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Tag: Medical research

  • Biden approval, views of economy steady, sour: AP-NORC poll

    Biden approval, views of economy steady, sour: AP-NORC poll

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    WASHINGTON — Fresh off his party’s better-than-anticipated performance in the midterm elections, President Joe Biden is facing consistent but critical assessments of his leadership and the national economy.

    A new poll from The Associated Press-NORC Center for Public Affairs Research finds 43% of U.S. adults say they approve of the way Biden is handling his job as president, while 55% disapprove. That’s similar to October, just weeks before the Nov. 8 elections that most Americans considered pivotal for the country’s future.

    Only about a quarter say the nation is headed in the right direction or the economy is in good condition. Both measures have been largely negative over the course of the year as inflation tightened its grip, but were more positive through much of Biden’s first year in office.

    Mishana Conlee said she tries to be optimistic about the coming year, but she thinks things are going to the gutter because “our president is incompetent” and not mentally fit for the White House. The 44-year-old in South Bend, Indiana, said she’s frustrated about rising expenses when she’s living paycheck to paycheck as a dietary aide at a nursing home.

    “The more I work, I just can’t get ahead,” Conlee said. “That’s just all there is to it.”

    She doesn’t blame Biden for the state of inflation, but “I feel like he’s not doing anything to change it,” said Conlee, an independent who voted for former President Donald Trump. Biden’s “not doing us any good.”

    The Biden administration in its second year in the White House relished economic growth, a series of legislative wins and relative success for the president’s party in the midterms. But that has yet to translate to glowing reviews from a pessimistic public.

    “I don’t understand why his approval ratings are so low,” said 56-year-old Sarah Apwisch, highlighting the administration’s investments in infrastructure and computer chip technology.

    Apwisch recognizes that it’s been “a tough year” and that prices are higher, but she’s hopeful because of the midterm results as a Republican-turned-Democrat who worries about the “Make America Great Again” movement’s influence on the GOP.

    “We’re headed in the right direction,” said the Three Rivers, Michigan, resident who works for a market research company’s finance department. She is eager to see Democrats press forward on a wide-ranging agenda, including codifying abortion rights.

    Even as Republicans took control of the House, Democrats defied historical precedent to stunt GOP gains and even improve their Senate majority, which was cemented with this week’s runoff win for Sen. Raphael Warnock, the lone Democrat in Georgia this year to be elected statewide.

    Glen McDaniel of Atlanta, who twice voted for Warnock, thinks the Biden administration has moved the country forward and weathered the economic storm as well as possible.

    “I think that this administration has done as much as they can” to fight inflation, the Democrat said.

    But McDaniel, a 70-year-old medical research scientist, also thinks the nation faces “social headwinds” that he wants Biden and the party to prioritize.

    “I think that the Democrats can be a little bit more aggressive” in legislating on things like marriage equality, reproductive rights and voting reform, he said.

    The poll shows majorities of Democrats and Republicans alike think things in the country are on the wrong track, likely for different reasons.

    But Democrats have shown renewed faith in Biden, boosting his overall job approval rating from a summer slump. Even so, the 43% who approve in the new survey remains somewhat depressed from 48% a year ago and much lower than 60% nearly two years ago, a month after he took office.

    Seventy-seven percent of Democrats, but only 10% of Republicans, approve of Biden.

    While many Americans don’t entirely blame Biden for high inflation, AP-NORC polling this year showed Biden consistently hit for his handling of the economy.

    As in recent months, the new poll shows only a quarter of U.S. adults say economic conditions are good, while three-quarters call them bad. Nine in 10 Republicans, along with about 6 in 10 Democrats, say the economy is in bad shape. Ratings of the economy have soured amid record-high inflation, even as Biden touts falling gas prices and a low unemployment rate at 3.7%.

    Joshua Steffens doubts that the job market is as good as indicators show. The 47-year-old in St. Augustine, Florida, said he has been unemployed and struggling to find an information technology job since September.

    “Even though they’re trying to claim that things are looking good,” Steffens said, “in the trenches, it definitely does not appear that it’s so accurate.”

    Biden’s shopping and vacationing, captured on broadcast news, is “tone deaf,” said the Republican, who called the president “a habitual liar.”

    Steffens said he and his wife are experiencing rising expenses for electricity and groceries, and relying on his wife’s income has “put a strain” on their holiday shopping. He doesn’t think Biden is handling high inflation well.

    “If he has policies that he’s trying to push through, then they’re not working currently,” Steffens said.

    ———

    The poll of 1,124 adults was conducted Dec. 1-5 using a sample drawn from NORC’s probability-based AmeriSpeak Panel, which is designed to be representative of the U.S. population. The margin of sampling error for all respondents is plus or minus 3.8 percentage points.

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  • Oldest DNA reveals life in Greenland 2 million years ago

    Oldest DNA reveals life in Greenland 2 million years ago

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    NEW YORK — Scientists discovered the oldest known DNA and used it to reveal what life was like 2 million years ago in the northern tip of Greenland. Today, it’s a barren Arctic desert, but back then it was a lush landscape of trees and vegetation with an array of animals, even the now extinct mastodon.

    “The study opens the door into a past that has basically been lost,” said lead author Kurt Kjær, a geologist and glacier expert at the University of Copenhagen.

    With animal fossils hard to come by, the researchers extracted environmental DNA, also known as eDNA, from soil samples. This is the genetic material that organisms shed into their surroundings — for example, through hair, waste, spit or decomposing carcasses.

    Studying really old DNA can be a challenge because the genetic material breaks down over time, leaving scientists with only tiny fragments.

    But with the latest technology, researchers were able to get genetic information out of the small, damaged bits of DNA, explained senior author Eske Willerslev, a geneticist at the University of Cambridge. In their study, published Wednesday in the journal Nature, they compared the DNA to that of different species, looking for matches.

    The samples came from a sediment deposit called the Kap København formation in Peary Land. Today, the area is a polar desert, Kjær said.

    But millions of years ago, this region was undergoing a period of intense climate change that sent temperatures up, Willerslev said. Sediment likely built up for tens of thousands of years at the site before the climate cooled and cemented the finds into permafrost.

    The cold environment would help preserve the delicate bits of DNA — until scientists came along and drilled the samples out, beginning in 2006.

    During the region’s warm period, when average temperatures were 20 to 34 degrees Fahrenheit (11 to 19 degrees Celsius) higher than today, the area was filled with an unusual array of plant and animal life, the researchers reported. The DNA fragments suggest a mix of Arctic plants, like birch trees and willow shrubs, with ones that usually prefer warmer climates, like firs and cedars.

    The DNA also showed traces of animals including geese, hares, reindeer and lemmings. Previously, a dung beetle and some hare remains had been the only signs of animal life at the site, Willerslev said.

    One big surprise was finding DNA from the mastodon, an extinct species that looks like a mix between an elephant and a mammoth, Kjær said.

    Many mastodon fossils have previously been found from temperate forests in North America. That’s an ocean away from Greenland, and much farther south, Willerslev said.

    “I wouldn’t have, in a million years, expected to find mastodons in northern Greenland,” said Love Dalen, a researcher in evolutionary genomics at Stockholm University who was not involved in the study.

    Because the sediment built up in the mouth of a fjord, researchers were also able to get clues about marine life from this time period. The DNA suggests horseshoe crabs and green algae lived in the area — meaning the nearby waters were likely much warmer back then, Kjær said.

    By pulling dozens of species out of just a few sediment samples, the study highlights some of eDNA’s advantages, said Benjamin Vernot, an ancient DNA researcher at Germany’s Max Planck Institute for Evolutionary Anthropology who was not involved in the study.

    “You really get a broader picture of the ecosystem at a particular time,” Vernot said. “You don’t have to go and find this piece of wood to study this plant, and this bone to study this mammoth.”

    Based on the data available, it’s hard to say for sure whether these species truly lived side by side, or if the DNA was mixed together from different parts of the landscape, said Laura Epp, an eDNA expert at Germany’s University of Konstanz who was not involved in the study.

    But Epp said this kind of DNA research is valuable to show “hidden diversity” in ancient landscapes.

    Willerslev believes that because these plants and animals survived during a time of dramatic climate change, their DNA could offer a “genetic roadmap” to help us adapt to current warming.

    Stockholm University’s Dalen expects ancient DNA research to keep pushing deeper into the past. He worked on the study that previously held the “oldest DNA” record, from a mammoth tooth around a million years old.

    “I wouldn’t be surprised if you can go at least one or perhaps a few million years further back, assuming you can find the right samples,” Dalen said.

    ———

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • A growing push to fix pulse oximeters’ flawed readings in people of color: ‘This can be dangerous’ | CNN

    A growing push to fix pulse oximeters’ flawed readings in people of color: ‘This can be dangerous’ | CNN

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    CNN
     — 

    As a triple threat of respiratory illnesses – flu, Covid-19 and respiratory syncytial virus, known as RSV – sweeps the United States, emergency departments are using one small tool more than usual to monitor whether a patient needs oxygen: the pulse oximeter.

    “We’re in the midst of a respiratory flood,” said pediatric emergency physician Dr. Joseph Wright, chief health equity officer at the University of Maryland Medical System, which includes 11 hospitals.

    “And the pulse oximeter is used from any age to geriatrics,” he said. “This is a tool that is used on all patients, and right now, as with the height of the pandemic, it’s a tool that is used to assess children with respiratory distress as part of the RSV flood that we’re currently experiencing.”

    But a growing body of research suggests that these devices, which clamp onto a patient’s fingertip to measure their blood oxygen levels, may not work as well on people with dark skin tones.

    The US Food and Drug Administration is mulling over next steps for the regulation of pulse oximeter devices, which may give less accurate readings for people of color. A panel of its Medical Devices Advisory Committee met in November to review clinical data on the issue.

    “For all of us, we would like to have assurance or confidence that the accuracy of the pulse ox reading in children who are melanated or have darker skin tones is reliable,” Wright said. He was not involved in the FDA discussions, but his medical system offered written testimony for the meeting.

    “When I’m assessing a patient, a child, who is in respiratory distress, the pulse ox reading is but one tool. There’s the clinical assessment, obviously, and then other measures of how sick that child is,” he said, but “these devices need to be fixed. It appears that the technology to fix them is known, and the advancement here is to require manufacturers to incorporate this advanced technology.”

    Pulse oximeters work by sending light through your finger; a sensor on the other side of the device receives this light and uses it to detect the color of your blood. Bright red blood is highly oxygenated, but blue or purplish blood is less so.

    If the device isn’t calibrated for darker skin tones, melanin – which is responsible for the pigmentation of skin, hair and eyes – could affect how the light is absorbed by the sensor, leading to flawed oxygen readings.

    The members of the FDA advisory panel discussed recommendations on when and how to use these devices on people with dark skin, how to improve their accuracy and, until the situation improves, whether the devices should have labels – such as a black box warning, the strongest type of warning for medical device or prescription drug labeling – noting that inaccurate readings may be associated with skin color.

    “The agency considers this a high priority and we will work expeditiously to consider the Panel’s input and determine the appropriate next steps,” FDA spokesperson Shauna Nelson wrote in an email to CNN. “We will communicate any significant new information publicly.”

    Meanwhile, the American Medical Association adopted a policy last month calling for the FDA to ensure that pulse oximeters provide accurate and reliable readings for people of all skin colors.

    “Concerns about the accuracy of pulse oximeters in pigmented skin have been noted for more than 30 years, yet Black and Brown communities are still facing adverse health impacts from these devices – particularly during the COVID-19 pandemic when use of and reliance on pulse oximeters increased,” AMA President-elect Dr. Jesse Ehrenfeld said in a statement.

    “We urge the FDA to take swift action to address the growing uncertainty around these devices, including making sure health care professionals are aware of their limitations and increase testing of devices that were already cleared by the agency, to ensure the health and safety of the public.”

    Rekha Hagen told the FDA advisory panel during its meeting that she has seen a pulse oximeter give different readings for various members of her family, based on their skin tones.

    Speaking as a member of the patient and family advisory council at the Hospital of the University of Pennsylvania, Hagen said that she is an Indian woman, her skin tone differs from her husband’s, who is White, and from those of their three children.

    “In other words, we are many shades of brown and white,” she said.

    “It’s very important to have an accurate reading because people are acting, or not acting, on this information. For example, if your thermometer says you have a temp of 105, you would treat it differently from a temperature of 101,” Hagen said. “I think of the pulse oximeter reading in the same way. And frankly, if the reading was acceptable, I would not go to the hospital or seek help. Of course this can be dangerous.”

    Ultimately, the pulse oximeter can estimate the amount of oxygen a person has in their blood without the need for a blood sample.

    But on a person with darker skin, the oximeter could indicate that oxygen levels are normal, suggesting that the person may be discharged from a hospital or may not need oxygen support – when a blood sample might show that, in fact, their oxygen levels are low, suggesting that they need additional care and oxygen.

    Hagen asked the panel, “Since we have many skin tones in our immediate family, who would we use this device on?

    “As for current solutions for the FDA, perhaps you could have a skin tone color chart on the box whereby you are advised not to use the product if you are darker than a certain skin tone or sell the oximeter behind the pharmacy counter so that the pharmacist can explain usage to the patient,” she said. “The FDA has time to fix this communication. They should start now.”

    In order to resolve the core issue of flawed pulse oximeter readings, the FDA must expand premarket testing of the devices to include people with a broad array of skin colors, Dr. Ealena Callender of the National Center for Health Research said during the meeting.

    The FDA now recommends that every clinical study of pulse oximeters include participants who vary in age and gender, with a range of skin pigmentation, of which at least two people or 15% of the group – “whichever is larger,” the FDA guidance indicates – have dark skin.

    “This is woefully inadequate,” Callender said.

    She added that “dark skin” tends to be subjective, and there is a need for objective tools to make that call.

    “Only objective tools for assessment of skin pigmentation should be used in studies of how it affects pulse oximetry measurements,” Callender said, explaining that many variations in hue and other contributing factors make subjective assessments less accurate.

    “In general, inaccuracies related to skin pigmentation increase as the level of oxygenation decreases. Clinically, this means sicker patients are less likely to get an accurate reading, and are therefore less likely to get appropriate care,” she said. “The FDA should require more scrutiny to minimize bias in medical devices so they are accurate and reliable for everyone.”

    The FDA panel discussed certain skin color charts, descriptors and scales that have been used in medicine to determine a person’s skin tone, but those too can be subjective. None of those scales indicates how much melanin a person has in their skin.

    There are technologies, such as spectrophotometry, that can measure how much a chemical substance absorbs light and provide an objective measurement of melanin in the skin, but such spectrophotometers in the lab can cost thousands of dollars.

    All pulse oximeters need to be calibrated in humans in order for the optical signals used in the device to translate and produce an accurate oxygen saturation reading, Dr. Philip Bickler, professor and director of hypoxia research laboratory at the University of California, San Francisco, who has been studying pulse oximeters, said during the FDA panel meeting. Researchers at UCSF are working on a project called the Open Oximetry Project to improve equity in oximetry.

    “You can imagine that if all the calibration procedures are done in subjects with low skin melanin, you produce one marker that would produce pulse oximeters that would be accurate in individuals with lightly pigmented skin – and what has become apparent is that it’s been insufficient to account for the presence of melanin,” he said.

    “Now, you could do another calibration for subjects with darkly pigmented skin and you would get a different calibration curve,” he said. “So that is possible – and almost 20 years ago, we advocated for something like that.”

    Pulse oximeters were invented in 1974, and a body of research – dating to the 1980s – suggests that flawed pulse oximeter readings among Black and brown patients can be a real and life-threatening issue in medical care.

    This difference in how pulse oximeters perform for people with dark skin tones compared with those who have fair skin can drive racial disparities in the care patients receive.

    “This is distinct from some of the other race-based inequities that we’re currently tackling in health care. This one is really clear. It’s very straightforward what the scientific solution is,” the University of Maryland Medical System’s Wright said. “Here is an example where we have a very clearly defined biologic reason for why the infrared wavelengths of light don’t penetrate to detect oxygenation in folks with melanin as opposed to those without.”

    Another distinction: There has been evidence of colorism, or prejudices or discrimination against people with darker skin tones, playing a role in racial biases and the medical care some people get. Historically in medicine, medical data has involved a person’s race and not their skin color. Yet there are both light-skinned and dark-skinned Black people, Asians, Pacific Islanders, Native Americans and Hispanic people, and within each of those racial and ethnic groups, skin tone could play a role in biases in medical care.

    But the focus on specific skin tones – not race – when addressing the risk of inaccurate pulse oximeter readings appears to be “rooted in a very real desire to avoid medicine’s long and deeply appalling history” of disparities that arise when Black and brown communities are not provided the same quality of care as White populations, said Dr. Theodore J. Iwashyna, professor of pulmonary and critical care medicine, and of health policy and management, at Johns Hopkins University.

    The greater error rate in pulse oximeters for people with dark skin “is a prime example of valuing Black lives less,” said Iwashyna, who has studied how racially biased oxygen readings could put patients at risk.

    “There is a potential profound crisis that paying attention to these racial differences has made visible, in a ubiquitous device, that is disproportionately hurting Black patients,” he said. “And if attending to that difference can yield a set of monitoring devices that allow us to more safely and effectively care for all patients, including Black patients, that seems great.”

    In October, Iwashyna and two other researchers at the University of Michigan – Dr. Michael Sjoding and Dr. Thomas Valley – wrote an editorial, published in the American Journal of Respiratory and Critical Care Medicine, calling for the FDA to require pulse oximeter manufacturers to report how their devices perform in patients from diverse racial backgrounds. They wrote that the focus should remain on racial differences in accuracy until skin tone has been confirmed as “the underlying mechanism” for those discrepancies.

    “There are clearly these differences by race. And I think, as you read the historical record over the last 30 years, the reason those differences in accuracy were tolerated for so long is not because of physiology but because of a social valuation as to which patients these devices were less accurate in, and whether that was considered an unacceptable error,” Iwashyna said.

    At this point, he added, conversations should focus on fixing pulse oximetry inaccuracy in sick patients rather than the specific skin tones affected by the error.

    “We could just fix the damn problem,” he said. “Let’s build devices that work better and are calibrated across our entire population. We know, from NASA’s work in the 1960s, that this is possible – just it has not been done.”

    In response to the discussion, the makers of some pulse oximeters have reported that their studies show no evidence of racial biases in the accuracy of their devices.

    Studies of Medtronic’s Nellcor pulse oximeters found that they reported blood oxygen levels that were within 2% of participants’ drawn-blood oxygen levels – regardless of skin color, Dr. Sam Ajizian, chief medical officer of patient monitoring at Medtronic, said in an emailed statement to CNN.

    “Still, the data shows a small statistical discrepancy between results for those with light pigmentation and patients with darker skin pigmentation,” Ajizian said.

    “Medtronic is seeking to make improvements in our devices based on a greater understanding of the impact skin pigmentation has on pulse oximetry readings,” he said. “Through better information-sharing and an industry-wide commitment to continued innovation, we are advocating for improvements in the methods we use to validate pulse oximeters, including standardization of how we assess skin pigmentation and an increase in representation of patients with darker skin pigmentations in clinical trials.”

    The medical technology company Masimo had similar sentiments.

    “We have also calibrated and validated our oximeters using almost equal numbers of dark-skinned and light-skinned individual volunteers. We support prospective clinical studies, patient studies, on this topic, and we are pursuing these now,” Dr. William Wilson, Masimo’s chief medical officer, told the FDA advisory panel.

    “Masimo supports raising the standard on requirements for the percentage of dark-skinned subjects used in calibration and validation studies,” he said. “We also believe it is important that the FDA regulates and applies similar oversight recommendations on all pulse oximeters, including those sold directly to consumers.”

    Some experts worry that these studies of pulse oximeter devices in labs among healthy volunteers, as many manufacturers have done, might not be predictive of how the devices perform in medical centers among sick patients, indicating a need for more real-world data.

    “The lab studies were really small,” Iwashyna said. “And maybe if the things worked for everybody, we wouldn’t have to spend forever trying to figure out which people they don’t work for, because they just work for everybody.”

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  • Death in CRISPR gene therapy study sparks search for answers

    Death in CRISPR gene therapy study sparks search for answers

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    The lone volunteer in a unique study involving a gene-editing technique has died, and those behind the trial are now trying to figure out what killed him.

    Terry Horgan, a 27-year-old who had Duchenne muscular dystrophy, died last month, according to Cure Rare Disease, a Connecticut-based nonprofit founded by his brother, Rich, to try and save him from the fatal condition.

    Although little is known about how he died, his death occurred during one of the first studies to test a gene editing treatment built for one person. It’s raising questions about the overall prospect of such therapies, which have buoyed hopes among many families facing rare and devastating diseases.

    “This whole notion that we can do designer genetic therapies is, I would say, uncertain,” said Arthur Caplan, a medical ethicist at New York University who is not involved in the study. “We are out on the far edge of experimentation.”

    The early-stage safety study was sponsored by the nonprofit, led by Dr. Brenda Wong at the University of Massachusetts Chan Medical School and approved by the Food and Drug Administration. The hope was to use a gene-editing tool called CRISPR to treat Horgan’s particular form of Duchenne muscular dystrophy. The rare, genetic muscle-wasting disease is caused by a mutation in the gene needed to produce a protein called dystrophin. Most people with Duchenne die from lung or heart issues caused by it.

    At this point, it’s unclear whether Horgan received the treatment and whether CRISPR, other aspects of the study or the disease itself contributed to his death. Deaths are not unheard of in clinical trials, which test experimental treatments and sometimes involve very sick people.

    But trials involving CRISPR are relatively new. And Fyodor Urnov, a CRISPR expert at the Innovative Genomics Institute at University of California, Berkeley, said any death during a gene therapy trial is an opportunity for the field to have a reckoning.

    “Step one is to grieve for the passing of a brave human soul who agreed to be basically a participant in an experiment on a human being,” Urnov said. “But then, to the extent that we can, we must learn as much as we can to carve out a path forward.”

    FEW ANSWERS YET

    A statement from Cure Rare Disease said multiple teams across the country are looking into the details of the trial and its outcome, and the company intends to share findings with the scientific community.

    “It will probably be 3-4 months to come up with a full conclusion,” said spokesman Scott Bauman. “At this stage of the game, saying anything is pure speculation.”

    The company, which is also working on 18 other therapeutics, said in its statement that the teams’ work is essential not only to shed light on the study’s outcome but also “on the challenges of gene therapy broadly.” Meanwhile, it said, “we will continue to work with our researchers, collaborators, and partners to develop therapies for the neuromuscular diseases in our pipeline.”

    Bauman said the company has filed a report on death the with the FDA as required. The FDA declined to release or confirm the report.

    Sarah Willey, spokeswoman for Chan Medical School, said scientists there provided data to the company for the report. She later emailed to say no one there would comment further; out of respect for the family’s wishes, all information would come from Cure Rare Disease. Monkol Lek, a Yale genetics expert who has been collaborating on the effort, did not respond to a request for comment. Yale spokeswoman Bess Connolly asked a reporter for context on the story but didn’t respond to a follow-up email or phone call.

    A crucial question is whether CRISPR played a part in Horgan’s death.

    The chemical tool can be used to “edit” genes by making cuts or substitutions in DNA. The tool has transformed genetic research and sparked the development of dozens of experimental therapies. The inventors of the tool won a Nobel Prize in 2020.

    In this case, scientists used a modified form of CRISPR to increase the activity of a gene. The CRISPR therapeutic is inserted directly into the body and delivered to cells with a virus.

    But CRISPR is not perfect.

    “We know that CRISPR can miss its target. We know that CRISPR can be partially effective. And we also know that there may be issues with … viral vectors” that deliver the therapy into the body, Caplan said. “Red flags are flying here. We’ve got to make sure that they get addressed very, very quickly.”

    Safety issues have arisen in gene therapy studies before. Late last year, Pfizer reported the death of a patient in its early-stage trial for a different Duchenne muscular dystrophy gene therapy. And in a major earlier setback for the gene therapy field, 18-year-old Jesse Gelsinger died in 1999 during a study that involved placing healthy genes into his liver to combat a rare metabolic disease. Scientists later learned that his immune system overreacted to the virus used to deliver the therapy. Many recent studies, including the Cure Rare Disease trial, use a different virus that’s considered safer.

    Another difference? The recent trial involved just one person — a type of trial Caplan is skeptical about.

    Horgan’s recent death, he said, “may make us think whether we really do like studies that are just on one person, and do we want to say: ‘No, ethically, you’ve got to at least have a trial where you line up 5, 10, 20 people (and) you learn from the data.’ ”

    A ‘MEDICAL PIONEER’

    On the company’s web site, Horgan was described as a “medical pioneer” who “will be remembered as a hero.”

    In 2020, the Montour Falls, New York resident blogged that he was diagnosed with Duchenne at age 3. As a kid, he said, he loved computers — once building his own — and would play catch in the driveway with his family when he could still walk. Later in his life, he used a motorized wheelchair. He studied information science at Cornell University and went on to work at the school in the information science department.

    “As I grew up and began to understand what it meant to have DMD, my fears about this disease began to grow as it began to manifest,” Horgan wrote. “There weren’t many, or any, trials available to me through the years” — until this one brought the prospect of a customized drug.

    Horgan was enrolled in the study on Aug. 31. The plan was to suppress his immune system to prep his body for a one-time, gene-editing therapy delivered by IV at UMass medical school, followed by monitoring in the hospital. The company explained that the therapy is designed to increase the level of an alternate form of the dystrophin protein using CRISPR, with the goal of stabilizing or potentially reversing the progression of symptoms.

    Urnov, scientific director for technology and translation at the Berkeley genomics institute, said no other trial targeted this disease using this kind of virus to deliver this particular payload with its modified form of CRISPR.

    Some other gene therapy trials – such as those targeting the blood disorders sickle cell disease and beta thalassemia – involve removing stem cells from someone’s blood, using CRISPR in the lab, then putting the altered cells back into the person. The first time CRISPR was used to edit genes within the body was to address a blindness-causing mutation.

    Given the “exceptional distinctness” of the Cure Rare Disease approach, Urnov said he doesn’t think Horgan’s death will have a major impact on things like using gene therapy to fix blood diseases. But he said pinpointing the exact cause will help inform scientists throughout the field.

    “History teaches us that in the case of such fatalities – which have been rare – that a deep dive into what happened was critical for the field to move forward.”

    ———

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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  • By the next RSV season, the US may have its first vaccine | CNN

    By the next RSV season, the US may have its first vaccine | CNN

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    CNN
     — 

    It’s shaping up to be a severe season for respiratory syncytial virus infections – one of the worst some doctors say they can remember. But even as babies struggling to breathe fill hospital beds across the United States, there may be a light ahead: After decades of disappointment, four new RSV vaccines may be nearing review by the US Food and Drug Administration, and more than a dozen others are in testing.

    There’s also hope around a promising long-acting injection designed to be given right after birth to protect infants from the virus for as long as six months. In a recent clinical trial, the antibody shot was 75% effective at heading off RSV infections that required medical attention.

    Experts say the therapies look so promising, they could end bad RSV seasons as we know them.

    And the relief could come soon: Dr. Ashish Jha, who leads the White House Covid-19 Response Task Force, told CNN that he’s “hopeful” there will be an RSV vaccine by next fall.

    Charlotte Brown jumped at the chance to enroll her own son, a squawky, active 10-month-old named James, in one of the vaccine trials this summer.

    “As soon as he qualified, we were like ‘absolutely, we are in,’ ” Brown said.

    Babies have to be at least 6 months old to enter the trial, which is testing a vaccine developed at the National Institutes of Health – the result of decades of scientific research.

    Brown is a pediatrician who cares for hospitalized children at Vanderbilt University Medical Center in Nashville, and she sees the ravages of RSV firsthand. A recent patient was in the back of her mind when she was signing up James for the study.

    “I took care of a baby who was only a few months older than him and had had nine days of fever and was just absolutely pitiful and puny,” she said. Brown said his family felt helpless. “And I was like, ‘this is why we’re doing it. This single patient is why we’re doing this.’ “

    Even before this year’s surge, RSV was the leading cause of infant hospitalizations in the US. The virus infects the lower lungs, where it causes a hacking cough and may lead to severe complications like pneumonia and inflammation of the tiny airways in the lungs called bronchiolitis.

    Worldwide, RSV causes about 33 million infections in children under the age of 5 and hospitalizes 3.6 million annually. Nearly a quarter-million young children die each year from complications of their infections.

    RSV also preys on seniors, leading to an estimated 159,000 hospitalizations and about 10,000 deaths a year in adults 65 and over, a burden roughly on par with influenza.

    Despite this heavy toll, doctors haven’t had any new tools to head off RSV for more than two decades. The last therapy approved was in 1998. The monoclonal antibody, Synagis, is given monthly during RSV season to protect preemies and other high-risk babies.

    The hunt for an effective way to protect against RSV stalled for decades after two children died in a disastrous vaccine trial in the 1960s.

    That study tested a vaccine made with an RSV virus that had been chemically treated to render it inert and mixed with an ingredient called alum, to wake up the immune system and help it respond.

    It was tested at clinical trial sites in the US between 1966 and 1968.

    At first, everything looked good. The vaccine was tested in animals, who tolerated it well, and then given to children, who also appeared to respond well.

    “Unfortunately, that fall, when RSV season started, many of the children that were vaccinated required hospitalization and got more severe RSV disease than what would have normally occurred,” said Steven Varga, a professor of microbiology and immunology at the University of Iowa, who has been studying RSV for more than 20 years and is developing a nanoparticle vaccine against the virus.

    A study published on the trial found that 80% of the vaccinated children who caught RSV later required hospitalization, compared with only 5% of the children who got a placebo. Two of the babies who had participated in the trial died.

    The outcomes of the trial were a seismic shock to vaccine science. Efforts to develop new vaccines and treatments against RSV halted as researchers tried to untangle what went so wrong.

    “The original vaccine studies were so devastatingly bad. They didn’t understand immunology well in those days, so everybody said ‘oh no, this ain’t gonna work.’ And it really was like it stopped things cold for 30, 40 years,” said Dr. Aaron Glatt, an infectious disease specialist at Mount Sinai South Nassau in New York.

    Regulators re-evaluated the guardrails around clinical trials, putting new safety measures into place.

    “It is in fact, in many ways, why we have some of the things that we have in place today to monitor vaccine safety,” Varga said.

    Researchers at the clinical trial sites didn’t communicate with each other, Varga said, and so the US Food and Drug Administration put the publicly accessible Vaccine Adverse Events Reporting System into place. Now, when an adverse event is reported at one clinical trial site, other sites are notified.

    Another problem turned out to be how the vaccine was made.

    Proteins are three-dimensional structures. They are made of chains of building blocks called amino acids that fold into complex shapes, and their shapes determine how they work.

    In the failed RSV vaccine trial, the chemical the researchers used to deactivate the virus denatured its proteins – essentially flattening them.

    “Now you have a long sheet of acids but no more beautiful shapes,” said Ulla Buchholz, chief of the RNA Viruses Section at the National Institutes of Allergy and Infectious Diseases.

    “Everything that the immune system needs to form neutralizing antibodies that can block and block attachment and entry of this virus to the cell had been destroyed in that vaccine,” said Buchholz, who designed the RSV vaccine for toddlers that’s being tested at Vanderbilt and other US sites.

    In the 1960s trial, the kids still made antibodies to the flattened viral proteins, but they were distorted. When the actual virus came along, these antibodies didn’t work as intended. Not only did they fail to recognize or block the virus, they triggered a powerful misdirected immune response that made the children much sicker, a phenomenon called antibody-dependent enhancement of disease.

    The investigators hadn’t spotted the enhancement in animal studies, Varga says, because the vaccinated animals weren’t later challenged with the live virus.

    “So of course, we require now extensive animal testing of new vaccines before they’re ever put into humans, again, for that very reason of making sure that there aren’t early signs that a vaccine will be problematic,” Varga said.

    About 10 years ago, a team of researchers at the NIH – some of the same investigators who developed the first Covid-19 vaccines – reported what would turn out to be a pivotal advance.

    They had isolated the structure of the virus’s F-protein, the site that lets it dock onto human cells. Normally, the F-protein flips back and forth, changing shapes after it attaches to a cell. The NIH researchers figured out to how freeze the F-protein into the shape it takes before it fuses with a cell.

    This protein, when locked into place, allows the immune system to recognize the virus in the form it’s in when it first enters the body – and develop strong antibodies against it.

    “The companies coming forward now, for the most part, are taking advantage of that discovery,” said Dr. Phil Dormitzer, a senior vice president of vaccine development at GlaxoSmithKline. “And now we have this new generation of vaccine candidates that perform far better than the old generation.”

    The first vaccines up for FDA review will be given to adults: seniors and pregnant woman. Vaccination in pregnancy is meant to ultimately protect newborns – a group particularly vulnerable to the virus – via antibodies that cross the placenta.

    Vaccines for children are a bit farther behind in development but moving through the pipeline, too.

    Four companies have RSV vaccines for adults in the final phases of human trials: Pfizer and GSK are testing vaccines for pregnant women as well as seniors. Janssen and Bavarian Nordic are developing shots for seniors.

    Pfizer and GSK use protein subunit vaccines, a more traditional kind of vaccine technology. Two other companies build on innovations made during the pandemic: Janssen – the vaccine division of Johnson & Johnson – relies on an adenoviral vector, the same kind of system that’s used in its Covid-19 vaccine, and Moderna has a vaccine for RSV in Phase 2 trials that uses mRNA technology.

    So far, early results shared by some companies are promising. Janssen, Pfizer and GSK each appear effective at preventing infections in adults for the first RSV season after the vaccine.

    In an August news release, Annaliesa Anderson, Pfizer’s chief scientific officer of Vaccine Research and Development, said she was “delighted” with the results. The company plans to submit its data to the FDA for approval this fall.

    GSK has also wrapped up its Phase 3 trial for seniors. It recently presented the results at a medical conference, but full data hasn’t been peer reviewed or published in a medical journal. Early results show that this vaccine is 83% effective at preventing disease in the lower lungs of adults 60 and older. It appears to be even more protective – 94% – for severe RSV disease in those over 70 and those with underlying medical conditions.

    “We are very pleased with these results,” Dormitzer told CNN. He said the company was moving “with all due haste” to get its results to the FDA for review.

    “We’re confident enough that we’ve started manufacturing the actual commercial launch materials. So we have the bulk vaccine actually in the refrigerator, ready to supply when we are licensed,” he said.

    Even as the company applies for licensure, GSK’s trial will continue for two more RSV seasons. Half the group getting the vaccine will be followed with no additional shots, while the other group will get annual boosters. The aim is to see which approach is most protective to guide future vaccination strategies.

    Janssen’s vaccine for older adults appears to be about 70% to 80% effective in clinical trials so far, the company announced in December.

    In a study on Pfizer’s vaccine for pregnant women published in the New England Journal of Medicine this year, the company reported that the mothers enrolled in the study made antibodies to the vaccine and that these antibodies crossed the placenta and were detected in umbilical cord blood just after birth.

    The vaccines for pregnant women are meant to get newborns through their first RSV season. But not all newborns will benefit from those. Most maternal antibodies are passed to baby in the third trimester, so preemies may not be protected, even if mom gets the vaccine.

    For vulnerable infants and those whose mothers decline to be vaccinated, Dr. Helen Chu, an infectious disease specialist at the University of Washington, says the long-acting antibody shot for newborns, called nirsevimab, should cover them for the first six months of life. She expects it to be a “game-changer.”

    That shot, which has been developed by AstraZeneca, was recently recommended for approval in the European Union. It has not yet been approved in the United States.

    The field is so close to a new approval that public health officials say they’ve been asked to study up on the data.

    Chu, who is also a member of an RSV study group of the Advisory Committee on Immunization Practices, a panel that advises the US Centers for Disease Control and Prevention on its vaccine recommendations, says her group has started to evaluate the new vaccines – a sign that an FDA review is just around the corner.

    No companies have yet announced that process is underway. FDA reviews can take several months, and then there are typically discussions and votes by FDA and CDC advisory groups before vaccines are made available.

    “We’ve been working on this for several months now to start reviewing the data,” Chu said. “So I think this is imminent.”

    Watching this year’s RSV season unfold, Brown, the pediatrician who enrolled her son in the vaccine trial for toddlers, says progress can’t come fast enough.

    “The hospital is surging. We’re not drowning the way some states are. I mean, Connecticut, South Carolina, North Carolina, they’re really drowning. But our numbers are huge, and our services are so busy,” she says.

    Brown says her son is mostly healthy. He doesn’t have any of the risks for severe RSV she sees with some of her patients, so she was happy to have a way to help others.

    And while it’s far too early to say whether the vaccine James is helping to test will prove to be effective, the trial was unblinded last week, and Brown learned that her son was in the group that got the active vaccine, not the placebo

    He has done well through this heavy season of illness, she says. The NIH-sponsored study they participated in is scheduled to be completed next year.

    The vaccine, which is made with a live but very weak version of virus, is given through a couple of squirts up the nose, so there are no needles. The hardest part for squirmy James, she said, was being held still.

    “If we can do anything to move science forward and help another child, like, sorry, James. You had to have your blood drawn, but it absolutely was worth it.”

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  • Study: Cancer-causing gas leaking from CA stoves, pipes

    Study: Cancer-causing gas leaking from CA stoves, pipes

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    Gas stoves in California homes are leaking cancer-causing benzene, researchers found in a new study published on Thursday, though they say more research is needed to understand how many homes have leaks.

    In the study, published in Environmental Science and Technology on Thursday, researchers also estimated that over 4 tons of benzene per year are being leaked into the atmosphere from outdoor pipes that deliver the gas to buildings around California — the equivalent to the benzene emissions from nearly 60,000 vehicles. And those emissions are unaccounted for by the state.

    The researchers collected samples of gas from 159 homes in different regions of California and measured to see what types of gases were being emitted into homes when stoves were off. They found that all of the samples they tested had hazardous air pollutants, like benzene, toluene, ethylbenzene and xylene (BTEX), all of which can have adverse health effects in humans with chronic exposure or acute exposure in larger amounts.

    Of most concern to the researchers was benzene, a known carcinogen that can lead to leukemia and other cancers and blood disorders, according to the National Cancer Institute.

    The finding could have major implications for indoor and outdoor air quality in California, which has the second highest level of residential natural gas use in the United States.

    “What our science shows is that people in California are exposed to potentially hazardous levels of benzene from the gas that is piped into their homes,” said Drew Michanowicz, a study co-author and senior scientist at PSE Healthy Energy, an energy research and policy institute. “We hope that policymakers will consider this data when they are making policy to ensure current and future policies are health-protective in light of this new research.”

    Homes in almost every region in the study — Greater Los Angeles, the San Francisco Bay Area, Sacramento and Fresno — had benzene levels that far exceed the limit determined to be safe by the California Office of Environmental Health Hazards Assessment. But the region with the highest benzene levels by far was the North San Fernando and Santa Clarita valleys.

    This finding in particular didn’t surprise residents and health care workers in the region who spoke to The Associated Press about the study. That’s because many of them experienced the largest-known natural gas leak in the nation in Aliso Canyon in 2015.

    Back then, 100,000 tons of methane and other gases, including benzene, leaked from a failed well operated by Southern California Gas Co. It took nearly four months to get the leak under control and resulted in headaches, nausea and nose bleeds.

    Dr. Jeffrey Nordella was a physician at an urgent care in the region during this time and remembers being puzzled by the variety of symptoms patients were experiencing. “I didn’t have much to offer them,” except to help them try to detox from the exposures, he said.

    That was an acute exposure of a large amount of benzene, which is different from chronic exposure to smaller amounts, but “remember what the World Health Organization said: there’s no safe level of benzene,” he said.

    Kyoko Hibino was one of the residents exposed to toxic air pollution as a result of the Aliso Canyon gas leak. After the leak, she started having a persistent cough and nosebleeds and eventually was diagnosed with breast cancer, which has also been linked to benzene exposure. Her cats also started having nosebleeds and one recently passed away from leukemia.

    “I’d say let’s take this study really seriously and understand how bad (benzene exposure) is,” she said.

    ———

    Follow Drew Costley on Twitter: @drewcostley.

    ———

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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  • Vilcek Foundation Awards $600,000 in Prizes to Immigrant Scientists and Musicians

    Vilcek Foundation Awards $600,000 in Prizes to Immigrant Scientists and Musicians

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    Prizes awarded in honor of immigrant leaders in the arts and sciences, including musicians Du Yun and Angélique Kidjo, and scientist Alejandro Sánchez Alvarado


    NEW YORK, October 18, 2022 (Newswire.com)
    –
    The Vilcek Foundation announces the recipients of the 2023 Vilcek Foundation Prizes. Awarded annually in the arts and sciences, the prizes recognize and celebrate immigrant contributions to the arts, culture, and society, and build awareness of how important immigration is for intellectual and cultural life in the United States.

    Since 2006, the Vilcek Foundation has awarded prizes each year in biomedical science and in rotating categories in the arts and humanities. In 2023, the arts and humanities prizes are awarded in music. The foundation awards two primary types of prizes in each category: the Vilcek Prizes, and the Vilcek Prizes for Creative Promise.

    The Vilcek Prizes are $100,000 awards bestowed on immigrant professionals whose career achievements represent a legacy of major accomplishments in their field. The Vilcek Prizes for Creative Promise honor immigrant professionals whose early-career work demonstrates a singular innovation or represents a significant contribution to their field. Recipients of the Vilcek Prizes for Creative Promise each receive an unrestricted cash award of $50,000. 

    The Vilcek Foundation typically awards one Vilcek Prize and three Vilcek Prizes for Creative Promise in each category every year. In 2023, the Vilcek Foundation is awarding two Vilcek Prizes in Music. 

    The Vilcek Prize in Biomedical Science

    The 2023 Vilcek Prize in Biomedical Science is awarded to Alejandro Sánchez Alvarado, executive director and chief scientific officer of the Stowers Institute for Medical Research, and a Howard Hughes Medical Institute investigator. Born in Caracas, Venezuela, Sánchez Alvarado receives the Vilcek Prize for his contributions to the field of regeneration—from the identification of genes that control regeneration in living organisms to the potential for regenerative medicine to revolutionize how we treat disease in humans. 

    “Alejandro Sánchez Alvarado has devoted his career to understanding the fundamental molecular and cellular bases of regeneration, from the specific genes responsible for regeneration to epigenetic regulators that compel the expression of these genes,” said Vilcek Foundation Chairman and CEO Jan Vilcek. “Using a freshwater flatworm—an organism called Schmidtea mediterranea—as a powerful experimental tool to study the molecular mechanisms of tissue regeneration, he has pioneered and expanded the field of regeneration. His work has broad applications for our understanding of the pathology of degenerative disease.”

    The Vilcek Prize in Music

    The Vilcek Foundation has made the decision to award two Vilcek Prizes in Music in 2023 to Du Yun and to Angélique Kidjo. Each will receive a cash award of $100,000 and a commemorative trophy.

    “Music transcends language,” said Vilcek Foundation Cofounder, Vice Chair, and Secretary Marica Vilcek. “It defies borders and boundaries, and has a unique power to resonate with people across cultures. Rhythm, melody, and harmony are critical parts of how we communicate with one another as humans.” She continued, “With this year’s prizes, we wanted to honor the range of impact that immigrants have on this expansive art form. As such, we made the decision to award two Vilcek Prizes in Music this year, to Du Yun and Angélique Kidjo.”

    Says Vilcek Foundation President Rick Kinsel, “The sheer scope of Du Yun and Angélique Kidjo’s work defies any easy categorization. Du Yun’s virtuosic range and arresting compositions expand the horizons of contemporary and classical music. Kidjo’s resonant songwriting and engaging performances have captivated audiences globally, and introduced generations of audiences to Afropop, Afrobeat, and traditional West African music. These distinctions convey the breadth of music as an art form, as well as the broad impact immigrants have on culture and society.” 

    Du Yun receives the Vilcek Prize in Music for her open approach to composition, which subverts the boundaries of traditional classical music by incorporating influences from punk, electronic, and experimental music, and for the virtuosity of her Pulitzer Prize-winning opera, Angel’s Bone. Born in Shanghai, China, Du Yun began studying piano at the age of four and began attending the Preparatory Divisions of the Shanghai Conservatory of Music at age six. She came to the United States to pursue higher education in music, earning her bachelor’s at Oberlin Conservatory and her Ph.D. in Music Composition at Harvard University. In 2001, Du Yun co-founded the International Contemporary Ensemble with the goal of advancing the genre of experimental music through collaborations, commissions, and performances.

    Angélique Kidjo receives the Vilcek Prize in Music in recognition of her exceptional range as a singer-songwriter, and for her artistic leadership through her performances, albums, and collaborations. Born in Ouidah, Benin, Kidjo had her musical debut with the album Pretty in 1981. She rose to international fame in the 1990s with albums like Logozo, Ayé, and Fifa. In 1997, Kidjo immigrated to the United States, moving to Brooklyn, New York. Since then, she has continued to write, record, and tour extensively, while undertaking humanitarian work as an international Goodwill Ambassador for UNICEF and with the Batonga Foundation, which she founded in 2006. 

    The Vilcek Prizes for Creative Promise in Biomedical Science

    The recipients of the 2023 Vilcek Prizes for Creative Promise in Biomedical Science are Edward Chouchani (b. Canada), Biyu J. He (b. China), and Shixin Liu (b. China).

    Edward Chouchani receives the Vilcek Prize for Creative Promise in Biomedical Science for his work to decipher the molecular mechanisms that drive metabolic disease, with the aim of developing therapeutic interventions targeted at the molecular drivers of metabolism within cells. 

    Biyu J. He receives the Vilcek Prize for Creative Promise in Biomedical Science for her leadership in the field of cognitive neuroscience, and for her groundbreaking discoveries on the biological bases of perceptual cognition and subjective experience.

    Shixin Liu receives the Vilcek Prize for Creative Promise for applying cutting-edge biophysical tools to directly visualize, manipulate, and understand the physiological function of nanometer-scale biomolecular machines including DNA replication and transcription complexes at the single-molecule level.

    The Vilcek Prizes for Creative Promise in Music

    The 2023 Vilcek Prizes for Creative Promise in Music are awarded to Arooj Aftab (b. Saudi Arabia, to Pakistani parents) Juan Pablo Contreras (b. Mexico), and Ruby Ibarra (b. the Philippines).

    Arooj Aftab receives the Vilcek Prize for Creative Promise in Music for her evocative songs and compositions that incorporate a range of influences from semi-classical Pakistani music and Urdu poetry, to jazz harmonies and experimental music. 

    Juan Pablo Contreras receives the Vilcek Prize for Creative Promise in Music for his work as a composer and conductor of orchestral music that draws on his Mexican heritage, and for his leadership in founding the Orquesta Latino Mexicana. 

    Ruby Ibarra receives the Vilcek Prize for Creative Promise in Music for her hip-hop and spoken word performances that center her experience as a Filipina American woman, and for her powerful lyrics that address colonialism, immigration, colorism, and misogyny.

    The Vilcek Foundation

    The Vilcek Foundation raises awareness of immigrant contributions in the United States and fosters appreciation for the arts and sciences. The foundation was established in 2000 by Jan and Marica Vilcek, immigrants from the former Czechoslovakia. The mission of the foundation was inspired by the couple’s respective careers in biomedical science and art history. Since 2000, the foundation has awarded over $7 million in prizes to foreign-born individuals and has supported organizations with over $5.8 million in grants.

    The Vilcek Foundation is a private operating foundation, a federally tax-exempt nonprofit organization under IRS Section 501(c)(3). To learn more, please visit vilcek.org. 

    Source: The Vilcek Foundation

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  • Scientists grow human brain cells in rats to study diseases

    Scientists grow human brain cells in rats to study diseases

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    Scientists have transplanted human brain cells into the brains of baby rats, where the cells grew and formed connections.

    It’s part of an effort to better study human brain development and diseases affecting this most complex of organs, which makes us who we are but has long been shrouded in mystery.

    “Many disorders such as autism and schizophrenia are likely uniquely human” but “the human brain certainly has not been very accessible,” said said Dr. Sergiu Pasca, senior author of a study describing the work, published Wednesday in the journal Nature.

    Approaches that don’t involve taking tissue out of the human brain are “promising avenues in trying to tackle these conditions.”

    The research builds upon the team’s previous work creating brain “organoids,” tiny structures resembling human organs that have also been made to represent others such as livers, kidneys, prostates, or key parts of them.

    To make the brain organoids, Stanford University scientists transformed human skin cells into stem cells and then coaxed them to become several types of brain cells. Those cells then multiplied to form organoids resembling the cerebral cortex, the human brain’s outermost layer, which plays a key role in things like memory, thinking, learning, reasoning and emotions.

    Scientists transplanted those organoids into rat pups 2 to 3 days old, a stage when brain connections are still forming. The organoids grew so that they eventually occupied a third of the hemisphere of the rat’s brain where they were implanted. Neurons from the organoids formed working connections with circuits in the brain.

    Human neurons have been transplanted in rodents before, but generally in adult animals, usually mice. Pasca, a psychiatry professor at the Stanford School of Medicine, said this is the first time these organoids have been placed into early rat brains, creating “the most advanced human brain circuitry ever built from human skin cells and a demonstration that implanted human neurons can influence an animal’s behavior.”

    To examine a practical use of this approach, scientists transplanted organoids into both sides of a rat’s brain: one generated from a healthy person’s cells and another from the cells of a person with Timothy syndrome, a rare genetic condition associated with heart problems and autism spectrum disorder.

    Five to six months later, they saw effects of the disease related to the activity of the neurons. There were differences in the two sides’ electrical activity, and the neurons from the person with Timothy syndrome were much smaller and didn’t sprout as many extensions that pick up input from nearby neurons.

    Researchers, whose study was funded partly by the National Institutes of Health, said they could do the same sorts of experiments using organoids made from the cells of people with disorders such as autism or schizophrenia — and potentially learn new things about how these conditions affect the brain, too.

    Dr. Flora Vaccarino of Yale University – who previously grew lumps containing cerebral cortex that were made with DNA from people with autism – said the study moves the field forward.

    “It’s extremely impressive what they do here in terms of what these cells can actually show us in terms of their advanced development … in the rat,” said Vaccarino, who wasn’t involved with the study.

    Such experiments in animals raise ethical concerns. For example, Pasca said he and his team are cognizant of the rats’ well-being and whether they still behave normally with the organoids inside them, which he says they do. Still, Pasca does not believe this should be tried in primates. Ethicists also wonder about the possibility of brain organoids in the future attaining something like human consciousness, which experts say is extremely unlikely now.

    Some scientists are studying human brain organoids outside of animals. For example, researchers at ETH Zurich in Switzerland published a study in Nature earlier this month describing how they are growing brain-like tissue from stem cells in the lab and then mapping the cell types in various brain regions and genes regulating their development. Some are using these structures to study autism.

    Pasca said brain organoids could also be used to test new treatments for neuropsychiatric disorders, the largest cause of disability worldwide. Such research, he said, should help scientists make strides that have been extremely difficult until now because it’s so hard to get at the human brain – which is “the reason why we’re so much more behind in psychiatry compared to any other branch of medicine in terms of therapeutics.”

    ———

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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  • 2 South American researchers killed in Missouri

    2 South American researchers killed in Missouri

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    KANSAS CITY, Mo. — Missouri homicide and arson detectives are investigating the deaths of two South American researchers whose bodies were found after a weekend apartment fire near the Kansas City biomedical research center where they worked.

    Kansas City police identified the victims as Camila Behrensen, 24, of Buenos Aires, Argentina, and Pablo Guzmán Palma, 25, of Santiago, Chile.

    The Stowers Institute for Medical Research said in a tweet Tuesday that both Behrensen and Palma were predoctoral researchers there.

    “Our deepest sympathies are with their families,” the tweet said. “During this difficult time, and most importantly, out of respect to the two families, we want to honor and remember the joy, optimism, and exceptional work these two individuals embodied and all that they have accomplished.”

    Behrensen and Palma were suffering from what police described as “apparent trauma” when fire crews responded Saturday and extinguished the blaze. Both were declared dead at the scene.

    Police released few details but said there is a $25,000 reward for information leading to an arrest. They asked Tuesday for help from anyone with surveillance video.

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  • SinuSonic Announces Presentation of Double-Blind, Sham-Controlled Trial Data Showing Regular Use of the Device Improved Nasal Congestion

    SinuSonic Announces Presentation of Double-Blind, Sham-Controlled Trial Data Showing Regular Use of the Device Improved Nasal Congestion

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    New technology provides non-prescription, non-addictive, mess-free alternative to relieve congestion and runny nose

    Press Release
    –

    May 26, 2022


    COLUMBIA, S.C., May 26, 2022 (Newswire.com)
    –
    SinuSonic, a brand of Healthy Humming, LLC, is pleased to announce the presentation of the results from their study on “Double-blind, sham-controlled trial of a novel device for the treatment of viral upper respiratory tract infection.” This study was discussed during an oral podium presentation at the American Rhinological Society Spring meeting in Dallas, Texas, on April 28-29, 2022. This study showed, with the highest level of evidence, a randomized sham-controlled study that regular use of the active SinuSonic device improved nasal congestion.

    The prospective study was conducted at the Medical University of South Carolina in 2020-2021. Administration of acoustic vibration and oscillating expiratory positive pressure with SinuSonic has been shown in a prior study to improve nasal congestion and air flow. These interventions are hypothesized to release nasal nitric oxide, a molecule with known antiviral properties. The current study investigated the use of this device to prevent viral upper respiratory infections (URI) and reduce the severity and duration of rhinologic symptoms. 

    Asymptomatic community-dwelling adults were randomized to receive an active or a sham device (3:1). Subjects used the assigned device twice daily beginning at the start of the fall URI season. A validated metric of viral URI symptoms, Total Symptoms Score (TSS), was assessed each day for 8 weeks.

    Topline outcomes:

    • Those using the active device had 70% more days with no nasal congestion (57.2% vs 33.5%, p= 0.033)
    • A statistically significant difference in nasal congestion score was seen between the active and sham groups (0.503 vs. 0.843, p = 0.036)
    • No subject in either the active or sham group developed symptoms meeting the study definition of a viral URI, likely due to viral precautions during the pandemic.
    • No major adverse events were detected, with 97.5% of subjects reporting zero pain or discomfort at the study conclusion.

    ABOUT NASAL CONGESTION

    Chronic nasal congestion impacts roughly 20% of the population and is associated with reduced quality of life, difficulty sleeping, reduced daytime performance, and increased healthcare utilization. It has been estimated that the financial impact of chronic nasal congestion is more than $5 – 10 billion annually. A survey conducted by Allergies in Americas found that despite the availability of pharmacologic options, many patients are not satisfied with available options. 

    Learn more about the science of SinuSonic and how SinuSonic works.

    ABOUT SINUSONIC

    Founded in Columbia, South Carolina, and born through the research and partnerships of Richard K. Bogan, M.D., and David J. Lewis, SinuSonic is the first-ever multi-patented (5) nasal congestion relief device to use acoustic vibrations to help provide nasal congestion relief. SinuSonic is designed in the U.S. with parts molded in the U.S. and assembled in an FDA-registered facility in Columbia, South Carolina. Since launching in July 2019, SinuSonic is being used in all 50 states. For more information and to view instructional videos, visit www.sinusonic.com.

    SinuSonic is available to the public at www.sinusonic.com.

    Media Contact:
    David Lewis
    Info@SinuSonic.com 
    (803) 888-6170

    Source: Healthy Humming, LLC

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  • Genomelink and Sano Genetics Partner to Encourage More Consumers to Donate their DNA for Research and Get Rewarded

    Genomelink and Sano Genetics Partner to Encourage More Consumers to Donate their DNA for Research and Get Rewarded

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    SAN FRANCISCO, October 3, 2019 (Newswire.com)
    –
    ​The biotech startup, Genomelink, has announced it is partnering with genomic research and data-sharing startup, Sano Genetics, that will match consumers’ genetic information with new medical research.

    Under this partnership, consumers will get paid for contributing their time and genetic data to medical research, and will receive health benefits, including access to new treatments via clinical trials. In addition, participants will receive regular updates on the research they support and free personalized health and wellness reports based on their genetic profiles.

    Together, Genomelink and Sano Genetics will use the DNA data to research common disorders such as eczema, psoriasis, diabetes, and mental health conditions, as well as rare diseases like muscular dystrophy.

    The CEO and co-founder of Genomelink, Tomohiro Takano, says this new partnership will transform drug discovery and accelerate the growth of personalized medicine, enabling large-scale genetic and medical research without sacrificing data privacy.

    Genomelink is a web platform that enables consumers to upload their raw DNA report – for free – and discover more about their DNA identities and traits that go beyond ancestry. The consumer platform reveals more than 125 genetic traits in five categories – food and nutrition, personality, cognitive, fitness and physical traits. 

    Sano Genetics is a data-sharing platform where consumers submit their medical history and genetic data, which is matched with clinical studies that can benefit from their DNA. The biotech company matches participants with research projects that offer free genome sequencing and opportunities to try new treatments via clinical trials. Genome sequencing can typically cost more than $1000. 

    Takano says unlike traditional genetic data sharing partnerships, Genomelink and Sano Genetics have created a transparent, secure platform that allows individuals to explicitly opt in or out of different studies – and make money while doing so.

    “The process to submit your DNA is incredibly easy and fast,” said Takano. “Consumers can share as much – or as little information – as they wish. Once their DNA has been selected for research, consumers can then learn how to make money off their contribution.”

    How Consumers Benefit from Participating in Research

    Takano says it’s very simple to participate in the DNA research. Consumers upload their DNA report to Genomelink and give consent to sharing their genetic information with Sano. Consumers who are selected will be compensated for their contribution. 

    Several hundred Genomelink users have already contributed their DNA as part of a project to understand whether there is an interaction between genetics and common anti-inflammatories, such as Aspirin, in people with stomach ulcers. 

    Additionally, researchers conducting nonprofit studies at the University of Cambridge, the University of Liverpool, and Imperial College London are using this DNA data to research autism and autoimmune conditions.

    Genomelink users can also join studies run by for-profit companies, including clinical trials for eczema and psoriasis; research and development of new treatments for rare and chronic diseases; and several studies on how genetics influences the way people respond to medicines. The money participants will receive varies depending on the type of research – from $10 for a simple survey to hundreds of dollars for more complex studies. 

    In addition, participants who join for-profit studies are also eligible to receive free genetic testing, free upgrades to Genomelink premium or other non-monetary rewards, depending on the specifics of the study. 

    Takano says DNA data from Genomelink will not be used in research unless participants explicitly opt in. Both Genomelink and Sano Genetics have a strong commitment to transparency and data ownership for participants.

    “We believe partnerships like ours are the first step in researching rare diseases and disorders with no cures,” said Takano. “By donating your DNA to researchers studying diseases like diabetes and depression, we can learn more about how we can cure them and help thousands of patients around the world.”

    To learn more about this partnership and how consumers can get involved, visit https://sanogenetics.com/genomelink

    About Genomelink

    Genomelink is a graduate of Berkeley SkyDeck accelerator and backed by several investors, including Global Brain, Digital Garage, Sony Innovation Fund, IronFire Ventures and 500 Startups Japan. The web platform helps members learn about their DNA data, while ensuring ultimate transparency. It enables members to upload their raw DNA data file and discover more about their DNA identities and traits through intuitive visualization and scientific educational content. Genomelink’s dedicated science team updates its trait database weekly with curated research papers and academic literature that provides analysis for over 125 traits in five categories: food & nutrition, personality, cognitive, fitness, and physical traits. The research database enables users to discover new trait reports every week.

    The company was founded in 2017 by three Japanese founders – Tomohiro Takano, Yuta Matsuda and Kensuke Numakura – who have worked in genomics for years, including M3, Inc., DeNA, and P5, Inc., which was founded as a joint venture of SONY and Illumina.

    About Sano Genetics

    Sano Genetics is a UK-based platform for research in personalized medicine. Founded by three Ph.D. students from the University of Cambridge -  Patrick Short, Charlotte Guzzo and William Jones – the platform is free to use and gives users the option to upload existing genetic and medical data to match with research studies and clinical trials powering the future of personalised medicine.

    Media Contact:

    Mark Macias
    Phone: 646-770-0541
    Email: mmm@maciaspr.com

    Source: Genomelink

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  • American Academy of Stem Cell Physicians Makes History as First Board Certification for Stem Cell Physicians

    American Academy of Stem Cell Physicians Makes History as First Board Certification for Stem Cell Physicians

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    MIAMI, August 8, 2019 (Newswire.com)
    –
    ​The AASCP Scientific Congress met on Aug. 2-4, 2019 in Miami and offered the first Board certifications to eligible physicians.

    The American Academy of Stem Cell Physicians hosted yet another Scientific Congress, which was held at the Hyatt Regency in Miami, Florida, on Aug. 2-4, 2019. The conference featured three days of educational and social events with leading physicians and pioneers in the fields of stem cell, live cell and regenerative medicine. A very challenging three-hour written examination for Board certification was awarded, creating a pathway for Diplomat and Fellowship certification in Regenerative medicine.  

    The Board of American Academy of Stem Cell Physicians is the official board certifying body of the American Academy of Stem Cell Physicians (AASCP). As a nationally recognized academy with a mission to bring like-minded physicians together to increase awareness and education of regenerative medicine, the AASCP is proud to announce the Fellowship and Diplomat certification.

    In order to be eligible for certification or recertification through the AASCP, licensed physicians in great standing must meet the stringent eligibility requirements that have been defined by the board. AASCP places an emphasis on not only psychometrically evaluated testing and advanced training but also moral character and experience. Furthermore, AASCP has a clear path toward recertification for qualified physicians. Their standards for recertification typically include a commitment to continuing medical education, successful completion of a recertification examination, participation in a non-remedial medical ethics program and other similar requirements. 

    AASCP is also well known for working with physicians to provide unique opportunities for board certification in their specialty of regenerative medicine. For instance, the AASCP offers ongoing workshop modules led by highly prestigious and esteemed physicians in this field certifying and educating on different treatments and techniques.

    Another defining characteristic of the AASCP is their commitment to ongoing education and awareness. This is why they’ve developed innovative new committees, including the Institutional Review Board and opportunities for physicians and researchers to submit their work for review and exposure.

    The AASCP was founded to recognize licensed physicians who have shown a specialty and interest in regenerative medicine. Increasingly, hospitals and medical staff placement agencies are prioritizing hiring board-certified physicians, and the AASCP feels it is important to offer qualified professionals a choice when they’re researching board certifying bodies. The AASCP was founded by a group of leading physicians in 2017, and over the last two years their team of professionals has worked tirelessly to improve the certification process in order to ensure that their Diplomats are recognized for their achievements in the medical profession.

    Currently, licensed physicians in great standing will complete eight modules for certification. At that point, they will qualify to complete a written and oral exam which is given to them by the eight workshop leaders. Upon approval, the AASCP will confer upon them the title of Diplomat of the AASCP, and at that point after one year of good standing, they will qualify to become a Fellow of American Academy of Stem Cell Physicians, granting them the title of FAASCP.

    The AASCP aims to serve as an educational resource for physicians, scientists, and the public in diseases that can be caused by physiological dysfunction that are ameliorable to medical treatment. The American Academy of Stem Cell Physicians (AASCP) is an organization created to advance research and the development of therapeutics in regenerative medicine, including diagnosis, treatment, and prevention of disease related to or occurring within the human body.

    Dr. Joseph Purita, Board Certified Orthopedic Surgeon and head of the AASCP Review Board and Examination Committee was thrilled with the outcome of this August event, stating, “I want to say I am so pleased with how well our first test-takers did on the exam. Their studying paid off. I am sure they will tell you the questions were challenging. I think it is a credit to our entire organization. We all need to realize one important fact, unlike any other field in medicine where things are well established, in the field of Regenerative Medicine, any of us has the ability to make a significant discovery to advance the entire field. I am certain advances will come from this group.”

    Dr. Martin Dayton, the President of the AASCP stated, “Successful board certifications took place at this event, and I want to congratulate the following physicians for their outstanding contributions to AASCP and for their Board Certifications”:​

    1. David Nebbeling, DO

     -Dr. David Nebbeling is a physiatrist in Lansing, Michigan. He received his medical degree from Michigan State University College of Osteopathic Medicine and has been in practice for more than 20 years.

    2. Dr. Paula Marchionda, MD

    – Dr. Paula Marchionda is a preventive medicine physician in Grand Junction, Colorado. She received her medical degree from University of Arizona College of Medicine – Tucson and has been in practice for 10 years.

    3. Dr. Warren Bleiweiss, MD

    -Dr. Warren Bleiweiss received his medical degree from New York University School of Medicine. He completed an Internship in Internal Medicine at New York University Medical Center, University Hospital. He completed a Residency in Anesthesiology at Albert Einstein College of Medicine in New York and a visiting Fellowship in Pain Management at University of Virginia Medical Center. Dr. Bleiweiss returned to N.Y. to complete a Fellowship in Pediatric and Cardiac Anesthesia and Pain Management at Albert Einstein College of Medicine/Montefiore Medical Center. He is Board Certified in Anesthesiology and Pain Management.

    4. Dr. Kalpana Patel, MD –

    Dr. Patel graduated from the B.J. Medical College. Dr. Patel works in Buffalo, NY and 1 other location and specializes in Adolescent Medicine, Allergy and Pediatrics. 

    5. Rene Blaha, MD

    Dr. Rene Blaha is a family medicine doctor in New Albany, Ohio. He received his medical degree from Ludwig Maximilian University of Munich Faculty of Medicine and has been in practice for more than 20 years.

    6. Dr. Max Citrin, DO,  Dr. Max Citrin is a family medicine doctor in Boca Raton, Florida. He received his medical degree from Nova Southeastern University College of Osteopathic Medicine and has been in practice for five years. 

    The spokesperson for American Academy of Stem Cell Physicians, A.J. Farshchian, MD, stated: “The American Academy of Stem Cell Physicians is solely committed to creating an educational platform based on solid foundational research. Our goal is to enhance the quality of medical practice and the continued education of physicians. Currently, we are the most research-oriented group representing academia, clinical researchers and physicians from around the world. Our goal is to make available to physicians the benefit of stem cell therapeutics, to share ideas and techniques, to make stem cells the standard of care in the near future, to obtain funding for scientifically sound and innovative research, to develop innovative and diagnostic tools based on scientific research, and to assist in funding and promotion of research-based cell therapies.”

    Dr. A.J. Farshchian also noted, “I want to congratulate Dr. Martin Dayton for receiving the Lifetime Achievement award from the AASCP.”

    The 2019 conference features three days of educational events with leading physicians and pioneers in the fields of stem cells and regenerative medicine. At the event, attendees will meet, attend workshops and network with prominent doctors and scientists from around the world. In total, the summit will showcase more than 15 world-class speakers who are leading practitioners and researchers in the fields of stem cell therapy and science.  For doctors,  this is an incredible opportunity to network, learn and make connections while exploring new treatments and technologies. For medical students and trainees, this is a valuable opportunity to connect with physicians. 

    Dr. Sunny Kim, an AASCP Board Member and founder and president of Progressive Rehabilitation Medicine, whose mission of offering advanced non-surgical pain management solutions was quoted: “This past AASCP event was one small step for AASCP and one giant step for medicine.”

    Call Marie Barba at (305) 866-8384 for more information or to register by phone.

    Sponsorship and exhibition packages are available at every AASCP event but limited. Exhibitors will have ample time and access to attendees and presenters in a boutique and cutting edge medical environment.

    Source: The American Academy of Stem Cell Physicians

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