Tuesday 31 August 2021

Covid cases at this Texas school are spiking, yet officials buck local mask mandate


“I just felt this rage,” Woodard said.

What she feared most had come true: Her daughter, who attended school in a mask and face shield, had contracted the coronavirus. And Woodard believes this is the second time she’s had it.

But at Cara’s school, in the Humble Independent School District in Texas, masks are optional, which violates a local mask mandate for all public schools and daycare centers issued by Harris County Judge Lina Hidalgo earlier this month.

Instead, school officials told CNN, the district is following Texas Gov. Greg Abbott’s pandemic-related executive order banning school mask mandates. And Harris County authorities have not contacted them about the lack of compliance with the county order.

“Nobody in the school community cares about whether she is safe,” Woodard said, still shaking. “How can you call yourself a community when you don’t care, whether or not, the people in the community live or die?”

Since the start of the school year, more than 1,800 Humble ISD students and 350 staff have tested positive for Covid-19, according to the district’s dashboard.
And Covid-19 cases among Texas public school students have nearly tripled in a week, from August 15-22, according to the latest state data available, which shows more than 20,000 Texas students have tested positive for the coronavirus since the start of the school year.

Child hospitalizations spiking

Medical experts in the Houston area, which is where Humble ISD is located, are sounding the alarm about the record number of children contracting the coronavirus and requiring hospitalization.

“Over the past week we reached a peak in terms of the number of children hospitalized in a 24-hour period with Covid-19 at Texas Children’s,” Dr. James Versalovic, interim pediatrician in chief at Texas Children’s Hospital, told CNN Wednesday.

Last Wednesday, Versalovic told CNN his hospital had seen more than 65 pediatric patients in the previous week, a record number.

And children were showing up sicker than previously seen.

Despite the record numbers, CNN observed some parents walking their children to a Humble ISD school last week without a mask and asked if their kids would be wearing masks in the classroom.

“It’s a personal choice,” Jaime Urbina told CNN.

Urbina says his 7-year-old daughter, who attends second grade, doesn’t like wearing a mask. He says he knows the virus is real — because he lost his mother to Covid-19 last May, on Mother’s Day. But just like he doesn’t impose his will on others, he says, he expects the same in return when it comes to masks.

Ingrid Cuevas, a mom who dropped off two children, ages 5 and 7, without masks at school that morning, says her children were exposed to Covid-19 positive classmates last week. She says she kept them home for three days, monitored their health, and then sent them back to school without a mask.

“So far, they haven’t gotten sick,” Cuevas said.

According to its website, the school district will inform parents if there’s a positive case in their child’s elementary school classroom but children who’ve been exposed to the virus aren’t required to quarantine if they don’t show symptoms.

Instead, the district says, “families will determine what is best for their specific situation.”

‘It was the worst day of my life’

Woodard held back tears as she described Cara having trouble breathing in February of 2020 — before widespread lockdowns were imposed in the United States.

“It was the worst day of my life,” Woodard said, the pain clear in her voice.

Cellphone video shows Cara making wheezing sounds with every breath while sleeping in her mother’s arms.

One of the most frustrating things, Woodard said, was that doctors couldn’t explain why her daughter’s chest hurt so much, Woodard said.

“She was so inflamed,” Woodard said. “She kept saying it felt like someone was standing on her.”

Woodard says that months later, Cara’s pediatrician told her Cara possibly had Covid-19, given her condition and that she had just traveled internationally. At the time Covid-19 tests were not readily available.

Mom tries to explain Texas mask rules to her 5-year-old

That’s why she shared the 2020 cellphone video of her daughter, having trouble breathing, on social media with a small group of parents — to convince them to send their children to school wearing masks.

“I said, ‘this is real.’ This is not a joke. This isn’t politics. This is our kid’s health,” Woodard said.

But to Woodard’s disappointment, she says, the video did not persuade them to mask their children.

‘Do I have Covid? Am I going to die?’

CNN interviewed four mothers whose children attend Humble ISD.

Stacie Smith, Nicole Willis, Rosell Jenkins and Laura Castrillo say they are frustrated, angry, afraid, anxious and in disbelief that the district has not implemented a mask mandate, given the increasing number of Covid-19 cases among students and staff.

Willis says that while school administrators drag their feet, her 8-year-old daughter’s stress level is so high that when she had the sniffles last week, she asked her if she was going to die.

“Do I have Covid? Am I going to die?” Willis says her daughter asked her.

As Willis shares the story, she says she tries “not to cry because it’s really heartbreaking.”

Stacie Smith, Nicole Willis, Rosell Jenkins and Laura Castrillo have been advocating for a mask mandate at Humble ISD.

“I do feel like it’s going to take more deaths for our district to do something,” Castrillo said, holding back tears. “That’s what is really scary.”

Jenkins says her 9-year-old son has also asked her about death and she is worried about the potential long-term mental health effects associated with that.

“Why can’t our district step up and protect our kids?” Smith said.

‘We are continuing to follow the Governor’s order’

CNN emailed the district twice last week, on Monday and Tuesday, requesting an interview with the superintendent of Humble ISD.

When receipt of our requests was not acknowledged, CNN followed up Thursday in person at the district’s administration office. Jamie Mount, the district’s chief communications officer, said the superintendent had a “scheduling conflict” and that she would address our questions about masks.

“We are continuing to follow the governor’s order and masks will remain optional at this time,” Mount said.

Unvaccinated, unmasked teacher infected more than half of students in class with Covid-19, CDC reports
CNN pressed Mount about the Harris County mask mandate in schools, which has been upheld by Texas courts and remains law. Gov. Abbott is expected to appeal the latest court ruling, which was issued by a Texas judge Friday.

“Like many school districts in Harris County and throughout the state of Texas, we are continuing to follow the governor’s order and we will wait for the Texas Supreme Court to decide,” Mount said.

Mount also says that the district has adopted other mitigation measures like clean air technology and enhanced cleaning at school campuses, as well as offering students a virtual school option.

Harris County Judge Lina Hidalgo says school districts are expected to enforce the mask mandate as they do every other school policy.

“The consequences for failing to do our basic due diligence to protect children are severe — sick children, more hospitalizations, and the potential for young people suffering from long Covid-19,” Hidalgo said.

Stacie Smith and her children, Willow, Frances, Winnie, Lewis, and Patrick joined a demonstration to advocate for a mask mandate at Humble ISD Monday.

Parents protest for a mask mandate

More than a dozen parents protested on foot and from their cars outside the Humble ISD administration office Monday, according to Smith, who provided CNN with photos of the event. Smith says she attended with her children to show them how to advocate for themselves and others.

“I wanted the leadership of our district to see them [her children], to serve as a reminder that this is about real people’s lives and their safety,” Smith said.

Woodard said she planned to attend, but instead developed a fever, congestion, body aches and a cough. So she decided to stay home and schedule an appointment to get tested for Covid-19. The earliest appointment she could find was Wednesday, she said.

“I’m vaccinated. I’m going to recover. I’m going to be fine. My whole concern was my daughter,” Woodard told CNN by phone between coughs.

As for Cara, Woodard said she doesn’t have any Covid-like symptoms and is scheduled to go back to class next Tuesday. But with the district not requiring masks, Cara’s teacher in isolation with Covid and at least nine of her classmates also infected, Woodard said she might pull Cara out of public school and enroll her in private school.

“That’s how frustrated I am,” Woodard said. “I just don’t understand the leadership in the school district.”

CNN’s Maggie Fox, Kacey Cherry and Sarah Moon contributed to this report.



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Effect of exercise on Alzheimer’s patients – Harvard Medical School explains how



Effect of exercise on Alzheimer’s patients – Harvard Medical School explains how&nbsp | &nbspPhoto Credit:&nbspiStock Images

Key Highlights

  • A recent study sheds light on the benefits of exercise for patients with Alzheimer’s
  • Alzheimer’s is neurodegenerative disease that affects people over the age of 60
  • Alzheimer’s is a progressive disease, that is, it worsens over time

Alzheimer’s is a progressive neurodegenerative disease that affects the brain. It is considered a dangerous condition as it has the ability to destroy cognitive function drastically. What makes it particularly scary is the fact that there is no cure available for Alzheimer’s and the symptoms of this condition do not appear until it is too late. According to a recent study published in the journal Nature Metabolism titled “Exercise hormone irisin is a critical regulator of cognitive function”, exercise can benefit cognitive health associated with its decline due to Alzheimer’s disease. 

Hear it from the author

Christiane Wrann, an HMS assistant professor of medicine and leader of the Program in Neuroprotection in Exercise at Mass General and the senior author of the study said, “For the first time, we showed that soluble irisin, and not its full-length parent protein FNDC5, is sufficient to confer the benefits of exercise on cognitive function.”

“These effects can possibly go well beyond what exercise itself can bring. This is particularly important in as much as irisin, a small natural peptide, would be much easier to develop into a therapeutic than the much larger membrane-bound protein FNDC5,”, he added.

To understand this better, let us know what irisin is. Not discovered long ago, irisin emerged as a popular metabolic biomarker that is released by the muscles after stimulation through exercise. The benefits of this hormone pertain to thermoregulation and weight loss.

Key findings of the study 

The key findings of the study are as follows:

  • Exercising can lead to the secretion of irisin and it can prove to be beneficial for approaching brain issues that are a consequence of Alzheimer’s disease.
  • The increase in the level of irisin can lead to enhanced cognitive function. 
  • Neuroinflammation is one of the factors that affects and damages brain neurons. The study shows that irisin can also be helpful in dealing with neuroinflammation.

Disclaimer: Tips and suggestions mentioned in the article are for general information purpose only and should not be construed as professional medical advice. Always consult your doctor or a dietician before starting any fitness programme or making any changes to your diet.



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UK Receives $23.5 Million Clinical and Translational Science Award from the NIH


LEXINGTON, Ky. (Aug. 30, 2021)  The University of Kentucky Center for Clinical and Translational Science (CCTS) has received a $23.5 million, four-year award from the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health. This is the third time the CCTS has successfully competed for the prestigious Clinical and Translational Award (CTSA), with continuous funding since 2011 totaling $65.4 million in research dollars.

“For the past 15 years, CCTS has catalyzed clinical and translational discoveries through an integrated, transformative research environment aimed at improved health, with an emphasis on Central Appalachia,” said UK President Eli Capilouto. “This continued funding is a testament to the incredible talent we have at this institution and our enduring promise to improve health outcomes in Kentucky.”

Founded in 2006 with the mission of accelerating discoveries to improve health, the CCTS is a disease-agnostic center that supports research from bench to bedside to community, with particular focus on Appalachia. The center provides a robust research infrastructure for all types of health research, including pilot funding, training and career development for the next generation of translational researchers, a full spectrum of research support services, community engagement resources, multidisciplinary mentors and connections to local and national research networks.

“It was great to join President Capilouto and the rest of the University of Kentucky CCTS team to announce today’s transformational award. With the grant we are announcing today, UK’s capacity to help Kentuckians with groundbreaking health care innovations will only grow,” said U.S. Senate Republican leader Mitch McConnell. “I’ve been proud to help the University of Kentucky develop into a competitive research institution and bring new jobs and industries to the Bluegrass. With today’s announcement, we are further cementing Kentucky’s role as a national hub for medical research and technological development.”

Over the past 15 years, the center has introduced new efficiencies and programs to support clinical trials, trained scores of researchers and staff, enhanced regulatory supported, expanded UK’s biomedical informatics infrastructure, increased entrepreneurial support for researchers and helped establish innovative new centers and resources, both at UK and in the Appalachian region.

The vital role of the CCTS was never more evident than in 2020. When the COVID-19 pandemic struck, the CCTS leapt into action, leveraging its expert and responsive infrastructure, said CCTS Director Philip Kern, M.D. The center rapidly established a COVID-19 biobank, launched a pilot funding program specifically for COVID, and operationalized a hugely successful COVID-19 vaccine trial unit.

Janssen Pharmaceuticals (of Johnson & Johnson) approached UK vaccine researcher Richard Greenberg, M.D., to lead a site for the phase-three clinical trial of their COVID vaccine, and the CCTS infrastructure made it happen, Kern said. Within 83 days, a newly built COVID vaccine clinical trial unit was up and running. Nearly 900 Kentuckians, including many front-line workers, participated in that trial which got real vaccines in people’s arms two months before any vaccine had received emergency use authorization (EUA).

“With CCTS leadership, UK — with subsites at Baptist Health Lexington and Norton Healthcare in Louisville — became the top enrolling site in the world for the phase three trial whose data led to the EUA for the Johnson & Johnson vaccine,” Kern said.

“The success of that first COVID vaccine trial at UK paved the way for four more vaccine studies at the institution, three adult studies which the CCTS fully implements and a pediatric vaccine study it provides support for.”

With its new round of funding, the CCTS plans to expand funding opportunities including a new mechanism to support research on climate change and human health; ramp up its diversity, equity and inclusion efforts; and build more research partnerships with other institutions. The center will also develop a new team science training resource to provide personalized coaching to multidisciplinary research teams.

“Through its cumulative, multipronged efforts, the CCTS has been a driver of UK research expansion from $285.1 million in extramural awards in 2015 to $333.4 million in 2018,” said Lisa Cassis, Ph.D., UK vice president for research. 

The CCTS pilot funding program has, to date, yielded a 20-fold return on investment and resulted in 3,308 peer-reviewed publications with more than 39,000 citations between 2012 and 2017 alone. Pilot grants through the Appalachian Translational Research Network, of which the CCTS was a founding member, have seen a return on investment of nearly 18 to 1.

The CCTS also provides essential clinical and translational research education and training for undergraduates, faculty and staff through its “career development highway.” To date, 22 junior faculty have completed its KL2 career development program (five more are currently participating), and 41 pre- and post-docs have completed the TL1 clinical and translational science training program. More than 1,000 professional, medical, dental, pharmacy and clinical psychology students at UK have taken the CCTS’ Introduction to Clinical Research course, and the CCTS was instrumental in developing UK’s certificate and degree programs in clinical and translational science. The center additionally runs six seminar series throughout the academic year.

Since 2018, the CCTS has also led the DREAM Scholars program for faculty in health equity research and/or from minority populations, and in 2019 it launched a similar program, SPARK, for undergraduates.

The CCTS reaches far beyond campus, too. Its innovative Community Leadership Institute of Kentucky has partnered with 43 community leaders from 28 Appalachian counties to empower them with skills and funding to conduct needed health research in their community and implement local solutions. Meanwhile, the CCTS Community Seed Grant program has provided 21 small grants to partners in Appalachia for projects that address priority health needs; support for financial management, human research advice, and data collection is also provided. A community health educator in Johnson County, Kentucky, for example, leveraged her seed grant and her personal health journey to help her community members prevent diabetes; her work was even featured in a KET documentary.

“UK HealthCare has been a partner of the CCTS since its inception and we are especially proud to work with them over the past year to 18 months with these historic, lifesaving COVID vaccine studies,” said Mark F. Newman, M.D., UK executive vice president for health affairs. “While we are still struggling with the current pandemic, we are learning more every day and finding new ways to overcome these challenges and that is due to research performed here at CCTS.”



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Monday 30 August 2021

Covid-19 Surge in Asia Threatens Manufacture of Ceramic Bits in iPhones and PlayStations


Hidden inside the newest smartphones are more than a thousand tiny bits of ceramic to control the flow of electricity. Inside an electric vehicle, there are more than 10,000.

They are called MLCCs, for multilayer ceramic capacitors, and the surge of Covid-19 infections across East Asia is raising the risk that factories won’t be able to make enough of them.

Murata Manufacturing Co. of Kyoto, Japan, the biggest MLCC maker, closed a major factory for the final week of August because of a virus outbreak. Japan’s Taiyo Yuden Co. , another major maker, said in August that it suspended some operations at its factory in Malaysia because of employee infections.

“MLCC supply will remain very tight,” said Forrest Chen, an analyst at Taiwan-based research firm TrendForce.

The world has seen this year how a shortage of normally little-noticed components can hit the global supply chain. Global makers of cars and electronics have shut down factory lines and missed potential sales because they don’t have enough semiconductors.



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Is undergraduate ophthalmology teaching in the United Kingdom still fit for purpose?



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Quantum leap for medical research as microscope zooms in on tiny structures | Science


Australian researchers have developed a microscope that can image tiny biological structures that were previously not visible in what has been described as a significant step for quantum technology.

It is believed to be the first time that quantum technology has improved on existing light microscopes, which in future may lead to improvements in medical imaging and navigation systems.

Quantum technologies are based on the principles of quantum physics, used to describe how tiny systems like atoms and subatomic particles behave.

The quantum microscope works with 35% more clarity – at the scale of bonds between atoms in a cell – than existing state-of-the-art imaging techniques.

Though still an early proof of concept, it is hoped to eventually have wide-ranging applications, including improving MRI scans, and studying nerve degeneration and the effects of antibiotics.

Lead researcher Prof Warwick Bowen, from the University of Queensland, said the quantum microscope outperformed conventional technologies.

“We’ve shown it’s possible to go beyond the limits of classical physics, to see things you could not see in a regular microscope,” he said.

A common problem in imaging tiny structures is the ratio of the signal given off by the thing researchers are trying to look at compared with random light fluctuations in the background of an image.

Scientists had previously overcome this issue by increasing the intensity of a microscope’s light source, using lasers billions of times brighter than the sun – including in techniques that won the Nobel prize for chemistry in 2014.

This can cause problems in the biological samples being studied, said Prof Brant Gibson at RMIT, who was not involved in the study.

“They get killed, they change their behaviour,” said Bowen. “All sorts of stuff happens that makes it really difficult to interpret what is going on in biological systems.”

To get a clearer picture, the new microscope uses quantum technology to reduce random light fluctuations within an image. It works involving quantum entanglement, a phenomenon in which photons of light are linked to each other – an effect Einstein described as “spooky interaction at a distance”.

The microscope studies molecular vibrations within a cell. “It basically tells you about what chemical bonds there are in particular regions of the cell,” said Bowen. “That’s been shown to be able to distinguish cancerous from healthy cells.”

“If this technique that’s being proposed can extract more information from using not as intense light levels, then I think it’s quite a profound outcome,” said Gibson.

Prof Dayong Jin at the University of Technology Sydney, who was not involved in the research, said it would take time for the new imaging technology to be broadly adopted.

Jin cites the 2014 Nobel prize–winning research as an example: it was first developed in the early 1990s, but took more than a decade to be adopted in laboratories around the world.

“Hopefully within 10 years quantum microscopy can be widely developed and improved,” said Jin.

The researchers are hoping to further improve the performance of the new microscope, to give an image around 10 times clearer than existing technology.

Many governments around the world have invested heavily in quantum technology. The Australian Army Research Centre has identified it as having the potential for “unprecedented capabilities in sensing, imaging, communications and computing”. Developing sophisticated sensors such as this microscope also forms a key milestone in the UK’s quantum technologies roadmap.

In 2019, Google declared it had achieved “quantum supremacy” – that it had built a quantum computer capable of outperforming the world’s best traditional supercomputer.

The quantum microscopy research was partially funded by the US air force and was published in the prestigious journal Nature. The first author of the study was Catxere Casacio.



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Sunday 29 August 2021

Divorce attorneys brace for exes battling over kids getting COVID-19 vaccine


With COVID-19 vaccines recently approved for children 12 and older, more divorce attorneys around the country are starting to see divorced parents disagree on vaccinating their children.

“This is something we’ve been seeing increasingly over the last few months,” said Stephanie Tang, an attorney with Chicago law firm Kogut & Wilson and vice chair of the Illinois State Bar Association’s Family Law section council.

Tang, who has represented parents on both sides of the issue, said even before the pandemic, divorced parents argued over vaccinations. Now, with school starting and restrictions being tightened at many public places like restaurants and entertainment venues, it’s putting more pressure on parents to vaccinate their children against COVID-19.

Adding to the pressure was last week’s decision by the Food and Drug Administration to give final approval of Pfizer-BioNTech’s COVID-19 vaccine for people 16 and over, replacing its “emergency use” status and putting it on par with other marketed vaccines.

CPS and several other school districts already require employees to be vaccinated.

As for a vaccine mandate for students, the Illinois Department of Public Health “is looking at all options to help protect students, teachers and staff as they return to in-person learning,” spokeswoman Melaney Arnold said.

Brad Novak, a divorced father from Lansing, said there are too many unknowns for him to be comfortable getting his 13-year-old daughter vaccinated.

“I’m on the side of caution. I’m like, ‘No thank you’ for the COVID vaccine, not knowing how it’s going to affect my child,” Novak said.





Brad Novak got the COVID-19 vaccine but says there are too many unanswered questions for him to allow his teen daughter to get vaccinated.
Provided

“I don’t know how it’s going to affect her body or her potential for having kids or what it could mean to her children, how their DNA could be affected as well,” Novak said.

He got the vaccine, he said, because he has no plans for more children.

The Centers for Disease Control and Prevention recommends everyone 12 and older be vaccinated against COVID-19, and the American Academy of Pediatrics recommend it for all people without contraindications who are 12 and older.

Novak, who also has 11-year-old twin boys, said despite his objections, his ex-wife vaccinated their daughter a couple weeks ago, though she did tell him beforehand. Novak said he couldn’t afford to fight it in court, and he didn’t want to create tension between him and his daughter.

“It’s not that I’m opposed to standing up for what I believe in, but it didn’t cross my mind because of the financial costs.”

Sarah Stark, a divorced mother of 10-year-old Shayna, cannot wait to get her daughter vaccinated despite the objections of her own ex.

Novak’s objections don’t pass muster with her.

“I definitely understand the importance of questioning. I believe strongly that people should question things. But I have a problem with people getting their information from YouTube or TikTok videos, and people search for things that fit their beliefs. It’s called confirmation bias,” Stark said.



Sarah Stark, a divorced mother to 10-year-old Shayna, cannot wait to get her daughter vaccinated despite the objections of her ex.

Sarah Stark, a divorced mother to 10-year-old Shayna, cannot wait to get her daughter vaccinated despite the objections of her ex.
Provided

Stark said her daughter, who is doing remote learning again this year because she has epilepsy, which Stark said puts her at a higher risk if she contracts the coronavirus, is frustrated with people who refuse to get themselves or their kids vaccinated.

“There’s a piece of me where my compassion is becoming very thin because I think people sometimes just don’t want to see things differently,” Stark said.

Stark doesn’t believe she can change her ex’s opinion of the vaccine, but she doesn’t have to: She has sole responsibility for medical decisions concerning her daughter.

Other parents share responsibility for medical decisions. Tang said most parenting agreements have a provision requiring parents to try mediation first. Still, if mediation doesn’t work, the issue will end up in court — and Tang expects that to happen more often.

Once in court, a judge often will appoint an independent party, known as a guardian ad litem, to act as the eyes and ears of the child, said Staci Balbirer, a family law partner with Aronberg Goldgehn in River North.

“That person will look at the facts. Is the child immunocompromised, is this child attending in-person school, do they have siblings, are they in extracurricular activities? The court is going to look at that when determining if the vaccine is the best decision for the child, and it’s going to be a hard decision for the courts to make,” Balbirer said.

Chantelle Porter, a family law attorney at A. Traub & Associates in Lombard, has been a guardian ad litem in both DuPage and Cook counties. He said the coronavirus vaccination issue is coming up more and more, and judges are looking to science for guidance.

“The trend of the court seems to be that they are looking to see which parent has the responsibility for medical decisions. If they have joint decision-making responsibilities, they seem to be leaning toward science, for lack of a better word. Each case is specific, but they are looking at best practices, science and whatever the recognized authorities like the American Academy of Pediatrics states”, Porter said.

In cases where a specific medical issue is cited by a parent for not vaccinating their child, she checks them out. “I would get a release to speak to the child’s pediatrician or get their medical records so that I can verify things.”

Porter added that although the courts may see an influx of cases asking for decisions on child COVID-19 vaccinations, she expects the majority of cases will be whittled down to disputes with special circumstances.

“I think as we get further along, the courts are going to be relying more on science. The cases you’re going to see will be more of those outlier cases, where the family might have some unique circumstances that need to be looked into.”

Regardless of where someone falls in the debate, Stark said it’s important that people listen to each other to get somewhere without relying on the judicial system.

“I have personal friends who have very different views than I, and I’ve stayed friends, but it’s gotten harder and harder over the last few years. But at the end of the day, if I close the door, it just becomes two separate camps. To get anywhere, we have to be willing to make enough space inside of ourselves to hear one another.”



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Ashland pediatrician and parents establish Marshall Medical School scholarship | Features/Entertainment





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Gov’t injects £64m into clinical research plan




The UK government has announced today its plan to funnel £64m into a new plan designed to strengthen clinical research delivery in a bid to ‘save lives across the country’.

The Department of Health and Social Care (DHSC) has revealed the first phase of activity following the previously published policy paper ‘Saving and Improving Lives: The Future of UK Clinical Research Delivery’.

The £64m dedicated investment will go towards ensuring research has better health outcomes, allowing more patients to be involved in and benefit from clinical research.

Over the coming months, the first phase of activity will include the development and trial of new COVID-19 treatments and vaccines, developing more rapid ethics reviews and faster approval processes, boosting clinical research capacity with more virtual and remote trials and increasing diversity and participation in research in traditionally underserved communities.

“Clinical research has been vital in our fight against COVID-19 and has saved thousands of lives. Working with the Scottish, Welsh and Northern Ireland governments, our ambitious UK-wide vision for the future of clinical research delivery is essential if we are to build on this exciting and life saving momentum,” said Health and Social Care Secretary Matt Hancock.

“We are making this vision a reality by continuing to work closely with our partners across the UK, the NHS, regulators, industry and medical research sector. We will create a more innovative, resilient and patient-centred clinical research system,” he added.

As part of the plans, there will be close collaboration and partnership between different organisations across the UK through the Clinical Research Recovery, Resilience and Growth programme.

This includes representatives from all UK health departments, the NHS, regulatory, the National Institute for Health Research (NIHR), medical research charities and industry.

“This is the first step in a big ambitious vision. We will continue to build upon these strong foundations to deliver a research ecosystem that positions the UK as a global leader in cutting-edge clinical research. With research embedded across the NHS, UK will be a global leader in trials for new treatments and technologies,” commented Lord Bethell, Minister for Innovation.



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Saturday 28 August 2021

New Mask, COVID Vaccine Requirements Taking Effect In New York – CBS New York


NEW YORK (CBSNewYork) — New mask policies and COVID vaccine requirements are taking effect in New York.

State health officials are requiring face masks at all public and private schools, while US Open officials reversed course and will require fans to show proof of vaccination before entering the grounds.

READ MORE: US Tennis Association Reverses Course, Will Now Require Proof Of Vaccination For US Open Fans

Mayor Bill de Blasio served up a last-minute vaccine mandate to the US Open on Friday after criticism mounted over the tournament’s decision not to require vaccinations, mask or even a COVID test.

“If there’s no screening for vaccination, or even a negative test, this is an extremely high-risk event,” said Mark Levine, chairman of the New York City Council Health Committee.

Fans 12 and older will now have to show proof of having at least one dose of the vaccine in order to enter the tennis center grounds. It comes after the city informed the USTA that vaccine guidelines must be followed.

Meanwhile, the New York State Department of Health issued an emergency regulation requiring face masks inside all public and private school buildings.

The order applies to students, teachers, staff, contractors and visitors from pre-K through 12th grade, regardless of vaccination status.

READ MORE: New York Weather: CBS2’s 8/28 Sunday Morning Update

Sixty percent of city residents are now fully vaccinated, with sharp increases among 12 to 17-year-olds.

“What happens in the schools reflects the larger reality of the city,” de Blasio said.

That’s why the race to vaccinate is intensifying with less than three weeks to go before the school year.

The city is renewing its strategy to center the vaccination push around houses of worship by deploying 50 mobile vaccination units to various sites this weekend.

“Faith leaders speaking up to get our young people vaccinated is going to be a difference maker,” said de Blasio.

So far, the city is on a positive trajectory. According to the CDC, the vaccination rate for 12 to 17-year-olds in New York City is 9% higher than the national average.

MORE NEWS: Gunpoint Robbery At Brooklyn Gas Station Caught On Video

CBS2’s Christina Fan contributed to this report.



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Op-Ed: What I didn’t learn in med school: How to become a writer



This year, at 46, I finally published a book. People who don’t know me often ask, “How did you find the time to write it?” — as if I might confess that I had help from either amphetamines or private access to an additional dimension. But I like to point out that, for most of my life, what I really made a career out of was being a non-writer.

As a result, it’s quite plausible that my real expertise lies in how not to write a book, and for prospective writers, there are lessons lurking in that failure that are just as telling as whatever I later managed to get right.

I was always driven to write. Some version of the words “write my book” appeared on my endless to-do lists for almost 30 years. I had some early successes — a play here, a short story there. But then, in my early 20s, I left my postgraduate studies in English to pursue a career in medicine. There’s a long tradition of doctor-writers — William Carlos Williams, Anton Chekhov, Abraham Verghese — and I believed I would soon join them.

For a few months at the start of my medical residency, I got up every morning at 6, intending to — you guessed it — write my book. But residency was a marathon of hundred-hour workweeks and one tragic case after another. Before long, I desperately needed that extra sleep, and the early pages of that earnest effort were surrendered to a shoe box. They would lie in that cardboard tomb for several years.

Soon, I was into my 30s, with one child, then two, balancing my role as a 24-hour milk bar with trying to retain a sense of my own identity. All the time I thought this is the year. This year I’ll write it. But somehow each day was just another X on the calendar, one more day when I’d succeeded in caring for my babies and being a doctor and folding cloth diapers to help the environment but failed to do that thing I really needed to do. Write my book.

When my second child was just a few months old but before my third was born, I reached out to a doctor who is also a writer. I didn’t know him well, but I’d just finished his memoir and had the sudden, irrational, postpartum urge to pour my heart out to someone who might understand what I was carrying. I sent him a raw, brittle email. I told him I was grieving for what I hadn’t yet been able to do with my life. I told him there was something I knew I needed to be doing, but I’d gotten so good at not doing it that I didn’t know if I’d ever actually do it again.

An hour later, his reply landed in my inbox. He said he recognized the voice of a fellow writer. He said sometimes it was overwhelming to try to figure out where to begin our life’s work. And then he gave me a piece of simple but life-altering advice. Start small.

I told him the same thing would-be writers often tell present-day me: I don’t want to start small! I wanted an agent! I wanted a book deal! I wanted a publisher! What was the point of starting small? But in the coming weeks, he helped me realize something important. I wanted to be published in The Times before I had done the time. It took me seven years of postgraduate education to become a doctor. Why did I think becoming a serious writer would be any different?

His words that day brought reality into focus. I was fixated on an end product — holding a book in my hand. But any big achievement begins with focusing on a small action, every single day, and repeating it consistently. I needed to tweak my goal in a critical way. It shouldn’t have been “write my book.” It should have just been: Write.

Ten years after that revelation, I wonder how I would have made it through the pandemic without writing. It’s become the way I metabolize my life, how I sort it intentionally. Some days it’s as mundane and rote as taking out the garbage. Other days it feels profound, epiphanic, a revelation.

Once in a while, a friend or a stranger reaches out to me in a voice I would know anywhere, just the way another writer recognized it in me. They say, “I’ve always wanted to write,” and the pain in their words makes me sit up a little straighter, because I was there once, too, carrying that same deep ache in my heart.

I always give them some practical advice, things that got me past the finish line: Don’t watch Netflix. Use the Freedom app to limit access to social media. Less is almost always more.

But my most important advice is also the most obvious, and yet it is the advice all successful writers struggle to heed until one day we finally do. Begin somewhere, anywhere, every single day, for any increment of time, and keep going. Sometimes it will hurt, because writing is an act of masochism.

But it is also an act of faith — faith that, at least once in a while, it will be a portal to another dimension, one that is worth a 30-year wait.

Jillian Horton is a writer and physician. She is the author of “We Are All Perfectly Fine: A Memoir of Love, Medicine and Healing.”

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URMC team seeks to close racial gap in medical research


In early 2020, researchers at the Center for Health and Technology at the University of Rochester Medical Center were conducting one of their many studies, and they noticed a strange pattern.

“We focus on neurological disorders, and a lot of the participants at our study tended to be caucasian, but neurological disorders don’t discriminate by race,” said Ifunanya Dallah, a member of the study team. 

Rochester is a diverse city, where nearly 40% of the population is Black, 48% is white, and at least 37% is Hispanic, according to the most recent United States Census. 

The medical study’s lack of diversity was problematic, said Olivia Brumfield, another of study’s team members. 

“If all of your research is being conducted on one kind of person, it’s not generalizable for the kind of world we live in, or even the people who live next door,” said Brumfield.

The team decided to look into why the original study failed to reach a broader range of people. Researchers spent six months developing a new study that would determine the factors that left out Black or Latino respondents. 

Led by Dr. Gretchen Birbeck, the group of eight graduate and undergraduate research students developed the questionnaire that set out to get to the bottom of the racial divide. 

The study, officially launched January, included out-of-the-box outreach ideas to disseminate the survey by focusing on groups that have direct connection to minority communities in Rochester — such as refugee groups, churches, community centers — and getting involved with leaders and advocates. 

The survey asks several questions about the participant’s demographics, past involvement in a study, and what factors might have kept them from participating in the past, and what would make it easier for someone to participate in research.

Want to help?

The team is still collecting responses. It takes around 15 to 20 minutes to complete the survey, and the data stays with the research team at the Center for Health and Technology.

The questionnaire can be completed over the phone by calling (585)-275-9751 or can be completed online.

The research team said it also will conduct in-person outreach at public events such as the Public Market, festivals and recreation centers. 

While the survey was released earlier this year, the research team hopes to get more answers to reach an informed conclusion that will help more people of color and from varying ethnicities to participate in research studies. 

Brumfield said that the COVID-19 pandemic showed that it’s important for everyone to be represented in research, because it helps with medical advancement and in the end, the overall health of the community. 

The survey also is available in Spanish. 

Natalia Rodríguez Medina is a bilingual reporter covering the Puerto Rican and Latino population for the Democrat and Chronicle in partnership with Report for America. Follow her on Twitter at @nataliarodmed or email her at nrodriguezmedina@gannett.com. You can support her work with a tax-deductible donation to Report for America.



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Friday 27 August 2021

Fierce Pharma Asia—Samsung’s $205B investment; Moderna COVID vaccine impurities; Brii’s COVID antibody data


Samsung is plotting a $205 investment across its businesses including for its biosimilars and CDMO units. Moderna is probing contaminations in its COVID-19 vaccines in Japan as about 1.63 million doses are put on hold. Brii Biosciences reported positive phase 3 data from its antibody cocktail in nonhospitalized COVID-19 patients. And more.

1. Samsung plots $205B investment, massive hiring spree to ramp up CDMO, biosimilars and more

The Samsung Group is investing 240 trillion won ($205 billion) through 2023 across its many businesses including its biosimilars unit Samsung Bioepis and its contract manufacturing operation Samsung Biologics. The South Korean conglomerate will channel 180 trillion won ($154 billion) to upgrade its domestic facilities. Among them, Samsung Biologics will build two new plants, dubbed Plant 5 and Plant 6, at its existing hub in Incheon.

2. Moderna probes reports of COVID-19 vaccine contamination in Japan

Japan has suspended the use of about 1.63 million doses of Moderna’s COVID-19 vaccine after distributor Takeda received reports of impurities in some vials. Moderna said it hasn’t identified any safety concerns but has put the lot at question and two additional lots on hold. The company said it suspects the problem at a contract manufacturing facility in Spain might be the cause.

3. Brii’s COVID-19 antibody slashes hospitalizations and deaths in late-phase trial, teeing it up to take on Regeneron

Brii Biosciences has reported positive data for its COVID-19 antibody cocktail. The two-drug combo, BRII-196/BRII-198, slashed the risk of hospitalization and death by 78% against placebo in high-risk, nonhospitalized COVID patients in the NIH-sponsored ACTIV-2 study. Brii’s figures compare favorably to phase 3 data from Regeneron’s antibody cocktail, REGEN-COV.

4. Takeda, CSL hereditary angioedema meds need steep discounts following real-world evidence review, ICER says

In an updated analysis of cost-effectiveness of hereditary angioedema therapies, the Institute for Clinical and Economic Review suggests Takeda’s Takhzyro should cost 53% less than its current U.S. list price and its predecessor, Cinryze, 75% less. The new calculation came after the drug cost watchdog found patients suffered fewer baseline hereditary angioedema attacks in the real world than in recorded in clinical trials, suggesting the drugs’ benefits are smaller.

5. FibroGen scores a lifeline as Astellas-partnered roxadustat snags EU approval, triggering $120M milestone payment

FibroGen partner Astellas has won an EU nod for Evrenzo, better known as roxadustat, in anemia associated with chronic kidney disease. Astellas is also responsible for markets in Japan, Russia, the Middle East and South Africa. While the drug was recently rejected by the U.S. FDA, Mizuho analysts believe it can still collect $690 million sales from Europe and Japan at its peak.

6. Genevant pens $303M biobucks pact with Takeda aimed at rare liver diseases using gene therapy

Takeda already has a $600 million deal with Genevant to use the latter’s lipid nanoparticle tech to work on nucleic acid therapeutics that target liver fibrosis. Now, the Japanese pharma is back with another $303 million upfront-plus-biobucks pact to target two undisclosed rare liver diseases.

7. Lonza invests yet again, this time with a fill-finish line at a new manufacturing site in Guangzhou, China

Lonza is adding a new fill-finish line at its biologics plant in Guangzhou, China, which just opened in the second quarter of this year. The addition is expected to be complete next year and will create over 150 jobs. The expansion follows a 20 million Swiss franc investment at the Swiss CDMO’s API plant in Nansha, China, which was unveiled in June.

8. FDA puts Jubilant Generics plant through the wringer for cleanliness, quality flubs

In its first publicly posted Form 483 in months, the FDA blasted Jubilant Generics for a slate of problems at the company’s facility in Haridwar, India. During an inspection in March, FDA inspectors found an array of problems including that the factory didn’t clean and maintain its equipment often enough and didn’t conduct a proper investigation after a recall.

9. After vandalism during unrest in South Africa, India-based Cipla reopens Durban manufacturing site

Cipla has reopened a manufacturing site in Durban, South Africa, more than a month after it was vandalized and looted July 13 during civil unrest triggered by the jailing of former President Jacob Zuma. To mitigate the supply disruptions, Cipla said it leveraged other manufacturing sources in the country.

10. Coffee talk: Sun brings Ilumya patient stories to light with informal diner meetups

For Sun Pharma’s latest ad campaign, four psoriasis patients on its IL-23 inhibitor meet for the first time at a Savannah, Georgia, diner to share their stories living with the disease and finding treatments. The idea for the “Patient Stories” campaign was inspired by findings from a national survey that patients are interested in talking to other patients.



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Dunleavy announces Alaska medical school, state scholarships will be funded



The University of Alaska Anchorage, where the state’s WWAMI medical education program is based. The governor announced WWAMI and 17 other programs would be funded this year. (Photo by Jimmy Emerson)

Alaska’s medical education program and scholarships to attend college will be funded this year, announced Gov. Mike Dunleavy on Wednesday.

Dunleavy said he ordered his Office of Management and Budget to release funding for the WWAMI medical education program plus 17 other programs.

Kathryne Mitchell is a second-year WWAMI student. She’s glad about the announcement.

“We’re very excited that the funding for our program is secure for this year,” Mitchell said.

Without WWAMI, Mitchell would have to take on an extra $120,000 for four years of medical school — plus student loan interest.  She wants Dunleavy and the Legislature to secure long-term funding for the program.

“When this battle for funding for WWAMI comes up every year, we lose students — students who will go on to become excellent physicians. We lose them and they go train in other programs, where there’s more certainty as to funding. And then we don’t get them back as physicians in Alaska,” she said.

She’s originally from North Pole and wants to practice family medicine in rural Alaska.  She says the program benefits the whole state.

“For Alaska, it’s really, really important that we train home-grown students to become physicians here, because they’re the physicians that are going to stay,” she said.

The announcement allows more than $42.8 million to be spent on WWAMI and other programs that include funding to attend college through both $11.8 million in Alaska Performance Scholarships and $6.4 million in Alaska Education Grants. Oil spill prevention also received $3 million in additional funding.

WWAMI received $3.3 million. And reimbursements to municipalities to pay off their debt to build schools received $4.2 million.

Dunleavy’s administration previously had said that these programs could not be funded without the agreement of three-quarters of both chambers of the Legislature.

But Dunleavy said Wednesday that his administration reviewed this funding after a recent decision by a Superior Court judge. And this review led him to OK the spending.

That judge’s decision said that money in the Power Cost Equalization Endowment Fund was not subject to the three-quarters vote.

The administration said these programs received funding for this year’s budget before the money in the accounts used to fund them was swept into the Constitutional Budget Reserve.



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What is an Anesthesiologist

The field of anesthesiology is a medical specialty that focuses on the relief of pain and total care of the surgical patient as ...