may be found at: https://doi.org/10.1016/j.ajic.2022.09.025

 

AUTHORS

 

Jocelyn Vaughn, MS, MA (corresponding author: jvaugh20@uic.edu)

University of Illinois Chicago School of Public Health

Chicago, IL, USA

 

Evgenia Karayeva, MPH

University of Illinois Chicago School of Public Health

Chicago, IL, USA

 

Natalia Lopez-Yanez, MPH

University of Illinois Chicago School of Public Health

Chicago, IL, USA

 

Ellen M. Stein, MS

Kinsa Health

Chicago, IL, USA

 

Ronald C. Hershow, MD

University of Illinois Chicago School of Public Health

Chicago, IL, USA

# # #

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JOURNAL

American Journal of Infection Control

DOI

10.1016/j.ajic.2022.09.025 

METHOD OF RESEARCH

Case study

SUBJECT OF RESEARCH

Not applicable

ARTICLE TITLE

Implementation and Effectiveness of a COVID-19 Case Investigation and Contact Tracing Program at a Large, Urban Midwestern University

ARTICLE PUBLICATION DATE

17-Nov-2022

Crown-of-thorns seastar from Red Sea is endemic species

Peer-Reviewed Publication

LUDWIG-MAXIMILIANS-UNIVERSITÄT MÜNCHEN

LMU researchers have identified coral-eating crown-of-thorns seastars in the Red Sea as distinct species that occurs only in this location.

Tropical coral reefs are among the most endangered ecosystems on Earth. In addition to climate change, coral-eating crown-of-thorns seastars (Acanthaster spp.) pose one of the biggest threats in parts of the Indo-Pacific region. Up to 40 cm in length, these creatures feed mainly on the polyps of fast-growing stony corals. Mass outbreaks are not uncommon, whereby the seastars propagate at a rapid rate and many thousands of individuals can destroy large areas of coral reef. Such mass outbreaks have become increasingly frequent over recent decades, partly because the natural enemies of the seastars have been decimated by overfishing.

Crown-of-thorns seastars are widely distributed throughout the Indo-Pacific region. They get their name from the large venomous spines that protrude from their arms. Based on regional morphological differences, various species had been described in the past. However, the relationships between them remained somewhat hazy. “It was long assumed that the first species in the genus described, Acanthaster planci, was distributed from the Red Sea and the Indian Ocean over the entire Pacific,” says Gert Wörheide, Professor of Paleontology and Geobiology at LMU. However, DNA barcoding data from a doctoral thesis supervised by Wörheide showed more than 10 years ago that A. planci can be subdivided into four strongly diverging genetic lineages, which presumably represent different species. A team led by Wörheide and Gerhard Haszprunar, Professor of Systematic Zoology at LMU, has now demonstrated with the aid of morphological investigations and genetic analyses that the crown-of-thorns seastar native to the Red Sea form a distinct species, which has been given the name Acanthaster benziei. “This underlines once again the importance of the Red Sea as an ecosystem with unique fauna and numerous endemic species,” emphasizes Wörheide. The new species name honors John Benzie, Professor at University College Cork, who has done pioneering work with his groundbreaking genetic studies on crown-of-thorns seastars in the 1990s and his comprehensive collection.

Fewer arms, thinner spines

 

With A. benziei, the scientists managed to describe a new species of crown-of-thorns seastar for the first time in several decades. “Although isolated particular features had already been observed in crown-of-thorns seastars from the Red Sea, such as a tendency to a more nocturnal lifestyle and probable lower toxicity of the spines, we didn’t know yet that it was actually a distinct species,” says Wörheide. The research confirmed clear differences between A. benziei and the other species of the “A. planci” species complex. In addition to characteristic sequences in the mitochondrial DNA, this included morphological features such as a lower number of arms and thinner, differently shaped spines.

 

“Now that we know it’s a distinct species, we can direct our attention to the biology, ecology, and toxicology of A. benziei and the other Acanthaster species,” says Wörheide. In the past, scientists had also observed a lower tendency for mass outbreaks in Red Sea crown-of-thorns seastars. “Such outbreaks are known primarily from Acanthaster cf. solaris in the western Pacific and regularly cause major damage to the Great Barrier Reef, whereas the phenomenon appears to be less severe in the Red Sea – whether species-specific characteristics are a contributing factor could be the object of future investigations,” says Wörheide. Most data that have been gathered to date on the biology and ecology of crown-of-thorns seastars comes from Acanthaster cf. solaris from the western Pacific. “By clearly distinguishing the various species of coral-eating crown-of-thorns seastars, we can carry out more detailed research into the dynamics of mass outbreaks, one of the multiple stressors that affect tropical reefs. Ultimately, this is a step in the direction of better management of reef ecosystems.”

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JOURNAL

Zootaxa

DOI

10.11646/ZOOTAXA.5209.3.7 

ARTICLE TITLE

A new species of crown-of-thorns sea star, Acanthaster benziei sp. nov. (Valvatida: Acanthasteridae), from the Red Sea

ARTICLE PUBLICATION DATE

17-Nov-2022

COP must reverse rising pessimism over building sector decarbonization, new study argues

Social media engagement with climate policy events is vital to reducing building emissions and ensuring environmental justice, research led by the University of Cambridge suggests.

Peer-Reviewed Publication

UNIVERSITY OF CAMBRIDGE

Social media engagement with climate policy events is vital to reducing building emissions and ensuring environmental justice, research led by the University of Cambridge suggests.

Negativity on Twitter about decarbonising the built environment has increased by around a third since 2014, according to a new analysis of more than 250,000 tweets featuring #emissions and #building between 2009 and 2021.

 

The pessimistic trend has followed the launch of major climate action reports. The study, published today in Nature Scientific Reports, reveals that expressions of ‘fear’ in Twitter dialogue increased by around 60% following the launch of the IPCC’s Fifth Assessment Report on Climate Change in 2015.

The researchers, from Cambridge, Boston, Sussex and Aarhus Universities and Caltech, also found that ‘sadness’ increased by around 30% following the IPCC Special Report on Global Warming 1.5◦C in November 2019; while debate in November 2020 over lobbying of builders and utility companies over non-compliance with new building codes in the US triggered a spike in ‘anger’.

Mapping tweets that caused spikes in emotional engagement revealed that public concerns triangulated around inaction towards emission reduction, the fairness of carbon tax, the politicisation of building codes (distinctively seen for the US) and concerns over environmental degradation. This demonstrates, the researchers argue, “a strong environmental justice discourse.”

The findings appear on the heels of COP27’s building sector events (10th – 14th November), which sought to promote a just transition and enhancing building resilience with the tagline ‘Build4Tomorrow’.

Lead author Ramit Debnath, Cambridge Zero Fellow at the University of Cambridge and a visiting faculty associate in Computational Social Science at Caltech, says:

“Major climate policy events including COP have emphasised how difficult it is to decarbonise the built environment and this has been reflected in the rise of negative feelings on social media.

“But our research also offers hope – we found that climate policy events can and do foster public engagement, mostly positive, and that this has the power to increase the building sector’s focus on environmental justice.

“To build for tomorrow fairly, global climate action has to incorporate and empower diverse public voices. Policy actions are no longer isolated events in this digital age and demand two-way communication. Policy events and social media have a crucial role to play in this.”

The study highlights that the building sector is one of the most important and challenging to decarbonise. The IPCC suggests that restricting climate change to 1.5◦C requires rapid and extensive changes around energy use, building design, and broader planning of cities and infrastructure. The buildings and construction sector currently accounts for around 39% of global energy and process-related carbon emissions. The International Energy Agency estimates that to achieve a net-zero carbon building stock by 2050, direct building carbon emissions must decrease by 50%, and indirect building sector emissions must also decrease 60% by 2030.

But decarbonising the building sector is challenging because it involves a complex overlap of people, places and practices that creates a barrier to designing just emission reduction policies. The study argues that democratising the decarbonisation process “remains a critical challenge across the local, national and regional scales”.

Debnath says: “Our findings shed light on potential pathways for a people-centric transition to a greener building sector in a net-zero future.”

Using advanced natural language processing and network theory, the researchers found a strong relationship between Twitter activity concerning the building sector and major policy events on climate change. They identify heightened Twitter engagement around developments including: the Paris Agreement’s call for the building sector to reduce its emissions through energy efficiency and address its whole life cycle; COP-23’s ’Human Settlement Day’ which focused on cities, affordable housing and climate action; COP25’s discourse on green/climate finance for residential homes; and COP26’s ’Cities, Region and Built environment Day’.

The researchers found that despite negative sentiments gaining an increasing share since 2014, positive sentiments have continued to multiply as Twitter engagement has exploded. Across the entire study period (2009–21), positive sentiments have fairly consistently maintained a larger share of the conversation than negative sentiments.

The study highlights the fact that core topics covered by tweets have changed significantly over time, as new innovations, technologies and issues have emerged. Hashtags associated with COP26, for instance, included #woodforgood and #masstimber, as well as #housingcrisis, #healthybuildings #scaleupnow, and #climatejusticenow, all largely or entirely absent in Twitter conversations between 2009 and 2016.

The researchers found that discourse on innovative emissions reduction strategies which remain uncommon in the building sector— including use of alternate building materials like cross-laminated timber; implementing climate-sensitive building codes; and the circular economy – inspired Tweets expressing ‘anticipation’.

Debnath says: “COP26 was an extraordinary moment – the Twitter engagement surrounding the event connected public health, the circular economy, affordable housing, and decarbonisation of the built environment like never before.”

“We are seeing a paradigm shift in the building emission discourse towards broader social and environmental justice contexts. Reference to low-carbon alternatives to concrete, housing crisis, scaling-up and climate justice are all part of the growing social justice movement associated with healthy and affordable social housing narratives globally.”

The study notes that considering the size of Twitter’s current user base (around 211 million users globally), the number of tweets about emissions in the building sector, remains relatively small.

Debnath says: “It’s crucial that policymakers raise the salience of these issues and develop communications strategies to emphasise the importance of climate action in hard-to-decarbonise sectors like the building sector.”

The authors of the study intend to continue to analyse social media interaction with further climate policy events, beginning with COP27.

Co-author Professor Benjamin Sovacool, Director of Institute for Global Sustainability at Boston University said: “Some people dismiss Twitter as a poor focus of academic research, given its ability to spread misinformation and fake news. But we instead see it as a lens into the inner workings of how millions of people think, and rethink, about energy and climate change. It offers an incredible opportunity to reveal people’s true intentions, their revealed preferences, in unbiased form on a public forum.”

Co-author Prof R. Michael Alvarez, Professor of Political and Computational Social Science at Caltech, said: “This is an innovative and important study, showing how an interdisciplinary and international group of scholars can use big data and machine learning to provide policy guidance on how to decarbonize the build sector.  Research like this is critical at this time, to inform the debates at forums like COP27 and to energise additional scholarly work that can help further our goal of democratising climate action.”

Reference

Debnath, R., Bardhan, R., Shah, D.U., Mohaddes, K., Ramage, M.H., Alvarez, M.R., and Sovacool, B. (2022), 'Social media enables people-centric climate action in the hard-to-decarbonise building sector'. Nature Scientific Reports, https://doi.org/10.1038/s41589-022-23624-9

Notes to editor

The paper is co-authored by Dr Ramit Debnath (Cambridge Zero and Churchill College, University of Cambridge, and Caltech), Prof Ronita Bardhan (Selwyn College, Cambridge), Prof. Darshil U. Shah (St John’s College, Cambridge), Prof. Kamiar Mohaddes (King’s College, Cambridge), Prof. Michael H. Ramage (Sidney Sussex College, Cambridge), Prof. R. Michael Alvarez (Caltech) and Prof. Benjamin Sovacool (Boston University, Aarhus University and University of Sussex).

The collaborative team was established as a part of the deliverables of the Alan Turing Institute’s Postdoctoral Enrichment Award - 2022 to Dr Ramit Debnath.

This study is in parts funded by Laudes Foundation, Quadrature Climate Foundation, Bill & Melinda Gates Foundation, Keynes Fund, UK Space Agency NSIP Award and Caltech’s Resnick Sustainability Institute. 

Cambridge Zero is the University of Cambridge’s major climate initiative. It exists to maximise the University of Cambridge’s contribution towards achieving a resilient and sustainable zero-carbon world. Cambridge Zero is not just about developing greener technologies or a zero-carbon university. We are harnessing the full range and breadth of the Collegiate University’s capabilities, both in the UK and globally, to develop solutions that work for our lives, our society and our economy.

Media contact

Tom Almeroth-Williams, Communications Manager (Research), University of Cambridge: tom.williams@admin.cam.ac.uk  / tel: +44 (0) 07540 139 44

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JOURNAL

Scientific Reports

DOI

10.1038/s41589-022-23624-9 

SUBJECT OF RESEARCH

Not applicable

ARTICLE TITLE

Social media enables people-centric climate action in the hard-to-decarbonise building sector

ARTICLE PUBLICATION DATE

17-Nov-2022

AI tool predicts when a bank should be bailed out

An artificial intelligence tool developed by researchers at UCL and Queen Mary University of London could help governments decide whether or not to bail out a bank in crisis by predicting if the intervention will save money for taxpayers in the long term.

Peer-Reviewed Publication

UNIVERSITY COLLEGE LONDON

An artificial intelligence tool developed by researchers at UCL and Queen Mary University of London could help governments decide whether or not to bail out a bank in crisis by predicting if the intervention will save money for taxpayers in the long term.

The AI tool, described in a new paper in Nature Communications, assesses not only if a bailout is the best strategy for taxpayers, but also suggests how much should be invested in the bank, and which bank or banks should be bailed out at any given time.

The algorithm was tested by the authors using data from the European Banking Authority on a network of 35 European financial institutions judged to be the most important to the global financial system, but it can also be used and calibrated by national banks using detailed proprietary data unavailable to the public.

Dr Neofytos Rodosthenous (UCL Mathematics), corresponding author of the paper, said: “Government bank bailouts are complex decisions that have financial, social and political implications. We believe the AI approach we have developed can be an important tool for governments, helping officials assess specifically financial implications – this means checking if a bailout is in the best interest of taxpayers, or whether it would be better value for money to let the bank fail. Our techniques are freely available for banking authorities to use as tools in their decision-making process.”

Co-author Professor Vito Latora (Queen Mary University of London) added: “Governments and banking authorities can also use our approach to retrospectively review past crises and gain valuable learnings to inform future actions. One could, for example, review the UK government bailout of the Royal Bank of Scotland (RBS) during the financial crisis of 2007-9 and reflect on how this could potentially be improved (from a financial standpoint) in the future in order to primarily benefit taxpayers.”

In a bank bailout, a government investment in a bank increases the bank’s equity and reduces its risk of defaulting. This cost in the short term may be justified to the taxpayer if it leads to lower taxpayer losses in the long term – i.e., it prevents bank defaults that are more damaging to government finances.

In their study, the researchers created a mathematical framework for comparing different bailout strategies in terms of predicted losses to taxpayers. Considered factors include how long the financial crisis is expected to last, the likelihood of each bank defaulting and the effect of a default on other banks in the network, as well as taxpayers’ stakes in the banks.

Using a mathematical control process, called Markov Decision Process, the researchers incorporated into this framework the effect of a government intervention at any given point in time.

They then developed a bespoke AI algorithm to assess optimal bailout strategies, comparing no intervention to different types of intervention – that is, varying levels of investment in one bank or many banks – at different time points during a crisis. An AI technique is needed as modelling such a system is highly complex, as the future behaviour of all banks in the system can be infinite.

In their case study using data from the European Banking Authority, they showed that government bailout would be optimal only if the taxpayers’ stakes in the banks were greater than some critical threshold value, determined via the model. The optimal policy drastically changed once the percentage loss had gone above this threshold.

Moreover, it was shown that government bailout tended to be more favourable the greater the network’s distress (defined in terms of a percentage reduction in the banks’ equity), the longer the crisis lasted and the bigger the banks’ exposures to other banks were (that is, how much they had lent other banks and therefore stood to lose if these banks failed).

The researchers also found that, once a bank had received a bailout, the best strategy for taxpayers was if the government continued to invest in that bank to prevent default. This could lead to a lack of incentive for the rescued bank to guard against risk, potentially increasing risk-taking.

Lead author Dr Daniele Petrone said: “Banks have so far weathered the current economic storm triggered by the Covid-19 pandemic. Their resilience has been bolstered by regulatory measures introduced following the global financial crisis of 2007-9 and by accommodating central banks' monetary policies that have avoided bankruptcies across industries. However, no one can predict the effect on the financial system as central banks reverse previous policies, such as increasing interest rates due to inflation concerns, and so bailouts are still a possibility.”

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JOURNAL

Nature Communications

DOI

10.1038/s41467-022-34102-1 

METHOD OF RESEARCH

Computational simulation/modeling

SUBJECT OF RESEARCH

Not applicable

ARTICLE TITLE

'An AI approach for managing financial systemic risk via bank bailouts by taxpayers’

ARTICLE PUBLICATION DATE

17-Nov-2022