Federal health regulators said late Friday that kid-size doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues, as the U.S. weighs beginning vaccinations in youngsters. The Food and Drug Administration posted its analysis of Pfizer’s data ahead of a public meeting next week to debate whether the shots are ready for the nation’s roughly 28 million children ages 5 to 11. The agency will ask a panel of outside vaccine experts to vote on that question. In their analysis, FDA scientists concluded that in almost every scenario the vaccine’s benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children. But agency reviewers stopped short of calling for Pfizer’s shot to be authorized. The agency will put that question to its panel of independent advisers next Tuesday and weigh their advice before making its own decision. If the FDA authorizes the shots, the Centers for Disease Control and Prevention will make additional recommendations on who should receive them the first week of November. Children could begin vaccinations early next month — with the first youngsters in line fully protected by Christmas. Full-strength Pfizer shots already are recommended for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem infections from the extra-contagious delta variant and help keep kids in school. The FDA review affirmed results from Pfizer posted earlier in the day showing the two-dose shot was nearly 91% effective at preventing symptomatic infection in young children. Researchers calculated the figure based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts. Most of the study data was collected in the U.S. during August and September, when the delta variant had become the dominant COVID-19 strain. The FDA review found no new or unexpected side effects. Those that did occur mostly consisted of sore arms, fever or achiness. However, FDA scientists noted that the study wasn’t large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that occasionally occurs after the second dose. The agency used statistical modeling to try to predict how many hospitalizations and deaths from COVID-19 the vaccine would prevent versus the number of potential heart side effects it might cause. In four scenarios of the pandemic, the vaccine clearly prevented more hospitalizations than would be expected from the heart side effect. Only when virus cases were extremely low could the vaccine cause more hospitalizations than it would prevent. But overall, regulators concluded that the vaccine’s protective benefits “would clearly outweigh” its risks. While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the last six weeks as the delta variant surged, the American Academy of Pediatrics says. The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles. More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms. ___ AP Medical Writer Lindsey Tanner contributed to this story. ___ 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. from https://ift.tt/3vEVxr9 Check out https://takiaisfobia.blogspot.com/
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Dr. Laura Esserman answers the door of her bright yellow Victorian home in San Francisco’s Ashbury neighborhood with a phone at her ear. She’s wrapping up one of several meetings that day with her research team at University of California, San Francisco, where she heads the Carol Franc Buck Breast Care Center. She motions me in and reseats herself at a makeshift home office desk in her living room, sandwiched between a grand piano and set of enormous windows overlooking her front yard’s flower garden. It’s her remote base of operations when she’s not seeing patients or operating at the hospital. The research Esserman is discussing is a potentially groundbreaking study that could transform the way women are screened and treated for breast cancer. She and her team hope to bring a more personalized approach to figuring out each woman’s risk for the disease, and tailor a screening and treatment program appropriate for that risk. Not all doctors in the field are convinced that such a radical change is even needed, noting that current mammogram screening is sufficient in detecting most cancers. And some doctors aren’t quite willing to give up the tried and true, if crude, way of advising women when to get mammograms based on their age. Esserman knows she’s got a lot of convincing to do. That’s why she launched WISDOM, Women Informed to Screen Depending On Measures of risk, in 2016. After years of watching women diagnosed with the disease get the same, drastic treatment of disfiguring surgery or brutal chemotherapy and radiation, Esserman believed doctors not only could but should be able to do better. She also knew that to convince them, she needed data. Right now, women are screened for breast cancer essentially based on that one major risk factor: age. And experts can’t even agree on that. After decades of advising women to start getting yearly mammograms at age 40, the U.S. Preventive Services Task Force in 2016 recommended that women not start screening until age 50, and then get mammograms every two years rather than every year. The American Cancer Society, meanwhile, suggests women start annual screening at age 45. Major cancer centers still advise women to start screening yearly at age 40. “When you have so much controversy and so many smart people believing in very, very different things, you need to break the deadlock,” Esserman says. “And the only way to break the deadlock is with wisdom. The only way you get wisdom is to run a trial and test a new approach and give yourself a chance to make things better. I don’t want to end my career doing the same thing I did when I started. I want things to be different, and I want them to be better.” While age is certainly an important risk factor for many cancers, including breast cancer, other contributors, including a woman’s genetic makeup as well as what she eats and how much alcohol she drinks, aren’t incorporated into screening guidelines in a formal way, mostly because there isn’t convincing data to support using them. That’s where Esserman hopes WISDOM will make a difference. Rather than starting with a broad guideline like age, Esserman flips the script. She starts by asking patients, “What do we do with you?” It’s not a question born of frustration or exasperation or even genuine bewilderment. For her, it’s a thought exercise, a conscious effort to think about the person sitting in front of her as an individual and not a statistic, as someone with her own complicated amalgam of risk factors and behaviors that tilt her particular chance of developing breast cancer one way or the other. It’s also a reminder that each woman has her own, personally calibrated way of measuring risk and setting a threshold for how much risk she is comfortable with. The question forces Esserman to remember that what breast cancer experts generally advise when it comes to screening and treatment is just a starting point, and not the final answer. What may be right for hundreds of thousands of women isn’t necessarily right for the woman sitting in her office who wants to know how worried she should be about breast cancer. That might seem obvious enough, but it’s actually not. Breast cancer diagnosis and treatment are stunningly effective, and far more advanced than they were even a generation ago. That’s led to a stunning 40% decline in mortality from the disease from 1989 to 2017. But Esserman thinks we can and should be doing better. The current recommendations for breast cancer mammogram screening mean some women with very low risk of the disease are screened more often than they need to be, while others who are at higher risk aren’t screened frequently enough to catch faster-growing cancers. “We have got to do better than we are,” she says, fixing her laser-like gaze on me with an intensity that mirrors her passion for the subject. “We have 265,000 women a year being screened and getting diagnosed with breast cancer, over 40,000 women a year dying, despite everything we’re doing. Does anyone think that is good enough? My goodness, no—by no means.” More sophisticated imaging, as well as lab-based tests of breast cancer biopsies, make it clear that breast cancer is not a single disease but many different ones, and that even an individual patient may harbor different types of tumors. Yet, argues Esserman, studies on breast cancer and the resulting recommendations about how to screen and test for it “treated everybody as if they had one disease, or that one size fits all. It’s like the different perspectives you get when you snorkel or scuba dive—viewed from the water’s surface, everything looks uniform, yet slip underwater and you’ll find a teeming universe of different life forms.” WISDOM is an ambitious effort to find answers to the unanswered questions about breast cancer. Which women are at highest risk of the disease? Which risk factors, from genetics to family history to lifestyle factors, are most important in influencing that risk? Which women don’t need to get mammograms every year? How can doctors better answer questions about breast cancer risk among women of different racial and ethnic backgrounds? Are their cancers different? “The only way to do better is to know better,” Esserman says of these still-yawning gaps in breast cancer knowledge. “Every woman, regardless of her race, or ethnicity, is at risk for any one of these types of [breast] cancers. We just don’t know which one yet. We are not sophisticated enough to know who is at risk for these cases, but I believe that can all change. That’s why we do the WISDOM study.” Since launching in 2016, WISDOM has enrolled 35,000 women ages 40 to 74 years old from across the U.S., with the ultimate goal of including data from 100,000 diverse women from different racial, ethnic and socioeconomic backgrounds. Each woman is asked to fill out a 50-question survey every year for five years about her family history and lifestyle habits such as diet and exercise patterns, as well as her health status including weight, blood pressure and other medical metrics. She also chooses whether she would like to be randomly assigned to a traditional breast cancer screening schedule in which she follows current advice and gets a mammogram every year, or whether she would like to get a more personalized screening “prescription” based on her particular risk profile. If she chooses the customized approach, the WISDOM team sends her a DNA testing kit; she provides some saliva that is then analyzed for around 10 major breast cancer-related genes. Based on the results of that genomic test, as well as her survey answers, the WISDOM team gives her a proposed screening schedule—it could be a yearly mammogram, mammograms every two years if she is at low risk or, if she is at higher risk, alternating mammograms and MRIs every six months. All of the advice falls within the guidelines of screening recommendations by the various cancer bodies; none of the screening schedules ask women to screen any less than what is currently recommended. “The tailoring of screening actually identifies a group at lower risk, where, what a blessing if you don’t have to do something like an annual mammogram, then don’t do it,” says Esserman. “And it also allows us to do more for the people that are more likely to benefit from additional screening or more intensive surveillance. In my experience, the better we are at understanding biology, the more effective we will be. And the better outcomes we will have not only because people will survive longer, but because there will also be less toxicity from treatments that they might not necessarily need.” It’s the Holy Grail of where she hopes WISDOM will take us: to a smarter and more efficient way to manage women when it comes to breast cancer. “The WISDOM trial is an important step in the right direction, which is trying to clarify the optimal screening intervals for women,” says Dr. Larry Norton, medical director of the Evelyn H. Lauder Breast Center at Memorial Sloan Kettering Cancer Center. “The most important thing about WISDOM is that we’re doing it. Whatever the results of the study are, they are going to be informative in terms of the next study and next study and so on in the process.” In the past, the way that doctors think about screening, and the inertia of existing protocols, meant that the idea of even testing a different screening approach wasn’t a given. After hard-won efforts to raise awareness about breast cancer and the importance of screening regularly—preferably once a year—as the best way to prevent disease and death, many breast cancer experts remain reluctant to shift women away from annual screening. Some predicted that any move away from at least yearly mammograms would lead to a spike in cancer rates and more women being diagnosed with advanced cancers that weren’t treatable. Dr. Daniel Kopans, emeritus professor of radiology at Harvard Medical School and Massachusetts General Hospital, has been one of WISDOM’s most vocal critics. “WISDOM is based on a failure to understand the facts,” he says. “The randomized, controlled trials proved that early detection saves lives for women ages 40 to 74 years.” Kopans takes issue with the fact that in making the case for WISDOM, Esserman relies on a Canadian study that showed yearly screening wasn’t lowering deaths from breast cancer, and therefore researchers needed to revisit the advice to screen annually. That study, he says, was skewed to include more women with harder to treat or advanced cancers, so the benefits of annual screening weren’t obvious. In addition, Kopanssays, because WISDOM allows women to choose whether they get the recommended yearly screening or the personalized regimen, it’s not an unbiased comparison of the two; there could be selection bias that skews the findings. He acknowledges that WISDOM’s intention—to compare annual screening to biennial screening—will be useful, but doesn’t believe the trial is designed to provide reliably scientific answers. The genetic, lifestyle and other risk factors also may not be the right ones to analyze. “The vast majority of women diagnosed with breast cancer each year have none of the known elevators of risk,” he says. Esserman counters that while existing guidelines may be adequate, they aren’t enough. The current screening recommendations are based on studies done at a time when doctors knew much less about the different types of breast cancer, and don’t take into account newer ways to analyze cancers through imaging and genetic testing. And even with screening, she says, 40,000 women a year still die of the disease. She says only the data from women who are randomly assigned to a screening regimen will be included in the final scientific analysis, so there won’t be selection bias in the data. And she says there is no evidence that more women will die of breast cancer if not all of them are screened every year. “I don’t think there’s any evidence for that at all,” she says, pointing to other countries where women are screened every other year, or even the U.K., where women 50 to 70 years get mammograms every three years. “The best way to answer that question—and there are deep divisions on this; it’s almost religious, of people who feel strongly one way or the other—the best thing to do is to test it in a trial. I’m not saying let’s go out and do personalized screening. I’m saying, ‘let’s test it, let’s let it have its day in court.’” Esserman’s position comes from years of painstaking work studying breast cancer cells, and trying to understand the different ways they can present in patients. She was among the early researchers who recognized that since not all breast cancers are the same, they should not all be treated in the same way, and that contrary to initial understanding, not every cancer detected in breast tissue must be so aggressive and fast-growing that it requires rapid, radical and toxic treatments. Rather, there are indolent cancers, similar to those in the prostate, that grow more slowly, or hardly at all. These likely aren’t as dangerous to people’s health. “People had trouble believing that,” she says. “And that’s why I worked so hard to molecularly characterize them and show that they existed.” That work, especially with cancers known as ductal carcinoma in situ (DCIS), or very early lesions that some doctors believe are not even cancerous yet, convinced her that treating all women as if they harbor fast-growing tumors that would spread throughout their bodies wasn’t doing them—or the health system, in terms of financial cost—much good. If DCIS doesn’t pose an immediate threat to a woman’s health, is it necessary to have her risk potential complications from surgery, chemotherapy or radiation to remove it? At Duke University, another pioneering breast cancer expert, Dr. Shelley Hwang, is putting this idea to the test. She’s leading a study comparing women diagnosed with DCIS who are assigned to careful monitoring of their growths with a mammogram every six months, or treatment with surgery or radiation according to current guidelines, to see how the rates of cancer recurrence or spread compare in the two groups. “I think we are all benefiting from taking a big step back, and looking at the big picture of what we have been doing that hasn’t been benefiting the patient in any way,” Hwang says. “The next challenge is going to be to pull the rest of society with us in saying that we now have biomarkers, we have data and clinical trials that show us that doing a lot of the things we were doing in the past that we thought we had to do, we’ve now shown that we don’t really need to do. The place to do that is in people with very low-risk conditions—that’s where the opportunity is to really start digging into ideas of de-escalation.” Finding those sweet spots where doctors can pull back on screening and treatment recommendations is Esserman’s goal. “In the late 70s and early 80s when I was in medical school and training, women were taken to the operating room and they had no idea if they actually had breast cancer or not,” she says. “They would do a frozen section [biopsy] in the operating room; we would have no idea what was going to happen; it was a terrible experience. And I watched this as a medical student.” While she was working with mentors who began questioning whether all women needed chemotherapy, and starting to build profiles—based on more sophisticated understanding of what was driving different cancers in different women—Esserman was inspired to focus on breast cancer. “I thought, ‘here is an opportunity where biology could lead to different outcomes if we applied it properly,’” she says. That questioning of the status quo has become a feature of Esserman’s career. After finishing medical school at Stanford, she was offered a fellowship to pursue a business degree. It was during that program that she first hatched the idea for a more comprehensive approach to managing breast cancer, from screening to treatment to research trials, and finding innovative ways to improve care. For a business school project, she recruited fellow student Robin Joy, now senior vice president at DocuSign, to study ways that different countries screened for breast cancer, and developed models for figuring out which screening schedule—yearly, every other year, every three years—led to the best outcomes for women. “That became the foundation for much of what I’ve done around screening for the rest of my life,” she says. It also established a trait Esserman carried with her to UCSF to direct the breast cancer center there: questioning the status quo to ask, “can’t we do better?” As basic research on breast cancer revealed the universe of different diseases under the seemingly uniform surface of the singular term of breast cancer, she became more convinced that the only way to dramatically keep new breast cancers from occurring, and from saving more lives among those that did, was to develop better ways of measuring an individual woman’s risk. Esserman took her cue from heart disease—in the 1940s, the Framingham Heart Study revolutionized the way doctors treated the leading killer of Americans. That groundbreaking trial, which initially involved more than 5,000 people and has now blossomed into tens of thousands, including the next generations of the original participants, created a new precedent for differentiating people’s risk of heart disease by collecting information on a suite of things influencing that risk—from blood pressure to cholesterol to exercise, diet and family history. The study produced an algorithm for weighting those factors, known as the Framingham Risk Score, that gave people a rough predictor of how likely they were to have a heart problem in the next five or 10 years. Esserman is convinced the same should and can be done for breast cancer risk. “The Framingham study started by understanding people’s risk,” she says. “And then they built risk models and started thinking about which risk factors contributed to heart disease—blood pressure, weight cholesterol—and one after the other they started going after each one of these. And they brought the risk of dying from heart disease or getting a stroke way down. We can do that in breast cancer.” Having such a formula for assessing risk would have a profound impact on women on a number of different levels. For Shelia Bauer, joining WISDOM has already changed the way she manages her breast cancer risk. Bauer, 74, who lives in Cape Cod, Mass., joined WISDOM after her daughter, who works with Esserman on recruitment efforts, recommended it to her mother. Bauer’s sisters, who were twins, both died of breast cancer, and for most of her life, she thought that she too carried the same genetic lottery that had given her sisters the disease. For 30 years, she got both an annual mammogram and an annual MRI of her breasts since she has dense breast tissue, and studies show that MRIs are more likely to pick up potential tumors. But the latter were particularly anxiety-provoking for Bauer, since she is claustrophobic. “Having to go to a breast MRI face down in an MRI machine in itself has been extremely stressful to me, but I’ve done it because that’s what the protocol has been.” As part of WISDOM, Bauer received a genetic testing kit in the mail, and sent in a saliva sample so her DNA could be analyzed. To her surprise, she was negative for nearly 10 major breast cancer genes. The WISDOM team recommended that she could scale back to getting just a mammogram once every other year, which eases her concern over the accumulated radiation exposure she’s had over the past 30 years of getting the annual scans. It also means she doesn’t have to enter the tight space of the MRI tube as often either—only if the mammogram picks up something unusual. “That was an enormous relief for me,” she says. On the flip side, WISDOM, and the more customized lens through which it looks at women’s risk, could also uncover hidden risks that mammograms might not find in time. Heather Mann, 49, from San Francisco, never thought she was at risk of developing the disease. Her genetic test from WISDOM, however, was positive for a mutation called CHEK2, which is known to increase breast cancer risk. Her regular mammogram, just after she received these genetic test results, showed nothing unusual, but an MRI, which she got because the genetic test results indicated she was at higher risk for the disease, revealed a suspicious growth. A biopsy proved it was cancer— t was small, and detected early, but still malignant. “We really thought they needed to go back to the lab and recheck the results because they had the wrong patient or the wrong phone number,” she says. “I was absolutely in shock.” But she was grateful that she had joined WISDOM, which led to her getting the genetic test and MRI that exposed the cancer. “To me, this is one of the great success stories of WISDOM,” says Esserman, who removed Mann’s tumor with surgery and is currently treating her with targeted anti-cancer drugs. “Her tumor was very small, and she was able to do a fairly small surgery and take it out. And CHEK2 mutations are almost all hormone-positive, so by taking endocrine therapy, she reduced the risk that she would get breast cancer on the other side, and she didn’t feel that she had to have a bilateral mastectomy.” In fact, during Mann’s appointment with Esserman about her surgical options, she asked her father, a retired physician who treated cancer patients with radiation, to join by speaker phone. “He was very worried for me, and he was like, ‘do a double mastectomy right away, just get rid of it,’” she says of the cancer. “Laura jumped in and talked about breast conservation, and I thought, ‘that’s so awesome.’ To feel like you can just cut off your breasts and it’s no big deal is completely inaccurate. I loved her approach of ‘let’s do what we can to keep your breasts and not put your life in danger; we have many ways. I thought that was really great.” So far, however, there are just under 10 major genetic markers tied to breast cancer that tests seek out. There are certainly teems of other combinations of genetic mutations that, while alone might not contribute to a significant increase in risk, together might. Having the genetic tests of the tens of thousands of women will help the WISDOM team start parsing out those so-called polygenic, high-risk combinations. “Polygenic risk scores have been percolating for a couple of decades now,” says Dr. Jennifer Litton, vice president of clinical research at the University of Texas MD Anderson Cancer Center. “They have been interesting, but certainly nothing has gotten to the point where I thought they should be routinely applied to everyone yet. When we think of genetic risk, everything dwarfs when compared to the BRCA mutations, but that doesn’t mean there isn’t quite a bit more we can learn from other constellations of genes. I think it’s time to start addressing that question.” That’s why Litton says she would encourage any of her patients to join the study if they were interested. Bauer, for one, appreciates the evolution in thinking that WISDOM represents. “Things haven’t changed in the past 30-odd years in the way we do testing,” she says. “I’ve been waiting a very long time for somebody like Dr. Esserman to come up with maybe a new approach and new protocols and have a more personalized approach to individuals. I believe that the way we look at breast cancer is ‘one size fits all’ right now. It needs to change. We are all individuals; we don’t all have the same family backgrounds, we don’t all have the same ethnic backgrounds, so why are we all being tested the same way?” For women of color in particular, such data could be life-changing, since most guidelines and data on breast cancer have come from studies of white women of European descent. “I don’t experience the screening recommendations in the same way that white women do,” says Yvette Gullatt, chief diversity officer for the University of California, who joined the study to improve the information on breast cancer that’s available to other Black women. “I experience breast cancer in Black women as highly aggressive and lethal. I had a former student of mine [a Black woman] pass away earlier this year; she left a 3-year old daughter. Her breast cancer was discovered while she was pregnant, and essentially early, but two and a half years later, she’s gone,” she says. “I’ve had white colleagues who were diagnosed with breast cancer and go to radiation in the morning, and are back at work by 10 a.m.; they never miss a day. We need more studies like this because [researchers] need more data in order to diagnose and treat us better.” Esserman and her team are working closely with community advocates to increase awareness and education about clinical trials among Black women, who already have a deep mistrust of the medical system given notorious episodes of medical exploitation, including the Tuskeegee and Henrietta Lacks experiences in which Black patients were used in research studies without being fully informed of their participation or the potential risks of participating. It’s especially important, since about 25% of breast cancers among Black women are triple negative, a highly aggressive form missing the locks to three hormone-based drug “keys” that have become effective weapons in fighting the disease in recent years. Without these locks, the drugs can’t work, and tumors grow more quickly and seed new growths in other parts of the body. Most of these cancers also start in younger Black women, under age 40, so they aren’t picked up because they aren’t getting mammograms yet according to current guidelines. “There is this background genetic information that we can use to tailor risk assessment in different ethnic groups,” says Esserman. “Most of the studies where these risk factors have been developed are mostly from women of European ancestries. So we really, really, really want to encourage African-American women, Latina women, women of all backgrounds to participate in this study. This is the way in which we can make sure that the results of WISDOM are helpful for the whole population.” As part of WISDOM’s recruitment, Esserman has also reached out to the VA health system in the U.S., to include female veterans whose risk of breast cancer may be related to not just hereditary factors but environmental exposures during their service. Lisa Edwards, a veteran who was discharged from the Army in 1989, says the study is also an opportunity to raise awareness and resources for women’s health in the VA system in general. Edwards, who was getting sporadic mammograms, had two needle biopsies when doctors found suspicious growths during her screenings. After joining WISDOM, the genetic test revealed she did not have a genetically higher risk of disease, but because of her dense breast tissue and history of biopsies, the team recommended she continue with yearly mammograms. But because her VA in Wilkes-Barre, Penn., does not have a mammogram machine, Edwards goes to an imaging center nearby for her yearly screening. “As female veterans, we faced chemicals and exposure just as the men did. But because our bodies react differently, I think in the future it may help researchers understand certain cancers from chemicals that react differently in women than in men,” she says. On the same day I visit Esserman at her home, she is boiling over the Texas governor’s decision to ban abortions past six weeks in the state. As an organizer for the annual San Antonio Breast Cancer Conference, a major gathering of key leaders and physicians from around the world involved in the research and clinical care of breast cancer, she was busy writing an op-ed calling for doctors and scientists to boycott the meeting in protest. “Where is the sense of outrage?” she asks. In the commentary, which she sent to both the New York Times and the Washington Post, she and seven other organizers argued that a conference focused on finding ways to improve treatment for disease that mainly affects women should be held in a state that discriminates against women. Esserman isn’t afraid to speak her mind, especially when it comes to advocating for women’s health. She jokes that her husband, Michael Endicott, a professional photographer, warned her throughout last year that her unfiltered comments about the Trump Administration’s views on science and handling of the COVID-19 pandemic would jeopardize her government-based grant funding. But Esserman wasn’t concerned—a singer and piano player, she’s penned a political parody musical entitled Audacity that makes her views on Trump very clear. Esserman’s sense of social justice was nurtured from a young age by her parents Ron, who was in the auto business, and Charlene, a teacher and community advocate, both of whom were active civic leaders in Miami, where the family moved when Esserman was 10 years ol. The young Esserman was fascinated by the story of Marie Curie after reading her biography. “I still remember the book—the tattered leather cover,” she says. “I was so impressed by her observations and how she turned those into major discoveries by her persistence and her ability to succeed as a woman. When I was little, women did not have the opportunities they have today. And I felt like I, too, could maybe grow up and make a difference in science.” Esserman nurtured her love of science along with a talent for music. She admits she once took a stipend when she was a research assistant in medical school and spent it on a piano—”I was very thin and hungry for a quarter or two, but I had a piano that I have had ever since.” She’s just as likely to break out into song as she is to cite statistics about the slow progress in breast cancer care, and early in her career as a surgeon, started a unique singing tradition for her patients. During her second year at UCSF, she noticed one of her patients in the operating room was getting extremely anxious about the upcoming procedure; it was a Saturday, and the patient needed surgery because of a complication. “I was just watching her blood pressure go up, and my blood pressure was going up watching that,” she says. Esserman had just seen Phantom of the Opera the night before, and she asked if the patient liked music. She did, and Esserman began serenading the operating room with “All I Ask Of You,” beginning with the appropriately reassuring lyrics “No more talk of darkness/ Forget these wide-eyed fears/ I’m here/ Nothing can harm you/ My words will warm and calm you.” Her patient’s blood pressure dropped back down. “I thought, I will make this a part of what I do,” she says. It’s a tradition she continues today with every patient on whom she operates. But rather than deciding herself what she’ll sing, she asks her patients for their favorite song and learns the lyrics so they can hear them as they slip under anesthesia. The requests have ranged from Broadway tunes to arias (Esserman requests a week to prepare for those; for the rest, she picks up the melodies and lyrics pretty quickly). For Mann, Esserman sang the aptly worded “For Good” from Wicked. “A lot of times in [medical] training people say, ‘be guarded, and don’t share.’ That’s just not my style. I think it’s important to share a little bit of yourself and for people to share a little bit of themselves. Caring for someone is an art, it’s a privilege.” She’s still defending her conviction that doctors can and should improve on the way they evaluate women’s risk of breast cancer. If women are better segregated into lower and higher risk groups, then doctors can better advise them about how to potentially prevent the disease as well. “We are working with data that is old,” says Litton from MD Anderson. “It doesn’t take into account in many cases the imaging techniques we are using now. It doesn’t take into account if you’re not a white woman. And it doesn’t take into account what we’ve known for a long time, that hereditary breast cancer has a different growth pattern. WISDOM is a start to trying to answer those questions.” Norton also sees WISDOM as a catalyst for rethinking the way doctors calculate cancer risk—by looking for more precise markers of tumors in the blood, for example, that can indicate not just a breast cancer but any type of abnormally growing cell in any tissue in the body. And the idea of honing the crude models we now have of which genes contribute to cancer to the precise suites of mutations that confer the highest risk is also an important harbinger for how doctors might manage breast cancer in the coming years. Esserman recognizes that WISDOM won’t fill all the gaps in our knowledge about breast cancer. “The WISDOM study is a start. This is the beginning of a change in screening; we’re going to build on this platform,” she says. “In my fondest dreams I hope, five years from now, that we might be able to really identify a group of people that are so low risk, they don’t actually need to get screened. I think that would be very exciting. As well, I think it would be fantastic if we really had a way to identify those women who are at risk for aggressive cancers.” Finding those women, she says, will allow doctors to start building trials to test ways to prevent these aggressive cancers from appearing in the first place or, at the very least, from progressing if they do. “The best outcome would be 10 years from now that the rates of breast cancer are half, and that the people who need screening are doing more of it, and the people who don’t need screening are doing less of it or not at all.” Marc and Lynne Benioff, the co-chairs and owners of TIME, have been philanthropic supporters of Dr. Esserman’s breast cancer research. The WISDOM study receives software support from Salesforce, where Marc Benioff is chairman and CEO. from https://ift.tt/3B4x6UP Check out https://takiaisfobia.blogspot.com/ Kid-size doses of Pfizer’s COVID-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday as the U.S. considers opening vaccinations to that age group. The shots could begin in early November — with the first children in line fully protected by Christmas — if regulators give the go-ahead. Details of Pfizer’s study were posted online. The Food and Drug Administration was expected to post its independent review of the company’s safety and effectiveness data later in the day. Advisers to the FDA will publicly debate the evidence next week. If the agency ultimately authorizes the shots, the Centers for Disease Control and Prevention will make the final decision on who should receive them. Full-strength Pfizer shots already are authorized for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem rising infections from the extra-contagious delta variant and help keep kids in school. More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms. The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s roughly 28 million 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles. A Pfizer study tracked 2,268 kids in that age group who got two shots three weeks apart of either a placebo or the low-dose vaccine. Each dose was one-third the amount given to teens and adults. Researchers calculated the low-dose vaccine was nearly 91% effective, based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts. In addition, young children given the low-dose shots developed coronavirus-fighting antibody levels just as strong as teens and young adults who got regular-strength vaccinations. That’s important information considering that hospitalizations of mostly unvaccinated children reached record levels last month. The CDC reported earlier this week that even as the delta mutant surged between June and September, Pfizer vaccinations were 93% effective at preventing hospitalizations among 12- to 18-year-olds. Pfizer’s study of younger kids found the low-dose shots proved safe, with similar or fewer temporary side effects such as sore arms, fever or achiness that teens experience. The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second dose, mostly in young men. While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the last six weeks as the delta mutant surged, the American Academy of Pediatrics says. Moderna also is studying its COVID-19 shots in elementary school-age youngsters. Pfizer and Moderna are studying even younger children as well, down to 6-month-olds. Results are expected later in the year. 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. from https://ift.tt/3poe4GZ Check out https://takiaisfobia.blogspot.com/ U.S. Conservatives Want to Save Australia From COVID Tyranny. Australians Arent Interested10/22/2021 Australian lawmakers took to Twitter to school American critics of the country’s COVID-19 public health measures, pointing to how well they have worked to prevent deaths in comparison to policies in the U.S., where the death toll has been one of the worst in the world. Since the pandemic began, Australia has enforced strict measures to prevent the spread of COVID-19, including some of the world’s longest lockdowns. State and territory-wide restrictions can only be lifted once more than 80% of the local population aged 16 and older is fully inoculated against the virus. In the U.S., by comparison, many states lifted COVID-19 measures despite low vaccination rates. Outspoken political commentator Candace Owens went as far as suggesting that the U.S. military should invade Australia because it has turned into a “police state,” comparing the country’s government to the regimes of Adolf Hitler, Joseph Stalin, Fidel Castro and Hugo Chávez. “When do we deploy troops to Australia? When do we invade Australia and free an oppressed people who are suffering under a totalitarian regime? When do we spend trillions of dollars to spread democracy in Australia?” the right wing pundit said on her Daily Wire TV show Friday night. Owens’ rant is the latest condemnation of Australia’s COVID-19 measures by U.S. conservatives. Republican Senator Ted Cruz has also been critical of certain policies in the country. Earlier this month, anti-vaccine protesters surprisingly focused on Australia’s vaccine mandate in a protest outside its consulate in New York City. Lawmakers from down under responded to criticism on social media. Michael Gunner, chief minister of Australia’s Northern Territory, took to Twitter to rebuke Cruz’s claim last week that the territory’s vaccine mandate places people under a “COVID tyranny.” “We don’t need your lectures, thanks mate,” Gunner tweeted Sunday. “You know nothing about us. And if you stand against a lifesaving vaccine, then you sure as hell don’t stand with Australia.”
Gunner’s response also included a series of facts about the Northern Territory’s COVID-19 response. Mirroring language used by Cruz in his original tweet, Gunner concluded: “I love Texas (go Longhorns), but when it comes to COVID, I’m glad we are nothing like you.” Cruz had earlier tweeted that he stands with Australia, in response to a Sky News video in which Gunner announces that workers interacting with the public must have at least one dose of a COVID-19 vaccine before Nov. 13, or face a fine of AU$5,000 (roughly US$3,750).
Mark Bailey, a member of the Queensland Parliament, also lambasted Cruz on Twitter, comparing the death toll of Texas to the entirety of Australia. “If you stood with us, you’d have learned from us,” Bailey said. The state of Texas has recorded 68,573 COVID-19-related deaths since the start of the pandemic, while Australia has reported 1,590.
Other social media users in Australia ridiculed Owens on Twitter for criticizing local anti-epidemic measures, responding with images of themselves continuing to enjoy the outdoors, such as pristine, largely empty beaches.
A recent Lowy Institute poll found that the majority of Australians are confident in how their government is handling the pandemic. from https://ift.tt/30SJr2b Check out https://takiaisfobia.blogspot.com/ In two unanimous decisions, a 15-member expert panel convened by the Centers for Disease Control and Prevention (CDC) today recommended booster doses for people who have been vaccinated with either the Moderna or Johnson&Johnson-Janssen COVID-19 vaccines. CDC director Dr. Rochelle Walensky will take this advice into consideration before making a final recommendation. The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends that anyone who was initially vaccinated with the Moderna shot get a booster at least six months later, while the committee recommends that J&J-Janssen recipients receive a booster at least two months after their initial vaccination. The endorsement follows a similar decision from an expert Food and Drug Administration (FDA) panel that allows people to receive any of the three authorized or approved COVID-19 vaccines, from Pfizer-BioNTech, Moderna and J&J-Janssen, as the booster dose. The Moderna booster will be half the dose of the original dose. For now, the decision only applies to certain groups of people who have been vaccinated against COVID-19. Those include people over age 65, as well as people aged 18 to 64 who are at increased risk of severe COVID-19 due to underlying health conditions or who live or work in a higher risk setting. For example: health care workers, grocery store workers, teachers and those living in long-term care facilities or homeless shelters. The CDC and FDA previously authorized a booster dose of vaccine made by Pfizer-BioNTech, and this decision supersedes and includes that authorization. As with the previous discussion about boosters, the 15-member committee were relatively agreed on two things: that due to the lower efficacy of J&J-Janssen’s vaccine, people who got that shot should receive a booster; and that for people vaccinated with the two mRNA vaccines from Pfizer-BioNTech and Moderna, those over age 65 and anyone with underlying health conditions, regardless of their age, should get a booster dose. The panel continued to debate the need for a booster dose among younger people whose jobs or living conditions present a higher risk. Dr. Sarah Long, professor of pediatrics at Drexel University College of Medicine, asked “what available evidence is there that people under age 50 should receive a booster at this point?” When the committee discussed this population at the meeting when they decided on the Pfizer-BioNTech booster, they voted against recommending boosters for those under 50. But Walensky decided to allow people aged 18 to 64 years who are at high risk of occupational or institutional exposure to have the option of getting a booster. That final decision says that these groups can, rather than should, get a booster if they so choose. “The last decision made in this regard is not the correct decision,” Long said, referring to today’s final recommendation. “And we are somewhat stuck with it. I can’t say that I am comfortable that anybody under age 50—otherwise healthy individuals—needs a booster at this time, either with Moderna or Pfizer-BioNTech.” Long noted that the data for this age group aren’t as strong as for older individuals or those with underlying health conditions, and said that the authorization implies “smoke and mirrors and underhanded winks and nods.” Long, however, ultimately voted in favor of a booster after members discussed the need to include specific reminders to doctors in the accompanying fact sheets and clinical guidance that will be distributed. In particular, this information will caution that the need for a booster, especially among younger people, should be carefully weighed against rare but known side effects, which include inflammation of the heart tissue in the case of the mRNA vaccines, and blood clots and Guillain-Barre Syndrome for the J&J-Janssen shot. Data presented from the vaccine manufacturers and evaluated by the FDA and CDC showed that the mRNA vaccines continue to provide good protection against severe COVID-19 disease, although their ability to protect people from getting infected in the first place is waning. So the unanimous decisions reflected the fact that the committee members accepted that the authorization would mean some people who would be getting boosters might not actually need them from a purely immunological point of view but that from a pubic health perspective, authorizing the booster to ensure that people can protect themselves in whatever way they can against the ongoing pandemic takes precedence over that. With the recommendation, it now falls to providers—pharmacists, doctors, community health care workers and school nurses—to figure out how to roll out booster doses. After the Pfizer-BioNTech booster authorization, Walensky noted that most vaccinators will be relying on people to self-attest that they fall into one of the eligible groups, and that they won’t be requiring documentation or other proof of medical conditions or age. Administering the boosters will be complicated, since Moderna’s booster is a half dose, and both patients and doctors will likely try to game the one study that evaluated so-called mixing and matching of boosters to figure out which one will provide the greatest protection. The panel members heard from the co-lead researcher of that study, conducted by the National Institute of Allergy and Infectious Diseases, who stressed that the trial was not designed to compare different combinations, but rather to show that mixing boosters was both safe and efficacious. Still, that data, which included more than 450 people, suggested that those who were originally vaccinated with a single dose of J&J-Janssen’s shot enjoyed the greatest increase in protection in the form of virus-fighting antibodies if they received a Moderna booster. The panel members also discussed the fact that given the risk of clotting events, especially among younger women vaccinated with J&J-Janssen, providers might consider boosting this population with an mRNA vaccine. Complicating matters further is the fact that in August, the FDA and CDC authorized a third dose of the mRNA vaccines for people with weakened immune systems, including cancer patients, those who have had organ transplants or are taking drugs that suppress their immune systems. Those doses are not considered booster doses but an additional dose to bolster their immune systems as part of their primary vaccination against COVID-19. The committee discussed that under the current booster authorization these patients too would be eligible for booster shots at the appropriate time, which would mean a fourth dose for people originally vaccinated with an mRNA shot and a third dose for those getting J&J-Janssen. Dr. Grace Lee, chair of the ACIP committee, said that it’s up to providers to educate themselves and the public about the complicated booster recommendations, and to make sure that those who really need them get them and benefit from the enhanced protection. “Our recommendation is just one step along the way,” she said. “It’s important for us to make sure in our implementation that patients are truly educated about the benefit-risk balance based on their own personal situation. It’s the hardest thing for us to do, but I encourage all of us to go beyond these recommendations and do our best to educate our communities and provider teams, and partner with public health.” The fact that mixing doses appears to be both safe and efficacious could help support the U.S. government’s booster campaign as well. Smaller doctor’s offices or community clinics, or mobile units that go into long-term care facilities, for example, won’t have to store all three vaccines, but instead could focus on one, streamlining the logistics of their vaccination efforts. The White House has said it has purchased the necessary supply of booster doses and is prepared to ship them now that the FDA and CDC have authorized them. from https://ift.tt/2Z8ulVl Check out https://takiaisfobia.blogspot.com/ In the wake of multiple legal challenges, the Biden Administration late last month aimed to fortify the Deferred Action for Childhood Arrivals (DACA) program with a new rule that would shield more than 600,000 undocumented people brought to the U.S. by their parents. While proponents of the program welcomed the move and heralded it an “effort to bulletproof the DACA program,” our response in this moment overlooks a fundamental problem: each challenge on immigration—whether the Muslim Ban, family separation, or challenging DACA—takes a toll on refugee and migrants through vicarious trauma and weathering, regardless of the outcome. While we debate annual refugee caps, if Title 42 should be repealed and whether to welcome Haitian and Afghan refugees, each day migrants experience the trauma of instability. This additional trauma—often ignored because of other acute, pressing issues--has lasting physical and psychological health effects that we document in our refugee and migrant patients for decades. Understanding this often-invisible trauma is a vital component of recovery and rehabilitation. Shock experiments conducted in the 1980s in rats showed that when rats can control when they are subjected to pain, they develop tolerance to it. On the other hand, rats that have no control over when they are shocked become depressed, dejected, develop ulcers, lose weight and have compromised immune systems that make them more susceptible to disease. Similarly, humans experience a crippling response when faced with persistent uncertainty. Consider the simple routines and patterns in our lives that allow us to function. For example, the uncertainty of in-person school for children during the COVID-19 pandemic debilitated many American families, which led to record rates of women quitting their jobs, sent many families to move to the suburbs where schools were more likely to have in-person classes and put substantial stress and strain on families and marriages. DACA recipients and refugees and migrants in Afghanistan, Greece or at the U.S.-Mexico border experience weeks, months or years of instability. The impact of uncertainty extends beyond a single affected individual or family: it permeates entire communities through vicarious trauma, or trauma transmitted second-hand through bearing witness to stories of other people who have experienced pain and suffering. Imagine struggling to drive after taking care of a friend who had a bad car accident or being crippled by the decision of whether or not to send your children to school after a school shooting close to home. Vicarious trauma produces its own psychological weight and burden. Read more: The Invisible Tragedy Facing Refugees Like Me As director of the Human Rights Impact Lab and as a forensic medical evaluator of torture and trauma, I document in my refugee and asylum seeking patients significant trauma from instability: the inability to sleep at night after hearing the story of a friend who was deported in an immigration raid; flashbacks after hearing about a child who was separated from her parent and placed in a shelter; extreme stress as a result of persistent challenges to evacuating vulnerable Afghan allies; debilitating fear after reading news articles about the cartel-sponsored kidnapping and trafficking of young girls who were forced to remain in Mexico while waiting for their immigration hearings. These stories leave notable and prominent physical and psychological imprints on my patients. As a result of the instability and vicarious trauma, immigrants of all legal statuses experience weathering, a term used in medicine to describe the physiological wear and tear of stress that can result in advanced aging, elevated blood pressure and heart attacks. Like the shock experiments with rats, uncertainty and instability can be as harmful as the outcomes themselves. Weathering may have a multi-generational effect. Traumatic experiences have the power to change our gene function through multiple mechanisms such as methylation marks, which attach to our DNA and act as on-off switches. These methylation marks can be triggered by cues in the external environment, such as symptoms of starvation, stress or violence. The damage from trauma can extend for generations, potentially through non-genetic mechanisms that regulate our DNA function. Vicarious trauma has typically been described as an individual phenomenon—a social worker who is devastated by hearing again and again about the abuse of children; a physician who is overwhelmed by seeing pain and suffering of dying ICU patients; a firefighter who is traumatized by seeing a child die in flames—but vicarious trauma can also be collective. We experienced vicarious trauma in seeing the World Trade Center towers fall on Sept. 11, 2001. We experienced vicarious trauma in witnessing George Floyd’s murder on video. We experienced vicarious trauma in watching police officers mowed down during the siege of the Capitol on Jan. 6. The vicarious trauma of anti-immigrant policies is now directly affecting our American collective. When the Trump administration, for example, embraced a “zero tolerance” policy at the U.S.-Mexico border resulting in family separation, vicarious trauma affected the immigration officers who were responsible for tearing children from their parents or keeping watch over toddlers wrapped in foil blankets on the floor. The same was true at the Kabul airport in Afghanistan, where young military officers within arm’s reach of desperate families with young children had to enforce a security zone and block them from coming in. Vicarious trauma may soak into the DNA of those Americans as well and permeate the communities in which they reside. Read more: Too Many Leaders Are Failing To Uphold Their Promise To Protect Refugees My first step as a physician when treating a hemorrhaging patient in the operating room is to step back and assess the full scale of the trauma. Only then can I recognize the source of the bleed and resuscitate the patient. For advocates of migrant rights, recognizing the sources of trauma is a critical first step. Studies have demonstrated that trauma, and perhaps even DNA methylation, may be reversed if we can identify the cause and treat it. This includes, at minimum, a trauma-informed assessment of physical and psychological health, and targeted therapies where appropriate. For example, after torture we might diagnose and treat nerve injuries and chronic pain with medications or physical therapy; we might also diagnose and treat post-traumatic stress or anxiety disorder from the events. Acknowledging vicarious trauma and weathering in refugees and migrants from instability itself is important. So too is understanding the damage that we are precipitating in our own communities, and their multigenerational effects. Once we step back and assess these impacts, we can begin to explore, address and account for the trauma that we have caused in refugee and migrant communities, and in our own. from https://ift.tt/3E6UIdl Check out https://takiaisfobia.blogspot.com/ Historians have long observed the links between the natural environment and the fate of civilization. Natural emergencies like droughts, floods and crop failure regularly plunge people into chaos. Long term changes in the earth’s climatic conditions lead flourishing societies like the Roman Empire to wither and fade. But perhaps there is no greater example of the explosive intersection of climate disruption and political upheaval than the period surrounding the French Revolution of 1789. Starting in the mid-13th century, the northern hemisphere entered a period of prolonged cooling known as the Little Ice Age. This extended chill was not smooth and uniform, however, but marked by intervals of plummeting temperatures in the midst of otherwise stable warmth. Around 1770, one such interval of abrupt freezing began in the Northern Atlantic, wreaking immediate havoc on shipping, transportation and agriculture. In 1775, severe grain shortages in France caused by successive years of poor harvests resulted in bread riots throughout the kingdom. Later dubbed the Flour War, it was a harbinger of things to come. Compounding the worsening climate, the Laki volcanic fissure in Iceland erupted in June 1783. Over the next eight months, the fissure spewed 120 million tons of sulfur dioxide into the atmosphere. Across northern Europe, a “blood coloured sun” barely showed through a thick persistent haze. In addition to the excess mortality caused by the foul air, the Laki eruption radically altered the atmosphere, causing the climate of the 1780s to become extremely volatile. After a long spell of cooling, the summer of 1783 was suddenly the hottest on record. The unseasonably hot weather triggered severe thunderstorms with hailstones large enough to kill livestock. The scorching summer gave way to an equally extreme winter of severe freezing, followed by a warm spring that rapidly melted the snow and ice which caused extensive flooding. These abnormally wild extremes defined weather patterns for years to come: dry and blistering summers interspersed by violent thunderstorms, followed by deep winter freezes, snowstorms and sub-zero temperatures. The fluctuations ravaged the lives of the French population, ruining crops, killing livestock and creating an unbreakable cycle of hunger, poverty, stress, fear and hardship. Touring France in 1785, John Adams wrote, “The country is a heap of ashes. Grass is scarcely to be seen and all sorts of grain is short, thin, pale and feeble while the flax is quite dead….I pity this people from my soul. There is at this moment as little appearance of a change of weather as ever.” Read more: How Climate Change May Be Contributing to Our Political Instability The damage caused by these weather problems exacerbated an ongoing financial crisis that stalked the kingdom of France in the 1770s and 1780s. The finances of the kingdom had never been well-managed, as the wealthiest aristocratic families in France continued to enjoy exemption from most taxes. With the agricultural devastation and the kingdom’s already insufficient tax revenue, King Louis XVI’s ministers introduced economic and financial reforms to stabilize the Crown’s finances. But these efforts were met with intransigent hostility from the privileged elite, who refused to accept new taxes unless the king offered equally meaningful political concessions. Both sides refused to yield, and deadlock ensured the crisis remained unaddressed. The years of climatic stress, financial instability and political conflict brutally converged in 1788 and 1789. A severe drought in the spring of 1788 left staple crops crippled and withered. On July 13, 1788, one of the most severe hailstorms in recorded history swept across France. The storm sliced a swath of destruction that pummeled and destroyed fields and vineyards. Grain shortages sent prices skyrocketing, and families who once spent 50% of their income on food now devoted more than 90% of their household budget just to stay alive. With all disposable income going to buy bread, consumer demand for all other commodities cratered, driving the kingdom’s already shaky economy into a recession. Thousands of urban workers lost their jobs and wages, exacerbating the growing social crisis. Amid the terrible harvests of 1788, the political conflict among the elite over financial, economic and political reform reached a crescendo. The King’s attempts to force changes were met by angry resistance. A population psychologically battered by years of stress and fear were now ready to push the envelope against the policies of an absolute monarchy that did not serve the people. Demands for a national assembly to address the mountain of accumulated grievances grew so loud the king finally acquiesced. In late-1788, King Louis called for the Estates-General to convene the following spring. Just as Louis announced this momentous concession, France was hit by the coldest winter in almost a century. Thomas Jefferson, America’s then-minister to France, wrote, “there came on a winter of such severe cold, as was without example in the memory of man, or in the written records of history. …[A]ll outdoor labor was suspended, and the poor, without the wages of labor were, of course, without either bread or fuel.” This vicious winter froze an already starving population. The death grip of winter lasted for months. As late as April 1789, the comte de Mirabeau observed in the south of France: “every scourge has been unloosed. Everywhere I have found men dead of cold and hunger, and that in the midst of the week for lack of flour, all the mills being frozen.” Get your history fix in one place: sign up for the weekly TIME History newsletter When the Estates General convened in Versailles in May 1789, the population of France had endured long and difficult years battered by endlessly destructive climate fluctuations. The spring and summer of 1789 offered no relief. It would be months before the year’s harvests overcame the shortfalls of the previous year. The traumatized population of Paris, egged on by political orators, were ready to explode. Like many previous summers, the July heat was an oppressively sweltering contrast to the ice-cold chill of the previous winter. Months of ongoing political deadlock in Versailles were finally resolved in July 1789 when rumors of a reactionary conspiracy hit the streets of Paris, and the alarmed and angry population rose to tear down the Bastille, marking the beginning of the French Revolution. The French Revolution is a particularly dire cautionary tale, as scientists now know that the climate chaos experienced at that time was a result of natural processes, while the warming crisis we are living through today is caused by human actions and—unless we take immediate steps to halt it—will only get worse. The link between climate and political destabilization has become an urgent field of study. A landmark 2013 study comparing climate data to major historical conflicts found “strong causal evidence linking climate events to human conflict… The magnitude of climate’s influence is substantial.” The study warned that as the earth’s temperature rises in the decades to come, “amplified rates of human conflict could represent a large and critical social impact…in both low and high-income countries.” In August, the United Nations released an IPCC report described as “code red for humanity.” The report said that “extreme weather, meager crop yields, and low GDP are also associated with increased violence.” The French Revolution was not caused by climate disruptions alone. Those disruptions ravaged the economy, destabilized the social order and traumatized the population, but it required a broken political system unable and unwilling to address the effects to tip the scales toward revolution. As we enter a new epoch of a human created climate emergency, we have it in our power to mitigate the ecological consequences, but it will not be enough to simply lower emissions or convert to green energy. We must also ensure our political structures can respond to the inevitable social crises caused by global warming and are flexible and resilient enough to weather the coming storm. from https://ift.tt/3DYcOyd Check out https://takiaisfobia.blogspot.com/ The Food and Drug Administration (FDA) today followed the advice of its advisory committee and recommended booster shots of COVID-19 vaccines from Moderna and Johnson&Johnson-Janssen. The agency also authorized mixing or matching booster doses, meaning that people can either get another dose of the same vaccine they originally received, or get a booster with a different vaccine. More than 150 million doses of the Moderna vaccine and 15 million of the J&J-Janssen vaccine have been administered in the U.S. In a briefing discussing the agency’s decision, acting FDA director Dr. Janet Woodcock said the primary reason behind recommending boosters is growing evidence that immunity provided by the original COVID-19 immunizations is starting to wane. “The availability of authorized boosters will be important for continued protection against COVID-19 disease,” she said. “The actions taken today help address waning immunity.” The decision means that anyone who has been vaccinated against COVID-19—with one of the three available vaccines in the U.S.—could eventually get a booster shot. Until today’s decision, only people who were initially vaccinated with Pfizer-BioNTech’s shot, or those with weakened immune systems, could get an extra dose. The FDA clarified that for now, people who are eligible for a booster include those already vaccinated with Pfizer-BioNTech or Moderna who are over age 65, or anyone aged 18 to 64 who has an underlying health condition or works or lives in a setting that puts them at higher risk of exposure to COVID-19. That includes teachers, public transportation employees and essential health-care and front-line workers, as well as those living in homeless shelters or prisons. Anyone previously vaccinated with J&J-Janssen’s vaccine is eligible for a booster, however, given the lower initial efficacy of that vaccine compared to the other two. On Sept. 22, the FDA authorized booster shots for people immunized with the Pfizer-BioNTech shot, and the Centers for Disease Control and Prevention (CDC) supported that decision, with subtle caveats. While the CDC recommends Pfizer-BioNTech boosters for people over age 65 and those with health conditions that might put them at higher risk of developing severe COVID-19, the agency stopped short of recommending them for younger people. CDC director Dr. Rochelle Walensky instead decided to allow younger people in higher risk jobs or settings to get an additional dose if they so choose. The FDA’s recommendation on the Moderna and Johnson&Johnson-Janssen boosters follows the guidance the agency made for the Pfizer-BioNTech booster, with a few exceptions. The Pfizer-BioNTech booster is another dose of the same shot that people already received twice, while the Moderna booster is half the dose of the original shot. Moderna’s scientists showed that the lower dose produced a strong enough immune response and generated fewer potential side effects; they noted that the half dose would also double the number of people who could get a booster shot. J&J-Janssen’s vaccine is the only one that requires a single dose. Unlike both the Pfizer-BioNTech and Moderna boosters, which are recommended at least six months after the initial vaccination, J&J-Janssen’s booster is recommended starting two months after the first dose. It is also recommended for anyone who received the shot, without any restrictions, because of its lower efficacy initially in protecting against COVID-19 compared to the Pfizer-BioNTech and Moderna vaccines. Woodcock and Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, acknowledged that rolling out boosters, with their different dosing schemes and target populations, will be complicated. That’s why the agency authorized the mixing and matching of booster doses, to allow providers the flexibility of boosting people with any COVID-19 vaccine if people can’t recall which one they were immunized with, or if it’s not practical for mobile vaccination teams or pharmacies or hospitals to carry all three vaccines. It’s now up to the CDC’s Advisory Committee on Immunization Practices, which meets on Oct. 21, to iron out the details of how the boosters will be administered. Once the committee reviews and discusses the data and the FDA’s decision, Walensky will issue a final recommendation. The White House has said that the federal government, which will pay for booster shots as it did for the original COVID-19 vaccinations, is ready to start shipping doses so eligible people will have access soon. from https://ift.tt/3jlufRH Check out https://takiaisfobia.blogspot.com/ The White House outlined its COVID-19 plan to vaccinate younger children which would focus on smaller doses administered with smaller needles if the shots are authorized by regulators. “We will be ready to get shots in arms,” President Joe Biden’s COVID-19 response coordinator, Jeff Zients, said Wednesday during a White House briefing on the plan, which includes supporting vaccination by primary care doctors and in pharmacies and schools. The U.S. has ordered enough supply to vaccinate all kids 5 to 11, the White House said in a statement Wednesday. The vaccination campaign for kids would differ from the one targeting adults and children 12 and older in that it will enlist pediatricians to work with parents, rather than utilizing mass inoculation sites. The vials and needles used to administer doses also will be smaller, the White House said. The shots will be available at more than 25,000 doctors’ offices and primary care sites, as well as children’s hospitals and pharmacies. “The administration will work with states and local partners to make vaccination sites available at schools and other trusted community-based sites across the country,” according to the White House statement. The doses, which are one-third the strength of the regular dose given to those 12 and up, will be shipped in smaller configurations more easily stored at a typical pediatrician’s office, the White House said. It will be possible to store them for up to 10 weeks at standard refrigeration temperatures and 6 months at ultra-cold temperatures. The Department of Health and Human Services will also launch an education campaign about the kids’ vaccine. Pfizer Inc. and BioNTech SE have submitted data to the Food and Drug Administration ahead of an advisory panel meeting set for Oct. 26 that could help pave the way for kids ages 5 to 11 could get a COVID-19 vaccine as soon as the first week in November. Vaccinating kids could could provide a boost both to Biden’s political fortunes and and public-health goals. Reaching children younger than age 12 would be a crucial step toward ending the pandemic, insulating them from the worst risks of COVID and further shrinking the pool of Americans vulnerable to spreading the virus. Public approval of Biden’s handling of the pandemic, and other issues including Afghanistan and his economic agenda, has been falling. Many parents, including the suburban voters Democrats need to keep control of Congress in the 2022 midterm elections, are eagerly anticipating a vaccine for children. It could also help working parents return to their offices and boost the travel sector with more families finally able to be fully inoculated. The White House outlined its Covid-19 plan to vaccinate younger children which would focus on smaller doses administered with smaller needles if the shots are authorized by regulators. “We will be ready to get shots in arms,” President Joe Biden’s Covid-19 response coordinator, Jeff Zients, said Wednesday during a White House briefing on the plan, which stresses the use of supporting school-based vaccine clinics. The U.S. has ordered enough supply to vaccinate all kids 5 to 11, the White House said in a statement Wednesday. The vaccination campaign for kids would differ from the one targeting adults and children 12 and older in that it will enlist pediatricians to work with parents, rather than utilizing mass inoculation sites. The vials and needles used to administer doses also will be smaller, the White House said. The shots will be available at more than 25,000 doctors’ offices and primary care sites, as well as children’s hospitals and pharmacies. “The administration will work with states and local partners to make vaccination sites available at schools and other trusted community-based sites across the country,” according to the White House statement. The doses, which are one-third the strength of the regular dose given to those 12 and up, will be shipped in smaller configurations more easily stored at a typical pediatrician’s office, the White House said. It will be possible to store them for up to 10 weeks at standard refrigeration temperatures and 6 months at ultra-cold temperatures. The Department of Health and Human Services will also launch an education campaign about the kids’ vaccine. Pfizer Inc. and BioNTech SE have submitted data to the Food and Drug Administration ahead of an advisory panel meeting set for Oct. 26 that could help pave the way for kids ages 5 to 11 could get a COVID-19 vaccine as soon as the first week in November. Vaccinating kids could could provide a boost both to Biden’s political fortunes and and public-health goals. Reaching children younger than age 12 would be a crucial step toward ending the pandemic, insulating them from the worst risks of COVID and further shrinking the pool of Americans vulnerable to spreading the virus. Public approval of Biden’s handling of the pandemic, and other issues including Afghanistan and his economic agenda, has been falling. Many parents, including the suburban voters Democrats need to keep control of Congress in the 2022 midterm elections, are eagerly anticipating a vaccine for children. It could also help working parents return to their offices and boost the travel sector with more families finally able to be fully inoculated. from https://ift.tt/3jkyHjj Check out https://takiaisfobia.blogspot.com/ Scientists temporarily attached a pig’s kidney to a human body and watched it begin to work, a small step in the decades-long quest to one day use animal organs for life-saving transplants. Pigs have been the most recent research focus to address the organ shortage, but among the hurdles: A sugar in pig cells, foreign to the human body, causes immediate organ rejection. The kidney for this experiment came from a gene-edited animal, engineered to eliminate that sugar and avoid an immune system attack. Surgeons attached the pig kidney to a pair of large blood vessels outside the body of a deceased recipient so they could observe it for two days. The kidney did what it was supposed to do—filter waste and produce urine—and didn’t trigger rejection. “It had absolutely normal function,” said Dr. Robert Montgomery, who led the surgical team last month at NYU Langone Health. “It didn’t have this immediate rejection that we have worried about.” This research is “a significant step,” said Dr. Andrew Adams of the University of Minnesota Medical School, who was not part of the work. It will reassure patients, researchers and regulators “that we’re moving in the right direction.” The dream of animal-to-human transplants—or xenotransplantation—goes back to the 17th century with stumbling attempts to use animal blood for transfusions. By the 20th century, surgeons were attempting transplants of organs from baboons into humans, notably Baby Fae, a dying infant, who lived 21 days with a baboon heart. Read more: Scientists Report Creating the First Embryo With Human and Non-Human Primate Cells With no lasting success and much public uproar, scientists turned from primates to pigs, tinkering with their genes to bridge the species gap. Pigs have advantages over monkeys and apes. They are produced for food, so using them for organs raises fewer ethical concerns. Pigs have large litters, short gestation periods and organs comparable to humans. Pig heart valves also have been used successfully for decades in humans. The blood thinner heparin is derived from pig intestines. Pig skin grafts are used on burns and Chinese surgeons have used pig corneas to restore sight. In the NYU case, researchers kept a deceased woman’s body going on a ventilator after her family agreed to the experiment. The woman had wished to donate her organs, but they weren’t suitable for traditional donation. The family felt “there was a possibility that some good could come from this gift,” Montgomery said. Montgomery himself received a transplant three years ago, a human heart from a donor with hepatitis C because he was willing to take any organ. “I was one of those people lying in an ICU waiting and not knowing whether an organ was going to come in time,” he said. Several biotech companies are in the running to develop suitable pig organs for transplant to help ease the human organ shortage. More than 90,000 people in the U.S. are in line for a kidney transplant. Every day, 12 die while waiting. The advance is a win for Revivicor, a subsidiary of United Therapeutics, the company that engineered the pig and its cousins, a herd of 100 raised in tightly controlled conditions at a facility in Iowa. The pigs lack a gene that produces alpha-gal, the sugar that provokes an immediate attack from the human immune system. Read more: The Gene-Editing Revolution Is Already Here In December, the Food and Drug Administration approved the gene alteration in the Revivicor pigs as safe for human food consumption and medicine. But the FDA said developers would need to submit more paperwork before pig organs could be transplanted into living humans. “This is an important step forward in realizing the promise of xenotransplantation, which will save thousands of lives each year in the not-too-distant future,” said United Therapeutics CEO Martine Rothblatt in a statement. Experts say tests on nonhuman primates and last month’s experiment with a human body pave the way for the first experimental pig kidney or heart transplants in living people in the next several years. Raising pigs to be organ donors feels wrong to some people, but it may grow more acceptable if concerns about animal welfare can be addressed, said Karen Maschke, a research scholar at the Hastings Center, who will help develop ethics and policy recommendations for the first clinical trials under a grant from the National Institutes of Health. “The other issue is going to be: Should we be doing this just because we can?” Maschke said. 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. from https://ift.tt/3BYDUF2 Check out https://takiaisfobia.blogspot.com/ |
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