First AI system for contactless monitoring of heart rhythm using smart speakers

Smart speakers, such as Amazon Echo and Google Home, have proven adept at monitoring certain health care issues at home. For example, researchers at the University of Washington have shown that these devices can detect cardiac arrests or monitor babies breathing.
But what about tracking something even smaller: the minute motion of individual heartbeats in a person sitting in front of a smart speaker?
UW researchers have developed a new skill for a smart speaker that for the first time monitors both regular and irregular heartbeats without physical contact. The system sends inaudible sounds from the speaker out into a room and, based on the way the sounds are reflected back to the speaker, it can identify and monitor individual heartbeats. Because the heartbeat is such a tiny motion on the chest surface, the team’s system uses machine learning to help the smart speaker locate signals from both regular and irregular heartbeats.
When the researchers tested this system on healthy participants and hospitalized cardiac patients, the smart speaker detected heartbeats that closely matched the beats detected by standard heartbeat monitors. The team published these findings March 9 in Communications Biology.
“Regular heartbeats are easy enough to detect even if the signal is small, because you can look for a periodic pattern in the data,” said co-senior author Shyam Gollakota, a UW associate professor in the Paul G. Allen School of Computer Science & Engineering. “But irregular heartbeats are really challenging because there is no such pattern. I wasn’t sure that it would be possible to detect them, so I was pleasantly surprised that our algorithms could identify irregular heartbeats during tests with cardiac patients.”
While many people are familiar with the concept of a heart rate, doctors are more interested in the assessment of heart rhythm. Heart rate is the average of heartbeats over time, whereas a heart rhythm describes the pattern of heartbeats.

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For example, if a person has a heart rate of 60 beats per minute, they could have a regular heart rhythm — one beat every second — or an irregular heart rhythm — beats are randomly scattered across that minute but they still average out to 60 beats per minute.
“Heart rhythm disorders are actually more common than some other well-known heart conditions. Cardiac arrhythmias can cause major morbidities such as strokes, but can be highly unpredictable in occurrence, and thus difficult to diagnose,” said co-senior author Dr. Arun Sridhar, assistant professor of cardiology at the UW School of Medicine. “Availability of a low-cost test that can be performed frequently and at the convenience of home can be a game-changer for certain patients in terms of early diagnosis and management.”
The key to assessing heart rhythm lies in identifying the individual heartbeats. For this system, the search for heartbeats begins when a person sits within 1 to 2 feet in front of the smart speaker. Then the system plays an inaudible continuous sound, which bounces off the person and then returns to the speaker. Based on how the returned sound has changed, the system can isolate movements on the person — including the rise and fall of their chest as they breathe.
“The motion from someone’s breathing is orders of magnitude larger on the chest wall than the motion from heartbeats, so that poses a pretty big challenge,” said lead author Anran Wang, a doctoral student in the Allen School. “And the breathing signal is not regular so it’s hard to simply filter it out. Using the fact that smart speakers have multiple microphones, we designed a new beam-forming algorithm to help the speakers find heartbeats.”
The team designed what’s called a self-supervised machine learning algorithm, which learns on the fly instead of from a training set. This algorithm combines signals from all of the smart speaker’s multiple microphones to identify the elusive heartbeat signal.

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“This is similar to how Alexa can always find my voice even if I’m playing a video or if there are multiple people talking in the room,” Gollakota said. “When I say, ‘Hey, Alexa,’ the microphones are working together to find me in the room and listen to what I say next. That’s basically what’s happening here but with the heartbeat.”
The heartbeat signals that the smart speaker detects don’t look like the typical peaks that are commonly associated with traditional heartbeat monitors. The researchers used a second algorithm to segment the signal into individual heartbeats so that the system could extract what is known as the inter-beat interval, or the amount of time between two heartbeats.
“With this method, we are not getting the electric signal of the heart contracting. Instead we’re seeing the vibrations on the skin when the heart beats,” Wang said.
The researchers tested a prototype smart speaker running this system on two groups: 26 healthy participants and 24 hospitalized patients with a diversity of cardiac conditions, including atrial fibrillation and heart failure. The team compared the smart speaker’s inter-beat interval with one from a standard heartbeat monitor. Of the nearly 12,300 heartbeats measured for the healthy participants, the smart speaker’s median inter-beat interval was within 28 milliseconds of the standard monitor. The smart speaker performed almost as well with cardiac patients: of the more than 5,600 heartbeats measured, the median inter-beat interval was within 30 milliseconds of the standard.
Currently this system is set up for spot checks: If a person is concerned about their heart rhythm, they can sit in front of a smart speaker to get a reading. But the research team hopes that future versions could continuously monitor heartbeats while people are asleep, something that could help doctors diagnose conditions such as sleep apnea.
“If you have a device like this, you can monitor a patient on an extended basis and define patterns that are individualized for the patient. For example, we can figure out when arrhythmias are happening for each specific patient and then develop corresponding care plans that are tailored for when the patients actually need them,” Sridhar said. “This is the future of cardiology. And the beauty of using these kinds of devices is that they are already in people’s homes.”
This research was funded by the National Science Foundation.

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Head injury 25 years later: Study finds increased risk of dementia

Head injury in the United States is common, with over 23 million adults age 40 or older reporting a history of head injury with loss of consciousness. Many head injuries can be caused by a host of different situations — from car and motorcycle accidents to sports injuries. What’s more, it has become increasingly recognized that the effects from head injuries are long-lasting. New research led by the Perelman School of Medicine at the University of Pennsylvania shows that a single head injury could lead to dementia later in life. This risk further increases as the number of head injuries sustained by an individual increases. The findings also suggest stronger associations of head injury with risk of dementia among women compared to among men and among white as compared to among Black populations.
The researchers, whose findings were published today in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, conducted the investigation using data from the Atherosclerosis Risk in Communities (ARIC) Study, which aimed to uncover associations between head injury and dementia over the span of 25 years in a diverse population in the United States. Previously, data on traumatic brain injury has been limited to select populations, such as military and medical claims databases. These are among the first findings to specifically investigate head injury and dementia risk in both Black and white populations, as well as among both males and females, in a community-based setting.
“Head injury is a significant risk factor for dementia, but it’s one that can be prevented. Our findings show that the number of head injuries matter — more head injuries are associated with greater risk for dementia,” said lead investigator, Andrea L.C. Schneider, MD, PhD, an assistant professor of Neurology at Penn. “The dose-dependence of this association suggests that prevention of head injury could mitigate some risk of dementia later in life. While head injury is not the only risk factor for dementia, it is one risk factor for dementia that is modifiable by behavior changes such as wearing helmets and seat belts.”
The findings show that compared to participants who never experienced a head injury, a history of a single prior head injury was associated with a 1.25 times increased risk of dementia, and a history of two or more prior head injuries was associated with over 2 times increased risk of dementia compared to individuals without a history of head injury. Overall, 9.5 percent of all dementia cases in the study population could be attributed to at least one prior head injury.
To illustrate the relationship between dementia and head injuries, the authors gathered data from a diverse cohort with a mean baseline age of 54 years, comprised of 56 percent female and 27 percent Black participants from four different communities across the United States. Participants were followed for a median of 25 years through up to six in-person visits and semi-annual telephone follow-ups. Data on head injuries of participants was drawn from hospital records, as well as self-reporting from some participants.
Previous research on dementia and traumatic brain injuries suggests that women are at higher risk for dementia compared to men. Additionally, Black populations overall are at higher risk for dementia compared to people who are white. However, few prior studies have evaluated for possible differences in associations of head injury with dementia risk by sex and race.
This data from the ARIC study found evidence that females were more likely to experience dementia as a result of head injury than males. Further, the study showed that although there is increased dementia risk associated with head injury among both White and Black participants, White participants were at higher risk for dementia after head injury compared to Black participants. The authors conclude that more research is needed to better understand reasons for these observed sex and race differences in the association of head injury with dementia risk.
“Given the strong association of head injury with dementia, there is an important need for future research focused on prevention and intervention strategies aimed at reducing dementia after head injury,” Schneider said. “The results of this study have already led to several ongoing research projects, including efforts to uncover the causes of head injury-related dementia as well as investigations into reasons underlying the observed sex and race differences in the risk of dementia associated with head injury.”

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Materials provided by University of Pennsylvania School of Medicine. Note: Content may be edited for style and length.

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Tropical cyclone exposure linked to rise in hospitalizations from many causes for older adults

An increase in overall hospitalizations was reported for older adults in the week following exposure to a tropical cyclone, according to a new study by researchers at Columbia University Mailman School of Public Health, Columbia University’s Earth Institute and colleagues at Colorado State University and Harvard T. H. Chan School of Public Health.
The researchers used data over 16 years on 70 million Medicare hospitalizations and a comprehensive database of county-level local winds associated with tropical cyclones to examine how tropical cyclone wind exposures affect hospitalizations from 13 mutually exclusive, clinically meaningful causes, along with over 100 sub-causes. This study is the first comprehensive investigation of the impact of hurricanes and other tropical cyclones on all major causes and sub-causes of hospitalizations. The findings are published in Nature Communications.
Over 16,000 additional hospitalizations were associated with tropical cyclones over a ten-year average exposure. Analyses showed a 14 percent average rise in respiratory diseases in the week after exposure. The day after tropical cyclones with hurricane-force winds respiratory disease hospitalizations doubled. Also reported was an average 4 percent rise in infectious and parasitic diseases and 9 percent uptick in injuries. Hospitalizations from chronic obstructive pulmonary disease (COPD) surged 45 percent the week following tropical cyclone exposure compared to weeks without exposure.
This rise in hospitalizations was driven primarily by increases in emergency hospitalizations. The researchers point out that there may have been cases where exposure to the cyclones prevented normal medical care, compelling people to go to the hospital to access services that they might otherwise get outside a hospital setting without the storm. For example, if those with respiratory issues experienced loss of power — often a result from tropical cyclone winds — they may have turned to hospitals if they needed power for medical equipment that a hospital could furnish.
However, for certain causes, such as certain cancers, the authors also reported decreases in hospitalizations. These decreases were driven by non-emergency hospitalizations, indicating that people possibly cancelled scheduled hospitalizations because of the storm, which may have longer-term impacts on health.
“We know that hurricanes and other tropical cyclones have devastating effects on society, particularly on the poorest and most vulnerable” said Robbie M. Parks, PhD, Earth Institute post-doctoral fellow at the Columbia University Mailman School of Public Health and first author. “But until now only limited previous studies have calculated their impacts on health outcomes. Current weather trends also indicate that we can expect tropical cyclone exposure to remain a danger to human health and wellbeing, and could cause devastation to many more communities, now and into the future. There is no doubt that extreme weather events, such as tropical cyclones, are a great threat to human health in the U.S. and many other places in the world — now and with climate change in the future. Our study is a major first step in understanding how tropical cyclone exposure impacts many different adverse health outcomes.”
The researchers anticipate that adequate forecasting of tropical cyclones might help, for example, in the planning of setting up shelters to provide electricity and common medications and creating easy ways for vulnerable people with certain chronic conditions to find and use those resources outside of the hospital.
One of the main impediments for research in this field has been the difficulty in readily accessing data for exposure assessment. This research was greatly facilitated by the work of G. Brooke Anderson, PhD, associate professor at Colorado State University, who curated an open-source dataset to easily assess exposure to tropical cyclones for epidemiologic studies. The authors coupled the exposure data with comprehensive hospitalization data among Medicare enrollees. “The development of environmental health data research platforms that provide a one-point access to data, like the one we used for this study, can be a very powerful tool allowing research in directions that were not possible before,” said Francesca Dominici, PhD, professor of biostatistics at the Harvard Chan School and co-author.
“While serious gaps in knowledge remain, we gained valuable insights into the timing of hospitalizations relative to exposure and how cause-specific hospitalizations can be impacted by tropical cyclones,” said Marianthi-Anna Kioumourtzoglou, ScD, assistant professor of environmental health sciences at Columbia Mailman School, and senior author. “These important discoveries will be key for preparedness planning, including hospital and physician preparedness. Our study is just a first step in this process.”

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Full evolutionary journey of hospital superbug mapped

Modern hospitals and antibiotic treatment alone did not create all the antibiotic resistant strains of bacteria we see today. Instead, selection pressures from before widespread use of antibiotics influenced some of them to develop, new research has discovered.
By using analytical and sequencing technology that has only been developed in recent years, scientists from Wellcome Sanger Institute, University of Oslo and University of Cambridge have created an evolutionary timeline of the bacterium, Enterococcus faecalis, which is a common bacterium that can cause antibiotic resistant infections in hospitals.
The results, published today (9th March 2021) in Nature Communications show that this bacterium has the ability to adapt very quickly to selection pressures, such as the use of chemicals in farming as well as the development of new medications, which have caused different strains of the same bacterium to be found in many places worldwide, from the majority of people’s guts to many wild birds. As it is so widespread, the researchers suggest people should be screened for this type of bacteria when entering the hospital, in the same way they are for other superbugs, to help reduce the possibility of developing and spreading infection within healthcare.
Enterococcus faecalis is a common bacterium that, in most people, is found in the intestinal tract and doesn’t cause harm to the host. However, if someone is immunocompromised and this bacterium gets into the bloodstream, it can cause a serious infection.
In hospitals, it is more common to find antibiotic resistant strains of E. faecalis and it was initially thought that the wide use of antibiotics and other antibacterial control measures in modern hospitals caused these strains to develop.
In a new study, scientists from Wellcome Sanger Institute, University of Oslo and University of Cambridge analysed around 2000 samples of E. faecalis from 1936 to present day using blood stream isolates from patients and stool samples from animals and healthy humans.
By sequencing the genome (including chromosomes and plasmids) using technology from Oxford Nanopore, the team mapped the evolutionary journey of the bacterium and created a timeline of when and where different strains developed, including those nowadays found to be resistant to antibiotics. They found that antibiotic resistant strains developed earlier than previously thought, before the widespread use of antibiotics, and therefore it was not antibiotic use alone that caused these to emerge.
Researchers found that agricultural and early medical practices, such as the use of arsenic and mercury, influenced the evolution of some of the strains we see now. In addition to this, strains similar to the antibiotic resistant variants we see in hospitals now were found in wild birds. This shows how adaptable and flexible this species of bacterium is at evolving into new strains in the face of different adversity.
Professor Jukka Corander, co-lead author and Associate Faculty member at the Wellcome Sanger Institute, said: “This is the first time we have been able to map out the full evolution of E. faecalis from samples up to 85 years old, which enables us to see the detailed effect of human lifestyles, agriculture and medicines on the development of different bacterial strains. Having the full timeline of evolutionary changes would not have been possible without analytical and sequencing techniques that can be found at the Sanger Institute.”
Dr Anna Pöntinen, co-lead author and post-doctoral fellow at University of Oslo, said: “Currently, when patients are admitted to hospital, they are swabbed for some antibiotic resistant bacteria and fungi and are isolated to ensure that infection rates are kept as low as possible. Thanks to this study, it is possible to scrutinize the diversity of E. faecalis and identify those that are more prone to spread within hospitals and thus could cause harm in immunocompromised people. We believe that it could be beneficial to also screen for E. faecalis on admission to hospitals.”
Professor Julian Parkhill, co-author and Professor in the Department of Veterinary Medicine at University of Cambridge, said: “This research has discovered that these hospital-associated strains of antibiotic resistant bacteria are much older than we previously thought, and has highlighted their incredible metabolic flexibility combined with numerous mechanisms enhancing their survival under harsh conditions that has allowed them to spread widely across the globe.”

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A remote, computerized training program eases anxiety in children

Anxiety levels in the United States are rising sharply and have especially intensified in younger populations. According to the Anxiety and Depression Association of America, anxiety disorders affect 31.9 percent of children ages 13 to 18 years old. Because of the COVID-19 pandemic, children and adolescents have experienced unprecedented interruptions to their daily lives and it is expected that these disruptions may precipitate mental illness, including anxiety, depression, and/or stress related symptoms.
Traditional anxiety and depression treatments include cognitive behavioral therapy and psychiatric medications, which are somewhat successful in alleviating symptoms in adults. However, they have yielded some mixed results in children. Therefore, discovering appropriate means for reducing childhood anxiety and depression that are both affordable and accessible is paramount.
Using a computerized and completely remote training program, researchers from Florida Atlantic University’s Charles E. Schmidt College of Science have found a way to alleviate negative emotions in preadolescent children. They examined the relationship between anxiety, inhibitory control, and resting-state electroencephalography (EEG) in a critical age-range for social and emotional development (ages 8 to 12 years old). Inhibitory control is the ability to willfully withhold or suppress a thought, action or feeling. Without it, people would act purely on impulses or on old habits of action and thought.
Results of the study published in the journal, Applied Neuropsychology: Child, reveal that computerized inhibitory training helps to mitigate negative emotions in preadolescent children. EEG results also provide evidence of frontal alpha asymmetry shifting to the left after children completed an emotional version of the training. At the baseline time point, there was further indication to support the link between inhibitory control dysfunction and anxiety/depression. Decreased inhibitory control performance predicted higher levels of anxiety and depression, signifying that inhibitory impairments could be a risk factor for the development of these conditions in children.
Prior research has focused on adults and has only used self-report measures to operationalize anxiety and depressive symptoms. This novel study expands upon research investigating cognitive and neurological mechanisms involved in childhood anxiety and depression. In addition, it includes an objective outcome measure (resting-state EEG) to enable more succinct conclusions about training efficacy.
“In the current social climate of the world, internalizing conditions like anxiety and depression are becoming increasingly common in children and adolescents. Meanwhile, the availability and accessibility of computer and tablet technology also has rapidly increased,” said Nathaniel Shanok, lead author and a recent Ph.D. graduate of FAU’s Department of Psychology, who received an award from the American Psychological Society in 2020 for this research. “Providing computerized cognitive training programs to children can be a highly beneficial use of this technology for improving not only academic performance, but as seen in our study, psychological and emotional functioning during a challenging time period of development.”
Participants in the study were assigned to four weeks of either an emotional inhibitory control training program, a neutral inhibitory control training program, or a waitlisted control, and were tested using cognitive, emotional and EEG measures. Researchers evaluated the effects of the four-week, 16-session computerized inhibitory control training program using three tasks (go/no-go, flanker, and Stroop). The training program utilized for the study is gFocus from IQ Mindware and was created by Mark Ashton Smith, Ph.D.
Researchers found that inhibitory control accuracy was significantly and negatively related to anxiety as well as depression. Emotional and neutral training conditions led to significant reductions in anxiety, depression, and negative affect relative to the waitlist group, with the emotional training condition showing the largest reductions in anxiety and negative affect. These two conditions showed comparable improvements in inhibitory control accuracy relative to the waitlist, with greater increases observed in the neutral training condition.
“Given the predominately adverse influence of anxiety on social, psychological and cognitive functioning; early prevention, management and quality treatment plans are critical research areas to explore,” said Nancy Aaron Jones, Ph.D., co-author, an associate professor, and director of the FAU WAVES Emotion Laboratory in the Department of Psychology, Charles E. Schmidt College of Science, and a member of the FAU Brain Institute. “Advancements in technology have made it possible to train certain cognitive abilities using child-friendly applications or games that can be easily accessed from a home computer. Devising computerized training programs, which target underlying cognitive characteristics related to anxiety is a promising method for attenuating symptoms and risk in children.”
Anxiety involves strong cognitive and emotional influences, which are both explicit (obsessive thought processes and ruminations) as well as implicit (negative processing bias and reduced cognitive control). Inhibitory control impairment is believed to be a cognitive mediator of anxiety through both explicit and implicit mechanisms. The explicit theory of generalized anxiety disorder explains that the manifestation of anxiety occurs in part due to the inability of individuals to effectively recognize unrealistic or overly critical thinking patterns (thoughts) and suppress them.

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Pandemic Forces F.D.A. to Sharply Curtail Drug Company Inspections

AdvertisementContinue reading the main storySupported byContinue reading the main storyPandemic Forces F.D.A. to Sharply Curtail Drug Company InspectionsThe steep decline in oversight has stalled a number of new drug applications. The agency says it is trying to protect its employees but critics say inspectors should be considered essential workers and do their jobs.The F.D.A. conducted more than 1,671 inspections of foreign and domestic drug manufacturing facilities in 2019. Last year, that number dropped by more than half, to 742. Credit…Ariana Lindquist/BloombergMarch 9, 2021, 5:00 a.m. ETThe Covid-19 pandemic has forced the Food and Drug Administration to postpone hundreds of drug company inspections, creating an enormous backlog that is delaying new drug approvals and leading the industry to warn of impending shortages of existing medicines.Pandemic-related travel restrictions and safety concerns have also hampered the F.D.A.’s ability to ensure the safety of the ever-increasing number of imported medicines, which make up more than 60 percent of the drugs sold in the United States.“Regardless of where drugs are manufactured, domestically or overseas, the F.D.A. has the responsibility to ensure they are effective and safe,” said Mary Denigan-Macauley, director of health care, public health and private markets for the Government Accountability Office, a congressional watchdog agency. “Any drop in inspections, or backlog, is concerning.”The numbers show a steep decline. The F.D.A. conducted 52 inspections of domestic pharmaceutical plants between March 2020, when the pandemic took hold in the U.S., and Oct. 1, compared with 400 during the same months in 2019, according to the G.A.O. Inspections of foreign manufacturing facilities have been at a virtual standstill for months.In an interview, F.D.A. officials said they sharply curtailed the inspections to protect their investigators, following guidelines from the Centers for Disease Control and Prevention, which discouraged federal employees from travel during the pandemic.But some people in both industry and public health communities say that federal drug inspections are essential, and that the agency should bypass travel restrictions by taking precautions, including wearing proper personal protective equipment.“I think they can and they should,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, a nonprofit advocacy organization. “They should be considered essential workers and they should be vaccinated as soon as possible. And they should be provided with N95s masks, gowns and gloves to ensure their own safety during travel and during the inspection.”Dr. Denigan-Macauley said that the F.D.A. has postponed more than 1,000 surveillance inspections — the routine visits that the agency conducts to check for adherence to good manufacturing practices. “Drugs that are waiting for pre-approval inspections will also have a backlog,” she said.In interviews, F.D.A. officials denied that the dramatic drop in inspections has slowed drug approvals. But a number of drug companies, including Spectrum Pharmaceuticals, Biocon Biologics and Bristol Myers Squibb, has issued statements noting deferred F.D.A. action because of the agency’s inability to conduct inspections.In October, Spectrum announced that the F.D.A. had deferred action on its application for Rolontis, a treatment for cancer patients who have a very low number of certain white blood cells, because it could not inspect the manufacturing plant the company uses in South Korea.In late December, Biocon Biologics notified shareholders that the F.D.A. deferred action on its joint application with Mylan for a proposed biosimilar to Avastin, a cancer drug.Bristol Meyers Squibb announced in November that the F.D.A. would miss its November deadline for taking action on a lymphoma treatment, lisocabtagene maraleucel because it could not inspect a third-party Texas manufacturing plant. The agency eventually did complete its inspection and approved the drug last month.In addition, Nivagen, a pharmaceutical company specializing in generic versions of injectable medications, filed an application in January 2019 for an expedited review of a generic version of a drug used in cardiac therapy and for other problems. In March 2019, the F.D.A. granted its request for what is known as a competitive generic therapy designation, for products that the F.D.A. believes should get high priority for consideration. Then the pandemic hit, and the F.D.A. pushed the company’s inspection back twice, according to Jay Shukla, Nivagen’s chief executive officer. He said he does not know when one will be scheduled.Dr. Erin Fox, who tracks drug shortages for the American Society of Health System Pharmacists, says shortages of the brand name version of the drug, which is made by only one company in its injectable form, have occurred on and off since 2006. That’s why Mr. Shukla said he decided it would be a good product for his new business.“For me, a small start-up company, our growth depends on this product for the manufacturing I want to build in the U.S.,” said Mr. Shukla. “It all depends on this approval. The review is done, it’s only pending the facility inspection. We appreciate the hard work the F.D.A. is doing, but we are suffering too.”Mr. Shukla has proposed an alternative — a virtual inspection using remote video technology to permit the F.D.A. inspector to view inside the facility. The pharmaceutical industry has been pressing the F.D.A. to adopt remote inspections, but the agency said that it is still evaluating the idea, as it has been doing for months. So far, it has conducted virtual sessions sparingly, generally more for viewing a company’s documents than for actual remote viewing of a manufacturing plant.Donald D. Ashley, director of compliance for the agency’s Center for Drug Evaluation and Research, said he was wary of relying heavily on remote viewing, especially for inspections at facilities that had had past violations.“When we go back to reassess whether they have corrected their ways, we want to use our most robust tool, and that’s an on site inspection,” Mr. Ashley said.F.D.A. inspectors at a mail facility in New York in 2018. The agency cited pandemic-related restrictions and safety concerns for hampering its  ability to conduct on-site reviews of the increasing number of imported medicines.Credit…Michael J. Ermarthh/U.S. Food and Drug AdministrationDuring most drug company inspections, investigators review the company’s internal records and scrutinize the building, checking how supplies are handled, reviewing quality controls and determining whether the company complies with good manufacturing practices. The F.D.A. conducts three types of inspections: pre-approval inspections when companies have filed applications for new drugs; routine surveillance inspections, which it tries to do at least once every five years; and those following up on a problem.Proponents of remote audits say they can do the same thing virtually. Peter Miller, president of Dynamic Compliance Solutions, of New Jersey, which helps life science companies comply with F.D.A. regulations, says his remote audit kit can do a great inspection. The kit features a tiny 360-degree camera, which an on-site host carries on a tripod while the investigator watches on a computer screen.“The inspector can say, ‘I see a stack of boxes there. Can we move a little closer? I’d like to see if they have proper stickers,’ ” he said. “I believe the auditor should be in control of what they are looking at. We do a livestream, unrecorded broadcast.”Industry lawyers believe the F.D.A. is being too fussy in rejecting remote inspections, given the current backlog. Mark I. Schwartz, a former F.D.A. deputy director who had oversight of inspections conducted by the agency’s Center for Biologics Evaluation and Research, thinks wider use of remote inspections is way overdue. Mr. Schwartz believes that when done properly, remote inspections will yield similar results to in-person visits — which he said more than a dozen of his clients are desperate to have done.“The suggestion that being on-site makes a whole hell of a difference in finding things is a fallacy,” said Mr. Schwartz, now a director at Hyman, Phelps & McNamara, a law firm with a large pharmaceutical industry practice. At best, Mr. Schwartz said, investigators on-site see only about 15 percent of a company even when they are there in person.The issue has drawn congressional attention. Dr. Denigan-Macauley is scheduled to testify on Tuesday before the House appropriations subcommittee that oversees the F.D.A. Representative Sanford Bishop, a Georgia Democrat who is chairman of the panel, said, “The pressure to ensure F.D.A. is still able to assess the safety and efficacy of the drug supply grows every day. ”While public health experts are troubled by the big drop in inspections, most believe that virtual inspections would be a poor substitute for in-person reviews.“Remote inspections just aren’t going to cut it,” Dr. Carome said. “Often the F.D.A. identifies serious problems and if you aren’t on-site, those will go undetected.”“There have been examples where F.D.A. have found filthy conditions in the manufacturing facility or they found rodents or insects that could contaminate products,” Dr. Carome said. “The facility isn’t going to show you that.”The F.D.A. has increasingly relied on electronic submission of manufacturing records during the pandemic, but prefers to view them in person to confirm accuracy. Mr. Ashley of the F.D.A. recalled a 2019 inspection of an over-the-counter drug manufacturer in China, where an investigator found falsification of records that would not have been detected by simply studying them on line.“The front management presented these to our investigator, who noticed that the documents were dated a long time ago, but the ink was still wet,” Mr. Ashley said. “We asked them to recall all their drug products.”The F.D.A. was already behind on inspections before the pandemic, according to congressional investigators, particularly those overseas. The G.A.O. placed part of the blame on the lack of investigators qualified to conduct the inspections.But the watchdog also questioned the wisdom of the F.D.A.’s practice of giving foreign manufacturers up to 12 weeks notice before the inspection, potentially enabling them to fix or hide problems. The pandemic has also prompted the F.D.A. to provide domestic facilities advance notice of its visits, the G.A.O. noted. Another problem is the F.D.A.’s reliance on translators chosen by the company being inspected.Dr. Denigan-Macauley of the G.A.O. said that from March to October 2020, the F.D.A. conducted only three foreign inspections that it considered “mission critical,” compared to more than 600 during the same time period in 2019 and 2018. The G.A.O. also said that the F.D.A. was able to put 54 overseas manufacturers on what are called “import alerts” by sampling their products, rather than doing an inspection. An import alert permits the F.D.A. to block that company’s products from entering the United States.The F.D.A. confirmed that the vast majority of foreign inspections continue to be postponed.“If this continues,” Dr. Denigan-Macauley said, “they are going to be very challenged.”AdvertisementContinue reading the main story

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Covid-19 Relief Bill Fulfills Biden’s Promise to Expand Obamacare, for Two Years

#masthead-section-label, #masthead-bar-one { display: none }The Coronavirus OutbreakliveLatest UpdatesMaps and CasesRisk Near YouVaccine RolloutNew Variants TrackerAdvertisementContinue reading the main storySupported byContinue reading the main storyPandemic Relief Bill Fulfills Biden’s Promise to Expand Obamacare, for Two YearsWith its expanded subsidies for health plans under the Affordable Care Act, the coronavirus relief bill makes insurance more affordable, and puts health care on the ballot in 2022.President Biden after delivering remarks on the Affordable Care Actin November. The changes to the health law would cover 1.3 million more Americans.Credit…Amr Alfiky/The New York TimesMarch 8, 2021Updated 8:30 p.m. ETWASHINGTON — President Biden’s $1.9 trillion coronavirus relief bill will fulfill one of his central campaign promises, to fill the holes in the Affordable Care Act and make health insurance affordable for more than a million middle-class Americans who could not afford insurance under the original law.The bill, which will most likely go to the House for a final vote on Wednesday, includes a significant, albeit temporary, expansion of subsidies for health insurance purchased under the act. Under the changes, the signature domestic achievement of the Obama administration will reach middle-income families who have been discouraged from buying health plans on the federal marketplace because they come with high premiums and little or no help from the government.The changes will last only for two years. But for some, they will be considerable: The Congressional Budget Office estimated that a 64-year-old earning $58,000 would see monthly payments decline from $1,075 under current law to $412 because the federal government would take up much of the cost. The rescue plan also includes rich new incentives to entice the few holdout states — including Texas, Georgia and Florida — to finally expand Medicaid to those with too much money to qualify for the federal health program for the poor, but too little to afford private coverage.“For people that are eligible but not buying insurance it’s a financial issue, and so upping the subsidies is going to make the price point come down,” said Ezekiel Emanuel, a health policy expert and professor at the University of Pennsylvania who advised Mr. Biden during his transition. The bill, he said, would “make a big dent in the number of the uninsured.”But because those provisions last only two years, the relief bill almost guarantees that health care will be front and center in the 2022 midterm elections, when Republicans will attack the measure as a wasteful expansion of a health law they have long hated. Meantime, some liberal Democrats may complain that the changes only prove that a patchwork approach to health care coverage will never work.“Obviously it’s an improvement, but I think that it is inadequate given the health care crisis that we’re in,” said Representative Ro Khanna, a progressive Democrat from California who favors the single-payer, government-run system called Medicare for All that has been embraced by Senator Bernie Sanders, independent of Vermont, and the Democratic left.“We’re in a national health care crisis,” Mr. Khanna said. “Fifteen million people just lost private health insurance. This would be the time for the government to say, at the very least, for those 15 million that we ought to put them on Medicare.”Mr. Biden made clear when he was running for the White House that he did not favor Medicare for All, but instead wanted to strengthen and expand the Affordable Care Act. The bill that is expected to reach his desk in time for a prime-time Oval Office address on Thursday night would do that. The changes to the health law would cover 1.3 million more Americans and cost about $34 billion, according to the Congressional Budget Office.Representative Frank Pallone Jr. of New Jersey, who helped draft the health law more than a decade ago and leads the House Energy and Commerce Committee, has called it “the biggest expansion that we’ve had since the A.C.A. was passed.”But as a candidate, Mr. Biden promised more, a “public option” — a government-run plan that Americans could choose on the health law’s online marketplaces, which now include only private insurance.“Biden promised voters a public option, and it is a promise he has to keep,” said Waleed Shahid, a spokesman for Justice Democrats, the liberal group that helped elect Representative Alexandria Ocasio-Cortez and other progressive Democrats. Of the stimulus bill, he said, “I don’t think anyone thinks this is Biden’s health care plan.”Just when Mr. Biden or Democrats would put forth such a plan remains unclear, and passage in an evenly divided Senate would be an uphill struggle. White House officials have said Mr. Biden wants to get past the coronavirus relief bill before laying out a more comprehensive domestic policy agenda.Senators Bill Hagerty and Chris Coons at the Capitol on Saturday during a series of votes on amendments to the relief bill.Credit…Anna Moneymaker for The New York TimesThe Affordable Care Act is near and dear to Mr. Biden, who memorably used an expletive to describe it as a big deal when he was vice president and President Barack Obama signed it into law in 2010. It has expanded coverage to more than 20 million Americans, cutting the uninsured rate to 10.9 percent in 2019 from 17.8 percent in 2010.The Coronavirus Outbreak

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Pandemic Relief Bill Fulfills Biden’s Promise to Expand Obamacare, for Two Years

#masthead-section-label, #masthead-bar-one { display: none }The Coronavirus OutbreakliveLatest UpdatesMaps and CasesRisk Near YouVaccine RolloutNew Variants TrackerAdvertisementContinue reading the main storySupported byContinue reading the main storyPandemic Relief Bill Fulfills Biden’s Promise to Expand Obamacare, for Two YearsWith its expanded subsidies for health plans under the Affordable Care Act, the coronavirus relief bill makes insurance more affordable, and puts health care on the ballot in 2022.President Biden after delivering remarks on the Affordable Care Actin November. The changes to the health law would cover 1.3 million more Americans.Credit…Amr Alfiky/The New York TimesMarch 8, 2021Updated 8:30 p.m. ETWASHINGTON — President Biden’s $1.9 trillion coronavirus relief bill will fulfill one of his central campaign promises, to fill the holes in the Affordable Care Act and make health insurance affordable for more than a million middle-class Americans who could not afford insurance under the original law.The bill, which will most likely go to the House for a final vote on Wednesday, includes a significant, albeit temporary, expansion of subsidies for health insurance purchased under the act. Under the changes, the signature domestic achievement of the Obama administration will reach middle-income families who have been discouraged from buying health plans on the federal marketplace because they come with high premiums and little or no help from the government.The changes will last only for two years. But for some, they will be considerable: The Congressional Budget Office estimated that a 64-year-old earning $58,000 would see monthly payments decline from $1,075 under current law to $412 because the federal government would take up much of the cost. The rescue plan also includes rich new incentives to entice the few holdout states — including Texas, Georgia and Florida — to finally expand Medicaid to those with too much money to qualify for the federal health program for the poor, but too little to afford private coverage.“For people that are eligible but not buying insurance it’s a financial issue, and so upping the subsidies is going to make the price point come down,” said Ezekiel Emanuel, a health policy expert and professor at the University of Pennsylvania who advised Mr. Biden during his transition. The bill, he said, would “make a big dent in the number of the uninsured.”But because those provisions last only two years, the relief bill almost guarantees that health care will be front and center in the 2022 midterm elections, when Republicans will attack the measure as a wasteful expansion of a health law they have long hated. Meantime, some liberal Democrats may complain that the changes only prove that a patchwork approach to health care coverage will never work.“Obviously it’s an improvement, but I think that it is inadequate given the health care crisis that we’re in,” said Representative Ro Khanna, a progressive Democrat from California who favors the single-payer, government-run system called Medicare for All that has been embraced by Senator Bernie Sanders, independent of Vermont, and the Democratic left.“We’re in a national health care crisis,” Mr. Khanna said. “Fifteen million people just lost private health insurance. This would be the time for the government to say, at the very least, for those 15 million that we ought to put them on Medicare.”Mr. Biden made clear when he was running for the White House that he did not favor Medicare for All, but instead wanted to strengthen and expand the Affordable Care Act. The bill that is expected to reach his desk in time for a prime-time Oval Office address on Thursday night would do that. The changes to the health law would cover 1.3 million more Americans and cost about $34 billion, according to the Congressional Budget Office.Representative Frank Pallone Jr. of New Jersey, who helped draft the health law more than a decade ago and leads the House Energy and Commerce Committee, has called it “the biggest expansion that we’ve had since the A.C.A. was passed.”But as a candidate, Mr. Biden promised more, a “public option” — a government-run plan that Americans could choose on the health law’s online marketplaces, which now include only private insurance.“Biden promised voters a public option, and it is a promise he has to keep,” said Waleed Shahid, a spokesman for Justice Democrats, the liberal group that helped elect Representative Alexandria Ocasio-Cortez and other progressive Democrats. Of the stimulus bill, he said, “I don’t think anyone thinks this is Biden’s health care plan.”Just when Mr. Biden or Democrats would put forth such a plan remains unclear, and passage in an evenly divided Senate would be an uphill struggle. White House officials have said Mr. Biden wants to get past the coronavirus relief bill before laying out a more comprehensive domestic policy agenda.Senators Bill Hagerty and Chris Coons at the Capitol on Saturday during a series of votes on amendments to the relief bill.Credit…Anna Moneymaker for The New York TimesThe Affordable Care Act is near and dear to Mr. Biden, who memorably used an expletive to describe it as a big deal when he was vice president and President Barack Obama signed it into law in 2010. It has expanded coverage to more than 20 million Americans, cutting the uninsured rate to 10.9 percent in 2019 from 17.8 percent in 2010.The Coronavirus Outbreak

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Coronavirus testing: How to do a lateral flow test at home

Coronavirus lateral flow tests are free and provide a quick result within 30 minutes. But how do you do one?Secondary pupils across the UK are taking them as part of plans to reduce the risk of Covid-19 spreading in schools.All businesses in England can also request tests for their workers as part of the government’s roadmap out of the pandemic.Although the tests are quick, it’s important they’re done correctly to give accurate results.Our health reporter Laura Foster explains.

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Many ‘Long Covid’ Patients Had No Symptoms From Their Initial Infection

#masthead-section-label, #masthead-bar-one { display: none }The Coronavirus OutbreakliveLatest UpdatesMaps and CasesRisk Near YouVaccine RolloutNew Variants TrackerAdvertisementContinue reading the main storySupported byContinue reading the main storyMany ‘Long Covid’ Patients Had No Symptoms From Their Initial InfectionAn analysis of electronic medical records in California found that 32 percent started with asymptomatic infections but reported troubling aftereffects weeks and months later.The study of 1,407 people who tested positive for coronavirus found more than 30 symptoms, including anxiety, low back pain, fatigue, insomnia, gastrointestinal problems and rapid heart rate.Credit…Pete Kiehart for The New York TimesMarch 8, 2021, 6:52 p.m. ETMany people who experience long-term symptoms from the coronavirus did not feel sick at all when they were initially infected, according to a new study that adds compelling information to the increasingly important issue of the lasting health impact of Covid-19.The study, one of the first to focus exclusively on people who never needed to be hospitalized when they were infected, analyzed electronic medical records of 1,407 people in California who tested positive for the coronavirus. More than 60 days after their infection, 27 percent, or 382 people, were struggling with post-Covid symptoms like shortness of breath, chest pain, cough or abdominal pain.Nearly a third of the patients with such long-term problems had not had any symptoms from their initial coronavirus infection through the 10 days after they tested positive, the researchers found.Understanding long-term Covid symptoms is an increasingly pressing priority for doctors and researchers as more and more people report debilitating or painful aftereffects that hamper their ability to work or function the way they did before. Last month, the director of the National Institutes of Health, Dr. Francis S. Collins, announced a major initiative “to identify the causes and ultimately the means of prevention and treatment of individuals who have been sickened by Covid-19, but don’t recover fully over a period of a few weeks.”David Putrino, director of rehabilitation innovation at Mount Sinai Health System in New York City, who was not involved in the new research, said that he and his colleagues at Mount Sinai’s center for post-Covid care are seeing a similar pattern.“Many people who had asymptomatic Covid can also go on to develop post-acute Covid syndrome,” said Dr. Putrino, who is a co-author of a smaller study on the topic published last year. “It doesn’t always match up with severity of acute symptoms, so you can have no symptoms but still have a very aggressive immune response.”The new study is published on the preprint site MedRxiv and has not finished undergoing peer review. Its strengths include that it is larger than many studies on long-term symptoms published so far and that the researchers used electronic records from the University of California system, allowing them to obtain health and demographic information of patients from throughout the state. The researchers also excluded from the study symptoms that patients had reported in the year before their infection, a step intended to ensure a focus on post-Covid symptoms.Among their findings: Long-term problems affect every age group, including children. “Of the 34 children in the study, 11 were long-haulers,” said one of the authors, Melissa Pinto, an associate professor of nursing at the University of California Irvine.The study found more than 30 symptoms, including anxiety, low back pain, fatigue, insomnia, gastrointestinal problems and rapid heart rate. The researchers identified five clusters of symptoms that seemed most likely to occur together, like chest pain and cough or abdominal pain and headache.Most previous studies of long-term symptoms have tended to involve people who were sick enough from their initial infection to be hospitalized. One of the largest found that more than three-quarters of about 1,700 hospitalized patients in Wuhan, China, had at least one symptom six months later.The Coronavirus Outbreak

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