Tuesday, May 25, 2021

Women’s Access to Abortion Care Under Oregon's Reproductive Health Equity Act
JAMA Health Forum. 2021;2(5):e210402. doi:10.1001/jamahealthforum.2021.0402

Research Letter
May 21, 2021
Introduction

Unintended pregnancy and abortion are becoming increasingly concentrated among women in disadvantaged communities who experience substantial barriers to obtaining health care.1 A common barrier to accessing needed abortion care is cost, as more than half of all abortions are paid for out of pocket.2 While no federal funds can be used for abortion, 16 states, including Oregon, use state funds to cover all or most abortions in Medicaid.3 However, federal law restricts access to Medicaid for undocumented and recent immigrants.4

Oregon’s Reproductive Health Equity Act (RHEA) took effect January 1, 2018, and ensured coverage for family planning (abortion and contraception) using state funds for all low-income state residents regardless of citizenship status. We describe the first 24 months of abortion services covered under RHEA and distances traveled by women to receive care.

Methods

We conducted a cross-sectional study of abortion services that were reimbursed under RHEA in 2018 and 2019. We used data from the program’s “Clinic Visit Record,” which includes demographic and medical information, as well as billing claims. This program is separate from the state’s Medicaid program. We included abortions that were reimbursed under RHEA at 11 clinics statewide that provide abortion services, with the exception of 1 hospital-based clinic. No hospital was contracted to provide scheduled abortion care during the study period. Emergency hospital-based abortions for life-threatening conditions (eg, hemorrhage) would be reimbursed by Medicaid and are not included in the study sample. This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline. The institutional review boards at Oregon Health & Science University and the Oregon Health Authority approved the study and granted a waiver of informed consent based on the lack of HIPPA identifiers.

We describe sociodemographic, clinical, and abortion characteristics of women who received abortions under RHEA by metropolitan residence (vs nonmetropolitan) based on zip code. Our primary outcome was the distance traveled to receive an abortion. We used the patient-reported zip code of residence to calculate the distance the patient traveled to receive an abortion using the straight-line distance between centroids of the patient’s zip code and the latitude and longitude of the clinic where the patient received an abortion. Statistical analyses were conducted using Stata, version 16 (StataCorp), and statistical significance was set at P < .05.

Results

Oregon’s RHEA provided access to 625 clinic-based abortions. Nearly half (302 [48.3%]) of the abortions were for women aged 25 to 34 years (range, 15-46 years). Most abortions (498 [79.7%]) were for women who resided in metropolitan zip codes. Consistent with national trends, most abortions (583 [93.9%]) occurred during the first trimester, and slightly more than half (358 [57.3%]) were surgical abortions.5 More than 509 abortions (80%) were performed for women who had previously given birth. There was no difference in rates of second trimester abortion by residence (5.6% metropolitan vs 6.3% nonmetropolitan; P = .94).

In the overall cohort, the median distance traveled for an abortion was 8.73 miles (interquartile range, 4.78-17.20 miles; range, 0.42-124.44 miles). A third of women (189 [30.2%]) traveled less than 5 miles to receive abortion care, and 32 (5.1%) traveled 50 or more miles.

Discussion

In the first 2 years following RHEA implementation, immigrant women across the state used the expanded coverage to access abortion, indicating that the policy was fully implemented in metropolitan and nonmetropolitan areas. The distances traveled for abortion in Oregon were lower than national averages (5.1% of RHEA clients vs 18% nationally traveling more than 50 miles).5 Our study is limited by the lack of information on abortions received by low-income immigrants before implementation of the RHEA policy and not including information on contraception. State policies, such as RHEA, can ensure that low-income individuals are not excluded from family planning services based on citizenship status.

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Article Information

Accepted for Publication: March 15, 2021.

Published: May 21, 2021. doi:10.1001/jamahealthforum.2021.0402

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Rodriguez MI et al. JAMA Health Forum.

Corresponding Author: Maria I. Rodriguez, MD, MPH, 3181 SW Sam Jackson Park Rd, UHN 50, Portland, OR 97239 (rodrigma@ohsu.edu).

Author Contributions: Drs Rodriguez and Darney had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Rodriguez, Darney.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Rodriguez.

Critical revision of the manuscript for important intellectual content: Skye, Shokat, Linz, Pedhiwala, Darney.

Statistical analysis: Rodriguez, Skye, Shokat, Darney.

Administrative, technical, or material support: Rodriguez, Linz, Pedhiwala.

Supervision: Rodriguez, Darney.

Conflict of Interest Disclosures: Dr Rodriguez reported personal fees from the American Congress of Obstetrics and Gynecology, World Health Organization, and Bayer as well as grants from Merck, the National Institutes of Health, and Arnold Ventures outside the submitted work. No other disclosures were reported.

References
1.
Finer  LB, Zolna  MR.  Declines in unintended pregnancy in the United States, 2008-2011.   N Engl J Med. 2016;374(9):843-852. doi:10.1056/NEJMsa1506575PubMedGoogle ScholarCrossref
2.
Jerman  J  Jr, Onda  T. Characteristics of US abortion patients in 2014 and changes since 2008. Accessed May 8, 2019. https://www.guttmacher.org/sites/default/files/report_pdf/characteristics-us-abortion-patients-2014.pdf
3.
Guttmacher Institute. State funding of abortion under Medicaid. Accessed June 8, 2020. https://www.guttmacher.org/print/state-policy/explore/state-funding-abortion-under-medicaid
4.
DuBard  CA, Massing  MW.  Trends in emergency Medicaid expenditures for recent and undocumented immigrants.   JAMA. 2007;297(10):1085-1092. doi:10.1001/jama.297.10.1085
ArticlePubMedGoogle ScholarCrossref
5.
Kortsmit  K, Jatlaoui  TC, Mandel  MG,  et al.  Abortion surveillance—United States, 2018.   MMWR Surveill Summ. 2020;69(7):1-29. doi:10.15585/mmwr.ss6907a1PubMedGoogle ScholarCrossref

 #PHARMACARE NOW!

Providing medications for free leads to greater adherence and cost-savings, study shows

ST. MICHAEL'S HOSPITAL TORONTO CANADA

Research News

IMAGE

IMAGE: DR. NAV PERSAUD, A SCIENTIST AT THE LI KA SHING KNOWLEDGE INSTITUTE OF ST. MICHAEL'S HOSPITAL. view more 

CREDIT: UNITY HEALTH TORONTO

Free access to essential medicines increases patient adherence to taking medication by 35 per cent and reduces total health spending by an average of over $1,000 per patient per year, according to a two-year study that tested the effects of providing patients with free and convenient access to a carefully selected set of medications.

The findings, published May 21 in PLOS Medicine, come as advocates urge Canada to carve a path toward single-payer, public pharmacare. Canada is the only country with universal healthcare that does not have a universal pharmacare program.

A group of researchers led by St. Michael's Hospital of Unity Health Toronto recruited a total of 786 patients across nine primary care sites in Ontario who reported cost-related non-adherence to medications. Most of the study participants were recruited from St. Michael's Department of Family and Community Medicine and others were recruited from three rural sites. Participants were randomized into two groups - half received free medications via mail, the other half had their usual access to medications.

Two years into the study, adherence to all appropriate prescribed medicines was 35 per cent higher in the free distribution group compared with the group that had usual access to medications. Free distribution of medication also showed to reduce healthcare costs, including hospitalization, by an average of $1,222 per patient per year.

"The cost savings are substantial, but they are less important than people simply being able to afford taking lifesaving medications," said Dr. Nav Persaud, a scientist at the Li Ka Shing Knowledge Institute of St. Michael's and lead author of the study.

"This is the first study of providing people with free access to a comprehensive set of medicines, and hopefully it will be the last one needed before policy changes," said Dr. Persaud, who is also a family physician at St. Michael's Hospital.

In June 2019, the Advisory Council on the Implementation of National Pharmacare recommended a universal, single-payer, public pharmacare, estimating such a program would save Canada an estimated $5 billion per year. The report cited a list of medicines like the one used in the CLEAN Meds study as "a starting point" for determining which drugs all Canadians should have free access to.

The CLEAN Meds Trial focused on 128 essential medicines, adapted from the WHO Model List of Essential Medicines and removed treatments not needed in Canada. The medicines in the study included treatments for acute conditions, such as antibiotics and pain relievers, as well as chronic conditions, such as antipsychotics and HIV-AIDS medications.

The paper is the final result of the CLEAN Meds Trial. Preliminary results of the trial after one year of free medication indicated improved adherence, improvements in some health outcomes, and that free distribution of essential medicines led to a 160 per cent increase in the likelihood of participants being able to make ends meet.

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PUBLIC OWNERSHIP OF BIG PHARMA

Nonprofits, federal government surpass pharma to lead Alzheimer's drug development

ALZHEIMER'S ASSOCIATION

Research News

Two articles published online today by Alzheimer's & Dementia: Translational Research & Clinical Interventions, a journal of the Alzheimer's Association, show substantial changes in the focus and funding of clinical trials for Alzheimer's disease therapies. The newly published articles throw a greater spotlight on a decision -- now before the U.S. Food and Drug Administration (FDA) -- that would potentially bring a new drug therapy to Alzheimer's patients for the first time in nearly 20 years.

Researchers analyzed clinicaltrials.gov, the U.S. National Library of Medicine's database, and five years of annual Alzheimer's pipeline reviews published by UNLV School of Integrated Health Sciences research professor Jeffrey L. Cummings and colleagues. The results capture the well-publicized retreat of pharma from Alzheimer's clinical trials, especially early phase human trials, and the emergence of federal agencies and nonprofit organizations as the primary drivers of growth and innovation.

In the first study, "Who Funds Alzheimer's Disease Drug Development?," Cummings and colleagues found that the number of Alzheimer's clinical trials supported by pharmaceutical companies has decreased over the past five years, while trials supported by federal government sources and public-private partnerships (PPP) have increased. The authors observe that pharma companies are not increasing their involvement in Alzheimer's trials and drug development except through PPP, enabling them to distribute the cost and risk. And they largely engage only in late-stage (Phase 3) clinical trials.

The researchers found that the trials gap is increasingly being filled by academic medical centers (AMCs). Trials by AMCs are up 78% over the past five years, primarily funded by the U.S. National Institutes of Health (NIH) and programs of the National Institute on Aging (NIA), Alzheimer's Association, and Alzheimer's Drug Discovery Foundation (ADDF), including the Alzheimer's Association's Part The Cloud initiative.

"Nonprofits and the NIH are making a huge difference in drug development for Alzheimer's and all other dementia," Cummings said. "Recent years have been a time of pharma retrenchment after multiple negative clinical trials, but also a time of innovation in early-stage trials and re-evaluation of previously under-resourced ideas. We found in our review that, in the newer early-stage clinical trials, the therapeutic mechanisms are more diversified, biomarkers are more regularly used, and repurposed agents are being explored -- increasingly led by academic researchers and funded by NIH, the Alzheimer's Association, and ADDF.

A second paper, "Alzheimer's Disease Drug Development Pipeline: 2021," also by Cummings and colleagues, including a student, Justin Bauzon, from the UNLV School of Medicine, reinforces these trends by showing that, despite pharma's retreat from Alzheimer's, the total number of agents in Alzheimer's clinical trials has been relatively steady over the last five years. The total is up slightly from 2020, driven by additional agents in Phase 2 studies. There is also increasing diversity of targets and therapeutic mechanisms of drugs in the Alzheimer's pipeline, driven by innovative Phase 1 and 2 trials.

"Alzheimer's Association funding, partnerships - including the NIA and ADDF - and advocacy for federal Alzheimer's research funding are now the primary drivers of growth in Alzheimer's clinical trials, filling the gap left by pharma's retreat, and growing and diversifying the front end of the drug pipeline," said Maria C. Carrillo, Alzheimer's Association chief science officer.

The NIA now distributes more than $3 billion annually for Alzheimer's and dementia research, up from $500 million just a few years ago. "This great victory is almost completely due to Alzheimer's Association legislative efforts, our grassroots advocates, and our champions in Congress," Carrillo said.

The FDA is reviewing aducanumab (Biogen) for the treatment of Alzheimer's disease. A decision is expected by June 7.

"If pharma companies do not see a clear path to FDA approval, they will continue not to invest in Alzheimer's," Cummings said. "This further highlights the importance of the decision before the FDA at this moment."

There are four drugs approved and commonly used to treat the symptoms of Alzheimer's dementia, plus a combination therapy that includes two of these drugs. There are currently no approved drugs that change the course or delay the progression of the disease or that delay or stop clinical decline. No new drugs have been approved for Alzheimer's since 2003.

The article authors say, "If new therapies are approved by regulatory authorities, more sponsors and more funding may be attracted to Alzheimer's research with accelerated innovation."

The two studies were supported by the Chambers-Grundy Center for Transformative Neuroscience at UNLV, dedicated to advancing clinical trial methods to get better treatments to patients faster.

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UNLV Department of Brain Health

The UNLV Department of Brain Health was launched by the School of Integrated Health Sciences (SIHS) in 2019 to advance research, education, and practice to benefit brain health and the care and treatment of people with brain disorders. The department's faculty specialize in basic and clinical research in neurodegenerative disease, neuropsychology, and occupational therapy.

Alzheimer's & Dementia: Translational Research & Clinical Interventions (TRCI)

Alzheimer's & Dementia: TRCI is a peer-reviewed, open-access journal from the Alzheimer's Association that bridges the full scope of explorations between basic research, drug discovery, and clinical studies in Alzheimer's and dementia. The journal publishes findings from multifaceted domains of research and disciplines to accelerate what is learned at the bench and translated and applied at the bedside.

Can antibiotics treat human diseases in addition to bacterial infections?

UIC researchers prove that drugs designed for bacteria have potential to act on human cells

UNIVERSITY OF ILLINOIS AT CHICAGO

Research News

IMAGE

IMAGE: AN ANTIBIOTIC (GREEN), BOUND IN THE HUMAN-LIKE YEAST RIBOSOME (GRAY), ALLOWS FOR SYNTHESIS OF SOME PROTEINS (REPRESENTED IN ORANGE, PURPLE, AND BLUE) BUT NOT OTHERS (DARK GREEN). view more 

CREDIT: MAXIM SVETLOV/UIC

According to researchers at the University of Illinois Chicago, the antibiotics used to treat common bacterial infections, like pneumonia and sinusitis, may also be used to treat human diseases, like cancer. Theoretically, at least.

As outlined in a new Nature Communications study, the UIC College of Pharmacy team has shown in laboratory experiments that eukaryotic ribosomes can be modified to respond to antibiotics in the same way that prokaryotic ribosomes do.

Fungi, plants, and animals -- like humans -- are eukaryotes; they are made up of cells that have a clearly defined nucleus. Bacteria, on the other hand, are prokaryotes. They are made up of cells, which do not have a nucleus and have a different structure, size and properties. The ribosomes of eukaryotic and procaryotic cells, which are responsible for the protein synthesis needed for cell growth and reproduction, are also different.

"Some antibiotics, used for treating bacterial infections, work in an interesting way. They bind to the ribosome of bacterial cells and very selectively inhibit protein synthesis. Some proteins are allowed to be made, but others are not," said Alexander Mankin, the Alexander Neyfakh Professor of Medicinal Chemistry and Pharmacognosy at the UIC College of Pharmacy and senior author of the study. "Without these proteins being made, bacteria die."

When people use antibiotics to treat an infection, the cells of the patient are not affected because the drugs are not designed to bind to the differently shaped ribosomes of eukaryotic cells.

"Because there are many human diseases caused by the expression of unwanted proteins -- this is common in many types of cancer or neurodegenerative diseases, for example -- we wanted to know if it would be possible to use an antibiotic to stop a human cell from making the unwanted proteins, and only the unwanted proteins," Mankin said.

To answer this question, Mankin and study first author Maxim Svetlov, research assistant professor with the department of pharmaceutical sciences, looked to yeast, a eukaryote with cells similar to human cells.

The research team, which included partners from Germany and Switzerland, performed a "cool trick," Mankin said. "We engineered the yeast ribosome to be more bacteria-like."

Mankin and Svetlov's team used biochemistry and fine genetics to change one nucleotide of more than 7,000 in yeast ribosomal RNA, which was enough to make a macrolide antibiotic -- a common class of antibiotics that works by binding to bacterial ribosomes -- act on the yeast ribosome. Using this yeast model, the researchers applied genomic profiling and high-resolution structural analysis to understand how every protein in the cell is synthesized and how the macrolide interacts with the yeast ribosome.

"Through this analysis, we understood that depending on a protein's specific genetic signature -- the presence of a 'good' or 'bad' sequence -- the macrolide can stop its production on the eukaryotic ribosome or not," Mankin said. "This showed us, conceptually, that antibiotics can be used to selectively inhibit protein synthesis in human cells and used to treat human disorders caused by 'bad' proteins."

The experiments of the UIC researchers provide a staging ground for further studies. "Now that we know the concepts work, we can look for antibiotics that are capable of binding in the unmodified eukaryotic ribosomes and optimize them to inhibit only those proteins that are bad for a human," Mankin said.

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Additional co-authors of the study are Dorota Klepacki and Nora Vázquez-Laslop of UIC; Timm Koller and Daniel Wilson of the University of Hamburg; Sezen Meydan and Nicholas Guydosh of the National Institutes of Health; and Norbert Polacek and Vaishnavi Shankar of the University of Bern.

This work was supported by grants from the National Institutes of Health (R35 GM127134, DK075132, 1FI2GM137845), the German Research Foundation (WI3285/6-1), and the Swiss National Science Foundation (31003A_166527).

No cause for alarm about graduate students' mental health

UNIVERSITY OF OTAGO

Research News

Talk of a graduate student mental health crisis is abundant in academic and popular media, but a University of Otago study has found no evidence of one in New Zealand.

The study, published in Frontiers in Psychology, used data from the Graduate Longitudinal Study New Zealand to compare the mental wellbeing of students who did, and did not, transition into PhD study after completing their undergraduate degree.

Co-author Dr Damian Scarf, from the Department of Psychology, says the researchers found poor mental health is not an inevitable consequence of PhD study in New Zealand.

This is despite numerous studies out of the US and Europe reporting the opposite.

"There is a plethora of editorials, career features, empirical papers, etc. that talk of a graduate student mental health crisis. One paper in the US reported that graduate students were six times more likely to experience anxiety or depression than the general population - that is alarming," Dr Scarf says.

However, no New Zealand-based study had been done into graduate student mental health, so the researchers wanted to plug the gap.

"To date, quantitative studies on graduate student mental health have looked at one particular point in time, limiting any discussion about temporal links between entry into graduate education and mental health. The Graduate Longitudinal Study provides a super unique dataset in this regard, allowing us to track the mental health of graduate students before and after they enter a PhD programme."

The GLSNZ conducted baseline sampling across all eight New Zealand universities in 2011, following up in 2014. For the study, the researchers compared 269 students who transitioned to PhD study, with 4230 who did not.

"Unlike data on graduate student mental health from Europe and the US, it seems that entering graduate study in New Zealand does not lead to a big drop in mental health," Dr Scarf says.

The difference in outcomes for students may be the structure of New Zealand PhD programs which have little, if any, course work, take fewer years to complete, and have higher completion rates.

Dr Scarf says the problem with coverage of a supposed graduate student mental health crisis is that it may lead people, including students, to think that poor mental health is just part of being a PhD student.

"This belief can have several negative effects, including PhD students being less likely to seek professional help for any mental health problems, because they think poor mental health and PhD study go hand in hand."

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Publication details:

A Longitudinal Study of Mental Wellbeing in Students in Aotearoa New Zealand Who Transitioned Into PhD Study

Taylor Winter, Benjamin C. Riordan, John A. Hunter, Karen Tustin, Megan Gollop, Nicola Taylor, Jesse Kokaua, Richie Poulton and Damian Scarf

Frontiers in Psychology

DOI: 10.3389/fpsyg.2021.659163

Otago study helps explain how religious beliefs are formed

UNIVERSITY OF OTAGO

Research News

Feeling anxious can direct our attention and memory toward supernatural beings such as gods, a University of Otago study has found.

Lead author Dr Thomas Swan, of the Department of Psychology, says the research may help explain how religious beliefs are formed.

For the study, published in the International Journal for the Psychology of Religion, 972 participants completed an online recall test to determine if a bias to recall supernatural agents was stronger in anxious people, rather than non-anxious people.

Those who felt anxious were more likely to remember beings with supernatural abilities than beings without.

"Anxiety is an emotion that evolved to make us pay greater attention to potential threats, so when we feel anxious, a god that can read our thoughts and punish us for them, or flood the Earth, is going to be memorable," he says.

Previous research has shown anxiety can lead to greater levels of religious belief, with the explanation being that belief provides comfort. However, this so-called 'comfort theory' has problems: why are there punishing gods and hellish afterlives when these are far from comforting?

Dr Swan believes the theory also fails to address what comes between feeling anxious and becoming a believer. This research suggests the first step involves the cognitive effects of anxiety, which cause people to attend to and recall threats.

"In our previous research, we found that supernatural beings are perceived as potentially threatening because they have abilities that defy our expectations about the world. The present research confirms that the cognitive effects of anxiety also extend to the threat that is afforded by supernatural beings.

"Ironically then, our research suggests comfort theory has it somewhat backwards: anxious people are attracted, at least initially, to the scary traits of gods, which may explain why so many gods have scary features. Comfort, we suspect, comes later when some people transform their view of the god into something more palatable that they are happier believing," he says.

The research also suggests other supernatural concepts - such as ghosts, psychics, and astrology - will be digested in the same way because of how they alarmingly defy our expectations about what is possible.

Dr Swan hopes the research prompts people to develop a greater understanding of how their emotional states affect the information they look at and remember, particularly religious information.

"We should all be mindful of how we came to believe the things we do, especially those with anxiety disorders who feel anxious much of the time - they should be mindful of what they are attracted to and why. If they find themselves reading fantasy novels, that may be harmless. If they find themselves joining a cult, then it's time for some reflection. The same goes for people without disorders who are just in anxious situations, such as sitting in a hospital bed or suffering financial troubles."

On the flipside, he hopes religious groups pay more attention to people's mental states.

"They should be providing care but also giving people time to overcome their troubles before integrating them into a highly religious system of beliefs and practices. If they are still willing to join the religion when the turmoil is over, that might be a more ethical moment."

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Publication details:

Anxiety Enhances Recall of Supernatural Agents

Thomas Swan and Jamin Halberstadt

The International Journal for the Psychology of Religion

https://doi.org/10.1080/10508619.2021.1898808

 

Early research suggests climate change could lead to more stillbirths

UNIVERSITY OF QUEENSLAND

Research News

Scientists are investigating whether rising global temperatures may lead to more stillbirths, saying further study is needed on the subject as climates change.

Researchers from The University of Queensland's School of Earth and Environmental Science and the Mater Research Institute reviewed 12 studies, finding extreme ambient temperature exposures throughout pregnancy appeared to increase risk of stillbirth, particularly late in pregnancy.

UQ PhD candidate Jessica Sexton said while this was very early research, it did show a possible link between stillbirth and high and low ambient temperature exposures during pregnancy.

"Overall, risk of stillbirth appears to increase when the ambient temperature is below 15 degrees Celcius and above 23.4 degrees Celsius, with the highest risk being above 29.4 degrees Celsius," Ms Sexton said.

"An estimated 17 to 19 per cent of stillbirths are potentially attributable to chronic exposure to extreme hot and cold temperatures during pregnancy.

"And, as the world's temperatures rise due to climate change, this link will potentially increase stillbirth likelihood globally.

"But these findings are from the very limited research currently available, so expectant mothers shouldn't be anxious - there's still plenty of follow-up research that needs to happen."

Environmental scientist Dr Scott Lieske said the findings suggested that as temperatures rise, women in the developing world would feel the effects..

"More than two million stillbirths occur every year around the world, with the most occurring in low resource settings," Dr Lieske said.

"Not only are these poorer countries already affected disproportionately by stillbirth, they're now going to be disproportionately affected by climate change as well.

"If the link apparent in this research bears out upon further scrutiny, the majority of new stillbirths will occur invariably in the nations already suffering the most."

Professor Vicki Flenady, Director of the Centre of Research Excellence in Stillbirth (Stillbirth CRE) at Mater Research, said the research highlighted the importance of research to reduce global stillbirth rates.

"Even in 2021, a stillbirth occurs somewhere in the world every 16 seconds," Professor Flenady said.

"Stillbirth has a traumatic long-lasting impact on women and their families, who often endure profound psychological suffering as well as stigma, even in high-income countries.

"Here in Australia, stillbirth is still a major public health problem.

"As outlined in my recent research, in 2015 Australia's late gestation stillbirth rate was over 30 per cent higher than that of the best-performing countries globally.

"Further work is needed to understand the role that temperature plays in keeping women and babies safe during pregnancy.

"To fully understand the effects of maternal exposure to ambient temperatures and stillbirth, future studies should focus on the biological mechanisms involved and contributing factors, in addition to improving measurement of ambient temperature exposure.

"In the meantime, we would encourage pregnant women to talk to their healthcare providers about staying safe during the cold days of winter and hot days of summer."

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The research is published in Environmental Research (DOI: j.envres.2021.111037).

It was conducted with the input of the above researchers, as well as Dr Christine Andrews, Professor Sailesh Kumar and SEES Winter Research Program researcher Selina Carruthe

 

COVID-19 vaccine benefits still outweigh risks, despite possible rare heart complications

Statement from the American Heart Association/American Stroke Association

AMERICAN HEART ASSOCIATION

Research News

DALLAS, Sunday, May 23, 2021 - Late last week, the U.S. Centers for Disease Control and Prevention (CDC) alerted health care professionals that they are monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of young adults developing the rare heart-related complication myocarditis, after receiving a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna. The COVID-19 Vaccine Safety Technical Work Group (VaST) of the CDC's Advisory Committee on Immunization Practices (ACIP) is reviewing several dozen cases of myocarditis that have been reported in adolescents and young adults: more often in males rather than females; more frequently after the second dose rather than the first dose of either the Pfizer-BioNTech or Moderna vaccine; and typically appearing within 4 days of vaccination.

The benefits of COVID-19 vaccination enormously outweigh the rare, possible risk of heart-related complications, including inflammation of the heart muscle, or myocarditis. The American Heart Association/American Stroke Association, a global force for longer, healthier lives, urges all adults and children ages 12 and older in the U.S. to receive a COVID vaccine as soon as they can.

The following statement reflects the views of the American Heart Association/American Stroke Association and its science leaders:

  • President Mitchell S.V. Elkind, M.D., M.S., FAHA, FAAN,

  • Immediate Past President Robert A. Harrington, M.D., FAHA,

  • President-Elect Donald M. Lloyd-Jones, M.D., Sc.M., FAHA,

  • Chief Science and Medical Officer Mariell Jessup, M.D., FAHA, and

  • Chief Medical Officer for Prevention Eduardo Sanchez, M.D, M.P.H., FAAFP.

"We strongly urge all adults and children ages 12 and older in the U.S. to receive a COVID vaccine as soon as they can receive it, as recently approved by the U.S. Food and Drug Administration and the CDC. The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection. According to the CDC as of May 22, 2021, over 283 million doses of COVID-19 vaccines have been administered in the U.S. since December 14, 2020, and more than 129 million Americans are fully vaccinated (i.e., they have received either two doses of the Pfizer-BioNTech or Moderna COVID-19 vaccine, or the single-dose Johnson & Johnson/Janssen COVID-19 vaccine).

"We commend the CDC's continual monitoring for adverse events related to the COVID-19 vaccines through VAERS and VSD, and the consistent meetings of ACIP's VaST Work Group, demonstrating transparent and robust attention to any and all health events possibly related to a COVID-19 vaccine. The few cases of myocarditis that have been reported after COVID-19 vaccination are being investigated. However, myocarditis is usually the result of a viral infection, and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine, especially since the COVID-19 vaccines authorized in the U.S. do not contain any live virus.

"We remain confident that the benefits of vaccination far exceed the very small, rare risks. The risks of vaccination are also far smaller than the risks of COVID-19 infection itself, including its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including myocarditis. The recommendation for vaccination specifically includes people with cardiovascular risk factors such as high blood pressure, obesity and type 2 diabetes, those with heart disease, and heart attack and stroke survivors, because they are at much greater risk of an adverse outcome from the COVID-19 virus than they are from the vaccine.

"We also encourage everyone to keep in touch with their primary care professionals and seek care immediately if they have any of these symptoms in the weeks after receiving the COVID-19 vaccine:

  • chest pain including sudden, sharp, stabbing pains;

  • difficulty breathing/shortness of breath;

  • abnormal heartbeat;

  • severe headache;

  • blurry vision;

  • fainting or loss of consciousness;

  • weakness or sensory changes;

  • confusion or trouble speaking;

  • seizures;

  • unexplained abdominal pain; or

  • new leg pain or swelling.

"We will stay up to date with the CDC's recommendations regarding all potential complications related to COVID-19 vaccines, including myocarditis, pericarditis, central venous sinus thrombosis (CVST) and other blood clotting events, thrombosis thrombocytopenia syndrome (TTS), and vaccine-induced immune thrombosis thrombocytopenia (VITT).

"The American Heart Association recommends all health care professionals be aware of these very rare adverse events that may be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, or symptoms of severe inflammation. Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly. As detailed in last month's AHA/ASA statement, all suspected CVST or blood clots associated with the COVID-19 vaccine should be treated initially using non-heparin anticoagulants. Heparin products should not be administered in any dose if TTS/VITT is suspected, until appropriate testing can be done to exclude heparin-induced antibodies. In addition, health care professionals are required to report suspected vaccine-related adverse events to the Vaccine Adverse Event Reporting System, in accordance with federal regulations.

"We also support the CDC recommendations last week that loosen restrictions on mask wearing and social distancing for people who are fully vaccinated. For those who are unable to be vaccinated, we reiterate the importance of handwashing, social distancing and wearing masks, particularly for people at high risk of infection and/or severe COVID-19. These simple precautions remain crucial to protecting people who are not vaccinated from the virus that causes COVID-19.

"Individuals should refer to their local and state health departments for specific information about when and where they can get vaccinated. We implore everyone ages 12 and older to get vaccinated so we can return to being together, in person - enjoying life with little to no risk of severe COVID-19 infection, hospitalization or death."

MYOCARDITIS AND PERICARDITIS

Both myocarditis and pericarditis are most often the result of an infection and/or inflammation caused by a virus.

Myocarditis is inflammation of the middle layer of the wall of the heart muscle, and it can weaken the heart muscle and the heart's electrical system, which keeps the heart pumping regularly. Severe myocarditis can lead to heart failure, abnormal heartbeat and sudden death. Signs and symptoms of myocarditis are chest pain, abnormal heartbeat (arrhythmia) and unexpected shortness of breath. Approximately 10 to 20 per 100,000 people are diagnosed with myocarditis in the U.S. annually, and many cases resolve on their own or with treatment, leading to a full recovery.

Pericarditis is a condition often related to myocarditis, and involves swelling and inflammation of the pericardium, a sac-like structure with two thin layers of tissue that surround the heart to hold it in place and help it function properly. Pericarditis can progress and lead to severe complications, including cardiac tamponade, which results from too much fluid in the pericardium that can cause a sharp drop in blood pressure and can be fatal; and chronic constrictive pericarditis, when scar-like tissue develops in the pericardium causing it to become stiff, affecting the heart's ability to contract. Symptoms of pericarditis are sharp, stabbing chest pain that comes on suddenly; fever; weakness; and trouble breathing or shortness of breath. Approximately 45,000 people in the U.S. are hospitalized with pericarditis each year.

TYPICAL VACCINE- RELATED SYMPTOMS

According to the CDC, typical COVID-19 vaccine symptoms are tiredness, headache, muscle pain, chills, fever and nausea. Symptoms typically appear within 24 - 48 hours and usually pass within 36-48 hours after receiving the vaccine. If symptoms are severe and include difficulty breathing, seek immediate medical attention - call 911 or go to the nearest emergency room.

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    About the American Heart Association/American Stroke Association

    The American Heart Association is a relentless force for a world of longer, healthier lives and includes the American Stroke Association. We are dedicated to ensuring equitable health in all communities. Through collaboration with numerous organizations, and powered by millions of volunteers, we fund innovative research, advocate for the public's health and share lifesaving resources. The Dallas-based organization has been a leading source of health information for nearly a century. Connect with us on heart.org, Facebook, Twitter or by calling 1-800-AHA-USA1.

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    A natural food supplement may relieve anxiety

    Mice receiving the plant-derived substance were less anxious than the controls

    WEIZMANN INSTITUTE OF SCIENCE

    Research News

    A natural food supplement reduces anxiety in mice, according to a new Weizmann Institute of Science study. The plant-derived substance, beta-sitosterol, was found to produce this effect both on its own and in synergic combination with an antidepressant known under the brand name Prozac. If these findings, published today in Cell Reports Medicine, are confirmed in clinical trials, they could point the way toward the use of beta-sitosterol as a treatment for relieving anxiety in humans.

    Anxiety is not always a bad thing. In fact, in evolutionary terms, feeling anxious about potential threats is critical for survival because it helps us mount an appropriate response. That's precisely why developing antianxiety drugs is so challenging. The circuits for anxiety in the brain are closely related to those responsible for memory, awareness and other functions vital for handling danger, so scientists are on the lookout for compounds that can selectively suppress anxiety without causing unwanted side effects.

    The starting point for the present study was research conducted several years ago in the lab of Prof. Mike Fainzilber in Weizmann's Biomolecular Sciences Department. Dr. Nicolas Panayotis and other lab members studied the roles of proteins that shuttle cargoes into the nuclei of nerve cells, and they discovered that in stressful situations, mice lacking a shuttling protein known as importin alpha-five showed less anxiety than the control mice. The researchers then checked how these "calmer" mice differed from regular ones in terms of gene expression, and they identified a genetic signature of their "calmness": about 120 genes with a characteristic pattern of expression in the hippocampus, one of the brain regions that regulate anxiety.

    In the new study, Panayotis, now a senior intern in Fainzilber's lab, together with colleagues, searched an international genomic database for existing drugs or other compounds that might mimic the same gene expression signature. He identified five candidates and tested their effects on behavior in mice. That was how the researchers zeroed in on beta-sitosterol, a plant substance sold as a dietary supplement intended mainly to reduce cholesterol levels.

    In a series of behavioral experiments, mice given beta-sitosterol showed much less anxiety than the controls. They were, for example, less fearful than the controls when placed in an illuminated enclosure, daring to walk into its brightly lit center, whereas regular mice were careful to stay on the darker periphery, avoiding the stress of the bright light. Moreover, the mice receiving beta-sitosterol did not exhibit any of the side effects that might be expected from antianxiety medications - their locomotion was not impaired, and they did not refrain from exploring novel stimuli.

    Next, the researchers tested the effects of beta-sitosterol on mice when given in combination with fluoxetine, a drug belonging to the class of selective serotonin reuptake inhibitors, or SSRIs, and sold under the brand name Prozac, among others. The combination had a synergistic effect: Both beta-sitosterol and fluoxetine reduced the anxiety of mice at lower doses when given together, compared with the doses needed to produce the same effect when they were administered separately.

    "One of the major problems with existing antianxiety medications is that they produce side effects, so if beta-sitosterol could help cut down the dosage of such medications, it might potentially also reduce the unwanted side effects," Panayotis says.

    A great advantage of beta-sitosterol is that it is naturally present in a variety of edible plants, and it is thought to be safe, as it has been marketed for years as a nutraceutical. It is found in particularly large concentrations in avocados, but also in pistachios, almonds and other nuts, in canola oil, in various grains and cereals and more.

    However, this does not mean that eating avocado can induce a calming effect, since it doesn't contain enough beta-sitosterol. "You'd need to eat avocado day and night to get the right dose - and you would be more likely to develop digestive problems than relieve your anxiety," Panayotis says.

    The precise mechanism of beta-sitosterol's effect on anxiety remains to be revealed, but the scientists did find that the expression of several genes known to be activated in stressful situations was reduced in mice given the supplement. They also found that these mice had changes in the levels of certain metabolites and neurotransmitters in brain areas involved in anxiety.

    Since the study focused on brain regions and neural pathways that are involved in regulating anxiety in both mice and humans, it is likely that the findings will apply to humans as well. This will, however, require further clinical testing.

    As Fainzilber points out: "There's a need for a clinical trial to test the use of beta-sitosterol for reducing anxiety in humans. Until then, we recommend that people consult their physicians before taking the supplement for this purpose."

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    Study participants included Philip Freund and Dr. Letizia Marvaldi of the Biomolecular Sciences Department; Dr. Tali Shalit of the Nancy and Stephen Grand Israel National Center for Personalized Medicine; Dr. Alexander Brandis and Tevie Mehlman of the Life Sciences Core Facilities Department; and Dr. Michael Tsoory of the Veterinary Resources Department.

    Prof. Michael Fainzilber is the incumbent of the Chaya Professorial Chair in Molecular Neuroscience

    Prof. Fainzilber's research is supported by the Moross Integrated Cancer Center; the David Barton Center for Research on the Chemistry of Life; the Laraine and Alan A. Fischer Laboratory for Biological Mass Spectrometry; the Dr. Miriam and Sheldon G. Adelson Medical Research Foundation; Miel de Botton; and the Estate of Lola Asseof for Alzheimer's Disease Research.