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Saturday, March 4, 2023

Samantha Power Lets Slip The US Is At War With Russia, But "Ukrainians Doing The Fighting"

 In a CNN panel last week, the head of the United States Agency for International Development (USAID) Samantha Power issued some very revealing words on the Russia-Ukraine war, wherein she admitted that the US is at war with Russia but that it's "Ukrainians doing the fighting"

Her words came during a CNN 'town hall' event, which also featured Biden national security adviser Jake Sullivan, marking the one-year anniversary of Russia’s invasion. She had specifically responded to a question from an audience member, who asked: "What vital interest does to the US have in Ukraine?" At one point in forming a response she actually gave what ranks among the most ridiculously simplistic clichés sometimes uttered by D.C. policymakers - that America stands up to "bullies"

"I think Americans understand bullies and the importance of standing up to bullies," she said. But here's where she said the quiet part out loud, letting it slip that in some sense the US sees Ukraine as a pawn in the greater geostrategic game of ultimately defeating Russia: She explained the need for a broad coalition of countries in order to show "This isn't just the United States and Russia, this in fact is Ukrainians on the front lines, Ukrainians doing the fighting..." The set of assumptions behind this statement by a top Biden admin official is very revealing, however casually she may have slipped it in. Watch the clip below:


Auditors Are Finding Millions In Mishandled COVID-Era Education Funds

 by Ryan Morgan via The Epoch Times (emphasis ours),

Millions of dollars in pandemic-era relief spending that went to K-12 public education and universities was misspent, according to federal and state audits.

As COVID-19 spread around the world in 2020, federal, state, and local officials encouraged or ordered policies that led to the closures of businesses and schools around the United States. Between 2020 and 2021, Congress appropriated about $7 trillion in economic stimulus spending, including about $280 billion for states, K–12 schools, school districts, and institutions of higher education.

The U.S. Department of Education’s (DoE) Office of Inspector General has compiled audit reports from several states, at times finding state governments had insufficient procedures for distributing pandemic-era funds given to them by the federal government.

For example, a DoE audit of funds (pdf) given to Oklahoma through the Governor’s Emergency Education Relief (GEER) fund found that the state lacked assurances that $31 million, out of the $40 million appropriated to the state, was used appropriately. An audit of Michigan’s GEER-related spending (pdf) found potentially insufficient assurances that $5.4 million, of the $89.4 million the state received, was used properly.

In a comment to the Wall Street Journal, Republican Oklahoma Governor Kevin Stitt blamed the lack of accounting for pandemic-relief money in part on pressure from the federal government to quickly disburse education relief money without clear guidance on how it was to be awarded.

“That’s what happens when big government goes out just throwing money around,” Stitt told the publication.

A DoE audit of pandemic relief money for the University of Cincinnati (pdf) determined the university “did not provide complete and accurate student eligibility and financial data to support 3,297 (totaling $3.4 million), or 6 percent, of its award determinations.”

Local officials have also uncovered evidence of mishandled COVID relief. In February, California’s Fiscal Crisis and Management Assistance Team (FCMAT) published a report (pdf) faulting the  Stockton Unified School District for awarding a $6.6 million contract to install air purification systems in schools to an out-of-state firm without a competitive bidding process.

Fraud and Scams

While the DoE found some states and schools lacked a sufficient documentary process to ensure the eligibility of their pandemic-era relief fund awards, some individuals have been charged with outright fraud in their handling of education relief money.

In January, a Louisiana man was sentenced to 11 years in prison and ordered to pay restitution of millions of dollars. Prosecutors alleged the man, who ran an education consulting firm, used the information of 180 of his student clients to enrol them in education programs that received pandemic-era relief funding; and instead, directed all of that funding to his personal bank account. The Louisiana man received $1,468,239 in pandemic-era federal student aid loans through this scheme.

The DoE has issued a warning that the pandemic-era scams “can take many shapes, like missing school funds or property, irregularities in contracts or undue influence by people in decision-making positions, identity theft and fraudsters posing as students to steal student aid, or scammers targeting student loan borrowers offering to provide services related to coronavirus student loan relief for a fee.”

Even without being able to directly defraud education relief spending programs, fraudsters have appeared to take advantage of the confusion surrounding pandemic education relief to scam students out of their money.

In September, the Central Connecticut State University Police Department warned students of a scam in which the perpetrator would contact individual students, telling them that they were eligible for financial aid through a “Covid Relief Fund.” Victims would receive a check and believe it to be real, only for the fraudsters to claim that there was an error and request that the money be returned. The victim student would repay out of their own funds only to see the original check they had been issued bounce, leaving them short the amount of money they originally believed they had been awarded. The university warned that one student had already fallen victim to the scam.

On Thursday, President Joe Biden’s administration joined calls for Congress to approve more funding and resources and extend statutes of limitations to investigate and prosecute pandemic-era fraud.

https://www.zerohedge.com/political/auditors-are-finding-millions-mishandled-covid-era-education-funds

89bio: Positive New Analysis of Data from Phase 2 liver, cardio trial

 Post hoc analysis data demonstrated pegozafermin treatment significantly reduced triglycerides and other atherogenic lipids in patients with SHTG regardless of their background lipid-modifying therapy status –

89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the presentation of additional data from the Phase 2 ENTRIGUE trial of pegozafermin in patients with severe hypertriglyceridemia (SHTG) at the American College of Cardiology’s 72nd Annual Scientific Session & Expo Together with World Congress of Cardiology (ACC.23/WCC). The presentation featured results of a post hoc analysis exploring the effect of pegozafermin treatment on lipids among study participants based on their background lipid-modifying therapy (LMT) status. These results were presented by Deepak L. Bhatt, M.D., M.P.H., Director of Mount Sinai Heart and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai, and a copy of the poster is accessible under “Scientific Publications” in the pipeline section of 89bio’s website.

https://www.marketscreener.com/quote/stock/89BIO-INC-74010954/news/89bio-Presents-New-Analysis-of-Data-from-Phase-2-ENTRIGUE-Trial-of-Pegozafermin-in-Patients-with-Sev-43157118/

Pseudomonas bacteria produce a molecule that paralyzes immune system cells

 Bacteria of the species Pseudomonas aeruginosa are antibiotic-resistant hospital germs that can enter blood, lungs and other tissues through wounds and cause life-threatening infections. In a joint project, researchers from the Universities of Freiburg and Strasbourg in France have discovered a mechanism that likely contributes to the severity of P. aeruginosa infections. At the same time, it could be a target for future treatments. The results were recently appeared in the journal EMBO Reports.

Many bacterial species use sugar-binding molecules called lectins to attach to and invade host cells. Lectins can also influence the immune response to bacterial infections. However, these functions have hardly been researched so far. A research consortium led by Prof. Dr. Winfried Römer from the Cluster of Excellence CIBSS -- Centre for Integrative Biological Signalling Studies at the University of Freiburg and Prof. Dr. Christopher G. Mueller from the IBMC -- Institute of Molecular and Cell Biology at the CNRS/University of Strasbourg has investigated the effect of the lectin LecB from P. aeruginosa on the immune system. It found that isolated LecB can render immune cells ineffective: The cells are then no longer able to migrate through the body and trigger an immune response. The administration of a substance directed against LecB prevented this effect and led to the immune cells being able to move unhindered again.

LecB barricades the path for immune cells

As soon as they perceive an infection, cells of the innate immune system migrate to a nearby lymph node, where they activate T and B cells and trigger a targeted immune response. LecB, according to the current study, prevents this migration. "We assume that LecB not only acts on the immune cells themselves in this process, but also has an unexpected effect on the cells lining the inside of the blood and lymph vessels," Römer explains. "When LecB binds to these cells, it triggers extensive changes in them." Indeed, the researchers observed that important structural molecules were relocated to the interior of the cells and degraded. At the same time, the cell skeleton became more rigid. "The cell layer thus becomes an impenetrable barrier for the immune cells," Römer said.

An effective agent against LecB

Can this effect be prevented? To find out, the researchers tested a specific LecB inhibitor that resembles the sugar building blocks to which LecB otherwise binds. "The inhibitor prevented the changes in the cells, and T-cell activation was possible again," Mueller said, summarizing the promising results of the current study. The inhibitor was developed by Prof. Dr. Alexander Titz, who conducts research at the Helmholtz Institute for Pharmaceutical Research Saarland and Saarland University.

Further studies are needed to determine how clinically relevant the inhibition of the immune system by LecB is to the spread of P. aeruginosa infection and whether the LecB inhibitor has potential for therapeutic application. "The current results provide further evidence that lectins are a useful target for the development of new therapies, especially for antibiotic-resistant pathogens such as P. aeruginosa," the authors conclude.

Journal Reference:

  1. Janina Sponsel, Yubing Guo, Lutfir Hamzam, Alice C Lavanant, Annia Pérez‐Riverón, Emma Partiot, Quentin Muller, Julien Rottura, Raphael Gaudin, Dirk Hauck, Alexander Titz, Vincent Flacher, Winfried Römer, Christopher G Mueller. Pseudomonas aeruginosa LecB suppresses immune responses by inhibiting transendothelial migrationEMBO reports, 2023; DOI: 10.15252/embr.202255971

Bioengineering an endocrine pancreas for type 1 diabetes

 In people with type 1 diabetes, the body's immune system attacks and destroys insulin-producing β cells that control blood glucose levels and are part of a group of cells in the pancreas called pancreatic islets. In research published in Cell Reports Medicine, a team led by investigators at Massachusetts General Hospital (MGH), a founding member of Mass General Brigham, recently developed an efficient way to transplant pancreatic islets and demonstrated that the method can effectively reverse type 1 diabetes in nonhuman primates.

Pancreatic islet transplantation is a promising treatment approach for type 1 diabetes; however, current methods, which involve transplanting islets to the liver, are inefficient and can result in the loss of as much as half of transplanted β cells due to immune attack. Also, the liver can only accommodate a limited volume of transplanted tissue. Scientists have wondered if an alternative site might provide a more hospitable environment and lead to better results. One promising site is the omentum, the fatty tissue that starts in the stomach and drapes over the intestines.

To optimize the omentum as a transplant site in an individual, investigators used topical recombinant thrombin (which stops bleeding), an enzyme, and the recipient's own plasma to engineer a bio-degradable matrix by which donor islets are immobilized onto the omentum. When this strategy was used along with an immunosuppressive therapy to protect islets from immune attack, the method normalized blood glucose levels and restored glucose-responsive insulin secretion in three nonhuman primates with type 1 diabetes for as long as the animals were tested. "The achievement of complete glycemic control is attributed to the bioengineering approach that facilitates the process of revascularization and reinnervation for the transplanted islets," says first author Hong Ping Deng, MD, MSc, a researcher of Transplant Surgery at MGH. "which is the first time that such a demonstration has been made in a nonhuman primate model."

"This pre-clinical study can inform the development of new strategies for β cell replacement in diabetes and could change the current paradigm of clinical pancreatic islet transplantation," says senior corresponding author Ji Lei, MD, MBA, MSc, a principal physician investigator of Transplant Surgery at MGH and an assistant professor of Surgery at Harvard Medical School. "A clinical trial is being planned to test this approach."

Lei, who is also the director of the Human Islet/Cell Processing Special Service cGMP Facility at MGH, notes that in addition to transplanting islets from donors, researchers are also studying the potential broad application of transplanting stem cell-derived islets, which cured a patient with type 1 diabetes for the first time in human history in 2022 and could offer an endless supply of transplantable tissue. There are concerns about this approach, however, including the possibility of tumor development. Unlike the liver, the omentum is easily accessible for monitoring purposes, and its non-vital site status can allow for the removal of transplanted tissue should complications occur, with either stem cell-derived islets or islets from donors. In addition, the engineered omental site can be home to many other types of genetically engineered cells, especially for liver-based or inherited metabolic or endocrine disorders.

Co-author James F. Markmann, MD, PhD, chief of the Division of Transplant Surgery and director of Clinical Operations at the Transplant Center at MGH, stresses that the non-human primate study is a highly translational pre-clinical animal model. "The application of this strategy, particularly in stem cell-based therapy, has the potential to revolutionize the paradigm for treating patients with type 1 diabetes," he says.

Additional co-authors include Alexander Zhang, Dillon Ren Rong Pang, Yinsheng Xi, Zhihong Yang, Rudy Matheson, Guoping Li, Hao Luo, Kang M. Lee, Qiang Fu, Zhongliang Zou, Tao Chen, Zhenjuan Wang, Ivy A. Rosales, Cole W. Peters, Jibing Yang, María M. Coronel, Esma S. Yolcu, Haval Shirwan, and Andrés J. García.

This work was supported by the Juvenile Diabetes Research Foundation, and the National Institutes of Health.

Journal Reference:

  1. Hongping Deng, Alexander Zhang, Dillon Ren Rong Pang, Yinsheng Xi, Zhihong Yang, Rudy Matheson, Guoping Li, Hao Luo, Kang M. Lee, Qiang Fu, Zhongliang Zou, Tao Chen, Zhenjuan Wang, Ivy A. Rosales, Cole W. Peters, Jibing Yang, María M. Coronel, Esma S. Yolcu, Haval Shirwan, Andrés J. García, James F. Markmann, Ji Lei. Bioengineered omental transplant site promotes pancreatic islet allografts survival in non-human primatesCell Reports Medicine, 2023; 100959 DOI: 10.1016/j.xcrm.2023.100959

Seizures can be predicted more than 30 minutes before onset in temporal lobe epilepsy

 Seizures can be predicted more than 30 minutes before onset in patients with temporal lobe epilepsy, opening the door to a therapy using electrodes that could be activated to prevent seizures from happening, according to new research from UTHealth Houston.

The study, led by Sandipan Pati, MD, associate professor in the Department of Neurology with McGovern Medical School at UTHealth Houston, was recently published in NEJM Evidencea publication of the New England Journal of Medicine.

"The ability to predict seizures before they occur is a major step forward in the field of epilepsy research," said Pati, senior author of the study and a member of the Texas Institute for Restorative Neurotechnologies at UTHealth Houston Neurosciences. "These findings are significant because they suggest that we may be able to develop more effective therapies for epilepsy, which could greatly improve the quality of life for patients who suffer from this condition."

Surgery is a common treatment for many patients with epilepsy. But when seizures affect larger areas of the brain, removing part of the brain surgically is not an option. Neuromodulation therapy could offer an alternative solution for patients with these seizures, Pati said.

Past studies of continuous electroencephalography (EEG) -- the measurement and recording of electrical activity in different parts of the brain -- have suggested that seizures in people with focal-onset epilepsies tend to occur during periods of heightened risk, represented by pathologic brain activities known as "pro-ictal states." The EEG-based detection of pro-ictal states is critical to the success of adaptive neuromodulation, with the early detection of seizures allowing electrodes to be applied therapeutically to the brain's seizure onset zone and thalamus.

To distinguish these pro-ictal states, Pati's team studied a prospective, consecutive series of 15 patients with temporal lobe epilepsy who underwent limbic thalamic recordings in addition to routine intracranial EEG for seizure localization. In total, they analyzed 1,800 patient hours of continuous EEG.

The researchers were able to detect pro-ictal states in patients with temporal lobe epilepsy at least 35 minutes before seizure onset. Pro-ictal states were distinguished at least 45 minutes before seizure onset in 13 of 15 participants. In two of 15 participants, they were distinguished up to 35 minutes prior.

While Pati believes that modulation of these brain regions during pro-ictal periods may be an effective therapeutic approach to the treatment of temporal lobe epilepsy, his theory still needs to be tested in clinical trials. However, this information could lead to the development of electrical or drug therapies aimed at preventing seizures.

"This study was made possible by the collaboration of a team of experts in neurology, neurosurgery, and neuroscience," he said. "It highlights the importance of interdisciplinary research in advancing our understanding of brain disorders."

Temporal lobe epilepsy is the most common seizure disorder, affecting some 50 million people globally. There are two temporal lobes, one on each side of the head behind the temples. Mesial temporal lobe epilepsy, which accounts for about 80% of all temporal lobe seizures, involves seizures starting in or near a part of the brain called the hippocampus, which controls memory and learning. Neocortical or lateral temporal lobe epilepsy involves seizures starting in the outer section of the temporal lobe.

Omar A. Alamoudi, PhD, postdoctoral research fellow in the Department of Neurology with McGovern Medical School at UTHealth Houston, contributed to the study. Other co-authors included Adeel Ilyas, MD, and Kristen O. Riley, MD, both with the University of Alabama at Birmingham.

Journal Reference:

  1. Adeel Ilyas, Omar A. Alamoudi, Kristen O. Riley, Sandipan Pati. Pro-Ictal State in Human Temporal Lobe EpilepsyNEJM Evidence, 2023; 2 (3) DOI: 10.1056/EVIDoa2200187

Home-based cardiac rehabilitation may help people live longer

 Participating in home-based cardiac rehabilitation after a heart attack or cardiac procedure was associated with a 36% lower likelihood of death from heart-related complications among U.S. military veterans within four years compared to those who opted out of rehabilitation programs, according to new research published today in the Journal of the American Heart Association, an open access, peer-reviewed journal of the American Heart Association.

Although cardiac rehabilitation has been shown to reduce the risks of hospital readmissions and death, it is significantly underused, according to the American Heart Association. Cardiac rehabilitation emphasizes eliminating tobacco use, improving diet, engaging in physical exercise, managing stress and taking medications that treat high blood pressure or high cholesterol.

"Whether in a hospital or home, cardiac rehabilitation is all about healthy behavior changes," said senior study author Mary A. Whooley, M.D., a primary care physician at the San Francisco Veterans Affairs (VA) Medical Center and professor of medicine at the University of California, San Francisco. "However, changing behaviors is difficult, and while care facilities may offer on-site cardiac rehabilitation, many patients don't choose to take advantage of follow-up treatment. The biggest surprise of our analysis was how few patients chose to participate in cardiac rehabilitation."

While cost can be a barrier to participating in cardiac rehabilitation, along with geography and logistics, cost should not have been a factor as health care services were covered by the VA in this study.

"We don't know why so many patients opted out of rehabilitation," Whooley said. "Even when home-based cardiac rehabilitation was offered at the time and place of their choosing, only 44% of eligible patients chose to participate. Many patients were simply not interested in changing their behaviors."

Data indicated that among patients hospitalized for heart attack from 2007-2011, only 16% of Medicare patients and 10% of veterans participated in cardiac rehabilitation. Among eligible Medicare beneficiaries in 2016, only 24% opted to participate in on-site/facility-based cardiac rehabilitation. According to the Million Hearts® Cardiac Rehabilitation Collaborative, a national initiative co-led by the Centers for Disease Control and Prevention and the Centers for Medicare & Medicaid Services, it's estimated that increasing cardiac rehabilitation participation to 70% of cardiac patients after hospitalization could save 25,000 lives and prevent 180,000 additional hospitalizations each year.

"Many randomized trials have demonstrated similar mortality benefits from home-based and facility-based cardiac rehabilitation," Whooley said.

This is the first U.S. study to provide evidence of survival benefit with home-based cardiac rehabilitation in people with heart disease, according to the study authors. The ongoing COVID-19 pandemic which temporarily closed countless facility-based rehabilitation programs indicates a growing need to explore opportunities in telehealth care for people with heart disease, they said.

This study analyzed data for 1,120 veterans who were eligible for cardiac rehabilitation at the San Francisco VA Medical Center between August 2013 and December 2018. Among this study group, 98% were men, 2% were women, 76% were white, 88% were non-Hispanic and 68% lived in an urban area. About half had been hospitalized for percutaneous coronary intervention -- also known as angioplasty, 20% for coronary artery bypass grafting, 14% for heart attack and 18% for other reasons. Enrolling in the San Francisco Healthy Heart home-based cardiac rehabilitation program was voluntary, and only 44% (490 people) enrolled.

The home-based cardiac rehabilitation program lasted 12 weeks, during which participants received up to nine coaching calls, motivational interviews, a workbook and a personal health journal to document vital signs, exercise and diet. They also received a blood pressure monitor, a scale and (if desired) a stationary bike. A nurse or exercise physiologist worked one-on-one with participants to create achievable physical activity goals. Participants received follow-up phone calls from program staff at three and six months after program completion and were followed for an average of 4.2 years after hospitalization.

Among the researchers' findings:

  • The death rate at one-year after hospitalization was 4% among those who did not participate in cardiac rehabilitation versus 2% among those who participated in home-based cardiac rehabilitation.
  • Overall, those who participated in the cardiac rehabilitation program were linked with a 36% reduction in odds of dying from complications compared with those who did not.
  • Deaths during the entire follow-up period occurred in 12% of rehabilitation participants versus 20% of non-participants.

Researchers note scientists don't yet know the optimal number of at-home cardiac rehabilitation sessions are needed to achieve lasting success for people with heart disease, and this warrants further research. Moreover, when compared with traditional, facility-based programs, researchers believe home-based cardiac rehabilitation may lead to more lasting behavior changes that improve outcomes, because integrating healthy behaviors into a participant's home routine from the outset has been associated with better adherence rates.

While there is no standardized approach to delivering home-based cardiac rehabilitation, it is generally shorter than on-site care, and "as technology expands, behavior modification in a participants' own home environment may help make cardiac rehabilitation more accessible and lifestyle changes more sustainable," Whooley said.

Another advantage of home-based cardiac rehabilitation is that, because capacity is not constrained by the availability of facility-based programs, it has shorter wait times to begin therapy (average of 25 days versus 77 days after a cardiac event).

"Our biggest challenge in the U.S. is that home-based cardiac rehabilitation is not covered by many health insurers," she said. "Currently, Medicare only pays for on-site or facility-based cardiac rehabilitation."

The American Heart Association supports congressional legislation such as the bipartisan "Increasing Access to Quality Cardiac Rehabilitation Care Act,"' which calls for expanding cardiac rehabilitation resources.

Randal J. Thomas, M.D., chair of the 2019 joint American Heart Association/American College of Cardiology statement on the effectiveness of home-based cardiac rehabilitation called this study a "unique, landmark report."

"This study suggests that home-based cardiac rehabilitation is associated with a lower death rate when compared to individuals who receive no cardiac rehabilitation," said Thomas, who is professor of medicine in the Mayo Clinic Alix School of Medicine working with the Mayo Clinic Cardiac Rehabilitation Program in Rochester, Minnesota. "Previous home-based cardiac rehabilitation studies have not been designed to address this important benefit. Additional studies are needed, but this study strongly suggests a mortality benefit from home-based cardiac rehabilitation.

"Even though the study did not clarify if home-based cardiac rehabilitation impacts death rates as well or even better than center-based rehabilitation, it does show that home-based cardiac rehabilitation reduces death rates compared to those patients who do not participate in cardiac rehabilitation."

The joint statement strongly recommends cardiac rehabilitation for people diagnosed with heart attack, chest pain, heart failure or after having bypass surgery, percutaneous coronary intervention, heart valve surgery or heart transplantation. In addition, an American Heart Association scientific statement notes that home-based rehabilitation is an effective alternative to cardiac rehabilitation for those unable to participate in an on-site cardiac rehabilitation program.

The study has several limitations, including that there was no comparison to facility-based cardiac rehabilitation; participants were not randomized; and most were English-speaking, older men. Researchers note it's unclear whether the benefits of home-based cardiac rehabilitation would produce similar benefits in women or non-English speaking people.

The Veterans Health Services Research and Development Quality Enhancement Research Initiative funded the study.

Journal Reference:

  1. Nirupama Krishnamurthi, David W. Schopfer, Hui Shen, Gregory Rohrbach, Abdelaziz Elnaggar, Mary A. Whooley. Association of Home‐Based Cardiac Rehabilitation With Lower Mortality in Patients With Cardiovascular Disease: Results From the Veterans Health Administration Healthy Heart ProgramJournal of the American Heart Association, 2023; DOI: 10.1161/JAHA.122.025856