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The way doctors treat asthma in both children and adults just got a major update.Speaking to the Journal of the American Medical Association, respiratory experts said the changes in guidelines focus on six key areas, including improving asthma diagnosis, management, and treatment.It’s the first published update in 13 years.“So, one of the goals of our update was to address the issue of who can use intermittent inhaled corticosteroids and when used, are they as effective as daily use,” said Michelle M. Cloutier, MD with UConn Health.One of the biggest changes is that many patients may not need to use an inhaler every day anymore.“Especially those families of young children who don’t necessarily buy into using daily medication when their children are having intermittent symptoms,” said Stephanie Lovinsky-Desir, MD, MS with Columbia University Irving Medical Center.The new recommendations for inhaler use vary by age and severity of asthma, so it’s important to talk to your doctor about the new guidelines.Asthma affects nearly 5% of adults and 10% of children.During the pandemic, because of the higher death rate of asthma patients from COVID-19, more people have been seeking treatment for the condition.The average annual cost of asthma per person is more than ,200. But research has also shown among other things, regular use of medication and flu vaccines can reduce the chances of someone with asthma being hospitalized, driving up those costs. 1472
The U.S. recorded more than 120,000 new cases of COVID-19 on Thursday as cases continue to skyrocket across the country.According to Johns Hopkins University, there were 121,888 new cases of COVID-19 recorded across the country on Thursday. That shatters the previous record of 102,000 cases that were reported on Wednesday.Johns Hopkins reports that more than 1,200 people died of the virus in the U.S. on Thursday, the highest death total since Sept. 15. The highest daily death total throughout the pandemic occurred on April 15, when 2,600 people died.According to Johns Hopkins, COVID-19 is currently spreading faster in the U.S. than it is anywhere else in the world. The U.S. has recorded an average of about 80,000 new cases of COVID-19 in the last seven days; the country with the second-highest rate of new cases is India, with an average of about 45,000 new cases of the virus each day.Health officials warn that the U.S. is entering what could be the most dangerous and deadly period of the pandemic, as colder weather forces social gatherings indoors, where the virus is more easily spread.Since the start of the pandemic, there have been 9,606,369 cases reported in the US, 234,911 being fatal. Both totals mark the most of any country. 1258

The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___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. 6274
The skies started darkening over Lake Charles, Louisiana, on Wednesday, as Hurricane Laura trekked toward the state.People planning to hunker down at home raced to a local home supply store.“My wife didn't want to travel this time,” said resident Robert Deboest. “So, we decided to go head on and kind of stick it out.”That includes Adam Johnson, who was busy buying plywood to cover the windows of his home.“It was like a sheet,” he said.Johnson moved to the Lake Charles area several years ago from Colorado. Laura will be the first hurricane he experiences.“[The] duplex I live in was built in 2015, so it should be pretty secure,” Johnson said.Others, though, feel far less secure.“I was going to stay because I didn’t have nowhere to go,” said resident Yvonne Lancto.However, local officials made arrangements at the Burton Coliseum Complex in Lake Charles for anyone wanting to evacuate, with the National Guard and dozens of buses ready to carry evacuees out of the danger zone and to shelter.Just a few days before her 77th birthday, Lancto chose to flee the storm.“I feel more safer now (sic),” she said, shortly before boarding a bus, “Because I was gonna have to drive - I was scared.”What is scaring a lot of people in Lake Charles is not just the potential for Category 4 winds from Hurricane Laura, but massive storm surge, especially along the coast – which can easily swamp the first floor of a building.Paul and Wanda Bertrand said that is why they are getting out of their home in coastal Cameron Parish.“I’m ready to get back you know,” Paul Bertrand said. “I just left and I’m ready to get back already.”His wife, Wanda, said their lives were far more important and hopes that evacuating will only be temporary.“Hopefully, this will be over soon,” she said, “and we can get back home and everything will be like it was normal.”It’s a normalcy that Hurricane Laura will put to the test. 1917
The White House announced Friday that President Donald Trump intends to appoint Mehmet Oz, better known as Dr. Oz, to his council on sport, fitness and nutrition.Oz is well-known as a host of an eponymous television show on health and medical issues and, before that, for appearances on "The Oprah Winfey Show." But he has become a lightning rod for controversy for featuring what critics say is unscientific advice on his show.In 2015, a group of doctors criticized him harshly, saying he manifested "an egregious lack of integrity" in his TV and promotional work and called his faculty position at Columbia University unacceptable.Oz defended himself in a written statement at the time, saying, "I bring the public information that will help them on their path to be their best selves. We provide multiple points of view, including mine which is offered without conflict of interest."The-CNN-Wire 906
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